Proper Patient Positioning Guidelines: Lithotomy Position

• 
  Home








• 
  Proper Patient Positioning Guidelines: Lithotomy Position

June 21, 2018

The supine position is the most commonly used position in surgery and has many variants; one such variant is the lithotomy position. The patient is placed on their back and legs are elevated at their hips. It is primarily used for procedures involving the perineum, pelvic organs, rectum, and genitalia.¹ If the nursing assessment indicates limited range of hip motion due to arthritis, prosthesis, contractures or other conditions, patients may be placed into the position while awake so that they can participate in ensuring their comfort.

The head is supported by a patient positioning headrest like the AliGel Head Positioner or Single-Use Head Donuts. Ensuring the head and spine are aligned and the neck is in a neutral position. The patient’s arms are secured, using a strap such as AliMed Soft Precut Patient Positioning Straps, on padded arm boards to prevent crushing fingers and hands. The arm boards should be positioned at no more than 90 degrees, AliMed’s pivoting Armboard allows for incremental adjustments and to secure the board firmly in place. The legs are elevated, abducted, and supported in stirrups, such as the Ultrafin Stirrups, with the buttocks even with the lower break of the table. During elevation, the feet are held in one hand and the lower part of the leg in the other while the legs are slowly flexed. To prevent hip dislocation or muscle strain from the exaggerated range of motion, the legs should be raised and lowered slowly and simultaneously. At-risk pressure points vary depending upon the type of stirrups used, so perioperative nurses should pay particular attention to the femoral epicondyle, tibial condyles, and lateral and medial malleoli. The inner thighs and sacrum should be free of pressure, which should be accomplished via sufficient padding¹, the Azure Sacral Pad is designed to relieve pressure on the sacrum. Correct placement of the safety strap is difficult in the lithotomy position. There is not a best practice for its placement; however, the safety restraint should not be placed over the patient’s chest or abdomen.

Modifications of the lithotomy position include low, standard, high, hemi, and exaggerated as dictated by how high the lower body is elevated for the procedure.¹

• Low: The patient’s hips are flexed until the angle between the posterior surface of the patient’s thighs and the O.R. bed surface is 40 degrees to 60 degrees. The patient’s lower legs are parallel with the O.R. bed.²
• Standard: The patient’s hips are flexed until the angle between the posterior surface of the patient’s thighs and the O.R. bed surface is 80 degrees to 100 degrees. The patient’s lower legs are parallel with the O.R. bed.
• Hemi: The patient’s non-operative leg is positioned in standard lithotomy. The patient’s operative leg may be placed in traction.
• High: The patient’s hips are flexed until the angle between the posterior surface of the patient’s thighs and the O.R. bed surface is 110 degrees to 120 degrees. The patient’s lower legs are flexed.
• Exaggerated: The patient’s hips are flexed until the angle between the posterior surface of the patient’s thighs and the O.R. bed surface is 130 degrees to 150 degrees. The patient’s lower legs are almost vertical.

Following the procedure, the lower portion of the table is raided or replaced to align with the rest of the O.R. table. The patient’s legs are removed from the stirrups simultaneously, extended fully to prevent abduction of the hips and slowly lowered onto the table and the table strap, like the VeriClean Patient Safety Strap, is applied for safety.

References

1. Burlingame B, Davidson J, Denholm B, et al. Guideline for positioning the patient. Guidelines for Perioperative Practice. 2017;1. DOI: 10.6015/psrp.17.01.e1.
2. Rowen L, Hunt D, Johnson KL. Managing obese patients in the OR. OR Nurse. 2012; 6(2):26-36.

Lithotomy Position – an overview

Injuries Resulting From Lithotomy Position

Standard lithotomy position requires the patients’ legs to be separated from the midline into 30 to 45 degrees of abduction, with the hips flexed until the thighs are angled between 80 and 100 degrees. The patient’s legs are placed into stirrups, with the knees bent such that the lower legs are parallel to the plane of the torso.¹⁰⁰ The lithotomy position is used for a variety of open and endoscopic urologic procedures. Therefore, an understanding of potential postoperative complications related to this position is essential to the care of these patients. In addition to neurologic complications, which are discussed here, other complications that have been reported after procedures in the lithotomy position include lower extremity compartment syndrome, venous thrombosis, and rhabdomyolysis.^101,102 The frequency of perioperative complications may increase with an exaggerated or “high” lithotomy position because the angle of the hips and lower extremities in this position is even more pronounced.¹⁰³

Neurologic injuries related to the lithotomy position may affect the femoral, sciatic, and common peroneal nerves. One series found that the most common lower extremity neuropathies associated with procedures in the lithotomy position were common peroneal (81%), sciatic (15%), and femoral (4%).¹⁰⁴ Other, less commonly injured nerves include the obturator and femoral cutaneous nerves. A study of 1170 patients operated on in the lithotomy position found postoperative neurapraxic complications in 1% of patients.¹⁰³ Age >70 years, operative time >180 minutes, and improper positioning were cited as risk factors for neurologic injury.¹⁰³ These findings were supported by a separate investigation, which noted lower extremity neuropathies in 1.5% of 991 patients undergoing procedures in the lithotomy position and found that prolonged (>2 hours) positioning in the lithotomy position was a risk factor for injury.¹⁰⁵ A previous study reported postoperative neurapraxia in 21% of patients undergoing perineal prostatectomy using the exaggerated lithotomy position.¹⁰⁶

Positioning-related nerve injuries in the lithotomy position have been attributed to overflexion of the hips and knees, which causes stretching and compression of the nerves. For example, hyperabduction of the thighs with external rotation of the hips may lead to injury of the femoral nerve secondary to ischemia from compression of the nerve beneath the inguinal ligament. Presentation, management, and prevention of femoral nerve injuries have been discussed. The sciatic nerve, meanwhile, is the largest nerve in the body and arises from the fourth lumbar through the third sacral nerve roots of the lumbosacral plexus.

The sciatic nerve then exits the pelvis through the sciatic foramen and travels through the thigh before dividing in the popliteal fossa into the common peroneal and tibial nerves. The sciatic nerve functions to provide cutaneous innervation to the foot and leg, as well as motor innervation of the biceps femoris (hamstring muscle), leg, and foot.¹⁰⁷

Excessive stretching of the sciatic nerve by overflexion of the hip and extension of the knee during establishment of the lithotomy position or by shifting of the patient during the procedure may result in injury. In particular, investigators have suggested that excessive hip flexion in the lithotomy position may compress the nerve as it passes through the sciatic notch, thus potentially resulting in ischemic neuropathy.^108,109 The potential sequelae of sciatic depend on the location of the insult along the course of the nerve. Injury to the thigh portion of the sciatic nerve, for example, results in difficulties with flexion of the leg, whereas disruption of the tibial nerve abolishes the ankle jerk reflex.

The common peroneal nerve, meanwhile, arises from the sciatic nerve behind the knee and then wraps around the head of the fibula before separating into the superficial peroneal, which provides sensory innervation to the lateral leg, and the deep peroneal, which provides motor innervation to the tibialis anterior that allows dorsiflexion of the foot. Because this nerve is very superficial when it crosses the head of the fibula, it may easily be compressed and injured at this point (i.e., by direct contact of the leg against an immobile, hard support). Therefore, padding the lateral leg supports during positioning for lithotomy procedures is recommended. Injury to the peroneal nerve most commonly manifests as foot drop, resulting from an inability to dorsiflex the foot. In addition, patients may experience numbness of the lateral aspect of the lower leg and dorsum of the foot.¹⁰⁹

Overall, nerve injuries during procedures in the lithotomy position may be minimized by careful attention to proper patient positioning, including padding of exposed peripheral nerves, avoiding unnecessary tension on the hips and knees by checking to see that the muscles of the lower extremity are not taut after the lithotomy position is established, and minimizing operative times. Modifications in stirrup design have also been proposed to help minimize the complications of lithotomy positioning.¹¹⁰

Patient Positioning: Sims Position, Fowler’s Position

THE IMPORTANCE OF PATIENT POSITIONING

Patient positioning is vital to a safe and effective surgical procedure. Proper patient positioning depends on the type and length of procedure, anesthesia access to the patient, devices required and other factors. Safely positioning the patient is a team effort. All members of the surgical team play a significant role in the process and share responsibility for establishing and maintaining the correct patient positions.^1,2

The goals of proper patient positioning include:

• Maintain the patient’s airway and circulation throughout the procedure
• Prevent nerve damage
• Allow surgeon accessibility to the surgical site as well as for anesthetic administration
• Provide comfort and safety to the patient
• Prevent soft tissue or musculoskeletal and other patient injury

Patient Positioning Guidelines

Following standard patient positioning guidelines and practices helps to ensure patient safety and physical well-being before, during and after a procedure. A sufficient number of personnel should always be available during a patient procedure to position the patient safely and effectively. General positioning practices include having an adequate number of personnel, devices, and equipment available during a procedure to ensure patient and staff safety. The patient should be maintained in a neutral alignment, without extreme lateral rotation or hyperextension.

Ensure that pressure is not concentrated on one point in order to avoid pressure injuries. Pressure ulcers, localized injuries to skin or underlying tissue, can occur because of pressure or pressure in combination with shear and/or friction. A sedated or anesthetized patient is not always able to communicate physical feeling such as numbness, tingling, tissue temperature, and other issues.²

Patient Positioning Risk Factors

Various factors play a role in risk during a patient procedure as a result of positioning. Intrinsic and extrinsic factors can interact to contribute to the risk of developing pressure sores. Extrinsic factors may include pressure intensity and duration and overall effects of anesthesia. Intrinsic factors can include the overall health of the patient, and preexisting conditions such as respiratory or circulatory disorders, diabetes mellitus, anemia, malnutrition, advanced age, and body size.³ Additionally, the musculoskeletal system of the patient may be subjected to stress during patient positioning. When anesthetics and muscle relaxants depress pain, pressure receptors and muscle tone, the normal defense mechanisms cannot guard against joint damage or muscle stretch and strain. One of the main goals of proper patient positioning is to keep the patient’s body as naturally aligned as possible while providing the surgical staff access to the surgical site, and quick, jerky movements should be avoided.³

Common Patient Positions

High Fowler’s Position

In High Fowler’s position, the patient is usually seated (Fowler’s position) at the head end of the operating table. The upper half of the patient’s body is between 60 degrees and 90 degrees in relation to the lower half of their body. The legs of the patient may be straight or bent.

Jackknife Position

Jackknife position, also known as Kraske, is similar to Knee-Chest or Kneeling positions and is often used for colorectal surgeries. This position places extreme pressure on the knees. While positioning, surgical staff should place extra padding for the knee area.

Kidney Position

The kidney position resembles lateral position, except the patient’s abdomen is placed over a lift in the operating table that bends the body to allow access to the retroperitoneal space. A kidney rest is placed under the patient at the location of the lift.

Trendelenburg Position

Trendelenburg position is typically used for lower abdominal, colorectal, gynecology, and genitourinary surgeries, cardioversion, and central venous catheter placement. In this position, the patient’s arms should be tucked at their sides, and the patient must be secured to avoid sliding on the surgical table. The Trendelenburg position should be avoided for extremely obese patients. Risks to a patient while in this position include diminished lung capacity, diminished tidal volume and pulmonary compliance, venous pooling toward the patient’s head, and sliding and shearing.^2,3

Reverse Trendelenburg Position

Reverse Trendelenburg position is typically used for laparoscopic, gallbladder, stomach, prostrate, gynecology, bariatric and head and neck surgeries. Risks to a patient in this position include deep vein thrombosis, sliding and shearing, perineal nerve, and tibial nerve. Padded foot boards should be used to prevent the patient from sliding on the surgical table and reduce the potential for injury to the peroneal and tibial nerves from foot or ankle flexion.^2,3

Explore our Surgical Tables

PATIENT POSITIONING BY SURGICAL PROCEDURE

Positioning for Cardiovascular Procedures

The most common position used for cardiovascular procedures is the supine position. This position allows the best possible surgical access to the chest cavity. For coronary artery bypass grafting (CABG), the anterior thorax is exposed with the patient in a supine position. A roll is placed in the interscapular region to improve access to the sternum by extending the neck and elevating the sternal notch.

Positioning for Femoral-Popliteal Procedures

The supine position is used for Femoropopliteal (Fem/Pop) bypass surgery. Fem-pop is used to bypass narrowed or blocked arteries above or below the knee. The bypass restores blood flow to the leg. Typically, surgical table accessories such as the FEM POP Board will attach to the surgical table to increase lower body, intraoperative, fluoroscopic imaging coverage during the procedure.

Positioning for Cystoscopy/Urology/GYN Procedures

Variations of the lithotomy position are most commonly used in cystoscopy, urology or gynecology procedures. Surgical table accessories such as stirrups, split-leg positioners and well leg-holders are commonly used to support patient legs during procedures.

Positioning for Ophthalmic/ENT Procedures

The supine position with an additional headrest accessory, is most used for ophthalmic/ENT procedures. When the procedure is performed using a STERIS Surgical Table, a specialized adaptor accommodates standard Neuro and Eye-ENT-Neuro accessory attachments with cylindrical post attachments that are midline to the table.

Positioning for Bariatric/Split Leg Procedures

The lithotomy position in reverse Trendelenburg is most commonly used for bariatric/split leg procedures. Split Leg Positioners provide mid-line access to the patient with independent controls for full abduction/adduction as well as high and low lithotomy positioning.

Positioning for Kidney & Thoracic Procedures

A variation of lateral position with kidney elevation (flexion) is most commonly used for kidney and thoracic procedures. Lateral positioners, arm boards, headrests and restraint straps are used to safely position the patient for this procedure.

Positioning for Orthopedic Procedures

A variety of positions may be used for orthopedic procedures depending on the specific type of procedure. Common positions include supine with additional attachments for traction of lower extremities. Such procedures include hip arthroscopies and anterior hip replacements. Other common orthopedic procedures utilize Fowler’s position (beach chair) for shoulder arthroscopy procedures.

Positioning for Shoulder Chair Procedures

Fowler’s position is commonly used for shoulder arthroscopy procedures. Surgical tables may be articulated to place patients in a seated position or shoulder chair (beach chair) accessories may be used as an alternative. The patient is placed supine on the operating table and general endotracheal anesthesia is induced. The endotracheal tube should be taped to the contralateral side of the mouth to assure easy airway access during the procedure if needed. After induction, protective foam face masks and/or head restraints are used for ocular protection during the procedure. The patient is moved into the upright beach chair position in conjunction with the anesthesia staff to ensure that the patient does not become hypotensive during this positioning maneuver.

Explore our Surgical Table Accessories

References

^{1 Phillips, N. F. (2004). Berry & Kohn’s operating room technique (10th ed.). St. Louis, MO: Mosby; St-Arnaud, D., & Paquin, M. (2008). Safe Positioning for Neurosurgical Patients. AORN Journal, 87 (6), 1156-1172. doi:10.1016/j.aorn.2008.03.004}

^{2 Guideline for positioning the patient. (2017). AORN Journal, 105 (4), P8-P10. doi:10.1016/s0001-2092(17)30237-5}

^{3 Rothrock, J. C. (2011). Alexander’s care of the patient in surgery (14th ed.). St. Louis, MO: Mosby.}

^{4 Patient positioning during anesthesia: Supine position. (2016, December 20). Retrieved from http://www.clinicalpainadvisor.com/anesthesiology/patient-positioning-during-anesthesia-supine-position/article/582929}

Patient Positioning (Sims, Orthopneic, Dorsal Recumbent) Guide [2020]

Lithotomy Positioning

The lithotomy position is a commonly used position in urologic, gynecologic and proctologic examinations and procedures, but is most well-known because of its widespread adoption in obstetrics. The name of the position goes back to its original use to visualize the perineal area in order to make incisions in this region to gain access for bladder stone extraction.

Patient positioning 5 – Lithotomy positionPlay

Technique and Indications

The lithotomy position has the patient lying on the dorsum with the knees, as well as the hips flexed at 90 degrees. The hips are also abducted to about 30 degrees, while the calves are supported on appropriately padded leg supports. This provides excellent surgical access to the perineum.

Indications for the lithotomy position are presented briefly below:

• Pelvic examination
• Urologic examination of the prostate
• Transurethral or perineal resection of the bladder or prostate
• Female incontinence procedures
• Ureteroscopy
• Male urethral surgery

Nerve Complications

Care should be taken to pad all points of contact between the lower limbs and the limb holders. Again, it is essential to avoid extreme flexion and abduction of the hip joint, and to minimize the time in which the limbs are required to be held in this position. It may produce stretching and compression of the nerves.

Injuries following the overuse of this position may include femoral nerve injury, peroneal nerve injury and compartment syndrome of the leg. The latter injury is characterized by a massive rise in intracompartment pressure within the leg, leading to compromised perfusion and damage to the nerves and muscles of the leg.

Obstetric Complications

There has been recent light on the adverse events associated with the use of the lithotomy position. These include:

• Restricted maternal movement during labor and delivery
• Increased trauma to the perineum and cervix
• Increased intrapartum discomfort
• Slower progress of labor and more painful contractions
• Increased need for medical intervention during all stages of labor – including labor augmentation, forceps delivery and cesarean section
• Emotional and physical trauma to the mother
• Aortocaval compression and fetal acidosis
• Neonatal respiratory distress and low Apgar scores (newborn status assessment)
• Increased rates of neonatal intensive care

Contraindications

In some conditions it is not advisable to adopt the lithotomy position, such as if there is an injury which prevents proper flexion or abduction of the hip joint. In obstetrical practice, particularly, recent research has focused on the risk-benefit ratio of this position, with special focus on the maternal and fetal outcomes.

It is, therefore, worth considering the abandonment of this position in the labor suite in favor of a more upright position. This may require physician and patient education as to the benefits of alternative birthing positions. Even with no special equipment, it is possible to adopt semi-upright positions for delivery, while the woman can remain upright throughout the first and early second stages of labor.

References

Further Reading

Anatomy, Patient Positioning – StatPearls

Introduction

Appropriate patient position can facilitate proper physiologic function during pathophysiologic processes and also facilitate access to certain anatomical locations during surgical procedures. Multiple factors should be considered when choosing the patient’s position. These factors include patient age, weight, and size as well as past medical history, including respiratory or circulatory disorders.

Structure and Function

The most common patient positions with common indications and concerns include the following.[1][2][3][4]

Supine Position

This is the most common position for surgery with a patient lying on his or her back with head, neck, and spine in neutral positioning and arms either adducted alongside the patient or abducted to less than 90 degrees.

• Arm abduction maintained less than 90 degrees prevents undue pressure of the humerus on the axilla, thereby preventing brachial plexus injury.

• Arm adduction with hands and forearms maintained in neutral position with palms facing the body or supinated decreases external pressure on the ulnar nerve and prevents injury. A “draw sheet” that passes under the body and over the arm before tucking under the torso can hold the arm in proper position against the body.

Supine Position Variations

Lawnchair position: A variation of supine in which the hips and knees are slightly flexed and above the level of the heart relieves pressure on the back, hips, and knees and facilitates venous drainage from the lower extremities, and reduces tension on the abdominal musculature

Frog-leg position: A variation of supine in which the hips and knees are flexed, and the hips are externally rotated facilitates access to the perineum, groin, rectum, and inner thigh, but the knees must be supported to avoid stress and dislocation of the hips.

Trendelenburg position: A variation of supine in which the head of the bed is tilted down such that the pubic symphysis is the highest point of the trunk facilitates venous return and improves exposure during abdominal and laparoscopic surgeries

• Hemodynamic changes, including increased venous return and cardiac output, are temporary, with most hemodynamic variables returning to baseline within ten minutes.

• Respiratory changes, including upward displacement of the abdominal contents into the diaphragm, decrease functional residual capacity and respiratory compliance, therefore, requiring higher airway pressures to maintain ventilation.

• Gravitational changes from prolonged head-down positioning can result in increased intracranial pressure, increased intraocular pressure, swelling of the face, larynx, and tongue, increasing the risk for postoperative airway obstruction.

• Sliding and shifting of a patient in Trendelenburg positioning are often prevented with shoulder braces. However, caution must be used to prevent undue pressure, potentially resulting in compression or stretch injury to the brachial plexus.

Reverse Trendelenburg position: A variation of supine in which the head of the bed is tilted upward such that the head is the highest point of the trunk facilitates upper abdominal surgery

• Hemodynamic changes include decreased venous return and can result in hypotension.

• Gravitational changes in concert with hemodynamic changes can result in decreased cerebral perfusion, and invasive arterial monitoring should be considered.

• Sliding and shifting a patient in reverse Trendelenburg positioning can increase pressure over the posterior calcaneus.

Lithotomy Position

Commonly used during gynecologic, rectal, and urologic surgeries with a patient lying supine with legs abducted 30 to 45 degrees from midline with knees flexed and legs held supported with the foot of the bed lowered or removed to facilitate the procedure.

• Legs are raised and lowered in concert with one another to prevent spinal torsion and muscular injury; prolonged procedure time increases the risk for lower extremity compartment syndrome secondary to inadequate perfusion; recommendations include periodically lowering the extremities throughout prolonged procedures.

• Lower extremity padding prevents nerve compression against leg supports; common peroneal nerve injury is most common as the peroneal nerve wraps around the head of the fibula, which rests against leg supports

• Hemodynamic changes include the increased venous return and transient increases in preload and cardiac output.

• Respiratory changes result from cephalad displacement of abdominal contents resulting in decreased lung compliance, functional residual capacity, and tidal volume.

Lateral Decubitus Position

Commonly used during surgery requiring access to the thorax, retroperitoneum, or hip with a patient lying on the nonoperative side and careful positioning of the extremities.

• The lower extremities are carefully padded between the knees and below the dependent knee to avoid excessive external pressure over bony prominences. The dependent lower extremity is somewhat flexed to avoid stretch or compression of the lower extremity nerves.

• Upper extremities are placed in front of the patient with neither arm abducted more than 90 degrees to prevent brachial plexus injury; an axillary roll should be placed below the axilla to prevent compression of the brachial plexus and axillary vascular structures.

• The dependent upper extremity is flexed at the shoulder and slightly flexed at the elbow and secured on a padded arm board with padding under bony prominences; invasive arterial monitoring should be placed in the dependent arm to better detect compression of the axillary vascular structures.

• The non-dependent upper extremity is flexed at the shoulder and slightly flexed at the elbow and often secured with a suspended armrest with care not to abduct the arm more than 90 degrees and to pad the bony prominences.

• The head and neck are maintained in a neutral position to prevent lateral rotation and stretch injury to the brachial plexus; care must be given to avoid folding or rolling the dependent ear or undue external pressure on the dependent eye.

• Respiratory changes from the lateral weight of the mediastinum and cephalad displacement of abdominal contents result in decreased pulmonary compliance, and lateral decubitus positioning favors ventilation of the nondependent lung.

Prone Position

Commonly used during surgery requiring access to the posterior fossa of the skull, posterior spine, buttocks or perirectal area, or lower extremities with the patient lying on his or her front with head, neck, and spine maintained in a neutral position; the patient is turned from supine to prone while maintaining the neutral position of the head, neck, and spine.

• The risk of dislodgement of monitors and tubes can be minimized by disconnecting as many monitors, lines, and catheters as possible before turning the patient; temporary disconnection of the ventilator from the endotracheal tube prevents dislodgement.

• Many commercially available headrests and pillows are designed to support the forehead and malar regions with openings for the eyes, nose, and chin, preventing external pressure on these structures; special caution must be taken to avoid undue pressure on the eyes as perioperative vision loss is an avoidable complication of the prone position.

• Respiratory changes result in alveolar recruitment and increased oxygenation without affecting cardiac output and, therefore, is a useful maneuver in severely hypoxemic patients in early acute respiratory distress syndrome (ARDS)

Fowler’s Position

This is the most common position for patient resting comfortably, whether inpatient or in the emergency department, with knees either straight or slightly bent and the head of the bed between 45 and 60 degrees.

• Respiratory changes result in increased oxygenation by maximizing chest expansion, minimizing abdominal muscular tension, and minimizing the effects of gravity on the chest wall; therefore, a useful maneuver for patients in mild to moderate respiratory distress.

• High Fowler’s position with the head of the bed between 60 and 90 degrees is useful during placement of orogastric and nasogastric tubes as it decreases the risk of aspiration

Blood Supply and Lymphatics

Lower extremity compartment syndrome is a rare but serious complication of the lithotomy position resulting from inadequate perfusion of the lower extremity. The resulting tissue ischemia, edema, and muscle breakdown increase facial compartmental pressure. Recommendations include periodically lowering the legs of patients in lithotomy position during prolonged procedures to promote perfusion.

Nerves

Nerves are most commonly injured during surgical procedures secondary to external compression or stretch. The most commonly injured nerve is the ulnar nerve from malpositioning of the upper extremity in the supine position. Ensure that the arm is supinated or in the neutral position to avoid ulnar nerve compression and abducted no more than 90 degrees from the body to prevent stretch injury to the brachial plexus.[5][6][7][8]

Lower extremity nerve injuries are less common, though precautions can still be taken. Common peroneal nerve compression can result from direct compression over the fibular head in the lithotomy position; ensure proper padding between bony prominences and supports. Sciatic nerve stretch can result from flexion at the hip in the lithotomy position; take care when positioning the patient to move the lower extremities in concert with one another and prevent hyperflexion at the hip.[9][10]

Muscles

Muscle strain is a less common side effect of patient positioning but can result from the patient’s inability to react to the movement of the extremities. Take care, especially with the lower extremities, to move simultaneously to avoid muscle and joint injury.

Surgical Considerations

A significant consideration for patient positioning, especially during prolonged surgical procedures, is compression and damage to underlying nervous and vascular structures. Common surgical positions and frequently associated complications can be found above. Providers should ensure that all bony prominences, as well as foreign bodies held against the patient, are appropriately padded to avoid undue pressure on the skin and soft tissues.

Clinical Significance

Proper positioning of the patient can facilitate access to anatomical locations during surgical procedures and promote appropriate physiologic function during pathologic states, for example, the Trendelenburg position to increase the venous return in a hypovolemic patient. Care to position the patient properly both facilitates procedural aims and aids in preventing subsequent complications.

The dangers of lithotomy positioning in the operating room: case report of bilateral lower extremity compartment syndrome after a 90-minutes surgical procedure | Patient Safety in Surgery

A 23-year-old woman, gravida 1, para 0, at unknown gestational age presented to our emergency department with lower abdominal pain, vaginal spotting, and lightheadedness for 2 days. The patient’s medical history was significant for morbid obesity with body mass index, history of Chlamydia infection and pelvic inflammatory disease at age 15, and laparoscopic cholecystectomy at age 19. Physical examination including a transvaginal ultrasonographic evaluation revealed a ruptured ectopic pregnancy. The patient was hemodynamically stable and underwent a laparoscopic right salpingectomy. The procedure was performed in a standard “low” lithotomy position (using Allen® stirrups). Care was taken not to flex hips or knees beyond 90°, with hip abduction less than 45° and neutral hip rotation (Fig. 1). The patient was in Trendelenburg position to allow for adequate visualization of the pelvis. Pneumatic compression devices on both calves were in place throughout the procedure. Skin-to-skin surgical time was 90 min due to the need for lysis of omental adhesion and the presence of pelvic adhesive disease consistent with the patient’s prior surgical and gynecologic history. Intraoperative findings and pathologic evaluation confirmed the diagnosis of a ruptured ectopic pregnancy. Immediately upon awakening from general anesthesia, the patient complained of severe bilateral calf pain. Initial evaluation of the lower extremities revealed no compression marks, ecchymoses, erythema or edema, and the peripheral neurovascular exam was unremarkable. Serum electrolytes were within normal limits. Serum creatine kinase (CK) was elevated at 22,760 units/L (Norm: 38–176 units/L), consistent with rhabdomyolysis. An urgent bilateral lower extremity Doppler ultrasound was obtained which ruled out a deep venous thrombosis. The patient was treated symptomatically with analgesics and muscle relaxants. As her pain continued to escalate, a concern for acute compartment syndrome (ACS) was raised and the orthopedic surgery service was consulted. Based on the high level of suspicion for ACS in light of the clinical exam and exacerbating pain out of proportion, the patient was taken back emergently to the operating room by the orthopedic surgery team for bilateral lower extremity four-compartment fasciotomies. Surgery was accomplished approximately 8 h after her initial laparoscopic surgery. Intraoperatively, the diagnosis of ACS was confirmed. All muscles in the four compartments in bilateral legs were viable on clinical exam and bovie stimulation testing, without any signs of muscle necrosis. The patient required two additional staged surgical procedures for scheduled 2nd looks, soft tissue debridement and delayed primary wound closures. Her serum CK decreased to 1278 units/L prior to discharge and she did not sustain any renal failure or crush syndrome throughout the hospitalisation. The patient’s serum creatinine remained in a normal range of 0.6–0.8 mg/dL (Norm: 0.5–1.0 mg/dL). She was discharged home on postoperative day four after definitive wound closure, with home physical therapy arranged. She had an uneventful further recovery, with pristine wound healing, no infection and a normal neurovascular status on bilateral lower extremities on follow-up exam. By 3 months after discharge from the hospital, she had regained full unrestricted function and a normal quality of life.

Fig. 1

Demonstration of lithotomy position technique applied at the authors’ institution

Discussion

We present a rare case of bilateral lower extremity acute compartment syndrome that developed in a healthy 23-year-old female after undergoing a laparoscopic salpingectomy for ruptured ectopic pregnancy in the usual lithotomy position. This case highlights a rare complication that has been previously associated with lithotomy or hemilithotomy positioning [2, 5, 12, 13]. Lower extremity ACS is a pathologic condition in which increased tissue pressure within a closed osseofascial space compromises blood circulation and normal function of tissues within the compartment leading to tissue hypoxia and necrosis [8, 14]. If left untreated, patients with ACS can develop muscle contracture, sensory deficits, paralysis, possible need for limb amputation, and potentially multi-system organ failure secondary to crush syndrome [15, 16]. The osseofascial lining of the four lower extremity compartments (anterior, lateral, superficial and deep posterior) form an enclosed environment of muscle, blood vessels and nerves with limited ability to expand or accommodate increased volume or pressure [8, 17]. ACS in the postoperative state occurs as a result of intraoperative compression with a prolonged decrease in arterial pressure and/or increase in venous pressure, followed by reperfusion [18]. Local ischemia can subsequently damage endothelial cells resulting in leakage of proteins and fluid into the interstitial space. The subsequent increase in interstitial pressure elevates compartmental pressures, thus perpetuating the cycle of hypoperfusion and tissue ischemia [19]. Specifically, in the lithotomy position, ischemia occurs from compressive forces of the external leg holsters and diminished blood flow from leg elevation and kinking of the popliteal artery, leading to ischemia/reperfusion injury with subsequent compartment syndrome [1]. When the lower extremities are taken out of lithotomy position and elevation, limb reperfusion occurs and can lead to injury with the formation of oxygen free radicals and cytokines that perpetuate endothelial damage and interstitial edema [20]. In addition to lithotomy position, other risk factors associated with ACS after surgery include: ankle dorsiflexion, Trendelenburg position, leg holders, length of surgery greater than 2 h, intraoperative hypotension or hypovolemia, and epidural analgesia [1]. Bauer and colleagues recently published two articles documenting cases of lower extremity ACS following gynecologic surgery in the lithotomy position and found that the vast majority of ACS cases occurred following procedures lasting longer than 4 h [4, 12]. Other studies have demonstrated that calf compartment pressure increases at a rate of 1.1 mmHg per hour in the lithotomy position [1]. In addition, elevation of the leg above heart level (“high” lithotomy positon) has been associated with increased risk of compartment syndrome [21]. Intermittent pneumatic compressive devices used for the prevention of deep venous thrombosis intraoperatively, as applied in the patient presented in this case report, have also been identified as causative factors for ACS [22]. We postulate that lithotomy with adjunctive Trendelenburg position was likely the contributory root cause of bilateral lower extremity ACS in the young 23-old patient described in this case report. Multiple technical tricks have been described to prevent ACS in lithotomy position, including intraoperative repositioning of the legs, avoiding pressure in the popliteal fossa and kinking of the popliteal artery by avoiding knee flexion beyond 90° [1, 23]. Lower extremity ACS remains a clinical diagnosis, and immediate recognition and surgical management are paramount in avoiding long-term impairment and poor outcomes [14]. The most common clinical symptom is represented by uncontrolled pain out of proportion and exacerbated pain by passive stretch of the toes and ankle joint [14]. Measurement of the compartment pressure can aid in the diagnosis, albeit there is dispute among orthopedic surgeons regarding the pressure threshold for the diagnosis of ACS and subsequent need for fasciotomy. The most effective method of diagnosis of ACS remains a clinical diagnosis requiring a high level of suspicion by the treating physician. Given the short duration of our patient’s procedure and lack of risk factors with the exception of lithotomy position and her full recovery after immediate recognition and surgical management, our case highlights the imperative of understanding the pathophysiology of ACS in lithotomy position and raising a high level of suspicion in a patient with postoperative calf pain after gynecological procedures.

Position on the operating table for various operations

How is the operating table used?

The operation of medical equipment depends on its design and technical characteristics. For example, some are designed for a wide variety of tasks, while others are tailored specifically for orthopedic sessions.

During the procedure, the patient is placed on a special tabletop. Its purpose is to keep the patient in place while the medical team is working, and can move different parts of the body with special accessories to facilitate access to the desired location.

Countless manipulations are performed on the operating tables. These include cardiovascular, gynecological, pediatric, orthopedic and pediatric surgeries. Due to the variety of surgical table types, weight and height restrictions are imposed to ensure patient safety.

What types of operating tables are there?

Consider three main categories: general purpose, orthopedic, and radiolucent for imaging.

General surgical tables

These devices are often called universal, as they are used for a wide range of tasks: cardiovascular, pediatric, gynecological and plastic interventions.Such installations do not have one specialization.

They can be adjusted in height and length, tilted to any side or horizontally. On most general operating tables, the head section is removable and can have a variety of attachable headrests.

Orthopedic surgical tables

The second type – orthopedic, is designed for easy manipulation and flexibility of movement. To successfully complete the work, surgeons need precise control and maneuverability in positioning a person.

Operating X-ray table

This view is intended for minimally invasive procedures that require fluoroscopy. Some of them can be endovascular, vascular, or pain relieving. Radio transparent equipment is ideal for processes that require clear, high quality images.

Consider general positions on the operating table

Surgery requires correct positioning of the patient in order for him to feel comfortable and safe during the operation.And also so that the surgeon has easy and unhindered access to the required place. Many factors influence the decision on how to position the patient:

1. General condition of the patient
2. Duration of surgery
3. Techniques to be used
4. Exposure at the surgical site
5. Expected anatomical and physiological changes associated with anesthesia

Except In addition, there are various conditions that can lead to the patient’s vulnerability or injury from misalignment, such as:

1. Duration (3 hours or more)
2. Condition of bones and joints
3. Skin destruction due to aging
4. Malnutrition, hypovolemia, anemia, paralysis, obesity, excessive thinness or diabetes

The most common patient positions are supine, Trendelenburg, reverse Trendelenburg, lithotomy, sitting and lateral positions.

Supine

This position is the natural resting position of the body, which makes it the most common posture. Hands should be carefully fixed in relation to the body, extended along or abducted on supports. The patient must be fixed.

Complications and their prevention:

1. Closure of the lower airways
2. Increases the likelihood of aspiration of gastric contents
3. Increased venous return to the heart and increased cardiac output
4. Injured brachial plexus
5. Injury of the ulnar nerve lining
6. Injury to the hairline

Trendelenburg

Trendelenburg Pose is a variation of the back position.The upper torso is lowered and the feet are raised for optimal visualization of the pelvic organs during laparoscopy and lower abdominal surgery.

Possible difficulties:

1. Increased venous, intracranial and intraocular pressure. May develop cerebral edema or retinal detachment
2. Possible venous congestion with cyanosis of the face and neck

Reverse Trendelenburg

Commonly known as head up and down, often used in head and neck processes.

Positive effects and exacerbations:

1. Positive physiological effects include: improved venous drainage from the head and neck, decreased intracranial pressure, lower risk of passive aspiration
2. The main complications of this position are lowering blood pressure and increased air embolism

Face down

In this position, the person lies on his stomach. At the same time, the minimum flexion of the neck and shoulders is in a state of slight flexion and external rotation at an angle of less than 90 degrees.

Potential impairments:

1. Increase in intra-abdominal pressure, decrease in cardiac output
2. Pulmonary dysfunction. Very often this position is associated with other injuries that can be avoided with the correct rotation of the patient from the back to the abdomen
3. Injury of the shoulder joint
4. Damage to the front surface of the foot, knees, pelvis, chest, armpits, elbows, face is possible – all these areas are susceptible significant risk of developing pressure ulcers

Lithotomy position

Used for operations on the perineum, anus, vagina.The person is laid so that his buttocks are at the end of the table, his legs are lifted, spread apart and placed on special supports.

Possible difficulties:

1. Increased blood flow from the lower extremities, which may lead to the accumulation of fluid
2. Possible endotracheal tube connection
3. Inadvertent induction of carina, which causes bronchospasm
4. With excessive flexion of the hip, it can cause damage to the obturator and ischial nerves

Lateral position (on the side)

Used for thoracotomy, urology, hip and shoulder interventions.The leg below is bent at the knee, while the other leg can be in an arbitrary position. The upper arm can lie freely or on a special stand. The head rests on the pillow, and the upper body is slightly raised.

Possible complications:

1. The lower lung is less ventilated, but it is better supplied with blood
2. The shoulder is under high stress
3. Venous hypertension appears in the lower arm
4. Injury to the sural and subcutaneous nerves
5. Corneal injury

How to make a choice ?

While there is no perfect operating table, the choice depends on the specific application to ensure safety and improve efficiency.The decision to use one type over the other depends on risk factors, positioning capabilities, mobility and flexibility, type of process and its duration.

Some of the characteristics of good equipment include versatility, ease of use, reliability, and large size limitations.

Author: Alina Dubovik

Operating tables Medifa. Possible patient locations.

Neurosurgery

Neurosurgery

Spinal neurosurgery

Neurosurgery – sitting position

Lateral position for kidney / chest surgery

Position for shoulder / shoulder joint surgery

Position for traction surgery for fractures of the lower extremities

Position for surgery for femoral neck injuries

Lateral position for lower limb surgery with lower support

Position for shin surgery

Lateral position for lower limb surgery with upper support

Position for arthroscopy of the knee joint

Gynecology / urology / lithotomy position

Urology (TUR) / Gynecology

Proctology / spinal neurosurgery

Endoscopy

Position for shoulder / shoulder joint surgery

Lateral position

Position for kidney / gallbladder surgery

Spinal neurosurgery

Lateral position for kidney / chest surgery

Position for head / neck surgery

General Surgery

General application

Gynecology / Urology

Proctology

Neurosurgery / Spinal neurosurgery

Ophthalmology / Otolaryngology

Traumatology / Orthopedics

Urolithiasis surgery – IMS Clinic

Urolithiasis surgery is performed in case of ineffectiveness of drug therapy.Surgical intervention can be performed with stones located in any part of the urinary system. At the same time, emergency operations are most often carried out with calculi “stuck” in the ureter. The first step as an emergency aid for a ureteral stone, the doctor most often provides a normal flow of urine. This is done by placing an internal stent or nephrostomy. Most kidney stones, bladder stones, and some ureteral stones are routinely operated on.

Insertion of an internal stent into the ureter

The ureteral stent is a plastic tube as shown. A stent is inserted into the ureter to allow urine to drain above the blockage.

One end of the stent is placed in the region of the kidney, the other opens into the lumen of the bladder. The stent is placed under the control of a cystoscope (tube with lenses) inserted through the urethra. The cystoscope has a lumen through which the guidewire is first inserted.Next, a stent is passed along the guidewire to the kidney. The position of the stent is monitored using fluoroscopy. An X-ray unit is used in the form of an X-ray arc with a reduced radiation load on the body.

Thus, ureteral stenting is a temporary measure that allows urine to drain until the stone is removed. The stent is removed after the blockage is removed.

Percutaneous nephrostomy

Percutaneous nephrostomy – an operation for urolithiasis, which ensures the outflow of urine from the kidney when the ureter is blocked by a stone.

For percutaneous nephrostomy, a small plastic hollow tube is used, inserted into the renal-pelvic system of the kidney through a skin incision (about 4 mm) in the lumbar region.

Percutaneous nephrostomy is performed under the control of ultrasound or fluoroscopy. The essence of the procedure lies in the fact that a hollow needle with a mandrel (internal solid base) is brought through the skin to the renal calyx. After puncture of the kidney under ultrasound control, the inner base is removed and a guidewire is inserted through the lumen of the needle into the kidney.The needle is removed and a catheter is passed through the guidewire. The catheter attaches to the urine collection bag.

A percutaneous nephrostomy tube requires care to prevent infection, your doctor will tell you about this. Catheter replacement is required every 4-6 weeks.

The nephrostomy tube can be removed after the blockage is removed.

Each person is individual, as well as the anatomical features of his body. At the same time, calculi that form in the urinary organs have a different structure, size, density, shape, etc.e. In response to this, there are a large number of different technological solutions and tools for removing calculi. Let’s give an analogy with the development of mobile communications, or rather the phones themselves. In the beginning, they were large, inconvenient and lacking in function. Today these are high-tech smartphones with millions of possibilities. It is the same in medicine: in parallel with the requests of patients, the quality of the services provided is also growing. Both the equipment manufacturing companies and doctors try to make the operations less invasive, which allows avoiding complications, discharging the patient faster, so that he can return to normal life and work as quickly as possible.All this together leads to the appearance on the market of a large amount of equipment, the acquisition of which by a particular clinic is limited only by financial possibilities. Nevertheless, there are basic types or, more simply, the principles of getting rid of the patient from stones. These include:

Ureteroscopy (examination of the ureter)

Ureteroscopy – endoscopic minimally invasive manipulation, the purpose of which is to remove calculus. The essence of the procedure is that through the urethra the surgeon introduces an endoscope to the location of the stone and removes it.

Figure. The figure shows the lumen of the ureter, in which the stone is located.

Ureteroscopy can be used to remove stones 1-2 cm in size located in the kidney, as well as ureter and bladder stones. If it is impossible to extract the stone entirely, it is first crushed into smaller fragments (the procedure for transurethral contact lithotripsy is described below).

Stone crushing (lithotripsy)

Lithotripsy is a modern method of treatment of urolithiasis, which consists in crushing stones into smaller fragments, which then leave the urinary system on their own.

There are two types of lithotripsy:

• extracorporeal or extracorporeal lithotripsy;
• contact lithotripsy.

Lithotripter is a tool used to break stones. Shock waves can be generated by electrohydraulic, electromagnetic or piezoelectric sources. The shockwaves are focused on the stone, the generated energy shatters the stones into smaller fragments.

Laser holmium lithotripters are currently most widely used.

Contact lithotripsy

Contact lithotripsy can be performed using endoscopic techniques with access to the stone through the urethra (transurethral) or through a skin puncture (percutaneous).

Percutaneous lithotripsy – destruction of kidney or ureteral stones after percutaneous puncture of the renal cavity system. There are techniques of nephrostomy and nephrostomy-free percutaneous lithotripsy.

Percutaneous lithotripsy is the most effective and safest treatment for large kidney stones.Percutaneous lithotripsy is the removal of a kidney stone by crushing it through a nephroscope. An endoscopic port, called a nephroscope, is inserted into the calyx-pelvic system, which provides visual control over the course of the procedure. Through the lumen of the nephroscope, a lipotriptor is brought to the stone, the stone is fragmented, if possible, the fragments are removed. At the end of the procedure, if necessary, a ureteral stent or nephrostomy tube (kidney drainage) is placed.

Contact transurethral lithotripsy consists in the destruction of urinary stones using endoscopic equipment (ureteronephroscope) inserted through the urethra.The integrity of the skin is not compromised.

Depending on the position of the stone, the following types of contact transurethral lithotripsy are distinguished:

• Contact transurethral ureterolithotripsy – destruction of ureteral stones.

• Contact transurethral nephrolithotripsy – destruction of kidney stones.

• Contact transurethral cystolithotripsy – destruction of bladder stones.

Extracorporeal lithotripsy

Remote lithotripsy is a modern method of treatment of urolithiasis, which consists in the destruction of stones using an acoustic shock wave.This method of treatment is performed without incisions in the skin, since there is no violation of the integrity of the skin.

Extracorporeal lithotripsy is most effective for urinary stones less than 2 cm in diameter located in the superior or middle renal calyx.

Contraindications to remote lithotripsy are pregnancy, disorders of the blood coagulation system, stones located close to each other, etc. In addition, the use of lithotripsy is limited in the presence of very dense stones, cystine stones, in overweight patients.

Extracorporeal shock wave lithotripsy is less effective if the patient has a stone larger than 1.5 cm in diameter or is located in the lower parts of the kidney.

Lithotomy

Lithotomy – surgery for urolithiasis, the purpose of which is to remove the urinary stone by dissecting the organ in which it is located.

Nephrolithotomy – removal of a kidney stone.

Ureterolithotomy – removal of ureteral stone.

Cystolithotomy – removal of a bladder stone.

Lithotomy can be performed in the following ways:

• Percutaneous lithotomy.
• Laparoscopic lithotomy.
• Open lithotomy.

Percutaneous lithotomy

Percutaneous lithotomy is used to localize stones in the kidney (nephrolithotomy) or ureter (ureterolithotomy). The procedure is similar to percutaneous lithotripsy, except that the stone is removed without prior crushing.This is only possible in the case of small stones. As a rule, the extraction of a large stone is preceded by its crushing.

Laparoscopic lithotomy

The first laparoscopic lithotomy was performed by Wickham in 1979, during the operation, a ureteral stone was removed from the retroperitoneal approach. In 1992, Raboy proposed the technique of laparoscopic lithotomy from the transperitoneal approach.

Thus, the operation for urolithiasis can be performed from two approaches, each of which has its own advantages and disadvantages.With retroperitoneal access, the operation is performed without violating the integrity of the peritoneum, i.e. outside the abdominal cavity. Transperitoneal access requires a violation of the integrity of the peritoneum, i.e. “Entry” into the abdominal cavity.

The choice of the method of laparoscopic surgery for urolithiasis depends on many factors: the position of the stone, the skills of the surgeon, the general condition of the patient, the history of operations on the abdominal organs, etc.

The essence of laparoscopic surgery for urolithiasis is to remove stones using endoscopic equipment through small (0.5 to 1.5 cm) skin incisions.A special instrument is inserted through one of the skin incisions – a laparoscope, equipped with a video camera and providing visual control over the course of the operation. Through the rest of the skin incisions, working instruments are brought to the operating field, with the help of which surgical manipulations are performed.

Laparoscopic surgery for urolithiasis is more invasive than the methods described above for removing urinary stones. However, the laparoscopic technique undoubtedly has many advantages over open lithotomy.

Advantages of laparoscopic surgery for urolithiasis in comparison with open lithotomy:

• shorter period of hospitalization and postoperative recovery;
• satisfactory cosmetic effect;
• fewer intra- and postoperative complications;
• less pronounced pain syndrome in the postoperative period, etc.

Open lithotomy

Currently, open lithotomy is almost completely replaced by non-invasive or minimally invasive methods of treatment and is used in less than 1% of cases of urolithiasis.

Operations for kidney stones

So, among the operations for kidney stones are used:

• ureteronephroscopy;
• percutaneous contact nephrolithotripsy;
• transurethral contact nephrolithotripsy;
• Extracorporeal shock wave lithotripsy;
• percutaneous nephrolithotomy;
• laparoscopic nephrolithotomy;
• open nephrolithotomy.

More detailed information can be found in the article “Operations for a kidney stone”.

Ureteral stone surgery

Currently, surgeons can perform the following operations for ureteral stones:

• ureteroscopy;
• percutaneous contact ureterolithotripsy;
• transurethral contact ureterolithotripsy;
• Extracorporeal shock wave ureterolithotripsy;
• percutaneous ureterolithotomy;
• laparoscopic ureterolithotomy;
• Open ureterolithotomy.

For more information on the surgical treatment of ureterolithiasis, see the article “Operations for Ureteral Stone”.

Operations for bladder stone

• transurethral cystolitolapaxy – crushing and removing stones using a cystoscope.
• percutaneous suprapubic litholapaxy – crushing and removal of bladder stones through a puncture in the suprapubic region
• laparoscopic cystolithotomy;
• open cystolithotomy.

For more information, see the article “Operations for bladder stones”.

Device for extracorporeal treatment with focused ultrasound of diseases of the pelvic organs

The invention relates to a device for extracorporeal treatment of diseases of the pelvis with focused ultrasound, related to the field of treatment technology with high-intensity focused ultrasound. The device contains a sound-emitting surface of an ultrasonic transducer, which is a spherical surface having a first cut, a second cut and a third cut, one large circle of the sphere is the main great circle, the first cut and the second cut, respectively, are located at two intersections of the spherical surface and the diameter, perpendicular to the main great circle, and the third slice connects the first slice with the second slice; the cross-section of the sound-emitting surface, parallel to the main great circle, is in the form of an arc; wherein the sound-emitting surface is capable of reflecting ultrasound, and the ultrasonic wave generated by the sound generating unit is focused on the center of the sphere corresponding to the sound-emitting surface.The treatment table is made with the possibility of placing the human body in the position for lithotomy, and the pelvic cavity is placed in the center of the sphere corresponding to the sound-emitting surface, with two legs, respectively, leaving the sound-emitting surface through the first cut and the second cut, and the upper part of the human body emerging from the sound-emitting surface. surface through the third cut. The device can solve the problems of low efficiency, effect and safety of the existing ultrasound treatment for prostate disease.The treatment device contains an ultrasound transducer and a treatment table. 17 p.p. f-ly, 16 ill.

FIELD OF THE INVENTION

The present disclosure relates to the field of high intensity focused ultrasound treatment technology, and specifically relates to a device for extracorporeal focused ultrasound treatment of pelvic diseases.

Background of the Invention

High Intensity Focused Ultrasound (HIFU) technology is widely used to treat benign and malignant tumors such as liver cancer, breast cancer, kidney cancer, bone tumor, uterine fibroids, etc.e. Through the use of focusing and permeability of ultrasound, ultrasound is focused on the affected area of ​​the human body, and mechanical energy with high energy density in the focal region is converted into thermal energy, causing coagulation necrosis (also called ultrasonic thermal ablation) of diseased tissues; meanwhile, because the density of ultrasonic energy in the beam path is small, it can be ensured that the effect on normal tissues around the diseased tissue and in the beam path is negligible or tolerable.

Most of the existing focused ultrasound transducers for extracorporeal high-intensity focused ultrasound treatment have a sound-emitting surface in the form of a spherical segment, and the ultrasound emitted by the existing focused ultrasound transducer is a traveling wave. The focal region formed by the existing ultrasound transducer is shaped like a cigar or spindle, its length in the direction of the sonic axis is relatively large and usually exceeds 10 mm, and its dimensions along the other two short axes vary from 2 mm to 3 mm (for example ultrasonic frequency 1 MHz), so that the focal area is relatively large, which affects the focusing of energy and is unfavorable for the safety of treatment.In addition, ultrasound emitted by an existing ultrasound transducer can be scattered or reflected by non-uniform tissues such as bones, air-containing organs and the like, causing highly non-linear propagation of ultrasound, which in turn damages tissues in the beam path, causes unpredictable deflection, and curvature of the focal area, and affects the placement of the focal area.

Due to the shortcomings of existing ultrasonic transducers, their therapeutic use is limited.For example, prostate hyperplasia and prostate cancer are common diseases in adult men, and the incidence of prostatic hyperplasia among men aged 40 to 79 years in China is approximately 50%, and the incidence of prostatic hyperplasia among men over 80 years of age. years is 80%. However, the prostate gland is located in the pelvic cavity, and there are many heterogeneous tissues around the prostate gland, such as bones, air-containing organs and the like, so that ultrasound emitted from outside the body can hardly be accurately focused on the prostate gland through the heterogeneous tissues.As a consequence, for the existing focused ultrasound treatment of prostate diseases, the ultrasound transducer needs to be inserted into the body through the urethra or rectum, which causes discomfort in patients and easily causes damage to the urethra or rectum, and because of this, the ultrasound transducer has a limited size, low energy. and obstruction of movement, and poor outcome, effectiveness and integrity of treatment. Meanwhile, due to the fact that the existing focal region of ultrasound is cigar-shaped, it is difficult to accurately limit the focal region to the desired position, and when one part of the focal region is located on the diseased tissue, it is very likely that the other part of the focal region extends beyond the diseased tissue and is located on normal tissue and can cause damage to normal tissue, impairing the safety of treatment.

Brief disclosure of the present invention

The present disclosure at least partially resolves the problems of poor treatment outcome, efficacy and safety of the existing focused ultrasound treatment device for prostate diseases, and presents a device for extracorporeal focused ultrasound treatment of pelvic diseases, which has high treatment efficiency, good result and good safety.

As a technical solution adopted to solve the technical problem of the present disclosure, a device for extracorporeal treatment with focused ultrasound of pelvic diseases is presented, which contains an ultrasonic transducer and a treatment table, and the ultrasonic transducer contains a sound-emitting surface and a sound generating unit, which is configured to generate ultrasonic waves; the sound emitting surface is a spherical surface having a first cut, a second cut and a third cut, the sphere corresponding to the spherical surface has a diameter ranging from 400 mm to 800 mm, one large circle of the sphere is the main large circle, the first cut and the second cut, respectively, located at two intersections of the spherical surface and the diameter perpendicular to the main great circle, and the third slice connects the first slice with the second slice; within distances from 100 mm to 200 mm from the main great circle, respectively, on both sides of the main great circle, the cross-section of the sound-emitting surface, parallel to the main great circle, has the shape of an arc, the arc opening corresponds to the third cut, and the central angle corresponding to the arc is more 180 degrees and less than 300 degrees; and the sound emitting surface is capable of reflecting ultrasound, and the ultrasonic wave generated by the sound generating unit is focused on the center of the sphere corresponding to the sound emitting surface.

The treatment table is designed to place the human body in the lithotomy position, and when the human body is on the treatment table in the lithotomy position, the pelvic cavity of the human body is placed in the center of the sphere corresponding to the sound-emitting surface, with two legs of the human body, respectively, coming out from the sound-emitting surface through the first cut and the second cut, and the upper part of the human body exits the sound-emitting surface through the third cut.

Optionally, the first slice edge and the second slice edge are located in the first plane and the second plane, respectively.

Optional, the first plane and the second plane are both parallel to the main great circle.

Optional, the distance between the first plane and the second plane ranges from 200 mm to 400 mm.

Optional, the distance between the first plane and the main great circle is the same as the distance between the second plane and the main great circle.

Optionally, the diameter of the sphere corresponding to the sound emitting surface ranges from 420 mm to 600 mm; and

within distances from 100 mm to 150 mm from the main great circle, respectively, on both sides of the main great circle, the corresponding arc central angle in the cross section of the sound emitting surface parallel to the main great circle is more than 180 degrees and less than 300 degrees.

Optional, each cross-section of the sound emitting surface parallel to the main great circle is in the shape of an arc, and the corresponding center angle is greater than 200 degrees and less than 260 degrees.

Optionally, the arc opening in each cross-section of the sound emitting surface parallel to the main great circle is oriented in the same direction, and the central angle corresponding to the arc is the same.

Optionally, the sound emitting surface is symmetrical about the main great circle.

Optionally, when the human body is in the lithotomy position on the treatment table, the ultrasound emitted from the first area of ​​the sound emitting surface enters the pelvic cavity through the abdominal cavity of the human body.

When the human body is in the lithotomy position on the treatment table, ultrasound emitted from the second area of ​​the sound-emitting surface penetrates the pelvic cavity through the area between the coccyx and the pubic symphysis of the human body.

Optionally, the device for extracorporeal focused ultrasound treatment of pelvic diseases further comprises:

first ultrasound probe for B-mode, configured to emit ultrasound for visualization by the first area of ​​the sound-emitting surface into the pelvic cavity through the abdominal cavity of the human body to form an image of the pelvic cavity; and / or

a second ultrasound probe for B-mode, configured to emit ultrasound for visualization by the second area of ​​the sound-emitting surface into the pelvic cavity through the perineum of the human body to form an image of the pelvic cavity.

Optional, treatment table and ultrasound transducer are separate designs; and

the device for extracorporeal treatment with focused ultrasound of diseases of the pelvic organs additionally contains a movement unit made so that the treatment table is closer to the ultrasound transducer or further from it.

Optionally, the device for extracorporeal focused ultrasound treatment of pelvic diseases further comprises:

a medium-containing block configured to hold a sound-transmitting medium between a human body surface and a sound-emitting surface.

Optionally, the device for extracorporeal focused ultrasound treatment of pelvic diseases further comprises:

a drive unit configured to drive the ultrasound transducer relative to the treatment table.

Optionally, the device for extracorporeal focused ultrasound treatment of diseases of the pelvic organs further comprises:

an imaging unit configured to form an image of the pelvic cavity.

Optionally, the ultrasound generated by the sound generating unit has a frequency in the range of 0.4 MHz to 1.5 MHz.

Optional, the acoustic power of the ultrasound generated by the sound generating unit is in the range from 0 W to 1200 W.

Optional, the acoustic power of the ultrasound generated by the sound generating unit is in the range of 0 W to 800 W.

The device for extracorporeal focused ultrasound treatment of pelvic diseases is equipped with a special C-shaped ultrasound transducer, and the focal area of ​​the ultrasound transducer has a shape close to a sphere, small size and high energy density, so that the device has a good therapeutic effect, high efficiency, little effect on normal fabrics and good safety; in addition, heterogeneous tissues such as bones and the like have little effect on the focusing effect of the ultrasound generated by the ultrasound transducer, while the human body is on the back on the treatment table in a specific position so that the pelvic cavity is located near the focal region of the ultrasound transducer to ensure the penetration of ultrasound into the human body with the maximum beam path.As a consequence, an extracorporeal focused ultrasound treatment device for pelvic diseases can treat pelvic diseases by externally focusing ultrasonic waves, so that the size of the ultrasound-emitting surface (i.e., the sound-emitting surface) of the ultrasound transducer can be larger, and provided that the ultrasonic energy, emitted per unit area is the same, the area of ​​the acoustic window for the penetration of ultrasound into the human body can be larger, and the density of the energy received in the focal region is higher.As a result, the result of the treatment is improved, the efficiency of treatment is increased, the comfort of treatment is increased, the convenience of work is increased, the harm to the human body is reduced, and the safety of the treatment is improved.

Extracorporeal focused ultrasound treatment device for pelvic diseases is suitable for treating pelvic diseases such as prostate cancer, prostatic hyperplasia, uterine fibroids, adenomyosis, cervical cancer, ovarian cancer, rectal cancer, colon cancer, etc. similar, and is especially suitable for the treatment of prostate diseases.

Brief Description of Figures

FIG. 1 is a schematic structural view of an ultrasound transducer according to an embodiment of the present disclosure;

in FIG. 2 is a schematic structural view of a sound emitting surface in an ultrasonic transducer according to an embodiment of the present disclosure;

in FIG. 3 is a schematic diagram of a structure, in a direction parallel to the main great circle, of a sound emitting surface of an ultrasonic transducer according to an embodiment of the present disclosure;

in FIG.4 is a schematic view of the structure, in a direction perpendicular to the major great circle, of a sound emitting surface of an ultrasonic transducer according to an embodiment of the present disclosure;

in FIG. 5 is a schematic structural view of a cross-sectional view of a sound emitting surface parallel to the main great circle in an ultrasound transducer according to an embodiment of the present disclosure;

in FIG. 6 is a schematic side view of the structure of an extracorporeal focused ultrasound treatment device for pelvic diseases in a split state according to an embodiment of the present disclosure;

in FIG.7 is a schematic top view of the structure of an extracorporeal focused ultrasound treatment device for pelvic diseases in a split state according to an embodiment of the present disclosure;

in FIG. 8 is a schematic side view of a structure of a focused ultrasound extracorporeal treatment device for pelvic diseases in a connected state according to an embodiment of the present disclosure;

in FIG. 9 is a schematic top view of the structure of an extracorporeal focused ultrasound treatment device for pelvic diseases in a connected state according to an embodiment of the present disclosure;

in FIG.10 is a schematic side view of the structure of an extracorporeal focused ultrasound treatment device for pelvic diseases in a connected state and with a human body according to an embodiment of the present disclosure;

in FIG. 11 is a schematic top view of the structure of an extracorporeal focused ultrasound treatment device for pelvic diseases in a connected state and with a human body according to an embodiment of the present disclosure;

in FIG.12 is a photograph of a cavitated region formed at a focal point in a free region by a focused ultrasound extracorporeal treatment for pelvic diseases according to an embodiment of the present disclosure;

in FIG. 13 is a photograph of a necrotic area of ​​biological tissues formed after ultrasound irradiation of a bovine liver ex vivo with a focused ultrasound extracorporeal treatment device for pelvic diseases according to an embodiment of the present disclosure;

in FIG.14 is an illustration of a test device for performing ultrasonic irradiation of bovine muscle ex vivo in a pelvic bone with a focused ultrasound extracorporeal treatment device for pelvic diseases according to an embodiment of the present disclosure;

in FIG. 15 is a B-mode ultrasound image of an ex vivo bovine muscle in a pelvic bone ultrasonically irradiated by an extracorporeal focused ultrasound treatment device for pelvic diseases according to an embodiment of the present disclosure; a

in FIG.16 is a photograph of a necrotic area of ​​biological tissues formed after ultrasound irradiation with a focused ultrasound extracorporeal treatment device for pelvic diseases according to an embodiment of the present disclosure of bovine muscle tissue ex vivo in the pelvic bone.

Reference numbers: 1. Ultrasonic transducer; 11. Housing; 12. Top cover; 13. Piezoelectric matrix element; 14. End cover; 2. Procedure table; 3.Sound emitting surface; 31. First cut; 32. Second cut; 33. Third cut; 35. First area; 36. Second area; 41. First ultrasonic probe for B-mode; 42. Second ultrasonic probe for B-mode; 91. First plane; 92. The second plane; 99. Main great circle.

Detailed Disclosure of the Present Invention

In order for those skilled in the art to better understand the technical solutions of the present disclosure, the present disclosure will be further detailed below with reference to the accompanying figures and specific embodiments.

First Embodiment:

As shown in FIG. 1-16, the present embodiment provides a device for extracorporeal focused ultrasound treatment of pelvic diseases.

The device for extracorporeal focused ultrasound treatment of pelvic diseases is equipped with an ultrasound transducer 1 in a specific shape, and when the human body is in the position for lithotomy so that the pelvic cavity enters the ultrasound transducer 1, the ultrasound emitted by the ultrasound transducer 1 can be focused in a specific position in the pelvic cavity of the human body for the treatment of a pelvic organ disease such as prostate cancer, prostatic hyperplasia, uterine myoma, adenomyosis, cervical cancer, ovarian cancer, rectal cancer, colon cancer and the like, and the extracorporeal treatment device is focused ultrasound for pelvic diseases is especially suitable for the treatment of prostate diseases.

A device for extracorporeal focused ultrasound treatment of pelvic diseases according to an embodiment comprises an ultrasound transducer 1 and a treatment table 2.

An ultrasound transducer 1 comprises a sound emitting surface 3 and a sound generating unit that is configured to generate an ultrasonic wave; the sound-emitting surface 3 is a spherical surface having a first cut 31, a second cut 32 and a third cut 33, the sphere corresponding to the spherical surface has a diameter in the range from 400 mm to 800 mm, one great circle of the sphere is taken as the main great circle 99, the first slice 31 and the second slice 32, respectively, are located at two intersections of the spherical surface and the diameter perpendicular to the major great circle 99, and the third slice 33 connects the first slice 31 to the second slice 32; within distances from 100 mm to 200 mm from the main great circle 99, respectively, on both sides of the main great circle 99, the cross-section of the sound-emitting surface 3, parallel to the main great circle 99, has the shape of an arc, the arc opening corresponds to the third cut 33, and the corresponding arc central angle is more than 180 degrees and less than 300 degrees; moreover, the sound-emitting surface 3 is capable of reflecting ultrasound, and the ultrasonic wave generated by the sound generating unit is focused on the center of the sphere corresponding to the sound-emitting surface 3.

Treatment table 2 is configured to place the human body in the lithotomy position, and when the human body is in the lithotomy position on the treatment table 2, the center of the sphere corresponding to the sound-emitting surface 3 is located in the pelvic cavity of the human body, with two legs, respectively

1 has a sound generating unit, which is a device capable of generating ultrasound.For example, the material of the sound generating unit may include a piezoelectric ceramic material, a type 1-3 piezoelectric composite material, and the like. The shape, number, position and other parameters of the sound generating unit can be designed so that the sound generating unit can emit ultrasound from all positions of the sound emitting surface 3, and the ultrasound emitted at each position propagates along the direction perpendicular to the sound emitting surface 3 in this position , and the ultrasound could eventually be focused (including directly focusing or focusing after reflection) at the desired position.

In the embodiment shown in FIG. 1, the sound emitting surface 3 may be an acoustically transparent surface of a predetermined shape, and a sound generating unit (eg, piezoelectric array element 13) may be located behind the sound emitting surface 3; alternatively, the sound emitting surface 3 may be the emitting surface of the sound generating unit itself.

In an embodiment, the sound generating unit can also take various forms.For example, the sound generating unit may be a plurality of piezoelectric matrix elements 13 (eg, rectangular piezoelectric ceramic plates) located at different positions of the sound emitting surface 3, that is, a plurality of piezoelectric matrix elements 13 are connected together to form a sound emitting surface 3; alternatively, the sound generating unit may also have the same shape as the sound emitting surface 3 (for example, the sound generating unit is a specially shaped piezoelectric ceramic plate).

Obviously, as shown in FIG. 1, the ultrasonic transducer 1, in addition to the sound-emitting surface 3 and the sound generating unit, may further comprise a driver circuit for the sound generating unit, a housing (for example, the housing of the sound generating unit may include a housing 11, a top cover 12, a bottom cover, an end cover 14, etc.) etc.) to accommodate the driver circuit and sound generating unit and other components that will not be described in detail in this document.

Unlike a conventional spherical segment-shaped sound emitting surface, the sound emitting surface 3 of the ultrasonic transducer 1 according to the present embodiment is equivalent to a spherical surface lacking three portions, and the spherical surface may have a diameter in the range of 400 mm to 800 mm, preferably range from 420 mm to 600 mm.

As shown in FIG. 2-4, two areas (first slice 31 and second slice 32) that are absent on the sound-emitting surface 3 represent areas of a spherical surface at both ends of the same diameter, and a large circle (that is, a plane passing through the spherical center), perpendicular to the diameter, represents the main great circle 99.The third region (third slice 33), absent on the sound-emitting surface 3, is the region laterally connecting the first slice 31 to the second slice 32.

That is, if the plane in which the main large circle 99 is located extends in the horizontal direction, and the diameter perpendicular to the main large circle 99 extends in the vertical direction, portions of the upper end and lower end of the spherical surface can be cut in the vertical direction, respectively, then a portion of one side of the spherical surface can be cut off, and the cut portion of the side must connect the cuts of the upper end and the lower end so that the remaining spherical surface is the sound emitting surface 3.

Within distances from 100 mm to 200 mm (preferably 100 mm to 150 mm, and the distances on both sides may be different) from the main great circle 99, respectively, on both sides of the main great circle 99, cross-section of the sound-emitting surface 3 parallel to the main great circle 99 is arc-shaped, the central angle corresponding to the arc is more than 180 degrees and less than 300 degrees, and preferably is more than 200 degrees and less than 260 degrees, and the arc opening corresponds to the third cut 33.That is, at least within a certain distance from the major great circle 99, the portion of the spherical surface cut by the third cut 33 has a limited range, and the center angle corresponding to the remaining portion is within the above range.

In addition, the sound-emitting surface 3 has the ability to reflect ultrasound, and at least in some positions, the third cut 33 cuts off only the spherical surface less than half of the spherical surface.As a consequence, as shown in FIG. 5, ultrasound emitted by a part of the arc at an angle greater than the central angle of 180 degrees is reflected by the opposite part of the sound-emitting surface 3, and a part of the arc at an angle greater than the central angle of 180 degrees can also reflect ultrasound emitted by the opposite part of the sound-emitting surface 3, so that the ultrasound can return in a partial region (the region shaded with oblique lines in Fig. 5), forming a standing wave, thereby changing the focusing state and the shape of the focal region of ultrasound; meanwhile, the ultrasound emitted by the part of the arc corresponding to the hole is not reflected, so that the ultrasound emitted by this part of the arc will still be a traveling wave.

That is, the ultrasound generated by the ultrasonic transducer 1 according to the present embodiment is actually a traveling wave-standing wave combination, and thus its propagation and focusing will change. In particular, by using the ultrasound transducer 1, the main axis of the original cigar-shaped focal area can be compressed so that the focal area has a shape closer to a spherical shape and has a smaller size, the energy density in the focal area is increased, the result and effectiveness of treatment are increased, and damage to normal tissues is reduced. and safety improved.Meanwhile, the ultrasound transducer 1 can also reduce the adverse effect of tissue and bone unevenness and the like on the focusing of ultrasound when the ultrasound propagates in the human body, and reduce the deflection and curvature of the focal region, which facilitates accurate positioning of the focal region.

In an embodiment, the edges of the first slice 31 and the second slice 32 are located in the first plane 91 and the second plane 92, respectively. In an embodiment, the first plane 91 and the second plane 92 are both parallel to the major great circle 99.

As shown in FIG. 3, in an embodiment, the first slice 31 and the second slice 32 are plane-cut spherical segments. In an embodiment, the first cut 31 and the second cut 32 are spherical segments cut by two parallel planes, that is, the bottom surfaces of the two cut spherical segments are parallel to each other. In this regard, the spherical surface, with the exception of the first cut 31 and the second cut 32, is equivalent to the structure formed by joining the lower surfaces of the two spherical segments.Obviously, the bottom surfaces of the two spherical segments represent the main great circle 99, and the two spherical segments may have different heights. The sound-emitting surface 3 in this form has a shape similar to a spherical segment and has a regular and simple design.

Obviously, it is also possible for the first cut 31 and the second cut 32 to be cut by non-parallel planes or non-flat curved surfaces.

In an embodiment, the distance between the first plane 91 and the second plane 92 ranges from 200 mm to 400 mm.In an embodiment, the distance between the first plane 91 and the second plane 92 ranges from 200 mm to 300 mm.

That is, the distance between the first slice 31 and the second slice 32 (ie, the vertical dimension of the sound emitting surface 3) is preferably in the above range (of course, the diameter of the sphere corresponding to the sound emitting surface 3 should be greater than the distance). Such a sound emitting surface 3 has a sufficient area to generate ultrasound suitable for treatment and a size that is not too large to allow the legs of a person to protrude.

In an embodiment, the distance between the first plane 91 and the major major circle 99 is equal to the distance between the second plane 92 and the major major circle 99.

That is, the first slice 31 and the second slice 32 are preferably obtained by cutting with two planes that have the same distance to the center of the sphere, so that the two slices are the same size and distributed in a symmetrical manner, which contributes to the symmetry of the focal region and the placement of the legs of the human body.

Obviously, it is also possible that the first slice 31 and the second slice 32 have different distances to the center of the sphere or have different shapes.

In an embodiment, any cross section of the sound emitting surface 3 parallel to the major great circle 99 is arc-shaped, and the arc-corresponding center angle is greater than 180 degrees and less than 300 degrees.

It has been defined above that the sound emitting surface 3 is arcuate in cross section parallel to the main great circle 99, at least adjacent to the main great circle 99.In an embodiment, any cross-section of the sound emitting surface 3 parallel to the main great circle 99 may be in the form of an arc, thereby ensuring that the sound emitting surface 3 can generate a standing wave at each position in the vertical direction.

Obviously, it is also possible that the cross-section of the sound-emitting surface 3, parallel to the main great circle 99, in some positions does not have the shape of an arc (for example, it represents two separate arcs).

In an embodiment, the arcs of the sound-emitting surface 3 in any of its cross-sections parallel to the main great circle 99 have holes oriented in the same direction and correspond to central corners that are the same.

That is, in different positions in the vertical direction, the third slice 33 is oriented in the same direction and corresponds to the same central angle. That is, the third cut 33 is preferably obtained by cutting with a plane perpendicular to the major great circle 99.

As shown in FIG. 4, the sound emitting surface 3 is formed in a “C” shape when viewed in a direction perpendicular to the main great circle 99.

In an embodiment, the sound emitting surface 3 is symmetrical about the main great circle 99.

As shown in FIG. 3, the sound emitting surface 3 is preferably symmetrical with respect to the main great circle 99, that is, the portions of the sound emitting surface 3, respectively, on either side of the main great circle 99 preferably have the same shape, so that the sound region and the focal region formed by the sound emitting surface are also symmetrical. relative to the main great circle 99, and are more uniform and easier to control.

As shown in FIG. 6-11, the treatment table 2 is configured to accommodate the human body during treatment. In an embodiment, the person lies on the treatment table 2 on their back with their legs raised and apart, that is, in the lithotomy position.

Thus, as shown in FIG. 10 and 11, in the case when the third slice 33 of the ultrasound transducer 1 is directed to the treatment table 2, and the first slice 31 and the second slice 32, respectively, are directed to both sides, when the center of the sphere is located in the pelvic cavity of the human body, the upper part of the human body can exit the sound emitting surface 3 through the third slice 33, and at the same time both legs of the human body can also exit the sound emitting surface 3 through the first slice 31 and the second slice 32, respectively.

It can be seen that if such a position is required between the human body and the ultrasonic transducer 1, it is necessary that the size and central angle of the ultrasonic transducer 1 (sound-emitting surface 3) meet certain requirements, and the above limitation of the parameters of the sound-emitting surface 3 only allows adaptation ultrasonic transducer 1 to the human body.

Obviously, in order to ensure the placement of the human body on the treatment table 2 in the lithotomy position, the treatment table 2 must have a chair, leg support, etc.that will not be detailed in this document.

Obviously, in a real device for extracorporeal treatment with focused ultrasound of diseases of the pelvis, the ultrasound transducer 1 cannot be suspended, and an appropriate housing, support structure, defining contour, etc. should be provided, but for simplicity these structures are not shown in the figures. …

The device for extracorporeal focused ultrasound treatment of pelvic diseases according to the embodiment is equipped with a special Conforming ultrasound transducer 1, and the focal region of the ultrasound transducer 1 has a shape close to a sphere, small size and high energy density, so that the extracorporeal focused ultrasound treatment device for pelvic diseases provides good healing effect, high efficacy, little effect on normal tissue, and good safety.

In addition, heterogeneous tissues, such as bones and the like, have little effect on the propagation of ultrasound generated by the ultrasound transducer 1 while the human body is on the treatment table 2 on the back in a specific position of the body, and the specific tissue of the pelvic organ is located near focal area of ​​the ultrasound transducer 1, which ensures the penetration of ultrasound into the pelvic cavity of the human body with the maximum beam trajectory, and facilitates the treatment of a specific lesion on a specific tissue of the pelvic cavity organ.

Thus, a focused ultrasound extracorporeal treatment device for pelvic diseases can treat diseases of the pelvic organs by externally focusing ultrasonic waves, so that the size of the ultrasound-emitting surface (i.e., sound-emitting surface 3) of the ultrasound transducer can be larger, provided that the ultrasonic energy emitted per unit area is the same, the area of ​​the acoustic window for the penetration of ultrasound into the human body can be larger, and the density of the energy received in the focal region is higher.As a result, the result of the treatment is improved, the efficiency of treatment is increased, the comfort of treatment is increased, the convenience of work is increased, the harm to the human body is reduced, and the safety of the treatment is improved.

In an embodiment, the treatment table 2 and the ultrasound transducer 1 may be separate structures; The device for extracorporeal treatment with focused ultrasound of diseases of the pelvic organs also contains a movement unit configured to move the treatment table 2 and the ultrasound transducer 1 closer or further from each other.

As shown in FIG. 10 and 11, according to the above parameters of the sound-emitting surface 3, when the center of the sphere corresponding to the sound-emitting surface 3 of the transducer is located in the pelvic cavity of the human body, the distances from the abdominal cavity and the back of the human body to the ends of the sound-emitting surface 3 are small, and as a result, if the treatment table 2 is located near the ultrasound transducer 1, it is difficult to insert the perineum through the gap between the treatment table 2 and the ultrasound transducer 1.As a consequence, as shown in FIG. 6 and 7, the treatment table 2 and the ultrasound transducer 1 are preferably separated, and the treatment table 2 can be moved closer to or further from the ultrasound transducer 1 by means of a movement unit (eg, a wheel, a rail, etc.). Thus, the human body can be positioned on the treatment table 2 in the lithotomy position when the treatment table 2 is at a distance from the ultrasound transducer 1, and then the treatment table 2 is moved closer to the ultrasound transducer 1, ensuring the placement of the perineum on the sound-emitting surface 3 through the third section 33, thus obtaining the structure shown in FIG.10 and 11.

In an embodiment, when the human body is on the treatment table 2 in the lithotomy position, ultrasound emitted by the first region 35 of the sound emitting surface 3 enters the pelvic cavity through the abdominal cavity of the human body; when the human body is on the treatment table 2 in the lithotomy position, the ultrasound emitted by the second region 36 of the sound-emitting surface 3 penetrates into the pelvic cavity through the area between the coccyx and the pubic symphysis of the human body.

Most of the pelvic cavity of the human body is surrounded by the pelvic bones, and the bones have the effect of strongly blocking ultrasound; in contrast, there are no bones in the abdominal cavity, and there are fewer bones in the area between the coccyx and the pubic symphysis (including the perineum, anus, etc.), so ultrasound is less blocked when it enters the pelvic cavity through these two sites. As a consequence, as shown in FIG. 10, the sound-emitting surface 3 of the ultrasound transducer 1 preferably has at least a first region 35 and a second region 36, and the ultrasonic waves emitted from the two regions, to enter the pelvic cavity, can respectively pass through the abdominal cavity and the region between the coccyx and the pubic symphysis, maximizing the path of the beam.

Obviously, the sound emitting surface 3 should also have a region between the first region 35 and the second region 36, and since the central angle between the first region 35 and the second region 36 is usually less than 150 degrees, as shown in FIG. 10, the sound emitting surface 3 should in fact have a portion larger than the first region 35 and the second region 36, for example a portion corresponding to the sacrum. Thus, ultrasonic waves emitted from all positions of the sound emitting surface 3 can together form a better sound field.

In an embodiment, the device for extracorporeal focused ultrasound treatment of pelvic diseases further comprises an imaging unit configured to image the pelvic cavity.

That is, the device for extracorporeal focused ultrasound treatment of pelvic diseases may also contain an imaging unit (for example, ultrasound in B-mode, CT, MRI, or a combination thereof) for imaging the pelvic cavity in such a way as to position the lesion before treatment and so that during treatment in real time to form an image of the area around the treated part to evaluate the effect of the treatment at any time and to adjust the treatment plan.

In an embodiment, a device for extracorporeal focused ultrasound treatment of pelvic diseases may comprise:

a first B-mode ultrasound probe 41 configured to emit an imaging ultrasound wave from the first region 35 of the sound-emitting surface 3 into the pelvic cavity through the abdominal cavity of the human body to form images of the pelvic cavity;

and / or

second ultrasonic probe 42 for B-mode, configured to emit an imaging ultrasonic wave by the second region 36 of the sound-emitting surface 3 into the pelvic cavity through the perineum of the human body to form an image of the pelvic cavity.

That is, B-mode ultrasound can be used to image the pelvic cavity for monitoring, and since B-mode ultrasound also provides imaging through the use of ultrasound, it is also blocked by bones, so B-mode ultrasound probes also need to be positioned in the first region 35 and the second region 36, as shown in FIG. 10 to avoid bones for imaging at these positions, ensuring clear images and minimizing the effect of the B-mode ultrasound probe on therapeutic ultrasound.In an embodiment, the first B-mode ultrasound probe 41 is in the first region 35 and emits ultrasound for imaging through the abdominal cavity, while the second B-mode ultrasound probe 42 is at a specific position in the second region 36, i.e. the ultrasound for imaging. the visualization radiates through the perineum (rather than through the anus, etc.).

Since the human body is supine in the lithotomy position, the angle between the first B-mode ultrasound probe 41 and the vertical direction is usually approximately 30 degrees, and the angle between the second B-mode ultrasound probe 42 and the vertical direction is approximately 80 degrees. …

In an embodiment, the B-mode ultrasonic probes can be positioned in the respective positions of the sound emitting surface 3 and imaging can be performed in a non-contact manner; alternatively, as shown in FIG. 10, the B-mode ultrasonic probes can protrude from the sound emitting surface 3 and can be retractable so that one or two B-mode ultrasonic probes can be selected to extend and contact the human body for imaging.

It can be seen that for the focused ultrasound extracorporeal treatment device for pelvic diseases according to the embodiments, by providing B-mode ultrasound probes at specific positions, the best quality ultrasound image can be obtained from the optimal position while minimizing the effect on therapeutic ultrasound; in addition, the ultrasonic probes for B-mode are located on the sound-emitting surface 3 (i.e. on the ultrasonic transducer 1), so that when the ultrasonic transducer 1 moves, the ultrasonic probes for B-mode will move together with the ultrasonic transducer 1, and thus the ultrasonic probes for B-mode are aimed at the optimal imaging positions at any time.

In an embodiment, the device for extracorporeal focused ultrasound treatment of pelvic diseases further comprises a drive unit for driving the ultrasound transducer 1 in order to move relative to the treatment table 2.

It is understood that the focal region of ultrasound during treatment must be located in the lesion position, and the exact positions of the lesion differ depending on the differences in body type, type of disease, treatment conditions, and the like, and therefore, during treatment, the position of the focal region needs to be adjusted in real time.Consequently, it is possible to provide a drive unit for driving the ultrasonic transducer 1 and then driving the focal region.

The movement provided by the drive unit may include translational movement in three axial directions perpendicular to each other, and such movement may also cause movement of the focal region; alternatively, the movement may include rotating the ultrasound transducer 1 around different axial directions to allow the ultrasound to penetrate the human body from different directions.

In an embodiment, the device for extracorporeal treatment of pelvic diseases with focused ultrasound further comprises a medium-containing block for holding the sound-transmitting medium between the surface of the human body and the sound-emitting surface 3.

to reduce the attenuation of ultrasound during its propagation in the air between the sound-emitting surface 3 of the ultrasonic transducer 1 and the human body, a sound-transmitting medium such as deaerated water can be provided, and for this reason a medium-containing block capable of retaining a sound transmitting medium (for example deaerated water) is preferably provided, providing a space between the sound emitting surface 3 of the ultrasonic transducer 1 according to the present embodiments, and the surface of the human body through which the ultrasound must pass to fill it with a sound-transmitting medium, wherein the block containing the medium may have the form of a water reservoir and the like, and will not be described in detail herein.

In an embodiment, the ultrasound generated by the sound generating unit has a frequency in the range of 0.4 MHz to 1.5 MHz.

In an embodiment, the ultrasound generated by the sound generating unit has an acoustic power in the range of 0 W to 1200 W. In an embodiment, the acoustic power of the ultrasound generated by the sound generating unit ranges from 0 W to 800 W.

For the ultrasound transducer 1 in any of the above forms, when it is used to treat a disease of a pelvic cavity organ, the parameters of the ultrasound emitted by the ultrasound transducer 1 are preferably in the above ranges to achieve a good treatment effect.

An extracorporeal focused ultrasound treatment device for pelvic diseases according to embodiments emits ultrasonic waves with an acoustic power of 200 W in the direction of deaerated water to cavitate water in the focal region, and FIG. 12 shows a photograph of the cavitated region, taken from the side of the first slice 31. It can be seen that the cavitated region (that is, the focal region) in the photograph has a shape close to a circle, the size is 1.8 mm * 1.2 mm and the length-width ratio is 3 : 2, which shows that, compared to the conventional traveling wave-only focused ultrasound transducer, the focused ultrasound extracorporeal treatment device for pelvic diseases according to the embodiments has a focused ultrasound transducer having a focal region whose main axis is significantly compressed, the shape of which is changed from cigar-shaped shape to an approximately spherical shape, and which has a reduced size, increased energy density and a more regular shape.

When an extracorporeal focused ultrasound treatment device for pelvic diseases according to the embodiments is used to treat bovine liver ex vivo with ultrasound at 400 W for 2 seconds, as shown in FIG. 13, the target area at a depth of 80mm is obviously damaged in a short time, and the damaged part is spindle-shaped and has a clear border, the size is 4.4mm * 1.5mm, and the length-to-width ratio is less than 3: 1, which is less than the ratio length-width (usually greater than 5: 1) of the damaged part caused by a traditional focused ultrasound transducer.This also shows that the focal region of the focused ultrasound extracorporeal treatment device for pelvic diseases according to the present embodiments has a more regular shape.

As shown in FIG. 14, the pelvic bone is positioned on the inner side of the ultrasound transducer 1 of the focused ultrasound extracorporeal treatment device for pelvic diseases to simulate the position of the pelvic bone of the human body, and then into the pelvic bone, as shown in FIG.15, bovine muscle tissue was placed ex vivo. The focal area is in a position equivalent to a position of 10 mm from the human rectum, and the prostate treatment process is simulated, the ultrasound power is 400 W, the target area is 55 mm deep, and the ultrasonic irradiation time is 2 seconds * 5 times … As shown in FIG. 16, the ultrasound-irradiated bovine muscle tissue has an apparently damaged target area with a clear boundary, the membrane is not damaged, and the interface between the simulated rectum and the prostate is not damaged.It has been shown that the ultrasound emitted by the focused ultrasound extracorporeal treatment device for pelvic diseases according to the embodiments is less affected by heterogeneous tissues such as human body bones, can also maximize the beam path when applied to a real human body environment, form a small focal area excellent shape and precise position, ensures good treatment results and efficacy, and prevents damage to normal tissues.

It should be understood that the above embodiments are merely illustrative embodiments to explain the principle of the present disclosure, but the present disclosure is not limited thereto. Various modifications and improvements can be made by those skilled in the art without departing from the spirit and spirit of the present disclosure, and these modifications and improvements should also be considered within the protection scope of this disclosure.

1. Device for extracorporeal treatment with focused ultrasound of pelvic diseases, containing an ultrasound transducer and a treatment table, in which

ultrasonic transducer contains a sound-emitting surface and a sound generating unit, which is configured to generate an ultrasonic wave; the sound emitting surface is a spherical surface having a first cut, a second cut and a third cut, the sphere corresponding to the spherical surface has a diameter ranging from 400 mm to 800 mm, one large circle of the sphere is the main large circle, the first cut and the second cut, respectively, located at two intersections of the spherical surface and the diameter perpendicular to the main great circle, and the third slice connects the first slice with the second slice; within distances from 100 mm to 200 mm from the main great circle, respectively, on both sides of the main great circle, the cross-section of the sound-emitting surface, parallel to the main great circle, has the shape of an arc, the arc opening corresponds to the third cut, and the central angle corresponding to the arc is more 180 degrees and less than 300 degrees; and the sound emitting surface is capable of reflecting ultrasound, and the ultrasonic wave generated by the sound generating unit is focused on the center of the sphere corresponding to the sound emitting surface; moreover,

the treatment table is made with the possibility of laying the human body in the position for lithotomy, and when the human body is on the treatment table in the position for lithotomy, the pelvic cavity of the human body is placed in the center of the sphere corresponding to the sound-emitting surface, with two legs of the human body, respectively, exit from the sound-emitting surface through the first cut and the second cut, and the upper part of the human body exits from the sound-emitting surface through the third cut.

2. Device for extracorporeal treatment with focused ultrasound of pelvic diseases according to claim 1, in which the edge of the first slice and the edge of the second slice are located in the first plane and the second plane, respectively.

3. Device for extracorporeal treatment with focused ultrasound of pelvic diseases according to claim 2, in which the first plane and the second plane are both parallel to the main great circle.

4. Device for extracorporeal treatment with focused ultrasound of pelvic diseases according to p.3, in which the distance between the first plane and the second plane is in the range from 200 mm to 400 mm.

5. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 3, in which the distance between the first plane and the main great circle is equal to the distance between the second plane and the main great circle.

6. Device for extracorporeal treatment with focused ultrasound of diseases of the pelvic organs according to claim 1, in which

the diameter of the sphere corresponding to the sound-emitting surface is in the range from 420 mm to 600 mm; and

within distances from 100 mm to 150 mm from the main great circle, respectively, on both sides of the main great circle, the corresponding arc central angle in the cross section of the sound emitting surface parallel to the main great circle is more than 180 degrees and less than 300 degrees.

7. Device for extracorporeal treatment with focused ultrasound of pelvic diseases according to claim 1, in which each cross-section of the sound-emitting surface parallel to the main great circle has the shape of an arc, and the central angle corresponding to the arc is more than 200 degrees and less than 260 degrees.

8. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 7, in which the arc opening in each cross-section of the sound-emitting surface, parallel to the main great circle, is oriented in the same direction, and the central angle corresponding to the arc is the same.

9. Device for extracorporeal treatment with focused ultrasound of diseases of the pelvic organs according to claim 1, in which the sound-emitting surface is symmetrical with respect to the main great circle.

10. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 1, in which, when the human body is on the treatment table in the lithotomy position, the ultrasound emitted by the first area of ​​the sound-emitting surface penetrates into the pelvic cavity through the abdominal cavity of the human body; and,

, when the human body is on the treatment table in the lithotomy position, ultrasound emitted from the second region of the sound-emitting surface penetrates the pelvic cavity through the area between the coccyx and the pubic symphysis of the human body.

11. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 10, further comprising:

first ultrasound probe for B-mode, configured to emit ultrasound to obtain images of the first area of ​​the sound-emitting surface into the pelvic cavity through the abdominal cavity of the human body to form an image of the pelvic cavity; and / or

a second B-mode ultrasound probe configured to emit ultrasound for imaging with a second area of ​​a sound emitting surface into the pelvic cavity through the perineum of the human body to form an imaging of the pelvic cavity.

12. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 1, in which

treatment table and ultrasound transducer are separate structures; and

The device for extracorporeal focused ultrasound treatment of pelvic diseases further comprises a movement unit configured to move the treatment table closer to or further from the ultrasound transducer.

13.The device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 1, further comprising:

medium-containing block configured to hold the sound-transmitting medium between the surface of the human body and the sound-emitting surface.

14. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 1, further comprising:

a drive unit configured to drive the ultrasonic transducer relative to the treatment table.

15. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 1, additionally comprising:

imaging unit configured to form an image of the pelvic cavity.

16. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 1, in which

ultrasound generated by the sound generating unit has a frequency in the range from 0.4 MHz to 1.5 MHz.

17.The device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 1, wherein the

ultrasound generated by the sound generating unit has an acoustic power in the range from 0 W to 1200 W.

18. Device for extracorporeal focused ultrasound treatment of pelvic diseases according to claim 17, in which

the acoustic power of ultrasound generated by the sound generating unit is in the range from 0 W to 800 W.

Page not found |

Page not found |

404.Page not found

Monthly archive

MonTueWedThuFtSaSun

27282930

12

12

1

3031

12

15161718192021

25262728293031

123

45678910

12

17181920212223

31

2728293031

1

1234

5678

12

8