CN215458091U - Bladder autonomic nerve detector with adjustable length and angle - Google Patents

Abstract

This document relates to a length and angle adjustable bladder autonomic nerve probe. Provided herein is a nerve probe comprising: the nerve probe, the conducting rod, conducting rod length adjustment component, conducting rod angle adjustment component, operating handle, wherein the conducting rod distal end is connected with the nerve probe, and the conducting rod proximal end is connected with operating handle, conducting rod length adjustment component is connected with the conducting rod and is adjusted its length, conducting rod angle adjustment component is connected with the conducting rod and adjusts its angle. The length and the angle of the nerve detector provided by the utility model can be adjusted, the operation is simple, the depth and the flexibility of the deep operation of the pelvic cavity can be met, the difficulty of separating nerves can be reduced, and the operation effect can be improved.

Description

Bladder autonomic nerve detector with adjustable length and angle

Technical Field

The present invention relates to the field of medical devices. In particular, the present invention relates to a nerve detector for detecting nerves in surgical operations such as radical cervical cancer surgery.

Background

According to the National Cancer Complex Network (NCCN) guidelines, cervical radical cancer (also known as extensive total hysterectomy) and systemic lymphadenectomy are standard protocols for the treatment of early stage cervical cancer. Different types of cervical cancer radical surgery require the resection of a range of parauterine tissue to achieve the thoroughness of the tumor resection. A large number of pelvic autonomic nerves are distributed in the tissues beside the uterus, and are easily damaged in the operation, so that the patients have bladder, rectum and sexual dysfunction after the operation, wherein the bladder dysfunction is the most prominent. The incidence rates of dysuria, stress incontinence, urge incontinence, urinary frequency and urgency after cervical cancer surgery are reported in the literature to be 36% -47%, 20% -76%, 8% -45%, 23% and 19%, respectively. These seriously affect the quality of life of cancer survivors. Cervical cancer radical surgery (NSRH) for retaining pelvic autonomic nerves is a C1 type surgery of Querleu-Morrow new type (Q-M type), and has become a mainstream surgical approach for treating cervical cancer by retaining autonomic nerves, pelvic visceral nerves and hypogastric nerves that innervate the bladder to reduce the incidence of postoperative dysfunction of patients.

The hypogastric nerve mainly containing sympathetic nerve components is derived from the upper hypogastric plexus emitted from T10-12, runs in front of abdominal aorta, is divided into two branches of hypogastric nerves through the front of sacrum, runs below ureter, and clings to rectal mesentery to reach the level of pelvic uterine artery; the pelvic visceral nerve, which is predominantly parasympathetic, originates from the branch of S2-S4 emanating from the anterior sacral foramen. The pelvic autonomic nerve is intersected with pelvic visceral nerves at the uterine artery level via the hypogastric nerve to form a hypogastric plexus (also called pelvic plexus, IHP), runs on the anterior and lateral sides of the rectum to send out a uterine branch, a rectal branch, a urinary bladder branch and a vaginal branch, which respectively innervate the uterus, the rectum, the urinary bladder, the vagina and the clitoris. The bladder branches reach the bladder bottom through the cervix and the vaginal side wall and are the IHP branches which are most easily damaged in the cervical cancer radical operation. The bladder branches emanate from the ventral side of the IHP, spread in the superficial and deep layers of the bladder cervical ligament, immediately adjacent to the distal end of the ureter, and are located dorsolaterally within the mid and sub-vesical veins of the bladder.

IHP nerve fibers are tiny and difficult to accurately identify by naked eyes. Improper use of intraoperative energy devices can cause direct or indirect damage to nerve tissue, resulting in bladder voiding dysfunction in a post-operative patient. Therefore, accurate identification of the bladder branch of IHP is a key link in NSRH surgery, and is essential with the help of a nerve detection device.

Muallem M Z, et al, New spacing radial hysteresis: short-term environmental, scientific, and functional outcomes [ J ]. Cancers, 2020, 12 (2): 483. the ISIS Xpert nerve monitoring system was used in the study and included a manually guided disposable 400 mm ball-head stimulator probe and needle electrodes, signal amplifier and operating software NeuroExplorer. A catheter with a pressure transducer was placed inside the bladder to reflect changes in intravesical pressure caused by the contraction of the IHP limb. The detection system is complex, and the length and the angle of the stimulation probe and the needle electrode cannot be adjusted to meet the requirement of NSRH operation.

Katahira A, et al, internal electrical simulation of the physiological specific nerves and reducing-specific radial selectivity [ J ]. Gynecology on-demand, 2005, 98 (3): 462- & 466-in the study, a single long-handle bipolar electrode (8 mm in diameter and 40 cm in length) was used to stimulate IHP, and bladder contraction and increased pressure were observed via an intravesical pressure sensor. The nerve detection electrode is made of silver, IHP is easily damaged due to improper operation in the operation, and the length and the angle cannot be adjusted to meet the NSRH operation requirement of cervical cancer.

However, the nerve probe devices reported in the prior literature are not suitable for deep pelvic surgeries such as NSRH. There remains a need in the art for a bladder autonomic nerve monitor that is adaptable to the depth and flexibility of deep pelvic procedures.

SUMMERY OF THE UTILITY MODEL

A length and angle adjustable bladder autonomic nerve probe is provided herein to suit the depth and flexibility requirements of the procedure. The nerve probe provided herein is particularly suited for deep pelvic procedures such as NSRH.

The bladder autonomic nerve detector with the adjustable length and angle can be used for conveniently implementing NSRH (non-responsive relative humidity) operation of cervical carcinoma, detecting the position of IHP nerves in real time and detecting functions in the separation process, and accurately reserving the IHP nerve branches which dominate the bladder. The method is favorable for overcoming the problems of small neural structure and difficult recognition, reducing the difficulty of separating nerves and improving the operation effect of NSRH.

In some embodiments, provided herein are the nerve probes described in each of the following items.

1. A nerve probe, comprising: the nerve probe, the conducting rod length adjustment component, the conducting rod angle adjustment component and operating handle, wherein the conducting rod distal end is connected with the nerve probe, and the conducting rod proximal end is connected with operating handle, the conducting rod length adjustment component is connected with the conducting rod and is adjusted its length, the conducting rod angle adjustment component is connected with the conducting rod and is adjusted its angle.

2. The nerve detector of item 1, wherein the conducting rod includes inlayer conducting rod and outer conducting rod, forms inside and outside double-deck nested structure, and wherein the inlayer conducting rod is connected with nerve probe, and outer conducting rod is connected with operating handle, conducting rod length adjustment component includes sliding element, sliding element is connected with the inlayer conducting rod, makes nested structure's inlayer conducting rod and outer conducting rod relative movement through sliding element to adjust the length of conducting rod.

3. The nerve probe of item 2, wherein the diameter of the inner conductive rod is 0.50-0.90cm, the diameter of the outer conductive rod is 0.80-1.20cm, and the diameter of the inner conductive rod is smaller than that of the outer conductive rod, thereby forming an inner and outer double-layer nested structure.

4. The nerve probe of any of items 1 to 3, wherein the conductive rod angle adjusting element is an elastic element, the elastic element includes an operating member, a spring member and a leaf spring member, the elastic element is connected to the conductive rod through the leaf spring member, and the angle of the conductive rod is adjusted by the elastic element.

5. The nerve probe of item 4, wherein a degree of compression of the spring member in the elastic member is related to an angle of the conductive rod, and the angle of the conductive rod is adjusted by adjusting the degree of compression.

6. The nerve probe of any one of items 1 to 5, wherein the nerve probe comprises a brush-like structure of a plurality of wires.

7. The nerve probe of item 6, wherein the length of the filaments is 0.80 to 1.20cm, the diameter of a single filament is 0.08 to 0.12cm, the number of filaments is 8 to 10, and the filaments are arranged in a circular, polygonal or irregular shape.

8. The nerve probe of any one of items 1 to 7, wherein the operation handle is made of an anti-slip material or the surface of the handle includes anti-slip lines or particles.

9. The nerve probe of any one of items 1 to 8, wherein the nerve probe and/or the conductive rod is/are a conductive silicone material.

10. The nerve probe of any one of items 1-9, wherein the operating handle includes a lead interface through which a lead is connected to transmit the electrical signal from the nerve probe.

The nerve detector provided by the utility model can be used for detecting the autonomic nerve of a urinary bladder, the probe part can be made of a highly conductive silica gel material and can be arranged into a brush-shaped structure, the nerve detector is conductive and has the characteristic of soft material, and the nerve injury possibly caused by detecting the autonomic nerve of a pelvic cavity in an operation can be reduced.

The length of the nerve detector provided by the utility model can be adjusted in a sliding manner, the requirement of the NSRH operation of cervical cancer under the gynecological laparotomy and laparoscope on the force arm length of the nerve detector is met, and the nerve detector is suitable for the operation depth of patients with different body types.

The angle of the head of the nerve detector can be adjusted to adapt to anatomical structures and angle changes in a pelvic cavity, and operation of an operator is facilitated.

The nerve detector provided by the utility model can be used in cooperation with a nerve monitor comprising a detector current transmitting module and a bladder pressure sensor signal analyzing module, is simple to operate, can directly obtain the change waveform of the bladder pressure, and is convenient for an operator to use and analyze data.

Drawings

FIG. 1 shows a schematic cross-sectional view of a nerve probe according to an embodiment disclosed herein, wherein: 1, a nerve probe; 2, a conductive rod; 3, conducting rod angle adjusting elements; 4, operating a handle; and 5, a conducting rod length adjusting element.

Fig. 2 shows a schematic side view of a nerve probe of an embodiment disclosed herein, wherein: wire of a nerve probe (length may be, for example, 1.00 cm); 2, a conductive rod.

Fig. 3 shows a schematic front view of a nerve probe of an embodiment disclosed herein, wherein: the filaments of the nerve probe (which may be, for example, 0.10cm in diameter) may be arranged to form a square or circle (which may be, for example, 1.00cm in side length or diameter).

Fig. 4 shows a schematic relaxed state diagram of the conductive rod angle adjustment element (e.g., elastic element) of the nerve probe according to an embodiment disclosed herein, wherein: 31, an operating member; 32, a spring member (showing a relaxed state); 33, a leaf spring member.

Fig. 5 shows a schematic view of a compressed state of a conductive rod angle adjusting element (e.g., an elastic element) of a nerve probe according to an embodiment disclosed herein, wherein: 31, an operating member; 32, a spring member (showing a compressed state, a dotted line showing a horizontal line, an angle of the conductive rod being adjusted by spring compression); 33, a leaf spring member.

FIG. 6 shows a schematic side view of a conductive rod length adjustment element of a nerve probe according to an embodiment disclosed herein, wherein: 21, an inner layer conductive rod; 51, a sliding element; 22, outer conductive rod.

FIG. 7 shows a schematic front view of a conductive rod length adjustment element of a nerve probe according to an embodiment disclosed herein, wherein: 21, inner conductive rod (diameter may be 0.80cm, for example); 51, a sliding element; 22, outer conductive rod (diameter may be, for example, 1.00 cm).

FIG. 8 shows a schematic diagram of the operation of a nerve probe according to an embodiment disclosed herein, wherein: 4, operating a handle; 41, anti-skid lines; 42, a wire interface; 6, electric signal conducting wires; 7, a pressure sensor signal conducting wire; 8, a nerve monitor; 81, a current transmitting module; 82, a sensor data analysis module; 9, a double-cavity catheter with a pressure sensor; 91, a pressure sensing element; 92, an inner layer urethral catheterization cavity, a urethral catheterization hole and a miniature pressure sensing element are arranged at the top end of the inner layer urethral catheterization cavity, and the far end of the inner layer urethral catheterization cavity can be connected with a urethral bag; 93, an outer cavity for injecting water and fixing the catheter in the bladder; 94, urine bag connecting port.

Detailed Description

Exemplary embodiments herein are described below in conjunction with the appended drawings. Those skilled in the art will appreciate that modifications may be made to the detector without departing from the spirit and scope of the disclosure herein. Accordingly, the drawings and detailed description herein are to be regarded as illustrative in nature and not as restrictive. In some of the figures and examples, structures well known to those skilled in the art have not been shown in detail in order to enable a clear and concise description of the corresponding embodiments. However, it is to be understood that the present application encompasses various embodiments that enable corresponding functionality.

In some embodiments, provided herein is a nerve probe comprising: the nerve probe comprises a nerve probe 1, a conducting rod 2, a conducting rod length adjusting element 5, a conducting rod angle adjusting element 3 and an operating handle 4, wherein the far end of the conducting rod 2 is connected with the nerve probe 1, the near end of the conducting rod is connected with the operating handle 4, the conducting rod length adjusting element 5 is connected with the conducting rod to adjust the length of the conducting rod, and the conducting rod angle adjusting element 3 is connected with the conducting rod to adjust the angle of the conducting rod. In some embodiments, the conductive rod 2 in the nerve probe may include an inner conductive rod 21 and an outer conductive rod 22, forming an inner and outer nested structure, wherein the inner conductive rod 21 is connected to the nerve probe 1, the outer conductive rod 22 is connected to the operation handle 4, and the conductive rod length adjustment element 5 may include a sliding element 51 connected to the inner conductive rod 21, and the inner conductive rod 21 and the outer conductive rod 22 of the nested structure are relatively moved by the sliding element, so as to adjust the length of the conductive rod 2. In some embodiments, the sliding element 51 may comprise any suitable component, including, for example, a drawable wire connected to the inner conductive rod via a self-wound gear, the inner conductive rod and the outer conductive rod being moved relative to each other by the actuation of the drawable wire. In some embodiments, the inner conductive rod 21 in the nerve probe may have a diameter of 0.50-0.90cm (e.g., 0.50cm, 0.60cm, 0.70cm, 0.80cm, 0.90cm, or any range therebetween, such as 0.85cm), the outer conductive rod diameter 22 may be 0.80-1.20cm (e.g., 0.80cm, 0.90cm, 1.00cm, 1.10cm, 1.20cm, or any range therebetween, such as 1.05cm), and wherein the inner conductive rod diameter is less than the outer conductive rod diameter, forming an inner and outer double nested structure. In some embodiments, the conductive rod in the nerve probe may be adjusted in length in other ways, for example, may include a distal portion (connected to the nerve probe) and a proximal portion (connected to the operating handle), the distal portion and the proximal portion being connected by a resilient member therebetween, such that the overall length of the conductive rod is adjusted by compression of the resilient member. When the distal and proximal portions of the conductive rod are connected by the elastic member, the diameters of the distal and proximal portions are not limited, and may be such that the diameter of the distal portion is larger than, equal to, or smaller than the diameter of the proximal portion; the conductive rod length adjustment element may include a sliding element that may be coupled to the distal end portion of the conductive rod, and the length of the conductive rod may be adjusted by compressing and relaxing the elastic member between the distal end portion and the proximal end portion by the sliding element. In some embodiments, the conductive rod angle adjusting element 3 in the nerve probe may be an elastic element including an operating member 31, a spring member 32, and a leaf spring member 33, and the elastic element is connected to the conductive rod through the leaf spring member, and the angle of the conductive rod is adjusted by the elastic element. In some embodiments, the spring member 32 and the leaf member 33 may be directly connected or indirectly connected through a transmission mechanism. In some embodiments, the conductive rod angle may be adjusted by the resilient element in any suitable manner known in the art. In some embodiments, the degree of compression of the spring member in the resilient element is related to the angle of the conductive rod, and the angle of the conductive rod is adjusted by adjusting the degree of compression. In some embodiments, the nerve probe comprises a brush-like structure of a plurality of filaments 11. In some embodiments, the filaments in the brush-like structure may have a length of 0.80 to 1.20cm (e.g., 0.80cm, 0.90cm, 1.00cm, 1.10cm, 1.20cm or any range therebetween, e.g., 1.05cm), a single filament may have a diameter of 0.8 to 1.2mm (e.g., 0.80mm, 0.90mm, 1.00mm, 1.10mm, 1.20mm or any range therebetween, e.g., 1.05mm), and the number of filaments may be 8 to 10 (e.g., 8, 9, 10) arranged in a circle, polygon or irregular shape. In some embodiments, the surface of the operation handle 4 of the nerve probe includes anti-slip lines 41 or anti-slip particles. In some embodiments, the nerve probe and/or the conductive rod may be a conductive silicone material. In some embodiments, the operating handle 4 includes a lead interface 42 through which the electrical signals from the nerve probe are transmitted with the lead connection 6.

In some embodiments, the nerve probe, conductive rod, and manipulation handle may be of any suitable construction or material known in the art. For example, the shape of the nerve probe is not limited at all, and a sphere, a cylinder, a ring, a flat, a spoon, a hook, a prism, a needle, or the like can be used. When the nerve probe is provided with the brush structure, the brush can also form a spherical shape, a column shape, a ring shape, a flat shape, a spoon shape, a hook shape, a prism shape, a needle shape and the like. When the shape is formed, the length of each part wire forming the brush can be adjusted, so that a plane, convex surface or concave surface probe and tissue contact surface is formed, and the probe is suitable for flexibly detecting nerves in tissues. In some embodiments, the conductive rod may take the form of a central wire with an outer layer of a rigid material, so long as it is capable of conducting electrical signals and has some rigidity. In some embodiments, the operating handle may be shaped and sized for operation, and may be made of non-slip material, provided with non-slip threads and/or particles, to allow for flexible operation. In some embodiments, an operating switch or a control circuit device can be further arranged on the operating handle.

In some embodiments, the nerve detector with adjustable length and angle is provided, wherein the probe part adopts a high-conductivity silica gel material, the conductivity and the flexibility are simultaneously satisfied, the probe is in a hairbrush-shaped structure formed by a plurality of silica gel wires, the length is 1.00cm, the total diameter is 1.00cm, the diameter of a single silica gel wire is 0.10cm, the outer layer of the conductive silica gel rod outside the probe is provided with an insulating coating, and the far end is connected with the handle. The silica gel rod is of an inner-outer double-layer nested structure, the diameter of the outer layer is 1.00cm, the diameter of the inner layer is 0.80cm, the nested structure is connected with a sliding element, the silica gel rod on the inner layer can be pushed outwards or inwards, and the purpose of adjusting the length of the silica gel rod is achieved. Elastic element is connected to inlayer silica gel pole contactability, and when the spring was the relaxed state, silica gel pole and silica gel head were the horizontality, and when the spring compressed down, the metal shrapnel of compression element distal end compressed the silica gel pole correspondingly downwards, because of the handle end is fixed, then silica gel probe end can be the angle, and the angle is positive correlation with spring compression degree, reaches angle regulation's purpose. The surface of the handle is provided with threads to play a role in skid resistance, and the handle is connected with the lead and can transmit current stimulation signals. In some embodiments, the connection referred to herein may be a fixed connection or a flexible connection.

In some embodiments, the nerve probes provided herein may be used in conjunction with a dual lumen urinary catheter 9 with a pressure transducer. The catheter can be made of rubber, the outer layer cavity contains an inflatable balloon, and when the catheter is inserted into the bladder of a patient, 6-8ml of normal saline is injected into the outer layer cavity 93 to fix the catheter and prevent the catheter from falling off. The top end of the inner layer cavity 92 is provided with a micro sensor 91 which can sense the pressure change in the bladder and transmit signals to the nerve monitor analysis module, and the top end of the inner layer cavity is additionally provided with a small hole which can drain urine into a urine bag through a urine bag connecting port 94. In some embodiments, the nerve probes provided herein can be further used in conjunction with a nerve monitor 8. The nerve monitor may contain a current emission module 81 and a data analysis module 82. The current transmitting module can transmit stimulating current and pulse to the nerve detector through a lead, and the data analyzing module can recover pressure change signals transmitted back by the pressure sensor in the bladder and analyze the signals to form waveforms.

The nerve probe provided herein can operate as follows. After the patient is anesthetized, the double-cavity catheter with the pressure sensor at the head end is placed into the bladder, 8ml of normal saline is injected into the outer layer cavity to fix the catheter, the inner layer cavity is outwards connected with a urine bag, and the sensor signal conducting wire 7 is connected to the nerve monitor module. The nerve probe electrical signal conduction wires 6 are connected to the nerve monitor module.

And performing NSRH operation, dissecting pelvic cavity autonomic nerves and branches, and identifying bladder branches in the pelvic cavity autonomic nerves and branches by using the nerve detector in the operation and accurately reserving the bladder branches. Specifically, the method comprises the following steps: after separation of the pelvic autonomic nerve and each branch, the urinary bag is removed, 400ml of warm normal saline is injected into the bladder, so that the bladder is full, and the ureter is clamped. Turning on the nerve monitor, transmitting an electric signal: 30mA, 10s, 10Hz monophase burst pulse lasting 1 ms. And (3) selecting two time phases before and after the uterus resection, respectively and lightly scanning the IHP initial sections and bladder branches at two sides by using the head ends of the nerve detectors, observing the pressure change curve in the bladder displayed by the nerve monitor module, and recording and analyzing data. The length and the angle of the detector can be properly adjusted according to the requirement in the operation.

Claims (10)

1. A nerve probe, comprising: the nerve probe, the conducting rod, conducting rod length adjustment component, conducting rod angle adjustment component, operating handle, wherein the conducting rod distal end is connected with the nerve probe, and the conducting rod proximal end is connected with operating handle, conducting rod length adjustment component is connected with the conducting rod and is adjusted its length, conducting rod angle adjustment component is connected with the conducting rod and adjusts its angle.

2. The nerve probe of claim 1, wherein the conductive rod comprises an inner conductive rod and an outer conductive rod, forming an inner and outer nested structure, wherein the inner conductive rod is connected to the nerve probe, the outer conductive rod is connected to the operation handle, the conductive rod length adjustment element comprises a sliding element, the sliding element is connected to the inner conductive rod, and the inner conductive rod and the outer conductive rod of the nested structure are relatively moved by the sliding element, so as to adjust the length of the conductive rod.

3. The nerve probe of claim 2, wherein the diameter of the inner conductive rod is 0.50-0.90cm, the diameter of the outer conductive rod is 0.80-1.20cm, and the diameter of the inner conductive rod is smaller than that of the outer conductive rod, forming an inner and outer nested structure.

4. The nerve probe according to claim 1 or 2, wherein the conductive rod angle adjusting element is an elastic element, the elastic element includes an operating member, a spring member and a leaf spring member, the elastic element is connected with the conductive rod through the leaf spring member, and the angle of the conductive rod is adjusted through the elastic element.

5. The nerve probe according to claim 4, wherein a degree of compression of the spring member in the elastic member is related to an angle of the conductive rod, and the angle of the conductive rod is adjusted by adjusting the degree of compression.

6. A nerve probe according to claim 1 or claim 2, in which the nerve probe comprises a brush-like structure of a plurality of wires.

7. The nerve probe according to claim 6, wherein the length of the filament is 0.80-1.20cm, the diameter of the single filament is 0.08-0.12cm, the number of filaments is 8-10, and the filaments are arranged in a circular, polygonal or irregular shape.

8. The nerve probe of claim 1 or 2, wherein the operation handle is made of an anti-slip material or the surface of the operation handle comprises anti-slip grains or particles.

9. The nerve probe of claim 1 or 2, wherein the nerve probe and/or the conductive rod is a conductive silicone material.

10. The nerve probe of claim 1 or 2, wherein the operating handle includes a lead interface through which a lead is connected to transmit the electrical signal from the nerve probe.

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