CN112869796A

CN112869796A - Transurethral bladder suture system

Info

Publication number: CN112869796A
Application number: CN202110062935.2A
Authority: CN
Inventors: 奚伟; 郭剑明; 姜帅
Original assignee: Zhongshan Hospital Fudan University
Current assignee: Zhongshan Hospital Fudan University
Priority date: 2021-01-18
Filing date: 2021-01-18
Publication date: 2021-06-01
Also published as: CN218009823U

Abstract

The invention relates to a transurethral bladder suturing system, and belongs to the technical field of medical instruments. Comprises a stitching instrument and a double-ended needle; the tail end of the stitching instrument is provided with a mechanism for installing a double-ended needle; the stitching instrument comprises a fixer, a sight glass and a stitching needle holder; two ends of the double-ended needle are provided with annular grooves. The invention splits the complex suture action into simple actions and solves the problem that the suture can not be performed under the cystoscope. The boundaries of various operations under the cystoscope are widened, and the bladder can be sutured and completed under the cystoscope if tumors which need to be subjected to partial excision of the bladder in an open manner originally exist, so that the bladder is prevented from being communicated with the outside of the bladder. Is simple and minimally invasive, and avoids various defects of open surgery.

Description

Transurethral bladder suture system

Technical Field

The invention relates to a transurethral bladder suturing system, and belongs to the technical field of medical instruments.

Background

Bladder cancer is the most common malignancy of the urinary system, originating from transitional epithelial cells of the bladder. According to the infiltration depth, the bladder cancer can be divided into non-muscle invasive bladder cancer (NMIBC, 75% -85%) and muscle invasive bladder cancer (MIBC, 15% -25%). Surgical treatment of bladder cancer includes transurethral cystectomy (TURBT), open bladder partial resection, and radical cystectomy, both of which are bladder-preserving procedures.

TURBT enters bladder through urethra in the reverse direction, performs tumor electrosurgery and stops bleeding through electrocoagulation, and is a classic therapeutic method for treating bladder cancer. TURBT is operated through a natural channel, and the whole operation process is limited in the bladder, so that the TURBT has the advantages of minimal invasion, quick postoperative recovery and the like, but has the defects of easy residual tumor, easy stage underestimation and the like due to limited excision range. According to the report of the literature, the tumor stage after TURBT is 9-49% lower than the actual stage, the tumor leakage rate is 4-78%, and the 5-year recurrence rate is 50-80%. Retrospective analysis 2004 and 2008 for forest establishment and the like in China and 80 cases of 80 patients diagnosed with superficial bladder cancer by TURBT in the first 2008 find that after secondary electrotomy, 38 cases (47.5%) have tumor residues, wherein 79% of relapsers at the original part account for indicating that invisible tumor tissues exist near or in the depth of a primary focus of a large number of patients; the extension of the range and depth of primary excision helps to reduce residues, accurately stage and reduce recurrence rate. However, since there is no endoscopic bladder suturing device currently available, the depth and extent of TURBT resection is significantly limited. Although the excision range and depth (full layer) can be enlarged by the open bladder partial excision, the open bladder partial excision has the risks of large trauma, difficult discovery of tiny lesions at other parts in the operation, potential implantation metastasis and the like, and is not a clinical mainstream choice.

Analyzing the reasons for the above clinical problems, those skilled in the art would recognize that if a reliable and stable transurethral bladder suture medical device could be invented, it would be helpful to improve the therapeutic effect of bladder cancer, especially early bladder cancer. Meanwhile, the novel bladder treatment method also provides new treatment options for other diseases which may need bladder treatment (such as severe bladder perforation, bladder basket, bladder diverticulum excision and the like).

Disclosure of Invention

The invention aims to solve the technical problem of how to carry out endoscopic bladder suture.

At present, no technical scheme of transurethral bladder suture exists clinically, and any operation requiring bladder suture cannot be completed under a cystoscope. The invention solves the problem and provides minimally invasive selection for various scenes needing bladder suture.

In order to solve the above problems, the present invention adopts a technical solution of providing a transurethral bladder suturing system, comprising a suturing device and a double-ended needle; the tail end of the stitching instrument is provided with a mechanism for installing a double-ended needle; the stitching instrument comprises a fixer, a sight glass and a stitching needle holder; two ends of the double-ended needle are provided with annular grooves.

Preferably, the fixer is provided with a hollow lens channel for penetrating the endoscope, and an operation channel for penetrating and holding a suture needle is arranged adjacent to the lens channel; the end of the fixer close to the operator is provided with a sliding module sleeved on the lens channel, and one side of the sliding module, which is far away from the operator, is provided with a handle module fixed on the lens channel of the fixer.

Preferably, a distance adjusting device is arranged between the sliding module and the fixed handle module; the sliding module and the handle module are provided with channels which pass through the sight glass and the suture needle; one end of the sliding module close to the operator is provided with a connecting mechanism for connecting the fixer and the suture needle.

Preferably, the suture needle holder comprises a distal end jaw clamp, a main body rod and an operating handle; the operating handle is connected with the tail end claw clamp through the main body rod and is arranged on one side, close to an operator, of the sliding module.

Preferably, the tail end claw clamp comprises two needle holding clamps capable of opening and closing and two movable connecting rods; the main body rod comprises a sliding rod and an outer tube; after the two needle holding clamps are connected through a common rotating shaft, one end, close to an operator, of each of the two needle holding clamps is connected with one end of a movable connecting rod, the other ends of the two movable connecting rods are connected with sliding rods penetrating through the outer tube, and one ends, close to the operator, of the sliding rods are connected with operating handles.

Preferably, one end of the needle holding clamp, which is far away from the operator, is provided with a double-ended needle through hole for the double-ended needle to pass through.

Preferably, a movable fixing piece for fixing the double-ended needle is arranged in the through hole of the double-ended needle; a slide way for moving the movable fixing piece is arranged in the needle holding clamp; the movable fixing piece is connected with the needle holding clamp through an elastic connecting piece, and a pulling line used for moving the movable fixing piece is arranged on the movable fixing piece.

Preferably, the width of the annular groove arranged at the two ends of the double-ended needle is correspondingly matched with the thickness of the movable fixing piece.

Preferably, the double-ended needle is provided with an arc shape; the double-ended needle through hole on the needle holding clamp is arranged into an arc-shaped channel correspondingly matched with the arc-shaped double-ended needle.

Preferably, the movable fixing piece is connected with the needle holding clamp through a spring.

Compared with the prior art, the invention has the following beneficial effects:

1. the invention provides a device and a method for suturing bladder in cavity, the device of the invention enters bladder through urethra in reverse direction, and suturing bladder is carried out in bladder, thus widening the boundary of original bladder endoscope operation, being used for TURBT with wider scope and deeper (whole layer or near whole layer) when endoscope moves downwards, improving resection efficiency, reducing residue, accurately staging and reducing recurrence rate.

2. The invention splits the complex suture action into simple actions and solves the problem that the suture can not be performed under the cystoscope. The boundaries of various operations under the cystoscope are widened, and the bladder can be sutured and completed under the cystoscope if tumors which need to be subjected to partial excision of the bladder in an open manner originally exist, so that the bladder is prevented from being communicated with the outside of the bladder. Is simple and minimally invasive, and avoids various defects of open surgery. Meanwhile, the method is also suitable for various scenes needing bladder suture, such as a iatrogenic bladder perforation repair operation carried out under an endoscope, and an open surgery is avoided; secondly, bladder diverticulum excision is carried out in a descending manner by an endoscope, so that an open surgery is avoided; the bladder after the internal section of the bladder wall of the ureter is cut off is sutured in the hemiurotomy; fourthly, the micro-wound repairing instrument is matched with an electrotome or a cold knife and is used for micro-wound repairing of rectal bladder fistula and vaginal bladder fistula.

Drawings

FIG. 1 is a schematic view of the overall structure of the present invention;

FIG. 2 is a schematic view of a split structure of the present invention;

FIG. 3 is a schematic view of the fastener of the present invention;

wherein, the B figure is a side view of the tail structure of the fixer in the A figure E, and the C figure is a back view of the tail structure of the fixer in the A figure E; d is a partial enlarged view of the A and F;

FIG. 4 is a schematic view of a retainer handle module according to the present invention;

wherein, figure A is a side view of the handle module; FIG. B is a rear view of the handle module;

FIG. 5 is a schematic structural view of a sliding module of the fastener of the present invention;

wherein, figure A is a side view of the sliding module; b is a rear view of the sliding module;

FIG. 6 is a schematic view of a connection structure of a sliding module and a fixing device according to the present invention;

wherein, A is a side view of the connecting structure; FIG. B is a rear view of the connection structure;

FIG. 7 is a schematic view of the connection structure of the sliding module and the handle module according to the present invention;

FIG. 8 is a view showing the structure of a speculum according to the present invention;

FIG. 9 is a schematic view of a suture holding structure of the present invention;

wherein, the A is a side view of the suture needle holding structure; FIG. B is an enlarged view of a portion of the end jaw of FIG. A;

FIG. 10 is a schematic view of a needle holder according to the present invention;

wherein, the A picture is a perspective view of the needle holding clamp; FIG. B is a side view of the needle holder; FIG. C is a front view of the needle holder;

FIG. 11 is a schematic view of the needle holder clamping and releasing a double ended needle according to the present invention;

wherein, A is a schematic view of a needle holder clamping a double-ended needle; b is a schematic view of the double-ended needle released after the needle holding clamp pulls the traction line;

FIG. 12 is a schematic view of a double ended needle according to the present invention;

wherein, the A picture is a schematic diagram of a double-ended needle; b is an enlarged partial view of the end of the suture at C in the A;

FIG. 13 is a schematic view of a double-ended needle suturing process of the present invention;

reference numerals: 1. a holder; 2. a sight glass; 3. holding the suture needle; 4. a metal ring; 5. a handle module; 6. a sliding module; 7. a first clamping hole; 8. a first clamping hole release button; 9. a first spring; 10. a sliding tooth release lever; 11. clamping a needle; 12. a light beam connection port; 13. a main body lever; 14. an operating handle; 15. a second clamping hole; 16. a second clamping hole release button; 17. needle path; 18. fixing the metal sheet; 19. a second spring; 20. a slideway; 21. a pulling wire; 22. a needle tip; 23. a needle body; 24. a trench; 25. a suture; 26. a distal end jaw clamp; 27. a needle holding clamp; 28. a movable connecting rod; 29. a slide bar; 30. an outer tube; 31. a lens channel; 32. an operation channel; 33. and a lens entrance.

Detailed Description

In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:

as shown in FIGS. 1-13, the present invention provides a transurethral bladder suturing system comprising a suturing device and a double-ended needle; the tail end of the stitching instrument is provided with a mechanism for installing a double-ended needle; the stitching instrument comprises a fixer 1, a sight glass 2 and a stitching needle holder 3; the double-ended needle is provided with annular grooves 24 at both ends. The fixer 1 is provided with a hollow lens channel 31 for penetrating the sight glass 2, and an operation channel 32 for penetrating the suture needle holder 3 is arranged adjacent to the lens channel 31; the end of the fixer 1 close to the operator is provided with a sliding module 6 sleeved on the lens channel 31, and one side of the sliding module 6 far away from the operator is provided with a handle module 5 fixed on the lens channel 31 of the fixer 1. A distance adjusting device is arranged between the sliding module 6 and the fixed handle module 5; the sliding module 6 and the handle module 5 are provided with channels which pass through the sight glass 2 and the suture needle holder 3; the end of the sliding module 6 close to the operator is provided with a connecting mechanism for connecting the holder 1 and the suture needle holder 3. The suture needle holder 3 comprises a distal end jaw 26, a main body rod 13 and an operation handle 14; the operating handle 14 is connected to the end gripper 26 via the main body rod 13, and the operating handle 14 is provided on the side of the slide module 6 close to the operator. The end jaw clamp 26 comprises two needle holding clamps 27 capable of opening and closing and two movable connecting rods 28; the main body rod 13 includes a slide rod 29 and an outer tube 30; after the two needle holding clamps 27 are connected through a common rotating shaft, one end of each needle holding clamp 27 close to an operator is connected with one end of one movable connecting rod 28, the other end of each movable connecting rod 28 is connected with a sliding rod 29 penetrating through the outer tube 30, and one end of each sliding rod 29 close to the operator is connected with the operating handle 14. The end of the needle holding clamp 27 away from the operator is provided with a double-ended needle through hole for the double-ended needle to pass through, namely a needle channel 17. A movable fixing piece 18 for fixing the double-ended needle is arranged in the through hole of the double-ended needle; a slide way 20 for moving the movable fixing piece 18 is arranged in the needle holding clamp 27; the movable fixing piece 18 is connected with the needle holding clamp 27 through an elastic connecting piece, and a pulling line 21 for moving the movable fixing piece 18 is arranged on the movable fixing piece 18. The width of the annular groove 24 arranged at the two ends of the double-ended needle is matched with the thickness of the movable fixing piece 18 correspondingly. The double-ended needle is arc-shaped; the double-ended needle through hole on the needle holding clamp is arranged into an arc-shaped channel correspondingly matched with the arc-shaped double-ended needle. The movable fixing piece 18 is connected with the needle holding clamp 27 through a second spring 19.

As shown in FIG. 1, the suture instrument shown in FIG. 2 is composed of a holder 1, a scope 2 and a suture needle holder 3. After the stitching instrument is installed, the stitching instrument is connected with a sheath tube and a visualization system which are clinically used, and a video is displayed on a screen. The anchor 1 is used to carry a scope 2 and a suture needle holder 3, and the latter two are interlocked with each other in the anchor 1. The holder contains two channels, a lens channel 31 and an operation channel 32. The lens enters from the lens inlet 33 at the rear and is fixed with the fixer 1 through the clamping needle 11 and the clamping hole I7, and the fixing can be released by pressing the clamping hole release button I8.

The operation passage 32 is composed of the front ferrule 4, the handle module 5, and the slide module 6. The metal ring 4 is made of elastic metal sheet, the operation apparatus can be put in from the lower gap and is weakly fixed by the elastic metal ring, so that the apparatus can only move back and forth. The handle module 5 is fixed on the lens channel 31, and has a notch at the side, and the instrument can be transversely placed in the notch. The sliding module 6 is connected to the lens channel 31 of the holder by elastic means including a spring-9 (as shown in fig. 6) and can slide back and forth along the lens channel 31. The sliding module 6 is naturally close to the tail of the sheath, and the operator can push the handle on the sliding module to move the module forwards and fix the module at a specific position through a sliding tooth structure (as shown in fig. 7). When the operation instrument needs to be moved forwards, the sliding module is pushed forwards and is naturally fixed. When it is desired to move the operating instrument backwards, the sliding tooth release lever 10 is pressed backwards and the sliding module 6 is moved backwards.

The structure of the speculum body is similar to the lens of the current clinical electrotomy device as shown in fig. 8. The front end of the lens enters the lens channel 31 through the lens entrance 33 on the holder 1 and is exposed out of the front end of the holder 1. The clip needle 11 on the sight glass enters the clip hole I7 at the tail part of the fixer 1 to form fixation. The scope 2 is provided with a light guide beam connection port 12.

The suture needle holder 3 is composed of a distal end gripper 26, a main body rod 13, and an operation handle 14. After the suture needle holder is arranged in the sheath, the suture needle holder is fixed through the front metal ring 4, the operation channel 32 of the handle module 5 and the operation channel of the sliding module 6, the side surface of the suture needle holder 3 is provided with a clamping needle which is combined with the clamping hole II 15 arranged on the sliding module 6 to form fixation, so that the suture needle holder 3 can move along with the movement of the sliding module 6. A second clamping hole release button 16 is also arranged on the sliding module 6; the second card hole release button 16 is pressed to release the fixation of the suture needle and the sliding module 6.

The structure of the needle holding end claw clamp 26 is connected with the operating handle 14 through a joint and the main body rod 13, and the opening and closing of the two movable clamps at the tail ends are controlled through the movement of the handle of the operating handle 14.

The end jaw of the suture needle holder 3 has a special structure to fix or release the double-ended needle. The needle holder 27 of the movable jaw clamp comprises a through arc-shaped needle channel 17 near the end, and the cross section of the needle channel is the same as that of the double-ended needle. The needle holding clip 27 contains a fixed metal sheet 18, a second spring 19 and a slide way 20 for moving the fixed metal sheet 18. The end of the fixed metal sheet 18 is connected with a pulling line 21. The side wall of the channel of the needle channel 17 is provided with an inlet and an outlet for fixing the metal sheet 18 to enter and exit the needle channel 17; in a natural state, due to the pushing action of the second spring 19, the fixing metal sheet 18 is pushed to the end of the slideway 20, and the fixing metal sheet 18 partially enters the channel of the needle channel 17 of the needle holding clamp 27. When the double-ended needle enters the needle passage 17, the needle tip 22 presses the distal edge of the fixing metal sheet 18, causing the fixing metal sheet 18 to move backward. When the groove 24 of the needle body 23 is flush with the edge of the fixing metal sheet 18, the metal sheet 18 is suddenly inserted into the groove 24 under the action of the second spring 19, and the sewing needle is fixed. If the pull wire 21 is pulled backward and the metal sheet 18 moves backward, the sewing needle can be released (see fig. 11). The double-ended needle and the needle path are in the same radian, and the double-ended needle is prevented from rotating through the shape design of the groove 24 and the edge structure design of the fixed metal sheet 18, so that the double-ended needle can only move in the radian.

The double-ended needle is integrally arc-shaped, is matched with a needle channel on the suture needle and consists of a needle head 22, a needle body 23 and a suture 25. The cross section of the needle body 23 is a large semicircle which is matched with the section of the needle channel 17 held by the suture needle. The middle of the needle body is connected with an absorbable barbed suture 25, and the tail end of the absorbable barbed suture contains a movable hole (see figure 12) for tightening and fixing after the first needle is sutured. Both ends of the needle are pointed ends, both of which can be used as a needle to pierce tissue. The distal end of the needle body includes a groove 24 that is adapted to be inserted by the stationary blade 18 of the moveable jaw to be secured to the jaw of the stapler. When suturing, at least one side of the needle head of the double-ended needle is fixed on the claw clamp, and the suturing is completed through cross fixing and releasing.

At present, the operation can be completed only by electric excision and electric coagulation under the cystoscope, so the depth and the width of the excision are obviously limited. The suturing scheme under the cystoscope provided by the invention can greatly widen the boundaries of various operations under the cystoscope. The invention splits the sewing action into a plurality of forceps actions, so that the needle can be directly translated without turning the needle head after sewing. The complicated suturing action is separated into simple actions, so that the suturing under the cystoscope is possible.

The use process of the invention is as follows:

1. preparing:

in addition to the apparatus of the present invention, an endoscopic system (e.g., olympus) for TURBT, an irrigation device, and a sheath for TURBT are required.

2. And (4) connecting.

The system of the present invention was attached to the sheath used by the TURBT and to the fiber optics, camera, irrigation tubing.

3. And (6) sewing.

As shown in FIG. 13, the suture needle holder 3 is terminated with a double-ended needle, one end is fixed and the other end is in the needle track (to reduce the volume of the tip), and the suture instrument together with the double-ended needle is placed into the bladder from the sheath. The jaw clamps are opened, and at this time, the needle holding clamp 27a at one side fixes the double-ended needle, and the needle holding clamp 27a at the fixed needle is positioned outside the bladder wall at one side of the incision to be sutured and the needle holding clamp 27b at the other side is positioned in the incision by the overall movement of the suturing device or the back-and-forth movement of the suture needle holding (by the sliding module). The needle is held so that the needle penetrates the tissue and enters the needle channel 17 of the other needle holding clip 27b and is fixed. After the fixation is confirmed, the fixing metal piece 18 is pulled by the pulling wire 21, and the double-ended needle fixed on the original needle holding clip 27a is released, and the state of the double-ended needle is as follows: the side needle has penetrated into the tissue and passed out of the incision and is fixed to the needle holding clip 27 b. The needle is passed completely out of the wound with the double ended needle and the tail of the thread on either side of the tissue. The double-ended needle is returned and fixed to the needle holding clip 27a by the needle holding. The needle holding clamp 27a and the needle holding clamp 27b are respectively positioned in the wound and on the outer side of the bladder wall on the other side by moving the suturing device or suturing needle, and the first needle suturing is completed by clamping the needle, fixing the needle holding clamp 27b, releasing the needle holding clamp 27a, pulling and tightening and fixing the needle by a suture end coil structure. Subsequent stitching repeats the process. And (4) the last needle is sutured, and the last needle is crossed and penetrated with the sutured suture (the steps are the same as above) to form a plurality of single knots for fixation, so that the suturing is completed. Finally, the double-ended needle is released and the stapler is withdrawn.

While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims

1. A transurethral bladder suturing system is characterized in that: comprising a suturing device and a double-ended needle; the end of the suturing device is provided with a mechanism for installing the double-ended needle; the suturing device comprises a fixator, a speculum and a suture needle holder; Both ends of the double-ended needle are provided with annular grooves.

2. A transurethral bladder suturing system as claimed in claim 1, characterized in that: the fixator is provided with a hollow lens channel for passing a speculum, and a lens channel for passing a suture needle is provided adjacent to the lens channel an operation channel; the end of the holder close to the operator is provided with a sliding module sleeved on the lens channel, and the side of the sliding module away from the operator is provided with a handle module fixed on the lens channel of the holder.

3. A transurethral bladder suturing system as claimed in claim 2, characterized in that: a distance adjustment device is provided between the sliding module and the fixed handle module; the sliding module and the handle module are provided with a passing endoscope and the channel for the suture needle holder; the end of the sliding module close to the operator is provided with a connection mechanism for connecting the fixer and the suture needle holder.

4. A transurethral bladder suturing system as claimed in claim 3, wherein the suture needle holder comprises a terminal claw clip, a main body rod and an operating handle; the operating handle is connected to the terminal claw clip through the main body rod, and the operating handle is set. on the side of the sliding module close to the operator.

5 . The transurethral bladder suture system according to claim 4 , wherein the end claw clamp comprises two openable and closable needle-holding clamps and two movable links; the main body rod comprises sliding Rod and outer tube; after the two needle-holding clips are connected through a common rotating shaft, one end of the two needle-holding clips close to the operator is respectively connected with one end of a movable link, and the other end of the two movable links is then connected with the threaded rod. It is connected with the sliding rod in the outer tube, and the end of the sliding rod close to the operator is connected with the operating handle.

6 . The transurethral bladder suturing system according to claim 5 , wherein the end of the needle holder away from the operator is provided with a double-ended needle through hole for the double-ended needle to pass through. 7 .

7 . The transurethral bladder suture system according to claim 6 , wherein a movable fixing sheet for fixing the double-ended needle is provided in the through hole of the double-ended needle; A slideway for moving the piece; the movable fixing piece is connected with the needle holder through an elastic connecting piece, and a pulling wire for moving the movable fixing piece is arranged on the movable fixing piece.

8 . The transurethral bladder suture system according to claim 7 , wherein the width of the annular grooves provided at both ends of the double-ended needle corresponds to the thickness of the movable fixing sheet. 9 .

9 . The transurethral bladder suture system according to claim 8 , wherein: the double-ended needle is set as an arc; the through-hole of the double-ended needle on the needle holder is set as an arc-shaped double-ended needle through hole. 10 . For the corresponding matching arc channel.

10 . The transurethral bladder suturing system according to claim 9 , wherein the movable fixing piece is connected to the needle holder through a spring. 11 .