CN106821444B

CN106821444B - Clip loader and delivery device for titanium-nickel-based shape memory alloy tissue closure clip

Info

Publication number: CN106821444B
Application number: CN201611201139.8A
Authority: CN
Inventors: 杨西群; 杨潇
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-12-22
Filing date: 2016-12-22
Publication date: 2023-06-27
Anticipated expiration: 2036-12-22
Also published as: CN106821444A

Abstract

A clip loader and a delivery device for a titanium-nickel based shape memory alloy tissue closure clip. The clamping device comprises a clamping cone assembly; the clamping cone assembly comprises a clamping cylinder, a clamping cone and a prism which are sequentially connected. The clamp can easily expand the titanium-nickel-based shape memory alloy tissue closing clamp from a planar layout, a dish-shaped layout or a bowl-shaped layout into a cylindrical layout, thereby realizing the opening of the closing clamp and temporarily fixing the closing clamp on a columnar closing clamp seat of the presenter. The discharging device comprises a discharging device and a clamping device, wherein the discharging device shell comprises a shell, a handle, a pushing rod unit arranged in the shell and a pushing ring unit arranged at the front end of the shell. The invention relates to a release device which is a special device for releasing a memory alloy tissue anastomosis clamp and is mainly used for vascular closure of gastrointestinal bleeding points, perforation of gastrointestinal tissues, excision of local tissue hyperplasia, excision of hemorrhoids, closure of anal fistula inner openings and the like.

Description

Clip loader and delivery device for titanium-nickel-based shape memory alloy tissue closure clip

Technical Field

The invention relates to a clamping device and a releasing device for a tissue closing clamp, in particular to a clamping device and a releasing device for a tissue closing clamp made of a titanium-nickel-based shape memory alloy material. The tissue closure clip of the invention is used for closing tissue perforation, anal fistula internal orifice and alimentary canal hemorrhage and cutting polyp tissue.

Background

At present, a disposable digestive tract closer is used as an auxiliary instrument, such as anastomosis of a notch by a stainless steel nail when the internal opening of the anal fistula is closed, or closure of the internal opening of the anal fistula by a purse string suture method. The device is a traumatic surgical instrument, a patient suffers great pain, and the stainless steel nails can stay in the human body for a long time, even cause surgical failure.

For this reason, the applicant has invented a tissue closure clip for a titanium-nickel based shape memory alloy, see fig. 1 to 46, which uses shape memory characteristics and superelasticity of the titanium-nickel based shape memory alloy, opens below a set temperature or under the action of an external force, automatically closes after unloading above the set temperature or external force, and continuously and automatically pressurizes a lesion to achieve the purpose of treatment. However, the shape memory characteristics, superelasticity, and sterility requirements of the titanium-nickel based memory alloy closure clip during surgery make it difficult to open and temporarily secure the clip to the closure clip seat of the delivery device, and it is also very difficult to unload the external force to accurately close the device to the lesion. Therefore, there is a need for a clip and delivery device for use with a closure clip.

Disclosure of Invention

One of the objects of the present invention is to provide a clip for a new titanium-nickel based shape memory alloy tissue closure clip for use in surgical procedures that can be easily opened and temporarily secured to the closure clip seat of a presenter.

The invention also aims to provide a delivery device for a new titanium-nickel-based shape memory alloy tissue closure clip used in the operation process, which can temporarily fix the shape of the opened closure clip and then rapidly and accurately release the closure clip according to the action of a doctor.

The technical scheme of the invention is as follows:

the clamp for the titanium-nickel-based shape memory alloy tissue closing clamp is characterized in that: comprises a clamping cone assembly 40; the clamping cone assembly 40 comprises a clamping column 41, a clamping cone 43 and a prism 42 which are sequentially connected; a plurality of second guide slots 411 are uniformly distributed on the circumferential side surface of the clamping cylinder 41; a plurality of clamping cone grooves 431 are uniformly distributed on the conical surface of the clamping cone 43; the prism 42 includes a plurality of prisms 421 uniformly distributed around the circumference; the number of prisms 421 corresponds to the number of arcuate segments 92 in the closure clip 90 and the cross-sectional shape of the prism 42 matches the spacing between arcuate segments 92 in the closure clip; the prism 421 corresponds to the position of the second guide slot 411; one end of each clamping cone groove 431 is positioned at the middle position of two adjacent prisms 421, and the other end of each clamping cone groove is positioned at the middle position of two adjacent second guide grooves; the outer diameter of the clamping cylinder 41 is matched with the outer diameter of the closed clamping seat 22 of the player 80; the second guiding slots 411 are in one-to-one correspondence with the positions of the first guiding slots 221 on the closing clip seat 22.

The clamping cone assembly 40 further comprises a positioning column 44 arranged on the outer end surface of the clamping column 41; the locating post 44 mates with the through hole 21 of the closure clip seat 22 of the presenter 80.

The positioning column is provided with a positioning edge 441; the positioning ribs 441 are matched with positioning grooves on the through holes 21 of the closing clip seat 22 of the presenter 80.

Also included is a chuck assembly 30; the clamping seat assembly 30 comprises a shell, a plurality of clamping plates 31, a clamping column hole 32, a clamping taper hole 34 and a prismatic hole 33 which are sequentially arranged inwards from one end part of the shell; the clamping taper hole 34 is matched with the clamping taper 43 in shape; the prism holes 33 are matched with the prism body 42 in shape; the clamping plates 31 are circumferentially and uniformly distributed on the inner side surface of the clamping column hole 32; the outer end part of the inner side edge of each clamping plate is provided with a clamping tooth 311; the clamping plates 31 are consistent in number and position with the second guide slots 411 in a one-to-one correspondence manner; the latch 311 can clamp the corresponding outer arc section 91 of the closing clip 90, so as to drive the closing clip with a planar layout, a dish layout or a bowl layout to move to the clamping cylinder 41 after passing through the prism 42 and the clamping cone, and expand into a cylindrical layout.

The clamp further includes a reverse seat assembly 50; the inverted seat assembly 50 includes a stepped inverted post 52 and an inverted sleeve 51 fitted over the inverted post 52; a plurality of third guide slots 521, the number of which is identical to that of the second guide slots 411 and the positions of which are in one-to-one correspondence, are provided on the circumferential side surface of the reverse column 52; the outer diameter of the reverse column 52 is identical to the outer diameter of the positioning column 44; the reversing sleeve can move along the reversing column under the action of external force and reset under the action of an internal spring.

The inverted seat assembly 50 further includes an inverted positioning post 53 disposed on an outer end surface of the inverted post 52; the outer end surface of the clamping cylinder 41 is provided with a reverse column hole 45, and the reverse column hole 45 is matched with a reverse positioning column 53.

The number of prisms 421 is 3, 4, 5, 6, 8.

The device also comprises a presenter and any clamping device; wherein: the player comprises a shell, a push rod unit arranged in the shell and a push ring unit arranged at the front end of the shell; the shell is provided with a handle, and the handle and the shell are of a buckled cavity structure; the pushing rod unit comprises a trigger, a pushing rod, a reset spring and a limiting device; the push rod can move forwards under the action of the trigger and the limiting device and returns to the original position under the action of the reset spring and the limiting device; the pushing ring unit comprises an upper pressing seat, a lower pressing seat, a steel wire fixing seat, two steel wires and a pushing ring; the upper pressing seat and the lower pressing seat are buckled up and down to form an L-shaped tubular cavity structure, the rear end of the upper pressing seat and the lower pressing seat are connected with the front end of the shell, the front end of the upper pressing seat and the lower pressing seat downwards turns 80-100 degrees to form a closed clamping seat, and the closed clamping seat is provided with a through hole which penetrates up and down; the steel wire fixing seat is arranged at the rear end of the L-shaped tubular cavity structure and is connected with the front end of the pushing rod; the rear ends of the two steel wires are respectively fixed on the steel wire fixing seat, the middle parts of the two steel wires are arranged between the upper pressing seat and the lower pressing seat in parallel, and the front ends of the two steel wires are respectively hinged with the pushing rings sleeved outside the closed clamping seat.

The limiting device comprises a front limiting seat and a rear limiting seat which are arranged in the shell, the front part of the push rod is arranged in front of the front limiting seat, the middle part of the push rod is arranged between the front limiting seat and the rear limiting seat, a spring seat is arranged on the push rod, the reset spring is sleeved in the middle part of the push rod and is positioned between the front limiting seat and the spring seat, the rear part of the push rod is arranged behind the rear limiting seat, and a trigger groove is arranged below the push rod; the trigger is arranged on the inner side of the handle, one end of the trigger extends out of the handle, and the other end of the trigger is clamped into the trigger groove; the steel wire fixing seat is connected with the pushing rod through a rotating mechanism, the steel wire fixing seat is connected with one end of the rotating mechanism, the pushing rod is connected with the other end of the rotating mechanism, and the steel wire fixing seat can rotate around the central shaft of the pushing rod; the rotating mechanism comprises a fixed shaft and a movable shaft, a boss is arranged at the end part of the movable shaft, the boss is fixedly connected with the steel wire fixing seat through a neck, and the diameter of the boss is larger than that of the neck; the fixed shaft is provided with a clamping groove matched with the boss and a rotation limiting groove matched with the neck, the boss can be clamped into the clamping groove from the side face of the fixed shaft and rotate in the clamping groove, and the neck can be clamped into the rotation limiting groove from the side face of the fixed shaft and rotate in the rotation limiting groove.

The push rod unit further comprises a safety mechanism; the safety mechanism is a safety bracket, one end of the safety bracket is hinged to the middle part of the inner side of the trigger, and the other end of the safety bracket can be clamped on the inner side of the handle so as to fix the angle of the trigger relative to the handle; the handle and the shell are of a pistol-shaped cavity structure which is buckled left and right.

The beneficial effects of the invention are as follows:

1. the invention has simple operation process. The invention relates to a release device which is a special device for releasing a memory alloy tissue anastomosis clamp and is mainly used for vascular closure of gastrointestinal bleeding points, perforation of gastrointestinal tissues, excision of local tissue hyperplasia, excision of hemorrhoids, closure of anal fistula inner openings and the like. When the invention is used for tissue closure, the closure clip is clamped on the tissue perforation inner opening and outer opening, the inner arc section of the closure clip or the tooth-shaped bulge on the inner arc section automatically pressurizes the tissue to be anastomosed on the inner opening and outer opening of the tissue under the action of body temperature, the tissue on the inner opening and outer opening of the tissue does not form new wound, good blood circulation is maintained while the tissue tension is overcome, the closure of the tissue perforation inner opening is promoted, and the operation effect is good.

2. The closed clamp disclosed by the invention keeps good blood circulation at one end of clamped tissue, and when the tissue orifice is promoted to heal, the tissue necrosis at the other end of clamped tissue caused by tissue ischemia causes the closed clamp to automatically fall off, so that no foreign matters are left in the body.

3. The tissue closing clamp can be detached by a tool under special conditions, and can also be implanted into a body for a long time.

4. The invention has the dual functions of tissue excision and tissue anastomosis.

5. The invention adopts a centripetal closing mode, can realize omnibearing closing and has better closing effect than the prior parallel closing mode.

6. The invention relates to a non-invasive surgical instrument.

7. The invention has simple structure and convenient operation, can achieve the aim of tissue excision or anastomosis, and lightens the operation burden of doctors.

8. The pushing rod unit and the pushing ring unit of the delivery device adopt structures such as a coupler, a rotary joint and the like, so that the pushing ring unit can rotate around the shaft of the pushing ring unit under the condition that the handle is not moved, and the pushing ring unit is suitable for focuses at different angles.

9. The clamp can easily expand the titanium-nickel-based shape memory alloy tissue closing clamp from a planar layout, a dish-shaped layout or a bowl-shaped layout into a cylindrical layout, thereby realizing the opening of the closing clamp and temporarily fixing the closing clamp on a columnar closing clamp seat of the presenter.

10. The clamp can realize the forward mounting or reverse mounting of the closed clamp, and is suitable for various focuses.

11. The clamping device is simple in structure and convenient to use.

Drawings

FIGS. 1-4 are schematic views of a tissue closure clip comprising 3 outer arc segments; wherein:

FIG. 1 is a front view of a memory before deformation;

FIG. 2 is a perspective view of the ribbon prior to memory deformation, showing the ribbon in the same plane;

FIG. 3 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 4 is a perspective view of the memory after deformation, showing the inner arc offset to one side;

FIGS. 5-8 are schematic views of a tissue closure clip comprising 3 outer arc segments with toothed projections at the top of the inner arc segments; wherein:

FIG. 5 is a front view of the memory before deformation;

FIG. 6 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 7 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 8 is a perspective view of the memory after deformation, showing the inner arc offset to one side;

FIGS. 9-12 are schematic views of a tissue closure clip comprising 4 outer arc segments; wherein:

FIG. 9 is a front view of the memory before deformation;

FIG. 10 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 11 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 12 is a perspective view of the memory deformed inner arc segment as seen to shift to one side;

FIGS. 13-16 are schematic views of a tissue closure clip comprising 4 outer arc segments with toothed projections at the top of the inner arc segments; wherein:

FIG. 13 is a front view of the memory before deformation;

FIG. 14 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 15 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 16 is a perspective view of the memory after deformation, showing the inner arc offset to one side;

FIGS. 17-20 are schematic views of a tissue closure clip including 5 outer arc segments; wherein:

FIG. 17 is a front view before memory deformation;

FIG. 18 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 19 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 20 is a perspective view of the memory deformed inner arc segment as seen to shift to one side;

FIGS. 21-24 are schematic views of a tissue closure clip comprising 5 outer arc segments with toothed projections at the top of the inner arc segments; wherein:

FIG. 21 is a front view of the memory before deformation;

FIG. 22 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 23 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 24 is a perspective view of the memory after deformation, showing the inner arc offset to one side;

FIGS. 25-28 are schematic views of a tissue closure clip comprising 6 outer arc segments; wherein:

FIG. 25 is a front view of the memory before deformation;

FIG. 26 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 27 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 28 is a perspective view of the memory deformed inner arc segment as seen to shift to one side;

FIGS. 29-32 are schematic views of a tissue closure clip comprising 6 outer arc segments with toothed projections at the top of the inner arc segments; wherein:

FIG. 29 is a front view of the memory before deformation;

FIG. 30 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 31 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 32 is a perspective view of the memory deformed inner arc segment as seen to shift to one side;

33-36 are schematic views of a tissue closure clip comprising 8 outer arc segments; wherein:

FIG. 33 is a front view before memory deformation;

FIG. 34 is a perspective view of the ribbon prior to memory deformation, as can be seen in the same plane;

FIG. 35 is a bottom view of the memory deformed, showing the inner arc offset to one side;

FIG. 36 is a perspective view of the memory after deformation, showing the inner arc offset to one side;

FIGS. 37-38 are schematic views of a tissue closure clip comprising 8 outer arc segments with toothed projections at the top of the inner arc segments; wherein:

FIG. 37 is a front view before memory deformation;

FIG. 38 is a perspective view of the memory after deformation, showing the inner arc offset to one side;

FIG. 39 is a schematic view of a tissue closure clip comprising 4 outer arc segments, toothed projections on the top of the inner arc segments, 4 parallel clips with the toothed projections disposed on the parallel clips;

FIG. 40 is a schematic view of a tissue closure clip comprising 4 outer arc segments, toothed projections on the top of the inner arc segments, 4 parallel clips with the toothed projections and grooves disposed on the parallel clips;

FIG. 41 is a schematic view of a tissue perforation inner port closure clip comprising 4 outer arc segments, toothed projections on the top of the inner arc segments, 4 parallel clips with rounded projections and rounded runners disposed on the parallel clips;

FIG. 42 is a schematic view of an open state of a tissue perforation inner port closure clip comprising 3 outer arc segments, toothed projections on the top of the inner arc segments, 3 parallel clips with rounded projections and rounded runners disposed on the parallel clips;

FIG. 43 is a schematic view of a tissue piercing inner port closure clip comprising 3 outer arc segments, 3 toothed projections on the top of the inner 3 arc segments, 3 parallel clips with rounded protrusions and rounded runners disposed on the parallel clips;

FIG. 44 is a schematic perspective view of the tissue penetrating inner port closure clip of FIG. 43;

FIG. 45 is a schematic view of another tissue closure clip comprising 4 outer arc segments, toothed projections on top of the inner arc segments, 4 parallel clips with the toothed projections disposed on the parallel clips;

FIG. 46 is a schematic view of another tissue closure clip comprising 4 outer arc segments, toothed projections on the top of the inner arc segments, 4 parallel clips with rounded protrusions and rounded runners disposed on the parallel clips;

FIG. 47 is a cross-sectional view of the presenter;

FIG. 48 is a schematic view of the push ring unit with the upper press seat removed;

FIG. 49 is a schematic view of the construction of a push ring unit;

FIG. 50 is an overall view of the presenter;

FIG. 51 is an exploded schematic view of the presenter;

FIGS. 52 and 53 are schematic structural views of a chuck cone assembly of the present invention;

FIG. 54 is a schematic view of a chuck assembly of the present invention;

FIG. 55 is a cross-sectional view of FIG. 54;

FIG. 56 is an initial state diagram of a closure clip being installed on a chuck assembly of the present invention and the chuck assembly not yet installed;

FIG. 57 is a schematic view of the initial position of the cartridge assembly, the chuck cone assembly, the closure clip, and the presenter;

FIG. 58 is a schematic view of the cartridge assembly pressing the closure clip into the chuck assembly;

FIG. 59 is a schematic view of the fully engaged position of the chuck assembly and presenter;

FIG. 60 is a schematic view of the closed clamp position of the clamp shoe assembly just prior to disengagement from the presenter;

FIG. 61 is a schematic view of the presenter position of the cartridge assembly as it would come off the presenter;

FIG. 62 is an initial state diagram of a closure clip being installed on the chuck assembly of the present invention and the chuck assembly not yet installed;

FIG. 63 is a schematic view of the position of the closure clip being mounted on the inverted seat assembly of the present invention;

FIG. 64 is a schematic view of the location of the closure clip on the closure clip seat of the presenter of the present invention;

reference numerals: 1-handle, 2-trigger, 3-trigger torsion spring, 4-safety bolt, 5-rear limit seat, 6-trigger slot, 7-push rod, 8-safety bolt slot, 9-front limit seat, 10-return spring, 11-buckle, 12-housing, 13-rotary joint, 14-coupler, 15-wire holder, 16-fixing bolt, 17-wire, 18-upper press seat, 19-lower press seat, 20-push ring, 21-through hole, 22-closing clamp seat, 221-first guide slot, 23-spring seat, 24-guide post, 25-guide cone, 26-clamping neck, 27-safety bracket, 30-clamping seat assembly, 31-clamping plate, 311-clamping tooth, 32-clamping post hole, 33-clamping prismatic hole, 34-clamping taper hole, 40-clamping taper assembly, 41-clamping cylinder, 411-second guiding groove, 42-prismatic body, 421-prismatic body, 43-clamping taper, 431-clamping taper groove, 44-positioning column, 441-positioning groove, 45-inverted positioning hole, 451-inverted positioning hole groove, 50-inverted seat assembly, 51-inverted sleeve, 52-inverted column, 521-third guiding groove, 53-inverted positioning column, 80-emitter, 90-closing clip, 91-outer arc section, 92-inner arc section, 93-toothed protrusion, 94-clip body, 941-sharp tooth, 942-V-shaped groove, 943-rounded protrusion, 944-rounded groove.

Detailed Description

Referring to fig. 1 to 46, the titanium-nickel-based shape memory alloy tissue closing clip comprises a closing clip main body, wherein the closing clip main body is a closed strip made of titanium-nickel-based shape memory alloy material, and the strip is formed by sequentially connecting at least three outer arc sections and the same number of inner arc sections in a staggered manner end to form a planar layout, a dish-shaped layout or a bowl-shaped layout; the cone angle of the closed strips of the dish-like or bowl-like arrangement ranges from 120 to 180 °, preferably 160 °. The closure strip is processed into clinically desirable memory properties from a titanium nickel based shape memory alloy material having superelasticity above memory temperature. The shape of the memory device can be changed when the external force acts on the memory device or is lower than the memory temperature, and the memory shape is restored after the external force is unloaded or is higher than the memory temperature again. The optimum number of outer arc segments is 3 or 4, and 5, 6 or 8 may be used as required.

The strip is made of a titanium-nickel-based shape memory alloy material, has super elasticity at the memory temperature, can change the shape under the action of external force, and recovers the memory shape after the external force disappears.

In order to achieve the best operation effect, the memory shape is set under the condition of memory temperature, the diameter of the circle where the tops of all the inner arc sections are positioned is 1-4mm, and the diameter of the circle where the tops of all the outer arc sections are positioned is 10-20mm; the diameter of the circle where the top of the inner arc section is located can be changed under the condition of being lower than the memory temperature and being subjected to external force, and the diameter is the same as the size of the outer arc. When the memory temperature is reached or exceeded and the external force is unloaded, the diameters of the circles where the tops of all the inner arc sections are close to the center of the strip are restored to 1-4mm.

In order to prevent the closing clamp from accidentally falling off, a better closing effect can be achieved, and tooth-shaped bulges can be arranged at the top of each inner arc section and face the center of the closing clamp.

To further enhance the closing effect, the closing clip may further comprise parallel clips in a number consistent with the number of outer arc segments; each parallel clamp comprises two clamp bodies which are arranged in parallel; the fixed ends of the two clamp bodies are respectively fixedly connected with the two ends of the outer arc section, and the non-fixed ends of the two clamp bodies are positioned in the area surrounded by the outer arc section.

In order to prevent the two clamping bodies from accidentally falling off in the closing process, the opposite side edges of the two clamping bodies can be respectively provided with a meshing device. The engagement device can have various structural forms, and the main three structures are:

1. the meshing device comprises at least one convex pointed tooth, and the pointed tooth is staggered with the pointed tooth position of the opposite clamp body; in fig. 41, each clip body includes two tines, with 4 tines of each closure clip staggered.

2. The engagement device comprises at least one convex pointed tooth and a concave groove, the number and the shape of the groove are matched with those of the pointed teeth of the opposite clamp body, for example, the groove can be a smooth groove or a V-shaped groove; in fig. 42, each clip body includes 2 sharp teeth and 2 circular sliding grooves, and the sharp teeth are arranged corresponding to the circular sliding grooves on the opposite clip body.

3. The engagement device comprises at least one convex round protrusion and a concave round chute, and the round chute is matched with the round protrusion of the opposite clamp body in number and shape; in fig. 43, each clip body includes a rounded protrusion and a rounded chute.

The closing clamp is clamped on the peripheral tissue of the inner opening of the tissue perforation, the inner arc section or the inner arc section and the toothed bulge of the closing clamp with super elasticity jointly pressurize the inner opening of the tissue to be anastomosed, and when pressurizing, the tissue on the side with good blood circulation is proliferated, so that the inner opening heals, and the purposes of no wound and no foreign matter left in the body are achieved.

The working principle of the closing clamp is as follows: a titanium-nickel-based shape memory alloy tissue closure clip comprises a closure clip body composed of a closed strip; the closed strip is sequentially connected with the same number of inner arc sections from head to tail by at least three outer arc sections which are staggered; the closed strips form a planar, dished or bowl-like arrangement; the closed strip is made of a titanium-nickel-based shape memory alloy material having superelasticity above a memory temperature, and can change its shape when an external force acts or is below the memory temperature, and resume the memory shape after the external force is unloaded or is again above the memory temperature.

The working principle of the titanium-nickel-based shape memory alloy tissue closure clip is that the temperature effect and the super-elastic function of the titanium-nickel-based shape memory alloy are utilized to be pulled open under the action of low temperature and external force, the titanium-nickel-based shape memory alloy tissue closure clip is closed and restored to a memory shape at high temperature, the physiological mechanisms of human tissue proliferation and necrosis are combined, and the reasonability of the structural design of the titanium-nickel-based shape memory alloy tissue closure clip is realized, so that the aim of tissue anastomosis is fulfilled.

The closing clamp made of the shape memory functional characteristics of the titanium-nickel-based shape memory alloy material is released at the focus, so that the closing clamp which can be changed along with the temperature or under the action of external force can play the leading role of clinically implementing the operation.

Tissue anastomosis: the memory alloy anal fistula internal orifice closing clamp is memorized into a semi-closed state, and the closing gap is about 1-2 mm. The closed clamp is pulled open and then sleeved on the closed clamp seat of the dispenser, the trigger is pulled, the pushing rod moves forwards to drive the steel wire to move forwards, and the steel wire drives the pushing ring to move downwards to push the closed clamp to the tissue to be closed. If necessary, the tissue is bound by the thread, the thread is penetrated out of the through hole and tensioned, the tissue is pulled into the closing clamp, then the trigger is pulled, the closing clamp is released, the annular center clamps the tissue to be closed, and the automatic pressurization is continuously carried out, so that the tissue is tightly pressed and anastomosed. The pressurized tissue has good blood circulation, and the pressurized tissue proliferates to form scar tissue, which provides tissue regeneration and achieves the aim of tissue anastomosis.

Tissue excision: the memory alloy anal fistula internal orifice closing clamp is memorized into a complete closing state, and the rest steps are identical to tissue anastomosis. The pressurized ring causes ischemia of the tissue and necrosis of the tissue, and the tissue proliferation of the other surface outside the ring causes anastomosis of the tissue while the necrosis of one surface of the tissue in the ring. Because the inside tissue is ischemic and necrotized, an incision is formed, the necrotic tissue falls off, and the titanium-nickel shape memory alloy closing clip also falls off, and is discharged outside the body under the action of intestinal peristalsis after falling off, so that no foreign matters are left in the body.

Reliability of the closure clip: the constant pressure characteristic of the closing clamp made of the titanium-nickel-based shape memory alloy plates with different thicknesses determines and can compensate different tissue thicknesses, and stable and lasting pressure is generated on the tissue, so that a uniform and controllable pressurizing anastomosis process is ensured. The tissue of the tissue anastomosis part is regenerated in different time, and the necrotic tissue falls off, so that the reliability of tissue anastomosis is ensured.

Time to break off the closure clip: the working principle of the titanium-nickel-based shape memory alloy anal fistula inner opening closing clamp is that the temperature effect function of the titanium-nickel-based shape memory alloy is utilized to pull open at low temperature, the closing is restored to a memory shape at high temperature, the tissue healing time is ten days in combination with the physiological mechanism of human tissue proliferation and necrosis, and the closing clamp falls off to exclude the outside after ten days. The design principle and the design structure of the titanium-nickel-based shape memory alloy tissue closing clamp are more scientific and simpler than all metal nail anastomosis devices in clinic at present in clinical operation and use, and the titanium-nickel-based shape memory alloy tissue closing clamp is an ideal tissue closing clamp instrument.

52-61, the positive mounting type titanium-nickel-based shape memory alloy tissue closing clamp comprises a clamping cone assembly 40 and a clamping seat assembly 30; the clamping cone assembly 40 comprises a positioning column 44, a clamping column 41, a clamping cone 43 and a prism 42 which are sequentially connected; 4 axial second guide slots 411 are uniformly distributed on the circumferential side surface of the clamping cylinder 41; 4 clamping cone grooves 431 are uniformly distributed on the conical surface of the clamping cone 43; the prism body 42 comprises 4 prisms 421 uniformly distributed on the circumference; the cross-sectional shape of the prism matches the spacing between the arcuate segments 92 in the closure clip; the number of prisms 421 corresponds to the number of arcuate segments 92 in the closure clip 90; the prism 421 corresponds to the position of the second guide slot 411; each clamping cone groove 431 is positioned at the middle position of two adjacent prisms 421; the outer diameter of the clamping cylinder 41 is matched with the outer diameter of the closed clamping seat 22 of the player 80; the second guiding slots 411 are in one-to-one correspondence with the positions of the first guiding slots 221 on the closed clamp seat 22; the clamping seat assembly 30 comprises a shell, 4 clamping plates 31 which are axially arranged, a clamping column hole 32, a clamping taper hole 34 and a prismatic hole 33 which are sequentially arranged inwards from one end part of the shell; the clamping taper hole 34 is matched with the clamping taper 43 in shape; the prism holes 33 are matched with the prism body 42 in shape; the 4 clamping plates 31 are circumferentially and uniformly distributed on the inner side surface of the clamping column hole 32; the outer end part of the inner side edge of each clamping plate is provided with an overhanging clamping tooth 311; the clamping plates 31 are consistent in number and position with the second guide slots 411 in a one-to-one correspondence manner; the latch 311 can clamp the corresponding outer arc segment 91 of the closing clip 90, so as to drive the closing clip with planar layout, dish layout or bowl layout on the prism to move to the clamping cylinder 41 after passing through the prism and the clamping cone, and expand into the closing clip with cylindrical layout. The locating post 44 mates with the inner bore of the closure clip seat 22 of the presenter 80; the positioning column is provided with a positioning edge 441; the locating rib 441 mates with a locating groove of the inner bore of the closure clip seat 22 of the presenter 80.

Referring to fig. 62 and 63, the reverse-mounting type clamp for the titanium-nickel-based shape memory alloy tissue closure clamp comprises a reverse seat assembly 50, a clamping cone assembly 40 and a clamping seat assembly 30; the clamping cone assembly 40 comprises a clamping cylinder 41, a clamping cone 43 and a prismatic body 42 which are sequentially connected; 4 axial second guide slots 411 are uniformly distributed on the circumferential side surface of the clamping cylinder 41; 4 clamping cone grooves 431 are uniformly distributed on the conical surface of the clamping cone 43; the prism body 42 comprises 4 prisms 421 uniformly distributed on the circumference; the cross-sectional shape of the prism matches the spacing between the arcuate segments 92 in the closure clip; the number of prisms 421 corresponds to the number of arcuate segments 92 in the closure clip 90; the prism 421 corresponds to the position of the second guide slot 411; each clamping cone groove 431 is positioned at the middle position of two adjacent prisms 421; the outer diameter of the clamping cylinder 41 is matched with the outer diameter of the closed clamping seat 22 of the player 80; the second guiding slots 411 are in one-to-one correspondence with the positions of the first guiding slots 221 on the closed clamp seat 22; the clamping seat assembly 30 comprises a shell, 4 clamping plates 31 which are axially arranged, a clamping column hole 32, a clamping taper hole 34 and a prismatic hole 33 which are sequentially arranged inwards from one end part of the shell; the clamping taper hole 34 is matched with the clamping taper 43 in shape; the prism holes 33 are matched with the prism body 42 in shape; the 4 clamping plates 31 are circumferentially and uniformly distributed on the inner side surface of the clamping column hole 32; the outer end part of the inner side edge of each clamping plate is provided with an overhanging clamping tooth 311; the clamping plates 31 are consistent in number and position with the second guide slots 411 in a one-to-one correspondence manner; the latch 311 can clamp the corresponding outer arc segment 91 of the closing clip 90, so as to drive the closing clip with planar layout, dish layout or bowl layout on the prism to move to the clamping cylinder 41 after passing through the prism and the clamping cone, and expand into the closing clip with cylindrical layout. The locating post 44 mates with the inner bore of the closure clip seat 22 of the presenter 80;

the inverted seat assembly 50 includes a stepped inverted post 52 and an inverted sleeve 51 that fits over the inverted post 52; the circumferential side of the reverse column 52 is provided with 4 third guide slots 521, the number of which is consistent with that of the second guide slots 411, and the positions of which are in one-to-one correspondence; the outer diameter of the reverse column 52 is equal to the outer diameter of the positioning column 44; the reversing sleeve can move along the reversing column under the action of external force and reset under the action of an internal spring.

The titanium-nickel-based shape memory alloy tissue closing clamp is with the delivery device, including the delivery device and clamping device; referring to fig. 47 to 51, the presenter includes a housing, a push rod unit provided in the housing, a push ring unit provided at a front end of the housing; the shell is provided with a handle, the handle and the shell are of a pistol modeling cavity structure which is buckled left and right, and the push rod unit comprises a trigger, a push rod, a reset spring and a limiting device; the pushing rod can move forwards under the action of the trigger and returns to the original position under the action of the return spring; the limiting device comprises a front limiting seat and a rear limiting seat which are arranged in the shell, the front part of the push rod is arranged in front of the front limiting seat, the middle part of the push rod is arranged between the front limiting seat and the rear limiting seat, a spring seat is arranged on the push rod, a reset spring is sleeved at the middle part of the push rod and is positioned between the front limiting seat and the spring seat, the rear part of the push rod is arranged behind the rear limiting seat, and a trigger groove is arranged below the push rod; the trigger is arranged at the inner side of the handle, one end of the trigger extends out of the handle, and the other end of the trigger is clamped into the trigger groove; the push rod unit may further comprise a safety latch; the safety device may be a safety bolt or a safety bracket. The safety bolt is arranged at the rear part of the shell, the button is positioned on the outer surface of the shell, the clamping hook is arranged in the shell, and the clamping hook can be clamped into or separated from a safety bolt groove above the rear part of the push rod under the drive of the button; one end of the safety bracket is hinged to the middle part of the inner side of the trigger, and the other end of the safety bracket can be clamped on the inner side of the handle so as to fix the angle of the trigger relative to the handle. The pushing ring unit comprises an upper pressing seat, a lower pressing seat, a steel wire fixing seat, a steel wire and a pushing ring; the upper pressing seat and the lower pressing seat are buckled up and down to form an L-shaped tubular cavity structure, the rear end of the L-shaped tubular cavity structure is connected with the front end of the shell, the front end of the L-shaped tubular cavity structure is downwards turned 80-100 degrees to form a closed clamping seat, and the closed clamping seat is provided with a through hole which penetrates up and down; the steel wire fixing seat is arranged at the rear end of the L-shaped tubular cavity structure and is connected with the front end of the pushing rod; the middle part of the steel wire is fixed on the steel wire fixing seat, two ends of the steel wire extend forwards in parallel between the upper pressing seat and the lower pressing seat and are bent downwards to the closed clamping seat, and two ends of the steel wire are respectively hinged with the outer side of the pushing ring sleeved outside the closed clamping seat; the steel wire fixing seat is connected with the front end of the pushing rod through a coupler; the rear end of the L-shaped tubular cavity structure is connected with the front end of the shell through a rotary joint.

And (3) a positive mounting clamping process: referring to fig. 56 and 57, the closing clip 90 is sleeved on the prism 42 of the clamping cone assembly 40, the positioning column 44 of the clamping cone assembly 40 is clamped into the through hole of the closing clip seat of the dispenser, the clamping teeth of the four clamping plates of the clamping seat assembly 30 are used for clamping the 4 outer arc sections on the closing clip, then the clamping seat assembly 30 approaches to the clamping cone assembly 40 (see fig. 58), the closing clip 90 is driven to sequentially pass through the prism, the clamping cone 43 and the clamping cylinder 41, finally expands into a cylindrical shape and is sleeved on the closing clip seat of the dispenser (see fig. 59), then the clamping seat assembly 30 (see fig. 60 and 61) and the clamping cone assembly are sequentially removed, finally the closing clip seat is aligned with a tissue to be closed, the trigger is pulled, the closing clip is released, and the taper angle of the closing clip after release is outwards (i.e. the normal loading state).

And (3) reversely mounting and clamping: referring to fig. 62, the inverted positioning column 53 of the inverted seat assembly 50 is clamped into the inverted column hole 45 of the clamping cone assembly 40, the closing clamp 90 is sleeved on the prismatic body 42 of the clamping cone assembly 40, the 4 outer arc sections on the closing clamp are clamped by the clamping teeth of the four clamping plates of the clamping seat assembly 30, then the clamping seat assembly 30 approaches the clamping cone assembly 40, the closing clamp 90 is driven to sequentially pass through the prismatic body, the clamping cone 43 and the clamping cylinder 41, and finally expands into a cylindrical shape and is sleeved on the inverted column 52, and then the inverted seat assembly 50 and the clamping cone assembly 40 are separated. Referring to fig. 63, the reverse positioning post 53 of the reverse seat assembly 50 is snapped into the through hole of the closure clip seat of the dispenser,

the cartridge assembly 30 (see fig. 60 and 61) and the clamping cone assembly are sequentially removed, and finally the closure cartridge is aligned with the tissue to be closed, the trigger is pulled, the closure clip is released, and the taper angle of the released closure clip faces outwards (i.e., the normal state).

The invention can be applied to the titanium-nickel-based shape memory alloy tissue closing clamp with the number of the outer arc sections of 3, 5, 6 and 8 only by changing the number of the prisms 421.

Claims

1. A clamp for titanium nickel base shape memory alloy tissue closure clip, its characterized in that: comprises a clamping cone assembly (40) and a clamping seat assembly (30);

the clamping cone assembly (40) comprises a clamping column body (41), a clamping cone body (43) and a prismatic body (42) which are sequentially connected; a plurality of second guide grooves (411) are uniformly distributed on the circumferential side surface of the clamping cylinder (41); a plurality of clamping cone grooves (431) are uniformly distributed on the conical surface of the clamping cone (43); the prism body (42) comprises a plurality of prisms (421) which are uniformly distributed on the circumference; the number of prisms (421) corresponds to the number of inner arc segments (92) of the closure clip (90) and the cross-sectional shape of the prism (42) matches the spacing between the inner arc segments (92) of the closure clip; the prism (421) corresponds to the position of the second guide groove (411); one end of each clamping cone groove (431) is positioned at the middle position of two adjacent prisms (421), and the other end of each clamping cone groove is positioned at the middle position of two adjacent second guide grooves; the outer diameter of the clamping cylinder (41) is matched with the outer diameter of a closed clamping seat (22) of the player (80); the second guide grooves (411) are in one-to-one correspondence with the first guide grooves (221) on the closed clamping seat (22);

the clamping seat assembly (30) comprises a shell, a plurality of clamping plates (31), a clamping column hole (32), a clamping taper hole (34) and a prismatic hole (33) which are sequentially arranged inwards from one end of the shell; the clamping taper hole (34) is matched with the clamping taper (43) in shape; the prism holes (33) are matched with the prism body (42) in shape; the clamping plates (31) are circumferentially and uniformly distributed on the inner side surface of the clamping column hole (32); the outer end part of the inner side edge of each clamping plate is provided with a clamping tooth (311); the clamping plates (31) are consistent in number and correspond to the second guide slots (411) in position one by one; the clamping teeth (311) can clamp the corresponding outer arc sections (91) on the closing clamps (90) so as to drive the closing clamps in a planar layout, a dish layout or a bowl layout to move onto the clamping cylinder (41) after passing through the prismatic body (42) and the clamping cone, and expand into a cylindrical layout.

2. The clip applier of claim 1, wherein: the clamping cone assembly (40) further comprises a positioning column (44) arranged on the outer end face of the clamping column body (41); the positioning column (44) is matched with a through hole (21) of a closed clamping seat (22) of the player (80).

3. The clip applier of claim 2, wherein: the positioning columns are provided with positioning ribs (441); the positioning ribs (441) are matched with positioning grooves on the through holes (21) of the closed clamping seat (22) of the player (80).

4. A clip applier according to claim 3, wherein: the clamp further comprises a reverse seat assembly (50); the reversing seat assembly (50) comprises a stepped reversing column (52) and a reversing sleeve (51) sleeved on the reversing column (52); the circumferential side surface of the reversing column (52) is provided with a plurality of third guide grooves (521) which are consistent with the second guide grooves (411) in number and correspond to the second guide grooves in position one by one; the outer diameter of the reverse column (52) is consistent with the outer diameter of the positioning column (44); the reversing sleeve can move along the reversing column under the action of external force and reset under the action of an internal spring.

5. The clip applier of claim 4, wherein: the reversing seat assembly (50) further comprises a reversing positioning column (53) arranged on the outer end face of the reversing column (52); the outer end face of the clamping cylinder (41) is provided with a reverse column hole (45), and the reverse column hole (45) is matched with a reverse positioning column (53).

6. The clip applier of claim 5, wherein: the number of prisms (421) is 3, 4, 5, 6, 8.

7. A delivery device that is used for titanium nickel base shape memory alloy tissue closure to press from both sides, its characterized in that: further comprising a presenter and a clip applier according to any one of claims 1 to 6; wherein: the player comprises a shell, a push rod unit arranged in the shell and a push ring unit arranged at the front end of the shell; the shell is provided with a handle, and the handle and the shell are of a buckled cavity structure; the pushing rod unit comprises a trigger, a pushing rod, a reset spring and a limiting device; the pushing rod can move forwards under the action of the trigger and the limiting device and returns to the original position under the action of the reset spring and the limiting device; the pushing ring unit comprises an upper pressing seat, a lower pressing seat, a steel wire fixing seat, two steel wires and a pushing ring; the upper pressing seat and the lower pressing seat are buckled up and down to form an L-shaped tubular cavity structure, the rear end of the upper pressing seat and the lower pressing seat are connected with the front end of the shell, the front end of the upper pressing seat and the lower pressing seat downwards turns 80-100 degrees to form a closed clamping seat, and the closed clamping seat is provided with a through hole which penetrates up and down; the steel wire fixing seat is arranged at the rear end of the L-shaped tubular cavity structure and is connected with the front end of the pushing rod; the rear ends of the two steel wires are respectively fixed on the steel wire fixing seat, the middle parts of the two steel wires are arranged between the upper pressing seat and the lower pressing seat in parallel, and the front ends of the two steel wires are respectively hinged with the pushing rings sleeved outside the closed clamping seat.

8. The delivery device of claim 7, wherein: the limiting device comprises a front limiting seat and a rear limiting seat which are arranged in the shell, the front part of the push rod is arranged in front of the front limiting seat, the middle part of the push rod is arranged between the front limiting seat and the rear limiting seat, a spring seat is arranged on the push rod, the reset spring is sleeved in the middle part of the push rod and is positioned between the front limiting seat and the spring seat, the rear part of the push rod is arranged behind the rear limiting seat, and a trigger groove is arranged below the push rod; the trigger is arranged on the inner side of the handle, one end of the trigger extends out of the handle, and the other end of the trigger is clamped into the trigger groove; the steel wire fixing seat is connected with the pushing rod through a rotating mechanism, the steel wire fixing seat is connected with one end of the rotating mechanism, the pushing rod is connected with the other end of the rotating mechanism, and the steel wire fixing seat can rotate around the central shaft of the pushing rod; the rotating mechanism comprises a fixed shaft and a movable shaft, a boss is arranged at the end part of the movable shaft, the boss is fixedly connected with the steel wire fixing seat through a neck, and the diameter of the boss is larger than that of the neck; the fixed shaft is provided with a clamping groove matched with the boss and a rotation limiting groove matched with the neck, the boss can be clamped into the clamping groove from the side face of the fixed shaft and rotate therein, and the neck can be clamped into the rotation limiting groove from the side face of the fixed shaft and rotate therein.

9. The delivery device according to claim 7 or 8, wherein: the pushing rod unit further comprises a safety mechanism; the safety mechanism is a safety bracket, one end of the safety bracket is hinged to the middle part of the inner side of the trigger, and the other end of the safety bracket can be clamped on the inner side of the handle so as to fix the angle of the trigger relative to the handle; the handle and the shell are pistol-shaped cavity structures which are buckled left and right.