CN115486974A

CN115486974A - Detachable sharp end for assisting valve implantation

Info

Publication number: CN115486974A
Application number: CN202211442492.0A
Authority: CN
Inventors: 陈冰冰; 周志坚; 李峰
Original assignee: Shanghai Yuban Medical Technology Co ltd
Current assignee: Shanghai Yuban Medical Technology Co ltd
Priority date: 2022-11-18
Filing date: 2022-11-18
Publication date: 2022-12-20
Anticipated expiration: 2042-11-18
Also published as: CN115486974B

Abstract

The invention discloses a detachable tip for assisting valve implantation, which comprises: a conveying device; a working channel extending through the delivery device, the working channel being adapted to the valve system; a valve system of a foldable hollowed-out design; the detachable pointed end is arranged on the inner side of the valve system and can extend outwards along with the valve system; the detachable pointed end and the valve system are arranged on the end face of one side far away from the conveying device, so that the conveying distance is reduced; the device can realize that the loading mode of the valve system in the conveyor is changed by designing the detachable tip head, the valve and the detachable tip head can be directly loaded at the far end of the conveying sheath, so that the conveying distance is shortened, the whole conveying stroke is shortened, and the length and the size of the conveyor are smaller.

Description

Detachable sharp end for assisting valve implantation

Technical Field

The invention relates to the technical field of medical instruments, in particular to a detachable sharp tip for assisting valve implantation.

Background

Mitral regurgitation is the most common disease among the valvular disease, and severe mitral regurgitation symptom is painful, and the treatment of mitral regurgitation is untimely will seriously harm patient's health, and with the condition of an illness worsens and gradually develops into heart failure and death, at present, surgery is the standard of treatment mitral regurgitation, and a less operation time of wound is shorter and the operation is more convenient apparatus is the product that patient and operative person urgently needed at present, no matter be through the apex of the heart way access or through the thigh route access can both solve the wound that traditional surgery can't avoid to a great extent. But the market today has only one transcatheter apical access mitral valve system approved by the european union, the Tendyne mitral valve system of Abbott corporation. The product is punctured through a thoracic cavity small incision apex cordis pouch, a path is established by using a guide wire and a saccule, a valve is implanted into a mitral valve position of a patient to replace a diseased mitral valve, and the valve is connected to the outer wall of an apex ventricle through a traction rope and is fixed at the apex position through an anchoring disc; before the product is implanted, a valve is loaded to the near end of a delivery sheath, a small opening is formed in the side surface of the delivery sheath at the front end of the valve, a foldable Tip head is inserted into the small opening, the far end of the delivery sheath is full, and then the valve ring-crossing implantation operation can be carried out, but the product uses a similar saccule principle as Tip and has higher cost; the development technology difficulty, the production process, the use difficulty of a user and the like of the balloon product are much higher than those of a Tip head of a traditional intervention product;

after the delivery sheath crosses the valve ring, the foldable Tip head needs to be withdrawn from the sheath, and then the valve can be pushed from the proximal end of the delivery sheath to the distal end of the sheath to be released, the valve pushing distance is long, and the whole implantation time is relatively long; in the pushing process, the friction area between the valve product and the inner wall of the conveying sheath tube is increased, and the risk of valve damage is increased; the pushing stroke of the conveying handle is long, the whole length and the size of the conveyor are relatively large, and the operation difficulty is increased.

Disclosure of Invention

The invention aims to solve the defects in the prior art, and provides a detachable sharp tip for assisting valve implantation.

In order to achieve the purpose, the invention adopts the following technical scheme: a detachable tip for assisting in valve implantation, comprising:

a conveying device;

a working channel extending through the delivery device, the working channel being adapted to the valve system;

a valve system of a foldable hollow design;

the pointed end is arranged on the inner side of the valve system and extends outwards along with the valve system;

the pointed end and the valve system are arranged on the end surface of one side far away from the conveying device, so that the conveying distance is reduced;

the pointed head is divided into a first state, a second state and a third state, the pointed head is converted into the second state from the first state by pushing the pointed head and the valve system, and the pointed head is converted into the third state from the second state by controlling the detachment of the pointed head.

As a further description of the above technical solution: in the first state, the pointed end is conveyed on the conveying device along with the valve system to reach a target area, in the second state, the pointed end leaves the conveying device along with the valve system, meanwhile, the pointed end is split into a plurality of independent parts, the valve system is expanded, and in the third state, the pointed end contracts backwards and leaves the valve system.

As a further description of the above technical solution: the delivery device comprises a delivery sheath, one side of the delivery sheath is provided with a control handle, and the delivery and the release of the valve system in the delivery sheath are controlled through the control handle.

As a further description of the above technical solution: the valve system includes valve main part, coupling assembling and valve connecting rod, the valve connecting rod passes through coupling assembling with the valve main part is connected, coupling assembling keeps away from one side of valve main part is equipped with the connection rope, the connection rope other end is used for sewing up heart department.

As a further description of the above technical solution: the tip is divided into a plurality of tip main bodies in a radially equal or constant volume mode, the tip is divided into a conveying section and transition sections located on two sides of the conveying section, the conveying section is cylindrical, and the transition sections are conical.

As a further description of the above technical solution: a circular through hole is reserved in the middle of the pointed end, so that a conveying guide wire penetrates through the through hole, and auxiliary conveying is realized.

As a further description of the above technical solution: and a transition section on one side of the pointed main body is connected with a pointed connecting rod, and the movement of the pointed connecting rod is controlled to realize the control of the extension and retraction of the pointed main body.

As a further description of the above technical solution: the size of the tip main body is smaller than the size of the hollow part of the valve main body after being opened, so that the tip main body is retracted from the valve main body.

As a further description of the above technical solution: the valve main body is a plurality of.

As a further description of the above technical solution: the tip is made of one of PEEK, PC, PE, PVC, ABS, POM or rubber.

The technical scheme has the following advantages or beneficial effects:

1. the detachable cusp head is designed to realize that after the valve is released, the cusp head is integrally detached into parts with smaller volume, and the parts directly pass through the gap of the bracket connecting rod and are withdrawn out of the body.

2. The loading mode of the valve system in the conveyor is changed by designing the detachable tip head, the valve and the detachable tip head can be directly loaded at the far end of the conveying sheath, so that the conveying distance is shortened, the whole conveying stroke is shortened, and the length size of the conveyor is smaller.

Drawings

FIG. 1 is a perspective view of a tip head according to the present invention;

FIG. 2 is a schematic diagram of the internal structure of the tip head in a first state according to the present invention;

FIG. 3 is a schematic view of the tip of the present invention in a second state;

FIG. 4 is a schematic view of a third state of the tip head according to the present invention;

FIG. 5 is a front view of the delivery device of the present invention;

FIG. 6 is a front view of a valve system of the present invention;

FIG. 7 is a delivery end view of the tip body of the present invention;

fig. 8 is a schematic view showing a disassembled state of the tip head according to the present invention.

Illustration of the drawings:

1. a conveying device; 11. a delivery sheath; 12. a control handle; 2. a valve system; 21. a valve body; 22. a connecting assembly; 23. a valve connecting rod; 24. connecting ropes; 3. a pointed end; 31. a tip body; 32. a tip connecting rod.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention; the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance, and furthermore, unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "connected" are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Referring to fig. 1-4, one embodiment provided by the present invention: a detachable tip for assisting in valve implantation, comprising: a conveying device 1; the working channel penetrates through the conveying device 1 and is matched with the valve system 2; the valve system 2 is of a foldable hollow design; the pointed end 3 is arranged on the inner side of the valve system 2 and extends outwards along with the valve system 2; the pointed end 3 and the valve system 2 are arranged on the end surface of one side far away from the conveying device 1, so that the conveying distance is reduced.

In the embodiment, the valve system 2 is arranged on the inner side of the delivery device 1, the pointed end 3 is arranged on the inner side of the valve system 2, and the valve system 2 and the pointed end 3 are delivered to a specified position through the delivery device 1 to work.

The tip head 3 is divided into a first state, a second state and a third state, the tip head 3 is converted into the second state from the first state by pushing the tip head 3 and the valve system 2, and the tip head 3 is converted into the third state from the second state by controlling the detachment of the tip head 3;

specifically, tip head 3 carries on along with valve system 2 on conveyor 1 when first state, reaches the target area, and the target area is for treating the district, specifically apex ventricular outer wall department, and valve system 2 accessible haulage rope is fixed in the target area, and when the second state, tip head 3 leaves conveyor 1 along with valve system 2, and 3 splits into a plurality of independent parts of tip simultaneously, and valve system 2 becomes to open by the fold condition, and when the third state, tip head 3 contracts backward, leaves valve system 2.

In this embodiment, the delivery device 1 carries the valve system 2 and the tip head 3 to move, after the delivery device reaches a designated position, the valve system 2 and the tip head 3 are moved to the outer side of the delivery device 1 by pushing the valve system 2, after the valve system 2 reaches the designated position, the valve system 2 is controlled to be opened, the tip head 3 is separated, then the tip head 3 is controlled to be retracted backwards from the opened hollow part, and then gradually combined and retracted into the delivery device 1, and withdrawn from the body, and meanwhile, the heart repair operation can be performed through the valve system 2.

Referring to fig. 5, the delivery device 1 includes a delivery sheath 11, a control handle 12 is provided on one side of the delivery sheath 11, the valve system 2 located in the delivery sheath 11 is caused to be released by squeezing the control handle 12, and the delivery and release of the valve system 2 inside the delivery sheath 11 are controlled by withdrawing the delivery sheath 11 or pushing the valve attachment rod 23 to push the valve system 2 out of the delivery sheath 11 from the other end.

Referring to fig. 6, the valve system 2 includes valve main part 21, coupling assembling 22 and valve connecting rod 23, and valve main part 21 is a plurality of, and valve connecting rod 23 is connected with valve main part 21 through coupling assembling 22, and one side that coupling assembling 22 keeps away from valve main part 21 is equipped with and connects rope 24, connects the rope 24 other end and is used for sewing up heart department.

In the present embodiment, the valve system 2 belongs to a permanent implant, the number of the valve bodies 21 is three, the valve bodies 21 are designed to be petal-shaped, the connecting assembly 22 is provided with a valve connecting rod 23 on one side, the valve bodies 21 are hollow, the center of the valve bodies is connected with the valve connecting rod 23, the circumference of the valve bodies is connected with the connecting assembly 22, the connecting rope 24 is provided on the other side of the connecting assembly 22, and the suture operation is performed through the connecting rope 24 after the delivery device 1 and the tip head 3 are removed.

The tip head 3 is divided into a plurality of tip main bodies 31 along the radial direction or in a fixed volume manner, the tip head 3 is divided into a conveying section and transition sections positioned on two sides of the conveying section, the conveying section is cylindrical, the transition sections are conical, and a circular through hole is reserved in the middle of the tip head 3, so that a conveying guide wire passes through the through hole, and auxiliary conveying is realized.

Referring to fig. 7, in this embodiment, the tip 3 is configured to be conical at two sides and cylindrical in the middle, so that the tip 3 can be transported better, and a circular through hole is left in the middle of the tip 3, so that a guide wire can pass through the circular through hole to assist the tip 3 in transportation.

With reference to the drawings, a tip connecting rod 32 is connected to a transition section on one side of the tip main body 31, and the extension and retraction of the tip main body 31 are controlled by controlling the movement of the tip connecting rod 32; the size of the tip main body 31 is smaller than the size of the hollow part of the valve main body 21 after being opened, so that the tip main body 31 is retracted from the valve main body 21.

Referring to fig. 8, in the present embodiment, the radial size of the tip main body 31 is smaller than the size of the hollow portion of the valve main body 21 after being opened, so that the tip main body 31 is retracted from the valve main body 21, and the tip 3 is retracted into the delivery sheath 11.

In this embodiment, the tip 3 is made of one of PEEK, PC, PE, PVC, ABS, POM, or rubber, and the connecting rope 34 is made of a high-strength non-metal woven material, specifically, carbon fiber; the material of the conveying sheath tube 11 is a PTFE inner lining and a Pebax outer layer or a pipe with a metal braid layer in the middle.

The working principle is as follows: the valve system 2 is pressed and held to a proper position at the far end of a conveying sheath 11 loaded in the conveying device 1, and the power element is driven manually or by a motor through pushing and conveying; the tip 3 is then also loaded to the distal end of the delivery sheath 11 of the delivery device 1; inserting the delivery sheath 11 to a target position along a guide wire or a blood vessel, operating the control handle 12 at the proximal end of the delivery device 1 to push the tip head 3 out of the delivery sheath 11, and continuing to operate the control handle 12 to release the valve main body 21 to the target position; after the release of the valve is determined, the control handle 12 is continuously operated to slowly withdraw the tip heads 3 to the proximal position of the valve one by one or simultaneously, when one tip body 31 is independently operated, the corresponding tip body 31 can be moved forward, backward and rotated by operating the tip connecting rod 32, the tip head 3 is continuously recovered to the delivery sheath 11 by the operation, then the delivery device 1 and the tip head 3 are withdrawn from the body, the tail end of the connecting rope 24 is fixed at the apex or other positions, the wound is sutured, and the operation is finished.

Example 2

Developing structures can be arranged on the outer side of the tip head 3, such as a thread structure arranged on a transition section of the tip head 3, or a developing material embedded in the transition section, so that the position of the tip head 3 can be monitored conveniently during conveying and retracting of the tip head 3.

Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments or portions thereof without departing from the spirit and scope of the invention.

Claims

1. A detachable pointed end for assisting valve implantation is characterized in that: the method comprises the following steps:

a conveying device (1);

a working channel extending through the delivery device (1), the working channel being adapted to the valve system (2);

a valve system (2) of a collapsible hollowed-out design;

the pointed end (3) is arranged on the inner side of the valve system (2) and extends outwards along with the valve system (2);

the pointed end (3) and the valve system (2) are arranged on the end surface of one side far away from the conveying device (1) so as to reduce the conveying distance;

the pointed tip (3) is divided into a first state, a second state and a third state, the pointed tip (3) is converted into the second state from the first state by pushing the pointed tip (3) and the valve system (2), and the pointed tip (3) is converted into the third state from the second state by controlling the detachment of the pointed tip (3).

2. A detachable tip for assisting valve implantation according to claim 1, wherein: in the first state, the pointed tip (3) is conveyed on the conveying device (1) along with the valve system (2) to reach a target area, in the second state, the pointed tip (3) leaves the conveying device (1) along with the valve system (2), meanwhile, the pointed tip (3) is split into a plurality of independent components, the valve system (2) is opened, and in the third state, the pointed tip (3) is contracted backwards to leave the valve system (2).

3. The detachable pointed tip for assisting valve implantation according to claim 1, wherein: the delivery device (1) comprises a delivery sheath (11), one side of the delivery sheath (11) is provided with a control handle (12), and the delivery and the release of the valve system (2) in the delivery sheath (11) are controlled by the control handle (12).

4. The detachable pointed tip for assisting valve implantation according to claim 1, wherein: valve system (2) include valve main part (21), coupling assembling (22) and valve connecting rod (23), valve connecting rod (23) pass through coupling assembling (22) with valve main part (21) are connected, coupling assembling (22) are kept away from one side of valve main part (21) is equipped with connects rope (24), it is used for sewing up heart department to connect rope (24) other end.

5. The detachable pointed tip for assisting valve implantation of claim 4, wherein: the tip head (3) is divided into a plurality of tip main bodies (31) in a radially equal or constant volume mode, the tip head (3) is divided into a conveying section and transition sections located on two sides of the conveying section, the conveying section is cylindrical, and the transition sections are conical.

6. A detachable tip for assisting valve implantation according to claim 1, wherein: a round through hole is reserved in the middle of the pointed end (3), so that a conveying guide wire passes through the through hole, and auxiliary conveying is realized.

7. The detachable pointed tip for assisting valve implantation of claim 5, wherein: a transition section on one side of the pointed main body (31) is connected with a pointed connecting rod (32), and the telescopic movement of the pointed main body (31) is controlled by controlling the movement of the pointed connecting rod (32).

8. The detachable pointed tip for assisting valve implantation of claim 5, wherein: the size of the tip main body (31) is smaller than the size of the hollow part of the valve main body (21) after the valve main body (21) is opened, so that the tip main body (31) is retracted from the valve main body (21).

9. The detachable pointed tip for assisting valve implantation of claim 4, wherein: the valve main body (21) is in a plurality.

10. A detachable tip for assisting valve implantation according to claim 1, wherein: the tip (3) is made of one of PEEK, PC, PE, PVC, ABS, POM or rubber.