CN113813083A

CN113813083A - Tricuspid valve clamping device

Info

Publication number: CN113813083A
Application number: CN202111076394.5A
Authority: CN
Inventors: 吴明明; 耿肖肖; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2021-09-14
Filing date: 2021-09-14
Publication date: 2021-12-21
Anticipated expiration: 2041-09-14
Also published as: CN113813083B

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a tricuspid valve clamping device. A tricuspid valve clamping device comprises a clamping mechanism, a grabbing mechanism and an action mechanism; the fixture includes: a clamping portion; the locking part is provided with a locking piece and a clamping piece which are matched with each other and are respectively arranged at two sides of the clamping part; snatch the mechanism and include: a pushing head; the far end of the blocking component is connected with the pushing head; the action mechanism drives the locking piece to be close to or far away from the clamping piece, and drives the pushing head and the blocking component to be close to or far away from the clamping part. The invention performs annular contraction on the tricuspid valve on the basis of keeping the native valve leaflets as much as possible, so that the valve leaflets are completely closed when the heart contracts, and the tricuspid regurgitation phenomenon is reduced or avoided.

Description

Tricuspid valve clamping device

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a tricuspid valve clamping device.

Background

The tricuspid valve is located at the orifice of the right atrioventricular, and the common onset is tricuspid valve insufficiency, namely, systolic blood flow flows back from the right ventricle to the right atrium, which causes the height of the right atrium to be enlarged, the pressure to be increased and venous blood backflow disorder. Right heart failure is likely to occur due to the compensatory hypertrophy of the load in the right ventricle.

Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement and tricuspid valve annulus dilatation, is clinically common due to the causes of tricuspid regurgitation (left heart failure, pulmonary hypertension and the like), and is aggravated by symptoms of right heart failure such as hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like after the tricuspid regurgitation. Mild regurgitation of the tricuspid valve has no obvious clinical symptoms, but requires surgical treatment when regurgitation is severe.

The surgical replacement or repair treatment is still the first choice for patients with tricuspid valve insufficiency, but for the patients with advanced age, chest-opening history, poor cardiac function and combined multi-organ insufficiency, the surgical operation has large trauma, difficult healing, more complications and high risk, and even part of the patients cannot tolerate the surgical operation.

At present, several products for treating tricuspid valve regurgitation through minimally invasive catheters are clinically applied, but are all in experimental stages, mature application is not realized, and respective technologies are limited.

Disclosure of Invention

The invention aims to solve the technical problem that a clamping device suitable for minimally invasive clamping of a tricuspid valve is lacked in the prior art, and aims to provide the tricuspid valve clamping device.

A tricuspid valve clamping device comprises a clamping mechanism, a grabbing mechanism and an action mechanism;

the fixture includes:

a clamping portion;

the locking part is provided with a locking piece and a clamping piece which are matched with each other and respectively arranged at two sides of the clamping part;

the grabbing mechanism comprises:

a pushing head;

a blocking member having a distal end connected to the pusher head;

the action mechanism drives the locking piece to be close to or far away from the clamping piece, and drives the pushing head and the retarding member to be close to or far away from the clamping part.

The invention uses the action mechanism as the pushing mechanism of the whole tricuspid valve clamping device, can push the tricuspid valve clamping device into the preset part, can clamp and lock the locking piece and the clamping piece, because the locking piece and the clamping piece are respectively arranged at two sides of the clamping part, the clamping part deforms to realize the clamping state in the process that the locking piece approaches the clamping piece, can approach the blocking component to the clamping part, and in the process of approaching, the preset part of the valve leaflet is limited between the blocking component and the clamping part to realize the clamping action of the valve leaflet.

The action mechanism includes:

the far end of the outer pipe is detachably connected with the clamping piece;

the inner tube is arranged in the outer tube, and the far end of the inner tube penetrates through the outer tube and the clamping piece and is detachably connected with the locking piece to drive the locking piece to be close to or far away from the clamping piece;

and the inner core pipe is arranged in the inner pipe, and the far end of the inner core pipe penetrates through the inner pipe, the locking piece and the blocking component and then is detachably connected with the pushing head to drive the pushing head and the blocking component to be close to or far away from the clamping part.

The outer tube of the action mechanism is used as a pushing mechanism of the whole tricuspid valve clamping device, the blocking component can be close to the clamping part by pulling the inner core tube, and the locking component and the clamping component can be clamped and locked by pulling the inner tube. The inner core tube is continuously pulled, the blocking component can be further close to the clamping part, and in the process of closing, the preset part of the valve leaflet is limited between the blocking component and the clamping part, so that the clamping action of the valve leaflet is realized.

The clamping part can include the centre gripping subassembly that two sets of symmetries set up, every group centre gripping subassembly all includes:

the near end of the outer clamp is rotationally connected with the clamping piece;

the far end of the inner clamp is rotationally connected with the locking piece, the near end of the inner clamp is rotationally connected with the far end of the outer clamp, and the inner clamp can rotate inside the outer clamp under the driving of the locking piece;

when the locking piece is farthest away from the clamping piece, the clamping part is in a contraction state, when the locking piece is close to the clamping piece, the clamping part is in an opening state, and when the locking piece is connected with the clamping piece, the clamping part is in a clamping state.

The outer clamp and the clamping piece are connected, the inner clamp and the locking piece are connected, and the inner clamp and the outer clamp are connected through elastic pieces to achieve rotating connection.

The outer clip and the inner clip are both preferably made of memory alloy, preferably nickel-titanium alloy, and provide clamping force of the valve for the tricuspid valve clamping device.

The clamping part is provided with a covering film, the covering film is a biocompatible covering film, and the biocompatible covering film is a pericardium or a high polymer material and the like.

The grabbing mechanism further comprises:

the middle part of the condensation part is penetrated by the inner core pipe, the far end of the condensation part is connected with the blocking component, and the near end of the condensation part has a preset distance with the locking part and is detachably connected with the locking part;

when the inner core tube drives the pushing head and the blocking component to be close to the clamping part, the condensation part is connected with the locking part.

The condensation part is clamped with the locking part or can be rotatably connected with the locking part.

The middle part of the far end of the condensation part is detachably connected with the middle part of the near end of the pushing head;

when the inner core tube drives the pushing head and the blocking component to be close to the clamping part, the middle of the far end of the condensation part is connected with the middle of the near end of the pushing head.

The retarding component is a hollow structure formed by a plurality of retarding strips in a surrounding mode and can be in an expansion state or a compression state under the driving of the action mechanism.

The retarding strip is preferably made of silicone rubber, thermoplastic polyurethane elastomer (TPU) or Thermoplastic Polyolefin Elastomer (TPE) material.

The number of the blocking strips is preferably 6 to 12.

At least one developing point is arranged on the outer side surface of the blocking strip so as to detect the bending state of the blocking strip.

The development sites are disposed at least at the proximal, middle and distal ends of the retarder bars.

The developing points are made of alloy materials, and the alloy materials are platinum, iridium or tantalum.

The number of the developing points on each blocking strip is between 2 and 10.

The positive progress effects of the invention are as follows: the invention adopts the tricuspid valve clamping device, and the tricuspid valve is annularly contracted on the basis of keeping the native valve leaflets as much as possible, so that the valve leaflets are completely closed when the heart contracts, and the tricuspid valve regurgitation phenomenon is reduced or avoided.

Drawings

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

FIG. 2 is a schematic view of a clamping mechanism according to the present invention;

FIG. 3 is a schematic view of a clamping portion of the present invention in a clamping position;

FIG. 4 is a schematic view of the overall structure of the clamping portion of the present invention in a clamping state;

FIG. 5 is a schematic view of a grasping mechanism according to the present invention;

figure 6 is a schematic view of the blocking member of the present invention in an expanded state.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.

Referring to fig. 1 to 6, a tricuspid valve clamping device includes a clamping mechanism 100, a grasping mechanism 200, and an actuating mechanism 300.

Referring to fig. 2 to 4, the clamping mechanism 100 includes a clamping portion and a locking portion. The locking part has a locking element 121 and an engaging element 122 which are matched with each other, and the locking element 121 and the engaging element 122 are detachably connected, preferably in a snap connection. The engaging member 122 is disposed at the proximal end of the holding portion, and the locking member 121 is disposed at the distal end of the holding portion.

The holding portion may be an elastic ring body, and the locking member 121 and the engaging member 122 are fixed to two opposite inner walls of the elastic ring body, respectively.

The clamping portion may further include two sets of symmetrically disposed clamping assemblies, each set of clamping assemblies including an outer clamp 111 and an inner clamp 112. The proximal end of the outer clip 111 is rotatably connected to the catch 122. The distal end of the inner clip 112 is pivotally connected to the locking element 121 and the proximal end of the inner clip 112 is pivotally connected to the distal end of the outer clip 111.

The connection between the outer clip 111 and the engaging piece 122, the connection between the inner clip 112 and the locking piece 121, and the connection between the inner clip 112 and the outer clip 111 can be achieved by elastic connection or hinge connection.

Both the outer clip 111 and the inner clip 112 are preferably made of memory alloy to provide the tricuspid valve clamping device with clamping force of the valve. The memory alloy is preferably nickel-titanium alloy, which is a special alloy capable of automatically restoring the plastic deformation of the memory alloy to the original shape at a certain specific temperature, has recoverability and high elasticity, and is difficult to deform or even break while continuously exerting constraint in the long-term work of the tricuspid valve.

The clamping part is provided with a coating, namely the outer surface of the elastic ring body or the outer surfaces of the outer clamp 111 and the inner clamp 112 are coated with the coating. The covering membrane is a biocompatible covering membrane which is a pericardium or a high polymer material and the like. The axial length of the clamping part can be different in preparation process according to the condition of a patient so as to improve the universality of the product.

The inner clip 112 can rotate inside the outer clip 111 under the driving of the locking element 121. When the inner clips 112 rotate inside the outer clip 111, the included angle between two symmetrical inner clips 112 varies from 0 ° to 180 °. When the locking element 121 is farthest away from the engaging element 122, as shown in fig. 2, the clamping portion is in a contracted state, the two symmetrical inner clips 112 are parallel to each other, and the included angle between the two inner clips tends to be 0 °. When the locking element 121 is close to the engaging element 122, the included angle between the two symmetrical inner clips 112 changes from 0 ° to 180 °, and when the included angle between the two symmetrical inner clips 112 is 180 °, the two inner clips are laid flat, and the clamping portion is in an open state. When the locking element 121 is connected to the engaging element 122, as shown in fig. 3, the two symmetrical inner clips 112 are parallel to each other, the included angle between the two inner clips tends to 0 °, the clamping portion is in the clamping state, the two symmetrical inner clips 112 are both rotated into the two outer clips 111, and at this time, the inner clips 112 are tightly attached to the inner sides of the outer clips 111.

Referring to fig. 5 and 6, the grasping mechanism 200 includes a pusher head 210, a blocking member 220, and a condensing portion 230, which are connected in sequence.

The pusher head 210 may be of a distally projecting configuration.

The distal end of the blocking member 220 is connected to the pusher head 210 and the proximal end of the blocking member 220 is connected to the distal end of the condensation portion 230. The blocking member 220 is a hollow structure surrounded by a plurality of blocking strips 221, and can be in an expanded state or a compressed state under the drive of the inner core pipe, and when the blocking member 220 is in the expanded state, the blocking member can expand to form a petal-shaped blocking net. Specifically, the hollow cylindrical blocking member 220 may be provided with notches uniformly arranged along the axial direction, so as to divide the blocking member 220 into a plurality of blocking strips 221. Preferably, the blocking strip 221 is made of silicone rubber, thermoplastic polyurethane elastomer (TPU) or Thermoplastic Polyolefin Elastomer (TPE). So as to ensure the mechanical strength and the supporting capability of the blocking component 220, so that the supporting effect cannot be influenced because of insufficient material strength in the process of pulling the valve leaflet, and the treatment failure caused by the mechanical problem of the material is avoided. The number of the blocking strips 221 is preferably 6 to 12. To increase the contact area with the leaflets and reduce the risk of tearing the leaflets. At least one developing point is provided on the outer side surface of the blocking bar 221 to detect the bending state of the blocking bar 221. Visualization points are provided at least at the proximal, middle, and distal ends of the blocker strip 221. The developing point is made of alloy material, and the alloy material is platinum, iridium or tantalum. The number of development points on each resist strip 221 is between 2 and 10. The positioning and the observation of the bending state of the retardation strip 221 during the operation are facilitated, and the specific number of the developing points can be selected according to the actual requirement.

The distal end of the condensation portion 230 is connected to the blocking member 220, and the proximal end of the condensation portion 230 is spaced apart from the locking element 121 and is detachably connected to the locking element 121. The leaflets of the tricuspid valve are clamped between the condensation 230 and the locking element 121. When the pushing head 210 and the blocking member 220 approach the clamping portion, the contracting portion 230 is connected to the locking element 121, as shown in fig. 6, at this time, the blocking strips 221 of the blocking member 220 are deformed, the blocking strips 221 pulled to the extreme positions contact end to form a petaloid blocking net, and the blocking member 220 is in an unfolded state. The condensation portion 230 is engaged with or rotatably connected to the locking element 121. The middle portion of the distal end of the condensation portion 230 is detachably connected to the middle portion of the proximal end of the pushing head 210. When the pushing head 210 and the blocking member 220 approach the clamping portion, the middle of the distal end of the condensation portion 230 is connected to the middle of the proximal end of the pushing head 210. Causing the retarding member 220 to continue to maintain a stable deployed state.

The actuating mechanism 300 drives the locking element 121 to move closer to or away from the engaging element 122, and drives the pushing head 210 and the blocking member 220 to move closer to or away from the clamping portion.

The actuating mechanism 300 includes an outer tube 310, an inner tube 320, and an inner core tube 330.

The distal end of the outer tube 310 is removably attached, preferably threadably attached, to the snap 122.

The inner tube 320 is disposed inside the outer tube 310, and the distal end of the inner tube 320 passes through the outer tube 310 and the engaging member 122 and is detachably connected, preferably threadedly connected, to the locking member 121. The inner tube 320 drives the locking element 121 to move close to or away from the engaging element 122. When the inner tube 320 drives the locking element 121 to gradually approach the engaging element 122, the locking element 121 can be connected to the engaging element 122.

The inner core tube 330 is disposed inside the inner tube 320, and the distal end of the inner core tube 330 is detachably connected to the pushing head 210 after passing through the inner tube 320, the locking element 121, the contracting portion 230 and the blocking member 220. Through holes are formed in the locking member 121 and the condensation portion 230 for the inner core tube 330 to pass through. The inner core tube 330 brings the grasping mechanism 200 close to or away from the grip portion. When the inner core tube 330 drives the pushing head 210 to gradually approach the clamping portion, the middle of the proximal end of the pushing head 210 is connected to the middle of the distal end of the condensing portion 230. The proximal end of the condensation portion 230 is connected to the distal end of the locking element 121.

When the device is used, after a preset part of the tricuspid valve of a patient is punctured, the tricuspid valve clamping device is conveyed into the right atrium of the patient by using the conveying device, and the inner core tube controlling the grabbing mechanism 200 is pushed, so that the grabbing mechanism 200 passes through the puncture hole of the valve leaflet along the guide wire until the grabbing mechanism 200 completely reaches the position below the valve. At this time, the inner core tube is pulled, so that the blocking member 220 is in an expanded state, and the blocking member 220 expands into a petal-shaped blocking net, so as to avoid the phenomenon that the valve leaflets escape due to continuous shaking of the valve in the use process of the clamping mechanism 100.

After observing the development point and confirming that the retarding member 220 is completely opened, the grabbing mechanism 200 is pulled back to enable the retarding strips to be attached to the lower surface of the valve leaflet, the inner pipe of the control clamping mechanism 100 is pushed until the condensation part 230 is buckled and connected with the locking part 121, then the clamping part is released to be in an opening state, two symmetrical inner clamps 112 are flatly laid, namely, the included angle between the two symmetrical inner clamps is 180 degrees, and the valve leaflet clamping surface of the inner clamp 112 is attached to the upper surface of the valve leaflet. The leaflet preset site is now constrained between the blocking member 220 and the inner clip 112. The engagement between the contraction portion 230 and the locking element 121 prevents the blocking member 220 from being displaced during the subsequent clamping of the predetermined portion of the leaflet, thereby affecting the clamping effect.

The grasping mechanism 200 is continuously pulled, so that the grasping action of the valve leaflet can be further completed, in the pulling process, the inner clamp 112 and the outer clamp 111 gradually approach to each other until the inner clamp and the outer clamp are completely overlapped, and the locking piece 121 and the clamping piece 122 are buckled and connected to complete self-locking, so that the grasping part is prevented from being loosened.

The tricuspid valve clamping device is reliable in clamping, high in safety, small in damage to cardiac tissues, simple in structure and convenient to operate. The valve leaves and the structure under the valve of the tricuspid valve are reserved, the structure of the right ventricle is reserved to the maximum extent, the heart recession is slowed down, and the treatment effect of the tricuspid valve regurgitation is improved.

The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A tricuspid valve clamping device comprises a clamping mechanism, a grabbing mechanism and an action mechanism;

it is characterized in that the clamping mechanism comprises:

a clamping portion;

the grabbing mechanism comprises:

a pushing head;

a blocking member having a distal end connected to the pusher head;

2. The tricuspid valve clamping device according to claim 1, wherein the action mechanism comprises:

the far end of the outer pipe is detachably connected with the clamping piece;

3. The tricuspid valve clamping device according to claim 2, wherein the clamping portion comprises two symmetrically arranged sets of clamping assemblies, each set of clamping assemblies comprising:

4. The tricuspid valve clamping device according to claim 3, wherein the connection of the outer clip to the snap member, the connection of the inner clip to the locking member, and the connection of the inner clip to the outer clip are all connected by a resilient member to achieve rotational connection.

5. The tricuspid valve clamping device according to claim 3, wherein both the outer clip and the inner clip are made of a memory alloy;

the clamping part is provided with a covering film, and the covering film is a biocompatible covering film.

6. The tricuspid valve clamping device according to claim 3, wherein the grasping mechanism further comprises:

7. The tricuspid valve clamping device according to claim 6, wherein the condensation portion is snap-fit or rotatably connected to the locking element.

8. The tricuspid valve clamping device according to claim 6, wherein a distal middle portion of the condensation portion is detachably connected with a proximal middle portion of the pushing head;

9. The tricuspid valve holding device according to any one of claims 1 to 8, wherein the blocking member is a hollow structure surrounded by a plurality of blocking strips, and can be in an expanded state or a compressed state under the driving of the action mechanism;

at least one developing point is arranged on the outer side surface of the blocking strip.

10. The tricuspid valve clamping device according to claim 9, wherein the blocking strip is made of a silicone rubber, a thermoplastic polyurethane elastomer, or a thermoplastic polyolefin elastomer material;

the number of the blocking strips is 6 to 12;

the developing points are at least arranged at the near end, the middle part and the far end of the retarding strip;

the developing points are made of alloy materials;

the number of the developing points on each blocking strip is between 2 and 10.