CN113813083B

CN113813083B - Tricuspid valve clamping device

Info

Publication number: CN113813083B
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: 2023-07-07
Anticipated expiration: 2041-09-14
Also published as: CN113813083A

Abstract

The invention belongs to the technical field of medical appliances, 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 part; 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; the grabbing mechanism comprises: a pushing head; a blocking member, the distal end being connected to the pusher head; the actuating mechanism drives the locking piece to be close to or far away from the clamping piece, and drives the pushing head and the blocking member to be close to or far away from the clamping part. The invention can shrink the tricuspid valve on the basis of keeping the original valve leaves as much as possible, so that the valve leaves are completely closed when the heart is shrunk, and the tricuspid valve reflux phenomenon is reduced or avoided.

Description

Tricuspid valve clamping device

Technical Field

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

Background

The tricuspid valve is positioned at the right atrioventricular orifice, and the common occurrence is that the tricuspid valve is closed incompletely, namely, blood flows back from the right ventricle to the right atrium in the systolic period, so that the right atrium is enlarged in height, the pressure is increased, and venous blood backflow is blocked. Right heart failure is likely to occur due to the increased right ventricular load, compensatory and hypertrophic.

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

Surgical valve replacement or repair treatment is still the first choice for patients with tricuspid valve insufficiency, but for patients with advanced age, history of chest opening, poor cardiac function and combined multi-organ insufficiency, surgical operation is traumatic, difficult to heal, more complications, high risk and even intolerance for partial patients.

At present, several products for treating tricuspid regurgitation through a catheter have been clinically applied, but in the experimental stage, the products are not applied to maturity, and the respective technologies are limited.

Disclosure of Invention

Aiming at the technical problem that a clamping device suitable for minimally invasively clamping tricuspid valves is lacking in the prior art, the invention 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 clamping mechanism comprises:

a clamping part;

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;

the grabbing mechanism comprises:

a pushing head;

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

the actuating 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.

According to the invention, the action mechanism is used as a pushing mechanism of the whole tricuspid valve clamping device, the tricuspid valve clamping device can be pushed into a preset position, and the locking piece and the clamping piece can be clamped and locked.

The action mechanism comprises:

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

the inner tube is arranged in the outer tube, and the distal end of the inner tube passes 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;

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

According to the invention, the outer tube of the actuating mechanism is used as a pushing mechanism of the whole tricuspid valve clamping device, the blocking member can be close to the clamping part by pulling the inner tube, and the locking piece and the clamping piece can be clamped and locked by pulling the inner tube. The inner core tube is pulled continuously, the blocking member can be further close to the clamping part, and in the approaching process, the valve She Yushe part is limited between the blocking member and the clamping part, so that the clamping action of the valve leaves is realized.

The clamping part can include two sets of clamping components that the symmetry set up, every group clamping component all includes:

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

the inner clamp is rotationally connected with the locking piece at the distal end, is rotationally connected with the distal end of the outer clamp at the proximal end, and can rotate inside the outer clamp under the drive of the locking piece;

when the locking piece is farthest from the clamping piece, the clamping part is in a contracted state, when the locking piece is close to the clamping piece, the clamping part is in an opened 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 by elastic pieces to realize rotary connection.

The outer clip and the inner clip are preferably made of a memory alloy, preferably a nitinol alloy, to provide a valve gripping force for the tricuspid valve gripping device.

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

The grasping mechanism further includes:

a condensing part, the middle part of which is penetrated by the inner core tube, the far end of which is connected with the retarding component, and the near end of which is provided with a preset distance from the locking piece and is detachably connected with the locking piece;

when the inner core tube drives the pushing head and the blocking member to approach the clamping part, the condensation part is connected with the locking piece.

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

The middle part of the far end of the condensing 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 member to approach the clamping part, the middle part of the far end of the condensing part is connected with the middle part of the near end of the pushing head.

The blocking member is a hollow structure surrounded by a plurality of blocking strips and can be in an unfolding state or a compression state under the drive of the action mechanism.

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

The number of blocking strips is preferably 6 to 12.

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

The developing points are at least arranged at the proximal end, the middle part and the distal end of the retarding strip.

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

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

The invention has the positive progress effects that: the invention adopts the tricuspid valve clamping device, and the tricuspid valve is contracted on the basis of keeping the original valve leaves as much as possible, so that the valve leaves are completely closed when the heart is contracted, and the tricuspid valve reflux 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 showing a clamping portion of the present invention in a clamping state;

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

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

fig. 6 is a schematic view of a state in which the blocking member of the present invention is in an extended state.

Detailed Description

In order that the manner in which the invention is practiced, as well as the features and objects and functions thereof, will be readily understood and appreciated, the invention will be further described in connection with the accompanying drawings.

Referring to fig. 1 to 6, a tricuspid valve gripping apparatus includes a gripping 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 is provided with a locking piece 121 and a clamping piece 122 which are matched with each other, and the locking piece 121 and the clamping piece 122 are detachably connected, preferably in a clamping connection mode. The engaging member 122 is disposed at the proximal end of the clamping portion, and the locking member 121 is disposed at the distal end of the clamping portion.

The clamping part can adopt an elastic annular body, and two opposite side inner walls of the elastic annular body are respectively fixed with the locking piece 121 and the clamping piece 122.

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

The connection between the outer clip 111 and the engaging member 122, the connection between the inner clip 112 and the locking member 121, and the connection between the inner clip 112 and the outer clip 111 can be realized by elastic members, or by hinge structures.

Both outer clip 111 and inner clip 112 preferably use a memory alloy to provide the valve gripping force for the tricuspid valve gripping device. The memory alloy is preferably nickel-titanium alloy, which is a special alloy capable of automatically recovering plastic deformation of the memory alloy to an original shape at a certain specific temperature, has restorability and high elasticity, and is not easy to deform or even break while ensuring that the memory alloy can continuously exert constraint in long-term operation of the tricuspid valve.

The clamping part is provided with a coating film, 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 film. The coating is a biocompatible coating, and the biocompatible coating is pericardium or polymer material, etc. The axial length of the clamping part can be different according to the condition of a patient, so that the universality of the product is improved.

The inner clip 112 is rotatable inside the outer clip 111 by the locking member 121. When the inner clip 112 rotates inside the outer clip 111, the angle between the symmetrical two inner clips 112 varies between 0 ° and 180 °. When the locking element 121 is furthest from the engaging element 122, as shown in fig. 2, the clamping portion is in a contracted state, the symmetrical two inner clamps 112 tend to be parallel, and the included angle between the two tends to be 0 °. When the locking piece 121 approaches the clamping piece 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 tiled, and the clamping part is in an open state. When the locking member 121 is connected to the engaging member 122, as shown in fig. 3, the two symmetrical inner clips 112 are parallel, the included angle between the two inner clips is 0 °, the clamping portion is in a clamping state, and 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 pushing head 210, a blocking member 220, and a condensing portion 230, which are sequentially connected.

The pushing head 210 may have a structure with a distal end protruding.

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 bellows 230. The retarding member 220 is a hollow structure surrounded by a plurality of retarding strips 221, and can be in an expanded state or a compressed state under the drive of the inner core tube, and when in the expanded state, the retarding member 220 can expand into a petal-shaped retarding net. In particular, the cutouts may be uniformly arranged in the axial direction on the hollow cylindrical blocking member 220, dividing the blocking member 220 into a plurality of blocking strips 221. The blocking strip 221 is preferably made of silicone rubber, thermoplastic polyurethane elastomer (TPU), or Thermoplastic Polyolefin Elastomer (TPE) material. To ensure the mechanical strength and the supporting capability of the retarding member 220 so that the supporting effect is not affected by insufficient material strength in the process of pulling the valve leaflet, and the treatment failure caused by the material mechanical problem is avoided. The number of blocking strips 221 is preferably 6 to 12. To increase the contact area with the leaflet and reduce the risk of tearing the leaflet. At least one developing point is provided on the outer side of the blocking strip 221 to detect the bent state of the blocking strip 221. Developing points are provided at least at the proximal, middle and distal ends of the blocking strip 221. The developing point is made of alloy material, and the alloy material is platinum, iridium or tantalum and the like. The number of development points on each of the blocking strips 221 is between 2 and 10. The bending state of the blocking strip 221 is convenient to position and observe in operation, and the specific number of the developing points can be selected according to actual requirements.

The distal end of the condensation part 230 is connected to the blocking member 220, and the proximal end of the condensation part 230 is spaced a predetermined distance from the locking element 121 and is detachably connected to the locking element 121. The leaflets of the tricuspid valve are sandwiched between the condensation 230 and the locking element 121. When the pushing head 210 and the retarding member 220 approach the clamping portion, the condensing portion 230 is connected with the locking element 121, as shown in fig. 6, at this time, the retarding strips 221 of the retarding member 220 are deformed, and the retarding strips 221 pulled to the limit position contact end to end, so as to form a petal-shaped retarding net, and the retarding member 220 is in an unfolded state. The condensation 230 is snapped or rotatably connected with the locking element 121. The distal middle portion of the condensing part 230 is detachably connected with the proximal middle portion of the pushing head 210. When the pushing head 210 and the blocking member 220 approach the clamping portion, the distal middle portion of the condensing portion 230 is connected to the proximal middle portion of the pushing head 210. Causing blocking member 220 to remain in a stable deployed state.

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

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

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

The inner tube 320 is disposed in the outer tube 310, and the distal end of the inner tube 320 is detachably connected, preferably threaded, to the locking element 121 after passing through the outer tube 310 and the engaging element 122. The inner tube 320 drives the locking element 121 toward 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 in the inner tube 320, and the distal end of the inner core tube 330 is detachably connected to the pusher head 210 after passing through the inner tube 320, the locking member 121, the condensation section 230, and the blocking member 220. Through holes are provided on both the locking piece 121 and the condensed portion 230 for the core tube 330 to pass through. The inner core tube 330 drives the gripping mechanism 200 to approach or depart from the clamping portion. When the inner core tube 330 drives the pushing head 210 to gradually approach the clamping portion, the middle portion of the proximal end of the pushing head 210 is connected to the middle portion of the distal end of the condensing portion 230. The proximal end of the condensation 230 is connected to the distal end of the locking element 121.

When the tricuspid valve clamping 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 of the grabbing mechanism 200 is pushed and controlled, 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 to make the retarding member 220 in a unfolded state, and the retarding member 220 is expanded into a petal-shaped retarding net, so as to avoid the phenomenon that the valve leaflet escapes due to the continuous shaking of the valve in the using process of the clamping mechanism 100.

After observing the developing point to confirm that the blocking member 220 is completely opened, the grasping mechanism 200 is pulled back to enable the blocking strip to be attached to the lower surface of the leaflet, the inner tube of the control clamping mechanism 100 is pushed until the condensed part 230 is buckled and connected with the locking piece 121, and then the clamping part is released to be in an opened state, so that the two symmetrical inner clamps 112 are tiled, namely, the included angle between the two symmetrical inner clamps is 180 degrees, and the clamping surfaces of the leaflet of the inner clamps 112 are attached to the upper surface of the leaflet. Where the flap She Yushe is trapped between the blocking member 220 and the inner clip 112. The purpose of the engagement of the condensation 230 with the locking element 121 is to prevent displacement of the blocking member 220 during subsequent clamping of the flap She Yushe portion, thereby affecting the clamping effect.

The gripping action on the valve leaflet can be further completed by pulling the gripping mechanism 200, and in the pulling process, the inner clip 112 and the outer clip 111 gradually approach to each other until the inner clip and the outer clip overlap completely, so that the locking piece 121 and the clamping piece 122 are in buckled connection to complete self-locking, and the loosening of the clamping part is prevented.

The tricuspid valve clamping device is reliable in clamping, high in safety, less in damage to heart tissues, simple in structure and convenient to operate. The valve leaflet and the subvalvular structure of the tricuspid valve are reserved, the right ventricle structure is reserved to the greatest extent, the heart decay is slowed down, and the treatment effect of the tricuspid valve reflux is improved.

The foregoing has shown and described the basic principles, principal 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, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. 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;

the clamping mechanism is characterized by comprising:

a clamping part;

the grabbing mechanism comprises:

a pushing head;

a blocking member having a distal end coupled 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 blocking member to be close to or far away from the clamping part;

the action mechanism comprises:

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

an inner tube arranged in the outer tube, the distal end passing through the outer tube and the clamping piece and then detachably connected with the locking piece to drive the locking piece to approach or separate from the clamping piece, an inner core tube arranged in the inner tube, and the distal end of the inner core tube passing through the inner tube

The distal end of the inner core tube penetrates through the inner tube, the locking piece and the blocking member and then is detachably connected with the pushing head, so that the pushing head and the blocking member are driven to be close to or far away from the clamping part;

the grasping mechanism further includes:

when the inner core tube drives the pushing head and the blocking member to approach the clamping part, the condensation part is connected with the locking piece;

the clamping part includes two sets of clamping components that the symmetry set up, every group clamping component all includes:

2. A tricuspid valve gripping device according to claim 1, wherein the connection of the outer clip to the engagement member, the connection of the inner clip to the locking element and the connection of the inner clip to the outer clip are all by means of resilient members to provide a rotational connection.

3. The tricuspid valve gripping apparatus according to claim 1, wherein the outer clip and the inner clip each comprise a memory alloy;

the clamping part is provided with a coating, and the coating is a biocompatible coating.

4. Tricuspid gripping apparatus according to claim 1, wherein the constriction is snapped or rotatably connected with the locking element.

5. The tricuspid valve gripping apparatus according to claim 1, wherein a distal intermediate section of the converging portion is detachably connected to a proximal intermediate section of the pusher head;

6. A tricuspid valve gripping apparatus according to any one of claims 1 to 5, wherein the blocking member is a hollow structure defined by a plurality of blocking strips and is adapted to assume an expanded or compressed state under the action of the actuating mechanism;

at least one developing point is arranged on the outer side face of the retarding strip.

7. The tricuspid valve gripping device according to claim 6, wherein the barrier strip comprises 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;