CN112168427A

CN112168427A - Heart apex implantation cusp clamping device and heart apex implantation cusp clamping method

Info

Publication number: CN112168427A
Application number: CN202011204150.6A
Authority: CN
Inventors: 戴宇峰; 潘炳跃; 王智杰
Original assignee: Shanghai Hongyu Medical Technology Co ltd
Current assignee: Shanghai Hongyu Medical Technology Co ltd
Priority date: 2020-11-02
Filing date: 2020-11-02
Publication date: 2021-01-05
Also published as: CN112587284A

Abstract

The invention discloses a cusp clamping device and a cusp clamping method for apical implantation, which comprise an upper connecting piece, wherein the upper connecting piece is sequentially provided with a sealing end piece and a central net, a rod penetrating cavity is arranged in the central net, and an upper connecting mechanism is arranged at the near end of the sealing end piece; the inner frame net and the lower end of the central netting are connected to form an integral structure; the outer edge of the outer frame net and the outer edge of the inner frame net are connected into a whole, a lantern ring is arranged in the middle of the outer frame net, and a lower connecting mechanism is arranged on the outer ring surface of the lantern ring; the elastic clamp is fixed on the surface of the inner frame net; the clip opening mechanism is used for controlling the elastic clip to open; the outer frame net initially remembers the state that the outer frame net is folded towards the far end to wrap the inner frame net and the elastic clip. The invention greatly reduces the caliber of the clamping device when in compression insertion, can insert a small-caliber sheath tube, reduces the operation difficulty and the strength of the operation, can adopt the elastic clamp with large width, improves the capturing success rate, is independently controlled by the corresponding pull wire, is easy to control and capture valve leaflets, and has strong universality.

Description

Heart apex implantation cusp clamping device and heart apex implantation cusp clamping method

Technical Field

The invention relates to the technical field of medical instruments, in particular to an apical implantation cusp clamping device and an apical implantation cusp clamping method.

Background

As the population ages, the incidence of valvular heart disease is increasing, with a concomitant trend toward increased incidence of mitral regurgitation. According to statistics, in heart valve diseases, mitral valve lesions account for 70% of the valve diseases and account for a large proportion.

With the development of science and technology, instrument manufacturers at home and abroad develop a batch of interventional instruments for treating mitral regurgitation. Of which Yapei MitraClip and Edward PASCAL are typical representatives. The MitraClip is popularized earlier in clinic, the clip is designed to have a four-bar structure according to the mechanical working principle, the clip is conveyed from an atrium to the position near a mitral valve through the puncture of a catheter femoral vein and the puncture of an interatrial septum, the free edges of the front and the rear valve leaflets are clamped and fixed, and the mitral valve is clamped into a double hole by the clip, so that the valve leaflets are aligned and good at the end of systole, and the backflow is reduced. Edward PASCAL has a mechanical working principle which is different from that of MitraClip, and is designed into a clamp opening and closing mechanism similar to a rhombic folding structure, wherein the valve leaflet catching and clamping force and the valve leaflet fixing force of PASCAL are elastic retraction force of preset shape metal, and the mitral valve is clamped into a double hole by using a clamp through femoral vein puncture, catheter interatrial puncture and the like.

Both MitraClip and PASCAL suffer from the following problems: the operation is difficult and the operation time is long when the femoral vein is intervened through a long sheath. Due to the large-size sheath tube adopted in the operation, residual leakage of the interatrial septum can be remained after the operation. Therefore, a minimally invasive heart incessantly beating brief rapid surgical method and device are urgently needed to complete valve repair, the process can be easily operated, and the operation intensity and difficulty of an operator can be reduced.

Disclosure of Invention

The invention aims to provide an apex cordis implantation cusp clamping device and an apex cordis implantation cusp clamping method, and aims to solve the technical problems that in the prior art, a large-size long sheath catheter is adopted for intervention, the operation is difficult, the operation time is long, and complications are easily caused.

In order to achieve the purpose, the technical scheme of the invention is as follows:

in a first aspect, the present invention discloses an apical implant cusp clamping device comprising:

the upper connecting piece comprises a sealing end piece and a central braiding net which are sequentially arranged from a far end to a near end, a penetrating rod cavity is arranged in the central braiding net in a penetrating mode, and an upper connecting mechanism used for being detachably connected with the pushing rod is arranged at the near end of the sealing end piece;

the inner frame net is fixed on the near side of the central netting and is connected with the lower end of the central netting to form an integrated structure, the surface of the inner frame net is a plane, and the middle part of the inner frame net is provided with a first opening matched with the rod penetrating cavity;

the outer frame net is wrapped outside the inner frame net in an arc shape, the outer edge of the outer frame net and the outer edge of the inner frame net are connected into a whole, a lantern ring is arranged in the middle of the outer frame net, a second opening matched with the rod penetrating cavity is formed in the lantern ring, and a lower connecting mechanism used for being connected with the inner wall of the sheath pipe to keep the position is arranged on the outer ring surface of the lantern ring;

the elastic clamp is arranged on the surface of the inner frame net and used for clamping the cusp, and the initial state of the elastic clamp is a closed state;

the clamping opening mechanism is used for controlling the elastic clamp to be expanded to capture the cusp;

the outer frame net is a memory elastic material net, the initial memory state of the outer frame net is that the outer frame net and the elastic clamp are folded towards the far end to wrap the inner frame net and the elastic clamp, and an angle of 160-180 degrees is formed between the outer frame net and the inner frame net when the outer frame net is inserted into the sheath.

By "proximal" in the present invention is meant the end of the device that is closer to the user and further away from the implantation site. "distal end" refers to the end of the device that is further from the user and closer to the implantation site.

By adopting the scheme, the outer frame net is a woven net made of memory elastic materials, the initial memory state is that the inner frame net and the elastic clamp are folded and wrapped towards the far end, and the push rod can be detachably fixed with the sealing end piece through the rod penetrating cavity, so that the push rod can be controlled to push and contract to control the deformation states of the outer frame net and the inner frame net;

when the sheath tube needs to be inserted into initially, the pushing rod is pushed, the lantern ring moves towards the near end relative to the pushing rod to drive the outer frame net to gradually fold towards the near end and drive the inner frame net to turn towards the near end until an angle of 160-180 degrees is formed between the outer frame net and the inner frame net, so that the caliber is greatly reduced, and the sheath tube can be compressed and inserted into the sheath tube with a small caliber;

after the intervention is in place, the outer frame net and the inner frame net can be driven to reset under the action of the shape memory effect by contracting the push rod until the inner frame net is positioned at a platform position which is 90-120 degrees to the axial direction of the sheath tube, the elastic clamp can be opened through the clamp opening mechanism, and then the elastic clamp resets under the action of elasticity to capture the cusp; after the capture is completed, the outer frame net is continuously folded towards the end until the initial memory state is returned to complete the whole cusp clamping operation.

The caliber of the clamping device can be compressed to be very small during intervention, so that the clamping device can be inserted into a sheath tube with a very small caliber, the operation difficulty and the intensity of the operation are greatly reduced, the side effect of the operation on a patient is reduced, corresponding complications are reduced, and the success rate of the operation is improved; in addition, the inner frame net and the outer frame net form an angle of 160-180 degrees when the compression is inserted into the sheath tube, so that the influence of the length of the elastic clamp on the surface of the inner frame net on the caliber of the clamping device is small, and the elastic clamp with larger width can be adopted, thereby improving the capturing success rate and reducing corresponding complications.

On the basis of the technical scheme, the invention can be further improved as follows:

furthermore, the elastic clamp comprises a lower clamp and an upper clamp, the lower clamp and the upper clamp are matched to form the elastic clamp in a closed state, inverted teeth are arranged on a clamping surface of the upper clamp, the lower clamp is arranged on the surface of the inner frame net, the clamping opening mechanism comprises a pull wire connected with the upper clamp, and the clamping opening mechanism controls the elastic clamp to be opened to form an L-shaped structure for capturing the cusp.

Through adopting above-mentioned scheme, when interveneeing the operation, can wear out the acting line by the sheath pipe near-end, when needs are opened the elasticity and are pressed from both sides and carry out cusp and catch, the pulling is acted as go-between and is opened the upper clamp, easily independent control catches the leaflet, effectively improves and catches the success rate, reduces and catches the process and injure to the leaflet.

Furthermore, the clamp opening mechanism further comprises threading rings symmetrically arranged on two sides of the seal end piece, and the pulling wire penetrates through the threading rings to enter the seal end piece and penetrates through the seal end piece to enter the rod penetrating cavity.

Through adopting above-mentioned scheme, the thimble plays for acting as go-between guide effect, and the stay wire passes through seal end piece and poling chamber through the thimble in proper order to wear out by the near-end of sheath pipe, the control of the elasticity of being convenient for presss from both sides.

Further, be equipped with on the inside casing net with press from both sides the guide rail that matches down, the guide rail by first opening outwards extends the setting, press from both sides down and install on the guide rail, and slide along the guide rail and set up.

By adopting the scheme, the lower clamp is arranged along the guide rail in a sliding manner, and the elastic clamp is driven to slide towards the outer side along the guide rail in the clamping opening process controlled by the pull wire, so that the capturing range and the capturing efficiency of the elastic clamp are improved, the elastic clamp can be controlled to be close to the first opening side when a sheath tube is involved, and the influence of the length of the elastic clamp on the caliber of the clamping device is further avoided; each spring clip is controlled by a separate pull wire, enabling control of the number of leaflets captured.

Furthermore, a pair of elastic clamps is symmetrically arranged on the inner frame net.

By adopting the scheme, the pair of elastic clamps is suitable for clamping the mitral valve.

Furthermore, the inner frame net is evenly provided with three elastic clamps.

By adopting the scheme, the three elastic clamps are suitable for clamping the tricuspid valve.

Further, the upper connecting mechanism is a thread structure arranged at the proximal end of the seal end piece and used for being connected with the end of the pushing rod.

Furthermore, the lower connecting mechanism is provided with protrusions symmetrically arranged on the outer ring surface of the lantern ring.

Through adopting above-mentioned scheme, the position state that outer frame net and lantern ring were realized to the arch and the inner wall of sheath pipe are pasted tightly keeps, breaks the holding state when the push rod action, drives lantern ring and outer frame net action.

Further, the outer frame net is a nickel-titanium alloy woven net or a shape memory polymer material woven net; the elastic clamp is a nickel-titanium alloy elastic clamp, and the peripheral surface of the elastic clamp is wrapped with a PET (polyethylene terephthalate) film or a PTFE (polytetrafluoroethylene) film.

In a second aspect, the present invention discloses an apical implant cusp clamping method using the apical implant cusp clamping device, comprising the steps of:

s1, inserting the push rod into the rod penetrating cavity from the middle part of the lantern ring, and fixing the push rod with the sealing end piece through the upper connecting mechanism;

s2, pushing the push rod to control the lantern ring to move towards the direction far away from the sealing end piece, driving the outer frame net and the inner frame net to deform until an angle of 160-180 degrees is formed between the outer frame net and the inner frame net, then compressing the outer frame net and the inner frame net to intervene in the sheath tube, and connecting the lower connecting mechanism with the inner wall of the sheath tube to keep the state;

s3, starting to intervene in the sheath tube, slowly contracting and withdrawing the push rod after intervention in place, gradually expanding the outer frame net towards the direction of the sealing end piece under the action of memory reset, driving the lantern ring to move towards the far end and turning the inner frame net towards the direction of the sealing end piece, and correspondingly deforming the outer frame net and the inner frame net through the shape memory effect until the inner frame net is at a platform position which forms 90-120 degrees with the axial direction of the sheath tube, and opening the elastic clamp through the clamp opening mechanism to prepare for cusp capture;

s4, aligning the elastic clip to the cusp position, gradually clamping and capturing the cusp by the elastic clip, continuously withdrawing the push rod, driving the outer frame net to continuously retract towards the far end under the action of the shape memory effect until the outer frame net returns to the initial memory state to wrap the inner frame net and the elastic clip, finally detaching the push rod, and withdrawing the sheath tube.

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

1. the outer frame net is made of memory elastic materials, the pushing rod is pushed when the outer frame net is compressed to be inserted into the sheath tube, the lantern ring moves towards the near end relative to the pushing rod to drive the outer frame net to gradually fold towards the near end and drive the inner frame net to turn towards the near end until an angle of 160-180 degrees is formed between the outer frame net and the inner frame net, the caliber of the clamping device is greatly reduced, the outer frame net can be inserted into the sheath tube with a small caliber, the operation difficulty and the strength of the operation are greatly reduced, the side effect of the operation on a patient is reduced, corresponding complications are reduced, and the success rate of the operation is improved;

2. when the clamping device is inserted into the sheath tube, the inner frame net and the outer frame net form an angle of 160-180 degrees, so that the length of the elastic clamp on the surface of the inner frame net has small influence on the caliber of the clamping device, and the elastic clamp with larger width can be adopted, thereby improving the capturing success rate and reducing corresponding complications;

3. the elastic clips on the surface of the inner frame net are independently controlled by corresponding pull wires, so that the valve leaflet capturing is easy to control, the capturing success rate is effectively improved, and the damage to the valve leaflet in the capturing process is reduced;

4. the invention can be accurately implanted into the heart only by means of the navigation function of three-dimensional heart ultrasound, and has strong universality;

5. the elastic clamp is arranged along the guide rail in a sliding mode, and in the clamping opening process controlled by the pull wire, the elastic clamp is driven to slide towards the outer side along the guide rail, so that the capturing range and the capturing efficiency of the elastic clamp are improved, the elastic clamp can be controlled to be close to the first opening side when a sheath tube is involved, and the influence of the length of the elastic clamp on the caliber of the clamping device is further avoided.

Drawings

In order to more clearly illustrate the detailed description of the invention or the technical solutions in the prior art, the drawings that are needed in the detailed description of the invention or the prior art will be briefly described below. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.

Fig. 1 is a schematic structural diagram of an external frame network memory initial state according to an embodiment of the present invention.

Fig. 2 is a schematic structural view of a sheath insertion state according to an embodiment of the present invention.

Fig. 3 is a schematic structural view of a cusp capture state of the embodiment of the present invention.

Fig. 4 is a schematic view of a structure in which the cusp capture is completed according to the embodiment of the present invention.

Shown in the figure:

1. a seal end piece; 101. a thread structure; 102. a threading ring;

2. central netting; 201. a rod penetrating cavity;

3. an outer frame net; 301. a collar; 302. a protrusion; 303. a second opening;

4. an inner frame net; 401. a first opening; 402. a guide rail;

5. an elastic clip; 501. lower clamping; 502. clamping; 503. chamfering;

6. and pulling a wire.

Detailed Description

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The following examples are only for illustrating the technical solutions of the present invention more clearly, and therefore are only examples, and the protection scope of the present invention is not limited thereby.

It is to be noted that, unless otherwise specified, technical or scientific terms used herein shall have the ordinary meaning as understood by those skilled in the art to which the invention pertains.

The term "proximal" in embodiments of the present invention refers to the end of the device that is closer to the user and further away from the implantation site, and the term "distal" refers to the end of the device that is further away from the user and closer to the implantation site.

As shown in fig. 1, the present embodiment discloses a cusp clamping device for apical implantation, which comprises an upper connecting member, an inner frame net 4, an outer frame net 3, an elastic clamp 5 and an opening and clamping mechanism.

Go up the connecting piece and include seal end piece 1 and the central net 2 of weaving that sets gradually by distal end to near-end, seal end piece 1 and central net 2 are for adopting stainless steel or alloy material's the net structure of weaving, and the inside pole chamber 201 that wears through that is equipped with of central net 2, and seal end piece 1 near-end is equipped with and is used for dismantling the last coupling mechanism who is connected with the push rod.

The upper attachment means is a screw thread 101 provided at the proximal end of the seal face 1 for attachment to the end of a push rod.

The inner frame net 4 is made of titanium materials and fixed on the near side of the central braided net 2, the inner frame net 4 and the lower end of the central braided net 2 are connected to form an integral structure, the surface of the inner frame net 4 is a plane, and the middle of the inner frame net 4 is provided with a first opening 401 matched with the rod penetrating cavity 201. The inner frame mesh 43.

The outer frame net 3 wraps the outer side of the inner frame net 4 in an arc shape, the outer edge of the outer frame net 3 is connected with the outer edge of the inner frame net 4 into a whole, a lantern ring 301 is arranged in the middle of the outer frame net 3, a second opening 303 matched with the rod penetrating cavity 201 is arranged in the lantern ring 301, and a lower connecting mechanism used for being connected with the inner wall of the sheath pipe to keep the position is arranged on the outer annular surface of the lantern ring 301.

The outer frame 3 is a woven net made of memory elastic material, specifically, the outer frame 3 is made of nickel-titanium alloy, and other materials, such as woven net made of shape memory polymer material, which have memory elastic property and can be inserted into human body, can also be applied in this embodiment.

As shown in FIG. 1, the outer netting 3 initially remembers to collapse distally around the inner netting 4 and the clips 5. When the sheath is inserted, the angle between the outer frame net 3 and the inner frame net 4 is controlled to be 170 degrees as shown in fig. 2.

The lower connecting mechanism is provided with protrusions 302 symmetrically arranged on the outer ring surface of the lantern ring 301.

The protrusion 302 is tightly attached to the inner wall of the sheath tube to keep the position states of the outer frame net 3 and the lantern ring 301, and when the pushing rod moves, the keeping state is broken, so that the lantern ring 301 and the outer frame net 3 are driven to move.

A pair of elastic clips 5 are arranged on the surface of the inner frame net 4 and used for clamping the cusp, and the initial state of the elastic clips 5 is a clamping state; the clip opening mechanism is used for controlling the elastic clip 5 to open and capture the cusp.

The embodiment is provided with a pair of elastic clamps 5 which are suitable for clamping the mitral valve; similarly, when the three elastic clips 5 are uniformly arranged on the surface of the inner frame net 4, the three elastic clips can be suitable for the clamping operation of the tricuspid valve.

Specifically, the elastic clamp 5 is made of the same nickel-titanium alloy material as the outer frame net 3, and the periphery of the elastic clamp is wrapped with a PET (polyethylene terephthalate) film, so that the clamping state is maintained.

The elastic clamp 5 comprises a lower clamp 501 and an upper clamp 502, the lower clamp 501 and the upper clamp 502 are matched to form the elastic clamp 5 in an initial state of a closed state, inverted teeth 503 are arranged on a clamping face of the upper clamp 502, the lower clamp 501 is installed on the surface of the inner frame net 4, the clamping opening mechanism comprises a pull wire 6 connected with the upper clamp 502, and the clamping opening mechanism controls the elastic clamp 5 to be opened to form an L-shaped structure for capturing a cusp.

Intervene the operation, can wear out the acting as go-between 6 by the sheath pipe near-end, when needs open elasticity and press from both sides 5 and carry out cusp capture, the pulling acts as go-between 6 and opens and presss from both sides 502, easily independent control catches the leaflet, effectively improves and catches the success rate, reduces and catches the process and injure to the leaflet.

The clamp opening mechanism further comprises threading rings 7 symmetrically arranged on two sides of the seal end piece 1, and the pulling wire 6 penetrates through the threading rings 7 to enter the seal end piece 1 and penetrates through the seal end piece 1 to enter the threading rod cavity 201.

The threading ring 7 plays a role in guiding the pull wire 6, and the pull wire 6 sequentially passes through the sealing end piece 1 and the threading rod cavity 201 through the threading ring 7 and penetrates out of the proximal end of the sheath tube, so that the elastic clamp 5 is convenient to control.

In this embodiment, the inner frame net 4 is further provided with a rail 402 matching with the lower clip 501, the rail 402 extends from the first opening 401 to the outside, and the lower clip 501 is mounted on the rail 402 and slidably arranged along the rail 402.

Lower clamp 501 slides along guide rail 402 and sets up, and at the in-process of opening the clamp through the 6 control of acting as go-between, can drive elastic clamp 5 and slide towards the outside along guide rail 402 to improved elastic clamp 5's capture scope and capture efficiency, also can control elastic clamp 5 when intervene the sheath pipe and be close to first opening 402 side, further avoid elastic clamp 5 length to clamping device bore influence.

The working principle of the embodiment is as follows:

the outer frame net 3 is a woven net made of memory elastic materials, the initial memory state is that the inner frame net 4 and the elastic clamp 5 are folded and wrapped towards the far end, and the push rod can be detachably fixed with the sealing end piece 1 through the rod penetrating cavity 201, so that the deformation states of the outer frame net 3 and the inner frame net 4 can be controlled by controlling the push rod to push and contract;

as shown in fig. 2, when the sheath is required to be inserted into the sheath initially, the pushing rod is pushed, the collar 301 moves towards the proximal end relative to the pushing rod to drive the outer frame net 3 to gradually close towards the proximal end, and drive the inner frame net 4 to turn towards the proximal end until an angle of 160 degrees to 180 degrees is formed between the outer frame net 3 and the inner frame net 4, so that the diameter is greatly reduced, and the sheath can be inserted into the sheath with a small diameter in a compressed manner;

as shown in fig. 3, after the intervention is completed, the outer frame net 3 and the inner frame net 4 can be driven to reset under the action of the shape memory effect by contracting the push rod until the inner frame net 4 is located at a platform position which is 90 to 120 degrees away from the axial direction of the sheath, the elastic clamp 5 can be opened through the clamp opening mechanism, and then the elastic clamp 5 resets under the elastic action to capture the cusp.

After the capture is completed, the outer frame mesh 3 continues to collapse towards the ends until it returns to the initial memory state to complete the entire cusp clamping operation, as shown in fig. 4.

The caliber of the clamping device can be compressed to be very small during intervention, so that the clamping device can be inserted into a sheath tube with a very small caliber, the operation difficulty and the intensity of the operation are greatly reduced, the side effect of the operation on a patient is reduced, corresponding complications are reduced, and the success rate of the operation is improved; in addition, when the compression is inserted into the sheath tube, the inner frame net 4 and the outer frame net 3 form an angle of 160-180 degrees, so that the influence of the length of the elastic clamp 5 on the surface of the inner frame net 4 on the caliber of the clamping device is small, and the elastic clamp 5 with larger width can be adopted, thereby improving the capturing success rate and reducing corresponding complications.

The embodiment also discloses an apex implantation cusp clamping method adopting the apex implantation cusp clamping device, which comprises the following steps:

s1, inserting a push rod into the rod penetrating cavity 201 from the middle part of the lantern ring 301, and fixing the push rod with the sealing end piece 1 through an upper connecting mechanism;

s2, pushing the push rod to control the lantern ring 301 to move towards the direction far away from the sealing end piece 1, driving the outer frame net 3 and the inner frame net 4 to deform until an angle of 160-180 degrees is formed between the outer frame net 3 and the inner frame net 4, then compressing the materials to be inserted into the sheath tube, and connecting the lower connecting mechanism with the inner wall of the sheath tube to keep the state;

s3, starting to intervene in the sheath tube, slowly contracting and withdrawing the push rod after intervention in place, gradually expanding the outer frame net 3 towards the direction of the sealing end piece 1 under the action of memory reset, driving the lantern ring 301 to move towards the far end and turning the inner frame net 4 towards the direction of the sealing end piece 1, correspondingly deforming the outer frame net 3 and the inner frame net 4 through the shape memory effect until the inner frame net 4 is at a platform position which forms 90-120 degrees with the axial direction of the sheath tube, opening the elastic clamp 5 through the clamp opening mechanism, and preparing to capture the cusp;

s4, aligning the elastic clamp 5 to the cusp position, gradually clamping and capturing the cusp by the elastic clamp 5, continuously withdrawing the push rod, driving the outer frame net 3 to continuously fold towards the far end under the action of the shape memory effect until the outer frame net returns to the initial memory state to wrap the inner frame net 4 and the elastic clamp 5, finally detaching the push rod, and withdrawing the sheath tube.

In this embodiment, the outer frame net 3 is made of a memory elastic material, and the pushing rod is pushed when the outer frame net 3 is compressed to intervene in the sheath tube, so that the lantern ring 301 moves towards the near end relative to the pushing rod to drive the outer frame net 3 to gradually fold towards the near end and drive the inner frame net 4 to turn towards the near end until an angle of 160-180 degrees is formed between the outer frame net 3 and the inner frame net 4, thereby greatly reducing the caliber of the clamping device, greatly reducing the operation difficulty and intensity of the operation due to the intervention in the sheath tube with a small caliber, reducing the side effect of the operation on a patient, reducing corresponding complications and improving the success rate of the operation;

when the clamping device of the embodiment intervenes in a sheath, the inner frame net 4 and the outer frame net 3 form an angle of 160-180 degrees, so that the length of the elastic clamp 5 on the surface of the inner frame net 4 has small influence on the caliber of the clamping device, and the elastic clamp 5 with larger width can be adopted, thereby improving the capturing success rate and reducing corresponding complications;

in the embodiment, the elastic clips 5 on the surface of the inner frame net 4 are independently controlled by the corresponding pull wires 6, so that the valve leaflet capturing is easy to control, the capturing success rate is effectively improved, and the damage to the valve leaflet in the capturing process is reduced;

the embodiment can be accurately implanted into the heart only by means of the navigation function of three-dimensional cardiac ultrasound, does not need high-end image equipment, and has strong universality.

In the description of the present invention, numerous specific details are set forth. It is understood, however, that embodiments of the invention may be practiced without these specific details. In some instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention, and they should be construed as being included in the following claims and description.

Claims

1. An apical implant cusp clamping device, comprising:

2. The cusp clamping device for apical implant of claim 1, wherein the elastic clip comprises a lower clip and an upper clip, the lower clip and the upper clip cooperate to form the elastic clip in an initial state of a closed state, the clamping surface of the upper clip is provided with inverted teeth, the lower clip is mounted on the surface of the inner frame mesh, the clip opening mechanism comprises a pull wire connected with the upper clip, and the clip opening mechanism controls the elastic clip to open to form an L-shaped structure for capturing the cusps.

3. The apex implant cusp clamping device of claim 2, wherein the unclamping mechanism further comprises a threading ring symmetrically disposed on either side of the seal end piece, the pull wire passing through the threading ring into the seal end piece and through the seal end piece into the threading rod cavity.

4. The cusp clamping device for apical implant of claim 2, wherein the inner frame mesh is provided with a guide track matching the lower clamp, the guide track extending from the first opening towards the outside, and the lower clamp is mounted on the guide track and slidably arranged along the guide track.

5. The cusp clamping device for apical implant of claim 1, wherein a pair of said elastic clips are symmetrically disposed on said inner frame mesh.

6. The cusp clamping device for apical implant of claim 1, wherein three of said elastic clips are uniformly provided on said inner frame mesh.

7. The apex implant cusp clamping device of claim 1, wherein said upper attachment mechanism is a threaded structure disposed at the proximal end of said seal end piece for attachment to a push rod end.

8. The apical implant cusp clamping device of claim 1, wherein the lower attachment means is provided by protrusions symmetrically arranged on the outer circumferential surface of the collar.

9. The cusp clamping device for the apical implant of any one of claims 1 to 8, wherein the outer frame mesh is a woven mesh of nitinol or a woven mesh of shape memory polymer material; the elastic clamp is a nickel-titanium alloy elastic clamp, and the peripheral surface of the elastic clamp is wrapped with a PET (polyethylene terephthalate) film or a PTFE (polytetrafluoroethylene) film.

10. An apical implant cusp clamping method of the apical implant cusp clamping device according to any of the claims 1 to 9, comprising the steps of: