CN117982263A

CN117982263A - Valve holder for artificial heart valve

Info

Publication number: CN117982263A
Application number: CN202211346929.0A
Authority: CN
Inventors: 高卉; 吴宇航; 金亮; 刘世红; 陈国明
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2022-10-31
Filing date: 2022-10-31
Publication date: 2024-05-07

Abstract

The invention provides a valve holder of an artificial heart valve, a handle is detachably connected with a connecting part of a valve holding rotor through the head of the valve holder, each tightening line of the valve holding structure is detachably connected with a corresponding valve angle and the valve holding structure, an inserting part of the valve holding rotor can extend into a rotating hole of a first valve holding part to be detachably connected with the first valve holding part, the first valve holding part and a second valve holding part move back to each other along the axial direction, the tightening lines are stretched to retract the valve angles, the step of retracting the valve angles by utilizing the valve holding rotor and the valve holding structure and the step of disassembling and assembling the handle and the valve holding rotor can be mutually independent, the doctor can retract the valve angles before connecting the handle and the valve holding rotor in the operation process, the operation step is simple and natural in transition, the risk of contacting the artificial heart valve is avoided, the sewing ring of the artificial heart valve can not be pulled, and the whole operation process can not cause the risk of deformation or displacement of the artificial heart valve.

Description

Valve holder for artificial heart valve

Technical Field

The invention relates to the technical field of medical appliances, in particular to a valve holder of an artificial heart valve.

Background

Heart valve disease is one of the main categories of current heart disease, which can lead to significant dysfunction of the heart and ultimately requires replacement of the native heart valve with an artificial heart valve. Heart valves are largely divided into aortic, pulmonary, tricuspid and mitral valves.

The valve holder serves as an "auxiliary tool" during implantation of the prosthetic heart valve to assist the heart surgeon in performing prosthetic valve removal, placement, and native annulus suturing throughout the procedure. In addition, in the artificial heart valve implantation process, in order to prevent the valve angles of the artificial heart valve from interfering with human tissues to influence the operation effect and/or the operation progress, a convenient and wider operation field is provided for a cardiac surgeon, and the three valve angles of the artificial heart valve are required to be retracted by the valve holder before implantation.

The existing valve holder used clinically can not control the angle of folding the valve angle, the risk that the artificial heart valve is damaged due to plastic deformation and damaged or shifted due to the fact that the suture ring is pulled by the tightening wire is easy to occur due to the fact that the adduction angle is too large, and the convenience and usability of the whole operation flow are insufficient; or the valve angle retracting process is complicated, the artificial heart valve is easy to damage, and the tightening wires are crossed, so that the valve holder system is difficult to withdraw smoothly.

Disclosure of Invention

The invention aims to provide a valve holder of a prosthetic heart valve, which aims to solve the problems that the existing valve holder cannot control the angle of folding the valve angle, the folding process of the valve angle is complex, the prosthetic heart valve is easy to damage, the operation is complex and the like.

In order to achieve the above object, the present invention provides a valve holder for an artificial heart valve, comprising:

A handle comprising a head;

the valve-holding rotor comprises a connecting part and an inserting part which are axially connected, and the handle is detachably connected with the connecting part through the head part;

The valve holding structure comprises a first valve holding part, a second valve holding part and a tightening wire, wherein the first valve holding part and the second valve holding part are oppositely arranged along the axial direction, and the first valve holding part is provided with a rotating hole penetrating along the axial direction;

The artificial heart valve is positioned at the distal end side of the second valve holding part, each valve angle of the artificial heart valve corresponds to at least one tightening wire, and each tightening wire is detachably connected with the corresponding valve angle and the valve holding structure; and

The insertion part can extend into the rotation hole to be detachably connected with the first holding part, the first holding part and the second holding part move along the axial direction in opposite directions, and the tightening wire is stretched to retract the flap angle.

Optionally, at least two circumferentially distributed protruding blocks are arranged on the outer side wall of the head, a fixing hole and at least two groove groups circumferentially distributed along the fixing hole are arranged on the proximal end side of the connecting part, and the protruding blocks are in one-to-one correspondence with the groove groups; and

The groove sets comprise alignment grooves and locking grooves which are arranged on the inner side walls of the fixing holes, the alignment grooves and the locking grooves are distributed and communicated along the circumference of the fixing holes, when the protruding blocks are aligned and enter the corresponding alignment grooves, the heads extend into the fixing holes, the handles are rotated to enable the protruding blocks to enter the corresponding locking grooves, and the protruding blocks are clamped into the corresponding locking grooves.

Optionally, a first partition plate is arranged between the locking groove and the corresponding alignment groove, the distance between the first partition plate and the bottom of the fixing hole can be used for the protrusion to pass through, and the handle is rotated to enable the protrusion to switch positions in the corresponding alignment groove and the locking groove; and

The first partition plate is used as a first groove wall of the locking groove and a first groove wall of the alignment groove at the same time, and after the protruding block enters the corresponding locking groove, the handle is pulled outwards along the axial direction of the fixing hole, so that the protruding block is clamped between the first partition plate and a second groove wall of the corresponding locking groove.

Optionally, a second partition plate is arranged between the locking grooves and the alignment grooves of two adjacent groove groups, and the second partition plate is used as a second groove wall of the alignment groove and a second groove wall of the locking groove at the same time; and

The distance between the second partition plate and the bottom of the fixing hole can be used for the protruding block to pass through; or the second separator may stop the bump.

Optionally, a first mark is further provided on the proximal side of the connecting portion, for indicating the rotation direction of the handle.

Optionally, the valve holding structure includes at least three hole groups, the hole groups are circumferentially distributed along the rotation hole and each include at least one threading hole penetrating through the first valve holding part and the second valve holding part along the axial direction; each flap angle corresponds to at least one of the hole sets, and each tightening wire passes through the threading holes of the corresponding hole set and is knotted to fix the first and second flap portions.

Optionally, the outer side wall of the insertion part and the inner side wall of the rotation hole are respectively provided with matched threads, and the insertion part can be screwed into the rotation hole to be detachably connected with the first holding valve part.

Optionally, the first valve holding part and the second valve holding part each comprise a valve holding main body and at least two alignment tables, the alignment tables are circumferentially distributed along the valve holding main body, the positions of the valve holding main bodies of the first valve holding part and the second valve holding part correspond to each other, and the positions of the alignment tables of the first valve holding part and the second valve holding part correspond to each other.

Optionally, the number of hole groups is a multiple of 3, and each lobe angle corresponds to one or at least two adjacent hole groups.

Optionally, the hole group includes 3 the through wires hole is first through wires hole, second through wires hole and third through wires hole respectively, every the lamella angle corresponds two at least tightening threads, one tightening threads's knot end is followed the distal end side of second holding lamella portion is passed in proper order first through wires hole with the second through wires hole, another tightening threads's knot end is followed the distal end side of second holding lamella portion is passed in proper order third through wires hole, first through wires hole and second through wires hole, two tightening threads's knot end is tied.

Optionally, the hole group further includes a thread cutting groove for cutting thread, the thread cutting groove is communicated with the first threading hole and the second threading hole, the tightening thread between the first threading hole and the second threading hole is located in the thread cutting groove, and the tightening thread in the thread cutting groove is cut off to release the flap angle.

Optionally, the first tightening line of one lobe angle and the second tightening line of the adjacent lobe angle are the same line, and when the first lobe holding part and the second lobe holding part move axially in opposite directions, the lobe angles are synchronously retracted.

Optionally, the first valve holding part is provided with at least one guide hole penetrating along the axial direction, the proximal end side of the second valve holding part is provided with at least one guide post, the guide holes are in one-to-one correspondence with the guide posts, and the guide posts are arranged in the corresponding guide holes in a penetrating manner.

Optionally, the free end of the guide post exposes the guide hole, and a barb is disposed on the free end of the guide post to prevent the guide post from exiting the guide hole.

Optionally, an abutment post is disposed on the proximal side of the second holding lobe portion, the abutment post is located in the rotation hole, and after the insertion portion extends into the rotation hole, the insertion portion abuts the abutment post out of the rotation hole.

Optionally, a second mark is further arranged on the proximal end side of the first holding part and is used for indicating the rotation direction of the insertion part.

The valve holder of the artificial heart valve has the following beneficial effects:

1) The handle is detachably connected with the connecting part of the valve holding rotor through the head of the handle, each tightening line of the valve holding structure is detachably connected with the corresponding valve angle and the valve holding structure, the inserting part of the valve holding rotor can extend into the rotating hole of the first valve holding part to be detachably connected with the first valve holding part, the first valve holding part and the second valve holding part move along the axial direction back to each other, the tightening lines are stretched to retract the valve angle, the valve holding rotor and the valve holding structure are utilized to retract the valve angle, and the handle and the valve holding rotor are detached and assembled independently, so that a doctor can retract the valve angle and then connect the handle with the valve holding rotor in the operation process.

2) The head of the handle is provided with a bump, the near end side of the connecting part of the valve-holding rotor is provided with a fixing hole and a groove group corresponding to the bump one by one, the handle and the valve-holding rotor can be disassembled and assembled by rotating and pushing the handle, the assembly relation is simple, and the operation is more flexible; in addition, the tightening wire of each valve angle of the artificial heart valve passes through the threading hole of the corresponding hole group of the valve holding structure and is knotted, so that the first valve holding part and the second valve holding part of the valve holding structure can be fixed, the insertion part of the valve holding rotor can extend into the rotating hole of the first valve holding part to be detachably connected with the first valve holding part, the first valve holding part and the second valve holding part move along the axial direction opposite to each other, the tightening wire is stretched to retract the valve angle, a doctor can retract the valve angle through simple operation, and the learning curve is shorter.

3) The outer side wall of the insertion part of the valve-holding rotor and the inner side wall of the rotating hole of the first valve-holding part are respectively provided with matched threads, the insertion part is screwed into the rotating hole, so that the first valve-holding part and the second valve-holding part can move along the axial direction in opposite directions, the threaded structure is simple and easy to process, the screwing thrust of the insertion part is large, and the process of retracting the valve angle is easier and more labor-saving; after the flap angle is retracted, the positions of the first flap holding part and the second flap holding part are limited by threads, the tightening line cannot rebound, the flap angle can be always kept in the retracted state, the flap angle and human tissues are prevented from interfering to influence the operation effect and/or the operation process, and a wider operation view is provided for doctors.

4) Because each valve angle is provided with at least one corresponding hole group, the tightening wire of each valve angle only passes through the threading holes of the corresponding hole groups and is knotted, no cross winding exists among the tightening wires corresponding to the three valve angles, the valve holder cannot be withdrawn smoothly due to the fact that the tightening wires are knotted, and the tightening wires can be completely withdrawn after the tightening wires are cut off.

5) The angle of the flap angle retraction can be flexibly adjusted by adjusting the screwing depth of the insertion part, and the axial dimension of the insertion part along the axial direction and/or the axial dimension of the abutting column can be designed to adjust the angle range of the flap angle retraction.

6) Since the number of the valve angles of the artificial heart valve is 3, the number of the hole groups is set to be a multiple of 3, and each valve angle can correspond to one or at least two adjacent hole groups, so that the valve angles can be more stably retracted, and the retraction angles of each valve angle are not greatly different.

7) Each hole group comprises three threading holes, the knotting end of one tightening wire of each valve angle sequentially penetrates through the first threading hole and the second threading hole from the far-end side of the second valve holding part, the knotting end of the other tightening wire sequentially penetrates through the third threading hole, the first threading hole and the second threading hole from the far-end side of the second valve holding part, the knotting ends of the two tightening wires are knotted, the knot number is small, the identification is easy, sufficient vision and space can be ensured when a doctor cuts lines, the sewing difficulty is small, and the first valve holding part and the second valve holding part can be fixed more firmly.

8) A cutting groove is arranged between the first threading hole and the second threading hole, a doctor cuts the tightening wire at the cutting groove by using a scalpel, and the cutting operation is more convenient.

9) Set up guiding hole and guide post respectively in first hold lamella portion with the second holds lamella portion, pack up when the lamella angle provides guiding action, prevent first hold lamella portion with the second holds lamella portion and shifts, and set up the barb on the free end of guide post, the guide post can't withdraw from the guiding hole, first hold lamella portion with the second holds lamella portion and moves away from each other the distance limited, can avoid the lamella angle is excessively packed up.

10 A first mark is arranged on the proximal side of the connecting part to indicate the rotation direction of the handle, and a second mark is arranged on the proximal side of the first holding part to indicate the rotation direction of the inserting part, so that a doctor can operate in a foolproof mode, and the learning curve is shorter.

Drawings

FIG. 1a is an exploded schematic view of a valve holder for an artificial heart valve according to an embodiment of the present invention;

FIG. 1b is an enlarged view of the field of view A in FIG. 1 a;

FIG. 2 is a schematic view of another handle according to an embodiment of the present invention;

FIG. 3 is an enlarged partial schematic view of a head according to an embodiment of the present invention;

Fig. 4a is a schematic structural diagram of a lobe-holding rotor according to an embodiment of the present invention;

FIG. 4b is a schematic view of the proximal side of a valve-retaining rotor provided by an embodiment of the present invention;

FIG. 4c is a schematic cross-sectional view of the lobe-holding rotor of FIG. 4b taken along the direction a-a;

Fig. 5a and 5b are schematic views of a connection between a handle and a valve-holding rotor according to an embodiment of the present invention;

FIG. 6 is a schematic diagram of a valve-holding structure according to an embodiment of the present invention;

Fig. 7a is a schematic view of a structure of a proximal side of a first valve holding portion according to an embodiment of the present invention;

FIG. 7b is a schematic view of the proximal side of a second valve holder according to an embodiment of the present invention;

FIG. 8a is a diagram of the relationship between the position of an artificial heart valve and a cinching wire according to an embodiment of the present invention;

FIG. 8b is a schematic diagram of a relationship between a valve-holding structure and a prosthetic heart valve according to an embodiment of the present invention;

fig. 9 to 10 are schematic views showing steps for folding the valve angle of the artificial heart valve according to the embodiment of the present invention;

wherein, the reference numerals are as follows:

100-handle; 101-a grip; 102-a stem; 103-head; 104-bump; 105-a first anti-slip groove; 200-a lobe-holding rotor; 201-a connection; 211-fixing holes; 221-an alignment groove; 231-locking groove; 241-first separator; 251-a second separator; 261-second anti-slip grooves; 202-an insertion portion; 300-a valve-holding structure; 301-a first valve-holding portion; 311-rotating holes; 321-a first valve-holding body; 331-a first alignment stage; 361-a guide hole; 302-a second valve-holding portion; 312-a second valve-holding body; 322-a second alignment stage; 332-abutting the column; 342-guide posts; 342 a-barbs; 303-a set of wells; 303 a-a first threading aperture; 303 b-a second threading aperture; 303 c-a third threading hole; 313-a first via; 323-a second through hole; 333-third via; 343-cutting wire slots; 353-fourth through holes; 363-fifth through hole; 373-sixth through hole; 400-artificial heart valve; 401-lobe angle; 402-a first tightening wire; 403-a second tightening wire; 404-sewing ring.

Detailed Description

The valve holder of the prosthetic heart valve according to the invention is described in further detail below with reference to the drawings and the specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments. It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated.

In the present document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to the end of the medical device that is proximal to the physician during normal operation, and "distal" generally refers to the end that first enters the patient. The corresponding "proximal side" generally refers to the surface of the side corresponding to the "proximal end", while the "distal side" generally refers to the surface of the side corresponding to the "distal end".

Fig. 1a is an exploded schematic view of a valve holder of the prosthetic heart valve according to the present embodiment, and fig. 1b is an enlarged view of field a in fig. 1 a. As shown in fig. 1a and 1b, the valve holder of the artificial heart valve comprises a handle 100, a valve holding rotor 200 and a valve holding structure 300. The handle 100, the valve-holding rotor 200 and the valve-holding structure 300 are independent and mutually separable, and when the handle 100, the valve-holding rotor 200 and the valve-holding structure 300 are combined together, the handle 100, the valve-holding rotor 200 and the valve-holding structure 300 are sequentially and axially connected along the direction from the proximal end to the distal end; the valve-holding structure 300 is fixed with the artificial heart valve (not shown in fig. 1a and 1 b), and the artificial heart valve is located at the distal end side of the valve-holding structure 300.

With continued reference to fig. 1a, the handle 100 includes a grip 101, a shaft 102 and a head 103, and the grip 101, the shaft 102 and the head 103 are sequentially axially connected in a proximal-to-distal direction.

Specifically, the grip 101 is used for being held by a doctor, and a third mark (such as a text mark) may be provided on the outer side wall of the grip 101, for indicating the use of the handle 100.

Fig. 2 is a schematic view of another handle 100 according to the present embodiment. As shown in fig. 2, a plurality of first anti-slip grooves 105 may be further formed on the outer sidewall of the grip 101, so as to increase friction between the palm and the grip 101 and prevent the palm and the grip 101 from sliding relative to each other. In fig. 2, the first anti-slip grooves 105 are annular structures distributed along the axial direction of the handle 100, but this is not a limitation, and as an alternative embodiment, the first anti-slip grooves 105 may also be strip structures extending along the axial direction of the handle 100 and distributed along the circumferential direction of the handle 100, which are not illustrated here.

In the embodiment, the material of the grip 101 may be a thermoplastic polymer, such as polyoxymethylene (Polyoxymethylene, POM), but not limited thereto.

With continued reference to fig. 1a or fig. 2, the stem 102 is located between the grip 101 and the head 103, and is used to connect the grip 101 and the head 103, and in this embodiment, the maximum diameter of the stem 102 is smaller than the larger diameter between the grip 101 and the head 103, but not limited thereto.

In the present embodiment, the material of the rod 102 may be a metal material such as nickel-titanium alloy, stainless steel 304L or stainless steel 316L, but is not limited thereto.

Fig. 3 is a partially enlarged schematic view of the head 103 according to the present embodiment. As shown in fig. 3, the distal end of the head 103 has a rod extending along an axial direction, and 4 protrusions 104 are disposed on an outer side wall of the rod, the protrusions 104 protrude outwards relative to the outer side wall of the head 103, and the 4 protrusions 104 are uniformly distributed along a circumferential direction of the head 103, so as to form a cross-like structure, and the protrusions 104 are used for detachably connecting with the valve-holding rotor 200, which will be described later.

It should be understood that the number of the bumps 104 is not limited to 4, but at least 2, such as 2,3, 5, or 6, etc.; the projections 104 are not limited to be uniformly distributed along the circumferential direction of the head 103, but may be unevenly distributed; the head 103 and the bump 104 may be of a unitary structure or a split structure; the invention is not limited.

In the present embodiment, the material of the head 103 and the bump 104 may be a thermoplastic polymer, such as polyoxymethylene (Polyoxymethylene, POM), but not limited thereto.

Fig. 4a is a schematic structural view of the lobe-holding rotor 200 according to the present embodiment, fig. 4b is a schematic view of the proximal side of the lobe-holding rotor 200 according to the present embodiment, and fig. 4c is a schematic sectional view of the lobe-holding rotor 200 along the a-a direction in fig. 4 b. As shown in fig. 4a to 4c, the valve-holding rotor 200 includes a connection portion 201 and an insertion portion 202, and the connection portion 201 and the insertion portion 202 are sequentially axially connected in a distal-to-proximal direction. The connecting portion 201 is configured to be detachably connected to the handle 100, and the inserting portion 202 is configured to be inserted into the valve holding structure 300 to retract the valve angle of the artificial heart valve.

Specifically, a fixing hole 211 is provided on the proximal end side of the connection portion 201, the fixing hole 211 extends from the proximal end side of the connection portion 201 into the connection portion 201 in the axial direction, and the fixing hole 211 may or may not extend through the connection portion 201 in the axial direction. In this embodiment, the shape and size of the fixing hole 211 are matched with those of the head 103, for example, the shape of the head 103 and the fixing hole 211 are cross-shaped, and the size of the head 103 is slightly smaller than that of the fixing hole 211, so that the head 103 can just extend into the fixing hole 211.

Further, 4 groove groups are further disposed on the proximal end side of the connection portion 201, the 4 groove groups are uniformly distributed along the circumferential direction of the fixing hole 211 to form a cross-like structure, and the groove groups need to be in one-to-one correspondence with the protruding blocks 104 to realize the disassembly and assembly of the handle 100 and the flap holding rotor 200.

It should be noted that, since the groove groups are in one-to-one correspondence with the protruding blocks 104, the number of the groove groups is not limited to 4, but may be at least 2, for example, may be 2, 3, 5, or 6, and the groove groups are not limited to uniformly or non-uniformly distributed along the circumferential direction of the fixing hole 211, and the number and distribution manner of the groove groups may be adapted to the number and distribution manner of the protruding blocks 104.

The groove group includes alignment grooves 221 and locking grooves 231 disposed on the inner sidewall of the fixing hole 211, and the alignment grooves 221 and the locking grooves 231 are distributed along the circumferential direction of the fixing hole 211 and are communicated with each other. Specifically, the alignment groove 221 extends from the proximal end side of the connection portion 201 into the connection portion 201 in the axial direction until reaching the bottom of the fixing hole 211; the locking groove 231 extends axially inside the connecting portion 201 until reaching the bottom of the fixing hole 211; that is, the depth of the alignment groove 221 is equal to the depth of the fixing hole 211, and the proximal side of the alignment groove 221 penetrates the proximal side of the connection portion 201 to be in an open state, while the depth of the locking groove 231 is smaller than the depth of the fixing hole 211, and the proximal side of the locking groove 231 does not penetrate the proximal side of the connection portion 201 to be in a closed state.

It will be appreciated that the relative positions of the alignment slot 221 and the locking slot 231 in each slot set are corresponding. For example: in this embodiment, the alignment grooves 221 and the corresponding locking grooves 231 are arranged clockwise along the circumferential direction of the fixing hole 211, that is, each locking groove 231 is at a position where the corresponding alignment groove 221 rotates clockwise by a certain angle; of course, the alignment grooves 221 and the corresponding locking grooves 231 may be arranged counterclockwise along the circumferential direction of the fixing hole 211, that is, each locking groove 231 is located at a position where the corresponding alignment groove 221 rotates counterclockwise by a certain angle.

The alignment groove 221 and the locking groove 231 correspond to the shape and size of the corresponding protrusion 104, but are slightly different. Specifically, the dimensions of the alignment slot 221 may be slightly larger than the dimensions of the corresponding protrusion 104, such that after each protrusion 104 is aligned with and enters the corresponding alignment slot 221, the head 103 also enters the fixing hole 211; the size of the locking groove 231 may be slightly smaller than the corresponding size of the protrusion 104, so that the protrusion 104 may be snapped into the corresponding locking groove 231.

For the alignment groove 221 and the locking groove 231 in the same groove group, a first partition 241 is disposed between the locking groove 231 and the corresponding alignment groove 221, and the first partition 241 serves as both a first groove wall of the locking groove 231 and a first groove wall of the alignment groove 221. The distance between the first partition 241 and the bottom of the fixing hole 211 may be used for the corresponding protrusion 104 to pass through, so that the locking slot 231 is communicated with the corresponding alignment slot 221, and rotating the handle 100 may cause the protrusion 104 to switch positions between the corresponding locking slot 231 and the corresponding alignment slot 221.

Optionally, on the same cross section, the angle between the center line of the alignment slot 221 and the center line of the corresponding locking slot 231 may be smaller than 90 °, preferably 30 ° to 45 °, so as to avoid the excessive rotation angle of the handle 100, and reduce the operation difficulty of the doctor.

In this embodiment, a second partition plate 251 is disposed between the locking groove 231 and the alignment groove 221 of two adjacent groove groups, and the second partition plate 251 is used as the second groove wall of the alignment groove 221 and the second groove wall of the locking groove 231 at the same time, that is, the first partition plate 241 is disposed between two adjacent second partition plates 251, and the regions between the first partition plate 241 and two adjacent second partition plates 251 respectively form the alignment groove 221 and the locking groove 231. The height of the second spacer 251 may be equal to the depth of the fixing hole 211 such that the second spacer 251 is in contact with the bottom of the fixing hole 211 or the distance between the second spacer 251 and the bottom of the fixing hole 211 does not allow the corresponding protrusion 104 to pass therethrough, so that the second spacer 251 may block the corresponding protrusion 104, limiting the rotation area of the protrusion 104 between the locking groove 231 and the alignment groove 221 of one groove group, that is, the protrusion 104 may be located only in the locking groove 231 or the alignment groove 221 of one groove group.

Of course, as an alternative embodiment, the distance between the second partition 251 and the bottom of the fixing hole 211 may be used for the corresponding protrusion 104 to pass through, so that the rotation area of the protrusion 104 is wider, and the protrusion 104 may be located in the locking slot 231 or the alignment slot 221 of any slot group.

Fig. 5a and 5b are schematic views of the connection between the handle 100 and the valve-holding rotor 200 according to the present embodiment. As shown in fig. 5a and 5b, when the handle 100 and the flap holder 200 need to be connected, the handle 101 and the connecting portion 201 are first held, and the 4 protrusions 104 are aligned with the 4 alignment grooves 221 one by one, at this time, the 4 protrusions 104 may respectively enter the 4 alignment grooves 221, and the head 103 may also simultaneously enter the fixing hole 211, so as to push the handle 100 until the head 103 reaches the bottom of the fixing hole 211. After that, the handle 100 is rotated clockwise (or the handle 100 is held, and the flap holder 200 is rotated counterclockwise) by holding the connecting portion 201, so that the 4 protrusions 104 are respectively inserted into the 4 locking grooves 231, and the handle 100 is pulled outward, so that the 4 protrusions 104 are respectively engaged into the 4 locking grooves 231 (the protrusions 104 are engaged between the first partition 241 and the second partition 251), and thus, the head 103 is locked with the connecting portion 201, and the handle 100 and the flap holder 200 are connected together without relative movement therebetween.

When the handle 100 and the valve-holding rotor 200 need to be detached, the handle 100 is first held by the grip 101 and the connecting portion 201, and the handle 100 is pushed axially inward, so that the 4 protrusions 104 are unlocked from the 4 locking grooves 231 (the protrusions 104 are moved out from the region between the first partition 241 and the second partition 251); then, the connecting portion 201 is held, the handle 100 is rotated counterclockwise (or the handle 100 is held, and the flap holder 200 is rotated clockwise), so that the 4 protrusions 104 return to the 4 alignment grooves 221, respectively, and the head 103 can be pulled out of the fixing hole 211, so that the head 103 is separated from the connecting portion 201, and the handle 100 is detached from the flap holder 200.

Therefore, in this embodiment, the handle 100 and the valve-holding rotor 200 may be disassembled and assembled by rotating and pushing the handle 100, so that the assembly relationship is simple and the operation is more flexible.

It will be appreciated that, since the second spacer 251 can stop the protrusions 104 in this embodiment, each protrusion 104 can only rotate between the alignment groove 221 and the locking groove 231 in the corresponding groove group, so that the doctor does not need to observe the positions of the alignment groove 221 and the locking groove 231 during operation, and can determine that the protrusion 104 is rotated into place as long as the protrusion 104 is blocked during operation of the handle 100, thereby simplifying the doctor's operation.

In this embodiment, a first mark is further provided on the proximal end side of the connection portion 201 for indicating the rotation direction of the handle 100. For example, the first mark is an arrow mark, the handle 100 and the valve-holding rotor 200 can be locked by rotating the handle 100 along the arrow direction, and the handle 100 and the valve-holding rotor 200 can be unlocked and separated by rotating the handle 100 against the arrow direction, so that the learning curve of the doctor is shorter, and the doctor can operate in a foolproof manner. Of course, the first identifier is not limited to an arrow identifier, but may be a text or other pattern identifier.

Since the valve-holding rotor 200 is still held by the hand when the handle 100 is connected to or detached from the valve-holding rotor 200, the second anti-slip groove 261 is provided on the outer sidewall of the connecting portion 201, which increases the friction between the palm and the connecting portion 201 and prevents the mutual sliding between the palm and the connecting portion 201. In this embodiment, the second anti-slip grooves 261 are bar-shaped structures distributed along the circumferential direction, but this should not be limiting, and as an alternative embodiment, the second anti-slip grooves 261 may also be annular structures distributed along the axial direction, which is not illustrated here.

With continued reference to fig. 4 a-4 c, the outer sidewall of the insertion portion 202 is provided with external threads for detachably connecting with the valve-holding structure 300, which will be described later.

In this embodiment, the connection portion 201 has a disc-shaped structure, so that it is convenient to hold; the insertion part 202 has a columnar structure, so that the insertion is convenient; the diameter of the connecting portion 201 is larger than that of the inserting portion 202, so that the valve-holding rotor 200 is substantially T-shaped, but not limited thereto.

In this embodiment, the connection portion 201 and the insertion portion 202 are integrally formed, so that the connection portion 201 and the insertion portion 202 are made of thermoplastic polymer compounds, such as polyoxymethylene (Polyoxymethylene, POM); of course, in other embodiments, the connecting portion 201 and the inserting portion 202 may be a separate structure.

Fig. 6 is a schematic diagram of a valve holding structure 300 according to the present embodiment. As shown in fig. 6, the valve holding structure 300 includes a first valve holding portion 301, a second valve holding portion 302, three hole groups 303, and tightening threads, where the first valve holding portion 301 and the second valve holding portion 302 are disposed opposite to each other in an axial direction, and the first valve holding portion 301 and the second valve holding portion 302 are distributed in a proximal-to-distal direction, and each hole group 303 includes three threading holes penetrating through the first valve holding portion 301 and the second valve holding portion 302 in the axial direction. The artificial heart valve is located at the distal end side of the second valve holding part 302, each valve angle of the artificial heart valve corresponds to one hole group 303, each valve angle corresponds to at least one tightening wire, and the tightening wire corresponding to each valve angle passes through the threading hole of the corresponding hole group 303 and is knotted to fix the first valve holding part 301 and the second valve holding part 302.

Fig. 7a is a schematic view of the structure of the proximal side of the first flap portion 301 according to the present embodiment. As shown in fig. 7a, the first valve holding portion 301 includes a first valve holding body 321 and three first alignment tables 331, and the three first alignment tables 331 are uniformly distributed along the circumference of the first valve holding body 321. Fig. 7b is a schematic view of the structure of the proximal side of the second valve holding portion 302 according to the present embodiment. As shown in fig. 7b, the second valve holding portion 302 includes a second valve holding body 312 and three second alignment tables 322, and the three second alignment tables 322 are uniformly distributed along the circumference of the second valve holding body 312. Referring to fig. 6, the first valve holding body 321 corresponds to the second valve holding body 312, the first alignment tables 331 correspond to the second alignment tables 322 one by one, the corresponding first alignment tables 331 correspond to the second alignment tables 322, and the distal end side of the first valve holding portion 301 and the proximal end side of the second valve holding portion 302 are attached together.

In this embodiment, the first valve-holding body 321 and the second valve-holding body 312 have the same shape and size, the first alignment table 331 and the corresponding second alignment table 322 have the same shape and size, and the first alignment table 331 and the second alignment table 322 can be used for aligning the first valve-holding portion 301 and the second valve-holding portion 302; and, the first alignment stage 331 and the second alignment stage 322 are further used to set the hole group 303, that is: the hole groups 303 are disposed on the corresponding first alignment stage 331 and second alignment stage 322 in a one-to-one correspondence.

In this embodiment, the first valve body 321 and the first alignment table 331 are integrally formed, so that the materials of the first valve body 321 and the first alignment table 331 are thermoplastic polymer compounds, such as polyoxymethylene (Polyoxymethylene, POM), etc.; correspondingly, the second valve body 312 and the second alignment table 322 are also integrally formed, so that the materials of the second valve body 312 and the second alignment table 322 are thermoplastic polymer compounds, such as polyoxymethylene (Polyoxymethylene, POM), etc. Of course, in other embodiments, the first valve body 321 and the first alignment table 331 may be separate structures, and the second valve body 312 and the second alignment table 322 may be separate structures.

It should be understood that the number of the hole sets 303, the first alignment steps 331 and the second alignment steps 322 is not limited to 3, but may be more than 2, such as 4,5 or 6, etc., and since the artificial heart valve has 3 valve angles, the number of the hole sets 303, the first alignment steps 331 and the second alignment steps 322 is preferably a multiple of 3, such as 3,6 or 12, etc., so that each valve angle may correspond to one or at least two adjacent hole sets 303, and thus the valve angles may be more stably retracted, and the angle at which each valve angle is retracted may not differ greatly. Since the hole sets 303 are in one-to-one correspondence with the first alignment stage 331 and the second alignment stage 322, the number of the hole sets 303 may be adapted to the number of the first alignment stage 331 and the second alignment stage 322.

Referring to fig. 7a and 7b, in the present embodiment, a rotation hole 311 is formed in the first valve-holding body 321, and the rotation hole 311 axially penetrates the first valve-holding body 321; an abutment post 332 is provided on the proximal end side of the second valve holding body 312, the abutment post 332 being located in the rotation hole 311. Optionally, the height of the abutment post 332 is smaller than the depth of the rotation hole 311, such that the free end of the abutment post 332 does not protrude out of the rotation hole 311.

In this embodiment, the rotation hole 311 is located in the central area of the first valve body 321, and correspondingly, the abutment post 332 is also located in the central area of the second valve body 312, but the present invention should not be limited thereto, and the rotation hole 311 and the abutment post 332 may be located in other positions.

Further, an internal thread is provided on an inner sidewall of the rotation hole 311 for coupling with an external thread of the insertion portion 202, so that the internal thread is matched with the external thread.

Further, three of the threading holes in each of the hole groups 303 are a first threading hole 303a, a second threading hole 303b, and a third threading hole 303c, respectively. As shown in fig. 7a, each of the first alignment tables 331 is provided with three through holes penetrating through the first alignment table 331 along the axial direction, namely a first through hole 313, a second through hole 323 and a third through hole 333; as shown in fig. 7b, each of the second alignment tables 322 is also provided with three through holes penetrating through the second alignment table 322 along the axial direction, which are a fourth through hole 353, a fifth through hole 363, and a sixth through hole 373. Referring to fig. 6, the first through holes 313 are aligned with and communicate with the corresponding fourth through holes 353, thereby forming the first threading holes 303a; the second through holes 323 are aligned with and communicate with the corresponding fifth through holes 363, thereby forming the second threading holes 303b; the third through holes 333 are aligned with and communicate with the corresponding sixth through holes 373, thereby forming the third threading holes 303c. As can be seen from fig. 6, the hole sets 303 are disposed on the corresponding first alignment stage 331 and the second alignment stage 322 in a one-to-one correspondence, and the hole sets 303 are circumferentially distributed along the rotation hole 311.

In this embodiment, a thread cutting groove 343 is further disposed between the first threading hole 303a and the second threading hole 303b, the thread cutting groove 343 is located at the proximal end side of the first holding part 301 and extends from the proximal end side of the first holding part 301 into the first holding part 301, and the thread cutting groove 343 is a blind groove, and two ends of the thread cutting groove 343 are communicated with the first threading hole 303a and the second threading hole 303b.

Fig. 8a is a diagram of a position relationship between an artificial heart valve and a tightening wire according to the present embodiment, and fig. 8b is a schematic diagram of a position relationship between a valve holding structure 300 and an artificial heart valve 400 according to the present embodiment. As shown in fig. 8a and 8b, the artificial heart valve 400 has three valve corners 401, each valve corner 401 corresponding to one of the hole groups 303. Each flap angle 401 has two cinch wires, a first cinch wire 402 and a second cinch wire 403, respectively, that pass through the three threaded holes of the respective hole sets 303 and are knotted to secure the first and second flap portions 301, 302.

Taking one of the flap angles 401 as an example, the knotted end of the first tightening thread 402 passes through the first threading hole 303a from the distal end side of the second flap holding portion 302, reaches the proximal end side of the first flap holding portion 301, reaches the second threading hole 303b along the secant slot 343, and passes through the second threading hole 303b to the distal end side of the second flap holding portion 302; the knotted end of the second tightening wire 403 passes through the third threading hole 303c from the distal end side of the second holding part 302, reaches the proximal end side of the first holding part 301, passes through the first threading hole 303a, reaches the distal end side of the second holding part 302, and passes through the second threading hole 303b, and reaches the proximal end side of the first holding part 301. At this time, the knotting end of the first tightening wire 402 is located at the distal end side of the second valve holding portion 302, the knotting end of the second tightening wire 403 is located at the proximal end side of the first valve holding portion 301, and the knotting ends of the first tightening wire 402 and the second tightening wire 403 may be knotted at the sides of the first alignment table 331 and the second alignment table 322, so that the first valve holding portion 301 and the second valve holding portion 302 may be firmly sutured together. The other two flap angles adopt the same threading and knotting modes, and are not repeated. With continued reference to fig. 8a, in the present application, the sewing ring 404 of the artificial heart valve 400 is attached to the distal end side of the second valve holding portion 302, and two tightening wires corresponding to each valve angle extend from the valve angle, pass through the sewing ring 404, and then pass through the corresponding threading hole; and, same line runs through two adjacent lamella angles, and the both ends of this line are the knot end of tightening up the line, and the first tightening up line of one lamella angle is the second tightening up line of its adjacent lamella angle, and when first hold lamella portion 301 with the second holds lamella portion 302 relative movement, has driven three lamella angles and has packed up in step, has so realized the shrink control to the lamella angle. In this embodiment, the number of knots is small (only one knot is used for each two tightening wires of the valve angle 401), so that the knot is easy to identify, sufficient vision and space can be ensured when a doctor cuts a thread, and the suture difficulty is smaller. The application does not limit the threading path of each tightening wire, and a person skilled in the art can select the threading path by himself so as to meet the functions of contraction and knotting of the valve angle.

It should be appreciated that the manner of suturing the first cinch wire 402 and the second cinch wire 403 is not limited thereto, as long as the cinch wire of each flap corner 401 can be threaded through the corresponding set of apertures 303 and tied to secure the first and second flap portions 301, 302; based on this, the number of threading holes of each hole group 303 is not limited to 3, but may be 1,2, or 4 or more, for example: the number of the hole groups 303 is 6, each hole group 303 may have only 1 threading hole, each flap angle 401 corresponds to two adjacent hole groups 303, the knotting end of the first tightening wire 402 of each flap angle 401 may pass through the threading hole of a corresponding hole group 303 from the distal end side of the second holding flap portion 302, the knotting end of the second tightening wire 403 of each flap angle 401 may pass through the threading hole of a corresponding hole group 303 from the distal end side of the second holding flap portion 302, and then the knotting ends of the first tightening wire 402 and the second tightening wire 403 may be knotted.

In this embodiment, since the first tightening wire 402 passes through the thread cutting groove 343, the portion of the first tightening wire 402 located between the first threading hole 303a and the second threading hole 303b is limited in the thread cutting groove 343, and the flap angle 401 can be released by cutting the first tightening wire 402 along the thread cutting groove 343, the thread cutting groove 343 can facilitate thread cutting operation. In some embodiments, the secant slot 343 may also be omitted.

Fig. 9 to 10 are schematic views showing steps for folding up the valve angle of the artificial heart valve according to the present embodiment. As shown in fig. 9, when the valve angle of the prosthetic heart valve needs to be retracted, the valve holding rotor 200 and the valve holding structure 300 (specifically, the first valve holding portion 301 may be held) are held by hand, and the insertion portion 202 is screwed into the rotation hole 311 until the bottom of the insertion portion 202 contacts the abutment post 332. As shown in fig. 10, the insertion portion 202 is continuously screwed into the rotation hole 311 until the abutment post 332 is pushed out of the rotation hole 311, at this time, the first holding lobe 301 and the second holding lobe 302 move back to each other in the axial direction, the distance between the first holding lobe 301 and the second holding lobe 302 increases, the tightening wire is stretched to retract the lobe angle, a doctor can retract the lobe angle through simple operation, the learning curve is shorter, the screw structure is simple and easy to process, the pushing force of the insertion portion for screwing in is larger, and the process of retracting the lobe angle is easier and more labor-saving. After the hand is loosened, the internal thread and the external thread are matched, the valve holding rotor 200 and the first valve holding part 301 are also fixed together, the positions of the first valve holding part 301 and the second valve holding part 302 are fixed, the valve angle is kept in a retracted state, the interference of the valve angle and human tissues is prevented from influencing the operation effect and/or the operation progress, and a wider operation view is provided for doctors.

When the valve angle of the artificial heart valve needs to be released, the valve angle can be released only by cutting the tightening wire of each valve angle along the cutting line groove 343 with a surgical knife and then unscrewing the insertion part 202 from the rotation hole 311. Because each valve angle is provided with at least one corresponding hole group 303, the tightening wire of each valve angle only passes through the threading holes of the corresponding hole group 303 and is knotted, no cross winding exists among the tightening wires corresponding to the three valve angles, the valve holder cannot be withdrawn smoothly due to knotting of the tightening wires, and the tightening wires can be completely withdrawn after the tightening wires are cut.

Referring to fig. 7a and 7b, in this embodiment, three guide holes 361 are further provided on the first valve-holding body 321, the guide holes 361 axially penetrate the first valve-holding body 321, and the guide holes 361 are uniformly distributed along the circumferential direction of the rotation hole 311; three guide posts 342 are disposed on the proximal side of the second valve body 312, the guide posts 342 are in one-to-one correspondence with the guide holes 361, and the guide posts 342 are disposed in the corresponding guide holes 361 in a penetrating manner. The guide posts 342 and the guide holes 361 can provide a guiding action to prevent the first and second petals 301, 302 from being displaced when the first and second petals 301, 302 are moved axially back to each other to retract the petals.

Further, the length of the guide post 342 in the axial direction is greater than the depth of the guide hole 361, so that the free end of the guide post 342 is exposed out of the guide hole 361, and the free end of the guide post 342 has a barb 342a, and the barb 342a can prevent the guide post 342 from exiting the guide hole 361. In this way, the distance that the first lobe-holding portion 301 and the second lobe-holding portion 302 move away from each other is limited, so that the lobe angle can be prevented from being excessively retracted.

It should be understood that the number of the guide posts 342 and the guide holes 361 is not limited to 3, at least 1, such as 2,4, 5, or 6, and the guide posts 342 and the guide holes 361 are not limited to be uniformly distributed along the circumferential direction of the rotation hole 311, but may be non-uniformly distributed.

Optionally, a second mark is further provided on the proximal side of the first flap portion 301 for indicating the rotation direction of the insertion portion 202. For example, the second marks "a", "B" indicate that rotating the insertion portion 202 in the direction of "a" to "B" can retract the flap angle, and rotating the insertion portion in the direction of "B" to "a" can release the flap angle, so that the learning curve of the doctor is short and can be operated "fool". Of course, the second identifier is not limited to a text identifier, and may be a pattern identifier such as an arrow.

Since the dimension of the insertion portion 202 in the axial direction is not greatly different from the depth of the rotation hole 311, in order to ensure that a certain distance is provided between the first holding portion 301 and the second holding portion 302 in the axial direction after the insertion portion 202 is completely screwed into the rotation hole 311, to stretch the tightening wire of each of the flap angles, the abutment post 332 needs to be provided on the proximal end side of the second holding portion 302. In some embodiments, the abutment post 332 may be omitted when the axial dimension of the insert 202 is greater than the depth of the rotation hole 311.

It should be appreciated that in this embodiment, the doctor can adjust the depth of the insertion portion screwed into the rotation hole 311, so that the angle of the flap angle retraction can be flexibly adjusted. At the same time, the angular extent of the flap angle stow may be flexibly adjusted by designing the axial dimension of the insert 202 and/or the axial dimension of the abutment post 332. For example, when the size of the abutment post 332 in the axial direction is larger, the distance that the first lobe-holding portion 301 and the second lobe-holding portion 302 can move away from each other in the axial direction is also larger, and the angular range in which the lobe angles are retracted is correspondingly larger; when the abutment post 332 is omitted, the axial dimension of the insertion portion 202 is larger, the distance that the first and second holding portions 301 and 302 can move axially away from each other is also larger, and the angular range in which the flap angle is retracted is correspondingly larger. Of course, since the barbs 342a prevent the guide post 342 from exiting the guide hole 361, the axial dimension of the guide post 342 also determines the angular extent of the angular collapse of the petals, which is not illustrated herein.

Next, the operation steps of the valve holder of the prosthetic heart valve in the present embodiment will be specifically described, and it should be noted that, after the completion of the preparation of the valve holder of the prosthetic heart valve in the present embodiment, the valve holder rotor 200, the valve holder structure 300, and the prosthetic heart valve may be packaged together, and the valve holder structure 300 and the prosthetic heart valve are fixed, the valve holder rotor and the valve holder structure 300 being separated from each other, and the handle 100 being packaged separately.

First, retracting each valve angle of the prosthetic heart valve with the valve holder rotor and the valve holder structure 300, each valve angle remaining in a retracted state; thereafter, the handle 100 is coupled and locked with the valve holder rotor; holding the handle 100 by a doctor, placing the whole valve holder and the artificial heart valve above the plane of the native annulus through the chest, and positioning and suturing the artificial heart valve and the tissue of the native annulus; unlocking and separating the handle 100 from the valve holder rotor, withdrawing the handle 100; cutting a cinching wire of each valve corner of the prosthetic heart valve with a surgical knife and releasing the valve corner; the valve holder rotor is grasped with forceps or tweezers and the valve holder rotor, the valve holding structure 300 and all the tightening wires are withdrawn outwards.

It can be seen that, in this embodiment, the step of folding the valve angle by using the valve holding rotor 200 and the valve holding structure 300 and the step of assembling and disassembling the handle 100 and the valve holding rotor 200 are independent from each other, and in the operation process, a doctor can fold the valve angle first and then connect the handle 100 and the valve holding rotor 200, so that the operation steps are simple and transitional naturally, the risk of contacting the artificial heart valve is avoided, the sewing ring of the artificial heart valve is not pulled, and the risk of deformation or displacement of the artificial heart valve is not caused in the whole operation process.

In summary, in the valve holder of the artificial heart valve provided by the embodiment of the invention, the handle is detachably connected with the connecting portion of the valve holding rotor through the head of the handle, each tightening line of the valve holding structure is detachably connected with the corresponding valve angle and the valve holding structure, the insertion portion of the valve holding rotor can extend into the rotating hole of the first valve holding portion to be detachably connected with the first valve holding portion, the first valve holding portion and the second valve holding portion move back to each other in the axial direction, the tightening lines are stretched to retract the valve angle, the step of retracting the valve angle by utilizing the valve holding rotor and the valve holding structure and the step of disassembling and assembling the handle and the valve holding rotor can be mutually independent, in the operation process, the doctor can retract the valve angle and then connect the handle and the valve holding rotor, the operation step is simple and natural, the risk of contacting the artificial heart valve is avoided, the sewing ring of the artificial heart valve is not pulled, and the whole operation process does not cause deformation or displacement risk of the artificial heart valve.

Further, a lug is arranged on the head of the handle, a fixing hole and a groove group which corresponds to the lug one by one are arranged on the proximal side of the connecting part of the valve-holding rotor, the handle and the valve-holding rotor can be disassembled and assembled by rotating and pushing the handle, the assembly relation is simple, and the operation is more flexible; in addition, the tightening wire of each valve angle of the artificial heart valve passes through the threading hole of the corresponding hole group of the valve holding structure and is knotted, so that the first valve holding part and the second valve holding part of the valve holding structure can be fixed, the insertion part of the valve holding rotor can extend into the rotating hole of the first valve holding part to be detachably connected with the first valve holding part, the first valve holding part and the second valve holding part move along the axial direction opposite to each other, the tightening wire is stretched to retract the valve angle, a doctor can retract the valve angle through simple operation, and the learning curve is shorter.

Further, the outer side wall of the insertion part of the valve-holding rotor and the inner side wall of the rotating hole of the first valve-holding part are respectively provided with matched threads, the insertion part is screwed into the rotating hole, so that the first valve-holding part and the second valve-holding part can move along the axial direction in a reverse way, the threaded structure is simple and easy to process, the screwing-in thrust of the insertion part is large, and the process of retracting the valve angle is easier and more labor-saving; after the flap angle is retracted, the positions of the first flap holding part and the second flap holding part are limited by threads, the tightening line cannot rebound, the flap angle can be always kept in the retracted state, the flap angle and human tissues are prevented from interfering to influence the operation effect and/or the operation process, and a wider operation view is provided for doctors.

Further, as each valve angle is provided with at least one corresponding hole group, the tightening wire of each valve angle only passes through the threading holes of the corresponding hole groups and is knotted, no cross winding exists among the tightening wires corresponding to the three valve angles, the valve holder cannot be withdrawn smoothly due to knotting of the tightening wires, and the tightening wires can be completely withdrawn after cutting off the tightening wires.

Further, the angle of the flap angle retraction can be flexibly adjusted by adjusting the screwing depth of the insertion part, and the angle range of the flap angle retraction can be adjusted by designing the axial dimension of the insertion part and/or the axial dimension of the abutting column.

Further, since the number of the valve angles of the artificial heart valve is 3, the number of the hole groups is set to be a multiple of 3, and each valve angle can correspond to one or at least two adjacent hole groups, so that the valve angles can be more stably retracted, and the retraction angles of each valve angle are not greatly different.

Further, each hole group comprises three threading holes, the knotting end of one tightening wire of each valve corner sequentially penetrates through the first threading hole and the second threading hole from the far-end side of the second valve holding part, the knotting end of the other tightening wire sequentially penetrates through the third threading hole, the first threading hole and the second threading hole from the far-end side of the second valve holding part, the knotting ends of the two tightening wires are knotted, the number of knots is small, the knot is easy to identify, sufficient vision and space can be ensured when a doctor cuts a line, the suturing difficulty is small, and the first valve holding part and the second valve holding part can be fixed more firmly.

Further, a cutting line groove is formed between the first threading hole and the second threading hole, and a doctor cuts the tightening line at the cutting line groove by using a scalpel, so that the cutting operation is more convenient.

Further, set up guiding hole and guide post respectively in first hold lamella portion with the second holds lamella portion, when packing up the lamella angle provides guiding action, prevents first hold lamella portion with the second holds lamella portion and shifts, and set up the barb on the free end of guide post, the guide post can't withdraw from the guiding hole, first hold lamella portion with the second holds lamella portion and moves away from each other the distance limited, can avoid the lamella angle is excessively packed up.

Further, a first mark is arranged on the proximal end side of the connecting part to indicate the rotation direction of the handle, and a second mark is arranged on the proximal end side of the first holding part to indicate the rotation direction of the inserting part, so that a doctor can operate in a fool mode, and the learning curve is short.

It should be noted that, in the present description, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different manner from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the system disclosed in the embodiment, the description is relatively simple because of corresponding to the method disclosed in the embodiment, and the relevant points refer to the description of the method section.

It should be further noted that although the present invention has been disclosed in the preferred embodiments, the above embodiments are not intended to limit the present invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.

It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated.

It should also be understood that the terminology described herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses, and may include sub-steps as well as sub-apparatuses. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood as having the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates the contrary. Furthermore, implementation of the methods and/or apparatus in embodiments of the invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. A valve holder for an artificial heart valve, comprising:

A handle comprising a head;

2. The prosthetic heart valve holder of claim 1, wherein the outer sidewall of the head portion is provided with at least two circumferentially-distributed protrusions, the proximal side of the connecting portion is provided with a fixation hole and at least two groove groups circumferentially-distributed along the fixation hole, and the protrusions are in one-to-one correspondence with the groove groups; and

3. The prosthetic heart valve holder of claim 2, wherein a first spacer is disposed between the locking slot and the corresponding alignment slot, a distance between the first spacer and a bottom of the fixation hole being accessible for the tab to pass through, and the handle is rotated to shift the tab between the corresponding alignment slot and locking slot; and

4. The prosthetic heart valve holder of claim 3, wherein a second spacer is disposed between the locking slots and the alignment slots of adjacent two of the slot sets, the second spacer acting as both a second slot wall of the alignment slot and a second slot wall of the locking slot; and

5. The prosthetic heart valve holder of claim 3 or 4, wherein a first indicator is further provided on a proximal side of the connection portion for indicating a direction of rotation of the handle.

6. The prosthetic heart valve holder of claim 1, wherein the valve holding structure comprises at least three aperture sets circumferentially distributed along the rotation aperture and each comprising at least one threading aperture extending axially through the first and second valve holding portions; each flap angle corresponds to at least one of the hole sets, and each tightening wire passes through the threading holes of the corresponding hole set and is knotted to fix the first and second flap portions.

7. The prosthetic heart valve holder of claim 1, wherein the outer sidewall of the insertion portion and the inner sidewall of the rotation hole each have mating threads, and wherein the insertion portion is threadably received in the rotation hole to removably couple with the first valve holder.

8. The prosthetic heart valve holder of claim 6, wherein the first and second valve holders each comprise a valve holder body and at least two alignment stations circumferentially distributed along the valve holder body, the positions of the valve holder bodies of the first and second valve holders corresponding, and the positions of each of the alignment stations of the first and second valve holders corresponding.

9. The prosthetic heart valve holder of claim 6 or 8, wherein the number of hole sets is a multiple of 3, each of the valve corners corresponding to one or at least two adjacent hole sets.

10. The prosthetic heart valve holder of claim 6, wherein the orifice group comprises 3 threading orifices, a first threading orifice, a second threading orifice, and a third threading orifice, respectively, each of the valve angles corresponds to at least two of the cinching wires, a knotting end of one of the cinching wires sequentially passes through the first threading orifice and the second threading orifice from a distal side of the second holding valve portion, a knotting end of the other of the cinching wires sequentially passes through the third threading orifice, the first threading orifice, and the second threading orifice from a distal side of the second holding valve portion, and knotting ends of two of the cinching wires are knotted.

11. The prosthetic heart valve holder of claim 10, wherein the orifice set further comprises a secant slot for secant the first and second threaded orifices, the cinch wire between the first and second threaded orifices being located within the secant slot, the cinch wire within the secant slot being severed to release the valve angle.

12. The prosthetic heart valve holder of claim 10, wherein a first cinch line of one of the valve corners is collinear with a second cinch line of an adjacent valve corner, the valve corners being synchronously stowed when the first and second valve holders move axially back to back.

13. The prosthetic heart valve holder of claim 1 or 8, wherein the first holder has at least one axially extending guide hole therein, wherein the second holder has at least one guide post on a proximal side thereof, wherein the guide holes are in one-to-one correspondence with the guide posts, and wherein the guide posts are disposed through the respective guide holes.

14. The prosthetic heart valve holder of claim 13, wherein the free end of the guide post is exposed to the guide hole and the free end of the guide post is provided with a barb to prevent the guide post from exiting the guide hole.

15. The prosthetic heart valve holder of claim 1 or 7, wherein an abutment post is provided on a proximal side of the second holding portion, the abutment post being located in the rotation hole, the insertion portion abutting the abutment post out of the rotation hole after the insertion portion extends into the rotation hole.

16. The prosthetic heart valve holder of claim 1 or 7, wherein a second indicator is further provided on a proximal side of the first holding portion for indicating a direction of rotation of the insertion portion.