CN114948113A

CN114948113A - Apex of heart closing device

Info

Publication number: CN114948113A
Application number: CN202110209541.5A
Authority: CN
Inventors: 李中华; 马剑翔; 李天竹
Original assignee: Sano Xinchang Medical Technology Co ltd
Current assignee: Sino Medical Sciences Technology Inc
Priority date: 2021-02-24
Filing date: 2021-02-24
Publication date: 2022-08-30

Abstract

The invention provides a cardiac apex closing device, which belongs to the technical field of medical instruments and comprises: the puncture needle is spiral, and the far end of the puncture needle is a tip for puncture; an anchor adapted at one end for connection with a suture; the anchoring piece is in an entering state clamped in a first accommodating cavity of the tip of the puncture needle, and also in a using state of being released into the heart chamber from the first accommodating cavity and being abutted against the inner wall of the heart chamber; in the process that the puncture needle enters the heart, the anchoring piece is in an entering state; after the puncture needle enters a ventricle, the anchoring piece is changed from an entering state to a using state under the action of external force; the apex cordis closing device can control the time of the puncture needle releasing from the first accommodating cavity by controlling the time of the external force pushing the anchoring piece, so that medical personnel can control the time of actively releasing the anchoring piece, and the safety in the operation process is improved.

Description

Apex of heart closing device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an apex cordis closing device.

Background

The transapical approach is used as an approach for interventional therapy of structural heart diseases, and compared with the transvascular approach, the transapical approach is closer to an implantation position and is not limited by the diameter, the bent shape and the plaque of a vascular access, so that the transapical approach is easier for an operator to operate, and instruments with larger outer diameters can be accommodated, thereby providing conditions for the design of more complicated instruments.

The heart apex is opened, a professional surgeon is required to operate the heart apex, the surgical knife cuts the cross and performs manual suturing, the technical difficulty is high, the wound is large, and the patient needs long postoperative recovery time; aiming at the problems, the apex cordis closing instrument is designed, the apex cordis opening and closing process is simplified, the injury of the apex cordis is small in the operation process, and the instrument is praised by relevant experts.

However, such devices generally passively release the anchor within the myocardium or ventricle to secure the suture, but the timing of anchor release cannot be actively controlled during the procedure.

Disclosure of Invention

Therefore, the technical problem to be solved by the present invention is to overcome the defect that the apical closing instrument in the prior art cannot actively control the release timing of the anchor during the operation, thereby providing an apical closing device.

In order to solve the above technical problem, the present invention provides an apex cordis closure device, including:

the puncture needle is spiral, and the far end of the puncture needle is a tip for puncture; the puncture needle is internally provided with a first accommodating cavity; the suture is suitable for being wholly or partially accommodated in the first accommodating cavity of the puncture needle;

an anchor adapted at one end for connection with a suture; the anchoring piece is in an entering state clamped in a first accommodating cavity of the tip of the puncture needle, and also in a using state of being released into the heart chamber from the first accommodating cavity and being abutted against the inner wall of the heart chamber;

in the process that the puncture needle enters the heart, the anchoring piece is in an entering state; after the puncture needle enters the ventricle, the anchoring piece is changed from the entering state to the using state under the action of external force.

Preferably, the method further comprises the following steps:

the pushing piece is spiral and has the same pitch as the puncture needle; the pushing component is arranged in the first accommodating cavity of the puncture needle in a sliding manner; the pushing component pushes the anchoring component from the entering state to the using state.

Preferably, the method further comprises the following steps:

a handle, the distal end of which is provided with a sheath tube for accommodating the puncture needle; the handle is internally provided with a second accommodating cavity;

the first pushing assembly is rotatably arranged in the second accommodating cavity of the handle; the first pushing assembly is fixedly connected with the near end of the puncture needle; the first pushing assembly is internally provided with a third accommodating cavity;

the second pushing assembly is arranged in the third accommodating cavity of the first pushing assembly in a sliding mode; the second pushing assembly is coupled to the proximal end of the pusher.

Preferably, the inner surface of the handle has an internal thread, and the outer surface of the first pushing assembly has an external thread matching the internal thread of the handle.

Preferably, the first pushing assembly comprises:

a first base having a spiral groove for fixing the puncture needle;

one end of the first push rod is fixedly connected with the first base, and the other end of the first push rod extends out of the second accommodating cavity of the handle.

Preferably, the number of the puncture needles is two; the two puncture needles are arranged in a staggered spiral manner.

Preferably, the anchor comprises: a straight tube portion and a hook portion; when the anchoring piece is in an entering state, the straight pipe part and the hook part are in a pipe shape; when the anchor is in a use state, the hooking part is bent outwards at the connection point of the straight pipe part.

Preferably, the anchoring piece is in a shape of an arc tube; the pipe wall is provided with threading holes arranged at intervals.

Preferably, the pushing member is a spiral tube; the pushing piece is internally provided with a penetrating cavity suitable for penetrating a suture.

Preferably, the method further comprises the following steps: and the guide wire sleeve is arranged inside the second pushing assembly and extends to the end part of the distal end of the sheath tube.

The technical scheme of the invention has the following advantages:

1. the invention provides an apex cordis closure device, comprising: a puncture needle and an anchoring member; when the puncture needle enters a ventricle, the anchoring piece is clamped in the first accommodating cavity, and after the puncture needle enters the ventricle, the anchoring piece enters the ventricle from the first accommodating cavity of the puncture needle under the action of external force, is changed into a use state from an entering state and is abutted against the inner wall of the ventricle; the suture connected to the anchoring piece forms a spiral wound along the puncture needle and extends out of the heart;

the device can control the time of the puncture needle releasing from the first accommodating cavity by controlling the time of the external force pushing the anchoring piece, so that medical personnel can control the time of actively releasing the anchoring piece, and the safety in the operation process is improved.

2. According to the apex cordis closing device provided by the invention, the pushing member is arranged in the first accommodating cavity of the puncture needle in a sliding manner, the pushing member moves along the first accommodating cavity by pushing the proximal end of the pushing member, and the distal end of the pushing member is abutted against the anchoring member, so that the anchoring member is released from the first accommodating cavity.

3. The invention provides an apex cordis closing device, which further comprises: the handle, the first pushing assembly and the second pushing assembly; the puncture needle can be controlled to be screwed out of the sheath tube by rotating the first pushing assembly, so that the puncture needle penetrates through cardiac muscle from the apex of the heart and enters the ventricle; the second pushing assembly controls the movement of the pusher member and thus the timing of the release of the anchor from the needle.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic perspective view of an apex closure device of the present invention.

Fig. 2 is a schematic view of the internal structure of the sheath shown in fig. 1.

FIG. 3 is a cross-sectional view of an apex closure device of the present invention.

Fig. 4 is a partially enlarged view of a portion a shown in fig. 3.

Fig. 5 is a partially enlarged view of fig. 3 at B.

Figure 6 shows a first arrangement of the needle and the first mount of the present invention.

Fig. 7 shows a second mounting arrangement of the lancet and the first base of the present invention.

Fig. 8 is a schematic view of the configuration of the anchor of the present invention within the needle.

Fig. 9 is a schematic structural view of the pushing member of the present invention.

Fig. 10 is a structural view showing an entry state of the first anchor of the present invention.

Fig. 11 is a structural view showing a state of use of the first anchor of the present invention.

Fig. 12 is a perspective view of a second middle anchor according to the present invention.

Fig. 13 is a schematic view of the structure of the guide needle of the present invention entering the myocardium.

Fig. 14 is a schematic view of the structure of the super hard guidewire entry guide needle of the present invention.

FIG. 15 is a schematic view of the apex closure device of the present invention reaching the anterior end of the apex.

Fig. 16 is a schematic view showing the structure of the puncture needle of the present invention which is inserted into the myocardium.

Fig. 17 is a schematic view of the release of the anchor of the present invention from the needle into the ventricle.

Fig. 18 is a schematic view of the structure of the suture thread in the myocardium.

Fig. 19 is a schematic view of the access device of the present invention in use.

Fig. 20 is a schematic view of the retention of the anchor of the present invention within the ventricle.

Fig. 21 is a schematic view showing the installation position structure of the closer of the present invention.

FIG. 22 is a schematic view showing the structure of the suture threading position of the present invention.

Fig. 23 is a schematic view of the internal structure of the closer of the present invention.

FIG. 24 is a schematic view of the distal end of the occluder of the present invention.

Description of the reference numerals:

1. a sheath tube; 2. puncturing needle; 3. a first base; 4. a first push rod; 5. a first knob; 6. a second base; 7. a second push rod; 8. a second knob; 9. a handle; 10. a pushing member; 11. a guide wire sleeve; 12. an anchoring member; 13. a suture; 14. a straight tube portion; 15. a hook portion; 16. threading holes; 17. the myocardium; 18. a ventricle; 19. a guide pin; 20. a superhard guidewire; 21. an interventional instrument; 22. a felt sheet; 23. a closer; 24. a push rod; 25. a clamping member; 26. a surgical knot.

Detailed Description

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

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in a specific case to those of ordinary skill in the art.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

The apical closing device provided in this embodiment, as shown in fig. 1, is an overall assembly view of the device, and includes a sheath 1, a handle 9, a first knob 5 and a second knob 8; in the using process, the sheath tube 1 enters the human body and reaches the apex of the heart with the assistance of other instruments;

as shown in fig. 2, the sheath 1 has a schematic structural view, the sheath 1 has puncture needles 2 inside, the number of the puncture needles 2 can be 1-3, and the number of the puncture needles 2 in this embodiment is preferably 2, and it can be seen from the figure that the two puncture needles 2 are arranged in a staggered spiral manner. The far end of the sheath tube 1 is provided with a slot, so that the puncture needle 2 can be screwed out from the inside of the sheath tube 1; the puncture needle 2 is internally provided with a first accommodating cavity, and a pushing piece 10 is arranged in the first accommodating cavity;

as shown in fig. 3, the puncture needle 2 is fixedly connected with a first base 3, the other end of the first base 3 is fixedly connected with a first push rod 4, and the near end of the first push rod 4 is fixedly connected with a first knob 5; the first push rod 4 is rotatably arranged in a second accommodating cavity of the handle 9; the first push rod 4 is internally provided with a second accommodating cavity;

as shown in fig. 4, the pushing member 10 in the puncture needle 2 is fixedly connected with the second base 6, the other end of the second base 6 is fixedly connected with the second pushing rod 7, and the proximal end of the second pushing rod 7 is fixedly connected with the second knob 8; the second push rod 7 is arranged in the second accommodating cavity of the first push rod 4 in a sliding manner; the pitch of the pushing member 10 is the same as that of the puncture needle 2, and when the medical staff rotates the second knob 8, the pushing member 10 is driven to rotate and advance in the puncture needle 2, and finally penetrates out of the first accommodating cavity of the spiral puncture needle 2.

The pushing component 10 can be a tube with a through cavity inside, or a solid thread; the material of the pushing piece is stainless steel or cobalt-chromium alloy.

As shown in fig. 5, an internal thread is arranged in the second accommodating cavity of the handle 9, an external thread is arranged on the outer surface of the first push rod 4, the internal thread and the external thread are arranged in a matching manner, and in the operation process, the first knob 5 is rotated, and the external thread advances spirally in the internal thread to drive the puncture needle 2 to spirally screw out from the sheath tube 1;

as shown in fig. 6, the first base 3 is made of metal, the puncture needle 2 can be fixed on the first base 3 by laser welding, a semicircular spiral groove is formed in the first base 3, the pitch of the spiral groove is the same as that of the puncture needle 2, the puncture needle 2 can be accommodated in the spiral groove, and the two components can be firmly connected by laser welding at the hinged position of the spiral groove and the puncture needle 2.

As an alternative embodiment, as shown in fig. 7, the first seat 3 may be in the shape of a circular groove which can accommodate the puncture needle 2 therein such that the first seat 3 is concentrically arranged with the helical puncture needle 2, and the inner wall of the first seat 3 and the puncture needle 2 are laser-welded together.

The pusher 10 is described and illustrated as being tubular.

As shown in fig. 8, the distal end of the puncture needle 2 has a tip for puncture; an anchoring piece 12 is clamped at a position close to the tip, the anchoring piece 12 is connected with one end of a suture line 13, and the other end of the suture line 13 penetrates through a penetrating cavity of the pushing piece 10; after the puncture needle 2 enters the ventricle 18, the second knob 8 is rotated, the pushing piece 10 is pushed forwards, the anchoring piece 12 is pushed out of the first accommodating cavity, and the relationship between the puncture needle 2 and the pushing piece 10 is shown in fig. 9;

the anchoring piece 12 is formed by cutting a superelastic nickel-titanium alloy tube by laser, and comprises a straight tube part 14 and a hook part 15, wherein the outer diameter of the straight tube part 14 is smaller than the inner diameter of the puncture needle 2; when the anchoring piece 12 is clamped in the first accommodating cavity of the puncture needle 2, the anchoring piece is in an entering state, and as shown in fig. 10, the hooking part 15 is deformed into a straight section; the number of hooks 15 is between 2 and 6, preferably 3.

As shown in fig. 11, after the anchor 12 is released into the ventricle 18, the hook portion 15 is bent outward at the connection point with the straight tube portion 14; the suture 13 is passed through the straight tube portion 14 of the anchor 12, and the part of the suture 13 beyond the straight tube portion 14 is knotted to form a knot, which is fixed together by laser welding or gluing.

The hook 15 may also be 1/4 circle or 1/2 circle, and the hook 15 forms an extension circle with a diameter less than 5mm, preferably 3 mm. The smooth hook 15 contacts the tissue of the myocardium 17 to prevent damage to the myocardium 17.

Alternatively, as shown in fig. 12, the anchor 12 may be in the form of an arc tube, and the smooth and round shape ensures that the anchor 12 will not damage surrounding tissues after being implanted into the human body; the anchoring member 12 is formed by laser cutting a superelastic nickel-titanium alloy tube, and when compressed into the first receiving cavity of the puncture needle 2, it is a straight tube, and when released, the anchoring member 12 will change into an arc-shaped tube again. To make the anchor 12 more compliant, a laser can be used to cut a spiral pattern into the surface; the anchoring piece 12 is provided with threading holes 16 arranged at intervals; the suture 13 is threaded through one of the threading holes 16 and threaded out of the other threading hole 16, thereby fixing the anchor 12 and the suture 13.

As shown in fig. 4, a third accommodating cavity is formed inside the second pushing rod 7, a guide wire sleeve 11 for accommodating a guide wire is arranged in the third accommodating cavity, and the guide wire sleeve 11 extends to the end part of the distal end of the sheath 1;

method of use and principles

As shown in fig. 13 and 14, the guide needle 19 is first used to penetrate the myocardium 17 from the apex of the heart into the ventricle 18, and then the super hard wire 20 is passed through the guide needle 19 and into the ventricle 18, the super hard wire 20 functioning as a guide for the apex closure device; if the instrument is used with a mitral valve instrument, the distal end of the super hard guidewire 20 should enter the left atrium; if the device is used in conjunction with an active valve device, the distal end of the super hard guidewire 20 should enter the aorta.

Withdrawing the guide needle 19, inserting the superhard guide wire 20 into the guide wire sleeve 11 of the apex closure device, approaching the apex closure device along the superhard guide wire 20 to the heart muscle 17, screwing the puncture needle 2 towards the heart chamber 18 by rotating the first knob 5, and penetrating the heart muscle 17 into the heart chamber 18 as shown in fig. 16; as shown in fig. 17, the second knob 8 is rotated to drive the pushing element 10, so that the compressed anchor 12 is pushed out of the first receiving space of the puncture needle 2, and the suture 13 is already in the puncture needle 2 and enters the ventricle 18 with the anchor 12.

As shown in fig. 18, by rotating the first knob 5, the puncture needle 2 is withdrawn into the sheath 1, and the suture 13 is separated from the closure device, at which time the hook portion 15 of the anchor 12 is in contact with the myocardium 17;

as shown in fig. 19, other interventional devices 21 are introduced into the ventricle 18 along the apical path to perform an interventional procedure, in which case the suture 13 can be tightened to prevent blood leakage; finally, when the intervention is completed, the other interventional instrument 21 is withdrawn, the suture 13 is tightened, the window is tightened and the anchor 12 is permanently implanted in the ventricle 18; since the material is degradable, it can then be degraded within the ventricle.

As shown in fig. 20, the operator finally needs to fix the felt piece 22 outside the myocardium 17 by means of surgical knotting to ensure that the suture 13 is in a tensioned state and to close the wound of the myocardium 17 caused by the puncture needle 2, thereby completing the whole operation.

As an alternative embodiment, as shown in FIG. 21, a closure 23 may be added to the apex closure device, with the closure 23 hanging externally on the outside of the apex closure device, so that the suture 13 changes from being placed inside the pusher 10 to being placed outside the apex closure device; the suture 13 attached to the rivet needs to be threaded out of the tip of the needle 2 to be attached to the obturator 23.

In this manner, as shown in fig. 22, the suture 13 connected to the anchor member 12 is required to be passed out from the needle tip port of the helical puncture needle 2 to be connected to the obturator 23, and therefore, the anchor member 12 may be selected from a solid helical wire.

As shown in fig. 23, the closer comprises a pushing rod 24, the pushing rod 24 is tubular, and has a cavity for passing a suture inside, a clamping piece 25 for fixing the suture is arranged at the proximal end of the cavity, and the clamping piece 25 and the cavity of the pushing rod are arranged in a sliding way;

in use, as shown in figure 24, the felt sheet is positioned at the forward end of the push rod, after which the surgical knot 26 is tied; one end of the double-strand suture is a free end, the other end of the double-strand suture is fixed on the clamping piece, when a wound on the cardiac muscle needs to be closed, a medical staff can release the closer from the apical closed device, one hand is used for tensioning the free end of the suture, the other hand pushes the pushing rod of the closer towards the wound on the cardiac muscle until the felt piece 22 and the surgical knot 26 are placed on the surface of the heart to ensure that the cardiac muscle wound is completely closed, and finally, the redundant suture is cut off to complete the whole process.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications derived therefrom are intended to be within the scope of the invention.

Claims

1. An apex closure device, comprising:

the puncture needle (2) is spiral, and the far end of the puncture needle is a tip for puncture; a first accommodating cavity is formed in the puncture needle (2); the suture is suitable for being wholly or partially accommodated in the first accommodating cavity of the puncture needle;

an anchor (12) adapted at one end to be connected to a suture (13); the anchoring piece (12) has an entering state of being clamped in a first accommodating cavity of the tip of the puncture needle (2), and also has a using state of being released into the ventricle (18) from the first accommodating cavity and abutting against the inner wall of the ventricle (18);

in the process that the puncture needle (2) enters the heart, the anchoring piece (12) is in an entering state; after the puncture needle (2) enters a ventricle (18), the anchoring piece (12) is changed from the entering state to the using state under the action of external force.

2. The apex cardiac closure device of claim 1, further comprising:

the pushing piece (10) is spiral and has the same pitch as the puncture needle (2); the pushing component (10) is arranged in the first accommodating cavity of the puncture needle (2) in a sliding manner; the pushing component (10) pushes the anchoring component (12) from the entering state to the using state.

3. The apex cardiac closure device of claim 2, further comprising:

a handle (9) having a sheath (1) at a distal end thereof for accommodating the puncture needle (2); the handle (9) is internally provided with a second accommodating cavity;

the first pushing assembly is rotatably arranged in the second accommodating cavity of the handle (9); the first pushing assembly is fixedly connected with the near end of the puncture needle (2); the first pushing assembly is internally provided with a third accommodating cavity;

the second pushing assembly is arranged in the third accommodating cavity of the first pushing assembly in a sliding mode; the second pushing assembly is connected to the proximal end of the pusher (10).

4. The apex closure device of claim 3, wherein the inner surface of the handle (9) has internal threads and the outer surface of the first push assembly has external threads that mate with the internal threads of the handle (9).

5. The apex cardiac closure device of claim 3, wherein the first pushing assembly comprises:

a first base (3) having a spiral groove for fixing the puncture needle (2);

one end of the first push rod (4) is fixedly connected with the first base (3), and the other end of the first push rod extends out of the second accommodating cavity of the handle (9).

6. An apex closure device according to claim 1, wherein the puncture needle (2) has two; the two puncture needles (2) are arranged in a staggered and spiral manner.

7. The apex cordis closure device of any one of claims 1-6, wherein the anchor (12) includes: a straight tube portion (14) and a hook portion (15); when the anchor (12) is in an entering state, the straight tube portion (14) and the hook portion (15) are tubular; when the anchor (12) is in use, the hook portion (15) is bent outward at a connection point with the straight tube portion (14).

8. The apex cordis closure device of any one of claims 1-6 in which the anchor (12) is tubular in shape with an arc; the pipe wall is provided with threading holes (16) which are arranged at intervals.

9. The apex cordis closure device of claim 2, characterized in that the pushing member (10) is a helical tube; the pushing piece (10) is internally provided with a penetrating cavity suitable for penetrating a suture (13).

10. The apex cardiac closure device of claim 3, further comprising: and the guide wire sleeve (11) is arranged inside the second pushing assembly and extends to the end part of the distal end of the sheath (1).