CN112773472B

CN112773472B - Puncture needle, coupler, guide device and repair instrument

Info

Publication number: CN112773472B
Application number: CN201911214607.9A
Authority: CN
Inventors: 周晓军; 谢晨光; 董士勇; 谢北平
Original assignee: Beijing Lingjian Medical Technology Co ltd
Current assignee: Beijing Lingjian Medical Technology Co ltd
Priority date: 2019-12-02
Filing date: 2019-12-02
Publication date: 2021-11-09
Anticipated expiration: 2039-12-02
Also published as: CN113729885A; CN112773472A; CN113729885B

Abstract

The invention discloses a puncture needle, a coupler, a guide device and a repair instrument, wherein the puncture needle comprises a rod body, the two ends of the rod body are respectively a puncture end and a guide end, the puncture end is provided with a puncture part, and the guide end is provided with a guide structure for connecting an artificial implant; the coupler comprises a coupler body, and the coupler body is used for being connected with the puncture end of the puncture needle; the guiding device comprises a puncture needle and a coupler, and the puncture end of the puncture needle is connected with the coupler body of the coupler; the repair instrument comprises a guide device and an artificial implant, wherein the artificial implant comprises a flexible section and a gasket, the flexible section is connected to the guide end of the puncture needle, and the gasket is connected to the flexible section. The puncture needle, the coupler, the guiding device and the repair instrument are suitable for minimally invasive or interventional operations and have small trauma to target tissues.

Description

Puncture needle, coupler, guide device and repair instrument

Technical Field

The present invention relates to the field of medical devices, and in particular to a device for repairing a target tissue in a human body.

Background

The surgical methods of clinically implanting prosthetic chordae to repair damaged chordae, suturing the mitral valve leaflets edge to make them more apposite, and performing annuloplasty on patients with annuloplasty may be effective in treating valve diseases such as mitral regurgitation. All of the above procedures require the implantation of artificial implants, such as artificial chordae tendineae or surgical sutures. In cardiac surgery, such as open-chest surgery, because of the good surgical field and the sufficient operation space, the mitral regurgitation can be repaired by implanting artificial chordae tendineae or surgical sutures with the guidance of a traditional suture needle, which has small trauma to the target tissue and ideal repairing effect, but the operation path is large, such as the need for opening the chest, the need for cutting the heart and the need for establishing extracorporeal circulation. The minimally invasive or interventional operation does not need to open the chest and cut the heart, and the mitral regurgitation can be repaired without the heartbeat jumping, the artificial implant and the guiding device in the prior art have obvious defects, the flexible end in the prior art is provided with a fixing piece, the fixing piece is provided with a containing cavity for containing a puncture needle head, in order to anchor the flexible section, the fixing piece must pass through target tissues (such as mitral valve leaflets) to be coupled with the puncture needle, the damage to the leaflets is increased, and the risks of tearing the leaflets and causing complications are caused. Excessive tissue damage is detrimental to the anchorage of the chordae tendineae, e.g., larger and thicker shims are required to prevent anchor loss. In annuloplasty, since the flexible segment is subjected to a large tension, e.g., 8.9N-26.7N, excessive tissue damage often results in anchoring failure, and therefore, reducing trauma to the target tissue is clinically significant.

Disclosure of Invention

The invention aims to provide a puncture needle, a coupler, a guide device and a repair instrument which are suitable for minimally invasive or interventional operations and have small wound on target tissues.

The puncture needle comprises a rod body, wherein a puncture end and a guide end are respectively arranged at two ends of the rod body, a puncture part is arranged on the puncture end, and a guide structure used for connecting an artificial implant is arranged on the guide end.

In the puncture needle, the guide structure is a cavity arranged in the guide end, the cavity comprises a first cavity and a second cavity, the first cavity is communicated with the outside of the end face of the guide end, the inside of the first cavity is communicated with the second cavity through a connecting port, and the calibers of the connecting ports of the first cavity and the second cavity are smaller than the inner diameter of the second cavity.

The puncture needle comprises a guide structure and a guide structure, wherein the guide structure comprises a guide hole and a wire ring, the guide hole is arranged on the side wall of a guide end, and the wire ring is inserted and connected to the guide hole.

The puncture needle comprises a guide structure and a guide structure, wherein the guide structure comprises a guide hole which is arranged on the side wall of the guide end and penetrates through the guide end, and a loading and unloading hole which penetrates through the guide end is also arranged on the side wall of the guide end.

In the puncture needle, the side wall of the guide end is provided with the guide groove which is axially arranged, one end of the guide groove extends to the end face of the guide end, and the other end of the guide groove extends to the guide hole.

In the puncture needle, the guide end is internally provided with a channel which is axially arranged, one end of the channel is communicated with the guide hole and the loading and unloading hole, and the other end of the channel extends out of the end surface of the guide end.

The puncture needle of the present invention, wherein the diameter of the channel is smaller than the diameter of the guide hole.

The puncture needle has the advantages that the diameter of the channel is larger than that of the guide hole and the loading and unloading hole, and the channel is cylindrical or conical with the diameter gradually decreasing from outside to inside.

The puncture needle comprises a puncture needle body, a guide hole and a loading and unloading hole, wherein the puncture needle body is provided with a first channel and a second channel, the first channel and the second channel are sequentially arranged from outside to inside, the first channel and the second channel are communicated through a connecting port, the caliber of the connecting port is smaller than the diameter of the first channel, the guide hole is communicated with the second channel, and the loading and unloading hole is communicated with the first channel or the second channel.

According to the puncture needle disclosed by the invention, the side wall of the puncture needle is provided with the coupling part, and the coupling part is of a rough structure, a barb or a spiral structure.

The coupler comprises a coupler body, wherein the coupler body is used for being connected with the puncture end of the puncture needle.

The coupler comprises a coupler body and a puncture needle, wherein the coupler body comprises an outer sleeve, a coupling tube and a Y-shaped coupling claw, the coupling tube is sleeved in the outer sleeve, the coupling tube is connected with the Y-shaped coupling claw, the Y-shaped coupling claw is used for being connected with the puncture end of the puncture needle, when the Y-shaped coupling claw enters the outer sleeve, the Y-shaped coupling claw is closed, and when the Y-shaped coupling claw is positioned outside the outer sleeve, the Y-shaped coupling claw is opened.

In the coupler, the inner side wall of the Y-shaped coupling claw is provided with a rough structure or a barb.

In the coupler, the coupler body is made of a flexible material or is provided with an internal thread hole for connecting the puncture end of the puncture needle.

The guide device comprises the puncture needle and the coupler, and the puncture end of the puncture needle is connected with the coupler body of the coupler.

The repair instrument using the guide device comprises an artificial implant, wherein the artificial implant comprises a flexible section and a gasket, the flexible section is connected to the guide end of the puncture needle, and the gasket is connected to the flexible section.

According to the repairing instrument, one end of the flexible section is provided with the first fixing knot, the first fixing knot is located in the second cavity of the guide end of the puncture needle, the diameter of the first fixing knot is larger than the caliber of a connecting port of the first cavity and the second cavity, the other end of the flexible section penetrates through the first cavity and extends out of the guide end, the other end of the flexible section is provided with the second fixing knot, and the gasket is connected to the flexible section in a penetrating mode.

According to the repair instrument, two ends of the flexible section are connected through the fixing knot, the fixing knot is located in the second cavity of the puncture needle guide end, the diameter of the fixing knot is larger than the caliber of a connecting port of the first cavity and the second cavity, other parts of the flexible section extend out of the guide end through the first cavity, and the gasket is connected to the flexible section located outside the guide end in a penetrating mode.

According to the repair instrument disclosed by the invention, one end of the flexible section is connected with the wire ring through the first fixing knot, and the other end of the flexible section is provided with the second fixing knot after penetrating through the gasket.

The repair device comprises a pad, a flexible section and a wire ring, wherein the pad is arranged on the pad, and the two ends of the flexible section penetrate through the pad in the same direction and are connected with the wire ring or the guide hole through a fixing knot.

The repair device comprises a pad, a flexible section and a wire ring, wherein the pad is arranged on the pad, the pad is arranged on the flexible section, and the wire ring is arranged on the pad.

According to the repair instrument, one end of the flexible section is provided with the first fixing knot, the first fixing knot is located in the guide hole, the diameter of the first fixing knot is larger than that of the channel, the other end of the flexible section extends out of the guide end through the channel, and the other end of the flexible section penetrates through the gasket and then is provided with the second fixing knot.

According to the repair instrument disclosed by the invention, one end of the flexible section is connected into the channel through at least one first fixing joint, the diameter of the first fixing joint is larger than that of the guide hole, the other end of the flexible section penetrates through the guide hole and extends out of the guide end, and a second fixing joint is arranged at the other end of the flexible section after penetrating through the gasket.

According to the repair instrument disclosed by the invention, one end of the flexible section is connected into the first channel through at least one first fixing knot, the diameter of the first fixing knot is larger than the caliber of a connecting port of the first channel and the second channel, the other end of the flexible section penetrates through the second channel and the guide hole and extends out of the guide end, and the other end of the flexible section penetrates through the gasket and then is provided with the second fixing knot.

The repair instrument comprises two puncture needles, wherein the two puncture needles are respectively a first puncture needle and a second puncture needle, one end of the flexible section is connected with the guide end of the first puncture needle, and the other end of the flexible section penetrates through at least one gasket and then is connected with the guide end of the second puncture needle.

The repair instrument comprises at least two puncture needles, wherein the flexible sections sequentially penetrate through the guide hole of each puncture needle, two ends of each flexible section are respectively provided with a fixing knot, and the flexible sections on two sides of the guide hole of each puncture needle are jointly inserted and connected with one gasket.

The repair instrument comprises three puncture needles, wherein the three puncture needles are respectively a first puncture needle, a second puncture needle and a third puncture needle, the number of the flexible sections is two, the number of the two flexible sections is respectively a first flexible section and a second flexible section, the gaskets are respectively a first gasket and a second gasket, one end of the first flexible section is connected to the guide end of the first puncture needle, the other end of the first flexible section penetrates through at least one first gasket and then is connected to the guide end of the second puncture needle, one end of the second flexible section is connected to the guide end of the third puncture needle, and the other end of the second flexible section sequentially penetrates through the second gasket and the first gasket and then is provided with a fixing knot.

The puncture needle, the coupler, the guiding device and the repair instrument are different from the prior art in that when the puncture needle, the puncture needle and the coupler are separated by the puncture needle when the puncture needle is used, the puncture needle punctures target tissues such as mitral valve leaflets or mitral valve rings by means of the implantation system, the puncture needle is coupled with the puncture needle loading/unloading system, an operator operates the coupler handle to pull the puncture needle, the puncture needle and the flexible section sequentially penetrate through the target tissues, the flexible section is anchored on the target tissues due to the blocking of the gasket, one end of the flexible section is anchored on one side of the target tissues, the other end of the flexible section is pulled to the locking system by the coupler, and the operator pushes the locking device to the target tissues along the flexible section to implement locking by means of the locking system, for example, the locking device is pushed to the left ventricle wall to lock, so that chordae repair is completed; pushing the obtained product to the position below the mitral valve leaflets to finish edge-to-edge repair; push to the inferior of the mitral valve ring, finish the ring of valve to shrink, thus reduce the regurgitation of mitral valve effectively. It follows that the present invention is suitable for minimally invasive or interventional procedures and causes less trauma to the target tissue.

The invention will be further explained with reference to the drawings.

Drawings

FIG. 1 is a first view showing the connection state of a puncture needle, a flexible segment and a gasket according to the present invention;

FIG. 2 is a second view showing the connection state of the puncture needle, the flexible section and the spacer according to the present invention;

FIG. 3 is a first schematic structural view of the puncture needle of the present invention;

FIG. 4 is a cross-sectional view taken along line A-A of FIG. 3;

FIG. 5 is a third view showing the connection state of the puncture needle, the flexible section and the spacer according to the present invention;

FIG. 6 is a cross-sectional view taken along line B-B of FIG. 5;

FIG. 7 is a fourth view showing the connection state of the puncture needle, the flexible section and the spacer according to the present invention;

FIG. 8 is a cross-sectional view taken along line C-C of FIG. 7;

FIG. 9 is a fifth state view of the connection of the needle, flexible segment and spacer of the present invention;

FIG. 10 is a first cross-sectional view taken along line D-D of FIG. 9;

FIG. 11 is a second sectional view taken along line D-D of FIG. 9;

FIG. 12 is a third sectional view taken along line D-D of FIG. 9;

FIG. 13 is a fourth sectional view taken along line D-D of FIG. 9;

FIG. 14 is a cross-sectional view taken along line D-D of FIG. 9;

FIG. 15 is a sixth sectional view taken along line D-D of FIG. 9;

FIG. 16 is a first illustration of the loading of the needle of the present invention;

FIG. 17 is a second drawing showing the loading of the needle of the present invention;

FIG. 18 is a sixth view showing the connection state of the puncture needle, the flexible section and the spacer according to the present invention;

FIG. 19 is a seventh drawing showing the connection of the needle, flexible segment and spacer of the present invention;

FIG. 20 is a view showing the connection state of the puncture needle, the flexible section and the spacer in accordance with the present invention;

FIG. 21 is a ninth view showing the connection state of the puncture needle, the flexible section and the spacer according to the present invention;

FIG. 22 is a first cross-sectional view taken along line E-E of FIG. 18;

FIG. 23 is a second sectional view taken along line E-E of FIG. 18;

FIG. 24 is a third schematic view showing the loading of the needle of the present invention;

FIG. 25 is a cross-sectional view showing the connection state of the puncture needle, the flexible section and the spacer in the present invention;

FIG. 26 is a cross-sectional view taken along line F-F of FIG. 25;

FIG. 27 is a eleventh view showing the connection state of the puncture needle, the flexible section and the spacer in the present invention;

FIG. 28 is a cross-sectional view taken along line G-G of FIG. 27;

FIG. 29 is a twelfth state view showing the connection of the puncture needle, the flexible section and the spacer according to the present invention;

FIG. 30 is a sectional view taken along line H-H in FIG. 29;

FIG. 31 is a fourth schematic view of the loading of the needle of the present invention;

FIG. 32 is a thirteen drawing showing the connection state of the puncture needle, the flexible segment and the spacer in accordance with the present invention;

FIG. 33 is a fourteenth perspective view illustrating the connection of the needle, flexible segment and spacer of the present invention;

FIG. 34 is a fifteen schematic view showing the connection of the needle, flexible segment and spacer in accordance with the present invention;

FIG. 35 is a sixteen side view illustrating the connection of the needle, flexible segment and spacer of the present invention;

FIG. 36 is a seventeenth perspective view showing the connection of the puncture needle, the flexible section and the spacer according to the present invention;

FIG. 37 is a first schematic view of the piercing end structure of the puncture needle of the present invention;

FIG. 38 is a second schematic view of the piercing end structure of the piercing needle of the present invention;

FIG. 39 is a third schematic view showing the structure of the piercing tip of the puncture needle according to the present invention;

FIG. 40 is a fourth structural view of the piercing end of the puncture needle according to the present invention;

FIG. 41 is a fifth structural view of the piercing end of the puncture needle according to the present invention;

FIG. 42 is a sixth schematic structural view of the piercing end of the piercing needle of the present invention;

FIG. 43 is a seventh structural view of the piercing end of the puncture needle according to the present invention;

FIG. 44 is a structural view showing the puncturing end of the puncture needle according to the present invention;

FIG. 45 is a first schematic view of the coupling of the coupler to the needle of the present invention;

FIG. 46 is a second drawing of the coupling of the coupler to the needle of the present invention;

FIG. 47 is a third schematic view of the coupling of the coupler and the puncture needle according to the present invention;

FIG. 48 is a fourth schematic view of the coupling of the coupler to the needle of the present invention;

FIG. 49 is a fifth drawing illustrating the coupling of the coupler to the needle of the present invention;

FIG. 50 is a sixth schematic view of the coupling of the coupler to the needle of the present invention;

FIG. 51 is a seventh drawing illustrating the coupling of the coupler to the needle of the present invention;

FIG. 52 is an eighth schematic coupling view of the coupler and needle of the present invention;

FIG. 53 is a ninth schematic view of the coupling of the coupler and the needle of the present invention;

FIG. 54 is a tenth drawing illustrating the coupling of the coupler to the needle of the present invention;

FIG. 55 is an eleventh schematic view of the coupling of the coupler to the needle of the present invention;

FIG. 56 is a first view illustrating a first state of use of the prosthetic device of the present invention;

FIG. 57 is a second view illustrating a state of use of the prosthetic device according to the present invention;

FIG. 58 is a third view of a prosthetic device of the present invention in use;

FIG. 59 is a fourth illustration of the prosthetic device of the present invention in use;

FIG. 60 is a fifth schematic view illustrating the use of the prosthetic device of the present invention;

FIG. 61 illustrates a sixth use condition of the prosthetic device of the present invention;

fig. 62 is a seventh view illustrating a state of use of the prosthetic device according to the present invention;

fig. 63 is a schematic view eight illustrating a use state of the prosthetic device according to the present invention;

fig. 64 is a diagram nine illustrating the use state of the prosthetic device according to the present invention.

Detailed Description

As shown in fig. 25, and as shown in fig. 26 to 30, the guiding structure is a cavity disposed in the guiding end, the cavity includes a first cavity 2518 and a second cavity 2517, the first cavity 2518 is communicated with the outside of the end face of the guiding end, the inside of the first cavity 2518 is communicated with the second cavity 2517 through a connection port, the aperture of the connection port between the first cavity 2518 and the second cavity 2517 is smaller than the inner diameter of the second cavity 2517, so that the flexible segment 257 is connected to the second cavity 2517 through the fixing knot 255 (the diameter of the fixing knot 255 is larger than the aperture of the connection port), and thus, the fixing knot 255 cannot slip off from the first cavity 2518.

As shown in fig. 25 and 26, the flexible segment 257 is a single piece, with each end passing through a spacer 258 and then connected to the second chamber 2517 at the leading end of the puncture needle 2510 by a retaining knot 255. As shown in fig. 26, the diameter of the second chamber 2517 is larger than the diameter of the first chamber 2518 (i.e., the aperture of the connection port between the first chamber 2518 and the second chamber 2517 is smaller than the inner diameter of the second chamber 2517), and the diameter of the fixing knot 255 is larger than the diameter of the first chamber 2518. As shown in fig. 27 and 28, two flexible segments 277 are provided, one end of each of the two flexible segments 277 is connected to the second chamber 2517 through a fixed knot 275, the other end of each of the two flexible segments 277 extends out of the guide end through the first chamber 2518, and the other end of each of the two flexible segments 277 is provided with a fixed knot 275 after passing through a gasket 278. The two fixed junctions 275 located in the second chamber may be combined into one in practical applications. As shown in fig. 29 and 30, the difference between the two embodiments is that the flexible section 297 is a single piece with one end connected to the second chamber 2517 by a fixed knot 295 and the other end passing through the gasket and then having another fixed knot 295.

Fig. 31 is a schematic view of the loading of the puncture needle 2510, and the loading/unloading system 3115 is a clamping system for clamping the rear end of the puncture needle 2510 during loading and opening the loading/unloading system 3115 during unloading to separate the puncture needle 2510 from the loading/unloading system 3115.

As shown in fig. 18 and in conjunction with fig. 19-23, the guiding structure includes a guiding hole 184 and

wire rings

1816, 1916 and 2016, the guiding hole 184 is disposed on the side wall of the guiding end, and the wire rings 1816, 1916 and 2016 are inserted and connected to the guiding hole 184.

The guide end of the

puncture needle

1810 or 2010 in fig. 18 to 21 is provided with only one guide hole 184, and as shown in fig. 22 and 23, the guide end may be in the shape of a solid rod or a hollow rod.

In fig. 18, a guide hole 184 is formed at the leading end of the puncture needle 1810, a wire ring 1816 passes through the guide hole 184, and the flexible segments 187 can be two independent pieces, one end of each piece is commonly fixed with the wire ring 1816 by a fixing knot 185, and the other end of each piece is respectively provided with a fixing knot 185 after passing through the pad 188. The flexible segment 187 may also be a single piece, and both ends of the flexible segment are respectively provided with a fixing knot 185 after passing through the pad 188, and the middle segment is inserted and connected to the wire ring 1816, specifically, connected by the fixing knot 185. In this embodiment, the fixing knot 185 may be formed by a special structure such as titanium nail, or may be formed by a conventional knotting method. The wire ring 1816 may be of a material that is compatible with the flexible segment 187, or may be of a material that is incompatible with the flexible segment 187. As shown in FIG. 19, flexible segment 197 is a single piece, with both ends of flexible segment 197 extending in the same direction through spacer 188, and a middle section of flexible segment 197 threaded over wire ring 1816. As shown in fig. 20, flexible segment 207 is a single piece, and both ends of flexible segment 207 are connected to wire loop 2016 together by fastening knot 205 after passing through pad 188 in the same direction. As shown in fig. 21, the flexible segment 217 is a single piece, one end of which is connected to the wire loop by a fixed knot, and the other end of which is provided with another fixed knot 215 after passing through the pad.

As shown in fig. 24, which is a schematic view of the loading of a needle with a wire loop installed, using needle 1810 as an example, needle loading/unloading system 2415 loads needle 1810 with loading/unloading wire 2413, loading/unloading wire 2413 through wire loop 1816 completes the loading of needle 1810, and unloading wire 2413 for removal.

As shown in fig. 1 and in conjunction with fig. 2-6, the guiding structure includes a guiding hole 14 penetrating the guiding end and disposed on the side wall of the guiding end, and a loading and unloading hole 16 penetrating the guiding end and disposed on the side wall of the guiding end.

As shown in fig. 1 and in conjunction with fig. 3 and 4, the puncture needle 10 includes a shaft 11, a puncture end and a guide end are respectively disposed at two ends of the shaft 11, and the puncture needle 10 punctures a target tissue, such as a mitral valve leaflet and a mitral valve annulus, through a puncture portion 13 and guides a flexible segment 17 through the target tissue. The piercing end is provided with a coupling portion 12 for coupling with a coupler. The leading end is provided with a leading hole 14 for leading the flexible section 17 to pass through target tissues, and the flexible section 17 is connected with a gasket 18 for assisting in anchoring the flexible section 17 and reducing the risk of damage or tearing of the target tissues.

The two ends of the flexible section 17 penetrate through the pad 18 in the same direction and form a closed loop 130 in the middle section of the flexible section 17 to prevent the pad 18 from falling off from the flexible section 17, and the two ends of the flexible section 17 are respectively tied or tied together to the fixed knot 15 and connected to the guide hole 14 through the fixed knot 15, i.e. the fixed knot 15 is accommodated in the guide hole 14.

As shown in fig. 2, the flexible section 27 is inserted into the guiding hole 14, and two ends of the flexible section 27 are respectively provided with a fixing knot 25 after passing through the gasket in the same direction, so as to prevent the flexible section 27 from falling off the gasket 28.

As shown in fig. 5 in combination with fig. 6, the side wall of the guide end is provided with a guide groove 59 arranged axially, one end of the guide groove 59 extends to the end surface of the guide end, and the other end of the guide groove 59 extends to the guide hole 14. The guide grooves 59 are provided in two, and the two guide grooves 59 are arranged opposite to each other for accommodating the flexible segments 57. This reduces trauma to the tissue on the one hand, and also prevents the flexible segment 57 from being pinched by the needle loading/unloading system 1715, as shown in figure 17.

Fig. 16 and 17 are schematic views showing the mounting of a puncture needle having a mounting/dismounting hole at its leading end, in which fig. 16 illustrates a puncture needle 10 as an example, and fig. 17 illustrates a puncture needle 50 as an example, specifically as follows:

fig. 16 is a schematic loading view of the needle 10 showing a partial cross-sectional view of the needle loading/unloading system 1615. the needle loading/unloading system 1615 is provided with a guide channel 1614 for passing the flexible section 17 to prevent the flexible section 17 from being pinched. The puncture needle loading/unloading system 1615 is provided with a loading/unloading hole 1616, the loading/unloading line 1613 passes through the loading/unloading hole 1616 and the puncture needle loading/unloading hole 16, the puncture needle 10 is completely loaded, and the loading/unloading line 1613 is operated to be separated from the puncture needle loading/unloading hole 16, thereby completing the unloading of the puncture needle 10 and the puncture needle loading/unloading system 1615.

Fig. 17 is a loading schematic view of the puncture needle 50, and unlike fig. 16, the puncture needle loading/unloading system 1715 is not provided with a guide groove because the guide end of the puncture needle 50 is provided with a guide groove 59.

As shown in fig. 7 in conjunction with fig. 8-15, axially disposed

channels

710, 911, 912 are provided in the leading ends of the

needles

70, 910, one end of the

channels

710, 911, 912 communicating with the guide holes 74, 94 and the off-

load holes

76, 96, and the other end of the

channels

710, 911, 912 extending beyond the end of the leading end.

As shown in fig. 8, the diameter of the passage is smaller than the diameter of the guide hole 74. One end of the flexible segment 77 is provided with a first fixing knot 75, the first fixing knot 75 is positioned in the guide hole 74, and the diameter of the first fixing knot 75 is larger than that of the channel 710, so that the first fixing knot 75 is prevented from falling off from the channel 710. The other end of the flexible section 77 extends to the outside of the guiding end through the channel 710, and a second fixing knot is arranged on the other end of the flexible section 77 after passing through the gasket, so that the gasket is prevented from falling off from the flexible section 77.

As shown in fig. 9, in conjunction with fig. 10-13, the puncture needle 910 has

passages

911 and 912 having a diameter larger than the diameter of the guide hole 94 and the loading and unloading hole 96, the passage 912 shown in fig. 12 and 13 has a cylindrical shape, and the passage 911 shown in fig. 10 and 11 has a conical shape with a diameter gradually decreasing from the outside toward the inside.

As shown in fig. 14 and fig. 15, the channels include a first channel 913 and a second channel 914 arranged in this order from the outside to the inside, the first channel 913 and the second channel 914 communicate with each other through a connection port having a smaller diameter than the first channel 913, the guide hole 94 communicates with the second channel 914, and the loading/unloading hole 96 communicates with the first channel 913 or the second channel 914.

As shown in fig. 9 and in conjunction with fig. 10 to 15, one end of the flexible segment 97 is connected to the inside of the

channels

911 and 912 through at least one first fixing knot 95, the diameter of the first fixing knot 95 is larger than the diameter of the guiding hole 94, the other end of the flexible segment 97 passes through the guiding hole 94 and extends out of the guiding end, and a second fixing knot is arranged at the other end of the flexible segment 97 after passing through the gasket.

The first fixed knot 95 shown in fig. 10 is a single knot fixed between the guide hole 94 and the loading and unloading hole 96, and the passage 911 is conical; the first fixed knot 95 shown in fig. 11 is a single knot and is fixed behind the loading and unloading hole 96; the first fixed knot 95 shown in fig. 12 is a double knot fixed between the guide hole 94 and the loading and unloading hole 96, and the channel 912 is cylindrical; first fixed knot 95 shown in fig. 13 is a double knot and, after being fixed to load release hole 96, channel 912 is cylindrical.

As shown in fig. 14 and 15, one end of the flexible segment 97 is connected to the first channel 913 through at least one first fixing knot 95, the diameter of the first fixing knot 95 is larger than the diameter of a connection port between the first channel 913 and the second channel 914, the other end of the flexible segment 97 passes through the second channel 914 and the guide hole 94 and extends out of the guide end, and a second fixing knot is arranged at the other end of the flexible segment 97 after passing through the gasket.

The first fixing knot 95 shown in fig. 14 is a double knot fixed between the guide hole 94 and the loading and unloading hole 96 (i.e., the loading and unloading hole 96 communicates with the first passage 913), the diameter of the first passage 913 is larger than that of the second passage 914, and the first passage 913 and the second passage 914 are both cylindrical; the first fixing knot 95 shown in fig. 15 is a double knot, and after being fixed to the loading and unloading hole 96 (i.e., the loading and unloading hole 96 is communicated with the second passage 914), the diameter of the first passage 913 is larger than that of the second passage 914, and the first passage 913 and the second passage 914 are both cylindrical.

It should be noted that the first fixing knot 95 may be a single knot, or two or more knots, and the diameter of the first fixing knot 95 may be flexibly set according to the actual situation, for example, for a cylindrical channel, the diameter of the first fixing knot 95 is smaller than the diameter of the channel, but larger than the diameter of the guiding hole 94. For a conical channel, the diameter of the first retaining knot 95 may be larger than the smallest diameter of the conical channel, and in any case, the first retaining knot 95 is provided to prevent the flexible section 97 from slipping off the introducer end of the needle.

As shown in fig. 37, in conjunction with fig. 38-44, a different embodiment of the piercing end of the needle is shown.

As shown in fig. 37, the puncture tip is provided with a puncture portion 373, and the entire side wall of the puncture tip is smooth. As shown in fig. 38-44, the sidewall of the needle is provided with a coupling that is textured, barbed, or spiraled.

In fig. 37, the piercing portion 373 of the puncture needle is tapered and the entire side wall of the piercing end is smooth. In fig. 38, a smooth transition portion 3817 is provided between the puncture portion 383 and the coupling portion 382 of the puncture needle, and the coupling portion 382 has a rough structure, so that the puncture is easy to be ensured and the coupling reliability is not affected. Fig. 39 differs from fig. 38 in that the piercing portion 393 is triangular. In fig. 40, the absence of a smooth transition between the piercing portion 403 and the coupling portion 402 advantageously reduces the length of the piercing needle and, therefore, the size of the implant system (not shown). In fig. 41, a barb-formed coupling portion 412 is provided at the trailing end of the puncturing portion 413; fig. 42 differs from fig. 41 in that both the piercing portion 423 and the coupling portion 422 are of a tapered configuration, and an annular land-type barb is formed between the piercing portion 423 and the coupling portion 422. In fig. 43, the coupling part 432 is a spiral structure; fig. 44 is different from fig. 43 in that the puncturing part 443 has a triangular structure.

As shown in fig. 45, and in conjunction with fig. 46-55, the coupler of the present invention includes

coupler bodies

4524, 5125, 5526 for connection with the piercing end of a puncture needle.

As shown in fig. 45 and fig. 46, the coupler body 4524 includes an outer sleeve 4519, a coupling tube 4521 and a Y-shaped coupling claw 4520, the coupling tube 4521 is sleeved in the outer sleeve 4519, the coupling tube 4521 is connected with the Y-shaped coupling claw 4520, the Y-shaped coupling claw 4520 is used for being connected with a puncturing end of a puncturing needle 4510, the Y-shaped coupling claw 4520 is closed when the Y-shaped coupling claw 4520 enters the outer sleeve 4519, and the Y-shaped coupling claw 4520 is opened when the Y-shaped coupling claw 4520 is located outside the outer sleeve 4519. The overtube 4519 moves downward relative to the coupling tube 4521, the Y-shaped coupling claw 4520 automatically opens, the puncture needle 4510 enters the catching region, the overtube 4519 is pushed, the Y-shaped coupling claw 4520 closes, and as shown in fig. 46, the coupling 4524 is coupled with the puncture needle 4510.

As shown in fig. 47 and 48, roughness 4722 is provided on the inner sidewall of the Y-shaped coupling claw 4520 to increase the coupling reliability. Wherein the coupling portion of the needle of figure 48 is also textured to further increase coupling reliability.

As shown in fig. 49 and 50,

barbs

4923 and 5023 are provided on the inner side wall of the Y-shaped coupling claw 4520. Both sides of the Y-shaped coupling jaw 4520 in FIG. 49 are provided with barbs 4923, and one side of the Y-shaped coupling jaw in FIG. 50 is provided with barbs 5023.

As shown in fig. 51, and in conjunction with fig. 52, 53, and 54, the coupler body is made of a flexible material. After the puncture needle is attacked, the friction provides coupling force; the piercing end side wall of the piercing needle of fig. 51 is smooth and easily penetrates the coupler body 5125; the puncture needle with the barb structure of fig. 52 and 54 improves the coupling reliability after tapping into the coupler body; in fig. 53, the coupling portion of the puncture needle is a self-tapping screw, i.e., a screw structure, and the rotating coupler causes the coupling portion of the puncture needle to tap into the coupler body.

As shown in fig. 55, the coupling body 5526 is provided with an internal thread hole for connecting the puncture tip of the puncture needle, and the internal thread hole is spirally coupled to the puncture needle.

As shown in fig. 56, and in conjunction with fig. 57 and 58, the introducer device of the present invention includes the above-described puncture needle and coupler, and the puncture end of the puncture needle is connected to the coupler body of the coupler.

As shown in fig. 56 in combination with Figs. 57 and 58, the prosthetic device using the above-described introducer in accordance with the present invention comprises an artificial implant including a flexible section attached to the leading end of the puncture needle and a spacer attached to the flexible section.

As shown in fig. 27 in combination with fig. 28-30, the prosthetic device of the present invention is a prosthetic device, wherein one end of each of the

flexible segments

277, 297 is provided with a

first fixing knot

275, 295, the

first fixing knot

275, 295 is located in the second chamber 2517 at the leading end of the puncture needle, the diameter of the

first fixing knot

275, 295 is larger than the caliber of the connection port between the first chamber 2518 and the second chamber 2517, the other end of the

flexible segment

277, 297, which passes through the first chamber 2518, extends to the outside of the leading end, the other end of the

flexible segment

277, 297 is provided with a

second fixing knot

275, 295, and the gasket 278 is inserted and connected to the

flexible segment

277, 297.

Flex segments 277 shown in fig. 27 are provided in two and flex segments 297 shown in fig. 29 are provided in a single piece.

As shown in fig. 25 in combination with fig. 26, the prosthetic device of the present invention is characterized in that two ends of the flexible segment 257 are connected by a fixing knot 255, the fixing knot 255 is located in the second chamber 2517 of the guiding end of the puncture needle, the diameter of the fixing knot 255 is larger than the caliber of the connection port between the first chamber 2518 and the second chamber 2517, the other portion of the flexible segment 257 extends to the outside of the guiding end through the first chamber 2518, and two spacers 258 are inserted and connected to the flexible segment 257 located outside the guiding end.

As shown in fig. 21 in combination with fig. 18, the prosthetic device of the present invention is shown in which one end of the

flexible segments

217 and 187 is connected to the wire loop by a first fixed knot, and the other end of the

flexible segments

217 and 187 is provided with a second fixed

knot

215 and 185 after passing through the spacer. Fig. 18 differs from fig. 21 in that two flexible segments are provided.

As shown in fig. 20, and in conjunction with fig. 1 and 5, the prosthetic device of the present invention is shown in which the two ends of the

flexible segments

207, 17, 57 are passed through the spacer in the same direction and then connected to the wire loop 2016 or guide hole 14 by the

fastening knots

205, 15.

As shown in fig. 18 in combination with fig. 19 and 2, the prosthetic device of the present invention is characterized in that the

flexible segments

187, 197 and 27 are inserted into the wire rings 1816 and 1916 or the guide hole 14, and the two ends of the

flexible segments

187, 197 and 27 are respectively provided with a fixing knot after passing through the spacer in the same direction. Fig. 18 differs from fig. 19 in the manner in which the flexible segments are threaded into the loop, in fig. 18 flexible segments 187 are threaded into loop 1816 by anchor knot 185, and in fig. 19 flexible segments 197 are threaded only into loop 1916.

As shown in fig. 7 in combination with fig. 8, the prosthetic device of the present invention is characterized in that one end of the flexible segment 77 is provided with a first fixing knot 75, the first fixing knot 75 is located in the guide hole 14, the diameter of the first fixing knot 75 is larger than that of the channel 710, the other end of the flexible segment 77 extends out of the guide end through the channel 710, and the other end of the flexible segment 77 is provided with a second fixing knot after passing through the spacer.

As shown in fig. 10 in combination with fig. 11-13, the prosthetic device of the present invention is characterized in that one end of the flexible segment 97 is connected to the inside of the

channel

911, 912 through at least one first fixing knot 95, the diameter of the first fixing knot 95 is larger than the diameter of the guiding hole 14, the other end of the flexible segment 97 passes through the guiding hole 14 and extends out of the guiding end, and the other end of the flexible segment 97 passes through the spacer and is provided with a second fixing knot.

As shown in fig. 14 in combination with fig. 15, the prosthetic device of the present invention, wherein one end of the flexible segment 97 is connected to the first channel 913 through at least one first fixing knot 95, the diameter of the first fixing knot 95 is larger than the aperture of the connection port between the first channel 913 and the second channel 914, the other end of the flexible segment 97 passes through the second channel 914 and the guiding hole 14 to extend out of the guiding end, and the other end of the flexible segment 97 passes through the spacer and then is provided with a second fixing knot.

As shown in fig. 32 in combination with fig. 33, the prosthetic device of the present invention includes two puncture needles, the two puncture needles are a first puncture needle and a second puncture needle, one end of the flexible segment is connected to the leading end of the first puncture needle, and the other end of the flexible segment is connected to the leading end of the second puncture needle after passing through at least one gasket.

The flexible segment shown in fig. 32 is attached to the needle in the same manner as shown in fig. 8, and the flexible segment shown in fig. 33 is attached to the needle in the same manner as shown in fig. 9. Of course, the flexible segment can be attached to the needle in the same manner as shown in FIG. 21.

As shown in fig. 34 in combination with fig. 36, in the prosthetic device according to the present invention, the number of the puncture needles is at least two, the flexible segment sequentially passes through the guide hole of each puncture needle, two ends of the flexible segment are respectively provided with a fixing knot, and the flexible segments on two sides of the guide hole of each puncture needle are commonly inserted and connected with one gasket. The number of puncture needles shown in fig. 34 is two, and the number of puncture needles shown in fig. 36 is three.

As shown in fig. 35, the prosthetic device of the present invention includes three puncture needles, the three puncture needles are a first puncture needle 3512, a second puncture needle 3511 and a third puncture needle 3510, the number of the flexible segments is two, the two flexible segments are a first flexible segment 3517 and a second flexible segment 3514, the spacers are a first spacer 3516 and a second spacer 3513, one end of the first flexible segment 3517 is connected to the guiding end of the first puncture needle 3512, the other end of the first flexible segment 3517 passes through at least one first spacer 3516 and then is connected to the guiding end of the second puncture needle 3511, one end of the second flexible segment 3514 is connected to the guiding end of the third puncture needle 3510, and the other end of the second flexible segment 3514 sequentially passes through the second spacer 3513 and the first spacer 3516 and then is provided with a fixing knot 3515.

The flexible segment shown in fig. 35 is attached to the needle in the same manner as shown in fig. 8, although the flexible segment can be attached to the needle in the same manner as shown in fig. 9 or 21.

In fig. 56, the puncture needle 5610 and the flexible segment 567 can be retracted by the retraction coupler 5611, eventually passing the flexible segment 567 through the mitral annulus 5627 (e.g., the posterior annulus). Fig. 57 is a schematic view of the use of the prosthetic device of the present invention to guide a flexible segment through mitral valve leaflets 5728. Fig. 58 is a schematic view of another use of the prosthetic device of the present invention to guide a flexible segment through the mitral valve leaflets 5828. Fig. 59-60 are schematic illustrations of an annuloplasty procedure using the prosthetic device of the present invention, wherein a locking device 5929 is used. Fig. 61-62 are schematic illustrations of a mitral valve edge-to-edge repair performed using the repair device of the present invention, using locking device 6131. Figures 63-64 are schematic illustrations of chordae repair performed on the heart 6329 using the present invention.

The flexible segment may be a common suture, such as PET (polyester) or synthetic chordae, EPTFE (expanded polytetrafluoroethylene), the wire loop may be of PET or EPTFE, and the puncture needle is preferably of a medical metal material, such as medical stainless steel.

When the invention is used, the puncture needle punctures target tissues such as mitral valve leaflets or mitral valve annulus by means of an implantation system (not shown in the figure), the puncture needle is separated from a puncture needle loading/unloading system, at the moment, the puncture end of the puncture needle is coupled with a coupler, an operator operates a coupler handle (not shown in the figure), pulls the puncture needle, the puncture needle and a flexible segment sequentially pass through the target tissues, the flexible segment is anchored on the target tissues due to the blocking of a gasket, one end of the flexible segment is anchored on one side of the target tissues, the other end of the flexible segment is pulled to a locking system (not shown in the figure) by the coupler, and an operator pushes a locking device to the target tissues along the flexible segment to lock by means of the locking system, for example, the locking device is pushed to the left ventricle wall to lock, so that chordae repair is completed; pushing the obtained product to the position below the mitral valve leaflets to finish edge-to-edge repair; push to the inferior of the mitral valve ring, finish the ring of valve to shrink, thus reduce the regurgitation of mitral valve effectively. Therefore, the invention is suitable for minimally invasive or interventional operations, has small wound on target tissues, increases the anchoring reliability, reduces the operation risk and improves the operation success rate.

The above-mentioned embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and various modifications and improvements of the technical solution of the present invention by those skilled in the art should fall within the protection scope defined by the claims of the present invention without departing from the spirit of the present invention.

Claims

1. A puncture needle, characterized in that: the artificial implant guide rod comprises a rod body, the both ends of the rod body are puncture end and guide end respectively, the puncture end is provided with a puncture part, the guide end is provided with a guide structure for connecting an artificial implant, the guide structure comprises a guide hole which is arranged on the lateral wall of the guide end and runs through the guide end, and a loading and unloading carrying hole which runs through the guide end is also arranged on the lateral wall of the guide end.

2. A puncture needle according to claim 1, characterized in that: the side wall of the guide end is provided with a guide groove which is axially arranged, one end of the guide groove extends to the end face of the guide end, and the other end of the guide groove extends to the guide hole.

3. A puncture needle according to claim 1, characterized in that: the guide end is internally provided with a channel which is axially arranged, one end of the channel is communicated with the guide hole and the loading and unloading hole, and the other end of the channel extends out of the end surface of the guide end.

4. A puncture needle according to claim 3, characterized in that: the diameter of the channel is smaller than the diameter of the guide hole.

5. A puncture needle according to claim 3, characterized in that: the diameter of the channel is larger than that of the guide hole and the loading and unloading hole, and the channel is cylindrical or conical with the diameter gradually reduced from outside to inside.

6. A puncture needle according to claim 3, characterized in that: the channel comprises a first channel and a second channel which are sequentially arranged from outside to inside, the first channel and the second channel are communicated through a connecting port, the caliber of the connecting port is smaller than the diameter of the first channel, the guide hole is communicated with the second channel, and the loading and unloading hole is communicated with the first channel or the second channel.

7. A puncture needle according to claim 6, characterized in that: the side wall of the puncture needle is provided with a coupling part which is of a coarse structure, a barb or a spiral structure.

8. A coupler, characterized by: the puncture needle comprises a coupler body, wherein the coupler body is used for being connected with the puncture end of the puncture needle according to any one of claims 1 to 7, the coupler body is made of a flexible material or is provided with an internal thread hole for connecting the puncture end of the puncture needle.

9. A guide device, characterized by: comprising a puncture needle according to any one of claims 1 to 2 and a coupler according to claim 8, the puncture end of the puncture needle being connected to the coupler body of the coupler.

10. A prosthetic device using the guide device of claim 9, wherein: the puncture needle comprises an artificial implant, wherein the artificial implant comprises a flexible section and a gasket, the flexible section is connected to the guide end of the puncture needle, and the gasket is connected to the flexible section.

11. The prosthetic device of claim 10, wherein: two ends of the flexible section penetrate through the gasket in the same direction and then are connected with the guide hole through a fixed knot.

12. The prosthetic device of claim 10, wherein: the flexible section is inserted and connected on the guide hole, and two ends of the flexible section are respectively provided with a fixing knot after penetrating through the gasket in the same direction.

13. The prosthetic device of claim 10, wherein: the number of the puncture needles is two, the two puncture needles are respectively a first puncture needle and a second puncture needle, one end of the flexible section is connected with the guide end of the first puncture needle, and the other end of the flexible section penetrates through at least one gasket and then is connected with the guide end of the second puncture needle.

14. The prosthetic device of claim 10, wherein: the number of the puncture needles is at least two, the flexible sections sequentially penetrate through the guide hole of each puncture needle, two ends of each flexible section are respectively provided with a fixing knot, and the flexible sections on two sides of the guide hole of each puncture needle are jointly inserted and connected with one gasket.

15. The prosthetic device of claim 10, wherein: the utility model discloses a flexible section of puncture needle, including pjncture needle, first puncture needle, second puncture needle and third puncture needle, the flexible section is established to two, and two flexible sections are first flexible section and second flexible section respectively, the gasket is established to first gasket and second gasket, the one end of first flexible section is connected in the guide end of first puncture needle, the other end of first flexible section passes behind at least one first gasket and connects in the guide end of second puncture needle, the one end of second flexible section is connected in the guide end of third puncture needle, the other end of second flexible section is equipped with a fixed knot after passing second gasket and first gasket in proper order.

16. A guide device, characterized by: comprising a puncture needle according to any one of claims 3 to 5 and a coupler according to claim 8, the puncture end of the puncture needle being connected to the coupler body of the coupler.

17. A prosthetic device for use with the guide device of claim 16, wherein: the puncture needle comprises an artificial implant, wherein the artificial implant comprises a flexible section and a gasket, the flexible section is connected to the guide end of the puncture needle, and the gasket is connected to the flexible section.

18. The prosthetic device of claim 17, wherein: two ends of the flexible section penetrate through the gasket in the same direction and then are connected with the guide hole through a fixed knot.

19. The prosthetic device of claim 17, wherein: the flexible section is inserted and connected on the guide hole, and two ends of the flexible section are respectively provided with a fixing knot after penetrating through the gasket in the same direction.

20. The prosthetic device of claim 17, wherein: the one end of flexible section is equipped with first fixed knot, first fixed knot is located the guiding hole, the diameter of first fixed knot is greater than the diameter of passageway, the other end of flexible section passes through the passageway and extends to outside the guiding end, the other end of flexible section is equipped with the fixed knot of second after passing the gasket.

21. The prosthetic device of claim 17, wherein: one end of the flexible section is connected in the channel through at least one first fixing joint, the diameter of the first fixing joint is larger than that of the guide hole, the other end of the flexible section penetrates through the guide hole and extends out of the guide end, and a second fixing joint is arranged at the other end of the flexible section after penetrating through the gasket.

22. The prosthetic device of claim 17, wherein: the number of the puncture needles is two, the two puncture needles are respectively a first puncture needle and a second puncture needle, one end of the flexible section is connected with the guide end of the first puncture needle, and the other end of the flexible section penetrates through at least one gasket and then is connected with the guide end of the second puncture needle.

23. The prosthetic device of claim 17, wherein: the number of the puncture needles is at least two, the flexible sections sequentially penetrate through the guide hole of each puncture needle, two ends of each flexible section are respectively provided with a fixing knot, and the flexible sections on two sides of the guide hole of each puncture needle are jointly inserted and connected with one gasket.

24. The prosthetic device of claim 17, wherein: the utility model discloses a flexible section of puncture needle, including pjncture needle, first puncture needle, second puncture needle and third puncture needle, the flexible section is established to two, and two flexible sections are first flexible section and second flexible section respectively, the gasket is established to first gasket and second gasket, the one end of first flexible section is connected in the guide end of first puncture needle, the other end of first flexible section passes behind at least one first gasket and connects in the guide end of second puncture needle, the one end of second flexible section is connected in the guide end of third puncture needle, the other end of second flexible section is equipped with a fixed knot after passing second gasket and first gasket in proper order.

25. A guide device, characterized by: comprising a puncture needle according to any one of claims 6 to 7 and a coupler according to claim 8, the puncture end of the puncture needle being connected to the coupler body of the coupler.

26. A prosthetic device for use with the guide device of claim 25, wherein: the puncture needle comprises an artificial implant, wherein the artificial implant comprises a flexible section and a gasket, the flexible section is connected to the guide end of the puncture needle, and the gasket is connected to the flexible section.

27. The prosthetic device of claim 26, wherein: two ends of the flexible section penetrate through the gasket in the same direction and then are connected with the guide hole through a fixed knot.

28. The prosthetic device of claim 26, wherein: the flexible section is inserted and connected on the guide hole, and two ends of the flexible section are respectively provided with a fixing knot after penetrating through the gasket in the same direction.

29. The prosthetic device of claim 26, wherein: the one end of flexible section is equipped with first fixed knot, first fixed knot is located the guiding hole, the diameter of first fixed knot is greater than the diameter of passageway, the other end of flexible section passes through the passageway and extends to outside the guiding end, the other end of flexible section is equipped with the fixed knot of second after passing the gasket.

30. The prosthetic device of claim 26, wherein: one end of the flexible section is connected in the channel through at least one first fixing joint, the diameter of the first fixing joint is larger than that of the guide hole, the other end of the flexible section penetrates through the guide hole and extends out of the guide end, and a second fixing joint is arranged at the other end of the flexible section after penetrating through the gasket.

31. The prosthetic device of claim 26, wherein: one end of the flexible section is connected in the first channel through at least one first fixing joint, the diameter of the first fixing joint is larger than the caliber of a connecting port of the first channel and the second channel, the other end of the flexible section penetrates through the second channel and the guide hole to extend out of the guide end, and a second fixing joint is arranged at the other end of the flexible section after penetrating through the gasket.

32. The prosthetic device of claim 26, wherein: the number of the puncture needles is two, the two puncture needles are respectively a first puncture needle and a second puncture needle, one end of the flexible section is connected with the guide end of the first puncture needle, and the other end of the flexible section penetrates through at least one gasket and then is connected with the guide end of the second puncture needle.

33. The prosthetic device of claim 26, wherein: the number of the puncture needles is at least two, the flexible sections sequentially penetrate through the guide hole of each puncture needle, two ends of each flexible section are respectively provided with a fixing knot, and the flexible sections on two sides of the guide hole of each puncture needle are jointly inserted and connected with one gasket.

34. The prosthetic device of claim 26, wherein: the utility model discloses a flexible section of puncture needle, including pjncture needle, first puncture needle, second puncture needle and third puncture needle, the flexible section is established to two, and two flexible sections are first flexible section and second flexible section respectively, the gasket is established to first gasket and second gasket, the one end of first flexible section is connected in the guide end of first puncture needle, the other end of first flexible section passes behind at least one first gasket and connects in the guide end of second puncture needle, the one end of second flexible section is connected in the guide end of third puncture needle, the other end of second flexible section is equipped with a fixed knot after passing second gasket and first gasket in proper order.