CN216603187U - Anchoring instrument and anchor - Google Patents

Abstract

The utility model provides an anchoring instrument and an anchoring piece, mainly comprising a guide shaft and an anchoring piece, wherein the guide shaft comprises a positioning part extending along the axial direction of the guide shaft, the anchoring piece is in a spiral structure and can be movably sleeved on the periphery of the guide shaft, the guide shaft can be positioned relative to a target tissue by the aid of the positioning part, the anchoring piece can rotate in the circumferential direction and axially move relative to the guide shaft, so that one part of the anchoring piece attacks the target tissue, and the axial direction of the guide shaft is parallel to the exposed surface of the target tissue.

Description

Anchoring instrument and anchor

Technical Field

The embodiment of the utility model relates to the technical field of medical instruments, in particular to an anchoring instrument and an anchoring piece.

Background

The common diseases of the heart valves of the human body are valve insufficiency, valve leaflet prolapse and the like. In the case of the mitral valve, during systole, a portion of the left ventricle flows back through the orifice of the incompetent mitral valve to the left atrium. The left atrium receives both regurgitated blood from the left ventricle and the blood from the pulmonary vein, which increases the blood volume and pressure in the left atrium, resulting in hypertrophy of the left atrium. In diastole, more blood flows from the left atrium to the left ventricle, so that the left ventricle is enlarged due to the enhanced contraction, after the compensation phase is progressed to the decompensation phase, both the left atrium and the left ventricle are subjected to heart failure, and further pulmonary congestion, pulmonary arterial hypertension, right ventricular enlargement, right atrial enlargement, right heart failure and body circulation congestion sequentially occur.

Traditional treatment means include active surgical approaches or palliative efforts to combat inevitable heart failure with drugs. Among the surgical methods are valve replacement and annuloplasty. In surgical procedures, typical open chest surgery is very invasive, requires the establishment of extracorporeal circulation, and has a high incidence of complications and risk of infection. Patients are largely intolerant of significant surgical risks.

At present, the common technique for treating mitral valve and tricuspid valve regurgitation through a minimally invasive catheter is valve replacement and valve annulus repair. One of the difficulties with the annulus replacement technique is that the replacement device is securely fixed to the heart tissue of the human body, and the anchoring technique is one of the commonly used fixation methods. The annulus repair technique requires anchoring of a predetermined target soft tissue of the heart, thereby shaping the valve by pulling a predetermined anchor point, or fixing the repair device. While transcatheter treatment of leaflet prolapse typically involves creating artificial chordae tendineae in the leaflets and then anchoring them to the atrial tissue. In summary, reliable anchoring devices play an important role in the transcatheter treatment of structural visceral diseases.

SUMMERY OF THE UTILITY MODEL

In view of the above, the present invention provides an anchoring instrument and anchor that overcomes or at least partially solves the above-mentioned problems.

One embodiment of the present invention provides an anchoring device comprising a guide shaft including a positioning portion extending axially therealong; and an anchor in a helical configuration; the guide shaft can be positioned relative to a target tissue by the positioning part, the anchor can rotate circumferentially relative to the guide shaft and move axially, so that a part of the anchor is attacked into the target tissue, and the axial direction of the guide shaft is parallel to the exposed surface of the target tissue.

Optionally, the radial cross section of the guide shaft is any one of circular, triangular, rectangular, trapezoidal, and polygonal.

Optionally, the positioning portion may be attached to the exposed surface of the target tissue for positioning the guide shaft relative to the target tissue.

Optionally, the anchoring instrument further comprises an interference member that cooperates with the guide shaft to define an interference channel extending axially of the guide shaft; the interference channel can be penetrated by the anchor, and is used for providing interference for the movement trend of the anchor during the circumferential rotation and axial movement of the anchor relative to the guide shaft so as to keep the preset relative position between the anchor and the guide shaft.

Optionally, the guide shaft includes a first interference structure extending along an axial direction thereof, and the interference member includes a second interference structure corresponding to the first interference structure, the first interference structure and the second interference structure extending parallel to each other to form opposite sides of the interference passage.

Optionally, the radial cross-section of the interference channel is arcuate.

Optionally, both the interference member and the anchor member are any one of non-removably connected, and non-connected.

Optionally, the interference member is further provided with a guide structure for guiding the anchor member into the interference channel.

Optionally, the anchor further comprises a piercing portion for piercing the target tissue to perform the attack.

Optionally, the interference channel comprises a plurality of longitudinal guide slots arranged in parallel, wherein the spike of the anchor is advanceable along a movement trajectory defined by each of the longitudinal guide slots such that the anchor rotates circumferentially and moves axially relative to the guide shaft.

Optionally, the interference member is provided with an alignment formation for providing a passage access for the anchor member to access each of the longitudinal guide slots in the interference passage via the passage access.

Optionally, the anchor is comprised of a plurality of non-closed loops connected in series, wherein a first portion of each of the non-closed loops is disposed through the target tissue when the anchor is driven into the target tissue.

Optionally, each of the non-closed loops is exposed to a second portion of the target tissue to apply a force to the target tissue via each of the first portions of the non-closed loops.

Optionally, the guiding shaft further comprises a first coupling portion for coupling with a first delivery system to deliver or withdraw the guiding shaft to or from a first preset position corresponding to the target tissue by means of the first delivery system; the anchor further comprises a second combining part which is used for combining a second conveying system so as to convey the anchor to a second preset position corresponding to the guide shaft by the second conveying system and control the anchor to circumferentially rotate and axially move relative to the guide shaft so as to attack the target tissue.

Another embodiment of the utility model provides an anchor having a helical configuration with a portion of the anchor being configured to be driven into a target tissue, wherein an axial direction of the guide shaft in the anchored state is parallel to an exposed surface of the target tissue.

Optionally, the anchor is comprised of a plurality of non-closed loops connected in series, wherein a first portion of each of the non-closed loops is disposed through the target tissue when the anchor is driven into the target tissue.

Optionally, each of the non-closed loops exposed to the second portion of the target tissue may be configured to apply a force to the target tissue via each of the first portions of each of the non-closed loops.

According to the technical scheme, the anchoring instrument and the anchoring piece provided by the embodiment of the utility model anchor the human tissue in a transverse mode, namely along the axial direction of the anchoring piece, and have the advantage that the anchoring piece is not easy to fall off after anchoring the human tissue.

Furthermore, the anchoring element of the utility model can uniformly distribute the external force to the human tissue, and the lateral anchoring scheme of the utility model can form a plurality of closed through holes on the target tissue, so that the human tissue can bear larger traction force through the anchoring element and is not easy to tear, and the lateral anchoring scheme is particularly suitable for annuloplasty technology.

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, it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present invention, and it is also possible for a person skilled in the art to obtain other drawings based on the drawings.

FIG. 1 is a schematic structural view of a prior art anchoring instrument;

FIG. 2 is a schematic view of the overall architecture of an anchoring instrument according to an embodiment of the present invention;

fig. 3-4 are views of an embodiment of an anchoring instrument positioned on a target tissue;

FIGS. 5A to 7 are views showing different connection relationships between the interference member and the guide shaft;

FIG. 8 is a schematic structural view of the anchor;

FIGS. 9-14 are schematic views of different states of the anchor assembly as it is driven into the target tissue;

fig. 15-19 are schematic structural views of an anchoring instrument in accordance with another embodiment of the present invention;

fig. 20 to 22 are schematic views of different operating conditions of the anchoring device according to the utility model, applied to the anchoring of cardiac tissue.

Element number

1: anchoring instruments (prior art);

11: a helical tissue-coupling element;

12: a target tissue;

121: an exposed surface;

2: anchoring device (invention)

21: a guide shaft;

211: a positioning part;

212: a first interference structure;

213: a first coupling portion;

22: an anchor;

221: a non-closed loop;

222: a spike portion;

223: a second joint part;

23: an interference piece;

230: an interference channel;

231: a second interference structure;

232: a longitudinal guide groove;

233: a guide structure;

2331: a first inclined plane;

2332: a second inclined plane;

234: aligning structure;

2340: a channel inlet;

235: a third joint part;

3: a target tissue;

31: an exposed surface;

4: a first conveying system;

41: a guide rail;

5: an annulus;

51: a valve annulus.

Detailed Description

In order to make those skilled in the art better understand the technical solutions in the embodiments of the present invention, the technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments obtained by a person skilled in the art based on the embodiments of the present invention shall fall within the scope of the protection of the embodiments of the present invention.

As used herein, distal end refers to the end of the associated instrument or device that is distal from the operator, and proximal end refers to the end of the associated instrument or device that is proximal to the operator.

As mentioned in the background section above, a reliable anchoring device plays an important role in the transcatheter treatment of structural visceral diseases.

In the soft tissue anchoring device 1 (see fig. 1) commonly used at present, the axial direction of the helical tissue coupling element 11 is perpendicular to the exposed surface 121 of the target tissue 12, so that the distal end of the helical tissue coupling element 11 gradually spirally penetrates into the target tissue 12 along the vertical direction for anchoring. The problem with this solution is that since the helical tissue-coupling element 11 is in the shape of a helix, it may itself generate a slip force, and in addition the target tissue may be easily deformed and damaged when subjected to a force, resulting in a risk of the helical tissue-coupling element 11 falling out.

In view of this, embodiments of the present invention provide an anchoring technical solution that is not easy to fall off, and specific implementations of embodiments of the present invention will be further described with reference to the drawings of the embodiments of the present invention.

As shown in fig. 2 to 4, the anchoring instrument 2 of the present invention includes a guide shaft 21 and an anchor 22.

The guide shaft 21 includes a positioning portion 211 extending in an axial direction thereof, and the anchor 22 has a spiral structure.

In the present embodiment, the guide shaft 21 can be positioned relative to the target tissue 3 by the positioning portion 211, and the anchor 22 can be rotated circumferentially and moved axially relative to the guide shaft 21, so that a part of the anchor 22 is tapped into the target tissue 3, and the axial direction of the guide shaft 21 is parallel to the exposed surface 31 of the target tissue 3 (refer to fig. 9 to 12).

Accordingly, the present embodiment can improve anchoring stability and has an advantage of being less likely to fall off by causing the anchor 22 to perform attack anchoring with respect to the target tissue 3 in a direction parallel to the target tissue 3.

Alternatively, the radial cross section of the guide shaft 21 may be circular (refer to the embodiment of fig. 2 to 12), triangular (refer to the embodiment of fig. 15 to 19). However, the radial cross section of the guide shaft 21 may be rectangular, trapezoidal, or polygonal (not shown), and the present invention is not limited thereto.

Alternatively, the positioning portion 211 may be fitted to the exposed surface 31 of the target tissue 3 for positioning the guide shaft 21 relative to the target tissue 3 (refer to fig. 3 and 4).

In the present embodiment, when the radial cross section of the guide shaft 21 is circular, the positioning portion 211 is an arc surface extending in the axial direction of the guide shaft 21 (refer to fig. 3 and 4), and when the radial cross section of the guide shaft 21 is triangular, the positioning portion 211 is a flat surface extending in the axial direction of the guide shaft 21 (refer to fig. 15 and 16)

Optionally, the guide shaft 21 further includes a first coupling portion 213 (refer to fig. 3) for coupling with a first delivery system (not shown) to deliver the guide shaft 21 to a preset position corresponding to the target tissue 3 by the first delivery system or withdraw the guide shaft 21 from the preset position by the first delivery system.

In this embodiment, the anchoring device 2 further includes an interference member 23 that cooperates with the guide shaft 21 to define an interference channel 230 extending along the axial direction of the guide shaft 21.

Wherein, the interference channel 230 is used for the anchor 22 to pass through, and is used for providing interference to the movement trend of the anchor 22 during the circumferential rotation and axial movement of the anchor 22 relative to the guide shaft 21, so as to maintain the preset relative position between the anchor 22 and the guide shaft 21, thereby ensuring that the relative position of the anchor 22 relative to the target tissue 3 is kept stable during the activity, and the anchor 22 is relatively balanced for each anchor position of the target tissue 3 (for example, the spacing distance between each anchor position on the target tissue 3 and the anchoring depth are kept consistent), so as to improve the anchoring effect.

Alternatively, the guide shaft 21 includes a first interference structure 212 extending along an axial direction thereof, the interference piece 23 includes a second interference structure 231 corresponding to the first interference structure 212, and the first interference structure 212 and the second interference structure 231 extend in parallel with each other to constitute opposite sides of the interference channel 230.

Alternatively, when the radial cross section of the guide shaft 21 is circular, the first interference structure 212 and the second interference structure 231 may be two arc surfaces that are structurally matched, so that the radial cross section of the interference channel 230 is arc-shaped (refer to fig. 4), but not limited thereto, and the first interference structure 212 and the second interference structure 231 may also be other shapes such as a plane, a triangle, and the like, which is not limited by the present invention.

Alternatively, both the interference piece 23 and the guide shaft 21 may be any one of non-detachable connection, and non-connection.

For example, the interference member 23 and the guide shaft 21 may be integrally formed or fixedly connected (refer to fig. 5A and 5B). In this case, after the anchoring member 22 has completed the tapping operation on the target tissue 3, the interference member 23 and the guide shaft 21 may be placed together in the body (for example, the structure shown in fig. 5A) or withdrawn together from the body (for example, the structure shown in fig. 5B) according to actual needs.

For another example, the interference member 23 and the guide shaft 21 may be designed as separate components, i.e., there is no substantial connection relationship between the interference member 23 and the guide shaft 21 (see fig. 6), and the interference channel 230 may be defined by limiting the relative position relationship between the two by a medical auxiliary operation device such as a delivery system. In this case, after the anchoring member 22 has completed the attacking operation to the target tissue 3, the interference member 23 can be withdrawn from the body, and the guide shaft 21 can be selectively left in the body or selectively withdrawn from the body according to actual requirements.

For another example, the interference member 23 and the guide shaft 21 may be detachably connected (refer to fig. 7), for example, the interference member 23 and the guide shaft 21 may be detachably connected by a snap-fit manner. In this case, after the anchor member 22 has completed the attack operation on the target tissue 3, the interference member 23 and the anchor member 22 can be separated from each other to withdraw the interference member 23 from the body, and the guide shaft 21 can be selectively left in the body or withdrawn from the body as required.

Optionally, the interference piece 23 further comprises a third coupling portion 235 for coupling with a third delivery system (not shown) to deliver the interference piece 23 to a preset position (relative to the guide shaft 21) corresponding to the target tissue 3 or withdraw the interference piece 3 from the preset position by means of the third delivery system. The position of the third connecting portion 235 is not limited to the position shown in the drawings of the present invention, and may be changed according to actual operation requirements.

Optionally, interference member 23 is further provided with a guide structure 233 which can be used to guide anchor member 22 into interference channel 230.

In this embodiment, guide mechanism 233 includes a first bevel 2331 on guide shaft 21 and a second bevel 2332 on interference member 23 (see fig. 5 and 6) to form a flared entrance at the proximal end of interference channel 230 (i.e., the end near the operator) to facilitate guiding anchor member 22 into interference channel 230.

It should be noted that the guiding structure 233 is not limited to the above-mentioned trumpet-shaped inlet, and may be modified according to the actual design and/or use requirements.

As shown in fig. 8, the anchoring element 22 of the present embodiment further includes a spike portion 222, and in the present embodiment, the spike portion 222 is disposed at the distal end of the anchoring element 22 for puncturing the target tissue 3 to allow the anchoring element 22 to attack the target tissue 3 and anchor the target tissue.

In the present embodiment, the anchor 22 further includes a second engaging portion 223 for engaging a second delivery system (not shown) to deliver the anchor 22 to a second predetermined position corresponding to the guiding shaft 21 via the second delivery system, and to control the anchor 22 to rotate circumferentially and move axially relative to the guiding shaft 21 to attack the target tissue 3.

Referring to fig. 13 and 14, in the present embodiment, the anchoring element 22 is formed by sequentially connecting a plurality of non-closed rings 221. Wherein a first portion of each non-closed loop 221 (e.g., the portion of each non-closed loop 221 that is located in region a of fig. 14) is disposed through the target tissue 3 as the anchor 22 taps into the target tissue 3.

Further, a second portion of each of the non-closed loops 221 exposed to the target tissue 3 (e.g., the portion of each of the non-closed loops 221 located in region B of fig. 14) may be configured to apply a force and apply the force to the target tissue 3 via each of the first portions of each of the non-closed loops 221.

In this embodiment, the non-closed loops 221 are spaced apart at the same distance, so that the force applied to the anchoring elements 22 is uniformly distributed to the non-closed loops 221, and the force is uniformly distributed to the anchoring portions of the target tissue 3 by the non-closed loops 221. Therefore, the anchor 2 of the present invention can not only bear a large pulling force, but also effectively avoid the problem that the target tissue 3 is torn by force and the anchor 22 falls off because the force points of the target tissue 3 are distributed and uniform.

Referring to fig. 17-19, in one embodiment, the interference channel 230 further includes a plurality of longitudinal guide slots 232 disposed in parallel, wherein the spike 222 of the anchor 22 can travel along a movement track defined by each longitudinal guide slot 232, such that the anchor 22 rotates circumferentially and moves axially relative to the guide shaft 21.

In this embodiment, the longitudinal guide slots 232 are spaced apart a distance corresponding to the spacing of the non-closed loops 221 of the anchor 22.

Preferably, the interference member 23 is provided with an alignment feature 234 for providing a passage entrance 2340 for the anchor member 22 to access each longitudinal guide slot 232 in the interference passage 230 through the passage entrance 2340.

In the present embodiment, the alignment structure 234 is disposed at the proximal end of the interference member 23, and forms a passage entrance 2340 at the proximal end of the guide shaft 21 by pressing a portion of the target tissue 3 at the proximal end of the interference member 23, so that the anchor member 22 can smoothly enter each of the longitudinal guide grooves 232 in the interference passage 230 through the passage entrance 2340.

An embodiment of anchoring heart tissue with the anchoring device 1 according to the utility model will be described below with reference to fig. 20 to 22, in particular as follows:

first, the guide shaft 21 and the interference piece 23 are delivered to a preset position of the human heart by the first delivery system 4 having the guide rail 41, and the positioning part 211 of the guide shaft 21 is attached to the annulus surface 51 of the annulus 5 to be anchored (refer to fig. 20).

The anchor 22 is threaded on the guide rail 41 of the first delivery system 4, and the anchor 22 is pushed along the guide rail 41 to the proximal end of the guide shaft 21 by a second delivery system (not shown), and the anchor 22 is controlled to rotate circumferentially and move axially relative to the guide shaft 21 so that a part of the anchor 22 is tapped into the annulus 5 for anchoring (refer to fig. 21).

After the completion of the anchoring, it is possible to choose to leave the guide shaft 21 and the interference member 23 in the heart tissue (refer to the state shown in fig. 22), or to withdraw the interference member 23 and leave the guide shaft 21 in the heart tissue (refer to the state shown in fig. 7), or to withdraw the interference member 23 and the guide shaft 21 together from the heart tissue (refer to the states shown in fig. 13 and 14), according to the actual requirements.

In summary, the anchoring device and the anchor according to the present invention provide anchoring for anchoring a target tissue along an axial direction of the anchor, and have an advantage that the anchor, which has penetrated into the target tissue, is not easily detached.

Further, since the anchor of the present invention performs the attack on the target tissue in a lateral manner, the pulling force applied to the anchor can be uniformly distributed to various portions of the target tissue. Meanwhile, compared with the existing longitudinal anchoring scheme that a single and open anchoring hole is formed in the target tissue, the lateral anchoring scheme of the present application forms a plurality of closed through holes in the target tissue, so that the target tissue can bear a larger traction force through the anchor and is not easily torn, and the lateral anchoring scheme is particularly suitable for annuloplasty.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the embodiments of the present invention, and not to limit the same; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims (18)

1. An anchoring instrument, comprising:

a guide shaft including a positioning portion extending in an axial direction thereof; and

an anchor in a helical configuration;

the guide shaft can be positioned relative to a target tissue by the positioning part, the anchor can rotate circumferentially relative to the guide shaft and move axially, so that a part of the anchor is attacked into the target tissue, and the axial direction of the guide shaft is parallel to the exposed surface of the target tissue.

2. The anchoring instrument of claim 1, wherein the guide shaft has a radial cross-section that is any one of circular, triangular, rectangular, trapezoidal, and polygonal.

3. The anchoring instrument of claim 1, wherein the positioning portion is conformable to the exposed surface of the target tissue for positioning of the guide shaft relative to the target tissue.

4. The anchoring instrument of claim 1, further comprising:

an interference piece which defines an interference channel extending along the axial direction of the guide shaft together with the guide shaft;

wherein the interference channel is used for the anchor to pass through and is used for providing interference to the movement trend of the anchor during the circumferential rotation and axial movement of the anchor relative to the guide shaft so as to keep the preset relative position between the anchor and the guide shaft.

5. The anchoring instrument of claim 4,

the guide shaft includes a first interference structure extending in an axial direction thereof, and the interference member includes a second interference structure corresponding to the first interference structure, the first and second interference structures extending in parallel with each other to constitute opposite sides of the interference passage.

6. An anchoring instrument as defined in claim 5, wherein said interference channel is arcuate in radial cross-section.

7. The anchoring instrument of claim 4, wherein both the interference member and the anchor are any one of non-removably connected, and non-connected.

8. The anchoring instrument of claim 4, wherein the interference member is further provided with a guide structure for guiding the anchor into the interference channel.

9. The anchoring instrument of claim 4, wherein the anchor further comprises a spike for piercing the target tissue to perform an attack.

10. The anchoring instrument of claim 9, wherein the interference channel comprises a plurality of longitudinal guide slots arranged in parallel, wherein the spike of the anchor is advanceable along a movement trajectory defined by each of the longitudinal guide slots such that the anchor rotates circumferentially and moves axially relative to the guide shaft.

11. The anchoring instrument of claim 10, wherein the interference member is provided with an alignment feature for providing a channel access for the anchor to access each of the longitudinal guide slots in the interference channel via the channel access.

12. The anchoring instrument of claim 4, wherein the anchor is comprised of a plurality of non-closed loops connected in series, wherein a first portion of each of the non-closed loops is disposed through the target tissue when the anchor is driven into the target tissue.

13. The anchoring device of claim 12, wherein each of the non-occlusive rings is configured to apply a force to the target tissue via each of the first portions of each of the non-occlusive rings.

14. The anchoring instrument of claim 4,

the guide shaft further comprises a first combining part for combining with a first conveying system to convey the guide shaft to or withdraw from a first preset position corresponding to the target tissue by the first conveying system;

the anchor further comprises a second engaging portion for engaging a second delivery system to deliver the anchor to a second predetermined position corresponding to the guide shaft via the second delivery system and to control circumferential rotation and axial movement of the anchor relative to the guide shaft to attack the target tissue.

15. The anchoring instrument of claim 14,

the interference piece further comprises a third combining part for combining a third conveying system to convey the interference piece to or withdraw from the first preset position by the third conveying system;

wherein the third conveying system is the same as or different from the first conveying system.

16. An anchor, wherein the anchor is in a helical configuration and a portion of the anchor is configured to be driven into a target tissue, and wherein an axial direction of the guide shaft in the anchored state is parallel to an exposed surface of the target tissue.

17. The anchor of claim 16,

the anchor is comprised of a plurality of non-occlusive loops connected in series, wherein a first portion of each of the non-occlusive loops is disposed through the target tissue when the anchor is driven into the target tissue.

18. The anchor of claim 17,

each of the non-closed loops is exposed to the second portion of the target tissue for applying a force to the target tissue via each of the first portions of each of the non-closed loops.

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