CN118044918A - Method for stabilizing atrioventricular valve annulus formation - Google Patents

Abstract

The application relates to the field of medical instruments, in particular to a method for stabilizing atrioventricular valve annuloplasty, which comprises the following steps: the device comprises an outer sheath tube, a guide wire and an anchoring pipe fitting, wherein the ring shrinking device comprises a ring shrinking framework, a fabric layer, control wires and a fixing element, the fixing element is anchored in two rounds, the anchoring needle of the first round is mainly used for anchoring the ring shrinking framework on a self-body valve ring, after the ring shrinking framework is shrunk through the control wire, the anchoring pipe fitting is guided to an area needing anchoring in advance through the guide wire, then the anchoring needle of the second round is anchored to a preset anchoring area through the anchoring pipe fitting, the contracted valve ring tissue is further fixed through the needle of the second round, the force after the contraction of the valve ring is dispersed, and the state of the self-body valve ring after the ring shrinking forming is further stabilized.

Description

Method for stabilizing atrioventricular valve annulus formation

Technical Field

The application relates to the field of medical instruments, in particular to a method for stabilizing atrioventricular valve annuloplasty.

Background

In the prior art, aiming at the expansion of an autologous valve annulus and the occurrence of lesions, a treatment method of ring contraction forming is mostly adopted. The existing ring-shrinking forming devices all rely on an anchoring needle to position and anchor, and then the contraction of the self-body valve ring is realized through a stay wire, so that the treatment effect is achieved. However, in actual clinical trials, the applicant found that the muscle tissue at the native annulus is more and thicker, and although beneficial for needle anchoring, the force to return its muscle tissue to its original pre-lesion form after contraction is also greater. In addition, most of the existing devices only rely on a pull wire to realize contraction, the contraction force is concentrated on the wire and the anchoring needle, and long time, the contraction form is difficult to maintain, and the forming device can be loosened, so that the valve is in reflux.

In view of the foregoing, although the above techniques have some clinical advantages, there is a need for a new method for stabilizing atrioventricular annuloplasty that addresses the above problems.

Disclosure of Invention

The present application has been made in view of the above and other ideas. The primary purpose of the present application is to overcome some of the problems and deficiencies of the prior art.

In the aspect of application of atrioventricular valve operation, the application aims to provide a method for stabilizing atrioventricular valve annuloplasty aiming at a patient with lesion of a heart valve and needing interventional treatment, so that the problems that anchoring between a forming device and tissues is not stable enough, and the annuloplasty device may loosen after implantation in the prior art can be solved.

The technical scheme adopted for solving the technical problems of the invention is as follows: a method for stabilizing atrioventricular annuloplasty, comprising: providing a ring retracting device and a delivery system for delivering the ring retracting device into the heart, the ring retracting device comprising a ring retracting skeleton, a fabric layer, a control wire and at least 3 fixation elements, when the delivery system anchors the ring retracting device to the native valve annulus, at least 2 of the fixation elements anchor the ring retracting skeleton to the native valve annulus, pulling the control wire such that at least 2 of the fixation elements are forced and cause the ring retracting skeleton to retract, and, when the ring retracting skeleton is retracted into place, anchoring the remaining fixation elements to the contracted native valve annulus to maintain the ring-retracted native valve annulus.

As a further improvement of the invention, the delivery system comprises an outer sheath, a guide wire and an anchoring tube, the ring retraction device being preloaded in the outer sheath, wherein the anchoring tube is detachably connected to the ring retraction device by the guide wire, the outer sheath is retracted after the delivery system has passed through the atrial septum and into the left atrium so that the ring retraction device returns to a preset configuration, the delivery system is further operated so that the ring retraction device abuts against the native valve annulus, the anchoring tube is operated so that the fixation element penetrates the tissue, at which time the ring retraction frame is anchored on the native valve annulus, the control wire is pulled to force the fixation element thereof and to retract the ring retraction frame, and, when the ring retraction frame is retracted into place, the anchoring tube reaches a predetermined anchoring region by the guide wire, and the anchoring tube is again operated to anchor the fixation element in the predetermined anchoring region, finally the operation is completed by operating the guide wire so that the anchoring tube is detached from the ring retraction frame, and the delivery system is evacuated.

As a further improvement of the invention, the fixing element comprises a plurality of anchoring needles which are implanted and anchored in two rounds, wherein when the ring-shrinking framework is attached to the native valve annulus, after the anchoring needles are anchored in the first round through the anchoring tube, the ring-shrinking framework is anchored on the native valve annulus, then the control wire is operated to shrink the ring-shrinking framework and drive the native valve annulus to shrink, and when the ring-shrinking framework is shrunk in place, the anchoring needles are anchored in the second round through the anchoring tube, so that the native valve annulus is further fixed after shrinkage.

As a further improvement of the invention, the ring shrinking framework comprises a first shrinking piece and a second shrinking piece, and one ends of the first shrinking piece and the second shrinking piece, which are adjacent, are arranged in a set ring shrinking area.

As a further improvement of the invention, the anchoring tube reaches a predetermined anchoring area through the guide wire after the crimping framework is crimped in place, and the predetermined anchoring area is located at or near the set crimping area.

As a further improvement of the present invention, the first constriction member and the second constriction member are each composed of a plurality of constriction units having a diamond-shaped lattice structure, and the constriction units at adjacent ends of the first constriction member and the second constriction member are larger in size than the constriction units at the other ends, wherein the guide wire for guiding the anchoring tube is detachably connected at the constriction unit of a larger size when the anchoring needle performs the second round of anchoring.

As a further improvement of the invention, the stiffness of the constriction unit at the end adjacent to the first constriction member and the second constriction member is smaller than the stiffness of the constriction unit at the other end.

As a further improvement of the invention, the ring shrinking device further comprises a supporting framework, the supporting framework is of an open-loop structure, wherein one ends of the first shrinking piece and the second shrinking piece, which are adjacent, are respectively arranged at two ends of the supporting framework, the fabric layer is of a whole-loop structure and covers the supporting framework, and after the conveying system passes through a room septum and enters the left atrium, the outer sheath tube is retracted to enable the ring shrinking device to recover to a preset annular shape, and at the moment, the ring shrinking device is conveyed downwards to be abutted against the self-body valve ring tissue to finish positioning.

As a further improvement of the invention, the supporting framework is composed of a plurality of supporting units in omega shape, the rigidity of the supporting units corresponding to each area of the self-body valve annulus is different, the rigidity of the supporting units positioned in the set ring shrinking area is smaller than that of the supporting units positioned at the juncture of the valve leaves, after the anchoring needle completes the anchoring of the first round, the control wire is pulled, and the contraction amplitude of the ring shrinking framework positioned at the side of the set ring shrinking area is larger than that of the other side.

As a further improvement of the present invention, the anchoring tube includes a needle-storing tube in which the fixing member is preloaded, and a push rod provided in the needle-storing tube, the fixing member being anchored at a predetermined position by operating the push rod.

As a further development of the invention, the guide wire is detachably connected to the ring-shrinking device, wherein the needle-hiding tube is connected to the guide wire and is guided by the guide wire to a predetermined anchoring area.

Compared with the prior art, the application has the advantages and beneficial technical effects that at least the following are included:

1. In the prior art, after the forming device is contracted, because the contraction force of the self annulus is concentrated on a line for controlling the contraction and an anchoring needle for fixing, the stress is concentrated, and the shrinkage form is difficult to keep for a long time, so that the forming device can be loosened, and the treatment effect is influenced; thus, in one embodiment of the present application, the plurality of anchoring needles are fixed in two rounds, the anchoring needles of the first round are mainly used for anchoring the ring-contracting skeleton on the native valve annulus, after contraction is achieved through the control wire, the anchoring tube is guided to the area where anchoring is needed in advance through the guide wire, then the anchoring needles of the second round are anchored to the predetermined anchoring area through the anchoring tube, the contracted valve annulus tissue is further fixed by the needle insertion of the second round, so that the force after contraction of the valve annulus is dispersed, and the state of the native valve annulus after ring contraction is further stabilized.

2. In contrast to the prior art, in one embodiment of the present application, the adjacent ends of the first and second contractile members are disposed in a predetermined area of the annulus (e.g., the area of the annulus in the P2 region of the native annulus during mitral valve treatment), and the control wire is pulled to significantly draw the area of the annulus toward the center of the valve, thereby effectively increasing the coaptation area of the adjacent leaflets and reducing regurgitation of the valve.

3. Compared with the prior art, in one embodiment of the application, the supporting framework is provided, the supporting framework is in an open-loop structure, the adjacent ends of the first contraction piece and the second contraction piece are respectively arranged at the two ends of the supporting framework, and the adjacent ends of the first contraction piece and the second contraction piece are arranged in the set contraction ring area, so that the set contraction ring area (namely the P2 area) can be obviously close to the center of the valve during contraction forming, the front valve ring area can counteract the contraction force of part of the contraction ring component due to the force provided by the supporting framework, the moving distance of the front valve ring area to the center of the valve is not large, thereby effectively avoiding the influence on the aortic valve, meanwhile, the heart valve repairing device is in a whole-ring structure, positioning without excessively depending on images during implantation, and the whole-ring structure is favorable for anchoring the stent during subsequent replacement treatment, and has good clinical significance. ,

Embodiments of the application may achieve other advantageous technical effects not listed one by one, which may be partially described below, and which may be expected and understood by those skilled in the art after reading the present application.

Drawings

The above-mentioned and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a schematic diagram of a ring shrinking apparatus and a conveying system according to the present invention.

Fig. 2 is a schematic view showing a state that an anchor tube of the present invention is connected to a ring shrinking device through a guide wire.

Fig. 3a to 3d are schematic views of a process of anchoring a fixing element on a mitral valve annulus in a first round, wherein fig. 3a is a schematic view of an anchoring tube reaching a predetermined anchoring area through a guide wire, fig. 3b is a schematic view of a contracting ring member on the mitral valve annulus when a control wire is not pulled after the first round of anchoring of the fixing element, fig. 3c is a schematic view of the contracting ring member after contracting on the mitral valve annulus, and fig. 3d is a schematic view of the contracting ring member after removing a fabric layer in fig. 3 c.

Figures 3e and 3f are schematic views of the state of the fixation element after a second round of anchoring on the mitral valve annulus,

Fig. 4a and 4b are schematic structural views of the ring shrinking device according to the present invention, wherein fig. 4b is a schematic structural view of the ring shrinking device shown in fig. 4a with the fabric layer removed.

Fig. 5 is a schematic structural view of a fixing element according to the present invention.

The names of the parts indicated by the numerals in the drawings are as follows: 1-ring shrinking device, 11-ring shrinking framework, 111-first shrinking piece, 112-second shrinking piece, 113-shrinking unit, 12-fabric layer, 13-control wire, 14-fixing element, 15-supporting framework, 2-conveying system, 21-outer sheath tube, 22-guide wire, 23-anchoring pipe fitting, 231-hidden needle tube, 232-push needle rod and 3-set ring shrinking area.

Detailed Description

The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

It is to be understood that the illustrated and described embodiments are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. Examples are provided by way of explanation, not limitation, of the disclosed embodiments. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the various embodiments of the application without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still a further embodiment. Accordingly, the present disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items if any.

The application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

In the present application, the proximal end refers to the end that is closer to the operator, and the distal end refers to the end that is farther from the operator.

In the prior art, the native valve is not normally operated during the replacement of the atrioventricular valve, and the conventional treatment means can cause the whole valve to be in an open regurgitation state during the replacement, which results in very short operation time and high risk, and may cause various diseases.

Embodiment one:

As shown in fig. 1 and 2, a method for stabilizing atrioventricular annuloplasty, when used for mitral valve therapy, comprises: providing a ring retraction device 1 and a delivery system 2, wherein the delivery system 2 comprises an outer sheath 21, a guide wire 22 and an anchoring tube 23, the ring retraction device 1 comprises a ring retraction frame 11, a fabric layer 12, a control wire 13 and a fixing element 14, the fixing element 14 comprises a plurality of anchoring needles, and the anchoring needles are implanted and anchored in two rounds, the ring retraction device 1 is preloaded in the delivery system 2, wherein the anchoring tube 23 is detachably connected with the ring retraction device 1 through the guide wire 22, the outer sheath 21 is retracted after the delivery system 2 enters the right atrium through the atrial septum and enters the left atrium through the upper vena cava, the ring retraction device 1 is restored to a preset shape, the delivery system 2 is further operated to enable the ring retraction device 1 to directly abut against the self-annulus to achieve a preset position, the anchoring tube 23 is operated to pierce the fixing element 14 of the first round into the tissue, the ring retraction frame 11 is anchored on the anchoring wire 11 a and the anchoring ring 23 is pulled back to the preset position as shown in fig. 3b, the anchoring frame 3 is pulled back to the predetermined region 3, the anchoring tube 23 is further retracted as shown in fig. 3, and the predetermined region (fig. 3 is further shown by the guide wire 23, the preset region 3 is pulled back to the ring 11, the preset region is shown in fig. 3b, and the preset region is shown in fig. 3, the figure 3 is shown). Finally, the delivery system 2 is withdrawn to complete the procedure by manipulating the guide wire 22 such that the anchor tube 23 is detached from the crimping framework 11.

In this embodiment, the ring-shrinking frame 11 includes a first shrinking member 111 and a second shrinking member 112, as shown in fig. 4a and 4b, and one end of the first shrinking member 111 adjacent to the second shrinking member 112 is disposed in the set ring-shrinking region 3 (i.e. the P2 region of the native valve annulus), as shown in fig. 3 b.

In this embodiment, the anchoring tube 23 includes a needle hiding tube 231 and a push pin 232 disposed in the needle hiding tube 231, the fixing member 14 is preloaded in the needle hiding tube 231, and the fixing member 14 is anchored in a predetermined position by operating the push pin 232. The guide wire 22 is detachably connected to the ring retracting device 1, wherein the needle hiding tube 231 is connected to the guide wire 22, and the needle hiding tube 231 is guided to a predetermined anchoring area through the guide wire 22, as shown in fig. 1 and 3 a.

In this embodiment, the anchoring tube 23 is all pre-assembled in the sheath tube 21, and the anchoring tube 23 corresponds to the fixing element 14 and is set to the first and second turns, after the ring retracting frame 11 is abutted against the native valve annulus, the guide wire 22 corresponding to the first turn of the anchoring tube 23 is pulled up, and the anchoring tube 23 is operated to reach the target position in a predetermined route, and the push pin 232 is pushed to needle the fixing element 14 and penetrate the tissue, at this time, the ring retracting frame 11 is anchored on the native valve annulus, as shown in fig. 3a to 3d, and then the guide wire 22 corresponding to the second turn of the anchoring tube 23 is pulled up, and the anchoring tube 23 is operated to reach the predetermined anchoring area in a predetermined route, and the push pin 232 is operated to needle the fixing element 14 and penetrate the tissue, thereby completing the anchoring, as shown in fig. 3e and 3 f.

In this embodiment, the first contraction member 111 and the second contraction member 112 are each composed of a plurality of contraction units 113 having a diamond-shaped lattice structure, and the contraction units 113 at adjacent ends of the first contraction member 111 and the second contraction member 112 are larger in size than the contraction units 113 at the other ends, as shown in fig. 3a and 3b, wherein the guide wire 22 for guiding the anchor tube 23 is detachably connected at the contraction unit 113 of a larger size when the anchor needle performs the second round of anchoring; the main purpose of this design is: the anchoring of the second round is that after the shrinkage of the shrinkage ring skeleton 11, the region where the shrinkage ring skeleton 11 can be anchored becomes smaller, and thus, the location of the anchoring of the second round is at a larger cell.

In this embodiment, the stiffness of the shrinkage unit 113 at the adjacent end of the first shrinkage member 111 and the second shrinkage member 112 is smaller than the stiffness of the shrinkage unit 113 at the other end.

In this embodiment, the ring shrinking device 1 further includes a supporting framework 15, the supporting framework 15 is in an open loop structure, wherein, adjacent ends of the first shrinking member 111 and the second shrinking member 112 are respectively disposed at two ends of the supporting framework 15, the fabric layer 12 is in a whole loop structure and covers the supporting framework 15, as shown in fig. 4a and 4b, after the delivery system 2 passes through the atrial septum and enters the left atrium, the sheath tube 21 is retracted so that the ring shrinking device 1 is restored to a predetermined annular shape, and at this time, the ring shrinking device 1 is delivered downwards to abut against the self-body valve ring tissue to complete positioning.

In this embodiment, the supporting framework 15 is composed of a plurality of supporting units in an omega shape, and the supporting units corresponding to the respective areas of the native valve annulus have different rigidities, the rigidity of the supporting unit located in the set ring shrinking area 3 is smaller than that of the supporting unit located at the leaflet juncture, after the anchoring needle completes the anchoring of the first round, the control wire 13 is pulled, and the contraction amplitude of the ring shrinking framework 11 located at the side of the set ring shrinking area 3 is larger than that of the other side, as shown in fig. 3b and 3 c.

The product of the invention is not only suitable for repairing mitral valve diseases, but also suitable for tricuspid valve diseases.

Finally, it should be noted that the foregoing description is only a preferred embodiment of the present invention, and is not intended to limit the invention, but any modifications, equivalents, improvements, etc. within the spirit and principles of the present invention are intended to be included within the scope of the present invention.

Claims (11)

1. A method for stabilizing atrioventricular annuloplasty, comprising: set up and contract ring device and be used for carrying the ring device that contracts to endocardial conveying system, contract ring device including contracting ring skeleton, fabric layer, control silk and 3 at least fixation element, its characterized in that: when the delivery system attaches the ring-retracting device to the native valve annulus, at least 2 of the fixation elements anchor the ring-retracting skeleton to the native valve annulus, pulling the control wire causes at least 2 of the fixation elements to force and the ring-retracting skeleton to retract, and, when the ring-retracting skeleton is retracted into place, the remaining fixation elements are anchored at the contracted native valve annulus to maintain the ring-retracted native valve annulus state.

2. A method for stabilizing an atrioventricular annuloplasty according to claim 1, wherein: the delivery system comprises an outer sheath, a guide wire and an anchoring pipe fitting, wherein the ring shrinking device is preloaded in the outer sheath, the anchoring pipe fitting is detachably connected with the ring shrinking device through the guide wire, after the delivery system passes through a room and enters a left atrium, the outer sheath is retracted to enable the ring shrinking device to restore to a preset shape, the delivery system is further operated to enable the ring shrinking device to be abutted against a self-valve ring, the anchoring pipe fitting is operated to enable a fixing element to penetrate into tissues, at the moment, the ring shrinking framework is anchored on the self-valve ring, the control wire is pulled to enable the fixing element to be stressed and enable the ring shrinking framework to shrink, and when the ring shrinking framework is shrunk to a proper position, the anchoring pipe fitting reaches a preset anchoring area through the guide wire, the anchoring pipe fitting is operated again to anchor the fixing element to the preset anchoring area, finally, the anchoring pipe fitting is operated to enable the anchoring pipe fitting and the ring shrinking framework to be detached through the guide wire, and the delivery system is removed.

3. A method for stabilizing an atrioventricular annuloplasty according to claim 1, wherein: the fixing element comprises a plurality of anchoring needles which are implanted and anchored in two rounds, wherein when the ring-shrinking framework is attached to the self-body valve annulus, the anchoring needles are anchored on the self-body valve annulus after the ring-shrinking framework is anchored in the first round through the anchoring pipe fitting, then the control wire is operated to enable the ring-shrinking framework to shrink and drive the self-body valve annulus to shrink, and when the ring-shrinking framework is shrunk to a proper position, the anchoring needles are anchored in the second round through the anchoring pipe fitting, so that the self-body valve annulus is further fixed after being shrunk.

4. A method for stabilizing an atrioventricular annuloplasty according to claim 2, wherein: the ring shrinkage framework comprises a first shrinkage piece and a second shrinkage piece, and one ends of the first shrinkage piece and the second shrinkage piece, which are adjacent, are arranged in a set ring shrinkage area.

5. A method for stabilizing an atrioventricular annuloplasty according to claim 3, wherein: after the crimping framework is crimped in place, the anchor tubing passes through the guide wire to a predetermined anchor zone, and the predetermined anchor zone is at or near the set crimping zone.

6. The method for stabilizing an atrioventricular annuloplasty of claim 4, wherein: the first contraction member and the second contraction member are composed of a plurality of contraction units in a diamond-shaped lattice structure, and the size of the contraction unit at one end adjacent to the first contraction member and the second contraction member is larger than that of the contraction unit at the other end, wherein when the anchoring needle performs second round anchoring, a guide wire for guiding the anchoring pipe fitting is detachably connected to the contraction unit with the larger size.

7. The method for stabilizing an atrioventricular annuloplasty of claim 5, wherein: the stiffness of the contraction unit at one end adjacent to the first contraction member and the second contraction member is smaller than that of the contraction unit at the other end.

8. The method for stabilizing an atrioventricular annuloplasty of claim 6, wherein: the ring shrinking device further comprises a supporting framework, the supporting framework is of an open-loop structure, one ends, adjacent to the first shrinking piece and the second shrinking piece, of the first shrinking piece and the second shrinking piece are respectively arranged at two ends of the supporting framework, the fabric layer is of a whole-loop structure and covers the supporting framework, after the conveying system passes through a room septum to enter a left atrium, the outer sheath tube is retracted to enable the ring shrinking device to recover to a preset annular shape, and at the moment, the ring shrinking device is conveyed downwards to be close to an autologous valve ring tissue to finish positioning.

9. The method for stabilizing an atrioventricular annuloplasty of claim 7, wherein: the supporting framework is composed of a plurality of supporting units in an omega shape, the supporting units corresponding to all areas of the self-body valve annulus are different in rigidity, the rigidity of the supporting unit located in a set ring shrinking area is smaller than that of the supporting unit located at the junction of the valve leaflets, after the anchoring needle completes the anchoring of the first round, the control wire is pulled, and the contraction amplitude of the ring shrinking framework located at the side of the set ring shrinking area is larger than that of the other side.

10. A method for stabilizing an atrioventricular annuloplasty according to claim 1, wherein: the anchoring pipe fitting comprises a needle hiding tube and a needle pushing rod arranged in the needle hiding tube, the fixing element is preloaded in the needle hiding tube, and the fixing element can be anchored at a preset position by operating the needle pushing rod.

11. The method for stabilizing an atrioventricular annuloplasty of claim 8, wherein: the guide wire is detachably connected with the ring shrinking device, wherein the needle hiding tube is connected with the guide wire, and the needle hiding tube is guided to a preset anchoring area through the guide wire.