Device, system, and method for heart-valve annulus reinforcer

Abstract

To provide a device and a system for a quick and simple method for reducing expansion of an annulus and / or reinforcing the annulus so as to further reduce valve regurgitation, and the method.SOLUTION: A device, a system, and a method for heart-valve annulus repair techniques, comprising a reinforcing device with one or both of a heating mechanism or a clamping mechanism. The heating mechanism may function by heating a localized portion of the annulus so as to reduce the circumference of the annulus and / or increase the stiffness of the tissue. The clamping mechanism may function by gathering or pinching an area of tissue to then reduce the circumference of the annulus and / or increase the stiffness of the tissue.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 44,937, filed June 26, 2020, entitled "Devices, Systems, and Methods for a Mitral Annulus Reinforcer," the contents of which are incorporated herein by reference as if set forth in their entirety, and priority and benefit thereto are claimed.

[0002] The present disclosure relates generally to organ-tissue modification techniques, and more particularly to reinforcement devices, systems, and methods for modifying tissue within localized areas of an organ, such as in reducing dilation of a valve annulus. [Background technology]

[0003] Valve repair procedures are routinely performed to treat heart valve diseases. In heart valve regurgitation, a type of heart valve disease, the leaflets (flaps) of the mitral valve do not close properly, allowing blood to flow backward and reducing the efficiency of the valve. When regurgitation is significant, blood may not flow efficiently through the heart or the rest of the body, leading to a number of mild to severe symptoms. When regurgitation is caused by dilation of the annulus, i.e., the ring around the valve, annuloplasty is one approach to repair surgery. Annuloplasty is a surgical procedure to tighten or reinforce the annulus, performed using catheters, rings, and clips, or other devices. The procedure consists of measuring the size of the annulus and sewing a band to the annulus around the valve.

[0004] Unfortunately, current procedures and devices for the treatment of valvular regurgitation present limitations and risks. For example, percutaneous leaflet procedures focus on stabilizing the leaflets (edge-to-edge procedures) but do not address valve dilation and therefore fail to achieve significant reduction or complete elimination of regurgitation. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, what is needed are devices, systems, and methods for a quick and simple method of reducing annular dilation and / or strengthening the annulus to further reduce valve regurgitation. The individual elements for such devices, systems, and methods must not interfere with the overall motion of the mitral annulus, as full-length or partial-length annuloplasty rings do. In addition, these elements must be precisely and independently deployed to substantially provide the desired effect while avoiding critical structures, such as the atrioventricular node or central fibrous body when treating the tricuspid valve. The treatment must also allow for combination with other valve repair techniques. [Means for solving the problem]

[0006] The present disclosure is applicable to any valve or any area where it is desirable to achieve localized changes in tissue topology or behavior, either alone or as part of a coordinated multi-device procedure.

[0007] The following presents a simplified summary of example embodiments in order to provide a basic understanding of some embodiments of the present disclosure. This summary is not an extensive overview of example embodiments. It is not intended to identify key or critical elements of example embodiments or to delineate the appended claims. Its sole purpose is to present some concepts of example embodiments in a simplified form as a prelude to the more detailed description that is presented herein below. It is to be understood that both the following summary description and the following detailed description are exemplary and explanatory only and are not restrictive.

[0008] The present disclosure relates to devices, systems, and methods for cardiac valve annulus repair techniques. Such techniques include a reinforcement device having one or both of a heating mechanism or a fastening mechanism. The heating mechanism can function by heating a localized portion of the annulus to reduce the circumference of the annulus and / or increase the stiffness of the tissue. The fastening mechanism can function by gathering or pinching an area of ​​tissue, which then reduces the circumference of the annulus and / or increases the stiffness of the tissue.

[0009] Providing multiple independent and potentially unconnected elements to reduce annular dilation, as done herein, is a new approach for the treatment of heart valve regurgitation and a novel approach that provides a solution for augmenting previous repair approaches. Such disclosure is an improvement over existing technology because the individual elements are not overstressed by cardiac motion and because the present disclosure still provides annular reduction and strengthening without interfering with the annulus's natural function. The present disclosure thus allows for the ultimate in flexibility and customization of augmentation therapy.

[0010] Further advantages, embodiments, and features of the present disclosure will become readily apparent to those skilled in the art from the following description, in which preferred embodiments of the present disclosure are shown and described, merely by way of illustration of one of the best modes suitable for carrying out the present disclosure. As will be appreciated, the present disclosure is capable of other and different embodiments, and its several details are capable of modification in various obvious embodiments, all without departing from or limiting the scope of the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the summary description of the present disclosure given above and the detailed description of the drawings given below, serve to explain the principles of the present disclosure. In certain instances, details that are not necessary for understanding the present disclosure or that obscure other details may be omitted. [Brief explanation of the drawings]

[0012] [Figure 1A] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 1B] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 1C] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 2A] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 2B] 1 is a diagram generally illustrating an embodiment of a mitral valve annulus repair system as disclosed herein. [Figure 3] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 4] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 5] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 6] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 7] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 8] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 9A] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 9B] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 9C] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 10A]1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 10B] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 10C] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 10D] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 11A] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 11B] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 11C] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 12] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 13] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 14] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 15] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 16A] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 16B] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 17A] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 17B] 1A-1C illustrate generally an embodiment of a reinforcement device of an annulus repair system as disclosed herein. [Figure 18]1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 19] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. [Figure 20] 1 is a diagram generally illustrating an embodiment of a valve annulus repair system as disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0013] Before the present devices, systems, and methods are disclosed and described, it is to be understood that the present disclosure is not limited to particular methods, components, or implementations. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. Various embodiments are described with reference to the drawings. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. It will be apparent, however, that various embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate describing these embodiments.

[0014] Disclosed herein is a system for repairing and reinforcing a heart valve annulus ("reinforcement instrument"). In one embodiment, the reinforcement instrument comprises a deployment system for deploying a reinforcement device that reinforces tissue of the valve annulus. The reinforcement device can comprise either a heating mechanism or a fastening mechanism.

[0015] FIGURE 1A generally illustrates an embodiment of a valve annulus repair system as disclosed herein. FIGURE 1A illustrates the mitral valve, which is part of the left cardiac anatomy, consisting of the left atrium 115, left ventricle 135, and myocardium 135. The mitral valve further comprises a posterior leaflet 105 and an anterior leaflet 110, where malformation of the posterior leaflet 105 causes insufficiency.

[0016] In a preferred embodiment, catheter 125 is delivered percutaneously through the septum of left atrium 115, although catheter 125 may also be delivered via other techniques known in the art, such as trans-aortically. As shown in FIG. 1A , a reinforcement apparatus constriction clip 120 (herein referred to as the "reinforcement device" together with the heating mechanism) is delivered through catheter 125 and implanted into the posterior annulus and / or posterior leaflet 105. Once implanted, reinforcement device 120 modifies the shape of the annulus and / or leaflets by constricting tissue 130, i.e., therapeutically altering the annulus and / or leaflets.

[0017] FIG. 1B generally illustrates an embodiment of a valve annulus repair system as disclosed herein. As shown in FIG. 1B, an embodiment of a reinforcement device includes a laser catheter 140 that delivers energy to the posterior annulus and / or posterior leaflet 105 in a "spot welding" manner 145 such that the tissue is modified to shrink or tighten 150, i.e., modifying the annulus and / or leaflet in a therapeutic manner to improve leaflet function. In one embodiment, the temperature is a set temperature and may not be adjustable. In another embodiment, on / off is controlled via a switch or button on the delivery catheter handle.

[0018] FIG. 1C generally illustrates an embodiment of a valve annulus repair system as disclosed herein. FIG. 1C discloses a reinforcement device including a heating mechanism. As shown in FIG. 1C, the reinforcement device includes a catheter 160 and a pusher platform 165 for deployment of a heating mechanism 175. In this embodiment, the device can be deployed using the pusher platform 165, where the heating mechanism 175 is pressed against the tissue to contract or tighten the localized area. In other embodiments, after the initial application of the heating mechanism 175, the localized area may be somewhat loose and dilated, but the skin may still be tighter than before, and the heating mechanism 175 can be reapplied until the desired reinforcement is achieved. The heat contributes to the contraction and retraction of the skin. The heating mechanism can be heated electrically, electromagnetically, or through other methods of generating heat.

[0019] FIG. 2A generally illustrates an embodiment of a valve annulus repair system as disclosed herein. As shown in FIG. 2A, a reinforcement device 200 can include a deployment system such as a combination of a catheter 205, a coaxial pusher 210, and a pusher platform 215. The reinforcement device can further include two reinforcement devices 220, 225 loaded into the catheter 205. The pusher platform 215 provides a platform for applying pressure to push the devices 220, 225 out of the catheter 205. The pusher platform 215 slides along the inner diameter of the deployed devices 220, 225 until the devices 220, 225 are retracted sufficiently to expand under their own spring-loaded force. Deployment systems such as the catheter 205 and pusher platform 215 combination allow for the delivery of multiple devices to very precise locations and may also allow for device removal, such as in the event of misplacement or a change in indication.

[0020] FIG. 2B generally illustrates an embodiment of a valve annulus repair system as disclosed herein. FIG. 2B discloses an embodiment of a reinforcement device 225 being deployed. The process for deploying the reinforcement device can be repeated by retracting the pusher platform 215 through the next device to be deployed. In these embodiments, the catheter 205 allows for the rapid and precise delivery of multiple reinforcement devices.

[0021] In one embodiment, the reinforcement device is loaded into a delivery catheter using a 180-degree bent, scoured tip. Multiple reinforcement devices may be used on a patient so that the catheter can be loaded with the devices and delivered percutaneously quickly and accurately. Each device is individually positioned against the tissue at the desired location and then deployed so that the scoured tip grasps the tissue, pulls it together, and secures it. The scoured tip can include a piercing element that secures to and compresses the tissue, i.e., allowing for circumferential reduction or strengthening of the annulus. For example, the reinforcement device can reduce mitral regurgitation by one grade or a fraction of a grade (e.g., 3 to 2.5). The deployment system can also facilitate removal of the reinforcement device. For example, a pinching action at the proximal end of the device can cause tissue to release from the device.

[0022] Figure 3 generally illustrates an embodiment of a reinforcement device of a valve annulus repair system as disclosed herein. As shown in Figure 3, reinforcement device 300 can be a hollow cylindrical structure having an upper end and a lower end, both of which are open. Reinforcement device 300 can further include multiple arms extending downward from the upper end, where the multiple arms terminate in piercing elements and the multiple arms are configured to bend away from the device.

[0023] The reinforcement device 300 in Figure 3 is in a catheter-loading position with a scoured tip 305 that is used to penetrate and attach to the skin. This is the position the reinforcement device is in before it is deployed. The reinforcement device may also include a stress relief slot 310 and a coaxial control / release mechanism.

[0024] 4 generally illustrates an embodiment of a reinforcement device of an annulus repair system as disclosed herein. The reinforcement device 400 of FIG. 4 is in a deployed configuration with the scoured tip expanded 405.

[0025] In one embodiment, the reinforcement device with fastening mechanism is fabricated through laser cutting and electropolishing of nitinol tubing. Alternative processes include, but are not limited to, EDM and chemical etching. The piercing elements and the overall design of the scoured tip may be shape-set to further enhance their effectiveness. Other embodiments may include various stress relief elements, different scoured tip designs, and different coaxial control elements / features. Embodiments may also include reinforcement devices with coatings or sensors attached thereto that can elicit a response through drug delivery. Anchoring lines may also be attached to the reinforcement device to create anchoring of tether structures, such as for creating replacement chordae to support leaflet function or for anchoring devices such as replacement valves. Overall, the reinforcement device needs to be durable and biocompatible and able to withstand loading into a catheter and subsequent deployment. In another embodiment, the reinforcement tool provides the ability to remove and / or replace the device within the deployment system.

[0026] FIG. 5 generally illustrates an embodiment of a reinforcement device of the annulus repair system as disclosed herein. As shown in FIG. 5, the reinforcement device can include a straight piercing element and a hinge (like an old-fashioned clothespin). This design can also have a scooped tip and both an open and closed configuration. The ends with the small holes could move closer together when in the open configuration. It could be self-actuating, as shown, or it could include an additional element to force the upper ends (the ends with the small holes) apart when actuated to close. For example, a solid object could be first positioned inside the tube and below the ostia and then moved between the ostia to force the device closed. This could create a very rigid and forceful actuation of the clip.

[0027] FIG. 6 generally illustrates an embodiment of a valve annulus repair system as disclosed herein. FIG. 6 discloses a reinforcement device having both a fastening and heating mechanism. As shown in FIG. 6, the reinforcement device can include a catheter 605 and a pusher platform 610 for deployment of a reinforcement device 615 having a fastening mechanism 620 and a heating mechanism 625. In this embodiment, the device 615 can be deployed as disclosed in FIGS. 1-5 with the addition that the heating mechanism 625 can reduce tissue expansion or provide additional support for stiffening the tissue. In one embodiment, the heating mechanism 625 can be engaged to provide heat to a localized area while the device 615 penetrates and attaches to the skin.

[0028] FIG. 7 generally illustrates an embodiment of a valve annulus repair system as disclosed herein. As shown in FIG. 7, the reinforcement device may be circular or somewhat star-shaped with inward-pointing elements designed and configured to engage and pull inward on tissue when deployed / activated. These inward-pointing elements exhibit features that facilitate tissue engagement and secure containment. In one embodiment, the elements may feature textures / intentional breaks / patterns on their cutting edges to reduce the force required for the elements to penetrate tissue (much like porcupine quills, through their natural shape, reduce the force required to achieve and maintain skin penetration).

[0029] Figure 8 generally illustrates an embodiment of a valve annulus repair system as disclosed herein. As shown in Figure 8, the reinforcement device can utilize the features described above with respect to tissue-piercing elements that further comprise a "diamond" or other non-uniform shape. In this embodiment, the device uses anchors positioned along the midline of the device, and vertical tissue pulling or gathering can be achieved with a specific bias.

[0030] 9A-9C generally illustrate an embodiment of a valve annulus repair system as disclosed herein. As shown in FIGS. 9A-9C, the reinforcement device has radial symmetry and may be circular or somewhat star-shaped, and includes inward-pointing elements designed and configured to engage and pull inwardly against tissue when deployed / actuated. These inward-pointing elements possess features that facilitate tissue engagement and secure containment. In one embodiment, the elements can feature textures / intentional disruptions / patterns on their cutting edges to reduce the force required for the elements to penetrate tissue.

[0031] 10A-10D generally illustrate an embodiment of a valve annulus repair system as disclosed herein. Specifically, FIGS. 10A-10C illustrate embodiments of the shape and final shape of the reinforcement device when deployed. Also shown in FIGS. 10A-10C is a reinforcement device that can utilize the features described above with respect to tissue-piercing elements, including peripheral tines 1005 and a central tine 1010. The central tine 1010 can engage tissue during deployment. FIG. 10D illustrates an embodiment of the laser-cut shape of the reinforcement device prior to deployment. As shown in FIGS. 10A-10D, the reinforcement device can be a hollow cylindrical structure with radial symmetry when flattened, and with a first end and a second end when unflattened, the second end terminating in a piercing element. This radial symmetry can be further formed into an elliptical shape, resulting in a biasing force being applied to tissue in a specific direction.

[0032] 11A-11C generally illustrate an embodiment of a valve annulus repair system as disclosed herein. As shown in FIGS. 11A-11C, the reinforcement device may be circular or somewhat star-shaped and includes inward-pointing elements designed and configured to engage and pull inwardly against tissue when deployed / activated. These inward-pointing elements possess features that facilitate tissue engagement and secure containment. In one embodiment, the elements may feature textures / intentional breaks / patterns on their cutting edges to reduce the force required for the elements to penetrate tissue.

[0033] 12-15 generally illustrate an embodiment of a reinforcement device of an annulus repair system as disclosed herein. As shown in FIGS. 12-15, the reinforcement device can include a straight piercing element at each end. This design could also provide a biasing force by utilizing only two opposing piercing elements.

[0034] 16A-16B generally illustrate an embodiment of a reinforcement device of a valve annulus repair system as disclosed herein. FIG. 16A shows the reinforcement device in an intracatheter configuration, where the periphery of the reinforcement device is S-shaped and includes barbs and tines. FIG. 16B shows the same S-shaped reinforcement device configured with circumferential compression. FIG. 16B also illustrates the reinforcement device when deployed into the skin.

[0035] 17A-17B generally illustrate an embodiment of a reinforcement device of a valve annulus repair system as disclosed herein. FIG. 17A shows the reinforcement device in an intracatheter configuration, where the periphery of the reinforcement device is circular, includes barbs and tines, and includes strain relief features 1705. FIG. 17B shows the same circular reinforcement device configured using circumferential compression. FIG. 17B also illustrates the reinforcement device when deployed within the skin.

[0036] 18-20 generally illustrate an embodiment of an annulus repair system as disclosed herein. Specifically, FIGS. 18-19 illustrate a loaded configuration on a delivery tool. FIG. 20 illustrates a fully loaded configuration on a delivery tool ready for deployment.

[0037] Still other embodiments may use heating mechanisms that do not require a catheter or penetration of the skin or tissue. For example, the location of the area to be treated may be determined by 3D-mapping, ultrasound, or other methods. Once the location is determined, electromagnetic heat may be applied to the localized area.

[0038] Other embodiments may include combinations and subcombinations of features described or illustrated in some figures, including embodiments that are equivalent to, for example, providing or applying features in a different order than in the embodiments described above, extracting individual features from one embodiment and inserting such features onto another embodiment, removing one or more features from an embodiment, or removing one or more features from an embodiment and adding one or more features extracted from one or more other embodiments, while providing the advantages of the features incorporated in such combinations and subcombinations. As used in this paragraph, a "feature" or "features" can refer to the structure and / or function of an apparatus, article of manufacture, or system, and / or to a method step, act, or manner.

[0039] References throughout this specification to “one embodiment,” “embodiment,” “exemplary embodiment,” etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with one embodiment, it will be within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described. One skilled in the art will also recognize that the S-members can be oriented in a vertical manner (e.g., FIGS. 12-17) or in a horizontal manner within a device using a profile similar to FIGS. 9-11. While “horizontal” and “vertical” are shown here as explicit examples, it should be apparent to one skilled in the art that this orientation can take the form of any angle from vertical to horizontal to an inverted orientation.

[0040] Unless the relationship clearly indicates otherwise, (1) the word "and" indicates a conjunction, (2) the word "or" indicates a disjunction, (3) when a provision is phrased disjunctively and followed by the words "or both," both the conjunction and the disjunction are intended, and (4) the word "and" or "or" between the last two items in a series applies to the entire series.

[0041] When a group is expressed using the term "one or more" followed by a plural noun, any further use of that noun to refer to one or more members of the group should indicate both the singular and the plural of that noun. For example, a group expressed as having "one or more members" followed by a reference to a "member" of the group should mean "that member" if there is only one member of that group.

[0042] Non-plural nouns refer to one or more. Thus, the non-plural nouns, "one or more," and "at least one" can be used interchangeably herein. It should also be noted that the terms "comprise," "include," and "have" can be used interchangeably.

Claims

1. 1. A cardiac annular reinforcement device, comprising: a hollow cylindrical structure having an upper end and a lower end, both of which are open; a plurality of arms extending downwardly from the upper end, the plurality of arms terminating in a piercing element, the plurality of arms configured to bend away from the device; A device characterized by:

2. the plurality of arms having a plurality of elongated slot openings; the plurality of elongated slot openings extending along a portion of the plurality of arms between the upper and lower ends; The device of claim 1 .

3. the piercing element comprises a rounded blade having a pointed end; The rounded blades are curved inward toward the center of the cylindrical structure. The device of claim 1 .

4. a hinged connection between a first and a second arm of the plurality of arms; The device of claim 1 .

5. 1. A cardiac annular reinforcement device, comprising: a hollow cylindrical structure having radial symmetry when flattened and having a first end and a second end when unflattened; the second end terminating in a piercing element; A device characterized by:

6. the first end terminating in a piercing element; The device of claim 5.

7. the first end comprises a circular open end; The device of claim 5.

8. 1. A method of reducing the circumference of a valve annulus, comprising: inserting a reinforcement device comprising at least one of a heating reinforcement and a fastening reinforcement into a delivery catheter system; delivering the reinforcement device to tissue with the delivery system; deploying the reinforcement device at the tissue area with a deployment mechanism of the delivery system, the deployment mechanism being one or both of a coaxial pusher and a pusher platform. A method characterized by:

9. the fastener stiffener is a hollow cylindrical structure having an upper end and a lower end, both of which are open, with a plurality of arms extending downwardly from the upper end, the arms terminating in piercing elements, the arms configured to bend away from the device; inserting the reinforcement device into the delivery catheter system comprises bending out the plurality of arms and inserting a fastening reinforcement; Deploying the reinforcement device includes: positioning the fastening reinforcer against the tissue at a desired location; deploying the fastening reinforcement at the desired location on the tissue so that the bent arms straighten; penetrating the tissue with the piercing element; grasping a portion of the tissue with the piercing element; pulling the grasped portion of the tissue together with the piercing element; releasing the fastening reinforcement from the delivery system; Further comprising:

9. The method of claim 8.

10. the plurality of arms having a plurality of elongated slot openings; the plurality of elongated slot openings extend along a portion of the plurality of arms between the upper and lower ends; 10. The method of claim 9.

11. the piercing element comprises a rounded blade having a pointed end; The rounded blades are curved inward toward the center of the cylindrical structure.

10. The method of claim 9.

12. a hinge connection between a first and a second arm of the plurality of arms; 10. The method of claim 9.

13. the piercing element is coated with a tissue-absorbable chemical composition; 10. The method of claim 9.

14. the fastener reinforcer is a hollow cylindrical structure having radial symmetry when flattened and having a first end and a second end when unflattened, the second end terminating in a piercing element; Deploying the reinforcement device includes: positioning the fastening reinforcer against the tissue at a desired location; penetrating the tissue with the piercing element; grasping a portion of the tissue with the piercing element; pulling the grasped portion of the tissue together with the piercing element; and releasing the fastening reinforcement from the delivery system. The method of claim 8.

15. the first end terminating in a piercing element; 15. The method of claim 14.

16. the first end comprises a circular open end; 15. The method of claim 14.

17. the heat stabilizer is a heat-generating device; Deploying the reinforcement device includes: positioning the heat stabilizer against the tissue at a desired location; and deploying heat to the tissue at the desired location. The method of claim 8.

18. the heat-generating device is one of an electric heating mechanism, an electromagnetic heating mechanism, or a laser heating mechanism; 18. The method of claim 17.

19. retracting the deployment mechanism through a second reinforcement device; deploying the second reinforcement device at the area of ​​tissue with the deployment mechanism of the delivery system after deployment of the first reinforcement device. The method of claim 8.

20. the first-deployed reinforcement device is the fastening reinforcement and the second-deployed reinforcement device is the heating reinforcement; 20. The method of claim 19.

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