Felting-based anchoring system and method of use thereof

Abstract

A device (10) for tissue of a subject's heart, the device comprising a textile (12). The textile comprises a tether (16) and a felting tool (20). The tether extends through the textile fabric. The felting tool is lumen-advanceable into the heart of the subject and includes a plurality of barbs (22) at a distal end thereof. When the textile contacts the tissue, the plurality of barbs are adapted to secure the textile to the tissue by repeatedly: (i) distally passing through the textile and moving into the tissue to draw fibers of the textile into the tissue; and (ii) proximally removing the tissue and the textile while leaving the fibers within the tissue. Other embodiments are also described.

Description

Felt-based anchoring systems and their application methods

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 598,285, filed November 13, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Background Technology

[0003] The function of the mammalian heart is based on the contraction of the myocardium and the pressure generated in the ventricles of the heart, which causes blood to flow from the ventricles into the arteries. Typically, when the mammalian heart malfunctions, it can be repaired by inserting various implants into the heart. Some of these implants use tissue anchors with a head and tissue engagement elements, such as helical or dart-shaped tissue anchors, to anchor to the heart tissue.

[0004] There are several limitations or drawbacks to using conventional tissue anchors to anchor implants to tissue. For example, the implants are often too large and have an excessive number of components due to the presence of metal anchoring elements. Additionally, conventional tissue anchors provide localized loads to the tissue, for example, based on anchor spacing. These localized loads may exceed the tissue's limits, or conversely, may require large tissue anchors to distribute the load. Furthermore, some anatomical locations cannot tolerate the depth to which tissue anchors extend into the tissue and require only surface attachment. Achieving this only surface attachment using tissue anchors is difficult (if not impossible).

[0005] One surgical procedure for anchoring an implant to tissue is transcatheter anuloplasty (TCA), used to ensure that a heart valve does not leak and that its leaflets are properly aligned. Such a procedure may involve (i) securing multiple tissue anchors to the valve annulus tissue surrounding the valve in a series of manners, fixing a tether in an arc around the valve being treated, and then (ii) contracting the annulus by tensioning the tether, with the anchors slidably attached to the tether. Therefore, multiple tissue anchors are required in anuloplasty, which presents the aforementioned disadvantages.

[0006] Therefore, there is a need for improved techniques and devices for securing implants to the surface of cardiac tissue without driving tissue anchors deep into the tissue. There is also a need for improved techniques and devices for performing annulusoplasty without the use of tissue anchors. Summary of the Invention

[0007] This invention is intended to provide examples and is not intended to limit the scope of this disclosure in any way. For example, any features included in the examples of this invention are not claimed by the claims unless those features are expressly stated in the claims. Furthermore, the features, components, steps, concepts, etc., described in the examples of this invention and in other parts of this disclosure can be combined in various ways. Various features and steps described in other parts of this disclosure may be included in the examples summarized herein.

[0008] According to some embodiments described herein, a felting-based anchoring system and / or device is suitable for and / or used on the heart of a subject (e.g., a living subject, a simulant, etc.). The system / device comprises a textile containing multiple fibers, and has a tether extending longitudinally through the material. The textile is positioned to contact the tissue surface of the subject's heart. Multiple barbs, forming a felting tool together, repeatedly pass through the textile into and out of the tissue. The barbs entering the tissue draw some fibers of the textile into the tissue, and when the barbs are withdrawn, the fibers remain within the tissue, thereby attaching the textile to the tissue to the surface level. After the textile is attached to the tissue, for example as part of annular plasty, the tether extending through the textile can be tensioned to cause the attached textile to contract and thus deform the tissue as needed.

[0009] Therefore, according to some embodiments, a system and / or device suitable for and / or used for a real or simulated heart of a real or simulated subject is provided, the system / device comprising a textile, a tether, and / or felting tools that can be propelled perforally into the subject's heart. In some embodiments, the tether may extend through the textile (e.g., may be woven along the textile).

[0010] In some embodiments, the felting tool may have multiple barbs at its distal end. In some embodiments, when the textile contacts the tissue surface, the multiple barbs are adapted to secure the textile to the tissue by repeatedly performing the following movements: distally through the textile and moving into the tissue to draw the fibers of the textile into the tissue; and / or proximally removing from the tissue and the textile while leaving the fibers within the tissue.

[0011] In some implementations, the textile includes cell growth promoting substances.

[0012] In some implementations, the textiles include synthetic polymers.

[0013] In some implementations, the textiles include natural polymers.

[0014] In some implementations, the textile comprises a combination of various fiber types.

[0015] In some embodiments, the textile includes collagen. In some embodiments, the textile includes cellulose. In some embodiments, the textile includes chitin. In some embodiments, the textile includes chitosan. In some embodiments, the textile includes filament. In some embodiments, the textile includes hydrogel.

[0016] In some embodiments, the textile comprises polytetrafluoroethylene. In some embodiments, the textile comprises polypropylene. In some embodiments, the textile is a woven textile. In some embodiments, the textile is a woven textile having weft yarns and warp yarns, the weft yarns comprising a first fiber type and the warp yarns comprising a second fiber type.

[0017] In some implementations, the textile contains a non-transparent material.

[0018] In some implementations, the textile is a felted fiber mat.

[0019] In some implementations, the textile is a nonwoven textile.

[0020] In some implementations, the textile is felt.

[0021] In some implementations, the felting tools are sterile.

[0022] In some implementations, the textiles are sterile.

[0023] In some implementations, felting tools are suitable for positioning textiles on the fabric.

[0024] In some implementations, the multiple barbs of the felting tool include multiple notched barbs.

[0025] In some implementations, each of the barbs has a plurality of notches defined therein.

[0026] In some implementations, the notch is configured to hook the fiber.

[0027] In some implementations, multiple barbs have equal lengths to each other.

[0028] In some implementations, multiple barbs have different lengths from each other.

[0029] In some implementations, the felting tool is configured to extend and retract all the barbs synchronously.

[0030] In some implementations, the felting tool is configured to extend and retract multiple barbs in an alternating manner.

[0031] In some implementations, the felting tool is configured such that repeated extension and retraction of the barbs includes axial movement of the barbs in a reciprocating manner.

[0032] In some embodiments, the device is configured such that the reciprocating axial movement of the barbs entangles the fibers with the tissue and causes the fibers to entangle with each other.

[0033] In some embodiments, the system further includes a first longitudinal catheter configured to be advanced through a lumen to an anatomical site of the subject, the first longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween, and textiles can be advanced through the first longitudinal catheter to the heart of the subject.

[0034] In some implementations, the felting tool can be advanced into the subject's heart via a first longitudinal catheter.

[0035] In some embodiments, the system further includes a second longitudinal catheter configured to be advanced through a lumen to an anatomical site of the subject, the second longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween, and a felting tool can be advanced through the second longitudinal catheter into the subject's heart.

[0036] In some implementations, the textile and felting tool are simultaneously advanced into the subject's heart, such that when a portion of the textile comes into contact with the tissue, barbs secure that portion of the textile to the tissue.

[0037] In some implementations, the entire textile is in contact with the tissue before any part of the textile is attached to the tissue.

[0038] In some embodiments, the device further includes at least one tissue anchor adapted to be advanced into the heart of a subject and adapted to temporarily anchor the textile to the tissue prior to securing it to the tissue using a felting tool.

[0039] In some implementations, the cord is not pierced by the barbs when the felting tool passes through the textile distally.

[0040] In some implementations, a barb engages a first longitudinal section of the textile and secures the first longitudinal section to the fabric, and a cord extends through a second longitudinal section of the textile, the second longitudinal section being parallel to and distinct from the first longitudinal section.

[0041] In some embodiments, the cord includes a first cord extending along a first lateral edge of the textile and a second cord extending along a second lateral edge of the textile parallel to the first cord, such that a longitudinal gap is formed along the textile between the first cord and the second cord, and a barb is adapted to secure the textile to the tissue along the longitudinal gap.

[0042] In some embodiments, the tether extends along a single longitudinal length of the textile, and the felting tool includes a first set of barbs and a second set of barbs with a gap therebetween, wherein the barbs are adapted to secure the textile to the fabric along the width of the textile, such that the tether is positioned within the gap between the first set of barbs and the second set of barbs during securing.

[0043] In some implementations, at least one end of the tether extends outside the subject's body and can be manipulated to tension the tether.

[0044] In some implementations, the system also includes a frame adapted to hold the textile in place relative to the tissue during the operation of the felting tool.

[0045] In some embodiments, the system further includes at least one implant attached to a textile via a tether, the implant being adapted for transcavitary advancement into the heart of a subject and attached to the tissue by securing the textile to the tissue.

[0046] In some implementations, the longitudinal axes of the multiple barbs are arranged in a plane such that the distal tips of the multiple barbs form a straight line.

[0047] In some implementations, multiple barbs are arranged such that their distal tips form an annular or circular shape.

[0048] In some implementations, multiple barbs are arranged around a rotating cam that forms part of the felting tool. The rotating cam is associated with a drive belt, wherein pulling of the drive belt is adapted to rotate the rotating cam, thereby driving the multiple barbs into and out of the textile and fabric.

[0049] In some implementations, each of the plurality of barbs is attached to a rotating cam via a biasing element adapted to assist in the rapid insertion and extraction of the barbs into and from textiles and fabrics.

[0050] In some implementations, pulling the drive belt is also suitable for feeding the textile onto the tissue before felting it.

[0051] In some implementations, the drive belt is associated with or is said to be a cord that extends through the textile.

[0052] According to some embodiments, a device is provided for tissue of a subject (e.g., a living subject and / or a dummy subject). The device may include: a textile permissible through a cavity into the subject's body, the textile comprising multiple fibers; and a felting tool permissible through a cavity into the subject's body, the felting tool including one or more barbs at its distal end. In some embodiments, when the textile contacts the tissue, the one or more barbs are adapted to secure the textile to the tissue by repeatedly performing the following movements: distally through the textile and moving into the tissue to draw the fibers of the textile into the tissue; and proximally removing from the tissue and the textile while leaving the fibers within the tissue.

[0053] According to some embodiments, a method is provided suitable for and / or for a real or simulated heart of a real or simulated subject, the method comprising: (i) advancing a textile into the heart of the subject, the textile having a tether extending therethrough; (ii) bringing the textile into contact with a surface of tissue of the subject's heart; (iii) advancing a felting tool into the heart of the subject, the felting tool including a plurality of barbs at its distal end; (iv) securing the textile to the tissue by moving the felting tool across the textile in a reciprocating manner through the plurality of barbs: (i) moving distally through the textile and into the tissue, such that fibers of the textile are pushed into the tissue; and (ii) moving proximally out of the tissue and the textile, leaving the fibers within the tissue; and / or (v) tensioning the tether after securing the textile.

[0054] In some implementations, the method further includes applying intermittent pressure to the felted tissue during the fixation step.

[0055] In some implementations, the method further includes applying a pH-adjusting solution to the textile during a fixing step.

[0056] In some embodiments, the method further includes applying a composition of mesenchymal stem cells to the tissue after fixing a textile, the textile providing a scaffold for the growth of the mesenchymal stem cells.

[0057] In some implementations, the textile is a nonwoven textile, and the propulsion of the textile involves advancing the nonwoven textile into the heart of the subject.

[0058] In some implementations, the textile is a nonwoven textile, and / or the propulsion of the textile includes propelling the nonwoven textile into the heart of the subject.

[0059] In some implementations, the nonwoven fabric is felt, and / or the propulsion of the nonwoven fabric includes pushing the felt into the heart of the subject.

[0060] In some implementations, the felting tools are sterile.

[0061] In some implementations, the textiles are sterile.

[0062] In some implementations, the propulsion of the textile involves propelling the textile with a cord extending longitudinally through it.

[0063] In some implementations, the tension of the tether will cause the textile to contract.

[0064] In some implementations, advancing the textile involves pushing the textile distally through a first longitudinal conduit or through the first longitudinal conduit distally.

[0065] In some implementations, advancing the felting tool involves pushing the felting tool distally through the first longitudinal conduit or through the first longitudinal conduit distally.

[0066] In some implementations, advancing the felting tool involves pushing the felting tool distally through the second longitudinal conduit or through the second longitudinal conduit distally.

[0067] In some implementations, the textile comprises a first portion and a second portion, wherein contact and fixation of the first portion of the textile occurs prior to contact and fixation of the second portion of the textile.

[0068] In some implementations, contact between the textile and the tissue surface occurs before any part of the textile is fixed to the tissue.

[0069] In some embodiments, the method further includes anchoring the textile to the tissue using at least one tissue anchor before attaching the textile to the tissue.

[0070] In some implementations, the method further includes removing at least one tissue anchor after the textile has been secured to the tissue.

[0071] In some implementations, securing the textile to the tissue includes securing the textile so that the tether is not damaged by barbs.

[0072] In some implementations, securing the textile to the tissue includes securing the textile so that the tether is not pushed into the tissue by the barbs.

[0073] In some implementations, securing the textile to the tissue includes securing a first longitudinal section of the textile to the tissue, and extending a cord through a second longitudinal section of the textile, the second longitudinal section being parallel to and different from the first longitudinal section.

[0074] In some embodiments, the tether includes a first tether extending along a first lateral edge of the textile and a second tether extending along a second lateral edge of the textile parallel to the first tether, such that a longitudinal gap is formed along the textile between the first and second tethers, and securing the textile includes securing the textile to the tissue along the longitudinal gap.

[0075] In some embodiments, the tether extends along a single longitudinal length of the textile, and the plurality of barbs include a first set of barbs and / or a second set of barbs having a gap therebetween, and / or securing the textile to the fabric includes securing the textile to the fabric along the width of the textile such that the tether is positioned within the gap between the first set of barbs and the second set of barbs during securing.

[0076] In some implementations, the end of the tether extends outside the subject's body, and tensioning involves pulling the end of the tether located outside the subject's body.

[0077] In some implementations, the method further includes advancing the frame into the heart of the subject, and bringing the textile into contact with the tissue includes placing the textile on the frame such that the textile is held in place relative to and in contact with the tissue.

[0078] In some embodiments, the textile has an implant attached thereto via a cord, and the method further includes advancing the implant through a cavity into the heart of a subject, and securing the textile to tissue to secure the implant to the heart of the subject.

[0079] In some implementations, securing the textile to the tissue involves pulling a drive belt associated with a rotating cam having a plurality of barbs mounted thereon, thereby causing the rotating cam to rotate and causing the plurality of barbs to reciprocate through the textile and move into the tissue, and move proximally out of the tissue and textile.

[0080] According to some embodiments, an apparatus for a subject's tissue is also provided, the apparatus comprising: a textile permissible through a cavity into the subject's body, the textile comprising a plurality of fibers; and / or a felting tool permissible through a cavity into the subject's body, the felting tool comprising one or more barbs at its distal end, wherein when the textile contacts the tissue, the one or more barbs are adapted to secure the textile to the tissue by repeatedly performing the following movements: (i) distally through the textile and moving into the tissue to draw the fibers of the textile into the tissue; and / or (ii) proximally removing the tissue and / or the textile while leaving the fibers within the tissue.

[0081] In some implementations, the textile is a woven textile.

[0082] In some implementations, the textile contains cell growth promoting substances.

[0083] In some implementations, the textile contains a synthetic polymer.

[0084] In some implementations, the textile contains natural polymers.

[0085] In some implementations, the textile comprises a combination of various fiber types.

[0086] In some implementations, the textile contains collagen.

[0087] In some implementations, the textile contains cellulose.

[0088] In some implementations, the textile contains chitin.

[0089] In some implementations, the textile contains chitosan.

[0090] In some implementations, the textile comprises filaments.

[0091] In some implementations, the textile contains a hydrogel.

[0092] In some implementations, the textile contains polytetrafluoroethylene.

[0093] In some implementations, the textile contains polypropylene.

[0094] In some implementations, the textile is a woven textile.

[0095] In some embodiments, the textile is a woven textile having weft yarns and warp yarns, the weft yarns comprising a first fiber type and the warp yarns comprising a second fiber type.

[0096] In some implementations, the textile contains a non-transparent material.

[0097] In some implementations, the textile is a nonwoven textile.

[0098] In some implementations, the textile is felt.

[0099] In some implementations, the felting tools are sterile.

[0100] In some implementations, the textiles are sterile.

[0101] In some implementations, felting tools are suitable for positioning textiles on the fabric.

[0102] In some implementations, one or more barbs of the felting tool each include one or more notches.

[0103] In some embodiments, the system further includes a first longitudinal catheter configured to be advanced through a lumen to an anatomical site of the subject, the first longitudinal catheter having a proximal portion and a steerable distal portion, and the textile being advanced through the first longitudinal catheter to the subject's heart.

[0104] In some implementations, the felting tool can be advanced into the subject's heart via a first longitudinal catheter.

[0105] In some implementations, the system further includes a second longitudinal catheter configured to be advanced through a lumen to an anatomical site of the subject, the second longitudinal catheter having a proximal portion and a steerable distal portion, and a felting tool being advanced through the second longitudinal catheter into the subject's heart.

[0106] In some implementations, the textile and felting tool are simultaneously advanced into the subject's heart, such that when a portion of the textile comes into contact with the tissue, one or more barbs secure that portion of the textile to the tissue.

[0107] In some implementations, the entire textile is in contact with the tissue before any part of the textile is attached to the tissue.

[0108] In some embodiments, the device further includes at least one tissue anchor adapted to be advanced into the heart of a subject and adapted to temporarily anchor the textile to the tissue prior to securing it to the tissue using a felting tool.

[0109] In some embodiments, the system further includes a cord in which a barb engages and secures a first longitudinal section of the textile to the fabric, and the cord extends through a second longitudinal section of the textile, the second longitudinal section being parallel to and distinct from the first longitudinal section.

[0110] In some embodiments, the cord includes a first cord extending along a first lateral edge of the textile and a second cord extending along a second lateral edge of the textile parallel to the first cord, such that a longitudinal gap is formed along the textile between the first cord and the second cord, and a barb is adapted to secure the textile to the tissue along the longitudinal gap.

[0111] In some embodiments, the device further includes a cord extending along a single longitudinal length of the textile, and the felting tool includes a first set of barbs and a second set of barbs with a gap therebetween, wherein the barbs are adapted to secure the textile to the fabric along the width of the textile, such that the cord is positioned within the gap between the first set of barbs and the second set of barbs during securing.

[0112] In some implementations, the system also includes a tether, wherein at least one end of the tether extends outside the subject's body and can be operated to tension the tether.

[0113] In some implementations, the system also includes a frame adapted to hold the textile in place relative to the tissue during the operation of the felting tool.

[0114] In some embodiments, the system further includes a tether and at least one implant, the at least one implant being attached to a textile via the tether, the implant being adapted for transcavitary advancement into the heart of a subject and for attachment to the tissue by securing the textile to the tissue.

[0115] In some implementations, each of the one or more barbs defines a longitudinal axis, and the longitudinal axes of the one or more barbs are arranged in a plane such that the distal tips of the one or more barbs form a straight line.

[0116] In some implementations, one or more barbs are arranged such that their distal tips form an annular or circular shape.

[0117] In some implementations, the felting tool includes a rotating cam associated with a drive belt; and / or multiple barbs arranged along the rotating cam such that pulling the drive belt causes the rotating cam to rotate, thereby pushing the barbs sequentially through the fabric and into the weave as the cam rolls along the fabric.

[0118] In some implementations, each of one or more barbs is attached to a rotating cam via a biasing element adapted to assist in the rapid insertion and extraction of one or more barbs into and from textiles and fabrics.

[0119] In some implementations, pulling the drive belt is also suitable for feeding the textile onto the tissue before felting it.

[0120] Any of the methods described above, as well as any methods using the systems, components, devices, equipment, etc., described herein, may be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver's heart, a virtual human, a simulator, etc.). Through simulation, body parts may optionally be referred to as "simulated" (e.g., simulated heart, simulated tissue, etc.) and may optionally include computerized and / or physical representations.

[0121] Any of the aforementioned systems, components, devices, apparatuses, parts, etc., may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use in patients, and the methods described herein may include (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) sterilizing one or more of the systems, devices, apparatuses, parts, etc. described herein (or additional methods may include or consist of said sterilization).

[0122] This disclosure will be more fully understood from the following detailed description of the application of the invention, taken in conjunction with the accompanying drawings, in which: Attached Figure Description

[0123] Figures 1A, 1B and 1C are schematic diagrams of the steps of a method for treating a subject's heart valves using a felt-based anchoring device according to some embodiments.

[0124] Figures 2A, 2B, 2C and 2D are schematic diagrams of the steps of a method for treating a subject's heart valves using a felt-based anchoring device according to some embodiments.

[0125] Figures 3A and 3B are schematic diagrams of implants anchored to the heart of a subject using a felt-based anchoring device according to some embodiments.

[0126] Figures 4A, 4B, 4C and 4D are schematic diagrams of non-limiting arrangements of felt-based anchoring devices according to some embodiments.

[0127] Figures 5A and 5B are schematic diagrams of felting tools according to some embodiments;

[0128] Figures 6A, 6B, 7A, and 7B are schematic diagrams of exemplary textiles and felting processes; and

[0129] Figure 8 is a schematic diagram of the improved fiber arrangement in woven textiles. Detailed Implementation

[0130] The principles of felt-based anchoring devices and technologies can be better understood by referring to the accompanying drawings and the following description.

[0131] In the following description, various aspects of this disclosure will be described. Specific configurations and details are set forth for purposes of explanation in order to provide a thorough understanding of the different aspects of this disclosure. However, it will also be apparent to those skilled in the art that this disclosure can be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified so as not to obscure this disclosure. Additionally, to avoid excessive clutter with too many reference numerals and leaders in any particular figure, some elements may not be explicitly identified in every figure containing said elements.

[0132] It should be understood that the scope of this disclosure, in its implementation, is not limited to the details of the construction and arrangement of the components set forth in the following description or shown in the accompanying drawings. This disclosure can be implemented or performed in other ways. Furthermore, it should be understood that the wording and terminology used in this disclosure are for illustrative purposes and should not be considered limiting.

[0133] For the purposes of this disclosure, the term "subject" refers to any mammal, such as a human. In some embodiments, the subject may include a living subject or a simulated object (e.g., a corpse, a cadaver's heart, a simulator, a virtual human, etc.).

[0134] For the purposes of this implementation, the term "heart tissue" refers to any tissue of the heart and includes, for example, any tissue of the heart walls and any heart valves.

[0135] Referring now to the accompanying drawings, Figures 1A to 1C are schematic diagrams of a method for treating a subject's heart valves using a felt-based anchoring device 10 according to some embodiments. Although the mitral valve is shown, those skilled in the art will understand that this disclosure is applicable to and / or for other valves, including but not limited to the tricuspid valve.

[0136] As shown in Figure 1A, the felt-based anchoring device 10 includes a textile 12 (e.g., a section of textile or a strip of textile) defining a first wide surface 12a and a second opposite wide surface 12b. The textile 12 comprises multiple fibers and has a tether 16 extending longitudinally through it. In some embodiments, the textile 12 may comprise a nonwoven fabric, such as felt. Further details and properties of the textile 12 will be discussed below. The tether 16 may be formed of any suitable material, such as metal, polymer, biomaterial thread, strip, or plug cord, and have sufficient tensile strength to allow the textile 12 to contract when the tether is tensioned. In some embodiments, the textile 12 and the tether 16 may be considered components of an implant, such as a valve annuloplasty implant.

[0137] In some embodiments, the felting-based anchoring device may further include a felting tool 20. In some embodiments, the felting tool 20 has one or more barbs 22 at its distal end. In some embodiments, the felting tool 20 has multiple barbs 22 (e.g., notched barbs). In some embodiments, each barb 22 may have multiple notches 24 distributed along its longitudinal length. Box III of FIG1A illustrates two non-limiting embodiments of notched barbs: notched barb 22a has a triangular needle tip and includes notches 24a pointing in the longitudinal distal direction, and notched barb 22b has a helical profile and includes notches 24b along the helical direction. However, it should be understood that other variations of notched barbs may be used. For example, in some embodiments, the barb may include a rough or textured surface. The notches 24a, 24b and / or the rough or textured surface are configured to hook the fibers of the textile.

[0138] In some embodiments, the longitudinal axis of the notched barb 22 is arranged in a single plane such that the distal tip of the notched barb is arranged in a straight line, as shown in box I of FIG1A. In some embodiments, the distal tip of the notched barb may be arranged in a circular, semi-circular, or annular shape. In some embodiments, the notched barb 22 is arranged in a single plane, as shown in box I of FIG1A. FIG4A-D show further non-limiting and combinable examples of barb arrangements.

[0139] In the illustrated embodiment, the felted anchoring device 10 is used to treat (e.g., annulusoplasty) the mitral valve 30 of a subject. As shown in box V of Figure 1A, the leaflets 32 and 34 of the mitral valve are not fully aligned, such that a gap 36 remains between them even during ventricular systole. The treatment procedure described herein (e.g., annulusoplasty) reshapes the mitral valve 30 such that the leaflets 32 and 34 align and the gap 36 is reduced or eliminated (see the final result in Figure 1C). The mitral valve 30 comprises an annulus 38 and surrounding leaflets 32 and 34.

[0140] As shown in Figure 1A, a longitudinal catheter 40 is advanced into the heart of a subject. In the illustrated embodiment, the distal portion 42 of the catheter is advanced into the atrium of the heart (e.g., the left atrium) to be positioned upstream of the mitral valve 30. However, it should be understood that other heart valves (e.g., the tricuspid valve) can be treated similarly. The longitudinal catheter 40 also has an external proximal portion 44 comprising a stem 46. The distal portion 42 of the longitudinal catheter 40 can be guided to the anatomical site, for example by being actively steerable (e.g., by being operatively coupled to the proximal portion 44 by one or more drawstrings, such as a steering controller coupled to the stem 46), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). The longitudinal axis extends between the proximal portion 44 and the steerable distal portion 42 of the catheter 40. The catheter 40 can be advanced to the anatomical site using any method known in the art, such as transcaval (e.g., via the vena cava, and if necessary, via a septum separating the atria of the heart) or intercostal approach.

[0141] As shown, a textile 12 with a tether 16 extending through it is advanced into the subject's heart, for example, disengaging distally from the longitudinal catheter 40. In some embodiments, at least one end 16a of the tether 16 remains outside the subject's body while the textile 12 and the tether 16 are advanced into the body. In the example shown, a first lock 48 (which may alternatively be called a stop) is present at the second end of the tether 16 disposed inside the catheter. In some embodiments, the first lock 48 locks onto the tether, securing the second end of the tether to the textile 12, while the tether is advanced into the subject's heart together with the textile.

[0142] In some implementations, and as shown, the textile 12 can be advanced into the heart of the subject via the lumen 50 of the longitudinal conduit 40, as shown in box II of FIG1A. As shown in box IV of FIG1A, when a portion of the textile 12 is extruded from the longitudinal conduit 40, the second wide surface 12b of the textile comes into contact with the heart tissue of the subject, which in the illustrated example is the valve annulus 38.

[0143] Similarly, the felting tool 20 is advanced into the subject's heart, for example, by pushing the longitudinal catheter 40 distally. In some embodiments, and as shown in box II of FIG1A, the felting tool 20 may be advanced into the subject's heart via a dedicated lumen 52 of the longitudinal catheter 40. In some embodiments, the felting tool 20 may be advanced into the subject's heart along with the textile 12 via the lumen 50. In additional and / or alternative embodiments, the felting tool 20 may be advanced into the subject's heart via a second dedicated longitudinal catheter similar to the longitudinal catheter 40.

[0144] As shown in box IV of Figure 1A, when the second wide surface 12b of the textile 12 is positioned to engage with the valve annulus 38, the textile can be secured to the valve annulus by the notched barbs 22 of the felting tool 20. Specifically, multiple notched barbs 22 can be repeatedly advanced through the textile 12 and into the tissue of the valve annulus 38, entering the textile via the first wide surface 12a and exiting via the second wide surface 12b. During each such advancement, some fibers 55 of the textile 12 are hooked by the notches 24 of the notched barbs 22 and thereby pulled (e.g., pushed and / or dragged) into the tissue of the valve annulus 38. After each such advancement, the multiple notched barbs 22 are then retracted from the tissue and the textile in a proximal direction, leaving the fibers 55 within the tissue. The fibers 55 extending into the valve annulus 38 form multiple anchor points 56, as shown in box V of Figure 1A, for securing a portion of the textile to the valve annulus. For illustrative purposes, anchor points 56 are shown as discrete points with clear intervals between them. However, it should be understood that the number and proximity of anchor points can make them indistinguishable from each other. For example, needle 22 can be extended and retracted rapidly in a reciprocating manner during operation.

[0145] As explained below with respect to Figures 4A and 4B, the tether 16 and felting tool 20 are configured such that the tether is not damaged by the notched barb 22 or pushed into the valve ring 38.

[0146] Turning to Figure 1B, it can be seen that the conduit 40 gradually feeds out the textile 12 and places the textile along the flap 38. As the textile 12 is gradually placed along the flap 38, the felting tool 20 gradually secures the textile to the flap, as described above. As shown, the device 10 can be configured such that when the textile 12 is fed out, it is positioned on the surface of the tool 20 so that the needle 22 can contact it. This can also be described additionally and / or alternatively as the device 10 being configured to slide or wipe the tool 20 on the textile as it is fed out—e.g., in the case of continuous operation of the needle 22.

[0147] The textile 12 is secured to the valve annulus 38 until it is determined that the textile extends along a sufficiently long extension of the valve annulus—for example, fully enclosing the valve.

[0148] Figure 1C shows the final state of the mitral valve 30 after annulusoplasty is terminated using device 10. As shown, textile 12 surrounds at least half of the annulus 38 and has been secured to the annulus by felting tool 20.

[0149] As shown in the figure, for example, by pulling the end 16a of the tether 16 extending from the body, the tension in the tether has changed (e.g., tension is applied to the tether). This change in tension in the tether 16 causes the textile 12 to contract longitudinally, and thereby contracts the annulus of the valve 30, thus reshaping the valve to close the gap 36. As shown in Figure 1C, this reshaping of the mitral valve improves the engagement between the leaflets 32 and 34, thereby reducing (e.g., closing) the gap 36.

[0150] After the tension in the tether is altered and the valve is reshaped, the tension in the tether is locked. In the embodiments shown in Figures 1A-1C, when the tether is initially introduced into the subject's heart, a first lock 48 (which may alternatively be referred to as a stop) is positioned at the end 16b of the tether 16 and locked to the tether. In some embodiments, a second lock 58 slides along the tether 16 (e.g., from the end 16a positioned outside the subject's body) and locks to the tether. Locks 48 and 58 can lock the tension in the tether 16 by preventing the tether from slipping off the textile 12—e.g., by the lock abutting against the textile. For some embodiments, locks 48 and / or 58 have one or more features described in U.S. Patent Application 16 / 534,875, filed August 7, 2019, by Brauon et al., published as US 2020 / 0015971, which is incorporated herein by reference.

[0151] In some embodiments, the textile 12 is predetermined, for example, a textile of appropriate length is selected for use. In some embodiments, the textile 12 is secured along a desired extension of the tissue, and then excess textile is trimmed. In some embodiments, the device 10 is capable of securing multiple extensions of the textile 12 along multiple extensions of the tissue without removing the device from the subject.

[0152] In some embodiments, the textile 12 and / or tool 20 are configured such that the textile can be removed from the tissue immediately after felting—for example, the nature and quantity of the fibers 55 allow the textile to be pulled out of the tissue. This can advantageously allow for repositioning when needed. In such embodiments, after a certain period of time (e.g., minutes, hours, or days), the fibers 55 become more firmly attached to the tissue (e.g., due to tissue growth), thus allowing the shrinkage of the textile 12 to be delayed beyond said period.

[0153] In some embodiments, after the felting of the textile 12, excess tethering is cut and removed from the atrium. The advancement of locks 48 and 58 and the cutting of excess tethering 16 can be performed using tools known in the art.

[0154] Referring now to Figures 2A to 2D of the accompanying drawings, which are schematic diagrams of the steps of a method for treating a subject's heart valves using the felt-based anchoring device 10 described above with respect to Figures 1A to 1C, according to some embodiments. In some embodiments, the subject may include a living subject or a simulation (e.g., a cadaver, a cadaver's heart, a simulator, a virtual human, etc.).

[0155] As shown in Figure 2A, the textile 12 is placed inside the heart of the subject along the valve annulus 38 of the valve 30. For example, the textile can be advanced into the heart via the lumen 50 of the longitudinal conduit 40 (Figure 1A), essentially as described above with respect to Figures 1A to 1C. The textile 12 has a tether 16 extending through it, with the end 16a of the tether 16 extending outside the subject's body as the textile 12 and tether 16 are advanced into the body. In some embodiments, a first lock 48 (which may alternatively be called a stop) is present at a second end 16b of the tether 16 and locks it to the tether while the tether is advanced into the subject's heart together with the textile 12.

[0156] As shown, the second wide surface 12b of the textile 12 is positioned to contact the subject's cardiac tissue, in the illustrated example, the tissue being the valve annulus 38. To prevent the textile 12 from moving relative to the valve annulus 38 during its fixation, temporary tissue anchors 70 can be advanced into the subject's heart and driven through the textile 12 into the valve annulus 38 to temporarily anchor the textile to the valve annulus. As shown in Figure 2A, the tissue anchors 70 are positioned such that they do not interfere with the tether 16.

[0157] In some embodiments, the tissue anchor 70 is driven into the valve annulus 38 by a drive tool known in the art. The drive tool may be advanced into the subject's heart via a second catheter similar to catheter 40 or via catheter 40. In some embodiments, the drive tool is rotatable, and the tissue anchor 70 is anchored by passing the tissue anchor through the textile 12 and screwing it into the tissue of the valve annulus 38. After anchoring the tissue anchor 70, the drive tool may be retracted from the subject's heart, for example, via the catheter through which the drive tool was introduced. The type of tissue anchor is not intended to limit the scope of this disclosure, and other types of tissue anchors, such as barbs, darts, etc., may be used.

[0158] Turning to Figure 2B, it can be seen that the felting tool 20 is advanced into the subject's heart, for example, by pushing the longitudinal conduit 40 distally. In some embodiments, the tether 16 continues to extend out of the longitudinal conduit 40 during the advancement of the felting tool 20 into the subject's heart. In some embodiments, the felting tool 20 may be advanced into the subject's heart via a second dedicated longitudinal conduit similar to the longitudinal conduit 40. Figure 2C shows the textile after the entire length of the textile 12 has been secured to the valve annulus 38 by the felting tool 20, such that the felting tool 20 is shown in dashed lines at both ends of the textile. In some embodiments, the entire textile (e.g., the distal surface along the entire length of the textile) may be in contact with the tissue before being secured to it.

[0159] As clearly shown in box I of Figure 2B, the felting tool 20 begins to secure the textile 12 to the valve ring 38 at one end, forming a fixation point 56. The felting tool 20 secures the textile to the valve ring 38 by extending a notched barb 22 through the textile 12 and into the tissue of the valve ring 38 to form the fixation point 56, essentially as described above with respect to Figures 1A to 1C. It should be understood that the location of the fixation point 56 is chosen such that, for example, by skipping portions of the tissue anchor 70 extending into the textile 12, the tissue anchor does not interfere with the fixation process.

[0160] Figure 2D shows the final state of the mitral valve 30 after annulusoplasty is terminated using device 10. Textile 12 extends along the annulus 38 and has been secured to the annulus 38 by a plurality of anchor points 56 created by felting tool 20. As shown, temporary tissue anchors 70 (Figures 2A-2C) have been removed from the textile 12. These tissue anchors can be removed, for example, by rotating the drive tool in the opposite direction to release the tissue anchors 70, and by retracting the released tissue anchors through a catheter and away from the body. It should be understood that, in some embodiments, the anchors 70 may remain in place such that they engage with felting to secure the textile 12 to the tissue.

[0161] As shown in Figure 2D, by pulling the end 16a of the tether 16 extending from the body, the tension in the tether has been changed (e.g., tension is applied to the tether). This change in tension in the tether 16 causes the mitral valve 30 to reshape in order to close the gap 36. As shown in Figure 2D, the reshaping of the mitral valve improves the abutment between its leaflets, as described above.

[0162] After altering the tension of the tether and reshaping the valve, the tension in the tether is locked, for example, by introducing a second lock 58 essentially as described above. In some embodiments, the excess tether is then cut and removed from the left atrium. The advancement of locks 48 and 58 and the cutting of the excess tether 16 can be performed using tools known in the art.

[0163] Referring now to Figures 3A and 3B, which are schematic diagrams of felt-based anchoring systems and / or devices anchored to the heart of a subject according to some embodiments. In some embodiments, the subject may comprise a living subject or a simulant (e.g., a cadaver, a cadaver's heart, a simulator, a virtual human, etc.).

[0164] Figure 3A illustrates an artificial chordae tendineae 80 replacing a single chordae tendineae. The proximal portion of the chordae tendineae 80 (e.g., via textile 81) is attached to the leaflet 32 ​​of the mitral valve, and the distal portion of the chordae tendineae 80 extends through the textile 12 in a manner similar to that described above with respect to the tether 16. A lock 48 located at the distal end of the artificial chordae tendineae 80 locks the chordae tendineae to the textile 12. As shown, the textile 12 has been fixed to the myocardium 82 by felting, substantially as described above with respect to Figures 1A through 2D, such that a plurality of fixation points 56 extend along the textile 12. In some embodiments, the length of the chordae tendineae 80 within the heart can be controlled by the precise placement of the lock 48.

[0165] Figure 3B illustrates an artificial heart valve 84 positioned between leaflets 32 and 34 of the mitral valve in a user's heart. The artificial heart valve 84 comprises multiple tethers 86, which merge into a single tether 88 extending distally into the user's heart. The distal portion of the tether 88 extends through a textile 12 in a manner similar to that described above with respect to tether 16. A lock 48 located at the distal end of the tether 88 locks the tether to the textile 12. As shown, the textile 12 is secured to the myocardium 82 by felting, substantially as described above with respect to Figures 1A through 2D, such that multiple anchor points 56 extend along the textile 12. This, in turn, prevents the artificial heart valve 84 from shifting out of its position between the leaflets and moving toward the atrium. Those skilled in the art will understand that the length of the tether 88 within the heart can be controlled by the precise placement of the lock 48.

[0166] Referring now to Figures 4A-D, which are schematic diagrams of several non-limiting arrangements for portions of the felt-based anchoring device in the methods described in Figures 1A-1C and 2A-2D, according to some embodiments. Figure 4A shows an exemplary arrangement of the first set 90a and the second set 90b of the barbs 22 relative to the tie rope 16. Figure 4B shows an exemplary arrangement of the barbs 22 relative to the tie rope segments 94a and 94b of the tie rope 16. Figure 4C shows an alternative construction of the barbs 22a. Figure 4D shows an exemplary placement of the barbs 22 relative to the operation and resulting anchor points 56 within the felting tool 20. It should be noted that the embodiments and options shown in Figures 4A-D are independent of each other and can be combined with other variations of the embodiments shown in Figures 1A-4B herein.

[0167] As shown in Figures 4A and 4B, tethers 16 (Figure 4A) and 14 (Figure 4B) do not coincide with anchor point 56, thus preventing them from being caught or damaged when the textile 12 is secured to the fabric. For example, tether 16 may extend through the textile 12 adjacent to but separate from anchor point 56. In some embodiments, anchor point 56, created by notched barbs 22, is positioned along and / or defines a longitudinal section of the textile 12, and tether 16 extends adjacent to this longitudinal section (e.g., along a second longitudinal section of the textile)—e.g., parallel to the anchor point along its longitudinal section.

[0168] As shown in Figure 4A, the tie 16 is positioned along the centerline of the textile 12. The felting tool 20 includes a first set 90a and a second set 90b of notched barbs 22, creating a gap 92 between the two sets of barbs. During the attachment of the textile 12 to the fabric, the first set 90a of the notched barbs 22 is positioned on one side of the tie 16, and the second set 90b is positioned on the opposite side, aligning the tie with the gap 92. Therefore, as the barbs 22 extend into the textile 12, the tie 16 remains uncontacted by the barbs.

[0169] In Figure 4B, the tie 14 comprises a first segment 94a extending along a first lateral edge 96a of the textile 12 and a second segment 94b extending along a second lateral edge 96b of the textile 12, wherein a longitudinal gap 98 is provided between the two segments of the tie along the length of the textile (e.g., along the centerline of the textile). In the felting tool 20, the row of barbs 22 is short enough that the fixing point 56 is located within the longitudinal gap 98. For example, the barbs 22 may be located on the inside, leaving a gap 100 at the edge of the tool 20.

[0170] In the example shown, the tether 14 defines a bend 99 in which the tether itself folds back, the bend connecting tether segments 94a and 94b—for example, at one end of the textile 12 or toward the textile. In some such embodiments, and as shown, a lock 48 is already in place, securing the end of tether segment 94a to the textile 12 before delivery, pulling tether segment 94b to tension both ends of the tether and contract the textile, and then locking the lock 58 to tether segment 94b to lock the tension—for example, as described above, with necessary modifications.

[0171] In some embodiments, the two sections of tether 14 are pulled to tension the tether, and the tension is then locked by locking the respective locks 58 to each end of the tether, or by locking a single lock 58 to both ends of the tether.

[0172] In some implementations, instead of folding back a single tether 14 to define two segments, two separate tethers are arranged parallel to each other to produce a similar effect.

[0173] Figure 4C shows barbs 22a extending to different tie segments. In some embodiments, barbs 22a have different lengths from each other. Therefore, for such embodiments, the different tie segments shown in the illustration of Figure 4C can be considered as representing the actual lengths of the barbs. Thus, when the felting tool 20 extends through the textile 12 into the fabric, the tip penetrates the fabric to different depths. The resulting variable distribution of fibers within the fabric advantageously strengthens the felting process and the bond between the textile and the fabric.

[0174] In some embodiments, the felting tool 20 is configured to extend and retract all the barbs synchronously. In some embodiments, the felting tool 20 is configured to extend and retract the barbs 22a in an alternating manner (e.g., similar to the movement of a piston in an internal combustion engine). Thus, for such embodiments, the illustration in FIG4C can be considered as a snapshot representing a point in time. In such embodiments, the lengths of the barbs 22a themselves may be equal. In some embodiments, the felting tool 20 is configured such that the repeated extension and retraction of the barbs 22 includes axial movement of the barbs in a reciprocating manner. In some embodiments, the device 10 is configured such that the reciprocating axial movement of the barbs entangles the fibers with the tissue and entangles the fibers with each other (as shown in FIG6B and 7B).

[0175] In Figure 4D, the felting tool 20 is configured to alternately push the barbs 22 through the fabric into the weave at different angles around a central axis (e.g., a vertical axis) VA of multiple barbs 22. The central vertical axis VA can be positioned, for example, between groups 90a and 90b of the barbs 22. During the felting process, after pushing the barbs into the weave at multiple different angles along the vertical axis VA at a single location along the longitudinal axis LA, the felting tool is pushed forward one step along the longitudinal axis. While driving the fibers into the weave, the process of extending the barbs 22 through the weave at multiple angles around the axis VA is repeated in a reciprocating manner. As shown in Figures 4A and 4C, the barbs 22 are arranged to avoid penetrating the fabric and weave along the path of the cord 16 even when rotating around the axis VA.

[0176] Referring now to Figures 5A-B, which are schematic diagrams of felting tools 120, 120a according to some embodiments. In Figure 5A, the textile 12 has been applied to the surface of the tissue 8 before the barbs 22 extend through both the textile 12 and the tissue 8. In Figure 5B, the textile 12 is applied to the surface of the tissue 8 as the barbs 22 rotate along the tissue.

[0177] In Figure 5A, the textile 12 is positioned above the surface of the tissue 8. The felting tool 120 includes a plurality of barbs 22 (which may be substantially as described above, with necessary modifications) mounted on a rotating cam 122 (e.g., a cylindrical roller), which is functionally associated with a drive belt (or drive rope) 124. Pulling the drive belt 124 causes the rotating cam 122 to rotate in the direction of arrow 126, thereby causing the barbs 22 to repeatedly enter and exit the textile 12 and the tissue surface, and to felt the textile as described above.

[0178] In Figure 5B, the drive belt 124 is shown as associated with the textile 12 such that pulling the drive belt feeds the textile 12 from the conduit 40 of the felting tool 120a and onto the surface of the tissue 8, and causes the barbs 22 to perform the felting process.

[0179] In some embodiments, the drive belt may be associated with the tether 16, or may actually be the tether. In some embodiments, each of the barbs 22 is associated with a spring or biasing element 128, which facilitates the retraction of the barbs from the fabric 8 and textile 12.

[0180] In some embodiments, instead of operating / powering the cam 122 from outside the subject (e.g., via a drive belt), it is rotated by causing the distal end of the felting tool to roll along the tissue and / or textile as it moves along the tissue. In some such embodiments, this rolling pulls the textile out of the conduit—for example, similar to a tape-based writing correction pen.

[0181] It should be understood that, according to some embodiments, the use of the felting tool 120 shown in Figures 5A-B can enable the actuation of the barb 22 to be faster than its linear actuation, as described above with respect to Figures 1A to 2D. This may be the case, for example, when comparing rotational actuation of the barb with actuation of the barb via a catheter or other long tube, where each movement at the proximal end of the catheter must be delivered to the distal end to activate the barb, and vice versa.

[0182] Referring now to Figures 6A-B, 7A-B, and 8, which are schematic diagrams of several non-limiting examples of textile fiber arrangements. Textiles 11, 13, and 15 are exemplary variations of textile 12 and can replace textile 12 in any of the embodiments discussed in Figures 1A-5. Figures 6A and 7A respectively show textiles 11 and 13, with the fibers constituting the textiles having different arrangements. Figures 6B and 7B illustrate the process of integrating textiles into the fabric during the felting process. Figure 8 shows an embodiment of woven textile 15 with a modified fiber arrangement.

[0183] In Figure 6A, the textile 11 is shown as a felt-like mass composed of fibers 11a. Such fibers have a random arrangement, which can facilitate the formation of inextricable knots within the fabric during the felting process shown in Figure 6B. The box shows an enlarged view of a single fiber 11a of the textile, revealing its rough outer surface. This rough surface of the fiber, particularly when contacted by the felting tool 20 (see, for example, Figure 1A, box III) with the notch 24 on the barb 22, can facilitate the integration of the fiber 11a into the fabric and / or facilitate the formation of fiber entanglements within the fabric.

[0184] In Figure 7A, textile 13 is shown as (e.g., loosely woven) fabric. The textile consists of two interlaced fiber layers at right angles, such as warp yarns 13a and weft yarns 13b, an arrangement that provides both strength and pre-felt integration of the two layers. The felting process shown in Figure 7B creates felt-like clumps of fibers within the fabric, where the right-angled fibers significantly resist pull forces. Barbs 22 engage and propel textile fibers 13a and fibers 13b that extend perpendicularly to and are distinct from fibers 13a within the fabric 8.

[0185] In Figure 8, a woven textile 15 similar to the woven textile shown in Figure 7A is shown at a higher magnification. Fibers 15a and 15b are woven into a loose fabric. Prior to use in the felting process, the weave is disrupted by creating breaks 18 in the warp fibers 15a and / or breaks 19 in the weft fibers 15b. These breaks advantageously allow the barbs to more easily push the fibers out of the fabric plane and into the weave. Breaks can be created in the weave by, for example, laser, ionizing radiation, or mechanical means. Similarly, chemical or mechanical treatments can be used to provide a rough surface to the fibers to enhance integration with the weave 8.

[0186] Referring again to Figures 6A-8, the specific arrangement of fibers in a textile can provide advantages and / or properties that may be particularly beneficial to fiber-tissue integration, thereby contributing to improved implant strength and lifespan within the tissue. Furthermore, the structure, surface, and / or chemical characteristics of the textile can have a considerable impact on integration success and the strength of the textile-tissue bond. For example, as a non-limiting example, textile fibers may include one or more of the following natural or synthetic molecular structures: collagen, cellulose, chitin, chitosan, silk, hydrogel, polypropylene, polytetrafluoroethylene, synthetic polymers, and / or natural polymers.

[0187] Various combinations of the aforementioned fiber types can be combined to enhance the integration and strength of the implant-tissue structure. In some embodiments, the textile may include different fiber types with different properties. For example, in the case where the textile includes a woven textile having warp and weft yarns, the warp yarns may include a first fiber type, and the weft yarns may include a second fiber type. In some embodiments, the textile may contain a radiopaque material, such as radiopaque fiber yarns.

[0188] In some implementations, the textile fibers may be treated prior to implantation to enhance integration (feltification) between the fibers and / or with the tissue. Such treatment may include, for example, biochemical treatment or coating of the fibers before / during / after implantation, pH adjustment, and / or coating with chemicals to stimulate cell growth, tissue repair, and / or scar formation. The textile may be configured such that mesenchymal stem cells can be incorporated into / on the textile prior to implantation, for example, incorporated into a hydrogel.

[0189] During the felting process, for example, as shown in Figures 6B and 7B, various additional steps may be included, such as applying intermittent pressure to the tissue, applying a pH-adjusting solution to the textile, and / or applying a solution of mesenchymal stem cells or hydrogel.

[0190] The various systems, devices, components, and equipment described in this disclosure can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safe use in patients, and the methods described herein may include such sterilization of associated systems, devices, components, and equipment (or additional methods that include or consist of said sterilization). Furthermore, for some applications, the scope of this disclosure includes sterilization of one or more of the various systems, devices, components, and equipment (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0191] Furthermore, any techniques, methods, operations, procedures, etc., described or suggested herein or in the references incorporated herein, and any methods using the systems, components, devices, apparatuses, etc., described herein, may be performed on a living subject (e.g., a human, other animals, etc.) or on a simulated object (e.g., a cadaver, a cadaver's heart, a simulated body, a virtual human, etc.). When performed on a simulated object, it may be assumed that body parts (e.g., a heart, tissue, valves, etc.) are simulated, or said body parts may be optionally referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valves, etc.) and may optionally include computerized and / or physical representations of body parts, tissues, etc. The term "simulated object" covers use in cases involving cadavers, computer simulators, virtual humans (e.g., if they are simply demonstrated in the air on an imaginary heart), etc.

[0192] This disclosure is not limited to what has been specifically shown and described above. Rather, the scope of this disclosure includes both combinations and sub-combinations of the various features described above, as well as variations and modifications thereof not found in the prior art, which will be apparent to those skilled in the art upon reading the foregoing description. Furthermore, the techniques, methods, operations, steps, etc., described or suggested herein can be performed on living animals or non-living replicas, such as on cadavers, cadaver hearts, replicas (e.g., simulated body parts, tissues, etc.).

[0193] Although some embodiments of the disclosed methods have been described in a specific chronological order for ease of presentation, it should be understood that this descriptive approach encompasses rearrangements unless the specific language used above requires a particular order. For example, in some cases, the operations or steps described in sequence may be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be combined with other methods. Additionally, this specification sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be identified by those skilled in the art.

[0194] Example Application(The following are some non-limiting examples of the concepts in this article):

[0195] Example 1. An apparatus for tissue of a real or simulated heart of a real or simulated subject, the apparatus comprising a textile, a tether, and / or a felting tool. The textile is configured to extend through the textile. The felting tool is pereluted into the real or simulated heart of the real or simulated subject. The felting tool includes a plurality of barbs at its distal end. When the textile contacts the tissue, the felting tool is adapted to secure the textile to the tissue by repeatedly performing the following operations: (i) extending the barbs through the textile and / or into the tissue to draw fibers of the textile into the tissue; and / or retracting the barbs to detach them from the tissue and / or the textile, while leaving the fibers within the tissue.

[0196] Example 2. The device according to Example 1, wherein the textile comprises a cell growth promoting substance.

[0197] Example 3. The apparatus according to any one of Examples 1 to 2, wherein the textile comprises a synthetic polymer.

[0198] Example 4. The device according to any one of Examples 1 to 3, wherein the textile comprises a natural polymer.

[0199] Example 5. The device according to any one of Examples 1 to 4, wherein the textile comprises a combination of multiple different fiber types.

[0200] Example 6. The device according to any one of Examples 1 to 5, wherein the textile comprises collagen.

[0201] Example 7. The apparatus according to any one of Examples 1 to 6, wherein the textile comprises cellulose.

[0202] Example 8. The apparatus according to any one of Examples 1 to 7, wherein the textile comprises chitin.

[0203] Example 9. The apparatus according to any one of Examples 1 to 8, wherein the textile comprises chitosan.

[0204] Example 10. The apparatus according to any one of Examples 1 to 9, wherein the textile comprises filaments.

[0205] Example 11. The device according to any one of Examples 1 to 10, wherein the textile comprises a hydrogel.

[0206] Example 12. The apparatus according to any one of Examples 1 to 11, wherein the textile comprises polytetrafluoroethylene.

[0207] Example 13. The apparatus according to any one of Examples 1 to 12, wherein the textile comprises polypropylene.

[0208] Example 14. The apparatus according to any one of Examples 1 to 13, wherein the textile is a woven textile.

[0209] Example 15. The apparatus according to any one of Examples 1 to 14, wherein the textile is a woven textile having weft yarns and / or warp yarns, the weft yarns comprising a first fiber type and / or the warp yarns comprising a second fiber type.

[0210] Example 16. The device according to any one of Examples 1 to 15, wherein the textile comprises a non-transparent material.

[0211] Example 17. The apparatus according to any one of Examples 1 to 16, wherein the textile is a nonwoven textile.

[0212] Example 18. The device according to any one of Examples 1 to 17, wherein the textile is a felted fiber mat.

[0213] Example 19. The device according to any one of Examples 1 to 18, wherein the felting tool is sterile.

[0214] Example 20. The apparatus according to any one of Examples 1 to 19, wherein the textile is sterile.

[0215] Example 21. The apparatus according to any one of Examples 1 to 20, wherein the felting tool is adapted to position the textile on the tissue.

[0216] Example 22. The device according to any one of Examples 1 to 21, wherein each of the barbs has a plurality of notches defined therein.

[0217] Example 23. The device according to Example 22, wherein the notch is configured to hook the fiber.

[0218] Example 24. The device according to Example 22, wherein the plurality of barbs have equal lengths to each other.

[0219] Example 25. The device according to Example 22, wherein the plurality of barbs have different lengths from each other.

[0220] Example 26. The device according to Example 22, wherein the felting tool is configured to extend and / or retract all the barbs synchronously with each other.

[0221] Example 27. The device according to Example 22, wherein the felting tool is configured to extend and / or retract the plurality of barbs in an interlaced manner.

[0222] Example 28. The device according to Example 22, wherein the felting tool is configured such that repeatedly extending and / or retracting the barb includes axially moving the barb in a reciprocating manner.

[0223] Example 29. The device according to Example 28, wherein the device is configured such that the reciprocating axial movement of the barb entangles the fiber with the tissue and / or entangles the fiber with each other.

[0224] Example 30. The device according to any one of Examples 1 to 29 includes a first longitudinal catheter configured to advance through a lumen to an anatomical site of the subject, the first longitudinal catheter having a proximal portion and / or a steerable distal portion, and / or wherein the textile can be advanced via the first longitudinal catheter into the heart of the real or simulated subject.

[0225] Example 31. The device according to Example 30, wherein the felting tool can be advanced into the heart of the real or simulated subject via the first longitudinal catheter.

[0226] Example 32. The device according to any one of Examples 1 to 31 further includes a second longitudinal catheter configured to be advanced via a lumen to an anatomical site of the subject, the second longitudinal catheter having a proximal portion and / or a steerable distal portion, and / or wherein the felting tool can be advanced via the second longitudinal catheter into the heart of the real or simulated subject.

[0227] Example 33. The device according to any one of Examples 1 to 32, wherein the textile and / or the felting tool are simultaneously advanced into the heart of the real or simulated subject, such that when a portion of the textile comes into contact with the tissue, the barbs secure the portion of the textile to the tissue.

[0228] Example 34. The device according to any one of Examples 1 to 33, wherein the entire textile is in contact with the tissue before any portion of the textile is secured to the tissue.

[0229] Example 35. The device according to Example 34 further includes at least one tissue anchor, the at least one tissue anchor being adapted to be advanced into the heart of the real or simulated subject, and / or adapted to temporarily anchor the textile to the tissue before it is secured to the tissue by the felting tool.

[0230] Example 36. The device according to any one of Examples 1 to 35, wherein the tether is not pierced by the barb when the barb of the felting tool passes through the textile distally.

[0231] Example 37. The device according to any one of Examples 1 to 36, wherein the barb engages a first longitudinal section of the textile and / or secures the first longitudinal section to the fabric, and / or wherein the tether extends through a second longitudinal section of the textile, the second longitudinal section being parallel to and / or different from the first longitudinal section.

[0232] Example 38. The device according to Example 37, wherein the tether comprises a first tether segment extending along a first lateral edge of the textile, and / or a second tether segment extending along a second lateral edge of the textile parallel to the first tether segment, such that a longitudinal gap is formed along the textile between the first tether segment and / or the second tether segment, and / or wherein the barb is adapted to secure the textile to the tissue along the longitudinal gap.

[0233] Example 39. The device according to Example 37, wherein the tether extends along a single longitudinal length of the textile, and / or wherein the plurality of barbs define a first set of barbs and / or a second set of barbs having a gap therebetween, wherein the barbs are adapted to secure the textile to the fabric along the width of the textile such that during the securing process the tether is positioned within the gap between the first set of barbs and / or the second set of barbs.

[0234] Example 40. The device according to any one of Examples 1 to 39, wherein at least one end of the tether extends outside the subject's body and / or can be operated to tension the tether.

[0235] Example 41. The device according to any one of Examples 1 to 40 further includes a frame, wherein the frame is adapted to hold the textile in place relative to the tissue during operation of the felting tool.

[0236] Example 42. The device according to any one of Examples 1 to 41 further includes at least one implant attached to the textile via the tether, the implant being adapted for transcavitary advancement into the heart of the real or simulated subject and / or for attachment to the tissue by securing the textile to the tissue.

[0237] Example 43. The device according to any one of Examples 1 to 42, wherein the longitudinal axes of the plurality of barbs are arranged in a plane such that the distal tips of the plurality of barbs form a straight line.

[0238] Example 44. The device according to any one of Examples 1 to 43, wherein the plurality of barbs are arranged such that their distal tips form an annular or circular shape.

[0239] Example 45. The device according to any one of Examples 1 to 44, wherein: (i) the felting tool includes a rotating cam associated with a drive belt; and / or (ii) the plurality of barbs are arranged along the rotating cam such that pulling the drive belt causes the rotating cam to rotate, thereby pushing the barbs sequentially through the textile and into the fabric as the cam rolls along the textile.

[0240] Example 46. The device according to Example 45, wherein each of the plurality of barbs is attached to the rotary cam by a biasing element adapted to assist the barb in rapid insertion into and / or extraction from the textile and / or the tissue.

[0241] Example 47. The apparatus according to Example 45, wherein pulling the drive belt is also adapted to feed the textile onto the tissue prior to felting the tissue.

[0242] Example 48. The device according to Example 45, wherein the drive belt is associated with or is the tether extending through the textile.

[0243] Example 49. A method for using tissue of a real or simulated heart of a real or simulated subject, the method comprising: (i) advancing a textile into the heart of the real or simulated subject, the textile having a tether extending therethrough; (ii) bringing the textile into contact with a surface of tissue of the heart of the real or simulated subject; (iii) advancing a felting tool into the heart of the real or simulated subject, the felting tool including a plurality of barbs at its distal end; (iv) securing the textile to the tissue by moving the felting tool across the textile in a reciprocating manner through the plurality of barbs: (a) moving distally through the textile and / or into the tissue such that fibers of the textile are pushed into the tissue; and / or (b) moving proximally out of the tissue and / or the textile such that the fibers remain within the tissue; and / or (v) tensioning the tether after securing the textile.

[0244] Example 50. The method according to Example 49 further includes applying intermittent pressure to the felted tissue during the fixing step.

[0245] Example 51. The method according to any one of Examples 49 to 50 further includes applying a pH-adjusting solution to the textile during the fixing step.

[0246] Example 52. The method according to any one of Examples 49 to 51 further includes applying a composition of mesenchymal stem cells to the tissue after fixing the textile, the textile providing a scaffold for the growth of the mesenchymal stem cells.

[0247] Example 53. The method according to any one of Examples 49 to 52, wherein the textile is a nonwoven textile, and / or wherein the propulsion of the textile comprises propulsing the nonwoven textile into the heart of the real or simulated subject.

[0248] Example 54. The method according to Example 53, wherein the nonwoven textile is felt, and / or the propulsion of the nonwoven textile comprises propulsing the felt into the heart of the real or simulated subject.

[0249] Example 55. The method according to any one of Examples 49 to 54 further includes sterilizing the felting tool before advancing it.

[0250] Example 56. The method according to any one of Examples 49 to 55 further includes sterilizing the textile before it is fed into the fabric.

[0251] Example 57. The method according to any one of Examples 49 to 56, wherein the propulsion of the textile comprises propulsing the textile with the tether extending longitudinally through the textile.

[0252] Example 58. The method according to any one of Examples 49 to 57, wherein the tension of the tether will contract the textile.

[0253] Example 59. The method according to any one of Examples 49 to 58, wherein the advancement of the textile comprises pushing the textile distally through a first longitudinal conduit or passing the textile distally through a first longitudinal conduit.

[0254] Example 60. The method according to Example 59, wherein advancing the felting tool includes pushing the felting tool distally through a first longitudinal conduit or through the first longitudinal conduit distally.

[0255] Example 61. The method according to Example 59, wherein advancing the felting tool includes pushing the felting tool distally through the second longitudinal conduit or through the second longitudinal conduit distally.

[0256] Example 62. The method according to any one of Examples 49 to 61, wherein the textile comprises a first portion and / or a second portion, wherein the contact and / or fixation of the first portion of the textile occurs prior to the contact and / or fixation of the second portion of the textile.

[0257] Example 63. The method according to any one of Examples 49 to 62, wherein the contact between the textile and the surface of the organization occurs before any portion of the textile is fixed to the organization.

[0258] Example 64. The method according to Example 63 further includes anchoring the textile to the tissue using at least one tissue anchor before attaching the textile to the tissue.

[0259] Example 65. The method according to Example 64 further includes removing the at least one tissue anchor after securing the textile to the tissue.

[0260] Example 66. The method according to any one of Examples 49 to 65, wherein securing the textile to the fabric comprises securing the textile such that the tether is not damaged by the barbs.

[0261] Example 67. The method according to any one of Examples 49 to 66, wherein securing the textile to the tissue comprises securing the textile such that the tether is not pushed into the tissue by the barb.

[0262] Example 68. The method according to any one of Examples 49 to 67, wherein securing the textile to the fabric comprises securing a first longitudinal section of the textile to the fabric, and / or wherein the tether extends through a second longitudinal section of the textile, the second longitudinal section being parallel to and / or different from the first longitudinal section.

[0263] Example 69. The method according to Example 68, wherein the tether comprises a first tether segment extending along a first lateral edge of the textile, and / or a second tether segment extending along a second lateral edge of the textile parallel to the first tether segment, such that a longitudinal gap is formed along the textile between the first tether segment and the second tether segment, and / or wherein the securing of the textile comprises securing the textile to the tissue along the longitudinal gap.

[0264] Example 70. The method according to Example 68, wherein: (i) the tether extends along a single longitudinal length of the textile, (ii) the plurality of barbs includes a first set of barbs and / or a second set of barbs having a gap therebetween, and / or (iii) securing the textile to the fabric includes securing the textile to the fabric along the width of the textile such that during the securing, the tether is positioned within the gap between the first set of barbs and the second set of barbs.

[0265] Example 71. The method according to any one of Examples 49 to 70, wherein the end of the tether extends outside the subject's body, and / or wherein the tensioning includes pulling the end of the tether located outside the subject's body.

[0266] Example 72. The method according to any one of Examples 49 to 71 further includes advancing the frame into the heart of the real or simulated subject, and / or wherein contacting the textile with the tissue includes placing the textile on the frame such that the textile is held in place relative to the tissue and / or in contact with the tissue.

[0267] Example 73. The method according to any one of Examples 49 to 72, wherein the textile has an implant attached thereto via the tether, the method further comprising advancing the implant via a cavity into the heart of the real or simulated subject, and / or wherein securing the textile to the tissue causes the implant to be secured to the heart of the real or simulated subject.

[0268] Example 74. The method according to any one of Examples 49 to 73, wherein securing the textile to the tissue comprises pulling a drive belt associated with a rotating cam having a plurality of barbs mounted thereon, thereby causing the rotating cam to rotate and / or causing the plurality of barbs to move in a reciprocating manner through the textile and / or into the tissue and / or proximally out of the tissue and / or the textile.

[0269] Example 75. An apparatus for tissue of a real or simulated subject, the apparatus comprising: (i) a textile permissible through a cavity into the real or simulated subject, and / or (i) a felting tool. The textile comprises a plurality of fibers. The felting tool is permissible through a cavity into the subject, and / or includes one or more barbs at its distal end. When the textile contacts the tissue, the one or more barbs are adapted to secure the textile to the tissue by repeatedly performing the following movements: (i) distally through the textile and / or moving into the tissue to draw the fibers of the textile into the tissue; and / or (ii) proximally removing the tissue and / or the textile while leaving the fibers within the tissue.

[0270] Example 76. The apparatus according to Example 75, wherein the textile is a woven textile.

[0271] Example 77. The apparatus according to any one of Examples 75 to 76, wherein the textile comprises a cell growth promoting substance.

[0272] Example 78. The apparatus according to any one of Examples 75 to 77, wherein the textile comprises a synthetic polymer.

[0273] Example 79. The apparatus according to any one of Examples 75 to 78, wherein the textile comprises a natural polymer.

[0274] Example 80. The apparatus according to any one of Examples 75 to 79, wherein the textile comprises a combination of a variety of different fiber types.

[0275] Example 81. The device according to any one of Examples 75 to 80, wherein the textile comprises collagen.

[0276] Example 82. The apparatus according to any one of Examples 75 to 81, wherein the textile comprises cellulose.

[0277] Example 83. The apparatus according to any one of Examples 75 to 82, wherein the textile comprises chitin.

[0278] Example 84. The apparatus according to any one of Examples 75 to 83, wherein the textile comprises chitosan.

[0279] Example 85. The apparatus according to any one of Examples 75 to 84, wherein the textile comprises filaments.

[0280] Example 86. The device according to any one of Examples 75 to 85, wherein the textile comprises a hydrogel.

[0281] Example 87. The apparatus according to any one of Examples 75 to 86, wherein the textile comprises polytetrafluoroethylene.

[0282] Example 88. The apparatus according to any one of Examples 75 to 87, wherein the textile comprises polypropylene.

[0283] Example 89. The apparatus according to any one of Examples 75 to 88, wherein the textile is a woven textile.

[0284] Example 90. The apparatus according to any one of Examples 75 to 89, wherein the textile is a woven textile having weft yarns and / or warp yarns, the weft yarns comprising a first fiber type and / or the warp yarns comprising a second fiber type.

[0285] Example 91. The device according to any one of Examples 75 to 90, wherein the textile comprises a non-transparent material.

[0286] Example 92. The apparatus according to any one of Examples 75 to 91, wherein the textile is a nonwoven textile.

[0287] Example 93. The apparatus according to any one of Examples 75 to 92, wherein the textile is felt.

[0288] Example 94. The device according to any one of Examples 75 to 93, wherein the felting tool is sterile.

[0289] Example 95. The apparatus according to any one of Examples 75 to 94, wherein the textile is sterile.

[0290] Example 96. The apparatus according to any one of Examples 75 to 95, wherein the felting tool is adapted to position the textile on the tissue.

[0291] Example 97. The device according to any one of Examples 75 to 96, wherein each of the one or more barbs of the felting tool includes one or more notches.

[0292] Example 98. The device according to any one of Examples 75 to 97 further includes a first longitudinal catheter configured to advance through a lumen to an anatomical site of the subject, the first longitudinal catheter having a proximal portion and / or a steerable distal portion, and / or wherein the textile can be advanced via the first longitudinal catheter into the heart of the real or simulated subject.

[0293] Example 99. The device according to Example 98, wherein the felting tool can be advanced into the heart of the real or simulated subject via the first longitudinal catheter.

[0294] Example 100. The device according to any one of Examples 75 to 99 further includes a second longitudinal catheter configured to be advanced via a lumen to an anatomical site of the subject, the second longitudinal catheter having a proximal portion and / or a steerable distal portion, and / or wherein the felting tool is advanceable via the second longitudinal catheter into the heart of the real or simulated subject.

[0295] Example 101. The device according to any one of Examples 75 to 100, wherein the textile and / or the felting tool are simultaneously advanced into the heart of the real or simulated subject, such that when a portion of the textile comes into contact with the tissue, the one or more barbs secure the portion of the textile to the tissue.

[0296] Example 102. The apparatus according to any one of Examples 75 to 101, wherein the entire textile is in contact with the tissue before any portion of the textile is secured to the tissue.

[0297] Example 103. The device according to Example 102 further includes at least one tissue anchor, the at least one tissue anchor being adapted to be advanced into the heart of the real or simulated subject, and / or adapted to temporarily anchor the textile to the tissue before it is secured to the tissue by the felting tool.

[0298] Example 104. The device according to any one of Examples 75 to 103 further includes a cord, wherein the barbs engage a first longitudinal section of the textile and / or secure the first longitudinal section to the fabric, and / or wherein the cord extends through a second longitudinal section of the textile, the second longitudinal section being parallel to and / or different from the first longitudinal section.

[0299] Example 105. The device according to Example 104, wherein the tether comprises a first tether segment extending along a first lateral edge of the textile, and / or a second tether segment extending along a second lateral edge of the textile parallel to the first tether segment, such that a longitudinal gap is formed along the textile between the first tether segment and / or the second tether segment, and / or wherein the barb is adapted to secure the textile to the tissue along the longitudinal gap.

[0300] Example 106. The device according to Example 104 further includes a cord, wherein the cord extends along a single longitudinal length of the textile, and / or wherein the felting tool comprises a first set of barbs and / or a second set of barbs having a gap therebetween, wherein the barbs are adapted to secure the textile to the fabric along the width of the textile, such that during the securing process the cord is positioned within the gap between the first set of barbs and / or the second set of barbs.

[0301] Example 107. The device according to any one of Examples 75 to 106 further includes a tether, wherein at least one end of the tether extends outside the subject's body and / or can be operated to tension the tether.

[0302] Example 108. The device according to any one of Examples 75 to 107 further includes a frame, wherein the frame is adapted to hold the textile in place relative to the tissue during operation of the felting tool.

[0303] Example 109. The device according to any one of Examples 75 to 108 further includes a tether and / or at least one implant, said at least one implant being attached to the textile via the tether, said implant being adapted for transcavitary advancement into the heart of the real or simulated subject and / or being attached to the tissue by securing the textile to the tissue.

[0304] Example 110. The device according to any one of Examples 75 to 109, wherein each of the one or more barbs defines a longitudinal axis, the longitudinal axis of the one or more barbs being arranged in a plane such that the distal tips of the one or more barbs form a straight line.

[0305] Example 111. The device according to any one of Examples 75 to 110, wherein the one or more barbs are arranged such that their distal tips form an annular or circular shape.

[0306] Example 112. The device according to any one of Examples 75 to 111, wherein: (i) the felting tool includes a rotary cam associated with a drive belt; and / or (ii) the plurality of barbs are arranged along the rotary cam such that pulling the drive belt causes the rotary cam to rotate, thereby pushing the barbs sequentially through the textile and into the fabric as the cam rolls along the textile.

[0307] Example 113. The device according to Example 112, wherein each of the one or more barbs is attached to the rotary cam by a biasing element adapted to assist the one or more barbs in rapid insertion into and / or extraction from the textile and / or the tissue.

[0308] Example 114. The apparatus according to Example 112, wherein pulling the drive belt is also adapted to feed the textile onto the tissue prior to felting the tissue.

Claims

1. A device for use with tissue from the heart of a subject, the device comprising: Textiles; A tie that extends through the textile; And a felting tool capable of being inserted into the heart of the subject via a cavity, the felting tool including a plurality of barbs at its distal end, wherein when the textile contacts the tissue, the felting tool is adapted to secure the textile to the tissue by repeatedly performing the following operations: extending the barbs through the textile and into the tissue to draw the fibers of the textile into the tissue; And retract the barbs to detach them from the tissue and the textile, while leaving the fibers within the tissue.

2. The apparatus of claim 1, wherein the textile comprises a cell growth promoting substance.

3. The apparatus according to any one of claims 1 to 2, wherein the textile comprises a synthetic polymer.

4. The apparatus according to any one of claims 1 to 3, wherein the textile comprises a natural polymer.

5. The apparatus according to any one of claims 1 to 4, wherein the textile comprises a combination of a variety of different fiber types.

6. The device according to any one of claims 1 to 5, wherein the textile comprises collagen.

7. The apparatus according to any one of claims 1 to 6, wherein the textile comprises cellulose.

8. The apparatus according to any one of claims 1 to 7, wherein the textile comprises chitin.

9. The apparatus according to any one of claims 1 to 8, wherein the textile comprises chitosan.

10. The apparatus according to any one of claims 1 to 9, wherein the textile comprises filaments.

11. The device according to any one of claims 1 to 10, wherein the textile comprises a hydrogel.

12. The apparatus according to any one of claims 1 to 11, wherein the textile comprises polytetrafluoroethylene.

13. The apparatus according to any one of claims 1 to 12, wherein the textile comprises polypropylene.

14. The apparatus according to any one of claims 1 to 13, wherein the textile is a woven textile.

15. The apparatus according to any one of claims 1 to 14, wherein the textile is a woven textile having weft yarns and warp yarns, the weft yarns comprising a first fiber type and the warp yarns comprising a second fiber type.

16. The device according to any one of claims 1 to 15, wherein the textile comprises a non-transparent material.

17. The apparatus according to any one of claims 1 to 16, wherein the textile is a nonwoven textile.

18. The apparatus according to any one of claims 1 to 17, wherein the textile is a felted fiber mat.

19. The device according to any one of claims 1 to 18, wherein the felting tool is sterile.

20. The apparatus according to any one of claims 1 to 19, wherein the textile is sterile.

21. The apparatus according to any one of claims 1 to 20, wherein the felting tool is adapted to position the textile on the tissue.

22. The device according to any one of claims 1 to 21, wherein each of the barbs has a plurality of notches defined therein.

23. The device of claim 22, wherein the notch is configured to hook the fiber.

24. The device of claim 22, wherein the plurality of barbs have equal lengths to each other.

25. The device of claim 22, wherein the plurality of barbs have different lengths from each other.

26. The apparatus of claim 22, wherein the felting tool is configured to extend and retract all the barbs synchronously with each other.

27. The device of claim 22, wherein the felting tool is configured to extend and retract the plurality of barbs in an alternating manner.

28. The apparatus of claim 22, wherein the felting tool is configured such that repeatedly extending and retracting the barb includes axially moving the barb in a reciprocating manner.

29. The device of claim 28, wherein the device is configured such that the reciprocating axial movement of the barbs entangles the fibers with the tissue and causes the fibers to entangle with each other.

30. The device according to any one of claims 1 to 29, comprising a first longitudinal catheter configured to be advanced via a lumen to an anatomical site of the subject, the first longitudinal catheter having a proximal portion and a steerable distal portion, and wherein the textile is capable of being advanced via the first longitudinal catheter into the heart of the subject.

31. The device of claim 30, wherein the felting tool is capable of being advanced into the heart of the subject via the first longitudinal catheter.

32. The device according to any one of claims 1 to 31, further comprising a second longitudinal catheter configured to be advanced via a lumen to an anatomical site of the subject, the second longitudinal catheter having a proximal portion and a steerable distal portion, and wherein the felting tool is capable of being advanced via the second longitudinal catheter into the heart of the subject.

33. The device according to any one of claims 1 to 32, wherein the textile and the felting tool are simultaneously advanced into the heart of the subject such that when a portion of the textile comes into contact with the tissue, the barbs secure the portion of the textile to the tissue.

34. The device according to any one of claims 1 to 33, wherein the entire textile is in contact with the tissue before any portion of the textile is secured to the tissue.

35. The device of claim 34, further comprising at least one tissue anchor, the at least one tissue anchor being adapted to be advanced into the heart of the subject and adapted to temporarily anchor the textile to the tissue prior to securing the textile to the tissue by the felting tool.

36. The device according to any one of claims 1 to 35, wherein the tether is not pierced by the barb when the barb of the felting tool passes distally through the textile.

37. The device according to any one of claims 1 to 36, wherein the barb engages a first longitudinal section of the textile and secures the first longitudinal section to the fabric, and wherein the tether extends through a second longitudinal section of the textile, the second longitudinal section being parallel to and different from the first longitudinal section.

38. The device of claim 37, wherein the tether comprises a first tether extending along a first lateral edge of the textile and a second tether extending along a second lateral edge of the textile parallel to the first tether, such that a longitudinal gap is formed along the textile between the first tether and the second tether, and wherein the barb is adapted to secure the textile to the tissue along the longitudinal gap.

39. The device of claim 37, wherein the tether extends along a single longitudinal length of the textile, and wherein the plurality of barbs defines a first set of barbs and a second set of barbs having a gap therebetween, wherein the barbs are adapted to secure the textile to the fabric along the width of the textile such that the tether is positioned within the gap between the first set of barbs and the second set of barbs during the securing process.

40. The device according to any one of claims 1 to 39, wherein at least one end of the tether extends outside the subject's body and is operable to tension the tether.

41. The device according to any one of claims 1 to 40, further comprising a frame, wherein the frame is adapted to hold the textile in place relative to the tissue during operation of the felting tool.

42. The device according to any one of claims 1 to 41, further comprising at least one implant attached to the textile via the tether, the implant being adapted for transcavitary advancement into the heart of the subject and attached to the tissue by securing the textile to the tissue.

43. The device according to any one of claims 1 to 42, wherein the longitudinal axes of the plurality of barbs are arranged in a plane such that the distal tips of the plurality of barbs form a straight line.

44. The device according to any one of claims 1 to 43, wherein the plurality of barbs are arranged such that their distal tips form annular or circular shapes.

45. The device according to any one of claims 1 to 44, wherein: The felting tool includes a rotating cam associated with a drive belt; and the plurality of barbs are arranged along the rotating cam such that pulling the drive belt causes the rotating cam to rotate, thereby pushing the barbs sequentially through the fabric and into the fabric as the cam rolls along the fabric.

46. ​​The apparatus of claim 45, wherein each of the plurality of barbs is attached to the rotary cam by a biasing element adapted to assist the barb in rapid insertion into and extraction from the textile and the fabric.

47. The apparatus of claim 45, wherein pulling the drive belt is further adapted to feed the textile onto the tissue prior to felting the tissue.

48. The device of claim 45, wherein the drive belt is associated with or is the tether extending through the textile.

49. A method for using tissue of a simulated heart in a subject, the method comprising: The textile is pushed into the heart of the subject, the textile having a cord extending through it; The textile is brought into contact with the surface of the tissue of the subject's heart; a felting tool is advanced into the subject's heart, the felting tool having a plurality of barbs at its distal end; the textile is secured to the tissue by moving the felting tool across the textile in a reciprocating manner through the plurality of barbs: (i) moving distally through the textile and into the tissue, such that the fibers of the textile are pushed into the tissue; and (ii) removing the tissue and the textile proximally, leaving the fibers within the tissue; And after securing the textile, tension the tether.

50. A device for use with tissue of a subject, the device comprising: A textile fabric capable of being propelled into the subject's body via a cavity, the textile fabric comprising multiple fibers; And a felting tool, the felting tool being able to be inserted into the subject body via a cavity, the felting tool including one or more barbs at its distal end, wherein when the textile contacts the tissue, the one or more barbs are adapted to secure the textile to the tissue by repeatedly performing the following movements: extending distally through the textile and moving into the tissue to draw the fibers of the textile into the tissue; And move the tissue and the textile proximally while leaving the fibers within the tissue.

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