Device and system for grasping tissue at muscular level

Abstract

To provide an improved device, system and method for repairing muscle tissue walls.SOLUTION: The present invention relates to a tissue repair device, system, and method for grasping tissue, such as to repair the tissue (e.g., a defect in tissue), by anchoring a tissue-penetrating arm along a first location along the tissue, moving the anchored tissue-penetrating arm to a second location along the tissue, and grasping tissue at the second location with a tissue-grasping arm. The tissue-penetrating arm remains in a substantially axial straight configuration to facilitate tissue penetration. The tissue-grasping arm is movable towards and away from the tissue-penetrating arm to grasp tissue and hold the grasped tissue between the tissue-grasping arm and the tissue-penetrating arm. The tissue repair device may be left in place while holding the tissue in the grasped configuration.SELECTED DRAWING: Figure 3A

Description

Technical Field

[0001] The present disclosure generally relates to devices, systems, and methods for grasping tissue at the muscle level. More particularly, the present disclosure relates to devices, systems, and methods for repairing muscle tissue walls.

Background Art

[0002] Endoscopic treatment techniques such as EMR (endoscopic mucosal resection) and ESD (endoscopic submucosal dissection) are often performed as treatments / preventions for several conditions inside the gastrointestinal track. Mechanical closure of lesions using hemostatic clips often follows these endoscopic procedures. Through-The-Scope clip (TTS) has been most widely used to repair defects inside the digestive tract because it is relatively easy to use. However, currently commercially available TTS clips are designed to close defects at the surface level, i.e., defects in the mucosal and submucosal layers of tissue. Some procedures require deeper closure along the thickness up to the muscle layer of the tissue depending on the size and depth of the defect. To achieve this, physicians often resort to the use of other devices such as Over-The-Scope-Clip (OTSC) due to their larger size and strength which are beneficial for closing defects in deeper layers. Still, these devices are generally more difficult to use and do not provide the controlled actuation like TTS clips.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Accordingly, improved devices, systems, and methods for providing closure of tissue, such as defects in tissue, in the muscle layer should be welcome in the medical field. **Means for Solving the Problem**

[0004] This summary of the disclosure is provided to aid understanding and those skilled in the art will understand that each of the various aspects and features of the disclosure can be used advantageously either separately or, in other cases, in combination with other aspects and features of the disclosure. No limitation is intended by inclusion or non-inclusion of elements, components, or the like in this summary with respect to the scope of the claimed subject matter.

[0005] According to various principles of the present disclosure, tissue repair devices and related systems and methods are capable of penetrating muscle tissue to repair muscle tissue or otherwise affect muscle tissue.

[0006] According to some aspects of the present disclosure, a tissue repair device includes a tubular component having a longitudinal axis and a lumen defined therein, and a tissue penetration arm and a tissue grasping arm extendable from within the lumen of the tubular component to a position outside the lumen of the tubular component. The tissue penetration arm is maintained in a position substantially parallel to the longitudinal axis of the tubular component when extended to a position outside the lumen of the tubular component. The tissue grasping arm is movable toward or away from the tissue penetration arm with respect to the longitudinal axis of the tubular component.

[0007] In some embodiments of the tissue repair device, the tissue grasping arm is biased to move away from the tissue penetration arm when extended to a position outside the lumen of the tubular component, and the tissue penetration arm and the tissue grasping arm are in a closed configuration while within the lumen of the tubular component and in an open position when extended to a position outside the lumen of the tubular component.

[0008] In some embodiments of the tissue repair device, the tissue penetrating arm includes a sharp edge or tip configured to penetrate tissue. Additionally, or alternatively, the tissue penetrating arm has a length sufficient to penetrate the mucosal, submucosal, and muscular layers of the small intestine without penetrating the wall of the small intestine. Additionally, or alternatively, the tissue grasping arm has a blunt distal end. Additionally, or alternatively, the tissue grasping arm is configured to limit the depth to which the tissue penetrating arm can penetrate tissue. Additionally, or alternatively, the tissue penetrating arm includes a sharp distal end and a tissue penetrating hook positioned proximally relative to the sharp distal end. In some embodiments, the tissue penetrating hook extends laterally relative to the longitudinal axis of the tubular component. In some embodiments, the tissue penetrating hook is shaped and configured to hold tissue in place when the tissue penetrating arm is moved laterally. In some embodiments, the tissue grasping arm includes at least one tissue grasping hook. In some embodiments, the tissue grasping hook faces the tissue penetrating arm. In some embodiments, the tissue grasping hook includes a pair of tissue grasping hooks, and the tissue penetrating arm fits between the tissue grasping hooks when the tissue grasping arm is moved toward the tissue penetrating arm. In some embodiments, the tissue penetrating arm includes at least one hook shaped and configured to hold tissue in place when at least one of the tissue grasping arm or the tissue penetrating arm is moved laterally.

[0009] According to a further aspect of the present disclosure, a tissue repair system includes a flexible elongate member having a lumen defined therein and a longitudinal axis extending between a distal end of the flexible elongate member and a proximal end of the flexible elongate member; a pair of gripper arms that are shaped and configured differently from each other and are extendable from a position inside the lumen of the flexible elongate member to a position outside the lumen of the flexible elongate member; a control device having a proximal end and a distal end, wherein the distal end of the control device is connected to the gripper arms to move the gripper arms between a position inside the lumen of the flexible elongate member and a position distally outside the lumen of the flexible elongate member; and a control handle connected to the proximal ends of the flexible elongate member and the control device to control the movement of the flexible elongate member and the proximal end of the control device.

[0010] In some embodiments of the tissue repair system, the gripper arms include a tissue penetration arm that is maintained in a position substantially parallel to the longitudinal axis of the flexible elongate member when extended outside the lumen of the flexible elongate member, and a tissue gripping arm that is movable toward or away from the tissue penetration arm with respect to the longitudinal axis of the flexible elongate member. In some embodiments, the tissue repair system further includes a capsule connected to and defining a lumen therethrough at the distal end of the flexible elongate member, and the gripper arms are movable between a closed configuration within the capsule and an open configuration outside the capsule. In some embodiments, the capsule is separable from the flexible elongate member with the gripper arms positioned therein in the closed position.

[0011] According to a further aspect of the present disclosure, a method of repairing tissue includes axially advancing a tissue penetrating arm of a tissue repair device into tissue at a first location along a treatment site to anchor the tissue penetrating arm within the tissue at the first location; moving the tissue penetrating arm along the treatment site to a second location; gripping the tissue at the second location with a tissue gripping arm of the tissue repair device that extends laterally away from the tissue penetrating arm; and moving the tissue gripping arm toward the tissue penetrating arm to hold together the tissue at the first location and the tissue at the second location.

[0012] In some embodiments, the tissue penetrating arm is maintained in a substantially straight configuration during the tissue repair method. Additionally or alternatively, the tissue repair device includes a capsule surrounding proximal ends of the tissue gripping arm and the tissue penetrating arm and is coupled to a control device configured and arranged to control movement of the tissue penetrating arm and the tissue gripping arm, and the method further includes pulling the capsule away from the control device while the tissue gripping arm and the tissue penetrating arm within the capsule are in a closed configuration in which they grip the tissue at the first and second locations to close a tissue defect therebetween.

[0013] The foregoing and other features and advantages of the present disclosure will become readily apparent from the following detailed description, from the claims set forth in the appended claims defining the scope of the claimed invention. The following disclosure is presented from the perspective of aspects or embodiments, but it should be recognized that individual aspects may be claimed separately or in combination with aspects and features of their embodiments or any other embodiments.

[0014] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures in the drawings may vary. For example, a device may be enlarged so that details are distinguishable, but is intended to be reduced in connection with fitting within, for example, a delivery catheter or the working channel of an endoscope. In the figures, elements that are the same, nearly the same, or equivalent are typically represented by the same reference characters, and similar elements are typically designated using similar reference numbers that differ by increments of 100, with redundant description omitted. For clarity and simplicity, not all elements are labeled in all figures, and not all elements of each embodiment are shown where illustration is not necessary to enable one of ordinary skill in the art to understand the present disclosure.

[0015] The detailed description will be better understood in conjunction with the accompanying drawings in which like reference characters represent like elements.

Brief Description of the Drawings

[0016]

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DETAILED DESCRIPTION OF THE INVENTION

[0017] The following detailed description should be read with reference to the drawings that depict exemplary embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described and can therefore vary. All of the apparatus, systems, and methods discussed herein are examples of apparatus and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles, but is merely an example. Thus, references to elements or structures or features in the drawings must be recognized as references to examples of embodiments of the present disclosure and should not be understood as limiting the present disclosure to the specific elements, structures, or features illustrated. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure. In fact, it will become apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the scope or spirit of the subject matter. By way of example, features illustrated or described as part of one embodiment can be used with another embodiment to obtain a further embodiment. Thus, the subject matter is intended to cover modifications and variations that fall within the scope of the appended claims and their equivalents.

[0018] It will be recognized that the present disclosure is described at various levels of detail in this application. In some cases, details that are not necessary for those skilled in the art to understand the present disclosure or that make other details difficult to grasp may be omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit beyond the scope recited in the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by those skilled in the art to which the present disclosure pertains. All of the devices and / or methods disclosed and claimed herein are capable of being made and executed without undue experimentation in light of the present disclosure.

[0019] As used herein, "proximal" means the direction or location closest to a user (such as a healthcare provider, clinician, technician, operator, or physician, etc., such terms being used interchangeably without limitation or other intent) when using the device (e.g., when introducing the device to a patient, or during implantation, positioning, or delivery), and "distal" means the direction or location farthest from the user when using the device (e.g., when introducing the device to a patient, or during implantation, positioning, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Central" means at least generally bisecting a central point, and "central axis" means, with respect to an opening, a line that extends longitudinally along the length of the opening and at least generally bisects the central point of the opening when the opening comprises, for example, a tubular element, channel, cavity, or bore.

[0020] Tissue repair devices configured to repair tissue defects, such as in a muscle layer, as well as associated systems and methods, are disclosed and described herein. It will be recognized that references to tissue repair are for convenience only and are not intended to be limiting, as further applications and uses of the devices, systems, and methods disclosed herein are within the scope and spirit of the present disclosure. Further, references to tissue defects herein are for convenience only and are not intended to be limiting, and are intended to mean tissue sites where there is another separation of tissue, such as a wound, lesion, gap, fissure, crack, incision, laceration, perforation, fistula, stapling, etc., or tissue along a defect, tissue around a defect, tissue surrounding a defect, etc., defining sides, edges, etc. (in each individual listing of terms, such terms may be used interchangeably herein without limitation).

[0021] In various embodiments disclosed herein, tissue repair devices according to various aspects of the present disclosure have at least two arms. One of the arms may be configured differently from another arm, whereby it may perform or fulfill different functions. In some embodiments, one of the arms of a tissue repair device formed in accordance with various aspects of the present disclosure is configured to be a tissue-penetrating arm that can penetrate tissue such as intestinal tissue into the muscle layer of the tissue (e.g., beyond the mucosal and submucosal layers such as intestinal tissue). In some embodiments, the tissue-penetrating arm includes at least one sharp region such as a sharp tip (e.g., distal end) and / or a sharp longitudinal edge to penetrate an upper tissue layer such as the muscle layer of the tissue and reach the muscle tissue layer.

[0022] In some embodiments, the other arm of the tissue repair device is a tissue-grasping arm configured to engage and grip the tissue (such terms are used herein for simplicity without intention of limitation and may be used interchangeably with terms such as hook, grab, hold, grasp, clip, etc. herein) and draw the tissue towards the tissue-penetrating arm. The tissue-penetrating arm is preferably sufficiently stabilized or positioned or moored within the penetrated tissue such that when the tissue repair device is moved to different portions along the tissue defect (e.g., aligned or adjacent) where the tissue-grasping arm can grip different portions of the tissue, the tissue-penetrating arm draws the tissue along with it (such terms may be used interchangeably with terms such as carry along, transport, etc. herein without intention of limitation herein). The tissue-grasping arm may then be moved relative to the tissue-penetrating arm to grip the tissue between the arms (e.g., to close an opening in the tissue by attaching different portions of the tissue engaged by the tissue-penetrating arm and the tissue-grasping arm) to effect repair of the defect and the like.

[0023] In some embodiments, the tissue penetration arm remains substantially stationary and is prevented or inhibited from moving laterally (such as bending or pivoting) from a longitudinal position that is substantially aligned with the longitudinal axis of the flexible elongate member carrying the tissue repair device. Thus, the tissue penetration arm remains firmly anchored within the tissue it penetrates. In some embodiments, the tissue grasping arm is flexible or pivotable to move relative to the tissue penetration arm (such terms are used for convenience without intention of limitation and may be used interchangeably herein with terms such as expanding or extending). By way of example, the tissue grasping arm may be formed of a flexible material such as stainless steel or a shape memory material to bend away from the tissue penetration arm, or may be pivotable such that it can pivot away from the tissue penetration arm. The tissue grasping arm may be selectively moved away from the tissue penetration arm to engage the tissue and then moved closer to the tissue penetration arm to grasp the tissue between the tissue grasping arm and the tissue penetration arm.

[0024] A flexible elongate member (such as a shaft, catheter, sheath, tube, or the like, such terms being used interchangeably herein without intent to limit) can carry, in addition to the arm, an additional device for controlling the movement of the arm, such as a control device. The flexible elongate member can be a tubular element including a lumen extending longitudinally therethrough, and components of the system can be extended or delivered through the lumen, although in some embodiments, the flexible elongate member need not have a lumen therethrough. The control device can be a control wire or shaft or the like that can extend through (e.g., through an internal lumen) or along the flexible elongate member for manipulating (such terms being used for convenience without intent to limit and being used interchangeably herein including such terms as manipulate, move, control, actuate, and their various conjugations) the tissue repair device. The control device can extend from a distal end where the tissue repair device is carried to a proximal end where a control handle or the like can be provided to effect actuation of the control device.

[0025] In various embodiments, the tissue repair device includes a capsule in which the arm of the tissue repair device can be movably received, and the capsule is coupled or attached (such terms being used interchangeably herein without intent to limit) to the flexible elongate member. The capsule can be an integral part of the distal end of the flexible elongate member or a separate tubular component coupled to the distal end. The capsule can be separable from the flexible elongate member (along with the arm of the tissue repair device) for implanting the tissue repair device with the arm of the tissue repair device holding tissue together to repair a defect.

[0026] Next, various embodiments of the tissue repair device and associated assemblies and methods are described with reference to the examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more specific features, structures, and / or characteristics according to the principles of the invention may be included in that embodiment. However, such references do not necessarily mean that all embodiments include that specific feature, structure, and / or characteristic or that one embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations. Further, references herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., at various places do not necessarily all refer to the same embodiment, and distinct or alternative embodiments are not necessarily mutually exclusive of other embodiments. When a specific feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless the contrary is specified. It should be further understood that, because it would be too cumbersome to describe all possible combinations and sub-combinations of features, structures, and / or characteristics, such features, structures, and / or characteristics may be used or presented alone or in various combinations with each other to create alternative embodiments that are considered to be part of the present disclosure. Further, various features, structures, and / or characteristics are described that may be shown by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements that may be features, structures, and / or characteristics or requirements for some embodiments but not for other embodiments are described.Therefore, the present invention is not limited only to the embodiments clearly described herein.

[0027] In the following description, it will be recognized that like elements or components among the various embodiments illustrated in the accompanying drawings are generally designated using the same reference numbers incremented by only 100, and redundant descriptions are omitted. Common features are identified by common reference elements, and for the sake of brevity, descriptions of common features are generally not repeated. For clarity, not all components having the same reference number are numbered.

[0028] It should be understood that one or more of the features described with respect to one embodiment may be combined with one or more of the features of any of the other embodiments provided herein. That is, any of the features described herein may be mixed and matched to create a hybrid design, and such hybrid designs are within the scope of the present disclosure.

[0029] Next, turning to the drawings, an example of a tissue repair device 100 formed in accordance with various principles of the present disclosure is illustrated in FIG. 1. The tissue repair device 100 may be considered part of a tissue repair system 1000 that includes a delivery device such as a flexible elongate member 1010, which has a distal end 1011 along or at which the tissue repair device 100 is delivered, and a proximal end 1013 coupled to a control handle 1020 or the like by which the flexible elongate member 1010 can be manipulated. The term flexible elongate member is used herein for convenience in referring to the delivery device generally and without intent to limit, and it will be recognized that it can be in the form of a catheter, sheath, tube, cannula, or the like. In some embodiments, the flexible elongate member 1010 has a working channel therethrough, through which a tissue repair device controller 1030 (including control elements 1032 such as control wires, as illustrated in FIG. 3E) is guided. In other embodiments (not illustrated), the tissue repair device controller 1030 extends along but not through the flexible elongate member 1010. The tissue repair device controller 1030 (schematically shown by a phantom line extending through the flexible elongate member 1010) extends operably from the tissue repair device 100 at the distal end 1001 of the tissue repair system 1000 to the proximal end 1003 of the tissue repair system 1000 for access and manipulation by a user (e.g., a medical practitioner such as a physician, technician, endoscopist, etc., and / or an automated system or other) to control the tissue repair device 100 (e.g., at least one component thereof such as the control element 1032 extends). The control handle 1020 at the proximal end 1003 of the tissue repair system 1000 can be associated with the tissue repair device controller 1030 and / or a controller for the flexible elongate member 1010 (any controller known or otherwise in the art and not illustrated as it is not necessary for a complete understanding of the tissue repair device 100).

[0030] According to one aspect of the present disclosure, the tissue repair device 100 includes a pair of gripper arms 110, 120 extending from a shaft 130, as illustrated in more detail by FIGS. 2A and 2B and FIGS. 3A-3E. The shaft 130 may be a distal portion of the flexible elongate member 1010. In some embodiments, the tissue repair device 100 includes a capsule 140 (a tubular element having a lumen defined therein), within which the gripper arms 110, 120 are movably received. The capsule 140 may be coupled or attached to the distal end 1011 of the flexible elongate member 1010 (such terms are used interchangeably herein without intention of limitation) and may serve as the shaft 130.

[0031] The grasping arms 110, 120 are extendable from a closed configuration within the lumen 135 formed within the shaft 130 to an open configuration distal beyond the distal end 131 of the shaft 130. The tissue repair device 100 can extend distally through the flexible elongate member 1010 for delivery to the treatment site TS in the closed configuration (Figs. 1 and 3A - 3E). The grasping arms 110, 120 are housed within the shaft lumen 135 and have a profile low enough to move distally through the tissue repair system 1000, such as through the flexible elongate member 1010, and can be delivered in the closed configuration. The tissue repair device controller 1030 is operable (e.g., movable) to actuate the tissue repair device 100 to move the grasping arms 110, 120 from the closed configuration illustrated in Fig. 2A to the open configuration illustrated in Fig. 2B. In some embodiments, the tissue grasping arm 120 is biased or pivotable to move (e.g., move away) to an open configuration with respect to the tissue penetrating arm 110, such as when moving distally out of the boundary of the shaft lumen 135. In some embodiments, the tissue grasping arm 120 may be formed of an elastic flexible material (e.g., stainless steel) and also of a shape memory material (e.g., an alloy such as nitinol). In some embodiments, the tissue repair device controller 1030 can be moved distally or proximally to actuate at least the tissue grasping arm 120 to move to an open or closed configuration. However, other movements or controls of the tissue repair device 100 are included within the scope of the present disclosure, and the individual movements are not critical to the broad principles of the present disclosure.

[0032] According to various principles of the present disclosure, the tissue penetrating arm 110 is substantially straight and along the capsule longitudinal axis LA C (capsule longitudinal axis) and the shaft longitudinal axis LA S(shaft longitudinal axis), and is substantially straight when extending distally from the shaft 130. Further, the tissue penetrating arm 110 distally (generally along the shaft longitudinal axis LA S and / or the capsule longitudinal axis LA C along) into the tissue at the treatment site (e.g., the site having a tissue defect) without deflection or bending. It is preferably sufficiently rigid and strong so as to be able to be pushed. The tissue penetrating arm 110 has a length and a sharp distal end 111 shaped and configured to penetrate tissue, preferably muscle tissue, such as the sharp distal tip 115. Thus, the tissue penetrating arm 110 may be considered as the needle or spear of the tissue repair device 100. In some embodiments, the tissue penetrating arm 110 may include sharp longitudinal side edges 116 on one or both of its side edges (generally the narrow sides or edges of the tissue penetrating arm 110 that do not face the tissue gripping arm 120). In some embodiments, the sharp edge may be in the form of one or more teeth. Thus, in addition to being considered as a needle or spear, the tissue penetrating arm 110 may be considered as a blade, and the sharp longitudinal side edges 116 cut open the tissue when the tissue penetrating arm 110 extends axially towards the tissue. Since the tissue penetrating arm 110 is substantially rigid and strong, the tissue penetrating arm 110 moves axially when the tissue repair device 100 is moved distally, and transmits the axial force of the flexible elongate member 1010, the shaft 130, and / or the capsule 140 to the sharp distal end 111 to facilitate penetrating the tissue. The length of the tissue penetrating arm 110 may be determined based on the tissue in which the tissue repair device 100 is to be used. In some embodiments, the tissue is body lumen tissue (such as a part of the small intestine or large intestine), and the length of the tissue penetrating arm 110 is selected to penetrate from within the lumen to the muscle tissue layer M (and, in the case of the intestine, through the mucosal MC layer and the submucosal SM layer as illustrated in FIGS. 3A-3E) and not extend outside the lumen (or organ) by puncturing or passing through the lumen wall.

[0033] The tissue grasping arm 120 is movable with respect to the tissue penetrating arm 110 to provide sufficient space for the tissue penetrating arm to penetrate tissue that is close to or adjacent to the treatment site TS to be repaired without interference by the tissue grasping arm 120. When the tissue grasping arm 120 is pivoted away from the tissue penetrating arm 110 in a substantially axially oriented state, the tissue penetrating arm 110 is not prevented from penetrating the tissue by the tissue grasping arm 120 of the tissue repair device 100. However, in accordance with various principles of the present disclosure, it will be appreciated that the tissue grasping arm 120 can limit the extent to which the tissue penetrating arm 110 can extend through the tissue. By way of example, when the tissue penetrating arm 110 is extended toward the proximal end 113 of the tissue penetrating arm 110, the proximal region 123 of the tissue grasping arm 120 contacts an area surrounding the penetration site of the tissue penetrating arm 110, suppressing further advancement of the tissue penetrating arm 110. More particularly, the tissue grasping arm 120 contacts the surface of the tissue first contacted by the tissue penetrating arm 110 before penetrating it. In the context of the tissue repair device 100 used within a body lumen tissue, such first contacted tissue would be the inner surface of the lumen tissue. Such first contacted surface is referred to herein simply as the "surface" of the tissue for convenience and without intent to limit.

[0034] The tissue grasping arm 120 can have a distal end 121 that includes one or more hooks 122 configured to grasp tissue. In some embodiments, the hooks 122 are configured to present a substantially blunt distal end 121 to the treatment site TS. Accordingly, the distal end 121 of the tissue grasping arm 120, including the tissue grasping hooks 122, can serve to limit the insertion of the tissue penetrating arm 110 through the tissue by contacting the surface of the tissue. The tissue grasping hooks 122 can be spaced apart such that the tissue penetrating arm 110 can fit between the tissue grasping hooks 122 to provide a compact configuration during delivery (e.g., within the flexible elongate member 1010, and / or the shaft 130, and / or the capsule 140).

[0035] An example of how the tissue repair system 1000 is formed in accordance with various principles of the present disclosure is illustrated in FIGS. 3A-3E. As described above, and as illustrated in FIG. 3A, the tissue penetrating arm 110 can be advanced distally from the shaft 130 and the capsule 140 (if included) into the tissue T at the treatment site TS. The tissue penetrating arm 110 can be advanced through the mucosal layer MC and the submucosal layer SM and into the muscle tissue layer M, as illustrated. If extended too far, the tissue grasping arm 120 will contact the tissue surface and inhibit further advancement of the tissue penetrating arm 110 into the tissue.

[0036] As illustrated in FIG. 3B, when the tissue penetrating arm 110 has been sufficiently advanced, the tissue grasping arm 120 is brought closer to the tissue penetrating arm 110 (such as by retracting the tissue penetrating arm 110 and the tissue grasping arm 120 proximally into the shaft 130 / capsule 140) in order to close the tissue repair device 100. Thereby, the first tissue at the anchoring location where the tissue penetrating arm 110 is advanced or anchored is grasped by the tissue grasping arm 120 and generally by the tissue repair device 100. The tissue repair device 100 can then be moved or pulled along the treatment site TS (e.g., along the tissue defect) to another location (which can be referred to herein as the repair location for purposes of convenience and without intention of limitation) to repair the defect.

[0037] As illustrated in FIG. 3C, when located at the repair location, the tissue repair device 100 can be returned to an open configuration in which the tissue gripping arm 120 is positioned away from the tissue penetrating arm 110 to grip the tissue at the repair location. The tissue gripping hook 122 at the distal end 121 of the tissue gripping arm 120, if provided, can be used to grasp the tissue at the tissue repair site while the tissue penetrating arm 110 holds the first tissue at the anchoring location. In the illustrated embodiment, the tissue gripping hook 122 extends in a direction toward the tissue penetrating arm 110 from a side or surface of the tissue gripping arm 120 facing the tissue penetrating arm 110. At least one hook 112 can be provided on the tissue penetrating arm 110 and extend transversely (e.g., perpendicular or otherwise angled) with respect to the axial extent of the tissue penetrating arm 110. In some embodiments, the tissue penetrating arm hook 112 is positioned proximally spaced from the distal end 111 of the tissue penetrating arm 110. The tissue penetrating hook 112 can be used to secure the first tissue initially gripped (in the first position) in engagement with the tissue repair device 100 and to help maintain the position of the tissue penetrating arm 110 at a predetermined position within the anchoring location. The tissue penetrating hook 112 can be shaped and configured to secure the tissue against the tissue penetrating arm 110 and / or to secure the tissue penetrating arm 110 at a predetermined position within the tissue when the tissue gripping arm 120 is moved laterally (such as away from the tissue penetrating arm 110) and / or when the tissue penetrating arm 110 is moved laterally, such as to move the gripping arms 110, 120 to another position with respect to the treatment site TS.

[0038] As illustrated in FIG. 3D, when the tissue T is grasped by the tissue grasping arm 120 at the repair location (e.g., at a desired location, in a sufficient amount, etc.), the tissue repair device 100 can be returned to the closed configuration by moving the tissue grasping arm 120 closer to the tissue penetrating arm 110 (such as by retracting the tissue penetrating arm 110 and the tissue grasping arm 120 proximally into the shaft 130 / capsule 140) to close the tissue repair device 100. Then, further procedures can be performed at or near the treatment site TS as medically indicated.

[0039] As illustrated in FIG. 3E, the tissue repair device 100 can optionally be left in place, such as by locking the tissue penetrating arm 110 and the tissue grasping arm 120 in the closed configuration to maintain closure of the defect and separating the tissue repair device 100 from the tissue repair system 1000 (e.g., the flexible elongate member 1010). In some embodiments, the capsule 140 is separable from the flexible elongate member 1010 such that the grasping arms 110, 120 are continuously held in the closed configuration (e.g., grasping tissue) by the capsule 140, and the flexible elongate member 1010 can be retracted from the capsule 140.

[0040] In some embodiments, the above movement of the tissue penetrating arm 110 and the tissue grasping arm 120 is achieved via the tissue repair device control device 1030 described above. Further details of the interaction of the gripper arms 110, 120 and the tissue repair device control device 1030 can be appreciated with reference to FIG. 3E, which shows the capsule 140 in phantom lines. The distal end 1031 of the tissue repair device control device 1030 is connected to the gripper arms 110, 120 via a control element 1032 (such as a wire or shaft or other component or structure known or publicly known in the art that can move the gripper arms 110, 120 with respect to the shaft 130 and / or the capsule 140). The tissue repair device control device 1030 can be moved proximally to retract the gripper arms 110, 120 into the flexible elongate member 1010 and / or the shaft 130 and / or the capsule 140, thereby moving the tissue grasping arm 120 closer to the tissue penetrating arm 110. The tissue repair device control device 1030 is selectively detachably coupled to the tissue repair device 100 by a connection that allows for selective separation of the tissue repair device control device 1030 from the tissue repair device 100 in response to the application of a separating force. Various configurations of such connections, as disclosed in U.S. Patent No. 7,494,461, issued to Wells et al. on February 24, 2009, entitled "THROUGH THE SCOPE TENSION MEMBER RELEASE CLIP", U.S. Patent No. 8,080,021, issued to Griego on December 20, 2011, entitled "MULTIPLE CLIP DEPLOYMENT MAGAZINE", and U.S. Patent 8,162,959, issued to Cohen et al. on April 24, 2012, entitled "SINGLE STAGE HEMOSTASIS CLIPPING DEVICE", may be used in conjunction with the tissue repair device 100 of the present disclosure, and all of those patents are hereby incorporated by reference in their entirety for all purposes.In one example, as illustrated in FIG. 4E, the tissue repair device control apparatus 1030 is coupled to the gripper arms 110, 120 using a control device coupling 1034 (such terms are used herein for convenience and may be used interchangeably herein with terms such as bushings, yokes, collars, retainers, etc., without intent to limit) known or otherwise publicly available in the art and configured to transmit a desired control movement or action from the tissue repair device control apparatus 1030 to the gripper arms 110, 120. The control device coupling 1034 preferably holds the proximal ends 113, 123 of the gripper arms 110, 120 in a predetermined position while allowing flexure or other movement (e.g., radially outward movement or expansion) of the gripper arms 110, 120. The control device coupling 1034 can be positioned inside a window or notch or groove in the shaft 130 or capsule 140 to restrain or lock the gripper arms 110, 120 in a desired configuration. Additional protrusions or stops can be provided inside the shaft 130 or capsule 140 or adjacent to the proximal end 143 of the capsule 140 to create a hard stop for the control device coupling 1034. Other configurations such as bayonet locks or snap fits, and other elements are included within the scope of the present disclosure. When the gripper arms 110, 120 are moved to a desired closed configuration (e.g., to grip tissue), a control element 1032 coupled to the gripper arms 110, 120 can be proximally moved with a separation force sufficient to pull the control element 1032 away from the gripper arms 110, 120 via a weak connection or breakable connection or other method of weakened connection between the control element 1032 and the gripper arms 110, 120 as disclosed in the above-referenced patents. By way of example, the control element 1032 can have a weakened area (optionally proximal to the most distal end at which the control element 1032 is fixed to the gripper arms 110, 120), and this weakened area breaks or otherwise disconnects in response to the application of a separation force thereto.Further, or alternatively, the frictional force or specific (engaging with each other) geometries of the grasping arms 110, 120 and the control device connection part 1034 and / or the shaft 130 and / or the capsule 140 may provide the desired restraint of the tissue repair system 1000 for holding the grasping arms 110, 120 in a desired location or configuration. Further, or alternatively, the frictional force or specific (engaging with each other) geometries of the grasping arms 110, 120 and the control device connection part 1034 and / or the shaft 130 and / or the capsule 140 may provide the desired restraint of the tissue repair system 1000 for holding the grasping arms 110, 120 in a desired location or configuration. It will be appreciated that other configurations of the tissue repair device control device and the control device connection part are within the scope and spirit of the present disclosure, and the operation and movement of the grasping arms are not limited by the specific configuration of the control device or the control device connection part.

[0041] It will be appreciated that various modifications can be made to the shape and configuration of the grasping arms 110, 120 without departing from the scope and spirit of the present disclosure. By way of example, FIGS. 4A, 4B, 5A, 5B, 6A, 6B show various modifications to one or more hooks 112 on the tissue penetrating arm 110 illustrated in the embodiments of FIGS. 2A, 2B, 3A-3E. As described above, one or more tissue penetrating hooks 112 may be provided on the tissue penetrating arm 110 - a single hook 112 is illustrated in the embodiments of FIGS. 2A, 2B, 3A-3E, and two tissue penetrating hooks 112 are illustrated in the embodiments of FIGS. 4A and 4B. The hook 112 may be sharp enough to help hold the tissue when the tissue repair device 100 is pulled to another location along the treatment site TS (e.g., a defect).

[0042] Alternatively, or in addition thereto, the shaft longitudinal axis LA S and / or the capsule longitudinal axis LA CThe angle of the tissue-penetrating hook 112 can be changed. In the examples of the embodiments illustrated in FIGS. 2A, 2B, 3A-3E, 4A, 4B, the distal tip 115 of the tissue-penetrating hook 112 (e.g., the free end not connected to another element) is directed distally away from the shaft 130 / capsule 140. The tissue-penetrating hook 112 can be positioned at an obtuse angle with respect to the proximal region 113 of the tissue-penetrating arm 110 proximal to the tissue-penetrating hook 112. In contrast, in the examples of the embodiments illustrated in FIGS. 5A and 5B, the tissue-penetrating hook 212 can be provided with a distal tip 215 directed proximally toward the proximal region 113 of the tissue-penetrating arm 110. The tissue-penetrating hook 212 can be positioned at an acute angle with respect to the proximal region 113 of the tissue-penetrating arm 110 proximal to the tissue-penetrating hook 212. The distal tip 215 of the tissue-penetrating hook 212 can be sharp. Additionally or alternatively, optionally the side edge 216 can also be sharp in a similar manner.

[0043] Instead of being positioned on the wider side surface 118 of the tissue-penetrating arm 110 (facing the tissue-gripping arm 120 of the tissue repair device 100) as illustrated in FIGS. 2, 3A-3E, 4A-4F, 5A, and 5B, one or more tissue-penetrating hooks 312 including the distally facing distal tip 317 can be provided on the side edge 118 of the tissue-penetrating arm 110 as illustrated in FIGS. 6A, 6B, 7A, and 7B. In the examples of the illustrated embodiments, two tissue-penetrating hooks 312 are illustrated, but a single hook 312, or more than two hooks 312 can be provided. In the embodiments of FIGS. 6A and 6B, the tissue-penetrating hooks 312 are substantially parallel to or aligned with each other, while in the embodiments of FIGS. 7A and 7B, the tissue-penetrating hooks 312 are offset from each other in a direction along the shaft longitudinal axis LA S and / or the capsule longitudinal axis LA C along.

[0044] It will be appreciated that further variations (straight or curved hooks) to the shape and / or configuration of the tissue penetrating hooks 112 such as bends are within the scope and spirit of the present disclosure. The tissue penetrating arm 110 may include one or more tissue penetrating hooks 112 configured differently without departing from the scope and spirit of the present disclosure.

[0045] The devices, instruments, tools, etc. of the present disclosure may include, but are not limited to, various medical devices for accessing and grasping body tissue. The access may be through a body passage via, for example, a duodenoscope, catheter, ureteroscope, bronchoscope, colonoscope, arthroscope, cystoscope, hysteroscope, and the like, but is not so limited. The grasping of tissue may be for repairing a defect in the tissue or for performing a procedure on the grasped tissue or other tissue surrounding it.

[0046] All of the devices and methods discussed herein are examples of devices and / or methods implemented in accordance with one or more principles of the present disclosure. These examples are not the only ways to implement these principles and are merely examples. Thus, references to elements or structures or features in the drawings must be recognized as references to examples of embodiments of the present disclosure and should not be understood to limit the present disclosure to the specific elements, structures, or features illustrated. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure.

[0047] It will be appreciated that features described with respect to one embodiment can typically be applied to another embodiment whether or not they are explicitly shown. The various features described below can be used alone or in any combination thereof. Thus, the present invention is not limited to the embodiments explicitly described herein.

[0048] The foregoing discussion has broad application and is presented for purposes of illustration and explanation and is not intended to limit the present disclosure to the forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the present disclosure. Specifically, it will be apparent to those skilled in the art that the principles of the present disclosure can be embodied in other forms, structures, arrangements, proportions, and in combination with other elements, materials, and components without departing from the concepts, spirit, or scope, or characteristics of the present disclosure. For example, for purposes of streamlining the present disclosure, various features of the present disclosure are grouped in one or more aspects, embodiments, or configurations. However, it should be understood that the various features of a particular aspect, embodiment, or configuration of the present disclosure can be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented from the perspective of embodiments, it should be recognized that not all of the various separate features of the subject matter need to be present to obtain at least some of the desired characteristics and / or benefits of the subject matter or such individual features. The present disclosure may be used with many modifications or modifications to the structures, arrangements, proportions, materials, components, and other things used in the practice of the present disclosure, and such modifications are particularly adapted to particular environmental and operational requirements without departing from the principles or spirit or scope of the present disclosure, as will be recognized by those skilled in the art. For example, elements shown as integrally formed may be composed of multiple parts, or elements shown as multiple parts may be integrally formed, the operation of the elements may be reversed or otherwise changed, and the size or dimensions of the elements may be changed. Similarly, although operations or actions or techniques are described in a particular order, this should not be understood to require such a particular order to obtain a desired result or that all operations or actions or techniques need to be performed. Further, other embodiments are included within the scope recited in the following claims. In some cases, the acts recited in the claims can be performed in a different order and still obtain a desirable result.Accordingly, the embodiments disclosed herein are to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the specific embodiments or arrangements described or illustrated in the above description or in this specification. Considering the above, the individual features of any embodiment may be used separately or in combination with the features of that embodiment or any other embodiment and may be so claimed, and the scope of the subject matter is indicated by the appended claims and is not limited to the above description.

[0049] In the foregoing description and in the following claims, the following is recognized. As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a,” “an,” “the,” “first,” “second,” etc. are not intended to exclude plurality. For example, the term “a” or “an” entity as used herein means one or more of that entity. Thus, the terms “a or an,” “one or more,” and “at least one” may be used interchangeably herein. All directional references (e.g., proximal, distal, superior, inferior, upward, downward, left, right, lateral, longitudinal, anterior, posterior, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used for identification purposes only to assist the reader of this disclosure and / or to distinguish the regions of relevant elements from one another, and are not intended to limit relevant elements with respect to position, orientation, or use in the present disclosure. References to connection (e.g., attached, coupled, connected, and joined) should be construed broadly and may include intermediate members between a group of elements and relative movement between elements, unless otherwise indicated. Thus, a reference to connection does not necessarily imply that two elements are directly and fixedly connected to each other. References to identification (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another. The following claims are hereby incorporated by reference in this form of the invention as set forth herein, and each claim stands on its own as a separate embodiment of the present disclosure.

[0050] The following claims are hereby incorporated by reference in the specification as a form for carrying out the invention, and each claim is independent as a separate embodiment of the present disclosure. In the claims, the term "comprising" does not exclude the existence of other elements or steps. Furthermore, individual features may be included in different claims, but they may optionally be advantageously combined, and the inclusion in different claims does not imply that the combination of features is not feasible and / or advantageous. Moreover, a reference to the singular does not exclude the plural. Terms such as "a", "an", "the", "first", "second", etc. do not exclude the plural. The reference signs in the claims are provided merely as illustrative examples and should in no way be construed as limiting the scope set forth in the claims.

Claims

1. A tubular component having a longitudinal axis and a lumen defined therein, and A tissue penetrating arm and a tissue grasping arm extendable from within the lumen of the tubular component to a position outside the lumen of the tubular component, A tissue repair device comprising: The tissue penetrating arm is maintained in a position substantially parallel to the longitudinal axis of the tubular component when extended to a position outside the lumen of the tubular component, The tissue grasping arm is movable toward or away from the tissue penetrating arm with respect to the longitudinal axis of the tubular component. A tissue repair device.

2. The tissue grasping arm is biased to move away from the tissue penetrating arm when extended to a position outside the lumen of the tubular component, and the tissue penetrating arm and the tissue grasping arm are in a closed configuration while within the lumen of the tubular component and in an open position when extended to a position outside the lumen of the tubular component. The tissue repair device according to claim 1.

3. The tissue penetrating arm includes a sharp edge or tip configured to penetrate tissue. The tissue repair device according to claim 1 or 2.

4. The tissue grasping arm has a blunt distal end. The tissue repair device according to any one of claims 1 to 3.

5. The tissue grasping arm is configured to suppress the depth to which the tissue penetrating arm can penetrate. The tissue repair device according to any one of claims 1 to 4.

6. The tissue penetrating arm includes a sharp distal end and a tissue penetrating hook positioned proximal to the sharp distal end. The tissue repair device according to any one of claims 1 to 5.

7. The tissue penetrating hook extends laterally with respect to the longitudinal axis of the tubular component. The tissue repair device according to any one of claims 1 to 6.

8. The tissue grasping arm includes at least one tissue grasping hook. The tissue repair device according to any one of claims 1 to 7.

9. The tissue grasping hook faces the tissue penetrating arm. The tissue repair device according to any one of claims 1 to 8.

10. The tissue grasping hook includes a pair of tissue grasping hooks, and when the tissue penetrating arm is moved toward the tissue penetrating arm, the tissue penetrating arm fits between the tissue grasping hooks. The tissue repair device according to any one of claims 1 to 9.

11. A flexible elongate member having a lumen defined therein and a longitudinal axis extending between a distal end of the flexible elongate member and a proximal end of the flexible elongate member. A pair of grasping arms that can extend from inside the lumen of the flexible elongate member to a position outside the lumen of the flexible elongate member. A control device having a proximal end and a distal end, wherein the distal end of the control device is connected to the grasping arm to move the grasping arm between a position inside the lumen of the flexible elongate member and a position outside the distal end of the lumen of the flexible elongate member. Control device. A control handle connected to the proximal ends of the flexible elongate member and the control device to control the movement of the flexible elongate member and the control device. A tissue repair system comprising: The tissue repair system, wherein the grasping arms are shaped and configured differently from each other.

12. The grasping arm includes a tissue penetrating arm that is maintained in a position substantially parallel to the longitudinal axis of the flexible elongate member when extended outside the lumen of the flexible elongate member, and the tissue penetrating arm with respect to the longitudinal axis of the flexible elongate member. And a tissue grasping arm that is movable toward or away from the tissue penetrating arm. The tissue repair system according to claim 11.

13. The flexible elongate member further includes a capsule that is connected to and defines a lumen that penetrates the distal end of the flexible elongate member, and the grasping arm is movable between a closed configuration within the capsule and an open configuration outside the capsule. The tissue repair system according to claim 11 or 12.

14. The tissue repair system according to any one of claims 11 to 13, wherein the capsule is separable from the flexible elongate member with the grasping arm positioned inside in the closed position.

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