Tissue repair system

Abstract

This invention discloses a tissue repair system for securing a first tissue to a second tissue. The tissue repair system includes an instrument having a handle, a shaft extending distally from the handle, and a housing having a locking cap. A tissue anchor is disposed at the distal end of the shaft and is operatively coupled to an actuating member of the handle via a deployment member. The actuating member is configured to actuate the deployment member, deploying the tissue anchor and thereby coupling the tissue anchor to the first tissue. The system also includes a repair member for coupling the tissue anchor to the second tissue. The repair member has a first end operatively coupled to the tissue anchor and a second end attached to at least one coupling device. The second end of the repair member and the coupling device are housed within the instrument housing. Actuation of the actuating member is configured to unlock the housing cap.

Description

Technical Field

[0001] This disclosure relates to methods and apparatus for tissue repair. More specifically, this disclosure relates to anchor constructions, which may be soft anchors for tissue repair in patient limbs. Background Technology

[0002] Tissue repair may require the use of anchors and flexible members to attach bone to the repair tissue. The repair tissue may include soft tissue, another bone, or another segment of the same bone. Bone anchors with flexible members attached thereto can be attached to the bone. To complete the tissue repair, the bone can then be attached to the repair tissue via the flexible members. This may require attaching suture members, such as needles, to the flexible members, or attaching second anchors to the flexible members, which can be time-consuming. Moreover, for procedures in limbs (such as the hand or foot), the attachment devices such as suture members or anchors preferably have a smaller profile to minimize trauma to these more delicate and fragile tissues, such as the tissue of the anterior talofibular ligament (ATFL). Providing pre-attached suture members or second anchors can save time, especially when considering attachment to smaller profile attachment devices. However, managing these multiple components can become overly complex. Therefore, there is a need for improved tissue repair systems with pre-assembled, lower-profile attachment devices for attachment to smaller or more fragile tissues in the hand or foot. There is also a need for improved tissue repair systems for managing the tissue repair phase. Summary of the Invention

[0003] This document discloses a tissue repair system that improves tissue repair, which may include connecting two tissues. These tissues may include a first tissue and a second tissue, or two segments of the same tissue. For example, the first tissue may be bone, and the second tissue may be soft tissue. The system may include a repair structure comprising tissue anchors, connecting devices, and a flexible repair member connecting the two. The system may include an instrument that houses the repair structure and, according to tissue repair techniques, allows for the graded deployment or release of different portions of the repair structure, thereby simplifying the repair process.

[0004] The exemplary tissue repair system disclosed herein includes an instrument comprising a handle at a proximal end, a shaft extending distally from the handle, and a housing having a cap. The instrument manages a tissue repair configuration for attaching a first tissue to a second tissue. The tissue repair configuration includes a tissue anchor. The tissue anchor is disposed at the distal end of the shaft and operatively coupled to an actuating member of the handle via a deployment member. The deployment member extends along the shaft. The tissue repair configuration also includes a repair member for attaching the tissue anchor to the second tissue. The repair member has a first end operatively coupled to the tissue anchor and a second end operatively coupled to at least one coupling device. The second end and the coupling device are housed within the instrument housing. Actuation of the actuating member is configured to deploy the tissue anchor via the deployment member, thereby attaching the tissue anchor to the first tissue. Actuation of the actuating member also releases the housing cap to access the coupling device.

[0005] In some exemplary embodiments, the shaft has a first position and a second position, wherein in the first position, the shaft is operatively coupled to and locks the housing cover, and wherein actuation of the actuating member moves the shaft to the second position, unlocking the housing cover. In some exemplary embodiments, a distal end of the shaft may accommodate a tissue anchor, and actuation of the actuating member axially moves the shaft to expose the tissue anchor. In some exemplary embodiments, the housing cover defines an outer circumferential surface of the instrument. In some exemplary embodiments, the housing cover includes a groove for engaging the repair member, such that removing the housing cover removes a portion of the repair member. In some exemplary embodiments, the coupling device is selected from a needle, a threading member, a leather button, and another tissue anchor. In some exemplary embodiments, the tissue anchor is a soft anchor, and the unfolding member includes a flexible member repeatedly interwoven by the soft anchor. The flexible member may define a first cross-section, and the repair member may be another flexible member having a second, different cross-section smaller than the first cross-section. The flexible member may include a breakable portion that breaks at a predetermined value indicating the unfolding of the tissue anchor, such that the flexible member can then be removed to leave the tissue anchor unfolded within a first tissue. In some exemplary embodiments, the repair member includes at least two flexible members defining at least four flexible member branches, each branch being terminated with a coupling device, the coupling device being a needle.

[0006] An exemplary method for securing a first tissue to a second tissue is also disclosed, comprising inserting a tissue anchor into the first tissue using an instrument, the instrument including a handle at a proximal end, a shaft extending distally from the handle, and a housing having a cap locked to the instrument. An actuation member of the instrument is then actuated to deploy the tissue anchor and engage the tissue anchor with the first tissue. Actuation also unlocks the housing cap. The housing cap is then removed from the instrument to expose a coupling device and a repair member disposed within the housing. The repair member is operatively engaged to the tissue anchor. The repair member is then engaged to the second tissue via the coupling device.

[0007] In some exemplary methods, the actuating member of the actuating device axially moves the device axis through an opening in the housing cover to unlock the housing cover. Some exemplary methods also include removing a coupling device from a slot in the housing cover before coupling the repair member to a second tissue, to release the coupling device from the housing cover. In some exemplary methods, the repair member is removed from a retaining slot within the housing before coupling the repair member to the second tissue. In some exemplary methods, the coupling device includes at least one needle, and coupling the repair member to the second tissue via the coupling device includes inserting at least one needle through the second tissue. In some exemplary methods, the tissue anchor is a soft anchor operably coupled to the actuating member via a flexible member, and actuating the actuating member applies tension to the flexible member and unfolds the soft anchor. The flexible member may include a breakable portion, and actuating the actuating member further includes actuating the actuating member after unfolding the soft anchor to cause the flexible member to break. In some exemplary methods, the repair member includes at least two flexible members defining at least four flexible member branches, each branch terminating with a coupling device, the coupling device being a needle.

[0008] Another exemplary tissue repair system for securing a first tissue to a second tissue is disclosed. It includes an instrument having a handle at a proximal end, a shaft extending distally from the handle, and a housing with a removable cap. A tissue anchor is housed within the distal end of the shaft, and the tissue anchor is operatively coupled to an actuating member of the handle via a deployment member. A flexible member is coupled to the tissue anchor at a first end of the tissue anchor. A second end of the flexible member is operatively coupled to at least one coupling device. The second end and the coupling device are housed within the instrument housing. Actuation of the actuating member deploys the tissue anchor via the deployment member, thereby coupling the tissue anchor to the first tissue. It also axially moves the shaft and unlocks the housing cap to access the coupling device. In some exemplary embodiments, the coupling device is selected from a needle, a threading member, a leather button, and another tissue anchor. Attached Figure Description

[0009] This disclosure will be more fully understood by referring to the following detailed description in conjunction with the accompanying drawings, wherein:

[0010] Figure 1 An tissue repair system according to this disclosure is shown;

[0011] Figure 2 The remote end of the tissue repair system according to this disclosure is shown;

[0012] Figures 3A-3C A tissue repair method according to this disclosure is shown;

[0013] Figure 4 The components of an insertion device for a tissue repair system according to this disclosure are shown;

[0014] Figure 5 A cross-section of the insertion device according to this disclosure is shown;

[0015] Figure 6A and 6B A method for unfolding and unlocking the cover of a tissue repair system according to this disclosure is shown;

[0016] Figure 7A and 7B Various views of the hub cover according to this disclosure are shown;

[0017] Figure 8 Another exemplary hubcap according to this disclosure is shown;

[0018] Figure 9 A kit for tissue repair according to this disclosure is shown;

[0019] Figure 10A-10I The use of this disclosure is shown Figure 9 The kit shown represents a tissue repair method;

[0020] Figure 11A-11D An exemplary embodiment of hub attachment according to the present disclosure is shown;

[0021] Figure 12 A fracturing component according to this disclosure is shown;

[0022] Figures 13A-13C A method for tissue repair using easily deployable components according to this disclosure is shown; and

[0023] Figures 14A-14B An exemplary tissue repair structure including a second tissue anchor is shown according to this disclosure. Detailed Implementation

[0024] In the following description, similar parts have been given the same reference numerals, regardless of whether they are shown in different instances. To illustrate instances clearly and concisely, the figures may not necessarily be drawn to scale, and some features may be shown in a slightly schematic manner. Features described and / or shown with respect to one instance may be used in the same or similar manner in one or more other instances, and / or in combination with or in place of features of other instances.

[0025] As used in the specification and claims, for the purposes of describing and defining the invention, the terms “about” and “approximately” are used to indicate the inherent uncertainty attributable to any quantitative comparison, value, measurement, or other representation. The terms “about” and “approximately” are also used herein to indicate the extent to which a quantitative representation may differ from the stated reference without causing a change in the essential function of the subject matter under discussion. The forms “comprising,” “including,” and / or each” are open-ended and include the listed portions and may include additional portions not listed. “And / or” is open-ended and includes one or more listed portions and combinations of listed portions. The use of the terms “up,” “down,” “up,” etc., is intended only to help clearly describe this disclosure and is not intended to limit the structure, positioning, and / or operation of this disclosure in any way.

[0026] This document discloses a tissue repair system comprising an instrument for placing and securing a first tissue anchor to a first tissue (hereinafter defined as the deployment of the anchor). The tissue anchor may be coupled to at least one flexible member, which may have a coupling device, such as a needle, a suture member, or a second tissue anchor, attached thereto. The first and second tissue anchors may be different from each other. The coupling device may be attached to the at least one flexible member at a location spaced apart from the first tissue anchor, and the position of the coupling device may be fixed or adjustable. The coupling device may be used to couple at least one flexible member to the second tissue. For example, the flexible member may include a suture, suture tape, cord, spring, or thread. The insertion instrument includes means for managing and grading the release of the flexible member and the coupling device. The insertion instrument may include means for concealing or retaining the flexible member and the coupling device (as they may not be needed until after the first tissue anchor has deployed to the first tissue). The insertion instrument may include means for receiving and protecting at least one flexible member and the coupling device until after or during the deployment of the anchor. The insertion instrument may include means for grading the release of the flexible member and the coupling device to aid in managing the tissue repair components according to the method of use.

[0027] The first tissue anchor may be a soft anchor formed of a flexible material. The first tissue anchor may include a braided suture or a flexible strip of a certain length that changes shape via force from a deploying member. This shape change may include a change from an elongated configuration for insertion into a first tissue (such as bone) to an expanded form, whereby the soft anchor engages the wall of the first tissue and anchors or fixes the soft anchor to the bone. In the deployed state, the soft anchor begins to resist being pulled out of the tissue into which it is inserted. Deployment may be performed via tension operably coupled to the deploying member of the soft anchor. The deploying member may be a flexible member and may be a suture, thread, strip, cord, spring, or suture tape. Deployment may be controlled via an insertion device configured to receive or engage the soft anchor, insert the anchor into (and possibly through) the first tissue, and then control the deploying member to deploy the soft anchor. The soft anchor may be deployed from controlled tension to a target tension value. Soft anchors may be similar to the anchoring systems broadly described in U.S. Publication No. 2013 / 0123810 (Brown et al.) and U.S. Publication No. 2019 / 0247039 (Gregoire et al.), both of which are commonly assigned and incorporated herein by reference in their entirety.

[0028] In an exemplary soft anchor, the unfolding member may include an expanding or unfolding flexible member in the form of a suture that can be repeatedly interwoven with the soft anchor. The expanding suture extends along the instrument to engage with an actuation portion of the instrument handle. Tensing the expanding suture via the actuation means altering the soft anchor configuration to produce an expanding-unfolding configuration. As disclosed in at least U.S. Publication No. 2013 / 0123810 (Brown et al.), tensioning the expanding suture may include a wheel rotating the handle. The expanding suture may then be detached from the actuation and pass through a small cannula of the instrument to release the inserter instrument from the expanding member and the soft anchor. The expanding suture may then be engaged with a coupling device such as a needle, a threading member, or a second anchor to attach the soft anchor to a second tissue via the expanding suture and complete tissue repair.

[0029] As previously mentioned, especially with the evolution of increasingly smaller medical device sizes, inserting needles or attaching sutures to second anchors is time-consuming. This can increase procedure time and is not ideal for small tissues. Expanding sutures may also be relatively large in diameter or width to withstand the higher tensile loads required for anchor deployment, and these larger diameters are unsuitable for repairing smaller, more fragile tissues. Therefore, separate repair components (such as separate flexible components) operably coupled to the first anchor can be provided for attaching the first tissue to the second tissue. This repair component may include pre-assembled coupling devices, thereby overcoming the complexity of attaching coupling devices. This repair component may preferably be smaller in diameter or width than the deployment component for attachment to smaller or more fragile tissues. Thus, the system may include multiple components, such as deployment and repair components, each with a separate function and used during different stages of tissue repair.

[0030] For example, when used in small open procedures (typically in limbs such as the ankle, foot, or hand), pre-attached needles allow the surgeon to avoid passing the repair suture through the open needle eye. Preferably, these repair components are small in size (2-0, 0, or 1 suture). Repair components with pre-attached needles allow the surgeon to repair these small ligaments / tendons and small tissues more accurately and allow the needle to be repeatedly passed through the tissue. Pre-attaching these needles can maintain a minimal attachment profile via crimping. For example, crimping provides an attachment with a lower profile than the eyelet, which is preferred for repairing smaller or more fragile tissues.

[0031] In some embodiments, the deployment member may be removable once the anchor has been deployed and the repair device is attached to it. In some embodiments, a third flexible member may also be operatively attached to the soft anchor to lock or engage the system and prevent the anchor from loosening, and may be referred to as a locking member. In some exemplary embodiments, a single flexible member may perform at least two of these tasks. For example, a single member may act as both a locking member and a repair member.

[0032] This document discloses a tissue repair system comprising an insertion instrument and a flexible member having a coupling device attached thereto, the coupling device being housed within an inserter. A system for managing the coupling device is also disclosed. The coupling device is coupled to the repair member. The repair member may also act as a locking member. The insertion instrument may include means for selectively releasing or exposing the coupling device from the inserter and the repair member attached to the coupling device. The system may have an inserter with a working length preferably suitable for small open procedures typically performed by surgeons on limbs. For example, the inserter shaft length may be less than 5 inches, and more preferably about 3 inches. This contrasts with procedures, for example, on the hip, where the inserter shaft length may be between 6 and 8 inches, a longer shaft that is difficult to control during limb procedures, because the inserter shaft is not stabilized by a longer length of tissue as in the case of, for example, tissue around the hip. A tissue repair system comprising two repair members and its management is also disclosed. The second repair member may also include a coupling device and may provide the surgeon with the opportunity for additional tissue repair for each anchor.

[0033] Now for reference Figure 1 An exemplary tissue repair system 100 according to this disclosure is illustrated. System 100 includes an insertion instrument 110 having a handle 120 having an actuation device 125 for deploying an anchor (not shown). The anchor can be operatively coupled to a distal end 150 of the instrument 110. A hub 130 extends between the handle 120 and a shaft 140 extending from the hub 130 to the distal end 150. The hub 130 includes a cavity (shown in more detail later) for receiving at least one coupling device such as a needle, threading member, or anchor. The cavity also receives at least a portion of a repair member attached to the coupling device. The distal end 150 includes a slotted tube 152, with a slot 153 configured to allow the repair member to pass through it. The shaft 140 includes an elongated channel having an open lateral side to receive the repair member therein. Therefore, the repair component extends from the distal end 150, where it is operably coupled to the anchor, and extends through the slot 153 into and along the elongated channel 142 into the cavity. The hub 130 includes a removable cover 135 that can be selectively unlocked and removed to expose the coupling device and the repair component attached to it.

[0034] Similar to the Q-fix system provided by Smith and Nephew, the tissue repair system 100 can deploy soft anchors as disclosed herein via tension on a deploying member. In this exemplary system, the deploying member may include a flexible member, such as a suture operatively coupled to the soft anchor, which is received at a distal end 150 within a slotted tube 152. In this example, the deploying member is operatively coupled to a tension actuation device 125. The deploying member may be a suture of a certain length that can be wound around an axis of the actuation device 125, and rotation of the actuation device 125 about a longitudinal axis of the handle can wind the suture and apply tension sufficient to deploy the anchor.

[0035] Figure 2 A distal end 150 of an instrument is shown having an anchor 200 disposed along a slotted tube 152. A slot 153 extends from the distal edge of the slotted tube 152 and partially extends along the long axis of the tube 152. When the anchor 200 is in an elongated or non-expanded configuration, the slot 153 may have a nearest-proximal edge adjacent to a corresponding proximal edge of the anchor 200. An unfolding member 220 may be interwoven with the anchor 200 and extend along an axis 140. The unfolding member 220 may extend along an inner cavity of the axis 140. The anchor 200 may also be operatively coupled to at least one repair member 250, different from the unfolding member 220, which may extend through the slot 153 and into an externally disposed channel 142. The channel 142 is continuous with a cavity formed within a hub 130. For simplification purposes, the repair member 250 is... Figure 2 The proximal end of the repair member 250 is shown attached to the anchor 200. The connection between the repair member 250 and the anchor 200 can be achieved via attachment means such as glue, adhesive, knot, splice, heat treatment, or nails. Alternatively or additionally, the repair member 250 can be interwoven with the anchor 200 in a manner similar to that of the unfolded member 220. The repair member 250 can be interwoven partially or along the entire length of the anchor 200. Partially or along the entire length of the anchor 200, the repair member 250 can be interwoven along the same path as the unfolded member 220, or along that path and with a different weave pattern depending on the anchor thickness. The repair member 250 can be interwoven along a path parallel to the unfolded member 220 but along a plane rotating about the longitudinal axis of the anchor at a non-zero angle. In other words, the repair member 250 can be interwoven with the anchor 200 along a path parallel to the unfolded member 220 and circumferentially offset from the unfolded member path. The repair component 250 can be interwoven along a path parallel to the deployment component 220 via the anchor 200, the path also being inclined along a plane at an angle of approximately 90 degrees to the deployment component path.

[0036] Figure 3A , 3B The 3C diagram shows details of the remote 150 and the unfolding phase. Figure 3AThe distal end 150, initially inserted into the tissue hole 50, is shown, with the anchor 200 housed within the slotted tube 152. Notably, the proximal end 153a of the slot 153 is shown on the right side of the tube in the figure. The slotted tube 152 can be pushed into the tissue hole 50. The anchor pusher or check 154 is coaxial with the slotted tube 152 and is also at least partially accessible into the tissue hole 50, remaining close to or in contact with the proximal end of the anchor 200.

[0037] Turn now Figure 3B Another cross-sectional view is provided, illustrating exemplary use of the tissue repair system 100. Figure 3A The subsequent steps. Anchor 200 is shown placed coaxially into hole 50. During deployment, slotted tube 152 retracts axially while anchor pusher 154 is held in place. Slotted tube 152 is operatively coupled at its proximal end to actuation device 125. Thus, actuation of actuation device 125 can perform at least two operations: it can retract slotted tube 152 to expose or release anchor 200 into hole, and it can also apply tension to deployment member to deploy anchor 200. The two operations can be sequentially spaced or at least partially overlapped, such that some, but not all, retraction of tube 152 can occur before tension is induced on deployment member 220. Anchor pusher 154 can be fixedly attached to the proximal end of shank 120. Tissue hole 50 can be pre-formed using a drill. Tissue can be bone.

[0038] Figure 3C Anchor 200 in its fully deployed state is shown. Anchor pusher 154 ideally extends into the tissue, and when the tissue is bone, the anchor pusher has a distal edge adjacent to the bottom of the cortical layer (typically 0.02″ to 0.05″ below the bone / tissue surface). As the deploying member 220 tensions, anchor 200 retracts onto itself along with the end of anchor pusher 154 to provide counter-traction and presents a shortened expanded state with an increased effective diameter. "Counter-traction" refers to providing a check element to resist proximal movement of the proximal end of the anchor, thus causing anchor 200 to converge and expand.

[0039] Despite Figure 3B and 3C The image shows a separate anchor deployment stage, but the actuation device can be operatively connected to both the slotted tube 152 and the deployment member 220. (See reference) Figure 4 The actuator 125 can be connected to the driver block 128, which is connected to the slotted tube 152. Figure 4The device 110 is shown with a portion of the handle and hub 130 removed to simplify the understanding of the actuation mechanism. An actuating device 125 is threadedly coupled to a drive block 128. Actuation of the actuating device 125 (such as rotation of the actuation knob 126) axially retracts the drive block 128, which in turn axially retracts the slotted tube 152 back to... Figure 3B The position shown. Tension on the deploying member 220 can be delayed via a relaxation ring 222 formed along the deploying member 220 during assembly. The size of the relaxation ring 222 can be set such that the initial actuation of the axially retracting actuator block 128 retracts the slotted tube 152 to the length sufficient to expose the anchor 200 before the relaxation ring 222 tightens. The breakable portion 129 of the actuator block (shown as dashed lines) can then be broken, thereby stopping any further retraction of the actuator block 128. Figure 3C As shown, continued activation of the actuation device can apply tension only to the unfolding member 220 and expand the anchor 200 within the tissue. As will be explained below, at the distal end of the actuator block 128 is also a retractable hubcap key 156.

[0040] Figure 5 A cross-section of a hub 130, including a cover 135 and a cavity 136, is shown. The cavity 136 houses a flexible repair member 250 and a coupling device attached to the flexible repair member. For simplicity, the repair member 250 and the coupling device are omitted from this figure. A slotted tube 152 extends through the cavity 136. The proximal end of the cover 135 may include a slot 137 to receive a hub cover key 156 therein. When the hub cover key 156 is disposed within the slot 137, the cover 135 is locked in a closed position. The hub cover key 156 is operatively coupled to the tube 152 (or actuator block 128) such that an actuation device retracts the hub cover key 156 as the tube 152 retracts. This then releases the retention on the cover 135, allowing its removal and access to the repair member 250 and the coupling device.

[0041] Figure 6A and 6B An exemplary method for deploying the anchor and releasing the cover 135 is shown. Figure 6A In this configuration, the actuating component may be a rotary knob 126. Rotating 127 may first axially retract the tube 152 to release the anchor (e.g., Figure 3A , 3B (As shown in the diagram). Rotating 127 can also axially retract the key 156 from the cover groove 137. The groove is in Figure 7A This is also visible in the image. Key 156 may have an axial length sufficient to maintain engagement with slot 137 until most of tube 152 is retracted. Key 156 may have an axial length such that the cover unlocks once anchor deployment has begun. (As shown...) Figure 6BAs shown, once the key 156 is axially retracted into the shank housing, the cover 135 can be removed to access the repair member 250 and the coupling device 255 housed within the cavity 136.

[0042] The repair member 250 extends from the anchor 200 along the channel 142 and into the cavity 136. The channel 142 is an external channel that extends from the farthest edge of the shaft 140 into the cavity 136. The channel 142 can loosely hold the repair member 250 to a certain length. Once the cap 135 is removed, the user can easily access the coupling device 255 and retrieve the repair member 250 from both the cavity 136 and the channel 142. The diameter of the repair member 250 may be smaller than that of the unfolding member 220. For example, the repair member may be a No. 0 super-strong suture. The unfolding member 220 may be a flexible member, which may be a No. 1 super-strong suture, or any suture between No. 0 and No. 3 as defined by the USP designation. The unfolding member 220 is preferably configured to withstand the tension required to unfold the anchor 200. The repair member 250 may be a No. 0 super-strong suture and may be provided with needles attached thereto. The repair member 250 can connect anchors within both a first tissue and a second tissue (such as limb tissue). Therefore, preferably, the repair member 250 may be a flexible member, such as a 2.0 or 0-size small-contour suture according to the USP designation. The repair member 250 may define two branches extending proximally from the anchor 200. In some embodiments, more than one repair member 250 may be present. Each branch of the repair member 250 may be pre-attached individually to a separate coupling device. For example, if two repair members 250 are present, each with two branches, then four branches may extend along the channel 142 and be received in the cavity 136. Moreover, each of the four branches may have a needle attached thereto, such that four needles are also received within the cavity 136. In another exemplary embodiment, if two repair members 250 are present, each with two branches, then four branches may extend along the channel 142 and be received in the cavity 136. In instances where the coupling device includes a cortical anchor, all four branches may pass through a single cortical anchor. In some exemplary embodiments, the repair member may form a longitudinal locking pathway (similar to a finger trap) along which the coupling device can be knotlessly locked to a second tissue. In other exemplary embodiments, one flexible member, such as the unfolding member, may be a suture band, while other flexible members, such as the repair member, may be, for example, sutures with braids or hollow cores. Each flexible member may include markings to identify each individual flexible member during tissue repair. For example, the repair member 250 may have a different series of colors or markings than the unfolding member.

[0043] Figure 7A and 7BVarious views of the cover 135 and the slot 137 are shown. The slot 135 may define a first segment 137a configured to surround the key 156, and a second segment 137b extending from the first segment 137a configured to prevent the key 156 from passing through it. As shown, the first segment 137 defines a larger opening that can be nested or wrapped around the key 156 and allows the key 156 to slide axially through it. The second segment 137b defines a narrow channel extending to the edge surface of the cover, sized to allow the slotted tube 152 to pass through it but not the key 156. In operation, the cover 156 is locked onto the hub 130 until the key 156 is axially retracted. Once the key 156 is axially retracted, the tube 152 is disposed within the slot 137, and the cover can be removed. A tab 139 can be pulled to remove the cover 135. As shown, the cover 135 can be completely removed from the hub 130. In other configurations, cover 135 may be hingedly attached via, for example, a movable hinge, and cover 135 may be rotated away from hub 130 to expose repair component 250 and coupling device 255.

[0044] Figure 7B A cap 135 with a groove 137 is shown, and may include an optional suture management groove 141. The groove 141 can loosely capture a portion of the repair member 250, such that the repair member 250 is pulled out of the cavity 136 when the cap 135 is removed. In some exemplary embodiments, a second active engagement device may be formed between the cap 135 and the hub 130, holding the cap 135 in place until a user grasps the tab 139. For example, the groove 137 may be defined by at least one (two shown) resilient leg 237 configured to flex to release the cap 135. In other words, a second segment 137b may define a groove gap slightly smaller than the maximum diameter of the tube 152, such that removal of the cap requires at least one leg 237 to flex to temporarily increase the gap. Some deformation of the leg 237 may be required to remove the cap 135. In other instances, the second active engagement device may include a breakable portion engaging the cap 135 to the hub 130. For example, during assembly, weak ultrasonic welding or adhesive points may be applied to the portion between hub 130 and cover 135. This fragile portion must be broken to remove cover 135. As another example, at least one of cover 135 and hub 130 may include at least one post that frictionally engages within an orifice or channel in another of cover 135 and hub 130. The frictional engagement must be overcome to remove cover 135. Another example may include a snap-fit ​​engagement between cover 135 and hub 130. Thus, cover 135 may unlock during anchor deployment when key 156 is axially retracted, but external force from the user may be required to overcome the second active engagement device and remove cover 135 from hub 130. This ensures that the hub does not accidentally fall off and enter the surgical area during deployment. Figure 8In other exemplary embodiments shown, the cover 135 may include a cavity 230 that receives a portion of the coupling device and the repair member 250. The cavity 230 may include a notch or clamp 232 that allows the repair member 250 to pass through but may slightly clamp the repair member 250. In this example, removal of the cover 135 may simultaneously remove the repair member and the coupling device 255 from the instrument 110.

[0045] Figure 9 An exemplary kit is shown, including a tissue repair system 100, a disposable guide 300, and a drill 320. The disposable guide 300 may include a cannula 302 for receiving the distal end 150 of the system 100 therethrough. Figure 10A-10D A method for repairing limb tissue using a tissue repair system 100 as disclosed herein is illustrated. A guide 300 may be placed at an insertion site. The guide 300 is configured to receive and guide a drill 320 to drill a tunnel in a first tissue (such as bone tissue 40). The length of the guide may limit the depth of the hole drilled into the tissue 40. The guide 300 is also configured to receive the working end 150 of the system 100. The guide 300 may include an elongated slot 304 for receiving a channel 142. Figure 10B The guide groove 304 is best shown in the diagram, which is configured to align the channel 142 of the inserter. Figure 10C The figure shows that the insertion device 110 may include a surface, which may be the distal surface of the inserter handle hub 130, which bottoms out on the disposable guide 300 when the insertion device is fully inserted into the tissue to limit the insertion depth. Still in this figure, the inserter handle actuator 125 can then be actuated to deploy the anchor 200. The deployment member can then be removed from the inserter actuator 125 to release the deployment member ( Figure 10D In other exemplary methods, the deployment member may include a predetermined breakable portion thereal that breaks under high tension to release the deployment member from the anchor. Actuation of actuator 125 may also unlock or release cover 135 of hub 130. Cover 135 can then be removed to access repair member 250 and coupling device 255. In an exemplary method, coupling device may include needle 255. Removal of inserter and guide now leaves the deployed anchor in the target tissue 40, and repair member 250 coupled to coupling device 255 extends from anchor 200. Figure 10F Once the anchor 200 is deployed, the deployable member 220 can be completely removed from the anchor. Alternatively, the deployable member 220 can be cut.

[0046] Figures 11A-11BAlternative system 1100 is shown, wherein cover 1135 is hingedly connected to hub 1130. Hinge 1125 may extend parallel to the longitudinal axis of hub 1130 along the lateral side of hub 1130. Hinge 1125 may define a movable hinge. In this exemplary embodiment, pin 255 is shown oriented transversely to the longitudinal axis of hub. Cavity 1136 also includes a plurality of posts 1120 around which repair member 250 may be wrapped and stored within cavity 1136. Posts 1120 may be disposed adjacent to the periphery of cavity 1136 such that repair member 250 forms a large loop around post 1120. Four posts 1120 may be disposed relative to each other to define the vertices of the quadrilateral loop of repair member 250. As shown, two posts 1120 may be disposed relative to each other to define two opposite ends of the wrapping loop.

[0047] Figures 11C-11D Another embodiment in a closed and open configuration is shown, wherein the cover 1155 is axially slidable. The cover 1155 is directly coupled to the tube 152 such that axially retracting the tube 152 axially retracts the cover 1155. The cover 1155 is slidable into a groove in the handle to expose the repair member 250 and the coupling device 255 (not shown).

[0048] Figure 12 An exemplary soft anchor 200 is shown, wherein a deployable member 220 is interwoven with the soft anchor, and a repair member 250 is coupled to the soft anchor. The exemplary soft anchor 200 may be tubular. As shown, the repair member 250 may be coupled in various ways as disclosed herein. In this example, the repair member 250 is coupled along a path parallel to the deployable member 220 but circumferentially offset from the path of the deployable member 220. The deployable member 220 may include a breakable portion 224. As shown, this portion is located at the distal end of the anchor 200. However, the breakable portion 224 may be located anywhere along the deployable member 220. The breakable portion 224 may be formed by various means. The breakable portion 224 may be formed by weakening a portion of the deployable member 220. Weakening may be achieved by cutting, abrading, or damaging the deployable member. In other embodiments, the deployable member 224 may be formed as two separate lengths of flexible members coupled at the breakable portion 224 using a weak connection. For example, the ends of two separate flexible members can extend through tubular clamps or crimping members. A breakable portion 224 can be formed during the weaving process, and the weaving can be omitted during the shorter portion of the flexible member's length.

[0049] The fragile portion 224 is configured to break under a predetermined tension. This predetermined tension is at or above the tension required to deploy the anchor 200. Upon breakage, the deployable member 220 can be pulled out of the anchor 200 and removed from the tissue. Once the anchor 200 is deployed, continuous tension on the anchor is no longer needed to maintain the expanded configuration of the anchor 200. Therefore, the deployable member 220 may not be part of the final repair structure. This reduces the profile of the final repair structure at the end of the procedure. Due to the small and delicate tissue of the limb, a minimal profile repair structure is preferred. Given that the deployable member 220 can be a large-diameter suture relative to the repair member 250, removing this larger-diameter element significantly reduces the volume of the final repair structure.

[0050] Therefore, a method of connecting a first tissue to a second tissue may include inserting an anchor into the first tissue, and deploying the anchor within the tissue into an expanded configuration using a deployment member. Figure 13A The deployment of the anchor includes tensioning a deployment member operably coupled to the anchor. Tensioning may include tensioning the deployment member to a first predetermined tension to deploy the anchor. The method may then include applying tension to the deployment member at or above the first predetermined tension. The second predetermined tension is configured to break the deployment member at a predetermined breakable portion 224 along the deployment member. Figure 13B Then, the unfolded component is detached from the anchor and thus removed from the anchor. Figure 13C The first predetermined tension can be 120 N. The second predetermined tension can be 140 N. Then, the repair suture and connecting device operably coupled to the anchor can connect the anchor to the second tissue. The repair suture can be stored and covered in the anchor insertion instrument, with the cap locked in the provided coverage position. When the anchor is deployed, the cap lock is released simultaneously with deployment.

[0051] In some exemplary embodiments, the connecting device 255 may be at least one needle 255a. In other exemplary embodiments, the connecting device may include a second anchor 255b. The second anchor 255b may be different from the first anchor 200. The second anchor 255b may be a leather button-type anchor. Figure 14AA tissue repair system 1400 similar to system 100 is shown, wherein the anchor is housed within a slotted tube 152 (covered by the tube 152). Similar components are given the same reference numerals, wherein the elements or parts are the same as those in system 100. Repair members 250 (or more members) are operably coupled to both anchor 200 and anchor 255b at opposite ends and also extend along channel 142. A second anchor 255b may be stored within a cap 135 or cavity 136. As shown, anchor 255b may be stored within cap 136, and removal of the cap simultaneously removes anchor 255b and a portion of repair member 250. For the purpose of illustrating the figure, Figure 14A A cover 136 separate from the hub 130 is shown. However, similar to previous embodiments, given the positions of the tube 152 and key 156, the cover 136 will actually lock onto the hub 130. In some exemplary embodiments, the repair member (or multiple members) 250 may form multiple loops extending between the anchor 200 and the anchor 255b, and thus may extend multiple times along the channel 142. This is in Figure 14B Presented in the image. In some exemplary embodiments, the repair member 250 extends through itself to form a locking passage 251 (finger trap or splice). The locking passage 251 may also be stored within the cavity 136. Figure 14B As shown, the repair member 250 may extend along the entire length of the anchor 200. In other exemplary embodiments, the repair member 250 may extend only through a portion of the anchor 200. This makes it easier to reduce any loops formed by the repair member 250 and also reduces the volume of the anchor 200.

[0052] A method of securing a first tissue to a second tissue may include inserting a tissue anchor into the first tissue, the insertion utilizing an instrument including a handle at a proximal end, a shaft extending distally from the handle, and a hub with a cap between the handle and the shaft. An actuating member of the instrument is movable or actuated to deploy the tissue anchor and secure the tissue anchor to the first tissue. Actuation may include rotating a portion of the handle. Deploying the tissue anchor may include expanding the anchor within the tissue. Deploying the anchor may include deforming the anchor. Deployment may include reorienting the anchor. Deployment of the anchor may include applying tension to a deployment member operatively coupled to the anchor. Deployment of the anchor may include axially moving a portion of the instrument. Deployment of the anchor may include axially retracting a tube of the instrument, the distal end of the tube configured to receive the anchor during insertion. Deployment may simultaneously unlock a housing cap. Deployment may axially retract the tube to simultaneously expose the tissue anchor to the first tissue and unlock the housing cap.

[0053] The housing cover can then be removed to expose the coupling device and repair component housed within the housing. The repair component may extend along a channel along the outer portion of the shaft. The repair component is operatively coupled to tissue anchors. The repair component may be interwoven with the tissue anchors. Unlocking the cover releases the cover to detach it from the hub. Unlocking the cover may only unlock the cover, and removing the cover to expose the repair component and coupling device may further require overcoming secondary engagement between the hub and the cover. Removal may include breaking welds or adhesives, and removal may include hinged opening of the cover. Removal may include overcoming friction or snap-fit ​​engagement. Removal exposes the repair component and coupling device housed within the hub. Removing the cover may pull the repair component and / or coupling device out of the hub.

[0054] The coupling device may be a needle 255a, and the repair member may define two branches, each branch having a needle attached to the branch and received within a cap. The repair member can then be coupled to the second tissue by piercing it with one or more needles. In another exemplary method, the coupling device may be a repair anchor 255b, which may be different from the tissue anchor. The repair anchor may be a leather button. The repair member may form multiple loops between the tissue anchor and the repair anchor, with two branches extending from the repair anchor 255b. The repair anchor and the repair member may be inserted through holes in or around the second tissue to couple the repair anchor to the second tissue, and thereby couple the first tissue to the second tissue. Pulling on the two branches reduces the size of the multiple loops and pulls the second and first tissues toward each other. At least one locking passage may be formed along the length of the repair member such that tension on the repair member can lock the locking passage knotlessly and lock the first and second tissues in place. The locking passage may also be provided as a storage space within a hub.

[0055] The unfolding member may include a breakable portion, and unfolding may include tensioning the unfolding member to unfold the anchor, then tensioning the unfolding member to break the breakable portion, and then removing the unfolding member. The unfolding member may be interwoven with tissue anchors, and the breakable portion may be adjacent to the tissue anchors. In other embodiments, the instrument may include a separately activated cutting blade. After unfolding the anchors, the cutting blade may engage to tranverse a portion of the unfolding member. The tissue anchors may be formed of a soft material and may be formed of braided sutures. Removing the unfolding member leaves the tissue anchors, fixed to the first tissue, in the unfolded configuration.

[0056] Those skilled in the art will recognize that this disclosure may be practiced in other specific forms without departing from its spirit or essential characteristics. Therefore, the foregoing examples are to be considered illustrative in all respects and not to limit the disclosure described herein. The scope of this disclosure is therefore indicated by the appended claims rather than by the foregoing description, and thus all variations in the meaning and scope of the equivalents of the claims are intended to be included therein.

Claims

1. A tissue repair system for attaching a first tissue to a second tissue, comprising: An instrument, the instrument including a handle at a proximal end, a shaft extending distally from the handle, and the instrument also including a housing having a cover; Deployment component (220); Tissue anchor, the tissue anchor being disposed at the distal end of the shaft, the tissue anchor being operably connected to the actuating member of the handle via a deployment member; as well as A repair member configured to attach the tissue anchor to the second tissue, the repair member defining a first end operably attached to the tissue anchor and a second end operably attached to at least one coupling device; The second end and the coupling device are housed within the instrument housing, and wherein the actuation of the actuating member is configured to deploy the tissue anchor via the unfolding member, thereby coupling the tissue anchor to the first tissue, and is also configured to release the housing cover to access the coupling device. The unfolding member (220) interweaves through the tissue anchor (200) and extends along the axis (140), and the repair member (250) interweaves through the tissue anchor (200) along a path parallel to the path through which the unfolding member (220) passes through the tissue anchor (200) but is circumferentially offset from the path through which the unfolding member (220) passes through the tissue anchor (200). The repair member (250) is smaller in diameter or width than the unfolding member (220). The deployable member (220) includes a breakable portion (224) configured to break at a predetermined value indicating the deployment of the organization anchor.

2. The tissue repair system of claim 1, wherein the shaft has a first position and a second position, wherein in the first position, the shaft is operably coupled to the housing cover to lock the housing cover, and wherein actuation of the actuating member moves the shaft to the second position to release the housing cover.

3. The tissue repair system of claim 2, wherein the distal end of the shaft is configured to accommodate the tissue anchor therein. And wherein the actuating member moves the shaft axially to expose the tissue anchor.

4. The tissue repair system of claim 1, wherein the housing cover defines the peripheral surface of the instrument.

5. The tissue repair system of claim 1, wherein the housing cover includes a groove for engaging the repair member such that removing the housing cover removes a portion of the repair member.

6. The tissue repair system of claim 1, wherein the coupling device is selected from needles, leather buttons, and another tissue anchor.

7. The tissue repair system of claim 1, wherein the tissue anchor is a soft anchor, and the unfolding member comprises a flexible member repeatedly interwoven by the soft anchor.

8. The tissue repair system of claim 7, wherein the flexible member defines a first cross-section, and the repair member defines another flexible member having a second cross-section smaller than the first cross-section.

9. The tissue repair system of claim 1, wherein the repair component comprises at least two flexible components defining at least four flexible component branches, each branch being terminated with a coupling device, the coupling device being a needle.

10. A tissue repair system for attaching a first tissue to a second tissue, comprising: An instrument, the instrument including a handle at a proximal end, a shaft extending distally from the handle, and the instrument also including a housing having a cover; Deployment component (220); Tissue anchor, the tissue anchor being housed within the distal end of the shaft, the tissue anchor being operably coupled to the actuating member of the shank via a deployment member; as well as A flexible member defines a first end operably coupled to the tissue anchor and a second end operably coupled to at least one coupling device; the second end and the coupling device are housed within the instrument housing, and wherein actuation of the actuating member is configured to deploy the tissue anchor via the deploying member, thereby coupling the tissue anchor to the first tissue, and is also configured to axially move the shaft and unlock the housing cover to access the coupling device. The deployable member (220) interweaves through the tissue anchor (200) and extends along the axis (140), and the flexible member interweaves through the tissue anchor (200) along a path parallel to the path through which the deployable member (220) passes through the tissue anchor (200) but is circumferentially offset from the path through which the deployable member (220) passes through the tissue anchor (200). The flexible member is smaller in diameter or width than the deployable member (220). The deployable member (220) includes a breakable portion (224) configured to break at a predetermined value indicating the deployment of the organization anchor.

11. The tissue repair system of claim 10, wherein the coupling device is selected from a needle, a leather button, and another tissue anchor.

Images