WO2025239838A1 - A tissue repair device and an applicator for the device - Google Patents
A tissue repair device and an applicator for the deviceInfo
- Publication number
- WO2025239838A1 WO2025239838A1 PCT/SG2025/050337 SG2025050337W WO2025239838A1 WO 2025239838 A1 WO2025239838 A1 WO 2025239838A1 SG 2025050337 W SG2025050337 W SG 2025050337W WO 2025239838 A1 WO2025239838 A1 WO 2025239838A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- effector
- tissue repair
- repair device
- tissue
- applicator
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/064—Surgical staples, i.e. penetrating the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/10—Surgical instruments, devices or methods for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/0042—Surgical instruments, devices or methods with special provisions for gripping
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0495—Reinforcements for suture lines
Definitions
- tissue repair device an applicator for the tissue repair device, an installation module and a suture capturing device for the tissue repair device.
- Tissue damage, tears or degeneration at the rotator cuff often require surgical repair to reattach the tom or detached tissue to bone.
- the incidence of rotator cuff re-tears post-operation is high (ranging from 40 % to 60 % depending on original size of tear), often due to localized mechanical failure which occurs when the suture used to attach torn tissue to bone, cuts through the reattached tissue under repeated tension or stress, i.e. “cheese-wiring effect”.
- Biological graft augmentations may offer improved tendon healing; however, their application introduces additional surgical complexity. These procedures typically require precise graft positioning, delivery into the subacromial space, and supplementary fixation steps such as knot tying or placement of additional suture anchors. Moreover, the cost of such grafts substantially increases the expense of what is often considered an elective procedure. Many surgeons consider graft augmentation economically impractical for routine rotator cuff repair. In summary, such procedures are complex, expensive and often requires a pool of highly skilled and trained surgeons. [0005] Therefore, there is a need to address at least one of the above-mentioned problems.
- the disclosure was conceptualized to provide an improved tissue repair device for tissue repair, and an applicator for delivering and attaching the tissue repair device to tissue at a surgical site.
- the tissue repair device comprises a first aperture and a second aperture separate to and positioned apart from each other, to allow a suture to be threaded through two points of the tissue repair device.
- one or more portion(s) of the suture loops over the top surface of the device, which is positioned directly on the tissue, e.g. tendon.
- the device serves as a protective interface between the suture and the tendon, acting as a mechanical buffer that helps prevent suture-induced cutting or tearing of the tendon tissue.
- This configuration is particularly effective when combined with position-retention features, such as the integrated anchor members of the device that maintain its placement at the suture-tendon junction, or a knot tied in the suture to prevent the device from migrating away from the suture-tendon junction.
- position-retention features such as the integrated anchor members of the device that maintain its placement at the suture-tendon junction, or a knot tied in the suture to prevent the device from migrating away from the suture-tendon junction.
- the load- responsive mechanism can function as a lever, driving the anchor members deeper into the tendon under tensile load, thereby enhancing fixation strength.
- the disclosure provides an applicator comprising a delivery assembly having a driver assembly for urging the delivery rod having the tissue repair device attached thereto through the tissue to form the attachment.
- the applicator allows a user to deliver the tissue repair device in a quick and simple manner, reducing the need for specialized surgical instruments, and highly skilled and trained users.
- Various embodiments of the disclosure further provide an installation module that allows a user to attach the tissue repair device to the applicator in a quick and simple manner; and a suture capturing device for facilitating the threading of the suture to the tissue repair device, thereby reducing the complexity of the procedure.
- the disclosure further provides methods of manufacture of the tissue repair device, the applicator, the installation module and the suture capturing device, which are inexpensive and easy to manufacture.
- the tissue repair device and the applicator are particularly applicable for rotator cuff repairs, but can be used in the repair of soft tissue, for example in the repair of many other ligaments and tendons, or other connective tissue, such as in other joints in the body.
- the device according to various embodiments of the disclosure is also compatible with existing suture configurations for rotator cuff repairs.
- a tissue repair device comprising: a base plate; a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue; a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture; and a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture.
- the base plate comprises a first segment, a second segment and a third segment; wherein the first, second and third segments are connected to each other at the part of the base plate having the first aperture, and wherein the second aperture is arranged on the third segment.
- the third segment comprises a bellshaped profile; or wherein the third segment comprises an oblong profile having a curved surface arranged on an end of the third segment.
- the second aperture comprises a U-shaped channel extending partially along a perimeter of the third segment, the U-shaped channel having an area greater than an area of the first aperture.
- each anchor member extends from an anterior portion or a lateral portion of each of the first and second segments.
- the anterior portion or the lateral portion at which the anchor member extends from comprises a rounded surface.
- each anchor member comprises a barb operable to pierce tissue.
- the at least one of the plurality of anchor members or the one or more pairs of anchor members comprises a first anchor side and a second anchor side, each of the first and second anchor sides extending towards the third segment of the base plate.
- the device comprises a biocompatible material, optionally nitinol or bio-absorbable magnesium.
- an applicator for attaching a tissue repair device to a tissue
- the applicator comprising: an effector configured to receive the tissue repair device; a shaft having a hollow interior for housing a delivery assembly, the delivery assembly comprising; a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the delivery rod to drive the tissue repair device through the tissue to form the attachment.
- the driver assembly comprises a driver rod positioned adjacent to the delivery rod, the driver rod configured to slide along the length of the shaft; a biasing device positioned adjacent to the delivery rod, the biasing device configured to move between an compressed state in which the driver rod is spaced apart from the deliver ⁇ ' rod, and an extended state in which the driver rod abuts and propels the delivery rod to drive the tissue repair device through the tissue to form the attachment.
- the applicator further comprises a partition device housed in the hollow interior of the shaft, the partition device comprising a partition member configured to be positioned between the driver rod and the delivery rod, when the biasing device is in the compressed state.
- the driver assembly further comprises a holding assembly, the holding assembly configured to hold the biasing device in the compressed state in which the driver rod is spaced apart from the delivery rod.
- the holding assembly comprises at least one first holding member, the first holding member configured to be held in at least one recess formed along a length of the driver rod, to hold the biasing device in the compressed state.
- the first holding member comprises a bearing, optionally a ball bearing.
- the holding assembly comprises at least one second holding member, the second holding member positioned adjacent to and extending along a length of the driver rod, wherein the second holding member is configured to be held in at least one groove formed along the length of the shaft, to hold the biasing device in the compressed state.
- the effector comprises a first effector portion coupled to a second effector portion, the first and second effector portions configured to receive the tissue repair device.
- the effector further comprises a hook arranged on each of the first and second effector portions, wherein the hook is configured to receive and hold the tissue repair device.
- the delivery rod is configured to urge the first and second effector portions away from each other, to contact and drive the tissue repair device through the tissue to form the attachment.
- the delivery rod is pivotably coupled to the effector in a manner such that the effector is rotatable with respect to the delivery rod.
- the effector comprises a protrusion arranged on each of the first and second effector portions, and further comprises an effector cover for housing the effector, the effector cover comprising a first portion and a second portion positioned adjacent to the first portion, wherein the protrusion is configured to be held against the shaft or the first portion of the effector cover, when the biasing device is in the compressed state.
- the second portion of the effector cover comprises slots for receiving the protrusion arranged on the first and second effector portions, wherein the protrusion arranged on the first and second effector portion is configured to move into a respective slot of the second portion of the effector cover, when the biasing device is in the extended state.
- the effector cover comprises a serrated tip.
- the effector is removably attachable to the delivery rod.
- the delivery rod comprises a projection extending from an end of the delivery rod.
- an installation module for attaching the tissue repair device to the applicator, the installation module comprising: an installation body having a surface comprising an installation projection extending from the surface, the surface and the installation projection dimensioned to receive the tissue repair device, wherein the installation projection is configured to cooperate with the applicator, to permit the first and second effector portions to receive and hold the tissue repair device.
- the surface comprises an inclined surface.
- a suture capturing device for attaching a suture on to the tissue repair device, the suture capturing device comprising: a handle having a capturing member attached thereto, the capturing member configured to receive the suture, wherein the capturing member is configured to facilitate the threading of the suture through the first aperture and the second aperture, to attach the suture on to the tissue repair device.
- the capturing member comprises a loop, and wherein the capturing member comprises a flexible and bio-compatible material, optionally, nitinol.
- kits of parts of a tissue repair assembly comprising: at least one tissue repair device; the applicator; optionally, the installation module, and/or the suture capturing device.
- a method of manufacturing a tissue repair device comprising: providing a base plate; providing a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue; forming, a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture; and forming, a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture.
- forming the base plate comprises: forming a first segment, a second segment and a third segment; wherein the first, second and third segments are connected to each other at the part of the base plate having the first aperture, and wherein the second aperture is arranged on the third segment, hr some embodiments, the third segment comprises a bell-shaped profile; or wherein the third segment comprises an oblong profile having a curved surface arranged on an end of the third segment.
- the second aperture comprises a U-shaped channel extending partially along a perimeter of the third segment, the U-shaped channel having an area greater than an area of the first aperture.
- each anchor member extends from an anterior portion or a lateral portion of each of the first and second segments.
- the anterior portion or the lateral portion at which the anchor member extends from comprises a rounded surface.
- each anchor member comprises a barb operable to pierce tissue.
- the at least one of the plurality of anchor members or the one or more pairs of anchor members comprises a first anchor side and a second anchor side, each of the first and second anchor sides extending towards the third segment of the base plate.
- the device comprises a biocompatible material, optionally nitinol or bio-absorbable magnesium.
- a method of manufacturing an applicator for attaching a tissue repair device to a tissue comprising: providing an effector for receiving the tissue repair device; providing a shaft having a hollow interior; providing a delivery assembly housed within the shaft, comprising providing a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; providing a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the delivery rod to drive the tissue repair device through the tissue to form the attachment.
- providing the driver assembly comprises: providing a driver rod positioned adjacent to the delivery rod, the driver rod configured to slide along the length of the shaft; providing a biasing device positioned adjacent to the delivery rod, the biasing device configured to move between a compressed state in which the driver rod is spaced apart from the delivery rod, and an extended state in which the driver rod abuts the delivery rod to drive the tissue repair device through the tissue to form the attachment.
- the method further comprises: providing a partition device housed in the hollow interior of the shaft, the partition device comprising a partition member configured to be positioned between the driver rod and the delivery rod, when the biasing device is in the compressed state.
- providing the driver assembly further comprises: providing a holding assembly, the holding assembly configured to hold the biasing device in the compressed state in which the driver rod is spaced apart from the delivery rod.
- forming at least one recess along a length of the driver rod providing at least one first holding member, the first holding member configured to be held in the at least one recess, to hold the biasing device in the compressed state.
- providing the at least one first holding member comprises: forming a channel between an outer surface and the hollow interior of the shaft; positioning a first cap portion on an end of the shaft adjacent to the driver rod, the first cap portion positioned such that a cap channel of the first cap portion is in alignment with the channel; disposing the at least one first holding member into the channel, such that the first holding member is led into the cap channel; positioning a second cap portion on the first cap portion, the second cap portion configured to lodge the at least one first holding member in the first and second cap portions and seal the channel and the cap channel.
- providing the holding assembly comprises: forming at least one groove along the length of the shaft; providing at least one second holding member positioned adjacent to and extending along a length of the driver rod, the second holding member configured to be held in the at least one groove, to hold the biasing device in the compressed state.
- providing the effector comprises: providing a first effector portion coupled to a second effector portion, the first and second effector portions configured to receive the tissue repair device. In some embodiments, providing the effector further comprises: providing a hook arranged on each of the first and second effector portions, wherein the hook is configured to receive and hold the tissue repair device.
- the delivery rod is configured to urge the first and second effector portions away from each other, to contact and drive the tissue repair device through the tissue to form the attachment.
- the method further comprises: providing a protrusion arranged on each of the first and second effector portions, providing an effector cover for housing the effector, the effector cover comprising a first portion and a second portion positioned adjacent to the first portion, wherein the protrusion is configured to be held against the shaft or the first portion of the effector cover, when the biasing device is in the compressed state.
- providing the effector further comprises: providing slots arranged on the second portion of the effector cover for receiving the protrusion arranged on each of the first and second effector portions, wherein the protrusion arranged on the first and second effector portion is configured to move into a respective slot of the second portion of the effector cover, when the biasing device is in the extended state.
- providing the delivery rod comprises, forming a projection extending from an end of the delivery rod.
- the surface comprises an inclined surface.
- a method of manufacturing a suture capturing device for attaching a suture on to the tissue repair device comprising: providing a handle; attaching a capturing member to the handle, the capturing member configured to receive the suture, wherein the capturing member is configured to facilitate the threading of the suture through the first aperture and the second aperture, to attach the suture on to the tissue repair device.
- the capturing member comprises a loop, and wherein the capturing member comprises a flexible and bio-compatible material, optionally, nitinol.
- FIG. 2 shows a (A) perspective view; (B) top view; (C) bottom perspective view; (D) side view; and (E) front view of a schematic illustration of another exemplary tissue repair device 100B;
- FIG. 4 shows a schematic illustration of the applicator 300, showing the (A) front cross- sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration where the cap 306 of the depressed but before the tissue repair device is released from the applicator (“depressed pre-firing” configuration);
- FIG. 6 shows a schematic illustration of an expanded cross-sectional view of another embodiment of the delivery rod 312 of the applicator 300, (A) before a tissue repair device 100A, 100B is released from the applicator 300 (“pre-firing” configuration); and (B) after the tissue repair device 100 A, 100B is released from the applicator 300 (“postfiring” configuration);
- FIG. 7 show a schematic illustration of an expanded view of an embodiment of a holding assembly 340 of the applicator 300, (A) before a tissue repair device is released from the applicator 300 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 300 (“post-firing” configuration);
- FIG. 8 shows a schematic illustration of another embodiment of the applicator 400 showing a second holding assembly 440, (A) before a tissue repair device is released from the applicator 400 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 400 (“post-firing” configuration);
- FIG. 10 shows a schematic illustration of an exemplary installation module 600 for attaching a tissue repair device to an applicator, showing the (A) top view; and (B) perspective view of the installation module 600 without the tissue repair device; and the (C) top view; and (D) perspective view of the installation module 600 with the tissue repair device;
- FIG. 1 1 shows a pictorial representation of an exemplary suture capturing device 700 for attaching a suture to a tissue repair device;
- FIG. 12 shows a flowchart of an exemplary method 800 of manufacturing a tissue repair device
- - FTG. 13 shows a flowchart of an exemplary method 900 of manufacturing an applicator for attaching a tissue repair device to a tissue
- FIG. 14 shows the (A) cross-sectional view and (B) perspective view of a schematic illustration of a cap 306, c.g. two-part cap for providing the at least one first holding member 342 of the first holding assembly 340; and further shows the (C) cross-sectional view and (D) perspective view of the first cap portion 306a; the (E) cross-sectional view and (F) perspective view of the second cap portion 306b of the cap 306, e.g. two-part cap.
- FIG. 15 shows (A) a flowchart of an exemplary method 900A for providing the at least one first holding member 342 of the first holding assembly 340; and corresponding schematic illustrations of the first shaft portion 302a, the cap 306, e.g. two-part cap and the handle 304, showing the (B) positioning of the first cap portion 306a in alignment with a channel 309 formed between the outer surface and hollow interior of the first shaft portion 302a; (C) the first holding member 342 disposed in the cap channel 306c; and (D) the positioning of the second cap portion 306b into the first cap portion 306a
- FIG. 16 shows a flowchart of a method 1000 of manufacturing an installation module for attaching a tissue repair device to an applicator
- FIG. 17 shows a flowchart of a method 1 100 of manufacturing a suture capturing device for attaching a suture on to the tissue repair device.
- the articles “a”, “an” and “the” as used with regard to a feature or element include a reference to one or more of the features or elements.
- the term “and/or” includes any and all combinations of one or more of the associated listed items.
- first may be referred to as a second clement
- second element may be referred to as the first element
- the term “substantially” as used herein may refer to a large extent, for example, at least 80 % of indicated portion.
- tissue refers to connective tissue proper or soft tissue, including but not limited to tendons and ligaments.
- tissue is also contemplated to include cartilage.
- tissue may refer to the supraspinatus tendon.
- the term “repair” as used herein refers broadly to surgical means for the repair of the tissue, for example, surgery to repair a torn rotator cuff by reattaching the rotator cuff to the humerus bone.
- the term “repair” thus includes arthroscopy, open surgery, or a combination of both for rotator cuff repairs.
- the term “positioned adjacent to”, as used herein, may refers to the position of one element proximal to another element.
- the element may be proximal to but not in contact with the another element, for example, having one or more intervening elements.
- the clement may be proximal to and in direct contact with the another element.
- FIG. 1 shows a (A) perspective view; (B) top view; (C) bottom perspective view; (D) side view; (E) front view; (F) bottom view; and (G) back view of a schematic illustration of an exemplary tissue repair device 100A.
- FIG. 2 shows a (A) perspective view; (B) top view; (C) bottom perspective view; (D) side view; and (E) front view of a schematic illustration of another exemplary tissue repair device 100B.
- the tissue repair device 100A, 100B comprises a base plate 110 having a first surface 110a and a second surface 110b opposing the first surface 110a.
- the first surface 110a may be the upper or top surface
- the second surface 110b may be the bottom surface of the base plate 1 10.
- the base plate 110 may comprise a first segment 112, a second segment 114 and a third segment 116, each comprising the first surface 110a and opposing second surface 110b of the base plate 110.
- the third segment 116 may have a bell-shaped profile (see FIGS. 1A to 1G), or may have a substantially oblong profile having a curved surface arranged on an end of the third segment (see FIGS. 2 A to 2E).
- Each of the first segment 112, the second segment 114 and the third segment 116 may have a same thickness, for example, a thickness ranging from 0.1 mm to 3.0 mm, optionally, from 0.2 mm to 2.5 mm.
- each of the first segment 112, the second segment 114 and the third segment 116 may have a different thickness.
- the third segment 116 may have a thickness less than the first segment 112 and/or the second segment 114.
- the tissue repair device 100A, 100B comprises a plurality of anchor members 122, 124 or one or more pair of anchor members 122, 124 extending from a second surface 1 10b of the base plate 110.
- the plurality or one or more pair of anchor members 122, 124 may be integrally formed with the base plate 1 10 and may include a first anchor member 122 and a second anchor member 124 as shown in FIGS. 1A to 2E.
- the first and second anchor members 122, 124 are integrated onto the base plate 110.
- FIGS. 1A to 2E show two anchor members 122, 124, the disclosure is not limited thereto, and the tissue repair device 100A, 100B may include two or more anchor members 122, 124. It is also contemplated that the first and second anchor members 122, 124 may be removably detachable to the base plate 110.
- the first anchor member 122 and the second anchor member 124 may extend from an anterior portion, e.g. front portion, of each of the first segment 112 and second segment 114, respectively (sec FIGS. 1A to 1G). In various other embodiments, the first anchor member 122 and the second anchor member 124 may extend from a lateral portion, c.g. side portion, of each of the first segment 112 and second segment 114, respectively (see FIGS. 2A to 2E). In some embodiments, the anterior portion or the lateral portion at which the first anchor member 122 and the second anchor member 124 extend from, may comprise a rounded surface (see FIGS. 2A to 2E).
- first anchor member 122 and the second anchor member 124 may extend from the anterior portion or the lateral portion, substantially perpendicular to the base plate 110 (see FIGS. 1 A to IE). It is contemplated that the first anchor member 122 and the second anchor member 124 may be positioned to extend from the posterior portion of the third segment 1 16.
- Each of the first anchor member 122 and the second anchor member 124 may include an anchor end operable to pierce tissue.
- the anchor end of the first anchor member 122 and the second anchor member 124 may each comprise a barb, e.g. a sharp projection formed at the anchor end for piercing tissue.
- the barb may be angled away from the base plate 1 10 to secure the first anchor member 122 and the second anchor member 124 into the tissue.
- first anchor member 122 and the second anchor member 124 may comprise a first anchor side 126a and a second anchor side 126b, which may be positioned on opposing sides of the first anchor member 122 and/or the second anchor member 124.
- Each of the first anchor side 126a and second anchor side 126b may taper towards the third segment 116, e.g. posterior end, of the base plate 1 10.
- the first anchor side 126a and second anchor side 126b may therefore have a pointed or sharpened geometry, which may reduce the load transmitted to the first and second anchor members 122, 124 when the tissue repair device 100A, 100B is under tension, e.g.
- This embodiment may be used when the tissue repair device 100A, 100B is fabricated using material with relatively low yield strength, for example, materials such as magnesium alloys or bioresorbable polymers which may be easier to obtain and cheaper to manufacture.
- materials such as magnesium alloys or bioresorbable polymers which may be easier to obtain and cheaper to manufacture.
- first and/or second anchor member 122, 124 comprise the first and second anchor sides 126a, 126b, there may be reduced load-bearing contribution of the first and second anchor members 122, 124 at the interface where the tissue repair device 100A, 100B, and suture attaches to the tissue.
- first and second anchor members 122, 124 there may be a trade-off between preserving the structural integrity of the first and second anchor members 122, 124 based on material strength, preventing premature first and second anchor member 122, 124 detachment, and maximizing the overall resistance to the suture cutting through the tissue at the interface at which the suture and tissue repair device 100A, 100B attaches to the tissue, i.e. “cheese-wiring” failure mechanism.
- a user may therefore select the appropriate first and second anchor member 122, 124 type (see FIGS. 1A to IE, 2A to 2E, with respect to FIGS. IF and 1G) based on application-specific requirements, such as tissue integrity, suture tension and material selection of the tissue repair device 100A, 100B.
- the base plate 100 further includes a first aperture 132 and a second aperture 134.
- the first segment 112, second segment 114 and the third segment 116 may be connected to each other at the part of the base plate 110 having the first aperture 132.
- the first aperture 132 may have substantially, a curved or rounded profile.
- the second aperture 134 may be positioned on another part of the base plate 1 10, separate to and away from the first aperture 132, and in various embodiments, the second aperture 134 may be positioned on the third segment 116 of the base plate 110.
- the second aperture 134 may comprise a channel having substantially, a U-shaped profile, and may extend partially along a perimeter of the third segment 116.
- the second aperture 134 may have a width ranging from 0.5 mm to 2 mm, optionally 1.1 mm. In various embodiments, the area of the second aperture 134 having a U-shaped channel may be greater than an area of the first aperture 132.
- the tissue repair device 100A, 100B may comprise a biocompatible material that has a high structural strength for secure attachment to the tissue.
- the tissue repair device 100A, 100B may comprise nitinol, i.e., a nickeltitanium alloy which is super-elastic and has high structural strength.
- Nitinol comprises a tensile strength ranging from 900 MPa to 1,400 MPa, depending on the composition, heat treatment, and processing of the material.
- Nitinol is also particularly applicable due to its superelasticity and shape memory properties, which contribute to its effectiveness in dynamic soft- tissue applications, e.g. at the tissue repair device 100A, 100B and tissue interface. In medical devices, nitinol is often employed when both flexibility and high load-bearing capacity are required.
- the tissue repair device 100A, 100B may comprise bio- absorbable magnesium, which may degrade over time under physiological conditions.
- Bio- absorbable magnesium exhibits a tensile strength of approximately 200 MPa to 300 MPa, and a compressive yield strength of around 150 MPa to 200 MPa, depending on alloying elements, processing, and surface finish.
- bio-absorbable magnesium may be gradually resorbed after the healing process, there is no or a minimized need for surgical removal of the tissue repair device 100A, 100B.
- Alternative bioresorbable materials may include polymeric compounds such as PLGA (poly (lactic -co-glycolic acid)) and PLLA (poly-L-lactic acid). These polymers are commonly used in soft tissue fixation devices and exhibit tensile strengths in the range of 40 MPa to 100 MPa, depending on molecular weight and processing.
- PLGA and PLGA are highly biocompatible, and have predictable degradation profiles.
- the tissue repair device 100A, 100B may also comprise absorbable bone graft materials, such as calcium phosphate cements or bioactive ceramics, which exhibit compressive strengths between 20 MPa to 100 MPa, depending on formulation. These materials are typically used where osteoconductive or space-filling properties are required.
- absorbable bone graft materials such as calcium phosphate cements or bioactive ceramics, which exhibit compressive strengths between 20 MPa to 100 MPa, depending on formulation. These materials are typically used where osteoconductive or space-filling properties are required.
- the suture may be threaded through the first aperture 132, to extend across the first surface 110a, e.g. upper surface of the first segment 112 and the second segment 114 of the base plate 110, and subsequently threaded through the second aperture 134, to extend across the second surface 110b, e.g. bottom surface of the third segment 116. This may be performed prior to attaching the tissue repair device 100A, 100B to an applicator for delivery to the tissue at the surgical site.
- the suture may loop around the first surface 1 10a of the first and second segments 112, 114, and around the second surface 110b of the third segment 116 of the base plate 1 10 of the tissue repair device 100A, 100B.
- the tissue repair device 100A, 100B provides increased contact area and improved mechanical interlock between the suture and the tissue repair device 100A, 100B.
- the tissue repair device 100A, 100B when the tissue repair device 100A, 100B is placed over tom tissue for reattachment to bone, the tissue repair device 100A, 100B and the suture may be firmly secured onto the tissue. This, in turn, ensures stable fixation of the tissue repair device 100A, 100B into the tissue, reducing the risk of suture slippage, detachment from the tissue repair device 100A, 100B, and/or failure at the tissue interface.
- the suture becomes tensioned, and additional load is transferred downward to the first surface 110a, e.g. upper surface of the first and second segments 112, 114 of the tissue repair device 100A, 100B.
- This downward force enhances the apposition of the tissue repair device 100A, 100B to the tissue, e.g. tendon, thereby improving fixation.
- the tension in the suture is relieved, reducing the force applied to the tissue repair device 100A, 100B.
- the tissue repair device 100A, 100B of the present disclosure is particularly effective when used in combination with position-retention features. These include the integrated first and second anchor members 122, 124 of the tissue repair device 100A, 100B, which resist displacement at the suture-tissue junction, or a knot tied in the suture to prevent the tissue repair device 100A, 100B from migrating or shifting away from the suture-tissue junction.
- the load-responsive mechanism may also serve a secondary function as a lever — where tension applied to the suture at the rear of the third segment 116 causes the third segment 116 to pivot upward, generating a downward force on the first segment 112 and second segment 114, and thereby driving the first and second anchor members 122, 124 deeper into the tissue under tensile load and enhancing fixation strength.
- FIG. 3 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration before a tissue repair device is released from the applicator 300 (“pre-firing” configuration).
- FIG. 3 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration before a tissue repair device is released from the applicator 300 (“pre-firing” configuration).
- FIG. 3 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device
- FIG. 4 shows a schematic illustration of the applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration where the cap 306 of the depressed but before the tissue repair device is released from the applicator (“depressed pre-firing” configuration).
- FIG. 4 shows a schematic illustration of the applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration where the cap 306 of the depressed but before the tissue repair device is released from the applicator (“depressed pre-firing” configuration).
- FIG 5 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view as the tissue repair device is released from the applicator 300 (“post-firing” configuration); (B) side cross-sectional view as the tissue repair device is released from the applicator 300 (“postfiring” configuration); (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, after the tissue repair device is released from the applicator 300 (“post-firing” configuration).
- the tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E.
- the applicator 300 may be particularly suitable for delivery and facilitating the attachment of the tissue repair device 100A, 100B to overlay torn tissue at a surgical site, for example, for rotator cuff repairs or for the repair of soft tissue.
- the applicator 300 comprises an effector 380 for receiving a tissue repair device 100A, 100B.
- the effector 380 may comprise a first effector portion 382 coupled to a second effector portion 384, using one or more elastic members.
- the elastic member may comprise a sealing ring, such as an O-ring, and in some embodiments, the first effector portion 382 may be coupled to the second effector portion 384 using a plurality of O-rings. The elastic member provides a clamping force to hold the first effector portion 382 and the second effector portion 384 together, and to hold the tissue repair device 100A, 100B in the effector 380.
- a hook (not shown) may be arranged on each of the first effector portion 382 and the second effector portion 384, to receive and hold the tissue repair device 100A, 100B.
- the hook arranged on the first effector portion 382 and the second effector portion 384 may hook onto the first segment 112 and the second segment 114, respectively, of tissue repair device 100A, 100B to hold the tissue repair device 100A, 100B for delivery to a surgical site.
- the effector 380 may further comprise a first protrusion 386 arranged on the first effector portion 382, and a second protrusion 388 arranged on the second effector portion 384.
- the first protrusion 386 and the second protrusion 388 may be held against the shaft 302, specifically, the third shaft portion 302c, or effector cover 385 of the applicator 300 in the “prefiring” configuration (see FIG. 3D), and may act as a safety mechanism to prevent the first effector portion 382 and the second effector portions 384 from moving away from each other and accidentally disengaging the tissue repair device 100A, 100B held in the first 382 and second 384 effector portions. This may occur when the suture is unintentionally pulled with excessive force before deployment.
- the effector 380 may further comprise an effector cover 385 housing the first effector portion 382 and the second effector portion 384.
- the effector cover 385 may be transparent to allow a user to easily view the attachment of the tissue repair device 100A, 100B to tissue at a surgical site during use.
- the effector cover 385 may comprise a first, c.g. upper portion and a second, c.g. lower portion positioned adjacent to the first portion.
- the second, e.g. lower portion may comprise two slots in alignment with and configured to receive the first 386 and second 388 protrusions of the first 382 and second 384 effector portions, respectively.
- the applicator 300 comprises a delivery assembly 310 housed within a hollow interior of a shaft 302, for attaching the tissue repair device 100A, 100B to tissue.
- the shaft 302 may comprise a first shaft portion 302a, second shaft portion 302b and third shaft portion 302c.
- the delivery assembly 310 comprises a delivery rod 312 coupled to the effector 380, the delivery rod 312 configured to slide along the length of the shaft 302, for example, the second and third shaft portions 302b, 302c.
- the deliver ⁇ ' rod 312 may be pivotably coupled to the effector 380 in a manner such that the effector 380 is rotatable with respect to the delivery rod 312.
- the effector 380 may be positioned at an angle with respect to the delivery rod 312. This may facilitate attachment of the tissue repair device 100A, 100B to tissue, and/or improve the attachment of the tissue repair device 100A, 100B to tissue.
- the driver assembly 320 may comprise a driver rod 322 positioned adjacent to the delivery rod 312, and configured to slide along the length of the shaft 302, for example, along the first shaft portion 302a.
- the driver assembly 320 may further comprise a biasing device 324, such as another spring, for moving between a compressed state, e g. “pre-firing” configuration (see FIGS. 3A to 3C), and an extended state, e g. “post-firing” configuration (sec FIGS. 5A to 5C) for driving the tissue repair device 100A, 100B through the tissue.
- a biasing device 324 such as another spring
- the applicator 300 may include a handle 304 and a cap 306, e.g. two-part cap 306, to facilitate the movement of the biasing device 324 between the compressed state, and the extended state.
- the driver assembly 320 may further include a holding assembly 340 to hold the biasing device 324 in the compressed state in which the driver rod 322 is spaced apart from the delivery rod 312.
- a holding assembly 340 to hold the biasing device 324 in the compressed state in which the driver rod 322 is spaced apart from the delivery rod 312.
- the applicator 300 may further comprise a partition device 330 housed within the hollow interior of the shaft 302.
- the partition device 330 may comprise a partition member 332 pivotably coupled to a partition shaft 334, and may be positioned between the delivery rod 312 and the driver rod 322 to hold the biasing device 324 in the compressed state, e.g. “prefiring” configuration.
- the partition device 330 may serve as a safety mechanism to prevent the delivery rod 312 from contacting from driver rod 322, even in the event of a premature release of the biasing device 324 and/or unintended advancement of the driver rod 322.
- the partition device 330 helps prevent accidental ejection or premature deployment of the tissue repair device 100A, 100B before the applicator is properly positioned at the surgical site.
- the partition device 330 and may act as a safety mechanism to prevent accidental release of the biasing device 324 and/or the driver rod 322, and premature ejection or release of the tissue repair device 100A, 100B.
- the applicator 300 may be in the “pre-firing” configuration, e.g. “rest” configuration.
- the tissue repair device 100A, 100B may be attached to the effector 380, the biasing device 324 may be in a compressed state, and the driver rod 322 may be positioned to be spaced apart from the delivery rod 312 (see FIG. 3B).
- the partition member 332 may be positioned between the delivery rod 312 and the driver rod 322, and may acts as a separation mechanism to prevent accidental disengagement of the biasing device 324 and/or the driver rod 322.
- the partition member 332 may prevent the driver rod 322 from abutting and propelling the delivery rod 312 in the “pre-firing” configuration.
- the first protrusion 386 arranged on the first effector portion 382, and the second protrusion 388 arranged on the second effector portion 384 may be held against the third shaft portion 302c or effector cover 385, when the biasing device 324 is held in the compressed state.
- the first 386 and second 388 protrusion may act as a clutch to engage the first 382 and second 384 effector portions in the third shaft portion 302c or effector cover 385. That is, the first 386 and second 388 protrusions may act as a safety mechanism to prevent the first 382 and second 384 effector portions from accidental dislodgment and disengagement of the tissue repair device 100A, 100B held therein.
- the biasing device 324 may store the energy required to propel the driver rod 322 towards the delivery rod 312 to drive the tissue repair device 100A, 100B into the tissue.
- a user may pull the handle 304 of the applicator 300 to move the biasing device 324 into the compressed state, and to pull the driver rod 322 away from the delivery rod 312. In some embodiments, this pulling action also resets the applicator 300 into the “pre-firing” configuration, preparing it for a subsequent deployment cycle by reloading the driver assembly 320.
- the applicator 300 may move into the “depressed prefiring” configuration.
- the spring 314 housed in the second shaft portion 302b may be compressed, and the partition shaft 334 of partition device 330 may be displaced toward the handle 304, e.g. upwards of the applicator 300.
- the partition member 332, which is pivotably coupled to the partition shaft 334 may pivot toward the partition shaft 334 and move into a recess (not shown) formed in the partition shaft 334 (see FIG. 4C). Accordingly, the delivery rod 312 and the driver rod 322 may no longer be spaced apart by a separation mechanism, e.g.
- partition member 332 and may be free to move into the “post-firing” configuration.
- the partition member 332 which acts as a separation mechanism between the delivery rod 312 and the driver 322 may move into a recess (not shown), and the driver rod 322 may be free to abut and propel the delivery rod 312 as it moves into the “post-firing” configuration.
- the holding assembly 340 may hold the biasing device 324 in the compressed state, in which the driver rod 322 is spaced apart from the delivery rod 312.
- a user may, for example, push the applicator 300 having the tissue repair device 100A, 100B attached thereto, against the tissue surface to push up firing assembly 305 and compress the spring 314 and to move the partition device 330 comprising the partition shaft 334 and partition member 332.
- the applicator 300 may move into the “post-firing” configuration in which the biasing device 324 moves into the extended state.
- the driver rod 322 may move to abut and propel the delivery rod 312 positioned adjacent thereto, to drive the tissue repair device 100A, 100B into the tissue to form the attachment.
- this may cause the effector 380 holding the tissue repair device to move or be pushed into the second, e.g. lower portion of effector cover 385.
- the first protrusion 386 and second protrusion 388 of the first 382 and second 384 effector portions, respectively, may move into the second, e.g.
- the effector cover 385 may separate laterally and no longer obstruct the delivery rod 312 from advancing to contact and drive the tissue repair device 100A, 100B into the tissue.
- the effector cover 385 may comprise a width greater than the third shaft portion 302c, the first protrusion 386 and second protrusion 388 which are positioned in the effector cover 385 may have additional space to extend away from each other, and may no longer obstruct the delivery rod 312 from contacting and driving the tissue repair device 100A, 100B into the tissue.
- the delivery rod 312 may therefore urge the first 382 and second 384 effector portions away from each other, to contact and drive the tissue repair device 100A, 100B into the tissue to form the attachment.
- the partition member 322 may be housed in the recess (not shown) formed in the partition shaft 334 and does not obstruct the movement of the driver rod 322 to abut and propel the delivery rod 312.
- the first 386 and second 388 protrusions of the first 382 and second 384 effector portions, which are propelled into the effector cover 385, may not obstruct the movement of the delivery rod 312 to contact and eject the tissue repair device 100A, 100B from the first 382 and second 384 effector portions of the applicator 300.
- FIG. 6 shows a schematic illustration of an expanded cross-sectional view of another embodiment of the delivery rod 312 of the applicator 300, (A) before a tissue repair device 100A, 100B is released from the applicator 300 (“pre-firing” confi uration); and (B) after the tissue repair device 100A, 100B is released from the applicator 300 (“post-firing” configuration).
- the delivery rod 312 may further comprise a projection 316 extending from an end of the delivery rod 312.
- the end of the delivery rod 312 may resemble a “S-shaped” structure.
- the projection 316 may provide an additional push to eject the tissue repair device 100A, 100B from the applicator 300.
- the projection 316 may provide a force to eject the front portion of the tissue repair device 100A, 100B (e.g. portion having the anchor members 122, 124 extending therefrom). This may provide a stronger ejection force to eject the tissue repair device 100A, 100B from the effector 380 of the applicator 300 to form the attachment.
- FIG. 7 show a schematic illustration of an expanded view of an embodiment of a holding assembly 340 of the applicator 300, (A) before a tissue repair device is released from the applicator 300 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 300 (“post-firing” configuration).
- the holding assembly 340 may be configured to hold the biasing device 324 in the compressed state (“pre-firing” configuration).
- at least one first holding member 342 may be disposed in a first recess 326 formed along a length of the driver rod 322.
- the first holding member 342 may act as an obstruction mechanism to prevent the driver rod 322 from abutting the deliver ⁇ ' rod 312 and prematurely ejecting the tissue repair device 100A, 100B.
- the first holding member 342 may act as a mechanical stopper or holder to prevent the release of the driver rod 322, for example, due to an accidental force applied on the cap 306 or handle 304 of the applicator 300.
- the first holding member 342 may be a bearing, optionally a ball bearing.
- the first holding member 342 may move from the first recess 326 of the driver rod 322, into a second recess 308 formed in the cap 306.
- the force applied by a user to eject the tissue repair device 100A, 100B may cause the first holding member 342 to move from the first recess 326 formed on the driver rod 322, into the second recess 308 formed on the cap 306.
- the driver rod 322 may be free to move toward the delivery rod 312, to drive the tissue repair device 100A, 100B into the tissue to form the attachment.
- FIG. 8 shows a schematic illustration of another embodiment of the applicator 400 showing a second holding assembly 440, (A) before a tissue repair device is released from the applicator 400 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 400 (“post-firing” configuration).
- the applicator 400 may be based on applicator 300 discussed with reference to FIGS. 3A to 5D, and may only comprise a different holding assembly 440.
- the second holding assembly 440 may include at least one second holding member 410 positioned adjacent to and extending along a length of the driver rod 322, and configured to hold the biasing device 324 in the compressed state, i.e. “pre-firing” configuration.
- the second holding member 410 may be configured to be held in at least one groove 402 formed along the length of the shaft 302.
- the groove 402 may be formed to extend from the hollow interior of the shaft 302 and to create a groove 402 to hold the second holding member 410.
- the second holding member 410 may therefore act as an obstruction mechanism to prevent the driver rod 322 from abutting the delivery rod 312 and prematurely ejecting the tissue repair device 100A, 100B.
- the second holding member 410 acts as a mechanical stopper or holder to prevent the release of the driver rod 322, for example, due to an accidental force applied on the cap 306 or handle 304 (not shown) of the applicator 400.
- the second holding member 410 may be a flexible member, and may be formed of a flexible material.
- the second holding member 410 which is arranged within the interior of the applicator 300, need not comprise a bio-compatible material. This may reduce the cost of manufacture as flexible and bio-compatible materials such as nitinol may be expensive.
- the second holding member 410 may comprise a flexible and bio-compatible material.
- the second holding member 410 which is flexible, may flex or bend and move into a third recess 420 formed in the cap 306.
- the force applied by a user to eject the tissue repair device 100A, 100B may cause the second holding member 410 to bend and move into the third recess 420 formed on the cap 306.
- the driver rod 322 may be free to move toward the delivery rod 312, to drive the tissue repair device 100A, 100B into the tissue to form the attachment.
- FIG. 9 shows a schematic illustration of the applicator 300 where the effector 380 is removably attachable to the delivery rod 312 of the applicator 300.
- the effector 380 comprising the first 382 and second 384 effector portions may be removably attachable to the delivery rod 312.
- the effector 380 may comprise an effector shaft 381 that may be slid on to the delivery rod 312 housed in the third shaft portion 302c of the shaft 302 of the applicator 300.
- the effector 380 may be configured to be disposable and may be discarded after attaching a tissue repair device 100A, 100B to a tissue at a surgical site, while the applicator 300 may be reusable and may receive another effector 380.
- the applicator 300 may comprise various biocompatible materials, such as but not limited to a biocompatible metal, including nitinol, stainless steel, e.g. 316L, titanium and titanium alloys, e.g.
- PE polyethylene
- PTFE polytetrafluoroethylene
- PEEK polyetheretherketone
- POM polyoxymethylene
- PMMA polylactic acid
- PGA polyglycolic acid
- PCL polycaprolactone
- ABS acrylonitrile butadiene styrene
- nylon e.g. PA6 or PA 12.
- PA6 or PA 12 nylon, e.
- FIG. 10 shows a schematic illustration of an exemplary installation module 600 for attaching a tissue repair device to an applicator, showing the (A) top view; and (B) perspective view of the installation module 600 without the tissue repair device; and the (C) top view; and (D) perspective view of the installation module 600 with the tissue repair device.
- the tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E, and the applicator may refer to applicator 300, 400 discussed with reference to FIGS. 3 A to 9.
- the installation module 600 may include an installation body 602 having a surface 604, which may comprise the top surface 604 of the installation body 602.
- the surface 604 may be inclined to facilitate the attachment of the tissue repair device 100A, 100B onto the effector 380 of the applicator 300, 400.
- the surface 604 may include an installation projection 608 extending from the surface 604.
- the surface 604 and the installation projection 608 may be dimensioned to receive the tissue repair device 100A, 100B.
- a cut-out corresponding to a shape of the tissue repair device e.g. shape of a base plate 110 and anchor members 122, 124 may be formed on the surface 604 of the installation body 602, and the installation projection 608 may be configured to receive the first aperture 132 of the tissue repair device 100A, 100B (sec FIGS. 10C and 10D).
- the installation projection 608, with the tissue repair device 100A, 100B positioned thereon may be configured to receive the applicator 300, 400 in the “post-firing” configuration, wherein the delivery rod 312 is in a protruded state that urges the first effector portion 382 and the second effector portion 384 away from each other, thereby stretching the elastic member, e.g., plurality of O-rings.
- the installation projection 608 may displace the delivery rod 312 upward towards the handle 304 of the applicator 300, 400, thereby relieving the outward bias applied to the first 382 and second 384 effector portions.
- the restoring tension of the elastic member may cause the first 382 and second 384 effector portions to return to a closed configuration.
- the first 382 and second 384 effector portions may receive and hold the tissue repair device 100A, 100B.
- the hooks arranged on each of the first 382 and second 384 effector portions may engage the first segment 112 and second segment 114 of the base plate 110 of the tissue repair device 100A, 100B to secure the device in place.
- FIG. 11 shows a pictorial representation of an exemplary suture capturing device 700 for attaching a suture to a tissue repair device.
- the tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E, which is shown to be positioned on the installation module 600 discussed with reference to FIG. 10.
- the suture capturing device 700 may include a handle 702, and a capturing member 704 attached to the handle 704.
- the capturing member 704 may comprise a loop which may be flexible.
- the capturing member 704 comprises a flexible and biocompatible material, such as nitinol.
- a suture may be threaded through the capturing member 704.
- a user may then use the handle 702 to thread the suture, contained in the capturing member 704, through the first aperture 132 and the second aperture 134, to attach the suture on to the tissue repair device 100A, 100B.
- the capturing member 704 may comprise a clip extending at an angle from the handle 702 and having an elastic lip for receiving the suture and threading the suture through the tissue repair device 100A, 100B.
- the kit of parts may further comprise, the installation module 600 discussed with reference to FIG. 10; and/or the suture capturing device 700 discussed with reference to FIG. 1 1 .
- FIG. 12 shows a flowchart of an exemplary method 800 of manufacturing a tissue repair device.
- the tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E.
- Method 800 comprises: providing a base plate (step 802); providing a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue (step 804); forming, a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture (step 806); and forming, a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture (step 808).
- providing a base plate comprises: providing a first segment, a second segment and a third segment; wherein the first, second and third segments are connected to each other at the part of the base plate having the first aperture, and wherein the second aperture is arranged on the third segment.
- the third segment comprises a bell- shaped profile; or comprises an oblong profile having a curved surface arranged on an end of the third segment.
- the second aperture comprises a U-shaped channel extending partially along a perimeter of the third segment, the U-shaped channel having an area greater than an area of the first aperture.
- each anchor member extends from an anterior portion or a lateral portion of each of the first and second segments.
- the anterior portion or the lateral portion at which the anchor member extends from comprises a rounded surface.
- each anchor member comprises a barb operable to pierce tissue.
- at least one of the plurality of anchor members or the one or more pairs of anchor members comprises a first anchor side and a second anchor side, each of the first and second anchor sides extending towards the third segment of the base plate.
- the device comprises a biocompatible material, optionally nitinol or bio-absorbable magnesium.
- FIG. 13 shows a flowchart of an exemplary method 900 of manufacturing an applicator for attaching a tissue repair device to a tissue.
- the applicator may refer to applicator 300, 400 discussed with reference to FIGS. 3A to 9.
- FIG. 14 shows the (A) cross-sectional view and (B) perspective view of a schematic illustration of a cap 306, e.g. two-part cap for providing the at least one first holding member 342 of the first holding assembly 340.
- FIG. 14 further shows the (C) cross-sectional view and (D) perspective view of the first cap portion 306a; the (E) cross-sectional view and (F) perspective view of the second cap portion 306b of the cap 306, e.g. two-part cap.
- FIG. 14 shows the (A) cross-sectional view and (B) perspective view of a schematic illustration of a cap 306, e.g. two-part cap for providing the at least one first holding member 342 of the first holding assembly 340.
- Method 900 includes: providing an effector for receiving the tissue repair device (step 902); providing a shaft having a hollow interior (step 904); providing a delivery assembly housed within the shaft, comprising: providing a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; and providing a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the delivery rod to drive the tissue repair device through the tissue to form the attachment (step 906).
- providing the driver assembly comprises: providing a driver rod positioned adjacent to the delivery rod, the driver rod configured to slide along the length of the shaft; providing a biasing device positioned adjacent to the delivery rod, the biasing device configured to move between a compressed state in which the driver rod is spaced apart from the delivery rod, and an extended state in which the driver rod abuts the delivery rod to drive the tissue repair device through the tissue to form the attachment.
- method 900 further comprises: providing a partition device housed in the hollow interior of the shaft, the partition device comprising a partition member configured to be positioned between the driver rod and the delivery rod, when the biasing device is in the compressed state.
- providing the driver assembly further comprises: providing a holding assembly, the holding assembly configured to hold the biasing device in the compressed state in which the driver rod is spaced apart from the delivery rod.
- providing the holding assembly comprises: forming at least one recess along a length of the driver rod; providing at least one first holding member, the first holding member configured to be held in the at least one recess, to hold the biasing device in the compressed state.
- the at least one first recess 326 may be formed along the length of the driver rod 332.
- the cap 306 of the applicator 300 may comprise a two-part cap 306 comprising a first cap portion 306a and a second cap portion 306b.
- the second cap portion 306b may be configured to be inserted into a slot formed on the first cap portion 306b as will be explained below.
- providing the at least one first holding member may comprise: forming a channel between an outer surface and the hollow interior of the shaft (step 912); and positioning a first cap portion on an end of the shaft adjacent to the driver rod, the first cap portion positioned such that a cap channel of the first cap portion is in alignment with the channel (step 914).
- the channel 309 formed between the outer surface and the hollow interior of the shaft 302, and the cap channel 306c formed on the first cap portion 306a may be in alignment with each other.
- method 900A further comprises, disposing the at least one first holding member into the channel, such that the first holding member is led into the cap channel (step 916).
- the first holding member 342 may be inserted through the channel 309 and may be led into the cap channel 306c.
- method 900A further comprises, positioning a second cap portion on the first cap portion, the second cap portion configured to lodge the at least one first holding member in the first and second cap portions, and seal the channel and the cap channel (step 918).
- the second cap portion 306b may be inserted into a slot 3O6d (see FIG. 14D) formed in the first cap portion 306a and may seal the cap portion 306c and the channel 309.
- the first holding member 342 may be lodged in place in the first and second cap portions 306a, 306b, and may be held in the second recess 308 formed in the cap 306.
- providing the holding assembly comprises: forming at least one groove along the length of the shaft; providing at least one second holding member positioned adjacent to and extending along a length of the driver rod, the second holding member configured to be held in the at least one groove, to hold the biasing device in the compressed state.
- providing the effector comprises: providing a first effector portion coupled to a second effector portion, the first and second effector portions configured to receive the tissue repair device.
- the delivery rod is configured to urge the first and second effector portions away from each other, to contact and drive the tissue repair device through the tissue to form the attachment.
- providing the effector further comprises: providing a hook arranged on each of the first and second effector portions, wherein the hook is configured to receive and hold the tissue repair device.
- method 900 further comprises: providing a protrusion arranged on each of the first and second effector portions, providing an effector cover for housing the effector, the effector cover comprising a first portion and a second portion positioned adjacent to the first portion, wherein the protrusion is configured to be held against the shaft, when the biasing device is in the compressed state.
- method 900 further comprises: providing slots arranged on the second portion of the effector cover for receiving the protrusion arranged on each of the first and second effector portions, wherein the protrusion arranged on the first and second effector portion is configured to move into a respective slot of the second portion of the effector cover, when the biasing device is in the extended state.
- the effector cover comprises a serrated tip.
- providing the effector comprises, providing the effector such that the effector is removably attachable to the delivery rod.
- providing the delivery rod comprises, forming a projection extending from an end of the delivery rod.
- FIG. 16 shows a flowchart of a method 1000 of manufacturing an installation module for attaching a tissue repair device to an applicator.
- the tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1A to 2E; and the applicator may refer to applicator 300, 400 discussed with reference to FIGS. 3A to 9.
- Method 1000 comprises: providing an installation body having a surface (step 1002); forming an installation projection extending from the surface, the surface and the installation projection dimensioned to receive the tissue repair device, wherein the installation projection is configured to cooperate with the applicator, to permit the first and second effector portions to receive and hold the tissue repair device (step 1004).
- the surface comprises an inclined surface.
- FIG. 17 shows a flowchart of a method 1 100 of manufacturing a suture capturing device for attaching a suture on to the tissue repair device.
- the tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1A to 2E.
- Method 1100 comprises: providing a handle (step 1102); attaching a capturing member to the handle, the capturing member configured to receive the suture, wherein the capturing member is configured to facilitate the threading of the suture through the first aperture and the second aperture, to attach the suture on to the tissue repair device (step 1104).
- the capturing member comprises a loop, and may comprise a flexible and bio-compatible material, optionally, nitinol.
- tissue repair device which comprises a first aperture and a second aperture separate to and positioned apart from each other, to allow a suture to be threaded through two points of the tissue repair device, thereby increasing the contact area and improving the mechanical interlock between the suture and the tissue repair device, and improving the attachment of the suture to the tissue repair device.
- tissue repair device 100A, 100B when the tissue repair device 100A, 100B is placed over tom tissue for reattachment to bone, the tissue repair device 100A, 100B and the suture may be firmly secured onto the tissue.
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Abstract
Disclosed is a tissue repair device comprising: a base plate; a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue; a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture; and a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture. Further disclosed include an applicator for attaching the tissue repair device to a tissue, an installation module, a suture capturing device, a kit of parts and methods of manufacturing the applicator, the tissue repair device, the installation module and the suture capturing device.
Description
A TISSUE REPAIR DEVICE AND AN APPLICATOR FOR THE DEVICE
TECHNICAL FIELD
[0001] Various aspects of this disclosure relate to a tissue repair device, an applicator for the tissue repair device, an installation module and a suture capturing device for the tissue repair device.
BACKGROUND
[0002] Tissue damage, tears or degeneration at the rotator cuff often require surgical repair to reattach the tom or detached tissue to bone. However, the incidence of rotator cuff re-tears post-operation is high (ranging from 40 % to 60 % depending on original size of tear), often due to localized mechanical failure which occurs when the suture used to attach torn tissue to bone, cuts through the reattached tissue under repeated tension or stress, i.e. “cheese-wiring effect”.
[0003] Currently, complex suture configurations, flat sutures, or graft augmentations facilitate the reattachment of the torn or detached tissue to bone. Conventional suture configurations used in rotator cuff repair are often time-consuming and technically demanding for surgeons, increasing the overall duration of the procedure. Under tension, such configurations are associated with a high incidence of “cheese- wiring” failure mechanism, due to the suture cutting through a penetration point in the tissue, e.g. tendon. Although flat sutures are designed to distribute load more evenly across their width and reduce peak stress concentration, they arc still passed through a single penetration point in the tendon. Under tension, the flat suture tends to collapse inward, concentrating the load at the center and ultimately causing the same "cheese-wiring" failure mechanism. As such, both traditional suture configurations and the use of flat sutures have shown limited effectiveness in reducing postoperative retear rates.
[0004] Biological graft augmentations may offer improved tendon healing; however, their application introduces additional surgical complexity. These procedures typically require precise graft positioning, delivery into the subacromial space, and supplementary fixation steps such as knot tying or placement of additional suture anchors. Moreover, the cost of such grafts substantially increases the expense of what is often considered an elective procedure. Many surgeons consider graft augmentation economically impractical for routine rotator cuff repair. In summary, such procedures are complex, expensive and often requires a pool of highly skilled and trained surgeons.
[0005] Therefore, there is a need to address at least one of the above-mentioned problems.
SUMMARY
[0006] The disclosure was conceptualized to provide an improved tissue repair device for tissue repair, and an applicator for delivering and attaching the tissue repair device to tissue at a surgical site. To this end, the tissue repair device comprises a first aperture and a second aperture separate to and positioned apart from each other, to allow a suture to be threaded through two points of the tissue repair device. In this configuration, one or more portion(s) of the suture loops over the top surface of the device, which is positioned directly on the tissue, e.g. tendon. As a result, the device serves as a protective interface between the suture and the tendon, acting as a mechanical buffer that helps prevent suture-induced cutting or tearing of the tendon tissue. This also allows the suture to secure the implant firmly on top of the tendon. When tensile force is applied to the suture, the suture becomes tensioned, transmitting additional load onto the superior surface of the implant. This, in turn, enhances the fixation of the implant against the tendon. Conversely, when the joint is at rest or the tendon is unloaded, the tension in the suture decreases accordingly, relieving the force exerted on the implant. As a result, this mechanism is load-responsive — it activates only when mechanical stress is present at the suture-tendon interface, avoiding unnecessary tension or overloading during periods of minimal or no joint movement. This configuration is particularly effective when combined with position-retention features, such as the integrated anchor members of the device that maintain its placement at the suture-tendon junction, or a knot tied in the suture to prevent the device from migrating away from the suture-tendon junction. In configurations where the anchor members are employed to resist the “cheese-wiring” failure mechanism, the load- responsive mechanism can function as a lever, driving the anchor members deeper into the tendon under tensile load, thereby enhancing fixation strength.
[0007] In addition, the disclosure provides an applicator comprising a delivery assembly having a driver assembly for urging the delivery rod having the tissue repair device attached thereto through the tissue to form the attachment. The applicator allows a user to deliver the tissue repair device in a quick and simple manner, reducing the need for specialized surgical instruments, and highly skilled and trained users. Various embodiments of the disclosure further provide an installation module that allows a user to attach the tissue repair device to the applicator in a quick and simple manner; and a suture capturing device for facilitating the threading of the suture to the tissue repair device, thereby reducing the complexity of the procedure. The disclosure further provides methods of manufacture of the tissue repair device,
the applicator, the installation module and the suture capturing device, which are inexpensive and easy to manufacture.
[0008] The tissue repair device and the applicator are particularly applicable for rotator cuff repairs, but can be used in the repair of soft tissue, for example in the repair of many other ligaments and tendons, or other connective tissue, such as in other joints in the body. The device according to various embodiments of the disclosure is also compatible with existing suture configurations for rotator cuff repairs.
[0009] According to an aspect of the disclosure, there is provided a tissue repair device comprising: a base plate; a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue; a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture; and a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture.
[0010] In various embodiments, the base plate comprises a first segment, a second segment and a third segment; wherein the first, second and third segments are connected to each other at the part of the base plate having the first aperture, and wherein the second aperture is arranged on the third segment. In some embodiments, the third segment comprises a bellshaped profile; or wherein the third segment comprises an oblong profile having a curved surface arranged on an end of the third segment.
[001 1] In various embodiments, the second aperture comprises a U-shaped channel extending partially along a perimeter of the third segment, the U-shaped channel having an area greater than an area of the first aperture.
[0012] In various embodiments, each anchor member extends from an anterior portion or a lateral portion of each of the first and second segments. In some embodiments, the anterior portion or the lateral portion at which the anchor member extends from, comprises a rounded surface.
[0013] In various embodiments, the anchor end of each anchor member, comprises a barb operable to pierce tissue.
[0014] In various embodiments, the at least one of the plurality of anchor members or the one or more pairs of anchor members comprises a first anchor side and a second anchor side, each of the first and second anchor sides extending towards the third segment of the base plate.
[0015] In various embodiments, the device comprises a biocompatible material, optionally nitinol or bio-absorbable magnesium.
[0016] According to another aspect of the disclosure, there is provided an applicator for attaching a tissue repair device to a tissue, the applicator comprising: an effector configured to receive the tissue repair device; a shaft having a hollow interior for housing a delivery assembly, the delivery assembly comprising; a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the delivery rod to drive the tissue repair device through the tissue to form the attachment.
[0017] In various embodiments, the driver assembly comprises a driver rod positioned adjacent to the delivery rod, the driver rod configured to slide along the length of the shaft; a biasing device positioned adjacent to the delivery rod, the biasing device configured to move between an compressed state in which the driver rod is spaced apart from the deliver}' rod, and an extended state in which the driver rod abuts and propels the delivery rod to drive the tissue repair device through the tissue to form the attachment.
[0018] In various embodiments, the applicator further comprises a partition device housed in the hollow interior of the shaft, the partition device comprising a partition member configured to be positioned between the driver rod and the delivery rod, when the biasing device is in the compressed state.
[0019] In various embodiments, the driver assembly further comprises a holding assembly, the holding assembly configured to hold the biasing device in the compressed state in which the driver rod is spaced apart from the delivery rod.
[0020] In various embodiments, the holding assembly comprises at least one first holding member, the first holding member configured to be held in at least one recess formed along a length of the driver rod, to hold the biasing device in the compressed state. In some embodiments, the first holding member comprises a bearing, optionally a ball bearing.
[0021] In various embodiments, the holding assembly comprises at least one second holding member, the second holding member positioned adjacent to and extending along a length of the driver rod, wherein the second holding member is configured to be held in at least one groove formed along the length of the shaft, to hold the biasing device in the compressed state. [0022] In various embodiments, the effector comprises a first effector portion coupled to a second effector portion, the first and second effector portions configured to receive the tissue repair device. In some embodiments, the effector further comprises a hook arranged on each of
the first and second effector portions, wherein the hook is configured to receive and hold the tissue repair device.
[0023] In various embodiments, the delivery rod is configured to urge the first and second effector portions away from each other, to contact and drive the tissue repair device through the tissue to form the attachment.
[0024] In various embodiments, the delivery rod is pivotably coupled to the effector in a manner such that the effector is rotatable with respect to the delivery rod.
[0025] In various embodiments, the effector comprises a protrusion arranged on each of the first and second effector portions, and further comprises an effector cover for housing the effector, the effector cover comprising a first portion and a second portion positioned adjacent to the first portion, wherein the protrusion is configured to be held against the shaft or the first portion of the effector cover, when the biasing device is in the compressed state.
[0026] In various embodiments, the second portion of the effector cover comprises slots for receiving the protrusion arranged on the first and second effector portions, wherein the protrusion arranged on the first and second effector portion is configured to move into a respective slot of the second portion of the effector cover, when the biasing device is in the extended state. In some embodiments, the effector cover comprises a serrated tip.
[0027] In various embodiments, the effector is removably attachable to the delivery rod.
[0028] In various embodiments, the delivery rod comprises a projection extending from an end of the delivery rod.
[0029] According to another aspect of the disclosure, there is provided an installation module for attaching the tissue repair device to the applicator, the installation module comprising: an installation body having a surface comprising an installation projection extending from the surface, the surface and the installation projection dimensioned to receive the tissue repair device, wherein the installation projection is configured to cooperate with the applicator, to permit the first and second effector portions to receive and hold the tissue repair device.
[0030] In various embodiments, the surface comprises an inclined surface.
[0031] According to another aspect of the disclosure, there is provided a suture capturing device for attaching a suture on to the tissue repair device, the suture capturing device comprising: a handle having a capturing member attached thereto, the capturing member configured to receive the suture, wherein the capturing member is configured to facilitate the
threading of the suture through the first aperture and the second aperture, to attach the suture on to the tissue repair device.
[0032] In various embodiments, the capturing member comprises a loop, and wherein the capturing member comprises a flexible and bio-compatible material, optionally, nitinol.
[0033] According to another aspect of the disclosure, there is provided a kit of parts of a tissue repair assembly, comprising: at least one tissue repair device; the applicator; optionally, the installation module, and/or the suture capturing device.
[0034] According to another aspect of disclosure, there is provided a method of manufacturing a tissue repair device, the method comprising: providing a base plate; providing a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue; forming, a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture; and forming, a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture.
[0035] Tn various embodiments, forming the base plate comprises: forming a first segment, a second segment and a third segment; wherein the first, second and third segments are connected to each other at the part of the base plate having the first aperture, and wherein the second aperture is arranged on the third segment, hr some embodiments, the third segment comprises a bell-shaped profile; or wherein the third segment comprises an oblong profile having a curved surface arranged on an end of the third segment.
[0036] In various embodiments, the second aperture comprises a U-shaped channel extending partially along a perimeter of the third segment, the U-shaped channel having an area greater than an area of the first aperture.
[0037] In various embodiments, each anchor member extends from an anterior portion or a lateral portion of each of the first and second segments. In some embodiments, the anterior portion or the lateral portion at which the anchor member extends from, comprises a rounded surface.
[0038] In various embodiments, the anchor end of each anchor member, comprises a barb operable to pierce tissue.
[0039] In various embodiments, the at least one of the plurality of anchor members or the one or more pairs of anchor members comprises a first anchor side and a second anchor side, each of the first and second anchor sides extending towards the third segment of the base plate.
[0040] In various embodiments, the device comprises a biocompatible material, optionally nitinol or bio-absorbable magnesium.
[0041] According to another aspect of disclosure, there is provided a method of manufacturing an applicator for attaching a tissue repair device to a tissue, the method comprising: providing an effector for receiving the tissue repair device; providing a shaft having a hollow interior; providing a delivery assembly housed within the shaft, comprising providing a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; providing a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the delivery rod to drive the tissue repair device through the tissue to form the attachment.
[0042] In various embodiments, providing the driver assembly comprises: providing a driver rod positioned adjacent to the delivery rod, the driver rod configured to slide along the length of the shaft; providing a biasing device positioned adjacent to the delivery rod, the biasing device configured to move between a compressed state in which the driver rod is spaced apart from the delivery rod, and an extended state in which the driver rod abuts the delivery rod to drive the tissue repair device through the tissue to form the attachment.
[0043] In various embodiments, the method further comprises: providing a partition device housed in the hollow interior of the shaft, the partition device comprising a partition member configured to be positioned between the driver rod and the delivery rod, when the biasing device is in the compressed state.
[0044] In various embodiments, providing the driver assembly further comprises: providing a holding assembly, the holding assembly configured to hold the biasing device in the compressed state in which the driver rod is spaced apart from the delivery rod.
[0045] In various embodiments, forming at least one recess along a length of the driver rod; providing at least one first holding member, the first holding member configured to be held in the at least one recess, to hold the biasing device in the compressed state.
[0046] In various embodiments, providing the at least one first holding member comprises: forming a channel between an outer surface and the hollow interior of the shaft; positioning a first cap portion on an end of the shaft adjacent to the driver rod, the first cap portion positioned such that a cap channel of the first cap portion is in alignment with the channel; disposing the at least one first holding member into the channel, such that the first holding member is led into the cap channel; positioning a second cap portion on the first cap portion, the second cap
portion configured to lodge the at least one first holding member in the first and second cap portions and seal the channel and the cap channel.
[0047] In various embodiments, providing the holding assembly comprises: forming at least one groove along the length of the shaft; providing at least one second holding member positioned adjacent to and extending along a length of the driver rod, the second holding member configured to be held in the at least one groove, to hold the biasing device in the compressed state.
[0048] In various embodiments, providing the effector comprises: providing a first effector portion coupled to a second effector portion, the first and second effector portions configured to receive the tissue repair device. In some embodiments, providing the effector further comprises: providing a hook arranged on each of the first and second effector portions, wherein the hook is configured to receive and hold the tissue repair device.
[0049] In various embodiments, the delivery rod is configured to urge the first and second effector portions away from each other, to contact and drive the tissue repair device through the tissue to form the attachment.
[0050] In various embodiments, the method further comprises: providing a protrusion arranged on each of the first and second effector portions, providing an effector cover for housing the effector, the effector cover comprising a first portion and a second portion positioned adjacent to the first portion, wherein the protrusion is configured to be held against the shaft or the first portion of the effector cover, when the biasing device is in the compressed state.
[0051] In various embodiments, providing the effector further comprises: providing slots arranged on the second portion of the effector cover for receiving the protrusion arranged on each of the first and second effector portions, wherein the protrusion arranged on the first and second effector portion is configured to move into a respective slot of the second portion of the effector cover, when the biasing device is in the extended state.
[0052] In various embodiments, providing the effector comprises, providing the effector such that the effector is removably attachable to the delivery rod.
[0053] In various embodiments, providing the delivery rod comprises, forming a projection extending from an end of the delivery rod.
[0054] According to another aspect of the disclosure, there is provided a method of manufacturing an installation module for attaching the tissue repair device to the applicator, the method comprising: providing an installation body having a surface; forming an installation
projection extending from the surface, the surface and the installation projection dimensioned to receive the tissue repair device, wherein the installation projection is configured to cooperate with the applicator, to permit the first and second effector portions to receive and hold the tissue repair device.
[0055] In various embodiments, the surface comprises an inclined surface.
[0056] According to another aspect of the disclosure, there is provided a method of manufacturing a suture capturing device for attaching a suture on to the tissue repair device, the method comprising: providing a handle; attaching a capturing member to the handle, the capturing member configured to receive the suture, wherein the capturing member is configured to facilitate the threading of the suture through the first aperture and the second aperture, to attach the suture on to the tissue repair device.
[0057] In various embodiments, the capturing member comprises a loop, and wherein the capturing member comprises a flexible and bio-compatible material, optionally, nitinol.
BRIEF DESCRIPTION OF THE DRAWINGS
[0058] The disclosure will be better understood with reference to the detailed description when considered in conjunction with the non-limiting examples and the accompanying drawings, in which:
- FIG. 1 shows a (A) perspective view; (B) top view; (C) bottom perspective view; (D) side view; (E) front view; (F) bottom view; and (G) back view of a schematic illustration of an exemplary tissue repair device 100A;
- FIG. 2 shows a (A) perspective view; (B) top view; (C) bottom perspective view; (D) side view; and (E) front view of a schematic illustration of another exemplary tissue repair device 100B;
- FIG. 3 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration before a tissue repair device is released from the applicator 300 (“pre-firing” configuration);
- FIG. 4 shows a schematic illustration of the applicator 300, showing the (A) front cross- sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the
configuration where the cap 306 of the depressed but before the tissue repair device is released from the applicator (“depressed pre-firing” configuration);
- FIG. 5 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view as the tissue repair device is released from the applicator 300 (“post-firing” configuration); (B) side cross-sectional view as the tissue repair device is released from the applicator 300 (“post-firing” configuration); (C) expanded cross- sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, as the tissue repair device is released from the applicator 300 (“postfiring” configuration);
- FIG. 6 shows a schematic illustration of an expanded cross-sectional view of another embodiment of the delivery rod 312 of the applicator 300, (A) before a tissue repair device 100A, 100B is released from the applicator 300 (“pre-firing” configuration); and (B) after the tissue repair device 100 A, 100B is released from the applicator 300 (“postfiring” configuration);
- FIG. 7 show a schematic illustration of an expanded view of an embodiment of a holding assembly 340 of the applicator 300, (A) before a tissue repair device is released from the applicator 300 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 300 (“post-firing” configuration);
- FIG. 8 shows a schematic illustration of another embodiment of the applicator 400 showing a second holding assembly 440, (A) before a tissue repair device is released from the applicator 400 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 400 (“post-firing” configuration);
- FIG. 9 shows a schematic illustration of the applicator 300 where the effector 380 is removably attachable to the delivery rod 312 of the applicator 300;
- FIG. 10 shows a schematic illustration of an exemplary installation module 600 for attaching a tissue repair device to an applicator, showing the (A) top view; and (B) perspective view of the installation module 600 without the tissue repair device; and the (C) top view; and (D) perspective view of the installation module 600 with the tissue repair device;
- FIG. 1 1 shows a pictorial representation of an exemplary suture capturing device 700 for attaching a suture to a tissue repair device;
- FIG. 12 shows a flowchart of an exemplary method 800 of manufacturing a tissue repair device;
- FTG. 13 shows a flowchart of an exemplary method 900 of manufacturing an applicator for attaching a tissue repair device to a tissue;
- FIG. 14 shows the (A) cross-sectional view and (B) perspective view of a schematic illustration of a cap 306, c.g. two-part cap for providing the at least one first holding member 342 of the first holding assembly 340; and further shows the (C) cross-sectional view and (D) perspective view of the first cap portion 306a; the (E) cross-sectional view and (F) perspective view of the second cap portion 306b of the cap 306, e.g. two-part cap.
- FIG. 15 shows (A) a flowchart of an exemplary method 900A for providing the at least one first holding member 342 of the first holding assembly 340; and corresponding schematic illustrations of the first shaft portion 302a, the cap 306, e.g. two-part cap and the handle 304, showing the (B) positioning of the first cap portion 306a in alignment with a channel 309 formed between the outer surface and hollow interior of the first shaft portion 302a; (C) the first holding member 342 disposed in the cap channel 306c; and (D) the positioning of the second cap portion 306b into the first cap portion 306a
- FIG. 16 shows a flowchart of a method 1000 of manufacturing an installation module for attaching a tissue repair device to an applicator; and
- FIG. 17 shows a flowchart of a method 1 100 of manufacturing a suture capturing device for attaching a suture on to the tissue repair device.
DETAILED DESCRIPTION
[0059] The following detailed description refers to the accompanying drawings that show, by way of illustration, specific details and embodiments in which the disclosure may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the disclosure. Other embodiments may be utilized and structural, and logical changes may be made without departing from the scope of the disclosure. The various embodiments are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments.
[0060] Features that are described in the context of an embodiment may correspondingly be applicable to the same or similar features in the other embodiments. Features that arc described in the context of an embodiment may correspondingly be applicable to the other embodiments, even if not explicitly described in these other embodiments. Furthermore, additions and/or
combinations and/or alternatives as described for a feature in the context of an embodiment may correspondingly be applicable to the same or similar feature in the other embodiments.
[0061] In the context of various embodiments, the articles “a”, “an” and “the” as used with regard to a feature or element include a reference to one or more of the features or elements. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
[0062] While terms as "first," "second," etc., may be used to describe various elements, such terms are used only to distinguish one element from another for purposes of clarity, and do not define corresponding elements, for example, an order and/or significance of the elements. Without departing a scope of rights of the specification, a first element may be referred to as a second clement, and similarly, the second element may be referred to as the first element.
[0063] In the context of various embodiments, the term “substantially” as used herein, may refer to a large extent, for example, at least 80 % of indicated portion.
[0064] Throughout the description, the term “tissue” as used herein, refers to connective tissue proper or soft tissue, including but not limited to tendons and ligaments. The term “tissue” is also contemplated to include cartilage. Within the context of rotator cuff repairs, the term “tissue” may refer to the supraspinatus tendon.
[0065] Throughout the description, the term “repair” as used herein, refers broadly to surgical means for the repair of the tissue, for example, surgery to repair a torn rotator cuff by reattaching the rotator cuff to the humerus bone. The term “repair” thus includes arthroscopy, open surgery, or a combination of both for rotator cuff repairs.
[0066] Throughout the description, the term “positioned adjacent to”, as used herein, may refers to the position of one element proximal to another element. In various embodiments, the element may be proximal to but not in contact with the another element, for example, having one or more intervening elements. In various other embodiments, the clement may be proximal to and in direct contact with the another element.
[0067] FIG. 1 shows a (A) perspective view; (B) top view; (C) bottom perspective view; (D) side view; (E) front view; (F) bottom view; and (G) back view of a schematic illustration of an exemplary tissue repair device 100A. FIG. 2 shows a (A) perspective view; (B) top view; (C) bottom perspective view; (D) side view; and (E) front view of a schematic illustration of another exemplary tissue repair device 100B.
[0068] Referring to FIGS. 1 A to 2E, the tissue repair device 100A, 100B comprises a base plate 110 having a first surface 110a and a second surface 110b opposing the first surface 110a.
The first surface 110a may be the upper or top surface, and the second surface 110b may be the bottom surface of the base plate 1 10.
[0069] The base plate 110 may comprise a first segment 112, a second segment 114 and a third segment 116, each comprising the first surface 110a and opposing second surface 110b of the base plate 110. In various embodiments, the third segment 116 may have a bell-shaped profile (see FIGS. 1A to 1G), or may have a substantially oblong profile having a curved surface arranged on an end of the third segment (see FIGS. 2 A to 2E). Each of the first segment 112, the second segment 114 and the third segment 116 may have a same thickness, for example, a thickness ranging from 0.1 mm to 3.0 mm, optionally, from 0.2 mm to 2.5 mm. Alternatively, each of the first segment 112, the second segment 114 and the third segment 116 may have a different thickness. For example, the third segment 116 may have a thickness less than the first segment 112 and/or the second segment 114.
[0070] The tissue repair device 100A, 100B comprises a plurality of anchor members 122, 124 or one or more pair of anchor members 122, 124 extending from a second surface 1 10b of the base plate 110. The plurality or one or more pair of anchor members 122, 124 may be integrally formed with the base plate 1 10 and may include a first anchor member 122 and a second anchor member 124 as shown in FIGS. 1A to 2E. In other words, the first and second anchor members 122, 124 are integrated onto the base plate 110. While FIGS. 1A to 2E show two anchor members 122, 124, the disclosure is not limited thereto, and the tissue repair device 100A, 100B may include two or more anchor members 122, 124. It is also contemplated that the first and second anchor members 122, 124 may be removably detachable to the base plate 110.
[0071] In various embodiments, the first anchor member 122 and the second anchor member 124 may extend from an anterior portion, e.g. front portion, of each of the first segment 112 and second segment 114, respectively (sec FIGS. 1A to 1G). In various other embodiments, the first anchor member 122 and the second anchor member 124 may extend from a lateral portion, c.g. side portion, of each of the first segment 112 and second segment 114, respectively (see FIGS. 2A to 2E). In some embodiments, the anterior portion or the lateral portion at which the first anchor member 122 and the second anchor member 124 extend from, may comprise a rounded surface (see FIGS. 2A to 2E). Alternatively, in some other embodiments, the first anchor member 122 and the second anchor member 124 may extend from the anterior portion or the lateral portion, substantially perpendicular to the base plate 110 (see FIGS. 1 A to IE). It
is contemplated that the first anchor member 122 and the second anchor member 124 may be positioned to extend from the posterior portion of the third segment 1 16.
[0072] Each of the first anchor member 122 and the second anchor member 124 may include an anchor end operable to pierce tissue. For example, the anchor end of the first anchor member 122 and the second anchor member 124 may each comprise a barb, e.g. a sharp projection formed at the anchor end for piercing tissue. In some embodiments, the barb may be angled away from the base plate 1 10 to secure the first anchor member 122 and the second anchor member 124 into the tissue.
[0073] Referring to FIGS. IF and 1G, in some embodiments, at least one of the first anchor member 122 and the second anchor member 124 may comprise a first anchor side 126a and a second anchor side 126b, which may be positioned on opposing sides of the first anchor member 122 and/or the second anchor member 124. Each of the first anchor side 126a and second anchor side 126b may taper towards the third segment 116, e.g. posterior end, of the base plate 1 10. The first anchor side 126a and second anchor side 126b may therefore have a pointed or sharpened geometry, which may reduce the load transmitted to the first and second anchor members 122, 124 when the tissue repair device 100A, 100B is under tension, e.g. subject to a backward pulling force, providing localized stress relief and minimizing the risk of the first and second anchor member 122, 124 detaching from the tissue under tensile loading. [0074] This embodiment may be used when the tissue repair device 100A, 100B is fabricated using material with relatively low yield strength, for example, materials such as magnesium alloys or bioresorbable polymers which may be easier to obtain and cheaper to manufacture. However, when the first and/or second anchor member 122, 124 comprise the first and second anchor sides 126a, 126b, there may be reduced load-bearing contribution of the first and second anchor members 122, 124 at the interface where the tissue repair device 100A, 100B, and suture attaches to the tissue.
[0075] As such, there may be a trade-off between preserving the structural integrity of the first and second anchor members 122, 124 based on material strength, preventing premature first and second anchor member 122, 124 detachment, and maximizing the overall resistance to the suture cutting through the tissue at the interface at which the suture and tissue repair device 100A, 100B attaches to the tissue, i.e. “cheese-wiring” failure mechanism. A user may therefore select the appropriate first and second anchor member 122, 124 type (see FIGS. 1A to IE, 2A to 2E, with respect to FIGS. IF and 1G) based on application-specific requirements,
such as tissue integrity, suture tension and material selection of the tissue repair device 100A, 100B.
[0076] The base plate 100 further includes a first aperture 132 and a second aperture 134. The first segment 112, second segment 114 and the third segment 116 may be connected to each other at the part of the base plate 110 having the first aperture 132. The first aperture 132 may have substantially, a curved or rounded profile.
[0077] The second aperture 134 may be positioned on another part of the base plate 1 10, separate to and away from the first aperture 132, and in various embodiments, the second aperture 134 may be positioned on the third segment 116 of the base plate 110. The second aperture 134 may comprise a channel having substantially, a U-shaped profile, and may extend partially along a perimeter of the third segment 116. The second aperture 134 may have a width ranging from 0.5 mm to 2 mm, optionally 1.1 mm. In various embodiments, the area of the second aperture 134 having a U-shaped channel may be greater than an area of the first aperture 132.
[0078] In various embodiments, the tissue repair device 100A, 100B may comprise a biocompatible material that has a high structural strength for secure attachment to the tissue. In some embodiments, the tissue repair device 100A, 100B may comprise nitinol, i.e., a nickeltitanium alloy which is super-elastic and has high structural strength. Nitinol comprises a tensile strength ranging from 900 MPa to 1,400 MPa, depending on the composition, heat treatment, and processing of the material. Nitinol is also particularly applicable due to its superelasticity and shape memory properties, which contribute to its effectiveness in dynamic soft- tissue applications, e.g. at the tissue repair device 100A, 100B and tissue interface. In medical devices, nitinol is often employed when both flexibility and high load-bearing capacity are required.
[0079] In some other embodiments, the tissue repair device 100A, 100B may comprise bio- absorbable magnesium, which may degrade over time under physiological conditions. Bio- absorbable magnesium exhibits a tensile strength of approximately 200 MPa to 300 MPa, and a compressive yield strength of around 150 MPa to 200 MPa, depending on alloying elements, processing, and surface finish. As bio-absorbable magnesium may be gradually resorbed after the healing process, there is no or a minimized need for surgical removal of the tissue repair device 100A, 100B. Alternative bioresorbable materials may include polymeric compounds such as PLGA (poly (lactic -co-glycolic acid)) and PLLA (poly-L-lactic acid). These polymers are commonly used in soft tissue fixation devices and exhibit tensile strengths in the range of
40 MPa to 100 MPa, depending on molecular weight and processing. PLGA and PLGA are highly biocompatible, and have predictable degradation profiles.
[0080] In yet some embodiments, the tissue repair device 100A, 100B may also comprise absorbable bone graft materials, such as calcium phosphate cements or bioactive ceramics, which exhibit compressive strengths between 20 MPa to 100 MPa, depending on formulation. These materials are typically used where osteoconductive or space-filling properties are required.
[0081] When a suture is threaded through the tissue repair device 100A, 100B of the disclosure, the suture may be threaded through the first aperture 132, to extend across the first surface 110a, e.g. upper surface of the first segment 112 and the second segment 114 of the base plate 110, and subsequently threaded through the second aperture 134, to extend across the second surface 110b, e.g. bottom surface of the third segment 116. This may be performed prior to attaching the tissue repair device 100A, 100B to an applicator for delivery to the tissue at the surgical site. In other words, the suture may loop around the first surface 1 10a of the first and second segments 112, 114, and around the second surface 110b of the third segment 116 of the base plate 1 10 of the tissue repair device 100A, 100B. By threading the suture through the first aperture 132 and the second aperture 134, the tissue repair device 100A, 100B provides increased contact area and improved mechanical interlock between the suture and the tissue repair device 100A, 100B. As such, when the tissue repair device 100A, 100B is placed over tom tissue for reattachment to bone, the tissue repair device 100A, 100B and the suture may be firmly secured onto the tissue. This, in turn, ensures stable fixation of the tissue repair device 100A, 100B into the tissue, reducing the risk of suture slippage, detachment from the tissue repair device 100A, 100B, and/or failure at the tissue interface.
[0082] Specifically, when tensile force is applied to the suture, the suture becomes tensioned, and additional load is transferred downward to the first surface 110a, e.g. upper surface of the first and second segments 112, 114 of the tissue repair device 100A, 100B. This downward force enhances the apposition of the tissue repair device 100A, 100B to the tissue, e.g. tendon, thereby improving fixation. Conversely, in the absence of external loading — such as when the joint is at rest — the tension in the suture is relieved, reducing the force applied to the tissue repair device 100A, 100B. As a result, the mechanism is load-responsive, providing dynamic reinforcement only when mechanical stress is present at the repair site, while avoiding unnecessary tension or overloading under unloaded conditions.
[0083] The tissue repair device 100A, 100B of the present disclosure is particularly effective when used in combination with position-retention features. These include the integrated first and second anchor members 122, 124 of the tissue repair device 100A, 100B, which resist displacement at the suture-tissue junction, or a knot tied in the suture to prevent the tissue repair device 100A, 100B from migrating or shifting away from the suture-tissue junction. In embodiments where the first and second anchor members 122, 124 are utilized to resist the “cheese-wiring” failure mechanism, the load-responsive mechanism may also serve a secondary function as a lever — where tension applied to the suture at the rear of the third segment 116 causes the third segment 116 to pivot upward, generating a downward force on the first segment 112 and second segment 114, and thereby driving the first and second anchor members 122, 124 deeper into the tissue under tensile load and enhancing fixation strength.
[0084] FIG. 3 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration before a tissue repair device is released from the applicator 300 (“pre-firing” configuration). FIG. 4 shows a schematic illustration of the applicator 300, showing the (A) front cross-sectional view; (B) side cross-sectional view; (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, in the configuration where the cap 306 of the depressed but before the tissue repair device is released from the applicator (“depressed pre-firing” configuration). FIG. 5 shows a schematic illustration of an exemplary applicator 300, showing the (A) front cross-sectional view as the tissue repair device is released from the applicator 300 (“post-firing” configuration); (B) side cross-sectional view as the tissue repair device is released from the applicator 300 (“postfiring” configuration); (C) expanded cross-sectional view of a partition device 330; and (D) expanded cross-sectional view of the effector 380, after the tissue repair device is released from the applicator 300 (“post-firing” configuration). The tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E.
[0085] The applicator 300 may be particularly suitable for delivery and facilitating the attachment of the tissue repair device 100A, 100B to overlay torn tissue at a surgical site, for example, for rotator cuff repairs or for the repair of soft tissue.
[0086] The applicator 300 comprises an effector 380 for receiving a tissue repair device 100A, 100B. As shown in FIGS. 3D, 4D and 5D, the effector 380 may comprise a first effector portion 382 coupled to a second effector portion 384, using one or more elastic members. In
various embodiments, the elastic member may comprise a sealing ring, such as an O-ring, and in some embodiments, the first effector portion 382 may be coupled to the second effector portion 384 using a plurality of O-rings. The elastic member provides a clamping force to hold the first effector portion 382 and the second effector portion 384 together, and to hold the tissue repair device 100A, 100B in the effector 380.
[0087] In various embodiments, a hook (not shown) may be arranged on each of the first effector portion 382 and the second effector portion 384, to receive and hold the tissue repair device 100A, 100B. For example, the hook arranged on the first effector portion 382 and the second effector portion 384 may hook onto the first segment 112 and the second segment 114, respectively, of tissue repair device 100A, 100B to hold the tissue repair device 100A, 100B for delivery to a surgical site.
[0088] The effector 380 may further comprise a first protrusion 386 arranged on the first effector portion 382, and a second protrusion 388 arranged on the second effector portion 384. The first protrusion 386 and the second protrusion 388 may be held against the shaft 302, specifically, the third shaft portion 302c, or effector cover 385 of the applicator 300 in the “prefiring” configuration (see FIG. 3D), and may act as a safety mechanism to prevent the first effector portion 382 and the second effector portions 384 from moving away from each other and accidentally disengaging the tissue repair device 100A, 100B held in the first 382 and second 384 effector portions. This may occur when the suture is unintentionally pulled with excessive force before deployment.
[0089] The effector 380 may further comprise an effector cover 385 housing the first effector portion 382 and the second effector portion 384. The effector cover 385 may be transparent to allow a user to easily view the attachment of the tissue repair device 100A, 100B to tissue at a surgical site during use. In various embodiments, the effector cover 385 may comprise a first, c.g. upper portion and a second, c.g. lower portion positioned adjacent to the first portion. The second, e.g. lower portion may comprise two slots in alignment with and configured to receive the first 386 and second 388 protrusions of the first 382 and second 384 effector portions, respectively. In various embodiments, the effector cover 385 may comprise a serrated tip, which allows the user to easily and firmly press the effector 380 against the tissue surface before releasing the tissue repair device 100A, 100B is from the applicator 300. In various embodiments, the effector cover 385 may have a width that is greater than a third shaft portion 302c of the shaft 302 housing the delivery rod 312. The third shaft portion 302c and the effector cover 385 may cooperate to protect the tissue repair device 100A, 100B, in
particular, the first and second anchor members 122 and 124, from unintentionally attaching onto the cannula or surrounding tissue during insertion of the applicator 300 and prior to deployment of the tissue repair device 100A, 100B into the tissue.
[0090] Referring to FIGS. 3A, 3B, 4A, 4B, 5A and 5B, the applicator 300 comprises a delivery assembly 310 housed within a hollow interior of a shaft 302, for attaching the tissue repair device 100A, 100B to tissue. The shaft 302 may comprise a first shaft portion 302a, second shaft portion 302b and third shaft portion 302c. The delivery assembly 310 comprises a delivery rod 312 coupled to the effector 380, the delivery rod 312 configured to slide along the length of the shaft 302, for example, the second and third shaft portions 302b, 302c. In some embodiments, the deliver}' rod 312 may be pivotably coupled to the effector 380 in a manner such that the effector 380 is rotatable with respect to the delivery rod 312. For example, the effector 380 may be positioned at an angle with respect to the delivery rod 312. This may facilitate attachment of the tissue repair device 100A, 100B to tissue, and/or improve the attachment of the tissue repair device 100A, 100B to tissue.
[0091] The delivery assembly 310 further comprises a driver assembly 320 positioned adjacent to the delivery rod 312, and configured to urge the delivery rod 312 to drive the tissue repair device 100A, 100B into the tissue to form the attachment. The delivery assembly 310 may further include a firing assembly 305, which comprises the second shaft portion 302b, the third shaft portion 302c, spring 314, partition device 330, and the effector cover 385, which acts as a movement regulator to allow or prevent the movement of the delivery rod 312 during firing.
[0092] As shown in FIGS. 3A, 3B, 4A, 4B, 5A and 5B, the driver assembly 320 may comprise a driver rod 322 positioned adjacent to the delivery rod 312, and configured to slide along the length of the shaft 302, for example, along the first shaft portion 302a. The driver assembly 320 may further comprise a biasing device 324, such as another spring, for moving between a compressed state, e g. “pre-firing” configuration (see FIGS. 3A to 3C), and an extended state, e g. “post-firing” configuration (sec FIGS. 5A to 5C) for driving the tissue repair device 100A, 100B through the tissue.
[0093] In various embodiments, the applicator 300 may include a handle 304 and a cap 306, e.g. two-part cap 306, to facilitate the movement of the biasing device 324 between the compressed state, and the extended state.
[0094] The driver assembly 320 may further include a holding assembly 340 to hold the biasing device 324 in the compressed state in which the driver rod 322 is spaced apart from the
delivery rod 312. Various embodiments of the holding assembly 340 will be explained with reference to FIGS. 7 and 8.
[0095] The applicator 300 may further comprise a partition device 330 housed within the hollow interior of the shaft 302. The partition device 330 may comprise a partition member 332 pivotably coupled to a partition shaft 334, and may be positioned between the delivery rod 312 and the driver rod 322 to hold the biasing device 324 in the compressed state, e.g. “prefiring” configuration. Tn various embodiments, the partition device 330 may serve as a safety mechanism to prevent the delivery rod 312 from contacting from driver rod 322, even in the event of a premature release of the biasing device 324 and/or unintended advancement of the driver rod 322. In this manner, the partition device 330 helps prevent accidental ejection or premature deployment of the tissue repair device 100A, 100B before the applicator is properly positioned at the surgical site. In some embodiments, the partition device 330 and may act as a safety mechanism to prevent accidental release of the biasing device 324 and/or the driver rod 322, and premature ejection or release of the tissue repair device 100A, 100B.
[0096] During the attachment of a tissue repair device 100A, 100B to tissue, and with reference to FIGS. 3A to 3D, the applicator 300 may be in the “pre-firing” configuration, e.g. “rest” configuration. In this configuration, the tissue repair device 100A, 100B may be attached to the effector 380, the biasing device 324 may be in a compressed state, and the driver rod 322 may be positioned to be spaced apart from the delivery rod 312 (see FIG. 3B). In various embodiments, the partition member 332 may be positioned between the delivery rod 312 and the driver rod 322, and may acts as a separation mechanism to prevent accidental disengagement of the biasing device 324 and/or the driver rod 322. In other words, the partition member 332 may prevent the driver rod 322 from abutting and propelling the delivery rod 312 in the “pre-firing” configuration. In addition, the first protrusion 386 arranged on the first effector portion 382, and the second protrusion 388 arranged on the second effector portion 384 may be held against the third shaft portion 302c or effector cover 385, when the biasing device 324 is held in the compressed state. The first 386 and second 388 protrusion may act as a clutch to engage the first 382 and second 384 effector portions in the third shaft portion 302c or effector cover 385. That is, the first 386 and second 388 protrusions may act as a safety mechanism to prevent the first 382 and second 384 effector portions from accidental dislodgment and disengagement of the tissue repair device 100A, 100B held therein.
[0097] In the compressed state, the biasing device 324 may store the energy required to propel the driver rod 322 towards the delivery rod 312 to drive the tissue repair device 100A,
100B into the tissue. In various embodiments, a user may pull the handle 304 of the applicator 300 to move the biasing device 324 into the compressed state, and to pull the driver rod 322 away from the delivery rod 312. In some embodiments, this pulling action also resets the applicator 300 into the “pre-firing” configuration, preparing it for a subsequent deployment cycle by reloading the driver assembly 320.
[0098] Referring to FIGS. 4A to 4D, the applicator 300 may move into the “depressed prefiring” configuration. In this configuration, the spring 314 housed in the second shaft portion 302b may be compressed, and the partition shaft 334 of partition device 330 may be displaced toward the handle 304, e.g. upwards of the applicator 300. In various embodiments, the partition member 332, which is pivotably coupled to the partition shaft 334 may pivot toward the partition shaft 334 and move into a recess (not shown) formed in the partition shaft 334 (see FIG. 4C). Accordingly, the delivery rod 312 and the driver rod 322 may no longer be spaced apart by a separation mechanism, e.g. partition member 332 and may be free to move into the “post-firing” configuration. In other words, the partition member 332 which acts as a separation mechanism between the delivery rod 312 and the driver 322 may move into a recess (not shown), and the driver rod 322 may be free to abut and propel the delivery rod 312 as it moves into the “post-firing” configuration. In addition, as may be seen in FIGS. 4A and 4B, in the “depressed pre-firing” configuration, the holding assembly 340 may hold the biasing device 324 in the compressed state, in which the driver rod 322 is spaced apart from the delivery rod 312.
[0099] To move into the “depressed pre-firing” configuration, a user may, for example, push the applicator 300 having the tissue repair device 100A, 100B attached thereto, against the tissue surface to push up firing assembly 305 and compress the spring 314 and to move the partition device 330 comprising the partition shaft 334 and partition member 332.
[00100] Referring to FIGS. 5A to 5D, the applicator 300 may move into the “post-firing” configuration in which the biasing device 324 moves into the extended state. In this configuration, the driver rod 322 may move to abut and propel the delivery rod 312 positioned adjacent thereto, to drive the tissue repair device 100A, 100B into the tissue to form the attachment. In various embodiment, this may cause the effector 380 holding the tissue repair device to move or be pushed into the second, e.g. lower portion of effector cover 385. Accordingly, the first protrusion 386 and second protrusion 388 of the first 382 and second 384 effector portions, respectively, may move into the second, e.g. lower portion effector cover 385 which include two slots, each aligned with the first protrusion 386 and second protrusion
388 when the applicator 300 is pressed against the tissue and the effector cover 385 and third shaft portion 302c are moved upward towards the handle 304 of the applicator 300. The slots in the second, e.g. lower portion of the effector cover 385 provide clearance, e.g. space for the first 386 and second 388 protrusions to move apart from each other and into a respective slot. As a result, the first protrusion 386 and second protrusion 388, once positioned within the first, e.g. upper portion of the effector cover 385, may separate laterally and no longer obstruct the delivery rod 312 from advancing to contact and drive the tissue repair device 100A, 100B into the tissue. Alternatively, in some embodiments, the effector cover 385 may comprise a width greater than the third shaft portion 302c, the first protrusion 386 and second protrusion 388 which are positioned in the effector cover 385 may have additional space to extend away from each other, and may no longer obstruct the delivery rod 312 from contacting and driving the tissue repair device 100A, 100B into the tissue. In various embodiments, the delivery rod 312 may therefore urge the first 382 and second 384 effector portions away from each other, to contact and drive the tissue repair device 100A, 100B into the tissue to form the attachment. As may be seen from FIG. 5C, the partition member 322 may be housed in the recess (not shown) formed in the partition shaft 334 and does not obstruct the movement of the driver rod 322 to abut and propel the delivery rod 312. In addition, the first 386 and second 388 protrusions of the first 382 and second 384 effector portions, which are propelled into the effector cover 385, may not obstruct the movement of the delivery rod 312 to contact and eject the tissue repair device 100A, 100B from the first 382 and second 384 effector portions of the applicator 300.
[00101] FIG. 6 shows a schematic illustration of an expanded cross-sectional view of another embodiment of the delivery rod 312 of the applicator 300, (A) before a tissue repair device 100A, 100B is released from the applicator 300 (“pre-firing” confi uration); and (B) after the tissue repair device 100A, 100B is released from the applicator 300 (“post-firing” configuration).
[00102] Referring to FIGS. 6A and 6B, the delivery rod 312 may further comprise a projection 316 extending from an end of the delivery rod 312. For example, the end of the delivery rod 312 may resemble a “S-shaped” structure. The projection 316 may provide an additional push to eject the tissue repair device 100A, 100B from the applicator 300. In various embodiments, the projection 316 may provide a force to eject the front portion of the tissue repair device 100A, 100B (e.g. portion having the anchor members 122, 124 extending
therefrom). This may provide a stronger ejection force to eject the tissue repair device 100A, 100B from the effector 380 of the applicator 300 to form the attachment.
[00103] FIG. 7 show a schematic illustration of an expanded view of an embodiment of a holding assembly 340 of the applicator 300, (A) before a tissue repair device is released from the applicator 300 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 300 (“post-firing” configuration).
[00104] Referring to FIG. 7A, the holding assembly 340 may be configured to hold the biasing device 324 in the compressed state (“pre-firing” configuration). In this configuration, at least one first holding member 342 may be disposed in a first recess 326 formed along a length of the driver rod 322. The first holding member 342 may act as an obstruction mechanism to prevent the driver rod 322 from abutting the deliver}' rod 312 and prematurely ejecting the tissue repair device 100A, 100B. In other words, the first holding member 342 may act as a mechanical stopper or holder to prevent the release of the driver rod 322, for example, due to an accidental force applied on the cap 306 or handle 304 of the applicator 300. In various embodiments, the first holding member 342 may be a bearing, optionally a ball bearing.
[00105] Referring to FIG. 7B, upon an application of a force on the handle 304 or the cap 306 to move the biasing device 324 into the extended state (“post-firing” configuration), the first holding member 342 may move from the first recess 326 of the driver rod 322, into a second recess 308 formed in the cap 306. In other words, the force applied by a user to eject the tissue repair device 100A, 100B may cause the first holding member 342 to move from the first recess 326 formed on the driver rod 322, into the second recess 308 formed on the cap 306. Accordingly, the driver rod 322 may be free to move toward the delivery rod 312, to drive the tissue repair device 100A, 100B into the tissue to form the attachment.
[00106] FIG. 8 shows a schematic illustration of another embodiment of the applicator 400 showing a second holding assembly 440, (A) before a tissue repair device is released from the applicator 400 (“pre-firing” configuration); and (B) after a tissue repair device is released from the applicator 400 (“post-firing” configuration). The applicator 400 may be based on applicator 300 discussed with reference to FIGS. 3A to 5D, and may only comprise a different holding assembly 440.
[00107] The second holding assembly 440 may include at least one second holding member 410 positioned adjacent to and extending along a length of the driver rod 322, and configured to hold the biasing device 324 in the compressed state, i.e. “pre-firing” configuration. In this configuration, the second holding member 410 may be configured to be held in at least one
groove 402 formed along the length of the shaft 302. For example, the groove 402 may be formed to extend from the hollow interior of the shaft 302 and to create a groove 402 to hold the second holding member 410. The second holding member 410 may therefore act as an obstruction mechanism to prevent the driver rod 322 from abutting the delivery rod 312 and prematurely ejecting the tissue repair device 100A, 100B. In other words, the second holding member 410 acts as a mechanical stopper or holder to prevent the release of the driver rod 322, for example, due to an accidental force applied on the cap 306 or handle 304 (not shown) of the applicator 400. In various embodiments, the second holding member 410 may be a flexible member, and may be formed of a flexible material. The second holding member 410 which is arranged within the interior of the applicator 300, need not comprise a bio-compatible material. This may reduce the cost of manufacture as flexible and bio-compatible materials such as nitinol may be expensive. Alternatively, in some embodiments, the second holding member 410 may comprise a flexible and bio-compatible material.
[00108] Referring to FIG. 8B, upon an application of a force on the handle 304 or the cap 306 to move the biasing device 324 into the extended state (“post-firing” configuration), the second holding member 410, which is flexible, may flex or bend and move into a third recess 420 formed in the cap 306. In other words, the force applied by a user to eject the tissue repair device 100A, 100B may cause the second holding member 410 to bend and move into the third recess 420 formed on the cap 306. Accordingly, the driver rod 322 may be free to move toward the delivery rod 312, to drive the tissue repair device 100A, 100B into the tissue to form the attachment.
[00109] FIG. 9 shows a schematic illustration of the applicator 300 where the effector 380 is removably attachable to the delivery rod 312 of the applicator 300.
[00110] In various embodiments, the effector 380 comprising the first 382 and second 384 effector portions may be removably attachable to the delivery rod 312. The effector 380 may comprise an effector shaft 381 that may be slid on to the delivery rod 312 housed in the third shaft portion 302c of the shaft 302 of the applicator 300. For example, the effector 380 may be configured to be disposable and may be discarded after attaching a tissue repair device 100A, 100B to a tissue at a surgical site, while the applicator 300 may be reusable and may receive another effector 380.
[00111] In various embodiments, the applicator 300 may comprise various biocompatible materials, such as but not limited to a biocompatible metal, including nitinol, stainless steel, e.g. 316L, titanium and titanium alloys, e.g. Ti-6A1-4V, cobalt-chromium alloys, and anodized
aluminum (for non-load-bearing parts); and/or a biocompatible plastic, such as polyethylene (PE), polypropylene, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polyoxymethylene (POM), polycarbonate, polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polyurethane, acrylonitrile butadiene styrene (ABS), or nylon, e.g. PA6 or PA 12. The choice of material may depend on factors such as intended single-use or reusability, required mechanical strength, compatibility with sterilization methods, and biocompatibility with human tissue.
[00112] FIG. 10 shows a schematic illustration of an exemplary installation module 600 for attaching a tissue repair device to an applicator, showing the (A) top view; and (B) perspective view of the installation module 600 without the tissue repair device; and the (C) top view; and (D) perspective view of the installation module 600 with the tissue repair device. The tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E, and the applicator may refer to applicator 300, 400 discussed with reference to FIGS. 3 A to 9.
[00113] The installation module 600 may include an installation body 602 having a surface 604, which may comprise the top surface 604 of the installation body 602. In various embodiments, the surface 604 may be inclined to facilitate the attachment of the tissue repair device 100A, 100B onto the effector 380 of the applicator 300, 400.
[00114] The surface 604 may include an installation projection 608 extending from the surface 604. The surface 604 and the installation projection 608 may be dimensioned to receive the tissue repair device 100A, 100B. In various embodiments, a cut-out corresponding to a shape of the tissue repair device, e.g. shape of a base plate 110 and anchor members 122, 124 may be formed on the surface 604 of the installation body 602, and the installation projection 608 may be configured to receive the first aperture 132 of the tissue repair device 100A, 100B (sec FIGS. 10C and 10D).
[00115] During attachment of the tissue repair device 100A, 100B to the applicator 300, 400, the installation projection 608, with the tissue repair device 100A, 100B positioned thereon, may be configured to receive the applicator 300, 400 in the “post-firing” configuration, wherein the delivery rod 312 is in a protruded state that urges the first effector portion 382 and the second effector portion 384 away from each other, thereby stretching the elastic member, e.g., plurality of O-rings. As the applicator 300, 400 is advanced and stabbed onto the installation projection 608, the installation projection 608 may displace the delivery rod 312 upward towards the handle 304 of the applicator 300, 400, thereby relieving the outward bias applied
to the first 382 and second 384 effector portions. Upon release of this bias, the restoring tension of the elastic member may cause the first 382 and second 384 effector portions to return to a closed configuration. In this closed configuration, the first 382 and second 384 effector portions may receive and hold the tissue repair device 100A, 100B. For example, the hooks arranged on each of the first 382 and second 384 effector portions may engage the first segment 112 and second segment 114 of the base plate 110 of the tissue repair device 100A, 100B to secure the device in place.
[00116] Alternatively, in some embodiments, the installation projection 608 may urge the first 382 and second 384 effector portions, away from each other. As the first 382 and second 384 effector portions are held together by one or more elastic members, e.g. plurality of O- rings, the installation projection 608 may expand the clastic member to urge the first 382 and second 384 effector portions away from each other. Accordingly, the first 382 and second 384 effector portions may receive and hold the tissue repair device 100A, 100B. For example, the hooks arranged on each of the first 382 and second 384 effector portions, may hook onto the first 112 and second 114 segments of the base plate 110 of the tissue repair device 100A, 100B. In some embodiments, after deployment of a first tissue repair device 100A, 100B, the applicator 300 may be reset and a subsequent tissue repair device 100A, 100B may be reattached to the effector 380 using the installation module 600 for continued use.
[00117] FIG. 11 shows a pictorial representation of an exemplary suture capturing device 700 for attaching a suture to a tissue repair device. The tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E, which is shown to be positioned on the installation module 600 discussed with reference to FIG. 10.
[00118] The suture capturing device 700 may include a handle 702, and a capturing member 704 attached to the handle 704. The capturing member 704 may comprise a loop which may be flexible. In various embodiments, the capturing member 704 comprises a flexible and biocompatible material, such as nitinol.
[00119] During attachment of a suture on to the tissue repair device 100A, 100B, a suture may be threaded through the capturing member 704. A user may then use the handle 702 to thread the suture, contained in the capturing member 704, through the first aperture 132 and the second aperture 134, to attach the suture on to the tissue repair device 100A, 100B. It is contemplated that the capturing member 704 may comprise a clip extending at an angle from the handle 702 and having an elastic lip for receiving the suture and threading the suture through the tissue repair device 100A, 100B.
[00120] According to another aspect of the disclosure, there is provided a kit of parts of a tissue repair assembly, the kit of parts comprising, the applicator 300, 400 discussed with reference to FIGS. 3A to 9; and at least one tissue repair device 100A, 100B discussed with reference to FIGS. 1A to 2E.
[00121] In various embodiments, the kit of parts may further comprise, the installation module 600 discussed with reference to FIG. 10; and/or the suture capturing device 700 discussed with reference to FIG. 1 1 .
[00122] FIG. 12 shows a flowchart of an exemplary method 800 of manufacturing a tissue repair device. The tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1 A to 2E.
[00123] Method 800 comprises: providing a base plate (step 802); providing a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue (step 804); forming, a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture (step 806); and forming, a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture (step 808).
[00124] In various embodiments, providing a base plate comprises: providing a first segment, a second segment and a third segment; wherein the first, second and third segments are connected to each other at the part of the base plate having the first aperture, and wherein the second aperture is arranged on the third segment. In some embodiments, the third segment comprises a bell- shaped profile; or comprises an oblong profile having a curved surface arranged on an end of the third segment.
[00125] In various embodiments, the second aperture comprises a U-shaped channel extending partially along a perimeter of the third segment, the U-shaped channel having an area greater than an area of the first aperture.
[00126] In various embodiments, each anchor member extends from an anterior portion or a lateral portion of each of the first and second segments. In some embodiments, the anterior portion or the lateral portion at which the anchor member extends from, comprises a rounded surface.
[00127] In various embodiments, the anchor end of each anchor member, comprises a barb operable to pierce tissue.
[00128] In various embodiments, at least one of the plurality of anchor members or the one or more pairs of anchor members comprises a first anchor side and a second anchor side, each of the first and second anchor sides extending towards the third segment of the base plate.
[00129] In various embodiments, the device comprises a biocompatible material, optionally nitinol or bio-absorbable magnesium.
[00130] FIG. 13 shows a flowchart of an exemplary method 900 of manufacturing an applicator for attaching a tissue repair device to a tissue. The applicator may refer to applicator 300, 400 discussed with reference to FIGS. 3A to 9. FIG. 14 shows the (A) cross-sectional view and (B) perspective view of a schematic illustration of a cap 306, e.g. two-part cap for providing the at least one first holding member 342 of the first holding assembly 340. FIG. 14 further shows the (C) cross-sectional view and (D) perspective view of the first cap portion 306a; the (E) cross-sectional view and (F) perspective view of the second cap portion 306b of the cap 306, e.g. two-part cap. FIG. 15 shows (A) a flowchart of an exemplary method 900A for providing the at least one first holding member 342 of the first holding assembly 340; and corresponding schematic illustrations of the first shaft portion 302a, the cap 306, e.g. two-part cap and the handle 304, showing the (B) positioning of the first cap portion 306a in alignment with a channel 309 formed between the outer surface and hollow interior of the first shaft portion 302a; (C) the first holding member 342 disposed in the cap channel 306c; and (D) the positioning of the second cap portion 306b into the first cap portion 306a.
[00131] Method 900 includes: providing an effector for receiving the tissue repair device (step 902); providing a shaft having a hollow interior (step 904); providing a delivery assembly housed within the shaft, comprising: providing a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; and providing a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the delivery rod to drive the tissue repair device through the tissue to form the attachment (step 906).
[00132] In various embodiments, providing the driver assembly comprises: providing a driver rod positioned adjacent to the delivery rod, the driver rod configured to slide along the length of the shaft; providing a biasing device positioned adjacent to the delivery rod, the biasing device configured to move between a compressed state in which the driver rod is spaced apart from the delivery rod, and an extended state in which the driver rod abuts the delivery rod to drive the tissue repair device through the tissue to form the attachment.
[00133] In various embodiments, method 900 further comprises: providing a partition device housed in the hollow interior of the shaft, the partition device comprising a partition member
configured to be positioned between the driver rod and the delivery rod, when the biasing device is in the compressed state.
[00134] In various embodiments, providing the driver assembly further comprises: providing a holding assembly, the holding assembly configured to hold the biasing device in the compressed state in which the driver rod is spaced apart from the delivery rod.
[00135] In various embodiments, providing the holding assembly comprises: forming at least one recess along a length of the driver rod; providing at least one first holding member, the first holding member configured to be held in the at least one recess, to hold the biasing device in the compressed state. For example, as shown in FIGS. 15B to 15D, the at least one first recess 326 may be formed along the length of the driver rod 332.
[00136] Referring to FIGS. 14A to 14F, the cap 306 of the applicator 300 may comprise a two-part cap 306 comprising a first cap portion 306a and a second cap portion 306b. The second cap portion 306b may be configured to be inserted into a slot formed on the first cap portion 306b as will be explained below.
[00137] Referring to FIGS. 15A and 15B, providing the at least one first holding member may comprise: forming a channel between an outer surface and the hollow interior of the shaft (step 912); and positioning a first cap portion on an end of the shaft adjacent to the driver rod, the first cap portion positioned such that a cap channel of the first cap portion is in alignment with the channel (step 914). For example, as shown in FIG. 15B, the channel 309 formed between the outer surface and the hollow interior of the shaft 302, and the cap channel 306c formed on the first cap portion 306a may be in alignment with each other.
[00138] Referring to FIGS. 15A and 15C, method 900A further comprises, disposing the at least one first holding member into the channel, such that the first holding member is led into the cap channel (step 916). For example, as shown in FIG. 15C, the first holding member 342 may be inserted through the channel 309 and may be led into the cap channel 306c.
[00139] Referring to FIGS. 15A and 15D, method 900A further comprises, positioning a second cap portion on the first cap portion, the second cap portion configured to lodge the at least one first holding member in the first and second cap portions, and seal the channel and the cap channel (step 918). For example, as shown in FIG. 15D, the second cap portion 306b may be inserted into a slot 3O6d (see FIG. 14D) formed in the first cap portion 306a and may seal the cap portion 306c and the channel 309. Accordingly, the first holding member 342 may be lodged in place in the first and second cap portions 306a, 306b, and may be held in the second recess 308 formed in the cap 306.
[00140] In various embodiments, providing the holding assembly comprises: forming at least one groove along the length of the shaft; providing at least one second holding member positioned adjacent to and extending along a length of the driver rod, the second holding member configured to be held in the at least one groove, to hold the biasing device in the compressed state.
[00141] In various embodiments, providing the effector comprises: providing a first effector portion coupled to a second effector portion, the first and second effector portions configured to receive the tissue repair device.
[00142] In various embodiments, the delivery rod is configured to urge the first and second effector portions away from each other, to contact and drive the tissue repair device through the tissue to form the attachment.
[00143] In various embodiments, providing the effector further comprises: providing a hook arranged on each of the first and second effector portions, wherein the hook is configured to receive and hold the tissue repair device.
[00144] In various embodiments, method 900 further comprises: providing a protrusion arranged on each of the first and second effector portions, providing an effector cover for housing the effector, the effector cover comprising a first portion and a second portion positioned adjacent to the first portion, wherein the protrusion is configured to be held against the shaft, when the biasing device is in the compressed state.
[00145] In various embodiments, method 900 further comprises: providing slots arranged on the second portion of the effector cover for receiving the protrusion arranged on each of the first and second effector portions, wherein the protrusion arranged on the first and second effector portion is configured to move into a respective slot of the second portion of the effector cover, when the biasing device is in the extended state. In some embodiments, the effector cover comprises a serrated tip.
[00146] In various embodiments, providing the effector comprises, providing the effector such that the effector is removably attachable to the delivery rod.
[00147] In various embodiments, providing the delivery rod comprises, forming a projection extending from an end of the delivery rod.
[00148] FIG. 16 shows a flowchart of a method 1000 of manufacturing an installation module for attaching a tissue repair device to an applicator. The tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1A to 2E; and the applicator may refer to applicator 300, 400 discussed with reference to FIGS. 3A to 9.
[00149] Method 1000 comprises: providing an installation body having a surface (step 1002); forming an installation projection extending from the surface, the surface and the installation projection dimensioned to receive the tissue repair device, wherein the installation projection is configured to cooperate with the applicator, to permit the first and second effector portions to receive and hold the tissue repair device (step 1004).
[00150] In various embodiments, the surface comprises an inclined surface.
[00151] FIG. 17 shows a flowchart of a method 1 100 of manufacturing a suture capturing device for attaching a suture on to the tissue repair device. The tissue repair device may refer to tissue repair device 100A, 100B discussed with reference to FIGS. 1A to 2E.
[00152] Method 1100 comprises: providing a handle (step 1102); attaching a capturing member to the handle, the capturing member configured to receive the suture, wherein the capturing member is configured to facilitate the threading of the suture through the first aperture and the second aperture, to attach the suture on to the tissue repair device (step 1104). [00153] In various embodiments, the capturing member comprises a loop, and may comprise a flexible and bio-compatible material, optionally, nitinol.
[00154] Various embodiments of the disclosure thus provide a tissue repair device which comprises a first aperture and a second aperture separate to and positioned apart from each other, to allow a suture to be threaded through two points of the tissue repair device, thereby increasing the contact area and improving the mechanical interlock between the suture and the tissue repair device, and improving the attachment of the suture to the tissue repair device. As such, when the tissue repair device 100A, 100B is placed over tom tissue for reattachment to bone, the tissue repair device 100A, 100B and the suture may be firmly secured onto the tissue. This, in turn, ensures stable fixation of the tissue repair device 100A, 100B into the tissue, reducing the risk of suture slippage, detachment from the tissue repair device 100A, 100B, and/or failure at the tissue interface. The tissue repair device of the present disclosure is also particularly effective when used in combination with position-retention features, which include the anchor members of the tissue repair device which resist displacement at the suture-tissue junction, or a knot tied in the suture to prevent migration of shifting of the tissue repair device from the at the suture-tissue junction.
[00155] In addition, the disclosure provides an applicator comprising a delivery assembly having a driver assembly for urging the delivery rod having the tissue repair device attached thereto through the tissue to form the attachment. The applicator allows a user to deliver the tissue repair device in a quick and simple manner, reducing the need for specialized surgical
instruments and highly skilled and trained clinicians. Various embodiments of the disclosure further provide an installation module that allows clinicians to attach the tissue repair device to the applicator in a quick and simple manner; and a suture capturing device for facilitating the threading of the suture to the tissue repair device, thereby reducing the complexity of the procedure. The disclosure further provides methods of manufacture of the tissue repair device, the applicator, the installation module and the suture capturing device, which are inexpensive and easy to manufacture.
[00156] While the disclosure has been particularly shown and described with reference to specific embodiments, it should be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. The scope of the disclosure is thus indicated by the appended claims and all changes which come within the meaning and range of equivalency of the claims arc therefore intended to be embraced.
Claims
1 . A tissue repair device comprising a base plate; a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue; a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture; and a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture; wherein the second aperture is separate to and positioned away from the first aperture.
2. The tissue repair device of claim 1, wherein the base plate comprises a first segment, a second segment and a third segment; wherein the first, second and third segments are connected to each other at the part of the base plate having the first aperture, and wherein the second aperture is arranged on the third segment.
3. The tissue repair device of claim 2, wherein the third segment comprises a bell-shaped profile; or wherein the third segment comprises an oblong profile having a curved surface arranged on an end of the third segment; and/or wherein the second aperture comprises a U-shaped channel extending partially along a perimeter of the third segment, the U-shaped channel having an area greater than an area of the first aperture.
4. The tissue repair device of any one of claims 1 to 3, wherein each anchor member extends from an anterior portion or a lateral portion of each of the first and second segments, optionally, wherein the anterior portion or the lateral portion at which the anchor member extends from, comprises a rounded surface; and/or wherein the anchor end of each anchor member, comprises a barb operable to pierce tissue.
5. The tissue repair device of any one of claims 1 to 4, wherein at least one of the plurality of anchor members or the one or more pairs of anchor members comprises a first anchor side and a second anchor side, each of the first and second anchor sides extending towards the third segment of the base plate.
6. An applicator for attaching a tissue repair device to a tissue, the applicator comprising an effector configured to receive the tissue repair device; a shaft having a hollow interior for housing a delivery assembly, the delivery assembly comprising; a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the deliver}' rod to drive the tissue repair device through the tissue to form the attachment.
7. The applicator of claim 6, wherein the driver assembly comprises a driver rod positioned adjacent to the delivery rod, the driver rod configured to slide along the length of the shaft; a biasing device positioned adjacent to the delivery rod, the biasing device configured to move between a compressed state in which the driver rod is spaced apart from the delivery rod, and an extended state in which the driver rod abuts and propels the delivery rod to drive the tissue repair device through the tissue to form the attachment.
8. The applicator of claim 7, further comprising a partition device housed in the hollow interior of the shaft, the partition device comprising a partition member configured to be positioned between the driver rod and the delivery rod, when the biasing device is in the compressed state.
9. The applicator of claim 7 or 8, wherein the driver assembly further comprises a holding assembly, the holding assembly configured to hold the biasing device in the compressed state in which the driver rod is spaced apart from the delivery rod.
10. The applicator of claim 9, wherein the holding assembly comprises
at least one first holding member, the first holding member configured to be held in at least one recess formed along a length of the driver rod, to hold the biasing device in the compressed state; optionally, wherein the first holding member comprises a bearing, optionally a ball bearing.
11. The applicator of claim 9, wherein the holding assembly comprises at least one second holding member, the second holding member positioned adjacent to and extending along a length of the driver rod, wherein the second holding member is configured to be held in at least one groove formed along the length of the shaft, to hold the biasing device in the compressed state.
12. The applicator of any one of claims 6 to 11, wherein the effector comprises a first effector portion coupled to a second effector portion, the first and second effector portions configured to receive the tissue repair device, optionally wherein the effector further comprises a hook arranged on each of the first and second effector portions, wherein the hook is configured to receive and hold the tissue repair device, and/or wherein the delivery rod is configured to urge the first and second effector portions away from each other, to contact and drive the tissue repair device through the tissue to form the attachment.
13. The applicator of any one of claims 6 to 12, wherein the delivery rod is pivotably coupled to the effector in a manner such that the effector is rotatable with respect to the delivery rod.
14. The applicator of claim 12 or 13, wherein the effector comprises a protrusion arranged on each of the first and second effector portions, and further comprises an effector cover for housing the effector, the effector cover comprising a first portion and a second portion positioned adjacent to the first portion, wherein the protrusion is configured to be held against the shaft or the first portion of the effector cover, when the biasing device is in the compressed state.
15. The applicator of claim 14, wherein the second portion of the effector cover comprises slots for receiving the protrusion arranged on the first and second effector portions, wherein the protrusion arranged on the first and second effector portion is configured to move into a respective slot of the second portion of the effector cover, when the biasing device is in the extended state, optionally wherein the effector cover comprises a serrated tip.
16. The applicator of any one of claims 6 to 15, wherein the effector is removably attachable to the deliver}' rod; and/or wherein the delivery rod comprises a projection extending from an end of the delivery rod.
17. An installation module for attaching the tissue repair device of any one of claims 1 to 5 to the applicator of any one of claims 6 to 16, the installation module comprising an installation body having a surface comprising an installation projection extending from the surface, the surface and the installation projection dimensioned to receive the tissue repair device, wherein the installation projection is configured to cooperate with the applicator, to permit the first and second effector portions to receive and hold the tissue repair device.
18. A suture capturing device for attaching a suture on to the tissue repair device of any one of claims 1 to 5, the suture capturing device comprising a handle having a capturing member attached thereto, the capturing member configured to receive the suture, wherein the capturing member is configured to facilitate the threading of the suture through the first aperture and the second aperture, to attach the suture on to the tissue repair device.
19. A method of manufacturing a tissue repair device, the method comprising providing a base plate; providing a plurality of anchor members or one or more pairs of anchor members, extending from a surface of the base plate, each anchor member having an anchor end operable to pierce tissue;
forming, a first aperture arranged on a part of the base plate, the first aperture operable to receive a suture; and forming, a second aperture arranged on another part of the base plate, the second aperture operable to receive the suture, wherein the second aperture is separate to and positioned away from the first aperture.
20. A method of manufacturing an applicator for attaching a tissue repair device to a tissue, the method comprising providing an effector for receiving the tissue repair device; providing a shaft having a hollow interior; providing a delivery assembly housed within the shaft, comprising providing a delivery rod coupled to the effector, the delivery rod configured to slide along a length of the shaft; providing a driver assembly positioned adjacent to the delivery rod, the driver assembly configured to urge the delivery rod to drive the tissue repair device through the tissue to form the attachment.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SG10202401402Y | 2024-05-17 | ||
| SG10202401402Y | 2024-05-17 |
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| Publication Number | Publication Date |
|---|---|
| WO2025239838A1 true WO2025239838A1 (en) | 2025-11-20 |
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ID=97720895
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/SG2025/050337 Pending WO2025239838A1 (en) | 2024-05-17 | 2025-05-16 | A tissue repair device and an applicator for the device |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025239838A1 (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010051815A1 (en) * | 2000-03-15 | 2001-12-13 | Esplin Vermon S. | Soft tissue anchor |
| US20190247038A1 (en) * | 2017-12-20 | 2019-08-15 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
-
2025
- 2025-05-16 WO PCT/SG2025/050337 patent/WO2025239838A1/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20010051815A1 (en) * | 2000-03-15 | 2001-12-13 | Esplin Vermon S. | Soft tissue anchor |
| US20190247038A1 (en) * | 2017-12-20 | 2019-08-15 | Conextions, Inc. | Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone |
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