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US-20260124343-A1 - SOFT TISSUE AUGMENT AND METHODS OF MAKING AND USING SAME

US20260124343A1US 20260124343 A1US20260124343 A1US 20260124343A1US-20260124343-A1

Abstract

A soft tissue augment includes a first layer formed of a first material, the first material being a biological material, a synthetic material, or a composite material including both a biological material and a synthetic material, the first layer defining a first surface including a perimeter region surrounding a center region, and a second layer attached to the first surface of the first layer and formed of a second material, the second material being a biological material, a synthetic material, or a composite material including both a biological material and a synthetic material, the second material being different from the first material, the second layer extending from the perimeter region into the center region.

Inventors

  • Kyle Craig Pilgeram
  • J. Brook Burley
  • James Flom
  • Jeremy Graul

Assignees

  • STRYKER CORPORATION

Dates

Publication Date
20260507
Application Date
20251103

Claims (20)

  1. 1 . A soft tissue augment, comprising: a first layer formed of a first material, the first material being a biological material, a synthetic material, or a composite material including both a biological material and a synthetic material, the first layer defining a first surface comprising a perimeter region surrounding a center region; and a second layer attached to the first surface of the first layer and formed of a second material, the second material being a biological material, a synthetic material, or a composite material including both a biological material and a synthetic material, the second material being different from the first material, the second layer extending from the perimeter region into the center region.
  2. 2 . The soft tissue augment of claim 1 , wherein the second material has a greater strength than the first material.
  3. 3 . The soft tissue augment of claim 1 , wherein the second layer covers less than half of the surface area of the first layer.
  4. 4 . The soft tissue augment of claim 1 , wherein the second layer is attached to the first layer by sewing, felting, stitching, bonding, or combinations thereof.
  5. 5 . The soft tissue augment of claim 1 , wherein the second layer is formed of a biological material or a biodegradable polymeric material.
  6. 6 . The soft tissue augment of claim 1 , wherein the second layer extends beyond an outer perimeter defined by the first layer.
  7. 7 . The soft tissue augment of claim 1 , wherein the second layer comprises at least two portions defining a first linear strip of the first surface not covered by the second layer.
  8. 8 . The soft tissue augment of claim 1 , wherein the second layer defines a first linear strip of the second material.
  9. 9 . The soft tissue augment of claim 8 , wherein the second layer further defines a second linear strip of the second material.
  10. 10 . The soft tissue augment of claim 9 , wherein the first linear strip of the second material intersects with the second linear strip of the second material, and wherein the first linear strip and the second linear strip are configured to be positioned under sutures used in a surgical repair.
  11. 11 . The soft tissue augment of claim 9 , wherein the first linear strip and the second linear strip extend parallel across the center region to form a detent for a spring arm of an augment delivery device.
  12. 12 . The soft tissue augment of claim 1 , wherein the second layer is formed in pattern defining a plurality of openings, wherein portions of the first surface aligned with the openings are uncovered by the second layer.
  13. 13 . The soft tissue augment of claim 1 , wherein the second layer comprises a first portion with a first thickness and a second portion with a second thickness greater than the first thickness.
  14. 14 . The soft tissue augment of claim 13 , wherein the second portion with the second thickness is in the perimeter region.
  15. 15 . The soft tissue augment of claim 1 , wherein the first material is a collagen, and the second material is a synthetic material.
  16. 16 . The soft tissue augment of claim 15 , wherein the synthetic material comprises electrospun degradable fibers.
  17. 17 . The soft tissue augment of claim 1 , wherein the second layer defines an opening or a tunnel configured to receive a suture or filament.
  18. 18 . A method of forming a soft tissue augment, the method comprising: providing a first layer formed of a first material, the first material comprising a biological material, a synthetic material, or a composite material including both a biological material and a synthetic material, the first layer defining a first surface comprising a perimeter region surrounding a center region; and coupling a second layer to the first surface of the first layer with the second layer extending from the perimeter region into the center region, the second layer formed of a second material, the second material being a biological material, a synthetic material, or a composite material including both a biological material and a synthetic material, the second material being different from the first material.
  19. 19 . The method of claim 18 , wherein the second material is a nonwoven polymeric material, and wherein coupling the second layer to the first surface of the first layer comprises pressing fibers from the second layer through the first layer.
  20. 20 . The method of claim 18 , wherein coupling the second layer to the first layer comprises sewing, felting, stitching, bonding, or combinations thereof.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS The application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/715,301, filed Nov. 1, 2024, which is incorporated by reference herein in its entirety. BACKGROUND Joints of the human body may be susceptible to damage or injury due to excessive wear through intensive activity, a traumatic event, or through a long period of expected wear, among other reasons. One such joint susceptible to injury is the shoulder, where the soft tissue of the rotator cuff may tear. Surgeons have a variety of potential repairs of this soft tissue at their disposal, including the use of sutures and suture anchors to, in the case of cuff repair, reattach the soft tissue to the bone. Another implant gaining popularity in soft tissue repair is the use of a patch or sheet of material to augment the repair. Specifically, this augment material is intended to be positioned against the soft tissue to provide healing benefits to the tissue. For example, these augments can promote tissue growth and/or can provide support or strength to the soft tissue. There is much debate over the best type of augment material. Generally, some prefer biological or biodegradable materials as they commonly provide support and a scaffold for tissue in-growth but naturally degrade over time, leaving behind only natural tissue. However, such materials are typically fragile and can be difficult to manipulate and secure to the tissue. Others prefer non-biodegradable, typically polymeric, materials, in theory at least, as they are stronger, more user-friendly, and provide enduring support to the tissue. However, surgeons generally prefer to limit the amount of polymeric materials they implant in a patient, particularly when positioned within the articulating areas of a joint (such as in contact with the rotator cuff tissue). As such, a need exists for an improved augment material that can provide the benefits desired by surgeons but limit the negative features of currently-used materials. SUMMARY OF THE INVENTION In one aspect, the present application relates to a new soft tissue augment material with improved strength and usability while also providing the benefits of biological materials. In some instances, the augment may include at least one biological or degradable synthetic material and at least one non-biodegradable material. In one aspect, the present disclosure is a soft tissue augment including a first material and at least one second material positioned along at least a portion of an outer perimeter of the first material, wherein the second material is attached to the first material along at least a portion of both the first and second materials. The first material may be a biological material, a synthetic (degradable or non-degradable) material, or a composite material including both biological and synthetic components. The second material also may be a biological material, a synthetic (degradable or non-degradable) material, or a composite material including both biological and synthetic components. In another aspect, the present disclosure is a method of making a soft tissue augment, including obtaining a first component formed of a first material as described above, obtaining a second component formed of a second material as described above, and attaching the first component to the second component along at least a portion of both the first and second components. The attaching of the first component to the second component may include the use of sewing, felting, adhering, or stitching. The attaching of the first component to the second component may occur along at least a portion of an overlapping surface area of both the first and second components. In a further aspect, the present disclosure is a method of making a soft tissue augment, including obtaining a first component formed of a first material as described above, obtaining a second component formed of a second material as described above, attaching the first component to the second component along at least a portion of both the first and second components to form the soft tissue augment, and implanting the soft tissue augment against a portion of soft tissue. Implanting the augment may include the use of sewing, felting, adhering, or stitching of the soft tissue augment to the portion of soft tissue. The implanting may include positioning at least a portion of the second component against the soft tissue. The implanting may include positioning at least a portion of both the first component and the second components directly against the soft tissue. The implanting may include attaching the soft tissue augment to the soft tissue along at least one location within a surface area of the second component. A further aspect of the present disclosure relates to a soft tissue augment including a first layer formed of a first material, the first material being a biological material, a synthetic material, or a composite ma