Tissue augmentation scaffolds for use with soft tissue fixation repair systems and methods

Patent metadata

Field	Value
Publication number	US-11357495-B2
Application number	US-201715419360-A
Country	US
Kind code	B2
Filing date	Jan 30, 2017
Priority date	Feb 1, 2016
Publication date	Jun 14, 2022
Grant date	Jun 14, 2022

Abstract

Devices, systems, and methods to improve both the reliability of soft tissue repair procedures and the speed at which the procedures are completed are provided. The devices and systems include one or more tissue augmentation constructs, which include constructs that are configured to increase a footprint across which suture applied force to tissue when the suture is tied down onto the tissue. The tissue augmentation constructs can be quickly and easily associated with the repair suture, and can be useful in many different tissue repair procedures that are disclosed in the application. In one exemplary embodiment, one or more constructs are disposed on a suture threader, which can be used to associate the construct(s) with a repair suture(s) being used to repair the soft tissue. Tissue augmentation constructs can include various blocks and patches, among other formations. Exemplary methods for manufacturing the tissue augmentation constructs are also provided.

First claim

What is claimed is:

1. A soft tissue repair system, comprising:
a scaffold having a first, tissue-engaging surface with a surface area defined by a length and a width of the scaffold and a second surface with a surface area defined by the length and the width of the scaffold, the second surface being opposed to the first, tissue-engaging surface and a thickness of the scaffold being defined by a distance between the first, tissue-engaging surface and the second surface, the surface areas of the first, tissue-engaging surface and the second surface being larger than the surface areas of any other sides of the scaffold and the thickness being the shortest of the length, the width, and the thickness of the scaffold;
a first threader having a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle of the first threader and the distal receiving end of the first threader, the intermediate portion of the first threader extending continuously through a first lumen extending through the scaffold and along the length of the scaffold from a first opening of the first lumen in first end of the scaffold to a second opening of the first lumen in an opposed second end of the scaffold and the first threader being configured to dispose the scaffold onto a suture by associating the suture with the distal receiving end of the first threader and such that applying a force to the proximal handle of the first threader causes the distal receiving end of the first threader to advance towards and through the length of the scaffold;
a second threader having a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle of the second threader and the distal receiving end of the second threader, the intermediate portion of the second threader extending continuously through a second lumen extending through the scaffold and along the length of the scaffold from first opening of the second lumen in the first end of the scaffold to a second opening of the second lumen in the opposed second end of the scaffold and the second threader being configured to dispose the scaffold onto another suture by associating the another suture with the distal receiving end of the second threader and such that applying a force to the proximal handle of the second threader causes the distal receiving end of the second threader to advance towards and through the length of the scaffold; and
packaging having the scaffold and the first and second threaders disposed therein, at least one of the first threader and the second threader being pre-disposed through the scaffold in the packaging, and wherein the packaging releasably secures the scaffold and the first and second threaders.

2. The system of claim 1 , wherein the intermediate portion of each of the first and second threaders comprises at least one of a filament portion, a fiber, a thread, a wire, and a cord.

3. The system of claim 1 , further comprising:
a first suture configured to be associated with the distal receiving end of the first threader and configured to have the scaffold disposed thereon; and
a second suture configured to be associated with the distal receiving end of the second threader and configured to have the scaffold disposed thereon.

4. The system of claim 1 ,
wherein the intermediate portion of the first threader is disposed more proximate to a first side of the scaffold than a second, opposite side of the scaffold, the first and second sides of the scaffold, in conjunction with the first and second ends of the scaffold, defining the surface areas of the first, tissue-engaging surface and the second surface of the scaffold and
wherein the intermediate portion of the second threader is disposed more proximate to the second, opposite side of the scaffold than the first side.

5. The system of claim 4 , further comprising:
a third threader having a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle of the third threader and the distal receiving end of the third threader, the intermediate portion of the third threader extending continuously through the length of the scaffold from the first end of the scaffold to the opposed second end of the scaffold and the third threader being configured to dispose the scaffold onto another suture by associating the another suture with the distal receiving end of the third threader and such that applying a force to the proximal handle of the third threader causes the distal receiving end of the third threader to advance towards and through the length of the scaffold; and
a fourth threader having a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle of the fourth threader and the distal receiving end of the fourth threader, the intermediate portion of the fourth threader extending continuously through the length of the scaffold from the first end of the scaffold to the opposed second end of the scaffold and the fourth threader being configured to dispose the scaffold onto another suture by associating the another suture with the distal receiving end of the fourth threader and such that applying a force to the proximal handle of the fourth threader causes the distal receiving end of the fourth threader to advance towards and through the length of the scaffold,
wherein the intermediate portion of the third threader is disposed diagonally with respect to the scaffold such that the distal receiving end of the third threader is proximate to the distal receiving end of the first threader and the proximal handle portion of the third threader is proximate to the proximal handle of the second threader, and
wherein the intermediate portion of the fourth threader is disposed diagonally with respect to the scaffold such that the distal receiving end of the fourth threader is proximate to the distal receiving end of the second threader and the proximal handle portion of the fourth threader is proximate to the proximal handle of the first threader.

6. The system of claim 1 , wherein the proximal handles of the first and second threaders are disposed on the first end of the scaffold, the distal receiving ends of the first and second threaders are disposed on the second opposed end of the scaffold, and the intermediate portions of the first and second threaders extend from the first end to the second opposed end in a pre-installation configuration.

7. The system of claim 1 , wherein the scaffold comprises at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, biological autograft connective tissue, biological allograft connective tissue, biological xenograft connective tissue, human dermal matrix, porcine dermal matrix, bovine dermal matrix, periosteal tissue, pericardial tissue, fascia.

8. The system of claim 7 , wherein the scaffold comprises collagen.

9. The system of claim 1 , wherein a first layer of the scaffold comprises a biodegradable polymer, and a second layer of the scaffold comprises an extracellular matrix.

10. The system of claim 9 , wherein a thickness of the first layer is greater than a thickness of the second layer.

11. The system of claim 1 , wherein the scaffold further comprises one or more adjustable suture loops disposed on an edge of the scaffold, the one or more adjustable suture loops being configured to prevent the scaffold from unintentionally sliding with respect to a suture limb passed through the respective one or more adjustable suture loops.

12. The system of claim 1 , wherein the packaging is configured to releasably secure the scaffold whil

Assignees

• Medos Int Sarl

Inventors

• Sengun Mehmet Ziya
• Whittaker Gregory R
• Cleveland Benjamin
• Berti Stefano
• Diab Tamim
• Parrish William R
• Theis Reagan A

Classifications

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2002/0841

  Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire · CPC title

• A61F2002/0072

  Delivery tools therefor · CPC title

• A61F2/0063

  Implantable repair or support meshes, e.g. hernia meshes · CPC title

• A61B2017/0446

  Means for attaching and blocking the suture in the suture anchor · CPC title