IP Library Granted Patent US 10,441,403
Granted Patent B1
US 10,441,403 · App. 14/213,216 · Granted Oct 15, 2019

Biomedical patch and delivery system

Inventors: Matthew R. MacEwan (St. Louis, MO); Ralph Dacey (St. Louis, MO); Wilson Z. Ray (St. Louis, MO)
Assignee: Acera Surgical, Inc.
A61F2/0063A61L27/58A61F2002/0072
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Quick Facts
Patent No.
US 10,441,403
App. No.
14/213,216
Granted
Oct 15, 2019
Kind
B1
Abstract

A multi-laminar repair matrix for repairing a tissue defect may comprise a top patch and a bottom compliant patch. The bottom compliant patch may be compressed and sized to fit through a tissue defect, and expand to a substantially planar state after being implanted to the tissue defect. The top and/or bottom patch may include adhesives. A tool for implanting a patch to a tissue defect may include a shaft, a plurality of arms pivotally connected to the shaft, and a control. The control may be configured to radially expand the plurality of arms upon actuation of the control.

Claims (38)

1. A repair matrix for repairing a tissue defect, comprising:

a top flexible patch, the top flexible patch comprising a wholly synthetic dural substitute material that facilitates tissue growth, wherein a peripheral portion of the top flexible patch is configured to be implanted to an outer surface of tissue surrounding a tissue defect;

a bottom flexible patch, the bottom flexible patch comprising material that facilitates tissue growth, wherein the bottom flexible patch in a first state is configured to be compressed and sized to facilitate implantation of a peripheral portion of the bottom flexible patch to an inner surface of the same tissue surrounding the tissue defect, and the bottom flexible patch in a second state is configured to be expanded such that the bottom flexible patch substantially conforms to a curvature of the tissue surrounding the tissue defect,

wherein the bottom flexible patch in the first state comprises a distal end and a proximate end, wherein the distal end is configured to be inserted at least partially into the tissue defect before the proximate end,

wherein the distal end of the bottom flexible patch in the first state corresponds to an outer perimeter of the bottom flexible patch in the second state, and wherein the proximate end of the bottom flexible patch in the first state corresponds to a portion of the bottom flexible patch spaced from the outer perimeter of the bottom flexible patch in the second state,

wherein the bottom flexible patch in the second state comprises a top surface and a bottom surface, wherein the top surface faces the top flexible patch, wherein the top surface faces outward when the bottom flexible patch is in the first state, and wherein the bottom surface faces inward when the bottom flexible patch is in the first state,

wherein a periphery of the top surface comprises an adhesive for adhering the top surface of the bottom flexible patch to the inner surface of the tissue surrounding the tissue defect, and

wherein the bottom flexible patch comprises a plurality of creases, wherein the plurality of creases spans a diameter of the bottom flexible patch and intersects at the proximate end, wherein the plurality of creases are adapted to allow the bottom flexible patch to be substantially flattened when in the second state; and

a connecting portion connecting a non-peripheral portion of the top flexible patch with a non-peripheral portion of the bottom flexible patch, the connecting portion comprising a height adapted to prevent adhesion of the bottom flexible patch to the top flexible patch,

wherein the peripheral portion of the top flexible patch and the peripheral portion of the bottom flexible patch are separated by a void space, wherein the void space is sufficiently wide to allow the peripheral portion of the top flexible patch to be implanted to the outer surface of the tissue surrounding the tissue defect and the peripheral portion of the bottom flexible patch to be implanted to the inner surface of the same tissue surrounding the tissue defect,

wherein the top flexible patch comprises a first biodegrade time, the bottom flexible patch comprises a second biodegrade time, and the adhesive comprises a third biodegrade time, wherein the third biodegrade time is longer than the first biodegrade time and the second biodegrade time.

2. The repair matrix of claim 1 , wherein one or both of the top flexible patch and the bottom flexible patch comprises electro-spun fibers.

3. The repair matrix of claim 1 , wherein the bottom flexible patch when in the second state has a shape that follows a perimeter of the tissue defect.

4. The repair matrix of claim 1 , wherein a shape of the bottom flexible patch when in the second state is square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral.

5. The repair matrix of claim 1 , wherein one or both of the top flexible patch and the bottom flexible patch is configured to biodegrade after being implanted to the tissue surrounding the tissue defect.

6. The repair matrix of claim 1 , wherein the tissue defect is a dural defect.

7. The repair matrix of claim 1 , wherein the peripheral portion of the top flexible patch comprises an adhesive.

8. The repair matrix of claim 1 , wherein a shape of the top flexible patch follows a perimeter of the tissue defect.

9. The repair matrix of claim 1 , wherein a shape of the top flexible patch is square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral.

10. The repair matrix of claim 1 , wherein one or both of the top flexible patch and the bottom flexible patch comprises shape memory material.

11. The repair matrix of claim 1 , wherein a width of the void space between the peripheral portion of the top flexible patch and the peripheral portion of the bottom flexible patch is adjustable to substantially match a width of the tissue surrounding the tissue defect.

12. The repair matrix of claim 1 , wherein the connecting portion connecting the non-peripheral portion of the top flexible patch with the non-peripheral portion of the bottom flexible patch comprises an adhesive.

13. The repair matrix of claim 1 , wherein the connecting portion connecting the non-peripheral portion of the top flexible patch with the non-peripheral portion of the bottom flexible patch comprises a material same as the material of the top flexible patch and/or the bottom flexible patch.

14. The repair matrix of claim 1 , further comprising a delivery tool for implanting the bottom flexible patch to the inner surface of the tissue surrounding the tissue defect, wherein the delivery tool attaches to the proximate end of the bottom flexible patch in the first state to facilitate insertion of at least a part of the distal end of the bottom flexible patch in the first state into the tissue defect before the proximate end of the bottom flexible patch in the first state.

15. The repair matrix of claim 1 , wherein the top flexible patch comprises a substantially similar size and a substantially similar shape as the bottom flexible patch.

16. A kit for repairing a dural defect, comprising:

a sterile easily opened packet containing a plurality of biodegradable patches configured to repair a dural defect for a range of expected patients undergoing a surgical procedure, wherein the plurality of biodegradable patches are of a same shape and varying sizes, such that at least one of the plurality of biodegradable patches comprises a size sufficiently large to cover the dural defect and enable a water-tight seal of the dural defect for one of the range of expected patients, wherein each of the plurality of biodegradable patches comprises a wholly synthetic dural substitute material, wherein each of the plurality of biodegradable patches comprises a plurality of creases, wherein the plurality of creases spans a diameter of each of the plurality of biodegradable patches and intersects at an internal point spaced from an outer perimeter on each of the plurality of biodegradable patches, wherein the plurality of creases are adapted to allow each of the plurality of biodegradable patches to be substantially flattened, wherein at least two or more of the plurality of biodegradable patches comprises a different biodegrade time wherein a periphery of a top surface of the at least two or more of the plurality of biodegradable patches comprises an adhesive for adhering the top surface of the flexible patch to the inner surface of the tissue surrounding the dural defect, and wherein the at least two or more of the plurality of biodegradable patches comprise a first biodegrade time, and the adhesive of the at least two or more of the plurality of biodegradable patches comprises a second biodegrade time, wherein the second biodegrade time is longer than the first biodegrade time.

17. The kit of claim 16 , wherein the shape is square, rectangular, circular, triangular, elliptical, hexagonal, or quadrilateral.

18. The kit of claim 16 , wherein each of the plurality of biodegradable patches comprises shape memory material.

19. A repair matrix for repairing a tissue defect, comprising:

a flexible patch, the flexible patch comprising a wholly synthetic dural substitute material formed by electrospinning that facilitates tissue growth, wherein the flexible patch in a first state is configured to be compressed and sized to facilitate implantation of the flexible patch to an inner surface of tissue surrounding the tissue defect, and the flexible patch in a second state is configured to be expanded such that the flexible patch substantially conforms to a curvature of the tissue surrounding the tissue defect,

wherein the flexible patch in the first state comprises a distal end and a proximate end, wherein the distal end is configured to be inserted at least partially into the tissue defect before the proximate end,

wherein the distal end of the flexible patch in the first state corresponds to an outer perimeter of the flexible patch in the second state, and wherein the proximate end of the flexible patch in the first state corresponds to a portion of the flexible patch spaced from the outer perimeter of the flexible patch in the second state,

wherein the flexible patch in the second state comprises a top surface and a bottom surface, wherein the top surface faces outward when the flexible patch is in the first state, and wherein the bottom surface faces inward when the flexible patch is in the first state,

wherein a periphery of the top surface comprises an adhesive for adhering the top surface of the flexible patch to the inner surface of the tissue surrounding the tissue defect,

wherein the flexible patch comprises a first biodegrade time, and the adhesive comprises a second biodegrade time, wherein the second biodegrade time is longer than the first biodegrade time, and

wherein the flexible patch comprises a plurality of creases, wherein the plurality of creases spans a diameter of the flexible patch and intersects at the proximate end, wherein the plurality of creases are adapted to allow the flexible patch to be substantially flattened when in the second state.

20. The repair matrix of claim 19 , further comprising a delivery tool for implanting the flexible patch to the inner surface of the tissue surrounding the tissue defect, wherein the delivery tool attaches to the proximate end of the flexible patch in the first state to facilitate insertion of at least a part of the distal end of the flexible patch in the first state into the tissue defect before the proximate end of the flexible patch in the first state.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 12, 2026
From: ACERA SURGICAL, INC.
To: SOLVENTUM INTELLECTUAL PROPERTIES COMPANY
Reel/Frame 074933/0515 →
RELEASE OF SECURITY INTEREST Recorded Dec 23, 2025
From: WILSON FAMILY LEGACY TRUST NO. I
To: ACERA SURGICAL, INC.
Reel/Frame 073303/0131 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2025
From: RETECTIX, LLC
To: ACERA SURGICAL, INC.
Reel/Frame 072952/0236 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 22, 2025
From: MACEWAN, MATTHEW R.; DACEY, RALPH; RAY, WILSON Z.
To: RETECTIX, LLC
Reel/Frame 072332/0168 →
SECURITY INTEREST Recorded Dec 14, 2020
From: ACERA SURGICAL, INC.
To: WILSON FAMILY LEGACY TRUST NO. I
Reel/Frame 054638/0789 →
SECURITY INTEREST Recorded Jun 12, 2019
From: ACERA SURGICAL, INC.
To: WILSON FAMILY LEGACY TRUST NO. 1
Reel/Frame 049444/0313 →
Continuity (1)
Provisional Application 61798224 · Mar 15, 2013
Cited By (5)
US 12,201,749 US 12,246,114 US 12,263,269 US 12,491,061 US 12,564,658