IP Library Granted Patent US 11,819,202
Granted Patent B2
US 11,819,202 · App. 17/920,458 · Granted Nov 21, 2023

Systems and methods including an adjustable retractor frame

Inventors: Robert Richards (Clawson, MI); Stephen Maguire (Shelton, CT)
Assignee: BIOPHYX SURGICAL, INC.
A61B17/0293A61B2017/00946A61B2017/00951A61B2017/0287
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Quick Facts
Patent No.
US 11,819,202
App. No.
17/920,458
Granted
Nov 21, 2023
Kind
B2
Abstract

The system includes a frame composed of materials and geometry allowing selective deformation in a plane perpendicular to a patient's anatomy at the surgical site but resisting deformation in a plane parallel to the anatomy. The frame is connected to stabilizing features and sheets, which are attached to adhesive to secure the frame to the patient. The features, sheets, and adhesive layers extend both into and beyond the frame. An integrated sheet covers the prospective incision site on the patient. When positioned at the site, the frame conforms to the patient. Anchor points are distributed along the frame to reversibly secure and provide a stable base for surgical retractors, even when unilaterally applied. By adaptable positioning and design of the stabilizing members and adhesive layers on the frame, the system is able to provide optimal tractional stability when experiencing tensile loads in myriad surgical environments including ophthalmic and spinal surgery.

Claims (28)

1. A device for surgical retraction comprising:

a frame having a lower surface, and an opposing upper surface and a periphery defining an interior space, the frame including at least one anchor point extending therefrom for retaining a tissue retraction member, the frame flexible to conform to a patient's anatomy; and

a stabilizing member configured to provide tensile and compression load resistance, the frame integrated with the stabilizing member, the stabilizing member having a lower surface adhesively adhering to a skin of a patient or a surface overlying the skin of the patient to secure the frame and maintain position of the device relative to a surgical site, the stabilizing member extending underneath the frame, the stabilizing member and adhesive extending underneath an entire area of the frame, laterally outwardly from the periphery of the frame and laterally inwardly from the periphery of the frame toward an incision site into the interior space to thereby provide an adherence surface to an area larger than an area covered by the frame, the stabilizing member and underlying adhesive extending inwardly along an entire periphery of the frame.

2. The device of claim 1 , further comprising a removable protective layer, the protective layer removable to expose the adhesive for securement of the stabilizing member to the skin or the surface overlying the skin.

3. The device of claim 1 , wherein the frame is configured to allow deformation in a plane perpendicular to a surface of the patient's anatomy and resist deformation in a plane parallel to the surface of the patient's anatomy.

4. The device of claim 1 , wherein the stabilizing member adds resistance to the tissue retraction member anchored to the at least one anchor point.

5. The device of claim 1 , wherein the frame in a non-tensioned condition lies in a plane and has a first side and a second opposing side, the first and second sides bendable out of the first plane.

6. The device of claim 1 , wherein the frame is non-circular in configuration.

7. The device of claim 1 , wherein the stabilizing member comprises a membrane, and the frame is integrated with the membrane.

8. The device of claim 1 , wherein the stabilizing member reversibly adheres to the skin or the surface and the adhesive providing the adhesive adherence maintains sufficient adhesion to allow for multiple uses of the frame for repositioning of the frame.

9. The device of claim 1 , wherein the stabilizing member is configured to remain anchored to a surface of the patient's anatomy while the frame deforms to conform to the patient's anatomy when the patient's anatomy is repositioned without becoming detached from the skin or the surface overlying the skin.

10. The device of claim 1 , wherein the stabilizing member counteracts forces applied to the frame by one or more tissue retraction members affixed to the at least one anchor point to thereby stabilize the device even when the retraction forces applied by the one or more tissue retraction members are unbalanced.

11. The device of claim 1 , wherein the frame has sufficient rigidity to resist lateral movements applied by one or more tissue retraction members connected to the at least one anchor point.

12. The device of claim 1 , wherein the stabilizing member comprises a membrane, and the frame is more rigid than the membrane to translate forces through the frame to maximize an area of the membrane that is in tension.

13. The device of claim 1 , wherein the stabilizing member extends inwardly to completely cover the interior space defined by the periphery and cover a surgical site.

14. The system according to claim 1 , wherein the stabilizing member comprises a membrane extending inwardly from the periphery of the frame and is configured to be cuttable via a scalpel.

15. The device of claim 1 , wherein portions of the stabilizing member under tensile stress provide stability to the frame so that portions of the stabilizing member that are under compressive stress enable retraction from the frame.

16. The device of claim 1 , wherein the at least one anchor point comprises a plurality of fingers spaced apart about the periphery and configured to frictionally maintain tissue retraction members secured to the fingers and the at least one anchor point extends laterally outwardly of an outermost edge of the frame and in a direction non-parallel to a plane of the frame.

17. A device for surgical retraction comprising:

a frame having a periphery, a lower surface and an opposing upper surface, the frame including at least one anchor point extending therefrom for retaining a tissue retraction member, the frame flexible to conform to a patient's anatomy; and

a stabilizing member attached to the frame, the frame integral with the stabilizing member and in contact with an upper surface of the stabilizing member along an entire bottom surface of the frame, the stabilizing member having a lower surface adhesively adhering to a skin of a patient or a surface overlying the skin of the patient to secure the frame;

wherein the frame integrated with the stabilizing member is configured to allow deformation in a plane perpendicular to a surface of the anatomy and resist deformation in a plane parallel to the surface of the anatomy wherein the stabilizing member remains anchored to the skin or surface while enabling the frame to deform when the patient's anatomy is repositioned.

18. The device of claim 17 , wherein the stabilizing member is configured to remain anchored to a surface of the patient's anatomy while the frame deforms to conform to repositioning of the patient's anatomy.

19. A surgical retraction system for providing surgical retraction, comprising:

a frame having a periphery, a bottom surface, an opposing upper surface, and a periphery defining an interior surface, the frame including at least one anchor point extending therefrom for retaining a tissue retraction member, the frame flexible to conform to a patient's anatomy; and

a stabilizing member attached to the frame, the stabilizing member having a lower surface adhesively adhering to a skin of a patient or a surface overlying the skin of the patient to secure the frame, the stabilizing member extending inwardly along an entire periphery of the frame;

wherein the stabilizing member is configured to remain anchored to the surface of the anatomy while the frame deforms to conform to the patient's anatomy, wherein the system is configured such that the frame translates loads placed by a mono-directional retractor to the stabilizing member for distribution of the load.

20. The device of claim 19 , wherein the frame in a non-tensioned condition lies in a plane and has a first side and a second opposing side, the first and second sides bendable out of the plane.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2023
From: RICHARDS, ROBERT L.
To: BIOPHYX LLC
Reel/Frame 064506/0172 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2023
From: BIOPHYX LLC
To: BIOPHYX SURGICAL, INC.
Reel/Frame 064506/0341 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2023
From: MAGUIRE, STEPHEN
To: MEDDEV ADVISOR LLC
Reel/Frame 064506/0524 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2023
From: MEDDEV ADVISOR LLC
To: BIOPHYX SURGICAL, INC.
Reel/Frame 064506/0683 →
Continuity (3)
Provisional Application 63134782 · Jan 7, 2021
Provisional Application 63104569 · Oct 23, 2020
Related Publication 20230255611A1 · Aug 17, 2023
Cited By (2)
US 12,629,144 US 12,672,930