GB2562726B

GB2562726B - Acellular tissue matrix with projecting barbs

Info

Publication number: GB2562726B
Application number: GB1708136.5A
Authority: GB
Inventors: Pieri Andrew
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-05-21
Filing date: 2017-05-21
Publication date: 2019-06-19
Anticipated expiration: 2037-05-21
Also published as: GB2562726A; GB201708136D0

Description

TITLE: Acellular tissue matrix with projecting barbs

BACKGROUND OF THE INVENTION 1. Field of invention

The present invention relates generally to facilitating the vascularisation and incorporation of acellular tissue matrices by means of providing continuous contact with host tissue. 2. Description of the related art

Following mastectomy, patients increasingly undergo cosmetic breast reconstruction surgery. This is often achieved by performing a skin-sparing mastectomy and inserting a prosthetic (often silicone-based) implant to replace the volume and shape of the excised breast tissue. Placing an implant directly underneath the subcutaneous tissue can lead to poor cosmetic results as the texture of the implant can be seen or palpated through the relatively thin layer of subcutaneous tissue and skin overlying it (a phenomenon known as "rippling"). In order to reduce this, the thickness of overlying tissue can be increased by inserting a sheet of acellular tissue matrix between the subcutaneous tissue and the implant. This sheet becomes vascularised and incorporated into the patient's subcutaneous tissue, increasing its thickness and subsequently reducing rippling. Acellular tissue matrices can be derived from animal or human tissue, examples of which are Braxon RTM (Deco Med, Italy), Veritas RTM (Synovis Surgical Innovations, USA) and Strattice TM (Allergan, Ireland). A significant complication of using an acellular dermal matrix device is that it can fail to vascularise and incorporate with the adjacent host tissue. The cause of incorporation failure is multifactorial. However, movement of the acellular tissue matrix or complete loss of contact with subcutaneous host tissue (often due to seroma fluid) are certainly significant contributors.

Accordingly, there exists a need for an acellular tissue matrix device that can grip to the subcutaneous tissue and chest wall surfaces, in order to maintain continuous contact and thus aid vascularisation and incorporation.

In inguinal hernia surgery, mesh devices have been used for a number of years to reinforce the hernia defect. Most mesh devices are sutured in to place by the surgeon in order to prevent dislocation. ProGrip (Covidien, USA) comprises a mesh with barbs on one side, such that the mesh adheres to the underlying tissue, eliminating the necessity to manually suture the mesh in to place. In the context of hernia surgery, it has been reported that the adhesion is "substantially stronger than using fibrin glue" offering "immediate fixation" to the underlying tissue.

SUMMARY AND OBJECTS OF THE INVENTION

The principle object of the present invention is to provide an acellular tissue matrix based device that can effectively maintain continuous contact with the host tissue.

It is also an object of the invention to provide a device that can be used to minimise scar tissue formation during the process of wound/tissue healing.

It is another object of the invention to provide a device that is relatively easy to use, with minimal or no learning curve.

DESCRIPTION OF DRAWINGS FIG. 1 is a perspective schematic of the device in accordance with the principles of the present invention. FIG. 2 is a plane view of the device in FIG. 1, demonstrating single and double sided barb versions of the device of the present invention. FIG. 3 is an illustration of various barb heads suitable for use with the device of the present invention. FIG. 4 is a schematic plane view of the present device with barbs on a single surface, shaped around a silicone breast implant lying between the subcutaneous tissue and the chest wall. FIG. 5 is a schematic of the device with barbs on both surfaces placed between the subcutaneous tissue and chest wall in simple mastectomy surgery. FIG. 6 illustrates an embodiment of the device in which the barbs are in continuity with each other.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to various embodiments of the disclosed devices and methods, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of "or" means "and/or" unless stated otherwise. Furthermore, the use of the term "including", as well as other forms, such as "includes" and "included", is not limiting. Any range described herein will be understood to include the endpoints and all values between the endpoints.

The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

The illustrations in FIG. 4 and 5 are example uses of the disclosed device and are not to be construed as the extent of the intended device application.

The present disclosure relates generally to devices for surgical procedures and systems and methods relating to such devices. The devices can be used for breast augmentation, repair or regeneration of damaged tissue including breast reconstruction, correction of tissue defects and closure of potential space. As such, the devices, systems, and methods discussed herein can be suitable for a wide range of surgical applications, including but not limited to aesthetic surgery, breast reconstruction, augmentation and mastopexy and revision surgery.

With reference to FIG. 1 and 2, the device 10, illustrates an acellular tissue matrix device designed to grip at least one human tissue surface. An example of this application is when using an acellular tissue matrix to contain a prosthetic breast implant. The tissue gripping barbs 12 aim facilitate the incorporation and vascularisation of the acellular tissue matrix due to improved contact with the host tissue and also to reduce the risk of movement or rotation of the contained implant.

Device 10 is comprised of a sheet 11 of acellular tissue matrix with a plurality of barbs 12 distributed across at least one side of the sheet 11 projecting there from to facilitate continuous contact between the sheet 11 and the host tissue.

The sheet 11 can be comprised of a variety of different forms of acellular dermal matrices. For example, in certain embodiments the sheet 11 may be formed from Braxon RTM (Deco Med, Italy) or Strattice TM (LifeCell, USA) which are both derived from porcine dermis, AlloDerm TM (LifeCell, USA) which is manufactured from human dermis or Veritas RTM (Synovis Surgical Innovations, USA) which is derived from bovine pericardium. Alternatively, sheet 11 may be manufactured from a biocompatible synthetic matrix, which may be designed as a biological scaffold for tissue integration.

In certain embodiments, the sheet 11 may comprise of an acellular tissue matrix with at least one additional layer of material such as hydrogels, softgels, polyurethane or other biocompatible polymers known in the art, which may be manufactured to possess bioadhesive properties. The biocompatible polymer may contain or be coated in an antibacterial, anaesthetic or other therapeutic drug, such as vascular endothelial growth factor.

The sheet 11 may contain or be coated with an antibacterial, anaesthetic or other therapeutic drug, such as vascular endothelial growth factor.

In certain embodiments, the sheet 11 may contain or be coated with a biocompatible adhesive glue, such as but not limited to a fibrin sealant device. This applies to the acellular tissue matrix layer, or applies to any additional layer as afore mentioned.

The sheet 11 may be manufactured into any two or three dimensional shape including flat, tubular, or specifically shaped in order to serve a specific function. For example, Braxon RTM is specifically shaped to enclose a breast implant, designed for pre-pectoral implantation; AlloDerm TM is preshaped, designed for sub-pectoral reconstructions.

The sheet 11 may be solid but also can be perforated or fenestrated in order to allow fluid to pass freely across the tissue and allow two or more tissue surfaces to come into contact.

The barbs 12 are comprised of a biocompatible material such as the polymers of p-dioxanone, polyglycolides, polyorthoesters, polymers of trimethylene carbonate, stereocopolymers of L-lactic acid and D-lactic acid, homopolymers of L-lactic acid, copolymers of lactic acid and a compatible comonomer, such as derivatives of alpha-hydroxy acids or any other biocompatible polymer known in the art.

The barbs 12 may contain or be coated with an antibacterial, anaesthetic or other therapeutic drug, such as vascular endothelial growth factor.

In certain embodiments, the barbs 12 may be coated with a biocompatible adhesive glue, such as but not limited to a fibrin sealant device. A plurality of barbs 12 are present on at least part of at least one surface of the sheet 11.

In certain embodiments, the barbs 12 may be connected to other barbs by way of a yam running along the opposite surface of the sheet 11, with the barbs 12 perforating the sheet. An example is illustrated in FIG. 6.

The yarn may be comprised of one or more of polypropylene, polymers of p-dioxanone, polyglycolides, polyorthoesters, polymers of trimethylene carbonate, stereocopolymers of L-lactic acid and D-lactic acid, homopolymers of L-lactic acid, copolymers of lactic acid and a compatible comonomer.

The barb head 13 is comprised of a biocompatible material such as polypropylene, polymers of p-dioxanone, polyglycolides, polyorthoesters, polymers of trimethylene carbonate, stereocopolymers of L-lactic acid and D-lactic acid, homopolymers of L-lactic acid, copolymers of lactic acid and a compatible comonomer, such as derivatives of alpha-hydroxy acids or any other biocompatible polymer known in the art.

The barb head 13 is shaped such to maximise tissue adhesion, examples of which are illustrated in FIG. 3.

Claims

CLAIMS I claim:

1. An acellular tissue matrix device that grips to at least one human tissue surface, comprising: a sheet of acellular tissue matrix with a top surface and bottom surface, with an integrated plurality of barbs distributed across at least a portion of at least one of the two surfaces of the sheet, projecting there from in order to grip to host tissue.

2. The device of claim 1, wherein the tissue matrix comprises a tissue matrix derived from porcine tissue.

3. The device of claim 1, wherein the tissue matrix comprises a tissue matrix derived from human tissue.

4. The device Of claim 1, wherein the tissue matrix comprises a tissue matrix derived from bovine tissue.

5. The device of claim 1, wherein the tissue matrix comprises a tissue matrix derived from dermal tissue.

6. The device of claim 1, wherein the tissue matrix is either solid, perforated or fenestrated.

7. The device of claim 1, wherein the tissue matrix can be shaped for a specific application.

8. The device of claim 1, wherein the acellular tissue matrix contains or is coated with vascular endothelial growth factor, an antibacterial or anaesthetic agent.

9. The device of claim 1, with an additional material layer covering at least a portion of at least one surface of the acellular tissue matrix.

10. The device of claim 9, wherein the additional material layer is comprised of a biocompatible polymer.

11. The device of claim 10, wherein the biocompatible polymer contains or is coated in an antibacterial, anaesthetic or bioadhesive agent.

12. The device of claim 1, wherein the barbs comprise a biocompatible polymer.

13. The device of claim 12, wherein the biocompatible polymer is selected from one or more of polypropylene, polymers of p-dioxanone, polyglycolides, polyorthoesters, polymers of trimethylene carbonate, stereocopolymers of L-lactic acid and D-lactic acid, homopolymers of L-lactic acid, copolymers of lactic acid and a compatible comonomer.

14. The device of claim 1, wherein the barbs may be connected to at least one other barb by multiple yarns running along the opposite surface of the acellular tissue matrix, perforating the tissue matrix at various point to form the barbs.

15. The device of claim 1, wherein the barbs may contain or be coated with vascular endothelial growth factor, an antibacterial, anaesthetic or bioadhesive agent.