PRESHAPED BIOLOGIC SCAFFOLDS

Abstract

The present invention relates to biologic tissues, which are used to create cellular matrix scaffolds to help repair the body. The invention discloses two specific implant shapes that are pre-cut to address two separate pelvic floor prolapses (anterior and/or posterior). Additionally, the method of providing surgeries-specific pre-shaped biologic scaffolds is also claimed.

Claims

1. A pre-shaped biologic scaffold to repair various pelvic conditions comprising: a surgical implant, cut out of biological material, pre-cut with a shape suitable for a specific clinical purpose prior to packaging, wherein the shape is suitable for treating vaginal prolapse.

2. A surgical implant of claim 1, wherein the biological material undergoes a series of processing steps prior to packaging.

3. A surgical implant of claim 1, wherein the biological material is of human origins, such as donated or harvested human tissues.

4. A surgical implant of claim 1, wherein the biological material is of animal origin, such as, but not limited to, porcine, bovine, equine, or from fish tissues.

5. A surgical implant of claim 1, wherein the biological material is originated or derived from human, animal, or plant tissues.

6. A surgical implant of claim 1, wherein the specific shape is intended to address anterior pelvic organ prolapse.

7. A surgical implant of claim 1, wherein the specific shape is intended to address posterior pelvic organ prolapse.

8. A systems, devices, and methods for designing and producing pre-shaped biologic scaffold to repair various areas of the body comprising: a surgical implant, cut out of biological material, pre-cut with a shape suitable for a specific clinical purpose before final packaging.

9. A surgical implant of claim 8, wherein the biological material undergoes a series of processing steps prior to final packaging.

10. A surgical implant of claim 8, wherein the biological material is of human origin.

11. A surgical implant of claim 8, wherein the biological material is of animal origin, such as, but not limited to, porcine, bovine, equine, or:from fish origin.

12. A surgical implant of claim 8, wherein the biological material is derived from cells of biological origin such as human, animal, or plant.

13. A surgical implant of claim 8, wherein the specific shape is intended to address anterior pelvic organ prolapse.

14. A surgical implant of claim 8, wherein the specific shape is intended to address posterior pelvic organ prolapse.

15. A method of treating a patient, the method comprising: providing a surgical implant made of tissues of biological origin, the implant having a shape particularly suited for a specific surgery right out of its packaging, surgically implanting the implant.

16. A surgical implant of claim 15, wherein the tissues undergo a series of processing steps prior to final packaging.

17. A surgical implant of claim 15, wherein the tissues are derived from biological cells from human, animal, or plant origins.

18. The method of claim 15, wherein the implant is partially rimmed during the surgery, before, during, or after implantation.

19. The method of claim 15, wherein the method comprises treating a pelvic condition.

20. The method of claim 15, wherein the method comprises treating a vaginal prolapse condition.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views, together with the detailed description below, are incorporated in and form part of the specification and serve to illustrate further embodiments of concepts that include the claimed invention and explain various principles and advantages of those embodiments.

[0024] FIG. 1 is a front view of anterior pelvic prolapse implant cut out showing the new design.

[0025] FIG. 2 is a front view of a posterior view of pelvic prolapse implant cut out showing the new design.

[0026] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the features in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the present invention.

[0027] The apparatus and method components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

DETAILED DESCRIPTION

[0028] Detailed descriptions of the preferred embodiment are provided herein. However, it is to be understood that the present invention may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting but rather as a basis for the claims and a representative basis for teaching one skilled in the art to employ the present invention in virtually any appropriately detailed system, structure, or manner.

[0029] The terminology used herein describes particular embodiments only and is not intended to limit the invention. As used herein, the term “and” includes any combinations of one or more of the associated listed items. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well as the singular forms unless the context indicates otherwise. It will be further understood that the terms “comprises” and “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and components but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

[0030] The present invention relates to pre-shaped biological materials for implant applications. The process involves manufacturing/processing the biological product to pre-cut to a shape specific to a particular type of application prior to final packaging for commercial distribution.

[0031] The present invention is based on discovering new methods for obtaining a tissue graft (which may also be referred to herein as an “implant”). The method can be carried out, for example, by implanting a biocompatible scaffold (i.e., a three-dimensional, partially porous structure that fails to cause an acute reaction when implanted into a patient) into a mammal. The scaffold is implanted in direct contact with (i.e., physically touching over at least a portion of its external surface) or adjacent to (i.e., physically separated from the) mature or immature target tissue, for a period that is sufficient to allow cells of the target tissue to associate with the scaffold. The tissue graft includes the removed scaffold and the associated cells of the target tissue.

[0032] The biological tissues from various origins (human, animal, porcine, bovine, equine, or from fish) are created to create the implant in multiple application types (hernia, or pelvic organ prolapse). These biologics are processed to remove various components to ensure safety. Currently, these biologics are sent with either “as harvested” shape for human donor tissues or in a generally rectangular shape; the surgeon then needs to cut the implant to shape it for its particular application.

[0033] After the surgeon evaluates the specific requirements during surgery, the surgeon must cut the tissue into the desired shape. The surgeons bypass the implant cutting step during surgery, resulting in a shorter surgery duration.

[0034] Additionally, as the shapes are defined, it offers the potential to optimize the cutting to create more implants from a single piece of tissue, increasing overall yield from a precious limited-supply raw material such as donated human tissues.

[0035] As per its preferred embodiments, the current invention discloses a novel method of pre-shaped biologics material specifically for the anterior or posterior pelvic organ prolapse using pre-shaped biologics for implant applications.

[0036] By referring to figures, FIG. 1 shows the shape of an anterior pelvic prolapse implant cut out of biologics material by the manufacturer before packaging. FIG. 2 shows the shape of a posterior pelvic prolapse implant cut out of biologics material by the manufacturer before packaging.

[0037] The assembly is developed from biological sources. Tissue sources from which biologic scaffolds are chosen include both allografts, such as human-donated tissue, and xenograft, such as porcine (small intestine, dermis), bovine (pericardium, fetal, dermis), equine, or from fish tissues. Typically, the tissues are decellularized to remove DNA and other genetic materials and are provided in a generally rectangular shape.

[0038] While a specific embodiment has been shown and described, many variations are possible. With time, additional features may be employed. The particular shape or configuration of the platform or the interior configuration may be changed to suit the system or equipment with which it is used.

[0039] Having described the invention in detail, those skilled in the art will appreciate that modifications may be made to it without departing from its spirit. Therefore, it is not intended that the scope of the invention be limited to the specific embodiment illustrated and described. Instead, it is intended that the appended claims and their equivalents determine the scope of this invention.

[0040] The Abstract of the Disclosure is provided to allow the reader to ascertain the technical disclosure's nature quickly. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the preceding Detailed Description, it can be seen that various features are grouped in various embodiments to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Instead, as the following claims reflect, the inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.