Abstract:
Approaches for implanting a donor dermis (e.g., skin) in or on a patient body are provided. A device includes a piece of donor dermis and at least one tab formed in or on the donor dermis, wherein the tab is adapted for accepting a suture. A method includes manufacturing a device including a piece of donor dermis and at least one tab formed in or on the donor dermis, wherein the tab is adapted for accepting a suture. Another method includes fastening tissue using a device including a piece of donor dermis and at least one tab formed in or on the donor dermis, wherein the tab is adapted for accepting a suture.

Description:
CROSS REFERENCE 
     This application claims domestic priority to U.S. Provisional Patent Application No. 61/774,864, filed Mar. 8, 2013, the contents of which are incorporated by reference in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The invention generally relates to medical devices and associated methods of manufacture and use, and more particularly to donor dermis (e.g., skin) that is implanted in or on a patient body. 
     SUMMARY 
     In a first aspect of the invention, there is a device comprising: a piece of donor dermis; and at least one tab formed in or on the donor dermis, wherein the tab is adapted for accepting a suture. In embodiments, the at least one tab is a full thickness portion of the donor dermis. In other embodiments, the at least one tab is a partial thickness section of the donor dermis. In embodiments, the at least one tab has one end still connected to the donor dermis and can be pivoted to extend away from the donor dermis. In embodiments, the at least one tab is another section of donor dermis that is connected to the first section of donor dermis, e.g., by adhesive, suture, rivet, staple, etc. In embodiments, the at least one tab comprises a plurality of tabs. The plurality of tabs may be arranged in a predefined pattern on the donor dermis. The predefined pattern may correspond to location of a tissue of a patient body to which the donor dermis is to be attached. 
     In another aspect of the invention, there is a method of manufacturing a device comprising: a piece of donor dermis; and at least one tab formed in or on the donor dermis, wherein the tab is adapted for accepting a suture. In embodiments, the method comprises forming the tabs in the piece of donor dermis. 
     In another aspect of the invention, there is a method of fastening tissue using a device comprising: a piece of donor dermis; and at least one tab formed in or on the donor dermis, wherein the tab is adapted for accepting a suture. In embodiments, the method comprises suturing the at least one tab to subcutaneous tissue of a patient. In embodiments, the method comprises: suturing a first end of the donor dermis to a pectoral muscle of the patient; and suturing a second end of the donor dermis to a chest wall of the patient. 
     In another aspect of the invention, there is an implant device comprising a donor dermis with at least one tab as described herein. In additional aspects of the invention, there is a method of fastening tissue using a donor dermis with at least one tab as described herein. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The present invention is described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention. 
         FIGS. 1 a , 1 b , and 1 c    show aspects of a donor dermis with dermal tabs in accordance with aspects of the invention; and 
         FIG. 2  shows an exemplary implant of a donor dermis with dermal tabs in accordance with aspects of the invention. 
     
    
    
     DETAILED DESCRIPTION 
     The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the present invention may be embodied in practice. 
     In accordance with aspects of the invention,  FIGS. 1 a  and 1 b    show a portion of donor dermis  10  that is modified by creating at least one tab  15  in the donor dermis  10  from a section of the donor dermis  10  (also referred to as donor allograft, donor allograft dermis, and allograft dermis). The tab  15  may be mechanically created by cutting a full or partial thickness section of the donor dermis  10  to create a hinged flap of the donor dermis  10 . Embodiments thus include creating a tab  15  (full or partial thickness) on the existing allograft dermis  10  mechanically. As shown in  FIG. 1 b   , the tab  15  may be a full thickness cut of the donor dermis  10 , in which case a hole  17  is created entirely through the thickness of the main layer  18  of the donor dermis  10 . As also shown in  FIG. 1 b   , the tab  15 ′ may be a partial thickness cut of the donor dermis  10 , in which case a hole  17 ′ is created through less than the entire thickness of the main layer  18  of the donor dermis  10 . The tab  15  can stick up or be flush that comes up with a little teasing. Alternatively, the tab  15  can be a thicker area of dermis that is cut in relief by removing surrounding tissue to create a small mound of dermis to grab. Alternatively, a separate small piece of dermal tissue can be adhered (sewn, glued, fixed) to the allograft dermis  10  to create the tab  15 ″, as depicted in  FIG. 1 c   . The tabs  15  can be a multitude of sizes and or shapes or numbers of them on the donor allograft  10 . 
       FIG. 2  shows an exemplary implant of a donor dermis  10  with dermal tabs  15  in accordance with aspects of the invention. An advantage of the donor dermis  10  with dermal tabs  15  is the ability to safely place a suture  20  between the dermal tab  15  and a subcutaneous skin layer  25 . Stitching sutures  20  through the tabs  15  instead of through the main layer  18  of the donor dermis  10  advantageously decreases the chance of accidentally puncturing something (such as a tissue expander  30  that is behind the donor dermis  10  in the patient body) during the stitching. By placing a “quilting” stitch  20  between these two layers  18  and  25 , the chance of fluid/blood build up between the two layers  18  and  25  is lessened because the two layers are forced to become intimate by the stitch. Additionally, the allograft dermis  10  will be ingrown by the host tissue from the host dermis (e.g., layer  25 ) which it is touching. For the host (e.g., layer  25 ) to grow into the allograft dermis  10 , it is advantageous for it to be in intimate contact and not experience shear forces or other movement between the layers  18  and  25 . The dermal tab  15  serves as a mechanical joining by suture of these two layers  18  and  25 . 
     By having the tab  15  it becomes much easier the grab the allograft dermis  10  with a needle without fear of poking something behind the allograft dermis  10 , such as a tissue expander  30  in the breast or bowel when fixing a hernia. 
     Also, suturing the allograft dermis  10  to the subcutaneous skin (e.g., layer  25 ) may quicken the in-growth of the host into the donor dermis  10  because of the stability from shear and potential of fluid separation of the layers. This would be very helpful for patients. 
     In embodiments, and as shown in  FIGS. 1 a , 1 b   , and  2 , the dermal tabs  15  are formed in the donor dermis  10  by cutting, punching out, etc. Each tab  15  is left attached to the donor dermis  10  during the tab-forming process, e.g., one end of the tab  15  is uncut at the donor dermis  10 , e.g., as shown at location  40 . The tabs  15  can be moved relative to the donor dermis  10 , e.g., pivoted to extend outward from the donor dermis  10  with the one end of the tab  15  still attached to the donor dermis  10 . The tab  15  can be used as a portion of the donor dermis  10  to pass a needle  35  and suture  20  through for the purpose of suturing the donor dermis  10  to a part of a patient body, e.g., the patient subcutaneous tissue  25 , e.g., in the breast skin/dermis of the patient when implanting a tissue expander  30  in the patient. Ends of the donor dermis  10  may be sutured to the pectoral muscle  43  and/or the chest wall  45  without using tabs  15 , e.g., as shown at sutures  50 . 
     The donor dermis  10  may initially be a section of skin that is removed from (e.g., cut from) an organ or tissue donor, as is understood by those of skill in the art. A plurality of tabs  15  may be formed in a single section of donor dermis  10 . The plural tabs  15  may be formed in a predefined pattern in the donor dermis  10  to optimize the locations for attachment to the patient, e.g., to optimize the locations at which the donor dermis  10  is sutured to the subcutaneous tissue. In addition to a predetermined pattern, the tabs  15  may be formed in any suitable size and shape, and any desired number of tabs may be used. 
     Embodiments of the invention include a donor dermis having one or more tabs as described herein. Further embodiments of the invention include a method of manufacturing a donor dermis having one or more tabs as described herein. Even further embodiments of the invention include a method of implanting in a patient a donor dermis having one or more tabs as described herein. 
     It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.