Collagen compositions and uses for biomaterial implants

a biomaterial and composition technology, applied in the field of collagen compositions, can solve the problems of poor recipient site, poor tissue regeneration, graft failure, etc., and achieve the effects of promoting tissue regeneration, reducing scar formation, and promoting graft integration

Inactive Publication Date: 2016-09-15
MAM HLDG OF WEST FLORIDA L L C
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0017]It has been established that collagen, or collagen-containing compositions, promote tissue regeneration, reduce scar formation, and promote graft integration. Compositions and methods of use for collagen-containing biomaterials include Type I collagen and Type III collagen in an amount effective to promote wound healing at a site of surgery, injury, or wound relative to an untreated control. Methods of using the collagen compositions for tissue repair, or tissue augmentation in dermal filling, skin grafting, and hair grafting are also provided.

Problems solved by technology

Unfortunately, many synthetic, non-degradable dermal fillers such as calcium hydroxyapatite (e.g. RADIESSE®, Merz Pharmaceuticals GmbH) and Poly-L-Lactic Acid (PLLA, e.g SCULPTRA®, Valeant, West Laval, QC, Canada), have been shown to form granulomas (Jacovella, P F, Clin Intery Aging.
Skin grafting may be unsuccessful for numerous reasons.
Movement of the graft or shear forces may also lead to graft failure through disruption of the fragile attachment of the graft to the wound bed.
Another common source of failure is a poor recipient site.
The wound may have poor vascularity, or the surface contamination may have been too great to allow graft survival.
Some of the challenges of hair transplantation include the loss of some implanted grafts and limited hair growth (Parsley, W M et al., J Cutan Aesthet Surg.
It has been noted that at least one principal obstacle to good hair growth is the lack of vascularity.
If the graft does not receive adequate nutrition, it will greatly reduce the survival of the implanted hairs.
For example, a mismatch of size between the graft and recipient site is thought to play a negative role in hair survival.
In addition, dehydration of the graft, which may occur in times as short as 5 minutes, can have a detrimental effect on graft survival.
Other challenges associated with hair transplantation include the appearance of scars in the donor hair graft region.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Manufacture of a Skin Material

[0305]Collagen is extracted according to the preparations described. However, collagen obtained by methods described above or any other methods know to one skilled on the art is used. The composition of the collagen includes 0.3% lidocaine and has a ratio of 70% Type III collagen to 30% Type I collagen.

[0306]The collagen layer is then sterilized immediately before being joined to the skin layer. In this procedure, the collagen layer is frozen at a temperature of −20° C. Then, the collagen layer is treated with 8kGy of radiation, resulting in a sterility assurance level of 106 SAL for the collagen layer. The collagen is thawed to room temperature and a thin layer of the collagen is applied to the dermal side of a harvested skin section. The harvested skin is autologous and is a split-thickness graft that has been shaped to approximate the shape of the wound.

[0307]Alternatively, the placental collagen used in the manufacture of the skin material contains ...

example 2

Skin Material with Growth Factor

[0308]The skin material is prepared according to Example I. However, before terminal sterilization, EGF is added to the collagen layer. The EGF is effective to further increase the rate of healing of the wound than occurs using the skin graft of Example 1.

example 3

Applying the Skin Material to the Wound

[0309]The skin material, as prepared in Example 1, consists of the collagen layer and the harvested skin layer. The skin material is placed on the surface of a cleaned wound. The appropriate dressing is provided such that the wound heals and is protected from the environment or physical disturbances. The graft is periodically checked to ensure proper healing, adherence to the recipient tissue and drainage. The skin layer adheres well to the recipient tissue and is as strong and supple as the surrounding skin, due to the presence of the collagen.

[0310]In an alternative procedure, the collagen layer and harvested skin is applied in two separate steps to the wound. A thin layer of sterile collagen as prepared according to Example 1 is applied across the surface of a debrided wound. An autologous, split-thickness graft shaped in the form of the wound is applied dermal side to the surface of the wound.

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Abstract

Compositions containing purified collagen biomaterial derived from tissues, for example, insoluble amnion, soluble amnion, soluble chorion of the human placenta, are provided. The collagen compositions can be used to promote wound healing, promote tissue regeneration, prevent or reduce scarring, reduce local inflammation, minimize tissue rejection, promote graft integration. Methods for using the collagen composition as a biomaterial implant for dermal filling, skin grafting, and hair transplantation are also provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims benefit of U.S. Provisional Application No. 62 / 132,571, filed Mar. 13, 2015, and U.S. Provisional Application No. 62 / 132,559, filed Mar. 13, 2015, which are incorporated by reference in their entirety.FIELD OF THE INVENTION[0002]The invention relates generally to collagen compositions and methods of use in tissue regeneration and tissue augmentation, particularly in areas of dermal filling, skin grafting and hair transplantation.BACKGROUND OF THE INVENTION[0003]All materials intended for application in humans as biomaterials undergo tissue responses when implanted into living tissue. These responses involve wound healing responses, inflammatory, foreign body reactions, and fibrous encapsulation of the biomaterial.[0004]One area of great interest in the use of biomaterial is dermal filling. A dermal filler is a soft tissue filler injected into the skin to help fill in facial wrinkles, restoring a smoother appearance...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61L27/24A61L27/54A61K45/06A61K38/39A61K35/50
CPCA61L27/24A61K38/39A61K35/50A61L2430/34A61L27/54A61L2430/18A61K45/06A61L27/3604A61L2400/06A61L2430/40A61L27/362A61L27/3687A61L27/3804A61L27/60
Inventor HARRELL, CARL RANDALL
Owner MAM HLDG OF WEST FLORIDA L L C
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