Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone
Reexamination Certificate
1998-12-15
2001-05-15
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Bone
C623S902000, C604S264000
Reexamination Certificate
active
06231613
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods for soft tissue augmentation in mammals generally and humans in particular. In these methods, a composition comprising a biocompatible polymer and a biocompatible solvent is delivered to the tissue of a mammal.
The biocompatible polymer is selected to be soluble in the biocompatible solvent, but insoluble in the tissue. The biocompatible solvent is miscible or soluble in the fluids of this tissue and, upon contact with such fluids, the biocompatible solvent quickly diffuses away whereupon the biocompatible polymer precipitates to augment the tissue at the delivery site in the mammal.
REFERENCES
The following publications are cited in this application as numbers in brackets ([ ]):
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The disclosure of each of the above publications is herein incorporated by reference in its entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated herein by reference in its entirety.
2. State of the Art
Soft tissue augmentation to correct defects and counteract the effects of aging is becoming increasingly important. Currently, soft tissue augmentation may be achieved by the use of such means as injectable collagen, fat injections, silicone injections, insertion of shaped polyethylene based plugs, insertion of hollow-shaped tubes composed of expanded polytetrafluoroethylene or the injection of hydrogel based polymer compositions [1,31].
The ideal material for soft tissue augmentation would have the following properties: it must not be capable of causing a chronic inflammatory response or foreign body reaction; it must not be immunogenic or carcinogenic over time; its physical properties (compressibility, stress resistance, compressive strength, etc.) must appropriately match the local tissue environment at the delivery site; it should be possible to contour the material to the desired shape for augmentation; it should be non-resorbable; it should be available in adequate quantities; it should not degrade in the body and should be sufficiently durable that it does not wear out or generate particles that could cause an inflammatory response over time; it should remain in position and should not migrate from the implantation site; it should not change in shape or volume over time; and it should be cost effective [2].
Injectable collagen has been used extensively for soft tissue augmentation [3-8,10-16]. It has been used for filling wrinkles, earlobe and lip augmentation, correction of scarring, treatment of glottic insufficiency, rehabilitating the vocal folds and larynx, correction of atrophies, correction of contour deficiencies, and the like.
However, when using collagen for soft tissue augmentation, overcorrection (i.e., injection of more material than just the amount needed to fill a defect) is needed due to rapid resorption of the liquid carrier which represents a large percentage of the injected volume [3,11,13]. Hypersensitivity, including erythema, induration and possibly pruritis, may also be a problem [4,10,12-15] and an association between collagen implants and autoimmune diseases such as dermatomyositis has been shown [7,10]. Granulomatous reactions to collagen implants have been observed [8], as have abscess formation and local necrosis [9,10]. Collagen injection to the vocal folds has resulted in chronic inflammation of the larynx [ 11 ]. In some cases, correction of atrophy using collagen injection has resulted in an unacceptable pustulous appearance [16]. In addition to the above, collagen is bioabsorbed in vivo a
Greff Richard J.
Silverman David E.
Stein Alan
Enteric Medical Technologies, Inc.
Flehr Hohbach Test Albritton & Herbert LLP
Isabella David J.
Koh Choon P.
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