Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Hollow or tubular part or organ
Reexamination Certificate
1997-08-15
2001-01-09
Nguyen, Dinh X. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Hollow or tubular part or organ
C623S023660, C623S023710, C623S023720, C623S023740, C623S023760, C188S074000
Reexamination Certificate
active
06171344
ABSTRACT:
BACKGROUND OF THE INVENTION
Reconstructive surgery has been used for many years for the treatment of congenital tissue defects and for repair of damaged organs and tissues. An ideal material for tissue reconstruction should be biocompatible, able to incorporate into the native tissue without inducing an adverse tissue response, and should have adequate anatomical and functional properties (for example, size, strength, durability, and the like). Although a large number of bio-materials, including synthetic and naturally-derived polymers, have been employed for tissue reconstruction or augmentation (see, e.g., “Textbook of Tissue Engineering” Eds. Lanza, R., Langer, R., and Chick, W., ACM Press, Colorado (1996) and references cited therein), no material has proven satisfactory for use in every application.
For example, in the field of bladder reconstruction, synthetic biomaterials such as polyvinyl and gelatin sponges, polytetrafluoroethylene (Teflon) felt, and silastic patches have been relatively unsuccessful, generally due to foreign body reactions (see, e.g., Kudish, H. G.,
J. Urol.
78:232 (1957); Ashkar, L. and Heller, E.,
J. Urol.
98:91 (1967); Kelami, A. et al.,
J. Urol.
104:693 (1970)). Polymeric materials have been used as “scaffolds” for seeding cells; the seeded scaffolds can be implanted to provide a matrix for the growth of new tissue (see, e.g., Atala, A. et al.,
J. Urol.
148 (2 Pt 2): 658-62 (1992); Atala, A., et al.
J. Urol.
150 (2 Pt 2): 608-12 (1993)). Naturally-derived materials such as lyophilized dura, de-epithelialized bowel segments, and small intestinal submucosa (SIS) have also been proposed for bladder replacement (for a general review, see Mooney, D. et al., “Tissue Engineering: Urogenital System” in “Textbook of Tissue Engineering” Eds. Lanza, R., Langer, R., and Chick, W., ACM Press, Colorado (1996)).
It has been reported that bladders augmented with dura, peritoneum, placenta and fascia contract over time (Kelami, A. et al.,
J. Urol.
105:518 (1971)). De-epithelized bowel segments demonstrated an adequate urothelial covering for use in bladder reconstruction, but difficulties remain with either mucosal regrowth, segment fibrosis, or both. It has been shown that de-epithelization of the intestinal segments may lead to mucosal regrowth, whereas removal of the mucosa and submucosa may lead to retraction of the intestinal segment (see, e.g., Atala, A.,
J. Urol.
156:338 (1996)).
Xenogenous porcine SIS has been used recently with favorable results (e.g., Kropp, B. P. et al,
Urology
46:396 (1995)). This biodegradable collagen-rich xenogenic membrane had been previously studied as a potential material for vascular grafts (see, e.g., Hiles et al.,
J. Biomed. Materials Research
27:139 (1993)). However, SIS may be limited by the maximum size the graft can cover, which may not be sufficient for bladder replacement.
Other problems have been reported with the use of certain gastrointestinal segments for bladder surgery, including infection, perforation, stone formation, metabolic derangements and instances of tumor development. Formalin-preserved sections of bladder have been used for bladder reconstruction (see, e.g., Tsuji et al.,
J. Urol.
98:91 (1967)). However, the use of the formalin-preserved material generally did not result in effective long-term treatment.
Polymeric and naturally-derived “scaffolds” have also been used to support the regrowth of bone into bone defects (see, e.g., U.S. Pat. Nos. 5,112,354 and 4,172,128; for a general review, see Yaszemski, M. J.; et al.,
Biomaterials
17 (2): 175-85 (1996) and references cited therein). Bone-derived collagen implants have been used for bone repair. However, these materials do not always provide the requisite strength, flexibility, or non-immunogenicity needed for long-term repair of bone.
SUMMARY OF THE INVENTION
The present invention relates to materials and methods for repairing or augmenting tissues. More particularly, the invention relates to methods for tissue reconstruction or repair using bladder submucosa, to methods for preparing bladder submucosa segments suitable for use in tissue reconstruction or repair, and to materials for use in tissue reconstruction or repair. The invention also relates to the use of isolated bladder submucosa seeded with cells for repair, reconstruction, or augmentation of tissues or organs.
In one aspect, the invention provides a method for augmenting a tissue of a subject. The method includes the step of augmenting the tissue of the subject with isolated bladder submucosa seeded with cells. In preferred embodiments, the isolated bladder submucosa is seeded with cells of a type found in the tissue of the subject. The tissue of the subject can be bladder tissue. The isolated bladder submucosa can be allogenic bladder submucosa or xenogeic bladder submucosa. The isolated bladder submucosa seeded with cells can further include a growth factor for promoting growth of the tissue. The subject can be a mammal, including a human.
In another embodiment, the invention provides a method for repairing a damaged tissue, the method comprising contacting the damaged tissue with isolated bladder submucosa seeded with cells, under conditions such that growth of the tissue occurs, such that the damaged tissue is repaired. In certain embodiments, the damaged tissue is bladder tissue.
In another embodiment, the invention provides a method for increasing bladder capacity of a subject having a bladder. The method includes surgically grafting isolated bladder submucosa to the bladder of the subject, such that the bladder capacity is increased.
In another aspect, the invention provides a material for reconstruction, repair or augmentation of a subject's tissue. The material comprises isolated bladder submucosa seeded with cells. In certain embodiments, the isolated bladder submucosa is obtained from whole bladder tissue by microdissection; the isolated bladder submucosa can optionally be further treated to ensure an acellular material is obtained. In certain preferred embodiments, the isolated bladder submucosa has first and second surfaces and is seeded with urothelial cells on the first surface and is seeded with muscle cells on the second surface; this material is especially useful for bladder reconstruction, augmentation, and repair.
In another aspect, the invention provides a method for preparing a material which comprises isolated bladder submucosa seeded with cells. The method comprises obtaining isolated bladder submucosa and seeding the isolated bladder submucosa with cells. In preferred embodiments, the isolated bladder submucosa is obtained from whole bladder tissue by microdissection; the isolated bladder submucosa can optionally be further treated to ensure an acellular material is obtained. In certain preferred embodiments, the isolated bladder submucosa has first and second surfaces and the step of seeding the isolated bladder submucosa with cells comprises seeding the isolated bladder submucosa with urothelial cells on the first surface and with muscle cells on the second surface. The method can optionally include the further step of adding a growth factor to the isolated bladder submucosa.
REFERENCES:
patent: 4172128 (1979-10-01), Thiele et al.
patent: 5112354 (1992-05-01), Sires
patent: 5275826 (1994-01-01), Badylak et al.
patent: 5352463 (1994-10-01), Badylak et al.
patent: 5554389 (1996-09-01), Badylak et al.
patent: 5645860 (1997-07-01), Knapp, Jr. et al.
patent: 5654273 (1997-08-01), Gallo et al.
patent: 5711969 (1998-01-01), Patel et al.
patent: 5753267 (1998-05-01), Badylak et al.
patent: 5755791 (1998-05-01), Whitson et al.
patent: 5762966 (1998-06-01), Knapp, Jr. et al.
patent: WO 9000395 (1990-01-01), None
patent: WO 9305798 (1993-04-01), None
patent: WO 9307913 (1993-04-01), None
patent: WO 9631226 (1996-10-01), None
patent: WO 9631232 (1996-10-01), None
Ashkar, L. and Heller, E., “The Silastic Bladder Patch,”J. Urol., vol. 98, No. 6, 679-83 (1968).
Atala, A., “Commentary on the Replacement of Urologic Associated Mucosa,”J. Urol., vol. 15
Children's Medical Center Corporation
Lahive & Cockfield LLP
Nguyen Dinh X.
LandOfFree
Bladder submucosa seeded with cells for tissue reconstruction does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Bladder submucosa seeded with cells for tissue reconstruction, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Bladder submucosa seeded with cells for tissue reconstruction will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2496625