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12/29/05 - USPTO Class 623 |  10 views | #20050288796 | Prev - Next | About this Page  623 rss/xml feed  monitor keywords

Native soft tissue matrix for therapeutic applications

USPTO Application #: 20050288796
Title: Native soft tissue matrix for therapeutic applications
Abstract: A product for implantation within a soft tissue site of the human or animal body comprises a pulverized or morselized matrix of a substantially non-mineralized native soft tissue (NSTM) of the human or animal body, provided in a therapeutic amount to induce growth of native tissue or organs and healing at the tissue site. The NSTM is composed of at least one soft tissue selected from the group consisting of cartilage, meniscus, intervertebral disc, ligament, tendon, muscle, fascia, periosteum, pericardium, perichondrium, skin, nerve, blood vessels, and heart valves or from organs such as bladder, lung, kidney, liver, pancreas, thyroid, or thymus. Preferably, the NSTM is composed of a soft tissue of the same type of tissue native to the repair site. In another embodiment, the NSTM includes soft tissue of a different type than the tissue repair site. (end of abstract)



Agent: Maginot, Moore & Beck Bank One Center/tower - Indianapolis, IN, US
Inventors: Hani Awad, Bradley T. Estes, Farshid Guilak
USPTO Applicaton #: 20050288796 - Class: 623023720 (USPTO)

Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Implantable Prosthesis, Tissue

Native soft tissue matrix for therapeutic applications description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20050288796, Native soft tissue matrix for therapeutic applications.

Brief Patent Description - Full Patent Description - Patent Application Claims
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BACKGROUND OF THE INVENTION

[0001] The present invention relates to the repair, replacement and/or regeneration of diseased or traumatized soft tissue.

[0002] Tissue and organ failure represents a major socioeconomic burden and has been estimated to cost the economy over $400 billion per year. Numerous approaches are being developed in an effort to promote the repair or regeneration of tissues or organs. Recent studies suggest that the introduction of autologous or allogeneic tissues, with or without the addition of biologically active molecules such as growth factors, may have the ability to promote new tissue formation and serve as a material for cellular infiltration and tissue repair in the body. For example, Urist and co-workers have shown the potential for the induction of bone in ectopic sites such as muscle by the implantation of demineralized bone powder. See, Urist et al., Bone formation in implants of partially and wholly demineralized bone matrix, Clin. Orthop. 71:271-8 (1970) (including observations on acetone-fixed intra and extracellular proteins). This approach served as the basis of the discovery of specific molecules present in the non-mineral portion of bone, termed "bone morphogenetic proteins", which have since been shown to be potent promoters of bone regeneration.

[0003] While this approach suggested by Urist et al. has proven valuable for applications involving bone regeneration and repair, a similar approach is not available for the repair of soft tissues such as cartilage, meniscus, intervertebral disc, muscle, tendon/ligament, blood vessels, nerve, or other tissues. The repair of these soft tissues following degeneration, disease, or injury remains a major challenge to the medical field. In particular, avascular tissues such as the cartilaginous tissues show little or no intrinsic repair capacity. It is believed that the directed repair of these tissues will require an approach that is enhanced by biomaterials and biologically active molecules.

[0004] In such cases, there is often a need to replace missing or damaged tissues with functional tissue replacements. The current state of the art typically involves the use of autologous tissue grafts, cryo-preserved or fresh allograft tissues, or the use of synthetic (metal, polymer) replacement materials. Autogenous tissue is often limited in availability and is generally associated with significant donor site morbidity. Fresh allograft tissues are associated with significant risks of disease transmission, while intact but radiation sterilized allografts suffer a loss of biomechanical function and generally do not support repopulation by the host's cells, and therefore show limited long-term success. See, e.g., Rasmussen et al., The effects of 4 Mrad of gamma irradiation on the initial mechanical properties of bone-patellar tendon-bone grafts, Arthroscopy, Apr. 10(2):188-97 (1994).

[0005] Synthetic implants, on the other hand, have a limited fatigue life and often introduce problems of wear or integration in the body. Previous approaches have also implanted intact allograft tissues, but have shown minimal host cell infiltration, and thus significant tissue necrosis and degradation occurs over time. Thus, there are no satisfactory approaches currently available for the long-term repair of soft tissue injury or disease.

SUMMARY OF THE INVENTION

[0006] One important aspect of the present invention is to process soft tissue from specific sites in the body in a manner that produces pulverized morsels of the soft tissue devoid of immunogenic material and pathogens but with intact aspects of the composition of the extracellular matrix proteins including the growth factors and cytokines that are responsible for tissue growth and cellular infiltration and differentiation. This pulverized soft tissue in the form of morsels, hereafter Native Soft Tissue Matrix or NSTM, may be implanted or injected at the needed site(s) in the body. Alternatively, the NSTM may be combined with other known biomaterials, which are biologic, synthetic or a combination of the two prior to therapeutic use. The resulting composite, taking the form of a slurry or paste, may then be implanted or injected at the needed site(s) in the body. Alternatively, the NSTM composite can be reconstituted as a tissue scaffold to promote the ex vivo regeneration of various tissues which can then be implanted in the body. The development of a variety of biomaterial matrices that are biologic, synthetic or a combination of the two based on specific tissues of the body will provide an efficient and effective approach for promoting tissue repair using either cellular or acellular approaches.

[0007] In a further aspect of the invention, the NSTM may also be used to deliver cells and/or additional, exogenously introduced biologically active molecules, such as growth factors, cytokines, chemokines, antibiotics, DNA, other molecules that may induce directed growth and/or differentiation of cells, or vectors capable of delivering bioactive therapeutic genes to the product.

[0008] The present invention introduces the use of a native soft tissue matrix in the form of morsels that can be used either as an acellular (non-viable) filler material or combined with viable elements (cells) and/or bioactive molecules to promote the repair or regeneration of diseased or traumatized soft tissues. In an important aspect of the invention, the soft tissue product is non-mineralized, meaning that it is derived from body tissues that are essentially non-mineral in nature. Thus, the soft tissue product of this invention excludes tissues such as bone and teeth as sources of the NSTM.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments described in the following written specification. It is understood that no limitation to the scope of the invention is thereby intended. It is further understood that the present invention includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles of the invention as would normally occur to one skilled in the art to which this invention pertains.

[0010] This invention disclosure describes a native soft tissue matrix (NSTM) that can be used either as an acellular (non-viable) matrix or combined with viable elements (cells) and/or bioactive molecules (growth factors (GF)) for use as an implantable product in repair/replacement/regeneration of diseased or traumatized soft tissue and/or tissue engineering applications.

[0011] The NSTM according to this invention is derived from the soft tissues of the body, potentially to repair/replace/regenerate the same tissues. The NSTM is substantially non-mineralized meaning that it consists essentially of tissues or organs other than bone, teeth or other mineralized biologic materials. Suitable soft tissues include, but not limited to, any of the following:

[0012] a) Cartilage

[0013] b) Meniscus

[0014] c) Intervertebral Disc (IVD)

[0015] d) Ligament

[0016] e) Tendon

[0017] f) Muscle

[0018] g) Fascia

[0019] h) Periosteum

[0020] i) Perichondrium

[0021] j) Pericardium

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Previous Patent Application:
Shapeable bone graft substitute and instruments for delivery thereof
Next Patent Application:
Controlled absorption biograft material for autologous tissue support
Industry Class:
Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor

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