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Tissue prosthesis and a method of, and equipment for, forming a tissue prosthesis

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Tissue prosthesis and a method of, and equipment for, forming a tissue prosthesis


A tissue prosthesis 100 comprises an envelope 38 of a biologically inert, elastically deformable material capable of being expanded to conform to an interior surface of a cavity 36 formed at a site 10 in a patient's body. A filler material 60 is received in a fluent state in the envelope 38. The filler material 60 is of the same class of material as the envelope 38 to form, when cured, together with the envelope 38, a unified structure.
Related Terms: Fluent

Browse recent Spinecell Private Limited patents - Kogarah, AU
Inventors: ASHISH D. DIWAN, ZORAN MILIJASEVIC, JOHNATHON CHOI, SANDRA FISHER
USPTO Applicaton #: #20120290095 - Class: 623 1716 (USPTO) - 11/15/12 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Implantable Prosthesis >Bone >Spine Bone >Including Spinal Disc Spacer Between Adjacent Spine Bones

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The Patent Description & Claims data below is from USPTO Patent Application 20120290095, Tissue prosthesis and a method of, and equipment for, forming a tissue prosthesis.

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CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of International Application No. PCT/AU2006/001176, filed on Aug. 15, 2006, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/708,670, filed on Aug. 15, 2005, the full disclosures of which are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to the repair of tissue in a body and, more particularly, to a method of, and equipment for, forming a tissue prosthesis in situ and to a tissue prosthesis. The invention has particular, but not necessarily exclusive, application in the field of minimally invasive intervertebral disc nucleus repair.

Joints of the musculoskeletal system of the human or animal body rely on the presence of healthy cartilaginous tissue for proper operation. Cartilaginous tissue can degenerate due to a number of causes, eg. age or injury. Degradation of the tissue can reach a point where movement can cause severe discomfort and pain.

In the case of the spinal column, it comprises a series of 26 mobile vertebral bones or vertebrae connected by 75 stable articulations that control motion. The vertebrae are generally divided into posterior and anterior elements by thick pillows of bone called pedicles. The anterior element of the vertebra is a kidney shaped prism of bone with a concavity directed posteriorly and has flat superior and inferior surfaces called end plates. An intervertebral disc is sandwiched between adjacent pairs of vertebrae forming a joint between the adjacent pair of vertebrae. These discs are viscoelastic structures comprising a layer of strong deformable soft tissue. The intervertebral discs are subjected to a considerable variety of forces and moments resulting from the movements and loads of the spinal column. Each intervertebral disc has two components being the annulus fibrosis circumscribing a nucleus pulposus. The intervertebral disc cooperates with the end plates of the vertebrae between which it is sandwiched.

The primary function of the nucleus pulposus of the disc is to give the disc its elasticity and compressibility characteristics to assist in sustaining and transmitting weight. The annulus fibrosis contains and limits the expansion of the nucleus pulposus during compression and also holds together successive vertebrae, resisting tension and torsion in the spine. The end plates of the vertebrae are responsible for the influx of nutrients into the disc and the efflux of waste products from within the disc.

With age or injury, a degenerative process of the disc may occur whereby its structures undergo morphological and biological changes affecting the efficiency with which the disc operates. Thus, the nucleus pulposus may reduce in volume and dehydrate resulting in a load reduction on the nucleus pulposus, a loss in intradiscal pressure and, hence, additional loading on the annulus fibrosis. In a normally functioning disc, the intradiscal pressure generated results in deformation of the end plates of the adjacent vertebrae generating the natural pumping action which assists in the influx of the nutrients and the efflux of waste products as stated above. A drop in intradiscal pressure therefore results in less end plate deformation. The nutrients supplied to the discal tissue is reduced and metabolic wastes are not removed with the same efficiency. This contributes to a degenerative cascade.

Radial and circumferential tears, cracks and fissures may begin to appear within the annulus fibrosis. If these defects do not heal, some of the nuclear material may begin to migrate into the defects in the annulus fibrosis. Migration of the nuclear material into the annulus fibrosis may cause stretching and delamination of layers of the annulus fibrosis resulting in back pain due to stimulation of the sinu-vertebral nerve. An intervertebral disc without a competent nucleus is unable to function properly. Further, since the spine is a cooperative system of elements, altering the structure and mechanics at one location of the spinal column may significantly increase stresses experienced at adjacent locations thereby further contributing to the degenerative cascade.

In the past, operative intervention has occurred to relieve lower back pain arising from intervertebral disc degeneration. Most of this operative intervention has been by way of a discectomy where leaking nuclear material is removed or, alternatively, fusion. The primary purpose of a discectomy is to excise any disc material that is impinging on the spinal nerve causing pain or sensory changes. Fusion means eliminating a motion segment between two vertebrae by use of a bone graft and sometimes internal fixation. Biomechanical studies show that fusion alters the biomechanics of the spine and causes increased stresses to be experienced at the junction between the fused and unfused segments. This promotes degeneration and begins the degenerative cycle anew. Clearly, being an invasive operative procedure, fusion is a risky procedure with no guarantee of success.

Due to the minimal success rate of the previous two procedures, as well as their inability to restore complete function to the spinal column, alternative treatments have been sought in the form of artificial disc replacements. Theoretical advantages of artificial disc replacement over a fusion procedure include preservation or restoration of segmental motion in the spine, restoration of intervertebral architecture and foraminal height, sparing of adjacent segments of the spine from abnormal stresses and restoration of normal biomechanics across the lumbar spine. The established artificial disc replacement procedure consists of techniques that require a surgical incision on the abdomen, retraction of large blood vessels, a total excision of the anterior longitudinal ligament, anterior and posterior annulus along with the nucleus and near total removal of the lateral annulus and implantation of an articulated prosthesis. This is a major spinal column reconstruction operation.

There is therefore a need for a surgical procedure which, as far as possible, restores the biomechanics of joints such as those between adjacent vertebrae of the spine by the provision of a tissue prosthesis mimicking natural, healthy cartilaginous tissue.

2. Brief Summary of the Invention

Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

According to a first aspect of the invention, there is provided a tissue prosthesis which comprises: [0013] an envelope of a biologically inert, elastically deformable material capable of being expanded to conform to an interior surface of a cavity formed at a site in a patient\'s body; and [0014] a filler material received in a fluent state in the envelope, the filler material being of the same class of material as the envelope to form, when cured, together with the envelope, a unified structure.

The envelope may be of an elastomeric material capable of expanding to up to 100 times its relaxed state. Further, the filler material may be of an elastomeric material capable of absorbing shock and withstanding compressive, tensile, bending and torsional forces. The envelope may be expanded to be stretched and retained under tension after being charged with the filler material.

In this specification, the term “expanded” and its variations is to be understood as meaning “stretched elastically”.

Both the envelope and the filler material may be of an elastomeric material having a Shore Hardness in the range of between about 5 to 90 A. Preferably, the envelope and the filler material are of a silicone rubber material. However, to promote bonding between the envelope and the filler material, the envelope and the filler material may be of different grades of silicone rubber material and may be pre-treated in different ways prior to use.

The envelope may include a neck portion, the neck portion defining a zone of weakness for facilitating separation of the envelope from a delivery device. Further, the envelope may include a flow control device arranged at an inlet opening to the envelope for inhibiting back flow of the filler material from the envelope. In an embodiment, the prosthesis may include a flow control defining member, the flow control defining member being separate from the envelope and being arranged at the inlet opening to the envelope.

The envelope may carry a marker arrangement on an exterior surface for enabling the envelope to be used to assess dimensions and a shape of the cavity and positioning of the envelope in the cavity.

According to a second aspect of the invention, there is provided a tissue prosthesis which comprises:

an envelope of a foraminous, chemically inert material shaped to conform to an interior surface of a cavity formed at a site in a patient\'s body in which the envelope is to be placed; and

a filler material received in a fluent state in the envelope, the filler material being of an elastomeric material which, prior to being cured, is urged into foramens of the envelope to form an integrated structure which inhibits relative movement between the envelope and the filler material, in use, and once the filler material has cured.

The envelope may be of a knitted biological or synthetic polymeric material. More particularly, the envelope may be of a knitted polyester material, such as polyethylene terephthalate (PET). Further, the envelope may be coated with a material of the same class as the filler material.

Once again, the envelope may include a flow control device arranged at an inlet opening to the envelope for inhibiting back flow of the filler material from the envelope. The prosthesis may include a flow control defining member, the flow control defining member being separate from the envelope and being arranged at the inlet opening to the envelope.



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Previous Patent Application:
Spinal implants
Next Patent Application:
Transforaminal prosthetic spinal disc apparatus
Industry Class:
Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor
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stats Patent Info
Application #
US 20120290095 A1
Publish Date
11/15/2012
Document #
13558204
File Date
07/25/2012
USPTO Class
623 1716
Other USPTO Classes
International Class
61F2/42
Drawings
13


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