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Researchers Submit Patent Application, "Novel Biological Implant Compositions, Implants and Methods", for Approval

January 23, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventors Koford, Keith Cameron (Gainesville, FL); Long, Nathaniel Scott (Newberry, FL); Scharringhausen, Erica Lee (Gainesville, FL); Hilliard, Randall Keith (Gainesville, FL), filed on March 12, 2013, was made available online on January 9, 2014.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: "Many injuries and ailments throughout the human body are treated through surgical intervention utilizing either biological tissue or synthetic material implants. Among these are conditions including spinal degeneration, sports medicine, podiatric, trauma and general orthopedic injuries or maladies involving bone or hard tissue. Also commonly benefiting from surgical intervention utilizing either biological tissue or synthetic material implants are soft tissue conditions including hernia, urological, gynecological, cardiac, neural, and general abdominal injuries or maladies.

"In selecting implants to address these various injuries and maladies, surgeons are often faced with tradeoffs between natural, biological tissue materials and synthetic materials. Biological materials often offer natural healing, incorporation and regenerative capability, but may be lacking in material properties or handling characteristics as compared to synthetics. Surgeons must therefore often choose to accept the lack of regeneration and incorporation potential in using a synthetic material, which is at best inert and at worst inflammatory and prone to infection, in order to find an implant with the physical handling and material properties required for a particular surgical application. This is true in the growing area of minimally invasive surgical procedures, where synthetic material may offer strength, resiliency, compressibility, expansion, or an ability to fold or roll into a compact or compressed form for passage through a portal or delivery instrument before expanding, unfolding or unrolling at an implant site. Synthetic implants also offer a greater range of coating and combining materials due to their ability to bond and join together more efficiently than has been shown with natural materials.

"The present application is directed at developing a biological material that exhibits advantageous properties such as fluid absorption, compressibility, expansion, resiliency and shape retention, while allowing for good regeneration and incorporation."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventors' summary information for this patent application: "One embodiment of the present biological graft, consisting essentially of human tissue components is made by molding the graft into a first configuration and dehydrating the graft, rehydrating the graft with a first rehydration fluid and compressing the graft into a second configuration suitable for passage into a human patient wherein the second configuration is smaller in at least one dimension than the first configuration and dehydrating, packaging and sterilizing the graft in said second configuration. The graft can be rehydrated from the second configuration using a second rehydration fluid. The first and second rehydration fluids can be water, blood, blood components, saline, platelet rich plasma or bone marrow aspirate. The first and second rehydration fluids can be the same or different fluids. The graft can expand back to the first configuration upon application to a surgical site within the human patient. The first configuration can be, for example, a square, rectangle, circle, triangle or oval.

"One embodiment of the present method of surgery on a human patient using the graft described above comprises providing the dehydrated, packaged and sterilized graft in the form of a compressed sheet having an initial dehydrated thickness and an initial dehydrated shape, and passing said graft into a surgical site within said human patient through a minimally invasive access portal having a cross sectional area, and rehydrating and expanding said graft at said surgical site within said human patient, and positioning said graft at the surgical site covering an implant area that is larger than said cross sectional area of said portal, and fully rehydrating said graft, thereby causing said graft to return to a hydrated thickness greater than that of said initial dehydrated thickness.

"One embodiment of the present method of surgery on a human patient comprises providing an allograft unitary implant consisting essentially of human tissue components in a compressed dehydrated form, and providing a minimally invasive access portal into a surgical site within the human patient, and passing said implant through the minimally invasive access portal, and providing a hydration fluid in contact with the implant, wherein the implant expands following contact with the hydration fluid to create an expanded implant, and positioning or fixing the implant in place at the surgical site to create a fixed implant, wherein, the expanded implant has a fixed unitary shape which is larger than that which could have passed through said portal. The allograft unitary implant can be a molded tissue. The molded tissue can be demineralized bone matrix (DBM) or a combination of DBM and a component derived from a human tissue slurry. The allograft unitary implant can be rolled in a compressed dehydrated form. The expanded implant can be for example, a square, rectangle, circle, triangle or oval, as well as any regular or irregular shape suitable for or required by the specific surgical procedure or anatomical treatment site.

"One embodiment of the present biological graft, consisting essentially of human tissue components comprises a bone block of cortical bone, cancellous bone or both, the bone block having at least one porous or semi-porous surface and a molded tissue component comprising demineralized bone matrix (DBM) and a human tissue slurry wherein the molded tissue component is integrated into the porous or semi-porous surface of the bone block. The molded tissue component can be frozen and lyophilized along at least a portion of at least one outer surface of the bone block. The bone block can also comprise at least one slot, groove or hole to increase penetration of the molded tissue component. The molded tissue component can cover at least two sides of the bone block and substantially fill a passageway between at least two of the at least two sides. The bone block can be in the shape of a wedge, trapezoid, plank or ring.

"An embodiment of the present dehydrated, packaged and sterilized molded human tissue graft is in the form of a compressed sheet having an initial dehydrated thickness and an initial dehydrated compressed shape wherein the graft in the initial dehydrated compressed shape is small enough to be passed into a surgical site within a human patient through a minimally invasive access portal having a cross sectional area, and wherein the graft in said initial dehydrated compressed shape is rehydratable to return to a hydrated thickness greater than that of the initial dehydrated thickness at the surgical site, and to a hydrated size larger than the cross-sectional area.

"In one aspect, the present application is directed to a molded biological all human tissue graft for use in a human patient. The molded tissue implant (graft) is derived from a processed natural biological tissue source, such as xenograft, allograft, or autograft tissue for human implantation, allograft is preferred. An implant of the present application may be made from a soft tissue source such as dermis, fascia or tendon, in combination with demineralized bone matrix (DBM). An implant of the present application may also contain additional hard tissue materials such as bone, bone particles or bone fibers which have or have not been demineralized by methods known in the art. Preferred implants consist essentially of human tissue components. Preferred materials are osteoconductive, compressible, conformable, and hydratable.

"In one embodiment, the present application is directed to a processed minimally invasive biological graft for implantation into a human patient made from molded tissue components in a dehydrated state. In this embodiment the molded tissue graft is compressed into a first configuration suitable for passage into a human patient and is further capable of opening and expansion to a second configuration suitable for application to a surgical site within the human patient. In this embodiment the second configuration is larger in at least one dimension than the first configuration. As described in greater detail below, the compression is preferably achieved via rolling, folding, spiraling, winding or crumpling, for example. The compression occurs in one or more dimensions and the expansion is due, at least in part, to rehydration of the graft. This allows for implantation of larger grafts while still using minimally invasive procedures.

"In another embodiment, the present application is directed to an assembled bone allograft implant comprising two or more bone blocks which are substantially planar segments of cortical bone, cancellous bone or both, which also contains at least one component that is a molded tissue component. The molded tissue component can comprise at least one layer of substantially non-bone human allograft tissue which is osteoconductive, compressible, conformable, and hydratable. The molded tissue component is formed from a tissue slurry of substantially of non-bone origin together with demineralized bone matrix (DBM). As described in greater detail below, the molded tissue component can be sandwiched between at least two substantially planar segments of cortical bone, cancellous bone or both. In these embodiments, the bone components can be in the shape of a plank. In some embodiments the assembled implant also has at least one bone pin holding the assembled graft together. The pin can be made from cortical or cancellous bone.

"In another embodiment, the present application is directed to a unitary allograft bone block implant comprising a block of cortical bone, cancellous bone or both; and a molded tissue component which is integrated into the block. Optionally, the implant also has a compression zone formed by the molded tissue component, outside of the bone graft and adjacent to the machined outer surface. As described in greater detail below, in one embodiment, the bone block is a wedge or trapezoid and the molded tissue component is formed along at least one outer surface of the wedge or trapezoid. In other embodiments, the bone block is in the shape of a ring and the molded tissue component can fill all or some of the space inside.

"The present application is additionally directed to methods of surgery on a human patient using a compressed and dehydrated graft (or unitary implant). In one embodiment, the grafts have the form of a compressed sheet having an initial dehydrated thickness and an initial dehydrated shape. Preferably, the graft is passed into a surgical site through a minimally invasive access portal. In these embodiments, the graft is expanded at the surgical site within the patient, and the implant covers an implant surgical site area that is larger than said cross sectional area of the minimally invasive access portal. Preferably, the expansion is due to fully or partially rehydrating the graft, thereby causing the graft to return to a hydrated thickness greater than that of the dehydrated thickness. Preferably, the minimally invasive access portal has a cross sectional area and the graft covers an implant area that is larger than the portal cross sectional area. More preferably, the graft or implant expands following contact with a hydration fluid and the expanded implant has a fixed unitary shape or configuration which is larger than that which could have passed through the portal. Preferred shapes or configurations are a square, rectangle, circle, triangle or oval. Optionally the implants (grafts) are packaged and sterilized.

"These and other advantages and novel features of the present application, as well as details of illustrated embodiments thereof will be more fully understood from the following description of the drawings

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

"FIGS. 1A-1F show one embodiment of the present surgical method of a minimally invasive procedure using a rolled compressed dehydrated packaged sterilized molded tissue graft comprising demineralized bone together with a human tissue slurry. FIG. 1A shows a molded tissue graft having a rolled compressed configuration contained within a package. FIG. 1B shows a molded tissue graft being inserted through a minimally invasive portal into a minimally invasive surgical opening. FIG. 1C shows a molded tissue graft passing through a minimally invasive portal. FIG. 1D shows a molded tissue graft having passed through a minimally invasive portal into a patient body and lying adjacent a target surgical tissue being hydrated by a hydration fluid through a hydration needle being supplied by a hydration source. FIG. 1E shows a rolled compressed molded tissue graft unrolling to a partially open configuration following hydration inside a patient body and adjacent a target surgical tissue. FIG. 1F shows a rolled compressed molded tissue graft essentially completely unrolled to an open configuration following hydration and affixed to a target surgical tissue by fixation means.

"FIG. 2 shows one embodiment of the present folded, compressed, dehydrated, packaged and sterilized molded tissue graft comprising demineralized bone together with a human tissue slurry.

"FIGS. 3A-3C show one embodiment of the present molded tissue graft in three states: FIG. 3A--initial solid dehydrated state; FIG. 3B--rehydrated, compressed, rolled and finally dehydrated state; and FIG. 3C--secondarily rehydrated, expanded and unrolled state with fixation at a surgical site within a patient.

"FIGS. 4A and 4B show one embodiment of the present composite bone block wedge of human bone together with a molded tissue component. A top view is shown in FIG. 4A and a section view through the line A-A is shown in FIG. 4B.

"FIGS. 5A and 5B show one embodiment of the present composite bone block wedge of human bone together with a molded tissue component having discreet retention features along one surface. A top view is shown in FIG. 5A and a section view through the line A-A is shown in FIG. 5B.

"FIGS. 6A and 6B show one embodiment of the present composite bone block wedge of human bone together with a molded tissue component having passageways in communication between two surfaces. A top view is shown in FIG. 6A and a section view through the line A-A is shown in FIG. 6B.

"FIGS. 7A and 7B show one embodiment of the present composite bone implant having cortical bone, cancellous bone and a molded tissue components assembled to form an assembled implant. A section view through the line A-A is shown in FIG. 7A and top view is shown in FIG. 7B.

"FIG. 8 shows one embodiment of the present composite bone implant having a molded tissue component molded between and completely surrounded by only two pieces of cortical bone.

"FIG. 9 shows one embodiment of the present composite bone implant having a molded tissue component molded between and contacting at least 4 distinct pieces of cortical bone.

"FIG. 10 shows one embodiment of the present composite bone implant having a molded tissue component molded between and contacting at least 6 distinct pieces of cortical bone.

"FIG. 11 shows one embodiment of the present composite bone implant having a molded tissue component sandwiched between and contacting at least 2 cancellous bone planks.

"FIG. 12 shows one embodiment of the present composite bone implant having a molded tissue component sandwiched between and contacting at least 1 cancellous bone plank and at least 1 cortical bone plank.

"FIGS. 13A and 13B show one embodiment of the present composite bone implant having a molded tissue component molded into a machined recess within a bone plug. A top view is shown in FIG. 13A and a section view through the line A-A is shown in FIG. 13B.

"FIG. 14 shows one embodiment of the present composite allograft cortical bone strut implant with a molded tissue component covering one side of the cortical bone strut.

"The foregoing summary, as well as the following detailed description of certain embodiments of the present application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustration, certain embodiments are shown in the drawings. It should be understood, however, that the claims are not limited to the arrangements and instrumentality shown in the attached drawings. Furthermore, the appearance shown in the drawings is one of many ornamental appearances that can be employed to achieve the stated functions of the system."

For additional information on this patent application, see: Koford, Keith Cameron; Long, Nathaniel Scott; Scharringhausen, Erica Lee; Hilliard, Randall Keith. Novel Biological Implant Compositions, Implants and Methods. Filed March 12, 2013 and posted January 9, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1519&p=31&f=G&l=50&d=PG01&S1=20140102.PD.&OS=PD/20140102&RS=PD/20140102

Keywords for this news article include: Patents, Surgery, Bone Research.

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Source: Politics & Government Week


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