Patent Application
20080033575
Detailed embodiments of the instant invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific functional and structural details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representation basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.
In general, this invention provides an implant formed for stabilizing a targeted area (e.g., body cavity). The resilient member or implant is formed from a reversibly deformable biocompatible member 2, see cross-sectional profiles of
Moreover, the implant is constructed and arranged such that it is able to reversibly deform from a compressed state to an expanded state. The implant can be readily deformed to its compressed state having a reduced cross-sectional profile and/or reduced volume (see
Once inside the body cavity, the resilient member is able to expand without the application of pressure or temperature, to substantially conform to the dimension of the body cavity (
According to one particularly preferred embodiment, the implant is formed from a reticulated biocompatible material, which includes multiple pores or voids formed uniformly throughout the member. The size and density of the pores should substantially retain fluid introduced therein, while concomitantly permitting the ingrowth of surrounding tissue therein. Non-limiting examples of suitable a reversibly deformable member might include autograph, allograft, other osteobiologic tissue, or combinations thereof.
According to one non-limiting, illustrative embodiment shown in
As discussed above, the compressed implant is readily passed through the previously prepared narrow incision and channels and into the prepared body cavity by any suitable insertion tool known in the art. The compressed implant is capable of being readily inserted into the distal end of a conventional insertion device 14. For example, as shown in
Once the implant is positioned inside the prepared cavity, the containment means 10 is ruptured in situ, see ruptured ends 22, 24 of containment means shown in
The use of a vacuum to fill the implant will spontaneously distribute constituents throughout the interstices formed therein. After the implant is in situ, the containment means could be removed or the containment means could be made from a bioresorbable material and left inside the cavity to harmlessly absorb into the body. The term “bioresorbable material” is intended to encompass any non-toxic, non-immunogenic material, natural or synthetic, capable of being formed into a package which after insertion is gradually hydrolyzed and absorbed over a finite period of time by chemical/biological activity in the body. Illustrative, albeit non-limiting, examples are polylactic acid, polyglycolic acid, polycaprolactone, polyanhydrides, polydioxanone, polyamino acids, trimethylene carbonate, 1,5-dioxepan-2-one, copolymers of lactic acid, hydroxyapatite and alginates. Commercially available bioresorbable materials such as LACTOSORB (Walter Lorenz Surgical, Inc. Jacksonville, Fla.) could be used.
It is contemplated that the implant might be constructed and arranged to deform into its compressed state for a period of time after application of a vacuum source (not shown) directly thereto, without the need for containment means. Furthermore, it is contemplated that any means for creating a negative pressure (vacuum) inside the containment means could be used herein without departing from the scope of the invention. The vacuum source could be employed during the manufacturing process to create a negative pressure inside the containment means.
Alternatively, a kit might be supplied to the surgeon which includes at least one containment means, at least one implant, and optionally, at least one desired constituent. The surgeon could apply an available vacuum source to containment means (or implant) immediately prior to implantation. This is particularly desirable should the surgeon have specific flowable constituents in mind for introduction into the implant.
The flowable constituents used herein could include, albeit are not limited to, bone morphogenic proteins, bone growth factors, stem cell treatments, medication, platelet concentrations, bodily fluids, or the like.
Moreover, additional flowable constituents might be introduced into the expanded implant inside the targeted body region by any appropriate introduction means 16, such as, a cannula, lumen, or syringe, see
According to yet another embodiment particularly suitable for treatment of osteoporotic compression fractions, the resilient member may be coated with at least one reactive constituent that reacts with the flowable constituents introduced into the implant. For example, the implant may be coated with a material whereupon introduction of a hardening agent by the introducing means 16 into the expanded implant would cause the implant to sufficiently harden so as to form a rigid internal cast, thereby arresting the motion cause by the fraction and restore the loss of height caused by the fracture. According to another embodiment, the resilient member may be coated with at least one time-released constituent that could provide for the continuous delivery of the concentrated constituents over time.
Although the invention is described with reference to stabilization and fusion of adjacent spinal vertebrae, it is hereby contemplated that devices and methods disclosed herein could be used in all types of joints (knee, ankle, etc) found in the human or animal body.
All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.
It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.
One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.
