The present disclosure relates generally to bone plates and methods of using the same.
Internal fixation is the procedure by which a bone plate is implanted in a patient to facilitate the repair and healing of a fractured bone. In such a procedure, the bone plate is secured to bone fragments to secure the fragments in a desired orientation relative to one another. The bone plate is typically secured to the bone fragments by the use of bone screws threaded into the bone fragments. In some cases, the bone plate also compresses the bone fragments together in order to facilitate healing.
According to one aspect, an orthopaedic implant is disclosed. The orthopaedic implant includes a bone plate and a remodelable spacer configured to be positioned between the bone plate and a fractured bone. The remodelable spacer includes a plurality of sheets of extracellular matrix material.
In certain embodiments, the remodelable spacer includes a plurality of screw holes which align with a plurality of screw holes defined in the bone plate.
The remodelable spacer may be embodied as a strip implanted between the bone plate and the bone. The remodelable spacer may also be embodied as a wrap that is wrapped around the bone plate or a sleeve into which the bone plate is inserted.
The remodelable spacer may be vacuum dried or freeze dried to the bone plate.
The sheets of extracellular matrix material may be embodied as sheets of small intestinal submucosa.
The sheets of extracellular matrix material may be embodied as sheets of vertebrate small intestine submucosa, vertebrate liver basement membrane, vertebrate bladder submucosa, vertebrate stomach submucosa, vertebrate alimentary tissue, vertebrate respiratory tissue, or vertebrate genital tissue.
The sheets of extracellular matrix material may be embodied as sheets of bovine tissue, ovine tissue, or porcine tissue.
According to another aspect, a method of performing a bone plating procedure includes positioning a remodelable spacer having a plurality of sheets of extracellular matrix material in a surgical site proximate to a bone. The method also includes positioning a bone plate in the surgical site such that at least a portion of the remodelable spacer is positioned between the bone plate and the bone. The method also includes fastening the bone plate to the bone.
The bone plate may be screwed to the bone with bone screws. As such, both the remodelable spacer and the bone plate may be embodied to include at least one screw hole. The bone plate may be positioned in the surgical site such that the screw hole(s) of the bone plate is/are aligned with the screw hole(s) of the remodelable spacer.
The remodelable spacer may be wrapped around the bone plate prior to positioning the remodelable spacer in the surgical site. The remodelable spacer may be embodied as a sleeve into which the remodelable spacer is inserted prior to positioning the remodelable spacer in the surgical site.
The remodelable spacer may be positioned in direct contact with the bone. Likewise, the bone plate may be positioned in direct contact with the remodelable spacer.
According to another aspect, an implantable orthopaedic device includes a bone plate having an upper surface and a lower surface with a remodelable coating disposed on the lower surface of the bone plate. The remodelable coating includes an extracellular matrix material.
The remodelable coating may be embodied as a gel, emulsification, or paste.
The extracellular matrix material of the coating may include vertebrate small intestine submucosa, vertebrate liver basement membrane, vertebrate bladder submucosa, vertebrate stomach submucosa, vertebrate alimentary tissue, vertebrate respiratory tissue, and vertebrate genital tissue.
The extracellular matrix material of the coating may include bovine tissue, ovine tissue, and porcine tissue.
According to another aspect, an orthopaedic implant includes a remodelable spacer for use in a bone plating procedure. The remodelable spacer includes an elongated body having a number of sheets of an extracellular matrix material with a number of screw holes defined therein.
The sheets of extracellular matrix material may be embodied as sheets of small intestinal submucosa.
The sheets of extracellular matrix material may be embodied as sheets of vertebrate small intestine submucosa, vertebrate liver basement membrane, vertebrate bladder submucosa, vertebrate stomach submucosa, vertebrate alimentary tissue, vertebrate respiratory tissue, or vertebrate genital tissue.
The sheets of extracellular matrix material may be embodied as sheets of bovine tissue, ovine tissue, or porcine tissue.
The detailed description particularly refers to the following figures, in which:
While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Referring now to
The bone plate 12 includes an elongated body having a number of screw holes 18 defined therein. The bone plate 12 is constructed of a rigid material such as metal or rigid polymers. In the illustrative embodiment described herein, the bone plate 12 is constructed of a medical implant-grade metal such as stainless steel or a titanium alloy.
The remodelable spacer 14 is illustratively embodied as a thin strip in the form of an elongated body having a number of screw holes 20 defined therein. In the illustrative embodiment described herein, the screw holes 20 of the remodelable spacer 14 align with the screw holes 18 of the bone plate 12 when the remodelable spacer 14 and the bone plate 12 are implanted into a surgical site 32 proximate to the bone 16.
In the illustrative embodiment of
One such ECM is small intestine submucosa (SIS). Commercially available SIS material is derived from porcine small intestinal submucosa that remodels to the qualities of its host when implanted in human tissues. Further, it is taught that the SIS material provides a natural scaffold-like matrix with a three-dimensional microstructure and biochemical composition that facilitates host cell proliferation and supports tissue remodeling. Indeed, SIS has been shown to contain biological molecules, such as growth factors and glycosaminoglycans, that aid in the repair of tissue in the human body. SIS also contains antimicrobial polypeptides that inhibit bacterial growth in immediately surrounding tissues. SIS products, such as OASIS and SURGISIS, are commercially available from Cook Biotech Inc., Bloomington, Ind.
Another SIS product, RESTORE® Orthobiologic Implant, is available from DePuy Orthopaedics, Inc. in Warsaw, Ind. The DePuy product is described for use during rotator cuff surgery, and is provided as a remodelable framework that allows the rotator cuff tendon to regenerate. The RESTORE Implant is derived from porcine small intestine submucosa, a naturally occurring ECM (composed of mostly collagen type I (about 90% of dry weight), glycosaminoglycans and other biological molecules) that has been cleaned, disinfected, and sterilized. During seven years of preclinical testing in animals, there were no incidences of infection transmission from the implant to the host, and the RESTORE Implant has not adversely affected the systemic activity of the immune system. The material used to make the RESTORE Implant, with or without modification thereto, may be used to fabricate the remodelable spacers described herein.
While small intestine submucosa is available, other sources of submucosa are known to be effective for tissue remodeling. These sources include, but are not limited to, stomach, bladder, alimentary, respiratory, and genital submucosa, and liver basement membrane. See, e.g., U.S. Pat. Nos. 6,379,710, 6,171,344, 6,099,567, and 5,554,389, hereby incorporated by reference. Further, while SIS is most often porcine derived, it is known that these various submucosa materials may be derived from non-porcine sources, including bovine and ovine sources. Additionally, the ECM material may also include partial layers of laminar muscularis mucosa, muscularis mucosa, lamina propria, stratum compactum layer and/or other such tissue materials depending upon other factors such as the source from which the ECM material was derived and the delamination procedure.
As used in this disclosure, the terms “extracellular matrix” and “ECM” include ECM's that have been cleaned and/or comminuted, or in which the collagen within the ECM has been crosslinked. However, it is not within the definition of “extracellular matrix” or “ECM” to separate and purify the natural fibers and reform a matrix material from purified natural fibers. Also, while reference is made to SIS, it is understood that other ECMs, such as stomach, bladder, alimentary, respiratory, or genital submucosa, or liver basement membrane, for example, whatever the source (e.g. bovine, porcine, ovine, etc.) are within the scope of this disclosure. Thus, as used herein, the terms “extracellular matrix” or “ECM” are intended to refer to extracellular matrix material that has been cleaned, disinfected, sterilized, and optionally crosslinked.
The following patents, hereby incorporated by reference, disclose the use of ECMs for the regeneration and repair of various tissues: U.S. Pat. Nos. 6,379,710; 6,187,039; 6,176,880; 6,126,686; 6,099,567; 6,096,347; 5,997,575; 5,993,844; 5,968,096; 5,955,110; 5,922,028; 5,885,619; 5,788,625; 5,733,337; 5,762,966; 5,755,791; 5,753,267; 5,711,969; 5,645,860; 5,641,518; 5,554,389; 5,516,533; 5,460,962; 5,445,833; 5,372,821; 5,352,463; 5,281,422; and 5,275,826.
As alluded to above, the remodelable spacer 14 functions as a growth-supporting matrix for promoting tissue repair and regeneration thereby accelerating the healing of the periosteum and promoting osteosynthesis of the fractured bone. As such, when positioned adjacent a fractured bone, cells can migrate into and proliferate within the remodelable spacer 14, biodegrade the spacer 14 while, at the same time, synthesize new and healthy tissue to heal the fractured bone.
The remodelable spacer 14 may be configured any number of different ways to fit the needs of a given design. For example, as shown in the illustrative embodiment of
The remodelable spacer 14 may be prepared on site in the surgical room or prefabricated. Namely, the remodelable spacer 14 may be provided to the surgical room in the form of a strip of extracellular matrix material enclosed in a sterile package that is opened and cut into the desired shape with sterile scissors as part of the orthopaedic procedure. Alternatively, the remodelable spacer 14 may be die-cut by a manufacturer of the spacer 14. In such a case, the spacer 14 may be configured with a profile and hole pattern that mimics or compliments that of the bone plate 12. In such a case, the finished remodelable spacer 14 would likewise be provided to the surgery center in sterile packages. In the illustrative embodiment described herein, the remodelable spacer 14 is embodied as a prefabricated device which has been manufactured to closely compliment the bone plate 12.
The remodelable spacer 14 may be implanted as a separate component relative to the bone plate 12 during the orthopaedic procedure. Alternatively, the remodelable spacer 14 may be secured to the bone plate 12 prior to being implanted into the surgical site. Along this same line, the two components (i.e., the bone plate 12 and the remodelable spacer 14) may be secured to one another during fabrication. For example, the remodelable spacer 14 may be freeze-dried (e.g., via lypholization) to the bottom surface 24 of the bone plate as part of the fabrication process. In such a case, the two components would be shipped to the surgical location in a single sterilized package.
For purposes of demonstrating an illustrative embodiment, reference is now made to
Once implanted and positioned in such a manner, the bone plate 12 is fastened to the bone 16. Typically, this is done by the use of a plurality of bone screws 30. When the bone screws 30 are tightened, the remodelable spacer 14 is clamped between the bone plate 12 and the bone 16.
Referring now to
In the illustrative embodiment shown in
Similarly, the bone plate 12 may be inserted into the remodelable spacer 34 during the surgical procedure. In such a case, the bone plate 12 and the remodelable spacer 34 may be provided to the surgery room in separate sterilized packages. Alternatively, the bone plate 12 may be secured within the remodelable spacer 34 prior to arrival in the surgery room. For example, as part of the fabrication process, the remodelable spacer 34 may be vacuum-dried or freeze-dried (e.g., via lypholization) to the bone plate 12 by the manufacturer.
As alluded to above, in a similar manner to the remodelable spacer 14 of
Implantation of the orthopaedic implant of
Another embodiment of a remodelable spacer 44 is shown in
As with the other illustrative embodiments described herein, the remodelable spacer 44 shown in
The remodelable spacer 44 may be snugly or loosely wrapped around the bone plate 12. In some embodiments, the remodelable spacer 44 may be vacuum-dried or freeze-dried to the bone plate 12 after it has been wrapped around the plate 12. Such could be done either in the surgery room or during implant manufacture.
As alluded to above, in a similar manner to the remodelable spacers 14, 34, the remodelable spacer 44 may be constructed of a plurality of sheets of extracellular matrix material. Such a plurality of sheets of extracellular matrix material may be freeze-dried or vacuum-dried to one another. In the illustrative embodiment described herein, the remodelable spacer 44 is constructed of a plurality of sheets of SIS vacuum-dried to one another and formed into the shape of an elongated strip.
Although the remodelable spacer 44 shown in
As described in relation to
Further, a gel or emulsification of fabricated extracellular matrix material solids may be sprayed or brushed onto the bone plate 12 prior to implantation of the bone plate 12 into the patient. In a similar manner, a paste including ECM material solids may be formulated such that the surgeon could apply it in a similar manner to caulking prior to implanting the plate 12. Such a “caulk” could be used either in conjunction with, or in lieu of, one of the remodelable spacers described in relation to
While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.
There are a plurality of advantages of the present disclosure arising from the various features of the apparatus, system, and method described herein. It will be noted that alternative embodiments of the apparatus, system, and method of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the apparatus, system, and method that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure as defined by the appended claims.