Patent Application
20060029633
The present invention relates to various anatomical implant portions, and particularly to implants for soft tissue to substantially mimic anatomical tissue.
In an anatomy, such as a human anatomy, various portions are generally interconnected with one another to perform selected functions. For example, ligaments interconnect selected bones to hold a selected shape to provide for a selected articulation. Tendons interconnect tissue, such as muscle, with bones to provide anchors for the muscles to allow for the muscles to move selected bone portions. Although in an uninjured anatomy, the various soft tissues are generally able to perform their selected tasks, for various reasons, selected soft tissues may become injured or inoperable. Therefore, the bone portions, connected by ligaments, and the muscle portions, interconnected with the tendons, are not able to perform their selected anatomical functions.
After an injury or event that causes an inoperability or damage to various soft tissues, implants may be provided to perform similar functions in the soft tissue. For example, any graft, such as including a bone-tendon-bone (BTB) graft, can be used to interconnect two bone portions. Generally, the BTB graft can be harvested from a donor site including a selected length of the tendon and two bone portions, one at each end. This BTB graft can then be positioned in a selected anatomical position to replace or repair an injured or damaged anatomical portion. The BTB graft may be taken from the patient to form an autograft.
Alternatively, or in addition to the autograft, it may be desirable to provide an artificial implant that can simulate an anatomical implant. Particularly, to replace the donor site of the graft, such as the BTB graft, it may be desirable to provide a graft of similar material to reinforce the donor site. Therefore, although an autograft can be used, the donor site may be substantially maintained in its natural or strong state. Alternatively, if an appropriate donor site is not found, or it is more preferable to use a xenograft, it may be desirable to provide a xenograft of similar strength and including an appropriate shape.
Regardless, a soft tissue may become injured and allow for its reinforcement or replacement by a soft tissue implant. The soft tissue implant may be able to assist in restoring substantially natural movement and strength to the injured site after the implant.
An anatomical implant that can be used to replace various anatomical portions, such as soft tissue including tendons and ligaments is disclosed. The soft tissue implant can be formed of appropriate materials, such as xenograft materials, to substantially mimic a soft tissue. Various materials may be used such as collagen (such as intestinal collagen (ICL)) or human, porcine, or bovine pericardium, dermis, submucosa, etc. These materials can be used to form grafts of appropriate sizes and strengths for implantation into a body to repair or replace injured anatomical tissues. For example, any appropriately shaped graft can be positioned in a tendon that allows for substantial repair of the injury site.
According to an embodiment, a shaped graft may be formed that is substantially complimentary to a donor site for a selected graft. Therefore, a shaped xenograft implant can be positioned in the donor site to provide substantial anatomical or natural strength thereto. The graft may include various features such as preformed suture or anchor sites. Generally, the graft may be formed of a plurality of layers of the xenograft material to form a substantially laminated and strong implant.
Similarly, sheets of the xenograft material can be formed and shaped into appropriate shapes for various implants. For example, an implant of an appropriate shape may repair or replace a scaphoid-lunate ligament and includes anchor sites to allow for a substantially easy implantation and need for no or only minimal surgical customization. Therefore, the graft can be substantially customized and formed preoperatively to minimize time and duration of the surgical procedure.
Nevertheless, a selected graft can be partially or completely cross-linked, such as when the graft is laminated to allow for remolding or a selected rigidity. During the lamination process, the graft may be cross-linked, such as chemically or dehydrothermally, to increase strength and rigidity prior to implantation. In addition, the graft may be positioned on a selected jig or form such that the final graft will include the selected form. The jig or shaper may include various features, such as pins or sharp portions, that both shape and perforate the graft. The perforations may increase surface area to increase and/or allow for cellular ingrowth after implantation. Therefore, the pins may remain in the graft during the lamination or the cross-linking procedure such that appropriate pores remain in the graft.
Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
The following description of various embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.
With reference to
The patch 10 may include any appropriate or selected features. For example, the patch 10 may be formed of a plurality of graft layers 20. Each of the individual graft layers 20 may be an appropriate or selected material that is laminated together to form the patch 10. Various exemplary materials include intestinal collagen, or other appropriate materials, and are discussed in detail herein. Similarly, appropriate techniques may be used to laminate the plurality of the layers 20 to form the graft 10, also discussed herein. It will be understood, however, that the patch 10 may be formed of a single or unitary portion. That is, the graft 10 may be formed of a single piece of material that has been shaped into the appropriate shape to be implanted into the graft site 12. The solid piece of material can also include the various features that are used in the patch 10.
The patch 10, generally defining a T-shape, includes an upper or platform area 22 and a base or leg area 24. Although any appropriate shape may be selected, the T-shape including the upper platform 22 and the leg 24, may allow for the patch site 12 to be substantially filled with the patch 10 while allowing for a substantial surface area to affix the patch 10 to the soft tissue 14. For example, a tack area or aperture 30 may be formed in one or both ends of the patch 10. The tack aperture 30 allows for a selected tack or appropriate implant portion to pass through and engage the patch 10 and engage a selected portion of the soft tissue 14 or a underlayment thereof. For example, the soft tissue 14 may be formed around a hard tissue, such as a bone portion. Therefore, the patch area 12 may expose a selected area of the bone to which a tack may be affixed. The tack aperture 30 allows for a tack to pass through the patch 10 to engage the hard bone.
In addition to the tack aperture 30, or in lieu thereof, a plurality of suture bores or apertures 32 may also be provided along the platform area 22. The suture apertures 32 are preformed areas for a suture to pass through the patch 10 and engage the soft tissue 14. In this way, the patch 10 can be quickly affixed to the patch area 12 without substantial intraoperative planning. The patch 10 may be positioned in the patch area 12 and the various apertures, such as the tack aperture 30 or the suture aperture 32 may be used to affix the patch 10 to the selected tissue 14 and the patch area 12.
With reference to
The patch 10 may be formed of any appropriate material, such as acellular collagen, which can be formed from appropriate tissue, such as intestinal collagen (ICL). These various materials are generally bio-absorbable such that over a selected period of time the patch 10 may be absorbed into the body and the soft tissue 14 may replace it and the patch site 12 may be substantially regrown with the soft tissue 14. Therefore, the patch 10 allows for the patch site 12 to be substantially regrown with natural soft tissue 14 to increase the longevity of the donor site and the patient.
Furthermore, the selected materials allow for a substantially infinite number of appropriate shapes and sizes of the patch 10. The patch 10 may be formed in any appropriate shape or size depending upon the patch site 12. If a larger graft must be taken from the individual then the patch 10 may be formed larger. Also, the patch 10 can be formed preoperatively in any appropriate size or shape for significantly quick implantation during the operative procedure. Nevertheless, the patch 10 may also be molded intraoperatively, at least to a selected degree, to allow for a substantially precise fit of the patch 10 into the patch site 12. Therefore, it may be that the donor site is substantially less traumatized than if no or a non-customized patch were used to repair the donor site.
If a plurality of the layers 20 are used to form the patch 10, the layers may be laminated to form a graft of a selected shape, strength and size. In addition the various layers 20 of the patch 10 may be cross-linked to form a graft of a selected rigidity, strength, and resilience. The cross-linking of the various layers or the material within the various layers 20 may be of a selected amount to select various attributes of the patch 10. For example, a selected amount of cross-linking may be provided such that the patch 10 is substantially moldable during the implant procedure. Alternatively, a higher level of cross-linking may substantially stiffen and make rigid the patch 10 such that the patch 10 is substantially immobile after the cross-linking occurs. Therefore, the various amounts of cross-linking can be selected to achieve a selected property of the patch 10. If a greater rigidity and stiffness of the patch 10 is required, a greater amount of cross-linking may be performed to provide for a substantially stiff and rigid patch 10.
Without being limited by the theory, one use for the patch 10 is to reinforce a donor site for a BTB autograft. In this case, the patch site 12 would be a BTB graft harvest site in which the patch 10 would be used to substantially reinforce. Therefore, the patch 10 may be formed of a selected size to substantially compliment the size of the BTB graft that is harvested from the patch site 12. In this case, the patch 10 may help to reinforce the soft tissue from which the BTB graft is harvested to allow for an increased strength of the donor site, particularly for an autograft procedure. Therefore, the patch 10 may be able to provide for a substantially larger or stronger BTB graft to be removed from an autograft position or from a harvest site to allow greater reinforcement of a second site or injury site. Nevertheless, the patch 10 may also be used as a primary implant or as a replacement for an injured portion of the anatomy rather than simply providing a strengthening or BTB harvest site patch.
With reference to
The scaphoid patch 70 includes at least a first aperture 80. The aperture 80 extends from a first surface to a second surface of the scaphoid patch 70 and allows for fixation of the scaphoid patch 70 to a selected position. The aperture 80 may be used for any appropriate fixation of the scaphoid patch 70 to a selected position. For example, a suture or other fixation mechanism may be passed through the aperture 80 to fix the patch 70 to a selected portion of the soft tissue. In addition, an anchor may be passed through the aperture 80 to anchor the scaphoid patch 70 to a selected soft tissue portion or to a bone portion. It will be understood that either or both a suture and an anchor may be used to fix the scaphoid patch 70 to a selected position. In addition, a particular suture or anchor is not necessary and any appropriate suture or anchor may be used.
The scaphoid patch 70 may also be formed using a layer 84 or a plurality of the layers 84 to form the scaphoid patch 70. As described above, the plurality of the layers 84 may include any appropriate material such as ICL to form the scaphoid patch 70. The plurality of the layers may be laminated together and cross-linked for various characteristics. Nevertheless, it will be understood that the scaphoid patch 70 may also be formed of a substantially single portion of material as a unitary piece. As discussed above, the amount of cross-linking may be used to selectively stiffen or leave moldable the scaphoid patch 70. For example, substantially little cross-linking may be provided to allow for a maximum amount of moldability of the scaphoid patch 70 during the operative procedure.
With reference to
The scaphoid patch 70 and the scaphoid patch 90 can be used to repair or replace tendons or ligaments in any appropriate region. Generally, the scaphoid-lunate region for the wrist, which is susceptible to various injuries, such as sports injuries or chronic motion injuries, can benefit from the implantation of the scaphoid patch 70, 90.
With reference to
In addition, various soft tissue portions such as scaphoid lunate ligament 102 may interconnect the scaphoid 101a and lunate 101b. The scaphoid lunate ligament 102 holds the various bone portions relative to one another to allow for an appropriate articulation and resist dislodging the various bones during stressful activities. Nevertheless, for various reasons, the scaphoid lunate ligament 102 may become injured or damaged. When an injury occurs the various bone portions, such as the scaphoid 101a and the lunate 101b may no longer be held relative to one another in a substantially anatomical or proper manner. Therefore, it may be required or selected to re-secure the scaphoid 101a relative to the lunate 101b.
As described above, various portions may be provided of a material that is operable to replace or repair soft tissue portions. For example, the patch 70 (
For example, an anchor 103, or a plurality of the anchors 103, may be provided though the bores 82 formed in the patch 70 to engage the soft tissue or the bones directly. The patch 70 may therefore may replace or substantially repair the soft tissue interconnection of the scaphoid 101a and the lunate 101b. The soft tissue patch 70 may be attached directly to the bone such that reliance on a natural attachment of the scaphoid lunate ligament 102 is not required. Nevertheless, any appropriate attachment may be used to fix the patch 70 in a selected position relative to the scaphoid 101a and the lunate 101b.
Therefore, the patch 70, or any appropriate patch according to various embodiments, may be used to replace small portions or any appropriate size portions of soft tissue. In addition, the patch as according to various embodiments may be used to be affixed directly to bone portions or to soft tissue portions to provide a replacement thereof, as described above. For example, the patch 70 may include a soft tissue anchor or sutures that pass through the bores 82 to engage the remaining portions of the scaphoid lunate ligament 102. Moreover, any appropriate bone anchor may be provided to pass through the patch 70 to engage the bones 101a, 101b. It will be understood that a specific kind of anchor or suture is not required and any appropriate suture or anchor may be used.
With reference to
Nevertheless, it will be understood that the rotator cuff implant 110 may be cut or scribed to allow for a intraoperative customization of the rotator cuff implant 110. Although the rotator cuff implant 110 may be formed prior to implantation, or even the operative procedure, various intraoperative customizations may occur. For example, the rotator cuff patch 110 may be formed using a template that is determined in preoperative planning and may be determined using various x-ray or magnetic resonance imaging techniques to design a selected template. Regardless of customization prior to the operative procedure the rotator cuff patch 110 may require a certain amount of customization during the operative procedure. Therefore, it will be understood, that the rotator cuff implant 110 may be pre-operatively customized, such as including a plurality of radii, and also intra-operatively customized.
With reference to
Therefore, a rotator cuff patch 110, 140 may be provided for an operative procedure to replace or repair a rotator cuff of a selected patient. However, a substantially customized rotator cuff patch 110 may be provided for a selected patient if the specifics of the implant required are known prior to the operative procedure, such as with various pre-operative planning techniques. Alternatively, the general rotator cuff patch 140 may be supplied to be customized during the operative procedure.
The rotator cuff patch 110, 140 can be formed of a material similar to the materials for the patches described above in relation to
With relation to the laminated material, in regards to the patches described in
The layers 152 are generally equivalent in least a first dimension X. Although it will be understood that the dimension X need not be exact for each of the plurality of the layers 152, it will be understood that the layers 152 are generally equivalent in the dimension X. Therefore, the blank 150 can be formed by placing a plurality of layers 152 substantially adjacent one another in laminating the layers together.
With reference to
The lamination process may differ, depending upon the selected implant, as described herein, but generally includes substantially adhering each of the plurality of the layers 152 to at least one adjacent layer 152. In addition, a cross-linking initiator may be provided to allow for a selected amount of cross-linking between the plurality of the layers 152 to provide a selected characteristic of the blank 150 or a final implant. In addition, the material of each of the layers 152 may be internally cross-linked.
With continuing reference to
The final implant 156 includes a plurality of layers 152 of the material, which forms the implant 156 to provide various characteristics to the implant 156. For example, providing a laminated structure may include increased strength or rigidity to the final implant 156. In addition, it will be understood that the material of each of the plurality of the layers 152 need not necessarily be substantially identical to each of the other layers 152. That is, that one or more of the layers 152 may include a material that is not substantially similar to each of the other of the plurality of layers 152.
Once the blank 150 of the plurality of the layers of the material 152 is formed, it may also be shaped, either before, during, or after the lamination process, into a selected shape. For example, a selected jig or shaper 170 may be used to shape a selected implant design. With reference to
With reference to
For example, once the blank 150 is placed upon the jig 170, the lamination process may occur. The lamination of the blank forms a laminated construct, which may be the final implant or may be later worked to form the final implant. During the lamination process, the pores formed by the pins 170 may be used to or may provide for a means to substantially infiltrate the blank 150 with a laminating material to substantially form a laminated construct for the selected implant.
Also, the pores formed by the pins 172 in the substantially constant radius rotator cuff patch 140 may allow cellular infiltration after implantation. Although the holes may be formed after forming the patch 140 using generally known punching or drilling techniques. It will be understood, however, that the jig 170 or a jig similar to the jig 170 may be used to form any appropriate implant. Therefore, the benefits of providing the pores through the implant may be realized in any appropriate implant shape or form. Nevertheless, it will be understood that the pores formed by the pins 172 are not substantially required and may not be formed in the implant. That is, any appropriate jig or mold may be used to form a selected shape of the implant if a particular shape is required prior to implantation. Therefore, a substantially solid mold may also be used to form the implant with no pores save for any natural porosity.
In any case, any appropriate mold may be used to form the graft in a selected shape. For example, a generally oblong or tear-drop shaped mold may be used to form the rotator cuff patch 110. Similarly, an appropriate mold may be used to assist in the formation of the generally T-shaped cross-section implant 10, as illustrated in
In addition to the pin jig 170 or any other appropriate mold, the patch 140, or any other appropriate implant shape, may be formed over a selected three dimensional structure. For example, the material may be placed over a stint shape such that the stent shape provides a structure or scaffold for forming the implant. The stent structure, or any appropriate structure, provides an artificial scaffold structure that the material of the implant can be positioned over before implanting. Therefore, the scaffold and the implant material are substantially biologically compatible to allow for ease of implantation.
The implant may still contain the various features, such as including a three dimensional shape, a substantially layered structure and other appropriate and above-described features. In addition, the implant may be implanted according to any appropriate method, such as that described below. Nevertheless, the implant includes an internal artificial scaffold structure to define a three dimensional shape. Therefore, the implant and the scaffold structure assists in holding the implant in a selected shape for a selected implantation. For example, the stent may be implanted into a capillary, or other appropriate tubular shape in the body to achieve selected results.
The various patches, including the soft tissue patches and the rotator cuff patches 110, 140, can be implanted in any of an appropriate manner depending upon the various procedures, the individual patient, and the desires of the physician. Nevertheless, the patches can be implanted using various arthroscopic or less invasive techniques than requiring a substantially open procedure. For example, the patches may be passed through a small incision or through a sleeve or tube that is positioned relative to the area in which the patch is required. The following exemplary procedures are not intended to limit the scope of the present disclosure or claims, but are merely intended to provide an example of various techniques that may be used to implant the selected patch.
With reference to
One or a plurality of portals or incisions 193 are generally provided through the dermis 194 near the rotator cuff 190. The portals 196 allow for access to the rotator cuff 190 using any one or a plurality of instruments. For example, an arthroscope 198 may be provided through a first or a selected of the portals 196 while a tube or sleeve 200 is provided through a second.
Once it is determined that a selected patch is necessary, the patch material may be passed through the sleeve 200 in a properly deformed manner. For example, as described above, the rotator cuff patch 110 may be selectively cross-linked, such that a certain amount of moldability is allowed in the rotator cuff patch 110. Therefore, the rotator cuff patch 110 can be rolled or otherwise deformed to pass through the sleeve 200 adjacent to the tear 192. In this way, the rotator cuff patch 110 can be provided to the tear 192 in the rotator cuff 190 without providing a substantially large or overly traumatizing incision through the soft tissue or dermis 194.
An exemplary method of implanting a selected cuff patch 110 may be performed as generally described below. As discussed above, the selected area to which the cuff implant 110 is to be provided may provide or be used to create a template which is used to form or assist in the formation of the cuff patch 110. Once the template is designed, the template may be used to cut or form the cuff patch 110 to substantially match or mimic the template. Once the cuff patch 110 has been formed to substantially match the template, in both size, shape, etc. and is formed to include selected characteristics, such as moldability and strength, the cuff patch 110 may be provided for the procedure.
According to various embodiments, a suture 210 may be passed through the cuff patch 110 in various or selected positions. With reference to
Once the rotator cuff patch 110 has been positioned relative to the rotator cuff tear 192, the sutures 210 may be sutured or tied to the tissue of the rotator cuff 190 relative to the tear 192. Therefore, the suture 210 is provided already positioned through the rotator cuff patch 110 prior to its insertion through the dermis 194. Then the physician need only pass the sutures 210 through the soft tissue of the rotator cuff 190 and further tie the sutures to secure the rotator cuff patch 110 to the rotator cuff 190. Thus, the rotator cuff patch 110 can be used to patch the rotator cuff 190 through a less invasive procedure, not requiring a substantially large portal. Generally, the portals 196 may be about 0.5 cm to about 3 cm in length.
Although the rotator cuff patch 110 is described to pass through the sleeve 200, it will be understood that the rotator cuff patch 110, including the sutures 210, may be provided simply through the portal 196. That is, the sleeve 200 is not necessary and simply may allow for assistance in guiding the rotator cuff patch 110 to a selected position. Also, once the rotator cuff patch 110 is provided to the selected position, the sleeve 200, if used, can be removed from the portal 196 to allow for other instruments to be passed through the portal 196 to assist in positioning and fixing the rotator cuff patch 110 to the rotator cuff 190. For example, a suture tying instrument may be passed through the portal 196 to assist in tying the sutures 210 to the rotator cuff 190.
A further example of the method of implanting and affixing the rotator cuff patch 110 to a rotator cuff 190 will also be described. It will be understood that this exemplary description is also not intended to limit the scope of the disclosure or the appended claims. According to various embodiments, illustrated in
After the rotator cuff patch 110 has been formed, the sutures 220 engage the rotator cuff patch 110, such that the rotator cuff patch 110 can be fixed to the rotator cuff 190 relative to the tear 192. According to the exemplary embodiments the sutures 220 are first fixed to the rotator cuff 190 relative to the tear 192.
The rotator cuff patch 110 may then be passed over the sutures 220 to engage the rotator cuff 190 relative to the tear 192. The rotator cuff patch 110 may be passed over the sutures 220 according to commonly known techniques, such as those similar to a knot passing procedure. Therefore, a knot may be formed in the sutures 220 on the exterior of the dermis 194, such that the knots are passed with the rotator cuff patch 110 through the portal 196 in a selected manner. For example, as described above, the rotator cuff patch 110 may be generally moldable, such that even if it is larger than the portal 196 it may be deformed to pass through the portal 196. Therefore, the rotator cuff patch 110 may be passed through the portal 196 with knots that have been formed in the sutures 220, such that only the knots need to be tightened to fix the rotator cuff patch 110 relative to the tear 192. It will be understood that other portals 196 may be formed through the dermis 194 to allow for ease of viewing of the procedure. In addition, other portals may be provided to allow for instruments to be positioned relative to the tear 192 to the dermis 194. Nevertheless, the rotator cuff patch 110 may be provided through the selected portal 196, to repair the tear 192 and the rotator cuff 190.
Therefore, it will be understood that patches according to various design, sizes, and shapes can be formed using a plurality of materials. Generally the material may be laminated for selected characteristics, such as strength. The laminated material is generally co-extensive and can be cut or molded into a selected shape. In addition, the material may be cross-linked a selected amount to achieve a selected characteristic, such as moldability or rigidity. Nevertheless, the selected implant, formed from the laminated material can be used for a plurality of purposes or techniques, such as a rotator cuff patch or a reinforcement patch form a soft tissue harvest site. The patch may be substantially formed in a customized manner to fit the selected position or may be moldable to allow for on-site customization for the particular individual. It will also be understood that various exemplary embodiments are described in relation to specific exemplary procedures. Such description is not intended to limit the scope thereof, as each or all implants may be implanted using any appropriate procedure.
The description is merely exemplary in nature and, thus, variations that do not depart from the gist thereof are intended to be within the scope thereof. Such variations are not to be regarded as a departure from the spirit and scope of the description of the following claims.
