US20080033487A1 - Medical device for repair of tissue and method for implantation and fixation - Google Patents

Abstract

The present invention relates to medical devices for repairing tissue and more specifically to devices which facilitate tissue regeneration and to surgical methods for the implantation and fixation of such devices. In one embodiment, the medical device is an elongate conduit that includes a longitudinal bore extending therethrough to facilitate the transfer of blood from a vascular region of tissue to a tear or damaged area located in an avascular and/or semi-vascular region of tissue. A filament and/or filaments are attached to the conduit and are positioned to secure the conduit and fixate the adjacent tear walls in mutual engagement. In another embodiment, a series of conduits are connected via a filament and/or filaments to facilitate the implantation of multiple conduits.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to medical devices for repairing tissue and more specifically to devices which facilitate tissue regeneration and to surgical methods for the implantation and fixation thereof.
• 2. Description of the Related Art
• Various parts of the human body are comprised of fibrocartilage. Fibrocartilage forms the disc, meniscus, and labrums, located in the spine and temporo-mandibular joint, knee, and shoulder and hip, respectively. Additionally, fibrocartilage is present in other parts of the human body, such as fingers, wrists, and ankles. Fibrocartilage is a resilient, compressive tissue capable of accepting and withstanding high loads imparted during bodily movement. Generally, fibrocartilage is found between two adjacent bones, such as the locations set forth hereinabove.
• The fibrocartilage of the knee formsmenisci10,11, shown inFIG. 1. Menisci10,11 are semi-lunar, wedge-shaped portions of tissue that sit atop the tibia and articulate with the tibia and femur during movement of the tibia and/or femur relative to one another. Menisci10,11 have top articulatingsurfaces12 which interface with the femoral condyle and bottom articulating surfaces (not shown) which interface withtibia plateau14. Menisci10,11 function as shock absorbers between the femur and the tibia to distribute compressive and shear loads from the curved condyles of the femur to the relatively flat plateau of the tibia. While much ofmenisci10,11 can be classified as avascular and aneural, eachmenisci10,11 has three distinct zones of vascularity, shown inFIG. 2, ared zone16, a red/white zone18, and awhite zone20.Red zone16, comprised of approximately the outer peripheral third of each meniscus, is rich in blood supply and is highly vascular.White zone20, comprised of approximately the inner peripheral third of each meniscus, is completely void of blood supply and is avascular. Red/white zone18, comprised of the area between the red zone and white zone, has some limited vascularity with limited blood supply. As a patient ages, the size of thewhite zone20 will increase and the size ofred zone16 and red/white zone18 will correspondingly decrease.
• Due to the high stress imparted on fibrocartilage, injuries and pathologies can occur in the fibrocartilage which are manifested in the form of tears, such astear22 shown inFIG. 3, defects, and/or degeneration. Tears may occur due to the existence of prior defects in the fibrocartilage, shear loading of the fibrocartilage, and/or compounded loading resulting from repetitive compressive loading occurring over a period of time. Additionally, fibrocartilage can deteriorate as a result of aging, resulting in hard and/or soft areas which further facilitate the creation of tears therein.
• One common procedure for treating fibrocartilage tears is to surgically remove part or all of the fibrocartilage surrounding the tear, such as removing a portion of the meniscus. These procedures, known as meniscectomies or partial meniscectomies when performed on the meniscus, are commonly utilized in the case of “unrepairable” or complex tears such as radial tears, horizontal tears, and vertical longitudinal tears occurring outside the vascular zone. Additionally, these procedures may be performed when there is fibrillation and/or degeneration caused by defects in an avascular or limited vascular area, since these injuries are unlikely to heal. As shown inFIG. 4, a partial meniscectomy may be performed in which the meniscus is removed along lines extending inwardly toward the inner meniscus from the peripheral ends oftear22. In some cases, implants may be inserted to replace the portion of the meniscus removed during the procedure. Meniscectomies, and similar fibrocartilage procedures, typically provide immediate pain relief and restoration of knee function to a patient. However, cartilage wear on the condylar or tibial plateau surfaces and the eventual development of osteoarthritis may occur as a result of the meniscectomy. Additionally, the onset of osteoarthritis may lead to more chronic conditions resulting in the need for a total knee replacement procedure.
• Another method for treating fibrocartilage tears, including tears of the meniscus, is to attempt to surgically repair the torn tissue. This technique is most commonly performed when the tear is a longitudinal vertical tear located in the vascular area of the fibrocartilage, such asred zone16 ofmeniscus10, shown inFIG. 2. To facilitate tissue regeneration, the tear walls may be rasped or trephined to induce bleeding. Additionally, the tear walls may be stabilized with sutures or other retention devices.
• A further method for treating fibrocartilage tears is the subject of U.S. patent application Ser. No. 10/558,926 to Schwartz (“Schwartz '926”). The stent of Schwartz '926 is designed with an interior, longitudinally-extending bore and external threads or ribs.Stent24, shown inFIG. 6, is inserted through fibrocartilage tissue and positioned to extend acrosswalls26,28 offibrocartilage tear22, shown inFIG. 5, to secure the sides of the tear together. The threads or ribbing ofstent24, denoted by slanted, dashed lines inFIG. 6, effectively retain the stent, andcorresponding tear walls26,28, in position. Additionally, the outer wall ofstent24 includes a plurality of apertures, not shown, extending from the interior of the longitudinal bore to the exterior surface ofstent24. These apertures allow for the dissemination of blood, biological factors, and cells fromstent24, as blood, biological factors, and cells flow throughstent24 from a vascular region of the fibrocartilage to a semi-vascular or avascular tear region of the fibrocartilage. The dissemination of blood, biological factors, and cells viastent24 stimulates tissue regeneration. While the device disclosed in Schwartz '926 is effective, the walls of the fibrocartilage tear may actually be pushed apart during implantation of the stent and prevent effective healing of the tear. Additionally, even when the sides of the tear are properly aligned, the tear walls may loosen or migrate over time. Further, the blood dissemination apertures in the stent may not be as effective in providing maximum blood flow to the area of interest as desired to effect healing.
• What is needed is a device that is an improvement over the prior art.
SUMMARY OF THE INVENTION
• The present invention relates to medical devices for repairing tissue and more specifically to devices which facilitate tissue regeneration and to surgical methods for the implantation and fixation of such devices. In one embodiment, the medical device is an elongate conduit that includes a longitudinal bore extending therethrough to facilitate the transfer of blood, biological factors, and cells from a vascular region of tissue to a tear or damaged area located in an avascular and/or semi-vascular region of tissue. A filament and/or filaments are attached to the conduit and are positioned to fixate the adjacent tear walls in mutual engagement. In another embodiment, a series of conduits are connected via a filament and/or filaments to facilitate the implantation of multiple conduits while fixating the adjacent tear walls.
• Advantageously, the present medical device allows for the provision of blood, biological factors, and cells from a vascular region of tissue to a torn or damaged area located in an avascular and/or semi-vascular region of tissue and provides for fixation of the tear walls or damaged area and the securement of a conduit in a desired position. Additionally, because the conduit itself anchors one side of the primary tear fixation, the conduit can be located with one end adjacent the plane of a tear, damaged area, or implant, allowing the conduit to efficiently deliver blood, biological factors, and cells thereto and increase the rapidity of the healing process. Moreover, in addition to facilitating the transfer of blood, biological factors, and cells from a vascular region to an avascular and/or semi-vascular region, the conduit can also provide for delivery of biological treatments, drugs, and other substances, such as blood, platelet rich plasma, growth factors, or cells, to the tear or defect area through the bore of the conduit. The desired substance can be delivered before, during, or after the conduit is inserted and positioned.
• In one form thereof, the present invention provides a medical device including an elongate conduit formed of biocompatible material, the device body having an exterior, a first end, a second end, and a longitudinal bore; and a filament attached to the device body, whereby the filament can be positioned to fixate tissue in a desired position.
• In another form thereof, the present invention provides a method for implanting a medical device in tissue, the tissue having a first area of vascularity and a second area of vascularity, the vascularity of the second area being less than the vascularity of the first area, the method including the steps of: inserting a device into tissue, the device including a conduit and a filament attached to the conduit, the conduit having a first end, a second end, and a bore therethrough; positioning the first end of the conduit adjacent the outside wall of a torn or damaged area of tissue; positioning the filament through the tissue to secure the conduit and fixate the tissue in a desired position; and securing the filament.
• In another form thereof, the present invention provides a method for implanting a medical device in tissue, the method including the steps of: inserting a device into tissue, the device including a plurality of conduits and a filament attached to the conduits, the conduits having a first end, a second end, and a bore therethrough; positioning the first end of each of the conduits adjacent the outside wall of a torn or damaged area of tissue; positioning the filament through the tissue to secure the conduit and fixate the tissue in a desired position; and securing the filament.
BRIEF DESCRIPTION OF THE DRAWINGS
• The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following descriptions of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
• FIG. 1 is a perspective view of the menisci and other knee anatomy;
• FIG. 2 is a partial cross-sectional view along line2-2 ofFIG. 1;
• FIG. 3 is a perspective view of the menisci, including a tear in the lateral meniscus and other knee anatomy;
• FIG. 4 is a perspective view of the menisci and other knee anatomy following a partial meniscectomy of the lateral meniscus;
• FIG. 5 is a partial cross-sectional view along line5-5 ofFIG. 3;
• FIG. 6 is a partial cross-sectional view of the lateral meniscus ofFIG. 3 including a prior art stent;
• FIG. 7 is a plan view of an embodiment of the conduit of the present invention;
• FIG. 7A is a plan view of a conduit according to another embodiment;
• FIG. 7B is a cross-sectional view along line7B-7B ofFIG. 7A;
• FIG. 7C is a plan view of a conduit according to another embodiment;
• FIG. 8 is a plan view of a conduit according to another embodiment;
• FIG. 9 is a plan view of a conduit according to another embodiment;
• FIG. 10 is a perspective view of an embodiment of the present invention incorporating a conduit according to another embodiment;
• FIG. 11 is a perspective view of the device ofFIG. 10 implanted in a meniscus;
• FIG. 12 is a cross-sectional view along line12-12 ofFIG. 11;
• FIG. 13 is a perspective view of a device according to another embodiment;
• FIG. 14 is a perspective view of the device ofFIG. 13 implanted in a meniscus;
• FIG. 15 is a perspective view of a device according to another embodiment;
• FIG. 16 is a elevational view along line16-16 of the device ofFIG. 15
• FIG. 17 is a perspective view of the device ofFIG. 10 implanted in a meniscus and secured according to another embodiment;
• FIG. 18 is a perspective view of the device ofFIG. 10 implanted in a meniscus according to another embodiment;
• FIG. 19 is a perspective view of the device ofFIG. 10 implanted in a meniscus and secured according to another embodiment;
• FIG. 19A is a perspective view of the device ofFIG. 10 implanted in a meniscus and secured according to another embodiment;
• FIG. 20 is a perspective view of the device ofFIG. 10 implanted in a meniscus and secured according to another embodiment;
• FIG. 21 is a perspective view of the device ofFIG. 10 implanted in a meniscus including a scaffold replacement; and
• FIG. 22 is a perspective view of a device according to another embodiment.
• Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate preferred embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention any manner.
DETAILED DESCRIPTION
• FIG. 7 showsconduit30 according to one embodiment of the present invention. Conduit, as used herein, means only an elongate body and does not define any other structural features.Conduit30 includes afirst end32, asecond end34, and throughbore36 extending fromfirst end32 tosecond end34. In one embodiment, bore36 has a non-circular cross-section.Body30 can be manufactured from any biocompatible material.Body30 has a length fromfirst end32 tosecond end34 as small as 2 mm, 3 mm, or 4 mm and as large as 10 mm, 12 mm, or 15 mm. Additionally,conduit30 may be coated with biocompatible substances to facilitate tissue regeneration, improve circulation, or achieve any other biologically desirable responses. For example,interior38 of throughbore36 may be coated with an anti-coagulant to prevent coagulation of blood within throughbore36, thereby promoting the delivery of blood to a torn or damaged tissue area. Alternatively, bore36 may contain a scaffold material to promote tissue regeneration or to improve healing outcomes.
• Conduit30 may also be made of any porous material which would allow for the transfer of blood from a vascular to an avascular area as a result of physiological processes in the patient's body. Moreover, such a porous construct may be two-piece, shown inFIG. 7A and 7B, wherein end32′ ofconduit30′ is closed and constructed of a porous material, while the remainder ofconduit30′ is made of a substantially solid, biocompatible material. This allows for blood or other fluid to enter34 viabore36 and exit through the porous material atend32′. Alternatively,conduit30 may be constructed entirely of porous material and lack bore36, as shown inFIG. 7C. Fluid would enterconduit30 fromend34 and travel, due to the interconnected porosity of the porous material, throughconduit36, exiting atend32. The flow of fluid may be directed by altering the material properties of the porous material along the length ofconduit30.
• As shown inFIG. 7,conduit30 further includes a plurality ofapertures42,44 atend32 ofbody30.Apertures42,44 extend frominterior38 of throughbore36 toexterior surface46.Apertures42,44 may receivefilament48, as shown inFIG. 10 and described in detail hereinbelow, for securingconduit30 within tissue and fixating a tear, damaged tissue, or an implant in a desired position. As used herein, filament is inclusive of single or multiple strands, threads, fibers, strings, wires or sutures. In another exemplary embodiment,apertures42,44 are positioned adjacent one another on the same side ofconduit30, i.e., along the axial length ofconduit30, and receivefilament48 in the same manner described in detail herein below. Location ofapertures42,44 on the same side ofconduit30 provides for eccentric loading ofconduit30 whenfilament48 is fully secured, which impedes pull out ofconduit30. Additionally,conduit30 may includeslot47, shown inFIG. 7, inend32 ofconduit30 which allow for the exit of blood or other substances therethrough.Slot47 aid the surgeon inpositioning conduit30 within tissue by eliminating the need for the surgeon to precisely alignend32 ofbody30 with the plane of a tear, damaged area, or implant to provide blood thereto. As long as the surgeon positions a portion ofslot47 in or adjacent the plane of the tear, damaged area, or implant, blood or other substances will be delivered to the tear, damaged area, or implant. In effect,slot47 provides an increased length, only a portion of which the surgeon must locate adjacent the tear, damaged tissue, or implant, thereby increasing the likelihood of a successful implantation.
• In an exemplary embodiment, end32 is perforated with a plurality of apertures of sufficient size and spacing to provide a substantially similar benefit asslot47, described above. In another exemplary embodiment, shown inFIGS. 7A-7B,conduit30′ includesclosed end32′ perforated by a plurality ofapertures49 of sufficient size to allow for the dissemination of blood therethrough. In another embodiment, the entire length ofconduit30 is perforated by a plurality ofapertures49 of sufficient size to allow for the dissemination of blood therethrough. Additionally, in another exemplary embodiment, the entire length ofconduit30 is porous, allow the release of fluid along the entire length ofconduit30.
• FIGS. 8-10show conduits50,60,70, respectively, according to additional embodiments of the present invention.Conduits50,60,70 include several features which are identical to the embodiment ofFIG. 7 discussed above and identical reference numerals have been used to indicate identical or substantially identical features therebetween. Conduits50,60, shown inFIGS. 8 and 9, respectively, include surface features, such as outwardly extendingribs52 and outwardly extendingthread62, respectively, onexternal surface46 of conduits50,60.Ribs52 andthreads62 provide an additional mechanism for fixation of conduits50,60 within tissue. As shown inFIG. 10,conduit70 further includesnose72.Nose72 is separated frommain body portion74 via tapering section76. During implantation,nose72 facilitates insertion ofconduit70 into the tissue and can be positioned such thatnose72 is in a vascular tissue, such as the synovium, whileribs52 and/orthreads62 provide fixation. Additionally,nose72 may itself be tapered to further ease insertion.
• As shown inFIG. 10,conduit70 includesfilament48 attached thereto, forming completedmedical device78. The devices of the present invention are an improvement over the stent disclosed in U.S. patent application Ser. No. 10/558,926 to Schwartz, which is assigned to the assignee of the present invention, the entire disclose of which is incorporated by reference herein.Filament48 may be manufactured from any flexible, biocompatible material, such as polyglactin, polydioaxanone, surgical gut, nylon, polypropeylyene, polyglycolic acid, polylactic acid, co-polymers, Vicryl®, and Ethibond Excel®. Vicryl® and Ethibond Excel® are registered trademarks of Johnson & Johnson Corporation, One Johnson & Johnson Plaza, New Brunswick, N.J. 08933.Filament48 andconduit70 may be preassembled or may be assembled by the surgeon before or during surgery.Filament48 andconduit70 may be connected together by inserting a first end (not shown) offilament48 intointerior38 of throughbore36. The first end offilament48 is then threaded throughaperture42 and wrapped half-way aroundexterior surface46 until the first end reachesaperture44. In another embodiment,filament48 is wrapped substantially entirely aroundexterior surface46. The first end offilament48 is then inserted throughaperture44 intointerior38 of throughbore36. First end offilament48 is then pulled out of throughbore36 throughend32. In another embodiment,exterior surface46 includes a groove (not shown) on at least a portion ofexterior surface46 transverse to the longitudinal axis ofbody70. Asfilament48 is pulled fromend32 ofbody70,filament48 tightens, seatingfilament48 within the groove. Oncedevice78 is assembled,device78 may be inserted into the meniscus as described in detail hereinbelow.
• In another embodiment, the first end offilament48 is inserted throughaperture42 intointerior38 of throughbore36 and pulled out of throughbore36 throughaperture44. In this embodiment, a portion offilament48 extends throughinterior38 of throughbore36 in a direction transverse to the longitudinal axis ofbody70. In another embodiment,device80, as shown inFIGS. 15-16, includesconduit82 havingnose72, throughbore36, andovermolded end84.Device80 include several features which are identical to the embodiment ofFIG. 10 discussed above and identical reference numerals have been used to indicate identical or substantially identical features therebetween. As best seen inFIG. 16,overmolded end84 includesapertures86,88 extending fromrim90 ofend32 toward opposingend34 along a portion ofconduit82.Bores86,88 may be formed to be slightly larger thanfilaments92,94 and, during manufacturing, shrink around the ends offilaments92,94 to retain the ends therein. Utilizingovermolded end84 preventsfilaments92,94 from extending into throughbore36 and provides an uninterrupted path for the flow of blood and other substances therethrough. In another embodiment, a biocompatible adhesive is used to secure the ends offilaments92,94 withinbores86,88. Oncedevice80 is assembled,device80 may be inserted into the meniscus as described in detail hereinbelow.
• The method for inserting the devices will now be described in detail with reference tomedical device78, shown inFIG. 10.Device78 may be inserted intomeniscus10 as shown inFIGS. 11 and 12. In one embodiment, the entire procedure is performed arthroscopically using standard techniques, procedures, and devices.Device78 is inserted from the interior side oftear98 atinsertion point100, located betweeninner rim102 ofmeniscus10 and the interior side oftear98. In another exemplary embodiment, the insertion point is the face oftear98.Device78 is inserted along a plane substantially parallel tobottom articulation surface14 ofmeniscus10. Whiledevice78 may be inserted at any angle relative tobottom articulation surface14, insertion along a plane substantially parallel tobottom articulation surface14 provides the optimal purchase forconduit70. In one embodiment, insertion ofdevice78 is performed using a compatible insertion tool, such as those disclosed in U.S. patent application Ser. No. 10/558,926 to Schwartz. The insertion tool (not shown) may be inserted into the interior of throughbore36 to retaindevice78 thereon andadvance device78 throughmeniscus10. In one embodiment, the insertion device is cannulated. The use of a cannulated insertion tool allows for the delivery of biological substances through the insertion device andconduit70 directly to the torn or damaged area ofmeniscus10. In another exemplary embodiment,device78 is inserted utilizing any technique known technique, including an all-inside technique, inside-out technique, and/or an outside-in technique.
• Device78 is advanced via the insertion tool untilend32 ofconduit70 is substantially aligned with the plane oftear98, damaged area, or regenerative orreplacement meniscus implant134. Additionally, when inserted to align with a damaged area of tissue, the deterioration of the damaged tissue may provide tactile feedback to the surgeon that the outer plane of the damaged area has been encountered. As shown inFIG. 18,conduit70 may be positioned adjacent a tear, damaged area, or regenerative orreplacement meniscus implant134 withnose72 extending fromouter wall106 ofmeniscus10. In this position,nose72 extends into the synovium and/or other tissue surrounding the knee joint, which is a highly vascular membrane surrounding the knee. In the same manner as set forth above with reference tored zone16 ofmeniscus10, blood, biological factors, cells, and fluid from the synovium and/or other tissue surrounding the knee joint can be delivered to a torn or damaged area ofmeniscus10 viaconduit70.
• Once positioned, the insertion tool is removed, leavingconduit70 in position andfilament48 extending frominsertion point100. Ends (not shown) offilament48 are then looped overtear98 and inserted inmeniscus10 at second insertion points103,104, shown inFIG. 11, located betweenouter wall106 ofmeniscus10 and tear98 or betweeninner rim102 ofmeniscus10 andtear98, using, for example, a needle. The ends offilament48 are advanced throughmeniscus10 at diverging angles until the ends exitouter wall106 atpoints108,110. The ends offilament48 are then tightened by pulling the ends away fromouter wall106. In addition to the stitching method set out above,filament48 can be positioned via any method known to one of ordinary skill in the art, including any horizontal or vertical mattress suture technique.
• Withfilament48 taut, fixating inner and outer walls oftear98 in mutual engagement, the ends offilament48 are secured to one another. Once secured,device78 is secured and the walls oftear98 are fixed in their relative positions. In one exemplary embodiment, the ends offilament48 are secured by tying the ends together to formknot112, shown inFIG. 11. Excess portions offilament48 may then be trimmed and discarded.
• As shown inFIG. 17, in another exemplary embodiment,first end114 offilament48 is secured to a retention device, such as buckle116, by insertingfirst end114 through an aperture in end118 of buckle116 and tyingend114 to formknot120.Second end122 offilament48 may then be secured to buckle116 by insertingsecond end122 through opening124 in buckle116, loopingend122 aroundbar126, and threadingend122 through second opening128. In this manner,filament48 is looped back onto itself and retained by friction within buckle116. For large tears or damaged areas, multiple devices may be implanted in accordance with the method described hereinabove.
• As shown inFIG. 19, in another exemplary embodiment,first end114 andsecond end122 offilament48 are secured, via knots for example, to hooks130.Hooks130 are curved and terminate at sharpenedtips132. At any time during the procedure,tips132 are inserted through theupper articulation surface12 ofmeniscus10. Onceconduit70 is properly positioned and hooks130 attached tomeniscus10 viatips132,filament48 acts to fixatetear22 andsecure conduit70 in position, as described hereinabove.
• In another exemplary embodiment, shown inFIG. 19A,first end114 andsecond end122 offilament48 are pulled tight through top articulatingsurface12 ofmeniscus10. Knot115 is tied usingfirst end114 andknot117 is tied usingsecond end122 to secure the walls oftear98 in mutual engagement. Due to the physical properties ofmeniscus10,knots115,117 will sink into top articulatingsurface12, preventing any damage to or pain in the patient's knee. Similarly, any other securement method or device disclosed herein may potentially be used atop top articulatingsurface12 to secure ends114,122 offilament48 together and fixate tissue in the desired position.
• Additionally, in another exemplary embodiment shown inFIGS. 20-21,conduit70 is positioned withinmeniscus10 in a similar manner as described hereinabove. To secureconduit70 in position withinmeniscus10 and fixatetear22 or regenerative orreplacement meniscus implant134, shown inFIG. 21, slide136 is used. Slide136 has a body with a bore extending therethrough andflange138 projecting from an end of the body of slide136.First end114 offilament48 is threaded through the bore of slide136 towardflange138.Second end122 offilament48 is then secured tofirst end114 offilament48 viaslipknot140. By pullingfirst end114 offilament48 away fromouter wall106 ofmeniscus10,slipknot140 moves towardouter wall106 and pushes slide136 intomeniscus10. Oncefilament48 is taught,flange138 will contactouter wall106 ofmeniscus10, preventingslipknot140 from sliding further.Slipknot140 can then be tightened to secure ends114,122 offilament48 together. Once secured, ends114,122 offilament48 may be trimmed and the removed portion discarded.
• While the devices of the present invention may be implanted as an alternative to a meniscectomy, the devices may also be implanted in native meniscus tissue or a regenerative or replacement meniscus implant following a meniscectomy to encourage and/or promote tissue regeneration and, when a regenerative or replacement meniscus implant is used, the device may further fixate the implant to the natural meniscus tissue, as shown inFIG. 21. As shown inFIG. 21, regenerative orreplacement meniscus implant134 is fixated viafilament48 in position againstnatural meniscus10.Implant134 further receives blood, biological factors, cells, and other fluids from thered zone16 of meniscus or, in another embodiment shown inFIG. 18, from the synovium viaconduit70.
• As shown inFIG. 13, twoconduits70,70′ are connected together viafilament130. In connecting the conduits, a first end offilament142 is inserted throughinterior38 of throughbore36 ofconduit70, pulled fromaperture42, and wrapped half way aroundconduit70. The end is then inserted throughaperture44, shown in hidden lines inFIG. 10, and pulled frominterior38 of throughbore36, as discussed in detail hereinabove.Filament130 is then inserted through interior38′ of throughbore36′ ofconduit70′, pulled fromaperture42′, and wrapped half way aroundconduit70′. The end is then inserted throughaperture44′ and pulled from interior38′ of throughbore36′, as discussed in detail hereinabove. The ends offilament130 are then connected together viaslipknot144, forming device146. While two conduits are depicted inFIG. 13, any number of conduits needed to facilitate tissue regeneration and healing may be connected together. Generally, as the size of the tear or damaged area increases, the number of conduits needed to facilitate tissue regeneration and healing will correspondingly increase.
• By using multiple conduits, blood and/or other substances can be delivered to multiple points along the plane of a tear or damaged area of tissue and fixated by the tightening of only a single filament. The insertion of device146 will now be described in detail.Conduits70,70′ are inserted individually relative to tear148 using the same procedure discussed hereinabove with respect toconduit70 andtear98. Once eachconduit70,70′ is properly inserted, as shown inFIG. 14,filament142 remains partially exposed along top articulatingsurface12 ofmeniscus10.Filament142 is then tightened, by pullingend150 offilament142 away from top articulatingsurface12 until the inner and outer walls oftear148 are in mutual engagement. The interference of top articulatingsurface12 ofmeniscus10 with the tightening offilament142 securesconduits70,70′ in their desired positions.
• In one exemplary embodiment, a knot (not shown) is used to fixfilament142, and correspondingly secure device146, in position. In one exemplary embodiment,slip knot144 is used to retainfilament142 in the tightened position. To tightenfilament142,end150 is pulled away from top articulatingsurface12 ofmeniscus10 and, at the same time,slip knot144 slides downwardly toward top articulatingsurface12. Onceslip knot144 is tightened,excess filament142 can be trimmed and discarded. Due to the resilient nature of fibrocartilage tissue,filament142 andslipknot144 will become integrated with meniscus preventing any adverse effects, such pain or discomfort during articulation of the condyles of the femur againsttop articulation surface12 andfilament142. In one embodiment, a series ofdevices78, shown inFIG. 10, may be utilized with a single tear. Eachdevice78 can then be fixated in the manner discussed hereinabove providing additional tension ontear98, shown inFIG. 11, and placingknot112 outside of the contact area ofmeniscus10 and againstouter wall106.
• In another exemplary embodiment,conduit160, shown inFIG. 22, includesfilament162 secured through apertures in projection164. Projection164 may be overmolded, as described in detail above, or may allow for sliding movement offilament162 within projection164. If sliding movement offilament162 is allowed, end166 offilament162 could be pulled away from projection164drawing end168 toward projection164. In another embodiment, projection164 is replaced by apertures located adjacent one another on the same side ofconduit160, i.e., along the axial length ofconduit160. These apertures acceptfilament162 in the same manner asapertures42,44, described in detail above with reference toFIGS. 7-10. The use of either projection164 or the apertures located on the same side ofconduit160 provides for eccentric loading ofconduit160 whenfilament162 finally secured, which impedes pull out ofconduit160.
• While this invention has been described as having a preferred design, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims (15)

1. A medical device comprising:

an elongate conduit formed of biocompatible material, said device body having an exterior, a first end, a second end, and a longitudinal bore; and

a filament attached to said device body, whereby said filament can be positioned to fixate tissue in a desired position.

2. The medical device ofclaim 1 wherein said longitudinal bore of said conduit extends from said first end to said second end.

3. The medical device ofclaim 1, wherein said conduit further comprises an aperture.

4. The medical device ofclaim 3 wherein said filament is attached to said conduit via said aperture.

5. The medical device ofclaim 3 wherein said apertures are in communication with said longitudinal bore.

6. The medical device ofclaim 1 wherein said conduit further comprises a surface feature extending from said exterior of said body selected from the group consisting of ribs and threading.

7. The medical device ofclaim 1 wherein said conduit further includes a slot.

8. The medical device ofclaim 1 wherein said conduit further comprises a buckle.

9. A method for implanting a medical device in tissue, the tissue having a first area of vascularity and a second area of vascularity, the vascularity of the second area being less than the vascularity of the first area, the method comprising the steps of:

inserting a device into tissue, said device including a conduit and a filament attached to said conduit, said conduit having a first end, a second end, and a bore therethrough;

positioning said first end of said conduit adjacent the outside wall of a torn or damaged area of tissue;

positioning said filament through said tissue to secure said conduit and fixate the tissue in a desired position; and

securing said filament.

10. The method ofclaim 9 wherein the first said positioning step further comprises locating said first end in a second area of vascularity.

11. The method ofclaim 10 wherein the first said positioning step further comprises positioning said second end of said device body in a first area of vascularity.

12. The method ofclaim 9 wherein said securing step further comprises looping said filament over said outside wall of a torn or damaged area of tissue.

13. A method for implanting a medical device in tissue, the method comprising the steps of:

inserting a device into tissue, said device including a plurality of conduits and a filament attached to said conduits, said conduits having a first end, a second end, and a bore therethrough;

positioning said first end of each said conduits adjacent the outside wall of a torn or damaged area of tissue;

positioning said filament through said tissue to secure said conduit and fixate said tissue in a desired position; and

securing said filament.

14. The method ofclaim 13 wherein said tissue has a first area of vascularity and a second area of vascularity, said first area having greater vascularity than said second area, the first said positioning step further comprising positioning said first end in said second area of vascularity.

15. The method ofclaim 14 wherein the first said positioning step further comprises positioning said second end of said conduit in said second area of vascularity.

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