MEDICAL DEVICE FOR REPAIR OF TISSUE AND METHOD FOR IMPLANTATION AND FIXATION
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.
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This application is a continuation of U.S. application Ser. No. 12/283,474, filed on Sep. 12, 2008, which is a divisional of U.S. application Ser. No. 11/462,728, filed on Aug. 7, 2006, the disclosures of which are incorporated herein by reference.
FIELD OF THE INVENTIONThe 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.
DESCRIPTION OF THE RELATED ARTVarious 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 forms menisci 10, 11, shown in
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 as tear 22 shown in
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 in
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 as red zone 16 of meniscus 10, shown in
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. Stent 24, shown in
What is needed is a device that is an improvement over the prior art.
SUMMARY OF THE INVENTIONThe 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.
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:
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 DESCRIPTIONConduit 30 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 in
As shown in
In an exemplary embodiment, end 32 is perforated with a plurality of apertures of sufficient size and spacing to provide a substantially similar benefit as slot 47, described above. In another exemplary embodiment, shown in
As shown in
In another embodiment, the first end of filament 48 is inserted through aperture 42 into interior 38 of through bore 36 and pulled out of through bore 36 through aperture 44. In this embodiment, a portion of filament 48 extends through interior 38 of through bore 36 in a direction transverse to the longitudinal axis of body 70. In another embodiment, device 80, as shown in
The method for inserting the devices will now be described in detail with reference to medical device 78, shown in
Device 78 is advanced via the insertion tool until end 32 of conduit 70 is substantially aligned with the plane of tear 98, damaged area, or regenerative or replacement meniscus implant 134. 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 in
Once positioned, the insertion tool is removed, leaving conduit 70 in position and filament 48 extending from insertion point 100. Ends (not shown) of filament 48 are then looped over tear 98 and inserted in meniscus 10 at second insertion points 103, 104, shown in
With filament 48 taut, fixating inner and outer walls of tear 98 in mutual engagement, the ends of filament 48 are secured to one another. Once secured, device 78 is secured and the walls of tear 98 are fixed in their relative positions. In one exemplary embodiment, the ends of filament 48 are secured by tying the ends together to form knot 112, shown in
As shown in
As shown in
In another exemplary embodiment, shown in
Additionally, in another exemplary embodiment shown in
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 in
As shown in
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 device 146 will now be described in detail. Conduits 70, 70′ are inserted individually relative to tear 148 using the same procedure discussed hereinabove with respect to conduit 70 and tear 98. Once each conduit 70, 70′ is properly inserted, as shown in
In one exemplary embodiment, a knot (not shown) is used to fix filament 142, and correspondingly secure device 146, in position. In one exemplary embodiment, slip knot 144 is used to retain filament 142 in the tightened position. To tighten filament 142, end 150 is pulled away from top articulating surface of meniscus 10 and, at the same time, slip knot 144 slides downwardly toward top articulating surface 12. Once slip knot 144 is tightened, excess filament 142 can be trimmed and discarded. Due to the resilient nature of fibrocartilage tissue, filament 142 and slipknot 144 will become integrated with meniscus preventing any adverse effects, such pain or discomfort during articulation of the condyles of the femur against top articulation surface 12 and filament 142. In one embodiment, a series of devices 78, shown in
In another exemplary embodiment, conduit 160, shown in
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
1-7. (canceled)
8. A medical device comprising:
- a first elongate conduit having a first end, a second end, and a wall defining a longitudinal bore, the wall having an exterior surface and at least one surface feature protruding from the exterior surface;
- a second elongate conduit having a first end, a second end, and a wall defining a longitudinal bore, the wall having an exterior surface; and
- a filament attached to the first conduit and the second conduit.
9. The medical device of claim 8, wherein the longitudinal bore of the first conduit extends between the first end and the second end along an axis, the first conduit having a length dimension parallel to the axis and a width dimension transverse to the axis, the length dimension being greater than the width dimension, and
- wherein the longitudinal bore of the second conduit extends between the first end and the second end along an axis, the second conduit having a length dimension parallel to the axis and a width dimension transverse to the axis, the length dimension being greater than the width dimension.
10. The medical device of claim 8, wherein the wall of each of the first and second conduits includes at least one aperture in communication with the respective longitudinal bore and disposed between the respective first and second ends.
11. The medical device of claim 10, wherein the filament is connected to the first and second conduits at the respective at least one aperture.
12. The medical device of claim 8, wherein the at least one surface feature includes ribs or threads.
13. The medical device of claim 8, wherein the longitudinal bores of the first and second conduits are non-circular in cross-section.
14. The medical device of claim 13, wherein the cross-sections of the longitudinal bores of the first and second conduits are substantially similar in size.
15. The medical device of claim 13, wherein the cross-sections of the longitudinal bores of the first and second conduits are rectangular in shape.
16. The medical device of claim 8, wherein the first end of the second conduit includes at least one slot extending into the wall.
17. The medical device of claim 8, wherein the first and second conduits are bioabsorbable.
18. The medical device of claim 8, wherein the filament is selected from the group consisting of a strand, a thread, a fiber, a string, a wire, and a suture.
19. 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:
- providing a medical device including an elongate conduit, an anchor, and a filament attached to the conduit and the anchor, the conduit having a first end, a second end, and a wall defining a longitudinal bore, the wall having an exterior surface;
- inserting the conduit within the tissue;
- positioning the first end of the conduit adjacent to a face of a tear in the tissue such that the longitudinal bore is in communication with the tear;
- positioning the second end of the conduit in the first area of vascularity of the tissue;
- inserting the anchor through the tissue;
- positioning the anchor against an outer wall of the tissue; and
- securing the filament.
20. The method of claim 19, wherein the anchor includes a first end, a second end, and a wall defining a longitudinal bore, the wall having an exterior surface.
21. The method of claim 20, wherein the conduit includes at least one surface feature protruding from the exterior surface, and further comprising the step of securing the conduit within the tissue by engaging the at least one surface feature with the tissue.
22. The method of claim 21, wherein the longitudinal bore of the conduit extends between the first end and the second end along an axis, the conduit having a length dimension parallel to the axis and a width dimension transverse to the axis, the length dimension being greater than the width dimension, and the longitudinal bore of the anchor extends between the first end and the second end along an axis, the anchor having a length dimension parallel to the axis and a width dimension transverse to the axis, the length dimension being greater than the width dimension.
23. The method of claim 21, wherein the at least one surface feature includes ribs or threads.
24. The method of claim 23, wherein the longitudinal bore of the conduit is non-circular in cross-section, and wherein the step of inserting the conduit includes rotating the conduit about an axis parallel to the longitudinal bore of the first axis.
25. The medical device of claim 19, wherein the filament includes a first end and a second end, and the walls of the conduit and the anchor each include two apertures in communication with the respective longitudinal bore and disposed between the respective first and second ends, further comprising the steps of:
- inserting the first end of the filament through the two apertures of the conduit;
- inserting the first end of the filament through the two apertures of the anchor; and
- connecting the first end of the filament to the second end of the filament to form a slipknot.
26. The method of claim 25, wherein the step of securing the filament includes sliding the slipknot with respect to the filament.
Type: Application
Filed: Apr 14, 2010
Publication Date: Sep 30, 2010
Applicant: HOWMEDICA OSTEONICS CORP. (Mahwah, NJ)
Inventors: Herbert E. Schwartz (Fort Wayne, IN), Francis S. Proch (Huntertown, IN)
Application Number: 12/760,065
International Classification: A61B 17/04 (20060101);