The present invention relates generally to systems for repairing body tissue and more specifically to systems for repairing meniscal tissue.
Meniscal tissue in the knee may develop a longitudinal, vertical lesion sometimes referred to as a “bucket handle” lesion. It is recognized that such lesions will heal over time if the lesion is closed and stabilized. One known method for repairing a meniscus tear includes making an arthrotomy incision in the knee in order to place a suture into the inner portion of the torn meniscus, through to the outer portion. Another known procedure involves the use of a pair of long needles which contain a suture between them, and placing the two needles through the torn meniscus from the front of the knee joint exiting percutaneously the posterior area of the joint.
Another meniscal repair system, promoted by Bionx Implants, Inc., uses a fastener which is proposed to be inserted arthroscopically. The fastener has a shank, an enlarged head at one end of the shank, and one or more barbs at the other end and/or spaced along the length of the shank. The barbed end of the fastener is tapered to a point. In the Bionx system, the fastener is inserted, pointed end first, into the interior region of the meniscus adjacent to the tear. Insertion is continued until the enlarged head engages meniscal tissue. The length of the shank is selected to extend beyond the opposite side of the meniscus. The barbs are intended to prevent retraction of the fastener so that the meniscal tear is closed and the opposing sides of the tear will heal together.
The present invention provides an improved insertable surgical fastener and method for repairing torn body tissue. The improved fastener or stent preferably includes an elongated shank having an enlarged proximate head end and a pointed distal tip end. A long blind bore extends through the head end and shank to a location close to the tip. Transverse holes communicate between the blind bore and the exterior of the shank.
The improved fastener can be inserted into the interior region of a meniscus tear to be repaired. With the fastener held in position with the head end engaging the meniscus and holding the lesion closed and stabilized, medical adhesive is inserted into the bore through the head end and flows outward through the transverse holes. Preferably the adhesive sets almost immediately for stabilizing the now closed lesion without interfering with healing. In alternative embodiments, adhesive may be injected from the exterior of the stent to make the adhesive bond between the stent and adjacent tissue.
The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
The present invention is used to repair soft tissue, particularly a meniscal tear.
Thus, the Schreiber-Bionx system relies on the barbs of the fastener to prevent it from becoming dislodged and possibly allowing the tear to reopen or at least not be held together sufficiently to heal together as completely or reliably as otherwise might occur.
The present invention provides an improved insertable fastener and method for repairing torn body tissue.
With reference to
Preferably the interior surface (hidden from the viewer in
As indicated diagrammatically in
Preferably the stent will be sufficiently dimensionally stable that it will not bend or deflect substantially as it is inserted, nor elongate or stretch which could alter the abutting relationship of opposite sides of the tear and interfere with healing. However, the stent can be somewhat flexible in a transverse direction so as not to interfere with normal functioning of the repaired tissue. This may require that the stent, particularly the shank, be narrow. If too stiff or too large, abrasion could occur in the area of the shank of the stent. For the same reason, it is believed that the stent should not have exposed sharp edges.
The viscosity of the adhesive and size and location of the transverse holes are somewhat related. It is envisioned that such holes should be provided at least in opposite sides of the shank 20 of the stent 18 for adhering to surrounding tissue. Nevertheless, the adhesive should not be so fluid nor the transverse holes 26 so large that an excess quantity of the adhesive is injected, which could interfere with the healing process (e.g., the revascularization and/or neovascularization of the repair site). It may be preferable to position the holes toward the opposite ends of the stent shank, or at least away from the area expected to be adjacent to the tear, to prevent the adhesive from flowing between the opposite faces of the tear. For example, in the embodiment of
It is envisioned that the adhesive can be of the general type described in U.S. Pat. No. 5,350,798 of Linden et al. or a variant. Such an adhesive is, in general, a polymer gel and, more specifically, a cyanoacrylate polymer. Modified gels are described in U.S. Pat. Nos. 5,714,159 and 5,612,052 of Shalaby.
At the time of injection, preferably the adhesive flows freely without high adhesive properties relative to the tissue being repaired, but will thereafter set quickly and secure the sides of the tear in the desired abutting relationship. In the currently preferred embodiment, the adhesive will set within about 10 seconds to a condition of high shear strength and substantial rigidity, but not so rigid as to crack in the area of the shank if it flexes slightly during normal use of the joint. The adhesive may inherently have disinfectant characteristics and/or may be coated or impregnated with a compound having disinfectant characteristics. Alternatively or additionally, the adhesive and/or stent may serve as a delivery system for drugs and/or agents and/or factors to promote healing and/or growth. Both the stent and the adhesive preferably are bioabsorbable, but over a sufficiently long length of time that full healing of the tear occurs. In the case of a normal meniscal tear, the adhesive-stent combination should maintain full strength for approximately eight to twelve weeks and then degrade as the meniscus heals further.
While the preferred characteristics of the invention have been described and illustrated, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention. For example, while the preferred manner of delivery of the adhesive is through a bore of the stent, in another embodiment the adhesive could be injected by syringe from the exterior of the meniscus into the area of an inserted stent. Such a stent could have circumferential grooves 29 (
The present application is a continuation of International Application PCT/US01140061 filed Feb. 7, 2001 designating the United States, which claims the benefit of the filing date of Unites States Provisional Application Serial No. 60/180,702, filed on Feb. 7, 2000.
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Number | Date | Country | |
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Number | Date | Country | |
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60180702 | Feb 2000 | US |
Number | Date | Country | |
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Parent | PCT/US01/40061 | Feb 2001 | US |
Child | 10114709 | US |