The present invention relates to surgical devices and methods applied to position organic tissue into a bone structure. More particularly the present invention relates to the need to position a cannulated element in relation to a bone structure.
The prior art provides guide wires that are used to position cannulated elements, e.g., screws, dilators, notchers and taps, for engagement with a human or other mammalian bone. In particular, guide wires are conventionally used to position cannulated screws for the purpose of forming a fixation of a tissue with a bone. The bone may be part of a joint structure, e.g., a human knee. Certain fixation types known in the art that employ interference screws to affix a bone block or a soft tissue graft to a bone include definitive fixation and adjuvant fixation. The prior art also provides for additional methods of fixation, such as endobutton techniques, trans-fixations, and rigid-fixations.
Aperture fixation is a form of adjuvant fixation wherein a bone block or an end of a tendon or other soft tissue length is placed at least partially into a bone socket and an interference screw in driven in between, and engaged with, both a wall of the bone socket and the bone block or soft tissue length. The bone socket is generally surgically formed by drilling a round metallic bit into the bone. The bone socket may be dimensioned in the order of 20 to 35 millimeters in depth and have a cross sectional radius on the order of eight to eleven millimeters.
Some methods of fixation that provide highly stable/strong fixation can be suboptimal if the point of fixation with the bone from which a tendon extends is recessed form or located away from the actual joint or surface of the comprising bone. This distal placement of the point of fixation is not anatomic. A native ligament generally spans the length of a joint and may have one or more additional attachment points within the same joint and a surgical replacement for a native ligament will typically undergo equivalent functional requirements and demands. Furthermore, there is a well-described phenomenon (or “windshield wiper effect”) whereby a reconstructed ligament with a fixation point far from the joint, may move back and forth with joint activity, therefore widening the bone socket aperture, abrading the tendon or other graft material, and causing loosening, failure or degradation of the graft.
Therefore, in an effort to recreate the natural, native anatomy and prevent the windshield wiper effect it is generally preferable to put fixation closer to the joint line, e.g., a surface of the bone from which the surgically affixed tendon extends. In particular, when the screw is used by itself as a definitive fixation element, the screw may be driven into the bone socket so that an exposed end of the screw may be approximately placed up to the level of the bone socket opening, therefore providing aperture fixation.
The prior art further provides for fixating grafts of organic tissue, such as tendon tissue grafts and bone-tendon-bone tissue grafts (hereafter “BTB graft”), into sockets created in bone tissue. Certain prior art methods and devices are directed towards the reconstruction of the anterior cruciate ligament (hereafter “ACL”) using either solely tendon tissue or BTB graft fixation. The prior art generally enables a surgeon to position a tendon tissue graft or a bone element of a BTB graft into a socket drilled into a bone of a patient. In general, prior art methods of ACL reconstruction involve drilling a tunnel through the tibia, drilling a tunnel, i.e., a socket, into the femur, inserting a substitute an ACL tissue graft into the tunnels, and securing the tendon or BTB tissue grafts to the walls of tibial and femoral tunnels and sockets using interference screws.
Although interference screw attachment generally is secure, it is sometimes neither possible nor desirable to provide such fixation, particularly in the femoral socket. In revision situations, for example, where a previous reconstruction has been performed, placing a second femoral tunnel close to the previous socket may not be medically advisable.
A fixation technique that provides strong attachment of a graft in the femoral tunnel using a transverse implant is disclosed in U.S. Pat. No. 5,601,562. The transverse implant is inserted through a loop in a tendon graft. A threaded portion of the implant screws into the bone as the implant is advanced with rotation into the repair site. The technique is disadvantageous, however, because the graft can become wrapped around the implant as it is rotated. In addition, this technique requires a forked insertion tool to lift the tendon graft into the femoral socket, and large tibial and femoral tunnels are needed to accommodate the forked insertion tool. As a result of the large tunnels, the graft can slide laterally and “wipe” back and forth along the fixation implant.
An improved method for loading tendons into a femoral socket is disclosed in U.S. Pat. No. 5,918,604, the entire disclosure of which is incorporated by reference herein. In this technique, a strand of suture or nitinol wire is drawn transversely across the femoral socket, and a loop of the strand is pulled down from the socket and out of the tibial tunnel. The tendon graft is passed through the loop, and the strand loop with tendon attached is lifted back into the femoral socket. A transverse implant is then advanced under the tendon graft, preferably by impact insertion to avoid wrapping of the tendon graft during insertion.
U.S. Pat. No. 7,077,863 (hereafter '863) discloses an improved fixation technique, particularly in cruciate ligament reconstructions, utilizing a BTB graft, or construct, wherein a surgeon passes a strand through an opening of a femoral tunnel and through both the femoral tunnel and a tibial tunnel. The strand is then attached to a loop extending from a bone block of a BTB graft, and the strand is pulled back through the tibial tunnel and into the femoral tunnel, whereby the bone block proximate to the strand is pulled into the femoral tunnel. The surgeon must then insert a guide wire into the femoral tunnel and between the sidewall of the femoral tunnel and the BTB bone block positioned therein. The surgeon may then guide a cannulated implant, such as a fixating screw, along the guide wire and drive the implant to force a friction fit between the bone block, or alternatively a tendon graft, and the sidewall of the femoral tunnel. '863 advises that a nitinol wire may be used as a guide wire, and that the nitinol wire may be introduced after the bone block has been lifted into a femoral tunnel. Accordingly, there is a need for an improved technique to aid the surgeon in positioning the guide wire in concert with the positioning of a tendon or bone element of a tissue graft within a socket of a bone.
It is an object of the method of the present invention to provide a method for positioning a guide wire relative to tissue graft and a bone socket.
It is an additional object of certain alternate preferred embodiments of the method of the present invention to provide a device for driving a cannulated element into a bone socket.
It is another additional object of certain still alternate preferred embodiments of the method of the present invention to provide a method for driving a cannulated element between an inserted soft tissue graft, e.g., tendon tissue, and a sidewall of a bone socket to create support a grafting of the inserted soft tissue graft and the bone tissue.
Towards these and other objects that will be made obvious in light of the present disclosure, the method of the present invention provides a guide wire useful in surgical procedures. The guide wire may include a flexible tail length, a more rigid tip length and an attachment feature. Alternatively, the entire length of the guide wire may be substantially uniformly flexible, preferably having a tail and tip as flexible and rugged as a length of nitinol wire having across-section in the range of 0.5 millimeters to 2.0 millimeters.
The guide wire is configured to allow a cannulated screw to travel along the guide for insertion into bone, tendon or other tissue. The guide wire is further configured to enable a withdrawal of the tip length and the attachment feature through an internal channel of the cannulated screw after the cannulated screw has been inserted into bone, tendon or other tissue.
In certain alternate preferred embodiments of the method of the present invention the invented guide wire may be applied to position a dilator, notcher, or tap in relation to a bone or other body part or organ.
The attachment point is configured to enable the guide wire to be attached to a suture and to be positioned by movement of the suture into a proximity of a bone, tendon, or other tissue that the cannulated screw may be engaged with.
In certain alternate preferred embodiments of the present invention the tail length (hereafter, “tail”) may be or comprise a metal wire, a nitinol wire, a surgical suture stitching (hereafter, “suture”), a reinforced suture or thread, or a cord.
Alternatively or additionally, in certain other alternate preferred embodiments of the method of the present invention the tip length (hereafter, “tip”) may be or comprise a wire, a metal wire, nitinol, and/or a biodegradable wire.
Further alternatively or additionally, in certain other alternate preferred embodiments of the method of the present invention a tapered section may be disposed between the tip and the tail in order to reduce a possibility that the cannulated screw will be obstructed when being driven along the tail and onto the tip.
Even further alternatively or additionally, in certain other alternate preferred embodiments of the method of the present invention a the tip and the tail may present an equal or substantially equal radius in order to reduce a possibility that the cannulated screw will be obstructed when being driven along the tail and onto the tip.
In certain yet other alternate preferred embodiments of the method of the present invention the attachment feature may be or comprise a hook, a pair of hooks, an eye, one or more threads, and/or one or more wires.
The foregoing and other objects, features and advantages will be apparent from the following description of the preferred embodiment of the invention as illustrated in the accompanying drawings.
U.S. Pat. Nos. 7,329,281; 7,217,280; 7,211,111; 7,083,647; 7,077,863; 6,939,379; 6,833,005; 6,743,233; 6,599,289; 6,221,107; 6,146,408; 5,211,647; and 5,320,626; and US Patent App. Publication Serial Numbers 20060293689; 20060247642; 20060189991; and 20060149259 are incorporated herein by reference and for all purposes. In addition, each and all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent in their entirety and for all purposes as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
These, and further features of the invention, may be better understood with reference to the accompanying drawings depicting the preferred embodiment, in which:
In describing the preferred embodiments, certain terminology will be utilized for the sake of clarity. Such terminology is intended to encompass the recited embodiment, as well as all technical equivalents, which operate in a similar manner for a similar purpose to achieve a similar result.
It is understood that elements depicted in the drawings may be embodied in varying dimensions are that the drawings are therefore not presented in a particular scalar representation but as representative sizes.
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It is understood that the invented guide wire 2 or 12 may also be applied to position a dilator, notcher, or tap in relation to a bone or other body part or organ.
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It is understood that a close positioning of a top plane 22B of the bone block 22 in relation to an outer surface 20A of the bone 20 can reduce wear and tear of a tendon of a BTB graft that may be caused by the windshield wiper effect of the tendon rubbing against the bone 20. The method of the present invention enables positioning of the bone block top plane 22B within zero to ten millimeters of the bone top surface 20A, and preferably within three millimeters to five millimeters.
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The double looped attachment feature 36 includes an outer loop 36A and an inner loop 36B, each loop 36A & 36B comprising nitinol wire having a cross sectional diameter Z.3 preferably within the range for 0.5 millimeters to one millimeter, and/or within the range form one fourth to one half of the diameter Y.1 of the nitinol wire tip 6. Inner loop 36B and the outer loop 36A are sized and shaped to capture the strand 10.
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It is understood that the tip 6 may be formed of nitinol, or other suitable metallic, nonmetallic, plastic and/or biodegradable material known in the art.
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The tapered section 62 has a cross sectional radius Y.4 proximate to the tail and increases to a maximum cross-sectional radius Y.1 proximate to the tip 6. The tapered section may be comprised within either the tapered tail 64 or the tip 6 in various alternate preferred embodiments of the present invention. The tapered guide wire 60 may be a homogenous length of material, such as a length of nitinol. Alternatively, the tip 6 may be a nitinol wire section having a radius Y.1 in the range from 0.7 to 3.0 millimeters, and comprising the tapered section 62 of tapered nitinol wire, or other suitable material known in the art. The tapered tail 64 may be comprised of nitinol wire surgical suture, or other suitable material known in the art, and preferably having a maximum cross-sectional radius Y.4 in the range of 0.5 to 1.2 millimeters.
The tapered tail length X.4 is preferably in the range between 0.2 meters to 2.0 meters, and more preferably in the range between 0.3 meters and 0.6 meters.
The tapered section length X.5 may be a long as the cannulated screw length X.3, and/or preferably in the range between 5 millimeters to 20 meters, and more preferably in the range between 10 millimeters and 15 millimeters.
The foregoing disclosures and statements are illustrative only of the Present Invention, and are not intended to limit or define the scope of the Present Invention. The above description is intended to be illustrative, and not restrictive. Although the examples given include many specificities, they are intended as illustrative of only certain possible embodiments of the Present Invention. The examples given should only be interpreted as illustrations of some of the preferred embodiments of the Present Invention, and the full scope of the Present Invention should be determined by the appended claims and their legal equivalents. Those skilled in the art will appreciate that various adaptations and modifications of the just-described preferred embodiments can be configured without departing from the scope and spirit of the Present Invention. Therefore, it is to be understood that the Present Invention may be practiced other than as specifically described herein. The scope of the Present Invention as disclosed and claimed should, therefore, be determined with reference to the knowledge of one skilled in the art and in light of the disclosures presented above.