Abstract
An implant system for providing stabilized fixation of tissue includes a button having a slot, a band threaded through the slot, and a lock including a member having a slot for receiving an end of the band and a movable member for clamping the band in place. The movable member is movable between an open position and a locking position. The lock is a plug assembly which includes a flange. The slot is disposed in the flange. The movable member may be a cap which is movable between clamping and non-clamping orientations relative to the flange, or it may be a screw wherein a portion of the screw performs the clamping function. The flange is a portion of a plug, which plug further includes a boss extending from one side of the flange.
Claims
1. An implant system for stabilized fixation of tissue, comprising: a button comprising a pair of slots; a band having a length and being formed of suture material along its entire length which is adapted to be threaded through each of the pair of slots in sequence, so that the suture material is wrapped around a portion of the button separating the two slots; and a lock comprising a plug assembly, the plug assembly comprising a plug, the plug further comprising a horizontally disposed flange which lies across a majority of an entire width of the plug, and having a horizontally disposed slot disposed in the flange, the suture material also being adapted to be threaded through the slot disposed in the flange, so that between the button and the lock the band comprises said length of suture material doubled over itself along an entire distance between the lock and the button, the plug assembly further comprising a fastener which is movable between clamping and non-clamping orientations relative to the flange.
2. The implant system as recited in claim 1, wherein the suture material is a length of flat suture material.
3. The implant system as recited in claim 1, the flange further comprising a lip disposed about at least a portion of a periphery of the flange and defining a recess on the flange.
4. The implant system as recited in claim 1, and further comprising a cap which is movable with the fastener between the fastener's clamping and non-clamping orientations relative to the flange.
5. The implant system as recited in claim 1, wherein the fastener comprises a screw.
6. The implant system as recited in claim 5, wherein the screw has a flat head.
7. The implant system as recited in claim 1, and further comprising a second slot in the flange, so that the band may be threaded through the first slot in the flange, cross a surface of the flange, and then extend through the second slot in the flange, thereby securing the band to the flange.
8. The implant system as recited in claim 1, wherein the plug further comprises a boss extending from one side of the flange.
9. The implant system as recited in claim 8, wherein when the band is threaded through the slots of the flange, each end of the band extends along a length of the boss.
10. The implant system as recited in claim 9, wherein the boss comprises flat surfaces disposed along its length for accommodating the band ends extending therealong.
11. The implant system as recited in claim 1, and further comprising a suture tether attached to the button.
12. The implant system as recited in claim 11, and further comprising a guide needle attached to the suture tether.
13. A method for effecting repair of tissue using a tissue fixation band apparatus comprising a lock, a button, and a suture band, under tension, extending between the lock and the button, the suture band having first and second ends, comprising: pulling the button through a hole extending through the tissue to be repaired, until it exits a distal surface of the tissue and engages the distal surface of the tissue; pulling the suture band on each of the first and second ends to locate the lock in position on a proximal surface of the tissue; applying tension to the first and second ends of the suture band exiting from the lock of the fixation band apparatus to tension the suture band to a desired level; and causing a fastener within the lock to move to a locking position, to thereby engage the lock and clamp the suture band in place at the desired tension level, wherein the suture band comprises a length extending between the lock and the button, the suture band comprising doubled-over suture along said length, in its entirety, the causing step comprising tightening the fastener.
14. The method as recited in claim 13, wherein the causing step comprises tightening the fastener to cause a movable clamping member to move to its locking position, the movable clamping member comprising a head of the fastener.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1 is an isometric view of an implant system constructed in accordance with the principles of the present invention;
(2) FIG. 2A is a top isometric view of the assembly of FIG. 1, with suture tether, guide needle and cap excluded for clarity;
(3) FIG. 2B is a bottom isometric view, similar to FIG. 2A, of the assembly of FIG. 1;
(4) FIG. 3 is an isometric view of the inventive implant installed with a tibia and fibula, according to one particular method of the present invention;
(5) FIG. 4A is a top exploded isometric view of the plug assembly, including plug, screw, and cap components of the inventive system;
(6) FIG. 4B is a top isometric view of the plug assembly shown in FIG. 4A;
(7) FIG. 4C is a bottom isometric view of the plug assembly shown in FIGS. 4A and 4B;
(8) FIG. 5A is a top view of the cap component of the present invention;
(9) FIG. 5B is a cross-sectional view taken along lines 5B-5B of FIG. 5A;
(10) FIG. 5C is a top isometric view of the cap of FIGS. 5A and 5B;
(11) FIG. 5D is a bottom isometric view of the cap of FIGS. 5A-5C;
(12) FIG. 5E is a side view of the cap of FIGS. 5A-5D;
(13) FIG. 5F is a bottom view of the cap of FIGS. 5A-5E;
(14) FIG. 6A is a top isometric view of the plug component of the present invention;
(15) FIG. 6B is a bottom isometric view of the plug component of FIG. 6A;
(16) FIG. 6C is a top view of the plug component of FIGS. 6A-6B;
(17) FIG. 6D is a side view of the plug component of FIGS. 6A-6C;
(18) FIG. 6E is a bottom view of the plug component of FIGS. 6A-6D;
(19) FIG. 7A is a top exploded view of a modified embodiment of the plug assembly, including plug, screw, and cap components of the present invention;
(20) FIG. 7B is a top isometric view of the plug assembly of FIG. 7A;
(21) FIG. 7A is a bottom isometric view of the plug assembly of FIGS. 7A-7B;
(22) FIG. 8A is a top isometric view of the plug component of the assembly shown in FIGS. 7A-7C;
(23) FIG. 8B is a bottom isometric view of the plug component shown in FIG. 8A;
(24) FIG. 8C is a top view of the plug component shown in FIGS. 8A-8B;
(25) FIG. 8D is a cross-sectional view taken along lines 8D-8D of FIG. 8C;
(26) FIG. 8E is a side view of the plug component shown in FIGS. 8A-8D;
(27) FIG. 8F is a bottom view of the plug component shown in FIGS. 8A-8E;
(28) FIG. 9 is a top view of a modified embodiment of the plug portion of the present invention;
(29) FIG. 10 is a side view of the plug shown in FIG. 9;
(30) FIG. 11 is a differently oriented side view of the plug shown in FIG. 9;
(31) FIG. 12 is a cross-sectional view taken along lines B-B of FIG. 9;
(32) FIG. 13 is a cross-sectional view taken along lines A-A of FIG. 11;
(33) FIG. 14 is an isometric view of the plug shown in FIGS. 9-13; and
(34) FIG. 15 is an isometric view of the plug shown in FIG. 14, wherein the plug is lying on its side.
DESCRIPTION OF THE PREFERRED EMBODIMENT
(35) Referring more particularly to the drawings, there is shown in FIG. 1 an implant system 10 for providing stabilized fixation of tissues. The system 10 includes a guide needle 12, a protective cap 14 on one end of the needle 12, to protect the sharp tip of the needle and prevent needle sticks, a suture tether 16 attached at one end to an opposed second end of the guide needle 12, a button 18 attached to an opposed second end of the suture tether 16, a plug assembly 20, and a band 22 joined to and extending between the button 18 and plug assembly 20. Although the dimensions of these components may be varied considerably, within the scope of the invention, in one particular embodiment, the total length of the system is approximately 14 inches, with the length of the band 22, plug 20, and button 18 portion of the system totaling about 3.0 inches, the length of the suture tether 16 being about 5.0 inches, and the length of the guide needle 12 and cap 14 being about 6.0 inches. By itself, in one embodiment, by way of example only, the cap is about 0.77 inches in length.
(36) FIGS. 2A and 2B illustrate an implant assembly 23 of the implant system shown in FIG. 1. Notably, the button 18 may be manufactured from a surgical stainless steel or other suitable biocompatible material, such as 316 LVM stainless steel, titanium, or other suitable materials, such as bio-absorbables. Suture 24, comprising the suture band 22, is laced through slots 26 in a frame 28 forming the button 18, prior to use. As noted above, the band 22 is comprised of suture 24, which is, in particular embodiments, a woven polyester suture made from PET (polyethylene terephthalate), the same polyester as most commercially available sutures, or a suitable UHMWPE (Ultra-High Molecular Weight PolyEthylene). The band may be poly-coated or uncoated. In one embodiment, the suture 24 is provided in an overall length of 36 inches. The suture length between the narrow button 18 and the plug assembly 20 is nominally set to 3 inches, and is adjustable by the practitioner per the anatomical requirements of the patient.
(37) It is noted that the narrow button 18 is small enough to pass through a hole 42 through the tibia and fibula (discussed below), with a suture band attached and a tether suture and guide needle attached. The slots 26 in the button 18 are large enough to lace the suture band therethrough. The edges of the slots are smooth, with an internal radius to prevent band breakage during loading. The thickness of the narrow button is just enough to withstand ankle loads. The sides of the narrow button 18 are contoured in the shape of the hole 42 to provide maximum strength and clearance through the holes in the tibia and fibula.
(38) Now with reference more particularly to FIGS. 4A-4C, one illustrated embodiment of the plug assembly 20 is shown in greater detail. The plug assembly 20 comprises three main components, namely, a plug 30, a cap 32, and a screw 34. The entire assembly 20 is preferably made of 316 LVM stainless steel or titanium or other suitable biocompatible materials, such as bio-absorbables. The suture 24 is laced through slots 36 in a flange 37 of the plug 30 and the two ends of the suture 24 are tensioned. When the cap 32 is secured with the captive screw 34, as shown in FIGS. 4B and 4C, the plug assembly 20 is in a locked orientation.
(39) The screw is of sufficient strength to withstand the loads of tensioning the implant assembly 23 and to endure subsequent stresses after implantation. It preferably has a flat head 35 to allow the fastener to lie flush with the cap 32, and additionally has a cross feature to allow for a standard matching driver. The length of the screw threads 35a is sufficient to withstand the required loads and provide adjustment of the suture, plug, and cap during installation. The cap 32 has a countersink feature 33 for receiving the flat head 35 of the screw 34, as well as an undersized through hole 33a to keep the screw 34 captive. The cap 32 further has a round body with smooth radii edges to aid in concealing the plug assembly 20 beneath the patient's skin. An internal counter bore 33b provides clearance for the plug flange 37, as well as a load bearing surface for the suture band 22. An internal edge radius assists in tensioning the suture and an additional contact surface traps the suture between the cap edge and the bone.
(40) The plug flange 37 is thin, but of sufficient thickness to withstand the stresses of the ankle and thin enough to prevent excessive protrusion. The plug also comprises a boss 48, extending from the flange 37, which is long enough to allow for sufficient thread engagement. Flats 52 on the boss 48 act as clearance between the plug and bone to allow the suture to pass therebetween. A hole 54 in the plug flange accommodates the screw 34.
(41) Again referring to FIG. 1, the guide needle 12 may be made of 302 stainless steel, such as that used for most surgical needles, although other suitable biocompatible materials may be used as well. The needle, in the illustrated embodiment, is 6 inches in length and has a diameter of 0.078 inches. A 5 inch polyester (PET) suture is used to attach the needle 12 and the narrow button 18, the suture being attached to the needle 12 via an eyelet 53. After placement of the narrow button 18, the suture and the straight needle are discarded.
(42) In operation, the implant assembly 23 is delivered using similar techniques to other syndesmosis repair devices. In one such approach, a 3.6 mm hole 42 is pre-drilled through the cortices of the tibia 38 and fibula 40 (FIG. 3) from the open lateral side 44, for the purpose of repairing a separated syndesmosis 46. After appropriate reduction of the tibial and fibula bones, the straight guide needle 12 of the implant system 10 is passed through the drilled hole in the tibia and fibula and through the skin on the medial side, taking care to register the narrow button 18 into the pre-drilled hole 42. Tension is applied to the suture tether 16 to pull the narrow button 18 through both the fibula and tibia bones to the medial side, at which point the button 18 is toggled into position, lying flat against the medial cortex of the tibial bone 38, as shown. This creates tension across the two bone segments. At this juncture, the suture tether 16 and needle 12 are removed and discarded. Pulling the suture band 22 lightly on each end brings the lateral plug 30 to rest, flat on the fibula 40, as shown. Using a driver, the screw 34 is rotated within the cap 32 until the screw and cap are tight. The suture ends are then cut. The result is a syndesmosis repair with a knotless closure.
(43) FIGS. 7 and 8 illustrate an alternative embodiment of the plug assembly 20, which is particularly useful for providing stabilized fixation in an ACL repair, or other repairs where a separate anchor location is needed. The major difference between the FIG. 7 embodiment and that shown in FIGS. 1-6 is that the boss 48 of the FIG. 7 embodiment is substantially greater in length than the boss 48 of the FIG. 1-6 embodiment, and includes an aperture 50 extending laterally therethrough. In the ACL repair scenario, for example, a blind hole in the bone is drilled, the plug 30 is inserted into the hole, and, as the screw 34 is tightened, the plug body, particularly the boss 48, expands and compresses against the bone defining the blind hole, thereby anchoring the plug in place.
(44) It should be noted, however, that the FIG. 7 embodiment of the plug assembly 20 may be used in the procedure shown in FIG. 3, if desired.
(45) FIGS. 9-15 illustrate yet a further embodiment of the plug 30, which is substantially interchangeable with the plug 30 embodiments discussed above. The plug 30 includes a boss 48, and is adapted for receiving a screw or other suitable fastener 34 (not shown). The major difference between this embodiment and the previous embodiments is that the cap 32 has been eliminated in this embodiment, in favor of a flange 37 having a lip 55 which is configured to define a recess 56 therein. The recess 56 is sized and arranged to receive the screw head 35 therein, so that it is flush with the flange lip 55 in a manner similar to that shown in FIG. 7B for the prior embodiment using a cap 32. The flange lip 55 may extend entirely about the periphery of the flange 37, or it may extend only about a portion or portions thereof, as illustrated in FIGS. 9-15, depending upon design application considerations. A principal advantage of this embodiment is that it creates a lower profile on the bone than the cap embodiments. Instead of the cap providing the clamping surface for the suture, the lower surface of the head of the fastener provides that clamping surface. In all other respects, the plug 30 of FIGS. 9-15 is utilized in the same manner as the plug 30 in the prior described embodiments.
(46) Accordingly, although exemplary embodiments of the invention have been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.
