Patent Grant
10561410
This invention relates to methods and apparatuses (including devices and systems, as well as devices and systems for performing the methods described herein) for repair of tissue by anchoring the tissue to or within a bone using an anchor that is inserted almost completely through a bone before being anchored in place. In particular, described herein are methods and apparatus for repair of the anterior cruciate ligament (ACL).
Tears to the anterior cruciate ligament (ACL) are painful and often debilitating. Surgery for ACL injuries typically involves reconstructing the ACL using a graft material to replace the torn ACL. For example, ACL reconstruction surgery typically uses a graft to replace or support the torn ligament. The most common grafts are autografts from the patient (e.g., from a tendon of the kneecap or one of the hamstring tendons), though donor allograft tissue may also be used, as well as synthetic graft material. Although ACL reconstruction surgery is often referred to as ACL “repair” surgery, the current standard of care for ACL tears is to replace the torn ligament with a graft, rather than attempting to sew the torn ACL together. Merely sewing together the torn ACL has proven ineffective.
In general, ACL surgery may be performed by making small incisions in the knee and inserting instruments for surgery through these incisions (arthroscopic surgery) or by cutting a large incision in the knee (open surgery). During arthroscopic ACL reconstruction, the surgeon may make several small incisions around the knee. Sterile saline solution is pumped into the knee through one incision to expand it and to wash blood from the area. This allows the doctor to see the knee structures more clearly. The surgeon then inserts an arthroscope into one of the other incisions with a camera at the end of the arthroscope that transmits images of the internal region. Surgical drills may be inserted through other small incisions to drill small holes into the upper and lower leg bones where these bones come close together at the knee joint. The holes form tunnels through which the graft will be anchored. The surgeon may take an autograft at this point. The graft may also be taken from a deceased donor (allograft). In most prior art procedures, a graft may then be pulled through the two tunnels that were drilled in the upper and lower leg bones. The surgeon may secure the graft with screws or staples and close the incisions with stitches or tape.
Unfortunately, replacing the ACL with a graft material, which requires anchoring both ends of the graft material to bone, has proven technically difficult, resulting in a long surgical time, and may ultimately require a long recovery time. Replacement of native ACL material with graft material typically leads to the loss of native ACL proprioceptive fibers, and results in an alteration of the native ACL tibial footprint geometry. In some cases, removing autograft material from the patient may result in donor site morbidity, while donor allograft material presents an increased risk of HIV and Hepatitis C transmission.
In addition, anchoring tissue to bone, both in ACL procedure and more generally, has proven challenging. For example, anchoring tissue to bone in regions of limited access, such as the joints (e.g., knee, shoulder, hip, etc.) without having to displace, and potentially further damage, the joints has proven difficult. Access to the bone attachment site may be difficult in the confined region of the joint, making it particularly difficult to manipulate and secure an anchor within this region. One possible solution has been drill one or more passages through the bone from outside of the joint to form an opening in the joint space, and then anchor the tissue from the outside of the confined joint region, for example, by pulling the tissue, graft and/or suture through the bone passage to the opposite side of the bone. Unfortunately, this procedure results in poor fixation, as the tissue, graft and/or suture may stretch over time.
Thus, it would be desirable to provide devices, systems and methods for repair of the ACL that do not require the replacement of the ACL and the formation of multiple anchoring sites. The apparatuses (systems and devices) and methods for repair of the ACL described herein may address these concerns.
The present invention relates to apparatuses and methods for repair of tissue (including, but not limited to ACL) using an anchor that may be passed through a tunnel from a first opening on a first side of the bone channel to an opposite side of the bone tunnel. The anchor may be used with a graft material that may be sutured directly onto the torn tissue. The systems and methods described herein may use a suture passer configured to operate in the narrow confines of a bone joint, including those having independently operable sliding and bending jaws with a completely retractable tissue penetrator, such as those described in many of the applications previously incorporated by reference in their entirety, including at least: U.S. patent application Ser. No. 11/773,388, filed Jul. 3, 2007, titled “METHODS AND DEVICES FOR CONTINUOUS SUTURE PASSING,” Publication No. US-2009-0012538-A1; U.S. patent application Ser. No. 12/291,159, filed Nov. 5, 2008, titled “SUTURE PASSING INSTRUMENT AND METHOD,” Publication No. US-2010-0331863-A2; U.S. patent application Ser. No. 12/620,029, filed Nov. 17, 2009, titled “METHODS OF SUTURING AND REPAIRING TISSUE USING A CONTINUOUS SUTURE PASSER DEVICE,” Publication No. US-2010-0130990-A1; and U.S. patent application Ser. No. 12/942,803, filed Nov. 9, 2010, titled “DEVICES, SYSTEMS AND METHODS FOR MENISCUS REPAIR,” now U.S. Pat. No. 8,562,631; U.S. patent application Ser. No. 13/462,773, filed May 2, 2012, titled “SUTURE PASSER DEVICES AND METHODS,” now U.S. Pat. No. 8,465,505; and U.S. patent application Ser. No. 13/323,391, filed Dec. 12, 2011, titled “SUTURE PASSER DEVICES AND METHODS,” Publication No. US-2012-0283753-A1.
Although the methods and apparatuses described herein may be used to repair a torn anterior cruciate ligament (ACL), these methods and apparatuses are not limited to ACL repair, but may be generally applicable and used to repair tissue, and particularly tissue within a constricted region of the body (including joints) that would benefit from attachment to a bone. Thus, although the examples described herein illustrate ACL repair, it should be understood that any tissue, graft, or implant may be repaired using these methods and apparatuses. For example, repair of torn ligaments in the shoulder, hip, spine, or the like, including, without limitation, repair of the rotator cuff repair.
In general, the methods described herein may be referred to as transosteal because they may include the step of forming a passage, channel, tunnel, or the like (which may be referred to as a “tunnel” for convenience) through a bone (such as, for example, a femur head) from a first side of the bone to a second side of the bone, and passing an anchor through the tunnel from either the first side or the second side and all the way through the bone passage to the opposite side where it is anchored in place. The suture may be cinched in the anchor by pulling from the first side of the bone when the anchor is located on the second side of the bone. The bone anchor may be adapted for both passing through the tunnel and for anchoring into the bone after passing through the tunnel. The bone anchor may be referred to as a transosteal bone anchor (and/or suture anchor). A transosteal bone anchor may include a passageway through the anchor (e.g., along the length of the anchor) so that a suture, graft, and/or tissue may be pulled through the anchor and cinched in place. Thus, the suture anchor may include one or more locking elements (e.g., one-way locks) to permit suture, graft and/or tissue to be drawn into the anchor, but prevent the suture, graft and/or tissue from exiting the anchor.
For example, described herein are methods for transosteally repairing a tissue that include the steps of: forming a tunnel through a bone so that the tunnel extends from a first side of the bone to a second side of the bone; passing a suture anchor through the tunnel from the first side of the bone, through the tunnel and adjacent to the second side of the bone; securing the suture anchor within the tunnel adjacent to the second side of the bone; securing a torn end of the tissue to a suture; and cinching the suture in the suture anchor by pulling the suture through the anchor from the second side of the bone and out of the first side of the bone.
The method may also include securing the torn end of the tissue to a graft coupled to the anchor.
In some variations, forming a tunnel comprises drilling an elongate, straight tunnel through the bone. The tunnel may include a first opening (into the bone) on the first side of the bone, and a second opening (into the bone) on a second side of the bone. In general, the tunnel is straight, however the tunnel may also be curved. The anchor and tunnel may be configured to complement each other, so that the suture anchor may be configured for transit through the tunnel from a first side of the bone to the second (opposite) side of the bone. The tunnel and/or anchor may be sized and configured so that the anchor may pass through the tunnel until reaching the second side of the bone, wherein the anchor may be secured in position. For example, the tunnel may be tapered or may include a smaller second opening than first opening.
Any of the methods or apparatuses described herein may include a transosteal bone anchor that includes one or more elements to help the anchor stay fixed at or near the second end of the tunnel. For example, the anchor may be threaded or may include one or more projecting members that are configured to project from the anchor and engage the wall or walls of the tunnel. In some variations the wall of the tunnel may be adapted to receive one or more members from the anchor. For example, the wall of the tunnel may include an indentation, cavity, notch, or the like to receive a extending member from the anchor once the anchor is in position; the extending member from the anchor may be biased to open when the anchor is in position, pushing (extending) the extending members into the receiving region(s) and preventing the anchor from moving within the tunnel once in position. For example, securing the suture anchor within the tunnel adjacent to the second side of the bone may comprise extending one or more locking arms from the suture anchor once it has been positioned adjacent to the second side of the bone.
In some variations, the anchor is advanced in the tunnel and/or secured in the tunnel by screwing the anchor into the tunnel. In some variations, the tunnel may be threaded over all or a portion of its length (e.g., all except the portion near the second side of the bone.
In general, the tunnel may be formed by drilling. For example, forming a tunnel may comprise drilling an elongate, straight tunnel through the bone from the first side of the bone to the second side of the bone. In some variations the method may be performed with a guidewire. The guidewire may be used to form the tunnel and/or to place the anchor, and/or to draw the suture through the anchor and/or tunnel. For example, forming a tunnel may comprise driving a guidewire through the bone from the first side of the bone to the second side of the bone. The guidewire may be a needle or rigid wire. The guidewire may couple or connect to a suture and/or anchor.
In some variations, passing a suture anchor may comprises passing a suture anchor having a central passageway configured to permit a suture to be pulled in a first direction while preventing the suture from being pulled in a second direction that is opposite to the first direction.
In some variations, securing the suture anchor within the tunnel adjacent to the second side of the bone comprises securing the suture anchor within the tunnel so that a distal end of the suture anchor extends from the second side of the bone; alternatively, the suture anchor may be secured so that the suture anchor is recessed within the tunnel relative to the second side of the bone; alternatively, the suture anchor may be secured so that an end of the suture anchor is flush with the second side of the bone.
The step of securing a torn end of the tissue to a suture may comprise precutaneously suturing the torn end of the tissue with a suture passer near the second side of the bone. In general, a suture passer such as those discussed and described herein may be used to precutaneously suture the torn tissue. For example, a suture passer may be configured with a first jaw that is slideable relative to the second jaw, and the second jaw may be hinged to pivot relative to the first jaw and/or the elongate body of the suture passer. In a retracted configuration, with the first jaw retracted proximally relative to (and/or into) the elongate body of the suture passer, the second jaw may be angled to allow a high degree of maneuverability within a confined tissue region such as a joint that is at least partially surrounded by bone. The first jaw member may be extended after placing the second jaw adjacent to the target tissue, so that the first and second jaws may form an open, distal-facing mouth around the target tissue to pass a suture between the first and second jaws.
In general, the suture, and particularly the end of the suture extending from the anchor toward the first side of the bone, may be trimmed or cut. The thus, in some variations, the method may comprise cutting the end of the suture extending from the first side of the bone.
In general, the tunnel through the bone may be filled and/or closed off after cinching and securing the torn tissue (e.g., ligament) in or to the bone. For example, any of the methods described herein may include a step of filling the tunnel through the bone after cinching the suture in the anchor. The tunnel may be filled with bone cement (e.g., poly methyl methacrylate), and/or bone chips, or the like.
Also described herein are methods of repairing torn anterior cruciate ligaments (ACL). For example, described herein are methods for the transosteal repairing a torn anterior cruciate ligament (ACL), the method comprising: forming a tunnel through a femur so that the tunnel extends from a first side of the femur to a second side of the femur; passing a suture anchor through the tunnel from the first side of the femur, through the tunnel and securing the suture anchor near the second side of the femur; securing a torn end of the ACL to a suture; and anchoring the suture in the suture anchor by pulling the suture through the anchor from the second side of the femur and out of the first side of the femur, wherein the anchor comprises a one-way lock configured to prevent the suture from pulling out of the anchor toward the second side of the femur.
Also described herein are methods for transosteally repairing an anterior cruciate ligament (ACL) within the femoral notch, the method comprising: forming a tunnel through a femur so that the tunnel extends from a first side of the femur to a second side of the femur within the femoral notch; anchoring a suture anchor within the tunnel and adjacent to the second side of the femur; securing the suture anchor within the tunnel adjacent to the second side of the femur; securing a torn end of the ACL to a suture; and cinching the suture in the suture anchor by pulling the suture through the anchor from the second side of the femur and out of the first side of the femur, wherein the anchor comprises a one-way lock configured to prevent the suture from pulling out of the anchor toward the second side of the femur.
For example, described herein are methods for repairing a torn ACL within the femoral notch. In some variations, the methods include the steps of: anchoring a graft within the femoral notch; and suturing a torn end of the ACL to the graft within the femoral notch. In general, the step of anchoring the torn end of the ACL to the graft is performed precutaneously. The graft may be integral to (or pre-attached to) an anchor such as a knotless anchor. In some variations the torn end of the ACL is twice anchored within the femoral arch: both to a suture passed through and/or around the torn end of the ACL, and then to a graft that is anchored within the ACL. The connection to the graft may be made second, so that it may reinforce the suture which can be secured within the ACL to the same (or in some variations a different) bone anchor.
For example, in some variations, the step of anchoring a graft comprises securing an anchor to which a graft has been coupled within the femur so that a proximal end of the graft extends from the femur. For example, anchoring a graft may comprise driving a guidewire through the femur and drilling an opening to hold a graft anchor; and securing an anchor coupled to a graft within the opening over the guidewire.
The anchor may be secured by screwing the anchor into the opening (e.g., the tunnel drilled through a region of the femoral notch).
In some variations, the method includes securing the torn end of the ACL to a suture and pulling the suture through the femur to position the torn end of the ACL adjacent to the graft. The step of suturing the torn end of the ACL may comprise passing a suture through the graft and the ACL multiple times, e.g., with a suture passer that is adapted for use within the narrow confines of the tissue. For example, the step of suturing the torn end of the ACL may comprise passing a suture through the graft and the ACL multiple times with a continuous suture passer without removing the suture passer from the tissue.
In some variations the method further comprises securing the torn end of the ACL to a suture and pulling the suture through the femur to anatomically tension the ACL adjacent to the graft.
Also described herein are methods for repairing a torn ACL within the femoral notch, the method comprising: anchoring a graft within the femoral notch; positioning a torn end of the ACL adjacent to the graft; and percutaneously suturing the torn end of the ACL to the graft within the femoral notch.
In some variations, the step of positioning comprises securing a suture to the torn end of the ACL. For example, pulling the suture through a tunnel in the femoral notch to position the torn end of the ACL adjacent to the graft. In some variations, the method includes the step of anchoring the torn end of the ACL to the femoral notch with a suture before percutaneously suturing the torn end of the ACL to the graft.
In any of the variations of methods described herein, the method may include forming (e.g., drilling) a tunnel through the femoral arch for anchoring the torn ACL. The step of anchoring the graft within the femoral notch may include anchoring the graft within a tunnel drilled through the femoral arch.
Also described herein are methods for repairing a torn ACL within the femoral notch, the method comprising: drilling a tunnel through a portion of the femoral notch; anchoring a graft within the tunnel through the femoral notch, wherein the graft extends from the tunnel; pulling a suture connected to a torn end of the ACL through the tunnel through the femoral arch to positioning the torn end of the ACL adjacent to the graft; anchoring the suture connected to the torn end of the ACL; and percutaneously suturing the torn end of the ACL to the graft within the femoral notch.
In general, described herein are methods and apparatuses for repairing a torn tissue, including transosteal methods of repairing a torn tissue. These methods may include the steps of forming a channel through a bone that extends from a first side of the bone to an opposite (second) side of the bone, securing an anchor in the tunnel at or near the second side of the tunnel, percutaneously suturing the torn tissue to secure the suture to the torn end of the tissue, and pulling the suture and torn tissue toward the anchor, though an opening in the anchor and/or tunnel from the second end of the tunnel toward the first end of the tunnel, thereby securing the suture and/or tissue within the bone tunnel and/or anchor. In particular, these methods may include securing the anchor by passing the anchor though the tunnel from the first side of the bone to (or near) the second side of the bone. This method may allow minimally invasive repair of torn tissue and/or implantation of grafts or other materials, even in very narrow or confining spaces such as bone joints, without having to distend or otherwise open up the space and potentially damage the surrounding tissue, as is currently required in many tissue repairs.
For example, described herein are methods and devices for use in repair of a patient's anterior cruciate ligament (ACL). These methods (and devices for performing them) allow the repair, rather than merely replacement, of the ACL. As discussed above, although the ACL is used to exemplify the apparatus and methods of the present invention, these apparatuses (devices and systems) may also be used with many other tissues and are not limited to the repair and/or replacement of ACL tissue.
The anchoring devices described herein may be inserted into a bone and may hold a graft material within the bone so that the graft may also be attached to the torn or damaged ACL. The implanted anchoring device (which may also be referred to as an “implant” or “knotless graft anchor” or “suture anchor”) may be particularly well suited for use with any of the low-profile and/or continuous suture passers described herein, since these suture passers may allow access to previously inaccessible regions of the knee (or other body regions). For example, the methods described herein may include access into the notch region (e.g., the femoral notch) to anchor a graft in an optimal position, and to suture the graft to the damaged ACL while maintaining as much of the native ACL as possible. Previous methods of “repairing” (rather than replacing) the ACL have proven unsuccessful at least in part because this region was difficult or impossible to successfully access. Suturing in the notch region, without the benefit of the continuous suture passers described and incorporated by reference herein, has proven extremely difficult and time consuming, discouraging such surgical repairs.
In variations including a graft material, any appropriate graft material may be used. For example, an ACL graft for use with the methods and devices described herein may include: synthetic grafts (e.g., Gore-Tex, Dacron, carbon fibers, and polypropylene braids, etc.), biologic (e.g., porcine, human or other) allografts, autografts, etc. The graft materials describe herein may provide support or scaffolding for repair of the torn ACL, since the ACL is left in place and sutured to the graft. Thus, in some variations the graft may be a sleeve or patch (e.g., a graft jacket, Restore patch, etc.) The graft may include a biologic material such as a growth-promoting material that may promote in-growth, visualization, or the like (e.g., growth factors, etc.).
In general, the apparatuses (e.g., devices and/or systems) described herein may include a knotless anchor, such as a knotless ACL graft anchor, which may also be referred to as an ACL graft anchor, a one-way ACL graft anchor, a knotless ACL repair screw, or merely a “device” in the description below. These ACL graft anchors are one type of anchor that may be used, and (like other types of anchors) may include a one-way path for passing (and therefore anchoring) a suture. The ACL graft anchor may also include a coupling region for coupling to a graft material. Any of the anchors that may be used for the procedures described herein (including, but not limited to, the ACL anchors) may include a one-way path may be a central passage through the device. In general a one-way path forms a channel through the device and may include cams or other locking members that prevent a suture passing through the one-way path from pulling out the device. The one-way path may be referred to as the suture channel or path, since the suture may extend through (and be held within) the one-way path, although other elements (e.g., a guidewire, such as a beath pin, etc.) may also be passed through the channel. The one-way channel may extend from the proximal to the distal ends of the device, which may advantageously allow the anchor to be easily implanted and positioned, and may anchor the suture (e.g., connected to an ACL) at or within a bone region of the femoral notch. For example, the suture may be drawn through the implant to pull the distal end portion of a torn ACL towards (and to or into) the proximal end of the anchor. The anterior end of the implant is typically the end that faces the torn tissue, and may not be completely inserted into the bone, and may face away from the bone.
As mentioned above, some variations of the anchors described herein allow both securing (e.g., suturing) of the torn ACL to the scaffold/support (e.g., graft) after the graft has been anchored into the bone, and also tensioning of the torn ACL by pulling and locking the position of a suture that has been secured to the torn end of the ACL. In particular, the anchor includes a one-way pathway that allows the suture connected to the torn end of the ACL to be pulled and held (locked) distally, to adjust the tension on the ACL as it is being positioned adjacent to the graft so that it can then be sutured to the graft. The one-way locking mechanism in the suture pathway through the anchor allows this tensioning. Thereafter, the reinforcing support of the graft (scaffolding) maintains the tension and position of the ACL for short-term repair and long-term healing. Thus, described herein are anchor devices that are configured to both pre-tension a torn ACL and to secure the tensioned ACL to the reinforcement graft anchored in the bone by the device. Some variations of these devices therefore may include a one-way (locking) path for a suture to be drawn through the body of the anchor as well as a coupling region for a graft, or a graft that is already integrally part of the device.
The coupling region that may couple to a graft may be located as the distal end (e.g., the end to be inserted into the bone) of the device so that the graft will be anchored at one end in the bone. The coupling region may be positionable or rotatable around the circumference of the device. In some variations the coupling region is a loop or ring that is rotatably attached around the distal end region of the ACL anchor, which is also connected to a second loop or ring through which the graft (e.g., ACL graft) may pass and be secured. A coupling region may be referred to as a collar. Alternatively, the attachment region may include a suturing substrate (e.g. fabric) to which the graft may be coupled or connected. In some variations, the coupling region may include a passage through the device through which the graft may be passed. In some variations the coupling region is connected (or formed of) the distal end of the ACL anchor, which may be rotatable around the long axis of the ACL graft anchor.
Thus, in general, the ACL anchors described herein are configured to secure both an ACL graft (which is to be sutured to the ACL) and a suture that is also connected to the torn ACL.
The ACL anchors described herein may also be configured to secure within an opening drilled into the bone (e.g., a tunnel into the bone, as shown in the figures and discussed below). The sides of the anchor may be self-tamping, ridged, expandable, or the like, to secure the anchor within the bone. The body of the anchor may also include one or more passages or opening into which bone may grow (or be encouraged to grow). In some variations the device includes lateral openings into which a cross-pin or other additional anchoring device may be inserted.
For example,
Other examples of anchors that may be used may not include the graft attachment region, but may be otherwise similar. For example, the anchor may include threaded sides and a central channel with a one-way locking mechanism for the suture. In some variations it is not necessary to use a graft to secure the torn tissue (e.g., ACL) within the anchor and therefore the bone; the torn tissue may be directly sutured as shown and described below (e.g.,
An ACL repair screw (anchor) body such as the one shown in
A passageway for the suture and/or tissue (and/or graft) through the anchor may also be valved to allow only one-way travel through the device, as shown. In
As mentioned above, any appropriate suture passer may be used, particularly those described in: U.S. patent application Ser. No. 11/773,388, filed Jul. 3, 2007 and titled “METHODS AND DEVICES FOR CONTINUOUS SUTURE PASSING,” Publication No. US-2009-0012538-A1; U.S. patent application Ser. No. 12/291,159, filed Nov. 5, 2008 and titled “SUTURE PASSING INSTRUMENT AND METHOD,” Publication No. US-2010-0331863-A2; Ser. No. 12/620,029, filed Nov. 17, 2009, titled “METHODS OF SUTURING AND REPAIRING TISSUE USING A CONTINUOUS SUTURE PASSER DEVICE,” Publication No. US-2010-0130990-A1.” For example, suture passers having a suture shuttle that is configured to clamp to the side of a curved tissue penetrator that can be extended and retracted to pass the suture shuttle (and any attached suture) back and forth between two open/closed jaws or arms are of particular interest. In this example, the suture shuttle may generally include a shuttle body that clamps to the tissue penetrator, and has an extension region (“leash”) with a suture attachment region at the end. In this way the suture may be held slightly apart from the tissue penetrator, and not interact directly with the tissue penetrator.
In some variations, the shuttle used for passing the suture by a continuous suture passer may be further adapted for use with the devices and methods described herein. For example, the shuttle may be configured to include a lead wire that allows a region of one or more loop to be cut free after the initial ACL suture is placed (because the central part of the suture may be passed to allow a loop to be formed, through which the proximal aspect of the suture ends can be inserted for a self-cinching pattern. See, for example,
In any of the variations described herein, one or more arthroscopic devices may be used to help manipulate the tissue, in addition to the suture passers (or in place of the suture passers) described. For example,
In general, any of the anchors described herein may be used as part of a system for repairing ACL. Such a system may also include a continuous suture passer and or suture material. In particular, continuous suture passers that are capable of passing a suture back and forth (e.g., by connection to a shuttle member) between two arms or jaws while the jaws are open around the tissue (e.g., ACL tissue), are of particular interest. Thus, the system may include the suture passer, and one or more anchors as described herein. For example, the suture passers may include one such as that illustrated in
The suture passer of
For example,
A second control 813 (“lower jaw control”) is also configured as a lever or trigger, and may be squeezed or otherwise actuated to extend and/or retract the lower jaw 806 to form a distal-facing mouth with the upper jaw, as shown in
In addition to the suture passers described above, including in
In set of examples of transosteal methods as described herein are methods of repairing a torn ACL. These methods may include anchoring one end of an anchor (which may include a graft or scaffold) in the femoral notch, for example, by securing an anchor in the femur at the attachment site of the ACL to the bone in the femoral notch. The anchor may hold one end of a flexible scaffold for attaching to the patient's ACL. The scaffold may be a graft, sleeve, patch, or the like. The step of anchoring may include anchoring a scaffold (e.g., graft) using an ACL graft anchor such as those described above. The scaffold may be secured by first driving a pin (e.g., a beath pin) though the posterolateral femoral arch, and drilling an opening into which the ACL graft anchor may sit. In some variations a second tunnel or passage for the graft, adjacent to the first, may also be formed. An ACL graft anchor with an attached ACL scaffold may then be secured into the opening formed through the femoral arch bone. In some variations a guidewire may be used to guide both the drill and/or the anchor so that it can be positioned.
In some variations, as illustrated below, the anchor may be inserted in the desired location by first forming a tunnel through the bone (e.g. femur) and then driving or otherwise pushing the anchor from the outer (first bone) wall which faces away from the torn tissue (e.g., away from the femoral notch) thought the bone in the tunnel so that the anchor is positioned near the inner (second) wall of the bone, facing the femoral notch and the torn ACL tissue. The anchor may be positioned so that it is recessed, flush, or extends slightly from the second wall of the bone in the femoral notch. In variations in which the scaffold (e.g., graft) is attached to the anchor before positioning it in the bone, the graft and anchor may together be driven through the bone tunnel to the second bone wall. For example, the anchor may be adapted to hold the scaffold within a central region or channel of the anchor so that the scaffold can be extended from the anchor for attachment to the tissue once the anchor has been positioned.
In variations using a scaffold, once the scaffold (e.g., graft) is anchored in the femoral arch, the torn end of the ACL, when repairing the torn ACL, may be pulled towards the ACL anchor and scaffold and sutured to the scaffold while in the notch. For example, the end of the torn ACL may be sutured or connected to a suture and the suture drawn though the body of the suture anchor to pull the end of the ACL towards the anchor and the graft. The suture may hold the ACL in position so that it may be sutured (using a separate suture) to the graft material, thereby re-attaching the ACL to the femoral arch region. In some variations the end of the suture is passed through the anchor distally, along the one-way passage through the anchor, holding it in position. This step may be performed to secure the tissue with the anchor even when a graft is not used.
For example,
In
In
In one variation, the ACL is sutured to the anchor prior to implanting the anchor in the femoral notch, and the anchor with the end of the femoral notch is then positioned (e.g., by pulling the anchor using a guidewire and or the suture) into position, where it can be expanded or otherwise fixed into position.
Next, as shown in
In some variations, particularly those in which the scaffold (e.g., graft) attached to the distal tip of the anchor is positioned to the side of the anchor (as illustrated in
Once the anchor is secured in the femoral arch, and in variations using a scaffold/graft, with the graft extending from the arch, the end region of the ACL may be pulled into position using a suture. Prior to this step the ACL may be secured with a suture as shown in
Returning now to
The ligament can be tensioned by pulling on the sutures with the desired amount of force. This may reduce the knee (e.g., pulling the tibia back into position relative to the femur) and may bring the ACL tissue back to its origin on the femoral notch. Thereafter the proximal end of the suture may be knotted and cut, as shown in
Finally, the ACL can be sutured to the graft/support material, as shown in
In some variations, platelet-rich plasma or other biologic healing stimulants may also be added following or during the procedure in the notch. Note that
Once the suture has been secured to the torn tissue, the free end(s) of the one or more sutures may be pulled through the bone tunnel from second (e.g., inner) end of bone tunnel to the first (e.g., outer) end of the bone tunnel, as illustrated in
Once the torn tissue has been repaired, the loose end of the suture may be cut and/or tied off.
Thereafter, the bone tunnel may be capped and/or filled, as illustrated in
In some variations the tunnel through the bone may have a larger outer surface opening than inner surface opening, as illustrated in
In some variation, the methods and apparatuses described herein may be used to treat a torn meniscal root. For example, the meniscal root may be repaired as described above by forming a transosteal tunnel through the tibia (e.g., to the tibial plateau) and repairing the meniscal root by suturing the torn end of the root and securing it to an anchor held in tunnel near (e.g., adjacent) to the tibial plateau.
It is well-known in the art that repair of the meniscal root is both desirable and highly difficult. For any patient, even “ideal” young and highly active candidates, meniscal repair continues to represent a significant challenge. It is undisputed that vertical tears greater than 1 cm in the peripheral-third of the meniscus should be repaired, however, there has been new attention on repairing posterior root tears. With these root tear repairs, an inside-out repair is not feasible due to the posterior midline placement of the needles and the passage of the suture. Both the medial and lateral menisci have a stout attachment at their very posterior aspects, which is called the root attachment. The root of the meniscus is the region where the meniscus attaches to the central tibial plateau. This root attachment is important because it holds the meniscus in place, provides stability to the circumferential hoop fibers of the meniscus, and prevents meniscal extrusion. When there is a tear of the meniscal root, it has been demonstrated on biomechanical testing that it is equivalent to having the whole meniscus removed. Thus, a tear of the meniscal root is considered a very serious condition. An example of a meniscal root repair is shown in
Meniscal tears within the body of the meniscus or at the meniscocapsular junction represent a well-understood and manageable condition encountered in clinical practice. In comparison, however, meniscal root tears (MRTs) often go unnoticed and represent a unique injury pattern with unique biomechanical consequences. The root attachments of the posterior horns of the medial and lateral meniscus are very important for joint health. When these are torn, the loading of the joint is equivalent to having no meniscus on the affected side. Thus, these patients can often have early onset arthritis, the development of bony edema, insufficiency fractures, and the failure of concurrent cruciate ligament reconstruction grafts. For this reason, much research has gone in to meniscal root repairs over the last several years. However, current methods for repairing the meniscal root are not completely satisfactory. For example, meniscal repair techniques that suture the meniscus from the “outside” (e.g., though the capsule) may not properly restore the anatomy, for example, anchoring the meniscus to the posterior capsule, rather than the tibia.
For example,
The transosteal tunnel may be positioned with the opening onto the plateau in any appropriate position, including as close to the original location of the meniscal root attachment site as reasonable.
In
The second leg (e.g., the proximal end region) of the suture has been passed through a radially offset region of the meniscus from the inferior to the superior side as shown in
Thereafter, the first and second legs of the suture may be passed through the loop on the superior surface, as shown in
Once secured, the suture(s) may be pulled through the anchor positioned in the tibial tunnel near the opening 1205 and anchored in place. The free ends of suture may knotted and/or cut. The tunnel may be filled and/or sealed.
In some variations a combination of a locking loop and a second stitch or loop type may be used (e.g. non-locking loop stitch) to secure or repair tissue. The second stitch may be any appropriate type of stitch. For example,
In
The ends of the suture may be passed through the tibial tunnel and anchored to a suture anchor secured within the tibial tunnel. In some variations a guidewire/pin may be used to pull the suture ends thought the tunnel and/or anchor. The anchor may be configured to prevent withdrawal of the suture towards the tibial plateau.
In general, meniscal root repair may require suturing the posterior horn of the meniscus and then anchoring that tissue to the tibia. Traditional bone anchors are inserted into a bone tunnel from the opening that faces the tissue to be anchored. This is not possible in root repair as the constraints within the knee do not allow a straight vector into the tibial plateau at the required insertion point(s). Because of this, the suture may instead be threaded through the tibial tunnel where it exits inferiorly along the side of the tibia. It is then placed in tension around a button with an O.D. greater than the tunnel I.D. As a result, there are several inches of “free” suture from the meniscal tissue to the fixation at the button. Under loading, we have observed that this free suture stretches. The absolute distance that this free suture can stretch is a function of the length of the free suture. For example, depending on the modulus of elasticity of the suture material, if the function is linear and there is a 10% increase in length at a given load (hypothetically), 1 mm of suture will only creep 0.1 mm, but 4 inches of suture will stretch 0.4 inches (1 cm). At some point, this stretch may be clinically significant. The methods and apparatuses described herein may allow a substantial reduction in the length of free suture by placing the transosteal anchor closer to the origin of the tunnel, which will provide a more stable and physiological repair.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements, these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This patent application is a continuation of U.S. patent application Ser. No. 14/451,293, filed Aug. 4, 2014, titled “TRANSOSTEAL ANCHORING METHODS FOR TISSUE REPAIR,” now U.S. Pat. No. 9,913,638, which claims priority to U.S. Provisional Patent Application No. 61/862,414, filed Aug. 5, 2013, and titled “TRANSOSTEAL ANCHORING METHODS FOR TISSUE REPAIR,” each of which is herein incorporated by reference in its entirety. U.S. patent application Ser. No. 14/451,293 also claims priority as a continuation-in-part of U.S. patent application Ser. No. 13/893,209, filed May 13, 2013, titled “IMPLANT AND METHOD FOR REPAIR OF THE ANTERIOR CRUCIATE LIGAMENT,” now U.S. Pat. No. 8,888,848, which claims priority as a continuation of U.S. patent application Ser. No. 13/347,184, filed Jan. 10, 2012, titled “IMPLANT AND METHOD FOR REPAIR OF THE ANTERIOR CRUCIATE LIGAMENT,” now U.S. Pat. No. 8,500,809, which claims priority to U.S. Provisional Patent Application No. 61/431,293, filed Jan. 10, 2011, and titled “IMPLANT AND METHOD FOR REPAIR OF THE ANTERIOR CRUCIATE LIGAMENT.” Each of these patents and patent applications are herein incorporated by reference in their entirety. All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. In particular, the following patent applications are herein incorporated by reference in their entirety: U.S. patent application Ser. No. 11/773,388, filed Jul. 3, 2007, titled “METHODS AND DEVICES FOR CONTINUOUS SUTURE PASSING,” Publication No. US-2009-0012538-A1; U.S. patent application Ser. No. 12/291,159, filed Nov. 5, 2008, titled “SUTURE PASSING INSTRUMENT AND METHOD,” Publication No. US-2010-0331863-A2; U.S. patent application Ser. No. 12/620,029, filed Nov. 17, 2009, titled “METHODS OF SUTURING AND REPAIRING TISSUE USING A CONTINUOUS SUTURE PASSER DEVICE,” Publication No. US-2010-0130990-A1; and U.S. patent application Ser. No. 12/942,803, filed Nov. 9, 2010, titled “DEVICES, SYSTEMS AND METHODS FOR MENISCUS REPAIR,” now U.S. Pat. No. 8,562,631.
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| 20180199931 A1 | Jul 2018 | US |
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