Bone anchors are used extensively in open and minimally invasive surgery to reattach tissue to bone. The bone anchor is secured to the bone and one or more sutures attached to the bone anchor are used to secure the tissue to the bone. The tissue can be soft tissue anywhere in the body, for example, a torn rotator cuff in a shoulder or a torn ligament. One example of a bone anchor is disclosed in U.S. Pat. Nos. 8,721,650 and 9,539,001. The entire disclosure of each of those patents is incorporated herein by reference for all purposes.
Typically, in a first step to reattach tissue to bone, a hole is drilled into the bone under arthroscopic visualization. The bone anchor may be inserted into the hole and may be configured to lock itself within the hole in the bone upon deployment therein. Several means for securing the bone anchor within the hole of a bone are known in the art. Once the bone anchor is secured within the hole in the bone, one or both ends of suture attached to the bone anchor may be tensioned to approximate the positioning of the tissue with respect to the bone. Once the tissue is positioned as desired, the suture may be locked in place to maintain the tension in the suture. The free end or ends of the suture may be clipped under arthroscopic visualization to complete the procedure.
The bone hole size that is drilled when inserting the bone anchor corresponds to a patient's recovery time. Accordingly, a smaller bone hole size is desired to reduce recovery times for patients. A bone anchor, however, must have sufficient pull-out strength so that it stays in place and allows tissue to properly reattach to bone. Therefore, a bone anchor must be small enough to be inserted through a bone hole and also have reliable pull-out strength such that it is not pulled back through the bone hole. Further, bone hole sizes may vary depending on the location of the procedure in the body. It is therefore desired that a bone anchor may be configured in different sizes.
Accordingly, there is a need for a bone anchor that provides the above features.
The present disclosure provides new and innovative systems and methods for bone anchor insertion. In an example, a system includes an inserter, a plunger, a bone anchor, and at least one suture. The inserter includes a tube. The plunger is to be depressed through an interior of the tube. The bone anchor includes an insertion end and a plunger end. The plunger end is connected to the insertion end by a plurality of deformable members. Each respective deformable member includes a first portion, a second portion, and a third portion, the third portion being between the first and second portions. The third portion causes the respective deformable member to deform. When the bone anchor is in a compact configuration, the respective first portions are substantially parallel to the respective second portions. When the bone anchor is in an expanded configuration, the respective first portions are at an angle to the respective second portions. The bone anchor is positioned within the interior of the tube when the bone anchor is in the compact configuration. Forcing the insertion end towards the plunger end of the bone anchor in the compact configuration causes the bone anchor to transition to the expanded configuration. The at least one suture is coupled to the insertion end of the bone anchor.
In another example, a system includes an inserter, a plunger, a bone anchor, and at least one suture. The inserter includes a tube. The plunger is to be depressed through an interior of the tube. The bone anchor includes an insertion end and a plunger end. The plunger end is connected to the insertion end by a plurality of deformable members. Each respective deformable member includes a first portion and a second portion. The bone anchor is constructed of a shape memory material. When the bone anchor is in a compact configuration, the respective first portions are substantially parallel to the respective second portions. When the bone anchor is in an expanded configuration, the respective first portions are at an angle to the respective second portions. The bone anchor is positioned within the interior of the tube when the bone anchor is in the compact configuration. Upon the bone anchor exiting the interior of the tube, the bone anchor transitions from the compact configuration to the expanded configuration. The at least one suture is coupled to the insertion end of the bone anchor.
In another example still, a method includes inserting a bone anchor coupled to an inserter through a bone. The inserter includes a tube and a plunger that is to be depressed through an interior of the tube. The bone anchor includes an insertion end and a plunger end. The plunger end is connected to the insertion end by a plurality of deformable members. Each respective deformable member includes a first portion and a second portion. The bone anchor is initially in a compact configuration within the interior of the tube. The respective first portions are substantially parallel to the respective second portions when the bone anchor is in a compact configuration. The at least one suture includes a coupling end and a free end, and is coupled to the insertion end of the bone anchor at the coupling end. The tube is retracted while maintaining a positioning of the plunger, thereby causing the bone anchor to exit from the interior of the tube. The bone anchor is then transitioned from the compact configuration to an expanded configuration. When the bone anchor is in the expanded configuration, the respective first portions are at an angle to the respective second portions. The inserter is then removed from the bone.
The present disclosure provides new and innovative systems and methods for bone anchor insertion. The provided system includes an inserter, a bone anchor, and one or more sutures. The inserter includes a tube and a plunger within the tube's interior. The tube and the plunger may translate with respect to one another. The bone anchor is structured with multiple deformable members such that it can be transitioned from a compact configuration to an expanded configuration when the bone anchor's opposite ends are forced towards one another. When in a compact configuration, the deformable members are substantially straight, whereas in an expanded configuration the deformable members expand outward, forming an angle.
The deformable members are manufactured in the bone anchor by cutting slots in the bone anchor so that each of the deformable members are separated from one another by a slot. Each of the deformable members includes a zone of weakness that causes the deformable member to bend at the zone of weakness in particular when the bone anchor is transitioned to the expanded configuration. For instance, the zone of weakness may be narrower portion of material than the rest of the deformable member, which causes the deformable member to deform at the narrower portion. The bone anchor may be manufactured with zones of weakness at particular locations on the respective deformable members to obtain various features of the bone anchor.
When inserting the bone anchor, the bone anchor may initially be in a compact configuration within the inserter tube. The inserter tube may be inserted into a bone hole. Then, while the plunger is maintained in its positioned, the tube may be retracted so that the bone anchor is deployed from within the tube. The bone anchor may then be transitioned to an expanded configuration and secured with suture.
Accordingly, the bone anchor may be small and compact when it is inserted through the bone hole via the inserter, while also expanding at a desired location in the bone to provide suitable pull-out strength. The provided bone anchor insertion system therefore enables smaller bone holes without sacrificing pull-out strength. Additionally, the bone anchor may be manufactured with a variety of deformable member shapes, thus increasing the flexibility of the provided bone anchor as compared to typical bone anchors.
The plunger 106 is structured such that the plunger 106 and the tube 102 can be translated back and forth with respect to one another. One end of the plunger 106 is structured to contact the bone anchor 108. The other end of the plunger 106 is structured such that pressure may be applied to it during deployment of the bone anchor 108. A surgeon may manually apply pressure directly to the plunger 106 or may remotely control pressure applied to the plunger 106. In some examples, pressure applied to the plunger 106 may hold the plunger 106 stable while the tube 102 is retracted to deploy the bone anchor 108 from the interior of the tube 102. In other examples, pressure may be applied to the plunger 106 while the tube 102 is held stable so that the plunger 106 translates and deploys the bone anchor 108 from the interior of the tube 102. The plunger 106 may have a shape that corresponds to the shape of the tube 102. For example, in instances in which the tube 102 is cylindrical, the plunger 106 may also be cylindrical. In such instances, the bone anchor 108 may be cylindrical as well. The plunger 106 may be hollow such that it includes an interior channel 112.
The bone anchor 108 is constructed of one or more implant-compatible materials, such as titanium, a nickel-titanium alloy, stainless steel, or a polymeric composition including a polymer such as PEEK, PMMA, or ultra-high molecular weight polyethylene. In aspects in which the bone anchor 108 is constructed of a polymer, the bone anchor 108 may be manufactured by, for example, injection molding. In some instances, the material of the bone anchor 108 may be selected based on a density of the bone for which it will be used. For example, titanium or stainless steel may be used for harder, denser bone, whereas a nickel-titanium alloy or a polymeric composition may be used for softer, less dense bone.
The bone anchor 108 includes an insertion end 110A and a plunger end 110B. The insertion end 110A may include a suture anchor tip 118 that is molded or shaped to retain one or more sutures 114. Stated differently, when one portion of the suture 114 is retained by the suture anchor tip 118, and the opposite portion of the suture 114 is pulled while the suture anchor tip 118 is held stationary, tension is created in the suture 114. For example, the suture anchor tip 118 may include a pin configured such that a slidable loop of suture 114 may slide over the pin to secure it to the pin. Suture 114 retained by the suture anchor tip 118 is positioned through the interior of the bone anchor 108 and through the interior channel 112 of the plunger 106 so that a surgeon may access the suture 114 from the other end of the tube 102 either manually or remotely via a robotic surgical instrument. In some instances, the suture 114 is wound onto a release mechanism at the other end of the tube 102.
The suture 114 may typically be a polyethylene woven or braided, high-strength suture. In other examples, however, the suture 114 may be other implant-compatible materials. The suture 114, in some aspects, can be secured to the suture anchor tip 118 such that the suture 114 is prevented from sliding. For example, the suture 114 may be knotted at the suture anchor tip 118. In another example, the suture 114 may be heat formed into a shape that retains the suture 114 within the bone anchor 108.
Additionally, the bone anchor 108 is configured such that it may be in a compact configuration (
As stated above, to enable the transition from the compact configuration to the expanded configuration, the bone anchor 108 includes multiple (e.g., 2, 3, 4, 5, 6, 7, 8 etc.) deformable members between the insertion end 110A and the plunger end 110B. A bone anchor 108 having deformable members can be manufactured, for example, by cutting (e.g., laser cutting) slots in the bone anchor. The material of the bone anchor 108 between each slot constitutes a deformable member. Each of the slots starts or terminates at a suitable distance from the insertion end 110A and the plunger end 110B to help ensure a durability of the bone anchor 108. For instance, too little material between a slot and an end of the bone anchor 108 may cause the material to rip at that location. A bone anchor 108 having deformable members can therefore be simply and economically manufactured.
The first deformable member of the bone anchor 108 includes a zone of weakness 122 in between a first portion 116A and a second portion 116B. The second deformable member includes a zone of weakness 124 between the first portion 120A and a second portion 120B (i.e., the zone of weakness 124 may be a third portion distinct from the first portion and the second portion). When the bone anchor 108 is in a compact configuration (e.g., within the tube 102 in
When the bone anchor 108 is in an expanded configuration (e.g.,
In some instances, the bone anchor 108 may transition from the compact configuration to the expanded configuration due to tension in the suture 114. For example, the tube 102 may be retracted while the plunger 106 remains stable so that the bone anchor 108 is deployed from within the interior of the tube 102. The suture 114, which is retained by the suture anchor tip 118, may then be tensioned (e.g., by being pulled), thereby forcing the insertion end 110A of the bone anchor 108 towards the plunger end 110B because the plunger 106 prevents the bone anchor 108 from moving.
In other instances, the bone anchor 108 may be constructed of a shape memory material and may transition from the compact configuration to the expanded configuration as the result of a pre-set shape of the shape memory material. The shape memory material may be a superelastic nickel-titanium alloy, such as nitinol. For example, the bone anchor 108 having a pre-set shape in the expanded configuration may be compressed into the compact configuration and inserted into the tube 102 of the inserter, which maintains the bone anchor 108 in the compact configuration. When the bone anchor 108 is deployed, and is no longer constrained by the walls of the tube 102, the bone anchor 108 returns to its pre-set shape in the expanded configuration. In some instances, the distance between the insertion end 110A and the plunger end 110B of the shape-memory bone anchor 108 may be further adjusted using the suture 114 as described above. For instance, the pre-set shape may provide suitable pull-out strength in some instances, whereas in other instances, a surgeon may adjust the expanded shape-memory bone anchor 108 after inserting it to obtain a desired pull-out strength.
Additionally, as illustrated in
The zone of weakness 212 has a narrower width than the first portion 208 and the second portion 210, which causes the deformable member to deform at the zone of weakness 212, rather than at another location, when the bone anchor 200 is transitioned to the expanded configuration. In this example, the narrower width of the zone of weakness 212 is created by the design of the slots 206A and 206B that remove extra material adjacent to the zone of weakness 212 as compared to adjacent to the first and second portions 208 and 210. It should be appreciated that there may be multiple slots identical to the slots 206A and 206B around the perimeter of the anchor 200 that create multiple deformable members.
The zone of weakness 312 has a narrower width than the first portion 308 and the second portion 310, which causes the deformable member to deform at the zone of weakness 312, rather than at another location, when the bone anchor 300 is transitioned to the expanded configuration. In this example, however, the narrower width of the zone of weakness 312 is created by the tapered design of the slots 306A and 306. Each of the slots 306A and 306B converge towards one another symmetrically to create a deformable member with a tapered or hourglass shape. It should be appreciated that there may be multiple slots identical to the slots 306A and 306B around the perimeter of the anchor 300 that create multiple deformable members.
It should also be appreciated that the slot and deformable member shapes illustrated in
As illustrated in
For instance,
In some aspects of the present disclosure, the provided bone anchor's deformable members as a whole may be symmetrical such that they all expand outward symmetrically (e.g.,
In one example, the respective zones of weakness may have different locations on the deformable members on a bone anchor. This example results in a bone anchor having deformable members that expand outwardly different amounts and at different distances from the plunger end. In another example, the deformable members may be distributed unevenly around the bone anchor' perimeter. Some of the deformable members may be wider than other deformable members in such examples. For instance, the slots may be cut out of the bone anchor material in an asymmetric manner around the bone anchor's perimeter. This example results in a bone anchor having deformable members that are distributed asymmetrically around the bone anchor's perimeter. A bone anchor may also be constructed including both the above-described examples.
Accordingly, the bone anchor may be manufactured with a variety of shapes by varying the bone anchor width or length, the number of deformable members, the symmetry of an individual deformable member, and/or the symmetry of the deformable members as a whole. There are no limits on manufacturing larger bone anchors as described herein. Smaller versions of the bone anchors described herein are only limited by manufacturing techniques for cutting the slots and the size and number of the sutures required for a procedure. This flexibility enables a bone anchor with a wide variety of shapes, sizes, and/or pull-out strengths, which is not enabled by typical bone anchors.
Once the tube 702 is properly positioned, in some instances, the tube 702 may then be retracted while the plunger 706 is maintained in position. In other instances, the plunger 706 may be depressed while the tube 702 is maintained in position. In either instance, the bone anchor 708 is thereby deployed from within the interior of the tube 702 while the plunger 706 remains in contact with the bone anchor 708 (e.g., the plunger end of the bone anchor 708). After the bone anchor 708 is deployed, the bone anchor 708 is transitioned to an expanded configuration. In some aspects, transitioning the bone anchor 708 to an expanded configuration involves tensioning at least one suture 710 while the plunger 706 is maintained in position to apply opposing force to the bone anchor 708. The at least one suture 710 may be tensioned manually, remotely by a robotic arm, or by another suitable mechanism.
As described above, in aspects in which the bone anchor 708 is constructed of a shape memory material with a pre-set shape, the bone anchor 708 transitions to an expanded configuration upon being deployed from the tube 702. In some instances, however, the pre-set shape that the shape memory material bone anchor 708 transitions to is not the preferred final expanded configuration based on the bone and/or ligament anatomy. For example, the pre-set shape may not suitably conform to the bone and therefore may provide less than desired pull-out strength.
Accordingly, whether or not the bone anchor 708 is constructed of a shape memory material, the at least one suture 710 may be tensioned to adjust the bone anchor 708 until a final expanded configuration is obtained. For example, a final expanded configuration may include the respective first portions of the deformable members of the bone anchor 708 contacting the cortical bone. Once the final expanded configuration is obtained, the at least one suture 710 may be clipped under arthroscopic visualization. The tension in the at least one suture 710 helps to stabilize the bone anchor 708 within the bone. The tube 702 and/or the plunger 706 may be removed from the bone hole 704 before or after the at least one suture 710 is clipped.
In some instances, after deploying the bone anchor 708, a surgeon may be dissatisfied with the expected results of transitioning the bone anchor 708 to an expanded configuration. In such instances, the surgeon may remove the provided bone insertion system without transitioning the bone anchor 708 to an expanded state. For example, the surgeon can remove the components without applying force to the bone anchor 708 with the plunger 706 so that the bone anchor 708 is not transitioned to an expanded configuration.
In another example, after transitioning the bone anchor 708 to an expanded configuration, a surgeon may be dissatisfied with the bone anchor 708 positioning, estimated pull-out strength, etc. In such an example, the surgeon may transition the bone anchor 708 back to a compact configuration by tensioning the at least one suture to pull the expanded bone anchor 708 back into the tube 702. The plunger 706 is translated away from the bone anchor 708 if needed so that it does not contact the bone anchor 708 as it is pulled back into the tube 702. The surgeon may then remove the bone anchor insertion system from the bone hole 704.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the claimed inventions to their fullest extent. The examples and aspects disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described examples without departing from the underlying principles discussed. In other words, various modifications and improvements of the examples specifically disclosed in the description above are within the scope of the appended claims. For instance, any suitable combination of features of the various examples described is contemplated.
The present application claims priority to and the benefit of U.S. Provisional Application 62/829,908, filed Apr. 5, 2019, the entirety of which is herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62829908 | Apr 2019 | US |