Methods, systems, and devices for instability repair
10820915 ยท 2020-11-03
Assignee
Inventors
- Stephen J. Orphanos (Bridgewater, MA, US)
- Brian Otrando (Cumberland, RI, US)
- Kirsten H. Aarsvold (Quincy, MA, US)
Cpc classification
A61B2017/0438
HUMAN NECESSITIES
A61B17/1615
HUMAN NECESSITIES
A61B2017/0445
HUMAN NECESSITIES
A61B2017/00353
HUMAN NECESSITIES
A61B2017/0427
HUMAN NECESSITIES
A61F2002/0841
HUMAN NECESSITIES
A61B17/06061
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61F2002/0888
HUMAN NECESSITIES
A61B2090/0811
HUMAN NECESSITIES
A61B17/1633
HUMAN NECESSITIES
International classification
A61B17/16
HUMAN NECESSITIES
A61B17/17
HUMAN NECESSITIES
A61B17/04
HUMAN NECESSITIES
Abstract
Various exemplary methods, systems, and devices for instability repair are provided. In general, a surgical device can be configured to drill a hole in bone and to deliver a suture anchor into the hole. In this way, a single surgical device can drill the hole and deliver the anchor into the hole for securing soft tissue to the bone. The anchor can be configured to allow the soft tissue to be secured to the bone using a suture coupled to a suture anchor without the need to knot or otherwise tie the suture to secure the soft tissue in place relative to the bone.
Claims
1. A surgical system, comprising: an elongate shaft having an inner lumen; an anchor configured to be implanted in bone, the anchor having a passageway extending therethrough; and a drill disposed within the inner lumen of the shaft, configured to be disposed within the passageway of the anchor with a distal tip of the drill located distal to the anchor, and configured to rotate relative to the shaft and the anchor to allow a hole to be formed in bone, and the drill being configured to be removed from the anchor after formation of the hole by the drill sliding proximally within the inner lumen of the shaft and the passageway of the anchor such that the tip of the drill is not located distal to the anchor; wherein the anchor has an opening formed therein that is in communication with the passageway, the drill has a protrusion extending therefrom that is configured to form the hole, and the drill is prevented from sliding proximally within the inner lumen of the shaft and the passageway of the anchor unless the protrusion is aligned with the opening.
2. The system of claim 1, wherein the drill is configured to move from an extended position to a retracted position, when the drill is in the extended position the drill is disposed within the inner lumen of the shaft, is disposed within the passageway of the anchor with the distal tip of the drill located distal to the anchor, and is configured to rotate relative to the shaft and the anchor to allow the hole to be formed in bone, and when the drill is in the retracted position the anchor and the shaft are movable distally relative to the drill to insert the anchor in the hole.
3. The system of claim 2, wherein the anchor has a slot therein that is in communication with the passageway; and the drill is configured to move relative to the anchor to align the protrusion with the slot such that the protrusion is slidable within the slot in moving the drill from the extended position to the retracted position.
4. The system of claim 3, wherein the slot is formed in an inner surface of the anchor that defines the passageway.
5. The system of claim 3, wherein the protrusion is configured to abut a distal surface of the anchor when the protrusion and the slot are misaligned.
6. The system of claim 3, wherein the opening and the protrusion are misaligned when the protrusion and the slot are misaligned, and the opening and the protrusion are aligned when the protrusion and the slot are aligned.
7. The system of claim 2, further comprising a handle at a proximal end of the shaft, the handle including a first alignment feature; and an alignment mechanism including a second alignment feature, the alignment mechanism being configured to move relative to the handle to align the first and second alignment features, the alignment mechanism being operatively coupled to the drill such that the movement of the alignment mechanism relative to the handle also moves the drill relative to the handle; wherein the drill is prevented from moving from the extended position to the retracted position when the first and second alignment features are misaligned, and the drill allowed to move from the extended position to the retracted position when the first and second alignment features are aligned.
8. The system of claim 7, wherein the anchor has a slot formed therein; the drill is prevented from moving from the extended position to the retracted position when the slot and protrusion are misaligned; and the drill allowed to move from the extended position to the retracted position when the slot and protrusion are aligned.
9. The system of claim 7, further comprising a bias element disposed in the handle and configured to automatically move the drill from the extended position to the retracted position in response to the first and second alignment features becoming aligned.
10. The system of claim 1, wherein the protrusion is formed on the drill and extends from a location proximal to the distal tip of the drill.
11. The system of claim 1, further comprising a suture coupled to the anchor and releasably secured to a handle at a proximal end of the shaft.
12. A surgical system, comprising: an elongate shaft having a handle at a proximal end thereof, the handle including a first alignment feature; a drill configured to drill a hole in bone, the drill being movably disposed within the shaft; an anchor disposed on the drill distal to the shaft, the shaft and anchor being configured to move distally as a unit to insert the anchor into the hole; and an alignment mechanism movably coupled to the handle and operatively coupled to the drill such that movement of the alignment mechanism relative to the handle moves the drill relative to the shaft; wherein the drill is prevented from moving proximally within the shaft when the alignment mechanism and the alignment feature are misaligned, and the drill is allowed to move proximally within the shaft when the alignment mechanism and the alignment feature are aligned.
13. The system of claim 12, wherein the alignment mechanism includes a rotatable knob.
14. The system of claim 12, further comprising a bias element disposed in the handle, the bias element being configured to automatically move the drill proximally relative to the shaft in response to the alignment mechanism and the alignment feature becoming aligned.
15. The system of claim 12, wherein a proximal surface of the anchor abuts a distal surface of the shaft.
16. A surgical system, comprising: an elongate shaft having an inner lumen; an anchor configured to be implanted in bone, the anchor having a passageway extending therethrough; a drill disposed within the inner lumen of the shaft, configured to be disposed within the passageway of the anchor with a distal tip of the drill located distal to the anchor, and configured to rotate relative to the shaft and the anchor to allow a hole to be formed in bone, and the drill being configured to be removed from the anchor after formation of the hole by the drill sliding proximally within the inner lumen of the shaft and the passageway of the anchor such that the tip of the drill is not located distal to the anchor; a handle at a proximal end of the shaft, the handle including a first alignment feature; and an alignment mechanism including a second alignment feature, the alignment mechanism being configured to move relative to the handle to align the first and second alignment features, the alignment mechanism being operatively coupled to the drill such that the movement of the alignment mechanism relative to the handle also moves the drill relative to the handle; wherein: the drill is configured to move from an extended position to a retracted position; when the drill is in the extended position the drill is disposed within the inner lumen of the shaft, is disposed within the passageway of the anchor with the distal tip of the drill located distal to the anchor, and is configured to rotate relative to the shaft and the anchor to allow the hole to be formed in bone; when the drill is in the retracted position the anchor and the shaft are movable distally relative to the drill to insert the anchor in the hole; and the drill is prevented from moving from the extended position to the retracted position when the first and second alignment features are misaligned, and the drill allowed to move from the extended position to the retracted position when the first and second alignment features are aligned.
17. The system of claim 16, wherein the anchor has a slot formed therein; the drill is prevented from moving from the extended position to the retracted position when the slot and protrusion are misaligned; and the drill is allowed to move from the extended position to the retracted position when the slot and protrusion are aligned.
18. The system of claim 16, further comprising a bias element disposed in the handle and configured to automatically move the drill from the extended position to the retracted position in response to the first and second alignment features becoming aligned.
Description
BRIEF DESCRIPTION OF DRAWINGS
(1) This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
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DETAILED DESCRIPTION
(29) Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
(30) Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of components with which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used.
(31) Various exemplary methods, systems, and devices for instability repair are provided. In general, a surgical device can be configured to drill a hole in bone and to deliver a suture anchor into the hole. In this way, a single surgical device can drill the hole and deliver the anchor into the hole for securing soft tissue to the bone. The anchor can be configured to allow the soft tissue to be secured to the bone using a suture coupled to a suture anchor without the need to knot or otherwise tie the suture to secure the soft tissue in place relative to the bone.
(32) Using the same device for drilling the hole and delivering the anchor into the hole may facilitate delivery of the anchor into the hole at a proper angle, e.g., with a longitudinal axis of the anchor being substantially coaxial with a longitudinal axis of the hole, because the same device is performing the drilling and the delivery. A person skilled in the art will appreciate that the axes may not be precisely coaxial but nevertheless be considered to be substantially coaxial due to any number of factors, such as sensitivity of measurement equipment and manufacturing tolerances for the anchor.
(33) Using the same device for drilling the hole and delivering the anchor into the hole, instead of using one surgical device for the drilling and another surgical device for the anchor delivery, reduces a number of instruments used in the surgical procedure, which may reduce overall cost of the procedure and/or reduce operating room clutter. The surgical device can be configured to remain within the patient's body after drilling the hole such that the anchor can be delivered into the hole without removing the surgical device from the patient's body, which may facilitate the anchor's delivery into the hole at the proper angle since upon the completion of drilling the surgical device can be at a position relative to the hole that properly angularly aligns the anchor with the hole.
(34) Using the same device for drilling of the hole and delivering the anchor into the hole may eliminate the need for a surgeon or other medical personnel to locate the hole before delivering the anchor into the hole, thereby saving time.
(35) In general, the suture anchors discussed herein, also referred to herein as anchors, are configured to be implanted in a body of a patient. The anchors are configured to couple to a suture and to be used in a tissue repair procedure, e.g., an arthroplasty at a joint such as the hip, knee, or shoulder, a meniscal repair procedure for repairing a meniscal tear at a knee, a rotator cuff repair procedure for repairing a torn rotator cuff at a shoulder, etc.
(36) An anchor can be absorbable or non-absorbable. An anchor can be made from any of a variety of materials, e.g., Polyether ether ketone (PEEK), Polylactic acid or polylactide (PLA), BIOCRYL RAPIDE, stainless steel, etc. An anchor can be formed by a variety of techniques, for example by an injection molding process such as overmolding or by a post-molding process such as post-molding machining. An anchor can have any of a variety of sizes as appropriate for, e.g., use at a particular anatomical location and with a particular patient.
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(38) The anchor 12 has a suture-engaging channel 26 in an exterior thereof that extends circumferentially around an entire perimeter of the anchor 12. The channel 26 is configured to seat a suture therein to attach a suture to the anchor 12 to allow the suture to be anchored in bone with the anchor 12. A suture can be seated in the channel 26 by, for example, being tied around or looped around the anchor 12, molded to the anchor 12, sewn on, etc. The suture being seated in the channel 26 may help protect the suture from being damaged during drilling since the suture is located outside of the drill 36 and anchor 12. The suture seated in the channel 26 can be a tether suture to which one or more operative sutures attached to soft tissue are coupled, e.g., by piercing through the tether suture with a suture passing kite or otherwise, as will be appreciated by a person skilled in the art. The anchor 12 is not shown in
(39) In an exemplary embodiment, a suture has a hole formed therein to facilitate seating of the suture within the channel 26.
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(41) Referring again to
(42) The shaft 32 is an elongate member having an inner lumen 42 (see
(43) As mentioned above, the shaft 32 has a pair of opposed arms 38 extending distally therefrom. The arms 38 are sized and shaped to be received by press fit or snap fit within the anchor's pair of opposed openings 22. As discussed further below, when the anchor 12 is disposed in a bone hole, proximal movement of the shaft 32 will release the opposed arms 38 from the opposed openings 22 to release the shaft 32 from the anchor 12.
(44) The handle 34 is configured to be handheld by a user to facilitate handling of the device 10. The handle 34 can have any of a variety of sizes and shapes. As shown in
(45) As shown in
(46) A distal portion of the alignment mechanism 38 is disposed within the handle's inner lumen 46. The inner lumen 46 has an enlarged portion 46e that seats therein a corresponding enlarged portion 38e of the alignment mechanism 38 to help non-releasably secure the handle 34 and alignment mechanism 38 and to facilitate smooth rotation of the alignment mechanism 38 relative to the handle 34 about a longitudinal axis A of the handle 34, which is also the longitudinal axis of the shaft 32, drill 34, alignment mechanism 38, anchor 12, and connector 40 when assembled together as shown in
(47) The drill 36 includes an elongate shaft 54 having the distal tip 36t at its distal end. The distal tip 36t is configured to penetrate into bone to provide a stable position for the drill 36 to begin drilling the bone. The pointed shaped of the distal tip 36t facilitates this penetration. The drill 36 is configured to rotate about the longitudinal axis A relative to the anchor 12, shaft 32, handle 34, and alignment mechanism 38 to allow the drill 36 to drill material, e.g., bone, using a protrusion 52 thereof.
(48) As shown in
(49) The drill 36 is movable from an extended position to a retracted position. In the extended position the drill 36 is disposed within the inner lumen 42 of the shaft 32, is disposed within the passageway 14 of the anchor 12 with the drill's distal tip 36t located distal to the anchor 12, has its protrusion 52 located distal to the anchor 12, and is configured to rotate about the longitudinal axis A. The drill 36 is shown in the extended position in
(50) As shown in
(51) The device 10 includes a lock 62 configured to be actuated to move the bias element 56 from the compressed configuration to the uncompressed configuration, and hence allow the drill 36 to move from the extended position to the retracted position. In a default, initial position, shown in
(52) The drill 36 cannot be moved from the extended position to the retracted position unless the drill's protrusion 52 is aligned with the anchor's opening 18 to allow the protrusion 52 to enter and slide with the anchor's slot 16 before exiting the anchor 12. If the protrusion 52 is misaligned with the anchor's opening 18, the protrusion 52 abuts against the anchor's distal surface, as discussed above, thereby preventing retraction of the drill 36. Thus, if the lock 62 is actuated with the protrusion 52 misaligned with the opening 18, the drill 36 will not be retracted. It may be difficult to visualize the protrusion 52 and/or the opening 18 when disposed within a body of the patient due to space constraints and/or position of the anchor 12 and drill 36 within the patient's body, so it may be difficult to align the protrusion 52 and opening 18 by looking at the protrusion and opening 18. The alignment mechanism 38 is configured to facilitate alignment of the protrusion 52 with the anchor's opening 18 to allow for the retraction of the drill 36 even when the protrusion 52 and/or the opening 18 are not visible to a user.
(53) The alignment mechanism 38 is configured to move the position of the drill 36 relative to the anchor 12 and thus move the protrusion 52 relative to the anchor 12. As mentioned above, the alignment mechanism 38 is configured to rotate relative to the handle 34. The alignment mechanism 38 includes a knob 70 to facilitate handling of the alignment mechanism 38 for rotation. The alignment mechanism 38 can be rotated relative to the handle 34 to align the alignment features 48, 50. The alignment mechanism's alignment feature 50 being aligned with the handle's alignment feature 48 indicates that the protrusion 52 is aligned with the opening 18. Similarly, the alignment mechanism's alignment feature 50 being misaligned with the handle's alignment feature 48 indicates that the protrusion 52 is misaligned with the opening 18. Thus, when retraction of the drill 36 is desired, the alignment features 48, 50 can be aligned, thereby indicating that the drill 36 is positioned relative to the anchor 12 at a position that allows the drill 36 to move proximally through the anchor 12 with the protrusion 52 sliding within the anchor's slot 16 in response to actuation of the lock 62.
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(55) The drill tip 112 can be absorbable or non-absorbable and can be made from any of a variety of materials, e.g., PEEK, PLA, BIOCRYL RAPIDE, stainless steel, etc. The drill tip 112 being absorbable allows for instability repair without leaving material in the patient's body that cannot be removed without further surgical intervention. The drill tip 112 being non-absorbable may allow for more effective cutting since non-absorbable materials can generally cut bone more effectively than absorbable materials. The drill tip 112 can be a composite member including both absorbable materials and non-absorbable materials such that a partial portion of the drill tip 112 is configured to be bioabsorbed. As one example, edges 112e of the drill tip 112 can be non-absorbable metal to facilitate cutting, and a remainder of the drill tip can be absorbable.
(56) The anchor 102 is generally configured and used similar to the anchor 12 of
(57) The anchor 102 and the drill tip 112 are disposed on the drill 108 in this illustrated embodiment with a gap 120 therebetween, which may help protect the anchor 102 during drilling of bone. In other embodiments, the anchor 102 and drill tip 112 can be disposed on the drill 108 without a gap therebetween.
(58) The anchor 102 is disposed on the drill 108 with a clearance gap 122 between the anchor 102 and the shaft 104, which may help prevent premature distal movement of the anchor 102 along the drill 108. The device 100 includes a reduced diameter shaft extension 124 that extends distally from the shaft 104 and is seated within an enlarged diameter proximal portion 118a of the inner lumen 114 of the anchor 102. The reduced diameter shaft extension 124 is configured to facilitate insertion of the anchor 102 into a drilled bone hole by pushing the anchor 102 from within the anchor 102 where a distal surface of the reduced diameter shaft extension 124 abuts an interior proximal surface of the anchor 102, as shown in
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(61) As shown in
(62) With the device's distal portion in the patient's body, the drill 36 is in the extended position and the distal tip 36t is positioned relative to bone 72 in which the anchor 12 is desired to be implanted. The connector 40 is then coupled to the drill 36, if not already coupled. The drill 36 then drills a hole 74 in the bone 72, as shown in
(63) With the hole 74 having been formed in the bone 72 using the device 10, the anchor 12 can be inserted into the hole 74 using the device 10. First, the drill 36 is moved from the extended position to the retracted position. If the alignment features 48, 50 are not already aligned, thereby indicating that the drill's protrusion 52 is misaligned with the anchor's opening 18, the alignment mechanism 38 is rotated until the alignment features 48, 50 are aligned, thereby indicating that the drill's protrusion 52 is aligned with the anchor's opening 18 and that the drill 36 is in a position where the drill 36 can be retracted. The lock 62 was actuated by drilling via the connector 40, thereby causing the bias element 56 to compress within the handle 34 and, once done drilling, move the drill 36 proximally relative to the anchor 12, shaft 32, and handle 34. After drilling, the connector 40 is removed from the drill 36.
(64) With the drill 36 in the retracted position, as shown in
(65) A person skilled in the art will appreciate that the present invention has application in conventional minimally-invasive and open surgical instrumentation as well application in robotic-assisted surgery.
(66) One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.