SUTURE-ANCHOR INSERTION DEVICE
20230380829 · 2023-11-30
Inventors
- Tal ZEEVI (Pardes Hana-Karkur, IL)
- Ido ASHPIZ (Rosh Haayin, IL)
- Orahn PREISS-BLOOM (Zichron Yaakov, IL)
Cpc classification
A61B2017/0414
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61F2002/0888
HUMAN NECESSITIES
A61F2002/0852
HUMAN NECESSITIES
International classification
Abstract
The present invention is directed to a suture-anchor insertion device used to insert a suture anchor into bone, such that the suture anchor secures soft tissue to the bone in a manner that does not require the surgeon to tie suture knots to secure the tissue to the bone. The apparatus for securing a suture to a bone, comprises a suture anchor configured to be inserted into a hole in the bone, the suture anchor comprises: a tip component configured to be advanced into the hole, the tip component comprises: a widened end portion that defines an eyelet that is configured to receive the suture; a shaft that projects axially from the widened end portion; and a cannulated screw configured to secure the tip component within the hole within the bone by being advanced over the shaft of the tip component; and a suture-anchor insertion device comprises: a handle portion; one or more rods; and one or more spools configured to releasably secure proximal ends of the suture by the proximal ends of the suture being wound around the one or more spools.
Claims
1. Apparatus for securing a suture to a bone, the apparatus comprising: a suture anchor configured to be inserted into a hole in the bone, the suture anchor comprising: a tip component configured to be advanced into the hole, the tip component comprising: a widened end portion that defines an eyelet that is configured to receive the suture; a shaft that projects axially from the widened end portion; and a cannulated screw configured to secure the tip component within the hole within the bone by being advanced over the shaft of the tip component; and a suture-anchor insertion device comprising: a handle portion; one or more rods; and a, one or more spools configured to releasably secure proximal ends of the suture by the proximal ends of the suture being wound around the one or more spools; or b, one or more shoulder cleats extending substantially laterally at a distal end of the handle portion, the shoulder cleats being configured to releasably secure proximal ends of the suture by the proximal ends of the suture being inserted into the one or more shoulder cleats.
2. The apparatus according to claim 1, wherein the one or more spools are configured to secure the proximal ends of the suture, such as to hold the proximal ends of the suture out of the way of the suture-anchor insertion device and as to prevent twisting and/or knotting of the suture.
3. (canceled)
4. The apparatus according to claim 1, wherein the apparatus comprises the suture, and wherein the suture anchor insertion device is provided to a user with the suture passing through the eyelet and with proximal ends of the suture wound around the one or more spools.
5.-7. (canceled)
8. The apparatus according to claim 1, wherein the one or more spools are configured to allow a user to adjust tension of the suture by winding the one or more spools.
9. The apparatus according to claim 1, wherein the suture anchor defines a stay suture eyelet, the apparatus further comprising: a stay suture configured to pass through the stay suture eyelet and into the handle portion, by passing along a lumen defined by one of the one or more rods; and a stay-suture release tab configured to releasably hold a proximal end of the stay suture within the handle portion.
10. The apparatus according to claim 1, wherein the apparatus is configured for use with a suture that is coupled to a needle, and wherein the one or more spools are configured to accommodate the needle.
11. The apparatus according to claim 10, wherein the apparatus is configured for use with a suture that is coupled to a curved needle, and wherein the one or more spools has a curvature that is such as to accommodate a curvature of the curved needle; and wherein the one or more spools define one or more holes that are configured to receive a tip of the needle.
12. (canceled)
13. The apparatus according to claim 1, wherein the one or more spools are detachably coupled to the one or more rods.
14.-15. (canceled)
16. The apparatus according to claim 13, wherein the one or more rods include a segment having a non-smooth surface to facilitate coupling of the one or more spools to the one or more rods.
17. The apparatus according to claim 13, wherein the one or more spools comprises two or more spools that are coupled to each other, such as to be detached from the one or more rods simultaneously with each other.
18. (canceled)
19. The apparatus according to claim 1, wherein one or more spools are configured such that the suture is released from the spools by pulling the sutures while allowing the spools to rotate and release the suture.
20. The apparatus according to claim 19, wherein the one or more spools define round indents on outer surfaces thereof, which are configured such as to allow a user to insert their fingers into the indents and thereby hold the spools while the spools are rotated.
21. The apparatus according to claim 1, wherein the one or more rods comprise a rotation rod that is configured to rotate the cannulated screw.
22. The apparatus according to claim 21, wherein the one or more rods further comprise a pushing rod configured to push the cannulated screw, while it is being rotated.
23. The apparatus according to claim 22, wherein the one or more spools are coupled to the pushing rod.
24.-26. (canceled)
27. The apparatus according to claim 1, wherein the one or more shoulder cleats are configured to secure the proximal ends of the suture, such as to hold the proximal ends of the suture out of the way of the suture-anchor insertion device and prevent twisting and/or knotting of the suture.
28.-29. (canceled)
30. The apparatus according to claim 1, wherein the suture anchor insertion device is provided to a user without the suture passing through the eyelet and wherein the apparatus is configured for a user to insert the suture through the eyelet and to insert the proximal ends of the suture into the one or more shoulder cleats.
31.-33. (canceled)
34. The apparatus according to claim 1, wherein the one or more shoulder cleats comprise a trapping mechanism configured to mechanically trap the proximal ends of the suture such that the proximal ends of the suture cannot be pulled out of the shoulder cleats longitudinally but can be removed from the shoulder cleats by pulling the proximal ends of the suture laterally.
35. (canceled)
36. The apparatus according to claim 1, wherein the shoulder cleats extend laterally, such as to define lateral extensions that extend laterally past lateral edges of the handle portion.
37. (canceled)
38. The apparatus according to claim 1, wherein the shoulder cleats define a trapping mechanism and are configured to allow the user to secure the suture at a desired tightness by sliding the proximal ends of the suture laterally from the lateral extensions and into the trapping mechanism.
39.-47. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0110]
[0111]
[0112]
DETAILED DESCRIPTION OF EMBODIMENTS
[0113] Reference is now made to
[0114] For some applications, suture-anchor insertion device 20 is used to insert a suture anchor 21 into bone, such that the suture anchor secures soft tissue to the bone in a manner that does not require the surgeon to tie suture knots to secure the tissue to the bone. Typically, suture anchor 21 includes a tip component 22 that defines an eyelet 24. The tip component is configured to hold one or more sutures (e.g., between one and four sutures), which are typically tissue-affixing sutures, within a pilot hole 28 in bone 29 (suture 26, pilot hole 28, and bone 29 all shown in
[0115] Typically, the eyelet is a closed aperture and the tissue-affixing sutures are suture strands. For some applications (not shown), the eyelet is not a closed aperture. For example, the eyelet may define a portion of a circle, a portion of an ellipse, and/or a forked shape that is configured to hole the suture within the pilot hole. For some applications, tip component 22 defines a widened end portion 32 toward a first (distal) end 34 of the tip component, which is configured to be advanced to the bottom of the pilot hole. The widened end portion typically defines eyelet 24, through which the sutures are threaded. Typically, the tip component includes a shaft 38, which extends axially from the widened end portion of the tip component toward a second (proximal) end 35 of the tip component (which is configured to be placed closer to the top of the pilot hole).
[0116] For some applications, the suture anchor includes a plug component, which is configured to secure the tip component within the pilot hole by being advanced into and thereby plugging the pilot hole. Typically, the plug component is a cannulated screw 30, which is configured to secure the tip component within the pilot hole by being screwed into the pilot hole to thereby plug the pilot hole. Cannulated screw 30 typically defines a lumen therethrough, and the cannulated screw is typically advanced over shaft 38 of the tip component, such that the shaft is disposed within the lumen of the cannulated screw.
[0117] Suture-anchor insertion device 20 typically includes a handle portion 40 that includes a proximal rotation knob 42 and a distal pusher 44. (The term “proximal” is used herein to denote a portion that is closer to a user of the device (e.g., an orthopedic surgeon), while the term “distal” is used to denote a portion that is farther from the user.) Typically, a pushing rod 46 extends distally from the distal pusher to the proximal end of the cannulated screw. Further typically, a rotation rod 48 extends distally from the proximal rotation knob to the cannulated screw and through the lumen of the cannulated screw. For some applications, the rotation rod extends through the inside of the pushing rod, as shown. For some applications, the cannulated screw is advanced into the pilot hole and over shaft 38 of tip component 22 by using the pushing rod to push the screw distally, while simultaneously using the rotation rod to rotate the screw, and thereby screw the screw into the bone.
[0118] Typically, the rotation rod has a cross-sectional shape that conforms with an inner cross-sectional shape the defines the lumen of the cannulated screw, such that the rotation rod engages the internal surfaces of the cannulated screw. For example, the rotation rod may have a polygonal (e.g., a hexagonal shape) and the inner cross-sectional shape that defines the lumen of the cannulated screw may also be polygonal (e.g., hexagonal, as shown). Alternatively, other shapes may be used. Further alternatively or additionally, other methods may be used for rotating the canulated interference screw.
[0119] Reference is now made to
[0120] For some applications, suture-anchor insertion device 20 is provided to a user without the tissue-affixing suture(s) having been preloaded, but the insertion device is provided with spools Typically, once the tissue-affixing suture(s) has been inserted through eyelet 24 of tip component 22 by the user, the user then winds the proximal ends of the tissue-affixing suture(s) around spools 50. Thus, irrespective of whether or not the insertion device is provided with the tissue-affixing suture(s) having been inserted through eyelet 24 of tip component 22, for some applications, prior to insertion of the suture anchor and/or during the insertion of the suture anchor, the proximal ends of the tissue-affixing suture(s) are wound around the spools. Typically, the proximal ends of the tissue-affixing suture(s) are wound around the spools, such as to prevent damage to the tissue-affixing suture(s) (e.g., twisting and/or knotting of the tissue-affixing suture(s)) and to hold the proximal ends of the tissue-affixing suture(s) out of the way of the insertion device. For some applications, prior to insertion of the suture anchor and/or during the insertion of the suture anchor, the user is able to adjust the tension of the tissue-affixing suture(s) by winding the spools. For some applications, suture-anchor insertion device 20 is provided to a user with the tissue-affixing suture(s) having been preloaded onto the spools, and the user removes the proximal ends of the tissue-affixing suture(s) from the spools prior to the insertion of the suture anchor.
[0121] As described hereinabove, for some applications, some or all of tissue-affixing sutures 26 are attached to a curved or straight needle at one end or at both ends. For some applications, spools 50 are configured to safely store the needles. For example, the spools may define holes 51 that are shaped so as to receive tips of the needles and to thereby hold the needles in a way that does not expose the sharp tips of the needles. For some applications, the spool is shaped such as to accommodate the needle, for example, the needles may be curved and the radius of curvature of spool is similar to that of the needles, such that the spool accommodates the curvature of the needle.
[0122] Typically, after suture anchor 21 has been inserted, tissue-affixing sutures 26 are released from the spools by pulling the tissue-affixing sutures 26 while allowing the spools to rotate and release the strands, for example by holding the sides of the spools lightly and allowing them to rotate. For some applications, the spools define round indents 53 on their outer surfaces such as to allow a user to insert their fingers into the indents and thereby hold the spools while they are rotated as the sutures are pulled off. As noted above, for some applications, the user removes the proximal ends of the tissue-affixing suture(s) from the spools prior to the insertion of the suture anchor.
[0123] Typically, spools 50 are detachably attached to the suture-anchor insertion device such that the spools are configured to remain attached while the suture anchor is being inserted but can be readily removed following suture anchor insertion. For some applications, the user removes the spools from the suture-anchor insertion device prior to the insertion of the suture anchor. For some applications, the spools are attached to a rod of the suture-anchor insertion device, e.g., to pushing rod 46 of the suture-anchor insertion device. For some such applications, pushing rod 46 includes a segment 58 having a non-smooth surface (e.g., a segment that defines teeth, waves, and/or a ribbed segment, shown in
[0124] Referring again to
[0125] Typically, the shoulder cleats include a trapping mechanism (e.g., a male-female interlocking structure) for mechanically trapping the proximal ends of the tissue-affixing suture(s) such that the proximal ends of the tissue-affixing suture(s) cannot be pulled out longitudinally but can be removed by pulling the proximal ends of the tissue-affixing suture(s) laterally. As described hereinabove, for some applications, the shoulder cleats extend laterally outwardly past the lateral edges of the handle portion, e.g., as shown in
[0126] For some applications, the suture-anchor insertion device includes a stay suture 70 (shown in
[0127] Typically, the suture-anchor insertion device is provided to the user with cannulated screw pre-mounted on rotation rod 48 above tip component 22, such that when the proximal end of the cannulated screw is in contact with the distal end of pushing rod 46, there is an axial gap between the cannulated screw and the tip component. For some applications, the length of the gap is approximately equal to the length of the pilot hole.
[0128] Reference is now made to
[0129] Typically, in a first step, pilot hole 28 is drilled into bone 29.
[0130] Referring now to
[0131] Referring now to
[0132] Referring to
[0133] As described hereinabove, typically, spools 50 are detachably attached to the suture-anchor insertion device such that the spools are configured to remain attached while the suture anchor is being inserted but can be readily removed following suture anchor insertion. For some applications, the user removes the spools from the suture-anchor insertion device prior to the insertion of the suture anchor. Typically, the suture-anchor insertion device includes two spools, with one on each side of the suture anchor. For some such applications, the spools are coupled to each other. Typically, the spools are removable from the pushing rod with a single motion, for example by pulling the spools from the pushing rod. Typically, the spool is comprised of a material having the same or higher flexibility than the flexibility of the pushing rod.
[0134] For applications in which the proximal ends of the tissue-affixing suture(s) are inserted into shoulder cleats 54, the proximal ends of the tissue-affixing suture(s) are typically removed from the shoulder cleats at this stage. As described above, typically, the shoulder cleats include a trapping mechanism (e.g., a male-female interlocking mechanism) for mechanically trapping the tissue-affixing suture(s) such that the tissue-affixing suture(s) cannot be pulled out longitudinally but can be removed by pulling the tissue-affixing suture(s) to the side. For such applications, the tissue-affixing suture(s) are released from the mechanism in order to remove them from the shoulder cleats. For some applications, the user removes the proximal ends of the tissue-affixing suture(s) from the shoulder cleats prior to the insertion of the suture anchor.
[0135] Referring to
[0136] In order to release the tip component from the insertion device once the suture anchor has been properly implanted, the stay-suture release tab is typically manually removed (e.g. pulled away and/or ripped). For some applications, the stay-suture release tab is made of a manually tearable material, such as paper or fabric, that is configured to be manually torn such as to release the stay suture. Alternatively, the stay-suture release tab is made of is made of a non-tearable material (e.g., a material made of high-density spunbound polyethylene fibers, such as Tvvek®) that is configured to be pulled away such as to release the stay suture. In an alternative embodiment (not shown), a mechanical element such as a button or a lever is used to release the stay suture. Further alternatively, the stay suture may be released by opening up the handle portion (e.g., by opening up rotation knob 42 of the handle portion).
[0137]
[0138] It is noted that an alternative configuration from that described with reference to
[0139] It is noted that although some applications of the present disclosure are described as being applied to tissue-affixing suture(s), the scope of the present disclosure includes applying the apparatus and methods described herein to one or more sutures of any type, mutatis mutandis.
[0140] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.