METHOD AND APPARATUS FOR RE-ATTACHING THE LABRUM TO THE ACETABULUM, INCLUDING THE PROVISION AND USE OF A NOVEL SUTURE ANCHOR SYSTEM
20170231616 · 2017-08-17
Inventors
- Chris Pamichev (Cupertino, CA, US)
- J. Brook Burley (Mountain View, CA, US)
- Julian Nikolchev (Portola Valley, CA, US)
- James Flom (San Carlos, CA, US)
Cpc classification
A61B2017/0414
HUMAN NECESSITIES
A61B2017/0438
HUMAN NECESSITIES
A61B2017/0445
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61B2017/0412
HUMAN NECESSITIES
A61B2017/0424
HUMAN NECESSITIES
A61B2017/0458
HUMAN NECESSITIES
International classification
A61B17/04
HUMAN NECESSITIES
A61B17/17
HUMAN NECESSITIES
Abstract
Apparatus for securing a first object to a second object, the apparatus comprising: an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a first section and a second section, the first section of the lumen being disposed distal to the second section of the lumen, and with the first section of the lumen having a wider diameter than the second section of the lumen; at least one longitudinally-extending slit extending through the side wall of the elongated body and communicating with the lumen, the at least one longitudinally-extending slit having a distal end and a proximal end, with the distal end of the at least one longitudinally-extending slit being spaced from the distal end of the elongated body; and an elongated element extending through the lumen of the elongated body.
Claims
1. Apparatus for securing a first object to a second object, the apparatus comprising: an elongated body having a distal end, a proximal end, and a lumen opening on the proximal end and extending toward the distal end, the lumen comprising a first portion and a second portion, the first portion of the lumen being disposed distal to the second portion of the lumen, and with the first portion of the lumen having a wider diameter than the second portion of the lumen; at least one longitudinally-extending slit extending through the side wall of the elongated body and communicating with the lumen, the at least one longitudinally-extending slit having a distal end and a proximal end, with the distal end of the at least one longitudinally-extending slit being spaced from the distal end of the elongated body and with the proximal end of the at least one longitudinally-extending slit being spaced from the proximal end of the elongated body; and an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end and having an enlargement at its distal end, the enlargement having a diameter greater than the second portion of the lumen.
2.-3. (canceled)
4. Apparatus according to claim 1 wherein the elongated body is generally cylindrical.
5. Apparatus according to claim 1 wherein the distal end of the longitudinally-extending slit terminates in a distal relief hole and the proximal end of the longitudinally-extending slit terminates in a proximal relief hole.
6. Apparatus according to claim 1 wherein there are two longitudinally-extending slits, and further wherein the two longitudinally-extending slits are diametrically opposed to one another.
7. Apparatus according to claim 1 wherein the elongated element comprises a suture.
8. Apparatus according to claim 7 wherein the suture comprises (i) a distal loop connected to the enlargement, and (ii) a proximal loop connected to the distal loop.
9. Apparatus according to claim 7 wherein the enlargement comprises a solid member.
10. Apparatus according to claim 7 wherein the enlargement comprises a suture knot.
11. Apparatus according to claim 10 wherein the enlargement comprises a solid member and a suture knot, the solid member being disposed proximal to the suture knot.
12. Apparatus according to claim 1 wherein the elongated element comprises a rod.
13. Apparatus according to claim 1 wherein generally cylindrical body comprises ribs.
14. Apparatus according to claim 13 wherein the ribs are slotted.
15. Apparatus according to claim 13 wherein the ribs are resilient.
16. Apparatus according to claim 1 further comprising an inserter for manipulating the elongated body.
17. Apparatus according to claim 16 wherein the inserter comprises a hollow push tube having a lumen extending therethrough.
18. Apparatus according to claim 17 wherein the elongated element extends through the lumen of the push tube.
19. Apparatus according to claim 18 wherein the elongated body is held to the inserter by applying proximally-directed tension to the elongated element.
20. Apparatus according to claim 18 wherein the elongated body is held to the inserter with a male-female connection.
21. Apparatus according to claim 1 wherein the elongated element exits the lumen of the elongated body at the proximal end of the elongated body.
22.-25. (canceled)
26. Apparatus according to claim 1 wherein the lumen further comprises a third portion disposed proximal to the second portion first of the lumen, the third portion of the lumen having a diameter smaller than the second portion of the lumen.
27.-34. (canceled)
35. A method for securing a first object to a second object, the method comprising: providing apparatus comprising: an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a first portion and a second portion, the first portion of the lumen being disposed distal to the second portion of the lumen, and with the first portion of the lumen having a wider diameter than the second portion of the lumen; at least one longitudinally-extending slit extending through the side wall of the elongated body and communicating with the lumen, the at least one longitudinally-extending slit having a distal end and a proximal end, with the distal end of the at least one longitudinally-extending slit being spaced from the distal end of the elongated body and with the proximal end of the at least one longitudinally-extending slit being spaced from the proximal end of the elongated body; and an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end and having an enlargement at its distal end, the enlargement having a diameter greater than the second portion of the lumen; inserting the elongated body into the second object; moving the enlargement proximally so as to expand the elongated body; and securing the first object to the second object with the elongated element.
36. A method according to claim 35 wherein the elongated body is passed through the first object before the elongated body is inserted into the second object.
37. A method according to claim 35 wherein the elongated element is passed through the first object after the elongated body is inserted into the second object.
38. A method according to claim 35 wherein the first object comprises tissue and the second object comprises bone.
39.-42. (canceled)
43. A method according to claim 35 wherein the tissue comprises the labrum and the bone comprises the acetabulum.
44.-49. (canceled)
50. A method according to claim 35 wherein expansion of the elongated body does not cause the distal end of the elongated body to split open.
51.-54. (canceled)
55. A method according to claim 35 wherein expansion of the elongated body does not cause the proximal end of the elongated body to split open.
56. Apparatus according to claim 1 wherein the enlargement is initially completely disposed in the first portion of the lumen.
57. Apparatus according to claim 56 wherein the enlargement expands the elongated body when the enlargement is pulled proximally into the second portion of the lumen.
58. Apparatus according to claim 8 wherein the distal loop comprises suture of a first diameter and the proximal loop comprises suture of a second diameter.
59. Apparatus according to claim 58 wherein the second diameter is larger than the first diameter.
60. Apparatus according to claim 59 wherein the distal loop is formed out of #2-0 suture and the proximal loop is formed out of #1 suture.
61. Apparatus according to claim 8 wherein the distal loop extends out of the lumen of the elongated body, with the distal loop and the elongated body together forming an eyelet.
62. Apparatus according to claim 61 wherein the distal loop is movable relative to the elongated body, whereby to provide an eyelet of variable size.
63. Apparatus according to claim 62 wherein the proximal loop passes through the eyelet.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0073] These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:
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DETAILED DESCRIPTION OF THE INVENTION
The Novel Suture Anchor System of the Present Invention in General
[0099] The present invention provides a novel method and apparatus for arthroscopically re-attaching the labrum to the acetabulum. Among other things, the present invention comprises the provision and use of a novel suture anchor system.
[0100] More particularly, and looking now at
[0101] Looking next at
[0102] Near (but spaced from) the distal end 40 of generally cylindrical body 35, there is provided a longitudinally-extending slit 75 which extends completely through one side wall (but not the other) of generally cylindrical body 35. Thus, longitudinally-extending slit 75 communicates with lumen 50 of anchor 10. The distal end of longitudinally-extending slit 75 terminates in a distal relief hole 80, and the proximal end of longitudinally-extending slit 75 terminates in a proximal relief hole 85. It will be appreciated that distal relief hole 80 is spaced from distal end 40 of generally cylindrical body 35, so that a solid distal ring 90 is located at the distal end of generally cylindrical body 35, whereby to provide the distal end of generally cylindrical body 35 with a degree of structural integrity.
[0103] Looking now at
[0104] Looking now at
[0105] Preferably anchor 10, suture 15 and inserter 20 are pre-assembled into a single unit, with suture 15 extending back through lumen 115 of inserter 20 with a slight proximal tension so as to hold anchor 10 on the distal end of inserter 20.
[0106] Suture anchor system 5 preferably also comprises a hollow guide 25 for guiding components from outside of the body to the acetabulum. More particularly, hollow guide 25 generally comprises a lumen 130 for slidably receiving anchor 10 and inserter 20 therein, as will hereinafter be discussed. The internal diameter of hollow guide 25 is preferably approximately equal to the largest external feature of anchor 10 (e.g., one or more of the barbs 70), so that anchor 10 can make a close sliding fit within the interior of hollow guide 25. Alternatively, the internal diameter of hollow guide 25 may be slightly smaller or larger than the largest external feature of anchor 10 if desired. Where suture anchor system 5 also comprises a punch (or drill) 30, lumen 130 of hollow guide 25 is preferably sized to slidably receive punch (or drill) 30, as will hereinafter be discussed. The distal end of hollow guide 25 preferably includes a sharp tip/edge for penetrating the labrum and engaging the acetabulum, as will hereinafter be discussed.
[0107] If desired, and looking now at
Method for Arthroscopically Re-Attaching the Labrum to the Acetabulum Using the Novel Suture Anchor System of the Present Invention
[0108] Suture anchor system 5 is preferably used as follows to secure a detached labrum to the acetabulum.
[0109] First, the sharp distal end 136 of hollow guide 25 is passed through the labrum and positioned against the acetabulum at the location where anchor 10 is to be deployed. Preferably the sharp distal end of hollow guide 25 penetrates through the labrum and a short distance into the acetabulum so as to stabilize the hollow guide vis-à-vis the acetabulum. A stylet (e.g., an obturator) may be used to fill the hollow guide 25 during such insertion and thus prevent tissue coring of the labrum during insertion. The distal portion of the punch (or drill) 30 may also be used to fill the hollow tip of the hollow guide 25 during such insertion.
[0110] Next, if desired, punch (or drill) 30 may be used to prepare a seat in the acetabulum to receive anchor 10. More particularly, if punch (or drill) 30 is used, the sharp distal end 135 of punch (or drill) 30 is passed through hollow guide 25 (thereby also passing through the labrum) and advanced into the acetabulum so as to form an opening (i.e., a seat) in the bone to receive anchor 10. Then, while hollow guide 25 remains stationary, punch (or drill) 30 is removed from hollow guide 25.
[0111] Next, inserter 20, carrying anchor 10 thereon, is passed through hollow guide 25 (thereby also passing through the labrum) and into the seat formed in the acetabulum. As anchor 10 is advanced into the bone, the body of anchor 10 (e.g., ribs 70) makes an interference fit with the surrounding bone, whereby to initially bind the anchor to the bone. At the same time, the solid distal ring 90 located at the distal end of the anchor provides the structural integrity needed to keep the anchor intact while it penetrates into the bone. When anchor 10 has been advanced an appropriate distance into the acetabulum, the proximal end of suture 15 (i.e., proximal open loop 105) is pulled proximally while the distal end of inserter 20 is held in position, thereby causing enlargement 100 to move proximally relative to the generally cylindrical body 35, forcing the distal end of generally cylindrical body 35 to split and expand, in the manner shown in
[0112] Significantly, in view of the modest holding power required to secure the labrum in place, anchor 10 can have a very small size, much smaller than a typical bone anchor of the sort used to hold a ligament in place. By way of example but not limitation, anchor 10 may have a length of 0.325 inches, an outer diameter (unexpanded) of 0.063 inches, and an outer diameter (expanded) of 0.080 inches. This small size enables a minimal puncture to be made in the labrum (and hence a minimal hole to be made in the labrum), thus reducing potential damage to the labral tissue and enabling a more accurate puncture location through the labrum. The small size of anchor 10 also allows the anchor to be placed closer to, or directly into, the rim of the acetabular cup, without fear of the anchor penetrating into the articulating surfaces of the joint. See, for example,
[0113] Once anchor 10 has been set in the acetabulum, guide 25 is removed from the surgical site, leaving anchor 10 deployed in the acetabulum and suture 15 extending out through the labrum.
[0114] This process may then be repeated as desired so as to deploy additional anchors through the labrum and into the acetabulum, with each anchor having a pair of associated free suture ends extending out through the labrum.
[0115] Finally, the labrum may be secured to the acetabular cup by tying the labrum down to the acetabulum using the free suture ends emanating from the one or more anchors.
Some Alternative Constructions for the Novel Suture Anchor System of the Present Invention
[0116] If desired, and looking now at
[0117] Furthermore, one or more of the ribs 70 may utilize a different construction than that shown in
[0118] Or one or more of the ribs 70 may be slotted as shown in
[0119] If desired, alternative arrangements can be provided for coupling anchor 10 to the distal end of inserter 20. More particularly, in
[0120] Looking next at
[0121] In another form of the present invention, and looking now at
[0122] If desired, one or both of distal relief hole 80 and proximal relief hole 85 may be omitted, with longitudinally-extending slit 75 terminating in a blind surface at one or both ends.
[0123] Furthermore, if desired more than one longitudinally-extending slit 75 may be provided in anchor 10, e.g., two diametrically-opposed longitudinally-extending slits 75 may be provided. Additionally, if desired, longitudinally-extending slit 75 may extend all the way to the distal end of the anchor body, rather than stopping short of the distal end of the anchor body. See, for example,
[0124] If desired, and looking now at
[0125] Or anchor 10 may be provided with an angled through-hole to create varying wall thicknesses and non-symmetric effects as shown in
[0126] If desired, and looking now at
[0127] Alternatively, in another form of the invention, anchor 10 is constructed so that its generally cylindrical body 35 expands radially when enlargement 100 moves proximally, but the distal end of the anchor does not split open. See
Additional Construction Details
[0128] Anchor 10 can be made out of any material consistent with the present invention, e.g., anchor 10 can be made out of a biocompatible plastic (such as PEEK), an absorbable polymer (such as poly-L-lactic acid, PLLA), bio-active materials such as hydrogels, or metal (such as stainless steel or titanium).
[0129] Suture 15 can be made out of any material consistent with the present invention, e.g., common surgical suture materials. One such material is woven polymer such as PE or UHMWPE. Another material is a co-polymer material such as UHMWPE/polyester. Yet another material is an absorbable polymer such as polyglycolic acid, polylactic acid, polydioxanone, or caprolactone. Proximal loop 105 is preferably a #1 suture size; alternatively, it is a #2 suture size, a #0 suture size, or a #2-0 suture size. Distal loop 95 is preferably a #2-0 suture size; alternatively, it is a #2 suture size, a #1 suture size, or a #0 suture size.
[0130] As noted above, enlargement 100 may comprise a solid member attached to the distal end of distal loop 95, or it may comprise a suture knot formed by knotting off the distal ends of distal loop 95 of suture 15. In this latter construction, enlargement 100 can be formed out of a single knot or multiple knots. It can be an overhand knot or other knot such as a “Figure 8” knot. Suture 15 can also be heat formed so as to create the enlargement 100. This will create a more rigid feature that better enables movement of enlargement 100 from its distal position to its more proximal position. Such heat forming could also be done on a knot or to seal the suture ends distal to the knot.
Alternative Construction and Method of Use
[0131] In one form of the present invention, anchor 10 of suture anchor system 5 may be delivered trans-labrally, i.e., through the labrum and into the acetabular bone, e.g., such as was described above.
[0132] In an alternative embodiment of the present invention, anchor 10 may be placed directly into the acetabular bone, without passing through the labrum first, and then suture 15 may be passed through the labrum. In this form of the invention, the components of suture anchor system 5 may remain the same. Alternatively, in this form of the invention, the distal end of hollow guide 25 need not have a sharp tip/edge 136 for penetrating the labrum as described above, and may instead have engagement features for engaging the acetabular bone. One such feature may be a tooth or a plurality of teeth. In this form of the invention, the distal end of the hollow guide may also include a window for confirming that the anchor is properly placed into the bone.
Curved or Angled Configuration and Method of Use
[0133] Suture anchor system 5 may also comprise a curved or angled configuration. More particularly, hollow guide 25 may comprise a curve or angle at its distal end. In this form of the invention, the punch (or drill) 30, inserter 20 and anchor 10 are adapted to pass through the curved or angled hollow guide 25 so as to permit a curved or angled delivery of anchor 10.
Use of the Novel Suture Anchor System for Other Tissue Re-Attachment
[0134] It should be appreciated that suture anchor system 5 may also be used for re-attaching other soft tissue of the hip joint, or for re-attaching tissue of other joints, or for re-attaching tissue elsewhere in the body. In this respect it should be appreciated that suture anchor system 5 may be used to attach soft tissue to bone or soft tissue to other soft tissue, or for attaching objects (e.g., prostheses) to bone other tissue.
Modifications of the Preferred Embodiments
[0135] It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.