Bone anchor implantation device

• US 5,766,221 A
• Filed: 02/09/1995
• Issued: 06/16/1998
• Est. Priority Date: 12/03/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Technology Incorporated (Boston Scientific Corporation)
• Inventors: Benderev, Theodore V., Wallin, Sheila, Legome, Mark J., Naves, Neil H.
• Primary Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/385,897
• Time in Patent Office: 1,223 Days
• Field of Search: 606/72, 606/73, 606/75, 606/96, 606/99, 606/101, 606/102-104, 606/187, 606/232, 600/29, 128/DIG. 25, 623/13
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1775 for the foot or ankle
• CPC Class Codes: A61B 17/1778 for the shoulder
• CPC Class Codes: A61B 17/1796 for holes for sutures or flexible wires
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: A61B 46/30 : for surgery through the lower body openings, e.g. urology, gynaecology
• CPC Class Codes: Y10S 606/916 : Tool for installing or removing orthopedic fastener

Abstract

Bone anchor implantation devices for use in the surgical treatment of stress urinary incontinence are disclosed. Methods for positioning a bone anchor implantation device over a bone and for installing a bone anchor in a bone are also disclosed.

Claims

1. A bone anchor implantation device for directing a bone anchor at a selected site on a bone, comprising:

a generally rigid, nonconformable housing;

at least a first and a second probes on the housing, the first and second probes each having a proximal portion and a distal bone-contacting tip;

a stop attached to the proximal portion of each of the first and second probes, the stop providing a mechanical limit to distal travel of the first and second probes when the stop comes in contact with the housing;

a guide channel extending through the housing; and

an anchor driver for axially advancing the bone anchor through the guide channel and into the bone, said anchor driver having visual indicia for indicating the axial position of the bone anchor relative to the bone.

2. A bone anchor implantation device as in claim 1, further comprising a reference indicia on one of the probes or the housing, wherein said visual indicia comprises a mark on the anchor driver which, when aligned with said reference indicia, indicates the relative depth of the bone anchor.

3. A bone anchor implantation device as in claim 2, wherein said reference indicia comprises the proximal portion of at least one of the first and second probes.

4. A bone anchor implantation device as in claim 2, wherein the mark on the driver and reference indicia are located such that when the driver is advanced sufficiently distally to bring the mark and said reference indicia into alignment, and the first and second probes are in contact with the bone, the bone anchor is at an installed depth within the bone.

5. A bone anchor implantation device as in claim 1, wherein at least a first one of said probes is axially movable from a first proximal position to a second distal position.

6. A bone anchor implantation device as in claim 5, wherein the distal tip of the first probe is shielded within the housing when the probe is in the first position, and the distal tip of the first probe is exposed outside of the housing when the probe is in the second position.

7. A bone anchor implantation device as in claim 5, wherein at least two of said probes are axially movable between a first proximal position and a second distal position.

8. A bone anchor implantation device as in claim 1, wherein the longitudinal axis of the guide channel is approximately equidistant from the longitudinal axes of each of the probes.

9. A bone anchor implantation device as in claim 1, wherein said first probe comprises an elongate solid wire.

10. A bone anchor implantation device as in claim 1, wherein said probes have sufficient axial integrity to penetrate a bone, whereby said housing is maintained in a stable position.

11. A bone anchor implantation device as in claim 1, wherein the housing comprises a generally tubular structure.

12. A bone anchor implantation device as in claim 1, wherein the first and second probes are movably disposed in a first and a second probe channels, respectively, the first and second probe channels each having a diameter which is smaller than the diameter of the guide channel.

13. A bone anchor implantation device as in claim 1, wherein a distal end of the housing comprises a tissue contacting surface having a plurality of serrations thereon.

14. A bone anchor implantation device as in claim 13, wherein the tissue contacting surface is concave for complementary receipt of soft tissue overlying the bone in which the bone anchor is to be placed.

15. A bone anchor implantation device for positioning a bone anchor in a bone, comprising:

a housing, having proximal and distal ends;

at least a first and a second probes mounted to the housing, said first and second probes being axially movably disposed in a first and a second probe channels, respectively, said first and second probes having proximal and distal ends;

a stop attached to the proximal end of each of said first and second probes, the stop providing a mechanical limit to distal travel of said first and second probes when the stop comes in contact with the proximal end of the housing;

a guide channel extending through the housing for axially movably receiving a bone anchor and anchor driver; and

an anchor driver for advancing a bone anchor through the guide channel, said anchor driver having visual indicia for indicating the position of the bone anchor relative to the distal end of said first and second probe.

16. A bone anchor implantation device as in claim 15, wherein the distal end of the housing comprises a tissue contacting surface having a plurality of serrations thereon.

17. A bone anchor implantation device as in claim 16, wherein the tissue contacting surface is concave for complementary receipt of soft tissue overlying the bone in which the bone anchor is to be placed.

18. A bone anchor implantation device as in claim 15, wherein the longitudinal axes of said first and second probes are separated by a distance within the range of from about 5 mm to about 20 mm.

19. A bone anchor implantation device as in claim 15, wherein the housing comprises a generally tubular structure.

21. A bone anchor implantation device as in claim 15, wherein the housing is a generally rigid, nonconformable structure.

22. A bone anchor implantation device as in claim 15, further comprising a reference indicia on at least one of said probes, wherein said visual indicia comprises a mark on said anchor driver which, when aligned with said reference indicia, indicates the position of the bone anchor relative to the distal end of said first and second probes.

23. A bone anchor implantation device as in claim 22, wherein the mark on said driver and said reference indicia are located such that when said driver is advanced sufficiently distally to bring the mark and said reference indicia into alignment, and the first and second probes are in contact with the bone, the bone anchor is at installed depth within the bone.

24. A bone anchor implantation device as in claim 22, wherein said reference indicia comprises the proximal end of at least one of said first and second probes.

20. A bone anchor implantation device as in Clam 15, wherein the guide channel has a diameter which is larger than the diameter of each of the first and second probe channels.

25. A bone anchor implantation device for directing a bone anchor at a selected site, permitting introduction of a bone anchor through tissue and into a bone, comprising;

a housing;

at least a first and a second probes slidably extendable through the housing, said first and second probes each having a proximal portion and a distal bone contacting tip;

a stop attached to the proximal portion of each of said first and second probes, the stop providing a mechanical limit to distal travel of said first and second probes when the stop comes in contact with the housing;

a guide channel extending through the housing;

an anchor driver for passing through the guide channel;

a first visual indicia on the driver for indicating that the bone anchor is in contact with the surface of the bone; and

a second visual indicia on the driver for indicating that the bone anchor is at an implanted depth within the bone.

26. A bone anchor implantation device as in claim 25, wherein the housing comprises a generally tubular structure.

27. A bone anchor implantation device as in claim 25, wherein said first and second probes are movably disposed in a first and a second probe channels, respectively, said first and second probe channels each having a diameter which is smaller than the diameter of the guide channel.

28. A bone anchor implantation device as in claim 25, wherein the housing is a generally rigid, nonconformable structure.

29. A bone anchor implantation device as in claim 25, wherein a distal end of the housing comprises a tissue contacting surface having a plurality of serrations thereon.

30. A bone anchor implantation device as in claim 29, wherein the tissue contacting surface is concave for complementary receipt of soft tissue overlying the bone in which the bone anchor is to be placed.

31. A bone anchor implantation device as in claim 25, further comprising a reference indicia on at least one of said probes, such that the bone anchor is in contact with the surface of the bone when the reference indicia is aligned with the first visual indicia, and the bone anchor is at an implanted depth within the bone when the reference indicia is aligned with the second visual indicia.

32. A bone anchor implantation device as in claim 31, wherein the first and second visual indicia comprise marks on the anchor driver and said reference indicia comprises the proximal portion of at least one of the first and second probes.

33. A method of percutaneously installing a bone anchor in an unexposed bone, comprising the steps of:

providing a bone anchor implantation device comprising a housing, at least one axially extendable probe, the bone probe being extendable from a retracted position to an extended position relative to the housing, and a guide channel extending through the housing;

positioning the bone anchor implantation device over the exposed bone;

extending the bone probe relative to the housing so that the bone probe is advanced trough tissue until a distal end thereof is in contact with the unexposed bone, or until the bone probe reaches the extended position without contacting the unexposed bone;

if the bone probe does not contact the unexposed bone, retracting the bone probe from the extended position to the retracted position, adjusting the position of the bone anchor implantation device, and then reextending the bone probe through tissue until the bone probe contacts the unexposed bone to assure that the bone anchor implantation device is properly positioned over the unexposed bone;

providing an anchor driver having the bone anchor on a distal end thereof;

advancing the anchor driver through the guide channel to position the bone anchor in the bone; and

withdrawing the anchor driver from the guide channel, leaving the anchor in the bone.

34. A method as in claim 33, wherein said advancing step comprises rotating the anchor driver.

35. A method as in claim 34, wherein said advancing step comprises advancing the driver until visual indicia on the driver indicates that the anchor has reached a predetermined installed depth in the bone.

36. A method as in claim 33, wherein the step of positioning the bone anchor implantation device over the unexposed bone comprises positioning the bone anchor implantation device over a pubic bone.

37. A method as in claim 33, further comprising advancing a drill bit into the bone through the guide channel of the bone anchor implantation device to provide a recess in the bone, wherein the bone anchor is positioned in the recess.

38. A method as in claim 33, further comprising the step of selecting an anchor having a suture secured thereto.

42. A bone anchor implantation device as in claim 35, wherein the first and second probes are movably disposed in a first and a second probe channels, respectively, the first and second probe channels each having a diameter which is smaller than the diameter of the guide channel.

39. A bone anchor implantation device for directing a bone anchor at a selected site on a bone, comprising:

a housing;

at least a first and a second probes on the housing, the fist and second probes each having a proximal portion and a distal bone-contacting tip;

a reference indicia on one of said probes or said housing;

a stop attached to the proximal portion of each of the first and second probes, the stop providing a mechanical limit to distal travel of the first and second probes when the stop comes in contact with the housing;

a guide channel extending through the housing; and

an anchor driver for axially advancing the bone anchor through the guide channel and into the bone, said anchor driver having visual indicia for indicating the axial position of the bone anchor relative to the bone, wherein said visual indicia comprises a mark on the anchor driver which, when aligned with said reference indicia, indicates the relative depth of the bone anchor, the mark on the driver and said reference indicia being located such that when the driver is advanced sufficiently distally to bring the mark and said reference indicia into alignment, and the first and second probes are in contact with the bone, the bone anchor is at an installed depth within the bone.

40. A bone anchor implantation device as in claim 39, wherein said reference indicia comprises the proximal portion of at least one of the first and second probes.

41. A bone anchor implantation device as in claim 39, wherein the housing comprises a generally tubular structure.

43. A bone anchor implantation device as in claim 39, wherein the housing is a generally rigid, nonconformable structure.

44. A bone anchor implantation device as in claim 39, wherein a distal end of the housing comprises a tissue contacting surface having a plurality of serrations thereon.

45. A bone anchor implantation device as in claim 44, wherein the tissue contacting surface is concave for complementary receipt of soft tissue overlying the bone in which the bone anchor is to be placed.

46. A method of percutaneously installing a bone anchor in an unexposed bone, comprising the steps of:

providing a bone anchor implantation device of the type having at least one axially extending bone probe and a guide channel extending therethrough;

positioning the bone anchor implantation device over the unexposed bone;

extending the bone probe through tissue until a distal end proof is in contact with the unexposed bone to assure that the bone anchor implantation device is properly centered over the unexposed bone;

providing an anchor driver having the bone anchor on a distal end thereof;

advancing the anchor driver through the guide channel to position the bone anchor in the bone, wherein said advancing step comprises rotating the anchor driver; and

withdrawing the anchor driver from the guide channel, leaving the anchor in the bone.

47. A method as in claim 46, wherein the step of positioning the bone anchor implantation device over the unexposed bone comprises positioning the bone anchor implantation device over a pubic bone.

48. A method as in claim 46, further comprising the step of selecting an anchor having a suture secured thereto.

49. A method of percutaneously installing a bone anchor in an unexposed bone, comprising the steps of:

providing a bone anchor implantation device of the type having at least one axially extending bone probe and a guide channel extending therethrough;

positioning the bone anchor implantation device over the unexposed bone;

extending the bone probe through tissue until a distal end thereof is in contact with the unexposed bone to assure that the bone anchor implantation device is properly centered over the unexposed bone;

providing an anchor driver having the bone anchor on a distal end thereof;

advancing the anchor driver through the guide channel to position the bone anchor in the bone, wherein said advancing step comprises advancing the driver until visual indicia on the driver indicates that the anchor has reached a predetermined installed depth in the bone; and

withdrawing the anchor driver from the guide channel, leaving the anchor in the bone.

50. A method as in claim 49, wherein said advancing step comprises rotating the anchor driver.

51. A method as in claim 49, wherein the step of positioning the bone anchor implantation device over the unexposed bone comprises positioning the bone anchor implantation device over a pubic bone.

52. A method as in claim 49, further comprising the step of selecting an anchor having a suture secured thereto.

53. A bone anchor implantation device for directing a bone anchor at a selected site on a bone, comprising:

a housing;

a guide channel extending through the housing;

at least a first and a second probe channels extending through the housing, the first and second probe channels each having a diameter which is smaller than the diameter of the guide channel;

at least a first and a second probes movably disposed in the first and second probe channels, respectively, the first and second probes each having a proximal portion and a distal bone contacting tip;

a stop attached to the proximal portion of each of the first and second probes, the stop providing a mechanical limit to distal travel of the first and second probes when the stop comes in contact with the housing; and

an anchor driver for axially advancing the bone anchor through the guide channel and into the bone, said anchor driver having visual indicia for indicating the axial position of the bone anchor relative to the bone.

54. A bone anchor implantation device as in claim 53, further comprising a reference indicia on one of the probes or the housing, wherein said visual indicia comprises a mark on the anchor driver which, when aligned with said reference indicia, indicates the relative depth of the bone anchor.

55. A bone anchor implantation device as in claim 54, wherein the mark on the driver and said reference indicia arc located such that when the driver is advanced sufficiently distally to bring the mark and said reference indicia into alignment, and the first and second probes are in contact with the bone, the bone anchor is at an installed depth within the bone.

56. A bone anchor implantation device as in claim 54, wherein said reference indicia comprises the proximal portion of at least one of the first and second probes.

57. A bone anchor implantation device as in claim 53, wherein a distal end of the housing comprises a tissue contacting surface having a plurality of serrations thereon.

58. A bone anchor implantation device as in claim 57, wherein the tissue contacting surface is concave for complementary receipt of soft tissue overlying the bone in which the bone anchor is to be placed.

59. A bone anchor implantation device as in claim 53, wherein the housing comprises a generally tubular structure.

60. A bone anchor implantation device as in claim 53, wherein the housing is a generally rigid, nonconformable structure.

61. A bone anchor implantation device for directing a bone anchor at a selected site on a bone, comprising:

a generally tubular housing;

at least a first and a second probes on the housing, the first and second probes each having a proximal portion and a distal bone-contacting tip;

a stop attached to the proximal portion of each of the first and second probes, the stop providing a mechanical limit to distal travel of the first and second probes when the stop comes in contact with the housing;

a guide channel extending through the housing; and

an anchor driver for axially advancing the bone anchor through the guide channel and into the bone, said anchor driver having visual indicia for indicating the axial position of the bone anchor relative to the bone.

62. A bone anchor implantation device as in claim 61, further comprising a reference indicia on one of the probes or the housing, wherein said visual indicia comprises a mark on the anchor driver which, when aligned with said reference indicia, indicates the relative depth of the bone anchor.

63. A bone anchor implantation device as in claim 62, wherein the mark on the driver and said reference indicia are located such that when the driver is advanced sufficiently distally to bring the mark and said reference indicia into alignment, and the first and second probes are in contact with the bone, the bone anchor is at an installed depth within the bone.

64. A bone anchor implantation device as in claim 62, wherein said reference indicia comprises the proximal portion of at least one of the first and second probes.

65. A bone anchor implantation device as in claim 61, wherein a distal end of the housing comprises a tissue contacting surface having a plurality of serrations thereon.

66. A bone anchor implantation device as in claim 65, wherein the tissue contacting surface is concave for complementary receipt of soft tissue overlying he bone in which the bone anchor is to be placed.

67. A bone anchor implantation device as in claim 61, wherein the first and second probes are movably disposed in a first and a second probe channels, respectively, the first and second probe channels each having a diameter which is smaller than the diameter of the guide channel.

68. A bone anchor implantation device as in claim 61, wherein the housing is a generally rigid, nonconformable structure.