Non-linear anchor inserter device and bone anchors

• US 5,972,000 A
• Filed: 10/18/1996
• Issued: 10/26/1999
• Est. Priority Date: 11/13/1992
• Status: Expired due to Fees

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: Influence Medical Technologies Ltd.
• Inventors: Beyar, Mordechay, Sohn, Ze'ev
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/733,798
• Time in Patent Office: 1,103 Days
• Field of Search: 606/139, 606/220, 606/232, 606/144, 606/148, 227/175.1
• US Class Current: 606/139
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0493 Protective devices for suturing, i.e. for protecting the patient's organs or the operator
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• 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 17/863 with thread interrupted or changing its form along shank, other than constant taper
• CPC Class Codes: A61B 17/869 characterised by an open form, e.g. wire helix
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/2904 curved, but rigid
• CPC Class Codes: A61F 2/0045 : Support slings
• CPC Class Codes: Y10S 606/916 : Tool for installing or removing orthopedic fastener

Abstract

A novel medical stapler and screw inserter device is disclosed herein wherein the medical instrument is formed in a non-linear or "C" or "V" shaped conformation. The non-linear shape allows the physician to accomplish a per vaginal anchor or screw insertion into a patient'"'"'s pubic bone, while locating the triggering hand outside of the vagina of the patient and employing a pulling force on the inserter/stapler, against the pubic bone of the patient. In addition, the weight of a patient'"'"'s body may be used to counterweight the recoil effect to minimize stapler recoil during ejection of a staple from the stapler into a patient. Novel bone anchor screws and a related bone screw driver and a method of inserting it into the pubic bone through the vagina are also described for per vaginal bladder neck suspension procedures.

Claims

1. A medical device for installing a bone anchor into a patient, comprising:

a handle, said handle being located at the proximal end of said medical device;

a rigid body, said body having a first end and a second end, said body being attached to said handle at said first end;

an anchor housing, said anchor housing being located at said second end of said body and at the distal end of said medical device, said anchor housing having means for holding a bone anchor having a leading tip; and

,

a power means in communication with said anchor housing for providing driving power to the bone anchor;

wherein

said body and said handle together form a non-linear shape such that the center of said anchor housing is aligned with said handle.

2. A medical device as claimed in claim 1, wherein said body and said handle form a C shape.

3. A medical device as claimed in claim 1, wherein said body and said handle form a V shape.

4. A medical device as claimed in claim 1, wherein said device is a medical stapler for forcibly ejecting and implanting a self-tapping bone anchor into the bone of a patient.

5. A medical device as claimed in claim 1, wherein said device is a screw driving device for screwing a self-tapping bone anchor into the bone of a patient.

6. An inserter as claimed in claim 1, further comprising a retractable shield.

7. A medical device as claimed in claim 1, wherein said medical device comprises three segments, a first segment of said three segments comprising said handle, a third segment of said segments comprising said anchor housing, and a second segment of said segments being intermediate between said first segment and said third segment, said second segment being attached to said handle and forming a non-obtuse angle with said handle.

8. A system for pervaginal bone screw insertion, comprising:

a bone screw; and

,

a non-linear screw inserter means for inserting said bone screw into a patient'"'"'s bone, said inserter means comprising a first end having a handle and a second end having a retractable shield having sharp tips, said bone screw being held at said second end with said retractable shield protecting said bone screw, wherein pulling of said handle when said inserter means is positioned against the patient'"'"'s anatomy retracts said retractable shield and reveals said sharp tips, said sharp tips being used to hold the soft tissue of a patient surrounding said screw and preventing the soft tissue from rotation during the screwing of said bone screw through the soft tissue and into the bone.

9. A system as claimed in claim 8, wherein said non-linear screw inserter is C-shaped.

10. A system as claimed in claim 8, wherein said bone screw comprises a shaft further comprising a trailing end, said shaft having screw threads, and said bone screw further having a suture secured thereto.

11. A system as claimed in claim 10, wherein said bone screw further comprises leaf springs, said leaf springs expanding outwardly upon insertion of said bone screw into the bone of a patient to more securely fixate said bone screw in the bone.

12. A system as claimed in claim 10, wherein said bone screw is made of shape memory material.

13. A system as claimed in claim 10, wherein said suture is secured at a point about midway between said leading tip and said trailing end.

14. A system as claimed in claim 10, wherein said suture is secured at said trailing end.

15. A system as claimed in claim 10, wherein said bone screw is provided with threads comprised of wire wrapped around said shaft.

16. A system as claimed in claim 10, wherein said leading tip is conical.

17. A system as claimed in claim 10, wherein said leading tip of said bone screw and said shaft form a taper.

18. A medical device as claimed in claim 8, wherein said medical device comprises three segments, a first segment of said three segments comprising said handle, a third segment of said segments comprising said anchor housing, and a second segment of said segments being intermediate between said first segment and said third segment, said second segment being attached to said handle and forming a non-obtuse angle with said handle.

19. A screw-type anchor inserter comprising:

a) a handle;

b) a rigid body connected to said handle, said body having a first end and a second end, said body being connected to said handle at said first end;

c) a screw-holding adapter means secured to said body at said second end, said body and said handle together forming a non-linear shape such that said second end is substantially parallel to said handle; and

,

d) a power drive means connected to said screw-holding adapter means for providing rotational torque to said screw-holding adapter means.

20. An inserter as claimed in claim 19 wherein said power drive means comprises a finger-operated trigger means.

21. An inserter as claimed in claim 19 wherein said power drive means comprises a flexible rotating drive shaft extending between said handle and said screw holding adapter means.

22. An inserter as claimed in claim 19 wherein said power drive means comprises:

a) an actuating trigger means;

b) a motor electrically connected to said trigger means and having a rotating shaft;

c) electric generating means connected to said motor to drive said rotating shaft when said trigger means is activated; and

d) a flexible, rotating drive shaft extending between said rotating shaft of said motor and said screw-holding adapter means.

23. An inserter as claimed in claim 22 further comprising torque enhancing means to increase the rotational torque of said flexible shaft in comparison to the torque of said rotating shaft of said motor.

24. An inserter as claimed in claim 19 wherein said screw-holding adapter means is selectively, replaceably secured to said body.

25. An inserter as claimed in claim 19 further comprising a screw protector housing for said screw-holding adapter means.

26. An inserter as claimed in claim 25 wherein said housing is retractable.

27. An inserter as claimed in claim 25 wherein said housing retracts when said housing is in perpendicular contact with the tissue of a patient.

28. An inserter as claimed in claim 27 wherein said housing is spring biased to protect said screw-holding adapter means.

29. An inserter as claimed in claim 19, further comprising a retractable shield.

30. A medical device as claimed in claim 19, wherein said medical device comprises three segments, a first segment of said three segments comprising said handle, a third segment of said segments comprising said anchor housing, and a second segment of said segments being intermediate between said first segment and said third segment, said second segment being attached to said handle and forming a non-obtuse angle with said handle.

31. A medical bone anchor inserter comprising:

a) a handle;

b) a rigid body having a first end and a second end, said body being connected to said handle at said first end;

c) a staple-holding head secured to said body for holding a staple having a leading tip, said stable-holding head being secured at said second end, said handle and body forming a non-linear shape such that said handle is substantially parallel to said second end; and

,

d) a power drive means in said body for providing driving force to said staple holding head.

32. An inserter as claimed in claim 31 wherein said power drive means is a spring loaded, hammer means and an activating trigger for selectively releasing said hammer means.

33. An inserter as claimed in claim 32 wherein said hammer means comprises a reciprocating hammer rod;

a first spring held on one end against a hammer rod guide in said body;

an annular first weight slidable over a portion of one end of said hammer rod;

said weight being movable over said hammer rod by contact by said second end of said spring; and

said hammer rod having a flange which is contacted by said first weight when said trigger is activated.

34. An inserter as claimed in claim 33 wherein said hammer means is controlled by a second spring mechanism comprising:

a) a handle rod secured in said handle;

b) a second spring mounted on said handle rod and held in position on one of its ends; and

c) a slidable, annular second weight connected to said second end of said spring.

35. An inserter as claimed in claim 31 wherein said activating trigger comprises:

a) a trigger device;

b) a connecting cam rotatable about a pivot point;

c) said connecting cam having a first rod extending therefrom and in contact with said first weight;

d) said connecting cam having a second rod extending therefrom and in contact with said second weight;

such that with said triggering device, when in a first position, causes said first and second rods to maintain said first and second spring mechanisms in their compressed state and when said triggering device is moved to a second position, said first and second rods allow said first and second spring mechanisms to achieve their expanded state, thereby moving said respective first and second weights and in so doing causing said hammer rod to drive a staple.

36. An Inserter as claimed in claim 31, further comprising a retractable shield.

37. A medical device as claimed in claim 31, wherein said medical device comprises three segments, a first segment of said three segments comprising said handle, a third segment of said segments comprising said anchor housing, and a second segment of said segments being intermediate between said first segment and said third segment, said second segment being attached to said handle and forming a non-obtuse angle with said handle.

38. A medical device for installing a bone anchor into a patient, comprising:

a) a handle;

b) a body, said body having a first end and a second end, said body being attached to said handle at said first end, said body and said handle together forming a non-linear shape;

(c) an anchor housing, said anchor housing being located at said second end of said body, said anchor housing having means for holding a bone anchor having a leading tip; and

,

d) a retractable shield for protecting the leading tip of the bone anchor held in said anchor housing.

39. A medical device as claimed in claim 38, wherein said retractable shield is further provided with sharp tips.

40. A medical device as claimed in claim 38, wherein said retractable shield is further provided with a roughened edge surface.

41. A medical device as claimed in claim 38, wherein said retractable shield is further provided with pins for holding tissue in place.

42. A medical device as claimed in claim 38, wherein said said body and said handle together form a non-linear shape such that said second end is substantially parallel to said handle.

43. A medical device as claimed in claim 38, wherein the center of said anchor housing is aligned with said handle.

44. A medical device as claimed in claim 38, wherein said body and said handle form a C-shape.

45. A medical device as claimed in claim 38, wherein said body is rigid.

46. A medical device as claimed in claim 38, wherein said device is a medical screwdriver for inserting a bone screw into a patient.

47. A medical device as claimed in claim 38, wherein said device is a medical stapler for forcibly ejecting and inserting a self-tapping bone anchor into the bone of a patient.

48. A medical device as claimed in claim 38, wherein said device further comprises a power drive means in communication with said anchor housing.

49. A medical device as claimed in claim 48 wherein said power drive means further comprises a finger-operated trigger means.

50. A medical device as claimed in claim 48 wherein said power drive means comprises a flexible rotating drive shaft extending between said handle and said anchor housing, said anchor housing comprising a screw holding adapter means.

51. A medical device as claimed in claim 48 wherein said power drive means comprises:

a) an actuating trigger means;

b) a motor electrically connected to said trigger means and having a rotating shaft;

c) electric power generating means connected to said motor to drive said rotating shaft when said trigger means is activated; and

d) a flexible, rotating drive shaft extending between said rotating shaft of said motor and said anchor housing, said anchor housing comprising a screw-holding adapter means.

52. A medical device as claimed in claim 51 further comprising torque enhancing means to increase the rotational torque of said flexible shaft in comparison to the torque of said rotating shaft of said motor.

53. A medical device as claimed in claim 38 wherein said anchor housing comprises a screw-holding adapter means.

54. A medical device as claimed in claim 53 wherein said screw-holding adapter means is selectively, replaceably secured to said body.

55. A medical device as claimed in claim 38 wherein said retractable shield retracts when said shield comes into perpendicular contact with the tissue of a patient and said handle is pulled against the resistant force provided by the patient'"'"'s anatomy.

56. A medical device as claimed in claim 38 wherein said retractable shield is spring-biased.

57. A medical device as claimed in claim 48 wherein said power drive means is a spring loaded, hammer means, and further comprising an activating trigger for selectively releasing said hammer means.

58. A medical device as claimed in claim 57 wherein said hammer means comprises a reciprocating hammer rod;

a first spring held on one end against a hammer rod guide in said body;

an annular first weight slidable over a portion of one end of said hammer rod;

said weight being movable over said hammer rod by contact by said second end of said spring; and

said hammer rod having a flange which is contacted by said first weight when said trigger is activated.

59. A medical device as claimed in claim 58 wherein said hammer means is controlled by a second spring mechanism comprising:

a) a handle rod secured in said handle;

b) a second spring mounted on said handle rod and held in position on one of its ends; and

, c) a slidable, annular second weight connected to said second end of said spring.

60. A medical device as claimed in claim 49 wherein said trigger means comprises:

a) a trigger device;

b) a connecting cam rotatable about a pivot point;

c) said connecting cam having a first rod extending therefrom and in contact with said first weight;

d) said connecting cam having a second rod extending therefrom and in contact with said second weight;

such that with said triggering device, when in a first position, causes said first and second rods to maintain said first and second spring mechanisms in their compressed state and when said triggering device is moved to a second position, said first and second rods allow said first and second spring mechanisms to achieve their expanded state, thereby moving said respective first and second weights and in so doing causing said hammer rod to drive a medical staple.

61. A medical device as claimed in claim 38, wherein said medical device comprises three segments, a first segment of said three segments comprising said handle, a third segment of said segments comprising said anchor housing, and a second segment of said segments being intermediate between said first segment and said third segment, said second segment being attached to said handle and forming a non-obtuse angle with said handle.

62. A medical device for installing a bone anchor into a patient, comprising:

a) a handle, said handle being located at the proximal end of said medical device;

b) a rigid body, said body having a first end and a second end, said body being attached to said handle at said first end;

c) an anchor housing, said anchor housing being located at said second end of said body and at the distal end of said medical device, said anchor housing having means for holding a bone anchor having a leading tip; and

,

d) wherein said body and said handle together form a non-linear shape such that said handle is substantially parallel to said second end.

63. A medical device as claimed in claim 62, wherein said body and said handle form a C-shape.

64. A medical device as claimed in claim 62, wherein said device is a medical screwdriver for inserting a bone screw into a patient.

65. A medical device as claimed in claim 62, wherein said device is a medical stapler for forcibly ejecting and inserting a self-tapping bone anchor into the bone of a patient.

66. A medical device as claimed in claim 62, wherein said device further comprises a power means in communication with said anchor housing.

67. A medical device as claimed in claim 66, wherein said power means further comprises a finger-operated trigger means.

68. A medical device as claimed in claim 66, wherein said power means comprises a flexible rotating drive shaft extending between said handle and said anchor housing, said anchor housing comprising a screw holding adapter means.

69. A medical device as claimed in claim 66, wherein said power means comprises:

a) an actuating trigger means;

b) a motor electrically connected to said trigger means and having a rotating shaft;

c) electric power generating means connected to said motor to drive said rotating shaft when said trigger means is activated; and

d) a flexible, rotating drive shaft extending between said rotating shaft of said motor and said anchor housing, said anchor housing comprising a screw-holding adapter means.

70. A medical device as claimed in claim 69, further comprising torque enhancing means to increase the rotational torque of said flexible shaft in comparison to the torque of said rotating shaft of said motor.

71. A medical device as claimed in claim 62, wherein said trigger means comprises:

a) a trigger device;

b) a connecting cam rotatable about a pivot point;

c) said connecting cam having a first rod extending therefrom and in contact with said first weight;

d) said connecting cam having a second rod extending therefrom and in contact with said second weight;

such that with said triggering device, when in a first position, causes said first and second rods to maintain said first and second spring mechanisms in their compressed state and when said triggering device is moved to a second position, said first and second rods allow said first and second spring mechanisms to achieve their expanded state, thereby moving said respective first and second weights and in so doing causing said hammer rod to drive a staple.

72. A medical device as claimed in claim 66, wherein said power means is a spring loaded, hammer means and an activating trigger for selectively releasing said hammer means.

73. A medical device as claimed in claim 72, wherein said hammer means comprises a reciprocating hammer rod;

a first spring held on one end against a hammer rod guide in said body;

an annular first weight slidable over a portion of one end of said hammer rod;

said weight being movable over said hammer rod by contact by said second end of said spring; and

said hammer rod having a flange which is contacted by said first weight when said trigger is activated.

74. A medical device as claimed in claim 73, wherein said hammer means is controlled by a second spring mechanism comprising:

a) a handle rod secured in said handle;

b) a second spring mounted on said handle rod and held in position on one of its ends; and

c) a slidable, annular second weight connected to said second end of said spring.

75. A medical device as claimed in claim 62, wherein said anchor housing is selectively, replaceably secured to said body.

76. A medical device as claimed in claim 62, further comprising a retractable shield for said anchor housing.

77. A medical device as claimed in claim 76, wherein said retractable shield retracts when said shield is in substantially perpendicular contact with the tissue of a patient and said handle is pulled against the resistant force provided by the patient'"'"'s anatomy.

78. A medical device as claimed in claim 76, wherein said retractable shield is spring biased.

79. A medical device as claimed in claim 62, wherein said medical device comprises three segments, a first segment of said three segments comprising said handle, a third segment of said segments comprising said anchor housing, and a second segment of said segments being intermediate between said first segment and said third segment, said second segment being attached to said handle and forming a non-obtuse angle with said handle.