Minimally invasive surgical stabilization devices and methods

• US 20080041394A1
• Filed: 05/03/2007
• Published: 02/21/2008
• Est. Priority Date: 06/24/2005
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Tunstall, Kathryn, Swann, Betsy, Cruzada, Julian, Stout, Christopher, Chan, Ken
• Granted Patent: US 8,360,064 B2
• Time in Patent Office: Days
• US Class Current: 128/831
• CPC Class Codes: A61B 1/0014 Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/0034 adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61F 6/06 for use by females A61F6/20 takes precedence
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
• CPC Class Codes: A61F 6/225 transcervical
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10

Abstract

The various embodiments of the present inventions provide stabilization devices and methods for use of the stabilization devices with minimally invasive gynecological procedures such as methods of preventing pregnancy by inserting intrafallopian contraceptive devices into the fallopian tubes.

Claims

1. A minimally invasive method of sterilization, the method comprising:

coupling a handle of a catheter to an endoscope, the endoscope having a handle and an elongated portion designed for insertion into a patient;

inserting the catheter and scope device into a uterus of the patient;

inserting a sterilization device coupled to a distal portion of the catheter into a fallopian tube of the patient, the sterilization device having an outer expandable portion;

activating the outer expandable portion of the sterilization device to expand inside the fallopian tube, and

decoupling the catheter from the expanded sterilization device while keeping the endoscope and catheter in a stable position rotationally relative to the patient.

2. The method of claim 1 wherein the sterilization device is coupled to the catheter by an interference fitting.

3. The method of claim 2 wherein the sterilization device is linearly coupled to the catheter and wherein the decoupling decouples in an inner portion of the expandable sterilization device from the catheter.

4. The method of claim 1 additionally comprising aligning the sterilization device with the fallopian tube before activating.

5. The method of claim 1 additionally comprising viewing an image generated by the endoscope, wherein the image is wirelessly transmitted to a display.

6. The method of claim 5 wherein the display is a heads up display.

7. The method of claim 5 wherein the image is wirelessly transmitted in an wide band frequency range.

8. The method of claim 5 wherein the image is wirelessly transmitted by a camera which is coupled to the endoscope.

9. The method of claim 5 wherein the image is wirelessly transmitted by the endoscope.

10. A medical device stabilization device, comprising:

a clamp designed to couple to an endoscope;

an elongated member coupled on the clamp;

a handle coupled to the elongated member, the handle configured to be grasped by an operator'"'"'s hands; and

a holster attached to the elongated member, the holster configured to securely couple to a delivery catheter for a transcervical medical procedure.

11. The arm of claim 10 wherein the holster is linearly adjustable on the member.

12. The arm of claim 10 where the holster is attached by a hinge to the member.

13. The arm of claim 10 wherein the clamp includes an extension member.

14. The arm of claim 13 wherein the elongated member hinges at the extension member.

15. A system for a transcervical medical procedure, comprising:

a wireless camera coupled to the endoscope; and

a catheter coupled to the endoscope, the catheter configured for a transcervical medical procedure.

16. The system of claim 15 wherein the transcervical medical procedure is one of a contraceptive procedure or an ablation procedure.

17. The system of claim 16 wherein the contraceptive procedure comprises placing at least one implant device which is placed within the catheter inside a fallopian tube.

18. The system of claim 15 additionally comprising a stabilization arm coupled to the endoscope.

19. The system of claim 18 wherein the stabilization arm prevents one of too proximal or too distal placement of an implant device inside a fallopian tube.

20. The system of claim 15 additionally comprising a computer wirelessly coupled to the wireless camera, wherein the computer processes a video signal transmitted by the wireless camera.

21. The system of claim 20 additionally comprising a display coupled to the computer.

22. The system of claim 21 wherein the display is a wireless headset.

23. A medical device for a transcervical medical sterilization procedure, comprising:

a elongated catheter, the elongated catheter having an outer portion, an inner portion within the outer portion, and a corewire within the inner portion, wherein the outer portion and inner portion are slideable relative each other; and

a contraceptive implant removabley coupled to the elongated catheter, wherein the contraceptive implant is removabley coupled in a manner in which the elongated catheter remains in a stable position rotationally relative to a patient receiving the contraceptive implant.

24. The medical device of claim 23 additionally comprising a handle coupled to an end of the elongated catheter at a position opposite to the contraceptive implant, the handle having a release mechanism with a plurality of incremented positions.

25. The medical device of claim 24 wherein the handle has a plurality of labeled operations, each labeled operation on the handle referring to an operation in removing the contraceptive implant from the elongated catheter.

26. The medical device of claim 25 wherein a first labeled operation refers to moving the outer catheter to expose the contraceptive implant, a second labeled operation refers to checking positioning of the contraceptive implant, a third labeled operation refers to activating a safety mechanism, and the forth labeled operation refers to moving the core wire to remove the contraceptive implant.

27. The medical device of claim 24 wherein of the release mechanism is capable of moving to a position wherein the outer portion slides to expose the contraceptive implant, and a final position wherein a corewire slides to remove the contraceptive implant, and wherein the inner portion includes the corewire.

28. The medical device of claim 27 additionally comprising a safety mechanism which when activated allows the release mechanism to move to a second incremented position.

29. The medical device of claim 28 wherein the release mechanism comprises a thumbwheel coupled to the handle.

30. The medical device of claim 28 wherein the safety mechanism comprises a button.

31. The medical device of claim 23 wherein the contraceptive implant is coupled to the corewire by an interference fitting.

32. The medical device of claim 31 wherein the contraceptive implant is abutted against the inner portion, and wherein the inner portion is stationary and provides a counterforce against the contraceptive implant to decouple the interference fitting when the corewire moves in the proximate direction.

33. The medical device of claim 32 wherein the contraceptive device includes a first unexpanded state and a second expanded state.

34. The medical device of claim 33 wherein the contraceptive device expands before completely decoupling from the corewire.

35. The medical device of claim 31 wherein the contraceptive implant comprises an inner device member coupled to an outer expandable device member.

36. The medical device of claim 35 wherein the expandable device member comprises at least one of a coil or a stent.

37. The medical device of claim 35 wherein the contraceptive member additionally comprises fibers coupled to the inner device member, the fibers being adapted to induce tissue ingrowth.

38. A minimally invasive method of sterilization, the method comprising:

coupling a handle of a catheter to a stabilization arm which is coupled to an endoscope, the endoscope having a handle and an elongated portion designed for insertion into a patient;

inserting the catheter and the endoscope into a uterus of the patient;

inserting a sterilization device coupled to a distal portion of the catheter into a fallopian tube of the patient, wherein depth of insertion into the fallopian tube is limited by the stabilization arm relative to the endoscope; and

decoupling the catheter from the sterilization device, which is expandable, while keeping the endoscope and catheter in a stable position rotationally relative to the patient.

39. The method of claim 38 wherein the sterilization device has an outer expandable portion.

40. The method of claim 39 additionally comprising activating the outer expandable portion of the sterilization device to expand inside the fallopian tube.

41. The method of claim 40 wherein activating occurs before decoupling.

42. The method of claim 38 wherein the stabilization arm prevents a too distal insertion of the sterilization device into the fallopian tube.

43. The method of claim 38 wherein inserting is at least aided in part by a stabilization arm handle which is coupled to the sterilization arm.

44. The method of claim 43 wherein the stabilization arm handle is capable of supporting the endoscope.

45. The method of claim 44 wherein inserting may be performed by solely manipulating the stabilization arm handle.

46. The method of claim 44 wherein the stabilization arm handle extends approximately perpendicular from the endoscope handle.

47. A medical device for use in a transcervical medical procedure, the medical device comprising:

a delivery device having walls defining a lumen in the delivery device, the lumen configured to receive a fallopian tube contraceptive implant device to be delivered to a fallopian tube through the lumen;

an imaging sensor in the delivery device;

a wireless transmitter in the delivery device, the wireless transmitter being coupled to the imaging sensor to transmit at least one image from the imaging sensor to a wireless sensor;

a power source in the delivery device, the power source being coupled to the wireless transmitter and to the imaging sensor; and

a light source in the delivery device, the light source being coupled to the power source.

48. The medical device as in claim 47 further comprising:

a holster coupled to the delivery device, the holster being configured to receive a delivery catheter which is configured to deploy the fallopian tube contraceptive implant device into the fallopian tube.

49. The medical device of as in claim 47 wherein the imaging and the light source are disposed at a distal portion of the delivery device and wherein the imaging sensor provides a sequence of color images and wherein the lumen receives a delivery catheter which has a retractable outer sheath to expose the fallopian tube contraceptive implant device which self expands after the retractable outer sheath is retracted.

50. A medical device for a transcervical medical sterilization procedure, comprising:

an elongated catheter with a distal portion and a proximal portion;

a fallopian tube implant removably coupled to the distal portion;

a handle coupled to the proximal portion, wherein the handle includes a at least one indicator for a process of removably decoupling the fallopian tube implant, and wherein the indicator illuminates.

51. The medical device of claim 50 wherein the at least one indicator is an LED light.

52. The medical device of claim 50 wherein the handle additionally includes at least one more illuminating indicator.

53. The medical device of claim 50 wherein the handle additionally includes a power source for illuminating the at least one indicator.

54. The medical device of claim 50 additionally wherein handle additionally includes an audible indicator for the process of removably decoupling the fallopian tube implant.

55. A medical device for a transcervical medical sterilization procedure, comprising:

an elongated catheter with a distal portion and a proximal portion;

a fallopian tube implant removably coupled to the distal portion;

a handle coupled to the proximal portion, wherein the handle includes a at least one indicator for a process of removably decoupling the fallopian tube implant, and wherein the indicator is audible.

56. The medical device of claim 55 wherein the indicator emits at least a single tone.

57. The medical device of claim 55 wherein the indicator emits a spoken voice.

58. A medical device for a transcervical medical sterilization procedure, comprising:

an elongated catheter with a distal portion and a proximal portion;

a fallopian tube implant removably coupled to the distal portion;

a handle coupled to the proximal portion, wherein the handle includes a wireless transmitter for transmitting at least one signal, wherein the signal is triggered by an operation in decoupling the fallopian tube implant.

59. The medical device of claim 58 wherein the at least one signal is received by a separate instrument for triggering a visual or audible indicator.