Occlusion of tubular anatomical structures by energy application

• US 6,599,256 B1
• Filed: 09/11/2000
• Issued: 07/29/2003
• Est. Priority Date: 09/10/1999
• Status: Expired due to Term

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Transurgical, Inc.
• Inventors: Kavoussi, Louis R., Pant, Bharat B., Lopath, Patrick David, Acker, David E., Ebbini, Emad S.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): Lin, Jeoyuh
• Application Number:
  US09/659,068
• Time in Patent Office: 1,051 Days
• Field of Search: 601/2, 601/3, 604/20, 604/22, 604/24, 600/439
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/2808 Clamp, e.g. towel clamp
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61D 1/06 Castrating appliances
• CPC Class Codes: A61F 6/20 Vas deferens occluders; Fallopian occluders
• CPC Class Codes: A61N 2007/0052 using the same transducer for therapy and imaging
• CPC Class Codes: A61N 2007/0065 Concave transducers
• CPC Class Codes: A61N 2007/0095 by modifying an excitation signal
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A tubular anatomical structure in a mammalian subject is occluded by directing ultrasonic energy from outside of the body. For example, a male subject may be sterilized by directing ultrasonic energy through the skin of the scrotum, onto the vas deferens. The focal spot of an ultrasonic transducer may be registered with the structure to be treated by means of guide members on a probe holding the transducer. The procedure is simple and can be entirely non-invasive. Apparatus for performing this and other treatments may be provided as a disposable unit, and the guide members may be arranged to hold a fold of tissue without substantially obstructing the sonic path from the transducer to the fold.

Claims

1. A method of sterilizing a mammalian subject comprising the step of directing energy from outside of the subject'"'"'s body, through the skin of the scrotum into the body and onto the tissue constituting a spermatic duct to thereby kill at least some of such tissue at a location along the length of the spermatic duct, whereby scar tissue will form and occlude the spermatic duct.

2. A method as claimed in claim 1 wherein said step of directing energy includes directing ultrasonic energy.

3. A method as claimed in claim 2 wherein said directing step includes pinching the scrotum of the subject and capturing the spermatic duct in the pinched region, and applying energy through the skin covering the pinched region.

4. A method as claimed in claim 3 wherein said step of applying energy on the exterior of the pinched region includes the step of applying a probe adapted to emit energy to the pinched region of the scrotum.

5. A method as claimed in claim 4 further comprising the step of maintaining said probe in a preselected position relative to the pinched region by means of one or more guide members connected to said probe and engaged with said pinched region.

6. A method as claimed in claim 5 wherein said one or more guide members include a pair-of opposed guide members projecting from said probe and wherein said pinched region of the scrotum is engaged between said pair of opposed guide members.

7. A method as claimed in claim 6 wherein said pinched region of the scrotum projects generally in a Z direction relative to said guide members and said probe, and said pinched region and said spermatic duct extend generally in a Y direction transverse to said Z direction, and wherein said step of directing ultrasonic energy includes emitting the sonic energy from one or more transducers defining an emitting surface offset from the pinched region in said Z direction, the method further comprising the step of providing a sonic transmission element extending between the emitting surface and the skin of said engaged region.

8. A method as claimed in claim 7 wherein said emitting surface is substantially in the form of a sector of a cylindrical surface having an axis extending in said Y direction, the axis of the emitting surface being disposed within the pinched region of the scrotum.

9. A method as claimed in claim 8 wherein said transducer has an f-number of about 0.5 or less.

10. A method as claimed in claim 7 wherein a first one of said one or more guide members includes first and second elements spaced apart from one another in said Y direction and defining a first space therebetween, and wherein said sonic transmission element extends into said first space and engages the skin of the pinched region in said first space.

11. A method as claimed in claim 10 wherein a second one of said one or more guide members includes first and second elements spaced apart from one another in said Y direction and defining a second space therebetween, and wherein said sonic transmission element extends into said second space and engages the skin of the pinched region in said second space.

12. A method as claimed in claim 2 wherein said spermatic duct is the vas deferens.

13. A method as claimed in claim 1 wherein said step of directing energy is performed so as to deliver a predetermined dose of energy to the tissue surrounding the spermatic duct, without feedback control of such dose during the directing step.

14. A method as claimed in claim 1 further comprising the steps of monitoring one or more effects of the applied energy and controlling the dose of energy delivered to the tissue based upon said monitoring to thereby provide feedback control of the applied dose.

15. A method as claimed in claim 14 wherein said one or more effects include echogenicity of tissue surrounding the spermatic duct.

16. A method as claimed in claim 14 wherein said step of applying energy includes the step of actuating one or more transducers to apply heating pulses of ultrasonic energy and said monitoring step includes the step of monitoring signals generated by at least one of said one or more transducers responsive to ultrasonic energy impinging thereon.

17. A method as claimed in claim 16 further comprising the step of actuating at least one of said one or more transducers to emit one or more monitoring pulses of ultrasonic energy interspersed with said heating pulses, said monitoring step including the step of detecting signals generated by at least one of said one or more transducers responsive to echoes of said monitoring pulses impinging thereon.

18. A method as claimed in claim 17 wherein said one or more monitoring pulses includes an initial monitoring pulse prior to application of said heating pulses and one or more in-process monitoring pulses after application of at least one heating pulse, and wherein said monitoring step includes comparing signals produced by at least one of said transducers responsive to said in-process monitoring pulses with signals produced by the same one of said transducers responsive to the initial monitoring pulse.

19. A method as claimed in claim 1 further comprising the step of reversing the occlusion of said spermatic duct by surgically removing said scar tissue and reconnecting regions of said spermatic duct on opposite sides of said scar tissue.

20. A method of occluding a tubular anatomical structure in the body of a mammalian subject comprising the step of directing ultrasonic energy from outside of the subject'"'"'s body, into the body and onto the tissue constituting the tubular anatomical structure to thereby kill at least some of such tissue at a location along the length of the anatomical structure, whereby scar tissue will form and occlude the anatomical structure.

21. A method as claimed in claim 20 wherein said directing step includes maintaining a probe having one or more ultrasonic transducers associated therewith and adapted to emit ultrasonic energy so that said ultrasonic energy will be focused in a focal region at known disposition relative to the probe at a preselected disposition relative to a portion of the subject'"'"'s body incorporating the anatomical structure so that the focal region encompasses the anatomical structure.

22. A method as claimed in claim 21 wherein said step of maintaining said probe in a preselected disposition relative to the portion of the subject'"'"'s body is performed by engaging one or more guide members connected to said probe and with such portion of the subject'"'"'s body.

23. A method as claimed in claim 22 wherein said one or more guide members include a pair of opposed guide members and wherein said portion of the subject'"'"'s body is pinched between said pair of opposed guide members.

24. A method as claimed in claim 23 wherein said portion of the body generally in a Z direction relative to said guide members and said probe, and said pinched portion and said anatomical structure extend generally in a Y direction transverse to said Z direction, and wherein said step of directing ultrasonic energy includes emitting the sonic energy from one or more transducers defining an emitting surface offset from the pinched region in said Z direction, the method further comprising the step of providing a sonic transmission element extending between the emitting surface and the skin of said pinched portion.

25. A method as claimed in claim 24 wherein said emitting surface is substantially in the form of a sector of a cylindrical surface having an axis extending in said Y direction, the axis of the emitting surface being disposed within the pinched portion of the subject'"'"'s body.

26. A method as claimed in claim 24 wherein a first one of said one or more guide members includes first and second elements spaced apart from one another in said Y direction and defining a first space therebetween, and wherein said sonic transmission element extends into said first space and engages the skin of the pinched region in said first space.

27. A method as claimed in claim 26 wherein a second one of said one or more guide members includes first and second elements spaced apart from one another in said Y direction and defining a second space therebetween, and wherein said sonic transmission element extends into said second space and engages the skin of the pinched portion in said second space.

28. A method as claimed in claim 20 wherein said step of directing energy is performed so as to deliver a predetermined dose of energy to the tissue surrounding the anatomical structure, without feedback control of such dose during the directing step.

29. A method as claimed in claim 20 further comprising the steps of monitoring one or more effects of the applied energy and controlling the dose of energy delivered to the tissue based upon said monitoring to thereby provide feedback control of the applied dose.

30. A method as claimed in claim 29 wherein said one or more effects include echogenicity of tissue surrounding the anatomical structure.

31. A method as claimed in claim 29 wherein said step of applying energy includes the step of actuating one or more transducers to apply heating pulses of ultrasonic energy and said monitoring step includes the step of monitoring signals generated by at least one of said one or more transducers responsive to ultrasonic energy impinging thereon.

32. A method as claimed in claim 31 further comprising the step of actuating at least one of said one or more transducers to emit one or more monitoring pulses of ultrasonic energy interspersed with said heating pulses, said monitoring step including the step of detecting signals generated by at least one of said one or more transducers responsive to echoes of said monitoring pulses impinging thereon.

33. A method as claimed in claim 32 wherein said one or more monitoring pulses includes an initial monitoring pulse prior to application of said heating pulses and one or more in-process monitoring pulses after application of at least one heating pulse, and wherein said monitoring step includes comparing signals produced by at least one of said transducers responsive to said in-process monitoring pulses with signals produced by the same one of said transducers responsive to the initial monitoring pulse.

34. A method as claimed in claim 20 further comprising the step of reversing the occlusion of said tubular structure surgically by removing said scar tissue and reconnecting regions of said tubular structure on opposite sides of said scar tissue.

35. Apparatus for occluding a tubular anatomical structure including:

(a) a probe including a housing having an operative region and one or more ultrasonic transducers operatively associated with said housing, said transducers being adapted to deliver ultrasonic energy at a focal region having a known disposition relative to said operative region of said housing; and

(b) one or more guide members projecting from said housing for engaging a portion of a subject'"'"'s body to hold that portion of the body in position relative to the operative region of the housing so that the focal region will lie at a known disposition to the body portion engaged by the guide members.

36. Apparatus as claimed in claim 35 wherein said one or more guide members are adapted to engage the skin of the subject'"'"'s body covering the engaged portion of the body.

37. Apparatus as claimed in claim 35 wherein said one or more guide members include first and second opposed guide members adapted to receive a pinched portion of the body and maintain said operative region in preselected disposition relative to said pinched region.

38. Apparatus as claimed in claim 37 wherein one or both of said guide members is movable relative to the housing so that said guide members can be moved toward and away from one another so as to pinch a portion of the subject'"'"'s body in a gap between said guide members.

39. Apparatus as claimed in claim 38 wherein guide members are adapted to pinch said portion of the body therebetween so that the pinched portion projects generally in a Z direction relative to said guide members and said probe, said one or more transducers defining an emitting surface offset in said Z direction from the gap between said guide members.

40. Apparatus as claimed in claim 39 wherein said emitting surface is substantially in the form of a sector of a cylindrical surface having an axis extending in a Y direction transverse to said Z direction, said guide members being movable towards and away from one another generally in an X direction transverse to said Y and Z directions, the axis of the emitting surface being disposed within the gap between said guide members.

41. Apparatus as claimed in claim 39 wherein said transducer has an f-number less than 1.

42. Apparatus as claimed in claim 39 wherein said first guide member includes first and second elements spaced apart from one another in said Y direction and defining a first space therebetween.

43. Apparatus as claimed in claim 42 wherein a second one of said one or more guide members includes first and second elements spaced apart from one another in said Y direction and defining a second space therebetween.

44. Apparatus as claimed in claim 43 further comprising a sonic transmission element extending between the emitting surface and the gap between the guide members so that the flexible sonic transmission element will engage the skin of the pinched portion of the body held in said gap, said sonic transmission element extending into said spaces defined by said guide members.

45. Apparatus as claimed in claim 38 wherein said one or more transducers are adapted to deliver ultrasonic energy at a focal location, the apparatus further including means for moving said focal location relative to said housing as said guide members move towards and away from one another.

46. Apparatus as claimed in claim 38 wherein said one or more transducers include one or more transducers mounted to a carriage, said carriage being movable in carriage movement directions so that said carriage moves toward said guide members as said guide members move toward one another.