Devices for occlusion of the uterine arteries

• US 20010014805A1
• Filed: 04/17/2001
• Published: 08/16/2001
• Est. Priority Date: 12/08/1998
• Status: Active Grant

• Current Assignee: Fred Burbank, Michael Jones, Paul Lubock
• Original Assignee: Fred Burbank, Michael Jones, Paul Lubock
• Inventors: Jones, Michael, Lubock, Paul, Burbank, Fred
• Granted Patent: US 6,602,251 B2
• Time in Patent Office: Days
• US Class Current: 606/45
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Devices and methods are disclosed for treating a uterine disorder which receive its blood supply from a uterine arteries. In particular, uterine fibroids are effectively treated by occluding the uterine arteries using trans-vaginal, trans-uterine, transrectal, or retroperitoneal approaches. The devices and methods are advantageous because the inventive procedures may be performed by a patient'"'"'s gynecologist in the course of treatment, avoiding the need for referrals to specialist practitioners and for more radical treatments, such as hysterectomies. The methods include both temporary and permanent occlusion of the arteries. A cannula carries an imaging device and a member which will easily penetrate tissue, the member including a device which partially or completely, and temporarily or permanently, occludes a uterine artery.

Claims

1. A system for treating a disorder that receives blood from a uterine artery by causing at least partial occlusion of a uterine artery, comprising:

means for sensing a location of a uterine artery; and

means for at least partially penetrating an anatomical structure in the region of the uterine artery to cause at least partial occlusion of the uterine artery to thereby decrease the blood flow to the uterus and said disorder.

2. A system in accordance with

claim 1

, wherein said means for sensing is directed to sense in a plane, and said means for at least partially penetrating is movable in said plane.

3. A system in accordance with

claim 1

, wherein said means for at least partially penetrating is movable is a first direction, and further comprising means for supporting said means for at least partially penetrating against a wall of a uterus in a second direction, said second direction being substantially opposite said first direction.

4. A system in accordance with

claim 3

, wherein said means for supporting comprises an inflatable member.

5. A system in accordance with

claim 3

, wherein said means for supporting comprises a belt having a distal end fixedly attached to said system, said belt being formed of a material and having dimensions such that said belt can bow away from said means for at least partially penetrating and press against a uterine wall.

6. A system in accordance with

claim 1

, wherein said means for at least partially penetrating comprises a distal end and a burrowing element on said distal end.

7. A system in accordance with

claim 1

, wherein said means for at least partially penetrating comprises a cutting RF probe.

8. A system in accordance with

claim 1

, wherein said means for at least partially penetrating comprises a needle.

9. A system in accordance with

claim 1

, wherein said means for at least partially penetrating comprises a tubular cannula, said tubular cannula comprising a distal end and an RF cutting probe mounted on said tubular cannula distal end.

10. A system in accordance with

claim 1

, further comprising a cannula in which said means for sensing and said means for at least partially penetrating are located, said cannula having a proximal end and a distal end, said cannula comprising a pullwire system capable of deflecting said cannula distal end, said pullwire system including a wire attached to said cannula at a point adjacent said cannula distal end and extending proximally along said cannula, a first locking member attached to said wire proximal of said point, and a second locking member attached to said cannula which can engage with said first locking member to fix a position of said wire.

11. A system in accordance with

claim 1

, wherein said means for sensing a location of a uterine artery comprises means for imaging a uterine artery.

12. A system in accordance with

claim 1

, further comprising means for guiding said means for sensing and said means for at least partially penetrating into a uterus.

13. A system in accordance with

claim 1

, wherein said means for sensing a location of a uterine artery comprises a two-dimensional ultrasonic transducer and a Doppler imaging device.

14. A system in accordance with

claim 1

, wherein said means for sensing a location of a uterine artery comprises an ultrasonic transducer.

15. A system in accordance with

claim 1

, wherein said means for sensing a location of a uterine artery consists essentially of a two-dimensional ultrasonic transducer.

16. A system in accordance with

claim 1

, wherein said means for sensing consists essentially of a Doppler ultrasonic transducer.

56. A method of treating a disorder in accordance with

claim 56

, wherein said penetrating step comprises penetrating tissue with a system in accordance with

claim 1

.

59. A method of treating a disorder in accordance with

claim 56

, wherein said disorder is a uterine fibroid.

60. A method of treating a disorder in accordance with

claim 56

, further comprising:

locating said uterine artery with a locating device selected from the group consisting of a CT scanner, a fluoroscope, X ray, a MRI device, Doppler audio device, a gray scale color 2D Doppler ultrasound device, a landmark system, and combinations thereof.

61. A method of treating a disorder in accordance with

claim 56

, wherein said step of penetrating tissue comprises penetrating tissue along a path selected from the group consisting of through a uterine wall, through a vaginal wall, along a rectal wall, and through the peritoneal cavity.

62. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises temporarily occluding said uterine artery.

63. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises permanently occluding said uterine artery.

64. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises completely occluding said uterine artery.

65. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises occluding said uterine artery with a form of ionizing radiation selected from the group consisting of X rays, gamma rays, and implanting brachytherapy seeds.

66. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises occluding said uterine artery with a mechanism selected from the group consisting of a clip, a T-bar, a loop, a snare, a coil, a bulk agent, and a staple.

67. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises occluding said uterine artery with a chemical agent selected from the group consisting of EtOH, Sotradechol, acids, and bases.

68. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises occluding said uterine artery with heat transfer selected from the group consisting of lasers, hot fluid, cold fluid, RF energy, microwave, focused ultrasound, and mechanical ultrasound.

69. A method of treating a disorder in accordance with

claim 56

, wherein said step of occluding said uterine artery comprises occluding said uterine artery with forming a embolism in said uterine artery by performing step selected from the group consisting of injecting occluding particles into said uterine artery, injecting a thrombolytic agent into said uterine artery, systemically administering an agent to a vasculature which leads to said uterine artery and locally activating said agent, and coagulating blood in said uterine artery by localized heating of said blood.

17. A system for treating disorders in a human female, which receive blood from at least one of the uterine arteries, by causing at least partial occlusion of a uterine artery, comprising:

a cannula having a proximal end and a distal end;

an ultrasonic transducer positioned adjacent said distal end, said ultrasonic transducer capable of sensing the location of anatomical structures in a sensing plane when energized; and

a tissue penetrating member having a distal end and being movable relative to said cannula between a retracted position and a extended position, said tissue penetrating member distal end being substantially in said sensing plane when said tissue penetrating member is in said extended position.

18. A system for treating disorders in a human female in accordance with

claim 17

, wherein said tissue penetrating member further comprises means for at least partially occluding said uterine artery.

19. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a snare, said tissue penetrating member including a cavity at its distal and, said snare being extendable between a retracted position in said cavity and an extended position wherein said snare extends beyond said tissue penetrating member distal end.

20. A system for treating disorders in a human female in accordance with

claim 19

, wherein said snare is formed of a shape memory alloy having a transition temperature between about 65°

F. (18.3°

C.) and about 100°

F. (37.8°

C.), said snare having an open configuration below said transition temperature and a closed configuration above said transition temperature.

21. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a clip formed of a resilient material, said clip having a spring with two ends, a pair of jaws biased toward each other by said spring, and an actuation portion between said jaws and said spring, said actuation portion comprising two spaced apart angled extensions of said jaws each of which is joined to one of said two spring ends, said angled extensions forming angles with said jaws so that when said angled extensions are pressed toward each other by an opening force, said jaws open against a spring reaction force generated by said spring, and when said opening force is zero, said spring biases said jaws toward each other.

22. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a microwave antenna positioned in said tissue penetrating member distal end.

23. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a clip formed of a deformable material, a clamp, and a clamp actuating wire extending from said clamp toward said cannula proximal end, said clip being positioned in said clamp, said clamp being movable between an open orientation in which said clamp holds said clip, and a closed orientation in which said clamp deforms said clip.

24. A system for treating disorders in a human female in accordance with

claim 18

, wherein said clamp comprises a pair of jaws and a pivot point at which said pair of jaws are pivotally attached, said pair of jaws including at least one cam surface which bears against said tissue penetrating member, said clamp actuating wire attached to one of said pair of jaws, whereby when said clamp actuating wire is proximally retracted, said clamp actuating wire pulls said clamp at least partially into said tissue penetrating member, and said tissue penetrating member bears against said cam surface to force said jaws to at least partially close and deform said clip.

25. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a cinching member including an end member having two ends, an adjustment member attached to said end member and having at least one locking enlargement, and a backup disk having a hole therein, said adjustment member extending through said backup disk hole.

26. A system for treating disorders in a human female in accordance with

claim 25

, wherein said cinching member comprises a T-bar having said two ends, and wherein said adjustment member is attached to said T-bar between said two ends.

27. A system for treating disorders in a human female in accordance with

claim 25

, wherein said backup disk is formed of an elastic material having an elastic limit, and said backup disk hole is sufficiently smaller than said locking enlargement that said locking enlargement can be pulled through said backup disk hole without exceeding said elastic limit of said elastic material.

28. A system for treating disorders in a human female in accordance with

claim 25

, wherein said locking enlargement has an asymmetrical shape and said backup disk hole is substantially the same shape as said locking enlargement, said backup disk and said adjustment member being rotatable relative to each other, whereby when said locking enlargement is pulled through said backup disk hole, said locking enlargement and said backup disk hole can be rotated relative to each other so that said locking enlargement asymmetrical shape does not line up with said backup disk hole shape.

29. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a malecot having an inner member and an outer member surrounding said inner member, said outer member and said inner member being movable relative to each other, said outer member including a distal end, at least one distal wing, and at least one proximal wing positioned proximal of said at least one distal wing, said at least one distal wing and said at least one proximal wing being bendable away from said inner member, whereby when said outer member moves proximally relative to said inner member, said at least one distal wing and said at least one proximal wing bend away from said inner member.

30. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises an ultrasonic energy source mounted on one of said cannula and said tissue penetrating member, said ultrasonic energy source capable of emitting ultrasonic energy at a frequency and magnitude sufficient to initiate clotting of human blood by a mechanism selected from the group consisting of generating cavitation bubbles in human blood, heating human blood, rupturing blood cells, and combinations thereof.

31. A system for treating disorders in a human female in accordance with

claim 30

, wherein said ultrasonic energy source comprises an ultrasonic focusing element which focuses said ultrasonic energy at a point substantially in said sensing plane when said ultrasonic energy source emits ultrasonic energy.

32. A system for treating disorders in a human female in accordance with

claim 30

, wherein said ultrasonic energy source comprises an anvil distally movable from said tissue penetration member, an ultrasonic frequency vibrational energy generator, and a ultrasonic vibrational energy transmission member extending between said anvil and said ultrasonic frequency vibrational energy generator, whereby when said ultrasonic frequency generator generates vibrational energy, said energy is transmitted along said ultrasonic vibrational energy transmission member to said anvil.

33. A system for treating disorders in a human female in accordance with

claim 32

, wherein said tissue penetrating member and said means for at least partially occluding said uterine artery both comprise said ultrasonic energy source, said ultrasonic energy source being operable at a first set of frequencies and magnitudes which generate heat sufficient to allow said tissue penetrating member to advance from said cannula at least partially through a uterine wall, said ultrasonic energy source being operable at a second set of frequencies and magnitudes which generate heat sufficient to occlude said uterine artery.

34. A system for treating disorders in a human female in accordance with

claim 32

, wherein said ultrasonic frequency generator is capable of generating vibrational energy at a frequency between about 20 kHz and about 50 kHz at a magnitude up to about 0.001 inches (2.54×

10<sup>−

3</sup> cm).

35. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises an RF ablation probe positioned at said tissue penetrating member distal end.

36. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a lumen extending proximally from said tissue penetrating member distal end, said lumen having a sidewall formed of a material which is nonreactive to a chemical occluding agent.

37. A system for treating disorders in a human female in accordance with

claim 36

, wherein said chemical occluding agent is EtOH.

38. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a heat transfer cannula having a distal end, said tissue penetrating member comprising a lumen and a opening at said tissue penetrating member distal end, said heat transfer cannula positioned in said lumen and extendable from a retracted position and an extended position in which said heat transfer cannula distal end extends distally of said tissue penetrating member distal end, said heat transfer cannula comprising two lumens which are fluidly isolated from each other along the length of said cyrogenic cannula, said heat transfer cannula further comprising a sealed distal tip, said two lumens being in fluid communication in said heat transfer cannula only at said sealed distal tip.

39. A system for treating disorders in a human female in accordance with

claim 18

, wherein said means for at least partially occluding said uterine artery comprises a heating ablation element positioned on said tissue penetrating member distal end and a power transmission wire extending proximally from said heating ablation element.

40. A system for treating disorders in a human female in accordance with

claim 18

, wherein said cannula further comprises a lumen extending proximally from said distal end, and a guidewire having an atraumatic distal tip, said guidewire being in said lumen and movable between a retracted position and an extended position in which said guidewire atraumatic tip is distal of said cannula distal end.

41. A system for treating disorders in a human female in accordance with

claim 18

, wherein said cannula distal end has a longitudinal axis extending proximally from said distal end, and wherein said ultrasonic transducer is oriented in said cannula so that said sensing plane extends in a direction substantially perpendicular to said longitudinal axis.

42. A system for treating disorders in a human female in accordance with

claim 18

, wherein said ultrasonic transducer is oriented in said cannula so that said sensing plane extends distally from said distal end.

43. A system for treating disorders in a human female in accordance with

claim 18

, said cannula further comprises a guide port proximal of said distal end and a guide lumen extending proximally from said guide port, and wherein said tissue penetrating member is positioned in said guide lumen and movable in said guide lumen between a retracted position and an extended position in which said tissue penetrating member extends out of said guide port.

44. A system for treating disorders in a human female in accordance with

claim 18

, wherein said cannula further comprises a guide member at a distal end of said guide lumen adjacent said guide port, said guide member directing said tissue penetrating member into said sensing plane when moved from said retracted position and said extended position.

45. A system for treating disorders in a human female in accordance with

claim 18

, wherein said cannula is formed of a substantially rigid material, said cannula further comprises a bent portion proximal of said cannula distal end.

46. A system for treating disorders in a human female in accordance with

claim 18

, wherein said cannula further comprises a resilient flexible portion proximal of said cannula distal end.

51. A system for treating disorders in a human female in accordance with

claim 18

, wherein said tissue penetrating member comprises a hollow needle at said tissue penetrating member distal end, said needle having a distal tip sufficiently sharp to penetrate the tissue of a female human uterine wall.

52. A system for treating disorders in a human female in accordance with

claim 18

, wherein said tissue penetrating member comprises an RF energy cutting member at said tissue penetrating member distal tip and an RF energy transmission element extending through said tissue penetrating member to said RF energy cutting member.

57. A method of treating a disorder in accordance with

claim 56

, wherein said penetrating step comprises penetrating tissue with a system in accordance with

claim 17

.

47. A system for treating disorders in a human female in accordance with

claim 47

, wherein said cannula flexible portion includes a proximal end, and said cannula further comprises a stabilizing member at least portions of which are distal to said cannula flexible portion proximal end, said stabilizing member including uterine wall engaging portions which are positioned on said cannula opposite said sensing plane.

48. A system for treating disorders in a human female in accordance with

claim 48

, wherein said stabilizing member is movable from a retracted position in which said uterine wall engaging portions do not substantially extend beyond said cannula, and an extended position in which said uterine wall engaging portions extend from said cannula, whereby when said cannula is in a human uterus and said stabilizing member is in said extended position, said stabilizing member bears against a uterine wall and bends said cannula at said resilient flexible portion toward said sensing plane.

49. A system for treating disorders in a human female in accordance with

claim 48

, wherein said stabilizing member comprises a resilient belt having a distal end fixedly attached to said cannula at a point adjacent said cannula distal end, said resilient belt extending proximally from said resilient belt distal end, said resilient belt being longitudinally relatively rigid and laterally less rigid.

50. A system for treating disorders in a human female in accordance with

claim 48

, wherein said stabilizing member comprises an inflatable member and an inflation lumen in fluid communication with said dilator, said inflation lumen extending proximally from said inflatable member.

53. A system for treating disorders in a human female, which receive blood from at least one of the uterine arteries, by effecting at least partial occlusion of a uterine artery, comprising:

a locating cannula having a proximal end and a distal end, said locating cannula including a locating device positioned adjacent said distal end, said locating device capable of sensing the location of anatomical structures in at least a sensing plane when energized; and

a tissue penetrating cannula having a distal end and including a tissue penetrating member, said tissue penetrating cannula being movable independent from and relative to said locating cannula between a retracted position and a extended position, said tissue penetrating member distal end being substantially in said sensing plane when said tissue penetrating member is in said extended position.

54. A system for treating disorders in a human female in accordance with

claim 54

, further comprising a template including two holes, a first one of said two holes sized to receive said tissue penetrating cannula therein, a second one of said two holes sized to receive said locating cannula therein.

58. A method of treating a disorder in accordance with

claim 56

, wherein said penetrating step comprises penetrating tissue with a system in accordance with

claim 54

.

55. A method of treating a disorder that receives blood from at least one uterine artery by at least partially cutting off the blood supply to said disorder, comprising the steps of:

penetrating tissue to reach a point adjacent said uterine artery; and

occluding said uterine artery to at least partially cut of the blood supply to said disorder.