Method and associated device for removing material from body

• US 5,730,717 A
• Filed: 12/15/1995
• Issued: 03/24/1998
• Est. Priority Date: 12/16/1994
• Status: Expired due to Term

• Current Assignee: Gary A. Gelbfish
• Original Assignee: Gary A. Gelbfish
• Inventors: Gelbfish, Gary A.
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/573,323
• Time in Patent Office: 830 Days
• Field of Search: 604/21-22, 604/28, 604/30, 604/49, 604/51, 604/93, 604/158, 604/164, 604/170, 604/246, 604/256, 604/264, 604/268, 604/280, 606/107, 606/110, 606/115, 606/166, 606/167, 606/170-172, 128/751-755, 128/4, 128/772
• US Class Current: 604/22
• 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 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

A pull push device for removing a clot. The device includes an elongate tubular member having a suction port and an irrigation or fluid pressurization port respectively connectable to a vacuum source and a pressurizable fluid reservoir. The tubular member also has a clot intake port positionable through a patient'"'"'s skin inside a clogged vascular vessel. The vacuum source enables clot suction into the clot intake port for severing while liquid pressure supplies fluid for clot ejection and device clearance. A single piece rotating or reciprocating cutter and intake closure component is mounted inside the tubular member for closing the clot intake port upon each small vacuum assisted severing of clot mass by the cutting element. By simultaneously severing the clot and closing the intake port by the closure component, the device automatically converts from a suction to a pressure mode, thus ejecting any clot through the suction port. The ordered and continual suck, cut, push, pull tandem ejection system is aided by an automatic anticlogging mechanism which is operative when a sucked clot obstructs suction through the tubular member. This self-limiting feature closes off further suction and ends the process of clot intake. Only after window closure and clot ejection has occurred is vacuum restored to the intake port so that more clot may be sucked into the device for processing.

Claims

1. A method for removing material from inside a patient, comprising:

(a) providing an elongate tubular member having a suction part and an intake port, said suction port being spaced from said intake port;

(b) inserting a portion of said tubular member through a skin surface of a patient and into an internal organ of the patient;

(c) upon completion of said step of inserting, applying suction to said tubular member via said suction port to thereby draw material in said organ into said tubular member through said intake port;

(d) upon a drawing of said material at least partially into said tubular member through said intake port, severing a portion of said material inside said tubular member;

(e) upon severing of said material, closing said intake port to substantially seal said tubular member with respect to said organ;

(f) upon closure of said intake port and the substantial sealing of said tubular member with respect to said organ, feeding fluid to said tubular member essentially upstream of the severed portion of said material to enable a forcible ejection of the severed portion of said material under positive pressure through said tubular member;

(g) removing said tubular member from the patient; and

(h) prior to removal of said tubular member, repeating steps (c) through (f) so that each severed portion of said material is ejected from said tubular member prior to removal thereof from the patient.

2. The method defined in claim 1 wherein said tubular member has an obturator part disposed inside a tubular part, an irrigation inlet port being disposed in said obturator part, the applying of fluid pressure to the severed portion of said material including the feeding of fluid along said obturator part and through said tubular part.

3. The method defined in claim 1 wherein the tubular member is provided with a movable or shiftable cutter element, the severing of said portion of said material including shifting said cutter element so that a cutting edge of said cutter element moves past said intake port, the closing of said intake port including blocking said intake port with said cutter element.

4. The method defined in claim 3 wherein the feeding of said fluid to said tubular member includes feeding said fluid through said tubular member and past said cutter element.

5. The method defined in claim 3 wherein said cutter element is provided with a fluid-flow channel, the feeding of said fluid including guiding said fluid through said channel.

6. The method defined in claim 3 wherein said tubular member is cylindrical, said cutter element having a D-shaped cross-section defining two parallel D-shaped channels, the feeding of fluid including the feeding of fluid into one of said channels.

7. The method defined in claim 1 wherein the feeding of fluid includes directing fluid along a path through said tubular member past said intake port.

8. The method defined in claim 7 wherein the tubular member is provided with a cutter element, said path extending past said cutter element, the severing of said portion of said material including shifting a cutting edge of said cutter element past said intake port.

9. The method defined in claim 8 wherein said cutter element is provided with a fluid-flow channel, said path extending through said channel.

10. The method defined in claim 7, further comprising closing said intake port during the feeding of fluid to said tubular member, thereby enabling an increase in pressure in said tubular member to forcibly eject the severed portion of said material from said tubular member.

11. The method defined in claim 1 wherein the feeding of fluid includes connecting a pressurizable fluid source to said tubular member and feeding fluid under pressure from said source and at least partially along said tubular member past said intake port.

12. The method defined in claim 1, further comprising the step of applying suction to said tubular member at a point downstream of said intake port to pull the severed portion of said material from said intake port along said tubular member.

13. The method defined in claim 1 wherein said organ is a vascular component and said suction port and an irrigation inlet port are located on opposite sides of said intake port, the inserting of said portion of said tubular member including inserting a selected end of said tubular member through said skin surface of the patient into said vascular component and subsequently out of said vascular component and said skin surface so that said suction port and said irrigation port are located outside the patient while said intake port is located in said vascular component.

14. The method defined in claim 13, further comprising:

inserting a catheter with an inflatable balloon in a deflated configuration into said vascular component;

subsequently inflating said balloon;

after inflation of said balloon, pulling said catheter and said balloon along said vascular component towards an insertion point of said tubular member into said vascular component, whereby vascular debris is shifted along said vascular component toward said intake port.

15. The method defined in claim 1, further comprising longitudinally shifting said tubular member through said organ to remove material along an extended portion of said organ.

16. The method defined in claim 15 wherein at least a substantial part of said tubular member is made of a flexible material, the longitudinal shifting of said tubular member including bending said tubular member.

17. The method defined in claim 1 wherein said organ is a vascular component and said material comprises vascular debris, said tubular member being provided with a cutter element having an internally threaded bore, the severing of said portion of said vascular debris including shifting a cutting edge of said cutter element past said intake port, further comprising:

inserting a first guidewire into said vascular component prior to insertion of said tubular member, the insertion of said tubular member including inserting said tubular member into said vascular component along said guidewire;

after insertion of said tubular member into said vascular component, removing said guidewire;

providing a second guidewire having an externally threaded segment;

after removal of said first guidewire from said tubular member, inserting said second guidewire into said tubular member;

upon insertion of said second guidewire into said tubular member, threading said segment to said bore to thereby attach said second guidewire to said cutter element; and

after attachment of said second guidewire to said cutter element, moving said second guidewire to shift said cutter element past said intake port.

18. The method defined in claim 1 wherein said tubular member is provided on an inner surface with a constricting sleeve, said tubular element being further provided with a cutter element having a projection at a downstream end, the severing of said portion of said material including shifting a cutting edge of said cutter element past said intake port, further comprising the step of moving said projection into said sleeve after shifting of said cutting edge past said intake port, thereby reducing said severed portion of said material in size prior to pushing said severed portion of said material along said tubular member.

19. The method defined in claim 1 wherein the tubular member carries a movable cutter element provided with spring loading, the severing of said portion of said material including shifting said cutter element in a first direction so that a cutting edge of said cutter element moves past said intake port, further comprising shifting said cutter element in a second direction opposite said first direction after a severing of said portion of said material, the shifting of said cutter element in at least one of said first direction and said second direction being performed under action of said spring loading.

20. The method defined in claim 1 wherein the tubular member carries a movable cutter element, the severing of said portion of said material including shifting said cutter element in a first direction so that a cutting edge of said cutter element moves past said intake port, further comprising shifting said cutter element in a second direction opposite said first direction after a severing of said portion of said material, the shifting of said cutter element in at least one of said first direction and said second direction including the step of applying fluid pressure to said cutter element.

21. A device for removing material from inside a patient, comprising:

an elongate tubular member having a suction port and an intake port, said suction port being spaced from said intake port, said suction port being connectable to a vacuum generator for applying suction to said tubular member;

cutting means mounted to said tubular member for severing a portion of material drawn partially in through said intake port upon disposition of said tubular member through a skin surface so that said suction port is located outside the patient while said intake port is located in an internal organ of the patient;

fluid feed means operatively connected to said tubular member for feeding a fluid to said tubular member to cooperate with applied suction to move the severed material out of said tubular member through said suction port, said fluid feed means being disposed eccentrically relative to said tubular member at least in a region about said intake port; and

closure means mounted to said tubular member for closing said intake port upon a severing of said portion of said material by said cutting means and prior to ejection of the severed portion of said material by the applied suction and said fluid feed means.

22. The device defined in claim 21 wherein said cutting means includes a cutting edge of a movable element slidably mounted to said tubular member, said closure means including a surface of said movable element.

23. The device defined in claim 22 wherein said fluid feed means includes means for feeding said fluid past said movable element.

24. The device defined in claim 23 wherein said movable element is provided with a fluid-flow channel so that fluid fed by said fluid feed means flows through said channel.

25. The device defined in claim 23 wherein said tubular member is cylindrical, said movable element having a D-shaped cross-section defining two parallel D-shaped channels, said fluid feed means including one of said channels.

26. The device defined in claim 21 wherein said fluid feed means includes means for directing pressurized fluid along a path through said tubular member past said intake port.

27. The device defined in claim 26 wherein said tubular member is provided with a movable cutter element, said path extending past said cutter element.

28. The device defined in claim 21 wherein an irrigation inlet port is provided on a side of said intake port opposite said suction port.

29. The device defined in claim 21, further comprising a balloon mounted to an external surface of said tubular member and means connected to said balloon for alternately inflating and deflating said balloon.

30. The device defined in claim 21 wherein said cutting means includes a cutter element having an internally threaded bore, further comprising a guidewire having an externally threaded segment, said guidewire being connected to said cutter element via said internally threaded bore and said externally threaded segment.

31. The device defined in claim 21 wherein said tubular member is provided on an inner surface with a constricting sleeve, said tubular element being further provided with a cutter element having a projection at a downstream end, said projection being insertable into said sleeve after a shifting of said cutter element past said intake port, to thereby push the severed portion of said material through said sleeve and reduce said severed portion of said material in size prior to an ejection of said severed portion of said material by said fluid pressurizing means.

32. The device defined in claim 21 said cutting means includes a cutter element provided with spring loading.

33. The device defined in claim 21 wherein said cutting means includes a movable cutter element and fluid shifting means for applying fluid pressure to said cutter element to shift said cutter element in at least one direction along said tubular member during an operating cycle of the device.

34. The device defined in claim 21 wherein said tubular member has an obturator part disposed inside a tubular part, an irrigation inlet port being disposed in said obturator part.

35. The device defined in claim 34 wherein said cutting means includes a cutter element disposed at a distal end of said obturator part.

36. A device for removing material from inside a patient, comprising:

an elongate tubular member having a suction port and an intake port, said suction port being spaced from said intake port, said suction port being connectable to a vacuum generator for applying suction to said tubular member;

a cutter element movably disposed inside said tubular member for severing material sucked into said tubular member through said intake port and for closing said intake port upon a drawing of said material into said tubular member through said intake port;

fluid feed means operatively connected to said tubular member for feeding a fluid to said tubular member to cooperate with applied suction to move the severed material out of said tubular member through said suction port; and

a drive rod extending through said tubular member to said cutter element, said drive rod being connected to said cutter element for moving said cutter element to sever debris at said intake port, said drive rod being eccentrically located relative to said tubular member at least in a region about said intake port.

37. The device defined in claim 36 wherein said fluid feed means includes means for feeding said fluid past said cutter element.

38. The device defined in claim 37 wherein said cutter element is provided with a fluid-flow channel so that fluid fed by said fluid feed means flows through said channel.

39. The device defined in claim 36 wherein an irrigation inlet port is provided on a side of said intake port opposite said suction port.

40. A device for removing material from inside a patient, comprising:

an elongate tubular member having a debris intake port and defining a waste removal channel extending from said intake port to a suction port at one end of said channel;

a cutter element movably disposed inside said tubular member for severing debris sucked into said tubular member through said intake port and for closing said intake port upon a drawing of said debris into said tubular member through said intake port; and

irrigation means disposed at least partially inside said tubular member for feeding irrigation fluid to said tubular member essentially upstream of the severed debris to generate positive pressure behind the severed debris to move the severed debris through said waste removal channel to said suction port.

41. The device defined in claim 40 wherein said irrigation channel has an outlet port disposed upstream of debris severed by said cutter element.

42. The device defined in claim 41 wherein said outlet port is disposed in said cutter element.

43. The device defined in claim 40 wherein said irrigation means includes said drive rod, said irrigation channel being a lumen of said drive rod.

44. The device defined in claim 43 wherein said irrigation channel has an outlet port disposed in said drive rod.

45. The device defined in claims 40, further comprising a drive rod extending through said tubular member to said cutter element, said drive rod being connected to said cutter element for moving said cutter element to sever debris at said intake port, said drive rod being eccentrically located, relative to said tubular member, at least in a region about said intake port, said irrigation means being eccentrically disposed relative to said tubular member at least in a region about said intake port.