ULTRASONIC METHOD AND APPARATUS FOR REMOVING CHOLESTEROL AND OTHER DEPOSITS FROM BLOOD VESSELS AND THE LIKE

• US 3,565,062 A
• Filed: 06/13/1968
• Issued: 02/23/1971
• Est. Priority Date: 06/13/1968
• Status: Expired due to Term

• Current Assignee: Kuris Arthur
• Original Assignee: Kuris Arthur
• Inventors: KURIS ARTHUR
• Application Number:
  US04/736,653
• Time in Patent Office: 985 Days
• US Class Current: 606/169
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/32008 preventing clogging of suction channel
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

The method and apparatus of the invention relates to the removal of foreign deposits of material from vessels of living human beings, such as cholesterol from blood vessels, by means of accelerations of vibratory forces in the ultrasonic frequency range without causing any disruption or damage to the surrounding walls of the vessels. The layer of material is removed from the inner surface of a vessel of a human in vivo by supporting a portion of the wall of the vessel and inserting in the vessel a tool member having an output surface that is vibrated to provide peak accelerations of at least 1,000 g'"'"''"'"'s, as the output surface of the vibrated tool member is placed in contact with the material at substantially the supported wall portion so as to transmit the mechanical vibrations thereto for a time sufficient to effect disintegration of the contacted material, and at the same time effecting relative movement of the tool member relative to the vessel so as to progressively contact, disintegrate, and thereby remove the layer of material from the vessel.

Claims

2. an ultrasonic motor connected to said vibration generator, and

3. A method as in claIm 2, wherein said removal of said disintegrated material is facilitated by applying suction to said vessel.

4. A method as in claim 2, wherein said disintegrated material is removed through said vibrating tool member.

5. A method as in claim 2, wherein said material is removed from the said vessel by a combination of suction and ultrasonic pumping.

6. A method as in claim 1, wherein said layer of material is removed by:

a. supplying a treatment liquid to said portion so that contact of said output surface with said material pressurizes the liquid for enhancing the effectiveness of the liquid in mixing with the disintegrated material and forming a suspension thereof, and b. simultaneously applying suction to said vessel adjacent said tool member to remove said suspension therefrom.

7. A method as in claim 6, wherein said treatment liquid is supplied to said portion and the suction is applied to said portion at spaced apart locations between which at least a section of said vibrated tool member is interposed so that the suction induces the treatment liquid to flow across said vibrated tool member for ensuring the continuous mixing and the removal of said material.

8. A method as in claim 1:

a. wherein said step of effecting mechanical elastic vibration of said tool member includes coupling to said tool member an energy transmission member terminating exteriorly of said vessel and vibrated at an ultrasonic rate, and b. further including the step of maintaining said transmission member in spaced relation to said wall portion to prevent contact therewith.

9. A method as in claim 8, further including the step of continuously varying the frequency of vibration of said energy transmission member so as to change the position of said loops and nodes of vibration therein, whereby substantial heat buildup along said energy transmission member at any location is prevented.

10. A method as in claim 1, wherein said relative movement between said tool member and said internally supported wall portion is controlled such that said output surface is maintained within said supported wall portion of said vessel.

11. A method as in claim 1, wherein said relative movement of said tool member and said internally supported wall portion is such that there is a substantial component of relative motion perpendicular to said output surface.

12. A method as in claim 1, wherein said relative movement of said tool member and said internally supported wall portion is such that there is a substantial component of relative motion parallel to said output surface.

13. A method as in claim 1, wherein said depth of removal is controlled by providing a support member having an outer cross-sectional area adapted for supporting said vessel, and providing said output surface with a similar configuration as said support member but of a different cross-sectional area, whereby the thickness of said removed layer is substantially equal to the difference between said respective cross-sectional areas.

14. A method as in claim 13 wherein:

a. said support member cross-sectional area has a circular configuration, b. said output surface cross-sectional area of said tool member has a circular configuration, and c. said relative movement between said tool member and said support member is along the longitudinal axis of said support member, so as to substantially remove a circular layer of said material from said vessel.

15. A method as in claim 1, wherein said material is of a relatively low fatigue strength relative to the fatigue strength of said vessel and said vibratory energy is applied for a time sufficient to effect fatigue fracture of said material to effect said disintegration and of any bond of the latter to said vessel.

16. A method as in claim 1, wherein said step of supporting a portion of the wall of said vessel includes placing in said vessel a support member having a surface for engagement with and application of a radially oUtwardly directed force thereto, whereby said wall is supported along an axially extending portion.

17. A method as in claim 16, including the step of supporting said wall along a length of said axially extended portion in the range of from 0.20 to 2 inches.

18. A method as in claim 16, wherein said radially outwardly directed force is applied circumferentially to said wall along said axially extending portion.

19. A method as in claim 1, wherein said output surface of said tool member is elliptically vibrated.

20. A method as in claim 1, wherein said output surface of said tool member is torsionally vibrated.

21. A method as in claim 1, wherein said output surface is vibrated with simultaneous longitudinal and torsional vibration.

22. A method as in claim 1, wherein said tool output surface is vibrated in the frequency range of 10,000 to 100,000 cycles per second.

23. A method as in claim 1, further including the step of maintaining said material at a temperature below which permanent damage would occur to the surrounding wall, said temperature being maintained by supplying a treatment liquid at a preselected temperature.

24. A method as claimed in claim 1, wherein said vessel is a blood vessel.

25. A method as in claim 24, wherein said material removed is cholesterol.

26. A method as claimed in claim 24, wherein said blood vessel is an arterial.

27. A method as claimed in claim 24, wherein said blood vessel is a veinule.

28. A method as claimed in claim 24, wherein said blood vessel is an artery.

29. A method as claimed in claim 24, wherein said blood vessel is a vein.

30. A method as in claim 1;

a. wherein said wall portion is supported by applying said internally outwardly directed force and forming one or more nibs of said material extending inwardly from said supported wall portion, and b. further including the step of maintaining said radial force during said relative movement of said tool member and said internally supported wall portion until said respective nibs are removed.

31. A method as in claim 30, wherein said internally outwardly directed force is radially applied by inserting in said vessel a support member having a cross-sectional area adapted to apply said radial force to compress said material, said support member having a plurality of apertures adapted to receive said compressed material and form said nibs, and said relative movement is axially between said tool member and said vessel to remove said nibs.

32. A method as in claim 1, wherein said portion of the wall of said vessel is supported by said tool member.

33. A method of removing a layer of material adhered to the inner surface of a blood vessel in vivo, comprising the step of:

a. providing an opening in a blood vessel, b. Internally axially supporting a portion of said vessel by inserting therein a support member having a contacting surface for engagement with and application of a radially outwardly directed force to support said portion of said blood vessel, said support member having an axially extending first passageway therethrough, c. inserting in said vessel through said first passageway a tool member having an output surface, d. supporting said tool member at one end of a transmission member extending through said first passageway and terminating at its opposite end exteriorly of said blood vessel, e. vibrating said tool member at an ultrasonic rate by transmitting mechanical elastic energy waves to said transmission member, f. mounting said transmission member in said first passageway to transmit a minimum of vibratory energy to said support member, g. placing the output surface of said vibrating member in contact with said material at substantially said internally axially supported wall portion so as to transmit said vibrations thereto for a time sufficient to effect disintegration of said contacted material, h. effecting relative movement of said tool mEmber and said vessel so as to progressively contact, disintegrate, and thereby remove said layer of material from within said blood vessel, i. supplying a treatment fluid through a second passageway to said supported portion adjacent said vibrating tool member for forming a suspension of said disintegrated material and treatment fluid, j. applying a suction force through a third passageway to said supported portion adjacent said tool member to remove said suspension from said blood vessel, and k. controlling the depth of removal of said material during the relative movement between said support member and said tool member.

34. A method as in claim 33, further including the step of controlling the relative movement between said tool member and said vessel such that said output surface is maintained within said supported portion of said vessel

35. A method as in claim 33:

a. wherein said support member has a plurality of apertures extending between said contacting surface and said first passageway in the area of said supported portion, whereby said radially outwardly directed forces compresses said material and forms a plurality of nibs extending through said apertures and into said first passageway, and b. wherein said relative movement is axially in said first passageway, whereby said tool member engages and removes said nibs.

36. Apparatus for removing a layer of material adhering to the inner surface of a vessel of a human in vivo, comprising a. means adapted for internally supporting the wall portion of said vessel in the proximate area from which said layer of material is to be removed, b. a tool member movably supported within said means, said tool member adapted to be inserted within said vessel and having an output surface adapted for engagement with said material, c. vibration generating means coupled to said tool member to effect vibration of the latter at a high frequency sufficient to cause disintegration of material in contact with the output surface of said tool member, d. means adapted for effecting engagement of the output surface of said tool member with said material at substantially said supported wall portion so as to transmit said vibrations thereto for effecting disintegration of said contacted material, e. means coupled to said tool member for effecting relative movement between said tool member and said means for internally supporting the vessel, wherein the output surface thereof is adapted to move within said supported wall portion, so as to progressively contact, disintegrate and thereby remove said layer of material from said vessel, and f. means for controlling the depth of removal of said layer of material, said means including means for maintaining said means for internally supporting the wall potion and said tool member output surface in relatively fixed spaced relation to each other to define a spacing therebetween for controlling the depth of removal.

37. Apparatus as in claim 36, wherein said vibration generating means includes:

a. a vibration generator, b. an ultrasonic motor connected to said vibration generator, and c. a transmission member coupling said ultrasonic motor to said tool member for transmitting said ultrasonic vibrations thereto.

38. Apparatus as in claim 37, wherein said vibration generator includes means to continuously vary the frequency of vibration of said transmission member so as to vary the position of the loops and nodes of vibration therealong so as to prevent substantial heat buildup along said transmission member at any location thereon.

39. Apparatus as in claim 37, wherein said means adopted for supporting the portion of said vessel includes a support member adapted to be inserted therein and having a passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted to support said wall portion of said vessel, and said transmission member extending through said pasSageway.

40. Apparatus as in claim 39, further including radial support means maintaining said transmission member and support member in axially spaced relation to each other.

41. Apparatus as in claim 40, wherein said radial support means includes a plurality of radially extending flanges in longitudinally spaced relation to each other along said transmission member.

42. Apparatus as in claim 41, wherein said radial flanges are provided substantially at loops of longitudinal vibration along said transmission member.

43. Apparatus as in claim 39, wherein said support member is provided with a plurality of radially inwardly extending flanges in said passageway to support said transmission member.

44. Apparatus as in claim 39, wherein said means for effecting movement of said tool member relative to said means for internally supporting comprises said transmission member coupled to said tool member.

45. Apparatus as in claim 36, further including means to limit the relative movement of said tool member relative to said support means, such that said tool member output surface is adapted to remain within said supported wall portion.

46. Apparatus as in claim 36, further including means for removing the disintegrated material from said vessel.

47. Apparatus as in claim 46, wherein said means for removing said disintegrated material includes suction means communicating with said vessel for removal of the disintegrated material therefrom.

48. Apparatus as in clam 36, further including a. means for forming a fluidized suspension substantially at said supported wall portion containing the disintegrated material, which includes means for supplying a treatment fluid to said supported portion, and b. means for removing said fluidized suspension from the vessel so as to cave the supported wall portion substantially free of disintegrated material, said removing means including means adapted to communicate with said vessel for removal of said fluidized suspension therefrom.

49. Apparatus as in claim 36, wherein:

a. said means adapted for supporting the portion of said vessel includes a support member adapted to be inserted therein and having a passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted to support said portion of said vessel to provide a selected configuration of given internal cross-sectional area therein, and b. said tool member output surface having a similar configuration as said supported portion but of a different cross-sectional area, such that said depth of removal is equal to the difference between said respective cross-sectional areas.

50. Apparatus as in claim 36:

a. wherein said means adapted for supporting a portion of said vessel includes a tubular member having an annular exterior surface adapted for substantially complete engagement with the inner peripheral surface of said supported portion and a first passageway extending axially therethrough with a plurality of apertures connecting said first passageway and said exterior surface, and b. said exterior surface adapted to provide a radially outward pressure to compress said material and effect a flow of said material through said apertures to form a plurality of nibs in said first passageway, such that said relative movement removes said nibs.

51. Apparatus as in claim 50, including means for advancing said tool member axially through said first passageway to engage said nibs and remove them.

52. Apparatus for removing a layer of material adhering to the inner surface of vessel a of a human in vivo, comprising:

a. means adapted for internally supporting the wall portion of said vessel in the proximate area from which said layer of material is to be removed, said support means including a support member adapted to be inserted therein and having a first passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted tO support said wall portion of said vessel, b. a tool member movably supported within said means, said tool member adapted to be inserted within said vessel and having an output surface for engagement with said material, c. vibration generating means coupled to said tool member to effect vibration of the latter at a high frequency sufficient to cause disintegration of material in contact with the output surface of said tool member, said vibration generating means including

53. Apparatus as in claim 52, wherein said tool member is vibrated in the range of 1,000 to 500,000 cycles per second.

54. Apparatus as in claim 52:

a. wherein said tool member is adapted for movement within said first passageway, b. wherein said support member has an annular exterior surface adapted for substantially complete engagement with the inner peripheral surface of said supported portion and a plurality of apertures connecting said first passageway and said exterior surface, and c. said exterior surface adapted to provide a radially outward pressure to compress said material and effect a flow of said material through said apertures to form a plurality of nibs in said first passageway, such that said relative movement of said tool member removes said nibs contained therein.