Method for removing cellular material with endoscopic ultrasonic aspirator

• US 4,922,902 A
• Filed: 12/16/1987
• Issued: 05/08/1990
• Est. Priority Date: 05/19/1986
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG
• Original Assignee: Valleylab Inc. (Medtronic Plc)
• Inventors: Krawitt, Donald R., Katz, Louis, Brendolan, Robert, Wuchinich, David G.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/133,711
• Time in Patent Office: 874 Days
• Field of Search: 128/24 A, 128/32, 128/303 R, 128/305, 128/328, 604/22, 604/27, 604/43
• US Class Current: 604/22
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/32008 preventing clogging of suction channel
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: B06B 1/0261 taken from a transducer or electrode connected to the driving transducer

Abstract

A method and apparatus for endoscopic removal of compliant biological tissues utilizing an endoscopic ultrasonic aspirator comprising irrigation and aspiration means, a piezoelectric ultrasonic transducer, a first resonator such as a half-wave stepped velocity transformer, a probe including a second resonator such as a constant-stress velocity transformer, a blunt or modified working tip of open channel means or restricted tubular means for application of ultrasonic energy to cellular material, and a capacitive fluid sensor to detect the presence of irrigation fluid adjacent these transformers within the instrument. The surgery is advantageously performed by operating the transducer in the 10-20 kHz range to achieve maximum cavitation of the intracellular fluids in the tissues to be removed.

Claims

1. A method of removing cellular material from a compliant tissue relatively deep within a biological body through a narrow orifice comprising:

providing an elongated surgical instrument which comprises an elongated working end having a length of at least about 8 cm, a circumference of no more than about 29 mm, and a working tip at the forward end thereof, said instrument including means for viewing said working tip and said material to be removed;

inserting said forward end of said elongated surgical instrument into the orifice with said working tip located close to the material to be removed; and

vibrating said working tip longitudinally at a frequency of about 10-20 kHz so as to cavitate the intracellular fluids in such material to destroy the cells thereof while monitoring the removal of said material through the viewing means of said instrument.

2. The method of claim 1, including vibrating said working tip with a longitudinal stroke of at least about 350 microns.

3. The method of claim 2, wherein such longitudinal stroke is at least about 700 microns.

4. The method of claim 1, including vibrating said working tip with a maximum velocity of at least about 1000 cm/sec.

5. The method of claim 4, wherein said maximum velocity is at least about 2000 cm/sec.

6. The method of claim 1, including employing a blunt working tip.

7. The method of claim 1 which further comprises providing the working tip with open channel means to facilitate the removal of said material.

8. The method of claim 7 which further comprises selecting an open channel means which tapers and diminishes along its length.

9. The method of claim 7 which further comprises selecting an open channel means which comprises a base portion and two side portions.

10. The method of claim 7 which further comprises selecting an open channel means which has a cross-sectional area in the shape of a U or V.

11. The method of claim 7 which further comprises selecting an open channel means of substantially uniform cross-section.

12. The method of claim 7 which further comprises selecting an open channel means which further includes tip means of smaller cross-section than the open channel means.

13. The method of claim 1 which further comprises providing said instrument with a radio-frequency source so that said working tip can receive a RF current for cauterization of said tissue when said tip is not vibrating.

14. The method of claim 13 which further comprises providing said instrument with means for selecting the source of signal to be provided to said working tip from one of said radio frequency source or a source for generating ultrasonic vibrations.

15. The method of claim 14 which further comprises providing said instrument with a switch as the selecting means.

16. A method of removing cellular material from a compliant tissue at an operating site at least about 8 cm deep within a biological body through a narrow orifice comprising:

providing an elongated surgical instrument which comprises an elongated working end having a length of at least about 8 cm, a circumference of no more than about 29 mm, and a working tip at the forward end thereof, said instrument including means for viewing said working tip and said material to be removed;

inserting said elongated surgical instrument at least about 8 cm deep into said body through the orifice with said working tip being located close to the material to be removed; and

vibrating said working tip longitudinally at a frequency of about 10-20 kHz so as to produce pressure waves to disintegrate such material while monitoring the removal of said material through the viewing means of said instrument.

17. The method of claim 16 including vibrating said working tip with a longitudinal stroke of at least about 350 microns.

18. The method of claim 17, wherein such longitudinal stroke is at least about 700 microns.

19. The method of claim 16, including vibrating said working tip with a maximum velocity of at least about 1000 cm/sec.

20. The method of claim 19, wherein such maximum velocity is at least about 2000 cm/sec.

21. The method of claim 20, including cavitating the intracellular fluids in such material to destroy the cells thereof.

22. The method of claim 21, including employing a blunt working tip.

23. The method of claim 22, including inserting said narrow elongated surgical instrument at least about 19 cm into said body.

24. The method of claim 16 which further comprises providing said instrument with a radio-frequency source so that said working tip can receive a RF current for cauterization of said tissue when said tip is not vibrating.

25. The method of claim 24 which further comprises providing said instrument with means for selecting the source of signal to be provided to said working tip from one of said radio frequency source or a source for generating ultrasonic vibrations.

26. The method of claim 25 which further comprises providing said instrument with a switch as the selecting means.

27. A method of removing cellular material from a compliant tissue at an operating site at least about 8 cm deep within a biological body through an orifice no more than about 29 mm in circumference comprising:

providing a surgical instrument having an elongated sheath at least about 8 cm in length and no more than about 29 mm in circumference, the sheath having a hollow bore therethrough,

locating an elongated probe spaced within the hollow bore of the sheath, with a working end of the probe projecting beyond the end of the sheath, the probe having a hollow bore therethrough, thereby forming a first fluid passage in the space between the probe and the sheath, and a second fluid passage within the probe,

inserting the sheath into such body orifice with the working end of the probe being at such operating site and close to such material to be removed,

introducing a fluid into one of the two fluid passages to irrigate such operating site,

vibrating the probe longitudinally at a frequency of about 10-20 kHz so as to produce pressure waves sufficient to disintegrate the cells of such material to be removed, said instrument including means for viewing said working tip and said material to be removed, and

applying suction to the other of the fluid passages to withdraw such fluid and such matter to be removed from such operating sire while monitoring the removal of said material through the viewing means of said instrument.

28. The method of claim 27, including providing a surgical instrument no more than about 25 mm in circumference.

29. The method of claim 27, including providing a surgical instrument at least about 19 cm in length.

30. The method of claim 29, including providing a surgical instrument no more than about 25 mm in circumference.

31. A method for removing cellular material from a compliant tissue within a biological body through a natural or surgically created orifice comprising:

inserting into said orifice an aspirator comprising;

handpiece means;

elongated sheath means extending from said handpiece means and having a hollow bore therethrough;

unitary vibration generating means having a first portion which is mounted in said handpiece means, a second portion which is located in the hollow bore of said sheath, and a third portion comprising a resonator tip which extends beyond the end of said sheath for generating vibrations having an amplitude sufficient to disintegrate said cellular material at a work site in the body of the patient;

means for irrigating said work site with fluid to assist in the removal of disintegrated cellular material;

aspiration means for removing said disintegrated cellular material from said work site; and

means for viewing said work site from said handpiece

so as to position said resonator tip of said aspirator in close proximity to the cellular material to be removed;

vibrating said resonator tip of said aspirator to cavitate the intracellular fluids of the cellular material to destroy the cells thereof; and

removing the destroyed cellular material through said aspiration means of said aspirator.

32. The method of claim 31 which further comprises providing the aspirator with a radio-frequency source so that the resonator tip can receive RF current for cauterizing tissue at the work site when said tip is not vibrating.

33. The method of claim 32 which further comprises providing the aspirator with a switch for selectively connecting one of said radio-frequency source or said vibration generating system to said tip.

34. A method for removing cellular material from a compliant tissue within a biological body through a natural or surgically created orifice comprising:

inserting into said orifice an aspirator comprising;

a hollow handpiece;

an elongated sheath having a hollow bore communicating with the interior of the handpiece and having a working end away from the handpiece;

a vibration source within the handpiece for producing mechanical vibrations in response to an alternating current supplied to said vibration source;

means for supplying such alternating current to said vibration source;

elongated tool means coupled to the vibration source and passing through said hollow bore of the sheath to a work site beyond the working end of the sheath for transmitting such mechanical vibrations to the work site, said tool means including working tip means for contact with the work site;

viewing means extending from the handpiece to the work site for providing a view from the handpiece of the work site;

means for supplying fluid to said work site through a fluid space defined between said tool means and said hollow bore of said sheath;

fluid detection means for detecting the presence of fluid in the fluid space and connected to the means for supplying alternating current for terminating such supplied alternating current and thereby stopping such mechanical vibrations when such fluid is not present, and

means for removing said fluid from said work site through conduit means, the end of said conduit means nearest the work site formed by said working tip means

so as to position said working tip means of said aspirator in close proximity to the cellular material to be removed;

vibrating said working tip means of said aspirator to cavitate the intracellular fluids of the cellular material to destroy the cells thereof; and

removing the destroyed cellular material through said fluid removal means of said aspirator.

35. The method of claim 34 which further comprises providing the aspirator with a radio-frequency source so that the elongated tool means can receive RF current for cauterizing tissue at the work site when said tool means is not vibrating.

36. The method of claim 35 which further comprises providing the aspirator with a switch for selectively connecting one of said radio-frequency source or said vibration generating system to said elongated tool means.

38. The method of claim 34 which further comprises providing the aspirator with a radio-frequency source so that the working tip means can receive RF current for cauterizing tissue at the work site when said tip is not vibrating.

39. The method of claim 38 which further comprises providing the aspirator with a switch for selectively connecting one of said radio-frequency source or said vibration generating system to said working tip means.

37. A method for removing cellular material from a compliant tissue within a biological body through a natural or surgically created orifice comprising:

inserting into said orifice an apparatus comprising;

a handpiece;

an elongated sheath extending from the handpiece and having a hollow bore therethrough;

high frequency vibration source means mounted in the handpiece for generating a first amplitude;

first velocity transformer means located in the hollow bore within the sheath and spaced therefrom, having an input end and an output end, the input end being coupled to the vibration source to be vibrated thereby, and the output end vibrating in response to such received vibrations with a second amplitude greater than such first amplitude;

second velocity transformer means having an input end and an output end, the input end being coupled to the output end of the first transformer to be vibrated thereby, and the output end vibrating in response to such received vibrations with a third amplitude greater than such second amplitude, said third amplitude being sufficient to disintegrate said cellular material, said second velocity transformer means having working tip means extending beyond the end of the sheath away from the handpiece for contacting said cellular material, said working tip means having a smaller cross-sectional area than that of said second velocity transformer means;

the second transformer means when vibrating, having a substantially constant mechanical stress level in substantially all of its length, the output end of the first transformer velocity means and the second velocity transformer means forming a unitary component to minimize the production of transverse flexural vibrations;

said high-frequency vibration source means and said first and second velocity transformer means being elongated and having a continuous hollow bore extending along a common longitudinal axis thereof, thereby forming first fluid passage means in a space defined between the first and second velocity transformer means and the sheath, and second fluid passage means along said common longitudinal axis;

means for introducing fluid into one of said fluid passage means to irrigate an operating site adjacent said working tip means of the second velocity transformer means where said cellular material is contacted and disintegrated; and

means for applying suction to the other of said fluid passage means to remove such fluid and such disintegrated cellular material from such operating site

so as to position said working tip means of said apparatus in close proximity to the cellular material to be removed;

vibrating said working tip means of said apparatus to cavitate the intracellular fluids of the cellular material to destroy the cells thereof; and

removing the destroyed cellular material through said other fluid passage of said apparatus.

40. A method for removing cellular material from a compliant tissue within a biological body through a natural or surgically created orifice comprising:

inserting into said orifice an aspirator comprising;

a hollow handpiece;

an elongated sheath having a hollow bore communicating with the interior of the handpiece and having a working end away from the handpiece;

a vibration source within the handpiece for producing mechanical vibrations in response to an alternating current supplied to said vibration source;

means for supplying such alternating current to said vibration source;

elongated tool means coupled to the vibration source and passing through a hollow bore of the sheath to a work site beyond the working end of the sheath for transmitting such mechanical vibrations to such work site;

viewing means extending from the handpiece to such work site for providing a view from the handpiece of such work site;

means for supplying fluid to a fluid space defined between said tool means and said hollow bore of said sheath; and

fluid detection means for detecting the presence of fluid in the fluid space and connected to the means for supplying alternating current for terminating such supplied alternating current and thereby stopping such mechanical vibrations when such fluid is not present

so as to position said elongated tool means of said apparatus in close proximity to the cellular material to be removed;

vibrating said elongated tool means of said aspirator to cavitate the intracellular fluids of the cellular material to destroy the cells thereof; and

removing the destroyed cellular material.

41. The method of claim 40 which further comprises providing the aspirator with a radio-frequency source so that the elongated tool means can receive RF current for cauterizing tissue at the work site when said tool means is not vibrating.

42. The method of claim 41 which further comprises providing the aspirator with a switch for selectively connecting one of said radio-frequency source or said vibration generating system to said tool means.

43. A method for removing cellular material from a compliant tissue within a biological body through a natural or surgically created orifice comprising:

inserting into said orifice an apparatus comprising;

a handpiece;

an elongated sheath extending from the handpiece and having a hollow bore therethrough;

vibration means comprising;

high-frequency vibration source means mounted in the handpiece for vibrating with a selected wavelength and with a first amplitude;

first velocity transformer means located in the hollow bore within the sheath and spaced therefrom for amplifying vibrations from the vibration source means and having an input section and an output section, the input section being unitary with the vibration source means and the output section being smaller in cross-sectional area than the input section, and

second velocity transformer means having an input end and an output end, the input end being unitary with the output section of the first velocity transformer means for amplifying vibrations thereof to a sufficient velocity to disintegrate said cellular material and to minimize the production of transverse flexural vibrations, the output end vibrating in response to such received vibrational energy for further transmitting such vibrational energy;

said second velocity transformer means having a working tip extending beyond the end of the sheath away from the handpiece;

said high-frequency vibration source means and each of said velocity transformer means being elongated and each having a continuous hollow bore extending along a common longitudinal axis thereof, thereby forming;

first fluid passage means in a space defined between the first and second velocity transformer means and the sheath, and second fluid passage means along said common longitudinal axis;

means for introducing fluid into one of said fluid passage means to irrigate an operating site adjacent the working tip of the second velocity transformer means where said cellular material is disintegrated, and

means for applying suction to the other of said fluid passage means to remove said fluid and disintegrated cellular material from such operating site

so as to position said working tip of said apparatus in close proximity to the cellular material to be removed;

vibrating said working tip of said apparatus to cavitate the intracellular fluids of the cellular material to destroy the cells thereof; and

removing the destroyed cellular material.

44. The method of claim 43 which further comprises providing the aspirator with a radio-frequency source so that the working tip can receive RF current for cauterizing tissue at the work site when said tip is not vibrating.

45. The method of claim 44 which further comprises providing the aspirator with a switch for selectively connecting one of said radio-frequency source or said vibration generating system to said tip.

46. A method for removing cellular material from a compliant tissue within a biological body through a natural or surgically created orifice comprising:

inserting into said orifice an aspirator comprising;

a hollow handpiece;

an elongated sheath having a hollow bore communicating with the interior of the handpiece and having a working end away from the handpiece;

high-frequency vibration source means mounted in the handpiece comprising transducer means for generating high-frequency vibrations of a selected wavelength and having a first amplitude and vibration amplifying means for receiving the vibrations generated by the transducer means and amplifying said vibrations to ultrasonic vibrations of a frequency of between 10 and 20 KHz, said vibration amplifying means comprising;

first velocity transformer mens of an elongated member having an input end and an output end for amplifying vibrations from said vibration source means the input end being coupled to the transducer means and the output end vibrating in response to such received vibrations with a second amplitude greater than said first amplitude, and

second velocity transformer means of an elongated member having an input end and an output end for amplifying vibrations from the first velocity transformer means, the input end being unitary with the output end of the first velocity transformer means to be vibrated thereby and to minimize the production of transverse flexural vibrations, the output end vibrating in response to such received vibrations with the desired frequency while further having a substantially constant mechanical stress level in substantially all its length;

elongated tool means coupled to the output end of said second velocity transformer means and passing through the hollow bore of the sheath to a work site beyond the working end of the sheath for transmitting the amplified vibrations to said work site for disintegration of said cellular material thereof;

means for aspirating said disintegrated cellular material portion from the work site; and

viewing means extending from said handpiece to said work site for providing a view from the handpiece of said work site

so as to position said elongated tool means of said aspirator in close proximity to the cellular material to be removed;

vibrating said elongated tool means of said aspirator to cavitate the intracellular fluids of the cellular material to destroy the cells thereof; and

removing the destroyed cellular material.

47. The method of claim 46 which further comprises providing the aspirator with a radio-frequency source so that the elongated tool means can receive RF current for cauterizing tissue at the work site when said tool means is not vibrating.

48. The method of claim 47 which further comprises providing the aspirator with a switch for selectively connecting one of said radio-frequency source or said vibration generating system to said tool means.