Sphincter treatment apparatus

• US 6,254,598 B1
• Filed: 01/20/1999
• Issued: 07/03/2001
• Est. Priority Date: 06/24/1994
• Status: Expired due to Term

• Current Assignee: Mederi Therapeutics, Inc. (Respiratory Technology Corp.)
• Original Assignee: Curon Medical, Inc.
• Inventors: Gaiser, John W., Utley, David S., Edwards, Stuart D, Qin, Jay J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/235,060
• Time in Patent Office: 895 Days
• Field of Search: 606/41, 606/42, 606/45-50, 606/7, 606/8, 606/15, 607/101, 607/102, 607/115, 607/116, 607/122, 607/133, 600/372, 600/374
• US Class Current: 606/41
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00113 with foam
• CPC Class Codes: A61B 2018/00148 : with metal
• CPC Class Codes: A61B 2018/0016 : Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 : Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00267 : having a basket shaped structure
• CPC Class Codes: A61B 2018/00494 : Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00553 : Sphincter
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00654 : with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00666 : using a threshold value
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/00892 : Voltage
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/0091 : Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• 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: A61B 2018/0262 : using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1273 : including multiple generators in one device
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/183 : characterised by the type of antenna
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61M 16/0438 : Liquid-filled
• CPC Class Codes: A61M 16/0481 : through the cuff wall
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

A sphincter treatment apparatus includes an elongated member having at least one lumen including an inflation lumen and a basket assembly with first and second arms. The basket assembly is coupled to the elongated member and has deployed and non-deployed configurations. An inflatable member is coupled to the elongated member and positioned in an interior of the basket assembly. The inflatable member has deployed and non-deployed states and is coupled to the inflation lumen. In the deployed state, the inflatable member expands the basket assembly to its deployed configuration. A first energy delivery device is positionable in the first arm and advanceable from the first arm to a selected treatment site. A second energy delivery device is positionable in the second arm and advanceable from the second arm to a selected treatment site.

Claims

1. A sphincter treatment apparatus, comprising:

an elongated member having at least one lumen including an inflation lumen;

a basket assembly including a first and a second arm, the basket assembly being coupled to the elongated member and having a deployed and a non-deployed configuration;

an inflatable member coupled to the elongated member and positioned in an interior of the basket assembly, the inflatable member being coupled to the inflation lumen, the inflatable member having a deployed and a non-deployed state, wherein in the deployed state the inflatable member expands the basket assembly to the basket assembly deployed configuration; and

an energy delivery device coupled to the inflatable member and configured to deliver energy to a selected treatment site.

2. The apparatus of claim 1, wherein the energy delivery device is positioned on an exterior surface of the inflatable member.

3. The apparatus of claim 1, wherein the energy delivery device is integral to the inflatable member.

4. The apparatus of claim 1, wherein the energy delivery device is disposed in the inflatable member.

5. The apparatus of claim 4, wherein the energy delivery device is disposed on an interior surface of the inflatable member.

7. The apparatus of claim 1, wherein the first energy delivery device includes a first plurality of energy devices that are advanceable into a first circumferential region of a tissue site.

8. The apparatus of claim 7, wherein the second energy delivery device includes a second plurality of energy devices that are advanceable into a second circumferential region of a tissue site.

9. The apparatus of claim 1, wherein the inflatable member is a balloon.

10. The apparatus of claim 9, wherein the balloon has a non-spherical cross-sectional geometry in the deployed state.

11. The apparatus of claim 9, wherein the balloon has a symmetrical, non-spherical cross-sectional geometry in the deployed state.

12. The apparatus of claim 9, wherein the balloon has a shape configured to be positionable within at least a portion of a cardia of a stomach.

13. The apparatus of claim 9, wherein the balloon has at least a partially Cassini oval shape.

14. The apparatus of claim 13, wherein the Cassini oval is a dog bone shape or an oval shape.

15. The apparatus of claim 9, wherein the balloon has at least a partially pear shape.

16. The apparatus of claim 9, wherein at least a portion of the balloon is made of a compliant material.

17. The apparatus of claim 16, wherein the compliant material is an elastomer or a thermoplastic.

18. The apparatus of claim 9, wherein at least a portion of the balloon is made of a non compliant material.

19. The apparatus of claim 1, further comprising:

an energy delivery device advancement and retraction member coupled to the first and second energy delivery devices.

20. The apparatus of claim 19, wherein the energy delivery device advancement and retraction member provides simultaneous advancement of the first and second energy delivery devices.

21. The apparatus of claim 20, wherein the apparatus is configured to create multiple lesions within a sphincter wall while remaining in a substantially stationary position within a sphincter.

22. The apparatus of claim 20, wherein the energy delivery device advancement and retraction member is configured to be advanceable within the at least one lumen of the elongated member.

23. The apparatus of claim 1, further comprising:

a first power wire coupled to the first energy delivery device; and

a second power wire coupled to the second energy delivery device.

24. The apparatus of claim 1, further comprising:

an energy source coupled to the first and second energy delivery devices.

25. The apparatus of claim 24, wherein the energy source includes a first RF channel coupled to the first energy delivery device and a second RF channel coupled to the second energy delivery device, wherein the first RF channel is independent from the second RF channel.

26. The apparatus of claim 24, further comprising:

resources coupled to the first and second energy delivery devices and the energy source, the resources providing sequential delivery of energy from the energy source to the first and second energy delivery devices.

27. The apparatus of claim 1, wherein the first and second energy delivery devices are each RF electrodes.

28. The apparatus of claim 1, wherein the first energy delivery device includes a first plurality of RF electrodes and the second energy delivery device includes a second plurality of RF electrodes.

29. The apparatus of claim 28, wherein each of an RF electrode of the first and second plurality of RF electrodes includes an insulation sleeve positioned at an exterior surface of the RF electrode.

30. The apparatus of claim 28, wherein each of an RF electrode of the first and second plurality of RF electrodes has a tissue piercing distal end.

31. The apparatus of claim 28, wherein each of an RF electrode of the first and second plurality of RF electrodes is a needle electrode.

32. The apparatus of claim 27, further comprising:

an RF electrode advancement mechanism configured to advance an RF electrode to a first depth in a sphincter wall and at least partially withdraw the RF electrode to a second depth in the sphincter wall.

33. The apparatus of claim 32, wherein the RF electrode advancement mechanism is configured to reduce a tenting affect during insertion of the RF electrode in the sphincter wall.

34. The apparatus of claim 1, further comprising:

a sensor coupled to the basket assembly.

35. The apparatus of claim 1, further comprising:

a sensor coupled to the first energy delivery device.

36. The apparatus of claim 1, further comprising:

a sensor coupled to the inflatable member.

37. The apparatus of claim 35, further comprising:

a feedback control coupled to the sensor and configured to be coupled to an energy source.

38. The apparatus of claim 1, further comprising:

a fluidic media introduction port formed in the first arm.

39. The apparatus of claim 38, wherein the fluidic media introduction port is coupled to a fluidic media source.

40. The apparatus of claim 39, wherein the fluidic media source is a cooling solution source.

41. The apparatus of claim 1, further comprising:

a fluidic media introduction port formed in the first energy delivery device.

42. The apparatus of claim 41, wherein the fluidic media introduction port is coupled to a fluidic media source.

43. The apparatus of claim 42, wherein the fluidic media source is a cooling solution source.

44. The apparatus of claim 1, wherein the at least one lumen is configured to allow advancement of an elongated medical device through the at least one lumen.

45. The apparatus of claim 44, wherein the elongated medical device is an endoscope, a manometry catheter, a pH monitoring catheter, or a drug delivery catheter.

46. The apparatus of claim 1, wherein the apparatus is configured to be coupled to a medical device.

47. The apparatus of claim 46, wherein the medical device is a drug delivery device.

48. The apparatus of claim 47, wherein the drug delivery device is coupled to a medicament.

49. The apparatus of claim 48, wherein the at least one lumen is configured to deliver the medicament to the treatment site.

6. A sphincter treatment apparatus comprising:

an elongated member having at least one lumen including an inflation lumen;

a basket assembly including a first arm with a distal and a proximal section, a second arm with a distal and proximal section, the prioximal sections of the first and second arms being mutually coupled to each other and to the elongated member, the distal sections of the first and second arms being mutually coupled to each other, the basket assembly having a deployed and a non-deployed configuration;

an inflatable member coupled to the elongated member and positioned in an interior of the basket assembly, the inflatable member being coupled to the inflation lumen, the inflatable member having a deployed and a non-deployed state, wherein in the deployed state the inflatable member expands the basket assembly to the basket assembly deployed configuration;

a first energy delivery device positioned in the first arm and advanceable from the first arm to a selected treatment site; and

a second energy delivery device positioned in the second arm and advanceable from the second arm to a selected treatment site.

50. A sphincter treatment apparatus comprising:

an elongated member having at least one lumen including an inflation lumen;

a basket assembly including a first arm with a distal and a proximal section a second arm with a distal and proximal section, the proximal sections of the first and second arms being mutually coupled to each other and to the elongated member, the distal sections of the first and second arms being mutually coupled to each other, the basket assembly having a deployed and a non-deployed configuration;

an inflatable member coupled to the elongated member and positioned in an interior of the basket assembly, the inflatable member being coupled to the inflation lumen, the inflatable member having a deployed and a non-deployed state, wherein in the deployed state the inflatable member expands the basket assembly to the basket assembly deployed configuration;

a first energy delivery device coupled to the first arm and configured to deliver energy to a selected treatment site; and

a second energy delivery device coupled to the second arm and configured to deliver energy to a selected treatment site.

51. The apparatus of claim 50, wherein the first energy delivery device is integral to the first arm and the second energy delivery device is integral to the second arm.