Devices, systems, and methods for removing stenotic lesions from vessels

• US 8,465,452 B2
• Filed: 04/23/2009
• Issued: 06/18/2013
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/428,656
• Publication Number:
  US 20090204134A1
• Time in Patent Office: 1,517 Days
• Field of Search: 600/547, 600/587, 600/393, 600/439, 600/114, 600/117, 600/470, 606/21, 606/127, 606/159, 335/12, 29/253.5, 623/1.11
• US Class Current: 604/95.01
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

The present application provides various devices, systems, and methods for removing stenotic lesions from vessels. In at least one embodiment of an exemplary device, the device comprises at least one sizing portion and at least one treatment portion. Such a device may be useful to, for example, remove a stenotic lesion from a vessel by positioning the device within a vessel lumen, operating the sizing portion to obtain luminal size parameter data, operating the treatment portion at a location within the vessel lumen at or near a stenotic lesion, and ceasing operation of the treatment portion when the luminal size parameter data indicates a preferred luminal size parameter.

Claims

1. A method for removing a stenotic lesion of a vessel, the method comprising the steps of:

(a) measuring a first luminal size parameter at a first location within a vessel lumen;

(b) measuring a second luminal size parameter at a second location within the vessel lumen;

(c) determining a preferred second luminal size parameter based upon the first luminal size parameter and the second luminal size parameter;

(d) positioning a treatment device at the second location;

(e) operating the treatment device to increase the second luminal size parameter;

(f) measuring a then-current luminal size parameter at the second location;

(g) comparing the then-current luminal size parameter to the preferred second luminal size parameter; and

(h) if the then-current luminal size parameter does not equal the preferred second luminal size parameter, repeating steps (e), (f), and (g) until the then-current luminal size parameter equals the preferred second luminal size parameter,

wherein the treatment device comprises at least one sizing portion and at least one treatment portion, the at least one treatment portion operable to remove at least part of a stenotic lesion and wherein the at least one sizing portion comprises;

a first excitation electrode and a second excitation electrode positioned along the treatment device; and

a first detection electrode and a second detection electrode positioned along the treatment device in between the first excitation electrode and the second excitation electrode.

2. The method of claim 1, wherein the first luminal size parameter is a first luminal diameter, and wherein the second luminal size parameter is a second luminal diameter.

3. The method of claim 1, wherein the first luminal size parameter is a first luminal cross-sectional area, and wherein the second luminal size parameter is a second luminal cross-sectional area.

4. The method of claim 1, wherein the first location comprises a location without a stenotic lesion, and wherein the second location comprises a location with a stenotic lesion.

5. The method of claim 1, wherein the first location comprises a location with a relatively small stenotic lesion, and wherein the second location comprises a location with relatively large stenotic lesion.

6. The method of claim 1, wherein the step of measuring a first luminal size parameter and the step of measuring a second luminal size parameter are performed using a sizing device.

7. The method of claim 6, wherein the sizing device comprises:

an elongated body having a longitudinal axis extending from a proximal end to a distal end;

a first excitation electrode and a second excitation electrode positioned along the longitudinal axis of the elongated body near a distal end of the elongated body; and

a first detection electrode and a second detection electrode positioned along the longitudinal axis of the elongated body in between the first excitation electrode and the second excitation electrode.

8. The method of claim 7, wherein the elongated body comprises a catheter comprising a lumen extending along the longitudinal axis of the catheter, and wherein the step of measuring a first luminal size parameter comprises the steps of:

providing electrical current flow to the first location through the catheter;

injecting a first solution of a first compound having a first conductivity into the vessel lumen at the first location through the catheter;

measuring a first conductance value at the first location;

injecting a second solution of a second compound having a second conductivity into the vessel lumen at the first location through the catheter;

measuring a second conductance value at the first location; and

calculating a first luminal size parameter based on the first conductance value, the second conductance value, the first conductivity of the first solution, and the second conductivity of the second solution.

9. The method of claim 6, wherein the treatment device comprises a catheter comprising at least one treatment portion, and wherein the sizing device comprises a wire comprising:

a first excitation electrode and a second excitation electrode positioned along the sizing device; and

a first detection electrode and a second detection electrode positioned along the sizing device in between the first excitation electrode and the second excitation electrode.

10. The method of claim 9, wherein the wire comprises a guide wire, and wherein the guide wire is positioned at least partially within a lumen of the catheter.

11. The method of claim 1, wherein the at least one treatment portion comprises a treatment portion selected from the group consisting of a cutting balloon, a cryoplasty device, a rotational atherectomy device, a laser angioplasty device, a vibrating catheter, and a vibrating drill.

12. The method of claim 1, wherein the at least one treatment portion comprises a balloon, and wherein the at least one sizing portion comprises:

a first excitation electrode and a second excitation electrode positioned along the treatment device; and

a first detection electrode and a second detection electrode positioned along the treatment device in between the first excitation electrode and the second excitation electrode.

13. The method of claim 12, wherein the first excitation electrode, the second excitation electrode, the first detection electrode, and the second detection electrode are each positioned along the treatment device within the balloon, and wherein the then-current luminal size parameter comprises a parameter measured within the balloon at one or more stages of balloon inflation.

14. The method of claim 1, further comprising the step of ceasing the operation of the treatment device when the then-current luminal size parameter equals the preferred second luminal size parameter.

15. The method of claim 1, wherein the preferred second luminal size parameter is equal to the first luminal size parameter.

16. The method of claim 1, wherein the preferred luminal size parameter comprises a preferred second luminal size parameter range.

17. The method of claim 16, wherein the comparing step comprises comparing the then-current luminal size parameter to the preferred second luminal size parameter range.

18. The method of claim 1, further comprising the steps of:

selecting an appropriately-sized stent; and

implanting the stent into the vessel lumen.

19. The method of claim 1, further comprising the steps of:

obtaining at least one additional luminal size parameter between the first position and the second position; and

constructing a lumen profile based upon the second luminal size parameter and the at least one additional luminal size parameter.

20. The method of claim 19, wherein a length of the stenotic lesion is determined based upon the lumen profile.

21. A system for removing a stenotic lesion of a vessel, the system comprising:

a treatment device, the treatment device comprising at least one treatment portion operable to remove at least part of a stenotic lesion; and

a sizing device, the sizing device comprising electrodes operable to measure a first luminal size parameter when the sizing device is positioned at a first location, and wherein the sizing device is further operable to measure a second luminal size parameter when the sizing device is positioned at a second location, wherein the treatment device comprises a catheter, and wherein the sizing device comprises a wire selected from the group consisting of a guide wire, a pressure wire, and a flow wire.

22. The system of claim 21, wherein the at least one treatment portion comprises a treatment portion selected from the group consisting of a cutting balloon, a cryoplasty device, a rotational atherectomy device, a laser angioplasty device, a vibrating catheter, and a vibrating drill.

23. The system of claim 21, wherein the sizing device comprises an elongated body having a longitudinal axis extending from a proximal end to a distal end, and wherein the electrodes of the sizing device comprise:

a first excitation electrode and a second excitation electrode positioned along the longitudinal axis of the elongated body near the distal end of the elongated body; and

a first detection electrode and a second detection electrode positioned along the longitudinal axis of the elongated body in between the first excitation electrode and the second excitation electrode.

24. The system of claim 23, wherein the at least one treatment portion comprises a balloon.

25. The system of claim 24, wherein the first excitation electrode, the second excitation electrode, the first detection electrode, and the second detection electrode are each positioned along the treatment device within the balloon, and wherein said electrodes are operable to measure at least one luminal parameter within the balloon at one or more stages of balloon inflation.

26. The system of claim 23, further comprising a current source in communication with the first excitation electrode and the second excitation electrode, said current source operable to supply current to the first excitation electrode and the second excitation electrode to facilitate measurement of at least one conductance value, thereby facilitating calculation of a luminal size parameter.

27. The system of claim 26, further comprising a data acquisition and processing system operably coupled to the sizing device, the data acquisition and processing system operable to receive conductance data from the sizing device, the data acquisition and processing system further operable to calculate at least one luminal parameter based upon said conductance data.

28. The system of claim 27, wherein the data acquisition and processing system is further operable to display the calculated at least one luminal parameter to facilitate operational control of the treatment device.

29. The system of claim 21, wherein the at least one treatment portion comprises a balloon, and wherein the at least one sizing portion comprises at least one pressure sensor operable to detect at least one pressure within the balloon at one or more stages of balloon inflation.

30. The system of claim 29, wherein the at least one pressure sensor is operable to measure a first pressure gradient and calculate at least one luminal parameter based in part upon the first pressure gradient.

31. The system of claim 21, further comprising at least one suction/infusion port in communication with at least one lumen of the sizing device, said suction/infusion port operable to facilitate one or more fluid injections into a treatment site.

32. The system of claim 31, further comprising at least one fluid delivery source operably coupled to the at least one lumen of the sizing device, whereby one or more fluids may be injected from the at least one fluid delivery source through the at least one lumen of the sizing device, through the at least one suction/infusion port, and into the treatment site.

33. A method for removing a stenotic lesion of a vessel, the method comprising the steps of:

positioning a device within a vessel lumen, the device comprising at least one sizing portion and at least one treatment portion;

operating the at least one sizing portion of the device to obtain luminal size parameter data;

operating the at least one treatment portion at a location within the vessel lumen at a stenotic lesion, whereby operation of the at least one treatment portion is based upon the luminal size parameter data, whereby operation of the at least one treatment portion increases the luminal size parameter data value;

ceasing operation of the at least one treatment portion when the luminal size parameter data indicates a preferred luminal size parameter, wherein the device further comprises a data acquisition and processing system operably coupled to the device, the data acquisition and processing system operable to receive conductance data from the at least one sizing portion of the device, the data acquisition and processing system further operable to calculate at least one luminal parameter based upon said conductance data.

34. The method of claim 33, wherein the luminal size parameter data is displayed on a display, and wherein the step of operating the at least one treatment portion is performed based upon the displayed luminal size parameter data.

35. The method of claim 33, wherein the luminal size perimeter data comprises a first luminal size parameter obtained at a first location within the vessel lumen, a second luminal size parameter obtained at a second location within the vessel lumen, and at least one then-current luminal size parameters obtained after initial operation of the at least one treatment portion.

36. The method of claim 35, wherein the first luminal size parameter is selected from the group consisting of a first luminal diameter and a first cross-sectional area, and wherein the second luminal size parameter is selected from the group consisting of a second luminal diameter and a second cross-sectional area.

37. The method of claim 33, wherein the preferred luminal size parameter is determined based upon luminal size parameter data obtained at a location within the vessel lumen without a stenotic lesion.

38. The method of claim 33, wherein the preferred luminal size parameter is larger than luminal size parameter data obtained at a location within the vessel lumen at a stenotic lesion.

39. The method of claim 33, wherein the at least one sizing portion of the device comprises:

a first excitation electrode and a second excitation electrode positioned along the device near a distal end of the device; and

a first detection electrode and a second detection electrode positioned along the device in between the first excitation electrode and the second excitation electrode.

40. The method of claim 33, wherein the at least one treatment portion is operable to remove at least part of a stenotic lesion, and wherein the at least one treatment portion comprises a treatment portion selected from the group consisting of a cutting balloon, a cryoplasty device, a rotational atherectomy device, a laser angioplasty device, a vibrating catheter, and a vibrating drill.

41. The method of claim 33, wherein the at least one treatment portion comprises a balloon, and wherein the at least one sizing portion comprises:

a first excitation electrode and a second excitation electrode positioned along the device; and

a first detection electrode and a second detection electrode positioned along the device in between the first excitation electrode and the second excitation electrode.

42. The method of claim 33, wherein the preferred luminal size parameter is equal to the first luminal size parameter.

43. The method of claim 33, further comprising the steps of:

selecting an appropriately-sized stent based upon the preferred luminal size parameter; and

implanting the stent into the vessel lumen.

44. The method of claim 33, further comprising the steps of:

constructing a lumen profile based upon the luminal size parameter data; and

determining a length of the stenotic lesion based upon the lumen profile.

45. The method of claim 33, wherein the step of operating the at least one sizing portion comprises obtaining multiple luminal size parameter values during the step of operating the at least one treatment portion.

46. The method of claim 33, wherein the device further comprises at least one suction/infusion port in communication with at least one lumen of the device, said suction/infusion port operable to facilitate one or more fluid injections into a treatment site.

47. The method of claim 46, wherein the device further comprises at least one fluid delivery source operably coupled to the at least one lumen of the device, whereby one or more fluids may be injected from the at least one fluid delivery source through the at least one lumen of the device, through the at least one suction/infusion port, and into the treatment site.

48. The method of claim 33, wherein the data acquisition and processing system is further operable to display the calculated at least one luminal parameter to facilitate operational control of the at least one treatment portion of the device.

49. A device for removing a stenotic lesion of a vessel, the device comprising:

at least one sizing portion; and

at least one treatment portion operable to remove at least part of a stenotic lesion, wherein the at least one treatment portion comprises a balloon, and wherein the at least one sizing portion comprises at least one pressure sensor.

50. The device of claim 49, wherein the at least one sizing portion of the device comprises:

a first excitation electrode and a second excitation electrode positioned along the device near a distal end of the device; and

a first detection electrode and a second detection electrode positioned along the device in between the first excitation electrode and the second excitation electrode.

51. The device of claim 50, further comprising a current source in communication with the first excitation electrode and the second excitation electrode, said current source operable to supply current to the first excitation electrode and the second excitation electrode to enable measurement of at least one conductance value, thereby enabling calculation of a luminal size parameter.

52. The device of claim 49, wherein the at least one treatment portion comprises a treatment portion selected from the group consisting of a cutting balloon, a cryoplasty device, a rotational atherectomy device, a laser angioplasty device, a vibrating catheter, and a vibrating drill.

53. The device of claim 49, further comprising:

at least one suction/infusion port in communication with at least one lumen of the sizing device, said suction/infusion port operable to facilitate one or more fluid injections into a treatment site; and

at least one fluid delivery source operably coupled to the at least one lumen of the sizing device, whereby one or more fluids may be injected from the at least one fluid delivery source through the at least one lumen of the sizing device, through the at least one suction/infusion port, and into the treatment site.

54. The device of claim 49, further comprising a data acquisition and processing system operably coupled to the sizing device, the data acquisition and processing system operable to receive conductance data from the sizing device to calculate at least one luminal parameter based upon said conductance data and to display the calculated at least one luminal parameter to facilitate operational control of the at least one treatment portion of the device.