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

• US 9,603,545 B2
• Filed: 03/26/2010
• Issued: 03/28/2017
• 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): LOUIS, RICHARD G
• Application Number:
  US12/748,166
• Publication Number:
  US 20100222786A1
• Time in Patent Office: 2,559 Days
• Field of Search: 600/393, 600/372, 600/506, 600/547, 606/129, 606/127, 606/159, 604/114
• US Class Current: 1/1
• 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 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• 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 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• 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 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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: A61B 5/417 the bone marrow
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0002 : with a pressure sensor at the distal end
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10188 : Inflation or deflation data displays

Abstract

Devices, systems, and methods for removing targeted lesions from vessels. In at least one embodiment of a device for removing a stenotic lesion from a vessel, the device comprises a sizing portion capable of measuring a luminal size parameter when at least part of the device is positioned within a lumen of a luminal organ, a typing portion, wherein at least part of the at least one typing portion is capable of physically touching a portion of the luminal organ or a structure therein, and a treatment portion capable of removing at least part of a stenotic lesion from the luminal organ.

Claims

1. A device for insertion within a luminal organ, comprising:

an elongated body having a distal body end, a fixed portion, and a rotatable portion at or near the distal body end;

at least one directional sensor positioned on the rotatable portion of the elongated body, the at least one directional sensor configured for axial rotation relative to and distinct from the fixed portion of the elongated body and operable to obtain a measurement from the luminal organ or a structure therein, wherein the measurement is indicative of less than an entire circumference of the luminal organ; and

at least one treatment portion capable of removing at least part of a stenotic lesion from a luminal organ; and

an extension apparatus coupled to the at least one directional sensor, the extension apparatus capable of moving the at least one directional sensor radially relative a longitudinal axis of the elongated body between a first position and an extended second position.

2. The device of claim 1, wherein the elongated body is selected from the group consisting of a catheter and a wire.

3. The device of claim 1, wherein the elongated body is configured to fit within a lumen of a luminal organ.

4. The device of claim 1, further comprising:

a detector positioned along the elongated body at or near the distal body end, the detector capable of measuring a luminal size parameter when at least part of the elongated body is positioned within a lumen of a luminal organ.

5. The device of claim 4, wherein the detector comprises a tetrapolar arrangement of electrodes.

6. The device of claim 5, wherein the tetrapolar arrangement of electrodes comprises two detection electrodes positioned in between two excitation electrodes.

7. The device of claim 6, wherein the at least one directional sensor is at least one electrode of the tetrapolar arrangement of electrodes.

8. The device of claim 6, wherein the at least one directional sensor is independent of the tetrapolar arrangement of electrodes.

9. The device of claim 5, further comprising:

a current/voltage source in communication with one or more of the directional sensor and the tetrapolar arrangement of electrodes, the current/voltage source capable of supplying a constant current and/or a constant voltage thereto to facilitate one or more measurements indicative of electrical impedance of the luminal organ or a structure therein.

10. The device of claim 9, further comprising:

a data acquisition and processing system operably coupled to the device, the data acquisition and processing system capable of receiving the one or more measurements from the device and calculating at least one luminal size parameter and/or determining at least one luminal organ or structure type based upon the one or more measurements.

11. The device of claim 1, wherein the at least one directional sensor is further capable of-extending outward from the elongated body.

12. The device of claim 11, wherein when at least part of the elongated body is positioned within a lumen of a luminal organ, the at least one directional sensor is capable of extending outward from the elongated body to physically touch the luminal organ or the structure therein.

13. The device of claim 12, wherein the at least one directional sensor is capable of obtaining the measurement from the luminal organ or the structure therein that the directional sensor is touching.

14. The device of claim 13, wherein the at least one directional sensor is an impedance sensor, and wherein the measurement is an impedance measurement.

15. The device of claim 13, wherein when a constant voltage is applied to the at least one directional sensor, the measurement is a current measurement indicative of electrical impedance of the luminal organ or the structure therein that the directional sensor is touching.

16. The device of claim 13, wherein when a constant current is applied to the at least one directional sensor, the measurement is a voltage measurement indicative of electrical impedance of the luminal organ or the structure therein that the directional sensor is touching.

17. The device of claim 13, wherein the at least one directional sensor is a thermistor, and wherein the measurement is a temperature measurement.

18. The device of claim 1, wherein the extension apparatus is selected from the group consisting of a mechanical actuator, an electro-mechanical actuator, and a steering device.

19. The device of claim 1, further comprising

a rotation apparatus coupled to the rotatable portion of the elongated body, the rotation apparatus capable of rotating the rotatable portion.

20. The device of claim 19, wherein the rotation apparatus is selected from the group consisting of a mechanical actuator, an electro-mechanical actuator, and a steering device.

21. The device of claim 19, wherein when the at least one directional sensor is positioned along the elongated body on the rotatable portion, the at least one directional sensor is capable of rotation by operation of the rotation apparatus.

22. The device of claim 19, wherein the rotatable portion is capable of a full 360°

rotation about the elongated body.

23. The device of claim 1, wherein the at least one directional sensor is positioned at about 45 degrees to about 90 degrees of a circumference of the elongated body.

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

25. The device of claim 1, further comprising:

a detector comprising a tetrapolar arrangement of electrodes positioned along the device within a balloon, wherein the electrodes are operable to measure at least one luminal parameter within the balloon at one or more stages of balloon inflation.

26. The device of claim 1, wherein the elongated body comprises a catheter having a suction/infusion port in communication with a lumen of the catheter, wherein the catheter is configured to facilitate one or more fluid injections into a lumen of a luminal organ when at least part of the elongated body is positioned therein.

27. The device of claim 26, further comprising:

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

28. The device of claim 1, further comprising:

an inflatable balloon coupled to the elongated body, the inflatable balloon capable of inflation to place a stent positioned around the inflatable balloon within a lumen of a luminal organ.

29. A device for insertion within a luminal organ, comprising:

an elongated body having a distal body end, a fixed portion, and a rotatable portion at or near the distal body end, the elongated body configured to fit within a lumen of a luminal organ;

at least one directional sensor positioned on the rotatable portion of the elongated body, the at least one directional sensor configured for axial rotation relative to and distinct from the fixed portion of the elongated body and further capable of moving between a first position and an extended second position, the at least one directional sensor extending outward from the elongated body and toward the luminal organ or a structure therein when in the extended second position to facilitate physically touching the same, the at least one directional sensor operable to obtain a measurement from the luminal organ or the structure therein, wherein the measurement is indicative of less than an entire circumference of the luminal organ and indicative of electrical impedance of the luminal organ or the structure therein when the directional sensor is touching the luminal organ or the structure therein;

at least one detector positioned along the elongated body at or near the distal body end, the at least one detector capable of measuring a luminal size parameter when at least part of the elongated body is positioned within the lumen of the luminal organ;

an extension apparatus coupled to the at least one directional sensor, the extension apparatus capable of moving the at least one directional sensor radially relative a longitudinal axis of the elongated body between a first position and an extended second position; and

at least one treatment portion capable of removing at least part of a stenotic lesion from the luminal organ.

30. A device for removing a stenotic lesion from a vessel, comprising:

an elongated body having a fixed portion and a rotatable portion;

at least one sizing portion comprising a directional sensor capable of measuring a luminal size parameter when at least part of the device is positioned within a lumen of a luminal organ, at least part of the at least one sizing portion positioned on the rotatable portion of the elongated body, wherein the portion of the at least one sizing portion on the rotatable portion is configured for axial rotation relative to and distinct from the fixed portion of the elongated body and operable to obtain a measurement from the luminal organ or a structure therein, wherein the measurement is indicative of less than an entire circumference of the luminal organ;

at least one typing portion, wherein at least part of the at least one typing portion is capable moving to an extended position outward from the device and further capable of physically touching a portion of the luminal organ or a structure therein upon extension from the device;

an extension apparatus coupled to the at least one directional sensor, the extension apparatus capable of moving the at least one directional sensor radially relative a longitudinal axis of the elongated body between a first position and an extended second position; and

at least one treatment portion capable of removing at least part of a stenotic lesion from the luminal organ.

31. The device of claim 30, wherein the at least one sizing portion comprises a tetrapolar arrangement of two detection electrodes positioned in between two excitation electrodes.

32. The device of claim 31, further comprising:

a current source in communication with the two excitation electrodes, said current source operable to supply current to the two excitation electrodes to enable measurement of at least one conductance value, thereby enabling calculation of a luminal size parameter.

33. The device of claim 30, wherein the at least one treatment portion is selected from the group consisting of a cutting balloon, a cryoplasty device, a rotational atherectomy device, a laser angioplasty device, a vibrating catheter, a vibrating blade, and a vibrating drill.

34. The device of claim 30, wherein the at least one treatment portion comprises a balloon, and wherein the at least one sizing portion comprises at least one pressure sensor capable of detecting at least one pressure within the balloon at one or more stages of balloon inflation.

35. The device of claim 30, further comprising:

at least one suction/infusion port in communication with at least one device lumen, the suction/infusion port operable to facilitate one or more fluid injections into the lumen of the luminal organ; and

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

36. The device of claim 30, further comprising:

a data acquisition and processing system operably coupled to the device, the data acquisition and processing system operable to receive conductance data from the 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.

37. 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 capable of a removing at least part of a stenotic lesion from a luminal organ; and

a sizing/typing device separate from the treatment device, the sizing/typing device comprising;

an elongated body having a distal body end, a fixed portion, and a rotatable portion at or near the distal body end;

electrodes positioned along the elongated body for measuring a first luminal size parameter when the typing/sizing device is positioned within a lumen of the luminal organ,

at least one directional sensor positioned on the rotatable portion of the elongated body and configured for axial rotation relative to and distinct from the fixed portion of the sizing/typing device and configured to physically touch a portion of the luminal organ or a structure therein and operable to obtain a first vessel characteristic indicative of the luminal organ or the structure therein, wherein the measurement is indicative of less than an entire circumference of the luminal organ, and

an extension apparatus coupled to the at least one directional sensor, the extension apparatus capable of moving the at least one directional sensor radially relative a longitudinal axis of the elongated body between a first position and an extended second position.

38. The system of claim 37, wherein the treatment device comprises a catheter, and wherein the sizing/typing device comprises a wire selected from the group consisting of a guide wire, a pressure wire, and a flow wire.

39. A method of removing at least part of a stenotic lesion within a luminal organ, the method comprising the steps of:

(a) positioning at least part of a device within a luminal organ at a first location, the device comprising an elongated body having a distal body end with at least one directional sensor positioned on a rotatable portion thereof at or near the distal body end, the at least one directional sensor configured for axial rotation relative to and distinct from a fixed portion of the elongated body and operable to obtain a measurement from the luminal organ or a structure therein, wherein the measurement is indicative of less than an entire circumference of the luminal organ, and wherein the device further comprises an extension apparatus coupled to the at least one directional sensor, the extension apparatus capable of moving the at least one directional sensor radially relative a longitudinal axis of the elongated body between a first position and an extended second position;

(b) operating the device to obtain a first luminal size parameter and a first measurement indicative of electrical impedance of the luminal organ or a structure therein that at least part of the device is physically touching at the first location;

(c) moving at least part of the device to a second location within the luminal organ;

(d) operating the device to obtain a second luminal size parameter and a second measurement indicative of electrical impedance of the luminal organ or the structure therein that at least part of the device is physically touching at the second location;

(e) determining whether or not a stenotic lesion is present at either the first location or the second location based on one or more of the first luminal size parameter, the first measurement, the second luminal size parameter, and the second measurement;

(f) if the stenotic lesion is present, moving at least part of the device having a treatment portion to a stenotic lesion location, the treatment portion capable of removing at least part of the stenotic lesion from the luminal organ; and

(g) if the stenotic lesion is present, operating the treatment portion of the device to remove at least part of the stenotic lesion.

40. The method of claim 39, further comprising the steps of:

(h) measuring a then-current luminal size parameter at the stenotic lesion location;

(i) comparing the then-current luminal size parameter to either the first luminal size parameter or the second luminal size parameter that is indicative of the stenotic lesion location; and

(j) if the then-current luminal size parameter does not equal a preferred luminal size parameter, repeating steps (g), (h), and (i) until the then-current luminal size parameter equals or exceeds the preferred luminal size parameter.

41. The method of claim 40, wherein the step of measuring then then-current luminal size parameter at the stenotic lesion location further comprises measuring a then-current measurement indicative of electrical impedance of the luminal organ or structure therein, and wherein the step of comparing the then-current luminal size parameter to either the first luminal size parameter or the second luminal size parameter further comprises comparing either the first measurement or the second measurement to the then-current measurement.

42. The method of claim 41, wherein steps (g), (h), and (i) are repeated if the then-current luminal size parameter does not equal a preferred luminal size parameter or if the then-current measurement is indicative of electrical impedance of the stenotic lesion.

43. The method of claim 40, further comprising the step of:

ceasing the operation of the treatment portion of the device when the then-current luminal size parameter equals or exceeds the preferred luminal size parameter.

44. The method of claim 40, further comprising the steps of:

selecting an appropriately-sized stent; and

implanting the stent into the luminal organ.

45. The method of claim 39, wherein the preferred luminal size parameter is determined based upon the first luminal size parameter and the second luminal size parameter.

46. The method of claim 39, wherein steps (b) and (d) are performed in the presence of a saline injection.

47. The method of claim 39, wherein the step of moving at least part of the device to a second location comprises advancing or retracting at least part of the device within the luminal organ.

48. The method of claim 39, wherein the step of moving at least part of the device to a second location comprises rotating at least part of the device within the luminal organ.

49. The method of claim 39, wherein the first luminal size parameter, the second luminal size parameter, and then-current luminal size parameter(s) are obtained using a detector coupled to the device.

50. The method of claim 39, wherein the first measurement and the second measurement are obtained using the at least one directional sensor or another directional sensor coupled to the device.

51. A method for removing at least part of a stenotic lesion from a luminal organ, the method comprising the steps of:

positioning a device within a luminal organ, the device comprising an elongated body having a distal body end and having at least one sizing portion, at least one typing portion, and at least one treatment portion, at least one of the at least one sizing portion and/or the at least one typing portion at or near the distal body end and comprising at least one directional sensor positioned on a rotatable portion of the elongated body and configured for axial rotation relative to and distinct from a fixed portion of the elongated body and operable to obtain a measurement from the luminal organ or a structure therein, wherein the measurement is indicative of less than an entire circumference of the luminal organ, and wherein the device further comprises an extension apparatus coupled to the at least one directional sensor, the extension apparatus capable of moving the at least one directional sensor radially relative a longitudinal axis of the elongated body between a first position and an extended second position;

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

operating the at least one sizing portion of the device to obtain type data indicative of electrical impedance of the luminal organ or a structure therein; and

operating the at least one treatment portion capable of removing at least part of a stenotic lesion from the luminal organ at a location within the luminal organ at or near the stenotic lesion, whereby operation of the at least one treatment portion is based upon the luminal size parameter data and the type data, whereby operation of the at least one treatment portion removes at least part of the stenotic lesion.

52. The method of claim 51, further comprising the step of:

ceasing operation of the at least one treatment portion when the luminal size parameter data indicates a preferred luminal size parameter.

53. The method of claim 51, further comprising the step of:

ceasing operation of the at least one treatment portion when the type data is no longer indicative of electrical impedance of a stenotic lesion.

54. The method of claim 51, wherein the steps of operating the at least one sizing portion and operating the at least one sizing portion are performed in the presence of a saline injection.

55. A method of removing at least part of a stenotic lesion from a vessel, the method comprising the steps of:

(a) positioning a device within a luminal organ, the device comprising an elongated body having a distal body end and having at least one typing portion and at least one treatment portion, the at least one typing portion at or near the distal body end comprising at least one directional sensor positioned on a rotatable portion of the elongated body and configured for axial rotation relative to and distinct from a fixed portion of the elongated body and operable to obtain a measurement from the luminal organ or a structure therein, wherein the measurement is indicative of less than an entire circumference of the luminal organ, and wherein the device further comprises an extension apparatus coupled to the at least one directional sensor, the extension apparatus capable of moving the at least one directional sensor radially relative a longitudinal axis of the elongated body between a first position and an extended second position;

(b) operating the at least one typing portion of the device to obtain initial type data indicative of electrical impedance of the luminal organ or a structure therein;

(c) operating the at least one treatment portion capable of removing at least part of a stenotic lesion from the luminal organ if the type data is indicative of electrical impedance of the stenotic lesion to remove at least part of the stenotic lesion; and

(d) operating the at least one typing portion of the device again to obtain then-current type data indicative of electrical impedance of the luminal or the structure therein; and

(e) repeating steps (c) and (d) until the then-current type data does not indicate the presence of the stenotic lesion.