Devices and methods for removing stenotic lesions from vessels

• US 9,289,229 B2
• Filed: 06/18/2013
• Issued: 03/22/2016
• Est. Priority Date: 02/21/2003
• Status: Expired due to Fees

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/920,833
• Publication Number:
  US 20130282037A1
• Time in Patent Office: 1,008 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: 1/1
• 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 of the present disclosure, the device comprises at least one treatment portion operable to remove at least part of a stenotic lesion, and at least one sizing portion operable to measure a first luminal size parameter when positioned and operated at a first location and further operable to measure a second luminal size parameter when positioned and operated at a second location, wherein the device comprises an elongated body selected from the group consisting of a catheter and a wire.

Claims

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

(a) measuring a first luminal size parameter at a first location within a vessel and a second luminal size parameter at a second location within the vessel;

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

(c) operating a treatment device positioned at the second location to increase the second luminal size parameter, the treatment device comprising at least one sizing portion configured to obtain the first luminal size parameter and the second luminal size parameter using impedance and at least one treatment portion operable to remove at least part of a stenotic lesion;

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

(e) comparing the then-current luminal size parameter to the preferred luminal size parameter range; and

(f) if the then-current luminal size parameter does not fall within the preferred luminal size parameter range, repeating steps (c), (d), and (e) until the then-current luminal size parameter falls within the preferred luminal size parameter range.

2. The method of claim 1, wherein the first luminal size parameter is selected from the group consisting of a first luminal diameter and a first luminal cross-sectional area, and wherein the second luminal size parameter is selected from the group consisting of a second luminal diameter and a second luminal cross-sectional area.

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

4. 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.

5. The method of claim 1, further comprising the step of:

ceasing the operation of the treatment device when the then-current second luminal size parameter falls within the preferred luminal size parameter range.

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

selecting an appropriately-sized stent based in part upon the then-current luminal size parameter; and

implanting the stent into the vessel lumen.

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

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

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

8. The method of claim 7, wherein a length of the stenotic lesion is determined based upon the lumen profile.

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

at least one treatment portion operable to remove at least part of a stenotic lesion; and

at least one sizing portion comprising at least one impedance electrode, the at least one sizing portion operable to measure a first luminal size parameter when positioned and operated at a first location and further operable to measure a second luminal size parameter when positioned and operated at a second location;

wherein the device comprises an elongated body selected from the group consisting of a catheter and a wire.

10. The device of claim 9, 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, and a vibrating drill.

11. The device of claim 9, wherein the at least one sizing portion comprises at least one non-impedance sensor in addition to or in lieu of the at least one impedance electrode.

12. The device of claim 9, wherein the at least one treatment portion comprises a balloon, wherein the at least one sizing portion is positioned within the balloon, and wherein the at least one sizing portion is operable to measure at least one luminal parameter within the balloon at one or more stages of balloon inflation.

13. The device of claim 9, further comprising:

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; and

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.

14. A method of removing a stenotic lesion from a vessel, 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 to obtain a luminal size parameter data value;

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 performed in connection with the luminal size parameter data value, and whereby operation of the at least one treatment portion increases the luminal size parameter data value; and

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

wherein the device is configured for operation with a data acquisition and processing system operably coupled thereto, the data acquisition and processing system operable to receive conductance data from the at least one sizing portion and further operable to calculate the at least one luminal size parameter data value based upon said conductance data.

15. The method of claim 14, wherein the preferred luminal size parameter comprises a preferred luminal size parameter range, and wherein the ceasing operation step is performed when the luminal size parameter data is within the preferred luminal size parameter range.

16. The method of claim 14, further comprising the steps of:

selecting an appropriately-sized stent based at least in part upon the preferred luminal size parameter; and

implanting the stent into the vessel lumen.

17. The method of claim 14, 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 parameter obtained after initial operation of the at least one treatment portion.

18. The method of claim 17, 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.