Methods to generate luminal organ profiles using impedance

• US 9,066,708 B2
• Filed: 12/13/2011
• Issued: 06/30/2015
• 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:
  US13/324,222
• Publication Number:
  US 20120172746A1
• Time in Patent Office: 1,295 Days
• Field of Search: 600/547, 600/506, 600/505, 600/526, 600/587, 600/481, 600/486, 600/454, 600/561, 606/192, 606/194, 606/198, 128/898, 424/439, 623/1.11, 623/1.15, 623/23.7
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• 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 5/6853 with a balloon
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Methods to generate luminal organ profiles using impedance. One embodiment of such a method comprises the steps of introducing an impedance device having at least two detection electrodes positioned in between at least two excitation electrodes into a treatment site of a luminal organ at a first position, measuring a first treatment site conductance at the first position using the impedance device and at least two injections of solutions having different conductivities, moving the impedance device to a second position in the luminal organ, measuring a second treatment site conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities, calculating a first position cross-sectional area using the first treatment site conductance and a second position cross-sectional area using the second treatment site conductance, and constructing a profile of the treatment site.

Claims

1. A method of creating a cross-sectional area profile of a targeted treatment site, the method comprising the steps of:

introducing an impedance device having at least two detection electrodes positioned in between at least two excitation electrodes into a treatment site of a luminal organ at a first position;

measuring a first treatment site conductance at the first position using the impedance device and at least two injections of solutions having different conductivities, the at least two injections being made within the luminal organ so that undiluted boluses of the at least two injections flow from an injection location through the luminal organ to the first position prior to ultimate dilution within the luminal organ, the first treatment site conductance measured prior to ultimate dilution of the injections within the luminal organ at the first position;

moving the impedance device to a second position in the luminal organ;

measuring a second treatment site conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities, the at least two injections being made within the luminal organ so that undiluted boluses of the at least two injections flow from an injection location through the luminal organ to the second position prior to ultimate dilution within the luminal organ, the second treatment site conductance measured prior to ultimate dilution of the injections within the luminal organ at the second position;

calculating a first position cross-sectional area based in part upon the first treatment site conductance, a conductivity of blood, and a known distance between two of the at least two detection electrodes and calculating a second position cross-sectional area using the second treatment site conductance, the conductivity of blood, and the known distance between two of the at least two detection electrodes; and

constructing a profile of the treatment site based in part on the calculated first cross-sectional area and the calculated second cross-sectional area.

2. The method of claim 1, wherein the calculating step further comprises calculating a total conductance for a distance between the first position and the second position of the treatment site.

3. The method of claim 1, wherein the treatment site comprises a site selected from the group consisting of a body lumen, a body vessel, a coronary artery, a carotid artery, a femoral artery, a renal artery, a iliac artery, a cerebral artery, and an aorta.

4. The method of claim 1, wherein the step of introducing an impedance device into a treatment site comprises introducing a device selected from the group consisting of an impedance wire and an impedance catheter into the treatment site.

5. The method of claim 1, wherein the at least two injections comprise at least two injections of saline having different conductivities.

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

moving the impedance device to a third position in the luminal organ;

measuring a third treatment site conductance at the third position using the impedance device and the at least two injections of solutions having different conductivities;

calculating a third position cross-sectional area using the third treatment site conductance; and

including the third calculated cross-sectional area within the constructed profile.

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

inflating a balloon coupled to the impedance device to breakup materials causing a stenosis at the treatment site.

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

implanting a stent into the treatment site by inflating a balloon coupled to the impedance device.

9. The method of claim 8, wherein the balloon is inflated using a fluid, and the method further comprising the steps of:

providing electrical current into the fluid filling the balloon at various degrees of balloon distension;

measuring a conductance of the fluid inside the balloon; and

calculating a cross-sectional area of a balloon lumen.

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

measuring a velocity of fluid flow through the treatment site using the impedance device.

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

measuring a first pressure gradient at the treatment site using a pressure transducer coupled to the impedance device; and

calculating an additional cross-sectional area of the treatment site based in part on the first pressure gradient.

12. The method of claim 1, wherein the at least two injections of solutions temporarily displace blood present at the treatment site.

13. The method of claim 1, wherein the step of moving the impedance device to a second position comprises pushing the impedance device forward to the second position of the treatment site.

14. The method of claim 1, wherein the step of moving the impedance device to a second position of the treatment site further comprises the steps of:

obtaining one or more additional conductance measurements between the first position and the second position of the treatment site; and

calculating one or more additional cross-sectional areas based upon the one or more additional conductance measurements.

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

determining a length of a stenosis present within the treatment site based upon the calculated profile.

16. The method of claim 1, wherein the treatment site has a relative longitudinal axis, and wherein the constructed profile is indicative of the relative longitudinal axis of the treatment site.

17. The method of claim 1, wherein the introducing step comprises introducing the impedance device having the at least two detection electrodes spaced at or between 0.5 mm and 1.0 mm from each other.

18. A method of creating a cross-sectional area profile of a targeted treatment site, the method comprising the steps of:

introducing an impedance device having at least two electrodes positioned thereon into a luminal organ;

measuring a first treatment site conductance at the first position using the impedance device and a first injection of a solution having a known conductivity, the first injection being made within the luminal organ so that an undiluted bolus of the first injection flows from a first injection location through the luminal organ to the first position prior to ultimate dilution within the luminal organ, the first treatment site conductance measured prior to ultimate dilution of the injection within the luminal organ at the first position;

moving the impedance device to a second position in the luminal organ;

measuring a second treatment site conductance at the second position using the impedance device and a second injection of a solution having a known conductivity, the second injection being made within the luminal organ so that an undiluted bolus of the second injection flows from a second injection location through the luminal organ to the second position prior to ultimate dilution within the luminal organ, the second treatment site conductance measured prior to ultimate dilution of the injection within the luminal organ at the second position;

calculating a first position cross-sectional area based in part upon the first treatment site conductance, a conductivity of blood, and a known distance between two of the at least two detection electrodes and calculating a second position cross-sectional area using the second treatment site conductance, the conductivity of blood, and the known distance between two of the at least two detection electrodes; and

constructing a profile of the treatment site based in part on the calculated first cross-sectional area and the calculated second cross-sectional area.

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

moving the impedance device to at least one additional position in the luminal organ;

measuring at least one additional treatment site conductance at the at least one additional position using the impedance device and an additional injection of a solution having a known conductivity;

calculating at least one additional position cross-sectional area using the at least one additional treatment site conductance; and

including the at least one additional calculated cross-sectional area within the constructed profile.

20. A method of creating a cross-sectional area profile of a targeted treatment site, the method consisting essentially of the steps of:

introducing an impedance device having at least two detection electrodes positioned in between at least two excitation electrodes into a treatment site of a luminal organ at a first position;

measuring a first treatment site conductance at the first position using the impedance device and at least two injections of solutions having different conductivities, the at least two injections being made within the luminal organ so that undiluted boluses of the at least two injections flow from an injection location through the luminal organ to the first position prior to ultimate dilution within the luminal organ, the first treatment site conductance measured prior to ultimate dilution of the injections within the luminal organ at the first position;

moving the impedance device to a second position in the luminal organ;

measuring a second treatment site conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities, the at least two injections being made within the luminal organ so that undiluted boluses of the at least two injections flow from an injection location through the luminal organ to the second position prior to ultimate dilution within the luminal organ, the second treatment site conductance measured prior to ultimate dilution of the injections within the luminal organ at the second position;

moving the impedance device to at least one additional position in the luminal organ;

measuring at least one additional treatment site conductance at the at least one additional position using the impedance device and the at least two injections of solutions having different conductivities;

calculating a first position cross-sectional area based in part upon the first treatment site conductance, a second position cross-sectional area based in part upon the second treatment site conductance, and at least one additional position cross-sectional area based in part upon the at least one additional treatment site conductance, with each calculation also being based in part upon a conductivity of blood and a known distance between two of the at least two detection electrodes;

constructing a profile of the treatment site based in part on the calculated first cross-sectional area, the calculated second cross-sectional area, and the calculated at least one additional cross-sectional area.