PRESSURE-SENSING CATHETERS AND RELATED METHODS

• US 20160250444A1
• Filed: 02/25/2016
• Published: 09/01/2016
• Est. Priority Date: 02/27/2015
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Accisano, Nicholas III, Lampropoulos, Fred, Mottola, Jim
• Granted Patent: US 10,702,672 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A multi-lumen catheter can be used to measure pressure at multiple locations within the vasculature. The multi-lumen catheter can include multiple segments, such as a proximal portion, an intermediate portion, and a distal portion. A segment of a multi-lumen catheter may differ from another segment of the same multi-lumen catheter in radiodensity, hardness, and/or some other characteristic. Some multi-lumen catheters are designed to permit measurements of pressure in different lumens.

Claims

1. A catheter comprising:

a distal portion having at least one port that is in fluid communication with a first lumen of the catheter, wherein the distal portion has a first radiodensity;

a proximal portion having at least one port that is in fluid communication with a second lumen of the catheter, wherein the proximal portion has a second radiodensity; and

an intermediate portion disposed between the proximal portion and the distal portion, the intermediate portion having a third radiodensity;

wherein the third radiodensity differs from both the first radiodensity and the second radiodensity.

2. The catheter of claim 1, wherein the first lumen and the second lumen are not in fluid communication with one another.

3. The catheter of claim 1, wherein the intermediate portion is less radiodense than both the distal portion and the proximal portion.

4. The catheter of claim 1, wherein the intermediate portion is more radiodense than both the distal portion and the proximal portion.

5. The catheter of claim 1, wherein the bend of the intermediate portion forms an angle of between 130°

and 170°

when the catheter is in an unconstrained state.

6. The catheter of claim 1, wherein the proximal portion has a durometer hardness that is greater than a durometer hardness of the distal portion.

7. The catheter of claim 6, wherein the intermediate portion has a durometer hardness that is greater than the durometer hardness of the distal portion.

8. The catheter of claim 7, wherein the proximal portion has a durometer hardness that is greater than the durometer hardness of the intermediate portion.

9. The catheter of claim 8, wherein the proximal portion has a durometer hardness of between 90 and 100 Shore D, the intermediate portion has a durometer hardness of between 65 and 80 Shore D, and the distal portion has a durometer hardness of between 45 and 55 Shore D.

10. The catheter of claim 1, further comprising a first elongate tube and a second elongate tube that is at least partially disposed within the first elongate tube, wherein the first elongate tube and the second elongate tube form at least a portion of the proximal portion of the catheter.

11. The catheter of claim 10, further comprising:

a plurality of septal walls extending radially inward from the first elongate tube to the second elongate tube; and

a plurality of radial lumens defined, at least in part, by the plurality of the septal walls, wherein the plurality of radial lumens is disposed proximal of the intermediate portion and between the first elongate tube and the second elongate tube.

12. The catheter of claim 11, further comprising:

an elongate tubular catheter tip that forms at least a portion of the intermediate portion; and

a transition portion between the proximal portion of the catheter and the intermediate portion of the catheter, wherein the transition portion comprises a portion of the catheter tip that is disposed between and fused to both the first elongate tube and the second elongate tube.

13. The catheter of claim 1, wherein:

the proximal portion comprises a plurality of ports that spiral helically around the proximal portion; and

the plurality of ports of the proximal portion includes the at least one port that is in fluid communication with a second lumen of the catheter.

14. The catheter of claim 1, further comprising one or more pressure sensors configured to measure pressure within the first lumen and the second lumen.

19. The catheter of claim 1, further comprising one or more pressure sensors configured to measure pressure within the first lumen and the second lumen.

20. A method of performing an interventional procedure, the method comprising:

obtaining the catheter of claim 1;

introducing the catheter into the vasculature of a patient such that the first lumen is in fluid communication with blood of the patient at a distal location and the second lumen is in fluid communication with blood of the patient at a proximal location; and

measuring pressure in both the first and second lumens.

21. The method of claim 20, wherein introducing the catheter into the vasculature of the patient comprises inserting the catheter into the patient such that the distal location is on a first side of a heart valve and the proximal location is on a second side of the heart valve.

15. A catheter comprising:

a distal portion having at least one port that is in fluid communication with a first lumen of the catheter, wherein the distal portion has a first durometer hardness;

a proximal portion having at least one port that is in fluid communication with a second lumen of the catheter, wherein the proximal portion has a second durometer hardness; and

an intermediate portion disposed between the proximal portion and the distal portion, the intermediate portion having a third durometer hardness;

wherein the first durometer is between 45 and 55 Shore D, the second durometer is between 90 and 100 Shore D, and the third durometer is between 65 and 80 Shore D.

16. The catheter of claim 15, further comprising a terminal portion disposed distal of the distal portion, wherein the terminal portion has a durometer hardness of between 30 and 40 Shore D.

17. The catheter of claim 15, further comprising a first elongate tube and a second elongate tube that is at least partially disposed within the first elongate tube, wherein the first elongate tube and the second elongate tube form at least a portion of the proximal portion of the catheter.

18. The catheter of claim 17, further comprising:

a plurality of septal walls extending radially inward from the first elongate tube to the second elongate tube; and

a plurality of radial lumens defined, at least in part, by the plurality of the septal walls, wherein the plurality of radial lumens is disposed proximal of the intermediate portion and between the first elongate tube and the second elongate tube.