Pressure-sensing intravascular devices, systems, and methods

• US 10,238,302 B2
• Filed: 12/18/2013
• Issued: 03/26/2019
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Original Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Inventors: Millett, Bret C., Burkett, David H., Corl, Paul Douglas
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US14/133,374
• Publication Number:
  US 20140180143A1
• Time in Patent Office: 1,924 Days
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

Intravascular devices, systems, and methods are disclosed. In some embodiments, the intravascular devices include at least one pressure sensing component within a distal portion of the device. In that regard, one or more electrical, electronic, optical, and/or electro-optical pressure-sensing components is secured to an elongated substrate such that the pressure-sensing component is mounted perpendicular to a central longitudinal axis of the device. In some implementations, the elongated substrate has a cylindrical profile. Methods of making, assembling, and/or using such intravascular devices and associated systems are also provided.

Claims

1. An intravascular sensor assembly comprising:

a flexible elongate member having a longitudinal axis (LA);

a core member disposed inside the flexible elongate member;

an electrical conductor extending along the core member; and

an elongated, cylindrical-shaped substrate disposed distal to the core member and inside the flexible elongate member, the elongated, cylindrical-shaped substrate comprising;

a proximal surface and an opposing distal surface;

a semiconductor material;

at least one electrode disposed within at least one recess in an outer surface of the elongated, cylindrical-shaped substrate, the at least one recess extending in a longitudinal direction, wherein the at least one electrode comprises a proximal end surface substantially coplanar with the proximal surface of the elongated, cylindrical-shaped substrate and a distal end surface substantially coplanar with the distal surface of the elongated, cylindrical-shaped substrate, wherein the electrical conductor is coupled to the at least one electrode at the proximal end surface; and

a sensor circuit disposed on a distal surface of the elongated, cylindrical-shaped substrate, the sensor circuit coupled to the distal end surface of the at least one electrode, wherein the sensor circuit comprises an intravascular pressure sensor circuit.

2. The intravascular sensor assembly of claim 1 wherein the sensor circuit is a pressure sensor circuit.

3. The intravascular sensor assembly of claim 1 wherein the at least one electrode comprises three electrodes configured to be coupled to three different terminals of the sensor circuit.

4. The intravascular sensor assembly of claim 1 wherein the flexible elongate member comprises at least one through hole at a distal end so as to expose the sensor circuit to an intravascular ambient.

5. The intravascular sensor assembly of claim 1 wherein the elongated, cylindrical-shaped substrate includes a cylindrical axis along the LA.

6. The intravascular sensor assembly of claim 1 wherein the elongated, cylindrical-shaped substrate is made of the semiconductor material selected from the group consisting of silicon, germanium, a silicon-germanium alloy, silica, quartz, sapphire, a ceramic material, a plastic material, and a combination thereof.

7. The intravascular sensor assembly of claim 1 further comprising a cable extending along the core member between a proximal portion and a distal portion of the flexible elongate member, the cable including the electrical conductor.

8. The intravascular sensor assembly of claim 1 wherein the sensor circuit comprises a micro-electromechanical system (MEMS).

9. The intravascular sensor assembly of claim 1 wherein the elongated, cylindrical-shaped substrate is bonded to the core member using an adhesive selected from the group consisting of urethane acrylate, cyanoacrylate, silicone, epoxy, and any combination thereof.

19. The intravascular sensor assembly of claim 1 wherein the distal surface extends perpendicular to the LA.

22. The intravascular sensor assembly of claim 1, wherein the elongated, cylindrical-shaped substrate is coated with an insulating material.

23. The intravascular sensor assembly of claim 1, wherein the sensor circuit comprises at least one lead and the sensor circuit is coupled to the distal end surface of the at least one electrode through the at least one lead.

10. A sensor structure for use in an intravascular device assembly, the sensor structure comprising:

a substrate having an elongated cylindrical shape with a length defined along a longitudinal axis (LA) and a width extending perpendicular to the longitudinal axis, wherein the substrate includes a semiconductor material, the shape further comprising;

a proximal surface and an opposing distal surface, each extending substantially perpendicular to the LA; and

an outer surface extending substantially parallel to the LA between the proximal and distal surfaces;

at least one electrode disposed longitudinally within at least one recess in the outer surface of the substrate, wherein the at least one electrode comprises an distal end surface substantially coplanar with the distal surface of the substrate and a proximal end surface substantially coplanar with the proximal surface of the substrate, and

a sensor circuit disposed on the distal surface, the sensor circuit having at least one lead coupled to the distal end surface of the at least one electrode.

11. The sensor structure of claim 10 wherein the substrate is made of a material selected from the group consisting of silicon, germanium, a silicon-germanium alloy, quartz, glass, sapphire, a ceramic material, a plastic material, or a combination thereof.

12. The sensor structure of claim 10 wherein the sensor circuit is bonded to the distal surface in a flip chip configuration.

20. The sensor structure of claim 10 wherein the sensor circuit is formed on the distal surface of the substrate.

13. A system for performing measurements using a sensor exposed to an intravascular environment, the system comprising:

an intravascular device having;

a flexible elongate member having a longitudinal axis (LA);

a core member disposed inside the flexible elongate member;

an electrical conductor extending along the core member; and

an elongated, cylindrical-shaped substrate disposed distal to the core member and inside the flexible elongate member, the elongated, cylindrical-shaped substrate comprising;

a proximal surface and an opposing distal surface;

a semiconductor material;

at least one electrode disposed within at least one recess in an outer surface of the elongated, cylindrical-shaped substrate, the at least one recess extending in a longitudinal direction, wherein the at least one electrode comprises a proximal end surface substantially coplanar with the proximal surface of the elongated, cylindrical-shaped substrate, wherein the electrical conductor is coupled to the proximal end surface of the at least one electrode; and

a sensor circuit disposed on a distal surface of the elongated, cylindrical-shaped substrate, the sensor circuit coupled to the at least one electrode, wherein

the sensor circuit comprises an intravascular pressure sensor circuit; and

a control console coupled to the intravascular device.

14. The system of claim 13 further comprising an interface device positioned between the control console and the intravascular device, wherein the interface device provides power to the sensor circuit and processes a signal from the sensor circuit.

15. The system of claim 14 wherein the interface device comprises an analog to digital converting circuit to provide a digital signal to the console.

16. The system of claim 13 wherein the sensor circuit is a pressure sensor and the control console outputs a graph of a blood pressure along a longitudinal axis in the intravascular environment.

17. The system of claim 13 wherein the elongated, cylindrical-shaped substrate includes a cylindrical axis along the LA.

18. The system of claim 17 wherein the elongated, cylindrical-shaped substrate is bonded to the core member using an adhesive.

21. The system of claim 13 wherein the distal surface extends perpendicular to the LA.