Guidewires and Delivery Catheters Having Fiber Optic Sensing Components and Related Systems and Methods

• US 20090227952A1
• Filed: 03/10/2008
• Published: 09/10/2009
• Est. Priority Date: 03/10/2008
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Robinson, Timothy, Blakstvedt, Adam, Casas, Jesus
• Granted Patent: US 8,016,814 B2
• Time in Patent Office: Days
• US Class Current: 604/117
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter

Abstract

Methods, systems and devices for delivering a diagnostic or therapeutic treatment, substance or device to a target area located within the body of a human or animal subject. A tissue penetrating catheter is positioned within a body lumen near the target area. A hollow penetrator is then advanced from the tissue penetrating catheter and penetrated from the body lumen in which the penetrating catheter is positioned into tissue in the direction of the target area. Thereafter, an elongate optical device (e.g., an optically equipped guidewire or catheter) is advanced through the hollow penetrator and continues to advance through tissue, in the direction of the target area. The elongate optical device is connected to an optical processing device (e.g., a spectrometer) which provides optically determined data (e.g., spectral reflectance, pH, oxygen concentration, temperature) indicating when the elongate optical device has entered the target area. The elongate optical device is then used to facilitate delivery of a diagnostic or therapeutic modality, substance or device into the target area.

Claims

1. A method for delivering a diagnostic or therapeutic treatment, substance or device to a target area located within the body of a human or animal subject, said method comprising the steps of:

(A) providing an elongate optical device comprising an elongate shaft, a light transmitting fiber and a reflected light return fiber usable for optical determination of a tissue variable that distinguishes the target area from other areas;

(B) providing a tissue penetrating catheter device comprising a catheter shaft that is positionable in a body lumen within the subject'"'"'s body and a penetrator that is advanceable from the catheter to a location outside of the body lumen in which the catheter shaft is positioned, said penetrator having a lumen with a distal opening;

(C) positioning the tissue penetrating catheter within a body lumen;

(D) advancing the penetrator from the penetrating catheter to a position outside the body lumen in which the penetration catheter is positioned;

(E) advancing the elongate optical device through the lumen of the penetrator, out of the distal opening and through tissue in the direction of the target area;

(F) delivering light through the light transmitting fiber and using reflected light received from the reflected light return fiber to measure said tissue variable;

(G) determining when said tissue variable indicates that the elongate optical device is within the target area; and

(H) using the elongate optical device to facilitate delivery of a diagnostic or therapeutic modality, substance or device into the target area.

2. A method according to claim 1 wherein the distinguishing variable is selected from the group consisting of:

pH, concentration of hydrogen ions, oxygen concentration, dissolved oxygen concentration, temperature and spectral reflection data that matches known spectral reflection data for a type of tissue that is present in the target area.

3. A method according to claim 1 wherein the elongate optical device comprises a guidewire and wherein Step H comprises i) advancing a treatment catheter over the guidewire and into the target area and ii) using said treatment catheter to deliver a diagnostic or therapeutic treatment, substance or device to the target area.

4. A method according to claim 1 wherein the elongate optical device comprises a delivery catheter and wherein Step H comprises using said delivery catheter to deliver a diagnostic or therapeutic treatment, substance or device to the target area.

5. A method according to claim 4 wherein the delivery catheter has at least one working lumen and wherein Step H comprises delivering a substance or device through said at least one working lumen and into the target area.

6. A method according to claim 5 wherein Step H comprises delivering a substance selected form the group consisting of:

drugs, thrombolytics, platelet inhibitors, anti-restenotic agents, beta blockers, ion channel antagonists, positive or negative ionotropic agents, anti-arrhythmics, antibiotics, analgesics, chemotherapeutic agents, anti-neoplastic agents, natural or recombinant proteins, angiogenic proteins, vascular endothelial growth factor (VEGF), fibroblast growth factors (FGF), epidermal growth factor (EGF), platelet-derived growth factor (PDGF), nerve cell growth factor (NGF), hepatocyte growth factor (HGF)), cells, cellular preparations, adult stem cells, embryonic stem cells, progenetor cells, myocytes, myoblasts, pancreatic islet cells, dopamine secreting cells, genes, gene therapy preparations, viral vectors containing genes, genetic material for electrophoretic transmission into cells, plasmids, viral vectors, genetically modified cells, naked DNA, contrast media, dyes, radio-labeled diagnostic materials, radiolabled drugs, dialysis solutions, micro-dialysis solutions, radioactive pellets, radiotherapy preparations, radiofrequency absorption enhancers, nanoparticles, carbon nanoparticles, platelet rich plasma, thrombin solution, platelet gel, autologus platelet gel, fillers, bulking agents, collagen, hyaluronic acid and glycosaminoglycans.

7. A method according to claim 5 wherein the delivery catheter has a plurality of working lumens and wherein Step H comprises delivering a plurality of substances, in separate streams, through said plurality of working lumens such that said plurality of substances become combined within the target area.

8. A method according to claim 7 wherein said plurality of substances comprises i) platelet rich plasma and ii) a thrombin containing solution which become combined to form platelet gel within the target area.

9. A method according to claim 1 wherein the target area is within the subject'"'"'s myocardium.

10. A method according to claim 1 wherein the target area is within an organ.

11. A method according to claim 1 wherein the target area is within a pathological lesion.

12. A method according to claim 11 wherein the pathological lesion comprises a tumor.

13. A method according to claim 1 wherein the target area is within another body lumen.

14. A method according to claim 1 wherein the target area is within the subject'"'"'s heart, Step C comprises positioning the tissue penetrating catheter in a coronary blood vessel vein and Step D comprises advancing the penetrator to a location in the subject'"'"'s myocardium a spaced distance away from the target area.

15. A method according to claim 1 wherein Step H comprises using the elongate optical device to facilitate delivery into the target area of a device selected from the group consisting of:

substance eluting implants, radioactive implants, embolic members, markers, radiopaque markers, catheters, cannulae, wires, electrodes, sensors and implants.

16. A method according to claim 1 wherein the tissue penetrating catheter further comprises an orientation indicator useable for predicting the direction in which the penetrator will subsequently advance and wherein, prior to performance of Step D, the method further comprises the step of using the orientation indicator to adjust the rotational orientation of the catheter body within the body lumen as needed to increase the likelihood that the penetrator will subsequently advance in the direction of the target area.

17. A system comprising:

a penetrating catheter device comprising an elongate catheter shaft and a penetrator having a lumen, said penetrator being advanceable from the catheter shaft; and

an elongate optical device comprising an elongate shaft, a light transmitting fiber and a reflected light return fiber usable for optical determination of a tissue variable that distinguishes the target area from other areas, said elongate optical device being advanceable though the lumen of the penetrator.

18. A system according to claim 17 wherein the elongate optical device comprises a guidewire.

19. A system according to claim 17 wherein the elongate optical device comprises a delivery catheter.

20. A system according to claim 19 wherein the delivery catheter has at least one working lumen through which a substance or device may be delivered.

21. A system according to claim 20 wherein the delivery catheter has a single working lumen through which a substance or device may be delivered.

22. A system according to claim 20 wherein the delivery catheter has at least 2 working lumens so that at least two substances may be infused through the delivery catheter in separate streams.

23. A system according to claim 22 wherein the working lumens exit the delivery catheter at adjacent locations such that the substances become combined after exiting the delivery catheter.

24. A system according to claim 17 wherein the tissue penetrating catheter further comprises an orientation indicator useable for determining useable for predicting the direction in which the penetrator will subsequently advance from the penetrating catheter shaft.