Methods and devices for endovascular therapy

• US 9,375,223 B2
• Filed: 01/27/2014
• Issued: 06/28/2016
• Est. Priority Date: 10/06/2009
• Status: Active Grant

• Current Assignee: CardioProlific Inc. (Koninklijke Philips N.V.)
• Original Assignee: CardioProlific Inc. (Koninklijke Philips N.V.)
• Inventors: Wallace, Michael P
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US14/164,512
• Publication Number:
  US 20140142494A1
• Time in Patent Office: 883 Days
• Field of Search: 604 20- 22, 604/96.01, 604/101.01, 604/101.03, 604/101.05, 604/102.01, 604/102.02, 604/102.03, 604/103.01, 604/103.02, 601/2, 607 96- 99, 606/159
• 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 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/22014 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire not applied in A61B17/22012
• CPC Class Codes: A61B 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22088 ultrasound absorbing, drug activated by ultrasound
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

The present invention provides methods and devices for treating endovascular disease. Vibrational energy is delivered to change compliance and increase permeability at the treatment area. To improve clinical outcomes, one or more therapeutic drugs may be delivered to the treatment area.

Claims

1. A method of treating vascular stenosis, comprising the steps of:

performing balloon angioplasty at a treatment area inside a vessel;

positioning a distal end of a vibrational device at the treatment area, the vibrational device having a transmission member;

propagating vibrational energy through the transmission member from a proximal transducer located outside the patient to the distal end of the vibrational device at a frequency of 1 KHZ-20 MHZ while undergoing irrigation to form surface waves at the distal end of the vibrational device;

applying the surface waves at a power of less than 20 Watts at the distal end of the vibrational device to the treatment area to change the stenosis compliance and to increase permeability of the vessel for delivery of an anti-proliferative agent, wherein the surface waves are propagated from the distal end of the vibrational device to the treatment area through irrigation liquid;

positioning a blood flow protection device at a location distal to the treatment area to prevent the anti-proliferative agent from flowing distally;

delivering the anti-proliferative agent to the treatment area using a contrast agent as a matrix within less than 60 minutes from the application of the surface waves; and

applying the therapeutic agent in the treatment area for less than 60 minutes.

2. The method of claim 1, further including performing an interventional procedure that is selected from the group consisting of:

stent placement, atherectomy, laser, ultrasound, cryoplasty, and a combination thereof.

3. The method of claim 1, wherein the anti-proliferative agent in mixture with contrast further includes saline solution.

4. The method of claim 1, further including delivery of longitudinal waves, transverse waves, and a combination thereof.

5. The method of claim 1, wherein vibrational energy is propagated from the vibrational device to the treatment area in one of the following ways:

through irrigation liquid in mixture with blood, through direct contact with the tissue, and combination of all.

6. The method of claim 1, further comprising at least partially removing the anti-proliferative agent outside the body.

7. The method of claim 1, further including the treatment of endovascular stenosis in one of the following treatment areas:

arteries, veins, in-stent, grafts, fistulas, or combinations thereof.

8. The method of claim 1, wherein the blood flow protection device is a first blood flow protection device, further including positioning a second blood flow protection device proximally to the treatment area.

9. The method of claim 8, wherein the first and second blood flow protection devices comprise a dual balloon device having a first balloon adjacent a distal end of the treatment area and the second balloon adjacent a proximal end of the treatment area.

10. The method of claim 1, wherein the vibrational device includes a flexible member located on the distal end.

11. The method of claim 1, wherein the vascular stenosis includes a chronic total occlusion.

12. The method of claim 1, wherein treating vascular stenosis includes treating vulnerable plaque.

13. The method of claim 1, further including applying vibrational energy to the treatment area at one of the following times:

before balloon angioplasty, during balloon angioplasty, after balloon angioplasty, before drug application, during drug application, after drug application, or a combination thereof.

14. The method of claim 1, wherein the balloon angioplasty and blood flow protection are performed with the same device.

15. The method of claim 1, wherein the anti-proliferative agent is Paclitaxel.

16. A method of treating vascular stenosis, comprising the steps of:

performing balloon angioplasty at a treatment area inside a vessel;

positioning a vibrational device at the treatment area, the vibrational device having a transmission member;

propagating vibrational energy through the transmission member from a proximal transducer located outside the patient to the distal end of the vibrational device at a frequency of 1 KHZ-20 MHZ while undergoing irrigation to form surface waves at the distal end of the vibrational device;

applying the surface waves at a power of less than 20 Watts at the distal end of the vibrational device to the treatment area to change the stenosis compliance and to increase permeability of the vessel to receive an anti-proliferative agent, wherein the surface waves are propagated from the distal end of the vibrational device to the treatment area through irrigation liquid;

delivering an anti-proliferative agent to the treatment area using a drug delivery balloon device within less than 60 minutes from the application of the surface waves; and

applying the anti-proliferative agent in the treatment area for less than 60 minutes.

17. A method of treating vascular stenosis, comprising the steps of:

performing balloon angioplasty at a treatment area inside a vessel;

positioning a vibrational device at the treatment area, the vibrational device having a transmission member;

propagating vibrational energy through the transmission member from a proximal transducer located outside the patient to the distal end of the vibrational device at a frequency of 1 KHZ-20 MHZ and a power of less than 20 Watts while undergoing irrigation to form surface waves at the distal end of the vibrational device;

applying the surface waves from the vibrational device to the treatment area to change the stenosis compliance and to increase permeability of the vessel to receive an anti-proliferative agent, wherein the surface waves are propagated from the distal end of the vibrational device to the treatment area through irrigation fluid;

delivering an anti-proliferative agent to the treatment area within less than 60 minutes from the application of the surface waves; and

delivering a drug eluting stent within less than 60 minutes from the application of the surface waves.