METHOD AND SYSTEM FOR ASSISTING A WIRE GUIDE TO CROSS OCCLUDED DUCTS

• US 20110208185A1
• Filed: 02/24/2010
• Published: 08/25/2011
• Est. Priority Date: 02/24/2010
• Status: Active Grant

• Current Assignee: SafePass Vascular Ltd. (Nordson Corporation)
• Original Assignee: SafePass Vascular Ltd. (Nordson Corporation)
• Inventors: Diamant, Valery, Yasko, Nadezda, Lerner, Marat, Chernenko, Vladimir, Dutov, Alexey, Ivanova, Ludmila
• Granted Patent: US 9,743,980 B2
• Time in Patent Office: Days
• US Class Current: 606/42
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00422 Angioplasty
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/162 located on the probe body

Abstract

A method and a system for assisting a wire guide to cross obstructed ducts in mammalian body are described. The method and system is based on applying pulsed energy to occlusion obstructing the duct. The pulsed energy is applied by means of an auxiliary probe. The auxiliary probe is relatively displaceable with respect to the wire guide along a lumen provided within the probe. The distal region of the probe is provided with enhanced flexibility comparing with the reminder portion of the probe.

Claims

1. A method for assisting a wire guide to cross an occlusion obstructing a duct of a mammalian body, said method comprising:

a) providing an auxiliary probe insertable into the duct, said probe having a working head, said probe is electrically connectable to a control unit, said probe having a lumen for receiving the wire guide and said probe having at least one opening for introducing the wire guide in the lumen,

b) protracting the wire guide through the lumen along the duct until it approaches the occlusion,

c) displacing the probe relatively to the wire guide to bring the working head in physical contact with the occlusion,

d) supplying pulses of energy from the control unit to the working head to at least partially disrupt the occlusion and render further advancement of the probe along the duct possible,

e) displacing the wire guide relatively to the probe along the duct towards a required location.

2. A method of claim 1, in which said pulses of energy are defined by the following parameters:

duration not more then 5000 nanoseconds, pulse rise time less than 50 nanoseconds, pulse energy 0.01-1 Joule and the pulse amplitude which is sufficient for creation of stable discharge breakdown between two electrodes on the distal end of the probe'"'"'s head, for example 3-15 kV.

3. A method of claim 2, in which said pulses are one time discrete pulses.

4. A method of claim 2, in which said pulses are series of pulses supplied with frequency of 1-5 Hz.

5. A method of claim 1, comprising detachable electrical connecting the probe and the control unit.

6. A method of claim 1, comprising setting parameters of the pulses before supplying them to the probe.

7. A method of claim 1, in which said occlusion is selected from the group consisting of organic occlusions, inorganic occlusions and their combination.

8. A method of claim 7, in which said duct is selected from the group consisting of a hollow organ, a cavity and a vessel.

9. A method of claim 2, in which said occlusion is Chronic Total Occlusion (CTO).

10. A method of claim 9, in which said pulses of energy are defined by the following parameters:

duration not more then 5000 nanoseconds, pulse rise time less than 50 nanoseconds, pulse energy 0.01-0.3 Joule, the pulse amplitude which is sufficient for creation of stable discharge breakdown between two electrodes on the distal end of the probe'"'"'s head, e.g. 3-7 kV and amount of pulses 50-600.

11. A method of claim 1, in which said displacement of the wire guide is according to Monorail®

principle.

12. A system for assisting a wire guide to cross an duct in a mammalian body when the duct is obstructed by an occlusion, said system being suitable to at least partially to disrupt the occlusion by supplying pulses of energy to the occlusion, said system comprising:

an auxiliary probe insertable in the duct, said auxiliary probe is configured with elongate body portion having a distal end and a proximal end, said probe having a working head fitted with a potential electrode and with a ground electrode, said working head is coupled to the distal end and said auxiliary probe having a lumen longitudinally extending through at least a fraction of the body portion and through the working head;

a control unit for generation and controlling pulses of energy to be supplied to electrodes of the working head;

a power cable for electrical connection the auxiliary probe to the control unit;

wherein the lumen is provided with at least one opening for introducing the wire guide therethrough to allow relative displacement between the wire guide and the auxiliary probe along the lumen,

and the body portion comprises a region, which is disposed adjacent the working head, said region having enhanced flexibility comparing to a reminder of the body portion.

13. A system of claim 12, in which said auxiliary probe is provided with a miniature coaxial cable having an inner electrode and a shield electrode, said coaxial cable being received within a lumen extending along the body portion between the proximal end thereof and the region having enhanced flexibility.

14. A system of claim 12, in which said control unit is capable to supply to pulses defined by the following parameters:

duration not more then 5000 nanoseconds, pulse rise time less than 50 nanoseconds, pulse energy 0.01-1.0 Joule, pulse amplitude 3-15 kV.

15. A system of claim 12, in which said coupler is provided with a male portion associated with the probe and with a female portion associated with the power cable.

16. A system of claim 13, in which said power cable is a high voltage coaxial cable having a core electrode and a shield electrode, wherein the core electrode is electrically connected with the inner electrode of the microcable and the shield electrode of the power cable is electrically connected with the shield electrode of the microcable.

17. A system of claim 16, in which the inner electrode of the miniature coaxial cable is electrically connected with the potential electrode of the working head while the shield electrode of the microcable is electrically connected with the ground electrode of the working head.

18. A system of claim 17, in which the potential electrode and the ground electrode of the working head are configured as respective outer and inner cylindrical bushing.

19. A system of claim 18, in which a distal end of the inner bushing is not flush with a distal end of the outer bushing.

20. A system of claim 19, in which the distal end of the inner bushing is buried within the working head with respect to the distal end of the outer bushing.

21. A system of claim 13, in which the auxiliary probe is provided with an outside cover and with at least one reinforcing element affixed to an inwardly facing surface of the outside cover.

22. A system of claim 13, in which the lumen for receiving the wire guide comprises a plastic tube and the lumen for receiving the microcable comprises a stainless steel coil.

23. A system of claim 13, in which the lumen for receiving the wire guide and the lumen for receiving the microcable comprises a stainless steel coil.

24. A system of claim 23, in which the shield electrode of the miniature coaxial cable is electrically connected to the lumen for receiving the wire guide.

25. A system of claim 24, in which the auxiliary probe is provided with an additional grounding electrode, which is electrically connected with the shield electrode of the power cable and to the lumen for receiving the wire guide.

26. A system of claim 25, in which the auxiliary probe is provided with an intermediate member for coupling between region of enhanced flexibility and reminder portion of the auxiliary probe.

27. A system of claim 26, in which the intermediate member is configured as a muff made of polyurethane.