Methods, systems, and apparatuses for delivery of electrolysis products

• US 10,154,873 B2
• Filed: 11/14/2014
• Issued: 12/18/2018
• Est. Priority Date: 11/14/2013
• Status: Active Grant

• Current Assignee: RM2 Technology LLC
• Original Assignee: RM2 Technology LLC
• Inventors: Rubinsky, Boris, Mikus, Paul, Rubinsky, Liel
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US15/036,386
• Publication Number:
  US 20160287867A1
• Time in Patent Office: 1,495 Days
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00464 Subcutaneous fat, e.g. liposuction, lipolysis
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00892 Voltage
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/0293 : using an instrument interstitially inserted into the body, e.g. needle
• CPC Class Codes: A61B 2018/1266 : with DC current output
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61M 1/916 : specially adapted for deep wounds
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/054 : with electrotherapy
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61N 1/0502 : Skin piercing electrodes
• CPC Class Codes: A61N 1/205 : for promoting a biological process
• CPC Class Codes: A61N 1/32 : alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/325 : for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: C25B 1/26 : Chlorine; Compounds thereof by simultaneous production of alkali metal hydroxides and chlorine, oxyacids or salts of chlorine C25B1/34
• CPC Class Codes: C25B 11/04 : characterised by the material
• CPC Class Codes: C25B 9/17 : Cells comprising dimensionally-stable non-movable electrodes; Assemblies of constructional parts thereof

Abstract

Example apparatuses and systems are disclosed for providing controlled delivery of electrolysis products to a site which may be used the treatment of infection and ablation of undesirable cells and tissue. A system disclosed may include a power supply, two electrodes, an aqueous matrix that may close the electric circuit between the electrodes at the treated site, and a controller. The controller may control the electrical circuit to induce a direct current through the electrodes and an aqueous matrix to produce electrolysis products. The duration and magnitude of the charge applied may determine the dose of the products applied to the treatment site. The composition of the electrodes and the aqueous matrix may be chosen to produce desired products. An apparatus is disclosed that may be in the form of a pad for applying to a wound. An apparatus is disclosed that may be used for treating internal tissue.

Claims

1. An apparatus for delivery of electrolysis products to a site, the apparatus comprising:

a first electrode positioned to face a surface external to the apparatus and proximate the site;

a second electrode positioned distal from the surface external to the apparatus;

an aqueous matrix in contact with at least a first surface and a second surface of the first electrode and configured to be in contact with the surface external to the apparatus, the matrix positioned between the first electrode and the surface external to the apparatus such that the first electrode does not contact the surface external to the apparatus when the apparatus is in use, wherein the aqueous matrix includes a saline solution;

wherein at least one of the first electrode and second electrode comprises a material and the aqueous matrix has a pH, the material and the pH selected to produce the electrolysis products when a current is passed through the aqueous matrix using at least one of the first electrode and second electrode; and

wherein the and aqueous matrix and at least one of the first electrode and second electrode are packaged for placement proximate the site.

2. The apparatus of claim 1, wherein the aqueous matrix comprises a gel pad.

3. The apparatus of claim 1, wherein the aqueous matrix has a pH between and including 3 and 5.

4. The apparatus of claim 3, wherein the aqueous matrix has a pH of 4.

5. The apparatus of claim 1, further comprising a power supply coupled to at least one of the first electrode, and second electrode.

6. The apparatus of claim 5, wherein the power supply, at least one of the first electrode and second electrode, and aqueous matrix are included in a circuit.

7. The apparatus of claim 1, wherein the electrolysis products are produced when the current is passed through the aqueous matrix using the first and second electrodes.

8. The apparatus of claim 1, wherein at least one of the first electrode and second electrode is configured to receive an electronic signal from a controller, wherein the electronic signal is configured for control of at least one of the current or a voltage.

9. The apparatus of claim 8, wherein the controller is located remotely from at least one of the first electrode and second electrode.

10. The apparatus of claim 8, wherein the controller is packaged with at least one of the first electrode and second electrode.

11. The apparatus of claim 1, wherein the site comprises a tissue, and wherein the aqueous matrix and at least one of the first electrode and second electrode are packaged in a pad configured to adhere to the tissue.

12. The apparatus of claim 1, wherein the site comprises tissue to be ablated, and wherein the aqueous matrix and at least one of the first electrode and second electrode are packaged for placement on an implantable device.

13. The apparatus of claim 1, wherein the electrolysis products comprise hypochlorous acid and wherein the material comprises iridium oxide or rubidium oxide.

14. The apparatus of claim 1, wherein at least one of the electrode and second electrode is a needle electrode.

15. The apparatus of claim 1, wherein at least one of the first electrode and second electrode is included in a catheter.

16. The apparatus of claim 1, wherein at least one of the first electrode and second electrode is a surface electrode.

17. The apparatus of claim 1, wherein:

the first electrode comprises an anode;

the second electrode comprises a cathode.

18. The apparatus of claim 1, wherein the site comprises a tissue, wherein the apparatus comprises a power supply coupled to at least one of the first electrode and second electrode, and wherein the power supply, at least one of the first electrode and second electrode, and the tissue are included in a circuit.

19. A system for delivery of electrolysis products to a site, the system comprising:

a device positioned proximate the site, wherein the device comprises;

a first electrode positioned to face a surface external to the device and proximate the site;

a second electrode positioned distal from the surface external to the device; and

an aqueous matrix, the aqueous matrix in contact with at least a first surface and a second surface of the first electrode and in contact with the surface external to the device, the matrix positioned between the first electrode and the surface external to the device such that the first electrode does not contact the surface external to the device;

a power supply;

a controller, in electronic communication with at least one of the first electrode and second electrode; and

wherein the controller is programmed to provide an electronic signal to produce the electrolysis products at least one of the first electrode and second electrode, wherein the electronic signal is indicative of a dose of the electrolysis products.

20. The system of claim 19, wherein the electronic signal from the controller is further indicative of a time of delivery of the electrolysis products.

21. The system of claim 19, further comprising a negative pressure source positioned to remove fluids from proximate the device.

22. The system of claim 19, further comprising a sensor configured to measure pH near at least one of the first electrode and second electrode.

23. The system of claim 19, wherein the controller is configured to wirelessly provide the electronic signal to at least one of the first electrode and second electrode.

24. The system of claim 19, wherein the site comprises a wound, and wherein the electrolysis products are configured to sterilize the wound, the system further comprising a negative pressure device, irrigation system, fluid absorbing material, charged polymers, or combinations thereof.

25. The system of claim 19, wherein the electronic signal comprises a waveform, wherein the waveform is indicative of a timing and dose of the electrolysis products to the site.

26. The system of claim 19, wherein at least one of the first electrode and second electrode is a needle electrode.

27. The system of claim 19, wherein at least one of the first electrode and second electrode is a surface pad electrode.

28. The system of claim 19, wherein the device includes a catheter.

29. The system of claim 19, wherein the device is affixed to an implantable device comprising a pacemaker or joint implant.

30. The system of claim 19, wherein:

the first electrode comprises an anode;

the second electrode comprises a cathode.