System and method for optogenetic therapy

• US 10,022,553 B2
• Filed: 07/31/2014
• Issued: 07/17/2018
• Est. Priority Date: 11/21/2012
• Status: Active Grant

• Current Assignee: Circuit Therapeutics, Inc.
• Original Assignee: Circuit Therapeutics, Inc.
• Inventors: Lundmark, David C., Moll, Fred, Arrow, Alexander K.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US14/449,094
• Publication Number:
  US 20160045765A1
• Time in Patent Office: 1,447 Days
• Field of Search: 604506
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61K 38/16 Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof enzyme inhibitors A61K38/005
• CPC Class Codes: A61K 38/164 from bacteria
• CPC Class Codes: A61K 38/168 from plants
• CPC Class Codes: A61K 38/177 Receptors; Cell surface antigens; Cell surface determinants
• CPC Class Codes: A61K 41/00 Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
• CPC Class Codes: A61K 41/0057 Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 48/0075 characterised by an aspect of the delivery route, e.g. oral, subcutaneous
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 : adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 2005/0612 : using probes penetrating tissue; interstitial probes
• CPC Class Codes: A61N 2005/0626 : Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 2005/0627 : Dose monitoring systems and methods
• CPC Class Codes: A61N 2005/063 : comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 2005/0631 : using crystals
• CPC Class Codes: A61N 2005/0643 : Applicators, probes irradiating specific body areas in close proximity
• CPC Class Codes: A61N 2005/0651 : Diodes
• CPC Class Codes: A61N 2005/0653 : Organic light emitting diodes
• CPC Class Codes: A61N 2005/0665 : Reflectors
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/0622 : Optical stimulation for exciting neural tissue
• CPC Class Codes: A61N 5/067 : using laser light
• CPC Class Codes: A61P 9/12 : Antihypertensives

Abstract

Configurations are described for utilizing light-activated proteins within cell membranes and subcellular regions to assist with medical treatment paradigms, such as hypertension treatment via anatomically specific and temporally precise modulation of renal plexus activity. The invention provides for proteins, nucleic acids, vectors and methods for genetically targeted expression of light-sensitive proteins to specific cells or defined cell populations. In particular the invention provides systems, devices, and methods for millisecond-timescale temporal control of certain cell activities using moderate light intensities, such as the generation or inhibition of electrical spikes in nerve cells and other excitable cells.

Claims

1. A method for injecting a targeted tissue structure, comprising:

a. selecting the targeted tissue structure to be injected;

b. providing an elongate flexible injection member having a surface biased to assume an arcuate geometric configuration when released, the injection member comprising an array of injection needles fixed relative to the surface and being configured to assume a substantially straight geometric configuration based upon an input from an operator manipulating a remote actuator that is operatively coupled to the elongate flexible injection member;

c. causing the elongate flexible injection member to assume the substantially straight configuration based upon an input from the operator;

d. navigating the elongate flexible injection member into a position relative to the targeted tissue structure such that upon release of the input, the flexible injection member will be biased to return to the arcuate geometric configuration, and in reconfiguring toward the arcuate configuration, portions of the elongate flexible member will advance a plurality of the injection needles into the targeted tissue structure and remain biased to stay advanced therein until a further input causes the elongate flexible injection member to re-assume the substantially straight configuration;

e. releasing the input to advance the plurality of the injection needles into the targeted tissue structure; and

f. injecting the targeted tissue structure using the plurality of needles advanced into the targeted tissue structure.

2. The method of claim 1, wherein selecting the targeted tissue structure to be injected comprises imaging the target tissue using a modality selected from the group consisting of:

radiography, fluoroscopy, ultrasound, magnetic resonance imaging, computed tomography imaging, and endoscopy.

3. The method of claim 1, wherein the arcuate configuration comprises a substantially constant radius of curvature.

4. The method of claim 1, wherein the arcuate configuration comprises an irregularly arcuate geometric configuration.

5. The method of claim 1, wherein the elongate flexible injection member comprises a bending spine member configured to urge the elongate flexible injection member into the arcuate configuration when unloaded.

6. The method of claim 5, wherein the bending spine member comprises a shape-memory superalloy.

7. The method of claim 5, wherein the elongate flexible injection member further comprises a mechanical straightening bladder which may be pressurized based upon the input from the operator to overcome loads applied by the bending spine member and urge the elongate flexible injection member into the substantially straight geometric configuration, and wherein causing the elongate flexible injection member to assume the substantially straight configuration comprises increasing the pressure within the mechanical straightening bladder.

8. The method of claim 7, wherein the remote actuator comprises a straightening pressure reservoir pressurized by the operator, the straightening pressure reservoir fluidly coupled to the mechanical straightening bladder by a fluid conduit, and wherein increasing the pressure within the mechanical straightening bladder comprises increasing the pressure within the straightening pressure reservoir.

9. The method of claim 1, wherein the elongate flexible injection member has a substantially rectangular form when viewed in the substantially straight configuration.

10. The method of claim 1, wherein the arcuate geometric configuration comprises a circular shape.

11. The method of claim 1, wherein the arcuate geometric configuration comprises an at least partially helical shape.

12. The method of claim 1, wherein injecting the targeted tissue structure comprises increasing pressure within an injection fluid reservoir fluidly coupled to the array of injection needles.

13. The method of claim 1, wherein tips of the array of injection needles are coplanar when the elongate flexible injection member is in the substantially straight configuration.

14. The method of claim 1, further comprising movably coupling the elongate flexible injection member through a lumen defined through an elongate delivery conduit so that the elongate flexible injection member may be delivered atraumatically.

15. The method of claim 14, wherein the elongate delivery conduit comprises a catheter.

16. The method of claim 15, wherein the catheter is a remotely steerable catheter comprising one or more steering elements which may be proximally manipulated to cause controlled bending in the catheter, the method further comprising manipulating the one of more steering elements to navigate the catheter, thereby navigating the elongate flexible injection member.

17. The method of claim 14, further comprising an elongate delivery member coupled to the delivery conduit and configured to facilitate creation of relative motion between the elongate flexible injection member and the elongate delivery conduit during placement of the elongate flexible injection member, the method further comprising moving the elongate delivery member relative to the delivery conduit to at least partially remove the elongate flexible injection member from the delivery conduit.

18. The method of claim 17, wherein the elongate delivery member comprises a flexible shaft configured to bend in compliance with bending of the elongate delivery conduit.

19. The method of claim 18, wherein the flexible shaft comprises a polymeric material.