Drug Device Electroporation System
Active Energy Facilitated Drug Delivery platform for delivering therapeutics to biological tissue through electrical conductivity. This delivery method is comprised of an elastic alloy to encase a balloon or drug deposition, where the alloy acts to emit an electric field in aiding and actively allowing the pharmaceutical agent to have enhanced permeation, binding and internalization to cells and the biological matrix. A therapeutic agent is deposited onto a balloon to embody the drug deposition, reservoir whereby the electrical field facilitates the active transfer of a pharmaceutical agent to the target tissue is described.
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The narrowing of the blood vessels is commonly referred to as stenosis or restenosis that can occur after injury to the vessel wall, in example atherosclerotic injury, calcified plaque injury, or revascularization. Surgical procedures such as angioplasty, vascular grafting and transplantation can result in inflammation and/or overcompensation of tissue and result in restenosis. Percutaneous trans-luminal vascular intervention by either angioplasty balloons, atherectomy devices or stents is a frequent cause for restenosis.
Restenosis is mediated by overgrowth of vascular smooth muscle cells and the many smooth muscle cell intermediates as well as fibroblasts and other structural support cells and material in response to injury. This overgrowth is commonly referred to as hyperplasia or excessive neo-intimal growth occluding, or obstructing the flow of blood through the blood vessel. This type of vascular disease gives rise to clinical indications involving organ dysfunctions such as hypertension, cardiac failure, limb loss and chronic pain. Much effort has been made to overcome vascular disease without causing harmful secondary effects from potential and existing treatments.
New therapeutic modalities are needed to avoid unwanted long term complications of standard percutaneous therapies. The current invention has the potential to bypass these shortcomings by efficiently delivering therapeutic agents to the artery without resorting to procedures that result in acute tissue damage or chronic irritation.
Drug Coated Balloons (DCB)s were developed in an effort to outperform stenting with the use of anti-stenosis drugs. Cell senescence drugs are used to coat angioplasty balloons and are inflated to deliver drug to localized stenosis lesions in the artery. The senescence of cells at the site of angioplasty presumably prevents neo-intimal growth while allowing the endothelium to return, thereby shielding the smooth muscles from contents in the blood stream that cause inflammation and scar tissue growth. DCBs are still ineffective in the ability to distribute drugs in efficacious concentrations and/or evenly within vessel wall in some anatomical locations. In addition, clinical overexpansion of DCBs are useful to drive the drug into the tissue, but this also causes tissue trauma which can promote a vessel diameter late loss, which is particularly harmful to small vessels, such as the coronaries or leg arteries below the knee.
In the current invention, using an added electrical component known as electroporation to a DCB to enhance the drug binding efficiency to its target is the principal method for overcoming the problems of both DCBs and stents. Electroporation is a method commonly used in Cell Biology as a method of introducing a foreign material (i.e. DNA, virus, chemical compounds, etc. . . . ) into the intercellular or cytosol space. The mode of electroporation operates by sending an electrical or high voltage, low current electromagnetic pulse across the membrane of the cells or tissue whereby momentarily destabilizing the cellular matrix/membrane and exposing both inter and intracellular channels to any molecules that would otherwise require active transport into the cell or matrix.
In accordance with the purposes of the disclosed materials, compounds, compositions, and methods, as embodied and broadly described herein, the disclosed subject matter, in one aspect, relates to compounds and compositions and methods for preparing and using such compounds and compositions. In another aspect, disclosed herein is the use of pharmaceuticals in combination with a modified angioplasty device that will aid the drug delivery into the target location with an electrical pulse commonly known as electroporation.
The advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the aspects described below. The advantages described below will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive.
Claims
1. A balloon catheter In which the balloon is messed within an elastic conducting alloy cage, wherein the cage is bonded at both distal and proximal balloon ends with an electrical connection at the proximal taper to conductive elements along the body of the catheter to a proximal connection to an electrical power source, and wherein the working length of the balloon and optionally the cage section are coated with materials comprising a therapeutic bio-active agent and optional excipients.
2. The device of claim 1 in which the elastic conducting alloy is nitinol.
3. The device of claim 1 whereby the electrical conducting field can be provided by en energy generator where one polarity is delivered to the emitter while the opposing polarity is grounded to the surface or body of the Intended target.
4. The device of claim 2 whereby the energy field is primarily voltage driven with low current.
5. The device of claim 1 whereby the power supply delivers a square wave with a voltage range of 0.001 kV to 5 kV.
6. The device of claim in which the bio-active agents will comprise the broad classes of anti-neoplastic agents, mTOR inhibitors, taxanes, neurotoxins, steroids, and non-steroidal anti-inflammatory agents.
7. The device of claim 4, wherein the coating is also comprised of one or more of an organic excipient such as a polymer or oligomer with hydrophilic character (e.g. PEG), a citrate ester, an adipate ester, urea or substituted urea, a surfactant such as sorbitan mono oleate or block co-polymers of PEO and PPO.
8. The device of claim 1, wherein the conductive elements along the catheter body are shielded by dielectric material(s) so that the conductive energy is delivered to the emitter end in compliment with the pharmaceutical agent.
9. The device of claim 1, wherein energy emission can be delivered through any exposed conductive material with leads connected to the energy generator whereby anode and cathode can be bridged to form an energy field.
10. The device of claim 7 whereby a coating with a therapeutic as described in claims 2,4,5 is used in conjunction.
11. A method of treating stenosis or preventing restenosis using a balloon catheter in which the balloon is incased within an elastic conducting alloy cage, wherein the cage is bonded at both distal and proximal balloon ends with an electrical connection at the proximal taper to conductive elements along the body of the catheter to a proximal connection to an electrical power source, and wherein the working length of the balloon and optionally the cage section are coated with materials comprising a therapeutic bio-active agent and optional excipients, and wherein an electric power source is applied to the device while the balloon is inflated in the treatment zone.
12. The method of claim 9, comprising the composition in combination with a method for drug delivery by electro-poration, electromechanical or electric pulse for enhancing pharmaceutical or genetic material uptake and transfer.
13. The method of claim 10, wherein the subject is undergoing or has undergone a vascular procedure.
14. The method of claim 10, wherein the vascular procedure comprises balloon angioplasty.
15. The method of claim 10, wherein the vascular procedure comprises vascular stenting.
16. The method of claim 10, wherein the vascular procedure comprises revascularisation.
17. The method of claim 10, wherein the vascular procedure comprises arterial by-pass graft.
18. The method of claim 10, wherein, the vascular procedure comprises a Percutaneous Transluminal Vascular intervention (PTVI).
19. The method of claim 10, wherein the vascular procedure comprises intravascular device implantation.
20. The method of claim 10, wherein the vascular procedure comprises arterial denervation.
21. The method of claim 10, further comprising determining the degree of restenosis, arterial hyperplasia after administering the composition.
22. The method of claim 10, comprising the composition in combination with implantable devices.
23. The method of claim 10, comprising the composition In combination with particulate capture devices.
Type: Application
Filed: Apr 4, 2015
Publication Date: Jan 3, 2019
Patent Grant number: 10918840
Applicant: Hydra Vascular LLC (Scottsdale, AZ)
Inventor: Douglas Phat Hatran (Milpitas, CA)
Application Number: 14/678,966