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Chemical Renal Denervation Catheter

Abstract: The invention relates to a catheter, more specifically to an endovascular catheter (100) for drug delivery. The catheter (100) mainly comprises a handle (103, 203), a catheter shaft (102), an inner shaft (106, 206), a fluid injection shaft (114, 214), a capsule (108) and a drug delivery part (105, 205). The drug delivery part (105, 205) is either a specific structure (105) with perforations (109) on its periphery or an expandable balloon (205) with a double wall on its periphery wherein the outer wall has perforations (207). The perforations (109, 207) are used to perfuse the drug or drug containing solution on the target lesion. Reference Figure 1

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Patent Information

Application #
Filing Date
18 December 2021
Publication Number
25/2023
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
Parent Application

Applicants

Sahajanand Medical Technologies Limited
Sahajanand Estate, Wakhariawadi, Near Dabholi Char Rasta, Ved Road, Surat – 395 004, Gujarat, India

Inventors

1. Abhijeet Singhvi
House # 128/1, Opp. State Bank Of India, Bhilad, Valsad, Gujarat-396105, India
2. Ankur Jaykumar Raval
B-302, Kelly Residency, Opposite La Victoria, Besides Matangi Party Plot, Near Galaxy Circle, Pal Road, Pal, Surat, Gujarat-394510, India
3. Chhaya Babubhai Engineer
D-303, Millennium Residency, Near Ayodhyanagri, Anand Mahal Road, Surat, Gujarat-395009, India

Specification

DESC:TECHNICAL FIELD
[0001] The present invention relates, generally, to medical devices for assisting medical procedures inside or outside a lumen such as blood vessels or ducts to medical devices and, particularly but not exclusively, thereof to treat resistant hypertension by altering the behavior of nerves situated in renal artery.
BACKGROUND
[0002] Resistant hypertension refers to a condition of high blood pressure which is not responding to medication. Renal denervation (RDN) is a minimally invasive procedure to treat resistant hypertension. This process causes a reduction in the nerve activity, which decreases blood pressure. The renal nerves are deeply embedded in the renal artery wall and only a small portion of these nerves is exposed to the blood flow. Majority of these nerves are situated in the adventitia (outer) layer of the artery i.e. the renal nerves are closer to outer peripheral wall of the renal artery and up to some extent exposed on the outer wall as well. Hence, in different treatment approaches, the main objective is to reach to the renal nerves and deliver the energy, either from inside the artery or from outside the artery.
[0003] In the process, a catheter plays vital role to reach the target lesion. A catheter is a medical device of hollow thin-walled tubular structure that is inserted in a lumen or duct of a human or animal body through a natural access site, or a temporary artificial access site created by a physician. The access site provides access to the physician to insert the catheter and perform an interventional procedure or treat a disease.
[0004] During the interventional procedure, operator uses a specifically designed catheter to access the target lesion in the renal artery either endo-vascularly or peri-vascularly. Once the catheter reaches the target lesion, a distal part of the catheter that is specifically designed to transfer one or more particular type of energy(s) to the target lesion for a specified time, releases or transfers the energy type(s). Some of the well-known energy types are radiofrequency, thermal, electric, chemical/pharmaceutical, cryogenic etc. These energies can be released or transferred through electrodes, balloons, stents or microneedles.
[0005] Renal denervation procedures based on transferring the chemical energy to the target lesion involve use of chemicals that are known as neurotoxins, venom, neuromodulators, neurotransmitters, channel blockers etc. Alcohols, Phenols and compounds like Botulinum Oxide are very commonly used. In addition, pharmaceutical agents or drugs can also be administered through renal denervation procedure. Some examples are Rapamycin, Everolimus etc.
[0006] Conventional catheters are either designed for balloon expandable devices or for self-expandable devices whose main objective was to be a carrier to transport the device to the target lesion and deploy it. However, with time, catheters were designed with additional functionalities to replace some of the tasks being performed by deployable medical devices by the conventional catheter. In addition, deploying a medical device permanently in an artery may cause adverse aftereffects over a long period of time. Hence, there is a need for a functional catheter for renal denervation procedure that addresses or overcomes one or more aforementioned problems.
[0007] Hence, it is an objective of the invention to provide an effective catheter system for chemical-drug-based renal denervation catheter that can administer chemical or pharmaceutical agent or a combination at the target lesion either on the internal wall of the renal artery or inside the artery wall to treat Resistant hypertension.
SUMMARY OF THE INVENTION
[0008] An aspect of the present invention is to address at least the abovementioned problems and/or disadvantages and to provide at least the advantages described below.
[0009] According to an aspect of the invention, an endovascular catheter for drug delivery, comprises a hollow inner shaft, a hollow fluid injection shaft, a hollow catheter shaft, a handle, a capsule, and a drug delivery part. The inner shaft connected to a guidewire port and aids as a guidewire passage. The hollow fluid injection shaft encircles and extends along the inner shaft, wherein the fluid injection shaft coupled to a drug delivery part at a distal end and connected to a fluid injection port at a proximal end such that allows a fluid to flow between an outer surface of the inner shaft and an inner surface of the fluid injection shaft to the drug delivery part. The hollow catheter shaft encircles and extends along the fluid injection shaft, wherein the catheter shaft connected to a capsule at a distal end and the capsule houses the drug delivery part therein, and a proximal end of the catheter shaft is connected to the handle through a rotary knob and the rotary knob moves the catheter shaft along the longitudinal axis to cover and uncover the drug delivery part.
[0010] Other aspects and advantages of the invention will become apparent from the following description, taken in conjunction with the accompanying drawing, illustrating by way of example the principles of the invention.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[0011] The above and other aspects, features, and advantages of certain exemplary embodiments of the present invention will be more apparent from the following description taken in conjunction with the accompanying drawings in which:
The accompanying drawings incorporated herein in conjunction with detailed description serve to illustrate several aspects and principles of the present invention clearly. In the drawings:
Figure 1 illustrates a detailed view of a renal denervation catheter for chemical/drug delivery and magnified and detailed views of distal end (A) and proximal end (B) of the catheter, according to an embodiment of the present invention;
Figure 1A and Figure 1B illustrate magnified and detailed views of distal end of a renal denervation catheter for chemical/drug delivery, according to yet another embodiment of the present invention;
Figure 1C illustrates a detailed view of distal end of a renal denervation catheter for chemical/drug delivery and Figure 1D illustrates a magnified and detailed views of a drug delivery element (C) of the distal end, according to an embodiment of the present invention;
Figure 2 illustrates a detailed view of a renal denervation catheter and a magnified and detailed view of an expandable balloon (A) with regularly spaced perforations, according to another embodiment of the present invention; and
Figure 3 illustrates a detailed view of a renal denervation catheter and a magnified and detailed view of an expandable balloon (A) with irregularly spaced perforations, according to yet another embodiment of the present invention.
Persons skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may have not been drawn to scale. For example, the dimensions of some of the elements in the figure may be exaggerated relative to other elements to help to improve understanding of various exemplary embodiments of the present disclosure.
Throughout the drawings, it should be noted that like reference numbers are used to depict the same or similar elements, features, and structures.
DESCRIPTION OF THE INVENTION
[0012] The following description with reference to the accompanying drawings is provided to assist in a comprehensive understanding of exemplary embodiments of the invention as defined by the claims and their equivalents. It includes various specific details to assist in that understanding but these are to be regarded as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
[0013] Present disclosure provides an embodiment of a device, specifically an endovascular catheter, that is designed to deliver a drug/chemical to a target lesion in an artery. The catheter includes a handle, a hollow catheter shaft, a fluid injection shaft, an inner shaft, drug delivery part and a capsule. The hollow catheter shaft is connected to the handle through a rotary knob which allows to move the catheter shaft along the longitudinal axis with respect to the handle. The distal portion of the hollow catheter shaft is designed in such a way so that it can house a structure or drug delivery part near its one end distal from the handle. The distal end of the hollow catheter shaft is a capsule. The drug delivery part is designed to deliver a chemical/drug while the distal end is near the target lesion. The inner shaft, concentric to the catheter shaft, extends from the handle till a tip that is situated at the end of the catheter. The inner shaft also extends through the drug delivery part. The fluid injection shaft is present between the catheter shaft and the inner shaft. The fluid injection shaft is concentric to the catheter shaft and the inner shaft. The fluid injection shaft is connected to a fluid injection port situated at the proximal end of the catheter. The other end of the fluid injection shaft is connected to the drug delivery part. The inner shaft and the fluid injection shaft are fixed to the handle. Only the catheter shaft is movable with respect to the handle and in some embodiments, and the catheter shaft is optional.
[0014] According to an embodiment of the present disclosure, the drug delivery part is a hollow helix (a hollow tube in helical shape) that is attached to the fluid injection shaft. The hollow helix can be crimped to store inside the capsule at the distal end of the catheter. The hollow helix contains one or more perforations on its periphery, either at regular or at irregular distance, while the distal end of the hollow helix is sealed and free from tip to provide additional flexibility. On arrival of the capsule at the target lesion, the distal end of the catheter shaft is retracted towards the handle that exposes the hollow helix. The crimped hollow helix expands and comes in contact with the artery wall. The expansion of the crimped hollow helix can be due to nature of the material of construction for example use of shape memory alloys such as Nitinol. Also, the expansion of the crimped hollow helix can be caused by an external force such as balloon expansion. The perforations in the hollow helix are in fluid communication with the fluid injection shaft that is extended till the fluid injection port on the handle. The fluid injection port can be connected with a chemical/drug supply line.
[0015] In another embodiment, the distal end of the hollow helix is connected to the tip. This provides better control and maneuverability.
[0016] In another embodiment, the hollow helix is not expandable in nature. The hollow helix is instead wrapped around the inner shaft where one end of the hollow helix is attached to the fluid injection shaft and the other end is optionally sealed to the tip.
[0017] In another embodiment, the hollow helix comprises multiple helical structures intertwined among themselves and wrapped around the inner shaft where one ends of the helical structures are attached to the fluid injection shaft and the other ends are optionally sealed to the tip.
[0018] In another embodiment, the material of construction of the hollow helix is expandable in nature and the hollow helix is wrapped around the inner shaft in deflated state. After the hollow helix reaches the target lesion, an inflation fluid is injected through the fluid injection port that reaches the hollow helix through the fluid injection shaft and inflates the hollow helix due to injecting the inflation at a pressure higher than the atmospheric pressure.
[0019] The fluid injection is performed at a pressure higher than the atmospheric pressure for ensuring perfusion of chemical/drug through perforations situated on periphery of the hollow helix.
[0020] On supplying the chemical/drug under pressure, the chemical/drug perfuses through perforations and comes in contact with the wall of the renal artery and starts absorbing in the wall. The absorbed chemical/drug travels through the wall and comes in contact with the renal nerves and reduces their activity.
[0021] In another embodiment, there can be more than one chemical/drug in the fluid injection to treat the effects generated due to action of nerve-specific chemical/drug.
[0022] In another embodiment, the chemical/drug is suppled using a carrier fluid that can be selected from polymeric, non-polymeric, saline, biodegradable polymeric liquid or a mixture thereof. By controlling different structural properties and ratio of the carrier fluids; the rate of release of the chemical/drug can be controlled and a prolonged drug delivery is achieved.
[0023] According to yet another embodiment, the drug delivery part is an expandable balloon where the balloon is connected to the fluid injection shaft and the balloon is expanded using the inflation fluid by injecting it through the fluid injection port. On the peripheral side, the expandable balloon has an inner wall and an outer wall. Both the walls create a cavity in between. The cavity is used to store a chemical/drug. The inner wall is sealed to the tip and ensures that the internal side of the balloon is in fluid communication with the fluid injection shaft only. The outer wall has perforations and on expansion of the balloon the chemical/drug oozes through the perforations. The perforations on the outer wall are arranged either in a regular manner or arranged irregularly.
[0024] A chemical/drug can be supplied to the expandable balloon through the inflation pump. The supply is performed at a pressure higher than the atmospheric pressure for ensuring perfusion of chemical/drug through regularly spaced or irregularly spaced perforations on outer wall of the expandable balloon.
[0025] On supplying the chemical/drug under pressure, the chemical/drug perfuses through perforations and comes in contact with the wall of the renal artery and starts absorbing in the wall. The absorbed chemical/drug travels through the wall and comes in contact with the renal nerves and reduces their activity.
[0026] In another embodiment, there can be more than one chemical/drug in the inflation liquid to treat the effects generated due to action of nerve-specific chemical/drug.
[0027] In another embodiment, drug/chemical comprises drug-polymer encapsulates where the encapsulate size ranges from 1nm to 10000 µm.
[0028] The above aspects are further illustrated in the figures and described in the corresponding description below. It should be noted that the description and figures merely illustrate principles of the present invention. Therefore, various arrangements that encompass the principles of the present invention, although not explicitly described or shown herein, may be devised from the description, and are included within its scope.
[0029] According to an embodiment of the present invention, the endovascular catheter (100), as illustrated in Figure 1, shows an embodiment where the endovascular catheter (100) includes a handle (103), a catheter shaft (102), a capsule (108), a fluid injection port (104), a fluid injection shaft (114), a drug delivery part (105), a rotary knob (110) and a guidewire port (107). The catheter shaft (102), the fluid injection shaft (114) and an inner shaft (106) are hollow and concentrically arranged in such a way so that the inner shaft (106) is innermost shaft and the catheter shaft (102) is outermost shaft. The catheter shaft (102) is connected to the handle (103) through a rotary knob (110) at the proximal end and coupled with the capsule at the distal end. The rotary knob allows to move the catheter shaft (102) along the longitudinal axis with respect to the handle (103). The movement mechanism can be selected from a screw-based mechanism, rack and pinion-based mechanism, tether-based mechanism, push-pull based mechanism or a combination thereof. The capsule (108) houses a drug delivery part (105). The inner shaft (106) extends from the guidewire port (107) at the handle (103) till a tip (112, 212) that is situated at the end of the catheter (100). The fluid injection shaft (114) extends from the fluid injection port (104) situated at the handle (103) till the proximal end of the drug delivery part (105). The drug delivery part (105) contains regularly spaced or irregularly spaced perforations (109), while the distal end of the drug delivery part is sealed. Initially, the drug delivery part is compressed and housed inside the capsule. During the procedure, after the capsule part of the catheter reaches the target lesion, the operator actuates the rotary knob and the catheter shaft moves longitudinally. The drug delivery part exposes on movement of the catheter shaft and comes in contact or in proximation of the arterial wall. Following this, on injecting the pressurized inflation fluid, the inflation fluid passes through the fluid injection shaft and oozes from the perforation on the periphery of the drug delivery part.
[0030] As illustrated in Figure 1A, according to an embodiment of the present invention, the drug delivery part which can be a hollow helix (105) is made of a material that is self-expandable in nature. Hence, on moving the capsule (108) towards the handle (103) using the rotary knob (110), the hollow helix (105) expands and comes in contact of the arterial wall.
[0031] As illustrated in Figure 1B, according to an embodiment of the present invention, the hollow helix (105) is not expandable and only wrapped around the inner shaft. One end of the hollow helix is connected to the fluid injection shaft (114) and another end is sealed to the tip (112) in nature. The catheter shaft (102) can be optional in the present embodiment.
[0032] As illustrated in Figure 1C and Figure 1D, according to an embodiment of the present invention, the hollow helix (105) comprises multiple helical structures which are intertwined and wrapped around the inner shaft (106). One end of all the helical structures is connected to the fluid injection shaft (114) whereas the other ends are optionally connected to the tip (112). The hollow helix (105) is not expandable and only wrapped around the inner shaft. The catheter shaft (102) can be optionally used in the present embodiment.
[0033] As illustrated in Figure 2, according to an embodiment of the present invention, the drug delivery part is an expandable balloon (205) that has a plurality of perforations (207) arranged in a regular manner. One end of the expandable balloon (205) is connected to the fluid injection shaft (214) and the balloon is expanded using the inflation fluid by injecting it through the fluid injection port (204). The expandable balloon is mounted on an inner shaft (206). The inner shaft extends from a guidewire port (208) till a tip (212). The other end of the balloon (205) is sealed to the tip (212). The expandable balloon (205) on its periphery has two walls and a cavity formed therein stores at least a drug/chemical. The outer wall of the balloon has perforations and on expanding the balloon, the stored chemical/drug oozes through the perforations.
[0034] As illustrated in Figure 3, according to yet another embodiment of the present invention, the drug delivery part is an expandable balloon (205) that has a plurality of perforations (207) arranged in an irregular manner.
[0035] Referring Figures 1-3 illustrate a detailed view of a chemical renal denervation catheter, according to an embodiment of the present invention. The catheter may be placed inside the lumen of human or animal, such as an artery, vein, bile duct, urinary tract, alimentary tract, tracheobronchial tree, cerebral aqueduct, or genitourinary system. Specifically, the medical device may be used in femoral artery, superficial femoral artery, popliteal artery, tibial artery, genicular artery, cerebral artery, carotid artery, vertebral artery, subclavian artery, radial artery, brachial artery, axillary artery, coronary artery, peripheral artery, iliac artery, or neuro-arteries. For example, the renal denervation catheter may be used in chemical renal denervation procedure.
[0036] Further, the expandable balloon is made of a biodegradable or a non-biodegradable polymer. The hollow helix is made of a material selected from metal, non-metal, alloy, polymer, biodegradable, bioresorbable material or a combination of two or more thereof. For example, all deformable, biocompatible metal, metal alloy can be used and include but are not limited to Stainless steel, Cobalt alloys, pure Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, and Nitinol. In addition, based on the material selected for the hollow helix, the delivery mechanism can be a balloon catheter or a catheter for self-expandable or shape-memory alloy-based devices.
[0037] In addition, examples of polymers that can be used as the inflation liquid or the carrier fluid in accordance with the present subject matter include but are not limited to polymers of L-lactide, Glycolide or combinations of thereof, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, saline and copolymers and combinations thereof.
[0038] Further, examples of non-polymeric materials that can be used as the inflation liquid or the carrier fluid in accordance with the present subject matter include but are not limited to small molecular weight excipients, proteins, ionic surfactants, nonionic surfactants, zwitterionic surfactants, lipophilic surfactants, hydrophilic surfactants, amphiphilic surfactants, peptide chains and combinations thereof.
[0039] In addition, examples of chemical or drug that can be used in accordance with the present subject matter include but are not limited to anti-restenosis drugs, Neurolytic agents, Quaternary ammonium salts, Sodium Channel Blockers, Anesthetics, Conductive Fluids, Amino Acids, Amines, Calcium Channel Blockers, Diuretics, Heated fluids e.g. Saline, Hypotonic Fluids, Vasovasorum Constrictors, Neurotransmitter Chemicals, Venom, Sclerosant Agents, Anti-Nerve Growth Agents, Aminosteroids, Neurotoxins, Alcohols, 6-Hydroxydopamine, Acebutolol, Acetic Acid, Acetic Anhydride, Acetyl Chloride, Acetylcholine, Adenosine, Aflatoxins, Ambrisentan, Amiloride, Amiodarone, Amlodipine, Ammonia, Anti-Acetylcholinesterase, Anti-Dopamine Beta-Hydroxylase, Anti-Dopamine Beta-Hydroxylase Immunotoxin (DHIT), Anti-Dopamine Beta-Hydroxylase Saporin (DBH-SAP), Argon, Arsenic, Atenolol, Azitoxin, Benazepril, Benzocaine, Bepridil, Betanidine, Betaxolol, Bisoprolol, Bleomycin, Bosentan, Botulinum toxin, Bretylium Tosylate, BuLi, Bungarotoxin, Bupivacaine, Bupranolol hydrochloride, Butanol, Ca(OH)2, Caffeine, Calciceptin, Calcycludin, Capsaicin, Carbamazepine, Carbon Dioxide, Cardiac Glycoside, Caribodotoxin, Carteolol, Carteolol hydrochloride, Catopril, Cetylcholine, Cevacine, Cevadine, Chloroquine, Chlorotoxin, Clonidine, Conotoxin, Curare, Cymarins, Cytochalasin D, Debrisoquine, Decarbamoyl Saxitoxins, Dibucaine, Digitalis, Digitoxins, Digoxins, Diltiazem, Dimethyl Sulfoxide, Diprophylline, Disopyramide, Dobutamine hydrochloride, Domoic Acids, Dopamine hydrochloride, Doxazosin, Doxycycline, Enalapril, Enalaprilat, Encainide, Epinephrin, Esmolol, Ethanol, Ethanolamine Oleate, Ethyl Acetate, Ethyl Chloroformate, Ethyl Iodide, Ethyl Lactate, Ethyl Nitrate, Ethylene glycol, Everolimus, Felodipine, Fimolol, Flecainide, Fosinopril, Furosemide, Glutamate, Glycerin, Glycerol, Guanabenz, Guanacline, Guanadrel, Guanazodine, Guanethidine, Guanethidine Sulfates, Guanfacine, Guanidinium, Guanoclor, Guanoxabenz, Guanoxan, H2O2, Helium, Hexane, Hydriodic Acid, Hydrobromic Acid, Hydrochloric Acid, Hypertonic Saline, Indoramin, Isobutanol, Isopropanol, Isopropyl Acetate, Isopropyl Iodide, Isoquinoline, Isradipine, K2CO3, Ketanserin, KH, KOH, Labetalol, Lactic Acid, Laureth (Polidocanol), Leptocurare, Lidocaine, Lipiodol, Lisinopril, Losartan, Malonic Acid, Malonyl Chloride, Margatoxin, Maurotoxin, Mecamylamine, Methanol, Methyl Acetate, Methyldopa, Metildigoxin, Metirosine, Metoprolol, Metoprolol tartrate, Mexiletine, Minosteroids, Moexipril, Moricizine, Morrhuate Sodium, Moxonidine, Mycophenolic Acid, N-(2-Chloroethyl)-N-Ethyl-2-Bromobenzylamine (DSP4), Nadolol, NaH, NaHCO3, NaOEt, NaOH, NaSEt, Neosaxitoxins, NH4OH, Nicardipine, Nifedipine, Nimodipine, Nitric Acid, Nitric oxide, Nitrogen, Nitrous Acid, N-Methyl-(R)-Sarsolinol, Octopamine hydrochloride, Oleandrins, Ouabin, Oxalic Acid, Oxprenolol hydrochloride, Oxygen, Oxytetracycline, Pachycurare, Paclitaxel, Pargyline, Penbatolol, Peracetic Acid, Perchloric Acid, Phenol, Phentolamine, Pheoxybenzamine, Phosphoric Acid, Phtx3 (Phoneutria toxin), Pindolol, Polidocanol, Potassium Chloride, Povidone Iodine, Prazosin, Prazosin hydrochloride, Prazosin Plus Polythiazide, Procainamide, Propafenone, Propanol, Propranolol, Propranolol hydrochloride, Propyl Iodide, Proscillaridin, Pyruvic Acid, Quabains, Quinacrine, Quinapril, Quinidine, Quinine, Ramipril, Relmenidine, Rescinnamine, Reserpine, Resiniferatoxin, Saline, Saxitoxins, Sirolimus, MK-0431 (Sitagliptin phosphate), Sitaxentan, slatatoxin, Slototoxin, Sodium Chloride (Salt), Sodium Morrhuate, Sodium Tetradecyl Sulfate, Sotalol, Staurosporines, Sulfuric Acid, Talc, Taxol, Terazosin, Tetanus Toxin, Tetracaine, Tetracycline, Tetraethylammonium, Tetrodotoxin, Tocainide, Trichlormethiazide, Trimazosin, Trimethaphan, Tycatoxin, Ubidecarenon, Urapidil, Urea, Vanilloids, Vanilloylzygadenine, Heftoxin, Verapamils, Veratridine, Veratroylzygadenine with saline solution, Vinblastin, Vincristine, Zotarolimus, Zygacine, ß-carboline derivative, ?-conotoxin, Heparinized Saline, Butorakotoshkin.
[0040] In the above description, for purpose of explanation, specific details are set forth in order to provide an understanding of the present disclosure. It will be apparent, however, to one skilled in the art that the present disclosure may be practiced without these details. One skilled in the art will recognize that embodiments of the present disclosure, one of which is described below, may be incorporated into a number of systems. Further, structures and devices shown in the figures are illustrative of exemplary embodiment of the present disclosure and are meant to avoid obscuring the present disclosure.

List of Reference Numerals:
Number Element
100 Catheter
102 Catheter shaft
103, 203 Handle
104, 204 Fluid injection port
105, 205 Hollow helix
106, 206 Inner shaft
107, 208 Guidewire port
108 Capsule
109, 207 Perforations
110, 210 Rotary Knob
112, 212 Tip
114, 214 Fluid Injection shaft

,CLAIMS:
1. An endovascular catheter (100) for drug delivery, comprising:
a hollow inner shaft (106, 206) connected to a guidewire port (107, 208) to aid as a guidewire passage; and
a hollow fluid injection shaft (114, 214) enclosing and extending along the inner shaft (106, 206), the hollow fluid injection shaft (114, 214) coupled to a drug delivery part (105, 205) at a distal end thereof, the hollow fluid injection shaft (114, 214) connected to a fluid injection port (104, 204) at a proximal end thereof, the hollow fluid injection shaft (114, 214) allows a fluid to flow to the drug delivery part (105, 205) thereby allowing the fluid to flow between an outer surface of the inner shaft (106, 206) and an inner surface of the fluid injection shaft (114, 214).
2. The endovascular catheter (100) for drug delivery as claimed in claim 1, optionally comprises, a hollow catheter shaft (102) enclosing and extending along the hollow fluid injection shaft (114), the hollow catheter shaft (102) connected to a capsule (108) at a distal end thereof, the capsule (108) configured to house the drug delivery part (105, 205) therein, and the catheter shaft (102) connected to the handle (103) at a proximal end thereof through a rotary knob (110), the rotary knob (110) configured to move the catheter shaft (102) along the longitudinal axis to cover and uncover the drug delivery part (105).
3. The endovascular catheter (100) for drug delivery as claimed in claim 1, wherein, the drug delivery part (105, 205) comprises a plurality of perforations (109, 207) on periphery thereof.
4. The endovascular catheter (100) for drug delivery as claimed in claim 3, wherein the plurality of perforations (109, 207) are either in a regular pattern or in an irregular pattern.
5. The endovascular catheter (100) for drug delivery as claimed in any one of claims 1 to 4, wherein the drug delivery part is a hollow helix (105).
6. The endovascular catheter (100) for drug delivery as claimed in claim 1 to 5, wherein the hollow helix (105) is either self-expandable or balloon expandable.
7. The endovascular catheter (100) for drug delivery as claimed in claim any one of claims 5 to 6, wherein the hollow helix (105) is wrapped around the inner shaft (106) in helical structure such that the hollow helix (105) is attached to the fluid injection shaft (114) at one end and another end is optionally sealed to a tip (112) of the inner shaft (106).
8. The endovascular catheter (100) for drug delivery as claimed in claim any one of claims 5 to 7, wherein the hollow helix (105) comprises multiple helical structures intertwined and wrapped around the inner shaft (106).
9. The endovascular catheter (100) for drug delivery as claimed in claim any one of claims 5 to 8, wherein the hollow helix (105) is expandable structure wrapped around the inner shaft (106) in a deflated state thereof and perfuses the drug or the drug containing solution through the plurality of perforations (109) in an inflated state thereof.
10. The endovascular catheter (100) for drug delivery as claimed in any one of claims 1 to 4, wherein the drug delivery part is an expandable balloon (205).
11. The endovascular catheter (100) for drug delivery as claimed in claim 10, wherein the expandable balloon (205) has a double wall made of an outer wall and an inner wall, on its periphery along the longitudinal axis.
12. The endovascular catheter (100) for drug delivery as claimed in any one of claims 10 to 11, wherein the expandable balloon (205) has an outer wall and an inner wall such that the outer wall includes a plurality of perforations (207).
13. The endovascular catheter (100) for drug delivery as claimed in claim any one of claims 10 to 12, wherein the inner wall and the outer wall create a cavity that stores at least the fluid containing one drug or at least one drug containing solution.
14. The endovascular catheter (100) for drug delivery as claimed in claim any one of claims 10 to 13, wherein the expandable balloon (205) is configured to be inflated to perfuse the drug or the drug containing solution through the plurality of perforations (207).
15. The endovascular catheter (100) for drug delivery as claimed in any one of claims 10 to 14, wherein the expandable balloon (205) is made of a biodegradable or a non-biodegradable polymer.
16. The endovascular catheter (100) for drug delivery as claimed in claim 1, wherein the drug delivery part (105, 205) is made of a material selected from metal, non-metal, alloy, polymer, biodegradable, bioresorbable material or a combination thereof.
17. The endovascular catheter (100) for drug delivery as claimed in claim 1 or claim 16, wherein the drug delivery part (105, 205) is made of a material selected from Stainless steel, Cobalt alloys, pure Iron, Nickel-Titanium alloys, Tantalum, Niobium, Nickel alloys, Magnesium alloys, Zinc alloys, L605, MP25N, Nitinol or a combination thereof.
18. The endovascular catheter (100) for drug delivery as claimed in claim 1 or claim 16, wherein the drug delivery part (105, 205) is made of a material selected from polymers of L-lactide, Glycolide or combinations of thereof, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, saline and copolymers and combinations thereof.
19. The endovascular catheter (100) for drug delivery as claimed in claim 1, wherein the fluid containing at least one drug or at least one drug containing solution is injected in the fluid injection port (104, 204) for perfusion of the drug or the drug containing solution through the plurality of perforations (109, 207) situated on periphery of the drug delivery part (105, 205).
20. The endovascular catheter (100) for drug delivery as claimed in claim 19, wherein solvent for the drug-containing solution is selected from water, polymeric solvent, non-polymeric solvent, saline, biodegradable polymeric liquid or a mixture thereof.
21. The endovascular catheter (100) for drug delivery as claimed in claim 20, wherein solvent comprises polymers of L-lactide, Glycolide or combinations of thereof, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, and copolymers and combinations thereof.

Documents

Application Documents

# Name Date
1 202121053133-PROVISIONAL SPECIFICATION [18-11-2021(online)].pdf 2021-11-18
2 202121053133-FORM 1 [18-11-2021(online)].pdf 2021-11-18
3 202121053133-DRAWINGS [18-11-2021(online)].pdf 2021-11-18
4 202121053133-FORM-26 [13-12-2021(online)].pdf 2021-12-13
5 202121053133-Proof of Right [21-03-2022(online)].pdf 2022-03-21
6 202121053133-PostDating-(18-11-2022)-(E-6-273-2022-MUM).pdf 2022-11-18
7 202121053133-APPLICATIONFORPOSTDATING [18-11-2022(online)].pdf 2022-11-18
8 202121053133-FORM 3 [19-12-2022(online)].pdf 2022-12-19
9 202121053133-ENDORSEMENT BY INVENTORS [19-12-2022(online)].pdf 2022-12-19
10 202121053133-DRAWING [19-12-2022(online)].pdf 2022-12-19
11 202121053133-CORRESPONDENCE-OTHERS [19-12-2022(online)].pdf 2022-12-19
12 202121053133-COMPLETE SPECIFICATION [19-12-2022(online)].pdf 2022-12-19
13 Abstract1.jpg 2023-01-21
14 202121053133-FORM 18 [17-07-2023(online)].pdf 2023-07-17
15 202121053133-Response to office action [25-04-2024(online)].pdf 2024-04-25
16 202121053133-Response to office action [21-08-2024(online)].pdf 2024-08-21
17 202121053133-Response to office action [12-12-2024(online)].pdf 2024-12-12
18 202121053133-Response to office action [24-03-2025(online)].pdf 2025-03-24
19 202121053133-FER.pdf 2025-04-23
20 202121053133-FER_SER_REPLY [16-10-2025(online)].pdf 2025-10-16
21 202121053133-CLAIMS [16-10-2025(online)].pdf 2025-10-16

Search Strategy

1 202121053133_SearchStrategyNew_E_SearchstrategyE_17-04-2025.pdf