Catheter for Localized Drug Delivery and/or Electrical Stimulation

• US 20080065002A1
• Filed: 09/05/2007
• Published: 03/13/2008
• Est. Priority Date: 09/07/2006
• Status: Abandoned Application

• Current Assignee: NeuroSystec Corporation
• Original Assignee: NeuroSystec Corporation
• Inventors: Pananen, Jacob E., Lobl, Thomas J., Nagy, Anna Imola, Schloss, John V.
• Application Number:
  US11/850,156
• Publication Number:
  US 20080065002A1
• Time in Patent Office: Days
• US Class Current: 604/21
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/0085 Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/36038 Cochlear stimulation

Abstract

A drug-compatible, biocompatible, drug-delivery catheter can include multi-lumen tubing attached to an end fitting, with the end fitting having an internal fluid chamber and a fluid exit region. The catheter can also include multi-lumen tubing having one or more needles attached at a distal end.

Claims

1. A catheter, comprising:

a tubing portion having at least first and second lumens formed therein, wherein at least a portion of an internal surface of the first lumen is formed from a fluoropolymer; and

an end fitting coupled to a distal end of the tubing portion and having an internal fluid chamber and at least one fluid exit region, wherein

the first and second lumens are in fluid communication with the fluid chamber,

at least a portion of a surface of the fluid chamber is formed from a fluoropolymer, and

the fluid exit region is positioned so as to place the fluid chamber in fluid communication with a region external to the catheter.

2. The catheter of claim 1, wherein the end fitting is sized for placement in the round window niche of a human.

3. The catheter of claim 1, wherein the fluid exit region includes a plurality of holes.

4. The catheter of claim 1, wherein the end fitting includes an inflatable bladder coupled thereto, and wherein the tubing portion includes an additional lumen in fluid communication with an internal portion of the bladder.

5. The catheter of claim 1, wherein the end fitting includes a self-expanding ring coupled thereto.

6. The catheter of claim 5, further comprising a sheath, and wherein the tubing portion and end fitting fit within the sheath when the self-expanding ring is in a collapsed configuration, and wherein the catheter is configured such that the tubing portion can be pushed through the sheath so as to cause the end fitting to emerge from an end of the sheath.

7. The catheter of claim 1, further comprising:

an electrode located on a distal portion of the catheter, and

a wire placing the electrode in electrical communication with an electronics package configured to generate electrical stimulation pulses.

8. The catheter of claim 1, further comprising a pressure sensor coupled to the second lumen.

9. The catheter of claim 1, wherein the end fitting is removable, and wherein the catheter is configured to accept a second end fitting after said removal.

10. A catheter, comprising:

a tubing portion having at least first and second lumens formed therein, wherein at least a portion of an internal surface of the first lumen is formed from a fluoropolymer; and

a injection structure extending from a distal end of the tubing portion, the injection structure including first and second fluid passages, wherein

the first fluid passage is in fluid communication with the first lumen and has an opening configured to deliver fluid from the first lumen to a region external to the catheter, and

the second fluid passage is in fluid communication with the second lumen and has an opening configured to deliver fluid from the region external to the catheter to the second lumen.

11. The catheter of claim 10, further comprising a flexible insertion stop positioned on the end of the tubing portion.

12. The catheter of claim 10, wherein the first fluid passage opening is more distally located than the second fluid passage opening.

13. The catheter of claim 10, wherein the injection system comprises first and second needles, wherein the first fluid passage in within the first needle, and wherein the second fluid passage is within the second needle.

14. The catheter of claim 13, further comprising one or more electrical wires in electrical communication with an electronics package configured to generate electrical stimulation pulses to an ear tissue of a human when the end of the tubing portion is placed into a round window niche of a human.

15. A method, comprising:

placing an end fitting of a catheter into a round window niche of a human, wherein

the catheter includes a tubing portion having at least first and second lumens formed therein,

at least a portion of an internal surface of the first lumen is formed from a fluoropolymer,

the end fitting is coupled to a distal end of the tubing portion and includes an internal fluid chamber and at least one fluid exit region,

the first and second lumens are in fluid communication with the fluid chamber,

at least a portion of a surface of the fluid chamber is formed from a fluoropolymer, and

the fluid exit region is positioned so as to place the fluid chamber in fluid communication with a region external to the catheter;

delivering a drug-laden fluid through the first lumen to the internal fluid chamber; and

permitting excess drug-laden fluid to escape from the internal fluid chamber via the second lumen.

16. The method of claim 15, wherein the step of placing the end fitting of the catheter into a round window niche comprises placing the end fitting into the round window niche of a human having at least one of the following conditions:

autoimmune inner ear disorder, Meniere'"'"'s disease, a metabolic disorder, a bacterial infection, a viral infection, a fungal infection, an allergy, a neurological disorder, a blast injury, noise-induced hearing loss, drug-induced hearing loss, tinnitus, presbycusis, barotrauma, otitis media, infectious mastoiditis, infectious myringitis, sensorineural hearing loss, conductive hearing loss, vestibular neuronitis, labyrinthitis, post-traumatic vertigo, perilymph fistula, cervical vertigo, ototoxicity, Mal de Debarquement Syndrome, acoustic neuroma, migraine associated vertigo, benign paroxysmal positional vertigo, eustachian tube dysfunction, a malignant tumor, a non-malignant tumor, cancer of the middle ear, or cancer of the inner ear.

17. The method of claim 15, wherein the step of delivering a drug-laden fluid comprises delivering a fluid that includes at least one of gacyclidine, a neurologically active drug other than gacyclidine, an antibiotic, an anti-viral drug, an anti-inflammatory drug, an anti-cancer drug and a fungicide.

18. The method of claim 15, wherein an electrode is located on a distal portion of the catheter, and further comprising:

delivering electrical stimulation to ear tissue of the human through the electrode.

19. A method, comprising:

placing an end fitting of a catheter into a cochlea, an auditory nerve, an optic nerve, an eye, a pituitary gland, an adrenal gland, a thymus gland, an ovary, a testis, a heart, a pancreas, a liver, a spleen, a brain or a spinal cord of a human, wherein

the catheter includes a tubing portion having at least first and second lumens formed therein,

at least a portion of an internal surface of the first lumen is formed from a fluoropolymer,

the end fitting is coupled to a distal end of the tubing portion and includes an internal fluid chamber and at least one fluid exit region,

the first and second lumens are in fluid communication with the fluid chamber,

at least a portion of a surface of the fluid chamber is formed from a fluoropolymer, and

the fluid exit region is positioned so as to place the fluid chamber in fluid communication with a region external to the catheter;

delivering a drug-laden fluid through the first lumen to the internal fluid chamber; and

permitting excess drug-laden fluid to escape from the internal fluid chamber via the second lumen.

20. The method of claim 19, wherein the step of placing the end fitting of the catheter comprises placing the end fitting into a body region of a human having at least one of the following conditions:

a metabolic disorder, a bacterial infection, a viral infection, a fungal infection, an allergy, a neurological disorder, or a cancer.

21. A method, comprising:

placing a distal end of a catheter into a round window niche of a human so as to pierce the round window membrane with first and second injection needles, wherein

the catheter includes a tubing portion having at least first and second lumens formed therein,

at least a portion of an internal surface of the first lumen is formed from a fluoropolymer,

the first injection needle extends from a distal end of the tubing portion,

an internal passage of the first injection needle is in fluid communication with the first lumen,

the second injection needle extends from the distal end of the tubing portion,

an internal passage of the second injection needle is in fluid communication with the second lumen, and

the catheter includes at least one wire in electrical communication with the first injection needle;

delivering a drug-laden fluid through the first lumen to the internal fluid chamber;

permitting excess drug-laden fluid to escape from the internal fluid chamber via the second lumen; and

delivering electrical stimulation to ear tissue of the human through the at least one wire.