Claims for Patent: 8,088,150

Summary for Patent: 8,088,150

Title:	Device for disc shunt implantation and peri-shunt injection
Abstract:	A Quincke tipped introducer needle contains two shafts with lumens, one recessed, both connected by a slit for housing a U- or V-shaped disc shunt. The recessed shaft minimizes the penetration size of the introducer needle for insertion into a narrow and nerve laden space adjacent to a degenerated intervertebral disc. The longitudinal slit connecting the two lumens allows passage of the distal portion of the U-shaped disc shunt through the introducer needle, to be delivered into the intervertebral disc. Pain emitting from the avascular disc is extremely difficult to treat due to lack of penetration or permeability of drug. The lumens of the introducer needle are also used to retain a peri-shunt injectable into the disc shunt for delivery into the painful disc. The peri-shunt injectable can be an analgesic, narcotic, anti-inflammatory drug, antibiotic, anticonvulsant, antidepressant, buffer agent or alkaline agent to alleviate pain. The peri-shunt injectable can also be a nerve toxin retained within the lumens to be loaded within the shunt for terminating transmission of pain signal emitting from the disc.
Inventor(s):	Yeung; Jeffrey E. (San Jose, CA), Yeung; Teresa T. (San Jose, CA)
Assignee:	Aleeva Medical Inc. (San Jose, CA)
Application Number:	12/322,570
Patent Claims:	1. A disc shunt delivery device for treating a degenerated intervertebral disc, the delivery device comprising: a first shaft having a first lumen extending from proximal to distal end, said first shaft further comprising a pointed distal tip, a second shaft having a second lumen extending from proximal to distal end, wherein a distal portion of said first shaft is extended beyond a distal end of said second shaft, and a longitudinal slit formed by overlapping a longitudinal edge of said first lumen and with a longitudinal edge of said second lumen, said longitudinal slit thereby connecting said first and second lumens, wherein said first shaft, second shaft and longitudinal slit comprises a first position and a second position, wherein in said first position, said first shaft, second shaft and longitudinal slit further comprise a trocar, wherein said trocar comprises a cross-section shaped to fit within said first lumen, second lumen and longitudinal slit entirely, and wherein in said second position, said trocar is withdrawn from said first lumen, second lumen and longitudinal slit. 2. A disc shunt delivery device of claim 1, wherein in said second position, said first lumen houses a first proximal end of a U-shaped disc shunt, wherein said second lumen houses a second proximal end of said U-shaped disc shunt, and wherein said distal portion of said U-shaped disc shunt passes through said longitudinal slit. 3. A disc shunt delivery device of claim 1, further comprising a peri-shunt injection needle loaded with a drug into at least one of said first lumen and second lumen. 4. The disc shunt delivery device of claim 3, wherein said drug is an analgesic. 5. The disc shunt delivery device of claim 4, wherein said analgesic is chosen from the group consisting of bupivacaine, lidocain, ketorolac and Sarapin.RTM.. 6. The disc shunt delivery device of claim 3, wherein said drug is an opioid or narcotic. 7. The disc shunt delivery device of claim 6, wherein said drug is chosen from the group consisting of fentanyl, methadone, morphine, oxycodone, propoxyphene, meperidine, hydromorphone, codeine and hydrocodone. 8. The disc shunt delivery device of claim 3, wherein said drug is an inhibitor of cyclooxygenases. 9. The disc shunt delivery device of claim 8, wherein said drug is chosen from the group consisting of aspirin (acetylsalicylic acid or 2-acetoxybenzoic acid), ibuprofen (iso-butyl-propanoic-phenolic acid), naproxen [(+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid], celecoxib {4-[5-(4-methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide- }, rofecoxib, 6-methoxy-2-naphtyl acetic acids, diclofenac, etodolac, ketoprofen, ketorolac, meloxicam and acetaminophen. 10. The disc shunt delivery device of claim 3, wherein said drug is an inhibitor of nitric oxide synthase. 11. The disc shunt delivery device of claim 10, wherein said drug is chosen from the group consisting of methylene blue, 3-[(R)-2-carboxypiperazin-4-yl]-prop-2-enyl-1-phosphonic acid, 3-[(S)-2-carboxypiperazin-4-yl]-prop-2-enyl-1-phosphonic acid, tramadol, methadone, N(G)-nitro-L-arginine, N(G)-nitro-D-arginine, N(G)-methyl-L-arginine, N(G)-nitro-L-arginine methyl ester, 7-nitroindazole, N-iminoethyl-L-lysine, dimethyl arginine, N-[3-(aminomethyl)benzyl]acetamidine, miconazole, N-methylsulfonyl-6-(2-propargyloxyphenyl)hexanamide, aminoguanidine, lipochroman-6, methylprednisolone and indomethacin. 12. The disc shunt delivery device of claim 3, wherein said drug is an inhibitor of N-methyl-D-aspartate receptor (NMDA). 13. The disc shunt delivery device of claim 12, wherein said drug is chosen from the group consisting of ketamine, magnesium sulfate, magnesium chloride, magnesium hydroxide, amantadine, dextromethorphan, dextrorphan, ibogaine, phencyclidine, riluzole, tiletamine, dizocilpine (MK-801), aptiganel, memantine, remacimide, 7-chlorokynurenate, 5-, 7-dichlorokynurenic, kynurenic acid, 2-amino-7-phosphonoheptanoic acid, R-2-amino-5-phosphonopentanoate and 3-[(R)-2-carboxypiperazin-4-yl]-prop-2-enyl-1-phosphonic acid. 14. The disc shunt delivery device of claim 3, wherein said drug is an inhibitor of tumor necrosis factor alpha. 15. The disc shunt delivery device of claim 14, wherein said drug is chosen from the group consisting of thalidomide, doxycycline and naproxen. 16. The disc shunt delivery device of claim 3, wherein said drug is an inhibitor of 5-lipoxygenase. 17. The disc shunt delivery device of claim 3, wherein said drug is a non-steroidal anti-inflammatory drug. 18. The disc shunt delivery device of claim 17, wherein said drug is chosen from the group consisting of naproxen, flurbiprofen, diclofenac with misoprostal, celecoxib, sulindac, oxaprozin, piroxicam, meloxicam, ketoprofen, nabumetone, ketorolac and robecoxib. 19. The disc shunt delivery device of claim 3, wherein said drug is a steroidal anti-inflammatory drug. 20. The disc shunt delivery device of claim 19, wherein said drug is chosen from the group consisting of dexamethasone, prednisone and methylprednisolone. 21. The disc shunt delivery device of claim 3, wherein said drug is an antibiotic. 22. The disc shunt delivery device of claim 21, wherein said drug is chosen from the group consisting of doxycycline, tetracycline, cephalosporin and penicillin. 23. The disc shunt delivery device of claim 3, wherein said drug is a muscle relaxant. 24. The disc shunt delivery device of claim 23, wherein said drug is chosen from the group consisting of cyclobenzaprine, orphenadrine, methocarbamol, diazepam, alprazolam and tizanidine. 25. The disc shunt delivery device of claim 3, wherein said drug is an anticonvulsant. 26. The disc shunt delivery device of claim 25, wherein said drug is chosen from the group consisting of aldehyde, aromatic allylic alcohol, barbiturate, benzodiazepine, bromide, carbamate, carboxamide, fatty acid, fructose derivative, gaba analog, hydantoin, oxazolidinedione, propionate, pyrimidinedione, pyrrolidine, succinimide, sulfonamide, triazine, urea, valproylamide, acetazolamide, carbamazepine, clobazam, clonazepam, diazepam, divalproex sodium, ethosuximide, ethotoin, felbamate, fosphenyloin, gabapentin, lamotrigine, levetiracetam, mephenyloin, metharbital, methsuximide, methazolamide, mexiletine, oxcarbazepine, phenobarbital, phenyloin, phensuximide, pregabalin, primidone, sodium valproate, stiripentol, tiagabine, topiramate, trimethadione, valproic acid, vigabatrin and zonisamide. 27. The disc shunt delivery device of claim 3, wherein said drug is an antidepressant. 28. The disc shunt delivery device of claim 27, wherein said drug is chosen from the group consisting of tricyclic antidepressant, amitriptyline, desipramine, duloxetine, nortriptyline and doxepin. 29. The disc shunt delivery device of claim 3, wherein said drug is a buffer or alkaline agent. 30. The disc shunt delivery device of claim 29, wherein said drug is chosen from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, calcium carbonate, barium carbonate, potassium phosphate, sodium phosphate, magnesium oxide, magnesium hydroxide, sodium hydroxide, potassium hydroxide, barium hydroxide, cesium hydroxide, strontium hydroxide, calcium hydroxide, lithium hydroxide, rubidium hydroxide and neutral amines. 31. The disc shunt delivery device of claim 3, wherein said drug is a calcium channel blocker. 32. The disc shunt delivery device of claim 31, wherein said drug is chosen from the group consisting of ziconotide, amlodipine, aranidipine, azelnidipine, barnidipine, benidipine, cilnidipine, clevidipine, efonidipine, felodipine, isradipine, lacidipine, magnesium ion, manidipine, lercanidipine, nicardipine, nifedipine, nilvadipine, nimodipine, nisoldipine, nitrendipine, pranidipine, gallopamil, verapamil and diltiazem. 33. The disc shunt delivery device of claim 3, wherein said drug is a nerve toxin. 34. The disc shunt delivery device of claim 33, wherein said drug is chosen from the group consisting of botulinum toxin (BOTOX.RTM.), Isopropyl methylphosphonofluoridate (Sarin), Pinacolyl Methylphosphonofluoridate (Soman), O-ethyl dimethylamidophosphorylcyanide (Tabun), S[2-(diisopropylamino)ethyl]-O-ethyl methylphosphonothioate) and saporin (SAP). 35. The disc shunt delivery device of claim 3, wherein said drug is a nutrient. 36. The disc shunt delivery device of claim 35, wherein said drug is chosen from the group consisting of sulfate, amino acid, glucose, glucuronic acid, galactose, galactosamine, glucosamine, hydroxylysine, hydroxylproline, serine, threonine, boron, boric acid, magnesium trisilicate, magnesium mesotrisilicate, magnesium oxide, magnesium chloride, magnosil, pentimin, trisomin, orthosilicic acid, magnesium trisilicate pentahydrate, serpentine, sodium metasilicate, silanolates, silanol group, sialic acid and silicic acid. 37. The disc shunt delivery device of claim 3, wherein said drug is a growth factor. 38. The disc shunt delivery device of claim 37, wherein said drug is chosen from the group consisting of OP-1 and TGF-beta. 39. The disc shunt delivery device of claim 3, wherein said drug is an inhibitor of fibrous encapsulation over the disc shunts. 40. The disc shunt delivery device of claim 39, wherein said drug is chosen from the group consisting of azathioprine, 5-fluorouracil, mitomycin-C, halofuginone, anakinra, isoxazoles, leflunomide, mycophenolate, thalidomide, cyclosporine, abetimus, gusperimus, dexamethasone, prednisolone, methylprednisolone and steroid. 41. The disc shunt delivery device of claim 3, wherein said drug is an anti-angiogenic compound. 42. The disc shunt delivery device of claim 41, wherein said drug is chosen from the group consisting of marimastat, Bay 12-9566, AG3340, CGS 27023A, COL-3, Tetracycline.RTM., Neovastat, Sainte-Foy, BMS-275291, TNP-470, thalidomide, squalamine, Combretastatin A-4, endostatin collagen XVIII fragment, anti-VEGF Antibody, SU5416, SU6668, PTK787/ZK 22584, interferon-alpha, EMD121974, CAI, interleukin-12, IM862, Avastin, Celebrex, Erbitux, Herceptin, Iressa, Taxol, Velcade, TNP-470, CM101, carboxyamido-triazole, anti-neoplastic urinary protein, isotretionin, tamoxifen, tecogalan combrestatin, cyclophosphamide, angiostatin, platelet factor-4, Anginex, eponemycin, epoxomicin, epoxy-.beta.-aminoketone, antiangiogenic antithrombin III, canstatin, cartilage-derived inhibitor, CD59 complement fragment, fibronectin fragment, gro-beta, heparinases, heparin hexasaccharide fragment, human chorinonic gonadotropin, interferon beta, interferon gamma, interferon inducible protein (IP-10), interleukin-12 (IL-12), Kringle 5 (plasminogen fragment), tissue inhibitors of metalloproteinases, 2-methoxyestradiol (Panzem), placental ribonuclease inhibitor, plasminogen activator inhibitor, prolactin 16 kD fragment, retinoids, tetrahydrocortisol-S, thrombospondin-1, transforming growth factor beta, vasculostatin and vasostatin (calreticulin fragment). 43. The disc shunt delivery device of claim 3, wherein said drug is a chemotherapy drug.

Details for Patent 8,088,150

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2028-02-04
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2028-02-04
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	11/14/2001		2028-02-04
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2028-02-04
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2028-02-04
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2028-02-04