U-shaped disc shunt and delivery device

• US 20070142791A1
• Filed: 02/05/2007
• Published: 06/21/2007
• Est. Priority Date: 05/07/2003
• Status: Abandoned Application

• Current Assignee: Aleeva Medical Incorporated
• Original Assignee: Aleeva Medical Incorporated
• Inventors: Yeung, Teresa, Yeung, Jeffrey
• Application Number:
  US11/702,279
• Publication Number:
  US 20070142791A1
• Time in Patent Office: Days
• US Class Current: 604/264
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/90 Guides therefor
• CPC Class Codes: A61B 2017/061 hollow or tubular
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/28 Materials for coating prostheses

Abstract

The intervertebral disc contains no blood vessels. Nutrients and waste are diffused mainly through adjacent vertebral bodies. As we age, calcified layers form between the disc and vertebral bodies, blocking diffusion. The disc begins to starve and flatten. The weight shifts abnormally from disc to the facet joints causing strain and back pain. Under anaerobic conditions, lactic acid is produced causing acidic irritation and unspecific pain. A U-shaped disc shunt is delivered into and sealed within the degenerated disc simply by needle puncturing and withdrawal, to draw nutrients from bodily circulation into the avascular disc. A continual supply of nutrients increases biosynthesis of the water-retaining sulfated glycosaminoglycans, hence swelling pressure within the disc. The weight is re-shifted from the facet joints to the regenerated disc, alleviating back pain. With oxygen transported through the shunt, anaerobic production of lactic acid is minimized. In addition, the residual lactic acid is expelled through the U-shaped shunt during disc compression into bodily circulation to alleviate unspecific pain.

Claims

1. A device for treatment of an intervertebral disc, the device comprising:

an elongated shunt in a U-shaped configuration,

and a needle having a tubular passage extending in from a distal end thereof, said distal end sized and configured to enter the intervertebral disc and deploy said elongated shunt.

2. The device of claim 1, wherein prior to deployment, a portion of said elongated shunt is located within said tubular passage and a portion of said elongated shunt is located outside said tubular passage.

3. The device of claim 1, wherein at least a portion of said distal end is blunt or rounded.

4. The device of claim 3, wherein prior to deployment, a portion of said elongated shunt rests against the blunt or rounded portion of said distal end.

5. The device of claim 1, wherein at least a portion of said distal end is sharpened and beveled.

6. The device of claim 1, further comprising a slit in said needle, said slit extending from said distal end.

7. The device of claim 6, wherein prior to deployment, a portion of said elongated shunt is located within said slit.

8. The device of claim 1, further comprising a protrusion extending from said elongated shunt.

9. The device of claim 1, wherein said needle has a round cross section.

10. The device of claim 1, wherein said needle has a non-round cross section.

11. The device of claim 1, further comprising a stem located at least partially within said tubular passage.

12. The device of claim 11, further comprising two prongs extending from a distal tip of said stem.

13. The device of claim 12, wherein said stem and prongs having an insertion position and a deployment position, wherein in said insertion position, said stem and prongs are located within the tubular passage, and wherein in said deployment position said prongs and at least a portion of said stem extend distally from said tubular passage.

14. The device of claim 12, wherein prior to deployment, said stem and prongs engage said elongated shunt.

15. The device of claim 11, wherein said stem has a flat ribbon shape.

16. The device of claim 11, wherein the stem is flexible.

17. The device of claim 1, further comprising a second U-shaped shunt located proximate the first elongated U-shaped shunt.

18. The device of claim 17, wherein said second U-shaped shunt passes through a portion of said first elongated U-shaped shunt.

19. The device of claim 17, wherein said second U-shaped shunt is attached to said first elongated U-shaped shunt.

20. The device of claim 1, wherein said elongated shunt is formed of a material having a pore size smaller than 301 μ

m.

21. The device of claim 1, wherein said elongated shunt is formed of a material having a pore size larger than 1 nm.

22. The device of claim 1, wherein said elongated shunt is formed with sections having different pore sizes.

23. The device of claim 22, wherein the pore sizes range from 301 μ

m to 1 nm.

24. The device of claim 1, wherein said elongated shunt further comprising a buffer coating.

25. The device of claim 24, wherein said buffer coating is chosen from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, calcium carbonate, barium carbonate, potassium phosphate and sodium phosphate.

26. The device of claim 1, wherein said elongated shunt further comprising an alkaline coating.

27. The device of claim 26, wherein said alkaline coating is chosen from the group consisting of magnesium oxide, magnesium hydroxide, sodium hydroxide, potassium hydroxide, barium hydroxide, cesium hydroxide, strontium hydroxide, calcium hydroxide, lithium hydroxide, rubidium hydroxide and neutral amines.

28. The device of claim 1, wherein said elongated shunt further comprising an additive coating.

29. The device of claim 28, wherein said additive coating is chosen from the group consisting of sulfate, glucose, glucuronic acid, galactose, galactosamine, glucosamine, hydroxylysine, hydroxylproline, serine, threonine, chondroitin sulfate, keratan sulfate, hyaluronate, magnesium trisilicate, magnesium mesotrisilicate, magnesium oxide, Magnosil, Pentimin, Trisomin, orthosilicic acid, magnesium trisilicate pentahydrate, Serpentine, sodium metasilicate, silanolates, silanol group, sialic acid, silicic acid, boron, boric acid, minerals and other amino acids, growth factor, antibiotic and analgesic.

30. The device of claim 1, wherein said elongated shunt further comprising an immuno inhibitor coating.

31. The device of claim 30, wherein said immuno inhibitor coating is chosen from the group consisting of actinomycin-D, aminopterin, azathioprine, chlorambucil, corticosteroids, crosslinked polyethylene glycol, cyclophosphamide, cyclosporin A, 6-mercaptopurine, methylprednisolone, methotrexate, niridazole, oxisuran, paclitaxel, polyethylene glycol, prednisolone, prednisone, procarbazine, prostaglandin, prostaglandin E₁, sirolimus and steroids.

32. The device of claim 1, wherein said elongated shunt further comprising a calcium channel blocker coating.

33. The device of claim 32, wherein said calcium channel blocker coating is chosen from the group consisting of Amlodipine, Felodipine, Isradipine, Lacidipine, Lercanidipine, Nicardipine, Nifedipine, Nimodipine, Nisoldipine, Verapamil and Diltiazem.

34. The device of claim 1, wherein said elongated shunt further comprising a chelating agent coating.

35. The device of claim 34, wherein said chelating agent coating is chosen from the group consisting of ethylene diamine tetra acetate, diethylene triamine penta acetate, meso-2,3-dimercapto succinic acid, desferoxamine, 2,3-dimercapto-1-propane sulfonate, D-penicillamine, defarasirox, dimercaprol, N,N-bis (carboxymethyl) glycine, morpholine dithiocarbamate, tetra ammonium ethylene diamine diacetic acid dithiocarbamate, ammonium diethanolamine dithiocarbamate, sodium diethyl dithio carbamate, N-benzyl-D-glucamine dithio carbamate, alpha lipoic acid, tartaric acid, glutathione, methionine, L-arginine, carboxylated group, amine group and thiol group.

36. A method for implanting a shunt to treat an intervertebral disc, the method comprising the steps of:

(a) penetrating into a disc with a needle and a U-shaped shunt;

(b) and withdrawing the needle, thereby leaving the U-shaped shunt located partially within the intervertebral disc.

37. The method of claim 36, further comprising the steps of:

(c) puncturing the vertebral body with a trocar;

(d) inserting a sleeve over the trocar;

(e) withdrawing the trocar;

(f) inserting a drill into the sleeve;

(g) drilling into the vertebral body and endplate with the drill;

(h) advancing the sleeve over the drill;

(i) withdrawing the drill;

(j) and withdrawing the sleeve.

38. The method of claim 36, further comprising the steps of:

(c) puncturing the vertebral body and endplate into the disc with a trocar;

(g) inserting a sleeve over the trocar;

(h) withdrawing the trocar.

(i) and withdrawing the sleeve.