System and kit for delivery of restorative materials

• US 20040092946A1
• Filed: 09/02/2003
• Published: 05/13/2004
• Est. Priority Date: 02/20/2001
• Status: Active Grant

• Current Assignee: Orthovita Inc. (Stryker Corporation)
• Original Assignee: Orthovita Inc. (Stryker Corporation)
• Inventors: Gilbert, Stephen G., Erbe, Erik M., Bagga, Charanpreet S., Persenaire, Maarten, Koblish, Antony
• Granted Patent: US 7,544,196 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1617 with mobile or detachable parts
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1602 Mills
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity

Abstract

Novel kits are provided for the delivery of restorative or injectable compositions into an intraosseous space or surgical defect comprising cannulae for accessing an intraosseous space, mandarins insertable into the cannulae and movable therein, one or more catheters and a system for the delivery of aliquots of restorative compositions into the space via the catheters.

Claims

1. A kit for delivery of a composition into an intraosseous space comprising:

at least one cannula;

at least one stylet insertable into a cannula and being movable therein;

at least one catheter having a high-porosity-tip that are insertable into the cannula; and

a system for delivery of aliquots of said composition into the intraosseous space via said catheter.

2. The kit of claim 1 wherein the catheter is divided into graded markings.

3. The kit of claim 1 wherein said high-porosity tip comprises polylactic acid.

4. The kit of claim 1 wherein said high-porosity tip is partially coated with non-porous or semi-porous material.

5. The kit of claim 4 wherein said material is a ceramic polymer or metal.

6. The kit of claim 5 wherein said material is calcium phosphate, PLLA, or titanium.

7. The kit of claim 4 wherein said material is biocompatible or resorbable.

8. The kit of claim 1 wherein said high porosity tip is biocompatible or resorbable.

9. The kit of claim 1 further comprising a catheter with a plurality of apertures near the distal end.

10. A kit for delivery of a restorative or injectable composition to an intraosseoous space or surgically created osseous defect, comprising:

a micro-reamer comprising an expandable cylindrical section in communication with an outer shaft, said outer shaft and expandable section both surrounding an inner shaft, said expandable section comprising leaves that flex when said expandable section is actuated for creating a space for said composition;

at least one cannula for accessing said intraosseous space or defect;

at least one stylet insertable into the cannulae and being movable therein;

at least one catheter that are insertable into the cannulae; and

,

a system for delivery of aliquots of said composition into the intraosseous space via said catheter.

11. The kit of claim 10 wherein said expandable section comprises an elastic metal, a composite material, a polymer, or other substance suitably expandable.

12. The kit of claim 10 wherein the expandable section comprises nitinol.

13. The kit of claim 10 wherein the outer shaft provides the means of expanding said expandable section.

14. The kit of claim 10 wherein the outer shaft is divided into graded markings.

15. The kit of claim 10 wherein said catheter has a distal end and at least one placement orifice disposed proximate to said distal end;

said placement orifice being adapted for dispensing said composition radially from the catheter.

16. The kit of claim 10 further comprising a cannulated screw.

17. The kit of claim 10 wherein the stylet, micro-reamer, or cannula, all have a proximate end and distal end and a lateral surface responsive to impact blows is fixed to the proximate end.

18. The kit of claim 10 wherein said catheter comprises stainless steel.

19. The kit of claim 10 wherein said catheter comprises polyimide.

20. The kit of claim 10 wherein said catheter comprises latex.

21. The kit of claim 10 wherein said catheter comprises silicone.

22. The kit of claim 10 wherein said catheter comprises vinyl.

23. The kit of claim 10 wherein said catheter comprises a shape memory material.

24. The kit of claim 10 further comprising one or more syringes having a Luer lock.

25. The kit of claim 10 wherein said cannula is divided into grades, said grades being markings.

26. The kit of claims 10 wherein said micro-reamer is divided into grades, said grades being markings.

27. The kit of claim 10 wherein said catheter is divided into grades, said grades being markings.

28. The kit of claim 10 wherein the said composition comprises a hydrogel.

29. The kit of claim 10 wherein the said composition comprises a synthetic bone void filler.

30. The kit of claim 10 wherein the said composition comprises polymethyl methacrylate.

31. The kit of claim 10 wherein the said composition comprises replicated bone marrow.

32. The kit of claim 10 wherein the said composition comprises replicated bone marrow.

33. A micro-reamer for creating an intraosseoous space comprising:

an expandable cylindrical section in communication with an outer shaft, said outer shaft and expandable section both surrounding an inner shaft, said expandable section comprising leaves that flex when said expandable section is actuated for creating a space for a restorative or injectable composition;

wherein the leaves are situated along the length of the cylindrical section.

34. The micro-reamer of claim 33 wherein said expandable section comprises an elastic metal, a composite material, a polymer, or other substance suitably expandable.

35. The micro-reamer of claim 33 wherein the expandable section comprises nitinol.

36. The micro-reamer of claim 33 wherein the outer shaft provides the means of expanding said expandable section.

37. The micro-reamer of claim 33 wherein the outer shaft is divided into graded markings.

38. A micro-reamer for creating an intraosseoous space comprising:

an expandable cylindrical section in communication with an outer shaft, said outer shaft and expandable section both surrounding an inner shaft,

said expandable section comprising leaves that flex when said expandable section is actuated for creating a space for restorative or injectable composition;

wherein the leaves are situated at an angle to the length of the cylindrical section.

39. The micro-reamer of claim 38 wherein the angle is from about 5 degrees to about 30 degrees.

40. The micro-reamer of claim 38 wherein the angle is from about 10 degrees to about 15 degrees.

41. The micro-reamer of claim 40 wherein said expandable section comprises an elastic metal, a composite material, a polymer, or other substance suitably expandable.

42. The micro-reamer of claim 40 wherein the expandable section comprises nitinol.

43. The micro-reamer of claim 40 wherein the outer shaft provides the means of expanding said expandable section.

44. The micro-reamer of claim 40 wherein the outer shaft is divided into graded markings.

45. A method for delivery of a composition into an intraosseous space comprising:

accessing or creating an osseous defect using a cannula,

creating a space suitable for receipt of a composition using a micro-reamer,

delivering a composition using a system for delivery of aliquots of the restorative composition into the space via a catheter.

46. The method of claim 45 wherein said micro-reamer is an expandable micro-reamer comprising an expandable cylindrical section in communication with an outer shaft, said outer shaft and expandable section both surrounding an inner shaft, and said expandable section comprising leaves that flex when said expandable section is actuated for creating a space for a composition.

47. The method of claim 46 wherein said leaves are situated along the length of the cylindrical section.

48. The method of claim 46 wherein said leaves are situated at an angle to the length of the cylindrical section.

49. The method of claim 46 wherein said expandable micro-reamer comprises an expandable section comprising an elastic metal, a composite material, a polymer, or other substance suitably expandable.

50. The method of claim 46 wherein the expandable section comprises nitinol.

51. The method of claim 46 wherein the outer shaft provides the means of expanding said expandable section.

52. The method of claim 46 wherein the outer shaft is divided into graded markings.

53. The method of claim 48 wherein the angle is from about 5 degrees to about 30 degrees.

54. The method of claim 53 wherein the angle is from about 10 degrees to about 15 degrees.

55. The method of claim 45 wherein said system comprises placing in said osseous defect a first aliquot of restorative composition through a first catheter and then placing in said space a second aliquot of composition through a second catheter.