High pressure delivery system

• US 20040249347A1
• Filed: 12/04/2002
• Published: 12/09/2004
• Est. Priority Date: 09/30/1999
• Status: Active Grant

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Preissman, Howard E., Miller, Scott H.
• Granted Patent: US 7,048,743 B2
• Time in Patent Office: Days
• US Class Current: 604/181
• 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

Abstract

This relates to an improved delivery system for accurately loading and controlling the delivery of flowable material to a patient. Particularly, the system may be used in the injection of hard tissue implant materials such as PMMA under pressures up to about 4000 psi. The system includes an applicator with a first column having an implant material introduction section adapted to provide for effective loading of the implant material and a second column housing a piston. The introduction section has a larger size than that of a vessel section or bore in which the requisite pressure seal between the piston and bore wall is formed. The first column may include an introduction section flared open to an included larger funnel-like opening or a separate funnel may be used that interfaces with the introduction section to facilitate the introduction of implant material. Handles on the first and second columns to be turned relative to each other to advance the columns toward each other may be provided for manual actuation of the applicator to drive implant material through a cannula and deliver implant material to a desired site.

Claims

1. A high pressure applicator for driving the delivery of a flowable tissue implant material comprising:

a first column including a vessel section and an introduction section, said vessel section defining a substantially smooth bore having an outlet and an entrance adjoining said introduction section, said introduction section defining an opening having a larger cross-sectional area than said bore;

a second column drivably engageable with said receptacle member along an advancement axis; and

a piston member having a base and head, wherein said head is adapted to form a high-pressure seal in said bore and said base is positioned against a portion of said second column.

2. The applicator of claim 1 wherein said bore is cylindrical.

3. The applicator of claim 2 wherein at least a portion of said opening of said introduction section has a circular cross-section perpendicular to said advancement axis.

4. The applicator of claim 3 wherein said driveable engagement comprises a threaded interface on an outer portion of said first column and an inner portion of said second column.

5. The applicator of claim 1 wherein a handle is provided for said second column.

6. The applicator of claim 5 wherein said handle is in the form of a scalloped member at an end of said second column.

7. The applicator of claim 1 wherein a handle is provided for said first column.

8. The applicator of claim 7 wherein said handle is in the form of a member extending substantially perpendicular to said driving axis at an end of said first column.

9. The applicator of claim 1 wherein said piston head is sized for a close fit with said bore.

10. The applicator of claim 1 wherein said piston head has a groove and an O-ring configured to form a seal in said bore.

11. The applicator of claim 10 wherein said O-ring comprises PTFE/TEFLON.

12. A kit comprising the applicator of claim 1 in combination with tissue implant material.

13. The kit of claim 12 wherein said implant material comprises PMMA.

14. The applicator of claim 1 wherein said outlet exhausts though a Luer fitting.

15. The applicator of claim 14 wherein said Luer fitting is integrally formed in said first column.

16. The applicator of claim 15 wherein said first column comprises clear amorphous nylon.

17. The applicator of claim 16 wherein said second column comprises amorphous nylon.

18. The applicator of claim 1 wherein said base of said piston member is frictionally engaged with said second column by a restraint adapted to allow said piston member to turn during operation of the applicator.

19. The applicator of claim 4 wherein a smooth transition section connects said bore and said introduction section.

20. The applicator of claim 4 further comprising an integrated funnel section adjacent to said introduction section, said funnel section having an opening with a diameter between about 1 and about 2 inches.

21. The applicator of claim 20 wherein said funnel section has a height between about 0.25 and about 1.75 inches.

22. The applicator of claim 4 wherein said introduction section has a diameter between about 0.010 to about 0.25 greater than a diameter of said vessel opening.

23. The applicator of claim 22 wherein said introduction section has a height between about 0.1 and about 0.5 inches.

24. The applicator of claim 23 in combination with an independent funnel member adapted to interface with said introduction section.

25. The applicator of claim 1 wherein it is adapted to generate about 4000 psi with tissue implant material by hand actuation.

26. A high pressure applicator for driving the delivery of a flowable tissue implant material comprising:

a first column including a vessel section and an introduction section, said vessel section defining a substantially smooth bore having an outlet and an entrance open to said introduction section, said introduction section being flared open for at least one portion;

a second column drivably engageable with said first column along an advancement axis; and

a piston member a base and head, wherein said head is adapted to form a high-pressure seal in said bore and said base is positioned against a portion of said second column.

27. A high pressure applicator for driving the delivery of a flowable tissue implant material comprising:

a first column including a vessel section and an introduction section, said vessel section defining a substantially smooth bore having an outlet and an entrance open to said introduction section;

a second column drivably engageable with said first column along an advancement axis; and

a piston member having a base and head, wherein said head is adapted to form a high-pressure seal in said bore and said base is positioned against a portion of said second column,

wherein said piston head, said introduction section, and said vessel section are adapted to enable introduction of said piston head into said first column with the presence of the flowable tissue implant material without the introduction of a pocket of air into said vessel section.

28. A method of preparing a high pressure applicator for driving the delivery of a flowable tissue implant material for use comprising:

providing an applicator having a first column including a vessel section having a bore and an introduction section, a second column drivably engageable with said receptacle member along an advancement axis and a piston member having a base and a piston head;

filling the first column with implant material over the vessel section and at least partially into the introduction section;

introducing the head of the piston into the implant material; and

driving at least the head portion of the piston into the vessel section of the first column to form a high pressure seal between the bore and piston head without the introduction of compliant matter.

29. A method of introducing tissue implant material into a patient comprising:

preparing the applicator substantially as described in claim 28;

connecting a noncompliant tube in fluid communication with an outlet of the applicator;

connecting the tube to an inlet of a cannula in fluid communication with an implantation site; and

advancing the piston into the bore of the vessel of the first column to force a flow of the implant material into the implantation site.

30. The method of claim 29 wherein said advancement is achieved by hand turning the first and second columns relative to each other along a threaded interface between the columns.

31. The method of claim 29 wherein the first column is stabilized in a substantially constant position and the second column is turned.

32. A system for percutaneously delivering implant material, comprising:

a delivery port providing percutaneous access to an implant site;

a high pressure applicator for driving the delivery of the implant material; and

a substantially non-compliant tube adapted to interconnect with said high pressure applicator and said delivery port.

33. The system of claim 32, wherein said delivery port comprises a cannula.

37. The system of claim 32, wherein said substantially non-compliant tube has a compliance of less than about 25% internal volume change when pressurized internally to about 1200 psi, compared to a starting internal volume of said tube at atmospheric pressure.

38. The system of claim 32, wherein said system has a compliance of less than about 25% internal volume change when pressurized internally to about 1200 psi, compared to a starting internal volume of said system at atmospheric pressure.

39. The system of claim 32, wherein said high pressure applicator comprises a first column and a second column driveably engageable with said first column, said first column having a vessel section and an introduction section.

40. The system of claim 32, said delivery device comprising an input fitting, said applicator comprising an output fitting, and said conduit comprising first and second fittings at first and second ends thereof, respectively, wherein said first fitting releasably connects to said output fitting to provide a pressure tight seal therewith and said second fitting releasably connects to said input fitting to provide a pressure tight seal therewith.

34. The system of claim 34, wherein said substantially non-compliant tube comprises a flexible tube.

35. The system of claim 34, wherein said flexible, substantially non-compliant tube comprises a flexible tubing wall having a coil in said wall, said coil preventing radial expansion of said flexible tube.

36. The system of claim 34, wherein said flexible, substantially non-compliant tube comprises a material selected from the group consisting of polyvinyl chlorides, Nylon blends, FEP and PEEK.