Apparatus and method for delivery of biologic sealant

• US 20080060970A1
• Filed: 10/24/2007
• Published: 03/13/2008
• Est. Priority Date: 10/29/2004
• Status: Active Grant

• Current Assignee: Kevin Pauza
• Original Assignee: Spinal Restoration, Inc.
• Inventors: Wheeler, John, Gentile, Andrew, Ratz, J., Washburn, Thomas, Boccuti, A., Spiridigliozzi, John, Whipple, Gary
• Granted Patent: US 8,047,407 B2
• Time in Patent Office: Days
• US Class Current: 206/570
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/363 Fibrinogen
• CPC Class Codes: A61K 38/482 Serine endopeptidases (3.4.21)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/225 Fibrin; Fibrinogen
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: B05C 17/00553 with means allowing the stock of material to consist of at least two different components
• CPC Class Codes: B05C 17/0116 characterised by the piston driving means B05C17/0103, B05C17/0109, B05C17/0113, B05C17/015 take precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A device for delivery of biologic materials, comprising: a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid, a plunger within each cylinder for pushing the fluids out of the cylinder, a housing adapted to receive the cartridge, wherein the housing or cartridge includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge, at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore, a trigger connected to the housing, wherein the trigger includes a toothed drive rack, a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams, as well as methods of making the device, methods of using the device to treat discs, kits including the device.

Claims

1. A device for delivery of biologic materials, comprising:

a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid,

a plunger within each cylinder for pushing the fluids out of the cylinder,

a housing adapted to receive the cartridge, wherein the housing or cartridge includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge,

at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore,

a trigger connected to the housing, wherein the trigger includes a toothed drive rack,

a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams.

2. The device of claim 1, wherein the cartridge is a separate component from the housing that is inserted into the housing.

3. The device of claim 1, further comprising a pressure monometer operably connected to measure the pressure in at least one cylinder.

4. The device of claim 1, wherein the plungers are attached to the rams.

5. The device of claim 1, wherein the wheel assembly includes an inner toothed wheel sandwiched between two outer toothed wheels each of smaller diameter than the inner wheel.

6. The device of claim 1, wherein the drive rack engages the wheel assembly upon manual pressure to the trigger and wherein the drive rack disengages the wheel assembly upon release of pressure on the trigger, and falls away.

7. The device of claim 1, further comprising a fill manifold for introducing fluids into the cylinder, wherein the fill manifold comprises a fill manifold adaptor that couples to the adaptor of the delivery device wherein the adaptor includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two syringes, at least two conduits wherein one end of the conduit connects to the syringe and a second end of the conduit connects to an exit port of the fill manifold adaptor.

8. The device of claim 1, further comprising a delivery manifold for delivering the fluids, comprising a delivery adaptor that includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two conduits having two ends wherein a first end of each of the conduits connects to an exit port of the delivery manifold, and wherein a second end of each of the conduits connects to a duel port luer fittings, wherein the luer fitting is configured to deliver fluid from one conduit to an inner needle and wherein the luer fitting is configured to deliver fluid from the second conduit to a space defined by the exterior of the inner needle and by a second larger diameter needle that connects to the luer fitting with the inner needle being within the insider of the larger diameter needle.

9. The device of claim 8, wherein the inner needle does not extend past a distal tip of the second needle.

10. A method of making a device for delivery of biologic materials, comprising:

providing a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid,

providing a plunger within each cylinder for pushing the fluids out of the cylinder,

providing a housing adapted to receive the cartridge, wherein the housing or cartridge includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge,

providing at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore,

providing a trigger connected to the housing, wherein the trigger includes a toothed drive rack,

providing a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams.

11. The method of claim 10, wherein the housing and the cartridge are together monolithic.

12. The method of claim 10, wherein the cartridge is a separate component from the housing that is inserted into the housing.

13. The method of claim 10, further comprising providing a pressure monometer operably connected to measure the pressure in at least one cylinder.

14. The method of claim 10, wherein the plungers are attached to the rams.

15. The method of claim 10, wherein the wheel assembly includes an inner toothed wheel sandwiched between two outer toothed wheels each of smaller diameter than the inner wheel.

16. The method of claim 10, wherein the drive rack engages the wheel assembly upon manual pressure to the trigger and wherein the drive rack disengages the wheel assembly upon release of pressure on the trigger, and falls away.

17. The method of claim 10, further comprising providing a fill manifold for introducing fluids into the cylinder, wherein the fill manifold comprises a fill manifold adaptor that couples to the adaptor of the delivery device wherein the adaptor includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two syringes, at least two conduits wherein one end of the conduit connects to the syringe and a second end of the conduit connects to an exit port of the fill manifold adaptor.

18. The method of claim 10, further comprising providing a delivery manifold for delivering the fluids, comprising a delivery adaptor that includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two conduits having two ends wherein a first end of each of the conduits connects to an exit port of the delivery manifold, and wherein a second end of each of the conduits connects to a duel port luer fittings, wherein the luer fitting is configured to deliver fluid from one conduit to an inner needle and wherein the luer fitting is configured to deliver fluid from the second conduit to a space defined by the exterior of the inner needle and by a second larger diameter needle that connects to the luer fitting with the inner needle being within the insider of the larger diameter needle.

19. The method of claim 10, wherein the inner needle does not extend past a distal tip of the second needle.

20. A kit for treating a disc, comprising:

fibrinogen, thrombin, and a device for delivery of biologic materials, wherein the device comprises;

a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid,

a plunger within each cylinder for pushing the fluids out of the cylinder,

a housing adapted to receive the cartridge, wherein the housing or cartridge includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge,

at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore,

a trigger connected to the housing, wherein the trigger includes a toothed drive rack,

a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams.

21. The kit of claim 20, the cartridge is a separate component from the housing that is inserted into the housing, wherein the kit further comprises a pressure monometer operably connected to measure the pressure in at least one cylinder;

wherein the plungers are attached to the rams;

wherein the wheel assembly includes an inner toothed wheel sandwiched between two outer toothed wheels each of smaller diameter than the inner wheel;

wherein the drive rack engages the wheel assembly upon manual pressure to the trigger and wherein the drive rack disengages the wheel assembly upon release of pressure on the trigger, and falls away;

wherein the kit further comprises a fill manifold for introducing fluids into the cylinder, wherein the fill manifold comprises a fill manifold adaptor that couples to the adaptor of the delivery device wherein the adaptor includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two syringes, at least two conduits wherein one end of the conduit connects to the syringe and a second end of the conduit connects to an exit port of the fill manifold adaptor;

wherein the kit further comprises a delivery manifold for delivering the fluids, comprising a delivery adaptor that includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two conduits having two ends wherein a first end of each of the conduits connects to an exit port of the delivery manifold, and wherein a second end of each of the conduits connects to a duel port luer fittings, wherein the luer fitting is configured to deliver fluid from one conduit to an inner needle and wherein the luer fitting is configured to deliver fluid from the second conduit to a space defined by the exterior of the inner needle and by a second larger diameter needle that connects to the luer fitting with the inner needle being within the insider of the larger diameter needle; and

wherein the inner needle does not extend past a distal tip of the second needle.

22. A method of making a kit, comprising providing fibrinogen, providing thrombin, and providing a device for delivery of biologic materials, wherein the device comprises:

a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid,

a plunger within each cylinder for pushing the fluids out of the cylinder,

a housing adapted to receive the cartridge, wherein the housing or cartridge includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge,

at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore,

a trigger connected to the housing, wherein the trigger includes a toothed drive rack,

a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams.

23. The method of claim 22, wherein the cartridge is a separate component from the housing that is inserted into the housing further comprising providing a pressure monometer operably connected to measure the pressure in at least one cylinder;

wherein the plungers are attached to the rams;

wherein the wheel assembly includes an inner toothed wheel sandwiched between two outer toothed wheels each of smaller diameter than the inner wheel;

wherein the drive rack engages the wheel assembly upon manual pressure to the trigger and wherein the drive rack disengages the wheel assembly upon release of pressure on the trigger, and falls away;

further comprising providing a fill manifold for introducing fluids into the cylinder, wherein the fill manifold comprises a fill manifold adaptor that couples to the adaptor of the delivery device wherein the adaptor includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two syringes, at least two conduits wherein one end of the conduit connects to the syringe and a second end of the conduit connects to an exit port of the fill manifold adaptor;

further comprising providing a delivery manifold for delivering the fluids, comprising a delivery adaptor that includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two conduits having two ends wherein a first end of each of the conduits connects to an exit port of the delivery manifold, and wherein a second end of each of the conduits connects to a duel port luer fittings, wherein the luer fitting is configured to delivery fluid from one conduit to an inner needle and wherein the luer fitting is configured to delivery fluid from the second conduit to a space defined by the exterior of the inner needle and by a second larger diameter needle that connects to the luer fitting with the inner needle being within the insider of the larger diameter needle; and

wherein the inner needle does not extend past a distal tip of the second needle.

24. A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus, comprising:

injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and thrombin, wherein the fibrin sealant is injected using a delivery device that comprises;

a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid,

a plunger within each cylinder for pushing the fluids out of the cylinder,

a housing adapted to receive the cartridge, wherein the housing or cartridge includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge,

at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore,

a trigger connected to the housing, wherein the trigger includes a toothed drive rack,

a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams.

25. The method of claim 24, wherein the cartridge is a separate component from the housing that is inserted into the housing;

further comprising providing a pressure monometer operably connected to measure the pressure in at least one cylinder;

wherein the plungers are attached to the rams;

wherein the wheel assembly includes an inner toothed wheel sandwiched between two outer toothed wheels each of smaller diameter than the inner wheel;

wherein the drive rack engages the wheel assembly upon manual pressure to the trigger and wherein the drive rack disengages the wheel assembly upon release of pressure on the trigger, and falls away;

further comprising providing a fill manifold for introducing fluids into the cylinder, wherein the fill manifold comprises a fill manifold adaptor that couples to the adaptor of the delivery device wherein the adaptor includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two syringes, at least two conduits wherein one end of the conduit connects to the syringe and a second end of the conduit connects to an exit port of the fill manifold adaptor;

further comprising providing a delivery manifold for delivering the fluids, comprising a delivery adaptor that includes at least two exit ports that each couple to the at least two exit ports of the housing adaptor, at least two conduits having two ends wherein a first end of each of the conduits connects to an exit port of the delivery manifold, and wherein a second end of each of the conduits connects to a duel port luer fittings, wherein the luer fitting is configured to delivery fluid from one conduit to an inner needle and wherein the luer fitting is configured to delivery fluid from the second conduit to a space defined by the exterior of the inner needle and by a second larger diameter needle that connects to the luer fitting with the inner needle being within the insider of the larger diameter needle; and

wherein the inner needle does not extend past a distal tip of the second needle.