Dual component medicinal polymer delivery system and methods of use

• US 6,610,033 B1
• Filed: 10/13/2000
• Issued: 08/26/2003
• Est. Priority Date: 10/13/2000
• Status: Expired due to Fees

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Melanson, David A., Lyman, Michelle D., Sawhney, Amarpreet S., Edelman, Peter G.
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US09/687,588
• Time in Patent Office: 1,047 Days
• Field of Search: 604/82, 604/83, 604/84, 604/85, 604/92, 604/187, 604/252, 604/93.01, 606/92, 606/93, 606/94
• US Class Current: 604/181
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/3139 Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: B05C 17/00516 Shape or geometry of the outlet orifice or the outlet element
• CPC Class Codes: B05C 17/00593 Hand tools of the syringe type

Abstract

The present invention provides apparatus and methods for making and using a medicinal polymer formed from two components. The apparatus includes a double syringe holder housing first and second syringes that is adapted to be coupled with a predetermined orientation to a double vial holder housing first and second vials. The double syringe holder and double vial holder have mating key features that prevent the first syringe from being coupled to the second vial and the second syringe from being coupled to the first vial. The apparatus also includes a delivery device having first and second inlet ports and a key feature that prevents the first syringe from being coupled to the second inlet port and the second syringe from being coupled to the first inlet port.

Claims

1. Apparatus for reconstituting and using a medicinal polymer from first and second components, the apparatus comprising:

a double syringe holder having a first key feature and housing first and second syringes; and

a double vial holder comprising a second key feature and housing first and second vials,

the second key feature adapted to mate with the first key feature with a predetermined orientation;

with the first and the second components of the medicinal polymer being disposed in at least one member of the group consisting of the vials and the syringes; and

connectors for coupling the first and second syringes to the first and second vials, respectively, when the first key feature mates to the second key feature.

2. The apparatus of claim 1 further comprising a delivery device, the delivery device comprising a third key feature adapted to mate with the first key feature with a predetermined orientation.

3. The apparatus of claim 2 wherein the delivery device further comprises first and second inlet ports, the first and second inlet ports coupling to the first and second syringes, respectively, when the first key feature mates to the third key feature.

4. The apparatus of claim 1 wherein the double syringe holder further comprises a handle portion.

5. The apparatus of claim 1 wherein the double syringe holder further comprises a first groove and a second groove and wherein the first syringe is disposed within the first groove and the second syringe is disposed within the second groove.

6. The apparatus of claim 5 wherein the double syringe holder further comprises:

a first plurality of clips protruding through a first plurality of holes in the first groove to retain the first syringe in the first groove; and

a second plurality of clips protruding through a second plurality of holes in the second groove to retain the second syringe in the second groove.

7. The apparatus of claim 1 wherein the double vial holder further comprises a first groove for retaining the first vial and a second groove for retaining the second vial.

8. The apparatus of claim 7 wherein the double vial holder further comprises:

a plurality of clips protruding through a plurality of holes in the first and second grooves to retain the first and second vials in the first and second grooves, respectively.

9. The apparatus of claim 2 wherein the delivery device further comprises first and second lumens coupled to the first and second inlet ports, respectively.

10. The apparatus of claim 9 wherein the delivery device includes first and second outlet ports, the first and second outlet ports coupled to the first and second lumens, respectively.

11. A method for making and delivering first and second components that form a medicinal polymer, the method comprising:

providing a double syringe holder having a first key feature and housing first and second syringes;

providing a double vial holder housing first and second vials;

placing the first component and the second component into separate vials or syringes; and

coupling the double syringe holder to the double vial holder via a second key feature adapted to mate with a first key feature with a predetermined orientation so that the first syringe couples to the first vial and the second syringe couples to the second vial.

12. The method of claim 11 further comprising:

actuating the first and second syringes to introduce the first liquid into the first vial and the second liquid into the second vial; and

after the first liquid dissolves the first powder to form a first component and the second dissolves the second powder to form a second component, actuating the first and second syringes to withdraw the first component into the first syringe and the second component into the second syringe.

13. The method of claim 12 further comprising, prior to actuating the first and second syringes to withdraw the first and second components, agitating the first and second vials.

14. The method of claim 12 further comprising connecting a delivery device with a predetermined orientation by uncoupling the double syringe holder from the double vial holder, and coupling the double syringe holder to the delivery device with a predetermined orientation.

15. The method of claim 14 further comprising actuating the first and second syringes to introduce the first and second components through the delivery device to a target site.

16. The method of claim 15 further comprising positioning a distal end of the delivery device at a target site by advancing the distal end of the delivery device along a guidewire.

17. The method of claim 11 wherein providing a double syringe holder further comprises inserting a first syringe into a first groove of the double syringe holder and inserting a second syringe into a second groove of the double syringe holder.

18. The method of claim 17 wherein inserting a first syringe into a first groove of the double syringe holder comprises actuating a first plurality of clips protruding through a first plurality of holes in the first groove, and inserting a second syringe into the second groove of the double syringe holder comprised actuating a second plurality of clips protruding through a second plurality of holes in the second groove.

19. The method of claim 11 wherein providing a double vial holder further comprises inserting a first vial into a first groove of the double vial holder and inserting a second vial into a second groove of the double vial holder.

20. The method of claim 19 wherein inserting the first and second vials into the first and second grooves, respectively, further comprises actuating a plurality of clips protruding through a plurality of holes in the first and second grooves of the double vial holder.