Bioadhesive mixing and preparation systems and methods using two syringes

Patent metadata

Field	Value
Publication number	US-9717487-B2
Application number	US-201313779031-A
Country	US
Kind code	B2
Filing date	Feb 27, 2013
Priority date	Nov 14, 2012
Publication date	Aug 1, 2017
Grant date	Aug 1, 2017

Abstract

A bioadhesive mixing assembly includes first and second syringes and an adapter. The first syringe includes first and second chambers holding a first sealant component and an activator, respectively. The second syringe includes third and fourth chambers holding a second sealant component and one of an activator or a third sealant component, respectively. The adapter is mounted to the first syringe and includes first and second channels in flow communication with the first and second chambers, a first seal member providing sealed access to the first and second channels, first and second needles connected in flow communication with the third and fourth chambers, and a second seal member enclosing the first and second needles. Connecting the adapter to the second syringe punctures the first and second seal members with the first and second syringes to create flow communication between the first and third chambers and the second and fourth chambers.

First claim

What is claimed is:

1. A bioadhesive mixing assembly, comprising:
a first syringe having first and second chambers holding a first sealant component and an activator, respectively;
a second syringe having third and fourth chambers holding a second sealant component and one of another activator or a third sealant component, respectively;
an adapter mounted to the first syringe and comprising:
first and second channels in flow communication with the first and second chambers;
a first seal member providing sealed access to the first and second channels;
at least one protrusion;

first and second needles connected in flow communication with the third and fourth chambers;
a connector attached to the second syringe, the connector defining a chamber, the first and second needles being positioned within the chamber, the chamber having a connector lip, the at least one protrusion of the adapter engaging the connector lip;
a second seal member enclosing the first and second needles within the chamber of the connector;
wherein connecting the adapter to the second syringe punctures the first and second seal members with the first and second syringes to create flow communication between the first and third chambers and the second and fourth chambers.

2. The bioadhesive mixing assembly of claim 1 , wherein one of the first and second sealant components is stored under vacuum pressure.

3. The bioadhesive mixing assembly of claim 1 , wherein the first and second seal members comprise a rubber septum.

4. The bioadhesive mixing assembly of claim 1 , wherein the adapter and second syringe are connected together with a snap-fit connection.

5. The bioadhesive mixing assembly of claim 1 , wherein flow communication is created between the first and second syringes by relative longitudinal movement between the adapter and second syringe.

6. The bioadhesive mixing assembly of claim 1 , further comprising a first removable foil cap positioned on the first seal member, and a second removable foil cap positioned on the second seal member.

7. The bioadhesive mixing assembly of claim 1 , wherein the first sealant component comprises acrylate, and the second sealant component comprises one of PEG and thiol.

8. The bioadhesive mixing assembly of claim 1 , wherein the adapter includes at least one release tab to releasably connect the adapter to one of the first and second syringes.

9. The bioadhesive mixing assembly of claim 1 , wherein operating at least one of the first and second syringes mixes the first and second sealant components together, and mixes the activator and one of the another activator or the third sealant component.

10. A vascular closure system, comprising:
a sealant delivery device, comprising:
a delivery tube;

a sealant manifold;
a sealant mixing assembly, comprising:
a first syringe carrying at least a first sealant component;
a second syringe carrying at least a second sealant component, the second syringe having a first needle and a second needle;
an adapter connected to the first syringe and in flow communication with the first sealant component;
a stop extending from the adapter;
a connector attached to the second syringe, the connector having an end opening;
a lip extending inward from the end opening of the connector, the lip engaging the stop of the adapter;
a first rupturable seal carried by the adapter and configured to be ruptured upon connecting the adapter to the connector of the second syringe;
a second rupturable seal carried by the second syringe on the connector and configured to be ruptured upon connecting the adapter to the connector of the second syringe, the first and second needles being positioned within the second rupturable seal;
wherein the sealant mixing assembly is operable to mix the first and second sealant components, store the mixed first and second sealant components in at least one of the first and second syringes, and deliver the mixed first and second sealant components to the sealant delivery device via connection to the sealant manifold.

11. The vascular closure system of claim 10 , wherein at least one of the first and second rupturable seals comprise a rubber septum.

12. The vascular closure system of claim 10 , the first and second needles being configured to rupture the first and second rupturable seals upon connecting the adapter to the second syringe.

13. The vascular closure system of claim 10 , wherein each of the first and second syringes stores the mixed first and second sealant components.

14. The vascular closure system of claim 10 , wherein at least one of the first and second syringes carries a sealant component under vacuum.

15. The vascular closure system of claim 10 , wherein the adapter and second syringe are connected with a snap-fit connection.

16. The vascular closure system of claim 10 , wherein the first and second syringes are releasably connected to the adapter.

17. A method of delivering sealant to a tissue puncture, comprising:
providing a sealant delivery device and sealant mixing device, the sealant delivery device comprising a delivery tube insertable into a tissue puncture, the sealant mixing device comprising an adapter, a connector, and first and second syringes, the first syringe holding at least a first sealant component, and the second syringe holding at least a second sealant component, the second syringe having a first needle and a second needle, the connector being attached to the second syringe, the connector having an inwardly-extending lip, the adapter including a first sealing member and the connector including a second sealing member, the first and second needles being positioned within the second sealing member, the adapter including a protrusion;
connecting the adapter in fluid communication with the first syringe;
connecting the adapter to the connector of the second syringe to rupture the first and second sealing members, the lip engaging the protrusion, wherein rupturing the first and second sealing members connects the first and second syringes in flow communication to mix the first and second sealant components;
disconnecting one of the first and second syringes from the adapter, the one of the first and second syringes carrying the mixed first and second sealant components;
connecting the one of the first and second syringes in flow communication with the delivery tube;
delivering the mixed first and second sealant components through the delivery tube to the tissue puncture.

18. The method of claim 17 , wherein connecting the adapter to the second syringe includes providing a snap-fit connection between the adapter and the second syringe.

19. The method of claim 17 , wherein connecting the adapter to the second syringe ruptures the first and second sealing members with at least one of the first and second needles.

20. The method of claim 17 , wherein the adapter is releasably connected to at least one of the first and second syringes.

21. A method of preparing bioadhesive sealant for use in sealing a tissue puncture, comprising:
providing first and second syringes, a connector, and an adapter, the first syringe carrying at least a first sealant component and the second syringe carrying at least a second sealant component, the second syringe having a first needle and a second needle, the connector being attached to the second syringe, the connector comprising a first seal and the adapter comprising a second seal, the first and second needles being positioned within the first seal;
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Assignees

• St Jude Medical Puerto Rico

Inventors

• White Troy T
• Tegels Zachary J
• Parsonage Edward E
• Terwey Russell D
• Escobar Martha
• Mcglinch Timothy M
• Kaeferlein Bernhard

Classifications

• A61B2017/00495

  for two-component glue · CPC title

• A61B2017/0065

  the implement being an adhesive · CPC title

• A61B17/0057

  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 title

• A61B2017/22067

  Blocking; Occlusion (A61B2017/22054 takes precedence) · CPC title

• A61B17/00491 Primary

  Surgical glue applicators · CPC title