Dispenser for an adhesive tissue sealant having a housing with multiple cavities

• US 6,458,095 B1
• Filed: 03/10/2000
• Issued: 10/01/2002
• Est. Priority Date: 10/22/1997
• Status: Expired due to Term

• Current Assignee: Neomend, Inc. (Becton, Dickinson & Co)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Smith, Jeffrey D., Dodge, Larry H., Wirt, David F.
• Primary Examiner(s): Huson, Gregory
• Assistant Examiner(s): NGUYEN, TUAN N
• Application Number:
  US09/524,141
• Time in Patent Office: 935 Days
• Field of Search: 604/82-86, 604/89, 604/90, 604/191, 604/208, 604/500, 604/506, 604/508, 604/522, 222/137, 222/145.1, 222/145.3, 222/145.4
• US Class Current: 604/82
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61M 11/06 of the injector type
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence

Abstract

A dispenser in which a dry powder (one component of a two-part adhesive tissue sealant and/or adhesive) is stored in a container (e.g., a carpule) having a septum at one end, an open end opposite the septum, and a movable plug. The powder is retained at the septum end of the container by the movable plug, which is displaced and pushed back as the solvent used for reconstituting the powder is introduced (e.g., through the septum). The second part of the tissue sealant is contained within a second container, also with a movable plug. After the first part is reconstituted, a manifold is fitted which pierces both septums and allows the contents to be dispensed. A dual syringe body supports the containers, and has pistons that enter the open ends to advance the movable plugs. Other embodiments of tissue adhesive and/or sealant dispensers and kits as well as methods of preparing tissue sealants are also described.

Claims

1. A dispenser for simultaneously dispensing first and second components of an adhesive tissue sealant, wherein at least the first component is stored in the dispenser as dry powder that is dissolved prior to use by introduction of a solvent, the dispenser comprising the combination of:

(a) a first container comprising a first septum at one end, an open end opposite the first septum, and a first movable plug disposed therein, the first container containing a quantity of the first component in the form of a dry powder stored between the first septum and the first movable plug;

(b) a second container comprising a second septum at one end, an open end opposite the second septum, and a second movable plug disposed therein, the second container containing a quantity of the second component;

(c) a housing having a pair of cavities sized and configured to receive and support the first and second containers, each cavity having a base,

(d) pistons sized and configured to be received in the open ends of the first and second containers to advance the first and second movable plugs; and

the housing including a manifold sized and configured to fit over and pierce the first and second septums and to afford passage of the first and second components via first and second flow paths to a nozzle from which the first and second components are dispensed to combine to form the adhesive tissue sealant,

first and second piercers mounted in the manifold for piercing the first and second septums, each piercer extending through and being supported by a disk that is supported adjacent the base of said each cavity, each disk being supported a distance spaced from the base of the first and second cavities to form first and second plenums, each plenum defined by said each disk and adjacent walls of said each cavity, the first and second piercers affording passage of the first and second components to the first and second plenums.

2. The dispenser of claim 1 wherein, prior to use, the first movable plug is positioned in a position in which the space between the plug and the septum is substantially the minimum necessary to contain the dry powder, thereby reducing the amount of air in that space.

3. The dispenser of claim 1 wherein the a nozzle is sized and configured so that the first and second components are kept separated until dispensed from the nozzle.

4. The dispenser of claim 1 wherein the second component stored in the second container comprises a liquid.

5. The dispenser of claim 4 wherein the second component is a protein in an aqueous buffer and is capable of reacting with a solution of the first component to provide the adhesive tissue sealant.

6. The dispenser of claim 5 wherein the dry powder forming the first component is a water-compatible or water-soluble cross-linking agent.

7. The dispenser of claim 1 in combination with means for introducing the liquid solvent through the first septum into the first container that is other than the piercers.

8. The dispenser of claim 1 in combination with a syringe sized and configured to inject a liquid solvent into the first container through the first septum.

9. The dispenser of claim 8 wherein the syringe is preloaded with the liquid solvent.

10. The dispenser of claim 8 combined as a kit.

11. The kit of claim 10 wherein the first and second containers are sterile filled and the kit is terminally sterilized.

12. The dispenser of claim 1 wherein the first and second containers are carpules.

13. The dispenser of claim 1 wherein the pistons are connected to form a dual piston.

14. A dispenser for simultaneously dispensing first and second components of a two-part adhesive tissue sealant composition, the dispenser comprising the combination of:

(a) a first container comprising a first septum at one end, an open end opposite the first septum, and a first movable plug disposed therein, the first container containing a quantity of the first component;

(b) a second container comprising a second septum at one end, an open end opposite the second septum, and a second movable plug disposed therein, the second container containing a quantity of the second component, the second component being different from the first component;

(c) a housing sized and configured to receive and support the first and second containers;

(d) pistons sized and configured to enter the open ends of the containers to advance the first and second movable plugs;

the housing including a manifold sized and configured to fit over the first and second septums, the manifold having first and second cavities into which the first and second containers are received, each cavity having a base;

(e) first and second piercers mounted in the manifold for piercing the first and second septums, each piercer extending through and being supported by a disk that is supported adjacent the base of said each cavity, each disk being supported a distance spaced from the base of the first and second cavities to form first and second plenums, each plenum defined by said each disk and adjacent walls of said each cavity, the first and second piercers affording passage of the first and second components to the first and second plenums;

(f) first and second conduits in the manifold that afford passage of the first and second components from the first and second plenums to a nozzle from which the first and second components may be combined to form the adhesive tissue sealant.

15. The dispenser of claim 14 wherein said each disk is sealed to the surrounding wall of said each cavity.

16. The dispenser of claim 15 wherein the seal between the disk and the surrounding wall is provided by an elastomeric seal member on the disk.

17. The dispenser of claim 15 wherein the surronding wall of the cavity is cylindrical and the periphery of the disk is circular.

18. The dispenser of claim 15 wherein one of the first and second conduits and one of the first and second piercers communicate with the corresponding plenum at laterally spaced apart locations so that flow from the piercer lumen to the conduit changes direction from a generally longitudinal flow path through the piercer lumen, to a generally lateral direction in the plenum, and then to a generally longitudinal flow path in the conduit.

19. The dispenser of claim 15 wherein said each disk is supported from the base of said each cavity by standoffs.

20. The dispenser of claim 14 wherein the first container contains a quantity of the first component in the form of a dry powder so that the first component must be dissolved prior to use by introduction of an aqueous solvent and wherein the second component is a protein in an aqueous buffer and the first component is capable of reacting with the second component to provide an adhesive tissue sealant.

21. The dispenser of claim 14 wherein the first and second containers are carpules.

22. The dispenser of claim 14 wherein the first and second containers are sterile filled and the dispenser is terminally sterilized.

23. A dispenser for simultaneously dispensing first and second components of a tissue sealant, wherein at least the first component is stored in the dispenser as dry powder that is dissolved prior to use by introduction of a solvent, the dispenser comprising:

(a) a first container comprising a first septum at one end, an open end opposite the first septum, and a first movable plug disposed therein, the first container containing a quantity of the first component in the form of a dry powder stored between the first septum and the first movable plug;

the dry powder being adapted to be dissolved in a solvent just prior to application of the tissue sealant;

(b) a second container comprising a second septum at one end, an open end opposite the second septum, and a second movable plug disposed therein, the second container containing a quantity of the second component;

(c) a housing having internal surfaces with first and second piercers adapted to pierce the first and second septums of the first and second containers, the first and second piercers being situated in protected positions so that the first and second septums may be pierced without exposing a user to contact with the first or second piercers, the housing affording passage of the first and second components via first and second flow paths to a nozzle from which the first and second components are dispensed to combine to form the adhesive tissue sealant,

(d) pistons sized and configured to be received in the open ends of the first and second containers to advance the first and second movable plugs; and

(e) a body associated with the housing and sized and shaped to receive the first and second containers.

24. A dispenser according to claim 23, wherein the body comprises a retainer that is sized and shaped to protect and support the first and second containers.

25. A dispenser according to claim 24 wherein the retainer includes attachment means for releasably engaging the housing.

26. A dispenser according to claim 25 wherein the retainer includes a distal end that includes the attachment means, and a proximal end having an opening, and the retainer is sized and shaped so that the open ends of the first and second containers do not project beyond the opening of the retainer.

27. A dispenser according to claim 23 wherein the first and second plugs have a lubricant coating to facilitate movement.

28. A dispenser according to claim 27 wherein the lubricant is silicone.

29. A dispenser according to claim 23 wherein the first and second piercers each extend through and are supported by a disk that is supported adjacent the base of a cavity by an O-ring with a lubricant.

30. A dispenser according to claim 29 wherein the lubricant is silicone.