Dispenser for an adhesive tissue sealant

• US 6,569,113 B2
• Filed: 08/09/2002
• Issued: 05/27/2003
• 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., Wirt, David F., Dodge, Larry H.
• Primary Examiner(s): Huson, Gregory
• Assistant Examiner(s): NGUYEN, TUAN N
• Application Number:
  US10/216,406
• Publication Number:
  US 20020198490A1
• Time in Patent Office: 291 Days
• Field of Search: 604/82-87, 604/89, 604/90, 604/181, 604/187, 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: 604/84
• 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 method of preparing a multiple component tissue sealant and/or adhesive just prior to use comprising the steps of:

providing a first container having a septum and a dry powder stored therein;

providing a second container having a septum and a liquid therein;

providing a vial with a solvent for the dry powder therein;

providing a syringe and needle;

providing a housing having first and second piercers located in protected positions and a portion that is sized and shaped to receive the first and second containers;

withdrawing the solvent from the vial with the syringe and needle;

placing the solvent in the first container; and

installing the first and second containers in the housing and piercing the septums of the first and second containers with the first and second piercers without exposing a user to physical contact with the piercers.

2. A method according to claim 1 wherein the first and second components may be dispensed without being heated above room temperature.

3. A method according to claim 1 where the step of providing a syringe and needle comprises the step of providing a single syringe and a single needle for the syringe.

4. A method according to claim 1 wherein the first and second containers, the dispenser, the vial and syringe and needle are provided in sterile condition so that the tissue adhesive and/or sealant may be prepared by a single healthcare worker associated with a sterile field without the need to coordinate with another healthcare worker outside the sterile field.

5. A method according to claim 1 wherein the multiple component tissue sealant and/or adhesive comprises a two component tissue sealant and/or adhesive;

and

the second component is provided as the liquid in the second container without requiring reconstitution of the second component just prior to use of the tissue sealant and/or adhesive.

6. A method according to claim 1 wherein the step of placing the solvent in the first container and the steps of installing the first and second containers in the housing and piercing the septums of the first and second containers with the first and second piercers are conducted by a single healthcare worker.

7. A method according to claim 1 further comprising the step of providing a dispensing tip that is attachable to the housing.

8. A method according to claim 1 wherein the first and second containers, the dispenser, the vial and syringe and needle are provided in sterile condition within a first package and the first package is provided in a sterile condition within a second package so that the second package may be opened by a healthcare worker outside a sterile field and the first package may be aseptically taken from the second package and placed in the sterile field by a healthcare worker associated with the sterile field.

9. A kit having components useful for preparing and delivering a tissue sealant and/or adhesive having first and second components, the kit comprising:

a first container having a septum, at least a portion of the first component stored therein, and outer portions;

a second container having at least a portion of the second component therein, a septum, and outer portions;

a vial with a solvent for at least one of the first and second components therein;

a syringe and needle; and

a sterile housing having first and second piercers located in protected positions and a portion that is sized and shaped to receive the first and second containers.

10. A kit according to claim 9 wherein the kit comprises a single syringe and a single needle.

11. A kit according to claim 9 wherein the kit is free of any solution for reconstituting the second component within the second container.

12. A kit according to claim 9 wherein the components of the kit are packaged within a first package and the first package is packaged within a second package and the components within the second package are provided in a sterile condition.

13. A kit according to claim 9 wherein the outer portions of the first and second containers are provided in a sterile condition.

14. A kit according to claim 9 wherein the portion of the first component stored in the first container is a dry powder, and

the vial includes a solvent for the dry powder.

15. A kit according to claim 9 wherein the portion of the second component in the second container comprises the second component in the form of a liquid.