Refillable fibrinogen dispensing kit

• US 5,656,035 A
• Filed: 04/25/1995
• Issued: 08/12/1997
• Est. Priority Date: 04/25/1995
• Status: Expired due to Fees

• Current Assignee: Donald R. Avoy
• Original Assignee: Donald R. Avoy
• Inventors: Avoy, Donald R.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/428,670
• Time in Patent Office: 840 Days
• Field of Search: 604/232, 604/234, 604/235, 604/88, 604/148, 604/191, 604/200, 604/201, 604/181, 604/411-414, 222/82, 222/135, 222/137, 222/255, 222/630, 222/631, 239/304, 239/307, 239/309, 239/333, 239/303, 239/306, 141/2, 141/18, 141/20.5, 141/21, 141/22, 141/29
• US Class Current: 604/191
• 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: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: B05B 1/26 with means for mechanically breaking-up or deflecting the jet after discharge, e.g. with fixed deflectors; Breaking-up the discharged liquid or other fluent material by impinging jets
• CPC Class Codes: B05B 11/1084 each liquid or other fluent material being pumped by a separate pump

Abstract

Disclosed is a refillable dispenser for separately dispensing each of two biological fluids contained therein for intermixing at a site outside of the dispenser to produce hemostasis or a tissue adhesive. The dispenser is compact, contains integrally formed internal reservoirs for the two biological fluids, an injection port on each reservoir for refilling the reservoir, and is designed for efficient filling without compromising the integrity of the sterile field. The dispenser is capable of dispensing the biological fluids, such as fibrinogen and thrombin, at either a focused point or in an aerosol mist. In addition, spray elements are disclosed for uniformly distributing the two biological fluids along either the interior surface or the exterior surface of an implantable vascular graft.

Claims

1. A refillable dispenser for separately dispensing each of two biological fluids contained therein for intermixing at a remote site to produce hemostasis or a tissue adhesive, comprising:

a housing having a dispenser head thereon for separately dispensing each of two fluids;

a first and second pump in the housing;

a first hollow aspirating tube in the housing, in fluid communication with the first pump;

a second hollow aspirating tube in the housing, in fluid communication with the second pump;

a first and second reservoir for biological fluids integrally formed in the housing;

a first fluid injection port on the housing for providing fluid communication between the first reservoir and a first external fluid source and a second fluid injection port on the housing for providing fluid communication between the second reservoir and a second external fluid source, the first and second injection ports being adapted to permit independent and sterile refilling of the first and second reservoirs; and

wherein the first aspirating tube extends into the first reservoir and the second aspirating tube extends into the second reservoir, so that activation of the first and second pump produces a flow of biological fluid from the first and second reservoirs through the first and second aspirating tubes and out of the dispenser head for intermixing at a remote site outside of the dispenser.

2. A dispenser as in claim 1, wherein each of the first and second injection ports comprises a luer fitting with a self-closing diaphragm or resealable septum.

3. A dispenser for separately dispensing each of two biological fluids contained therein for intermixing at a site outside of the dispenser to product hemostasis or a tissue adhesive, said dispenser adapted for removably receiving a refillable cassette containing the biological fluids so that the dispenser may be refilled by removing an exhausted cassette, refilling the cassette under sterile conditions, and then reinserting the cassette into the dispenser, the dispenser comprising:

a dispenser housing having a chamber adapted for removably receiving a cassette;

a cassette removably disposed in the housing, the cassette having a first and a second reservoir for biological fluids integrally formed in the cassette, the cassette further having a first fluid injection port on the cassette for providing fluid communication between the first reservoir and a first external fluid source, and a second fluid injection port on the cassette for providing fluid communication between the second reservoir and a second external fluid source, the first and second injection ports being adapted to permit independent and sterile refilling of the first and second reservoirs after the cassette is removed from the housing;

a first and a second pump in the housing;

a first hollow aspirating needle in the housing, in fluid communication with the first pump and extending into the chamber so that when a loaded cassette is positioned in the chamber the first hollow needle will provide a path of fluid communication between the first reservoir and the first pump; and

a second hollow aspirating needle in the housing, in fluid communication with the second pump and extending into the chamber so that when a loaded cassette is positioned in the chamber the second hollow needle will provide a path of fluid communication between the second reservoir and the second pump;

wherein the first and second pumps are placed in fluid communication with the first and second reservoirs, respectively, when the cassette is engaged with the dispenser housing, so that the first and second pump when activated, produce a flow of biological fluid from the first and second reservoirs through the first and second aspirating needles and out to the dispenser.

4. A refillable dispenser for separately dispensing each of two biological fluids contained therein for intermixing at a remote site to produce hemostasis or a tissue adhesive, comprising:

a housing having a dispenser head thereon for separately dispensing each of two fluids;

a first and second pump in the housing;

a first hollow aspirating tube in the housing, in fluid communication with the first pump;

a second hollow aspirating tube in the housing, in fluid communication with the second pump;

a first reservoir and a second reservoir for biological fluids positioned in the housing;

a first reservoir pump pathway positioned in the housing, and a first reservoir refill pathway positioned in the housing for providing fluid communication between the first reservoir and an external fluid source, and a second reservoir pump pathway positioned in the housing, and a second reservoir refill pathway positioned on the housing for providing fluid communication between the second reservoir and an external fluid source, wherein the first reservoir pump pathway is adapted to receive the first hollow aspirating tube, and the second reservoir pump pathway is adapted to receive the second hollow aspirating tube, and the first refill pathway is adapted to permit sterile and independent refilling of the first reservoir, and the second reservoir refill pathway is adapted to permit sterile and independent refilling of the second reservoir; and

wherein the first hollow aspirating tube extends through the first reservoir pump pathway and into the first reservoir and the second hollow aspirating tube extends through the second reservoir pump pathway and into the second reservoir, so that activation of the first and second pump produces a flow of biological fluid from the first and second reservoirs through the first and second aspirating tubes and out of the dispenser head for intermixing at a remote site outside of the dispenser.

5. The dispenser of claim 4, wherein the first reservoir refill pathway and the second reservoir refill pathway further comprise a first and second luer fitting with a self-closing diaphragm or resealable septum.

6. A method for sterile refilling of a biological fluid dispenser adapted for remote site intermixing of fluids maintained separately therein, comprising the steps of:

providing a biological fluid dispenser with a separate first and second fluid reservoir, and a first and second fluid injection port on the first and second fluid reservoir, respectively, wherein the first and second fluid reservoirs are in fluid communication with a dispenser head which is adapted to spray biological fluids for intermixing at a remote site outside the biological fluid dispenser;

attaching an external biological fluid source in a sterile manner to at least one of the injection ports;

transferring biological fluid from the external biological fluid source through the injection port to at least one of the reservoirs without disrupting the fluid communication between the dispenser head and the reservoirs; and

disengaging the external biological fluid source from the injection port.

7. The method of claim 6, wherein the injection ports are standard luer connectors and the external biological fluid source is a syringe filled with thrombin or fibrinogen.