Method of filling a device

• US 7,779,609 B2
• Filed: 03/05/2007
• Issued: 08/24/2010
• Est. Priority Date: 10/03/2001
• Status: Expired due to Fees

• Current Assignee: Medical Instill Technologies Inc.
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Py, Daniel
• Primary Examiner(s): GERRITY, STEPHEN FRANCIS
• Application Number:
  US11/714,004
• Publication Number:
  US 20070156102A1
• Time in Patent Office: 1,268 Days
• Field of Search: 534/25, 534/26, 534/32, 534/67, 534/77, 531/67, 532/845, 532/85, 535/10, 141/2, 141/18, 141/82, 141/85, 141/329
• US Class Current: 53/426
• CPC Class Codes: A61J 1/2041 having removable plugs
• CPC Class Codes: A61J 1/2044 having slits
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• 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 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence

Abstract

A syringe and a reconstitution syringe are provided for the delivery of controlled doses of any of numerous different sterile substances, such as vaccines, medicaments, pharmaceutical preparations, cosmetics, and food products. A plunger of the syringe defines a resealable stopper frictionally and slidably received within a hollow syringe body for dispensing the medicament or other substance through a dispensing tip of the syringe upon movement of the plunger. The resealable stopper defines a heat-sealable portion to allow the stopper to be penetrated by a needle or other filling device to fill the syringe with a medicament or other substance, and in turn allow the hole remaining upon withdrawal of the needle to be heat sealed by transmission of laser energy thereon. The plunger assembly further defines a plurality of cam-like members that each engage and cooperate with a respective helical path of steps formed on the inner wall of the syringe body to provide stepwise movement of the plunger and, in turn, precise metering of the substance dispensed therefrom. A reconstitution syringe defines within a syringe body plural compartments, wherein each compartment stores a respective component of a multi-component medicament or other preparation. An elastomeric plug is coupled to the plunger and connected between the two compartments to prevent intermixing of the components. Upon moving the plunger, the plug is released to thereby place the compartments in fluid communication with each other, and to facilitate intermixing of the components upon shaking the syringe.

Claims

1. A method comprising the following steps:

providing a syringe including a syringe body, a plunger slidably received within the syringe body, and a resealable stopper including a resealable portion fusible in response to the application of thermal energy thereto;

sterilizing an exposed surface of the stopper;

penetrating the stopper with a needle coupled in fluid communication with a source of a substance;

introducing the substance through the needle and into the interior of the syringe body;

withdrawing the needle from the stopper; and

applying sufficient thermal energy to the penetrated region of the resealable portion of the stopper to fuse the penetrated region and form a substantially gas-tight seal between the penetrated region and the interior of the syringe body.

2. A method as defined in claim 1, wherein the introducing step includes introducing any of the following substances through the needle and into the interior of the syringe body:

a vaccine, a medicament, a pharmaceutical preparation, a cosmetic and a food product.

3. A method as defined in claim 1, further comprising sterilizing at least the interior of the syringe body, introducing a sterile substance through the needle and into the interior of the syringe body, and maintaining the interior of the syringe body and substance sterile during filling and storage thereafter.

4. A method as defined in claim 1, wherein the applying step includes applying laser radiation to the penetrated region of the resealable portion to fuse the penetrated region and form a substantially gas-tight seal between the penetrated region and the interior of the syringe body.

5. A method as defined in claim 4, wherein the applying step further includes applying with a laser sufficient energy to the resealable portion to fuse the resealable portion while preventing heating of the substance within the interior of the syringe body.

6. A method as defined in claim 5, further comprising applying laser energy at a power of less than about 10 watts.

7. A method as defined in claim 1, further comprising the step of venting air or other gas out of the interior of the syringe body during the step of introducing the substance through the needle and into the interior of the syringe body.

8. A method as defined in claim 1, further comprising hermetically sealing the interior of the syringe body and preventing contamination of the interior of the syringe body during filling and storage of the syringe.

16. A method as defined in claim 1, wherein the device is a syringe.

17. A method as defined in claim 1, further comprising the step of using the body to thermally insulate the sterile food product in the chamber from the laser energy applied by the laser source to avoid thermal damage to the sterile food product in the chamber.

18. A method as defined in claim 1, further comprising the step of introducing the sterile food product through a first fluid passageway of the filling member, and allowing fluid to flow out of the chamber of the device through a second fluid passageway upon introducing the sterile food product from the first fluid passageway into the chamber.

19. A method as defined in claim 1, wherein the filling member is a needle.

9. A method comprising the following steps:

providing a device including a sealed, empty storage chamber, and including a penetrable and thermally resealable portion in fluid communication with the storage chamber including a body defining a predetermined wall thickness that substantially absorbs laser radiation at a predetermined wavelength and power and substantially prevents the passage of such radiation therethrough, and a penetrable region that is penetrable with a filling member and that defines a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and power to hermetically seal an aperture therein;

sterilizing an exposed surface of the penetrable and thermally resealable portion;

penetrating the penetrable and thermally resealable portion with a filling member coupled in fluid communication with a source of a sterile food product;

introducing the sterile food product through the filling member and into the storage chamber;

withdrawing the filling member from the penetrable and thermally resealable portion;

applying laser radiation from a laser source at the predetermined wavelength and power to an aperture formed in the penetrable region of the body;

substantially absorbing within the penetrable region of the body the laser radiation at the predetermined wavelength and power and substantially preventing the passage of radiation through the predetermined wall thickness of the body; and

hermetically sealing the aperture in the penetrable region of the body with the laser radiation within a predetermined time period and, in turn, hermetically sealing the sterile food product within the chamber of the device.

10. A method as defined in claim 9, further comprising sterilizing the sealed empty device prior to introducing the sterile food product therein.

11. A method as defined in claim 9, further comprising sterilizing at least the sealed, empty storage chamber, and the penetrable and thermally resealable portion in fluid communication with the storage chamber, introducing the sterile food product through the filling member and into the storage chamber, and maintaining the storage chamber and food product sterile during filling and storage thereafter.

12. A method as defined in claim 9, wherein the applying step further includes applying with a laser sufficient energy to the resealable portion to hermetically seal the resealable portion while preventing heating of the food product within the storage chamber.

13. A method as defined in claim 12, wherein the applying step further includes applying laser energy at a power of less than about 10 watts.

14. A method as defined in claim 9, further comprising the step of venting air or other gas out of the storage chamber during the introducing step.

15. A method as defined in claim 9, further comprising hermetically sealing the storage chamber and preventing contamination of the storage chamber during filling and storage of the device.

20. A method comprising the following steps:

providing a device including a first body portion defining a first compartment forming a first sealed, empty storage chamber;

a second body portion defining a second compartment forming a second sealed storage chamber; and

a penetrable and thermally resealable portion in fluid communication with at least the first storage chamber, wherein the first and second compartments define a storage state in which the first and second compartments are hermetically sealed relative to each other, and a dispensing state in which the first and second compartments are in fluid communication with each other;

sterilizing an exposed surface of the penetrable and thermally resealable portion;

penetrating the penetrable and thermally resealable portion with a filling member coupled in fluid communication with a source of a first product component of a sterile food product;

introducing the first product component through the filling member and into the first sealed, empty storage chamber;

withdrawing the filling member from the penetrable and thermally resealable portion; and

applying sufficient thermal energy to the penetrated region of the penetrable and thermally resealable portion to fuse the penetrated region and form a substantially gas-tight seal between the penetrated region and the first compartment.

21. A method as defined in 20, further comprising:

filling the storage chamber of the second compartment with a second product component and sealing the second product component within the second compartment; and

maintaining the filled first and second compartments in the storage state hermetically sealed relative to each other while in the storage state.

22. A method as defined in claim 21, further comprising moving at least one of the first and second compartments from (i) the storage state in which the first and second product components are hermetically sealed relative to each other and are prevented from intermixing, to (ii) the dispensing state in which the first and second compartments are in fluid communication with each other, and further comprising intermixing the first and second product components into a food product, and dispensing the food product.