Syringe and reconstitution syringe

• US 20070156102A1
• Filed: 03/05/2007
• Published: 07/05/2007
• Est. Priority Date: 10/03/2001
• Status: Active Grant

• Current Assignee: Daniel Py
• Original Assignee: Daniel Py
• Inventors: Py, Daniel
• Granted Patent: US 7,779,609 B2
• Time in Patent Office: Days
• US Class Current: 604/218
• 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 syringe comprising:

a syringe body defining therein a chamber for receiving a predetermined substance to be dispensed from the syringe; and

a plunger slidably received within the syringe body for dispensing the substance upon movement therein, wherein the plunger includes a resealable stopper penetrable by a needle or like filling member for introducing the predetermined substance through the stopper and into the chamber of the syringe body, and wherein a penetrable region of the resealable stopper is fusible in response to the application of thermal energy thereto for hermetically sealing the penetrable region upon removing the needle or like filling member therefrom.

2. A syringe as defined in claim 1, wherein the resealable stopper includes:

a base portion formed of a first material compatible with the predetermined substance contained within the syringe, the base portion defining a peripheral surface for slidably contacting an inner wall of the syringe body and a substance-exposed surface defining the portion of the stopper exposed to the predetermined substance contained within the syringe; and

a resealable portion overlying the base portion, the resealable portion and base portion being penetrable by a needle or like filling member for introducing the predetermined substance through the stopper and into the syringe body, wherein the penetrable region of the base portion is substantially infusible in response to the application of thermal energy thereto, and the penetrable region of the resealable portion is fusible in response to the application of thermal energy thereto for hermetically sealing the penetrable region upon removing the needle or like filling member therefrom.

3. A syringe as defined in claim 1, wherein the resealable portion of the stopper is formed of at least one of a thermoplastic and elastomeric material.

4. A syringe as defined in claim 2, wherein the base portion of the stopper is formed of vulcanized rubber.

5. A syringe as defined in claim 2, wherein the base portion of the stopper defines an interior cavity, and the resealable portion is received within the interior cavity of the base portion.

6. A syringe as defined in claim 1, further including means for effecting step-wise movement of the plunger within the syringe body.

7. A syringe as defined in claim 6, wherein the means for effecting step-wise movement includes at least one cam-like member mounted on the plunger, and a plurality of steps located on an interior wall of the syringe body and engageable with the at least one cam-like member to effect step-wise movement of the cam-like member relative to the steps upon rotating the plunger.

8. A syringe as defined in claim 7, wherein the plurality of steps define an approximately helical path.

9. A syringe as defined in claim 1, wherein stopper defines a one-way valve extending about the periphery thereof for allowing gas to escape out of the chamber and through the valve and for preventing gas from passing in the other direction through the valve and into the chamber.

10. A syringe as defined in claim 9, wherein the one-way valve is defined by a flexible member extending outwardly from the plunger and engageable with the syringe body for forming a seal between the flexible member and syringe body.

11. A syringe as defined in claim 1, wherein the syringe body defines at least one axially elongated fluid-passageway extending between the syringe body and the plunger for allowing fluid to pass therethrough upon filling the chamber with the predetermined substance.

12. A syringe as defined in claim 11, further comprising a plurality of axially-elongated fluid passageways angularly spaced relative to each other.

13. A syringe as defined in claim 1, wherein the syringe is adapted to receive a multi-component preparation, and the plunger includes:

an outer member slidably received within the syringe body, wherein the outer member defines an aperture on an end portion thereof; and

an inner member slidably received within the outer member;

wherein the outer member defines a first chamber between the end portion thereof and the syringe body, the inner and outer members define a second chamber therebetween;

the syringe further includes a plug receivable within the aperture of the outer member for sealing the first and second chambers relative to each other, and the plug is disengageable from the aperture upon moving at least one of the inner and outer members relative to the other to thereby place the first and second chambers in fluid communication with each other.

14. A syringe as defined in claim 1, wherein the penetrable region of the resealable stopper is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, wherein the stopper comprises a thermoplastic body defining (i) a predetermined wall thickness in an axial direction thereof, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period of less than approximately 2 seconds and substantially without burning the needle penetration region.

15. A syringe as defined in claim 14, wherein the needle penetration region is formed of a thermoplastic blend of a first material consisting essentially of a styrene block copolymer and a second material consisting essentially of an olefin.

16. A syringe as defined in claim 15, wherein the first and second materials are blended within a range of about 50:

50 to about 95;

5 by weight.

17. A syringe as defined in claim 14, wherein the predetermined wavelength is approximately 980 nm.

18. A syringe as defined in claim 14, wherein the predetermined power is less than approximately 30 Watts.

19. A syringe comprising:

a syringe body defining therein a chamber for receiving a predetermined substance to be dispensed from the syringe; and

first means slidably received within the syringe body for dispensing the substance upon movement therein and for sealing the predetermined substance within the chamber, wherein the first means is capable of being penetrated by a needle or like member for introducing the predetermined substance therethrough and into the chamber, and the first means includes second means fusible in response to the application of thermal energy thereto for forming a substantially gas-tight seal between the first means and the chamber in a region thereof penetrable by the needle or like member.

20. A method of filling a syringe with a predetermined substance, 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 the predetermined substance;

introducing the predetermined 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.