Syringe with needle penetrable and laser resealable stopper
View Patent ↗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.
1. A syringe adapted to be filled with a substance by an apparatus including a needle or like filling member for piercing and introducing the substance through the needle or like filling member and into the syringe, and an energy source for directing energy into and thermally resealing an aperture caused by the needle or like filling member, the syringe comprising:
a syringe body defining therein a chamber for receiving the 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 the needle or like filling member for introducing the 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 from the energy source thereto for hermetically sealing the penetrable region after removing the needle or like filling member therefrom.
2. A syringe comprising:
a syringe body defining therein a chamber for receiving a 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 comprises a resealable stopper including:
a base portion formed of a first material compatible with the 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 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 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. The 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. The syringe as defined in claim 2 , wherein the base portion of the stopper is formed of vulcanized rubber.
5. The 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 comprising:
a syringe body defining therein a chamber for receiving a 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 substance through the stopper and into the chamber of the syringe body, a penetrable region of the resealable stopper is fusible in response to the application of thermal energy thereto for hermetically sealing the penetrable region after removing the needle or like filling member therefrom, wherein and the stopper defines a one-way valve extending adjacent to the periphery thereof for allowing gas to escape out of the chamber and through the valve and for preventing gas from passing in opposite direction through the valve and into the chamber.
10. The 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 comprising:
a syringe body defining therein a chamber for receiving a 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 substance through the stopper and into the chamber of the syringe body, a penetrable region of the resealable stopper is fusible in response to the application of thermal energy thereto for hermetically sealing the penetrable region after removing the needle or like filling member therefrom, and 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 substance.
12. The 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. The syringe as defined in claim 1 , wherein the energy source is a laser that transmits laser radiation at a predetermined wavelength and power, the penetrable region of the resealable stopper is heat resealable to hermetically seal the needle aperture by applying laser radiation from the laser at the predetermined wavelength and power thereto, and 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. The 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. The 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. The syringe as defined in claim 14 , wherein the predetermined wavelength is approximately 980 nm.
18. The syringe as defined in claim 14 , wherein the predetermined power is less than approximately 30 Watts.
19. The syringe as defined in claim 18 , wherein the predetermined power is less than or equal to about 10 Watts.
20. The syringe as defined in claim 14 , wherein the predetermined color is gray.
21. The syringe as defined in claim 14 , wherein the predetermined time period is less than about 1.5 seconds.
22. The syringe as defined in claim 14 , wherein the predetermined wavelength is about 980 nm, the predetermined power is within the range of about 8 to 10 Watts, the predetermined color is gray, and the predetermined opacity is defined by a dark gray colorant additive within the range of about 0.3% to about 0.6% by weight.
23. A syringe adapted to be filled with a substance by an apparatus including a needle or like filling member for piercing and introducing the substance into the Syringe, and an energy source for directing energy into and thermally resealing an aperture caused by the needle or like filling member, the syringe comprising:
a syringe body defining therein a chamber for receiving the substance to be dispensed from the syringe;
first means slidably received within the syringe body for dispensing the substance upon movement therein; and
second means penetrable by the needle or like filling member for introducing the substance therethrough and into the chamber, and fusible in response to the application of thermal energy from the energy source thereto for hermetically sealing the second means after removing the needle or like filling member therefrom.
24. A syringe comprising:
a syringe body defining therein a chamber for receiving a substance to be dispensed from the syringe;
first means slidably received within the syringe body for dispensing the substance upon movement therein;
second means penetrable by a needle or like filling member for introducing the substance therethrough and into the chamber, and fusible in response to the application of thermal energy from an energy source thereto for hermetically sealing the second means after removing the needle or like filling member therefrom; and
third means underlying the second means and substantially infusible in response to the application of thermal energy thereto and compatible with the substance in the chamber for exposure to the substance.
25. The syringe as defined in claim 24 , wherein the second means is a portion formed of at least one of a thermoplastic and elastomeric material.
26. The syringe as defined in claim 24 , wherein the third means is a portion formed of vulcanized rubber.
27. A syringe as defined in claim 24 , wherein the syringe is adapted to receive a multi-component preparation, and the first means 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; and the syringe further includes fourth means receivable within the aperture of the outer member for sealing the first and second chambers relative to each other, and being removable 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.
28. The syringe as defined in claim 23 , wherein the energy source is a laser that transmits laser radiation at a predetermined wavelength and power, and a needle penetration region of the second means is pierceable with a needle to form a needle aperture therethrough, and is heat resealable to hermetically seal the needle aperture by applying laser radiation at the predetermined wavelength and power thereto, wherein the second means includes (i) a thermoplastic body defining a predetermined wall thickness in an axial direction thereof, (ii) fourth means for substantially absorbing the laser radiation at the predetermined wavelength and substantially preventing the passage of radiation through the predetermined wall thickness thereof, and (ii) fifth means for causing 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.
29. The syringe as defined in claim 28 , wherein the fourth means is defined by a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of radiation through the predetermined wall thickness thereof.
30. The syringe as defined in claim 28 , wherein the fifth means is defined by 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.
31. The syringe as defined in claim 28 , 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.
32. The syringe as defined in claim 31 , wherein the first and second materials are blended within a range of about 50:50 to about 95:5 by weight.
33. The syringe as defined in claim 28 , wherein the predetermined wavelength is about 980 nm, the predetermined power is within the range of about 8 to 10 Watts, the predetermined color is gray, and the predetermined opacity is defined by a dark gray colorant additive within the range of about 0.3% to about 0.6% by weight.
34. A syringe as defined in claim 1 , wherein the plunger is formed by at least one of a first member and a second member;
the first member is received within the syringe body and defines an aperture formed therethrough, wherein a first chamber is formed between the aperture of the first member and the syringe body for receiving a first component therein;
the second member is received within the first member and defines a second chamber between the first and second members for receiving a second component therein; and
a plug is received within the aperture of the first member to prevent fluid communication between the first and second chambers and intermixing of the components therein, wherein the plug is releasable from the aperture upon movement of at least one of the first and second members relative to the other to, in turn, place the first and second chambers in fluid communication with each other and allow intermixing of the first and second components.
35. A reconstitution syringe as defined in claim 34 , further comprising means for effecting step-wise movement of the plunger assembly within the syringe body.
36. A reconstitution syringe as defined in claim 34 , wherein the plug is releasable within at least one of the first and second chambers upon moving at least one of the first and second members relative to the other to facilitate intermixing of the first and second components.