Device with penetrable and resealable portion

• US 20100276035A1
• Filed: 07/15/2010
• Published: 11/04/2010
• Est. Priority Date: 10/03/2001
• Status: Abandoned Application

• Current Assignee: Daniel Py
• Original Assignee: Daniel Py
• Inventors: Py, Daniel
• Application Number:
  US12/837,329
• Publication Number:
  US 20100276035A1
• Time in Patent Office: Days
• US Class Current: 141/98
• 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. 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.

Claims

1-20. -20. (canceled)

21. A device including a body defining a sealed empty chamber, and a penetrable and thermally resealable portion in fluid communication with the chamber, wherein the penetrable and thermally resealable portion defines a penetrable region that is penetrable by a filling member for introducing a sterile substance through the penetrable and thermally resealable portion and into the chamber, and is resealable in response to the application of laser radiation thereto at a predetermined wavelength and power for hermetically sealing the penetrable region and the sterile substance within the chamber after removing the filling member from the penetrable region, wherein the penetrable and thermally resealable portion defines (i) a predetermined wall thickness, (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 filling member aperture formed in the penetrable region within a predetermined time period and substantially without burning the penetrable region.

22. A device as defined in claim 21, further comprising a device that exerts pressure on sterile substance in the device in order to dispense the substance from the device.

23. A device as defined in claim 22, wherein the device is manually engageable to exert pressure on the sterile substance.

24. A device as defined in claim 23, wherein the manually engageable device exerts pressure on the sterile substance contained within the chamber in order to dispense the substance therefrom.

25. A device as defined in claim 21, further comprising a sterile food hermetically sealed within the chamber.

26. A device as defined in claim 21, further comprising a manually engageable device for dispensing substantially metered amounts of substance therefrom.

27. A device as defined in claim 21, further comprising 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;

wherein the penetrable and thermally resealable portion is in fluid communication with the first storage chamber, and 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.

28. A device as defined in claim 27, wherein at least one of the first and second body portions is movable relative to the other from the storage state to the dispensing state.

29. A device as defined in claim 27, wherein the penetrable and thermally resealable portion is penetrable by a needle for aseptically filling a respective chamber through the needle and is laser resealable for resealing a resulting needle hole therein upon removing the needle therefrom.

30. A device as defined in claim 21, wherein the penetrable and thermally resealable portion thermally insulates the sterile substance in the chamber from the laser energy applied by the laser source to avoid thermal damage to the sterile substance in the chamber.

31. A device as defined in claim 21, wherein the penetrable and thermally resealable portion includes an overlying portion formed of a first material, and an underlying portion formed of a second material.

32. A device as defined in claim 31, wherein the overlying portion is formed of a fusible material, and the underlying portion is formed of an infusible material.

33. A device as defined in claim 21, wherein the predetermined time period is approximately 2 seconds.

34. A device as defined in claim 33, wherein the predetermined time period is less than or equal to about 1.5 seconds.

35. A device as defined in claim 34, wherein the predetermined time period is less than or equal to about 1 second.

36. A device as defined in claim 21, wherein the predetermined wavelength is about 980 nm.

37. A device as defined in claim 21, wherein the predetermined power is less than about 30 watts.

38. A device as defined in claim 37, wherein the predetermined power is less than or equal to about 10 watts.

39. A device as defined in claim 21, wherein the predetermined opacity is defined by a colorant in an amount within the range of about 0.3% to about 0.6% by weight.

40. A device as defined in claim 39, wherein the colorant is gray.

41. A device as defined in claim 21, wherein the penetrable and thermally resealable portion includes a styrene block copolymer and an olefin.

42. A device as defined in claim 41, wherein the ratio of the styrene block copolymer to the olefin is within the range of about 50:

50 by weight to about 95;

5 by weight.

43. A device as defined in claim 21, wherein the predetermined color is gray.

44. A device for storing a sterile substance including a body defining a sealed empty chamber, and means in fluid communication with the chamber and defining a predetermined wall thickness for penetration by a filling member, for introducing the sterile substance therethrough and into the chamber, for substantially absorbing laser radiation at a predetermined wavelength and power, for substantially preventing the passage of the radiation through the predetermined wall thickness thereof, and for causing the laser radiation at the predetermined wavelength and power to hermetically seal a filling member aperture formed therein within a predetermined time period and substantially without burning the penetrable region for hermetically sealing the sterile substance within the chamber.

45. A device as defined in claim 44, wherein the means is a thermoplastic portion defining a penetrable region that is resealable to hermetically seal a filling member aperture by applying laser radiation at a predetermined wavelength and power thereto, wherein the penetrable and thermally resealable portion comprises a thermoplastic body defining (i) a predetermined wall thickness, (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 and substantially without burning the penetrable region.

46. A device as defined in claim 44, wherein the predetermined wavelength is about 980 nm, the predetermined power is less than about 30 watts, and the predetermined time period is approximately 2 seconds.

47. A device used to store and deliver a sterile food product including a body defining a sterile chamber, and a penetrable and thermally resealable portion in fluid communication with the chamber, wherein the penetrable and thermally resealable portion defines a penetrable region that is penetrable by a filling member for introducing the sterile food product through the penetrable and thermally resealable portion and into the chamber, and is resealable in response to the application of laser radiation thereto at a predetermined wavelength and power for hermetically sealing the penetrable region and the sterile food product within the chamber after removing the filling member from the penetrable region, wherein the penetrable and thermally resealable portion defines (i) a predetermined wall thickness, (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 filling member aperture formed in the penetrable region in a predetermined time period.

48. 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 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, the penetrable and thermally resealable portion is penetrable by a filling member coupled in fluid communication with a source of a first component for introducing the first component through the filling member and into the first sealed, empty storage chamber, and is resealable after withdrawing the filling member from the penetrable and thermally resealable portion by applying radiation thereto to reseal the penetrated region and form a substantially gas-tight seal between the penetrated region and the first compartment.

49. A device as defined in claim 48, wherein the first compartment contains the first component, and the second compartment contains a second component, and at least one of the first and second compartments is movable from (i) a storage state in which the first and second compartments are hermetically sealed relative to each other to prevent intermixing of the first and second components, to (ii) a dispensing state in which the first and second compartments are in fluid communication with each other to allow intermixing the first and second components into a multi-component preparation and dispensing the preparation.

50. A device as defined in claim 49, wherein the multi-component preparation is a vaccine, medicament, cosmetic or food product.

52. A device as defined in claim 50, wherein the radiation is laser radiation.

53. A device as defined in claim 50, wherein the penetrable and resealable portion includes an overlying portion formed of a first material, and an underlying portion formed of a second material.

51. A device used to store and deliver a sterile substance including a body defining a sealed empty chamber, and a penetrable and resealable portion in fluid communication with the chamber, wherein the penetrable and resealable portion defines a penetrable region that is penetrable by a filling member for introducing the sterile substance through the penetrable and resealable portion and into the chamber, and is resealable in response to the application of radiation thereto for sealing the penetrable region after removing the filling member therefrom, wherein the penetrable and resealable portion defines a predetermined wall thickness for penetration by the filling member to fill the sterile substance therethrough and into the chamber, and substantially absorbs the radiation at the predetermined wavelength and substantially prevents the passage of the radiation therethrough to hermetically seal a filling member aperture formed in the penetrable region thereof in a predetermined time period and substantially without burning the penetrable region.