Cryotherapeutic delivery device

Patent metadata

Field	Value
Publication number	US-11964137-B2
Application number	US-202016740927-A
Country	US
Kind code	B2
Filing date	Jan 13, 2020
Priority date	Jan 16, 2019
Publication date	Apr 23, 2024
Grant date	Apr 23, 2024

Abstract

A device for aseptic delivery of biological material from a vial includes a tubular barrel, a filter assembly, and a dispersion assembly. The dispersion assembly is at least partially disposed within the tubular barrel. The dispersion assembly includes a dispersion element, a piston, and a one-way valve. The dispersion element is in fluid communication with the vial to disperse the biological material from the vial. The piston is disposed at the distal end of the dispersion assembly and is in sealing contact with the tubular barrel. The one-way valve forms a fluid passageway in fluid communication with the dispersion element and the tubular barrel. The one-way valve is configured to allow a flow of the dispersed biological material from the dispersion element, through the fluid passageway, and into the tubular barrel, and to prevent a flow of the dispersed biological material from the tubular barrel into the dispersion assembly.

First claim

We claim:

1. A device for aseptic delivery of biological material from a vial, the device comprising:
a tubular barrel comprising:
a receiving end to accept a portion of the vial within the tubular barrel; and
a dispensing end opposite the receiving end;

a filter assembly fluidly connected to the dispensing end of the tubular barrel; and
a dispersion assembly having a proximal end configured to couple to the vial and a distal end opposite the proximal end, the dispersion assembly configured to be at least partially disposed within the tubular barrel, the dispersion assembly comprising:
a dispersion element configured to be in fluid communication with the vial to disperse the biological material from the vial, the dispersion element comprising a wall forming a plurality of openings through the wall;
a piston disposed at the distal end of the dispersion assembly, the piston in sealing contact with the tubular barrel; and
a one-way valve forming a fluid passageway in fluid communication with the dispersion element and the tubular barrel, the one-way valve configured to allow a flow of the dispersed biological material from the dispersion element, through the fluid passageway, and into the tubular barrel, and to prevent a flow of the dispersed biological material from the tubular barrel into the dispersion assembly;

wherein the filter assembly includes a filter medium, the filter assembly selectable between an open state wherein the filter medium prevents the biological material from passing through the filter assembly but permits liquid to pass through the filter assembly, a bypass state wherein the biological material can pass through the filter assembly to deliver the biological material, and, optionally, a closed state wherein no liquid or biological material can pass through the filter assembly.

2. The device of claim 1 , wherein the plurality of openings through the wall are sized to permit the passage of dispersed biological material through the wall and to prevent the passage of undispersed biological material through the wall.

3. The device of claim 1 , wherein the filter assembly further includes a filter medium assembly configured to support the filter medium.

4. The device of claim 3 , wherein the filter medium assembly is detachable from the filter assembly.

5. The device of claim 1 , wherein the filter assembly further includes:
a filter output port in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the open state; and
a bypass output port in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the bypass state.

6. The device of claim 5 , wherein the filter assembly further comprises:
a filter base comprising:
a first section in fluid communication with the filter output port;
a second section in fluid communication with the bypass output port; and
a third section that is not in fluid communication with either of the filter output port or the bypass output port; and

a filter selector rotatably coupled to the filter base, the filter selector comprising a filter inlet in fluid communication with the tubular barrel, the filter selector configured to fluidly connect the filter inlet to the first section, the second section, or the third section of the filter base as the filter selector rotates relative to the filter base.

7. The device of claim 6 , wherein the filter assembly further comprises:
a compression clasp coupled to the filter base to force the filter selector into sealing contact with the filter base; and
a wrench coupled to the filter selector.

8. The device of claim 1 , wherein the tubular barrel further comprises a barrel ventilation passageway extending through a wall of the tubular barrel from a first location between the dispensing end and the receiving end to a second location adjacent to the receiving end.

9. The device of claim 8 , wherein the tubular barrel further comprises a one-way barrel vent valve within the barrel ventilation passageway and configured to allow the passage of gases away from the first location, prevent the passage of gases toward the first location, and prevent the passage of liquids.

10. A system for aseptic storage and delivery of biological material, the system comprising:
a vial comprising:
a tubular body to contain the biological material until delivery;
a vial input port; and
a vial output port comprising a luer activated valve; and

a device for aseptic delivery of biological material from the vial, the device comprising:
a tubular barrel comprising:
a receiving end to accept a portion of the vial within the tubular barrel; and
a dispensing end opposite the receiving end;

a filter assembly fluidly connected to the dispensing end of the tubular barrel; and
a dispersion assembly having a proximal end and a distal end opposite the proximal end, the proximal end configured to open the luer activated valve when coupled to the vial output port to bring a dispersion element into fluid communication with the vial, the dispersion assembly configured to be at least partially disposed within the tubular barrel, the dispersion assembly comprising:
the dispersion element configured to be in fluid communication with the vial to disperse the biological material from the vial, the dispersion element comprising a wall forming a plurality of openings through the wall;
a piston disposed at the distal end of the dispersion assembly, the piston in sealing contact with the tubular barrel; and
a one-way valve forming a fluid passageway in fluid communication with the dispersion element and the tubular barrel, the one-way valve configured to allow a flow of the dispersed biological material from the dispersion element, through the fluid passageway, and into the tubular barrel, and to prevent a flow of the dispersed biological material from the tubular barrel into the dispersion assembly.

11. The system of claim 10 , wherein the tubular barrel further comprises a barrel ventilation passageway extending through a wall of the tubular barrel from the dispensing end to the receiving end.

12. The system of claim 10 , wherein the vial further comprises a vial ventilation passageway extending through a wall of the vial from vial output port to the vial input port.

13. The system of claim 12 , wherein the vial further comprises a one-way vial vent valve within the vial ventilation passageway and configured to allow the passage of gases away from the vial output port, prevent the passage of gases toward the vial output port, and prevent the passage of liquids.

14. The system of claim 10 , wherein the filter assembly includes a filter medium, the filter assembly selectable between an open state wherein the filter medium prevents the biological material from passing through the filter assembly but permits liquid to pass through the filter assembly, a bypass state wherein the biological material can pass through the filter assembly to deliver the biological material, and, optionally, a closed state wherein no liquid or biological material can pass through the filter assembly.

15. The system of claim 14 , wherein the filter assembly further includes a filter medium assembly configured to support the filter medium.

16. The system of claim 14 , wherein the filter assembly further comprises:
a filter base comprising:
a first section in fluid communication with a filter output port, the filter output port in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the open state;
a second section in fluid co

Assignees

• Boston Scient Scimed Inc

Inventors

• Mirigian Mark David
• Hannon Robert
• English James Michael
• Mcconville Aine
• Beatty Aideen Bridget
• Fawdry Martin L
• Mckenna Peter M
• Gannon Sophie A
• Callagy Sara J

Classifications

• A61M5/3145 Primary

  Filters incorporated in syringes · CPC title

• A61J1/1443

  Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters · CPC title

• A61J1/2075

  for external venting · CPC title

• A61J1/2086

  for fluid filtration · CPC title

• A61J1/2096

  Combination of a vial and a syringe for transferring or mixing their contents · CPC title