Syringe with rolling diaphragm

• US 10,583,256 B2
• Filed: 04/24/2015
• Issued: 03/10/2020
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Berry, Dave, Tucker, Barry L., Rhinehart, Edward J., Callan, Gerald W., Uber, III, Arthur E., Cowan, Kevin P., Hoffman, Raymond C., Krupp, Benjamin T., Gibler, Martin J., Spohn, Michael A.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Ulsh, Dung T
• Application Number:
  US15/305,285
• Publication Number:
  US 20170035974A1
• Time in Patent Office: 1,782 Days
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/14553 comprising a pressure jacket
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod

Abstract

A syringe for a fluid delivery system includes a pressure jacket having a distal end, a proximal end, and a throughbore therebetween. The syringe further includes a rolling diaphragm having a proximal end with an end wall for engaging a plunger, a distal end received within the throughbore of the pressure jacket. A sidewall extends between the proximal end and the distal end of the rolling diaphragm along a longitudinal axis. At least a portion of one of the sidewall and the end wall has non-uniform thickness. At least a portion of the sidewall is flexible and rolls upon itself when acted upon by the plunger such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the plunger is advanced from the proximal end to the distal end of the rolling diaphragm.

Claims

1. A rolling diaphragm for receiving a medical fluid therein, the rolling diaphragm comprising:

a proximal end comprising a concave end wall shaped for engagement with a plunger, a distal end having a discharge neck, and a sidewall extending between the proximal end and the distal end along a longitudinal axis, wherein at least a portion of at least one of the sidewall and the concave end wall has a non-uniform thickness,

wherein at least a portion of the sidewall is flexible such that the sidewall rolls upon itself when acted upon by the plunger such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the plunger is advanced from the proximal end to the distal end,

wherein the outer surface of the sidewall unrolls as the folding region is unfolded in a radially outward direction as the plunger is retracted from the distal end to the proximal end, and

wherein the concave end wall has a plunger engagement portion that protrudes proximally from the concave end wall such that the plunger engagement portion is at least partially recessed within a cavity defined by the concave end wall at least in an unrolled state or a rolled state of the rolling diaphragm and prior to engagement with the plunger.

2. The rolling diaphragm of claim 1, wherein the concave end wall has a radiused folding edge that transitions into a distally extending ramp having a continuously increasing thickness.

3. The rolling diaphragm of claim 2, wherein the plunger engagement portion protrudes proximally from a central region of the ramp.

4. The rolling diaphragm of claim 3, wherein the concave end wall has one or more ribs protruding radially outward from a surface of the concave end wall and extending from the plunger engagement portion toward the radiused folding edge.

5. The rolling diaphragm of claim 1, wherein a first portion of the sidewall distal of an approximate midpoint of the rolling diaphragm has a first thickness, wherein a second portion of the sidewall proximal of the approximate midpoint of the rolling diaphragm has a second thickness, and wherein the first thickness is greater than the second thickness.

6. The rolling diaphragm of claim 1, wherein the proximal end has a rigid plunger monolithically formed with the proximal end.

7. The rolling diaphragm of claim 3, wherein the plunger engagement portion is received within an opening on the plunger.

8. The rolling diaphragm of claim 7, wherein the plunger engagement portion is releasably retained with at least a portion of the plunger.

9. The rolling diaphragm of claim 7, wherein at least a portion of the plunger engagement portion is expanded radially outward to releasably retain the plunger engagement portion within the opening of the plunger.

10. The rolling diaphragm of claim 1, wherein an interior of the rolling diaphragm is pre-filled with a medical fluid.

11. The rolling diaphragm of claim 1, wherein the discharge neck has a connector for connecting to a fluid path set.

12. The rolling diaphragm of claim 11, wherein the connector is a luer connector.

13. The rolling diaphragm of claim 1, wherein the discharge neck has a piercable seal for sealing an interior of the rolling diaphragm.

14. The rolling diaphragm of claim 1, wherein the discharge neck has a first seal between the discharge neck and the sidewall of the rolling diaphragm and a second seal at an interface for connecting the discharge neck to a fluid path set.

15. The rolling diaphragm of claim 1, wherein the rolling diaphragm is in a first state where the concave end wall is inverted inwardly toward the distal end such that an internal volume of the rolling diaphragm is empty of fluid prior to initiation of an injection procedure.

16. A syringe for a fluid delivery system, the syringe comprising:

a pressure jacket having a distal end, a proximal end, and a throughbore extending between the distal end and the proximal end; and

a rolling diaphragm disposed within the throughbore of the pressure jacket, wherein the rolling diaphragm comprises a proximal end having a concave end wall shaped for engagement with a plunger, a distal end, a discharge neck at the distal end of the rolling diaphragm, and a sidewall extending between the proximal end and the distal end of the rolling diaphragm along a longitudinal axis, wherein at least one of the concave end wall and at least a portion of the sidewall has a non-uniform thickness,

wherein at least a portion of the sidewall of the rolling diaphragm is flexible and rolls upon itself such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the plunger is advanced from the proximal end to the distal end of the rolling diaphragm and such that the outer surface of the sidewall unrolls as the folding region is unfolded in a radially outward direction as the plunger is retracted from the distal end to the proximal end of the rolling diaphragm, and

wherein the concave end wall has a plunger engagement portion that protrudes proximally from the concave end wall such that the plunger engagement portion is at least partially recessed within a cavity defined by the concave end wall at least in an unrolled state or a rolled state of the rolling diaphragm and prior to engagement with the plunger.

17. The syringe of claim 16, wherein the pressure jacket has a removable closure for enclosing at least a portion of the distal end of the rolling diaphragm.

18. The syringe of claim 17, wherein the removable closure has a threaded end for engaging corresponding threads on the distal end of the pressure jacket or wherein the removable closure has one or more radially extending tabs for insertion into corresponding slots for engaging a bayonet locking mechanism on the distal end of the pressure jacket.

19. The syringe of claim 17, wherein the proximal end of the pressure jacket has a connection interface for releasably connecting to a fluid injector of the fluid delivery system.

20. A fluid delivery system, comprising:

a fluid injector comprising at least one reciprocally operable piston;

a plunger operably connectable to the at least one piston;

a pressure jacket having a distal end, a proximal end, and a throughbore extending between the distal end and the proximal end, wherein the pressure jacket is operably connectable to the fluid injector; and

a rolling diaphragm disposed within a throughbore of the pressure jacket, wherein the rolling diaphragm comprises a proximal end comprising a concave end wall shaped for engagement with the plunger, a distal end, a discharge neck at the distal end of the rolling diaphragm, and a sidewall extending between the proximal end and the distal end of the rolling diaphragm along a longitudinal axis, wherein at least a portion of at least one of the sidewall and the concave end wall has a non-uniform thickness,

wherein at least a portion of the sidewall of the rolling diaphragm is flexible and rolls upon itself such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the plunger is advanced by the piston from the proximal end to the distal end of the rolling diaphragm and such that the outer surface of the sidewall unrolls as the folding region is unfolded in a radially outward direction as the plunger is retracted by the piston from the distal end to the proximal end of the rolling diaphragm, and

wherein the concave end wall has a plunger engagement portion that protrudes proximally from the concave end wall such that the plunger engagement portion is at least partially recessed within a cavity defined by the concave end wall at least in an unrolled state or a rolled state of the rolling diaphragm and prior to engagement with the plunger.