Blood treatment systems and methods

• US 10,443,591 B2
• Filed: 06/30/2016
• Issued: 10/15/2019
• Est. Priority Date: 04/14/2006
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Wilt, Michael J., Dale, James D., Tracey, Brian D., Grant, Kevin L., Demers, Jason A.
• Primary Examiner(s): Lettman, Bryan M
• Application Number:
  US15/199,204
• Publication Number:
  US 20170000938A1
• Time in Patent Office: 1,202 Days
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/15625 the reservoirs acting as balance chambers
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3393 : by weighing the reservoir
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/258 : Piston pumps
• CPC Class Codes: A61M 60/427 : the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 : using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/508 : Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/847 : arranged in a cassette
• CPC Class Codes: A61M 60/851 : Valves
• CPC Class Codes: A61M 60/892 : Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 : Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: F04B 43/0054 : particularities of the flexible members
• CPC Class Codes: F04B 43/073 : the actuating fluid being controlled by at least one valve
• CPC Class Codes: F04B 53/16 : Casings; Cylinders; Cylinder liners or heads; Fluid connections
• CPC Class Codes: F17D 3/00 : Arrangements for supervising or controlling working operations

Abstract

Hemodialysis and similar dialysis systems including a variety of systems and methods that make hemodialysis more efficient, easier, and/or more affordable, and include new fluid circuits for fluid flow in hemodialysis systems and a blood pump. The blood pump is configured to pump blood to a dialyzer of a hemodialysis apparatus and comprises a pneumatically actuated or controlled reciprocating diaphragm pump. The diaphragm of the pump comprises a flexible membrane formed or molded to conform to a curved inner wall of a pumping chamber or control chamber of the pump, and the diaphragm is pre-formed or molded to have a control side taking a convex shape, so that any elastic tension on the diaphragm is minimized when fully extended into a control chamber of the pump.

Claims

1. A flexible diaphragm for use in a reciprocating diaphragm pump, the diaphragm pump comprising a first rigid body having a curved pumping chamber wall, a second rigid body having an opposing curved control chamber wall, the diaphragm configured to be interposed between the pumping chamber wall and the control chamber wall, the diaphragm, when in a free-standing, uninstalled configuration comprising:

a peripheral bead arranged to locate the diaphragm between the first rigid body and the second rigid body;

a diaphragm body having a curved, semi-spheroid or domed shape, the diaphragm body configured to conform to a curved inner surface of the pumping chamber wall or a curved inner surface of the control chamber wall, and the diaphragm body having a pumping side arranged to face the inner surface of the pumping chamber wall and an opposing control side arranged to face the inner surface of the control chamber wall;

a transition region between the peripheral bead and the diaphragm body, the transition region having a first portion next to the peripheral bead, a second portion next to the diaphragm body, and an intermediate portion between the first and second portions that is arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body;

wherein the diaphragm is resilient, such that when the diaphragm is in a relaxed position, the control side of the diaphragm body assumes a convex shape and the first, second, and intermediate portions of the transition region assume a step shape in which the first region and second region extend from the peripheral bead and intermediate portion, respectively, towards the convex control side of the diaphragm body.

2. The flexible diaphragm of claim 1, wherein any elastic tension near the transition region of the diaphragm is minimized when the diaphragm is fully extended toward the control chamber wall of the diaphragm pump.

3. The flexible diaphragm of claim 1, wherein the pumping side of the diaphragm comprises a plurality of raised features molded with the diaphragm, so that portions of the pumping side of the diaphragm do not contact the pumping chamber wall when the diaphragm is fully extended toward the pumping chamber wall.

4. The flexible diaphragm of claim 3, wherein the raised features comprise bumps or raised dots.

5. The flexible diaphragm of claim 1, wherein the first rigid body of the diaphragm pump comprises a top plate and the second rigid body of the diaphragm pump comprises a bottom plate, the diaphragm pump further comprising a mid-plate positioned between the top plate and the bottom plate, and wherein the peripheral bead of the diaphragm is configured to be positioned between the mid-plate and the bottom plate.

6. The flexible diaphragm of claim 5, wherein the transition region of the diaphragm is thicker than the body of the diaphragm.

7. The flexible diaphragm of claim 6, wherein the transition region of the diaphragm is configured to be clamped or pinched between a transition contact region of the mid-plate and a transition contact region of the bottom plate.

8. The flexible diaphragm of claim 7, wherein the transition contact region of the mid-plate comprises a projection or protuberance of the mid-plate.

9. A reciprocating diaphragm pump comprising a first rigid body having a pumping chamber wall, a second rigid body having an opposing control chamber wall, and a diaphragm configured to be interposed between the pumping chamber wall and the control chamber wall to define a pumping chamber and a control chamber, the diaphragm comprising:

a peripheral bead arranged to locate the diaphragm between the first rigid body and the second rigid body;

a diaphragm body having a curved, semi-spheroid or domed shape, the diaphragm body configured to conform to a curved inner surface of the pumping chamber wall or a curved inner surface of the control chamber wall, and the diaphragm body having a pumping side arranged to face the inner surface of the pumping chamber wall and a control side arranged to face the inner surface of the control chamber wall;

a transition region between the peripheral bead and the diaphragm body, the transition region arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body;

wherein the diaphragm is resilient, such that the diaphragm is in a relaxed position when the control side of the diaphragm body assumes a convex shape when positioned in the diaphragm pump,

wherein the transition region comprises a first portion next to the peripheral bead, a second portion next to the diaphragm body, and an intermediate portion between the first and second portions that is arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body; and

wherein when the diaphragm is in the relaxed position, the first, second, and intermediate portions of the transition region assume a step shape in which the first region and second region extend from the peripheral bead and intermediate portion, respectively, towards the convex control side of the diaphragm body.

10. The diaphragm pump of claim 9, wherein any elastic tension near the transition region of the diaphragm is minimized when the diaphragm is fully extended into the control chamber of the diaphragm pump.

11. The diaphragm pump of claim 9, wherein the pumping side of the diaphragm comprises a plurality of raised features molded with the diaphragm, so that portions of the pumping side of the diaphragm do not contact the pumping chamber wall when the diaphragm is fully extended into the pumping chamber.

12. The diaphragm pump of claim 11, wherein the raised features comprise bumps or raised dots.

13. The diaphragm pump of claim 9, wherein the first rigid body of the diaphragm pump comprises a top plate and the second rigid body of the diaphragm pump comprises a bottom plate, the diaphragm pump further comprising a mid-plate positioned between the top plate and the bottom plate, and wherein the peripheral bead of the diaphragm is configured to be positioned between the mid-plate and the bottom plate.

14. The diaphragm pump of claim 13, wherein the transition region of the diaphragm is thicker than the body of the diaphragm.

15. The diaphragm pump of claim 14, wherein the transition region of the diaphragm is configured to be clamped or pinched between a transition contact region of the mid-plate and a transition contact region of the bottom plate.

16. The diaphragm pump of claim 15, wherein the transition contact region of the mid-plate comprises a projection or protuberance of the mid-plate.

17. A pump cassette for pumping fluid comprising a first rigid body having a pumping chamber wall, a second rigid body having an opposing control chamber wall, and a diaphragm configured to be interposed between the pumping chamber wall and the control chamber wall to define a pumping chamber and a control chamber, the pumping chamber in fluid communication with a fluid inlet and fluid outlet of the cassette, the control chamber in fluid communication with a pneumatic control port for transmission of pneumatic pressure to the control chamber, the diaphragm comprising:

a peripheral bead arranged to locate the diaphragm between the first rigid body and the second rigid body;

a diaphragm body having a curved, semi-spheroid or domed shape, the diaphragm body configured to conform to a curved inner surface of the pumping chamber wall or a curved inner surface of the control chamber wall, and the diaphragm body having a pumping side arranged to face the inner surface of the pumping chamber wall and an opposing control side arranged to face the inner surface of the control chamber wall;

a transition region between the peripheral bead and the diaphragm body, the transition region arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body;

wherein the diaphragm is resilient, such that the diaphragm is in a relaxed position when the control side of the diaphragm body assumes a convex shape,

wherein the transition region comprises a first portion next to the peripheral bead, a second portion next to the diaphragm body, and an intermediate portion between the first and second portions that is arranged to be pinched or clamped between a clamping region of the first rigid body and an opposing clamping region of the second rigid body, and wherein when the diaphragm is in the relaxed position, the first, second, and intermediate portions of the transition region assume a step shape in which the first region and second region extend from the peripheral bead and intermediate portion, respectively, towards the convex control side of the diaphragm body.

18. The pump cassette of claim 17, wherein any elastic tension near the transition region of the diaphragm is minimized when the diaphragm is fully extended toward the control chamber wall.

19. The pump cassette of claim 17, wherein the pumping side of the diaphragm comprises a plurality of raised features molded with the diaphragm, so that portions of the pumping side of the diaphragm do not contact the pumping chamber wall when the diaphragm is fully extended toward the pumping chamber wall.

20. The pump cassette of claim 19, wherein the raised features comprise bumps or raised dots.

21. The pump cassette of claim 17, wherein the first rigid body of the diaphragm pump comprises a top plate and the second rigid body of the diaphragm pump comprises a bottom plate, the diaphragm pump further comprising a mid-plate positioned between the top plate and the bottom plate, and wherein the peripheral bead of the diaphragm is configured to be positioned between the mid-plate and the bottom plate.

22. The pump cassette of claim 21, wherein the transition region of the diaphragm is thicker than the body of the diaphragm.

23. The pump cassette of claim 22, wherein the transition region of the diaphragm is configured to be clamped or pinched between a transition contact region of the mid-plate and a transition contact region of the bottom plate.

24. The pump cassette of claim 23, wherein the transition contact region of the mid-plate comprises a projection or protuberance of the mid-plate.