Multimodal displacement pump and dissolution system for same

• US 5,098,377 A
• Filed: 07/26/1990
• Issued: 03/24/1992
• Est. Priority Date: 09/06/1988
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Pool, Scott L., Harp, Richard, Borsanyi, Alexander, Rondinone, Joseph, Lebo, Robert, Wall, Roxanne, Stone, Albert L., Sorensen, John T.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/559,124
• Time in Patent Office: 607 Days
• Field of Search: 604/4-6, 604/27-35, 604/49, 604/51, 604/118-120, 604/131, 604/151-153, 604/257, 604/319, 128/DIG. 12, 417/394, 417/472, 417/473
• US Class Current: 604/30
• CPC Class Codes: A61M 1/772 operating alternately
• CPC Class Codes: A61M 1/82 Membrane pumps, e.g. bulbs

Abstract

Disclosed is a pneumatically-driven volume controlled bellows pump apparatus for oscillating liquid into a localized area of the human body, preferably methyl-tertiary butyl ether or another solvent, into the gallbladder. The pump includes a fluid reservoir in the form of an inverted syringe attached via a stopcock to the bellows. The bellows is attached via a second stopcock to a catheter also attached to a priming syringe. An inlet pinch valve is disposed between the bellows and the fluid reservoir and an outlet pinch valve between the bellows and the fluid receiver.

To use the pump, a pigtail catheter with outlets in the pigtail is inserted into the desired area of the body, preferably a receptacle such as the gallbladder, to introduce a selected volume of liquid for gallstone dissolution. Liquid is infused into the receptacle by decompression of the bellows with the inlet but not the outlet valve open and then by compression of the bellows with the outlet but not the inlet valve open. Repeated infusion and aspiration is automatically accomplished by decompression and compression of the bellows with the inlet valve closed and the outlet valve open, or by compression and decompression of the bellows while the inlet valve is open and the outlet valve is closed alternated with compression and decompression while the inlet valve is closed and the outlet valve is open. Complete aspiration is accomplished by the use of a vacuum pump attached to the fluid reservoir. Also disclosed are syringe units and a transfer cap for use with the pump, together with a method for dissolving gallstones.

Claims

1. A pumping apparatus for pumping preselected volumes of fluid through a catheter means insertable into a fluid receiving body such as a human gallbladder, said pumping apparatus comprising:

a syringe means fluidly connectable to a fluid source;

a means for withdrawing a preselected volume of fluid into said syringe means;

a flexible bellows fluidly connected to said syringe means and connectable to said catheter means such that alternate compression and extension of said bellows may be employed to transfer fluid back and forth between syringe means and said catheter means;

a programmable controller operatively connected to said pumping apparatus to control the frequency and numerosity of fluid transfers back and forth between said syringe means and said catheter means.

2. The apparatus of claim 1 wherein said means for withdrawing a preselected volume of fluid into said syringe means comprises:

(a) a chamber sealably mounted on at least a portion of said syringe means such that creation of a vacuum within said chamber will cause withdrawal of fluid into said syringe means; and

(b) a vacuum source connected to said chamber to create a vacuum therein.

3. The apparatus of claim 2 further comprising:

a first valve for alternately opening and closing the fluidic connection between said syringe means and said fluid source;

a second valve for alternately opening and closing the fluidic connection between said syringe means and said bellows.

4. The apparatus of claim 3 wherein:

said controller is operatively connected to (a) said bellows, (b) said first valve, (c) said second valve and (d) said vacuum source; and

said controller is programmed to;

i. open said first valve and close second valve;

ii. cause said vacuum source to withdraw fluid from said fluid source into said syringe; and

, thereafter

iii. close said first valve and open said second valve to permit fluid from said syringe to be infused through said bellows and through said catheter.

5. The apparatus of claim 2 wherein said vacuum source comprises a Bernouilli'"'"'s valve.

6. The apparatus of claim 1 wherein said flexible bellows comprises:

a flexible bellows member sealably positioned between first and second rigid cap means and having a movable bellows drive piston connected to at least one of said rigid cap means to alternately compress and expand said bellows, the length of the stroke of said piston being adjustable to permit adjustment of the volume of fluid to be transferred by each compression and expansion of said bellows.

7. The apparatus of claim 1 further comprising:

a first valve for alternately opening and closing the fluidic connection between said syringe means and said fluid source;

a second valve for alternately opening and closing the fluidic connection between said syringe means and said bellows.

8. The apparatus of claim 7 wherein:

said controller is operatively connected to (a) said bellows, (b) said first valve and (c) said second valve; and

said controller is programmed to initially open said first valve and close said second valve to allow withdrawal of fluid from said fluid source into said syringe and to thereafter close said first valve and open said second valve to permit infusion of fluid from said syringe through said bellows and into said catheter.

9. The apparatus of claim 7 further comprising:

a third valve for alternately opening and closing the fluidic connection between said bellows and said catheter means.

10. The apparatus of claim 9 wherein:

said controller is operatively connected to (a) said second valve, (b) said third valve and (c) said bellows; and

said controller is programmed to alternately open and close said first and second valves and to alternately compress and expand said bellows in relative relation to the opening and closing of said first and second valves to thereby withdraw fluid from said fluid receiving body through said catheter means to said bellows and to pump said withdrawn fluid from said bellows into said syringe means.

11. The apparatus of claim 7 wherein:

said controller is operatively connected to (a) said first valve, (b) said second valve and (c) said bellows; and

said controller is programmed to;

i. close said first valve;

ii. open said second valve;

iii. repeatedly expand and compress said bellows to effect oscillatory movement of fluid back and forth through said catheter means.

12. The apparatus of claim 7 wherein the first valve and second valve opposite pinch valves.

13. The apparatus of claim 1 wherein said controller is operatively connected to said bellows and is programmable to effect programmed changes in the volume of fluid being pumped by said bellows.

14. The apparatus of claim 1 wherein the volumetric capacity of said bellows is adjustable to cause 1.0 to 7.0 milliliters of fluid to oscillate back and forth through said catheter means.

15. The apparatus of claim 1 further in combination with said catheter means, and wherein said catheter means is a pigtail catheter.

16. The apparatus of claim 1 wherein:

said bellows is disposed in a generally vertical orientation such that it will expand and contract in a generally vertical direction; and

a top fluidic connection port being formed in the top said bellows and a bottom fluidic connection port being formed in the bottom of said bellows.

18. The apparatus of claim 1 wherein the volumetric capacity of said bellows ranges from 0.5 to 20 milliliters.

19. The apparatus of claim 1 wherein said bellows further comprises a means for manually adjusting the volumetric capacity of said bellows between the range of about 0.5 to 20 milliliters.

20. The apparatus of claim 1 further comprising a waste container fluidly connected to said apparatus such that waste fluid may be withdrawn through said catheter means and expelled directly into said waste container.

21. The apparatus of claim 1 wherein said syringe comprises a plunger element slidably disposed within a barrel element and wherein said means for withdrawing a preselected volume of liquid into said syringe further comprises:

a sealed vacuum chamber formed about at least a portion of said syringe such that the formation of negative pressure within said chamber will cause the plunger of the syringe to withdraw within the syringe barrel; and

a negative pressure source connectable to said chamber to thereby evoke withdrawal of the plunger of said syringe within the barrel of said syringe.

22. The apparatus of claim 1 further comprising:

a second syringe attached to the fluidic interconnection between said bellows and said catheter to permit air to be purged from fluid passing from said bellows to said catheter.

17. The apparatus of claim 59 wherein:

the top fluidic connection port is connectable to the catheter means; and

,

the bottom fluidic connection port is connected to the syringe member;

said bellows being thereby operative to differentially pump a two-phase liquid contained therein such that the upper phase of said liquid will be expelled through said top port and into said catheter and the lower phase of said liquid will be expelled through said bottom port and into said syringe.

23. An apparatus for effecting in situ infusion and extraction of dissolution fluid into and out of a human gallbladder, said device comprising:

a dissolution fluid container;

a syringe pump fluidly connected to said dissolution fluid container;

a bellows pump fluidly connected to said syringe pump;

a catheter insertable into the gallbladder and fluidly connected to said bellows pump;

a first valve for opening and closing the fluidic connection between said dissolution fluid container and said syringe pump;

a second valve for opening and closing the fluidic connection between said syringe pump and said bellows pump;

a third valve for opening and closing the fluidic connection between said bellows pump and said catheter; and

a programmable logic controller operatively connected to (a) said first valve, (b) said second valve, (c) said third valve, (d) said syringe pump and (e) said bellows pump, said controller being programmed to;

i. open said first valve and close second valve;

ii. cause said syringe pump to withdraw dissolution fluid from said dissolution fluid container into said syringe pump;

iii. close said first valve; and

iv. alternately open and close said second and third valves while expanding and contracting said bellows relative to the opening and closing of said second and third valves so as to pump dissolution fluid from said syringe pump through said bellows and through said catheter;

v. close said second valve, open said third valve and repeatedly expand and contract said bellows to effect oscillatory back and forth movement of dissolution fluid through said catheter;

vi. open said second and third valve and cause said syringe pump to withdraw the dissolution fluid through said catheter through said bellows and into said syringe pump.

24. The apparatus of claim 23 further comprising a waste receptacle fluidly connected to said syringe pump and wherein said programmable controller is further programmed to:

vii. close at least said second valve; and

viii. cause said syringe pump to expel the withdrawn dissolution fluid from said syringe pump into said waste container.

25. The apparatus of claim 24 further comprising a float valve positioned within said waste receptacle to prevent over filling of said waste receptacle.

26. The apparatus of claim 23 further comprising:

a stopcock positioned in the fluid connection between said bellows and said catheter to permit bleed-off of air and excess fluid.

27. The apparatus of claim 26 wherein a syringe is attached to said stopcock positioned in the fluid connection between said bellows and said catheter such that said syringe may be utilized to draw a quantity of dissolution fluid from said syringe pump through said bellows and into said syringe, thereby effecting priming of at least said bellows pump.

28. The apparatus of claim 23 wherein said syringe pump comprises:

a syringe having a barrel portion and a plunger portion;

a chamber sealably mounted on at least a portion of said syringe such that creation of a vacuum within said chamber will cause the plunger of the syringe to withdraw within the syringe barrel; and

a vacuum source for creating a vacuum within said air-tight housing to cause withdrawal of the syringe plunger in the syringe barrel.

29. The apparatus of claim 28 further comprising a positive pressure source attached to said air-tight housing to create positive pressure therein to cause forward advancement of the syringe plunger within the syringe barrel.

30. The apparatus of claim 28 wherein the barrel of said syringe comprises an inner bore wherein the plunger of said syringe is slidably received and wherein at least a portion of said plunger is of reduced diameter relative to the bore of the barrel thereby minimizing the tendency of the piston to become immobilized relative to the barrel.

31. The apparatus of claim 23 wherein said bellows comprises:

a flexible bellows member sealably positioned between first and second rigid cap means and having a movable bellows drive piston connectable to at least one of said rigid cap means so as to alternately compress and expand said bellows, the length of the piston stroke being adjustable to permit a selected volume of fluid to be transferred by each compression and expansion of said bellows.

32. The apparatus of claim 23 wherein said controller comprises a programmable pneumatic controller.

33. The apparatus of claim 23 wherein said catheter comprises a pigtail catheter.

34. The apparatus of claim 23 wherein said first, second and third valves comprise pneumatically actuatable pinch valves.

35. The apparatus of claim 23 wherein said bellows further comprises means for manually adjusting the volumetric capacity of said bellows between the range of about 0.5 to 20 milliliters.