CHRONIC ACCESS SYSTEM FOR EXTRACORPOREAL TREATMENT OF BLOOD INCLUDING A CONTINOUSLY WEARABLE HEMODIALYZER

• US 20100030124A1
• Filed: 12/19/2007
• Published: 02/04/2010
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: Arnold J. Lande
• Original Assignee: Arnold J. Lande
• Inventors: Lande, Arnold J.
• Granted Patent: US 8,109,893 B2
• Time in Patent Office: Days
• US Class Current: 604/5.40
• CPC Class Codes: A61M 1/15 with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
• 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 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/1566 Means for adding solutions or substances to the treating fluid
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• 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 1/362263 Details of incorporated filters
• 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 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3675 : Deactivation
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• 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 2205/8206 : battery-operated
• CPC Class Codes: A61M 2209/088 : on the body

Abstract

A patient wearable, continuously operating extracorporeal pump apparatus which accesses the patient'"'"'s arterial venous pressure differential by applying external pressure to a subcutaneous graft that has been cannualized to modulate blood flow through an extracorporeal circuit and to drive the pump for delivering a medicament, such as an anticoagulant, to the site of an intravenous cannula to prevent clogging thereof and also to move a dialysate through a circuit, including a dialyzer and a dialysate rejuvenating cartridge, whereby kidney failure can be treated without recourse to prior art hemodialysis machines found in most treatment facilities. With slight modification, the present invention can be used to remove excess fluids from CHF patients, to remove toxins from the blood in those suffering from liver failure and to facilitate administration of insulin to diabetics and/or glucose to those having hypoglycemia.

Claims

1. Apparatus for the controlled introduction of a liquid medicament into the vascular system of a patient, comprising:

(a) at least one cuff comprising first and second superposed sheets of flexible plastic film selectively bonded to one another to define at least first and second fluid flow paths there between, the first fluid flow path including an expandable and compressible chamber, the second fluid flow path including a reservoir adapted to contain the liquid medicament, said cuff adapted to be worn on a limb of a person;

(b) a first cannula adapted for insertion into a blood vessel selectively sequentially exposed to arterial blood pressure and venous blood pressure and a second cannula adapted for insertion into a blood vessel exposed to only venous blood pressure, the first cannula being coupled to an inlet of the first fluid flow path on the cuff and the second cannula being coupled to an outlet of the first fluid flow path on the cuff; and

(c) a pump device adapted to be driven by expansion and compression of the expandable and compressible chamber in said first fluid flow path.

5. The apparatus as in claim 1 and further including a dialyzer coupled to the cuff, the dialyzer comprising a liquid impervious housing containing a plurality of semi-permeable membranous walls and where the first and second cannulae are in fluid communication with a flow path through the dialyzer.

6. The apparatus as in claim 5 wherein the housing includes an outlet port and the cuff includes a third fluid flow path leading from the housing outlet port to a fluid collection container.

10. The apparatus as in claim 1 wherein the pump comprises:

(a) a frame having a central opening;

(b) a lever plate disposed in the central opening and pivotally coupled at one end of the lever plate to the frame;

(c) a pair of roller members rotatably mounted on the frame and adapted to be unidirectionally driven by oscillatory movement of the lever plate; and

(d) said frame being disposed on the frame with the expandable and compressible chamber of the first fluid flow path on the cuff on one side of the lever plate and a compression spring on an opposite side of the lever plate, and with the pair of rollers cooperating with the second fluid flow paths on the cuff for moving the liquid medicament from the reservoirs and through the second fluid flow paths of the cuff to the second cannula.

15. The apparatus as in claim 1 wherein the cuff supports a dialyzer element having blood inlet and outlet ports and dialysate inlet and outlet ports, said blood inlet and outlet ports being connected in series with the first fluid flow path, a third fluid flow path formed in the cuff, the third fluid flow paths including a compressible and expansible chamber for holding a dialysate and positioned to be acted upon by the lever plate for flowing dialysate through the third fluid flow paths, the dialysate inlet and outlet ports of dialyzer element on the cuff being connected in series with the third fluid flow paths on the cuff.

16. The apparatus of claim 15 and further including one-way check valves disposed in the third fluid flow paths in the cuff.

17. The apparatus of claim 10 and further including:

(a) occluding members disposed in the frame in alignment with the first fluid flow paths on the cuff, the occluding members being on inlet and outlet sides of the expandable and compressible chambers for controlling the selective filling and emptying of said chambers.

18. The apparatus as in claim 17 and further including means for activating the occluding members to selectively block fluid flow into and from said chambers in the first fluid flow paths of the cuff.

19. The apparatus of claim 18 wherein said occluders comprise permanent magnets and the means for actuating the occluding members comprise electromagnets positioned to apply attracting and repelling forces to the permanent magnets;

and further including an electronic timer circuit for controlling energization of the electromagnets wherein the timer circuit is switched by reciprocal movement of the lever plate.

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22. Apparatus for the controlled introduction of a liquid medicament into the vascular system of a patient, comprising:

(a) first and second cuffs, each of said cuffs comprising first and second superposed sheets of flexible plastic film selectively bonded to one another to define at least first and second fluid flow paths there between, the first fluid flow path including an expandable and compressible chamber, the second fluid flow path including a reservoir adapted to contain the liquid medicament, said cuffs adapted to surround and be supported by a person'"'"'s limb;

(b) a first cannula adapted for insertion into a blood vessel selectively sequentially exposed to arterial blood pressure and venous blood pressure and a second cannula adapted for insertion into a blood vessel exposed to only venous blood pressure, the first cannula being coupled to an inlet of the first fluid flow path on the first and second flexible cuffs and the second cannula being coupled to an outlet of the first fluid flow path on the first and second cuffs;

(c) a pump device adapted to be driven by expansion and compression of the expandable and compressible chamber in said first fluid flow path;

(d) a dialyzer coupled to the first and second flexible cuffs, the dialyzer comprising a liquid impervious housing containing a plurality of semi-permeable membranous walls and where the first and second cannulae are in fluid communication with a flow path through the dialyzer; and

(e) the housing includes an outlet port and the first and second cuffs include a third fluid flow path leading from the housing outlet port to a fluid collection container.

31. The apparatus as in claim 22 wherein the pump comprises:

(a) a frame having a central opening;

(b) a lever plate disposed in the central opening and pivotally coupled at one end of the lever plate to the frame;

(c) a pair of roller members rotatably mounted on the frame and adapted to be unidirectionally driven by oscillatory movement of the lever plate; and

(d) said frame being disposed between the first and second cuffs with the expandable and compressible chamber of the first fluid flow path on the first and second cuffs on opposed sides of the lever plate and the pair of rollers cooperating with the second fluid flow paths on the first and second cuffs for moving the liquid medicament from the reservoirs and through the second fluid flow paths of the first and second cuffs to the second cannula.

32. The apparatus of claim 22 wherein the blood vessel comprises an arteriovenous fistula graft;

and further including a means of selectively compressing the arteriovenous fistula graft at a location between a point on the arteriovenous fistula graft where the first cannula is percutaneously inserted and a point on the arteriovenous fistula graft where the second cannula is percutaneously inserted.

33. The apparatus as in claim 22 wherein the blood vessel comprises an in situ debranched vein fistula graft anastomosed to an artery.

36. The apparatus as in claim 32 wherein the first and second cuffs each support a dialyzer element having blood inlet and outlet ports and dialysate inlet and outlet ports, said blood inlet and outlet ports being connected in series with the first fluid flow path, a third fluid flow path formed in each of the first and second cuffs, the third fluid flow paths including a compressible and expansible chamber for holding a dialysate and positioned to be acted upon by the lever plate for flowing dialysate through the third fluid flow paths, the dialysate inlet and outlet ports of dialyzer element on the first and second cuffs being connected in series with the third fluid flow paths on the first and second cuffs, respectively;

and one-way check valves disposed in the third fluid flow paths in the first and second cuffs.

38. The apparatus of claim 31 and further including:

(a) occluding members disposed in the frame in alignment with the first fluid flow paths on the first and second cuffs, the occluding members being on inlet and outlet sides of the expandable and compressible chambers for controlling the selective filling and emptying of said chambers; and

(b) means for activating the occluding members to selectively block fluid flow into and from said chambers in the first fluid flow paths of the first and second cuffs.

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43. A medical device for delivering metered quantities of a medicament into a patient'"'"'s vascular system comprising:

(a) a reservoir containing a medicament, the reservoir being in fluid communication with at least one percutaneous cannula via a compressible tube segment; and

(b) an extracorporeal peristaltic pump having a roller coacting with the compressible tube segment and adapted to be powered by the patient'"'"'s arteriovenous pressure differential for moving the medicament through the at least one cannula.

53. A method for obtaining therapeutic anticoagulation of an extracorporeal circuit comprising the steps of:

providing the medical device of claim 43, where the medicament is an anti-coagulant;

(a) percutaneously inserting the cannula into a debranched vein segment or a VFG;

(b) periodically compressing and releasing the debranched vein segment or the VFG to expose the blood exiting and entering said cannula to arterial pressure and venous pressure; and

(c) the pump being activated based on the difference between the arterial pressure and the venous pressure of the blood entering and exiting the cannula.

54. The method of claim 53 and further including the steps of:

(a) providing a dialyzer having a plurality of semi-permeable membranes within an outer housing;

(b) connecting the dialyzer to the cannula such that blood flows through a ventricle to power the pump and thence over a first surface of the plurality of membranes;

(c) the pump circulating dialysate through the housing and over a second surface of the membranes in proportion to the flow rate of the blood through the dialyzer; and

(d) providing a dialysate rejuvenating cartridge using the pump to move dialysate through said cartridge.

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45. The medical device of claim 44 wherein said peristaltic pump comprises:

(a) a frame having a central opening;

(b) a lever plate pivotally mounted to the frame and occupying the central opening;

(c) first and second expandable and compressible ventricles each having an inlet port and an outlet port and adapted to be selectively filled and emptied of the patient'"'"'s blood disposed on opposed sides of the lever plate and arranged such that expanding the first bladder pivots the lever plate in a direction to compress the second ventricle and expanding the second bladder pivots the lever plate in a direction to compress the first ventricle;

(d) means for selectively opening and closing said inlet ports and outlet ports of the first and second bladders; and

(e) means coupling the pivotally mounted lever plate to the roller for rotating the roller in one of a clockwise or counter-clockwise direction.

50. The medical device of claim 45 and further including:

(a) a dialyzer having a plurality of semi-permeable membranous wall surfaces contained within a liquid impervious housing, said housing having a pair of inlet ports and a pair of outlet ports;

(b) means for connecting a first of the pair of inlet ports and a first of the pair of outlet ports into the vascular system of a lower animal;

(c) means for connecting a second of the pair of inlet ports and a second of the pair of outlet ports in the vascular system of a human patient; and

(d) the first and second inlet ports and the first and second outlet ports in the housing arranged such that blood of the lower animal flows on one side of the wall surfaces and blood of the human patient flows over a second side of the wall surfaces.

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52. A method for obtaining access to a patient'"'"'s arteriovenous pressure differential comprising the steps of:

(a) selecting a venous segment in the patient'"'"'s forearm and surgically debranching the selected venous segment and tying off the distal end thereof;

(b) surgically anastomosing the distal end portion of the debranched vein to a selected artery in the patient'"'"'s forearm;

(c) inserting a needle cannula percutaneously into the debranched vein segment; and

(d) sequentially applying pressure to the forearm sufficient to substantially occlude blood flow through the debranched vein segment and releasing the pressure whereby when the pressure is being applied, the needle cannula is exposed to arterial pressure and when released, the cannula is exposed to venous pressure.

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