Patent Publication Number: US-5895571-A

Title: Separable hemodialysis system connected by a movable arm

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a continuation of U.S. application Ser. No. 08/696,319, filed Aug. 13, 1996, now abandoned, which is a continuation of U.S. application Ser. No. 08/360,381, filed Dec. 21, 1994, now abandoned, which is a Continuation-in-Part of Utterberg application Ser. No. 08/301,765, filed Sep. 7, 1994, now abandoned. 
    
    
     BACKGROUND OF THE INVENTION 
     Hemodialysis systems generally comprise a console or cabinet which provides both the blood and dialysate handling and processing functions that are necessary for hemodialysis. In prior art systems, the membrane dialyzer is mounted on the console, along with blood conduit set containing the bubble traps of the arterial and venous conduits, and the blood pump segment of the arterial conduit, which is typically of the roller pump type. 
     Inside of the console, the dialysate handling and processing equipment includes a proportioning system if the hemodialysis system is of the type which mixes a dialysis concentrate with water to form the dialysate. Temperature gauges, conductivity meters, a dialysis solution pump, and other known components for the processing, heating, monitoring, and pumping of dialysate through the membrane dialyzer unit are also provided in the console. 
     Also a pair of tubular dialysate conduits are provided for connecting the membrane dialyzer with a supply of dialysate, these dialysate conduits being fairly short since the membrane dialyzer is mounted on the face of the system console, or on a pole mounted on or near the system console. 
     The console also includes the blood handling and processing equipment comprising typically a blood pump, heparin pump, air bubble detector, line clamp, and blood pressure monitors and alarms. This equipment acts upon and/or communicates with the blood pathway inner lumens of the arterial and venous blood conduit sets. 
     The arterial and venous blood conduit sets are also connected to the membrane dialyzer, as well as being connected to the patient, to provide an extracorporeal blood flow circuit between the membrane dialyzer and the patient. Since the membrane dialyzer is carried on the console during the hemodialysis procedure, the arterial and venous blood conduit sets are typically each about eight feet long, since the relationship between the dialysis chair or bed and the hemodialysis system console is relatively fixed, and access sites on the patient range from the lower leg to the jugular vein. To avoid undue variation of the types of blood conduit sets, most or all of them provide such long tubing. 
     Such long tubing creates a significant extracorporeal blood volume that causes a strain on the patient&#39;s vascular system. Any reduction in extracorporeal blood volume (without an attendant rise in pressure drop) would result in a significant reduction in hypotension of other hemodynamic problems currently endemic to hemodialysis. 
     Also, typically, the arterial and venous blood conduit sets for hemodialysis are disposed of after one use, or a few uses at most. Thus, the cost of the sets represents a significant percentage of the cost of dialysis. Any reduction in the cost of the arterial and venous blood conduit sets would comprise a significant reduction in the cost of the long term hemodialysis of a patient, since the procedure is performed on a chronic basis, typically three times a week. 
     In accordance with this invention a modification of hemodialysis systems is provided, in which the length of the tubing of the arterial and venous blood conduit sets can be substantially reduced, by separating the blood processing and dialysate processing equipment into two consoles such that the blood processing equipment can be brought closer (horizontally) to the patient&#39;s vascular access, and closer (vertically) to the patient&#39;s heart level. This results in a potentially significant cost savings in the disposable sets, since more than a hundred fifty of them are typically used annually by each dialysis patient. 
     By way of further advantage, a reduction in the length of the tubing of the blood conduit sets reduces the priming volume of the sets, which, in turn, can reduce the loss of blood by the patient in each hemodialysis procedure. Also, at high blood flow rates, the pressures in a set with blood tubing of reduced length can have a reduced pressure drop. This reduces the risk of collapsing blood vessels in the patient, due to excessive suction pressure at the arterial end of the blood conduit set. 
     By way of further advantage, the pressure monitoring means (pressure transducers) can more practicably brought to the level of the patient&#39;s heart, thus eliminating blood pressure reading errors caused by differentials in the height of the patient relative to the height of the pressure monitoring means. The shortness of the tubing and the correct height of the pressure monitoring means allows very accurate blood pressure measurements in the patient&#39;s fistula or graft as called for in an ideal dialysis. 
     DESCRIPTION OF THE INVENTION 
     In accordance with this invention, a hemodialysis system is provided which comprises the following. 
     A dialysate handling unit is present for providing hemodialysis solution to the patient. The dialysate handling unit comprises a hemodialysis solution pump plus hemodialysis solution safety monitoring means, comprising typically conventional items such as a conductivity meter and a blood detector. Also, heating means for warming the dialysate to a desired temperature may be provided, as well as other conventional accessories such as a proportioning system for mixing concentrate with water to produce the dialysate, and providing negative pressure for delivering dialysate at subatmospheric pressures to the membrane dialyzer. 
     A first, flexible conduit is also provided for conveying fresh dialysate from the dialysate handling unit to the membrane dialyzer. A second flexible conduit is provided for conveying the spent dialysate away from the membrane dialyzer, either to a drain, or back to the dialysate unit for recirculation in desired circumstances, or for use in a known system for the measurement of ultrafiltration, for example. 
     Also, a blood handling unit is present, which comprises a membrane dialyzer holder optionally including a pole for carrying a membrane dialyzer holder, a blood pump, and means for safely handling blood as it is pumped from the patient, through the membrane dialyzer, and back to the patient. Such means for safely handling the blood may comprise any or all of a bubble detector, a heparin pump, pressure monitoring means on the arterial and venous blood conduits, line clamps, and the like in accordance with conventional practice. 
     In accordance with this invention, the equipment of the dialysate handling unit and the blood handling unit (together with the extra-corporeal circuit) are separate from each other and typically movable relative to each other while hemodialysis is being performed. For example, the blood handling unit may be carried on an I.V. pole next to the patient or a pole attached to the bed or chair, and positioned so that the arterial and venous blood conduits of the extra corporeal circuit each may be substantially shortened from their present, conventional eight foot lengths. Typically, the blood conduit lines used in this invention may each have a length of about one to three feet. On the other hand, the first, flexible conduit for dialysate is typically substantially lengthened over the corresponding conduit of the prior art, for example to a length of at least about six feet. 
     Thus, the console of the dialysate handling unit may in this invention be conveniently spaced from the patient, with the dialysate passing through a lengthened first conduit to reach the membrane dialyzer and/or the blood handling unit which carries the dialyzer. 
     As a further alternative, the blood handling unit and the dialysate handling unit may be connected by a movable arm of conventional design, to permit the blood handling unit to be positioned in a plurality of vertically and horizontally variable positions relative to the dialysate handling unit. Thus the blood handling unit may be positioned in the manner of other arm-mounted movable consoles or other equipment from the field of dentistry, computer design or the like, permitting the blood handling unit to be spaced from the dialysate handling unit, and also positioned next to the patient in a desired vertical and horizontal position. This also permits the blood handling unit to be varied in its position during the dialysis procedure if that is desirable, while also permitting the use of short blood lines for achieving the advantages described elsewhere herein. 
     The second conduit for conveying the spent dialysate away may also be lengthened, either to return the dialysis solution to the dialysate handling unit or to communicate with a drain, as may be desired. 
     Also, the dialysate handling unit may carry an electronic system for control of the system functions, with a cable communicating between the electronic system and the blood handling unit, being typically of a length similar to the first flexible conduit. Thus, the console containing the dialysate handling unit can provide power and control from its electronic system to the blood pump and any other electrically operated components of the blood handling unit, for example automatic blood flow shut off valves, the bubble detector, automatic pumps or valves for the administration of heparin or saline, and the like. 
     The blood pump of the blood handling unit may comprise a conventional roller pump which comprises a rotor and an approximately U-shaped track for receiving blood pump tubing. It is preferred for the U-shaped track to be in the position of a rightside up (upright) U, which facilitates the direct connection of the blood pump tubing to the membrane dialyzer unit and to a bubble trap. Such an arrangement is taught in Utterberg U.S. patent application Ser. No. 08/254,428 filed Jun. 6, 1994 , now U.S. Pat. No. 5,520,640, and entitled &#34;Blood Air Trap Chamber&#34;. Significant advantages are achieved in a system of this type that makes use of a roller pump, where the U-shaped track of the blood tubing is upright. 
     Thus, by this invention it becomes possible to shorten the tubing in the blood conduit sets for hemodialysis. Since the blood conduit sets are regularly replaced in this chronic and frequent procedure, any small saving in the cost of the set rapidly multiplies itself over a period of time. Also, a reduction in the priming volume and the pressure drop of the blood conduit sets provides significant functional advantages in the hemodialysis procedure. These advantages are achieved by separating the dialysate handling unit and the blood handling unit (as defined above), and connecting them with a lengthened, first, flexible inlet conduit for dialysate. One also typically provides a lengthened electronic cable for power and control of the blood handling unit from the dialysate handling unit and a lengthened, second, flexible outlet conduit for dialysate. 
     The first and second hemodialysis solution conduits and the electronic cable are reusable parts which can be reused for hundreds of dialysis procedures. Thus, the slightly increased cost of the increased length of these items is basically negligible, compared with the cost savings provided by the shortened blood sets, as accomplished in accordance with this invention. 
     Also, it is preferred for the hemodialysis system of this invention to use a membrane dialyzer, preferably a hollow fiber dialyzer, and which is mounted in the blood handling unit with the blood outlet of the membrane dialyzer being positioned higher than the blood inlet. This corresponds to a conventional &#34;priming&#34; position of a hollow fiber hemodialyzer in which air bubbles move upwardly through the blood outlet. Then, in the prior art, after priming of at least the blood conduit, the dialyzer is inverted by about 180° so that the blood outlet is vertically lower than the blood inlet. This is another reason that the blood lines between the patient and the blood handling units of the prior art have to be longer than in this present invention. By this invention, one can proceed with dialysis without inverting or &#34;flipping&#34; the dialyzer. 
     One reason this is possible is that, in traditional dialysis machines, the degassing of the incoming water and/or dialysate was not very good, so that under the significant negative pressure that was required for adequate ultrafiltration, dissolved air would out-gas in the dialysate in the form of bubbles. The typical membrane dialyzer is in the blood outlet end-down position during operation so the dialysate, air bubbles may rise to the top of the dialyzer in the dialysate flow path since typical membrane blood and dialysis flows are countercurrent. That is, with the blood outlet in the end-down position of dialysis, the dialysate outlet is vertically higher than the dialysate inlet. The dialysate bubbles, thus can rise and exit the dialysate outlet (which is at blood inlet end of the membrane or dialyzer). If the membrane dialyzer were run with the dialysate outlet end down (i.e., the priming position) with traditional dialysis machines, the dialysate air bubbles would accumulate in the dialysate compartment of the membrane dialysate, &#34;masking&#34; the membrane. This will reduce the performance of the membrane dialyzer. However, with new high flux dialysis membranes, ultrafiltration takes place at significantly lower negative pressures, so there is less tendency for air to outgas into bubbles in the dialysate during operation. Also, modern dialysis machines have much better gas removing capability from the incoming water and/or dialysate, all of which basically reduces or eliminates the air bubble problem in dialysate. However, on the blood side, there is typically an increased blood flow rate in modern, state of the art dialysis, which means that in the pre-pump segments of the arterial blood conduit line, it is the blood that is seeing much higher negative pressure. Blood has a high degree of dissolved gas in it. Thus, gas bubbles may come out in the blood as the higher flows &#34;stretch&#34; the blood coming through the narrow constriction of the blood access device, typically a 14-17 gauge fistula needle. There is an added advantage, therefore, in having the blood flow upwardly during dialysis, which is also the priming position, so that there is no necessity or advantage in rotating the dialyzer by 180° for operation after priming. However, this has not been recognized in the prior art, and rotation of the hollow fiber dialyzer between priming and operation is still normally followed in the prior art. 
     Thus, by this invention, the blood lines can be so short that inverting of the dialyzer after priming is impossible, and not needed, without encountering disadvantage. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of a hemodialysis system in accordance with this invention, in the process of use; 
     FIG. 2 is an enlarged,perspective view of a preferred blood handling unit as shown in FIG. 1; and 
     FIG. 3 is a fragmentary, plan view of another embodiment of the hemodialysis system in accordance with this invention, in which the blood handling unit and the dialysate handling unit are connected by a movable arm. 
    
    
     DESCRIPTION OF SPECIFIC EMBODIMENTS 
     Referring to the drawings, a hemodialysis system is shown which comprises a dialysate handling unit 10 having an outer console 12, which contains a conventional solution pump, a dialysate proportioning system, and various hemodialysis solution safety monitoring mechanisms such as a conductivity meter, a blood detector, and other conventional items for the preparation, monitoring, and delivery of hemodialysis solution to a membrane dialyzer. Additionally, a heater for the dialysate may be provided, as well as a temperature control device, all of which are basically conventional, there being numerous dialysis machines which are currently available for clinical use. A control panel 14 is provided on the console for control of the various dialysis functions, including the functions that relate to the safe handling of blood as it is pumped from the patient through a membrane dialyzer 18 and back to the patient. Additionally, a conventional degassing mechanism may be provided within console 12 as well. Alternatively, blood monitoring control can happen on the blood handling unit described below. 
     A first, flexible conduit 16 communicates from the hemodialysis solution unit 10 to the dialysate inlet 17 of membrane dialyzer 18, which is specifically shown to be of the hollow fiber type. The membrane dialyzer preferably is mounted on the blood handling unit 24 by means of a clamp 63 or the like. Alternatively, the membrane dialyzer can be mounted on the I.V. pole by a similar clamp. 
     The dialysate enters dialyzer 18 at port 17, flowing between the hollow fibers in countercurrent relation to flowing blood within the hollow fibers, and then out of port 20 into second, flexible conduit 22. In this embodiment, second flexible conduit 22 returns spent dialysate to the dialysate handling unit 10 for the measuring of ultrafiltration in a conventional manner. However, if desired, second, flexible conduit 22 may simply lead to a drain. 
     The blood handling unit 24 is small enough to be carried on a conventional I.V. pole 26, which may be moved during the dialysis procedure while carrying blood handling unit 24 to be close to the patient. Unit 24 may be placed by the patient&#39;s shoulder if the blood access site is in the arm or jugular vein, or by his feet if the blood access site is in the lower leg. Blood handling unit 24 can be moved to accomplish this, while the larger dialysate unit 10 remains stationary and relatively distant from the patient. The blood handling unit will comprise a blood pump module 34, blood pressure monitoring modules 51, 51a, bubble detector module 64, blood line clamp 66, and preferably a heparin pump module 60 and dialyzer holder 63. 
     Blood access needle connectors 28 and 28a are shown to be connected to conventional single lumen fistula needles, but which may also be any other conventional sources of blood access. For example, one double lumen needle may be used. Arterial conduit tubing is provided which comprises tubing 30, which communicates with a bubble trap chamber 32 similar to that described in the previously cited Utterberg patent application No. 08/254,428 The blood passes from arterial conduit tubing 30 to bubble trap chamber 32, and from there to a conventional roller pump 34. Roller pump tubing 36 extends from chamber 32 through a U-shaped track 67 surrounding rotor 37 of roller pump 34, in which the U-shape of the track is in upright form, for advantages described in the previously described Utterberg application. 
     Blood is thus pumped from chamber 32, through the roller pump around U-shaped track 36, to preferably a combination dialyzer/pump segment connector 68, to the blood inlet or arterial entrance 38 of hollow fiber dialyzer 18. Blood passes through the hollow fibers upwardly through membrane dialyzer 18, to exit through the blood outlet (venous port) 40 of the membrane dialyzer into a length of blood tubing 42, which communicates with bubble trap chamber 43, which is preferably defined with chamber 32 in an integral structure, as disclosed in the previously cited application. The blood passes through chamber 43 and out the bottom through venous conduit tubing 44, back to needle connector 28a for readministration to the patient. 
     A multiple wire electronic cable 46 communicates between hemodialysis solution unit 10 and blood dialysis unit 24, to provide power and/or electronic control to blood pump 34 and any other electrically powered components of blood dialysis unit 24 such as pressure monitor 51 and 51a and a bubble detector 64, and a line clamp 66, which are generally all of conventional design except as otherwise shown. The various electrically powered systems of blood dialysis unit 24 may be controlled by a conventional electronic system of the hemodialysis solution unit 10, with appropriate controlling signals being sent through cable 46 in both directions. 
     A saline solution bag 48 is provided in conventional manner to communicate via line 48a with chamber 32. Lines and connectors 50, 50a may be used in conventional manner to connect chambers 32, 43 to pressure monitors 51 and 51a. A heparin pump 60 may be included in blood dialyzer unit 24 and administered in conventional manner via syringe 61 through a branch connector line 62 which may be placed as desired in the system. 
     Tubing 69 provides syringe or needle access to the system. 
     In this specific embodiment, blood tubing 30, 44 may each have a length respectively of about one to three feet between needle connectors 28, 28a and bubble traps 32, 43. Blood tubing 42 is likewise of a length on the order of one foot. Thus, there is a substantial shortening of the blood tubing in the system disclosed, when compared with the use of corresponding and conventional arterial and venous blood conduit sets, each of which can have approximately a eight foot length of blood tubing analogous to tubings 30 or 44. It can be thus seen that by this invention a savings of more than fifty percent in the blood tubing lines can be achieved, resulting in a proportionate reduction in priming volume and pressure resistance to flow. 
     Flexible dialysate conduits 16, 22 may be on the order of six to fifteen feet in length, or whatever length is desirable so that the I.V. pole 26 can be placed close to the patient so that the short blood tubings 30, 44 are adequate. Blood handling unit 24 is thus substantially spaced from solution handling unit 10, which may be conveniently placed in a more remote location, out of the way of the technicians in the area. Similarly, electronic cable 46 may be of a corresponding length on the order of six to fifteen feet. 
     Thus, by this invention, hemodialysis may proceed in a manner which is substantially identical to currently available membrane hemodialysis procedures. However, the functions of the hemodialysis system that pertain to the safe handling and pumping of the blood from the patient, through the membrane dialyzer, and back to the patient are physically separated from the functions of the hemodialysis system which pertain to the providing of dialysate to the patient, including if desired the preparation thereof. This permits the shortening of the lengths of the blood tubing, which has both functional and economic advantages, typically with a corresponding lengthening of the dialysis solution flexible conduits and the control cable between the two units 10, 24. This latter modification is of relatively low cost because the latter components are reusable on a long term basis. Also, dialyzer 18 may be primed and then used without inverting the dialyzer, with blood inlet 38 being typically lower than blood outlet 40. 
     Referring to FIG. 3, another hemodialysis system is disclosed which is similar in structure, function, and advantage to the previous embodiment, except as otherwise described herein. Dialysate handling unit 10a is shown, being generally similar in structure and function to dialysate handling unit 10, but also with a special IV pole 70 if desired for carrying bags of intravenous solution and the like. A blood handling unit 24a is also provided, being similar in structure and function to blood handling unit 24 of the previous embodiment except as otherwise indicated. Thus details are omitted for clarity. 
     Blood handling unit 24a may carry its own IV pole 72 if desired, for hanging bags of IV solution and the like which are being used in the dialysis process. 
     Dialyzer 18 may be identical to the previous dialyzer but used in the embodiment of FIG. 3 rather than the previous embodiment, being carried on blood handling unit 24a by a conventional clamp 63a. First, flexible dialysate conduit 16a communicates with a dialysate inlet of the dialyzer 18, while second flexible conduit 22a communicates with the dialysate outlet of dialyzer 18. Both of these conduits communicate with dialysate handling unit 10a in a manner similar to the corresponding parts of the previous embodiment. 
     Electronic cable 46a connects between units 10a and 24a in a manner which is also similar to the corresponding parts of the previous embodiment. Blood lines 36a, 42a, 30a, 44a may be similar to and of the same function as there corresponding components in the embodiment of FIGS. 1 and 2, as may be the other components carried on or in blood handling unit 24a, which thus do not need to be described again in detail. 
     In accordance with this invention, a movable arm 74 of conventional design is pivotally attached at pivots 76, 78 respectively to dialysate handling unit 10a and blood handling unit 24a. Movable arm 74 may have one or more intermediate pivots 80, and may be constructed to carry blood handling unit 24a in a movably positionable manner so that blood handling unit 24a may be spaced from dialysis solution handling unit 10a and may occupy a wide range of vertical and horizontal positions near the patient. Thus, unit 24a may be vertically and/or horizontally adjusted to provide the greatest comfort and to best facilitate the dialysis procedure, thus permitting blood tubes 30a, 44a to be relatively short when compared with dialysate tubes 16a, 22a, in a manner previously discussed and for the same advantages. Specifically, blood tubes 30a, 44a may have a length of about one to three feet. 
     Horizontal movement of arm 74 may be provided by a horizontal pivot 82 carried on unit 10a. 
     Arm 74 may also carry retention rings 84 for the retention of the dialysate lines 16a, 22a and the power cord 46a. 
     Thus, the purposes of this invention can be better accomplished, with a movable support arm 74 carrying the blood handling unit 24a in movably spaced relation from the dialysate handling unit 10a, but the two units 10a, 24a remain physically connected together. Longitudinally expansible or telescoping arms may also be used as arm 74 to provide a great deal of spacing between the respective units 10a, 24a, coupled with great convenience of positional adjustment of blood handling unit 24a, to provide convenience to the procedure and comfort to the patient. 
     The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is as defined in the claims below.