CA1232502A - Single lumen catheter fluid treatment - Google Patents

Single lumen catheter fluid treatment

Info

Publication number
CA1232502A
CA1232502A CA000457150A CA457150A CA1232502A CA 1232502 A CA1232502 A CA 1232502A CA 000457150 A CA000457150 A CA 000457150A CA 457150 A CA457150 A CA 457150A CA 1232502 A CA1232502 A CA 1232502A
Authority
CA
Canada
Prior art keywords
fluid
line
reservoir
venous line
arterial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000457150A
Other languages
French (fr)
Inventor
Klaus F. Kopp
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Application granted granted Critical
Publication of CA1232502A publication Critical patent/CA1232502A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/30Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/30Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
    • A61M1/301Details
    • A61M1/302Details having a reservoir for withdrawn untreated blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/30Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
    • A61M1/301Details
    • A61M1/303Details having a reservoir for treated blood to be returned
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/30Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
    • A61M1/301Details
    • A61M1/305Control of inversion point between collection and re-infusion phase
    • A61M1/306Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs

Abstract

ABSTRACT OF THE DISCLOSURE

Single Lumen Catheter Fluid Treatment The invention concerns a novel procedure and apparatus for controlling opening and closing of venous and arterial lines in single lumen catheter fluid treatment procedures. Different types of apparatus useful for different types of fluid treatment procedures, in particular hemodialysis, hemofiltration, and plasmapheresis procedures, are disclosed.

Description

:~23;~5C~Z -1-SINGLE LUMEN CATHETER FLUID TREATMENT

This invention relates to single lumen catheter fluid treatment, and more particularly to a method and apparatus for controlling opening and closing of venous and arterial lines leading to and from said single lumen catheter.

BACKGROUND OF THE INVENTION

A variety of procedures and apparatuses related to single lumen catheter fluid treatment, more particu-larly blood treatrnent, have developed since the time of my US Patent No. 3,756,234, now Re 29,346. The most .successful procedures or apparatuses employ the concept of controlling at least one of opening or closing of the venous or arterial line in response to a high or low pressure value which develops in a closed extracorporeal blood circuit, comprising the arterial line leading from the single lumen catheter, the hemodialyser, hemofilter, hemodiafilter, plasmapheresis device, or ascites device, and the venous line, which venous line normally includes a venous line reservoir or drip chamber, leading back to the single lurnen catheter. Most popular are procedures involving opening of the venous line with substantially simultaneous closing of the arterial line in response to a preset higher pressure value which develops in the venous line.
These procedures sometimes also involve closing of the venous line with substantially simultaneous opening of the arterial line in response to a preset lower pressure value which develops in the venous line.
Generally, the pressure value in the venous line is ~23'~5~

sensed by sensing pressure in a gaseous cushion abovethe level of fluid, usually purified or treated blood, in the venous line reservoir. Also known are devices in which closing of the venous line with substantially simultaneous opening of the arterial line is in response to a predetermined or adjustable time increment.
Similarly, devices in which closing of the arterial line with substantially simultaneous opening of the venous line is in response to a predetermined or adjustable time increment are known, which devices-may either include means for closing of the venous line with substantially simultaneous opening of the arterial line in response to a preset lower pressure value which develops in the venous line, or may include means for closing of the venous line with substantially simultaneous opening of the arterial line in response to a predetermined cr adjustable time increment. The latter type of device, i.e. one in which closing of both the arterial and venous lines is in response to predetermined or adjustable time increments are not contemplated by my US Patent Re 29,346 and indeed have been avoided in further research for the I- reason that control of single lumen catheter fluid treatment procedures exclusively by timer mechanisms excludes achieving what is considered to be an extremely important advantage. Devices including means for closing of the arterial or venous lines in response to a pressure value which develops in the extracorporeal blood circuit are controlled dependently of a particular condition or status within the extracorporeal blood circuit. In other words, systems including means for controlling closing of the arterial and/or venous lines in response to a pressure value developed in the extracorporeal blood circuit are essentially self-regulating.

~3Z~C~2 With the above considerations in mind, and in particular bearing in mind the concept of achieving a self-regulating system, it has now been found that a parti-cular combination of means for controlling closing of venous and arterial lines in a single lumen catheter assembly can achieve substantially improved self-regulation as compared to systems employed in the past. More particularly, it has been observed that self-regulation in a single lumen catheter assembly is not complete if there is not also provided means for controlling closure of the venous line dependently of conditions in the arterial line. This consideration, coupled with the procedure of controlling closure of the arterial line dependently of conditions in the venous line, already known in part from devices such as discussed above, has led to a new and greatly improved method and apparatus useful for controlling the closing of an arterial line with substantially simultaneous opening of a venous line and the closing of said venous line with substantially simultaneous opening of said arterial line, which method and apparatus is the subject of the present invention. An assembly of fluid lines specially adapted for the method and apparatus is also provided by the present invention.

The present invention furthermore includes the consi-deration that there is little point in closing the venous line whilst there is an adequate quantity of ~32~3Z:

untreated fluid upstream of the fluid treatment device.
Similarly, or conversely, there is little point in closing the arterial line with substan-tially simultaneous opening of the venous line before there is an adequate quantity of treated fluid downstream of the fluid treatment device. It is of importance to bear in mind that time should be optimally employed in single lumen catheter fluid treatment procedures since if treatment time with a single lumen catheter exceeds treatment time with double lumen or dual needle treatment pro-cedures too significantly, the now well-known advantages of some single lumen catheter fluid treatment procedures could be outweighed by such increased fluid treatment time.

SUMMARY OF INYENTION
The method of the present invention comprises the steps of providing an arterial line reservoir upstream of the fluid treatment device for receiving untreated fluid from the fluid source, providing an arterial line opening and closing means upstream of the arterial line reservoir, providing '- a venous line reservoir downstream of the fluid treatment device for receiving treated fluid from the fluid treatment device, providing a venous line opening and closing means downstream of the venous line reservoir, withdrawing untreated fluid from said fluid source into said arterial line reservoir, passing such untreated fluid from said arterial line reservoir through the fluid treatment device and into the venous line reservoir, closing the arterial line and substantially simultaneously opening the venous line in response to a higher limit quantity of treated f]uid available in the venous line reservoir whereby treated fluid is returned to said fluid source, and closing the venous line and substantiallv simultaneously opening the arterial line in response to a lower limit quantity of untreated fluid available in l drterial line reserVir ~25~3~2 The arterial and venous line closing and opening means may be achieved in now conventional fashion, such as with solenoid-opera-ted clamps or stopping and starting of Eluid pumps conveniently peristaltic roller pumps. Generally, however, in the present invention, untreated Eluid would be con-tinuous'y passed from said ar-terial line reservoir and through the fluid treatmen-t device so tha-t treated fluid is continuously collec-ted in the venous line reservoir. Thus, the clamp means for controlling opening and closing of the arterial line would in general be provided upstream of an arterial line fluid pump and upstream of -the arterial line reservoir. Similarly, in general, clamp means for opening and closing the venous line would be provided downstream of the venous line reservoir.

In a simpler embodiment of the presen-t invention only one pump means is provided for the purpose of passing un-treated fluid from the arterial line reservoir and through the fluid treatment device so that treated fluid is collected in the venous line reservoir. In -this embodiment, pressure would fluctuate not only in the venous line reservoir but also in the fluid treatment device. This may not always be desirable, as in certain hemodialysis procedures in which so~called high-flux membrane fluid treatment devices are employed or in certain hemofiltration, hemodiafiltration, or plasmapheresis operations.
In such opera-tions, i-t would in general be of advantage if the fluid pressure in the fluid treatment device were to remain ~3~S~
5a substan-tially constan-t.

According to a .Eirst broad aspect of the invention there is provided a method of controlling the closing of an arterial line with substantially simultaneous opening of a venous line and the closing of said venous line with substantially simultaneous opening of said arterial line in a single lumen catheter assembly in which untreated fluid is withdrawn from a fluid source through said single l.umen catheter and said arterial line, passed through a Eluid treatment device and treated fluid returned to the :Eluid source through said venous line and single lumen catheter, which comprises the steps of providing an arterial line reservoir upstream of the fluid treatment device for receiving untreated fluid from the fluid source, providing an ar-terial line opening and closing means upstream of the arterial line reservoir, providing a venous line reservoir downstream of the fluid treatment device for receiving treated fluid from the fluid treatment device, providing a venous line opening and closing means downstream oE the venous line reservoir, withdrawing untreated fluid from said fluid source through the arterial line into said arterial line reservoir, passing such untreated fluid from said arterial line reservoir through the fluid treatment device and into the venous line reservoir, closing the arterial line and substantially simultaneously opening the venous line in response to a higher limit quantity of treated :Eluid available in the venous line reservoir whereby treated fluid is returned to ~2~2S~
5h said fluid source, and closing the venous line and substantially simultaneously opening the arterial line in response to a lower limit quantity of untreated fluid available in the arterial line reservoir.

According to a second broad aspect of the invention there is provided apparatus including means for controlling the closing of an arterial line with substantially simultaneous opening of a venous line and the closing of said venous line with substantially simul-taneous opening of said arterial line in a single lumen ca-theter assembly in which untreated fluid is withdrawn from a fluid source through said single lumen catheter and said arterial line, passed through a fluid treatment device and treated fluid returned to the fluid source through said venous line and single lumen catheter, which comprises at least one fluid pump means for passing untreated :Eluid from an arterial line reservoir provided in the arterial line upstream of the fluid treatment device, through the treatment device and into a venous line reservoir provided in the venous line downstream of the flui.d treatment device, high limit sensor means for sensing a higher limit quantity of treated fluid available in the venous line reservoir, arterial line closing means for closing the arterial line in response to a first signal transmitted by -the high limit sensor means to said arterial line closing means, closing of the arterial line by said arterial line closing means leading to substantially simu].taneous opening of the venous line, :~3;~0~
5c low limit sensor means Eor sensing a low limit quan-tity of untreated fluid available in the arterial line reservoir, and venous line closing means for closing the venous line in response to a second signal transmitted by the low limit sensor to the venous line closing means, closing of -the venous line by said venous line closing means leading to subs-tantially simultaneous opening of the arterial line.

According to a third broad aspect of the invention there is provided a fluid line assernbly for use with the apparatus of claim 9 comprising an arterial line having a first catheter free end for connection to one of two arms of a single lumen catheter, a second free end for connection -to an inlet of a fluid treatment device, an arterial line reservoir between said first and second free ends of the arterial line, a first peristal-tic tube section between the arterial line reservoir and said second free end for association with an arterial line peristaltic pump, a venous line having a first Eree end for connection to an outlet of said fluid treatment device, a second catheter free end for connection to the other of the two arms of said single lumen catheter, a venous line reservoir between said first and second free ends of the venous line, a second peristaltic tube section between the first free end of the venous line and the venous line reservoir for association with a venous line peristaltic pump, and a pressure reservoir between said first free end of the venous line and said second peristaltic tube section.

lZ3ZSO~

As is described in greater detail below, with reference to the accompanying drawings, a measure of protection of pressure vaiues can be achieved by increasing the volumetric proportion of a gaseous cushion in the venous line reservoir in relation to liquid volume therein. However, a dual pump system, involving the above considerations and including a first fluid pump upstream of the fluid treatment device and a second fluid pump downstream of the fluid treatment device and means for controlling pump speeds dependently of pressure between the two pumps, provides more reliable control of fluid pressure between the pumps and in the fluid treatment device.

The method and devices discussed above, and various further aspects of or related to the present invention are described below with reference to the accompanying drawings. The description with reference to the accompanying drawings also describes a single lumen catheter procedure and apparatus in accordance with the invention applied to a novel plasmapheresis procedure. This plasmapheresis procedure, however, could also be performed employing techniques other than a single lumen catheter technique. The plasma-pheresis procedure, and apparatus in accordance with the invention including a single lumen catheter approach is described below with reference to the accompanying drawings.

1~23Z5~ 7 BRIEF DESCRIPTION OF DRAWINGS

The invention will now be described with reference to the accompanying drawings showing exemplary constructions of apparatuses in accordance with the invention.

In the drawings:

Figure 1 shows a schematic representation of an apparatus and fluid lines operable with a single r fluid pump;

Figure 2 shows a schematic representation of an apparatus and fluid lines operable with two fluid pumps; and Figure 3 shows a schematic representation of an apparatus and fluid lines operable with a so-called double-head fluid pump and a further pump for introducing a substitution fluid DETAILED DESCRIPTION OF EMBODIMENTS OF DRAWINGS

Referring to Figure 1, reference numeral lo refers to an arterial line reservoir, which is located upstream of a fluid treatment device 12. The fluid treatment device employed in this apparatus would in general be a conventional hemodialyser, which could also.be of high flux nature if adequate means for controlling ultra-filtration is available. An arterial line 14 leads from a first arm 16 of a single lumen catheter assembly, referred to generally by reference numeral 18, and into the arterial line reservoi.r lo.

~3;~ 2 8 Arterial line opening and closing means and venous line opening and closing means, referred to generally by reference numeral 20, are in the schematic drawing of Figure 1 and also in Figures 2 and 3, shown by way of example to be a combined or single unit.
Thus, the ar-terial line opening and closing means constitutes a central member 22 displaceable to the left and right in the plane of the drawings between a first extreme position to the left in which the arterial -~0 line 14 is closed or occluded between the central member 22 and a first abutment element 24 and an extreme position to the right in which the arterial line is open. Closing and opening of the arterial line takes place upstream of the arterial line reservoir lo, arrow-heads 30 depicting fluid flow direction.

Reference numeral 32 refers to a venous line reservoir downstream of the fluid treatment device 12. A venous line 34 leads from the venous line reservoir 32 to a second arm 36 of the single lumen catheter assembly 18.
As already mentioned,venous line opening and closing means is comprised in the combined or single unit referred to generally by reference numeral 20. The venous line opening and closing means constitutes the central member 22 displaceable to the right and left in the plane of the drawings between an extreme position to the right in which the venous line 34 is closed or occluded between the central member 22 and a second abutment element 38 and an extreme position 'to the left in which the venous line is open. Closing and opening of the venous line 34 takes place downstream of the venous line reservoir 32.

1232S~Z

The apparatus of ~`igure 1 comprises a single fluid pump 40, conveniently of the roller pump type, for passing untreated fluid from the arterial line reservoir lo, through the fluid treatment device 12 and into the venous line reservoir 32.

High limit sensor means for sensing a higher limit quantity of treated fluid available in the venous line reservoir 32, comprises a high pressure value sensor 42 adapted to transmit a first signal via electrically conductive wire 45 to the arterial and venous line opening and closing unit 20 when a predetermined or preset high pressure value is reached in the pressure sensor 42. This high pressure value is trans-mitted to the pressure sensor 42 via pressure transmlttlng consult 44 which transmits the pressure which develops in a gaseous cushion 46 in the venous line reservoir 32. When the predetermined or preset high pressure value is reached in the venous line reservoir 32 and accordingly also in the pressure sensor 42, the first signal transmitted via electrically conductive wire 45 results in the displaceable member 22 being displaced to the left extreme in which the arterial line 14 is closed or occluded between the displaceable member 22 and the first abutment element 24.

The fluid pump 40 then continues to pass untreated fluid from the arterial line reservoir lo through the f]uid treatment device 12 and into the venous line reservoir 32 until a lower limit quantity of untreated fluiù is available in the arterial line reservoir lo.

~L;23ZS~ lo Low limit sensor means for sensing a lower limit quantity of untreated fluid in the arterial line reservoir lo, comprises a low pressure value sensor 48 adapted to transmit a second signalrconveniently via the same electrically conductive wire 45,to the arterial and venous line opening and closing unit 20 when a pre-determined or preset low pressure value is reached in the pressure sensor 48. This low pressure value is transmitted to the pressure sensor 48 via pressure transmitting conduit 50 which transmits the pressure which develops in a gaseous cushion 52 in the arterial line reservoir lo. When the predetermined or preset low pressure value is reached in the arterial line reservoir and accordingly also in the pressure sensor 48, the second signal transmitted results in the displaceable member 22 being displaced to the right extreme in which the venous line 34 is closed or occluded between the displaceable member 22 and the second abutment element 38.

It will be appreciated from the above description that closing of the arterial line 14 will lead to substantially simultaneous opening of the venous line 34 during operation of the apparatus. Similarly, closing of the venous line 34 will lead to substantially simultaneous opening of the arterial line 14.

~325~2 11 Mentioned above is a fluctuating pressure in the venous line reservoir 32. It is in most situations desirable that pressure in the venous line reservoir 32 not fall very much below the predetermined or preset high pressure limit, since high pressure (i.e. higher than fluid pressure at the fluid source) in this construction of the invention is the driving force leading to return of fluid to the fluid source through the venous line 34 and catheter assembly 18 ~10 whilst the venous line is open. The volume of treated fluid returned to the fluid source per unit time is the important factor, which is of course greatest when the pressure value is at or near the high pressure limit. Furthermore a degree of stability of pressure in the venous line reservoir 32 and accordingly also in the fluid treatment device can be of advantage in achieving an improved control of ultrafiltration rate, as for example in constructions in which ultrafiltration rate is controlled by trans-membrane pressure. In order to better preserve the high pressure value, it has been found that this can be achieved by increasing the volumetric pro-portion of the air cushion 46 in the venous line reservoir 32 as related to the volume of liquid therein. Thus, if the total volume of venous line reservoir 32 is increased as compared to standard constructions (in which the volume of liquid in the reservoir occupies up to about three-quarters of the total volume of the reservoir) so that the volume of liquid in the reservoir occupies say only one third or less of the total volume, the high pressure value in reservoir is better preserved and does not fall below the high pressure value to the same extent.

3~

Similarly, in the construction of Figure I of the drawings, it is desirable to better preserve the low pressure value in the arterial line reservoir lo, since the low pressure (in conjunction with pressure at the fluid source) is the driving force leading to withdrawal of fluid from the fluid source.
Improved preservation of the low pressure value in the arterial line reservoir lo can be achieved by increasing the volumtric proportion of the air cushion 52 as related to the volume of liquid therein, once again by suitably proportioning the volume of the arterial line reservoir.

Mentioned above in relation to Figure I of the drawings is that it may be desirable in certain fluid treatment procedures to achieve a substantially constant pressure of fluid in the fluid treatment device 12. In the construction of Figure I, it is necessary that a certain fluctuation of pressure take place in the venous line reservoir 32 and 2G accordingly also in the fluid treatment device 12 in order that pressure can develop to the high level value leading to closing of the arterial line.
This pressure fluctuation may not be desirable in certain fluid treatment procedures and may for example lead to inadequate control over volume of fluid passing from the fluid being treated across membrane material comprised in the fluid treatment device 12, as in hemodialysis employing so-called high-flux membrane dialysis, hemodiafiltration, hemofiltration or plasmapheresis procedures.

Accordingly, it can be necessary to isolate pressures which develop in -the venous line reservoir 32 from fluid passing through the fluid treatment device 12. This is conveniently achieved by providing a second fluid pump downstream of the fluid treatment device 12 and upstream of the venous line reservoir 32. Such a conctruction is illu-strated in Figure 2 of the drawings, in which integers of Figure I which are common to Figure2 are referred to by the same reference numerals.

In Figure 2 of the drawings, there is no need to again describe functioning of the arterial line chamber lo, venous line chamber 32, high and low pressure values and operation of the arterial and venous line opening and closing means 20, which func-tion essentially in the same fashion as described above in relation to Figure I. A second fluid pump 54 is, in Figure 2 provided downstream of the fluid treatment device 12 and upstream of the venous line reservoir 32. Fluid pressure between the pump 40 in the arterial line 14 and the second purnp 54, i.e.
including the fluid treatment device 12, is independent of pressure values which develop in the venous line reservoir 32, unlike the construction shown in Figure I.
In both the constructions of Figure I and Figure 2, the pump 40 isolates the pressure of fluid downstream of the pump 40 from pressure values which develop in the arterial line reservoir lo.

3~3'~ 14 The pumps 40 and 54 in Figure 2 may operate in a variety of fashions. However, as already mentioned in relati.on to Figure I, the pump 40 in the arterial line 14 most preferably operates continuously, which is also the preference in the construction of Figure 2. In the arrangement of Figure 2, with a continuously operating pump 40, it has also been found to be preferable that the second pump 54 also operate continuously, which mode of operation is believed to be new in a dual pump single lumen catheter construction. Additionally and more particularly, a dual pump construction as shown in Figure 2 in which relative pump speeds, i.e. the speed of pump 40 relative to the speed of pump 54, are controlled by fluid pressure between two continuously operating pumps is believed to be new, and is of high advantage over known dual pump systems presently available. Thus, a desired fluid pressure value may be selected, for example dependent on a desired ultrafiltration rate observed in a hemodialysis operation at a particular dialysis liquid pressure for a particular fluid treatment device 12. Conveniently, the speed of one or other of the fluid pumps 40 and 54 is operable at a constant speed which may be manually adjusted, and the speed of other fluid pump is variable in response to fluid pressure between the two pumps. In practice, it is preferable that the fluid pump 40 be the constant speed pump and the fluid pump 54 be the variable sveed pump.

~3~ 15 Fluid pressure between the two fluid pumps 40 and 54 may in the construction of figure 2 be sensed anywhere between the two pumps, i.e. upstream or downstream of the fluid treatment device 12, or if means therefor is available in the fluid treatment device itself.
However, in practice, it has been found convenient to provide a pressure reservoir 56 downstream of the fluid treatment device 12, as shown in Figure 2.
The pressure reservoir 56 is shown in Figure 2 to be essentially similar to the arterial line reservoir lo and venous line reservoir 32, with a gaseous cushion 58, pressure transmitting conduit 60, and pressure sensor 62. However, it will be appreciated that another type of arrangement for sensing fluid pressure between the two fluid pumps 40 and 54 could function equally well or perhaps even better.
For example, a pressure sensing arrangement including a flexible membrane (not shown) in contact on one side thereof with liquid between the two pumps, and a pressure transmitting liquid on the other side of the membrane would provide a greater impulse with pressure change than the illustrated arrangement including a compressible gas cushion. Thus, the control of the variable speed pump in response to pressure change between the two pumps could possibly be improved. In any event, in contrast to the preference for preserving pressure in the arterial line reservoir lo and venous line reservoir 32, the pressure sensing arrangement should provide an impulse responding to the smallest of pressure changes to enable accurate control of the speed of the variable speed pump in response to pressure. The pressure sensor 62 in Figure 2 is adjustable to any fixed pressure value, for example between 0 and 220 mm ~g, ~3 2~]l~ 16 and is adap-ted to control via electrically conductive wire 64 the amount of electrical current fed to the variable speed pump 54 so that this pump will be driven at that rate which will maintain the pressure value chosen in pressure sensor 62. For a given setting of the speed of the pump 4O, for example a setting leading to about 200 ml/min of blood being delivered to the fluid treatment device 12, and a given pressure setting of the pressure sensor 62, the variable speed pump 54 will automa-tically adjust to that speed which maintains the pressure set in the pressure sensor 62. Improved manage-ment of ultrafiltration rate may be achieved by virtue of improved control over the pressure of liquid between the pumps 4O and 54. Presuming accurate control and adjustability of dialysis liquid pressure in a hemodialysis operation, transmembrane pressure can be controlled to achieve the desired ultrafiltration rate for a given hemodialyser(fluid treatment device 12).

The construction illustrated in Figure 2 is of exceptional versatility and can for example find application in most types of extracorporeal blood treatment procedures such as in conventional hemodialysis, hemodiafiltration, hemofiltration and plasmapheresis . It has been found from practical experience with a so-called double-head blood pump in which the arterial line and venous line pumps are a single unit adapted to receive both a pump insert for pumping fluid from the arterial line reservoir to the fluid treatment device 12 and a pump insert for pumping fluid from the fluid treatment device 12 to the venous line reservoir, that such an arrangement is ~L2~Z56~ 17 particularly suited for performing a novel type of plasmapheresis operation.

Figure 3 of the drawings shows a construction comprising the abovementioned double-head blood pump.
It has been found that a double-head blood pump as described above can in actual practice be employed to ensure that precisely the same volume of liquid as is withdrawn from a patient can be returned to the patient, practically independently of the nature of the fluid treatment device 12 connected between the two pumps. For example, it has been found that in a conventional hemodialysis treatment over a period of three to four hours, in which dialysis liquid in the fluid treatment device 12 is maintained at conventional negative pressures below acmospheric pressure, such as - loo mm Hg, no ultrafiltration and accordingly no patient weight loss takes place.
This finding is associated with adequate or complete occlusion of both the arterial and venous line pump inserts in the double-head blood pump.

Referring now more particularly to Figure 3 of the drawings, integers common to this Figure and Figures 1 and 2 are once again referred to by the same reference numerals. The construction of Figure 3, however includes a double-head blood pump as above des-cribed and is conveniently referred to by double reference numeral 40 - 54 in view of the similarity ~3~ 18 (not identlty) of function with the pumps 4O and 54 of Figure 2.

wearing in mind that the double-head blood pump 4O - 54 leads to precisely the same volume of liquid being withdrawn from the patient as is returned to the patient, any volume of liquid intro-duced into the fluid flow line comprising the fluid treatment device 12 (plasmapheresis device 12 in Figure 3), i.e. downstream and upstream of the double-head blood pump, will lead to precisely the same volume of liquid being forced through membrane material comprised in the plasmapheresis device 12.
Arrow-heads 3O once again depict fluid flow direction.
Accordingly, if the volume OI liquid introduced is monitored, the volume of liquid (plasma) forced through the membrane material is automatically also monitored. In Figure 3, there is shown a container 66 for containing replacement or substitution fluid, a fluid pump 68 for introducing substitution fluid into a pressure chamber 7O provided downstream of the plasmapheresis device 12 and upstream of the double-head blood pump 4O - 54. A pressure-transmitting conduit 72 is provided for transmitting pressure in a gaseous cushion 74 in the pressure chamber 7O to a pressure sensor 78. The pressure sensor 78 is conveniently adjustable to any fixed pressure value, for example between O and 200 mm Hg.
The fluid pump 68 may be a variable speed pump, ~i~3~5~1~

variable to maintain the pressure value fixes in pressure sensor 78. An e:Lectrically conductive wire 80 leading from the pressure sensor 78 to the fluid pump 68 is shown for providing a pressure-dependent feed-back to the pump 68. However it will be understood that the pump 68 may be a manually adjustable variable speed pump of a volumetric type adapted to introduce a desired volume of substi-tution fluid per unit time. In such an arrangement, the pressure sensor 78 and feed-back to the pump 68 would be a preferable feature, for example for ensuring that fluid pressure in the p]asmapheresis device 12 does not exceed a maximum limit. In this latter arrangement, the pressure sensor 78 and the feed-back to the pump 68 would function to ensure that the pump speed of pump 68 is not manually set at a rate which for example exceeds the capacity of the plasmapheresis device 12 to separate plasma from whole blood at a safe maximum pressure value which can be set in pressure sensor 78.

The methods and apparatus in accordance with the present invention include considerations particularly related to simplicity of use and safety. Regarding simplicity of use, for example of the apparatus of Figure 1, the high pressure sensor 42 may be fixed at a high pressure value of for example 25o mm Hg, and the low pressure sensor 48 may be fixed at a low pressure value of for example -120 mm Hg. Presuming standard blood tubing sets with a standard pump insert, even the speed of the pump 40 can be fixed to deliver ~2 ~q~d 20 about 200 ml/min of blood Jo the fluid treatment device 12. Other than standard priming operations, practically nothing is required of attending staff.
It is however most preferable that the pump 40 be a variable speed pump which is conveniently manually adjustable so that this may be adjusted to the maximum stroke volume, i.e. so that maximum use is made of available blood flow, from the fistula or vein of a patient. Also, for the event that the speed of the pump is set to run too fast (leading to a pressure lower than the low pressure value) an alarm (not shown) condition will be reflected indicating insufficient availability of blood from the patient fistula or vein. It may therefore be necessary to lower the speed of the pump.

Similar to above, the apparatuses of Figures 2 and 3, may be provided with fixed high and low pressure values in the pressure sensors 42 and 48, and the pump 40 in Figure 2 or the double-head blood pump 40 - 54 in Figure 3 may be fixed to deliver a fixed amount of blood per unit time to the fluid treatment device 12. However, for the same reasons as indicated in relation to Figure 1, the speed of the pump 40 in Figure 2 and the double-head blood pump 40 - 54 in Figure 3 are most preferably variable speed pumps which are manually adjustable.

my vlrtue of the self-regulating nature of the apparatuses of the invention, stroke volumes for each selected pump speed is automatically maximized.
Jo needs arise to count cycles or calculate stroke volumes. The flow rate can for example be read directly from a pump speed control knob for con-trolling the speed of pump 40. The two extremes would be firstly where essentially unlimited flow of fluid is available from the patient, e.g. as with a large catheter placed in a large central vein, and secondly where flow of fluid is limited, e.g. as with a small fistula.

Referring specifically to Figure 2, it will be readily recognised that the pressure regulation leads to pump ~4 automatically adjusting to follow the speed of pump 40 so that the pressure value set in pressure sensor 62 is maintained.

Regarding safety of operation, it will be recognised from above that any changes in resistance to flow will be automatically responded to by changes in the time taken for the clamp assembly 20 to switch from one extreme position to the other. This self-regulation aspect is of exceptional value since it enables dispensing with a variety of monitoring functions. This novel aspect also allows for simple alarm condition control. If said time period is ~32sa~2 22 too long, e.g. longer than 5 seconds, an alarm condition could be initiated, e.g. by means of a timer or time delay (not shown) adapted to stop the pump or pumps if pressure remains below the low limit pressure value in the arterial line chamber lo for a period exceeding said time period of 5 seconds or if pressure remains above the high limit pressure value in the venous line reservoir 32 for a period exceeding said time period. A low pressure value in the arterial line reservoir lo over said time period would indicate either that the blood pump 40 has been set at too high a speed for the amount of fluid passing to the arterial line reservoir lo from the fluid source or that the single lumen catheter is obstructed.
Similarly, a high pressure value in the venous line reservoir 32 over said time period would indicate obstruction. A most preferable additional alarm condition in which pumps are stopped is when a low pressure value of about atmospheric pressure arises in the venous line reservoir 32, which would indicate that the venous line 30 is disconnected or that the single lumen catheter is not in place.
An additional optional alarm condition in which pumps are stopped is a high pressure in the arterial line reservoir lo, again of about atmospheric pressure, indicating that the arterial line 14 is disconnected or that the catheter is not in place.

The apparatuses of the invention, as illustrated in the drawi.ngs, are particularly intended to achieve a simple user interface. Thus, in the constructions of Figures 1 and 2 for example, in which pressure values are fixed in pressure sensors 42 and 48, (and also in pressure sensor 62 for a particular fluid treatment device 12~, the user will only be required to set pump 40 in motion after properly mounting of the fluid lines and fluid treatment device 12. The opening and closing of arterial and venous lines will set in automatically and in Figure 2, the speed of the pump 54 will automatically follow the speed of pump 40 to maintain the pressure value set in pressure sensor 62.

Claims (21)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A method of controlling the closing of an arterial line with substantially simultaneous opening of a venous line and the closing of said venous line with sub-stantially simultaneous opening of said arterial line in a single lumen catheter assembly in which untreated fluid is withdrawn from a fluid source through said single lumen catheter and said arterial line, passed through a fluid treatment device and treated fluid returned to the fluid source through said venous line and single lumen catheter, which comprises the steps of providing an arterial line reservoir upstream of the fluid treatment device for receiving untreated fluid from the fluid source, providing an arterial line opening and closing means upstream of the arterial line reservoir, providing a venous line reservoir downstream of the fluid treatment device for receiving treated fluid from the fluid treatment device, providing a venous line opening and closing means downstream of the venous line reservoir, withdrawing untreated fluid from said fluid source through the arterial line into said arterial line reservoir, passing such untreated fluid from said arterial line reservoir through the fluid treatment device and into the venous line reservoir, closing the arterial line and substan-tially simultaneously opening the venous line in response to a higher limit quantity of treated fluid available in the venous line reservoir whereby treated fluid is returned to said fluid source, and closing the venous line and substantially simultaneously opening the arterial line in response to a lower limit quantity of untreated fluid available in the arterial line reservoir.
2. A method according to claim 1, in which untreated fluid is continuously passed from said arterial line reservoir and through the fluid treatment device so that treated fluid is continuously collected in the venous line reservoir.
3. A method according to claim 1, in which the higher limit quantity of treated fluid available in the venous line reservoir is sensed by sensing a high limit pressure value which develops in a gaseous cushion in the venous line reservoir as treated fluid is collected therein whilst the venous line is closed.
4. A method according to claim 1, in which the lower limit quantity of untreated fluid available in the ar-terial line reservoir is sensed by sensing a low limit pressure value which delevops in a gaseous cushion in the arterial line reservoir as untreated fluid is passed from said arterial line reservoir through said fluid treatment device whilst the arterial line is closed.
5. A method according to claim 2, in which a first fluid pump is provided downstream of the arterial line reservoir and upstream of the fluid treatment device, and in which a second fluid pump is provided downstream of the fluid treatment device and upstream of the venous line reservoir, the pump speed of at least one of the pumps being variable in response to pressure fluctuations of fluid between the first and second fluid pumps.
6. A method according to claim 5, in which an infusion point is provided downstream of the fluid treatment device and upstream of the second fluid pump whereby substitution fluid substituting fluid removed from fluid treated by the fluid treatment device may be introduced into the treated fluid.
7. Apparatus including means for controlling the closing of an arterial line with substantially simultaneous opening of a venous line and the closing of said venous line with substantially simultaneous opening of said arterial line in a single lumen catheter assembly in which untreated fluid is withdrawn from a fluid source through said single lumen catheter and said arterial line, passed through a fluid treatment device and treated fluid returned to the fluid source through said venous line and single lumen catheter,which comprises at least one fluid pump means for passing untreated fluid from an arterial line reservoir provided in the arterial line upstream of the fluid treatment device, through the treat-ment device and into a venous line reservoir provided in the venous line downstream of the fluid treatment device, high limit sensor means for sensing a higher limit quantity of treated fluid available in the venous line reservoir, arterial line closing means for closing the arterial line in response to a first signal transmitted by the high limit sensor means to said arterial line closing means , closing of the arterial line by said arterial line closing means leading to substantially simultaneous opening of the venous line, low limit sensor means for sensing a low limit quantity of untreated fluid available in the arterial line reservoir, and venous line closing means for closing the venous line in response to a second signal transmitted by the low limit sensor to the venous line closing means, closing of the venous line by said venous line closing means leading to sub-stantially simultaneous opening of the arterial line.
8. Apparatus according to claim 7, in which the pump means is continuously operable to continuously pass untreated fluid from the arterial line reservoir and through the fluid treatment device into the venous line reservoir.
9. Apparatus according to claim 7, in which a first pump is operable between the arterial line reservoir and the treatment device and in which a second pump is operable between the fluid treatment device and the venous line reservoir.
10. Apparatus according to claim 9, in which at least one of the two pumps is a variable speed pump.
11. Apparatus according to claim lo, in which the variable speed pump is variable in response to pressure fluctuations in fluid between the two pumps.
12 . Apparatus according to claim 11, in which the second pump is variable in response to pressure fluctuations in the fluid between the two pumps.
13. Apparatus according to claim 9, in which at least one of the two pumps is a constant speed pump.
14. Apparatus according to claim 13, in which the constant speed pump is provided with means for manually adjusting said constant speed.
15. Apparatus according to claim 13, in which the first pump is the constant speed pump.
16. Apparatus according to claim 11, in which there is provided a pressure sensor for sensing pressure fluctuations in fluid between the two pumps, and means for varying the variable speed pump in response to a signal transmitted by the pressure sensor to said variable speed pump.
17. Apparatus according to claim 16, in which the pressure sensor includes a pressure reservoir provided downstream of the fluid treatment device and upstream of the second pump.
18. Apparatus according to claim 17, in which the pressure reservoir includes means for connection to an infusion line for introducing a substitution fluid or substituting fluid removed from fluid treated by the fluid treatment device.
19. Apparatus according to claim 7, in which the high limit sensor means is adapted to transmit said first signal to the arterial line closing means when a preselected fixed high pressure value develops in the venous line reservoir.
20. Apparatus according to claim 7, in which the low limit sensor means is adapted to transmit said sensor signal to the venous line closing means when a preselected fixed low pressure value develops in the arterial line reservoir.
21. A fluid line assembly for use with the apparatus of claim 9 comprising an arterial line having a first catheter free end for connection to one of two arms of a single lumen catheter, a second free end for connection to an inlet of a fluid treatment device, an arterial line reservoir between said first and second free ends of the arterial line, a first peristaltic tube section between the arterial line reservoir and said second free end for association with an arterial line peristaltic pump, a venous line having a first free end for connection to an outlet of said fluid treatment device, a second catheter free end for connection to the other of the two arms of said single lumen catheter, a venous line reservoir between said first and second free ends of the venous line, a second peristaltic tube section between the first free end of the venous line and the venous line reservoir for association with a venous line peristaltic pump, and a pressure reservoir between said first free end of the venous line and said second peristaltic tube section.
CA000457150A 1983-06-21 1984-06-21 Single lumen catheter fluid treatment Expired CA1232502A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US50688683A 1983-06-21 1983-06-21
US506,886 1983-06-21

Publications (1)

Publication Number Publication Date
CA1232502A true CA1232502A (en) 1988-02-09

Family

ID=24016349

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000457150A Expired CA1232502A (en) 1983-06-21 1984-06-21 Single lumen catheter fluid treatment

Country Status (7)

Country Link
JP (1) JPS6024849A (en)
BE (1) BE899956A (en)
CA (1) CA1232502A (en)
DE (1) DE3422375C2 (en)
FR (1) FR2548906B1 (en)
GB (1) GB2141936B (en)
IT (1) IT1175791B (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2672217B1 (en) * 1991-02-06 1998-09-11 Hospal Ind SINGLE NEEDLE BLOOD EXTRACORPOREAL CIRCULATION CIRCUIT FOR BLOOD TREATMENT DEVICE.
US5227049A (en) * 1990-08-20 1993-07-13 Hospal Industrie Single-needle circuit for circulating blood outside the body in blood treatment apparatus
FR2672218B1 (en) * 1991-02-06 1998-04-24 Hospal Ind DEVICE AND METHOD FOR LEVELING A LIQUID IN A CHAMBER OF AN EXTRACORPOREAL BLOOD CIRCUIT.
FR2672219B1 (en) * 1991-02-06 1998-09-11 Hospal Ind METHOD FOR CONTROLLING THE BLOOD CIRCULATION IN A SINGLE NEEDLE CIRCUIT.
JP2003265613A (en) * 2002-03-15 2003-09-24 Terumo Corp Method for controlling catheter with expander, blood specimen collection controller and catheter with expander
US7540958B2 (en) 2004-03-08 2009-06-02 Gambro Lundia Ab Device for controlling blood circulation for a single needle circuit
DE102005001779B4 (en) * 2005-01-14 2009-12-17 Fresenius Medical Care Deutschland Gmbh Disposable for operating a blood treatment device in single-needle or two-needle operation
DE102010022776A1 (en) 2010-06-04 2011-12-08 Fresenius Medical Care Deutschland Gmbh Method for initializing a device for blood treatment in single-needle operation and device for blood treatment in single-needle operation
EP2465553A1 (en) * 2010-12-14 2012-06-20 B. Braun Avitum AG Extracorporeal blood treatment device
WO2015173713A1 (en) * 2014-05-13 2015-11-19 Monica Zanotti Single needle hemo(dia)filtration apparatus

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE29346E (en) * 1971-06-04 1977-08-09 Vital Assists, Inc. Single needle dialysis
US3756234A (en) * 1971-06-04 1973-09-04 Vital Assists Single needle dialysis
DK152966C (en) * 1973-04-16 1988-10-17 Sandoz Ag PROCEDURE FOR MANAGING AN EXTRACORPORAL HAEMODIALALYSIS SYSTEM AND APPARATUS FOR USE IN EXERCISING THE PROCEDURE
CH582518A5 (en) * 1973-08-30 1976-12-15 Sandoz Ag
US3882861A (en) * 1973-09-24 1975-05-13 Vital Assists Auxiliary control for a blood pump
DE2636290A1 (en) * 1976-08-12 1978-02-16 Fresenius Chem Pharm Ind DEVICE FOR CONTROLLING AND MONITORING BLOOD FLOW DURING BLOOD DIALYSIS, PERFUSION AND DIAFILTRATION USING ONLY ONE CONNECTION POINT TO THE PATIENT'S BLOOD CIRCUIT (SINGLE NEEDLE TECHNOLOGY)
FR2397197A1 (en) * 1978-11-03 1979-02-09 Sodip Sa Extracorporeal blood purificn. - by simultaneous haemodialysis and haemo-filtration with incorporated flow ewuilibrantion
FR2471194A1 (en) * 1979-12-17 1981-06-19 Sodip Sa Blood ultrafiltration method for kidney dialysis - carries out separation and dialysis across membranes in separate zones simultaneously
DE3131075C2 (en) * 1981-08-05 1984-01-19 Dr. Eduard Fresenius, Chemisch-pharmazeutische Industrie KG, 6380 Bad Homburg Device for purifying blood

Also Published As

Publication number Publication date
GB2141936A (en) 1985-01-09
DE3422375C2 (en) 1994-12-15
FR2548906A1 (en) 1985-01-18
BE899956A (en) 1984-10-15
IT1175791B (en) 1987-07-15
GB2141936B (en) 1987-02-04
IT8421511A1 (en) 1985-12-20
FR2548906B1 (en) 1994-04-01
DE3422375A1 (en) 1985-01-03
JPS6024849A (en) 1985-02-07
GB8414464D0 (en) 1984-07-11
IT8421511A0 (en) 1984-06-20
JPH0425023B2 (en) 1992-04-28

Similar Documents

Publication Publication Date Title
EP1339315B1 (en) Apparatus for blood withdrawal and infusion using a pressure controller
US6955655B2 (en) Hemofiltration system
US4490135A (en) Single needle alternating blood flow system
US4486189A (en) Dual mode hemodialysis system
EP1480713B1 (en) Apparatus for an extracorporeal treatment device to control blood withdrawal and infusion
US7351218B2 (en) Device and process for extracorporeal treatment by citrate anticoagulant
EP1661591B2 (en) Apparatus for the purification of blood by means of hemodialysis and/or hemofiltration
USRE38869E1 (en) Extracorporeal circuit for peripheral vein fluid removal
US4776837A (en) Single lumen catheter fluid treatment
AU2015208235B2 (en) Device and method for regulating and specifying the pump rate of blood pumps
EP0104895B1 (en) Dual phase blood/flow system and method of operation
CA1232502A (en) Single lumen catheter fluid treatment
JP4304080B2 (en) Procedures and equipment for determining hematocrit and / or blood volume
JPH06134031A (en) Blood dialyzing and filtering device

Legal Events

Date Code Title Description
MKEX Expiry