CA2074670A1 - Priming system - Google Patents
Priming systemInfo
- Publication number
- CA2074670A1 CA2074670A1 CA002074670A CA2074670A CA2074670A1 CA 2074670 A1 CA2074670 A1 CA 2074670A1 CA 002074670 A CA002074670 A CA 002074670A CA 2074670 A CA2074670 A CA 2074670A CA 2074670 A1 CA2074670 A1 CA 2074670A1
- Authority
- CA
- Canada
- Prior art keywords
- fluid
- treatment element
- bypass
- fluid treatment
- patient
- 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.)
- Abandoned
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D19/00—Degasification of liquids
- B01D19/0068—General arrangements, e.g. flowsheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3643—Priming, rinsing before or after use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3643—Priming, rinsing before or after use
- A61M1/3644—Mode of operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3643—Priming, rinsing before or after use
- A61M1/3644—Mode of operation
- A61M1/3646—Expelling the residual body fluid after use, e.g. back to the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3643—Priming, rinsing before or after use
- A61M1/3644—Mode of operation
- A61M1/3647—Mode of operation with recirculation of the priming solution
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0464—Cerebrospinal fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
Abstract
ABSTRACT
Processes and systems and methods for priming fluid processing apparatus and for treating a fluid are disclosed.
Processes and systems and methods for priming fluid processing apparatus and for treating a fluid are disclosed.
Description
f ;
S~ ~ 7 i~
January 17, 1992~ Case # 40038 PRI~ING ~Y~T~M
Technical Field This invention relates to a system, apparatus, and method for priming a fluid processing or treating device. The invention also relates to a system, apparatus and method for treating a fluid.
Backqround of the Invention There are a number of methods and devices for processing and/or treating various ~luids. For example, a nun~er of therapeutic protocols for pathophysiological conditions involve the removal of a bodily fluid from a patient, treating that fluid to remove an undesirable component, and returning it to the patient. However, fluid processing and/or treatment need not be limited to therapeutic applications. For example, water may be rendered potable by passing it through a filter that removes substances such as bacteria.
Nevertheless, these methods, and the devices utilized to carry them out, have been inefficient in that they may require extra time and/or effort for priming. Additionally, these devices may waste ~luid since a portion of the ~luid may be held up in ~5 the devices. ~his may be expensive since the ~luid may be unrecoverable and/or incompletely processed.
Additionally, an additional labor intensive effort may be required to retrieve the held up fluid.
Furthermore, especially when a separate fluid treatment assembly or device is added to the system, h~ 2 the devices utilized may be awkward to use, or may compromise sterility by allowing the introduction of bacteria and/or air.
These problems involving cost, labor, sterility and time are magnified when the fluid is valuable, especially when only a limited amount is available.
For example, a number of therapeutic and non-therapeutic pro~ocols involve attaching an assembly to a individual, removing a bodily fluid ~e.g., blood), treating the fluid, and returning it to the individual. Since the individual only has a finite amount of that ~luid, it may be necessary to minimize loss, preferably with minimal additional effort.
~oreover, during such protocols it is important to maintain sterility without administering inappropriate substances such as air. Furthermore, since patient fluid treatment protocols may present some risk to the patient, the time and operator sophistication required to perform them should be minimized to decrease the risk t:o the patient.
In view of this, there is a demand for a system and method for easily, simply, and effectively, ~priming a fluid processing or treating device. The system and method should also provide these same advantages when a separate ~luid treatment assembly or device is added to the system. Additionally, there is a growing need for a simple system and method of processing or treating various fluids to deplete deleterious or undesirable substances from these fluids~ as well as for a system and method for administering them, e.g., to a patient, while minimizing loss of the fluid, and requiring minimal operator labor and sophistication. Moreover, particularly when the fluid is to be administered to f J i i a patient, there is a need for a system and method that minimizes risk to the patient by providing for quick priming and simple operation, while ~aintaining sterility, and without introducing inappropriate substances such as air.
Summary of the Invention The present invention relates to a device and method for priming a fluid processing or treating apparatus or system whereby a bypass assembly allows the efficient and effective priming of a fluid processing assembly, and whereby a vent allows the elimination of gas from the assembly.
The invention also relates to an apparatus and method for treating a fluid by passing the fluid through an apparatus according to the invention.
Brief Description o~ the Drawin~s Figure 1 is an embodiment of a priming and/or fluid processing system comprising an asse~bly according to the invention.
Figure 2 is another embodiment of the invention showing a vent at the upstream junction.
Specific Description of the Invention In accordance with the present invention, a device for priming a fluid processing or treating apparatus or system includes a fluid treatment element, a bypass connected in parallel with the fluid treatment element, a differential pressure generator in communication with the fluid treatment element and the bypass, and at least one vent in communication with at least one of the fluid treatment element, differential pressure generator, and the bypass assembly. Additionally, the present ~Is~ L~
invention provides a method for priming a fluid processing system.
The invention also relates to treating a fluid by passing the fluid through a previously primed porous medium which depletes a deleterious or undesirable substance from the fluid. The treated fluid may then be returned to the source, eOg., a patient.
An exemplary system is shown in Figure 1.
Assembly 100, which is preferably a closed system, may include a differential pressure generator 1, in fluid communication with a fluid treatment element 3 and bypass assembly 20. In the illustrated embodiment, the bypass assembly 20 and the fluid treatment assembly 3 communicate with differential pressure generator 1 by different fluid flow paths through junctions 4 and 5. The assembly 100 may also include at leas~ one ~ent 6, pre~erably communicating with the differential pressure generator 1 through junction 12. An assembly according to the invention may also include at least one flow control device; a conduit 2 connecting junction ~ with junction 5; a conduit 13 connecting junction 4 with junction 12; a variety of optional connectors 7~ and a spike 8 or catheter connector (not shown), or the like, connected to the assembly 100. In the illustrated embodiment, spika 8 is connected to a container of priming fluid 10.
Each of the components of the invention will now be described in more detail below.
DIFFERENTIAL PRE&S~RE GENE:RATOR
The differential pressure generator 1 may be any container or device which may be used to generate a pressure differential in the assembly h ~,3 1~ 7 100. Exemplary pressure differential generators include a pump, a flexible bag or a syringe~ A
syringe, and the like, is particularly preferred bscause it can be used to produce both a negative and a positive pressure differ~ntial, i~e., fluid can be drawn into the syringe and fluid can be expelled ~rom the syringe. As long as the material used to make ~he di~ferential pressure generator is suitable for use with the ~luid being processed, any device used to pull or push fluid through a system is within the scope of the present invention.
The composition of the differential pressure generator may vary depending on the nature of the fluid or fluids utilized. Accordingly, it may be constructed of any material compatible with the fluid or fluids being passed through the system.
Pressure differential generator 1 may be composed of a flexible material, ~or example, polyvinyl chloride (PVC), or plasticized PVC, ~.g., PVC plasticized with dioctylphthalate, diethylhexylphthalate, or trioctyltrimellitate, each of which may be used in the construction of conventional blood bags.
Alternatively, the differential pressure generator may be composed of a non-flexi~le material, for example, polypropylene, acrylonitrile butadiene styrene (ABS), polycarbonate, or stainless steel.
FL~ID TREATMENT ELENENT
The system 100 according to present invention also may include a fluid treatment element 3. It is intended that any device for treating and/or affecting the fluid, or performing some other desired function, is included within the scope o~
the invention. Typical fluid treatment elements include, but are not limited to, a bubble trap, a gas inlet, a gas outlet, an aerator, a pump, a column, a collection chamber or container, and the like. In a preferred embodiment, the fluid treatment element 3 is a filter asse~bly comprising a porous medium in a housing.
More preferably, the ~luid treatment element is a filter assembly for removing one or more deleterious substances ~rom the fluid. Exemplary fluid treatment elements include but are not limited to wat~r treatment filters; filter assemblies for removing leucocytes from a fluid, such as a blood component; and filter assemblies for removing proteins and the like from a ~luid such as cerebrospinal fluid.
The fluid treatment element 3 typically includes at least one inlet and at least one outlet which provide a flow path through the ~luid treatment element. If the fluid treatment element includes a porous medium, the porous medium may be positioned across the ~low path.
BYPASS ASSENBLY
The b~pass assembly 20, cormected in assembly 100 in parallel with a fluid treatment element 3, may be any component or combinat:ion of components 2S for bypassing a fluid treatment element 3. In accordance with the invention, a bypass assembly 20 may provide a fluid flow path around the fluid treatment element 3 (as illustrated), ~r may provide a separate, isolated fluid flow path through the fluid treatment element 3 (not shown).
Although the bypass assembly may be configured in a number of ways, the bypass assembly 20 preferably comprises a conduit 2, connecting junction 4 with junction 5, as illustrated in Figure ~ ~ 7 ~
1.
F~OW CO~q'ROL DEVICE
The system 100 may also include at least one flow control device used to establishr control or direct the flow of fluid in a desired direction.
Typical flow control devices incll-de a clamp, seal, valve, transfer leg closure, stopcock, or the like.
The flow control device may function automatically, e.g., a ch~ck valve, or it may be manually controlled, e.g., a stop cock or clamp.
The fluid flow control device or devices may be positioned in a variety of locations with respect to fluid flow. For example, a single fluid flow control device may be positioned to allow fluid to enter the difPerential pressure generator 1 without passing through the fluid treatment element 3.
Alternatively, the flow control device may be positioned to allow fluid to flow through the fluid treatment element 3 without passing through the bypass assembly 20. Likewise, multiple flow control devices may be utilized for a similar e~fect. In a preferred embodiment, j~mctions 4 and 5 each include a flow control de~ice. More pre~erably, junction 5 includes a rotatable three-way valve, and junction 4 includes two check valves.
VENI!
A system 100 according to the invention also includes at least one vent 6 in communication with at least one of the fluid treatment element 3, the pressure differential generator 1, and the bypass assembly 20. The vent 6 may be positioned anywhere in the system 100, for example, in a conduit or in the fluid treatment element or the bypass assembly, ~or venting air or gas, and the liXe, ~rom the system in order to prime the system and eliminate any extraneous gas. The vent 6 may includ~ a conduit and/or a container, pre~erably a ~lexible bag, to which the air or gas can be delivered. In a preferred embodiment o~ the invention, the vent 6 is a gas outlet, preferably positioned in, on, or near the pressure differential generator 1. More preferably, vent 6 communicates with pressure differential 1 by junction 12, as shown in Figure 1.
Exemplary gas outlets are disclosed in W0 91/17809.
Flow to or through the vent may be regulated by a flow control device, such as a clamp, seal, valve, transfer leg closure, stopcock and the like. The regulation may be automatic, e.g., by a device or element that blocks flow when wetted. In a preferred embodiment, junction 12, which connects vent 6 to the systemt includes a flow control device. More preferably, junction 12 includes a rotatable three-way valve.
The location of the vent 6 may be anywhere in the system 100, preferably positioned to provide the maximum amount of gas or air elimination from the assembly 100 during priming of t'he system.
Preferably, the vent 6 is located between the differential pressure generator 1 and the bypass assembly 20, more preferably, downstream of the bypass assembly 20. Alternatively, the vent may be positioned in other locations to optimize a desired result. Preferably, the vent is chosen so that sterility is not compromised. More preferably, the vent may have a pore rating of about 0.2 micrometers or less to preclude bacteria from entering the assembly 100.
Additionally, the vent may be included in a ~?
housing, and/or may include a cap or closure.
Other materials and configurations for the vent are included within the scope of the present invention. For example, a puncturable, non~porous material may ~e used, e.g., to allow insertion of the needle of a syringe to withdraw the air from the system.
Typically, the various components o~ the assembly 100 have at least one connector 7 to facilitate connection to the ~ther elements of the assembly. A variety of suitable conduits and connectors are known in the art.
NE~HOD
The invention also includes methods for priming a fluid processing apparatus wherein a priming fluid, for example, saline solution, is passed through the bypass assembly 20, through junction 4, and into pressure differential generator 1. The priming solution is then preferably directed through junction 4 and into and through fluid treatment element 3. At any point along the priming solution flow path, an appropriately placed vent may be opened in order to vent gas or air from the system.
An exemplary method according to the invention may be described with reference to Figure 1. The assembly lOo is connected to a source of priming ~olution 10, such as a container of saline solution.
~s the plunger in the syringe is withdrawn, a pressure di~ferential is created, drawing priming solution from the ~aline source container 10 into assembly 100. With the flow control device in junction 5 set to direct priming fluid into bypass assembly 20 and to block passage through the fluid treatment element 3, and the flow control device in ~7~
junction 12 set to direct fluid into the syringe and to block passage through the vent ~, priming fluid and gas in the ~arious components o~ the system pass into the bypass assembly ~0, through junction ~, conduit 13 and junction ~2 and into the syringe 1.
Once the gas and a desired amount of priming fluid is drawn into the syri~ge, ~etting ~he ~low control device in junction 12 to direct flow toward the vent ~ and to block flcw toward the bypass assembly 20 and the ~ilter element 3, and partially depxessing the plunger, allows gas to be expelled from the system through vent 6. Once the gas has been expelled, setting the flow control device in junction 12 to direct flow toward the bypass assembly 20 and the filter elemant 3, while blocking flow toward the vent 6, prevents gas from entering the system.
While the vent may be manually opened and closed, e.g., by capping or clamping, it may also be automatically controlled, e.g., the vent may include a device or element that passes gas until wetted by the priming fluid, and then bloc:ks all flow.
With the ~low control devicle in junction 5 set to allow priming fluid to flow through the fluid treatment element 3 and to block flow through the bypass, further depressing the plunger directs priming fluid from the syringe, throllgh junction 4, and into the fluid treatment element 3. As the priming fluid flows through the ~luid treatment element, it may displace gas and prime the fluid treatment element 3. The displaced gas, as well as priming fluid, may be directed through junction 5 back to the priming fluid bag.
Alternatively, as shown in Figure 2, a vent 11 may be located on the fluid treatment element side g ~
of junction 5. With the fluid control device in junction 5 set to blook flow through the fluid treatment element and the bypass, the priming ~luid may be forced from the syringe into the fluid treatment element and the gas displaced from the fluid treatment element by the priming ~luid may be expelled through the vent at the junction 5. Once the gas has been expelled through the vent, the vent may be closed and ~he flow control device at junction 5 ~ay be set to block flow through the bypass and allow flow between the fluid 'reatment element and the priming fluid bag. The remaining priming fluid in the syringe may then be returned to the bag.
~fter priming, the assembly 100 may be disconnected from the sourca of priming fluid, and linked to the source of the fluid to be processed or treated.
Once connected to the source of the fluid to be processed or treated, the fluid can be drawn and passed through the primed assemhly 100 in the same manner as described above for the priming fluid.
For example, if the fluid t:o be treated is water, it may be drawn through t:he primed assembly 100 in the same manner as described above for the priming fluid collecting treatecl water in a container. If additional processing vr treatment is desired, this step may be repeated to recirculate the water through the assembly.
Similarly, an embodiment of the invention includes an apparatus and method for priming an administration assembly, treating a fluid, and introducing the treated fluid into a patient. For example, the fluid may be drawn through the primed - 35 assembly as described above. In this embodiment, r ~ 3 the assembly 100 may include a connector or the like, e.g., a Y-connector, having one branch connected to the priming fluid bag, and the other connected to the patient. Once primed, the entire assembly can be connected to the patientO
Another embodiment of this invention includes an apparatus and method for priming an administration assembly, then collecting and treating a fluid from an individual (e.g., a donor or a p~tient), and then returning it to the individual, all while connected to the patient.
In a preferred embodiment of the inYention, all of these functions can be performed without adding or deleting elements of the apparatus, thus maintaininy a closed or sterile state.
For example, if the ~luid to be treated is a fluid obtainable directly from a patient, the primed assembly 100 can be connected to the patient, by, for example, a catheter (not shown)~ Fluid can be drawn from the patient and passed through the primed assembly 100 in the same manner as described above for priming fluid.
In these embodiments of the invention, the fluid treatment element typically includes a porous medium ~or depleting a deleterious or undesirable substance or substances from a fluid. This generally means removing a therapeutically or clinically significant amount of a deleterious or undesirable substance from a fluid such as a biological ~luid. "Therapeutically or clinically significant amount" refers to an amount necessary to produce a beneficial effect on the patient or animal receiving the substance-depleted fluid. Such a beneficial effect may be, for example, lessening a - 35 patient's symptoms.
d; ~
Removal of a therapeutically or clinically significant amount can vary depending on the intended use and/or from pakient to patient. For example~ a therapeutically or clinically significant amount can be greater for a Guillain-Barr~ syndrome treatment protocol than a multiple sclerosis treatment protocol. However, removal of a therapeutically or clinically significant amount can be and is routinely determined by a doctor or technician for treating a certain condition or disease as it pertains to the specific patient, and as it pertains to the particular application.
These embodiments are applicable to a wide range of clinical or therapeutic regimens in which the depletion of deleterious or undesirable substances from the substance-containing fluid is beneficial. Although a comprehensive list would be too extensive to include here, among the deleterious or undesirable substances which may be depleted or removed for a beneficial effect include, but are not limited to, proteins, polypeptides, interleukins, immunoglobulins, proteases, interferon, tumor necrosis ~actor, complement/ co~lplement associated factors, gliotoxic factors, leucocytes, lymphocytes, and viruses. These substances may be found in an individual's fluids, e.g., cerebrospinal f 1 uid (CSF), blood or blood component, urine, saliva, and the like.
One embodiment of the in~ention provides for treatment of Guillain-Barr~ syndrome. Guillain-Barr~ syndrome (acute polyradiculoneuropathy) is characterized by acute flaccid paralysis of muscles with associated muscle pains and paresthesia. In this embodiment, the cerebrospinal fluid (CSF) from a patient suffering from Guillain-Barr~ syndrome is $ t~ ~
passed through a previously primed assembly 100 and the deleterious or undesirable substance or substances associated with that syndrome are deplet~d from the ~luid, which may be then returned to the patient. While not intending to be limited to any particular theory, it ~s believed that therapeutic benefit may be achieved by depleting proteins from the CSF. In this e~bodiment, it should be noted that the term "deleterious or undesirahle substance" refers to both the singular and plural forms. Thus, e.g., a group of proteins is a deleterious or undesirable substance within the context of this invention. For convenience, the singular term "substance" will be used hereinafter, but it should be clear that the instant invention encompasses both the singular and plural forms.
With respect to this embodiment of the invention, the components of the apparatus 100 and the method of using it are generally as described previously.
The fluid treatment element 3 ipcludes a porous depletion medium. Typically, the fluid treatment element may include a housing. 'rhe depletion medium may be formed from any natural or synthetic fiber or from a porous or permeable membrane (or from other materials of similar surface area and pore size~
compatible with the fluid containing the deleterious or undesirable substance. The surface of the fibers or membrane may be unmodified or may be modified to achieve a desired property. Although the deleterious medium may remain untreated, the fibers or membrane are preferably treated with a charge modifying agent to produce a negatively or positively charged depletion medium. The charge-modified depletion medium may have negative or ~1 ~ 7 L~
positive zeta potential. A charge neutral depletionmedium may also be used in the instant invention.
While the depletion media can be produced from any material compatible with the fluid to be treated~ practical considerations dictate that consideration be giv~n first to the use o~
commercially available materials. The porous media of this invention may be preferably formed, for example, from a synthetic polymerO Suitable polymers include, but are not limited to, polyolefins, polyesters, polyamides, polysulfones, acrylics, polyacrylonitriles, polyaramides, polyarylene oxides and sulfides, and polymers and copolymers made from halogenated olefins and un-saturated nitriles. Examples include, but are not limited to, polyvinylidene fluoride, polyethylene, polypropylene, cellulose acetate, and Nylon 6 and 66. Preferred polymers are polyolefins, polyesters, and polyamides.
The depletion medium may be fashioned in a variety of ways to effectively de.plete the deleterious or undesirable substanca from the substance-containing liquid. For example, the depletion medium may be a porous web or sheet, membrane, fibrous mass~ or depth filter. It may have a large surface area. The depletion medium may be suitable for ultrafiltration, e~g., an ultrafiltration membrane.
The depletion medium may be formed into any geometric shape, preferably pre-formed, suitable for passing a fluid therethrough. In a preferred embodiment, the depletion medium is a substantially rectangular pleated depth filter.
Preferably, the depletion medium of this embodiment of the invention is a sheet formed into a !
7 ~i pleated, corrugated, or accordion formO
Additionally, the depletion medium may comprise a composite or multilayer element, or, in a less preferable alternative, separate elements may be used independently in a series arrangement. The depletion medium may also include additional components, including, but not limited to at least one layer to provide support and/or better drainage.
Exemplary supports and/or drainage components are non-wo~en polyester or polypropylene mesh.
The~depletion medium may have a substantially constant pore rating or it may vary in a continuous or stepwise manner, particularly when multiple layers are utilized. For example, it may include pore ratings withi~ the range of about .04 to about 40 micrometers, more preferably about 0.2 to about 5 micrometers.
Exemplary fluid treatment elements are disclosed in U.S. Patent Nos~ 4,702,840; 4,340,479;
20 4,855,163; 4,774,132; 4,906,374; 4,886,836;
4,964,989; and 4,707,266. When cerebrospinal fluid is the substance-containing fluid, media available from Pall Corporation under the trademark POSIDYNE~
are particularly preferred. Co~mercially available media, such as those available from Pall Corporation under the trademarXs ULTIPOR~, ULTIPOR N66 LOP~ODYNE~, FLUORODYNE~, CARBOXYDYNE~, and IMMUNODYNE~, BIODYNE ~, BIODYNE B~, and BIODYNE C~, may also be suitable.
As noted abo~e, the fluid treatment ~lement 3 may include a housing. Any housing of suitable shape to provide an inlet and an outlet may be employed. The housing may be fabricated from any suitably rigid, impervious material, including any impervious thermoplastic material, which is ~ 3 compatible with the fluid beiny processed. For example, the housing may be fabricated from a metal, such as stainless steel, or from a polymer. In a preferred embodiment, th~ housing is fabricated by injection molding from a polymer, more preferably a transparent or translucent pol~mer, such as an acrylic, polypropylene, polystyrene, or a polycarbonated resin~ Not only is such a housing easily and economically fabricated, but also it allows observation of the passage of the liquid through the housing. The surfaces of the housing contacting the fluid may be treated or untreated.
For example, the surfaces of the housing contacting the fluid may be rendered liquophilic for better priming. Methods for treating the surface of the housing include but are not limited to radiation grafting and gas plasma treatment.
IThe Eilter assembly in accordance with this invention may be fashioned in a variety of configurations. Housings can ~e designed to accept a variety of shapes of depletion media as long as adequate flow area is provided. All of these shapes are within the scope of the clai]med invention.
The depletion medium may be sealed or fit within the housing to achieve convenience of use, rapid priming, and efficient air clearance. For example, the depletion medium may be compression sealed or interference fit within the housing.
Alternatively, the housing may be overmolded, or heat welded, radiofrequency welded or ultrasonically w~lded. Additionally, a portion of the depletion medium may be located within the welds. Other suitable techniques for sealing or fitting the depletion medium within the housing are known to those skilled in the art.
!
In performing the method according to this embodiment of the invention, the flow rate of the patient's fluid is preferably sufficient to deplete a therapeutically or clinically significant amount of a deleterious or undesirable substance from the patient's fluido The flow rate may depend on a number o~ variables, and thus, a range of rates are suitable. For example, the rate may vary from patie~t to patient, or from one type of fluid to another. Preferably, when the fluid is cerebrospinal fluid from a patient with Guillain-Barr~ syndrome, a volume of about 20 to about 40 ml is utili2ed for the cycle of collection, treatment and return.
As noted above, the present invention may be used in a wide range of clinical or therapeutic regimens in which depletion of a deleterious or undesirable substance is bene~icial. Accordingly, the invention includes, but is not limited to treating pathophysiological conditions involving the ~ervous system, for example, Multiple Sclerosis and Amyotrophic Lateral Sclerosis; Acquired Immune De~iciency Syndrome (AIDS); dementia complex;
encephalitis (e.g., HIV-I encephalitis~; meningitis;
polio: rabies: lyme disease, tetanus: diabetes; and infections by bacteria (e.g., borreliosis).
However, other disorders may treated in this manner, e.g., autoimmune diseases such as Goodpasture's syndrome, rheumatoid arthritis, systemic lupus erythematosus, thyroiditis, myasthenia gravis, and anemia.
Suitable depletion media for these clinical or therapeutic regiments have been noted above.
However, since the characteristics and composition of the depletion media may vary depending on the ( JJ~
nature of the fluid, its intended use, and/or the pathophysiological condition being treated, other media may also be substituted or added.
Further embodiments are encompassed by the scope of the invention. In one embodiment, a unitary assembly is provided. In the context of the instant invention, unitary assembly refers to pre-assembled components that may be connected as a single unit to a fluid processing system or apparatus or to a patient. For example, a unitary assembly may refer to a fluid treatment element including at least one porous medium suitable f~r removing a deleterious or undesirable substance from a fluid, connected in parallel with a bypass. This 1~ unitary assembly may be pre-primed for ease of use in fluid processing.
In another embodiment, the bypass flow path may be a fluid flow path through the fluid treatment element 3.
While the present invention may be used to deplete a deleterious or undesirable substance directly from a fluid, the present invention may also be used therapeutically to deplete this substance indirectly. For example, since substances (e.g., proteins~ may attach to a carrier, such as a leucocyte or a virus, the present invention may be used to deplete the fluid of the carrier, and thereby accomplish depletion of the deleterious or undesirable substance attached to the carrier. The present invention may be used to deplete a deleterious or undesirable substance from a ~luid by immunoadsorption techniques. Such uses and devices are encompassed by the scope of the invention.
~7~
Examl~les Example 1.
The asse~bly used to perfonm this axample may be set up in a manner that generally corresponds to that described for Figure 1. The upstream junction of the bypass assembly includes a three-way valve, and the downstream junction of the bypass asse~bly includes ~wo check valves. Additionally, a junction including a three-way valve is interposed between the differential pressure generator and the ~ent, and this junction is connected to the downstream junction of the bypass assembly by a flexible tube.
Threaded connectors are used to connect these three junctions to the various components of the assembly.
An apparatus according to the invention may be used in treating a patient suffering from Guillain Barr~
Syndrome.
The differential pressure generator is a 60 cc plastic syringe, connected to the vent by the junction (which includes a three-way valve). This three-way valve (hereinafter the vent valve) provides ~or flow in and out of the syringe, and toward the vent or the bypass assembly and the fluid treatment element. The vent is a liquophobic polyamide membrane produced in ac~ordance with W0 91/17809, with a pore rating of 0.2 micrometers to maintain a barrier to bacteria.
The fluid treatment element is a pleated, layered, microporous polyamide membxane sold under the tradename Posidyne~, sealed into a substantially rectangular housing to form a filter assembly. The membrane includes a 0.8 micrometer layer downstream and a 0.2 micrometer layer upstream interposed between two polypropylene layers. The fluid treatment element in the housing (hereinafter the ~;J't~
filter assembly) is connected to the junctions of the bypass assembly. The upstream junction of the bypass asse~bly includes a three-way valve as well as a threaded connector to provide for removable connection to a spike. ThP downstream junction of the bypass assembly includes a dual check valve, so that fluid will pass through the bypass to the syringe, buk not vice-versa, and from the syringe to the filter assembly, but not into the bypass. This junction is connected to the syringe/vent junction by a flexible tube. The two junctions of the bypass assembly are also connected by a flexible tube to form a bypass loop.
With the exception o~ the syringe, all of the other elements of the assembly may b~ previously connected as a single unit. This single unit may be connected to the 60 cc syringe, with the plunger in the ~ully expelled position.
The spike may be placed in the saline pouch, and the three-way valve in the upstream junction of the bypass may be set so that fluid could flow through the bypass loop, but not to the filter assembly. The three-way vent vaLve may be rotated to provide for fluid flow to the syringe, but not to the vent.
The plunger of the syringe may be retracted to the 10 cc mark, and saline, pushing the air ahead of it, may pass through the bypass loop and into the syringe. The vent valve may then be rotated to allow fluid to flow to the vent, but not to the bypass and filter assembly. Air may be expelled by holding the syringe upright, and depressing the plunger approximately 3 cc until the air passes through the vent and the saline contacts the porous element of the vent.
The syringe, which now may contain about 7 cc of saline, may then be placed in a Harvard Apparatus Inc. programmable syringe pump, and operated according to the manufacturer's instructions. The vent valve may be rotated to block the flow path to the vent while opening the flow path leading to the filter assembly and the bypass. The first stsp of the H~rvard automated procedure may be performed, and the syringe may be filled with an additional 25 cc of ~aline. The three-way valve in the upstream junction of the bypass assembly may be rotated to close the bypass loop and open the flow path leading through the filter assembly toward the saline pouch.
The second step of the automated procedure may be run, which may prime the filter assembly with 30 cc of saline while forcing air into the saline pouchO
The filter asse~bly may be gently tapped to help remove trapped air.
After the assembly is primed, the spike may be removed from the saline pouch, and disconnected from the fitting. The fitting may then be attached to the catheter which is connected to the patient. The three-way valve in the upstream junction of the bypass may be rotated to open both the bypass loop and the path through the filter assembly, while the check valve arrangement in the downstream junction of the bypass assembly is sufficient to resist flow through the filter assembly while allowing flow forward through the bypass and into the syringe.
~he third step of the automated procedure may be run, which may fill the syringe with 25 cc of cerebrospinal fluid (CSF) at a flow rate of less than about 2 cc per minute.
Since the check valve arrangement in the downstream junction of the bypass assembly resists t`~,~
~low backward through the bypass, and directs flow through the filter assembly, the fourth step of the procedure may be run, which may infuse 25 cc of CSF
through the filtr assembly and the catheter and back into th~ patient, at a flow rate of less than about 5 cc per minute. The third and fourth step may then be repeated, resulting in treating approximately 75 cc of spinal fluid.
While the invention has been described in some detail by way of illustration and example, it should - be understood that the invention is susceptible to various modifications and alternative forms, and is not restricted to the specific embodiments set forth. It should be understood that these specific . 15 embodiments are not intended to limit the invention but, on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of t:he invention.
S~ ~ 7 i~
January 17, 1992~ Case # 40038 PRI~ING ~Y~T~M
Technical Field This invention relates to a system, apparatus, and method for priming a fluid processing or treating device. The invention also relates to a system, apparatus and method for treating a fluid.
Backqround of the Invention There are a number of methods and devices for processing and/or treating various ~luids. For example, a nun~er of therapeutic protocols for pathophysiological conditions involve the removal of a bodily fluid from a patient, treating that fluid to remove an undesirable component, and returning it to the patient. However, fluid processing and/or treatment need not be limited to therapeutic applications. For example, water may be rendered potable by passing it through a filter that removes substances such as bacteria.
Nevertheless, these methods, and the devices utilized to carry them out, have been inefficient in that they may require extra time and/or effort for priming. Additionally, these devices may waste ~luid since a portion of the ~luid may be held up in ~5 the devices. ~his may be expensive since the ~luid may be unrecoverable and/or incompletely processed.
Additionally, an additional labor intensive effort may be required to retrieve the held up fluid.
Furthermore, especially when a separate fluid treatment assembly or device is added to the system, h~ 2 the devices utilized may be awkward to use, or may compromise sterility by allowing the introduction of bacteria and/or air.
These problems involving cost, labor, sterility and time are magnified when the fluid is valuable, especially when only a limited amount is available.
For example, a number of therapeutic and non-therapeutic pro~ocols involve attaching an assembly to a individual, removing a bodily fluid ~e.g., blood), treating the fluid, and returning it to the individual. Since the individual only has a finite amount of that ~luid, it may be necessary to minimize loss, preferably with minimal additional effort.
~oreover, during such protocols it is important to maintain sterility without administering inappropriate substances such as air. Furthermore, since patient fluid treatment protocols may present some risk to the patient, the time and operator sophistication required to perform them should be minimized to decrease the risk t:o the patient.
In view of this, there is a demand for a system and method for easily, simply, and effectively, ~priming a fluid processing or treating device. The system and method should also provide these same advantages when a separate ~luid treatment assembly or device is added to the system. Additionally, there is a growing need for a simple system and method of processing or treating various fluids to deplete deleterious or undesirable substances from these fluids~ as well as for a system and method for administering them, e.g., to a patient, while minimizing loss of the fluid, and requiring minimal operator labor and sophistication. Moreover, particularly when the fluid is to be administered to f J i i a patient, there is a need for a system and method that minimizes risk to the patient by providing for quick priming and simple operation, while ~aintaining sterility, and without introducing inappropriate substances such as air.
Summary of the Invention The present invention relates to a device and method for priming a fluid processing or treating apparatus or system whereby a bypass assembly allows the efficient and effective priming of a fluid processing assembly, and whereby a vent allows the elimination of gas from the assembly.
The invention also relates to an apparatus and method for treating a fluid by passing the fluid through an apparatus according to the invention.
Brief Description o~ the Drawin~s Figure 1 is an embodiment of a priming and/or fluid processing system comprising an asse~bly according to the invention.
Figure 2 is another embodiment of the invention showing a vent at the upstream junction.
Specific Description of the Invention In accordance with the present invention, a device for priming a fluid processing or treating apparatus or system includes a fluid treatment element, a bypass connected in parallel with the fluid treatment element, a differential pressure generator in communication with the fluid treatment element and the bypass, and at least one vent in communication with at least one of the fluid treatment element, differential pressure generator, and the bypass assembly. Additionally, the present ~Is~ L~
invention provides a method for priming a fluid processing system.
The invention also relates to treating a fluid by passing the fluid through a previously primed porous medium which depletes a deleterious or undesirable substance from the fluid. The treated fluid may then be returned to the source, eOg., a patient.
An exemplary system is shown in Figure 1.
Assembly 100, which is preferably a closed system, may include a differential pressure generator 1, in fluid communication with a fluid treatment element 3 and bypass assembly 20. In the illustrated embodiment, the bypass assembly 20 and the fluid treatment assembly 3 communicate with differential pressure generator 1 by different fluid flow paths through junctions 4 and 5. The assembly 100 may also include at leas~ one ~ent 6, pre~erably communicating with the differential pressure generator 1 through junction 12. An assembly according to the invention may also include at least one flow control device; a conduit 2 connecting junction ~ with junction 5; a conduit 13 connecting junction 4 with junction 12; a variety of optional connectors 7~ and a spike 8 or catheter connector (not shown), or the like, connected to the assembly 100. In the illustrated embodiment, spika 8 is connected to a container of priming fluid 10.
Each of the components of the invention will now be described in more detail below.
DIFFERENTIAL PRE&S~RE GENE:RATOR
The differential pressure generator 1 may be any container or device which may be used to generate a pressure differential in the assembly h ~,3 1~ 7 100. Exemplary pressure differential generators include a pump, a flexible bag or a syringe~ A
syringe, and the like, is particularly preferred bscause it can be used to produce both a negative and a positive pressure differ~ntial, i~e., fluid can be drawn into the syringe and fluid can be expelled ~rom the syringe. As long as the material used to make ~he di~ferential pressure generator is suitable for use with the ~luid being processed, any device used to pull or push fluid through a system is within the scope of the present invention.
The composition of the differential pressure generator may vary depending on the nature of the fluid or fluids utilized. Accordingly, it may be constructed of any material compatible with the fluid or fluids being passed through the system.
Pressure differential generator 1 may be composed of a flexible material, ~or example, polyvinyl chloride (PVC), or plasticized PVC, ~.g., PVC plasticized with dioctylphthalate, diethylhexylphthalate, or trioctyltrimellitate, each of which may be used in the construction of conventional blood bags.
Alternatively, the differential pressure generator may be composed of a non-flexi~le material, for example, polypropylene, acrylonitrile butadiene styrene (ABS), polycarbonate, or stainless steel.
FL~ID TREATMENT ELENENT
The system 100 according to present invention also may include a fluid treatment element 3. It is intended that any device for treating and/or affecting the fluid, or performing some other desired function, is included within the scope o~
the invention. Typical fluid treatment elements include, but are not limited to, a bubble trap, a gas inlet, a gas outlet, an aerator, a pump, a column, a collection chamber or container, and the like. In a preferred embodiment, the fluid treatment element 3 is a filter asse~bly comprising a porous medium in a housing.
More preferably, the ~luid treatment element is a filter assembly for removing one or more deleterious substances ~rom the fluid. Exemplary fluid treatment elements include but are not limited to wat~r treatment filters; filter assemblies for removing leucocytes from a fluid, such as a blood component; and filter assemblies for removing proteins and the like from a ~luid such as cerebrospinal fluid.
The fluid treatment element 3 typically includes at least one inlet and at least one outlet which provide a flow path through the ~luid treatment element. If the fluid treatment element includes a porous medium, the porous medium may be positioned across the ~low path.
BYPASS ASSENBLY
The b~pass assembly 20, cormected in assembly 100 in parallel with a fluid treatment element 3, may be any component or combinat:ion of components 2S for bypassing a fluid treatment element 3. In accordance with the invention, a bypass assembly 20 may provide a fluid flow path around the fluid treatment element 3 (as illustrated), ~r may provide a separate, isolated fluid flow path through the fluid treatment element 3 (not shown).
Although the bypass assembly may be configured in a number of ways, the bypass assembly 20 preferably comprises a conduit 2, connecting junction 4 with junction 5, as illustrated in Figure ~ ~ 7 ~
1.
F~OW CO~q'ROL DEVICE
The system 100 may also include at least one flow control device used to establishr control or direct the flow of fluid in a desired direction.
Typical flow control devices incll-de a clamp, seal, valve, transfer leg closure, stopcock, or the like.
The flow control device may function automatically, e.g., a ch~ck valve, or it may be manually controlled, e.g., a stop cock or clamp.
The fluid flow control device or devices may be positioned in a variety of locations with respect to fluid flow. For example, a single fluid flow control device may be positioned to allow fluid to enter the difPerential pressure generator 1 without passing through the fluid treatment element 3.
Alternatively, the flow control device may be positioned to allow fluid to flow through the fluid treatment element 3 without passing through the bypass assembly 20. Likewise, multiple flow control devices may be utilized for a similar e~fect. In a preferred embodiment, j~mctions 4 and 5 each include a flow control de~ice. More pre~erably, junction 5 includes a rotatable three-way valve, and junction 4 includes two check valves.
VENI!
A system 100 according to the invention also includes at least one vent 6 in communication with at least one of the fluid treatment element 3, the pressure differential generator 1, and the bypass assembly 20. The vent 6 may be positioned anywhere in the system 100, for example, in a conduit or in the fluid treatment element or the bypass assembly, ~or venting air or gas, and the liXe, ~rom the system in order to prime the system and eliminate any extraneous gas. The vent 6 may includ~ a conduit and/or a container, pre~erably a ~lexible bag, to which the air or gas can be delivered. In a preferred embodiment o~ the invention, the vent 6 is a gas outlet, preferably positioned in, on, or near the pressure differential generator 1. More preferably, vent 6 communicates with pressure differential 1 by junction 12, as shown in Figure 1.
Exemplary gas outlets are disclosed in W0 91/17809.
Flow to or through the vent may be regulated by a flow control device, such as a clamp, seal, valve, transfer leg closure, stopcock and the like. The regulation may be automatic, e.g., by a device or element that blocks flow when wetted. In a preferred embodiment, junction 12, which connects vent 6 to the systemt includes a flow control device. More preferably, junction 12 includes a rotatable three-way valve.
The location of the vent 6 may be anywhere in the system 100, preferably positioned to provide the maximum amount of gas or air elimination from the assembly 100 during priming of t'he system.
Preferably, the vent 6 is located between the differential pressure generator 1 and the bypass assembly 20, more preferably, downstream of the bypass assembly 20. Alternatively, the vent may be positioned in other locations to optimize a desired result. Preferably, the vent is chosen so that sterility is not compromised. More preferably, the vent may have a pore rating of about 0.2 micrometers or less to preclude bacteria from entering the assembly 100.
Additionally, the vent may be included in a ~?
housing, and/or may include a cap or closure.
Other materials and configurations for the vent are included within the scope of the present invention. For example, a puncturable, non~porous material may ~e used, e.g., to allow insertion of the needle of a syringe to withdraw the air from the system.
Typically, the various components o~ the assembly 100 have at least one connector 7 to facilitate connection to the ~ther elements of the assembly. A variety of suitable conduits and connectors are known in the art.
NE~HOD
The invention also includes methods for priming a fluid processing apparatus wherein a priming fluid, for example, saline solution, is passed through the bypass assembly 20, through junction 4, and into pressure differential generator 1. The priming solution is then preferably directed through junction 4 and into and through fluid treatment element 3. At any point along the priming solution flow path, an appropriately placed vent may be opened in order to vent gas or air from the system.
An exemplary method according to the invention may be described with reference to Figure 1. The assembly lOo is connected to a source of priming ~olution 10, such as a container of saline solution.
~s the plunger in the syringe is withdrawn, a pressure di~ferential is created, drawing priming solution from the ~aline source container 10 into assembly 100. With the flow control device in junction 5 set to direct priming fluid into bypass assembly 20 and to block passage through the fluid treatment element 3, and the flow control device in ~7~
junction 12 set to direct fluid into the syringe and to block passage through the vent ~, priming fluid and gas in the ~arious components o~ the system pass into the bypass assembly ~0, through junction ~, conduit 13 and junction ~2 and into the syringe 1.
Once the gas and a desired amount of priming fluid is drawn into the syri~ge, ~etting ~he ~low control device in junction 12 to direct flow toward the vent ~ and to block flcw toward the bypass assembly 20 and the ~ilter element 3, and partially depxessing the plunger, allows gas to be expelled from the system through vent 6. Once the gas has been expelled, setting the flow control device in junction 12 to direct flow toward the bypass assembly 20 and the filter elemant 3, while blocking flow toward the vent 6, prevents gas from entering the system.
While the vent may be manually opened and closed, e.g., by capping or clamping, it may also be automatically controlled, e.g., the vent may include a device or element that passes gas until wetted by the priming fluid, and then bloc:ks all flow.
With the ~low control devicle in junction 5 set to allow priming fluid to flow through the fluid treatment element 3 and to block flow through the bypass, further depressing the plunger directs priming fluid from the syringe, throllgh junction 4, and into the fluid treatment element 3. As the priming fluid flows through the ~luid treatment element, it may displace gas and prime the fluid treatment element 3. The displaced gas, as well as priming fluid, may be directed through junction 5 back to the priming fluid bag.
Alternatively, as shown in Figure 2, a vent 11 may be located on the fluid treatment element side g ~
of junction 5. With the fluid control device in junction 5 set to blook flow through the fluid treatment element and the bypass, the priming ~luid may be forced from the syringe into the fluid treatment element and the gas displaced from the fluid treatment element by the priming ~luid may be expelled through the vent at the junction 5. Once the gas has been expelled through the vent, the vent may be closed and ~he flow control device at junction 5 ~ay be set to block flow through the bypass and allow flow between the fluid 'reatment element and the priming fluid bag. The remaining priming fluid in the syringe may then be returned to the bag.
~fter priming, the assembly 100 may be disconnected from the sourca of priming fluid, and linked to the source of the fluid to be processed or treated.
Once connected to the source of the fluid to be processed or treated, the fluid can be drawn and passed through the primed assemhly 100 in the same manner as described above for the priming fluid.
For example, if the fluid t:o be treated is water, it may be drawn through t:he primed assembly 100 in the same manner as described above for the priming fluid collecting treatecl water in a container. If additional processing vr treatment is desired, this step may be repeated to recirculate the water through the assembly.
Similarly, an embodiment of the invention includes an apparatus and method for priming an administration assembly, treating a fluid, and introducing the treated fluid into a patient. For example, the fluid may be drawn through the primed - 35 assembly as described above. In this embodiment, r ~ 3 the assembly 100 may include a connector or the like, e.g., a Y-connector, having one branch connected to the priming fluid bag, and the other connected to the patient. Once primed, the entire assembly can be connected to the patientO
Another embodiment of this invention includes an apparatus and method for priming an administration assembly, then collecting and treating a fluid from an individual (e.g., a donor or a p~tient), and then returning it to the individual, all while connected to the patient.
In a preferred embodiment of the inYention, all of these functions can be performed without adding or deleting elements of the apparatus, thus maintaininy a closed or sterile state.
For example, if the ~luid to be treated is a fluid obtainable directly from a patient, the primed assembly 100 can be connected to the patient, by, for example, a catheter (not shown)~ Fluid can be drawn from the patient and passed through the primed assembly 100 in the same manner as described above for priming fluid.
In these embodiments of the invention, the fluid treatment element typically includes a porous medium ~or depleting a deleterious or undesirable substance or substances from a fluid. This generally means removing a therapeutically or clinically significant amount of a deleterious or undesirable substance from a fluid such as a biological ~luid. "Therapeutically or clinically significant amount" refers to an amount necessary to produce a beneficial effect on the patient or animal receiving the substance-depleted fluid. Such a beneficial effect may be, for example, lessening a - 35 patient's symptoms.
d; ~
Removal of a therapeutically or clinically significant amount can vary depending on the intended use and/or from pakient to patient. For example~ a therapeutically or clinically significant amount can be greater for a Guillain-Barr~ syndrome treatment protocol than a multiple sclerosis treatment protocol. However, removal of a therapeutically or clinically significant amount can be and is routinely determined by a doctor or technician for treating a certain condition or disease as it pertains to the specific patient, and as it pertains to the particular application.
These embodiments are applicable to a wide range of clinical or therapeutic regimens in which the depletion of deleterious or undesirable substances from the substance-containing fluid is beneficial. Although a comprehensive list would be too extensive to include here, among the deleterious or undesirable substances which may be depleted or removed for a beneficial effect include, but are not limited to, proteins, polypeptides, interleukins, immunoglobulins, proteases, interferon, tumor necrosis ~actor, complement/ co~lplement associated factors, gliotoxic factors, leucocytes, lymphocytes, and viruses. These substances may be found in an individual's fluids, e.g., cerebrospinal f 1 uid (CSF), blood or blood component, urine, saliva, and the like.
One embodiment of the in~ention provides for treatment of Guillain-Barr~ syndrome. Guillain-Barr~ syndrome (acute polyradiculoneuropathy) is characterized by acute flaccid paralysis of muscles with associated muscle pains and paresthesia. In this embodiment, the cerebrospinal fluid (CSF) from a patient suffering from Guillain-Barr~ syndrome is $ t~ ~
passed through a previously primed assembly 100 and the deleterious or undesirable substance or substances associated with that syndrome are deplet~d from the ~luid, which may be then returned to the patient. While not intending to be limited to any particular theory, it ~s believed that therapeutic benefit may be achieved by depleting proteins from the CSF. In this e~bodiment, it should be noted that the term "deleterious or undesirahle substance" refers to both the singular and plural forms. Thus, e.g., a group of proteins is a deleterious or undesirable substance within the context of this invention. For convenience, the singular term "substance" will be used hereinafter, but it should be clear that the instant invention encompasses both the singular and plural forms.
With respect to this embodiment of the invention, the components of the apparatus 100 and the method of using it are generally as described previously.
The fluid treatment element 3 ipcludes a porous depletion medium. Typically, the fluid treatment element may include a housing. 'rhe depletion medium may be formed from any natural or synthetic fiber or from a porous or permeable membrane (or from other materials of similar surface area and pore size~
compatible with the fluid containing the deleterious or undesirable substance. The surface of the fibers or membrane may be unmodified or may be modified to achieve a desired property. Although the deleterious medium may remain untreated, the fibers or membrane are preferably treated with a charge modifying agent to produce a negatively or positively charged depletion medium. The charge-modified depletion medium may have negative or ~1 ~ 7 L~
positive zeta potential. A charge neutral depletionmedium may also be used in the instant invention.
While the depletion media can be produced from any material compatible with the fluid to be treated~ practical considerations dictate that consideration be giv~n first to the use o~
commercially available materials. The porous media of this invention may be preferably formed, for example, from a synthetic polymerO Suitable polymers include, but are not limited to, polyolefins, polyesters, polyamides, polysulfones, acrylics, polyacrylonitriles, polyaramides, polyarylene oxides and sulfides, and polymers and copolymers made from halogenated olefins and un-saturated nitriles. Examples include, but are not limited to, polyvinylidene fluoride, polyethylene, polypropylene, cellulose acetate, and Nylon 6 and 66. Preferred polymers are polyolefins, polyesters, and polyamides.
The depletion medium may be fashioned in a variety of ways to effectively de.plete the deleterious or undesirable substanca from the substance-containing liquid. For example, the depletion medium may be a porous web or sheet, membrane, fibrous mass~ or depth filter. It may have a large surface area. The depletion medium may be suitable for ultrafiltration, e~g., an ultrafiltration membrane.
The depletion medium may be formed into any geometric shape, preferably pre-formed, suitable for passing a fluid therethrough. In a preferred embodiment, the depletion medium is a substantially rectangular pleated depth filter.
Preferably, the depletion medium of this embodiment of the invention is a sheet formed into a !
7 ~i pleated, corrugated, or accordion formO
Additionally, the depletion medium may comprise a composite or multilayer element, or, in a less preferable alternative, separate elements may be used independently in a series arrangement. The depletion medium may also include additional components, including, but not limited to at least one layer to provide support and/or better drainage.
Exemplary supports and/or drainage components are non-wo~en polyester or polypropylene mesh.
The~depletion medium may have a substantially constant pore rating or it may vary in a continuous or stepwise manner, particularly when multiple layers are utilized. For example, it may include pore ratings withi~ the range of about .04 to about 40 micrometers, more preferably about 0.2 to about 5 micrometers.
Exemplary fluid treatment elements are disclosed in U.S. Patent Nos~ 4,702,840; 4,340,479;
20 4,855,163; 4,774,132; 4,906,374; 4,886,836;
4,964,989; and 4,707,266. When cerebrospinal fluid is the substance-containing fluid, media available from Pall Corporation under the trademark POSIDYNE~
are particularly preferred. Co~mercially available media, such as those available from Pall Corporation under the trademarXs ULTIPOR~, ULTIPOR N66 LOP~ODYNE~, FLUORODYNE~, CARBOXYDYNE~, and IMMUNODYNE~, BIODYNE ~, BIODYNE B~, and BIODYNE C~, may also be suitable.
As noted abo~e, the fluid treatment ~lement 3 may include a housing. Any housing of suitable shape to provide an inlet and an outlet may be employed. The housing may be fabricated from any suitably rigid, impervious material, including any impervious thermoplastic material, which is ~ 3 compatible with the fluid beiny processed. For example, the housing may be fabricated from a metal, such as stainless steel, or from a polymer. In a preferred embodiment, th~ housing is fabricated by injection molding from a polymer, more preferably a transparent or translucent pol~mer, such as an acrylic, polypropylene, polystyrene, or a polycarbonated resin~ Not only is such a housing easily and economically fabricated, but also it allows observation of the passage of the liquid through the housing. The surfaces of the housing contacting the fluid may be treated or untreated.
For example, the surfaces of the housing contacting the fluid may be rendered liquophilic for better priming. Methods for treating the surface of the housing include but are not limited to radiation grafting and gas plasma treatment.
IThe Eilter assembly in accordance with this invention may be fashioned in a variety of configurations. Housings can ~e designed to accept a variety of shapes of depletion media as long as adequate flow area is provided. All of these shapes are within the scope of the clai]med invention.
The depletion medium may be sealed or fit within the housing to achieve convenience of use, rapid priming, and efficient air clearance. For example, the depletion medium may be compression sealed or interference fit within the housing.
Alternatively, the housing may be overmolded, or heat welded, radiofrequency welded or ultrasonically w~lded. Additionally, a portion of the depletion medium may be located within the welds. Other suitable techniques for sealing or fitting the depletion medium within the housing are known to those skilled in the art.
!
In performing the method according to this embodiment of the invention, the flow rate of the patient's fluid is preferably sufficient to deplete a therapeutically or clinically significant amount of a deleterious or undesirable substance from the patient's fluido The flow rate may depend on a number o~ variables, and thus, a range of rates are suitable. For example, the rate may vary from patie~t to patient, or from one type of fluid to another. Preferably, when the fluid is cerebrospinal fluid from a patient with Guillain-Barr~ syndrome, a volume of about 20 to about 40 ml is utili2ed for the cycle of collection, treatment and return.
As noted above, the present invention may be used in a wide range of clinical or therapeutic regimens in which depletion of a deleterious or undesirable substance is bene~icial. Accordingly, the invention includes, but is not limited to treating pathophysiological conditions involving the ~ervous system, for example, Multiple Sclerosis and Amyotrophic Lateral Sclerosis; Acquired Immune De~iciency Syndrome (AIDS); dementia complex;
encephalitis (e.g., HIV-I encephalitis~; meningitis;
polio: rabies: lyme disease, tetanus: diabetes; and infections by bacteria (e.g., borreliosis).
However, other disorders may treated in this manner, e.g., autoimmune diseases such as Goodpasture's syndrome, rheumatoid arthritis, systemic lupus erythematosus, thyroiditis, myasthenia gravis, and anemia.
Suitable depletion media for these clinical or therapeutic regiments have been noted above.
However, since the characteristics and composition of the depletion media may vary depending on the ( JJ~
nature of the fluid, its intended use, and/or the pathophysiological condition being treated, other media may also be substituted or added.
Further embodiments are encompassed by the scope of the invention. In one embodiment, a unitary assembly is provided. In the context of the instant invention, unitary assembly refers to pre-assembled components that may be connected as a single unit to a fluid processing system or apparatus or to a patient. For example, a unitary assembly may refer to a fluid treatment element including at least one porous medium suitable f~r removing a deleterious or undesirable substance from a fluid, connected in parallel with a bypass. This 1~ unitary assembly may be pre-primed for ease of use in fluid processing.
In another embodiment, the bypass flow path may be a fluid flow path through the fluid treatment element 3.
While the present invention may be used to deplete a deleterious or undesirable substance directly from a fluid, the present invention may also be used therapeutically to deplete this substance indirectly. For example, since substances (e.g., proteins~ may attach to a carrier, such as a leucocyte or a virus, the present invention may be used to deplete the fluid of the carrier, and thereby accomplish depletion of the deleterious or undesirable substance attached to the carrier. The present invention may be used to deplete a deleterious or undesirable substance from a ~luid by immunoadsorption techniques. Such uses and devices are encompassed by the scope of the invention.
~7~
Examl~les Example 1.
The asse~bly used to perfonm this axample may be set up in a manner that generally corresponds to that described for Figure 1. The upstream junction of the bypass assembly includes a three-way valve, and the downstream junction of the bypass asse~bly includes ~wo check valves. Additionally, a junction including a three-way valve is interposed between the differential pressure generator and the ~ent, and this junction is connected to the downstream junction of the bypass assembly by a flexible tube.
Threaded connectors are used to connect these three junctions to the various components of the assembly.
An apparatus according to the invention may be used in treating a patient suffering from Guillain Barr~
Syndrome.
The differential pressure generator is a 60 cc plastic syringe, connected to the vent by the junction (which includes a three-way valve). This three-way valve (hereinafter the vent valve) provides ~or flow in and out of the syringe, and toward the vent or the bypass assembly and the fluid treatment element. The vent is a liquophobic polyamide membrane produced in ac~ordance with W0 91/17809, with a pore rating of 0.2 micrometers to maintain a barrier to bacteria.
The fluid treatment element is a pleated, layered, microporous polyamide membxane sold under the tradename Posidyne~, sealed into a substantially rectangular housing to form a filter assembly. The membrane includes a 0.8 micrometer layer downstream and a 0.2 micrometer layer upstream interposed between two polypropylene layers. The fluid treatment element in the housing (hereinafter the ~;J't~
filter assembly) is connected to the junctions of the bypass assembly. The upstream junction of the bypass asse~bly includes a three-way valve as well as a threaded connector to provide for removable connection to a spike. ThP downstream junction of the bypass assembly includes a dual check valve, so that fluid will pass through the bypass to the syringe, buk not vice-versa, and from the syringe to the filter assembly, but not into the bypass. This junction is connected to the syringe/vent junction by a flexible tube. The two junctions of the bypass assembly are also connected by a flexible tube to form a bypass loop.
With the exception o~ the syringe, all of the other elements of the assembly may b~ previously connected as a single unit. This single unit may be connected to the 60 cc syringe, with the plunger in the ~ully expelled position.
The spike may be placed in the saline pouch, and the three-way valve in the upstream junction of the bypass may be set so that fluid could flow through the bypass loop, but not to the filter assembly. The three-way vent vaLve may be rotated to provide for fluid flow to the syringe, but not to the vent.
The plunger of the syringe may be retracted to the 10 cc mark, and saline, pushing the air ahead of it, may pass through the bypass loop and into the syringe. The vent valve may then be rotated to allow fluid to flow to the vent, but not to the bypass and filter assembly. Air may be expelled by holding the syringe upright, and depressing the plunger approximately 3 cc until the air passes through the vent and the saline contacts the porous element of the vent.
The syringe, which now may contain about 7 cc of saline, may then be placed in a Harvard Apparatus Inc. programmable syringe pump, and operated according to the manufacturer's instructions. The vent valve may be rotated to block the flow path to the vent while opening the flow path leading to the filter assembly and the bypass. The first stsp of the H~rvard automated procedure may be performed, and the syringe may be filled with an additional 25 cc of ~aline. The three-way valve in the upstream junction of the bypass assembly may be rotated to close the bypass loop and open the flow path leading through the filter assembly toward the saline pouch.
The second step of the automated procedure may be run, which may prime the filter assembly with 30 cc of saline while forcing air into the saline pouchO
The filter asse~bly may be gently tapped to help remove trapped air.
After the assembly is primed, the spike may be removed from the saline pouch, and disconnected from the fitting. The fitting may then be attached to the catheter which is connected to the patient. The three-way valve in the upstream junction of the bypass may be rotated to open both the bypass loop and the path through the filter assembly, while the check valve arrangement in the downstream junction of the bypass assembly is sufficient to resist flow through the filter assembly while allowing flow forward through the bypass and into the syringe.
~he third step of the automated procedure may be run, which may fill the syringe with 25 cc of cerebrospinal fluid (CSF) at a flow rate of less than about 2 cc per minute.
Since the check valve arrangement in the downstream junction of the bypass assembly resists t`~,~
~low backward through the bypass, and directs flow through the filter assembly, the fourth step of the procedure may be run, which may infuse 25 cc of CSF
through the filtr assembly and the catheter and back into th~ patient, at a flow rate of less than about 5 cc per minute. The third and fourth step may then be repeated, resulting in treating approximately 75 cc of spinal fluid.
While the invention has been described in some detail by way of illustration and example, it should - be understood that the invention is susceptible to various modifications and alternative forms, and is not restricted to the specific embodiments set forth. It should be understood that these specific . 15 embodiments are not intended to limit the invention but, on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of t:he invention.
Claims (29)
1. An apparatus comprising:
a fluid treatment element;
a bypass connected in parallel with the fluid treatment element:
a differential pressure generator in communication with the fluid treatment element and the bypass: and at least one vent in communication with at least one of the differential pressure generator, the fluid treatment element, and the bypass.
a fluid treatment element;
a bypass connected in parallel with the fluid treatment element:
a differential pressure generator in communication with the fluid treatment element and the bypass: and at least one vent in communication with at least one of the differential pressure generator, the fluid treatment element, and the bypass.
2. The apparatus of claim 1 further comprising at least one flow control device in communication with at least one of the differential pressure generator, the fluid treatment element, and the bypass.
3. The apparatus of claim 1 wherein the fluid treatment element comprises at least one porous medium.
4. The apparatus of claim 3 wherein the porous medium comprises a membrane.
5. The apparatus of claim 4 wherein the membrane has a surface area in the range of from about 15 to about 300 cm2.
6. The apparatus of claim 4 wherein the membrane has a thickness in the range of from about 0.1 to about 1 mm.
7. The apparatus of claim 4 wherein the membrane has a pore rating in the range of about 0.04 to about 0.45 micrometers.
8. The apparatus of claim 1 wherein the differential pressure generator is flexible.
9. The apparatus of claim 1 wherein the differential pressure generator is non-flexible.
10. The apparatus of claim 9 wherein the differential pressure generator is a syringe.
11. The apparatus of claim 1 wherein the fluid treatment element includes the bypass.
12. A method for priming a fluid processing apparatus comprising:
passing a priming fluid through a bypass connected in parallel with a fluid treatment element;
venting gas from the fluid processing apparatus; and passing the priming fluid through the fluid treatment element.
passing a priming fluid through a bypass connected in parallel with a fluid treatment element;
venting gas from the fluid processing apparatus; and passing the priming fluid through the fluid treatment element.
13. The method of claim 12 wherein venting gas from the fluid processing apparatus comprises passing the gas displaced by the priming fluid in the bypass through a vent.
14. The method of claim 12 wherein venting gas from the fluid processing apparatus comprises passing the gas displaced by the priming fluid in the fluid treatment element through a vent.
15. The method of claim 12 wherein venting gas from the fluid processing apparatus comprises passing the gas displaced by the priming fluid in the bypass through a first vent, and passing the gas displaced by the priming fluid in the fluid treatment element through a second vent.
16. The method of claim 12 further comprising treating a fluid by passing it through the bypass and then the primed fluid treatment element.
17. The method of claim 16 wherein treating the fluid further comprises withdrawing the fluid from a patient and introducing the treated fluid back into the patient.
18. The method of claim 17 wherein withdrawing fluid from a patient comprises withdrawing cerebrospinal fluid.
19. A fluid treatment device comprising:
a fluid treatment element;
a bypass connected in parallel with the fluid treatment element: and at least one vent in communication with at least one of the fluid treatment element and the bypass.
a fluid treatment element;
a bypass connected in parallel with the fluid treatment element: and at least one vent in communication with at least one of the fluid treatment element and the bypass.
20. The device of claim 19 wherein the fluid treatment element further comprises a pre-primed filter assembly.
21. The device of claim 19 further comprising a differential pressure generator in communication with the fluid treatment element and the bypass.
22. The device of claim 21 wherein the differential pressure generator is in communication with the vent.
23. A fluid treatment device comprising:
a unitary assembly comprising a fluid treatment element including at least one porous medium suitable for removing a deleterious or undesirable substance from a fluid and a bypass, connected in parallel to the fluid treatment element.
a unitary assembly comprising a fluid treatment element including at least one porous medium suitable for removing a deleterious or undesirable substance from a fluid and a bypass, connected in parallel to the fluid treatment element.
24. The device of claim 23 wherein the unitary assembly is pre-primed.
25. A method of depleting a deleterious or undesirable substance from a patient's fluid comprising:
passing a priming fluid through a bypass connected in parallel with a fluid treatment element, wherein the fluid treatment element includes at least one porous medium suitable for removing a deleterious or undesirable substance from the patient's fluid;
exhausting the gas displaced by the priming fluid through a vent;
passing the priming fluid through the fluid treatment element;
withdrawing a fluid containing a deleterious or undesirable substance from a patient through the bypass; and passing the patient's fluid through the primed fluid treatment element to deplete the deleterious or undesirable substance from the fluid
passing a priming fluid through a bypass connected in parallel with a fluid treatment element, wherein the fluid treatment element includes at least one porous medium suitable for removing a deleterious or undesirable substance from the patient's fluid;
exhausting the gas displaced by the priming fluid through a vent;
passing the priming fluid through the fluid treatment element;
withdrawing a fluid containing a deleterious or undesirable substance from a patient through the bypass; and passing the patient's fluid through the primed fluid treatment element to deplete the deleterious or undesirable substance from the fluid
26. The method of claim 25 further comprising introducing the depleted fluid into the patient.
27. The method of claim 25 wherein withdrawing a fluid containing a deleterious or undesirable substance from a patient through the bypass and passing the patient's fluid through the primed fluid treatment element to deplete the deleterious or undesirable substance from the fluid comprises withdrawing cerebrospinal fluid from a patient through the bypass and passing it through the primed fluid treatment element.
28. The method of claim 27 further comprising introducing the depleted cerebrospinal fluid into the patient.
29. The method of claim 28 wherein introducing the depleted cerebrospinal fluid into the patient comprises introducing the cerebrospinal fluid depleted of the deleterious or undesirable substance associated with Guillain-Barré syndrome.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/824,788 US5334315A (en) | 1992-01-17 | 1992-01-17 | Priming system |
| US07/824,788 | 1992-01-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2074670A1 true CA2074670A1 (en) | 1993-07-18 |
Family
ID=25242318
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002074670A Abandoned CA2074670A1 (en) | 1992-01-17 | 1992-07-27 | Priming system |
| CA002126745A Abandoned CA2126745A1 (en) | 1992-01-17 | 1993-01-15 | Priming system |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002126745A Abandoned CA2126745A1 (en) | 1992-01-17 | 1993-01-15 | Priming system |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US5334315A (en) |
| EP (1) | EP0623048A4 (en) |
| JP (1) | JPH07502916A (en) |
| CA (2) | CA2074670A1 (en) |
| GB (1) | GB2278296A (en) |
| WO (1) | WO1993013852A1 (en) |
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-
1992
- 1992-01-17 US US07/824,788 patent/US5334315A/en not_active Expired - Fee Related
- 1992-07-27 CA CA002074670A patent/CA2074670A1/en not_active Abandoned
-
1993
- 1993-01-15 WO PCT/US1993/000333 patent/WO1993013852A1/en not_active Application Discontinuation
- 1993-01-15 GB GB9414501A patent/GB2278296A/en not_active Withdrawn
- 1993-01-15 CA CA002126745A patent/CA2126745A1/en not_active Abandoned
- 1993-01-15 EP EP93903492A patent/EP0623048A4/en not_active Withdrawn
- 1993-01-15 JP JP5512660A patent/JPH07502916A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP0623048A1 (en) | 1994-11-09 |
| JPH07502916A (en) | 1995-03-30 |
| WO1993013852A1 (en) | 1993-07-22 |
| GB2278296A (en) | 1994-11-30 |
| CA2126745A1 (en) | 1993-07-22 |
| GB9414501D0 (en) | 1994-09-14 |
| US5334315A (en) | 1994-08-02 |
| EP0623048A4 (en) | 1995-06-14 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |