Abstract:
A system and method of delivering and administering fluids used for infusion and similar therapies is provided that uses a reusable pump including a mechanism that eliminates contact between the pump material and the therapeutic fluid. An adapter for the pump, which is configured to interface with standard or customized drug reservoirs, is additionally provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims priority from co-pending Provisional Patent Application No. 62/002,818, entitled “Improved Elastomeric Pump Apparatus, System and Method of Use and filed on May 24, 2014; that application being incorporated herein, by reference, in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention relates to an improved pump apparatus, and more particularly, to an apparatus, system and method of delivering fluids used for infusion and similar therapies using an improved pump. 
         [0004]    2. Description of the Related Art 
         [0005]    In the field of medical devices used in infusion and similar therapies, medicinal or other fluidic treatments are delivered from a fluidic source via tubular lines to treatment areas within a patient via one or more needles or catheters inserted in the patient. In such medical devices, the tubular lines are interconnected via various connector assemblies such as luer connectors and other components. When fluidic therapy is delivered to a patient, a fluidic source and the means to deliver the fluidic treatment to the patient are required. Fluids may be sourced by a syringe and pump, a hanging bag, or other fluidic source. The fluidic delivery means may comprise a tubing set comprised of one or more tubular lines connects the fluid source (i.e., the proximal end) to the patient (i.e., the distal end). At the proximal end, tubular lines are terminated by connectors (usually female luer connectors) to permit their connection to the source of the fluid. At the distal end of the tubular lines, needles (such as subcutaneous, intramuscular, intravenous, epidural/spinal or similar types) deliver the fluidic treatment to the patient&#39;s treatment areas. 
         [0006]    Fluids may be sourced by a syringe, a hanging bag, or other fluidic source, which are impelled by a variety of means out of the distal end of the fluidic source into the tubing set or other fluidic delivery means. Such impelling mechanisms include an electrical or mechanical pump, or even gravity. 
         [0007]    Multiple pumps have been developed for the controlled infusion of pharmaceuticals over the last few decades. The state-of-the art has rapidly advanced and infusion pumps have been gradually improved relative to accuracy, user friendliness and ergonomics among other performance parameters. Infusion pumps can be categorized into ambulatory and hospital based devices. In terms of principle of operation, pumps can generally be electronic or mechanical devices. While electronic pumps have generally more accuracy than mechanical pumps, the latter offer sufficient control of drug delivery at a significant operation cost savings. 
         [0008]    Elastomeric pumps are mechanical pumps based on the ability of a balloon to produce a relatively constant force as it deflates. Elastomeric devices are based on a flexible balloon (elastomer) that, when inflated exerts pressure during deflation that results in a relatively constant flow rate controlled by a microbore tubing connected between the elastomer and the patient port/connector. The balloon is filled with a specific pharmaceutical fluid which is gently pushed into the patient via a small diameter tubing set that connects the elastomer to the patient, thus controlling the flow rate. One such pump is illustrated in U.S. Pat. No. 7,322,961 to Forrest, that patent being incorporated herein in its entirety. 
         [0009]    Elastomeric devices have been developed in various form factors as well as outer shell materials including hard and soft enclosures. Typical devices have a soft long shape that optimizes the form factor of the elastomer-pump/drug-reservoir combination. Outer shells are typically designed to match the overall geometry to serve as a case for the system device to be transported easily. 
         [0010]    The nature of pharmaceutical products and their chemical interaction with plastics is an important factor in the design of drug delivery platforms. Regulatory agencies around the world are raising thresholds of drug-reservoir compatibility as more in-depth toxicological ramifications of leachables related to drug reservoirs become better understood. 
         [0011]    In addition, pharmaceutical companies are continuously developing new drugs that demand increasingly more inert reservoirs, as these drugs&#39; chemical compositions make them more prone to chemical reactions with not only the containers in which they are packaged but also those used to transfer and then deliver them at the clinical site. 
         [0012]    Because known elastomeric devices make contact with the drug, they are discarded after use. What is needed is an elastomeric device that can be reused, so as to optimize the cost of such an elastomeric device. 
       BRIEF SUMMARY OF THE INVENTION 
       [0013]    It is accordingly an object of the invention to provide a system and method of delivering fluids used for infusion and similar therapies using an improved elastomeric pump. In one particular embodiment, an elastomeric pump is provided that eliminates drug-reservoir chemical incompatibility issues, or leaching of the container material into the drug. 
         [0014]    In another embodiment of the invention, a pump is provided having mechanical/geometrical compatibility with multiple factory-shipped drug reservoirs without requiring the transfer of medicinal fluid from the factory-shipped reservoir into a delivery reservoir, thus simplifying the transfer procedures and manipulation. 
         [0015]    In one embodiment, a cost benefit is provided based on the re-use of elastomeric components. In another embodiment, the size of the pump delivery system is optimized. 
         [0016]    As used herein, the term “or” may be construed in either an inclusive or exclusive sense. Similarly, the term “exemplary” is construed merely to mean an example of something or an exemplar and not necessarily a preferred or ideal means of accomplishing a goal. Additionally, although various exemplary embodiments discussed below focus on verification of experts, the embodiments are given merely for clarity and disclosure. Alternative embodiments may employ other systems and methods and are considered as being within the scope of the present invention. 
         [0017]    Reference in the specification to “one embodiment”, “one particular embodiment”, “an embodiment”, “another embodiment” or “another particular embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment. 
         [0018]    The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein. 
         [0019]    Although the invention is illustrated and described herein as embodied in a pump apparatus, system and method of use, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. 
         [0020]    The construction and method of operation of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]    For the purpose of illustrating the invention, there is shown in the drawings an exemplary embodiment that is presently preferred, it being understood however, that the invention is not limited to the specific methods and instrumentality&#39;s disclosed. Additionally, like reference numerals represent like items throughout the drawings. In the drawings: 
           [0022]      FIG. 1  is a block diagram of a system for delivering a medicine or drug to a patient in accordance with one particular embodiment of the present invention; 
           [0023]      FIG. 2  is a cut-away view of an elastomeric pump system in accordance with one particular embodiment of the invention; and 
           [0024]      FIG. 3  is a cut-away view of an elastomeric pump system in accordance with another particular embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0025]    Referring now to  FIG. 1 , there is shown a block diagram of a system for delivering a medicine or drug to a patient  40  in accordance with one particular embodiment of the present invention. More particularly, a pump  10  is used to drive a medicinal fluid from a drug reservoir  30 , via an interface adapter  20 . In one particular embodiment, the pump  10  is an elastomeric device that is inflated with water or another impelling fluid, but the impelling fluid is fluidly isolated from the medicinal fluid contained within the drug reservoir  30 . 
         [0026]    In one particular embodiment of the invention, the interface adapter  20  is used to establish a fluid-tight seal and impelling chamber that connects the pump  10  at one end  22  of the interface adapter  20  with the drug reservoir at the other end  24  of the interface adapter  20 . In one particular embodiment, a fluid-tight impelling chamber of the interface adapter  20  contains the impelling fluid as the pump  10  discharges the impelling fluid into the interface adapter  20  under pressure. Within the impelling chamber of the interface adapter  20 , as the impelling fluid&#39;s volume and pressure increase, it pushes against the proximal end of the lumen of the drug reservoir  30  and forces the medicinal fluid out of the distal end of the drug reservoir  30  and into a tubing set or other delivery device  32 , from which it is delivered into the patient  40 . In this way, the pressurized impelling fluid becomes an engine that drives the medicinal fluid out of the drug reservoir  30  and into the patient  40 . 
         [0027]    Referring now to  FIGS. 1 and 2 , a system for delivering a medicine or drug to a patient in accordance with one particular embodiment of the invention will now be described. A housing  100  is provided containing elements corresponding to the pump  10 , interface adapter  20  and drug reservoir  30 . More particularly, an infusion pump  10  is provided to hold a pressurized fluid, which in accordance with the present invention is an impelling fluid, rather than a drug or medicine. In one particular embodiment, the impelling fluid is water, but may be another impelling fluid isolated from the drug reservoir, as desired. 
         [0028]    The infusion pump  10  includes an elastomeric sleeve  110  surrounding a support member  112  and inlet and outlet ports  114 ,  116 , respectively. In one particular embodiment, the support member  112  is cylindrical, but other shapes may be used, as desired. The elastomeric sleeve  110  is expandable in a radial direction about the support member  112 . An inlet  114 , connecting with a channel in the support member  112 , is used to fill the elastomeric sleeve  110  with an impelling fluid  119 , thus expanding the elastomeric sleeve  110 . In one particular embodiment, the inlet  114  includes a one-way valve (not shown) to prevent fluid  119  within the sleeve  110  from exiting back through the inlet  114 . The inlet  114  can be sealed with a cap  115 . If desired, the pump  10  can be made, configured and operate as described in connection with the infusion pump of U.S. Pat. No. 7,322,961, incorporated herein by reference. 
         [0029]    Once expanded, the elastomeric sleeve  110  exerts a pressure on the impelling fluid  119  contained therein. The pump  10  additionally includes an outlet  116  in fluid communication with channels  117 ,  118  permitting a pressurized stream of impelling fluid  119  to flow in the direction of arrow “A” and into the interface adapter  20 , when a force is applied to the sleeve  110 . A connector (not shown) is provided external to the outlet  116 . In one particular embodiment, the connector is a luer lock connector. 
         [0030]    The interface adapter  20  is connected at a first side  22  to the outlet  116  of the pump  10  by a mating, fluid-tight connector, which in one particular embodiment is a luer lock connector  122  mating with the luer lock connector of the outlet  116 . At its other end  24 , the interface adapter  20  connects to the drug reservoir  30  with a fluid-tight mechanical connector  124 . In particular embodiments, the connector  124  may be a screw lock or a tongue-and-groove lock connector, as desired. A lumen of an impelling chamber  120  is connected between the connectors  122  and  124 . The length, volume and cross-sectional area of the lumen of the impelling chamber can be configured to impose a desired pressure and/or rate of flow on the impelling fluid passing into and through the impelling chamber  120 . 
         [0031]    In one particular embodiment of the invention, the impelling fluid  119  of the interface adapter  20  is fluidly isolated from the medicinal fluid  135  contained in the drug reservoir  30 , so that the medicinal fluid  135  does not make contact with the impelling fluid  119 , nor with the interface adaptor  20  or pump  10 . More particularly, in the embodiment illustrated in  FIG. 2 , the impelling fluid  119  of the interface adapter  20  is fluidly isolated from the medicinal fluid  135  contained in the drug reservoir  30  by a rubber gasket or plunger gasket  132  of a syringe  130  containing the drug reservoir  30 . Although, in the present embodiment, the impelling fluid  119  will enter the emptied portions of the drug reservoir  30  as the gasket  132  pushes the medicinal fluid  135  out from the reservoir  30 , the impelling fluid  119  does not come into contact with the medicinal fluid  135  itself. 
         [0032]    The rubber gasket  132  is configured as a plunging element to plunge the medicinal fluid  135  from the reservoir  30  in response to a driving force pushing (i.e., moving) the gasket  132  from one end of the reservoir  30  towards the other end. The gasket  132  has an outer diameter that closely approximates the inner diameter of the drug reservoir  30  of the syringe  132 , so as to permit movement within the drug reservoir  130  without permitting impelling fluid and medicinal fluid to mix on either side of the gasket  132 . In other words, although the impelling fluid  119  will enter the syringe  130  on one side of the gasket  132 , it does not pass through to the other side of the gasket  132 . The gasket  132  thus acts as an element, isolating the medicinal fluid  135  from the impelling fluid  119 , while driving the medicinal fluid  135  from the reservoir  30 . 
         [0033]    In use, medicinal fluid  135  is driven out of the drug reservoir  30  of the syringe  130  when a force applied to the elastomeric sleeve  110  forces pressurized impelling fluid out of the sleeve  110 , through the impelling chamber  120  and into the syringe  130  on one side of the rubber gasket  132 . The pressurized fluid  119  forced from the impelling chamber  120  thus drives the rubber gasket  132  from one end (i.e., the filled position) of the drug reservoir  30  to the other end (i.e., the empty position), and drives the medicinal fluid  135  from the outlet  137  and into the patient  40 , via a tubing set or other delivery device  32 . The gasket  132 , thus driven, both empties the medicinal fluid  135  from the drug reservoir  30  and isolates the medicinal fluid  135  from the impelling fluid  119 . In this way, the pump  10  and interface adapter  20  do not come into fluidic contact with the medicinal fluid  135 , thus eliminating chemical incompatibility between the medicinal fluid  135  and the sleeve  110 , and/or leaching of the container material from the pump  10  into the medicinal fluid  135 . 
         [0034]    Although illustrated as being contained in a syringe  130 , it should be understood that the drug reservoir  30  can configured in any shape and from any material desired, including but not limited to, a regular syringe, a prefilled syringe, a glass syringe, a drug vial and/or a bag or similar reservoir, without departing from the scope of the present invention. 
         [0035]    Referring now to  FIGS. 1 and 3 , there is shown another particular embodiment of the invention. Note that, with regard to  FIGS. 2 and 3 , like reference numerals will be used to denote like components, except that a prime (′) is added in connection with the impelling chamber  120 ′ of  FIG. 3 . More particularly, the embodiment of  FIG. 3  is substantially similar to that of  FIG. 2 , with the main different being that, in the present embodiment of  FIG. 3 , the interface adapter  20  includes a tight cap  124  at one end of the drug reservoir  30 , that connects to a balloon  128  at one end of the impelling chamber  120 ′, distal from the pump  10 . The balloon  128  is inflated under pressure by the impelling fluid  119  forced from the sleeve  118  and into the impelling chamber  120 ′. As it inflates, the balloon  128  pushes against the rubber gasket  132  at the end of the lumen of the drug reservoir  30 . Note that, in the present embodiment, impelling fluid  119  does not actually touch the walls of the drug reservoir  30  as the gasket  132  is moved through the reservoir, in contrast to the embodiment of  FIG. 2 . Rather, in the present embodiment, the impelling fluid  119  is fully contained within the balloon  128 . The balloon  128  and/or the gasket  132  act as an isolation element, isolating the medicinal fluid  135  from the impelling fluid  119 , while simultaneously forcing the medicinal fluid  135  out of the outlet  137  of the drug reservoir  30  and into a tubing set or other delivery device  32 . 
         [0036]    In one further alternate embodiment, not shown, the gasket  132  is omitted and the walls of the balloon  128  are used to isolate the impelling fluid  119  from the medicinal fluid  135  and to drive the fluid  135  from the chamber  30 , as the balloon  128  is inflated into and through the chamber  30 . Thus, in the present embodiment, the balloon  128  acts as an isolation element, isolating the medicinal fluid  135  from the impelling fluid  119 , while driving the medicinal fluid  135  from the reservoir  30 . 
         [0037]    Referring back to  FIG. 1 , although the foregoing embodiments are described in connection with an elastomeric pump, the invention is not limited only thereto. Rather, the present invention can also be implemented using a pump  10  other than an elastomeric pump to deliver the force to the impelling fluid, without departing from the scope or spirit of the present invention. For example, in accordance with one particular embodiment of the invention, the pump  10  includes an electronic valve operable to connect an interface adapter  20 ,  20 ′ to a miniature pump that pumps an impelling fluid  119  into the lumen of the interface adapter  20 ,  20 ′, in order to drive the gasket  132  through a drug reservoir  30 . Similarly, the pump  10  can include a peristaltic pump, a spring driven pump, a shaft driven by a motor, etc., as desired. 
         [0038]    More particularly, a non-elastomeric pump  10  would operate in the same manner as described in connection with the elastomeric pump  10  of  FIGS. 2 and 3 , to provide a force to the impelling fluid, forcing the impelling fluid through the interface adapter  20  to drive the medicinal fluid from the drug reservoir  30  into the patient  40 , while isolating the impelling fluid from the medicinal fluid in the reservoir  30 . 
         [0039]    As can be seen from the foregoing, the present invention provides a system including a pump wherein at least some of the components are reusable. An impelling fluid is used to drive the medicinal fluid from a drug reservoir, without interacting with the medicinal fluid. Similarly, in one particular embodiment, the pump of the system is operated without its elastomeric or other pump elements interacting directly with the medicinal fluid. This provides a cost savings by permitting reuse of the pump components, and additionally advantageously prevents leaching from the pump components into the medicinal fluid. 
         [0040]    The present invention provides an improved pump apparatus, system and method of use as described herein. Accordingly, while a preferred embodiment of the present invention is shown and described herein, it will be understood that the invention may be embodied otherwise than as herein specifically illustrated or described, and that within the embodiments certain changes in the detail and construction, as well as the arrangement of the parts, may be made without departing from the principles of the present invention as defined by the appended claims.