WO2021105981A9 - Fluid pump - Google Patents
Fluid pump Download PDFInfo
- Publication number
- WO2021105981A9 WO2021105981A9 PCT/IL2020/051186 IL2020051186W WO2021105981A9 WO 2021105981 A9 WO2021105981 A9 WO 2021105981A9 IL 2020051186 W IL2020051186 W IL 2020051186W WO 2021105981 A9 WO2021105981 A9 WO 2021105981A9
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- fluid pump
- distal
- proximal
- fluid
- membrane
- Prior art date
Links
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/0009—Special features
- F04B43/0081—Special features systems, control, safety measures
- F04B43/009—Special features systems, control, safety measures leakage control; pump systems with two flexible members; between the actuating element and the pumped fluid
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/08—Machines, pumps, or pumping installations having flexible working members having tubular flexible members
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14212—Pumping with an aspiration and an expulsion action
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/0009—Special features
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/0009—Special features
- F04B43/0054—Special features particularities of the flexible members
- F04B43/0072—Special features particularities of the flexible members of tubular flexible members
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M2005/14513—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons with secondary fluid driving or regulating the infusion
Definitions
- the present invention relates to devices, assemblies and systems for pumping fluids through compressible tubes, and in particular, for delivery of fluids, such as infusion fluids, in a pulsatile controllable manner.
- Fluid pumps are widely used in a variety of different applications for conveying fluids, such as various types of gas or liquid.
- Different types of fluid pumps are known in the art, including centrifugal pumps, peristaltic pumps, diaphragm pumps, and the like.
- Such pumps can be installed in systems applied to a variety of different industries, including, but not limited to, medical, pharmaceutical, agriculture, industrial, marine and military.
- the design parameters and dimensions of the fluid pumps can be adapted to the requirements of the specific application.
- IV infusion of fluids is commonly performed in medical care to administer medications or other fluids directly into the circulatory system of a patient.
- Infusion systems are composed of the reservoir with fluids, passive or active delivery systems and a flexible tube in series with a catheter which is usually inserted intravenously.
- passive infusion systems the fluid is driven by gravity, and the flow rate is controlled by roller clamps or other devices with preset restrictions to fluid flow.
- active infusion systems more accurate fluid delivery is controlled by electric or nonelectric non-disposable pumps.
- pressure infusion device used for treating severely hypovolemic patients, which only facilitates rapid yet largely uncontrolled fluid administration.
- nonelectric disposable pumps the pressure on the fluid is generated by a variety of mechanisms using nonelectric power, including a stretched elastomer or compressed spring, pressure generated during a chemical reaction, and pressure supplied from a cartridge of pressurized gas.
- the delivery flow rate is controlled by flow restrictors, which are integral to the administration set.
- the pressure generated by disposable pumps on fluid is typically within the range of 250 to 600 mm Hg, compared with a fluid reservoir pressure for electric pumps in the range of 5 to 1200 mm Hg, depending on flow rate and cannula size.
- Disposable pumps can infuse at flow rates ranging between 0.5-500 mL/hr, with running times from 30 minutes to 12 days.
- the factory determined flow accuracy for disposable pumps may go up to ⁇ 20%, while in modern electric infusion pumps it may be provided in a range of ⁇ 3-5%, depending on the implemented mechanisms. Absence of calibration standards may lead to overall accuracy of ⁇ 40% in the clinical setup.
- a fluid pump may be provided for mounting over a flexible tube, wherein the fluid pump includes a tapering membrane and is devoid of rotatable components or actuation mechanisms, thereby simplifying its structure and reducing costs.
- liquid pump comprising a housing and at least one membrane disposed within the housing.
- the housing comprises a proximal wall comprising a proximal opening, a distal wall comprising a distal opening, a central body portion extending between the proximal wall and the distal wall, an at least one pressure inlet.
- the at least one membrane comprises a proximal end, a distal end, and a tapering membrane portion extending at an inclined manner from the proximal end to the distal end, and having an outer membrane surface.
- the proximal opening and the distal opening are aligned with each other, and configured to accommodate a compressible tube.
- At least one sealed outer chamber is defined between the membrane and the housing.
- the at least one pressure inlet is in fluid communication with the at least one outer chamber.
- the tapering membrane portion is configured to flex radially inward, when pressure exceeding a threshold pressure value Pt is applied to the outer membrane surface.
- the membrane further comprises lateral extensions, configured to seal the at least one outer chamber.
- the housing further comprises lateral supports, configured to seal the at least one outer chamber.
- the housing formed with a relatively uniform elliptical cross-section along its length.
- the housing is shaped as a truncated cone tapering radially inward in the distal direction.
- the housing comprises a first housing section and a second housing section, and wherein the fluid pump is configured to be movable between an open state and a closed state.
- the two housing sections are hinged to each other along one edge of the two housing sections.
- the first housing section and the second housing section are similarly formed, and the membrane comprises a first membrane section and a second membrane section.
- the at least one outer chamber comprises a first outer chamber defined between the first housing section and the first membrane section, and a second outer chamber defined between the second housing section and the second membrane section.
- the at least one pressure inlet comprises a first pressure inlet in fluid communication with the first outer chamber, and a second pressure inlet in fluid communication with the second outer chamber.
- the at least one outer chamber comprises a single outer chamber defined between the first housing section and the membrane, wherein the at least one pressure inlet comprises a single pressure inlet in fluid communication with the outer chamber, and wherein the second housing section comprises a base.
- the base comprises a channel dimensioned to accommodate the compressible tube.
- the fluid pump further comprises a locking mechanism configured to retain the first housing section and the second housing section locked against each other in the closed state.
- the locking mechanism comprises at least one locking pin extending from at least one of the housing sections, and at least one locking recess comprised within the opposing housing section, wherein the at least one locking pin is configured to press-fit into the respective locking recess.
- the locking mechanism comprises at least one latch.
- the tapering membrane portion follows a cross- sectional concave arcuate path-line, sloping radially inward in the distal direction.
- the tapering membrane portion is provided with non- uniform thickness between the proximal end and the distal end.
- the at least one pressure inlet is formed as a protrusion extending radially outward from the housing, defining a port which is in fluid communication with the outer chamber.
- the at least one pressure inlet is positioned closer to the proximal wall than the distal wall.
- the fluid pump further comprises an internal compressible tube portion.
- the internal compressible tube portion comprises a proximal internal tube end, hermetically attached to the proximal wall and in fluid communication with the proximal opening, and a distal internal tube end, hermetically attached to the distal wall and in fluid communication with the distal opening.
- the proximal opening comprises a proximal inner recess, configured to accommodate the proximal internal tube end
- the distal opening comprises a distal inner recess, configured to accommodate the distal internal tube end.
- the proximal opening comprises a proximal outer recess, configured to accommodate a distal end of a proximal compressible tube
- the distal opening comprises a distal outer recess, configured to accommodate a proximal end of a distal compressible tube.
- the proximal opening comprises a proximal inner protrusion, configured to connect with the proximal internal tube end
- the distal opening comprises a distal inner protrusion, configured to connect with the distal internal tube end
- the proximal opening comprises a proximal outer protrusion, configured to connect with a distal end of a proximal compressible tube
- the distal opening comprises a distal outer protrusion, configured to connect with a proximal end of a distal compressible tube.
- the fluid pump further comprises a proximal inner clamp disposed over the proximal internal tube end, configured to clamp it over the proximal inner protrusion, and a distal inner clamp disposed over the distal internal tube end, configured to clamp it over the distal inner protrusion.
- the fluid pump further comprises a distal unidirectional valve attached to the distal opening.
- the fluid pump further comprises a proximal unidirectional valve attached to the proximal opening.
- a fluid pump assembly comprising the fluid pump, and the compressible tube extending through and mounted within the fluid pump.
- the compressible tube further comprises a proximal unidirectional valve.
- the compressible tube further comprises a distal unidirectional valve.
- the fluid pump assembly further comprises a fluid source.
- the fluid source is an infusion bag.
- a multi-pump assembly comprising a plurality of fluid pumps and the compressible tube, wherein the plurality of fluid pumps are serially mounted over the compressible tube.
- the plurality of fluid pumps are mounted in the same orientation over the compressible tube.
- a fluid pump system comprising at least one fluid pump, and a pressure source comprising at least one pressure line attached to the at least one pressure inlet of the at least one fluid pump.
- the pressure source is a gas pump.
- the fluid pump system further comprises a controller, configured to control the functioning of the fluid pump.
- the fluid pump system further comprises at least one compressible tube, extending through and mounted within the at least one infusion pump
- the at least one pressure line comprises a main actuation tube, which is branched at its distal portion to at least two tubular actuation branches.
- the fluid pump system further comprises a fluid source.
- the fluid source is an infusion bag
- the at least one fluid pump of the infusion system comprises a plurality of fluid pumps.
- Certain embodiments of the present invention may include some, all, or none of the above advantages. Further advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Aspects and embodiments of the invention are further described in the specification herein below and in the appended claims. [050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification, including definitions, governs.
- FIG. 1 shows a view in perspective of a fluid pump system implemented as an infusion system, according to some embodiments.
- FIG. 2A shows a view in perspective of a fluid pump mounted over a tube, according to some embodiments.
- Fig. 2B shows a sectional view in perspective of the fluid pump of Fig. 2A.
- Fig. 2C shows a cross-sectional side view of the fluid pump of Fig. 2A.
- Fig. 3A shows a full-blown view in perspective of components of the fluid pump next to a tube, according to some embodiments.
- Fig. 3B shows a view in perspective of the components shown in Fig. 3A assembled together and shown in an opened state.
- Figs. 4A-4F show different phases of a working cycle of the fluid pump, according to some embodiments.
- FIG. 5A shows a view in perspective of a fluid pump having a cylindrical housing, according to some embodiments.
- Fig. 5B shows a fluid pump having a housing formed with a uniform elliptical cross- section, according to some embodiments.
- Fig. 5C shows a fluid pump having a frustoconical housing, according to some embodiments.
- Fig. 6A shows a view in perspective of a fluid pump in an opened state, according to some embodiments.
- Fig. 6B shows a cross sectional side view of the fluid pump of Fig. 6A, according to some embodiments.
- Fig 7 shows a cross sectional side view of a fluid pump assembly, according to some embodiments.
- Fig. 8A shows a view in perspective of a multi-pump assembly, according to some embodiments.
- Fig. 8B shows a cross sectional side view of the multi-pump assembly of Fig. 7B.
- Fig. 9A shows a cross sectional side view of a fluid pump equipped with a proximal unidirectional valve and a distal unidirectional valve, according to some embodiments.
- Fig. 9B shows a cross sectional side view of a fluid pump equipped with a proximal unidirectional valve and a distal unidirectional valve, according to some embodiments.
- Fig 10 shows a view in perspective of a fluid pump system implemented as a paracentesis system, according to some embodiments.
- FIG. 11 shows a view in perspective of a fluid pump system implemented as a liquid filling system, according to some embodiments.
- FIG. 1 shows a view in perspective of a fluid pump system 300 implemented as an infusion pump system 300 m , comprising a fluid pump 100 implemented as an infusion pump, mounted over a tube 10 which can be an infusion tube, according to some embodiments.
- Figs. 2A, 2B and 2C show a view in perspective, a sectional view in perspective, and a cross- sectional side view, respectively, of a fluid pump mounted over a tube 10, according to some embodiments. While the fluid pump 100 is shown in Fig.
- liquid pump 100 can be utilized in any other fluid pump system for other types of applications, such as other medical application or any of a variety of non-medical applications, including, but not limited to, pharmaceutical, food industry, agriculture, and other industrial and/or military applications.
- fluid refers to either liquid or gas.
- a fluid pump 100 of the current specification may be utilized for conveying either gas or liquid, through a tube 10 mounted therein, as will be further elaborated hereinbelow.
- the fluid pump 100 comprises a housing 130 having a proximal wall 132, a distal wall 134, and a central body portion 136 extending between the proximal 132 and distal 134 walls.
- the proximal wall 132 comprises a proximal opening 164
- the distal wall 134 comprises a distal opening 166, wherein the proximal opening 164 and the distal opening 166 are aligned with each other along a flow-path axis 20 extending through their center-points, on opposite ends of the housing 130.
- the housing 130 is formed from a rigid material, such as, but not limited to, rigid polymeric materials, metals, and the like.
- the proximal 164 and distal 166 openings are configured to accommodate a compressible tube 10 (such as an infusion tube or any other type of flexible and/or compliant tube) that may extend through the housing 130.
- a compressible tube 10 such as an infusion tube or any other type of flexible and/or compliant tube
- the openings 164 and 166 are preferably of the same dimensions.
- the proximal opening 164 and the distal opening 166 are configured to retain the infusion tube extending there-through in position, so as to prevent unintentional axial movement thereof, relative to the housing 130.
- tube and “compressible tube”, as used herein, are interchangeable, and refer to a tube made of a flexible material that can be squeezed radially inward and decrease in volume when an external force (such as a force having a magnitude in the range of forces applied by a manual human hand squeezing motion) is applied thereto, and which will possibly increase in volume (i.e., revert back to its pre-squeezed radius) once the external force that led to the volume decrease is removed (i.e., the tube may be more or less regarded as elastic).
- an external force such as a force having a magnitude in the range of forces applied by a manual human hand squeezing motion
- proximal generally refers to the side or end of any device or a component of a device, which is closer to the inflow side of the tube 10.
- a proximal side or a proximal end may refer to an end of a device or a component thereof closer to the fluid source 30, such as the infusion bag 30 m shown in Fig. 1.
- distal generally refers to the side or end of any device or a component of a device, which is opposite to the proximal side, and is closer to the outflow side of the compressible tube 10.
- fluid pump is non-binding and does not intend to limit the pump to specific applications, such as medical-oriented application, but may be otherwise utilized as a pumping device for any other suitable application.
- compressible tube is non-binding and does not intend to limit the tube to specific applications, as delivering infusion fluids, but may rather refer to any other type of a flexible/compressible/squeezable tube.
- the fluid pump 100 further comprises at least one membrane 110 disposed within the housing 130, between the central body portion 136 and the flow-path axis 20.
- the membrane 110 comprises a proximal end 112, a distal end 114, and a tapering membrane portion 116 extending at an inclined manner from the proximal end 112 to the distal end 114.
- the tapering membrane portion 116 comprises an outer membrane surface 118 facing the central body portion 136 of the housing 130, and an inner membrane surface 120 facing the flow-path axis 20.
- the tapering membrane portion 116 is disposed between the central body portion 136 of the housing 130 and the flow-path axis 20, and more specifically, between the central body portion and the infusion tube 10, when the infusion tube 10 extends through the housing 130, such that the inner membrane surface 120 faces the infusion tube 10.
- the tapering membrane portion 116 tapers radially inward between its proximal 112 and distal 114 ends, such that the distal end 114 is closer to the flow-path axis 20, and more specifically, closer to the tube 10 when the tube 10 extends through the housing 130, than the proximal end 112.
- the proximal membrane end 112 and the distal membrane end 114 are affixed to the housing 130 in a hermetically sealed manner, while the tapering portion 116 is configured to flex radially inward (i.e., toward the flow-path axis 20, and more specifically, toward the tube 10 when the tube 10 extends through the housing 130), when pressure exceeding a threshold pressure value Pt is applied to the outer membrane surface 118.
- Threshold pressure value Pt is defined as the minimal pressure which is sufficient to distort and/or flex the tapering membrane portion 116 radially inward, and may depend on various parameters such as, but not limited to, material properties of the tapering membrane portion 116, and/or dimensions of the membrane 110 including the thickness of the tapering membrane portion 116.
- the tapering membrane portion 116 is provided with sufficient internal resiliency so as to revert back to its relaxed, non-flexed state, when pressure exceeding the threshold value Pt is no longer applied thereon.
- the pressure Pt is not a fixed value, but rather a function depending on the axial position along the tapering membrane portion 116.
- the pressure Pt required to flex the tapering membrane portion 116 radially inward along a region closer to the proximal end 112 may be lower than the pressure required to flex a region thereof, closer to the distal end 114.
- some regions of the tapering membrane portion 116 might deflect radially inward, while other regions will remain in a relatively relaxed position.
- applying a time-varying pressure Pt may result in different regions of the tapering membrane portion 116 deflecting radially inward at different phases of the pressure cycle.
- the proximal membrane end 112 is attached to the proximal wall 132. According to some embodiments, the proximal membrane end 112 is attached to the central body portion 136, for example in the vicinity of the proximal wall 132. According to some embodiments, the distal membrane end 114 is attached to the distal wall 134. According to some embodiments, the distal membrane end 114 is attached to the central body portion 136, for example in the vicinity of the distal wall 132. The proximal membrane end 112 and/or the distal membrane end 114 may be attached to the housing 130 by various methods as known in the art, including gluing, welding, clamping and the like.
- R The distance between the membrane 110 and the flow-path axis 20 is denoted R (see Fig. 2C). More specifically, R denotes the distance between the inner membrane surface 120 and the flow-path axis 20, and may vary along the axial length of the membrane 110. As shown in Fig. 2C, Rd denotes the distance between the inner membrane surface 120 and the flow-path axis 20 at the distal membrane end 114, and Rp denotes the distance between the inner membrane surface 120 and the flow-path axis 20 at the proximal membrane end 112. [092] According to some embodiments, Rp is larger than Rd. According to some embodiments, Rp is at least two times larger than Rd.
- Rp is at least three times larger than Rd. According to some embodiments, Rp is at least four times larger than Rd. [093] Rd is equal to or larger than the radius of the openings 164, 166. According to some embodiments, the distal membrane end 114 is offset from the distal opening 166, such that Rd is larger than the radius of the distal opening 166.
- the fluid pump 100 further comprises at least one sealed outer chamber 160, defined between the tapering membrane portion 116 and the housing 130.
- a first sealed outer chamber 160a and a second sealed outer chamber 160b of the fluid pump 100 are defined between the tapering membrane portion 116 and opposite sides of the housing 130.
- the fluid pump 100 can include lateral extensions 122, 124 of the membrane 110, and/or lateral supports 126, 128 of the housing 130, as will be further elaborated hereinbelow.
- each sealed outer chamber 160 can be defined between the tapering membrane 116, an opposite side of the housing 130, and lateral extensions 122, 124 and/or lateral supports 126, 128, wherein the lateral extensions 122, 124 and/or lateral supports 126, 128 are configured to seal the outer chambers 160a and 160b, so as to prevent fluid or gas flow there between.
- an inner chamber 162 is defined between the tapering membrane portion 116 and the tube 10, when the infusion tube extends through the housing 130.
- the proximal opening 164 and the distal opening 166 of the housing 166 further comprise seal members such as O-rings (not shown), or are otherwise configured to grip and/or seal against the tube 10 when the tube 10 extends there through.
- the diameters of the proximal opening 164 and the distal opening 166 are slightly smaller than the outer diameter of the tube 10, so as to tightly press against the tube 10 to prevent axial displacement thereof relative to the housing 130.
- Each outer chamber 160 is configured as a sealed space that can be varied in volume by displacing the tapering membrane portion 116.
- the terms "outer chamber” and “sealed outer chamber”, as used herein, are interchangeable, and refer to any embodiment of an outer chamber 160 disclosed throughout the specification, which is sealed as defined hereinabove.
- each inner chamber 162 is configured as a non- sealed space when a tube 10 is mounted within the fluid pump 100, wherein the inner chamber 162 can be varied in volume by displacing the tapering membrane portion 116, and wherein the inner chamber 162 is in fluid communication with the external environment, for example via airflow openings 108.
- Airflow opening 108 are configured to permit flow of air from the inner chamber 162 to the external environment, when the volume of the inner chamber 162 is decreased as the membrane 110 is pressed by the higher pressure applied thereto from the outer chamber 160, and to permit flow of air from the external environment back into the inner chamber 162 when the membrane 110 reverts to its free state as the pressure from the outer chamber 160 is released.
- airflow openings 108 may be comprised in the proximal wall 132, for example between the proximal opening 164 and the membrane's proximal end 112, as shown in Figs. 2B and 3B.
- the central body portion 136 comprises at least one pressure inlet 158 adapted for connection to a pressure line 50 coupled to a suitable pressure source 40 (see Fig. 1).
- the pressure source 40 can be a gas pump, such as an air pump, or any other suitable pressure source configured to deliver gas (e.g., air) or liquid at high pressure into a respective outer chamber 160.
- the pressure source 40 may be configured to perform as a pulsatile pressure source.
- the pressure inlet 158 may be formed as an aperture or an opening extending through the central body portion 136, as shown in the exemplary embodiment illustrated in Figs. 2A-2C.
- the pressure inlet 158 comprises a protrusion extending radially outward from the outer surface of the central body portion 136, or a fitting affixed thereto, configured to attach to, engage with or accept pressure line of the pressure source 40, such as an actuation tube 54 of a gas pump.
- the exemplary embodiment illustrated in Figs. 4A-4F shows a fluid pump 100 a .
- the fluid pump 100 a is of the same construction and configuration as that of fluid pump 100 shown in Figs. 2A-3B, with like numbers referring to like parts.
- the pressure inlet 158 a of the fluid pump 100 a is formed as a protrusion extending radially outward from the housing 130 a , defining a port which is in fluid communication with the outer chamber 160 a .
- the housing 130 comprises two opposing pressure inlets 158: a first pressure inlet 158a in fluid communication with the first outer chamber 160a, and a second pressure inlet 158b in fluid communication with the second outer chamber 160b.
- each pressure inlet 158 is positioned opposite to the plane defined by the lateral extensions 122, 124.
- each outer chamber 160 defines a sealed space that is hermetically sealed between the corresponding central body portion 136 and tapering membrane portion 116, except for the pressure inlet 158 which is in fluid communication with this sealed space.
- the lateral extensions 122, 124 are integrally formed with the membrane 110, or are otherwise affixed thereto, extending radially outward from the outer membrane surface 118 in two opposite directions, as shown in Figs 3A-3B.
- the outer edges of the lateral extensions 122, 124 i.e., the radial outermost edges
- the lateral extensions 122, 124 may be formed from the same material as the tapering membrane portion 116.
- the lateral extensions 122, 124 may be more rigid than the flexible tapering membrane portion 116.
- the lateral extensions 122, 124 are integrally formed with the housing 130, or are otherwise affixed thereto, extending radially inward from the central body portion 136 in two opposite directions (embodiments not shown).
- the inner edges of the lateral extensions 122, 124 i.e., the radial innermost edges
- the lateral extensions 122, 124 may be formed from the same material as the central body portion 136.
- housing 130 comprises at least two sections, a first housing section 130a and a second housing section 130b, attached or reversibly attachable to each other.
- Figs. 3A-3B shows an exploded view in perspective, and an assembled view, of components of the fluid pump 100 with the tube 10, according to some embodiments.
- Figs. 3A-3B shows an exploded view in perspective, and an assembled view, of components of the fluid pump 100 with the tube 10, according to some embodiments.
- the first and second housing sections 130a and 130b comprise a first and a second proximal wall 132a and 132b, a first and a second distal wall 134a and 134b, a first and a second central body portion 136a and 136b, a first and a second proximal opening portion 164a and 164b, a first and a second distal opening portion 166a and 166b, and a first and a second pressure inlet 158a and 158b, respectively.
- the membrane 110 comprises at least two sections, a first membrane section 110a and a second membrane section 110b, attached or attachable to each other.
- the first and second membrane sections 110a and 110b comprise a first and a second proximal end 112a and 112b, a first and a second distal end 114a and 114b, and a first and a second tapering membrane portion 116a and 116b, having a first and a second outer membrane surface 118a and 118b, and a first and a second inner membrane surface 120a and 120b, respectively.
- the fluid pump 100 is movable between an open state (shown for example in Fig. 3B), wherein the two housing sections 130a and 130b are at least partially detached from each other (meaning that at least a portion of one housing section 130a is spaced away from the corresponding portion of the second housing section 130b), and a closed state (shown for example in Fig. 2A), wherein the two housing sections 130a and 130b are locked against each other.
- the two housing sections 130a and 130b are hermetically locked against each other in the closed state.
- the first and a second distal opening portions 166a and 166b respectively, together defined the enclosed distal opening 166 in the closed state.
- first 130a and second 130b housing sections may be hinged to each other at one edge thereof, such as along their lateral edges 142a and 142b (also referred to as first lateral housing edges 142), while their opposite lateral edges 144a and 144b (also referred to as second lateral housing edges 144) may be detachably attached to each other, enabling the first 130a and second 130b housing sections to pivot relative to each other about the hinged edge 142, and having their opposite edges 144 extending away from each other in an open state as shown in Figs. 3A-3B.
- the first 130a and second 130b housing sections may be locked together, having their opposite edges 144a, 144b pressed against each other, in the closed state, as shown in Fig. 2A.
- the membrane 130 may be detachably attached to the housing 130.
- the first and second membrane sections 110a and 110b may be detachably attached to the first and second housing sections 130a and 130b, respectively, as shown in the exemplary embodiment illustrated in Figs. 3A-3B.
- the first and second membrane sections 110a and 110b may be affixed to the first and second housing sections 130a and 130b, respectively.
- the housing 130 may comprise recesses or slots configured to tightly accept the proximal end 112 and the distal end 114 of the membrane 110 therein, as illustrated in Figs. 2A-3B. It will be understood that the membrane 110 may be connected to the housing 130 by any other methods, including gluing, welding, clamping and the like. Moreover, the housing 130 can include various different features configured to facilitate hermetical connection of the membrane 110 thereto. For example, the housing 110 may be formed from separable portions that may be attached to each other when the proximal 112 and/or distal 114 ends of the membrane 110 are disposed there-between, so as to tightly press against and clamp the respective membrane portions hermetically when attached to each other.
- each of the first and second housing sections 130a and 130b further comprise lateral supports 126 and 128.
- the first housing section 130a may include a first lateral support 126a extending from the first lateral housing edge 142a toward the flow-path axis 20, and a second lateral support 128a extending from the second lateral housing edge 144a toward the flow-path axis 20 in the closed state.
- the second housing section 130b may include a first lateral support 126b extending from the first lateral housing edge 142b toward the flow-path axis 20, and a second lateral support 128b extending from the second lateral housing edge 144b toward the flow-path axis 20 in the closed state.
- each of the first and second membrane sections 110a and 110b further comprise lateral extensions 122 and 124.
- the first membrane section 110a may include first and second lateral extensions 122a and 124a, respectively, extending radially away from the first tapering membrane section 116a.
- the second membrane section 110b may include first and second lateral extensions 122b and 124b, respectively, extending radially away from the second tapering membrane section 116b.
- the lateral extensions 122 and 124 extend from the tapering membrane sections 116 toward the first lateral housing edges 142 and the second lateral housing edges 144, respectively, in the closed state.
- the lateral supports 126 and 128 of the housing 130 are shaped to accommodate the lateral extensions 122 and 124 of the membrane 110, when the membrane 110 is mounted within the housing 130.
- the lateral extensions 122 and 124 may be pressed against each other, between the corresponding lateral supports 126 and 128, in the closed state.
- membrane 110 is shown in the example embodiment of Figs. 3A-3B with lateral extensions 122 and 124, it is to be understood that this is shown for the sake of illustration and not limitations, and that in some embodiments, the membrane 110 does not necessarily include such lateral extensions.
- a first outer chamber 160a may be defined between the first housing section 130a and the first membrane section 110a
- a second outer chamber 160b may be defined between the second housing section 130b and the second membrane section 110b.
- each outer chamber 160 may be defined between a corresponding central body portion 136, proximal wall 132 and/or proximal end 112, distal wall 134 and/or distal end 114, tapering membrane portion 116, and lateral supports 126 and 128.
- each outer chamber 160 may be defined between a corresponding central body portion 136, proximal wall 132 and/or proximal end 112, distal wall 134 and/or distal end 114, tapering membrane portion 116, and lateral extensions 122 and 124.
- both membrane 110 is devoid of lateral extensions 122, 124
- housing 130 is devoid of lateral supports 126, 128.
- a housing 130 can be shaped such that the housing edges 142, 144 are in direct contact with the tapering membrane portion 116 in the closed state (embodiments not shown).
- each outer chamber 160 may be defined between a corresponding central body portion 136, proximal wall 132 and/or proximal end 112, distal wall 134 and/or distal end 114, and tapering membrane portion 116.
- forming the housing 130 and the membrane 110 from two sections that may be movable between open and closed states enables simple and convenient placement of an tube 10 within the fluid pump 100, for example by placing the infusion tube along the opening portions 164b and 166b of one of the housing sections 130a in the open state (see Fig. 3B), followed by locking both sections 130a and 130b over the tube 10 in the closed state (see Fig. 2A).
- disengagement of the fluid pump 100 from the tube 10 may also be performed in a simple and convenient manner by reversing the order of the aforementioned steps.
- both membrane 110 and housing 130 may be manufactured as a single piece (nevertheless, with different material properties for each), for example by utilizing various manufacturing techniques such as 3D printing.
- the tapering membrane portion 116 tapers axially in a relatively straight manner, such that the cross-sectional path line of the tapering membrane portion 116, defined between the proximal end 112 and the distal end 114, follows a relatively straight line sloping radially inward in the distal direction (i.e., a straight line angled relative to the flow-path axis 20).
- the tapering membrane portion 116 tapers axially in a non-linear manner, following a concave arcuate path-line sloping radially inward in the distal direction, as shown in Figs. 2B-2C.
- a non-conventional concave arcuate orientation of the tapering membrane portion 116, as shown in Figs. 2B-2C, has been found by the investors to exhibit superior flow pumping behavior, relative to straight sloping configurations.
- the membrane 110 further comprises at least one straight tubular portion, which may axially extend between the proximal end 112 and the tapering membrane portion 116, and/or between the tapering membrane portion 116 and the distal end 114 (embodiments not shown).
- the outer chambers 160 can be pressurized to a pressure higher than Pt so as to impart flexion of the tapering membrane portion 116, and can be depressurized to a pressure lower than Pt, allowing the tapering membrane portion 116 to revert to its resting state.
- the unique combination of the tapering profile of the membrane portion 116 and the axial position of the pressure inlet 158 relative thereto, results in radially inward flexion of the tapering membrane portion 116 in a rolling manner, configured to contact and press against the tube 10.
- Fig. 4A shows the membrane 110 in a relaxed state thereof, wherein the pressure within the at least one outer chamber 160 is lower than the threshold pressure Pt.
- the fluid pump 100 can be activated by the pressurized air (or any other gas or fluid), supplied by the pressure source 40 (e.g., air pump), through the pressure inlet 158, into the enclosed volume of the outer chamber 160. Due to the applied pressure, exceeding the threshold value Pt, the tapering membrane portion 116 starts to collapse inward toward flow-path axis 20, from an initial flexion point PI shown in Fig.
- the collapsing region of the tapering membrane portion 116 propagates progressively against the outer wall of the tube 10, as shown in Fig. 4C and 4D, for example pressing the tube 10 radially inward along a region extending between points PI and P2 as shown in Fig. 4C.
- This may be followed by subsequent restoration of the tapering membrane portion 116 shape as pressure is released in the outer chamber 160, as shown in Figs. 4D-4F.
- the tube 10 may be temporarily occluded along at least a portion thereof, as shown for around point P2 in the exemplary phase illustrated in Fig. 4D. In other instances, the tube 10 may be squeezed without being occluded.
- the pressure supplied into the outer chamber 160 is chosen to collapse the tapering membrane portion 116 inward toward flow path axis 20, sufficiently to press against and/or pinch the tube 10 in a rolling manner corresponding to the time-dependent distally-oriented collapse of the tapering membrane portion 116, so as to gradually compress the tube 10 to squeeze liquid contained in its lumen in a distally oriented direction, as shown in Figs. 4C-4E.
- the membrane 110 is a 3D structure (as shown, inter alia, in Figs. 3A- 3B)
- any collapse or re-expansion of the membrane portion 116 is a 3D collapse of the 3D structure of the membrane portion 116 toward or away from the flow path axis 20, respectively.
- any reference to collapse or re-expansion in the vicinity of points PI, P2 shown in the cross-sectional views of Figs. 4A-4F refers to collapse or re-expansion of 3D regions corresponding to respective points PI, P2.
- the tapering membrane portion 116 is configured to be reciprocally moved to create cyclic pressure pulses compressing the tube 10, to pump fluid out of the tube 10 through the distal opening 166.
- the pumping applied to the infusion tube 10 is affected by the oscillations of the tapering membrane portion 116.
- the tapering membrane portion 116 is caused to flex to compress the infusion tube 10, applying pressure to the fluid in the tube 10, and urging flow thereof through the distal opening 166.
- a proximal fluid source 30 e.g., an infusion bag as shown in Fig. 1
- the pressure source 40 can be configured to provide pulsatile pressure to the outer chamber 160, wherein the pressure waveform, amplitude and frequency can be adapted to provide a desired flow rate through the infusion tube 10 extending through the infusion pump 100.
- the housing 130 may be provided with transparent, or partially transparent, walls, to enable visual inspection of the pumping mechanism of the fluid pump 100.
- the housing 130 further comprises, for each outer chamber 160, a relief valve (not shown), which can be unidirectional valve configured to open and allow the pressure within the respective outer chamber 160 to return to a pressure lower than the threshold pressure Pt, such as the atmospheric pressure.
- a relief valve (not shown), which can be unidirectional valve configured to open and allow the pressure within the respective outer chamber 160 to return to a pressure lower than the threshold pressure Pt, such as the atmospheric pressure.
- pressure may be exhausted through the same pressure inlet 158, which allows for gradual restoration of the tapering membrane portion 116 back to its original shape due to resiliency of the membrane's material.
- housing 130 is shown in Figs. 2A-3B to have a generally cylindrical shape, and the housing sections 130a and 130b are shown to have generally half-cylindrical shapes, it will be understood that these shapes are shown by way of illustration and not limitation, and that other circular or non-circular cross-sectional shaped are contemplated, including non- uniform shapes and/or non-uniform dimensions along the longitudinal direction of the housing 130.
- longitudinally means along the length, or lengthwise, of a device or a component of a device such as the housing 130, i.e. its end-to-end direction.
- FIG. 5 A shows a cylindrically-formed housing 130 b , provided with a relatively uniform circular cross-section along its length.
- Fig. 5B shows a housing 130 c formed with a relatively uniform elliptical cross-section along its length.
- Fig. 5C shows a truncated conically- shaped housing 130 d , provided with a non-uniform cross-section along its length, for example a truncated cone tapering radially inward in the distal direction.
- each pressure inlet 158 is positioned mid-way along the axial length of the housing 130, equally spaced along the axial direction from the proximal wall 132 and from the distal wall 134, as shown for pressure inlet 158 c in Fig. 5B. According to some embodiments, each pressure inlet 158 is positioned mid-way along the axial length of the membrane 110, equally spaced along the axial direction from the proximal end 112 and from the distal end 114.
- each pressure inlet 158 is positioned closer to the proximal wall 132 than to the distal wall 134 of the housing 130, as shown for pressure inlet 158 d in Fig. 5C. According to some embodiments, each pressure inlet 158 is positioned closer to the proximal end 112 than to the distal end 114 of the membrane 110.
- each pressure inlet 158 is positioned closer to the distal wall 134 than to the proximal wall 132 of the housing 130, as shown for pressure inlet 158 b in Fig. 5A. According to some embodiments, each pressure inlet 158 is positioned closer to the distal end 114 than to the proximal end 112 of the membrane 110.
- each pressure inlet 158 is shown throughout the figures positioned at the central body portion 136, alternative configurations may include the at least one pressure inlet 158 positioned at the proximal wall 132 or the distal wall 134.
- FIGs. 6A and 6B show a view in perspective and a cross sectional side view, respectively, of another embodiment of an fluid pump 100 e , which unlike the symmetrical infusion pump 100 shown, inter alia, in Figs. 2A-3B as, is asymmetrical relative to the flow- path axis 20.
- the housing 130 e includes two un-identical housing sections: a first housing section 130 e a may be structured similarly to the first half-cylindrical housing section 130a as shown, inter alia, in Figs.
- a second housing section 130 e b is formed as a base or a plate, comprising the base 150 e shown in Figs. 6A-6B, instead of a second housing portion 130b of Figs. 2A-3B.
- the membrane 110 e may be formed similarly to any embodiment of the first membrane section 110a, for example as described and shown, inter alia, in Figs. 2A-3B.
- the fluid pump 100 e includes a single outer chamber 160 e defined between the first housing section 130 e a and the membrane 110 e , and a single inner chamber 162 e defined between the first housing section 130 e a, the membrane 110 e and the tube 10 when mounted within the fluid pump 100 e .
- a single pressure inlet 158 e is in fluid communication with the single outer chamber 160 e .
- the base 150 e further comprises a channel 152 e configured to accommodate at least a partial lower portion of the tube 10, so as to prevent spontaneous lateral displacement thereof along the base 150 e .
- the membrane 110 e can include lateral extensions 122 e a and 124 e a extending from the tapering membrane portion 116 e , optionally disposed over corresponding first and second lateral supports 126 e a and 128 e a (hidden from view), and configured to press against the first and second lateral supports 126 e b and 128 e b defined by the base 150 e between the respective edges 142 e b, 144 e b and the channel 152 e , in the closed state.
- the fluid pump 100 e does not necessarily include lateral extensions 122 e a, 124 e a.
- the fluid pump 100 e is configured to be movable between the open state (see Fig. 6A) and the closed state (see Fig. 6B), in a similar manner to that described and illustrated in conjunction with Figs. 2A-3B, inter alia.
- the first and second section of the housing 130 e may be pivotably movable relative to each other, hinged along one edge thereof.
- the housing 130 comprises a locking mechanism configured to retain the first 130a and second 130b housing sections tightly locked against each other in the closed state.
- at least one of the first 130a and/or second 130b housing sections comprises at least one pin, configured to press-fit against a corresponding recess comprised in the opposite housing section.
- Figs. 3A-3B show the second lateral housing edge 144a equipped with a two locking pins 154, configured to press-fit into respective locking recesses or bores 156, aligned there-against along the lateral housing edge 144b. While two locking pins 154 and two matching locking bores 156 are illustrated in Fig.
- any number of pins and bores is contemplated, including, for example, a single pin 154 with a single bore 156, or three or more pins 154 with a matching number of bores 156.
- one lateral housing edge 144a is illustrated to include only pins 154
- the opposite edge 144b is illustrated to include only bore 156
- any lateral housing edge 144 may include a mixture of both pins 154 and bores 156, while the opposite edge is equipped with matching bores 156 and pins 154.
- the housing 130 e shown in Fig. 6A is also illustrated with locking pins 154 e disposed along the lateral housing edge 144 e , and matching locking bores 156 e disposed along the base 150 e in alignment with the pins 154 e .
- the number of pins 154 a and bores 156 e , as well as the configuration the lateral housing edge 144 e and/or the base 150 e may follow the same embodiments described in conjunction with pins 154 and bores 156 herein above.
- the locking mechanism comprises a latch 168, such as the latch 168 b illustrated in Fig. 5A. While two forms of locking mechanisms, such as locking pins 154 with locking bores 156 and/or latches 168 are illustrated, it will be understood that any other locking mechanism, configured to retain the fluid pump 100 in a closed state, may be utilized, including threaded connections, circumferential clamps and the like.
- the first 130a and second 130b housing sections are not necessarily hinged to each other, but may rather be completely detached from each other in the open state such that the lateral edges 142a, 144a on both sides of the first housing section 130a, are spaced away from their counterparts 142b, 144b.
- the locking mechanism may include features configured to align the first 130a and second 130b housing sections while locking them in a closed state, such as a plurality of pins configured to snap-fit into a plurality of corresponding opposite apertures (embodiments not shown).
- the tapering membrane portion 116 is provided with a uniform thickness between the proximal end 112 and the distal end 114, as shown in Fig. 2C. According to alternative embodiments, the tapering membrane portion 116 is provided with a non-uniform thickness between the proximal end 112 and the distal end 114.
- Fig. 7 shows a cross-sectional side view of another embodiment of an fluid pump 100 f , which is of the same construction and configuration as that of infusion pump 100 shown in Figs. 2A-3B, with like numbers referring to like parts, except that the tapering membrane portion 116 f is provided with non-uniform thickness, for example gradually thinning in the proximal direction.
- the tube 10 comprises a distal unidirectional valve, as further shown for the fluid pump 10 f having a distal unidirectional valve 14 in Fig. 7.
- the distal unidirectional valve 14 may be positioned distal to the distal opening 166, configured to restrict the flow through the tube 10 f in one direction (i.e., in the distal direction) when fluid is pumped through the distal opening 166.
- the tube 10 comprises a proximal unidirectional valve (not shown), positioned proximal to the proximal opening 164, configured to restrict the flow through the tube 10 in one direction (i.e., in the distal direction) during filling of the tube 10.
- fluid pump assembly 200 comprising the fluid pump 100 according to any of the embodiments disclosed herein, and a tube 10 according to any of the embodiments disclosed herein, extending through the fluid pump 100.
- the fluid pump assembly 200 is an infusion assembly, comprising a fluid pump 100 implemented as an infusion pump, and a tube 10 implemented as an infusion tube.
- an infusion tube 10 of an infusion assembly 200 comprises an infusion catheter and a distal needle attached or attachable to a distal end of the infusion catheter, configured for insertion into a patient's blood vessel, such as a vein (see Fig. 1).
- the tube 10, which can be an infusion tube of an infusion assembly, or any other compressible tube 10 of a fluid pump assembly 200 utilized for any other application, comprises at least one of: the proximal unidirectional valve, the distal unidirectional valve 14, and/or both.
- Fig. 7 shows an exemplary embodiment of a fluid pump assembly 200 comprising a fluid pump 100 f mounted over a tube 10 f having a distal unidirectional valve 14 f .
- the fluid pump assembly 200 further comprises a fluid source 30 such as a fluid bag or container, which can be filled with the fluid to be conveyed through the tube 10.
- a fluid pump assembly 200 implemented as an infusion pump assembly can further comprise an infusion bag 30 m .
- the fluid source 30 of the fluid pump assembly 200 is pre-filled with fluid.
- a plurality of fluid pumps 100 may be serially mounted over a single tube 10.
- Figs. 8A and 8B show a view in perspective and a cross- sectional side view, respectively, of a multi-pump assembly 1200, according to some embodiments.
- the exemplary configuration illustrated in Figs. 8A-8B shows two consecutive fluid pumps 100, which can be implemented according to any embodiment disclosed herein, serially attached to or mounted over a single tube 10 in close proximity to each other. While both fluid pumps 100 are shown to be in spaced apart from each other in Figs. 8A-8B, it will be clear that in other embodiments, consecutive fluid pumps 100 may be in direct contact witch each other.
- At least two fluid pumps 100 are mounted in the same orientation over a single tube 10, meaning that their respective tapering membrane portions 116 are tapering radially inward in the same distal direction.
- at least two fluid pumps 100 may be attached to the tube 10 in opposite orientations, for example such that one tapering membrane portions 116 is tapering radially inward in the distal direction, with the consecutive tapering membrane portions 116 is tapering radially outward in the distal direction (embodiment not shown).
- a multi-pump assembly 1200 illustrated in Figs. 8A-8B includes two fluid pumps 100, it will be clear that a multi-pump assembly 1200 may include more than two fluid pumps 100 mounted over a single tube 10. Moreover, while the exemplary embodiment of the multi-pump assembly 1200 illustrated in Figs. 8A-8B includes two identical fluid pumps 100, it will be clear that a multi-pump assembly 1200 may include at least two distinct types of fluid pumps 100, for example, a fluid pump 100 b and a fluid pump 100 e , mounted over a single tube 10 (embodiment not shown).
- the phase of pulsatile pressure waves supplied to each of the plurality of fluid pumps 100 is offset from each other.
- pulsatile pressure may be supplied at a phase delay to a distal infusion pump, relative to the proximal infusion pump.
- a specific configuration of a multi-pump assembly 1200 may simplify device construction, by advantageously providing a net outflow similar to that provided with a fluid pump or a fluid pump assembly 200 having a distal unidirectional valve, without requiring incorporation of such a valve in the tube 10 or in the fluid pump.
- the fluid pump 100 comprises at least one unidirectional valve.
- the fluid pump 100 comprises a proximal unidirectional valve 182, disposed at, or in close proximity to, the proximal opening 164, configured to restrict the flow through the tube 10 in one direction (i.e., in the distal direction) during flow through the tube 10.
- the fluid pump 100 comprises a distal unidirectional valve 184, disposed at or in close proximity to the distal opening 166, configured to restrict the flow through the tube 10 in one direction (i.e., in the distal direction) when fluid is pumped through the distal opening 166.
- FIG. 9A shows another embodiment of a fluid pump 100 h , which is of the same construction and configuration as that of fluid pump 100 shown in Figs. 2A-3B, with like numbers referring to like parts, except that the fluid pump 100 h further comprises at least one unidirectional valve.
- the fluid pump 100 comprises an internal compressible tube portion 194.
- the internal compressible tube portion 194 comprises a proximal internal tube end 196, hermetically attached to the proximal wall 132 and in fluid communication with the proximal opening 164, and a distal internal tube end 198, hermetically attached to the distal wall 134 and in fluid communication with the distal opening 166.
- a proximal tube 10a may be attached to the proximal wall 132, and a distal tube 10b may be attached to the distal wall 134, such that both the proximal tube 10a and the distal tube 10b are in fluid communication with the internal tube portion 194, together defining a continuous internal lumen through which fluid may flow.
- the inner diameter of the internal compressible tube portion 194 is substantially equal to the inner diameters of the proximal and distal tubes 10a, 10b.
- the proximal opening 164 h at the proximal wall 132 h may comprise a proximal outer recess 170 h , configured to accommodate a distal end of the proximal tube 10 h a.
- the distal opening 166 h at the distal wall 134 h may comprise a distal outer recess 176 h , configured to accommodate a proximal end of the distal tube 10 h b.
- the proximal opening 164 h at the proximal wall 132 h may comprise a proximal inner recess 172 h
- the distal opening 166 h at the distal wall 134 h may comprise a distal inner recess 178 h , configured to accommodate the proximal internal tube end 196 h and the distal internal tube end 198 h , respectively.
- any of the proximal outer recess 170 h , the distal outer recess 176 h , the proximal inner recess 172 h and/or the distal inner recess 178 h may further include a seal member such as an O-ring (not shown) configured to grip and/or hermetically seal against the tube members mounted therein.
- a seal member such as an O-ring (not shown) configured to grip and/or hermetically seal against the tube members mounted therein.
- the diameters of the proximal outer recess 170 h and the distal outer recess 176 h are slightly smaller than the outer diameter of the distal end of the proximal tube 10 h a and the proximal end of the distal tube 10 h b, respectively, to tightly press against the distal end of the proximal tube 10 h a and the proximal end of the distal tube 10 h b so as to prevent axial displacement thereof relative to the housing 130 h , as well as to grip and/or hermetically seal the tube portions 10 h a and 10 h b.
- the diameters of the proximal inner recess 172 h and the distal inner recess 178 h are slightly smaller than the outer diameter of the distal end of the proximal internal tube end 196 h and the distal internal tube end 198 h , respectively, to tightly press against the proximal internal tube end 196 h and the distal internal tube end 198 h so as to prevent axial displacement thereof relative to the housing 130 h .
- the proximal outer recess 170 h and the proximal inner recess 172 h of the proximal opening 164 h may define a proximal opening central portion 174 h there-between.
- the distal outer recess 176 h and the distal inner recess 178 h the distal opening 166 h may define a distal opening central portion 180 h there-between.
- a proximal unidirectional valve 182 h is disposed within the proximal opening 164 h , for example attached to the proximal opening central portion 174 h .
- a distal unidirectional valve 184 h is disposed within the distal opening 166 h , for example attached to the distal opening central portion 180 h .
- FIG. 9B shows yet another embodiment of a fluid pump 100 1 , which is of the same construction and configuration as that of fluid pump 100 h shown in Figs. 9A, with like numbers referring to like parts, except that the fluid pump 100 1 comprises proximal outer and inner proximal protrusions 170 1 and 172 1 instead of respective recesses 170 h and 172 h , as well as outer and inner distal protrusions 176 1 and 178 1 instead of respective recesses 176 h and 178 h , as further elaborated herein below.
- the proximal opening 164 1 at the proximal wall 132 1 may comprise a proximal outer protrusion 170 1 , configured to connect with the distal end of the proximal tube 10' a coupled thereto.
- the distal opening 166 1 at the distal wall 134 1 may comprise a distal outer protrusion 176 1 , configured to connect with the proximal end of the distal tube 10'b coupled thereto.
- the proximal opening 164 1 at the proximal wall 132 1 may comprise a proximal inner protrusion 172 1
- the distal opening 166 1 at the distal wall 134 1 may comprise a distal inner protrusion 178 1 , configured to connect with the proximal internal tube end 196 1 and the distal internal tube end 198 1 , respectively.
- the protrusions 170 1 , 172 1 , 176 1 and 178 1 may be formed as tubular extensions, which may be rigid extension, for example, made of the same material as that of the remainder of the housing 130 1 .
- any of the proximal outer protrusion 170 1 , the distal outer protrusion 176 1 , the proximal inner protrusion 172 1 and/or the distal inner protrusion 178 1 may further include a seal member (not shown) configured to grip and/or hermetically seal the tube members mounted therein.
- the outer diameters of the proximal outer protrusion 170 1 and the distal outer protrusion 176 1 are equal to or slightly smaller than the outer diameter of the distal end of the proximal tube 10' a and the proximal end of the distal tube 10'b, respectively.
- the outer diameters of the proximal inner protrusion 172 1 and the distal inner protrusion 178 1 may be equal to or slightly smaller than the outer diameter of the distal end of the proximal internal tube end 196 1 and the distal internal tube end 198 1 , respectively.
- the inner diameters of the protrusions 170 1 , 172 1 , 176 1 , 178 1 are substantially equal to the inner diameters of the tubes 10'a, 10'b and/or 194 1 .
- the aforementioned dimensions may enable coupling of the fluid pump portions to the respective protrusions by inserting the protrusion 170 1 , 172 1 , 176 1 and 178 1 into the lumens at the ends of the respective tube portions 10'a, 196 1 , 10‘b and 198 1 .
- heat may be applied to tube end portions of 10‘a, 196 1 , 10‘b and 198 1 so as to enable expansion thereof, to conveniently wrap around and circumscribe the respective protrusion 170 1 , 172 1 , 176 1 and 178 1 .
- clamp members such as ring-shaped clamps, may be utilized to clamp the pipe portions to the respective protrusions.
- a proximal outer clamp 186 1 may be disposed over the distal end of the proximal tube 10‘a, clamping it over the proximal outer protrusion 170 1 .
- a proximal inner clamp 188 1 may be disposed over the proximal internal tube end 196 1 , clamping it over the proximal inner protrusion 172 1 .
- a distal outer clamp 190 1 may be disposed over the proximal end of the distal tube 10‘b, clamping it over the distal outer protrusion 176 1 .
- a distal inner clamp 192 1 may be disposed over the distal internal tube end 198 1 , clamping it over the distal inner protrusion 178 1 .
- the proximal outer protrusion 170 1 and the proximal inner protrusion 172 1 may define a proximal opening central portion 174 1 there-between, together forming an inner port through the proximal opening 164 1 .
- the distal outer protrusion 176 1 and the distal inner protrusion 178 1 may define a distal opening central portion 180 1 there-between, together forming an inner port through the distal opening 166 1 .
- a proximal unidirectional valve 182 1 is disposed within the proximal opening 164 1 , along the port defined by the proximal outer protrusion 170 1 , the proximal opening central portion 174 1 and the proximal inner protrusion 172 1 . While the proximal unidirectional valve 182 1 is shown in Fig. 9B attached to the proximal opening central portion 174 1 , it will be understood that alternative attachment positions are contemplated, such as attachment to the proximal outer protrusion 170 1 or the proximal inner protrusion 172 1 .
- a distal unidirectional valve 184 1 is disposed within the distal opening 166 1 , along the port defined by the distal inner protrusion 178 1 , the distal opening central portion 180 1 and the distal outer protrusion 176 1 . While the distal unidirectional valve 184 1 is shown in Fig. 9B attached to the distal opening central portion 180 1 , it will be understood that alternative attachment positions are contemplated, such as attachment to the distal inner protrusion 178 1 or the distal outer protrusion 176 1 .
- a fluid pump 100 may include, in some exemplary embodiments, an arrangement of outer protrusions, similar to protrusion 170 1 and 176 1 , and inner recesses, similar to recesses 172 h and 178 h .
- FIGs. 9A-9B show the proximal unidirectional valve 182 1 , 182 h , as well as the distal unidirectional valve 184 1 , 18 4h , attached to a portion of the proximal opening 164 1 , 164 h such as the proximal opening central section 174 1 , 174 h , as well as to the distal opening 166 1 , 166 h such as the distal opening central section 180 1 , 180 h
- alternative configurations may include the proximal unidirectional valve and/or the distal unidirectional valve disposed within the lumen of the internal tube portion 194.
- the proximal unidirectional valve may be positioned within the internal tube portion 194, in the vicinity of the proximal internal tube end 196, and the distal unidirectional valve may be positioned within the internal tube portion 194, in the vicinity of the distal internal tube end 198.
- a fluid pump system 300 which can be implemented as an infusion system 300 m or a fluid pump system utilized for other applications, comprising at least one fluid pump 100 according to any of the embodiments disclosed herein above, and the pressure source 40.
- the pressure source 40 is a gas pump.
- the pressure source 40 is an air pump.
- the pressure source 40 is a liquid pump.
- the pressure source 40 comprises at least one pressure line 50, configured to deliver pressurized gas (e.g., air) or liquid toward the at least one fluid pump 100.
- the pressure line 50 comprises at least one main actuation tube 52 extending from the pressure source 40.
- the main actuation tube 52 is branched at its distal portion (i.e., the portion father from its connection to the pressure source 40) to at least two tubular branches, such as a first actuation branch 54a attached to the first pressure inlet 158a, and a second actuation branch 54b attached to the second pressure inlet 158b.
- the fluid pump system 300 further comprises a controller 60, functionally coupled to the pressure source 40 and configured to control the functioning of the at least one fluid pump 100, for example by regulating the gas or liquid pressure supplied thereto by the pressure source 40.
- the controller 60 may be set to allow the fluid pump 100 to deliver pulsed flow through a tube 10 extending there-through.
- the controller 60 comprises one or more button that may be engaged by an operator, to control the operation of the fluid pump 100.
- the controller comprises a display, such as a digital screen, LED lights, and the like.
- components of fluid pump system 300 may communicate with other components via a network, thus allowing for remote inspection and/or remote control of the fluid pump 100.
- Components of the system 300 may be coupled to other components of the system 300, or to components external to the system 300, via cables as necessary for data communication. Alternatively or additionally, wireless communication may be utilized.
- the tube 10 may be compressed by pressure applied thereto from more than one side.
- the fluid pump system 300 further comprises a compressible tube 10 coupled to and extending through the at least one fluid pump 100.
- the tube 10 of an infusion pump system 300 m comprises an infusion catheter and a distal needle attached or attachable to a distal end of the infusion catheter, configured for insertion into a patient's blood vessel, such as a vein (see Fig. 1).
- the tube 10 of a fluid pump system 300 comprises at least one of: the proximal unidirectional valve 12, the distal unidirectional valve 14, and/or both.
- the fluid pump system 300 further comprises fluid source 30, such as a bag or a container.
- an infusion pump system 300 m comprises a fluid source in the form of an infusion bag 30 m (see Fig. 1).
- the fluid source 30 of a fluid pump system 300 is pre-filled with fluid.
- the infusion bag 30 m of an infusion pump system 300 m is pre-filled with infusion fluid.
- the flow rate through the tube 10 mounted within a fluid pump 100 may be influenced by a variety of factors, including but not limited to, the pressure supplied by the pressure source 40 (e.g., waveform, amplitude and/or frequency), the geometry of the housing 130 and the membrane 110 (e.g., the dimensions that may influence the size and shape of the outer chambers 160 and the inner chambers 162; the diameter of the pressure inlets 158; the position of the pressure inlets 158 along the housing 130; the uniform or non-uniform thickness of the tapering membrane portions 116), the geometry of the tube 10 (e.g., diameter and/or wall thickness of the tube 10), the material properties of the membrane 110 (influencing, for example, flexibility and/or resiliency of the tapering membrane portions 116), the material properties of the tube 10 (influencing, for example, flexibility, compliance and/or resiliency of the tube 10), the material properties of an internal tube portion 194 when present (influencing, for example, flexibility, compliance and/or resiliency of the infusion tube
- a fluid pump 100 or a fluid pump assembly 200 may be adapted to provide a desirable flow of fluid there-through, by setting and/or modifying at least one, and preferably at least some, of the variety of aforementioned flow influencing factors.
- the flow influencing factors may be tailored to provide flow which is matching the requirements of the relevant application. For example, when used for IV infusion, the infusion- flow influencing factors may be tailored to provide flow which is personalized to the clinical needs of a patient.
- different fluid pumps 100 or fluid pump assemblies 200 may be adapted to provide different desirable flow profiles, according to the requirements of specific applications.
- different fluid pumps 100 implemented as infusion pumps, or fluid pump assemblies 200 implemented as infusion pump assemblies may be adapted to provide different desirable flow profiles, according to the needs of different patients.
- different fluid pumps 100 or fluid pump assemblies 200 may be provided with at least some structurally different flow influencing factors, so as to facilitate different flow profiles of fluids through each.
- Structurally flow influencing factors may include, but are not limited to: the geometry of the housing 130 and the membrane 110, the geometry of the tube 10, the material properties of the membrane 110, the material properties of the tube 10, the material properties of an internal tube portion 194 when present, and/or the type and characteristics of a proximal unidirectional valve 12, 182 and/or a distal unidirectional valve 14, 184, when present.
- different fluid pumps 100 or fluid pump assemblies 200 may be provided with different pressure inputs through the pressure inlets 158. Different pressure inputs supplied to different fluid pumps 100 or fluid pump assemblies 200, which are otherwise structurally similar to each other, may result in different flows of the fluids through each of the fluid pumps 100 and/or fluid pump assemblies 200. Nevertheless, at least two different fluid pumps 100 and/or fluid pump assemblies 200 may be provided with both differing structural flow influencing factors, as well as different pressure inputs, together resulting in the desired flow of the fluid through each of the fluid pumps 100 and/or fluid pump assemblies 200, according to different flow-requirement for each.
- the flow of the fluid through a specific fluid pump 100 or a fluid pump assembly 200 may vary, for example, by varying the pressure input through the pressure inlet 158 over time. This may be useful, for example, for utilizing a single fluid pump 100 implemented as an infusion pump, or fluid pump assembly 200 implemented as an infusion pump assembly, connected to a specific patient, by varying the pressure input from the pressure source 40 to result in different flows of the infusion-fluid to the patient at different time periods, according to the clinical/physiological characteristics of the patient which might vary during a treatment period.
- a single pressure source 40 e.g., air pump
- a single controller 60 may be used in combination with a plurality of fluid pumps 100.
- each infusion pump 100 can serve to provide infusion fluid to a different patient.
- a single pressure source 40 which may be controlled by a single controller 60, may be coupled to a plurality of fluid pumps 100 via a corresponding plurality of pressure lines 50.
- a single pressure line 50 extending from the pressure source 40 may include a plurality of branched actuation tubes 54, such that at least one of the branched actuation tubes 54 is coupled to one of the plurality of the fluid pumps 100, and at least one other of the branched actuation tubes 54 is coupled to at least one other fluid pump 100.
- the pressure source 40 can be configured to provide a uniform pressure waveform through each, or at least some of, the plurality of pressure lines 50 and/or the plurality of branched actuation tubes 54, coupled to at least two of the plurality of the fluid pumps 100.
- the pressure source 40 can be configured to provide different pressure waveforms to at least two of the plurality of fluid pumps 100 via at least two respective pressure lines 50.
- the structurally flow influencing factors may further include the geometry of the pressure line 50 and/or the branched actuation tubes 54 (e.g., diameter, length), and/or the material properties of the pressure line 50 and/or the branched actuation tubes 54.
- a single pressure source 40 may be tailored to provide different pressure inputs to different fluid pumps 100, via a variety of different pressure lines 50 and/or pressure actuation tubes 54, connected there-between.
- a single pressure source 40 supplying the same pressure output (e.g., same pressure waveform) to a plurality of pressure lines 50 attached thereto at one end, and to different fluid pumps 100 and/or fluid pump assemblies 200 at the opposite end, may result in different flow of fluid through at least two of the fluid pumps 100 and/or fluid pump assemblies 200, by properly matching the material properties and/or geometries of the corresponding pressure lines 50 and or branched actuation tubes 54 and the respective fluid pumps 100, as well as setting and/or choosing other structurally flow influencing factors of the fluid pumps 100 and/or fluid pump assemblies 200, as mentioned hereinabove.
- the fluid pumps 100 and/or fluid pump assemblies 200 may be provided in a variety of structural configurations (e.g., different sizes and/or different material properties of at least some components thereof), enabling a user, such as a clinician or other caretaker in the case of fluid pumps 100 utilized for medical applications, to choose an appropriate type of fluid pump 100 and/or fluid pump assembly 200 for use with a specific patient, or for use for a specific device or apparatus for other, non-clinical applications.
- pressure lines 50 may be provided, to be chosen by a user, such as a clinician or a caretaker, to connect the pressure source 40 to each fluid pump 100 and/or fluid pump assembly 200 as necessary.
- the controller 60 may be provided with a software for setting an appropriate pressure output from the pressure source 40, according to required resultant flows of liquids through at least one fluid pump 100 and/or fluid pump assembly 200.
- the controller may include an interactive interface for receiving inputs from an operator, such as a clinician, caretaker or technician, and provide recommendations according to the input data.
- the input to a controller may include at least one, and preferably some, of the structurally flow influencing factors of the fluid pump 100, fluid pump assembly 200 and/or pressure lines 50.
- the controller includes a database, which can be stored locally or remotely (e.g., in a remote server), including a plurality of pre-stored sets of different models of fluid pumps 100, fluid pump assemblies 200 and/or pressure lines 50. This configuration enables the operator to choose, through the interactive interface, pre-stored models of fluid pump 100, fluid pump assembly 200, pressure lines 50, and/or combinations thereof, which can be retrieved from the database along with associated values of corresponding structural factors.
- the input to a controller 60 may further include patient-specific characteristics, such as clinical data of a patient (e.g., age, gender, weight, height, clinical conditions, medications administered to the patient, sensitivity of drugs and/or other compounds, etc.) when implemented for clinical applications.
- patient-specific characteristics such as clinical data of a patient (e.g., age, gender, weight, height, clinical conditions, medications administered to the patient, sensitivity of drugs and/or other compounds, etc.) when implemented for clinical applications.
- the controller 60 may include algorithms for receiving the data input from the operators, and providing recommendations related to a treatment regime accordingly.
- an operator may provide input regarding a chosen type of an fluid pump 100 and/or fluid pump assembly 200, as well as patient characteristics in the case of clinical applications, or other machinery or apparatus characteristics for other types of applications, and the controller 60 may provide recommendations for the pressure output waveform (including, for example, amplitude and/or frequency) from the pressure source 40.
- the controller 60 may provide recommendations for the type of pressure line 50 to be connected between the pressure source 40 and the fluid pump 100.
- the controller 60 may provide recommendation for a combination of a fluid pump 100 and/or fluid pump assembly 200, a pressure line 50, and a pressure output waveform from the pressure source 40.
- the characteristics of a plurality of patients may be input to the controller 60 by an operator, and the controller 60 may provide recommendations for appropriate fluid pumps 100 and/or fluid pump assemblies 200, pressure lines 50, pressure output waveforms from the pressure source 40 and/or combinations thereof, so as to facilitate utilization of a single pressure source 40 with a plurality of fluid pumps 100 and/or fluid pump assemblies 200 connected to different patients.
- the controller 60 may provide more than one option for a fluid pump 100 or fluid pump assembly 200, pressure line 50, pressure output waveform from the pressure source 40, and/or combinations thereof, which may result in similar flow of fluid through the fluid pump 100 or fluid pump assembly 200.
- An operator is able to choose one of the options according to additional preferences (e.g., cost, availability in stock, etc.).
- the fluid pump 100 of the current invention may generate fluid flow through a compressible tube 10, such as a conventional infusion tube, with the use of minimal number of components, which do not require actuation for reciprocating movement.
- a further advantage is that the relatively small number of components enables the fluid pump 100 to be manufactured at low costs, utilizing relatively fast and simple assembly procedures.
- the fluid pump 100 is a disposable pump. Disposable products are increasingly popular in light of concerns regarding hygiene. This is most applicable to institutional applications. Disposability, however, necessitates a firm cost ceiling for any product.
- the structural simplicity and low cost of the disclosed fluid pump 100 allows it to be used as a disposable pump.
- any fluid pump 100, fluid pump assembly 200, multi-pump assembly 1200 and/or fluid pump system 300 may be utilized for any other suitable application, including medical or non-medical applications, where controlled fluid delivery may be required.
- Fig. 1 shows an example of an infusion system 300 m , wherein a fluid pump 100 is utilized as an infusion pump 100 m to deliver infusion fluid from an infusion bag 30 m , through an infusion tube 10 m , to a patient in need thereof.
- the shape and dimension of different components of the fluid pump 100, as well as the stiffness of the membrane 110 may be tailored to specific requirements depending upon a chosen application.
- any fluid pump 100, fluid pump assembly 200, multi-pump assembly 1200 and/or fluid pump system 300, according to any of the embodiments disclosed herein, may be utilized to drain fluids from a fluid source, for example to a target container 32.
- Fig. 10 shows an example of a fluid pump 100 utilized for another, different medical application, such as paracentesis.
- Paracentesis is a procedure for removing excess peritoneal fluid that accumulates in the abdomen of a patient.
- a fluid pump system 300 can be utilized as a paracentesis or thoracentesis system 300 n , wherein the fluid source can be the patient's abdomen.
- the tube 10, such as catheter tube 10 n shown in Fig. 10, can include a needle at a proximal end thereof, such as a centesis catheter needle, configured to penetrate the abdomen of a patient and provide access to the fluid (e.g., the peritoneal fluid).
- the fluid pump 100 can then be utilized to drain/remove fluid from the patient's abdomen to an extracorporeal target container 32, such as fluid withdrawal cup 32 n shown in Fig. 10.
- an extracorporeal target container 32 such as fluid withdrawal cup 32 n shown in Fig. 10.
- fluid pump system 300 similar to the paracentesis system 300 n illustrated in Fig. 10 can be similarly utilized for amnioreduction to perform amniocentesis for intentional reduction of amniotic fluid volume.
- fluid pumps 100 can be used in combination or as part of a dialysis machine, to convey blood or dialysis fluid.
- a fluid pump system 300 comprises a plurality of fluid pumps 100 used in combination with a matching plurality of tubes 10.
- a single controller 60, and/or a single gas pump 40 can be utilized to control and/or activate the plurality of fluid pumps 100, wither via a single main actuation tube 50 branched into a plurality of actuation branches 52, connected to the plurality of fluid pumps 100, or via a plurality of main actuation tubes 50 (each of which can be further branched) configured, each, to actuate one of the corresponding fluid pumps 100.
- Fig. 11 shows another example of fluid pumps 100 utilized for non-clinical applications, such as filling liquids in packages or containers in the food and/or nutrition industries.
- the fluid pump system 300 illustrated in Fig. 11 is a liquid filling system 300° that can be used in combination, or as a part of, a beverage filling machine.
- the system 300° is shown to include a plurality of fluid pumps 100, such as fluid pumps 100a to lOOf.
- the fluid source 30 can be a fluid tank 30° containing the beverage to be filled within bottles 32°, serving as the target containers 32.
- a plurality of tubes 10° can extend from the tank 30°, through the corresponding plurality of fluid pumps 100, toward the corresponding bottles 32°.
- each tube 10° can include a nozzle at its distal end, through which the beverage may flow out of the tube 10° and into the corresponding bottle 32°.
- controller 60 and the gas pump 40 can be combined to a single assembly, such as shown in Fig. 11 for controller 60° and gas pump 40° combined into an actuation and control apparatus from which the plurality of actuation tubes 50 extend toward the fluid pumps 100.
- fluid pumps 100 can be used in a variety of other non-clinical applications, besides the example of the fluid filling system 300° illustrated in Fig. 11.
- fluid pumps 100 can be utilized for various operations in the biopharmaceutical industry, such as chromatography, virus filtration and tangential flow filtration (TFF), each of which may require specific operating characteristics.
- Chromatography requires constant fluid flowrates during their operations, but may have varying pumping pressures.
- Virus filtration on the other hand, will feature constant pumping pressures, but flowrates will change as the filters become clogged or fouled. In TFF, the main challenge is attempting to keep the flowrate and pressure unchanging throughout the process.
- Conventional peristaltic pumps may have several shortcomings, such as inducing shear, in the case of lobe pumps, that may damage the pumped fluid, as well as often resulting in inaccurate pulsatile flow profiles.
- Utilization of fluid pumps 100 according to the current disclosure may be adapted to gently, safely and securely convey low-viscosity aqueous solutions and biopharmaceutical materials that are highly sensitive to shear forces and pulsation while being pumped.
- fluid pumps 100 can be used for pumping abrasive fluid, that can entrain solids that may otherwise promote erosion.
- some pumped liquids can contain solid matter either as contaminants (such as lime-scale), as components of a slurry (sewage treatment) or in a suspension for transfer or transportation purposes (mining and paint applications). If such liquids are pumps through pumps that include components being in direct contact with the fluid, such solid matter can increased wear to components of the pumps either eroding surfaces through physical force. Another source of increased wear may be due to fluid which may cause chemical reaction with such components.
- the fluid pumps 100 of the current disclosure may reduce or eliminate such risks, since the pumped fluids are not in direct contact with components of the valve, as the membrane 110 is pressed against the tube 10 delivering the fluid, and not the fluid itself. Thus, tubes 10 can be easily replaced when required, while the fluid pumps 100 remain undamaged.
- Fluid pump 100 can be also miniaturized for use as micro-pumps in other industries, such as, but not limited to, the semiconductor industry and the printing industry, wherein liquid needs to be pumped without being damaged.
- fluid pumps 100 of the current specification can be adapted to advantageously produce high flow rate and high pressure, without generating excessive heat during operation thereof.
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Abstract
The present invention relates to devices, assemblies and systems for pumping fluids through compressible tubes, and in particular, for delivery of fluids, such as infusion fluids in a pulsatile controllable manner.
Description
FLUID PUMP
FIELD OF THE INVENTION
[001] The present invention relates to devices, assemblies and systems for pumping fluids through compressible tubes, and in particular, for delivery of fluids, such as infusion fluids, in a pulsatile controllable manner.
BACKGROUND OF THE INVENTION
[002] Fluid pumps are widely used in a variety of different applications for conveying fluids, such as various types of gas or liquid. Different types of fluid pumps are known in the art, including centrifugal pumps, peristaltic pumps, diaphragm pumps, and the like. Such pumps can be installed in systems applied to a variety of different industries, including, but not limited to, medical, pharmaceutical, agriculture, industrial, marine and military. The design parameters and dimensions of the fluid pumps can be adapted to the requirements of the specific application. [003] One example of a medical field in which fluid pumps can be utilized is Intravenous (IV) infusion. IV infusion of fluids is commonly performed in medical care to administer medications or other fluids directly into the circulatory system of a patient. It is extensively used in hospitals and home care settings for rapid and/or controlled rate fluid administration in the state of hypovolemic shock, and to deliver therapies such as chemotherapy, antimicrobials, analgesia, and anesthesia, as well as for postoperative pain control and chronic pain management. Systems and devices that may render this practice easier for the clinician, improve precision of patient care, and reduce overall costs, are highly desirable.
[004] Infusion systems are composed of the reservoir with fluids, passive or active delivery systems and a flexible tube in series with a catheter which is usually inserted intravenously. In passive infusion systems, the fluid is driven by gravity, and the flow rate is controlled by roller clamps or other devices with preset restrictions to fluid flow. In active infusion systems, more accurate fluid delivery is controlled by electric or nonelectric non-disposable pumps. A different type of system is the pressure infusion device used for treating severely hypovolemic patients, which only facilitates rapid yet largely uncontrolled fluid administration.
[005] In nonelectric disposable pumps, the pressure on the fluid is generated by a variety of mechanisms using nonelectric power, including a stretched elastomer or compressed spring, pressure generated during a chemical reaction, and pressure supplied from a cartridge of pressurized gas. The delivery flow rate is controlled by flow restrictors, which are integral to the administration set. The pressure generated by disposable pumps on fluid is typically within the range of 250 to 600 mm Hg, compared with a fluid reservoir pressure for electric pumps in the range of 5 to 1200 mm Hg, depending on flow rate and cannula size. Disposable pumps can infuse at flow rates ranging between 0.5-500 mL/hr, with running times from 30 minutes to 12 days. The factory determined flow accuracy for disposable pumps may go up to ±20%, while in modern electric infusion pumps it may be provided in a range of ±3-5%, depending on the implemented mechanisms. Absence of calibration standards may lead to overall accuracy of ±40% in the clinical setup.
[006] Most existing infusion pumps are designed to work with the fluid reservoir hanging vertically above the patient. Presently, there is no clear consensus about the overall cost advantages of conventional disposable devices over electric pumps, due to their low accuracy as compared with modern electric pumps. On the other hand, conventional electric pumps are expensive, cumbersome, require frequent maintenance, and are highly dependent on the operator's skills.
SUMMARY OF THE INVENTION
[007] The present disclosure is directed toward devices, assemblies and systems for conveying fluids, such as (but not limited to) infusion fluids, in a controllable manner which is independent of gravitational forces. According to some embodiments, a fluid pump may be provided for mounting over a flexible tube, wherein the fluid pump includes a tapering membrane and is devoid of rotatable components or actuation mechanisms, thereby simplifying its structure and reducing costs.
[008] According to one aspect, there is provided liquid pump comprising a housing and at least one membrane disposed within the housing. The housing comprises a proximal wall comprising a proximal opening, a distal wall comprising a distal opening, a central body portion extending between the proximal wall and the distal wall, an at least one pressure inlet. The at least one membrane comprises a proximal end, a distal end, and a tapering membrane
portion extending at an inclined manner from the proximal end to the distal end, and having an outer membrane surface.
[009] The proximal opening and the distal opening are aligned with each other, and configured to accommodate a compressible tube. At least one sealed outer chamber is defined between the membrane and the housing. The at least one pressure inlet is in fluid communication with the at least one outer chamber. The tapering membrane portion is configured to flex radially inward, when pressure exceeding a threshold pressure value Pt is applied to the outer membrane surface.
[010] According to some embodiments, the membrane further comprises lateral extensions, configured to seal the at least one outer chamber.
[Oil] According to some embodiments, the housing further comprises lateral supports, configured to seal the at least one outer chamber.
[012] According to some embodiments, the housing formed with a relatively uniform elliptical cross-section along its length. [013] According to some embodiments, the housing is shaped as a truncated cone tapering radially inward in the distal direction.
[014] According to some embodiments, the housing comprises a first housing section and a second housing section, and wherein the fluid pump is configured to be movable between an open state and a closed state. [015] According to some embodiments, the two housing sections are hinged to each other along one edge of the two housing sections.
[016] According to some embodiments, the first housing section and the second housing section are similarly formed, and the membrane comprises a first membrane section and a second membrane section. Furthermore, the at least one outer chamber comprises a first outer chamber defined between the first housing section and the first membrane section, and a second outer chamber defined between the second housing section and the second membrane section. Likewise, the at least one pressure inlet comprises a first pressure inlet in fluid communication with the first outer chamber, and a second pressure inlet in fluid communication with the second outer chamber.
[017] According to some embodiments, the at least one outer chamber comprises a single outer chamber defined between the first housing section and the membrane, wherein the at least one pressure inlet comprises a single pressure inlet in fluid communication with the outer chamber, and wherein the second housing section comprises a base. [018] According to some embodiments, the base comprises a channel dimensioned to accommodate the compressible tube.
[019] According to some embodiments, the fluid pump further comprises a locking mechanism configured to retain the first housing section and the second housing section locked against each other in the closed state. [020] According to some embodiments, the locking mechanism comprises at least one locking pin extending from at least one of the housing sections, and at least one locking recess comprised within the opposing housing section, wherein the at least one locking pin is configured to press-fit into the respective locking recess.
[021] According to some embodiments, the locking mechanism comprises at least one latch. [022] According to some embodiments, the tapering membrane portion follows a cross- sectional concave arcuate path-line, sloping radially inward in the distal direction.
[023] According to some embodiments, the tapering membrane portion is provided with non- uniform thickness between the proximal end and the distal end.
[024] According to some embodiments, the at least one pressure inlet is formed as a protrusion extending radially outward from the housing, defining a port which is in fluid communication with the outer chamber.
[025] According to some embodiments, the at least one pressure inlet is positioned closer to the proximal wall than the distal wall.
[026] According to some embodiments, the fluid pump further comprises an internal compressible tube portion. The internal compressible tube portion comprises a proximal internal tube end, hermetically attached to the proximal wall and in fluid communication with the proximal opening, and a distal internal tube end, hermetically attached to the distal wall and in fluid communication with the distal opening.
[027] According to some embodiments, the proximal opening comprises a proximal inner recess, configured to accommodate the proximal internal tube end, and the distal opening comprises a distal inner recess, configured to accommodate the distal internal tube end.
[028] According to some embodiments, the proximal opening comprises a proximal outer recess, configured to accommodate a distal end of a proximal compressible tube, and the distal opening comprises a distal outer recess, configured to accommodate a proximal end of a distal compressible tube.
[029] According to some embodiments, the proximal opening comprises a proximal inner protrusion, configured to connect with the proximal internal tube end, and the distal opening comprises a distal inner protrusion, configured to connect with the distal internal tube end.
[030] According to some embodiments, the proximal opening comprises a proximal outer protrusion, configured to connect with a distal end of a proximal compressible tube, and the distal opening comprises a distal outer protrusion, configured to connect with a proximal end of a distal compressible tube. [031] According to some embodiments, the fluid pump further comprises a proximal inner clamp disposed over the proximal internal tube end, configured to clamp it over the proximal inner protrusion, and a distal inner clamp disposed over the distal internal tube end, configured to clamp it over the distal inner protrusion.
[032] According to some embodiments, the fluid pump further comprises a distal unidirectional valve attached to the distal opening.
[033] According to some embodiments, the fluid pump further comprises a proximal unidirectional valve attached to the proximal opening.
[034] There is provided, according to some embodiments, a fluid pump assembly comprising the fluid pump, and the compressible tube extending through and mounted within the fluid pump.
[035] According to some embodiments, the compressible tube further comprises a proximal unidirectional valve.
[036] According to some embodiments, the compressible tube further comprises a distal unidirectional valve.
[037] According to some embodiments, the fluid pump assembly further comprises a fluid source. [038] According to some embodiments, the fluid source is an infusion bag.
[039] There is provided, according to some embodiments, a multi-pump assembly comprising a plurality of fluid pumps and the compressible tube, wherein the plurality of fluid pumps are serially mounted over the compressible tube.
[040] According to some embodiments, the plurality of fluid pumps are mounted in the same orientation over the compressible tube.
[041] There is provided, according to some embodiments, a fluid pump system comprising at least one fluid pump, and a pressure source comprising at least one pressure line attached to the at least one pressure inlet of the at least one fluid pump.
[042] According to some embodiments, the pressure source is a gas pump. [043] According to some embodiments, the fluid pump system further comprises a controller, configured to control the functioning of the fluid pump.
[044] According to some embodiments, the fluid pump system further comprises at least one compressible tube, extending through and mounted within the at least one infusion pump
[045] According to some embodiments, the at least one pressure line comprises a main actuation tube, which is branched at its distal portion to at least two tubular actuation branches.
[046] According to some embodiments, the fluid pump system further comprises a fluid source.
[047] According to some embodiments, the fluid source is an infusion bag
[048] According to some embodiments, the at least one fluid pump of the infusion system comprises a plurality of fluid pumps.
[049] Certain embodiments of the present invention may include some, all, or none of the above advantages. Further advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Aspects and embodiments of the invention are further described in the specification herein below and in the appended claims. [050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise. [051] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, but not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other advantages or improvements.
BRIEF DESCRIPTION OF THE FIGURES
[052] Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.
In the Figures:
[053] Fig. 1 shows a view in perspective of a fluid pump system implemented as an infusion system, according to some embodiments.
[054] Fig. 2A shows a view in perspective of a fluid pump mounted over a tube, according to some embodiments.
[055] Fig. 2B shows a sectional view in perspective of the fluid pump of Fig. 2A.
[056] Fig. 2C shows a cross-sectional side view of the fluid pump of Fig. 2A.
[057] Fig. 3A shows a full-blown view in perspective of components of the fluid pump next to a tube, according to some embodiments.
[058] Fig. 3B shows a view in perspective of the components shown in Fig. 3A assembled together and shown in an opened state. [059] Figs. 4A-4F show different phases of a working cycle of the fluid pump, according to some embodiments.
[060] Fig. 5A shows a view in perspective of a fluid pump having a cylindrical housing, according to some embodiments.
[061] Fig. 5B shows a fluid pump having a housing formed with a uniform elliptical cross- section, according to some embodiments.
[062] Fig. 5C shows a fluid pump having a frustoconical housing, according to some embodiments.
[063] Fig. 6A shows a view in perspective of a fluid pump in an opened state, according to some embodiments. [064] Fig. 6B shows a cross sectional side view of the fluid pump of Fig. 6A, according to some embodiments.
[065] Fig 7 shows a cross sectional side view of a fluid pump assembly, according to some embodiments.
[066] Fig. 8A shows a view in perspective of a multi-pump assembly, according to some embodiments.
[067] Fig. 8B shows a cross sectional side view of the multi-pump assembly of Fig. 7B.
[068] Fig. 9A shows a cross sectional side view of a fluid pump equipped with a proximal unidirectional valve and a distal unidirectional valve, according to some embodiments.
[069] Fig. 9B shows a cross sectional side view of a fluid pump equipped with a proximal unidirectional valve and a distal unidirectional valve, according to some embodiments.
[070] Fig 10 shows a view in perspective of a fluid pump system implemented as a paracentesis system, according to some embodiments.
[071] Fig. 11 shows a view in perspective of a fluid pump system implemented as a liquid filling system, according to some embodiments,
DETAILED DESCRIPTION OF SOME EMBODIMENTS
[072] In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure. In the figures, like reference numerals refer to like parts throughout.
[073] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different embodiments of the same elements. Embodiments of the disclosed devices and systems may include any combination of different embodiments of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative embodiment of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.
[074] Fig. 1 shows a view in perspective of a fluid pump system 300 implemented as an infusion pump system 300m, comprising a fluid pump 100 implemented as an infusion pump, mounted over a tube 10 which can be an infusion tube, according to some embodiments. Figs. 2A, 2B and 2C show a view in perspective, a sectional view in perspective, and a cross- sectional side view, respectively, of a fluid pump mounted over a tube 10, according to some embodiments. While the fluid pump 100 is shown in Fig. 1 to be implemented as an infusion pump within an infusion pump system 300m, it is to be understood that this implementation serves for illustration and not limitation, and that the liquid pump 100 can be utilized in any other fluid pump system for other types of applications, such as other medical application or
any of a variety of non-medical applications, including, but not limited to, pharmaceutical, food industry, agriculture, and other industrial and/or military applications.
[075] The term "fluid", as used herein, refers to either liquid or gas. Thus, a fluid pump 100 of the current specification may be utilized for conveying either gas or liquid, through a tube 10 mounted therein, as will be further elaborated hereinbelow.
[076] The fluid pump 100 comprises a housing 130 having a proximal wall 132, a distal wall 134, and a central body portion 136 extending between the proximal 132 and distal 134 walls. The proximal wall 132 comprises a proximal opening 164, and the distal wall 134 comprises a distal opening 166, wherein the proximal opening 164 and the distal opening 166 are aligned with each other along a flow-path axis 20 extending through their center-points, on opposite ends of the housing 130. According to some embodiments, the housing 130 is formed from a rigid material, such as, but not limited to, rigid polymeric materials, metals, and the like.
[077] According to some embodiments, the proximal 164 and distal 166 openings are configured to accommodate a compressible tube 10 (such as an infusion tube or any other type of flexible and/or compliant tube) that may extend through the housing 130. Thus, the openings 164 and 166 are preferably of the same dimensions. According to some embodiments, the proximal opening 164 and the distal opening 166 are configured to retain the infusion tube extending there-through in position, so as to prevent unintentional axial movement thereof, relative to the housing 130.
[078] The terms "tube" and "compressible tube", as used herein, are interchangeable, and refer to a tube made of a flexible material that can be squeezed radially inward and decrease in volume when an external force (such as a force having a magnitude in the range of forces applied by a manual human hand squeezing motion) is applied thereto, and which will possibly increase in volume (i.e., revert back to its pre-squeezed radius) once the external force that led to the volume decrease is removed (i.e., the tube may be more or less regarded as elastic).
[079] The term “proximal”, as used herein, generally refers to the side or end of any device or a component of a device, which is closer to the inflow side of the tube 10. For example, a proximal side or a proximal end may refer to an end of a device or a component thereof closer to the fluid source 30, such as the infusion bag 30m shown in Fig. 1.
[080] The term “distal”, as used herein, generally refers to the side or end of any device or a component of a device, which is opposite to the proximal side, and is closer to the outflow side of the compressible tube 10.
[081] The term "fluid pump", as used herein, is non-binding and does not intend to limit the pump to specific applications, such as medical-oriented application, but may be otherwise utilized as a pumping device for any other suitable application.
[082] The term "compressible tube", as used herein, is non-binding and does not intend to limit the tube to specific applications, as delivering infusion fluids, but may rather refer to any other type of a flexible/compressible/squeezable tube.
[083] According to some embodiments, the fluid pump 100 further comprises at least one membrane 110 disposed within the housing 130, between the central body portion 136 and the flow-path axis 20. The membrane 110 comprises a proximal end 112, a distal end 114, and a tapering membrane portion 116 extending at an inclined manner from the proximal end 112 to the distal end 114. The tapering membrane portion 116 comprises an outer membrane surface 118 facing the central body portion 136 of the housing 130, and an inner membrane surface 120 facing the flow-path axis 20.
[084] The tapering membrane portion 116 is disposed between the central body portion 136 of the housing 130 and the flow-path axis 20, and more specifically, between the central body portion and the infusion tube 10, when the infusion tube 10 extends through the housing 130, such that the inner membrane surface 120 faces the infusion tube 10.
[085] According to some embodiments, the tapering membrane portion 116 tapers radially inward between its proximal 112 and distal 114 ends, such that the distal end 114 is closer to the flow-path axis 20, and more specifically, closer to the tube 10 when the tube 10 extends through the housing 130, than the proximal end 112.
[086] According to some embodiments, the proximal membrane end 112 and the distal membrane end 114 are affixed to the housing 130 in a hermetically sealed manner, while the tapering portion 116 is configured to flex radially inward (i.e., toward the flow-path axis 20, and more specifically, toward the tube 10 when the tube 10 extends through the housing 130), when pressure exceeding a threshold pressure value Pt is applied to the outer membrane surface 118.
[087] Threshold pressure value Pt is defined as the minimal pressure which is sufficient to distort and/or flex the tapering membrane portion 116 radially inward, and may depend on various parameters such as, but not limited to, material properties of the tapering membrane portion 116, and/or dimensions of the membrane 110 including the thickness of the tapering membrane portion 116.
[088] According to some embodiments, the tapering membrane portion 116 is provided with sufficient internal resiliency so as to revert back to its relaxed, non-flexed state, when pressure exceeding the threshold value Pt is no longer applied thereon.
[089] According to some embodiments, the pressure Pt is not a fixed value, but rather a function depending on the axial position along the tapering membrane portion 116. For example, the pressure Pt required to flex the tapering membrane portion 116 radially inward along a region closer to the proximal end 112, may be lower than the pressure required to flex a region thereof, closer to the distal end 114. Thus, if a uniform pressure is applied along the entire outer membrane surface 118, some regions of the tapering membrane portion 116 might deflect radially inward, while other regions will remain in a relatively relaxed position. Moreover, applying a time-varying pressure Pt may result in different regions of the tapering membrane portion 116 deflecting radially inward at different phases of the pressure cycle.
[090] According to some embodiments, the proximal membrane end 112 is attached to the proximal wall 132. According to some embodiments, the proximal membrane end 112 is attached to the central body portion 136, for example in the vicinity of the proximal wall 132. According to some embodiments, the distal membrane end 114 is attached to the distal wall 134. According to some embodiments, the distal membrane end 114 is attached to the central body portion 136, for example in the vicinity of the distal wall 132. The proximal membrane end 112 and/or the distal membrane end 114 may be attached to the housing 130 by various methods as known in the art, including gluing, welding, clamping and the like.
[091] The distance between the membrane 110 and the flow-path axis 20 is denoted R (see Fig. 2C). More specifically, R denotes the distance between the inner membrane surface 120 and the flow-path axis 20, and may vary along the axial length of the membrane 110. As shown in Fig. 2C, Rd denotes the distance between the inner membrane surface 120 and the flow-path axis 20 at the distal membrane end 114, and Rp denotes the distance between the inner membrane surface 120 and the flow-path axis 20 at the proximal membrane end 112.
[092] According to some embodiments, Rp is larger than Rd. According to some embodiments, Rp is at least two times larger than Rd. According to some embodiments, Rp is at least three times larger than Rd. According to some embodiments, Rp is at least four times larger than Rd. [093] Rd is equal to or larger than the radius of the openings 164, 166. According to some embodiments, the distal membrane end 114 is offset from the distal opening 166, such that Rd is larger than the radius of the distal opening 166.
[094] According to some embodiments, the fluid pump 100 further comprises at least one sealed outer chamber 160, defined between the tapering membrane portion 116 and the housing 130. In the exemplary embodiment illustrated in Figs. 2A-2C, a first sealed outer chamber 160a and a second sealed outer chamber 160b of the fluid pump 100 are defined between the tapering membrane portion 116 and opposite sides of the housing 130. According to some embodiments, the fluid pump 100 can include lateral extensions 122, 124 of the membrane 110, and/or lateral supports 126, 128 of the housing 130, as will be further elaborated hereinbelow. In such embodiments, each sealed outer chamber 160 can be defined between the tapering membrane 116, an opposite side of the housing 130, and lateral extensions 122, 124 and/or lateral supports 126, 128, wherein the lateral extensions 122, 124 and/or lateral supports 126, 128 are configured to seal the outer chambers 160a and 160b, so as to prevent fluid or gas flow there between. [095] As further shown in Fig. 2A-2C, an inner chamber 162 is defined between the tapering membrane portion 116 and the tube 10, when the infusion tube extends through the housing 130.
[096] According to some embodiments, the proximal opening 164 and the distal opening 166 of the housing 166 further comprise seal members such as O-rings (not shown), or are otherwise configured to grip and/or seal against the tube 10 when the tube 10 extends there through.
[097] According to some embodiments, the diameters of the proximal opening 164 and the distal opening 166 are slightly smaller than the outer diameter of the tube 10, so as to tightly press against the tube 10 to prevent axial displacement thereof relative to the housing 130.
[098] Each outer chamber 160 is configured as a sealed space that can be varied in volume by displacing the tapering membrane portion 116. Thus, the terms "outer chamber" and "sealed outer chamber", as used herein, are interchangeable, and refer to any embodiment of an outer chamber 160 disclosed throughout the specification, which is sealed as defined hereinabove.
[099] According to some embodiments, each inner chamber 162 is configured as a non- sealed space when a tube 10 is mounted within the fluid pump 100, wherein the inner chamber 162 can be varied in volume by displacing the tapering membrane portion 116, and wherein the inner chamber 162 is in fluid communication with the external environment, for example via airflow openings 108. Airflow opening 108 are configured to permit flow of air from the inner chamber 162 to the external environment, when the volume of the inner chamber 162 is decreased as the membrane 110 is pressed by the higher pressure applied thereto from the outer chamber 160, and to permit flow of air from the external environment back into the inner chamber 162 when the membrane 110 reverts to its free state as the pressure from the outer chamber 160 is released. In some embodiments, airflow openings 108 may be comprised in the proximal wall 132, for example between the proximal opening 164 and the membrane's proximal end 112, as shown in Figs. 2B and 3B.
[0100] According to some embodiments, the central body portion 136 comprises at least one pressure inlet 158 adapted for connection to a pressure line 50 coupled to a suitable pressure source 40 (see Fig. 1). The pressure source 40 can be a gas pump, such as an air pump, or any other suitable pressure source configured to deliver gas (e.g., air) or liquid at high pressure into a respective outer chamber 160. The pressure source 40 may be configured to perform as a pulsatile pressure source.
[0101] According to some embodiments, the pressure inlet 158 may be formed as an aperture or an opening extending through the central body portion 136, as shown in the exemplary embodiment illustrated in Figs. 2A-2C.
[0102] According to some embodiments, the pressure inlet 158 comprises a protrusion extending radially outward from the outer surface of the central body portion 136, or a fitting affixed thereto, configured to attach to, engage with or accept pressure line of the pressure source 40, such as an actuation tube 54 of a gas pump. The exemplary embodiment illustrated in Figs. 4A-4F shows a fluid pump 100a. Unless stated otherwise for specific components or configurations, the fluid pump 100a is of the same construction and configuration as that of
fluid pump 100 shown in Figs. 2A-3B, with like numbers referring to like parts. According to some embodiments, and as shown, the pressure inlet 158a of the fluid pump 100a is formed as a protrusion extending radially outward from the housing 130a, defining a port which is in fluid communication with the outer chamber 160a.
[0103] In the exemplary embodiment illustrated in Figs. 2A-2C, the housing 130 comprises two opposing pressure inlets 158: a first pressure inlet 158a in fluid communication with the first outer chamber 160a, and a second pressure inlet 158b in fluid communication with the second outer chamber 160b. According to some embodiments, each pressure inlet 158 is positioned opposite to the plane defined by the lateral extensions 122, 124.
[0104] Thus, each outer chamber 160 defines a sealed space that is hermetically sealed between the corresponding central body portion 136 and tapering membrane portion 116, except for the pressure inlet 158 which is in fluid communication with this sealed space.
[0105] According to some embodiments, the lateral extensions 122, 124 are integrally formed with the membrane 110, or are otherwise affixed thereto, extending radially outward from the outer membrane surface 118 in two opposite directions, as shown in Figs 3A-3B. In such embodiments, the outer edges of the lateral extensions 122, 124 (i.e., the radial outermost edges) are attached to the housing 130. According to some embodiments, the lateral extensions 122, 124 may be formed from the same material as the tapering membrane portion 116. According to some embodiments, the lateral extensions 122, 124 may be more rigid than the flexible tapering membrane portion 116.
[0106] According to some embodiments, the lateral extensions 122, 124 are integrally formed with the housing 130, or are otherwise affixed thereto, extending radially inward from the central body portion 136 in two opposite directions (embodiments not shown). In such embodiments, the inner edges of the lateral extensions 122, 124 (i.e., the radial innermost edges) are attached to the membrane 110. According to some embodiments, the lateral extensions 122, 124 may be formed from the same material as the central body portion 136.
[0107] According to some embodiments, housing 130 comprises at least two sections, a first housing section 130a and a second housing section 130b, attached or reversibly attachable to each other. Figs. 3A-3B shows an exploded view in perspective, and an assembled view, of components of the fluid pump 100 with the tube 10, according to some embodiments.
[0108] As shown in the exemplary embodiment illustrated in Figs. 3A-3B, the first and second housing sections 130a and 130b, comprise a first and a second proximal wall 132a and 132b, a first and a second distal wall 134a and 134b, a first and a second central body portion 136a and 136b, a first and a second proximal opening portion 164a and 164b, a first and a second distal opening portion 166a and 166b, and a first and a second pressure inlet 158a and 158b, respectively.
[0109] According to some embodiments, the membrane 110 comprises at least two sections, a first membrane section 110a and a second membrane section 110b, attached or attachable to each other. As shown in the exemplary embodiment illustrated in Figs. 3A-3B, the first and second membrane sections 110a and 110b, comprise a first and a second proximal end 112a and 112b, a first and a second distal end 114a and 114b, and a first and a second tapering membrane portion 116a and 116b, having a first and a second outer membrane surface 118a and 118b, and a first and a second inner membrane surface 120a and 120b, respectively.
[0110] According to some embodiments, the fluid pump 100 is movable between an open state (shown for example in Fig. 3B), wherein the two housing sections 130a and 130b are at least partially detached from each other (meaning that at least a portion of one housing section 130a is spaced away from the corresponding portion of the second housing section 130b), and a closed state (shown for example in Fig. 2A), wherein the two housing sections 130a and 130b are locked against each other. According to some embodiments, the two housing sections 130a and 130b are hermetically locked against each other in the closed state. The first and a second proximal opening portions 164a and 164b, respectively, together defined the enclosed proximal opening 164 in the closed state. Similarly, the first and a second distal opening portions 166a and 166b, respectively, together defined the enclosed distal opening 166 in the closed state.
[0111] According to some embodiments, the first 130a and second 130b housing sections may be hinged to each other at one edge thereof, such as along their lateral edges 142a and 142b (also referred to as first lateral housing edges 142), while their opposite lateral edges 144a and 144b (also referred to as second lateral housing edges 144) may be detachably attached to each other, enabling the first 130a and second 130b housing sections to pivot relative to each other about the hinged edge 142, and having their opposite edges 144 extending away from each other in an open state as shown in Figs. 3A-3B. The first 130a and second 130b housing sections may be locked together, having their opposite edges 144a, 144b pressed against each other, in the closed state, as shown in Fig. 2A.
[0112] According to some embodiments, the membrane 130 may be detachably attached to the housing 130. According to some embodiments, the first and second membrane sections 110a and 110b may be detachably attached to the first and second housing sections 130a and 130b, respectively, as shown in the exemplary embodiment illustrated in Figs. 3A-3B. According to some embodiments, the first and second membrane sections 110a and 110b may be affixed to the first and second housing sections 130a and 130b, respectively.
[0113] According to some embodiments, the housing 130 may comprise recesses or slots configured to tightly accept the proximal end 112 and the distal end 114 of the membrane 110 therein, as illustrated in Figs. 2A-3B. It will be understood that the membrane 110 may be connected to the housing 130 by any other methods, including gluing, welding, clamping and the like. Moreover, the housing 130 can include various different features configured to facilitate hermetical connection of the membrane 110 thereto. For example, the housing 110 may be formed from separable portions that may be attached to each other when the proximal 112 and/or distal 114 ends of the membrane 110 are disposed there-between, so as to tightly press against and clamp the respective membrane portions hermetically when attached to each other.
[0114] According to some embodiments, each of the first and second housing sections 130a and 130b further comprise lateral supports 126 and 128. For example, as illustrated in Fig. 3A, the first housing section 130a may include a first lateral support 126a extending from the first lateral housing edge 142a toward the flow-path axis 20, and a second lateral support 128a extending from the second lateral housing edge 144a toward the flow-path axis 20 in the closed state. Similarly, the second housing section 130b may include a first lateral support 126b extending from the first lateral housing edge 142b toward the flow-path axis 20, and a second lateral support 128b extending from the second lateral housing edge 144b toward the flow-path axis 20 in the closed state.
[0115] According to some embodiments, each of the first and second membrane sections 110a and 110b further comprise lateral extensions 122 and 124. For example, as illustrated in Fig. 3 A, the first membrane section 110a may include first and second lateral extensions 122a and 124a, respectively, extending radially away from the first tapering membrane section 116a. Similarly, the second membrane section 110b may include first and second lateral extensions 122b and 124b, respectively, extending radially away from the second tapering membrane section 116b.
[0116] According to some embodiments, the lateral extensions 122 and 124 extend from the tapering membrane sections 116 toward the first lateral housing edges 142 and the second lateral housing edges 144, respectively, in the closed state.
[0117] According to some embodiments, the lateral supports 126 and 128 of the housing 130 are shaped to accommodate the lateral extensions 122 and 124 of the membrane 110, when the membrane 110 is mounted within the housing 130. For example, the lateral extensions 122 and 124 may be pressed against each other, between the corresponding lateral supports 126 and 128, in the closed state.
[0118] While membrane 110 is shown in the example embodiment of Figs. 3A-3B with lateral extensions 122 and 124, it is to be understood that this is shown for the sake of illustration and not limitations, and that in some embodiments, the membrane 110 does not necessarily include such lateral extensions.
[0119] According to some embodiments, a first outer chamber 160a may be defined between the first housing section 130a and the first membrane section 110a, and a second outer chamber 160b may be defined between the second housing section 130b and the second membrane section 110b. In embodiments that include lateral supports 126 and 128 of the housing 130, each outer chamber 160 may be defined between a corresponding central body portion 136, proximal wall 132 and/or proximal end 112, distal wall 134 and/or distal end 114, tapering membrane portion 116, and lateral supports 126 and 128.
[0120] While housing 130 is shown in the example embodiment of Fig. 3 A with lateral supports 126 and 128, it is to be understood that this is shown by way of illustration and not limitations, and that in some embodiments, the housing does not necessarily include such lateral supports. In embodiments that include lateral extensions 122 and 124 of the membrane 110, but not lateral supports of the housing 130, each outer chamber 160 may be defined between a corresponding central body portion 136, proximal wall 132 and/or proximal end 112, distal wall 134 and/or distal end 114, tapering membrane portion 116, and lateral extensions 122 and 124.
[0121] According to some embodiments, both membrane 110 is devoid of lateral extensions 122, 124, and housing 130 is devoid of lateral supports 126, 128. For example, a housing 130 can be shaped such that the housing edges 142, 144 are in direct contact with the tapering membrane portion 116 in the closed state (embodiments not shown). In such embodiments,
each outer chamber 160 may be defined between a corresponding central body portion 136, proximal wall 132 and/or proximal end 112, distal wall 134 and/or distal end 114, and tapering membrane portion 116.
[0122] Advantageously, forming the housing 130 and the membrane 110 from two sections that may be movable between open and closed states, as shown in Figs. 2A-3B, enables simple and convenient placement of an tube 10 within the fluid pump 100, for example by placing the infusion tube along the opening portions 164b and 166b of one of the housing sections 130a in the open state (see Fig. 3B), followed by locking both sections 130a and 130b over the tube 10 in the closed state (see Fig. 2A). Similarly, disengagement of the fluid pump 100 from the tube 10 may also be performed in a simple and convenient manner by reversing the order of the aforementioned steps.
[0123] While the membrane 110 is shown as a separate component that can be mounted within the housing 130, it is to be understood that in some embodiments, both membrane 110 and housing 130 may be manufactured as a single piece (nevertheless, with different material properties for each), for example by utilizing various manufacturing techniques such as 3D printing.
[0124] According to some embodiments, the tapering membrane portion 116 tapers axially in a relatively straight manner, such that the cross-sectional path line of the tapering membrane portion 116, defined between the proximal end 112 and the distal end 114, follows a relatively straight line sloping radially inward in the distal direction (i.e., a straight line angled relative to the flow-path axis 20). According to alternative embodiments, the tapering membrane portion 116 tapers axially in a non-linear manner, following a concave arcuate path-line sloping radially inward in the distal direction, as shown in Figs. 2B-2C. A non-conventional concave arcuate orientation of the tapering membrane portion 116, as shown in Figs. 2B-2C, has been found by the investors to exhibit superior flow pumping behavior, relative to straight sloping configurations.
[0125] According to some embodiments, the membrane 110 further comprises at least one straight tubular portion, which may axially extend between the proximal end 112 and the tapering membrane portion 116, and/or between the tapering membrane portion 116 and the distal end 114 (embodiments not shown).
[0126] The outer chambers 160 can be pressurized to a pressure higher than Pt so as to impart flexion of the tapering membrane portion 116, and can be depressurized to a pressure lower than Pt, allowing the tapering membrane portion 116 to revert to its resting state. The unique combination of the tapering profile of the membrane portion 116 and the axial position of the pressure inlet 158 relative thereto, results in radially inward flexion of the tapering membrane portion 116 in a rolling manner, configured to contact and press against the tube 10.
[0127] Reference is now made to Figs. 4A-4F, illustrating the working principle of the fluid pump 100. Fig. 4A shows the membrane 110 in a relaxed state thereof, wherein the pressure within the at least one outer chamber 160 is lower than the threshold pressure Pt. The fluid pump 100 can be activated by the pressurized air (or any other gas or fluid), supplied by the pressure source 40 (e.g., air pump), through the pressure inlet 158, into the enclosed volume of the outer chamber 160. Due to the applied pressure, exceeding the threshold value Pt, the tapering membrane portion 116 starts to collapse inward toward flow-path axis 20, from an initial flexion point PI shown in Fig. 4B, wherein the collapsing region of the tapering membrane portion 116 propagates progressively against the outer wall of the tube 10, as shown in Fig. 4C and 4D, for example pressing the tube 10 radially inward along a region extending between points PI and P2 as shown in Fig. 4C. This may be followed by subsequent restoration of the tapering membrane portion 116 shape as pressure is released in the outer chamber 160, as shown in Figs. 4D-4F. In some instances, the tube 10 may be temporarily occluded along at least a portion thereof, as shown for around point P2 in the exemplary phase illustrated in Fig. 4D. In other instances, the tube 10 may be squeezed without being occluded.
[0128] The pressure supplied into the outer chamber 160 is chosen to collapse the tapering membrane portion 116 inward toward flow path axis 20, sufficiently to press against and/or pinch the tube 10 in a rolling manner corresponding to the time-dependent distally-oriented collapse of the tapering membrane portion 116, so as to gradually compress the tube 10 to squeeze liquid contained in its lumen in a distally oriented direction, as shown in Figs. 4C-4E. It will be clear that since the membrane 110 is a 3D structure (as shown, inter alia, in Figs. 3A- 3B), any collapse or re-expansion of the membrane portion 116 is a 3D collapse of the 3D structure of the membrane portion 116 toward or away from the flow path axis 20, respectively. Similarly, it will be clear that any reference to collapse or re-expansion in the vicinity of points PI, P2 shown in the cross-sectional views of Figs. 4A-4F, refers to collapse or re-expansion of 3D regions corresponding to respective points PI, P2.
[0129] The tapering membrane portion 116 is configured to be reciprocally moved to create cyclic pressure pulses compressing the tube 10, to pump fluid out of the tube 10 through the distal opening 166. The pumping applied to the infusion tube 10 is affected by the oscillations of the tapering membrane portion 116. Specifically, as shown in Fig. 4A-4D, the tapering membrane portion 116 is caused to flex to compress the infusion tube 10, applying pressure to the fluid in the tube 10, and urging flow thereof through the distal opening 166.
[0130] During a trough of a pressure pulse, as the tapering membrane portion 116 is released from contact with the tube 10 so as to revert back to its relaxed state, the infusion tube 10 expands back (see Fig. 4E-4F) to its uncompressed state and draws fluid there-into through the proximal opening 164, from a proximal fluid source 30 (e.g., an infusion bag as shown in Fig. 1) connected thereto, in readiness for the next pumping stroke.
[0131] The pressure source 40 can be configured to provide pulsatile pressure to the outer chamber 160, wherein the pressure waveform, amplitude and frequency can be adapted to provide a desired flow rate through the infusion tube 10 extending through the infusion pump 100.
[0132] According to some embodiments, the housing 130 may be provided with transparent, or partially transparent, walls, to enable visual inspection of the pumping mechanism of the fluid pump 100.
[0133] According to some embodiments, the housing 130 further comprises, for each outer chamber 160, a relief valve (not shown), which can be unidirectional valve configured to open and allow the pressure within the respective outer chamber 160 to return to a pressure lower than the threshold pressure Pt, such as the atmospheric pressure. Alternatively or additionally, pressure may be exhausted through the same pressure inlet 158, which allows for gradual restoration of the tapering membrane portion 116 back to its original shape due to resiliency of the membrane's material.
[0134] While the housing 130 is shown in Figs. 2A-3B to have a generally cylindrical shape, and the housing sections 130a and 130b are shown to have generally half-cylindrical shapes, it will be understood that these shapes are shown by way of illustration and not limitation, and that other circular or non-circular cross-sectional shaped are contemplated, including non- uniform shapes and/or non-uniform dimensions along the longitudinal direction of the housing
130. In this context longitudinally means along the length, or lengthwise, of a device or a component of a device such as the housing 130, i.e. its end-to-end direction.
[0135] Reference is now made to Figs. 5A-5C, illustrating different configuration of the housing 130. Fig. 5 A shows a cylindrically-formed housing 130b, provided with a relatively uniform circular cross-section along its length. Fig. 5B shows a housing 130c formed with a relatively uniform elliptical cross-section along its length. Fig. 5C shows a truncated conically- shaped housing 130d, provided with a non-uniform cross-section along its length, for example a truncated cone tapering radially inward in the distal direction.
[0136] According to some embodiments, each pressure inlet 158 is positioned mid-way along the axial length of the housing 130, equally spaced along the axial direction from the proximal wall 132 and from the distal wall 134, as shown for pressure inlet 158c in Fig. 5B. According to some embodiments, each pressure inlet 158 is positioned mid-way along the axial length of the membrane 110, equally spaced along the axial direction from the proximal end 112 and from the distal end 114.
[0137] According to some embodiments, each pressure inlet 158 is positioned closer to the proximal wall 132 than to the distal wall 134 of the housing 130, as shown for pressure inlet 158d in Fig. 5C. According to some embodiments, each pressure inlet 158 is positioned closer to the proximal end 112 than to the distal end 114 of the membrane 110.
[0138] According to some embodiments, each pressure inlet 158 is positioned closer to the distal wall 134 than to the proximal wall 132 of the housing 130, as shown for pressure inlet 158b in Fig. 5A. According to some embodiments, each pressure inlet 158 is positioned closer to the distal end 114 than to the proximal end 112 of the membrane 110.
[0139] While each pressure inlet 158 is shown throughout the figures positioned at the central body portion 136, alternative configurations may include the at least one pressure inlet 158 positioned at the proximal wall 132 or the distal wall 134.
[0140] Figs. 6A and 6B show a view in perspective and a cross sectional side view, respectively, of another embodiment of an fluid pump 100e, which unlike the symmetrical infusion pump 100 shown, inter alia, in Figs. 2A-3B as, is asymmetrical relative to the flow- path axis 20. Specifically, while the symmetrical fluid pump 100 described and shown, inter alia, in Figs. 2A-3B, having the similarly half-cylindrically formed housing sections 130a and
130b, the housing 130e includes two un-identical housing sections: a first housing section 130ea may be structured similarly to the first half-cylindrical housing section 130a as shown, inter alia, in Figs. 2B-2C, while a second housing section 130eb is formed as a base or a plate, comprising the base 150e shown in Figs. 6A-6B, instead of a second housing portion 130b of Figs. 2A-3B.
[0141] The membrane 110e may be formed similarly to any embodiment of the first membrane section 110a, for example as described and shown, inter alia, in Figs. 2A-3B. Thus, the fluid pump 100e includes a single outer chamber 160e defined between the first housing section 130ea and the membrane 110e, and a single inner chamber 162e defined between the first housing section 130ea, the membrane 110e and the tube 10 when mounted within the fluid pump 100e. Similarly, a single pressure inlet 158e is in fluid communication with the single outer chamber 160e.
[0142] According to some embodiments, the base 150e further comprises a channel 152e configured to accommodate at least a partial lower portion of the tube 10, so as to prevent spontaneous lateral displacement thereof along the base 150e.
[0143] According to some embodiments, as shown in Fig. 6A, the membrane 110e can include lateral extensions 122ea and 124ea extending from the tapering membrane portion 116e, optionally disposed over corresponding first and second lateral supports 126ea and 128ea (hidden from view), and configured to press against the first and second lateral supports 126eb and 128eb defined by the base 150e between the respective edges 142eb, 144eb and the channel 152e, in the closed state. In alternative embodiments, the fluid pump 100e does not necessarily include lateral extensions 122ea, 124ea.
[0144] The fluid pump 100e is configured to be movable between the open state (see Fig. 6A) and the closed state (see Fig. 6B), in a similar manner to that described and illustrated in conjunction with Figs. 2A-3B, inter alia. According to some embodiments, the first and second section of the housing 130e. For example, as illustrated in Fig. 6A, the first section 130ea and the second section 130eb comprising the base 150e, may be pivotably movable relative to each other, hinged along one edge thereof.
[0145] According to some embodiments, the housing 130 comprises a locking mechanism configured to retain the first 130a and second 130b housing sections tightly locked against each other in the closed state. According to some embodiments, at least one of the first 130a and/or
second 130b housing sections comprises at least one pin, configured to press-fit against a corresponding recess comprised in the opposite housing section. For example, Figs. 3A-3B show the second lateral housing edge 144a equipped with a two locking pins 154, configured to press-fit into respective locking recesses or bores 156, aligned there-against along the lateral housing edge 144b. While two locking pins 154 and two matching locking bores 156 are illustrated in Fig. 3A-3B, it will be clear that any number of pins and bores is contemplated, including, for example, a single pin 154 with a single bore 156, or three or more pins 154 with a matching number of bores 156. Similarly, while one lateral housing edge 144a is illustrated to include only pins 154, while the opposite edge 144b is illustrated to include only bore 156, it will be clear that any lateral housing edge 144 may include a mixture of both pins 154 and bores 156, while the opposite edge is equipped with matching bores 156 and pins 154.
[0146] The housing 130e shown in Fig. 6A is also illustrated with locking pins 154e disposed along the lateral housing edge 144e, and matching locking bores 156e disposed along the base 150e in alignment with the pins 154e. The number of pins 154a and bores 156e, as well as the configuration the lateral housing edge 144e and/or the base 150e, may follow the same embodiments described in conjunction with pins 154 and bores 156 herein above.
[0147] According to some embodiments, the locking mechanism comprises a latch 168, such as the latch 168b illustrated in Fig. 5A. While two forms of locking mechanisms, such as locking pins 154 with locking bores 156 and/or latches 168 are illustrated, it will be understood that any other locking mechanism, configured to retain the fluid pump 100 in a closed state, may be utilized, including threaded connections, circumferential clamps and the like.
[0148] According to some embodiments, the first 130a and second 130b housing sections are not necessarily hinged to each other, but may rather be completely detached from each other in the open state such that the lateral edges 142a, 144a on both sides of the first housing section 130a, are spaced away from their counterparts 142b, 144b. In such embodiments, the locking mechanism may include features configured to align the first 130a and second 130b housing sections while locking them in a closed state, such as a plurality of pins configured to snap-fit into a plurality of corresponding opposite apertures (embodiments not shown).
[0149] The term "plurality", as used herein, means more than one.
[0150] According to some embodiments, the tapering membrane portion 116 is provided with a uniform thickness between the proximal end 112 and the distal end 114, as shown in Fig. 2C.
According to alternative embodiments, the tapering membrane portion 116 is provided with a non-uniform thickness between the proximal end 112 and the distal end 114. Fig. 7 shows a cross-sectional side view of another embodiment of an fluid pump 100f, which is of the same construction and configuration as that of infusion pump 100 shown in Figs. 2A-3B, with like numbers referring to like parts, except that the tapering membrane portion 116f is provided with non-uniform thickness, for example gradually thinning in the proximal direction.
[0151] According to some embodiments, the tube 10 comprises a distal unidirectional valve, as further shown for the fluid pump 10f having a distal unidirectional valve 14 in Fig. 7. The distal unidirectional valve 14 may be positioned distal to the distal opening 166, configured to restrict the flow through the tube 10f in one direction (i.e., in the distal direction) when fluid is pumped through the distal opening 166.
[0152] According to some embodiments, the tube 10 comprises a proximal unidirectional valve (not shown), positioned proximal to the proximal opening 164, configured to restrict the flow through the tube 10 in one direction (i.e., in the distal direction) during filling of the tube 10.
[0153] According to some embodiments, there is provided fluid pump assembly 200, comprising the fluid pump 100 according to any of the embodiments disclosed herein, and a tube 10 according to any of the embodiments disclosed herein, extending through the fluid pump 100.
[0154] According to some embodiments, the fluid pump assembly 200 is an infusion assembly, comprising a fluid pump 100 implemented as an infusion pump, and a tube 10 implemented as an infusion tube. According to some embodiments, an infusion tube 10 of an infusion assembly 200 comprises an infusion catheter and a distal needle attached or attachable to a distal end of the infusion catheter, configured for insertion into a patient's blood vessel, such as a vein (see Fig. 1).
[0155] According to some embodiments, the tube 10, which can be an infusion tube of an infusion assembly, or any other compressible tube 10 of a fluid pump assembly 200 utilized for any other application, comprises at least one of: the proximal unidirectional valve, the distal unidirectional valve 14, and/or both. Fig. 7 shows an exemplary embodiment of a fluid pump assembly 200 comprising a fluid pump 100f mounted over a tube 10f having a distal unidirectional valve 14f.
[0156] According to some embodiments, the fluid pump assembly 200 further comprises a fluid source 30 such as a fluid bag or container, which can be filled with the fluid to be conveyed through the tube 10. For example, a fluid pump assembly 200 implemented as an infusion pump assembly, can further comprise an infusion bag 30m. According to some embodiments, the fluid source 30 of the fluid pump assembly 200 is pre-filled with fluid.
[0157] According to some embodiments, a plurality of fluid pumps 100 may be serially mounted over a single tube 10. Figs. 8A and 8B show a view in perspective and a cross- sectional side view, respectively, of a multi-pump assembly 1200, according to some embodiments. The exemplary configuration illustrated in Figs. 8A-8B shows two consecutive fluid pumps 100, which can be implemented according to any embodiment disclosed herein, serially attached to or mounted over a single tube 10 in close proximity to each other. While both fluid pumps 100 are shown to be in spaced apart from each other in Figs. 8A-8B, it will be clear that in other embodiments, consecutive fluid pumps 100 may be in direct contact witch each other.
[0158] According to some embodiments, as further shown in Fig. 8B, at least two fluid pumps 100 are mounted in the same orientation over a single tube 10, meaning that their respective tapering membrane portions 116 are tapering radially inward in the same distal direction. Alternatively, at least two fluid pumps 100 may be attached to the tube 10 in opposite orientations, for example such that one tapering membrane portions 116 is tapering radially inward in the distal direction, with the consecutive tapering membrane portions 116 is tapering radially outward in the distal direction (embodiment not shown).
[0159] While the exemplary embodiment of the multi-pump assembly 1200 illustrated in Figs. 8A-8B includes two fluid pumps 100, it will be clear that a multi-pump assembly 1200 may include more than two fluid pumps 100 mounted over a single tube 10. Moreover, while the exemplary embodiment of the multi-pump assembly 1200 illustrated in Figs. 8A-8B includes two identical fluid pumps 100, it will be clear that a multi-pump assembly 1200 may include at least two distinct types of fluid pumps 100, for example, a fluid pump 100b and a fluid pump 100e, mounted over a single tube 10 (embodiment not shown).
[0160] In some applications, the phase of pulsatile pressure waves supplied to each of the plurality of fluid pumps 100 is offset from each other. For example, pulsatile pressure may be supplied at a phase delay to a distal infusion pump, relative to the proximal infusion pump.
Numerical analysis simulations conducted by the inventors surprisingly showed that in some configurations, a distal fluid pump 100 of a multi-pump assembly 1200 may result in total outflow which is similar to fluid pump or a fluid pump assembly 200 equipped with a distal unidirectional valve. Thus, a specific configuration of a multi-pump assembly 1200 may simplify device construction, by advantageously providing a net outflow similar to that provided with a fluid pump or a fluid pump assembly 200 having a distal unidirectional valve, without requiring incorporation of such a valve in the tube 10 or in the fluid pump.
[0161] According to some embodiments, the fluid pump 100 comprises at least one unidirectional valve. According to some embodiments, the fluid pump 100 comprises a proximal unidirectional valve 182, disposed at, or in close proximity to, the proximal opening 164, configured to restrict the flow through the tube 10 in one direction (i.e., in the distal direction) during flow through the tube 10. According to some embodiments, the fluid pump 100 comprises a distal unidirectional valve 184, disposed at or in close proximity to the distal opening 166, configured to restrict the flow through the tube 10 in one direction (i.e., in the distal direction) when fluid is pumped through the distal opening 166.
[0162] Fig. 9A shows another embodiment of a fluid pump 100h, which is of the same construction and configuration as that of fluid pump 100 shown in Figs. 2A-3B, with like numbers referring to like parts, except that the fluid pump 100h further comprises at least one unidirectional valve.
[0163] According to some embodiments, the fluid pump 100 comprises an internal compressible tube portion 194. The internal compressible tube portion 194 comprises a proximal internal tube end 196, hermetically attached to the proximal wall 132 and in fluid communication with the proximal opening 164, and a distal internal tube end 198, hermetically attached to the distal wall 134 and in fluid communication with the distal opening 166. In such embodiments, a proximal tube 10a may be attached to the proximal wall 132, and a distal tube 10b may be attached to the distal wall 134, such that both the proximal tube 10a and the distal tube 10b are in fluid communication with the internal tube portion 194, together defining a continuous internal lumen through which fluid may flow. Preferably, the inner diameter of the internal compressible tube portion 194 is substantially equal to the inner diameters of the proximal and distal tubes 10a, 10b.
[0164] According to some embodiments, as shown in Fig. 9A, the proximal opening 164h at the proximal wall 132h may comprise a proximal outer recess 170h, configured to accommodate a distal end of the proximal tube 10ha. Similarly, the distal opening 166h at the distal wall 134h may comprise a distal outer recess 176h, configured to accommodate a proximal end of the distal tube 10hb.
[0165] According to some embodiments, as further illustrated in Fig. 9A, the proximal opening 164h at the proximal wall 132h may comprise a proximal inner recess 172h, and the distal opening 166h at the distal wall 134h may comprise a distal inner recess 178h, configured to accommodate the proximal internal tube end 196h and the distal internal tube end 198h, respectively.
[0166] According to some embodiments, any of the proximal outer recess 170h, the distal outer recess 176h, the proximal inner recess 172h and/or the distal inner recess 178h, may further include a seal member such as an O-ring (not shown) configured to grip and/or hermetically seal against the tube members mounted therein.
[0167] According to some embodiments, the diameters of the proximal outer recess 170h and the distal outer recess 176h are slightly smaller than the outer diameter of the distal end of the proximal tube 10ha and the proximal end of the distal tube 10hb, respectively, to tightly press against the distal end of the proximal tube 10ha and the proximal end of the distal tube 10hb so as to prevent axial displacement thereof relative to the housing 130h, as well as to grip and/or hermetically seal the tube portions 10ha and 10hb.
[0168] According to some embodiments, the diameters of the proximal inner recess 172h and the distal inner recess 178h are slightly smaller than the outer diameter of the distal end of the proximal internal tube end 196h and the distal internal tube end 198h, respectively, to tightly press against the proximal internal tube end 196h and the distal internal tube end 198h so as to prevent axial displacement thereof relative to the housing 130h.
[0169] According to some embodiments, the proximal outer recess 170h and the proximal inner recess 172h of the proximal opening 164h, may define a proximal opening central portion 174h there-between. Similarly, the distal outer recess 176h and the distal inner recess 178h the distal opening 166h, may define a distal opening central portion 180h there-between.
[0170] According to some embodiments, a proximal unidirectional valve 182h is disposed within the proximal opening 164h, for example attached to the proximal opening central portion 174h.
[0171] According to some embodiments, a distal unidirectional valve 184h is disposed within the distal opening 166h, for example attached to the distal opening central portion 180h.
[0172] Fig. 9B shows yet another embodiment of a fluid pump 1001, which is of the same construction and configuration as that of fluid pump 100h shown in Figs. 9A, with like numbers referring to like parts, except that the fluid pump 1001 comprises proximal outer and inner proximal protrusions 1701 and 1721 instead of respective recesses 170h and 172h, as well as outer and inner distal protrusions 1761 and 1781 instead of respective recesses 176h and 178h, as further elaborated herein below.
[0173] According to some embodiments, as shown in Fig. 9B, the proximal opening 1641 at the proximal wall 1321 may comprise a proximal outer protrusion 1701, configured to connect with the distal end of the proximal tube 10' a coupled thereto. Similarly, the distal opening 1661 at the distal wall 1341 may comprise a distal outer protrusion 1761, configured to connect with the proximal end of the distal tube 10'b coupled thereto.
[0174] According to some embodiments, as further illustrated in Fig. 9B, the proximal opening 1641 at the proximal wall 1321 may comprise a proximal inner protrusion 1721, and the distal opening 1661 at the distal wall 1341 may comprise a distal inner protrusion 1781, configured to connect with the proximal internal tube end 1961 and the distal internal tube end 1981, respectively.
[0175] The protrusions 1701, 1721, 1761 and 1781, may be formed as tubular extensions, which may be rigid extension, for example, made of the same material as that of the remainder of the housing 1301. [0176] According to some embodiments, any of the proximal outer protrusion 1701, the distal outer protrusion 1761, the proximal inner protrusion 1721 and/or the distal inner protrusion 1781, may further include a seal member (not shown) configured to grip and/or hermetically seal the tube members mounted therein.
[0177] According to some embodiments, the outer diameters of the proximal outer protrusion 1701 and the distal outer protrusion 1761 are equal to or slightly smaller than the outer diameter of the distal end of the proximal tube 10' a and the proximal end of the distal tube 10'b, respectively. Similarly, the outer diameters of the proximal inner protrusion 1721 and the distal inner protrusion 1781 may be equal to or slightly smaller than the outer diameter of the distal end of the proximal internal tube end 1961 and the distal internal tube end 1981, respectively. Preferably, the inner diameters of the protrusions 1701, 1721, 1761, 1781, are substantially equal to the inner diameters of the tubes 10'a, 10'b and/or 1941.
[0178] The aforementioned dimensions may enable coupling of the fluid pump portions to the respective protrusions by inserting the protrusion 1701, 1721, 1761 and 1781 into the lumens at the ends of the respective tube portions 10'a, 1961, 10‘b and 1981. For example, heat may be applied to tube end portions of 10‘a, 1961, 10‘b and 1981 so as to enable expansion thereof, to conveniently wrap around and circumscribe the respective protrusion 1701, 1721, 1761 and 1781.
[0179] According to some embodiments, clamp members, such as ring-shaped clamps, may be utilized to clamp the pipe portions to the respective protrusions. As further shown in Fig. 9B, a proximal outer clamp 1861 may be disposed over the distal end of the proximal tube 10‘a, clamping it over the proximal outer protrusion 1701. A proximal inner clamp 1881 may be disposed over the proximal internal tube end 1961, clamping it over the proximal inner protrusion 1721. A distal outer clamp 1901 may be disposed over the proximal end of the distal tube 10‘b, clamping it over the distal outer protrusion 1761. A distal inner clamp 1921 may be disposed over the distal internal tube end 1981, clamping it over the distal inner protrusion 1781.
[0180] According to some embodiments, the proximal outer protrusion 1701 and the proximal inner protrusion 1721 may define a proximal opening central portion 1741 there-between, together forming an inner port through the proximal opening 1641. Similarly, the distal outer protrusion 1761 and the distal inner protrusion 1781 may define a distal opening central portion 1801 there-between, together forming an inner port through the distal opening 1661.
[0181] According to some embodiments, a proximal unidirectional valve 1821 is disposed within the proximal opening 1641, along the port defined by the proximal outer protrusion 1701, the proximal opening central portion 1741 and the proximal inner protrusion 1721. While the proximal unidirectional valve 1821 is shown in Fig. 9B attached to the proximal opening central
portion 1741, it will be understood that alternative attachment positions are contemplated, such as attachment to the proximal outer protrusion 1701 or the proximal inner protrusion 1721.
[0182] According to some embodiments, a distal unidirectional valve 1841 is disposed within the distal opening 1661, along the port defined by the distal inner protrusion 1781, the distal opening central portion 1801 and the distal outer protrusion 1761. While the distal unidirectional valve 1841 is shown in Fig. 9B attached to the distal opening central portion 1801, it will be understood that alternative attachment positions are contemplated, such as attachment to the distal inner protrusion 1781 or the distal outer protrusion 1761.
[0183] While the exemplary fluid pump 100*1 shown in Fig. 9A includes four recesses 170h, 172h, 176h and 178h, and the exemplary infusion pump 1001 shown in Fig. 9B includes four protrusions 1701, 1721, 1761 and 1781, other embodiments of the fluid pump 100 may include both recesses and protrusions. For example, a fluid pump 100 may include, in some exemplary embodiments, an arrangement of outer protrusions, similar to protrusion 1701 and 1761, and inner recesses, similar to recesses 172h and 178h.
[0184] While Figs. 9A-9B show the proximal unidirectional valve 1821, 182h, as well as the distal unidirectional valve 1841, 184h, attached to a portion of the proximal opening 1641, 164h such as the proximal opening central section 1741, 174h, as well as to the distal opening 1661, 166h such as the distal opening central section 1801, 180h, alternative configurations may include the proximal unidirectional valve and/or the distal unidirectional valve disposed within the lumen of the internal tube portion 194. For example, the proximal unidirectional valve may be positioned within the internal tube portion 194, in the vicinity of the proximal internal tube end 196, and the distal unidirectional valve may be positioned within the internal tube portion 194, in the vicinity of the distal internal tube end 198.
[0185] Reference is now made back to Fig. 1. According to some embodiments, there is provided a fluid pump system 300, which can be implemented as an infusion system 300m or a fluid pump system utilized for other applications, comprising at least one fluid pump 100 according to any of the embodiments disclosed herein above, and the pressure source 40. According to some embodiments, the pressure source 40 is a gas pump. According to some embodiments, the pressure source 40 is an air pump. According to some embodiments, the pressure source 40 is a liquid pump. According to some embodiments, the pressure source 40 comprises at least one pressure line 50, configured to deliver pressurized gas (e.g., air) or liquid
toward the at least one fluid pump 100. According to some embodiments, the pressure line 50 comprises at least one main actuation tube 52 extending from the pressure source 40. According to some embodiments, the main actuation tube 52 is branched at its distal portion (i.e., the portion father from its connection to the pressure source 40) to at least two tubular branches, such as a first actuation branch 54a attached to the first pressure inlet 158a, and a second actuation branch 54b attached to the second pressure inlet 158b.
[0186] According to some embodiments, the fluid pump system 300 further comprises a controller 60, functionally coupled to the pressure source 40 and configured to control the functioning of the at least one fluid pump 100, for example by regulating the gas or liquid pressure supplied thereto by the pressure source 40. According to some embodiments, the controller 60 may be set to allow the fluid pump 100 to deliver pulsed flow through a tube 10 extending there-through.
[0187] According to some embodiments, the controller 60 comprises one or more button that may be engaged by an operator, to control the operation of the fluid pump 100. According to some embodiments, the controller comprises a display, such as a digital screen, LED lights, and the like.
[0188] According to some embodiments, components of fluid pump system 300 may communicate with other components via a network, thus allowing for remote inspection and/or remote control of the fluid pump 100. Components of the system 300 may be coupled to other components of the system 300, or to components external to the system 300, via cables as necessary for data communication. Alternatively or additionally, wireless communication may be utilized.
[0189] In embodiments of a fluid pump 100 comprising at least two opposing outer chambers 162, connected to at least two branched actuation tubes 54, the tube 10 may be compressed by pressure applied thereto from more than one side.
[0190] According to some embodiments, the fluid pump system 300 further comprises a compressible tube 10 coupled to and extending through the at least one fluid pump 100. According to some embodiments, the tube 10 of an infusion pump system 300m comprises an infusion catheter and a distal needle attached or attachable to a distal end of the infusion catheter, configured for insertion into a patient's blood vessel, such as a vein (see Fig. 1).
[0191] According to some embodiments, the tube 10 of a fluid pump system 300 comprises at least one of: the proximal unidirectional valve 12, the distal unidirectional valve 14, and/or both. According to some embodiments, the fluid pump system 300 further comprises fluid source 30, such as a bag or a container. According to some embodiments, an infusion pump system 300m comprises a fluid source in the form of an infusion bag 30m (see Fig. 1). According to some embodiments, the fluid source 30 of a fluid pump system 300 is pre-filled with fluid. According to some embodiments, the infusion bag 30m of an infusion pump system 300m is pre-filled with infusion fluid.
[0192] The flow rate through the tube 10 mounted within a fluid pump 100 may be influenced by a variety of factors, including but not limited to, the pressure supplied by the pressure source 40 (e.g., waveform, amplitude and/or frequency), the geometry of the housing 130 and the membrane 110 (e.g., the dimensions that may influence the size and shape of the outer chambers 160 and the inner chambers 162; the diameter of the pressure inlets 158; the position of the pressure inlets 158 along the housing 130; the uniform or non-uniform thickness of the tapering membrane portions 116), the geometry of the tube 10 (e.g., diameter and/or wall thickness of the tube 10), the material properties of the membrane 110 (influencing, for example, flexibility and/or resiliency of the tapering membrane portions 116), the material properties of the tube 10 (influencing, for example, flexibility, compliance and/or resiliency of the tube 10), the material properties of an internal tube portion 194 when present (influencing, for example, flexibility, compliance and/or resiliency of the infusion tube internal tube portion 194), and/or the type and characteristics of a proximal unidirectional valve 12, 182 and/or a distal unidirectional valve 14, 184, when present (which may influence, for example, resistance to flow through the tube 10 and/or internal tube portion 194).
[0193] According to some embodiments, a fluid pump 100 or a fluid pump assembly 200 may be adapted to provide a desirable flow of fluid there-through, by setting and/or modifying at least one, and preferably at least some, of the variety of aforementioned flow influencing factors. The flow influencing factors may be tailored to provide flow which is matching the requirements of the relevant application. For example, when used for IV infusion, the infusion- flow influencing factors may be tailored to provide flow which is personalized to the clinical needs of a patient.
[0194] According to some embodiments, different fluid pumps 100 or fluid pump assemblies 200 may be adapted to provide different desirable flow profiles, according to the requirements
of specific applications. According to some embodiments, different fluid pumps 100 implemented as infusion pumps, or fluid pump assemblies 200 implemented as infusion pump assemblies, may be adapted to provide different desirable flow profiles, according to the needs of different patients.
[0195] In some implementations, different fluid pumps 100 or fluid pump assemblies 200 may be provided with at least some structurally different flow influencing factors, so as to facilitate different flow profiles of fluids through each. Structurally flow influencing factors may include, but are not limited to: the geometry of the housing 130 and the membrane 110, the geometry of the tube 10, the material properties of the membrane 110, the material properties of the tube 10, the material properties of an internal tube portion 194 when present, and/or the type and characteristics of a proximal unidirectional valve 12, 182 and/or a distal unidirectional valve 14, 184, when present.
[0196] In some implementations, different fluid pumps 100 or fluid pump assemblies 200 may be provided with different pressure inputs through the pressure inlets 158. Different pressure inputs supplied to different fluid pumps 100 or fluid pump assemblies 200, which are otherwise structurally similar to each other, may result in different flows of the fluids through each of the fluid pumps 100 and/or fluid pump assemblies 200. Nevertheless, at least two different fluid pumps 100 and/or fluid pump assemblies 200 may be provided with both differing structural flow influencing factors, as well as different pressure inputs, together resulting in the desired flow of the fluid through each of the fluid pumps 100 and/or fluid pump assemblies 200, according to different flow-requirement for each.
[0197] In some applications, the flow of the fluid through a specific fluid pump 100 or a fluid pump assembly 200 may vary, for example, by varying the pressure input through the pressure inlet 158 over time. This may be useful, for example, for utilizing a single fluid pump 100 implemented as an infusion pump, or fluid pump assembly 200 implemented as an infusion pump assembly, connected to a specific patient, by varying the pressure input from the pressure source 40 to result in different flows of the infusion-fluid to the patient at different time periods, according to the clinical/physiological characteristics of the patient which might vary during a treatment period.
[0198] While the fluid pump system 300 illustrated in the exemplary embodiment shown in Fig. 1, includes a pressure source 40 (e.g., air pump) coupled via a single pressure line 50 to a
single fluid pump 100, in some applications, a single pressure source 40 and a single controller 60 may be used in combination with a plurality of fluid pumps 100. For example, in the case of the infusion pump system 300m, each infusion pump 100 can serve to provide infusion fluid to a different patient. In such embodiments, a single pressure source 40, which may be controlled by a single controller 60, may be coupled to a plurality of fluid pumps 100 via a corresponding plurality of pressure lines 50. Alternatively or additionally, a single pressure line 50 extending from the pressure source 40 may include a plurality of branched actuation tubes 54, such that at least one of the branched actuation tubes 54 is coupled to one of the plurality of the fluid pumps 100, and at least one other of the branched actuation tubes 54 is coupled to at least one other fluid pump 100.
[0199] According to some embodiments, the pressure source 40 can be configured to provide a uniform pressure waveform through each, or at least some of, the plurality of pressure lines 50 and/or the plurality of branched actuation tubes 54, coupled to at least two of the plurality of the fluid pumps 100. Alternatively or additionally, the pressure source 40 can be configured to provide different pressure waveforms to at least two of the plurality of fluid pumps 100 via at least two respective pressure lines 50.
[0200] According to some embodiments, the structurally flow influencing factors may further include the geometry of the pressure line 50 and/or the branched actuation tubes 54 (e.g., diameter, length), and/or the material properties of the pressure line 50 and/or the branched actuation tubes 54. In some implementations, a single pressure source 40 may be tailored to provide different pressure inputs to different fluid pumps 100, via a variety of different pressure lines 50 and/or pressure actuation tubes 54, connected there-between.
[0201] In some applications, a single pressure source 40 supplying the same pressure output (e.g., same pressure waveform) to a plurality of pressure lines 50 attached thereto at one end, and to different fluid pumps 100 and/or fluid pump assemblies 200 at the opposite end, may result in different flow of fluid through at least two of the fluid pumps 100 and/or fluid pump assemblies 200, by properly matching the material properties and/or geometries of the corresponding pressure lines 50 and or branched actuation tubes 54 and the respective fluid pumps 100, as well as setting and/or choosing other structurally flow influencing factors of the fluid pumps 100 and/or fluid pump assemblies 200, as mentioned hereinabove.
[0202] According to some embodiments, the fluid pumps 100 and/or fluid pump assemblies 200 may be provided in a variety of structural configurations (e.g., different sizes and/or different material properties of at least some components thereof), enabling a user, such as a clinician or other caretaker in the case of fluid pumps 100 utilized for medical applications, to choose an appropriate type of fluid pump 100 and/or fluid pump assembly 200 for use with a specific patient, or for use for a specific device or apparatus for other, non-clinical applications. Alternatively or additionally, a variety of pressure lines 50 (e.g., provided with different sizes and/or material properties, and/or different configurations such as differing number of branched actuation tubes 54) may be provided, to be chosen by a user, such as a clinician or a caretaker, to connect the pressure source 40 to each fluid pump 100 and/or fluid pump assembly 200 as necessary.
[0203] According to some embodiments, the controller 60 may be provided with a software for setting an appropriate pressure output from the pressure source 40, according to required resultant flows of liquids through at least one fluid pump 100 and/or fluid pump assembly 200. In some applications, the controller may include an interactive interface for receiving inputs from an operator, such as a clinician, caretaker or technician, and provide recommendations according to the input data.
[0204] According to some embodiments, the input to a controller may include at least one, and preferably some, of the structurally flow influencing factors of the fluid pump 100, fluid pump assembly 200 and/or pressure lines 50. According to some embodiments, the controller includes a database, which can be stored locally or remotely (e.g., in a remote server), including a plurality of pre-stored sets of different models of fluid pumps 100, fluid pump assemblies 200 and/or pressure lines 50. This configuration enables the operator to choose, through the interactive interface, pre-stored models of fluid pump 100, fluid pump assembly 200, pressure lines 50, and/or combinations thereof, which can be retrieved from the database along with associated values of corresponding structural factors.
[0205] According to some embodiments, the input to a controller 60 may further include patient-specific characteristics, such as clinical data of a patient (e.g., age, gender, weight, height, clinical conditions, medications administered to the patient, sensitivity of drugs and/or other compounds, etc.) when implemented for clinical applications.
[0206] According to some embodiments, the controller 60 may include algorithms for receiving the data input from the operators, and providing recommendations related to a treatment regime accordingly. In some implementations, an operator may provide input regarding a chosen type of an fluid pump 100 and/or fluid pump assembly 200, as well as patient characteristics in the case of clinical applications, or other machinery or apparatus characteristics for other types of applications, and the controller 60 may provide recommendations for the pressure output waveform (including, for example, amplitude and/or frequency) from the pressure source 40. In some applications, the controller 60 may provide recommendations for the type of pressure line 50 to be connected between the pressure source 40 and the fluid pump 100. In some implementations, such as when used for clinical applications, only the patient characteristics may be provided by the operator, and the controller 60 may provide recommendation for a combination of a fluid pump 100 and/or fluid pump assembly 200, a pressure line 50, and a pressure output waveform from the pressure source 40.
[0207] According to some embodiments, the characteristics of a plurality of patients may be input to the controller 60 by an operator, and the controller 60 may provide recommendations for appropriate fluid pumps 100 and/or fluid pump assemblies 200, pressure lines 50, pressure output waveforms from the pressure source 40 and/or combinations thereof, so as to facilitate utilization of a single pressure source 40 with a plurality of fluid pumps 100 and/or fluid pump assemblies 200 connected to different patients.
[0208] According to some embodiments, the controller 60 may provide more than one option for a fluid pump 100 or fluid pump assembly 200, pressure line 50, pressure output waveform from the pressure source 40, and/or combinations thereof, which may result in similar flow of fluid through the fluid pump 100 or fluid pump assembly 200. An operator is able to choose one of the options according to additional preferences (e.g., cost, availability in stock, etc.).
[0209] While conventional peristaltic pumps are provided with a plurality of reciprocating components, configured to be sequentially urged against the pump, a noticeable advantage of the fluid pump 100 of the current invention is that it may generate fluid flow through a compressible tube 10, such as a conventional infusion tube, with the use of minimal number of components, which do not require actuation for reciprocating movement. A further advantage is that the relatively small number of components enables the fluid pump 100 to be manufactured at low costs, utilizing relatively fast and simple assembly procedures.
[0210] According to some embodiments, the fluid pump 100 is a disposable pump. Disposable products are increasingly popular in light of concerns regarding hygiene. This is most applicable to institutional applications. Disposability, however, necessitates a firm cost ceiling for any product. Advantageously, the structural simplicity and low cost of the disclosed fluid pump 100 allows it to be used as a disposable pump.
[0211] Any fluid pump 100, fluid pump assembly 200, multi-pump assembly 1200 and/or fluid pump system 300, according to any of the embodiments disclosed herein, may be utilized for any other suitable application, including medical or non-medical applications, where controlled fluid delivery may be required. Fig. 1 shows an example of an infusion system 300m, wherein a fluid pump 100 is utilized as an infusion pump 100m to deliver infusion fluid from an infusion bag 30m, through an infusion tube 10m, to a patient in need thereof. The shape and dimension of different components of the fluid pump 100, as well as the stiffness of the membrane 110, may be tailored to specific requirements depending upon a chosen application.
[0212] In some applications, any fluid pump 100, fluid pump assembly 200, multi-pump assembly 1200 and/or fluid pump system 300, according to any of the embodiments disclosed herein, may be utilized to drain fluids from a fluid source, for example to a target container 32. Fig. 10 shows an example of a fluid pump 100 utilized for another, different medical application, such as paracentesis. Paracentesis is a procedure for removing excess peritoneal fluid that accumulates in the abdomen of a patient. Medical procedures such as thoracentesis, in which fluid needs to be pumped from the lungs, and paracentesis, are typically performed by hand pumping to achieve a peristaltic movement of the excess fluid into drainage bags for disposal or syringes for laboratory analysis or any other medical use. Hand pumping is time consuming and requires a person to be in attendance at all times. Moreover, it is difficult to generate consistent suction forces using hand pumping. Depending upon the amount of excess fluid, hand pumping may take several hours of manual labor. A fluid pump system 300 can be utilized as a paracentesis or thoracentesis system 300n, wherein the fluid source can be the patient's abdomen.
[0213] In some embodiments, the tube 10, such as catheter tube 10n shown in Fig. 10, can include a needle at a proximal end thereof, such as a centesis catheter needle, configured to penetrate the abdomen of a patient and provide access to the fluid (e.g., the peritoneal fluid). The fluid pump 100 can then be utilized to drain/remove fluid from the patient's abdomen to an extracorporeal target container 32, such as fluid withdrawal cup 32n shown in Fig. 10.
[0214] While two medical applications, such as IV infusion and paracentesis, are illustrated, it is to be understood that the fluid pumps 100 can be utilized in a wide variety of other medical applications. For example, a fluid pump system 300 similar to the paracentesis system 300n illustrated in Fig. 10 can be similarly utilized for amnioreduction to perform amniocentesis for intentional reduction of amniotic fluid volume. In other examples, fluid pumps 100 can be used in combination or as part of a dialysis machine, to convey blood or dialysis fluid.
[0215] According to some embodiments, a fluid pump system 300 comprises a plurality of fluid pumps 100 used in combination with a matching plurality of tubes 10. A single controller 60, and/or a single gas pump 40, can be utilized to control and/or activate the plurality of fluid pumps 100, wither via a single main actuation tube 50 branched into a plurality of actuation branches 52, connected to the plurality of fluid pumps 100, or via a plurality of main actuation tubes 50 (each of which can be further branched) configured, each, to actuate one of the corresponding fluid pumps 100.
[0216] Fig. 11 shows another example of fluid pumps 100 utilized for non-clinical applications, such as filling liquids in packages or containers in the food and/or nutrition industries. The fluid pump system 300 illustrated in Fig. 11 is a liquid filling system 300° that can be used in combination, or as a part of, a beverage filling machine. The system 300° is shown to include a plurality of fluid pumps 100, such as fluid pumps 100a to lOOf. The fluid source 30 can be a fluid tank 30° containing the beverage to be filled within bottles 32°, serving as the target containers 32. As shown, a plurality of tubes 10° can extend from the tank 30°, through the corresponding plurality of fluid pumps 100, toward the corresponding bottles 32°. Appropriate fitments can be used to connect the proximal ends of the tubes 10° to the tank 30°, and each tube 10° can include a nozzle at its distal end, through which the beverage may flow out of the tube 10° and into the corresponding bottle 32°.
[0217] In some embodiments, the controller 60 and the gas pump 40 can be combined to a single assembly, such as shown in Fig. 11 for controller 60° and gas pump 40° combined into an actuation and control apparatus from which the plurality of actuation tubes 50 extend toward the fluid pumps 100.
[0218] It is to be understood that fluid pumps 100 can be used in a variety of other non-clinical applications, besides the example of the fluid filling system 300° illustrated in Fig. 11. For example, fluid pumps 100 can be utilized for various operations in the biopharmaceutical
industry, such as chromatography, virus filtration and tangential flow filtration (TFF), each of which may require specific operating characteristics. Chromatography requires constant fluid flowrates during their operations, but may have varying pumping pressures. Virus filtration, on the other hand, will feature constant pumping pressures, but flowrates will change as the filters become clogged or fouled. In TFF, the main challenge is attempting to keep the flowrate and pressure unchanging throughout the process.
[0219] Conventional peristaltic pumps may have several shortcomings, such as inducing shear, in the case of lobe pumps, that may damage the pumped fluid, as well as often resulting in inaccurate pulsatile flow profiles. Utilization of fluid pumps 100 according to the current disclosure may be adapted to gently, safely and securely convey low-viscosity aqueous solutions and biopharmaceutical materials that are highly sensitive to shear forces and pulsation while being pumped.
[0220] In other examples, fluid pumps 100 can be used for pumping abrasive fluid, that can entrain solids that may otherwise promote erosion. Specifically, some pumped liquids can contain solid matter either as contaminants (such as lime-scale), as components of a slurry (sewage treatment) or in a suspension for transfer or transportation purposes (mining and paint applications). If such liquids are pumps through pumps that include components being in direct contact with the fluid, such solid matter can increased wear to components of the pumps either eroding surfaces through physical force. Another source of increased wear may be due to fluid which may cause chemical reaction with such components.
[0221] The fluid pumps 100 of the current disclosure may reduce or eliminate such risks, since the pumped fluids are not in direct contact with components of the valve, as the membrane 110 is pressed against the tube 10 delivering the fluid, and not the fluid itself. Thus, tubes 10 can be easily replaced when required, while the fluid pumps 100 remain undamaged.
[0222] Fluid pump 100 can be also miniaturized for use as micro-pumps in other industries, such as, but not limited to, the semiconductor industry and the printing industry, wherein liquid needs to be pumped without being damaged. Specifically, fluid pumps 100 of the current specification can be adapted to advantageously produce high flow rate and high pressure, without generating excessive heat during operation thereof.
[0223] The above mentioned systems and setups merely serve to provide specific examples for utilization of the fluid pumps 100 disclosed herein. It is to be understood that the fluid pumps
100 of the current disclosure can be designed for use across the broad range of commercial and industrial applications, military applications, and research and training arrangements.
[0224] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub combination or as suitable in any other described embodiment of the invention. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such. [0225] Although the invention is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. It is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways. Accordingly, the invention embraces all such alternatives, modifications and variations that fall within the scope of the appended claims.
Claims
1. A fluid pump, comprising: a housing comprising: a proximal wall comprising a proximal opening; a distal wall comprising a distal opening; a central body portion extending between the proximal wall and the distal wall; and at least one pressure inlet; at least one membrane disposed within the housing, and comprising: a proximal end; a distal end; and a tapering membrane portion extending at an inclined manner from the proximal end to the distal end, and having an outer membrane surface; wherein the proximal opening and the distal opening are aligned with each other, and configured to accommodate a compressible tube; wherein at least one outer chamber is defined between the membrane and the housing; wherein the at least one pressure inlet is in fluid communication with the at least one outer chamber; and wherein the tapering membrane portion is configured to flex radially inward, when pressure exceeding a threshold pressure value Pt is applied to the outer membrane surface.
2. The fluid pump of claim 1, wherein the membrane further comprises lateral extensions.
3. The fluid pump of claim 1 or 2, wherein the housing further comprises lateral supports.
4. The fluid pump of any one of claims 1 to 3, wherein the housing is formed with a relatively uniform elliptical cross-section along its length.
5. The fluid pump of any one of claims 1 to 3, wherein the housing is shaped as a truncated cone tapering radially inward in the distal direction.
6. The fluid pump of any one of claims 1 to 5, wherein the housing comprises a first housing section and a second housing section, and wherein the fluid pump is configured to be movable between an open state and a closed state.
7. The fluid pump of claim 6, wherein the two housing sections are hinged to each other along one edge of the two housing sections.
8. The fluid pump of claim 6, wherein the first housing section and the second housing section are similarly formed, wherein the membrane comprises a first membrane section and a second membrane section, wherein the at least one outer chamber comprises a first outer chamber defined between the first housing section and the first membrane section, and a second outer chamber defined between the second housing section and the second membrane section, and wherein the at least one pressure inlet comprises a first pressure inlet in fluid communication with the first outer chamber, and a second pressure inlet in fluid communication with the second outer chamber.
9. The fluid pump of claim 6, wherein the at least one outer chamber comprises a single outer chamber defined between the first housing section and the membrane, wherein the at least one pressure inlet comprises a single pressure inlet in fluid communication with the outer chamber, and wherein the second housing section comprises a base.
10. The fluid pump of claim 9, wherein the base comprises a channel dimensioned to accommodate the compressible tube.
11. The fluid pump of any one of claims 6 to 10, further comprising a locking mechanism configured to retain the first housing section and the second housing section locked against each other in the closed state.
12. The fluid pump of claim 11, wherein the locking mechanism comprises at least one locking pin extending from at least one of the housing sections, and at least one locking recess comprised within the opposing housing section, wherein the at least one locking pin is configured to press-fit into the respective locking recess.
13. The fluid pump of claim 11, wherein the locking mechanism comprises at least one latch.
14. The fluid pump of any one of claims 1 to 13, wherein the tapering membrane portion follows a cross-sectional concave arcuate path-line, sloping radially inward in the distal direction.
15. The fluid pump of any one of claims 1 to 14, wherein the tapering membrane portion is provided with non-uniform thickness between the proximal end and the distal end.
16. The fluid pump of any one of claims 1 to 15, wherein the at least one pressure inlet is formed as a protrusion extending radially outward from the housing, defining a port which is in fluid communication with the outer chamber.
17. The fluid pump of any one of claims 1 to 16, wherein the at least one pressure inlet is positioned closer to the proximal wall than the distal wall.
18. The fluid pump of any one of claims 1 to 17, further comprising an internal compressible tube portion, which comprises: a proximal internal tube end, hermetically attached to the proximal wall and in fluid communication with the proximal opening; and a distal internal tube end, hermetically attached to the distal wall and in fluid communication with the distal opening.
19. The fluid pump of claim 18, wherein the proximal opening comprises a proximal inner recess, configured to accommodate the proximal internal tube end, and wherein the distal opening comprises a distal inner recess, configured to accommodate the distal internal tube end.
20. The fluid pump of claim 18, wherein the proximal opening comprises a proximal outer recess, configured to accommodate a distal end of a proximal compressible tube, and wherein the distal opening comprises a distal outer recess, configured to accommodate a proximal end of a distal compressible tube.
21. The fluid pump of claim 18, wherein the proximal opening comprises a proximal inner protrusion, configured to connect with the proximal internal tube end, and wherein the distal opening comprises a distal inner protrusion, configured to connect with the distal internal tube end.
22. The infusion pump of claim 18, wherein the proximal opening comprises a proximal outer protrusion, configured to connect with a distal end of a proximal compressible tube, and wherein the distal opening comprises a distal outer protrusion, configured to connect with a proximal end of a distal compressible tube.
23. The fluid pump of claim 21 , further comprising a proximal inner clamp disposed over the proximal internal tube end, configured to clamp it over the proximal inner protrusion, and a distal inner clamp disposed over the distal internal tube end, configured to clamp it over the distal inner protrusion.
24. The fluid pump of any one of claims 18 to 23, further comprising a distal unidirectional valve attached to the distal opening.
25. The fluid pump of any one of claims 18 to 23, further comprising a proximal unidirectional valve attached to the proximal opening.
26. An fluid pump assembly comprising the fluid pump of any one of claims 1 to 17, and the compressible tube extending through and mounted within the fluid pump.
27. The fluid pump assembly of claim 26, wherein the compressible tube further comprises a proximal unidirectional valve.
28. The fluid pump assembly of claims 26 or 27, wherein the compressible tube further comprises a distal unidirectional valve.
29. The fluid pump assembly of any one of claims 26 to 28, further comprising a fluid source.
30. The fluid pump assembly of claim 29, wherein the fluid source comprises an infusion bag.
31. A multi-pump assembly comprising a plurality of fluid pumps of any one of claims 1 to 17, and the compressible tube, wherein the plurality of fluid pumps are serially mounted over the compressible tube.
32. The multi-pump assembly of claim 31, wherein the plurality of fluid pumps are mounted in the same orientation over the compressible tube.
33. An fluid pump system comprising at least one fluid pump according to any one of claims 1 to 25, and a pressure source comprising at least one pressure line attached to the at least one pressure inlet of the at least one fluid pump.
34. The fluid pump system of claim 33, wherein the pressure source is a gas pump.
35. The fluid pump system of claims 33 or 34, further comprising a controller, configured to control the functioning of the at least one fluid pump.
36. The fluid pump system of any one of claims 33 to 35, further comprising at least one compressible tube, extending through and mounted within the at least one infusion pump.
37. The fluid pump system of any one of claims 33 to 36, wherein the at least one pressure line comprises a main actuation tube, which is branched at its distal portion to at least two tubular actuation branches.
38. The fluid pump system of any one of claims 33 to 37, further comprising a fluid source.
39. The fluid pump system of claim 38, wherein the fluid source comprises an infusion bag.
40. The fluid pump system of any one of claims 33 to 39, wherein the at least one fluid pump comprises a plurality of fluid pumps.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IL270895A IL270895B (en) | 2019-11-25 | 2019-11-25 | Infusion pump |
IL270895 | 2019-11-25 |
Publications (2)
Publication Number | Publication Date |
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WO2021105981A1 WO2021105981A1 (en) | 2021-06-03 |
WO2021105981A9 true WO2021105981A9 (en) | 2021-09-10 |
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ID=76130139
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/IL2020/051186 WO2021105981A1 (en) | 2019-11-25 | 2020-11-17 | Fluid pump |
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IL (1) | IL270895B (en) |
WO (1) | WO2021105981A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023006906A1 (en) * | 2021-07-28 | 2023-02-02 | Shl Medical Ag | Apparatus for large volume medication administration |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4778451A (en) * | 1986-03-04 | 1988-10-18 | Kamen Dean L | Flow control system using boyle's law |
US4983102A (en) * | 1988-10-14 | 1991-01-08 | Swain Danny C | Self-enclosed filter pumping system |
DE4432991C1 (en) * | 1994-09-16 | 1995-10-26 | Fresenius Ag | Infusion pump for dispensing medicines into human body |
WO2013121163A1 (en) * | 2012-02-16 | 2013-08-22 | Quanta Fluid Solutions Limited | Blood pump |
WO2015050732A1 (en) * | 2013-10-02 | 2015-04-09 | Saudi Arabian Oil Company | Peristaltic submersible pump |
-
2019
- 2019-11-25 IL IL270895A patent/IL270895B/en active IP Right Grant
-
2020
- 2020-11-17 WO PCT/IL2020/051186 patent/WO2021105981A1/en active Application Filing
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023006906A1 (en) * | 2021-07-28 | 2023-02-02 | Shl Medical Ag | Apparatus for large volume medication administration |
Also Published As
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IL270895A (en) | 2021-05-31 |
IL270895B (en) | 2021-06-30 |
WO2021105981A1 (en) | 2021-06-03 |
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