IL270895A

IL270895A - Infusion pump

Info

Publication number: IL270895A
Application number: IL270895A
Authority: IL
Inventors: Elad David; Halpern Pinchas; Zaretsky Uri; Kozlovsky Pavel
Original assignee: Elad David; Halpern Pinchas; Shmuel Einav; Zaretsky Uri; Kozlovsky Pavel
Priority date: 2019-11-25
Filing date: 2019-11-25
Publication date: 2021-05-31
Also published as: WO2021105981A9; WO2021105981A1; IL270895B

Description

36 FIELD AND BACKGROUND OF THE INVENTION 1. 1.

[001] The present invention relates to devices, assemblies and systems for pumping fluids through flexible tubes, and in particular, for delivery of infusion fluids in a pulsatile controllable manner.

BACKGROUND OF THE INVENTION 2. 2.

[002] Intravenous (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. 3. 3.

[003] 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. 4. 4.

[004] 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 minutes2 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. . .

[005] 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 6. 6.

[006] The present disclosure is directed toward devices, assemblies and systems for administering fluids, such as infusion fluids, in a controllable manner which is independent of gravitational forces. According to some embodiments, an infusion pump may be provided for mounting over an infusion tube, wherein the infusion pump includes a tapering membrane and is devoid of rotatable components or actuation mechanisms, thereby simplifying its structure and reducing costs. 7. 7.

[007] According to one aspect, there is provided an infusion tube comprising a housing, at least one membrane disposed within the housing, and two lateral extensions. The housing comprises a proximal wall comprising a proximal opening, a distal wall comprising a distal opening, a circumferential wall 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 two lateral extensions extend between opposite sides of the tapering membrane portion and the housing. 8. 8.

[008] The proximal opening and the distal opening are aligned with each other, and configured to accommodate an infusion tube. At least one outer chamber is defined between the membrane, the lateral extensions, and the housing. The at least one pressure inlet is in fluid communication with the at least one outer chamber. The tapering membrane portion is3 configured to flex radially inward, when pressure exceeding a threshold pressure value Pt is applied to the outer membrane surface. 9. 9.

[009] According to some embodiments, the lateral extension are integrally formed with the membrane. . .

[010] According to some embodiments, the lateral extension are integrally formed with the housing. 11. 11.

[011] According to some embodiments, the housing formed with a relatively uniform elliptical cross-section along its length. 12. 12.

[012] According to some embodiments, the housing is shaped as a truncated cone tapering radially inward in the distal direction. 13. 13.

[013] According to some embodiments, the housing comprises a first housing section and a second housing section, and wherein the infusion pump is configured to be movable between an open state and a closed state. 14. 14.

[014] According to some embodiments, the two housing sections are hinged to each other along one edge of the two housing sections. . .

[015] 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. 16. 16.

[016] 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.4 17. 17.

[017] According to some embodiments, the base comprises a channel dimensioned to accommodate the infusion pump. 18. 18.

[018] According to some embodiments, the infusion 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. 19. 19.

[019] According to some embodiments, the locking mechanism comprises at least one locking 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 at least one locking recess. . .

[020] According to some embodiments, the locking mechanism comprises at least one latch. 21. 21.

[021] According to some embodiments, the tapering membrane portion follows a cross sectional concave arcuate path-line, sloping radially inward in the distal direction. 22. 22.

[022] According to some embodiments, the tapering membrane portion is provided with non uniform thickness between the proximal end and the distal end. 23. 23.

[023] 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. 24. 24.

[024] According to some embodiments, the at least one pressure inlet is positioned closer to the proximal wall than the distal wall. . .

[025] According to some embodiments, the infusion pump further comprises an internal flexible tube portion. The internal flexible 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. 26. 26.

[026] 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.5 27. 27.

[027] According to some embodiments, the proximal opening comprises a proximal outer recess, configured to accommodate a distal end of a proximal infusion tube, and the distal opening comprises a distal outer recess, configured to accommodate a proximal end of a distal infusion tube. 28. 28.

[028] 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. 29. 29.

[029] According to some embodiments, the proximal opening comprises a proximal outer protrusion, configured to connect with a distal end of a proximal infusion tube, and the distal opening comprises a distal outer protrusion, configured to connect with a proximal end of a distal infusion tube. . .

[030] According to some embodiments, the infusion 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. 31. 31.

[031] According to some embodiments, the infusion pump further comprises a distal unidirectional valve attached to the distal opening. 32. 32.

[032] According to some embodiments, the infusion pump further comprises a proximal unidirectional valve attached to the proximal opening. 33. 33.

[033] There is provided, according to some embodiments, an infusion assembly comprising the infusion pump, and the infusion tube extending through and mounted within the infusion pump. 34. 34.

[034] According to some embodiments, the infusion tube further comprises a proximal unidirectional valve. . .

[035] According to some embodiments, the infusion tube further comprises a distal unidirectional valve. 36. 36.

[036] According to some embodiments, the infusion assembly further comprises an infusion bag.6 37. 37.

[037] There is provided, according to some embodiments, a multi-pump assembly comprising a plurality of infusion pumps and the infusion tube, wherein the plurality of infusion pumps are serially mounted over the infusion tube. 38. 38.

[038] According to some embodiments, the plurality of infusion pumps are mounted in the same orientation over the infusion tube. 39. 39.

[039] There is provided, according to some embodiments, an infusion system comprising at least one infusion pump, and a pressure source comprising at least one pressure line attached to the at least one pressure inlet of the at least one infusion pump. 40. 40.

[040] According to some embodiments, the pressure source is a gas pump. 41. 41.

[041] According to some embodiments, the infusion system further comprises a controller, configured to control the functioning of the infusion pump. 42. 42.

[042] According to some embodiments, the infusion system further comprises at least one infusion tube, extending through and mounted within the at least one infusion pump 43. 43.

[043] According to some embodiments, the at least one pressure line comprises a main tube, which is branched at its distal portion to at least two tubular branches. 44. 44.

[044] According to some embodiments, the infusion system further comprises an infusion bag. 45. 45.

[045] According to some embodiments, the at least one infusion pump of the infusion system comprises a plurality of infusion pumps. 46. 46.

[046] 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. 47. 47.

[047] 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.7 48. 48.

[048] 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 49. 49.

[049] 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: 50. 50.

[050] Fig. 1 shows a view in perspective of an infusion pump system, according to some embodiments. 51. 51.

[051] Fig. 2A shows a view in perspective of an infusion pump mounted over a tube, according to some embodiments. 52. 52.

[052] Fig. 2B shows a sectional view in perspective of the infusion pump of Fig. 2A. 53. 53.

[053] Fig. 2C shows a cross-sectional side view of the infusion pump of Fig. 2A. 54. 54.

[054] Fig. 3A shows a full-blown view in perspective of components of the infusion pump next to a tube, according to some embodiments. 55. 55.

[055] Fig. 3B shows a view in perspective of the components shown in Fig. 3A assembled together and shown in an opened state. 56. 56.

[056] Figs. 4A-4F show different phases of a working cycle of the infusion pump, according to some embodiments.8 57. 57.

[057] Fig. 5A shows a view in perspective of an infusion pump having a cylindrical housing, according to some embodiments. 58. 58.

[058] Fig. 5B shows an infusion pump having a housing formed with a uniform elliptical cross-section, according to some embodiments. 59. 59.

[059] Fig. 5C shows an infusion pump having a frustoconical housing, according to some embodiments. 60. 60.

[060] Fig. 6A shows a view in perspective of an infusion pump in an opened state, according to some embodiments. 61. 61.

[061] Fig. 6B shows a cross sectional side view of the infusion pump of Fig. 6A, according to some embodiments. 62. 62.

[062] Fig 7 shows a cross sectional side view of an infusion pump assembly, according to some embodiments. 63. 63.

[063] Fig. 8A shows a view in perspective of a multi-pump assembly, according to some embodiments. 64. 64.

[064] Fig. 8B shows a cross sectional side view of the multi-pump assembly of Fig. 7B. 65. 65.

[065] Fig. 9A shows a cross sectional side view of an infusion pump equipped with a proximal unidirectional valve and a distal unidirectional valve, according to some embodiments. 66. 66.

[066] Fig. 9B shows a cross sectional side view of an infusion pump equipped with a proximal unidirectional valve and a distal unidirectional valve, according to some embodiments DETAILED DESCRIPTION OF SOME EMBODIMENTS 67. 67.

[067] 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 in9 order not to obscure the disclosure. In the figures, like reference numerals refer to like parts throughout. 68. 68.

[068] 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. 69. 69.

[069] Fig. 1 shows a view in perspective of an infusion pump system 300 comprising an infusion pump 100 mounted over an infusion tube 10, 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 an infusion pump mounted over a tube 10, according to some embodiments. The infusion pump 100 comprises a housing 130 having a proximal wall 132, a distal wall 134, and a circumferential wall 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. 70. 70.

[070] According to some embodiments, the proximal 164 and distal 166 openings are configured to accommodate a flexible tube such as an infusion tube 10 that may extend through the housing 130. Thus, the opening 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. 71. 71.

[071] 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 infusion tube 10. For10 example, a proximal side or a proximal end may refer to an end of a device or a component thereof closer to the infusion bag 30 shown in Fig. 1. 72. 72.

[072] 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 infusion tube 10. 73. 73.

[073] The term "infusion 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. 74. 74.

[074] The term "infusion 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 tube. 75. 75.

[075] According to some embodiments, the infusion pump 100 further comprises at least one membrane 110 disposed within the housing 130, between the circumferential wall 156 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 circumferential wall 156 of the housing 130, and an inner membrane surface 120 facing the flow-path axis 20. 76. 76.

[076] The tapering membrane portion 116 is disposed between the circumferential wall 156 of the housing 130 and the flow-path axis 20, and more specifically, between the circumferential wall 156 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. 77. 77.

[077] 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 infusion tube 10 when the infusion tube 10 extends through the housing 130, than the proximal end 112. 78. 78.

[078] 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 20,11 and more specifically, toward the infusion tube 10 when the infusion tube 10 extends through the housing 130), when pressure exceeding a threshold pressure value Pt is applied to the outer membrane surface 118. 79. 79.

[079] 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. 80. 80.

[080] 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. 81. 81.

[081] 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. 82. 82.

[082] 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 circumferential wall 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 circumferential wall 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. 83. 83.

[083] 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 shown12 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. 84. 84.

[084] 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. 85. 85.

[085] 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. 86. 86.

[086] According to some embodiments, the infusion pump 100 further comprises two opposing lateral extensions, each extending laterally from the tapering membrane portion 116 to the housing 130, as shown for example in Figs. 3A-3B. A first lateral extension 122 may extend between the tapering membrane portion 116 and a first lateral housing edge 142, and a second lateral extension 124 may extend between the tapering membrane portion 116 and a second lateral housing edge 144, opposite to the first lateral housing edge 142. 87. 87.

[087] According to some embodiments, the infusion pump 100 further comprises at least one outer chamber 160, defined between the tapering membrane portion 116, the lateral extensions 122, 124 and the housing 130. In the exemplary embodiment illustrated in Figs. 2A-2C, a first outer chamber 160a and a second outer chamber 160b of the infusion pump 100 are defined between the tapering membrane portion 116, the lateral extensions 122, 124 and opposite sides of the housing 130, wherein the lateral extensions 122, 124 are configured to seal the outer chambers 160a and 160b, so as to prevent fluid or gas flow there-between. 88. 88.

[088] As further shown in Fig. 2A-2C, an inner chamber 162 is defined between the tapering membrane portion 116 and the infusion tube 10, when the infusion tube extends through the housing 130. 89. 89.

[089] 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 seal against the infusion tube 10 when the infusion tube 10 extends13 there-through, so as to hermetically seal the inner chamber 162, preventing escape of fluid or gas therefrom to the external environment. 90. 90.

[090] 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 infusion tube 10, so as to tightly press against the infusion tube 10 so as to prevent axial displacement thereof relative to the housing 130, as well as to hermetically seal the inner chamber 162. 91. 91.

[091] Each outer chamber 160 is configured as a sealed space that can be varied in volume by displacing the tapering membrane portion 116. According to some embodiments, each inner chamber 162 is configured as a sealed space when a tube 10 is mounted within the infusion pump 100, wherein the sealed inner chamber 162 can be varied in volume by displacing the tapering membrane portion 116. 92. 92.

[092] 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 fluid at high pressure into a respective outer chamber 160. The pressure source 40 may be configured to perform as a pulsatile pressure source. 93. 93.

[093] 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. 94. 94.

[094] 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 a tube 54 of a gas pump. The exemplary embodiment illustrated in Figs. 4A- 4F shows an infusion pump 100a. Unless stated otherwise for specific components or configurations, the infusion pump 100a 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. According to some embodiments, and as shown, the pressure inlet 158a of the infusion 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.14 95. 95.

[095] 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. 96. 96.

[096] 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. 97. 97.

[097] 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. 98. 98.

[098] 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 infusion pump 100 with the tube 10, according to some embodiments. 99. 99.

[099] 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. 100. 100.

[0100] 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 to15 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. 101. 101.

[0101] According to some embodiments, the first outer chamber 160a may be defined between the first housing section 130a, the first membrane section 110a, and lateral extensions 122a, 124a of the first outer chamber 160a, extending from the first tapering membrane portion 116a to the first housing section 130a. Similarly, the second outer chamber 160a may be defined between the second housing section 130b, the second membrane section 110b, and lateral extensions 122b, 124b of the second outer chamber 160b, extending from the second tapering membrane portion 116b to the second housing section 130b. 102. 102.

[0102] According to some embodiments, the infusion 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. 103. 103.

[0103] 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, while their opposite lateral edges 144a and 144b 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.16 104. 104.

[0104] 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. 105. 105.

[0105] 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. 106. 106.

[0106] 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 infusion tube 10 within the infusion 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 infusion tube 10 in the closed state (see Fig. 2A). Similarly, disengagement of the infusion pump 100 from the infusion tube 10 may also be performed in a simple and convenient manner by reversing the order of the aforementioned steps. 107. 107.

[0107] 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 been17 found by the investors to exhibit superior flow pumping behavior, relative to straight sloping configurations. 108. 108.

[0108] 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). 109. 109.

[0109] 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 infusion tube 10. 110. 110.

[0110] Reference is now made to Figs. 4A-4F, illustrating the working principle of the infusion 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 infusion 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 P1 shown in Fig. 4B, wherein the collapsing region of the tapering membrane portion 116 propagates progressively against the outer wall of the infusion tube 10, as shown in Fig. 4C and 4D, for example pressing the tube 10 radially inward along a region extending between points P1 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 infusion 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 infusion tube 10 may be squeezed without being occluded. 111. 111.

[0111] 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 infusion tube 10 in a rolling manner corresponding to the time-dependent distally-18 oriented collapse of the tapering membrane portion 116, so as to gradually compress the infusion 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 P1, P2 shown in the cross-sectional views of Figs. 4A-4F, refers to collapse or re-expansion of 3D regions corresponding to respective points P1, P2. 112. 112.

[0112] The tapering membrane portion 116 is configured to be reciprocally moved to create cyclic pressure pulses compressing the infusion 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 infusion tube 10, and urging flow thereof through the distal opening 166. 113. 113.

[0113] During a trough of a pressure pulse, as the tapering membrane portion 116 is released from contact with the infusion tube 10 so as to revert back to its relaxed state, the infusion tube 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. 114. 114.

[0114] 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. 115. 115.

[0115] 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 infusion pump 100. 116. 116.

[0116] 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,19 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. 117. 117.

[0117] 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. 118. 118.

[0118] Reference is now made to Figs. 5A-5C, illustrating different configuration of the housing 130. Fig. 5A 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. 119. 119.

[0119] 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. 120. 120.

[0120] 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. 121. 121.

[0121] 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 110.20 122. 122.

[0122] 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. 123. 123.

[0123] Figs. 6A and 6B show a view in perspective and a cross sectional side view, respectively, of another embodiment of an infusion 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 infusion 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. 124. 124.

[0124] 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 infusion pump 100e includes a single outer chamber 160e defined between the first housing section 130ea, the membrane 110e and the lateral extension 122e, 124e, and a single inner chamber 162e defined between the first housing section 130ea, the membrane 110e and the infusion tube 10 when mounted within the infusion pump 100e. Similarly, a single pressure inlet 158e is in fluid communication with the single outer chamber 160e. 125. 125.

[0125] According to some embodiments, the base 150e further comprises a channel 152e configured to accommodate at least a partial lower portion of the infusion tube 10, so as to prevent spontaneous lateral displacement thereof along the base 150e. 126. 126.

[0126] According to some embodiments, as shown in Fig. 2A, lateral extension portions 122ea and 124ea that may extend from the tapering membrane portion 116e, and may define together with the lateral extension portions 122eb and 124eb of the base 150e the resulting lateral extensions 122e and 124e, respectively. In alternative embodiments, the infusion pump 100e does not necessarily include lateral extension portions 122ea, 124ea, such that the lateral extensions 122e, 124e are defined solely by the lateral extensions portions 122eb, 124eb, respectively, which extend between the respective edges 142eb, 144eb and the channel 152e.21 127. 127.

[0127] The infusion 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. 128. 128.

[0128] 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. 129. 129.

[0129] 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. 130. 130.

[0130] 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 infusion pump 100 in a closed state, may be utilized, including threaded connections, circumferential clamps and the like.22 131. 131.

[0131] 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). 132. 132.

[0132] The term "plurality", as used herein, means more than one. 133. 133.

[0133] 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 infusion 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. 134. 134.

[0134] According to some embodiments, the infusion tube 10 comprises a distal unidirectional valve, as further shown for the infusion 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 infusion tube 10f in one direction (i.e., in the distal direction) when fluid is pumped through the distal opening 166. 135. 135.

[0135] According to some embodiments, the infusion tube 10 comprises a proximal unidirectional valve (not shown), positioned proximal to the proximal opening 164, configured to restrict the flow through the infusion tube 10 in one direction (i.e., in the distal direction) during filling of the infusion tube 10. 136. 136.

[0136] According to some embodiments, there is provided an infusion assembly 200, comprising the infusion pump 100 according to any of the embodiments disclosed herein, and an infusion tube 10 according to any of the embodiments disclosed herein, extending through the infusion pump 100. According to some embodiments, the infusion tube 10 of the 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, such23 as a vein (see Fig. 1). According to some embodiments, the infusion pump 10 of the infusion assembly 200 comprises at least one of: the proximal unidirectional valve, the distal unidirectional valve 14, and/or both. Fig. 7 shows an exemplary embodiment of an infusion assembly 200 comprising an infusion pump 100f mounted over an infusion tube 10f having a distal unidirectional valve 14f. According to some embodiments, the infusion assembly 200 further comprises an infusion bag 30 (see Fig. 1). According to some embodiments, the infusion bag 30 of the infusion assembly 200 is pre-filled with infusion fluid. 137. 137.

[0137] According to some embodiments, a plurality of infusion pumps 100 may be serially mounted over a single infusion tube 10. Figs. 8A and 8B shows a view in perspective and a cross-sectional side view of a multi-pump assembly 1200, according to some embodiments.

The exemplary configuration illustrated in Figs. 8A-8B shows two consecutive infusion pumps 100, which can be implemented according to any embodiment disclosed herein, attached to a single infusion tube 10 in close proximity to each other. While both infusion 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 infusions pumps 100 may be in direct contact witch each other. 138. 138.

[0138] According to some embodiments, as further shown in Fig. 8B, at least two infusion pumps 100 are mounted in the same orientation over a single infusion tube 10, meaning that their respective tapering membrane portions 116 are tapering radially inward in the same distal direction. Alternatively, at least two infusion pumps 100 may be attached to the infusion tube 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). 139. 139.

[0139] While the exemplary embodiment of the multi-pump assembly 1200 illustrated in Figs. 8A-8B includes two infusion pumps 100, it will be clear that a multi-pump assembly 1200 may include more than two infusion 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 infusion pumps 100, it will be clear that a multi-pump assembly 1200 may include at least two distinct types of infusion pumps 100, for example, an infusion pump 100b and an infusion pump 100e, mounted over a single tube 10 (embodiment not shown). 140. 140.

[0140] In some applications, the phase of pulsatile pressure waves supplied to each of the plurality of infusion pumps 100 is offset from each other. For example, pulsatile pressure may24 be supplied at a phase delay to a distal infusion pump, relative to the proximal infusion pump.

Simulation conducted by the inventors surprisingly showed that in some configurations, a distal infusion pump 100 of a multi-pump assembly 1200 may result in total outflow which is similar to an infusion pump or an infusion assembly 200 equipped with a distal unidirectional valve.

Thus, specific configuration of a multi-pump assembly 1200 may simplify device construction, by advantageously providing a net outflow similar to that provided with an infusion pump or an infusion assembly 200 having a distal unidirectional valve, without requiring incorporation of such a valve in the infusion tube 10 or in the infusion pump. 141. 141.

[0141] According to some embodiment, the infusion pump 100 comprises at least one unidirectional valve. According to some embodiments, the infusion 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 infusion tube 10 in one direction (i.e., in the distal direction) during filling of the infusion tube 10. According to some embodiments, the infusion 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 infusion tube in one direction (i.e., in the distal direction) when fluid is pumped through the distal opening 166. 142. 142.

[0142] Fig. 9A shows another embodiment of an infusion pump 100h, 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 infusion pump 100h further comprises at least one unidirectional valve. 143. 143.

[0143] According to some embodiments, the infusion pump 100 comprises an internal tube portion 194. The internal flexible 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 infusion tube 10a may be attached to the proximal wall 132, and a distal infusion tube 10b may be attached to the distal wall 134, such that both the proximal infusion tube 10a and the distal infusion 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 flexible tube portion 194 is substantially equal to the inner diameters of the proximal and distal infusion tubes 10a, 10b.25 144. 144.

[0144] 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 infusion 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 infusion tube 10hb. 145. 145.

[0145] 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. 146. 146.

[0146] 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 hermetically seal the tube members mounted therein. 147. 147.

[0147] 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 infusion tube 10ha and the proximal end of the distal infusion tube 10hb, respectively, to tightly press against the distal end of the proximal infusion tube 10ha and the proximal end of the distal infusion tube 10hb so as to prevent axial displacement thereof relative to the housing 130h, as well as to hermetically seal the tube portions 10ha and 10hb. 148. 148.

[0148] 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, as well as to hermetically seal the inner chambers 162h. 149. 149.

[0149] 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.26 150. 150.

[0150] 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. 151. 151.

[0151] 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 152. 152.

[0152] Fig. 9B shows yet another embodiment of an infusion pump 100i, which is of the same construction and configuration as that of infusion pump 100h shown in Figs. 9A, with like numbers referring to like parts, except that the infusion pump 100i comprises proximal outer and inner proximal protrusions 170i and 172i instead of respective recesses 170h and 172h, as well as outer and inner distal protrusions 176i and 178i instead of respective recesses 176h and 178h, as further elaborated herein below. 153. 153.

[0153] According to some embodiments, as shown in Fig. 9B, the proximal opening 164i at the proximal wall 132i may comprise a proximal outer protrusion 170i, configured to connect with the distal end of the proximal infusion tube 10ia coupled thereto. Similarly, the distal opening 166i at the distal wall 134i may comprise a distal outer protrusion 176i, configured to connect with the proximal end of the distal infusion tube 10ib coupled thereto. 154. 154.

[0154] According to some embodiments, as further illustrated in Fig. 9B, the proximal opening 164i at the proximal wall 132i may comprise a proximal inner protrusion 172i, and the distal opening 166i at the distal wall 134i may comprise a distal inner protrusion 178i, configured to connect with the proximal internal tube end 196i and the distal internal tube end 198i, respectively. 155. 155.

[0155] The protrusions 170i, 172i, 176i and 178i, 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 130i. 156. 156.

[0156] According to some embodiments, any of the proximal outer protrusion 170i, the distal outer protrusion 176i, the proximal inner protrusion 172i and/or the distal inner protrusion 178i, may further include a seal member (not shown) configured to hermetically seal the tube members mounted therein.27 157. 157.

[0157] According to some embodiments, the outer diameters of the proximal outer protrusion 1701 and the distal outer protrusion 176i are equal to or slightly smaller than the outer diameter of the distal end of the proximal infusion tube 10ia and the proximal end of the distal infusion tube 10ib, respectively. Similarly, the outer diameters of the proximal inner protrusion 172i and the distal inner protrusion 178i may be equal to or slightly smaller than the outer diameter of the distal end of the proximal internal tube end 196i and the distal internal tube end 198i, respectively. Preferably, the inner diameters of the protrusions 170i, 172i, 176i, 178i, are substantially equal to the inner diameters of the tubes 10ia, 10ib and/or 194i. 158. 158.

[0158] The aforementioned dimensions may enable coupling of the infusion pump portions to the respective protrusions by inserting the protrusion 170i, 172i, 176i and 178i into the lumens at the ends of the respective pipe portions 10ia, 196i, 10ib and 198i. For example, tube end portions of 10ia, 196i, 10ib and 198i may be heated to enable expansion thereof, to conveniently circumscribe the respective protrusion 170i, 172i, 176i and 178i. 159. 159.

[0159] 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 186i may be disposed over the distal end of the proximal infusion tube 10ia, clamping it over the proximal outer protrusion 170i. A proximal inner clamp 188i may be disposed over the proximal internal tube end 196i, clamping it over the proximal inner protrusion 172i. A distal outer clamp 190i may be disposed over the proximal end of the distal infusion tube 10ib, clamping it over the distal outer protrusion 176i. A distal inner clamp 192i may be disposed over the distal internal tube end 198i, clamping it over the distal inner protrusion 178i. 160. 160.

[0160] According to some embodiments, the proximal outer protrusion 170i and the proximal inner protrusion 172i may define a proximal opening central portion 174i there-between, together forming an inner port through the proximal opening 164i. Similarly, the distal outer protrusion 176i and the distal inner protrusion 178i may define a distal opening central portion 180i there-between, together forming an inner port through the distal opening 166i. 161. 161.

[0161] According to some embodiments, a proximal unidirectional valve 182i is disposed within the proximal opening 164i, along the port defined by the proximal outer protrusion 170i, the proximal opening central portion 174i and the proximal inner protrusion 172i. While the proximal unidirectional valve 182i is shown in Fig. 9B attached to the proximal opening central28 portion 1741, it will be understood that alternative attachment positions are contemplated, such as attachment to the proximal outer protrusion 170i or the proximal inner protrusion 172i. 162. 162.

[0162] According to some embodiments, a distal unidirectional valve 184i is disposed within the distal opening 166i, along the port defined by the distal inner protrusion 178i, the distal opening central portion 180i and the distal outer protrusion 176i. While the distal unidirectional valve 184i is shown in Fig. 9B attached to the distal opening central portion 180i, it will be understood that alternative attachment positions are contemplated, such as attachment to the distal inner protrusion 178i or the distal outer protrusion 176i. 163. 163.

[0163] While the exemplary infusion pump 100h shown in Fig. 9A includes four recesses 170h, 172h, 176h and 178h, and the exemplary infusion pump 100i shown in Fig. 9B includes four protrusions 170i, 172i, 176i and 178i, other embodiments of the infusion pump 100 may include both recesses and protrusions. For example, an infusion pump 100 may include, in some exemplary embodiments, an arrangement of outer protrusions, similar to protrusion 170i and 176i, and inner recesses, similar to recesses 172h and 178h. 164. 164.

[0164] While Figs. 9A-9B show the proximal unidirectional valve 182i, 182h, as well as the distal unidirectional valve 184i, 184h, attached to a portion of the proximal opening 164i, 164h such as the proximal opening central section 174i, 174h, as well as to the distal opening 166i, 166h such as the distal opening central section 180i, 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. 165. 165.

[0165] Reference is now made back to Fig. 1. According to some embodiments, there is provided an infusion system 300 comprising at least one infusion 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 or fluid (e.g., air) toward the at least one infusion pump 100. According to some embodiments, the pressure line 50 comprises at least29 one main tube 52 extending from the pressure source 40. According to some embodiments, the main 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 branch 54a attached to the first pressure inlet 158a, and a second branch 54b attached to the second pressure inlet 158b. 166. 166.

[0166] According to some embodiments, the infusion 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 infusion 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 infusion pump 100 to deliver pulsed flow through an infusion tube 10 extending there-through. 167. 167.

[0167] 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 infusion pump 100. According to some embodiments, the controller comprises a display, such as a digital screen, LED lights, and the like. 168. 168.

[0168] According to some embodiments, components of infusion system 300 may communicate with other components via a network, thus allowing for remote inspection and/or remote control of the infusion 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. 169. 169.

[0169] In embodiments of an infusion pump 100 comprising at least two opposing outer chambers 162, connected to at least two branched tubes 54, the infusion tube 10 may be compressed from more than one side. 170. 170.

[0170] According to some embodiments, the infusion system 300 further comprises an infusion tube 10 coupled to and extending through the at least one infusion pump 100. According to some embodiments, the infusion tube 10 of the infusion system 300 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). According to some embodiments, the infusion tube 10 of the infusion 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 infusion system 300 further comprises an infusion bag 30 (see Fig.30 1). According to some embodiments, the infusion bag 30 of the infusion system 300 is pre filled with infusion fluid. 171. 171.

[0171] The flow rate through the infusion tube 10 mounted within an infusion 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 infusion tube 10 (e.g., diameter and/or wall thickness of the infusion 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 infusion tube 10 (influencing, for example, flexibility and/or resiliency of the infusion tube 10), the material properties of an internal tube portion 194 when present (influencing, for example, flexibility 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 infusion tube 10 and/or internal tube portion 194). 172. 172.

[0172] According to some embodiments, an infusion pump 100 or an infusion assembly 200 may be adapted to provide a desirable flow of infusion fluid there-through, by setting and/or modifying at least one, and preferably at least some, of the variety of aforementioned infusion- flow influencing factors. The infusion-flow influencing factors may be tailored to provide infusion flow which is personalized to the clinical needs of a patient. 173. 173.

[0173] According to some embodiments, different infusion pumps 100 or infusion assemblies 200 may be adapted to provide different desirable flow profiles, according to the needs of different patients. 174. 174.

[0174] In some applications, different infusion pumps 100 or infusion assemblies 200 may be provided with at least some structurally different infusion-flow influencing factors, so as to facilitate different flow profiles of infusion fluids through each. Structurally infusion-flow influencing factors may include, but are not limited to: the geometry of the housing 130 and the membrane 110, the geometry of the infusion tube 10, the material properties of the membrane 110, the material properties of the infusion tube 10, the material properties of an31 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. 175. 175.

[0175] In some applications, different infusion pumps 100 or infusion assemblies 200 may be provided with different pressure inputs through the pressure inlets 158. Different pressure inputs supplied to different infusion pumps 100 or infusion assemblies 200, which are otherwise structurally similar to each other, may result in different flows of the infusion fluids through each of the infusion pumps 100 and/or infusion assemblies 200. Nevertheless, at least two different infusion pumps 100 and/or infusion assemblies 200 may be provided with both differing structural infusion-flow influencing factors, as well as different pressure inputs, together resulting in the desired flow of the infusion fluid through each of the infusion pumps 100 and/or infusion assemblies 200, according to different flow-requirement for each. 176. 176.

[0176] In some applications, the flow of the infusion fluid through a specific infusion pump 100 or an infusion 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 infusion pump 100 or infusion assembly 200, 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. 177. 177.

[0177] While the infusion 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 infusion pump 100, in some applications, a single pressure source 40 and a single controller 60 may be used in combination with a plurality of infusion pumps 100, wherein 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 infusion 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 tubes 54, such that at least one of the branched tubes 54 is coupled to one of the plurality of the infusion pumps 100, and at least one other of the branched tubes 54 is coupled to at least one other infusion pump 100. 178. 178.

[0178] 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 lines32 50 and/or the plurality of branched tubes 54, coupled to at least two of the plurality of the infusion 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 infusion pumps 100 via at least two respective pressure lines 50. 179. 179.

[0179] According to some embodiments, the structurally infusion-flow influencing factors may further include the geometry of the pressure line 50 and/or the branched tubes 54 (e.g., diameter, length), and/or the material properties of the pressure line 50 and/or the branched tubes 54. In some applications, a single pressure source 40 may be tailored to provide different pressure inputs to different infusion pumps 100, via a variety of different pressure lines 50 and/or pressure tubes 54, connected there-between. 180. 180.

[0180] 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 infusion pumps 100 and/or infusion assemblies 200 at the opposite end, may result in different flow of infusion-fluid through at least two of the infusion pumps 100 and/or infusion assemblies 200, by property matching the material properties and/or geometries of the corresponding pressure lines 50 and or branched tubes 54 and the respective infusion pumps 100, as well as setting and/or choosing other structurally infusion-flow influencing factors of the infusion pumps 100 and/or infusion assemblies 200, as mentioned hereinabove. 181. 181.

[0181] According to some embodiments, the infusion pumps 100 and/or infusion 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 clinical or other caretaker to choose an appropriate type of infusion pump 100 and/or infusion assembly 200 for use with a specific patient. 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 tubes 54) may be provided, to be chosen by the clinician or caretaker to connect the pressure source 40 to each infusion pump 100 and/or infusion assembly 200 as necessary. 182. 182.

[0182] 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 infusion-liquids through at least one infusion pump 100 and/or infusion assembly 200. In some applications, the controller may include an interactive interface for33 receiving inputs from an operator, such as a clinician, caretaker or technician, and provide recommendations according to the input data. 183. 183.

[0183] According to some embodiments, the input to a controller may include at least one, and preferably some, of the structurally infusion-flow influencing factors of the infusion pump 100, infusion 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 infusion pump 100, infusion assembly 200 and/or pressure lines 50. This configuration enables the operator to choose, through the interactive interface, pre-stored models of infusion pump 100, infusion assembly 200, pressure lines 50, and/or combinations thereof, which can be retrieved from the database along with associated values of corresponding structural factors. 184. 184.

[0184] According to some embodiments, the input to a controller 60 may further include patient-specific characteristics, such as clinical data of the patient (e.g., age, gender, weight, height, clinical conditions, medications administered to the patient, sensitivity of drugs and/or other compounds, etc.). 185. 185.

[0185] 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 applications, an operator may provide input regarding a chosen type of an infusion pump 100 and/or infusion assembly 200, as well as patient characteristics, 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 infusion pump 100. In some applications, only the patient characteristics may be provided by the operator, and the controller 60 may provide recommendation for a combination of an infusion pump 100 and/or infusion assembly 200, a pressure line 50, and a pressure output waveform from the pressure source 40. 186. 186.

[0186] 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 infusion pumps 100 and/or infusion assemblies 200, pressure lines 50, pressure output waveforms from the pressure source 40 and/or combinations thereof, so as to facilitate34 utilization of a single infusion source 40 with a plurality of infusion pumps 100 and/or infusion assemblies 200 connected to different patients. 187. 187.

[0187] According to some embodiments, the controller 60 may provide more than one option for an infusion pump 100 or infusion assembly 200, pressure line 50, pressure output waveform from the pressure source 40, and/or combinations thereof, which may result in similar flow of infusion-fluid through the infusion pump 100 or infusion assembly 200. An operator is able to choose one of the options according to additional preferences (e.g., cost, availability in stock, etc.). 188. 188.

[0188] While conventional peristaltic pumps are provided with a plurality of reciprocating components, configured to be sequentially urged against the infusion pump, a noticeable advantage of the infusion pump 100 of the current invention is that it may generate fluid flow through an 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 infusion pump 100 to be manufactured at low costs, utilizing relatively fast and simple assembly procedures. 189. 189.

[0189] According to some embodiments, the infusion 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 infusion pump 100 allows it to be used as a disposable pump. 190. 190.

[0190] While demonstrated and illustrated in Fig. 1 in conjunction with a conventional I.V. infusion-type tube for use in medical or hospital environments, it will be clear that the infusion pump 100, infusion assembly 200, multi-pump assembly 1200 and/or infusion system 300, according to any of the embodiments disclosed herein, may be utilized for any other suitable application, including non-medical applications, where controlled fluid delivery may be required, such as filling liquids in packages or containers in the food and/or nutrition industries, various military applications ,and the like. The shape and dimension of different components of the infusion pump 100, as well as the stiffness of the membrane 110, may be tailored to specific requirements depending upon a chosen application. 191. 191.

[0191] 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 single35 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. 192. 192.

[0192] 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. An infusion pump, comprising: a housing comprising: a proximal wall comprising a proximal opening; a distal wall comprising a distal opening; a circumferential wall 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; two lateral extensions extending between opposite sides of the tapering membrane portion and the housing; wherein the proximal opening and the distal opening are aligned with each other, and configured to accommodate an infusion tube; wherein at least one outer chamber is defined between the membrane, the lateral extensions, 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 infusion pump of claim 1, wherein the lateral extension are integrally formed with the membrane.

3. The infusion pump of claim 1, wherein the lateral extension are integrally formed with the housing.37

4. The infusion pump of any one of claims 1 to 3, wherein the housing formed with a relatively uniform elliptical cross-section along its length.

5. The infusion 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 infusion 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 infusion pump is configured to be movable between an open state and a closed state.

7. The infusion pump of claim 6, wherein the two housing sections are hinged to each other along one edge of the two housing sections.

8. The infusion 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 infusion 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 infusion pump of claim 9, wherein the base comprises a channel dimensioned to accommodate the infusion pump.

11. The infusion 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 infusion pump of claim 11, wherein the locking mechanism comprises at least one locking extending from at least one of the housing sections, and at least one locking recess comprised within the opposing housing section,38 wherein the at least one locking pin is configured to press-fit into the respective at least one locking recess.

13. The infusion pump of claim 11, wherein the locking mechanism comprises at least one latch.

14. The infusion 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 infusion 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 infusion 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 infusion 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 infusion pump of any one of claims 1 to 17, further comprising an internal flexible 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 infusion 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 infusion pump of claim 18, wherein the proximal opening comprises a proximal outer recess, configured to accommodate a distal end of a proximal infusion tube, and wherein the distal opening comprises a distal outer recess, configured to accommodate a proximal end of a distal infusion tube.39

21. The infusion 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 infusion tube, and wherein the distal opening comprises a distal outer protrusion, configured to connect with a proximal end of a distal infusion tube.

23. The infusion 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 infusion pump of any one of claims 18 to 23, further comprising a distal unidirectional valve attached to the distal opening.

25. The infusion pump of any one of claims 18 to 23, further comprising a proximal unidirectional valve attached to the proximal opening.

26. An infusion assembly comprising the infusion pump of any one of claims 1 to 17, and the infusion tube extending through and mounted within the infusion pump.

27. The infusion assembly of claim 26, wherein the infusion tube further comprises a proximal unidirectional valve.

28. The infusion assembly of claims 26 or 27, wherein the infusion tube further comprises a distal unidirectional valve.

29. The infusion assembly of any one of claims 26 to 28, further comprising an infusion bag.

30. A multi-pump assembly comprising a plurality of infusion pumps of any one of claims 1 to 17, and the infusion tube, wherein the plurality of infusion pumps are serially mounted over the infusion tube.

31. The multi-pump assembly of claim 30, wherein the plurality of infusion pumps are mounted in the same orientation over the infusion tube.40

32. An infusion system comprising at least one infusion 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 infusion pump.

33. The infusion system of claim 32, wherein the pressure source is a gas pump.

34. The infusion system of claims 32 or 33, further comprising a controller, configured to control the functioning of the infusion pump.

35. The infusion system of any one of claims 32 to 34, further comprising at least one infusion tube, extending through and mounted within the at least one infusion pump.

36. The infusion system of any one of claims 32 to 35, wherein the at least one pressure line comprises a main tube, which is branched at its distal portion to at least two tubular branches.

37. The infusion system of any one of claims 32 to 36, further comprising an infusion bag.

38. The infusion system of any one of claims 32 to 37, wherein the at least one infusion pump comprises a plurality of infusion pumps. Webb+Co. Patent Attorneys1/9 30 54a 100 60 40 54b 10 52 200 50 300 FIG. 12/9 100 136 158 130a 134 10 130 166 142 144 130b FIG. 2A 112 132 136 162 158a 118 116 130 160 10 134 164 166 120 20 110 158b 114 FIG. 2B 112 136 130 118 158a 160a 162a 120 134 20 132 166 R d R p 114 10 164 162b 116 158b 110 160b FIG. 2C3/9 112a 124a 100 114a 116a 144a 132a 154 158a 136a 116b 10 122a 166a 122b 164a 112b 124b 164b 110 114b 134a 132b 142a, 142b 144b 156 166b 130 136b FIG. 3A 134b 112a 154 144a 132a 136a 124a 100 164a 154 116a 142 134a 132b 114a 166a 112b 122a 156 116b 122b 124b 136b 144b 156 114b 134b 10 FIG. 3B4/9 100a 158aa 10 160aa 162aa 162ab 130a 160ab 158ab FIG. 4A P1 10 164a 166a FIG. 4B P2 P1 FIG. 4C5/9 P1 P2 FIG. 4D P1 P2 FIG. 4E P2 P1 FIG. 4F6/9 132b 130b 158b 134b 168b FIG. 5A 132c 158c 130c 134c FIG. 5B 158d 132d 130d 134d FIG. 5C7/9 144ea 154e 130ea 132ea 124ea 136ea 10 164ea 100e 154e 122eb 134ea 164eb 166ea 132eb 110e,116e 122eb 144eb 156e 124eb 142eb 130eb, 166eb 152e 150e 156e 134eb FIG. 6A 130ea 112e 158e 160e 116e 132e 134e 162e 114e 130e 166e 164e 130eb,150e 10 FIG. 6B 130f 200 112f 100f 158f 116f 10f 114f 164f 166f 132f 14 134f 110f 160f 162f FIG. 78/9 1200 100 10 100 FIG. 8A 130 130 100 100 110 110 10 FIG. 8B9/9 100h 136h 130h 158h 172h 174h 178h 132h 134h 180h 170h 176h 164h 182h 184h 166h 10ha 10hb 196h 194h 198h 162h 160h FIG. 9A 100i 136i 130i 158i 196i 192i 172i 178i 132i 134h 180i 186i 174i 166i 170i 176i 182i 184i 164i 10ia 190i 10ib 188i 162i 194i 198i 160i FIG. 9B1 INFUSION PUMP