WO2021165967A1 - Appareil de collecte de sang extensible - Google Patents

Appareil de collecte de sang extensible Download PDF

Info

Publication number
WO2021165967A1
WO2021165967A1 PCT/IL2021/050193 IL2021050193W WO2021165967A1 WO 2021165967 A1 WO2021165967 A1 WO 2021165967A1 IL 2021050193 W IL2021050193 W IL 2021050193W WO 2021165967 A1 WO2021165967 A1 WO 2021165967A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood bag
shape memory
flexible
blood
memory support
Prior art date
Application number
PCT/IL2021/050193
Other languages
English (en)
Inventor
Ronen Nahary
Eliav Korakh
Nili Philipp
Arava KORAKH
Original Assignee
Ronen Nahary
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from IL272785A external-priority patent/IL272785A/en
Application filed by Ronen Nahary filed Critical Ronen Nahary
Publication of WO2021165967A1 publication Critical patent/WO2021165967A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/64—Containers with integrated suction means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150038—Source of blood for blood from umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150366—Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0462—Placental blood, umbilical cord blood

Definitions

  • the disclosed technique relates to an apparatus for collecting blood, in general, and to systems and methods for collecting cord blood following birth, in particular.
  • Cord blood is used to harvest hematopoietic and mesenchymal progenitor cells for use in bone marrow transplants and blood transfusions. Consequently, the collection of cord blood following childbirth has become a routine procedure in many hospitals.
  • Cord blood is typically collected by draining the umbilical cord after childbirth. It can be collected using either an open or closed circuit system. Open circuit systems allow for faster collection of larger volumes of cord blood; however these are prone to contamination by bacteria. By contrast, closed circuit systems provide greater protection against contamination, but they are slow and yield a smaller amount of cord blood.
  • the vein of the umbilical cord is typically punctured with a needle.
  • the blood is drawn into a sterile receptacle, such as a blood bag or syringe containing an anti-coagulant.
  • a sterile receptacle such as a blood bag or syringe containing an anti-coagulant.
  • This process is slow, and can demand considerable time from nursing staff to massage, or ‘milk’ the umbilical cord and coax more blood flow into the receptacle.
  • sterility and regulatory requirements restricts the introduction of additional flow-inducing systems, such as pumps, for the collection of cord blood.
  • cord blood may be harvested prior to the delivery of the placenta, as post-childbirth contractions can enhance the flow of the cord blood out of the umbilical cord.
  • Fig. 1 illustrates a conventional regulation approved cord blood bag, generally referenced 10, which is known in the art and intended for use in a sterile environment.
  • Blood bag 10 has a port 12 and a label 14.
  • Blood bag 10 typically has a fill volume on the order of 200ml, and is supplied, in advance, with an anticoagulant, such as Citrate Phosphate Dextrose Solution USP (CPD).
  • CPD Citrate Phosphate Dextrose Solution USP
  • blood bag 10 has multiple ports, such as an inlet port, an outlet port and an injection site (not shown).
  • U.S. patent application publication no. 2016/0177250 to Arm et al. entitled “Tissue Transfer System” is directed to a system for collecting tissue, such as cord blood, by placing a tissue vessel (e.g. a flexible bag) inside a rigid canister that can withstand negative pressure without imploding.
  • the canister is provided with two ports. The first port is coupled to a conduit for harvesting tissue into the tissue vessel.
  • the second port is coupled to a vacuum source, such as a pump, syringe, and the like.
  • U.S. patent no. 5,097,842 to Bonn entitled “Device for Withdrawing
  • Fluids is directed to a system for collecting cord blood and routing the cord blood to multiple test tubes.
  • a valve housing is provided to direct the collected cord blood to each desired test tube.
  • U.S. patent no. 9,375,168 B2 to Shacham, entitled “Apparatus and Method for Collecting Cord Blood” is directed to open and closed systems for collecting cord blood.
  • the open system provides an apparatus into which the umbilical cord is inserted.
  • the apparatus applies pressure to the walls of the umbilical cord to induce blood flow.
  • the closed system provides an apparatus for disinfecting blood collecting bags and/or test tubes to reduce the risk of contamination.
  • PCT patent application publication no. WO 2005/041772 A2 to Patrice, entitled “Placental Blood Sampling Device” is directed to a system for collecting placental blood.
  • a needle for perforating the vein of the umbilical is connected to a suction means adapted to draw out placental blood.
  • the suction means includes a jar having a vacuum induced by a pump.
  • French patent application publication FR 2,677,254 A1 to Gadrat titled “Dispositif Medical de Recuperation et de Transfusion de Sang” is directed to an expandable blood collection apparatus with a blood bag provided with handles disposed on either side.
  • a practitioner holds the handles to pull them apart, thereby directly coupling both sides of the blood bag via the practitioner.
  • the blood bag may be positioned inside the jaws of a holder for pulling the sides apart. The jaws of the holder are coupled together, thereby coupling the two sides of the blood bag via the holder.
  • U.S. patent US 4,642,088 to Gunter titled “Apparatus for Receiving and Reinfusing Blood” describes an expandable blood bag with a compressible concertina-like structure.
  • the concertina structure encases and surrounds the entire blood bag, thereby directly coupling all sides of the blood bag.
  • the blood bag is additionally configured with an externally protruding holding structure that mechanically couples opposing sides of the blood bag.
  • the Device is directed to a fluid collection device having a blood bag provided with two stiffening panels on either side.
  • the panels are secured in place by an outer bag that encases the panels with the blood bag.
  • the device is operated by placing the blood bag with the encased panels inside a cylindrical holding structure.
  • the holding structure applies pressure, which bends the panels outwards and expands the blood bag.
  • the panels are coupled with each other via the encasing bag, and additionally via the holder.
  • a blood collecting apparatus comprising: a flexible blood bag configured to have at least a collapsed configuration enclosing a first volume and an expanded configuration enclosing a second volume, wherein the first volume is smaller than the second volume; and at least one shape memory support mechanically coupled with a first external side of the flexible blood bag, the at least one shape memory support configured to take on a first form and a second form, wherein the at least one shape memory support is mechanically decoupled from an opposite external side of the flexible blood bag, externally to the flexible blood bag, wherein the shape of the opposite external side is secured, wherein transforming the at least one shape memory support from the first form to the second form applies a mechanical force on the flexible blood bag that increases the distance between the at least first external side and the opposite external side of the flexible blood bag, and wherein the increased distance transforms the flexible blood bag from the collapsed configuration to the expanded configuration, thereby reducing the pressure inside the flexible blood bag to accelerate the rate for drawing blood into the flexible blood bag.
  • a method for accelerating the rate for drawing blood into a flexible blood bag comprising: providing a flexible blood bag configured to have a first, collapsed configuration enclosing a first volume and a second, expanded configuration enclosing a second volume, wherein the first volume is smaller than the second volume; and providing at least one shape memory support configured to take on a first form and a second form, wherein the at least one shape memory support is configured to be mechanically coupled to at least a first external side of the flexible blood bag, and mechanically decoupled from an opposite external side of the flexible blood bag, externally to the flexible blood bag, and wherein the shape of the opposite external side is configured to be secured, wherein transforming the at least one shape memory support from the first form to the second form, when the at least one shape memory support is mechanically coupled to the first external side of flexible blood bag applies a mechanical force on the flexible blood bag that increases the distance between the at least first external side and the opposite external side of the flexible
  • the method further comprises mechanically coupling the at least one shape memory support to the first external side of the flexible blood bag, wherein the at least one shape memory support is mechanically decoupled from the opposite external side of the flexible blood bag, externally to the flexible blood bag.
  • the at least one shape memory support comprises a spring, wherein the first form corresponds to a compressed configuration of the spring and the second form corresponds to a relaxed configuration of the spring, the method further comprising mechanically coupling the spring to the first external side of the flexible blood bag while the spring is in the compressed configuration and the flexible blood bag is in the collapsed configuration.
  • the method further comprises mechanically coupling an element with the opposite external side of the flexible blood bag, wherein the element is mechanically decoupled from the at least one shape memory support, externally to the flexible blood bag, and wherein the element supports the shape of the opposite external side to resist assuming the second form of the at least one shape memory support.
  • the element comprises a second spring, the method further comprising mechanically coupling the second spring to the opposite external side of the flexible blood bag while the second spring is in a compressed configuration and the flexible blood bag is in the collapsed configuration.
  • the method further comprises fastening the opposite external side of the flexible blood bag to a surface, wherein the surface is mechanically decoupled from the at least shape memory support, externally to the flexible blood bag, and wherein the surface supports the shape of the opposite external side to resist assuming the second form of the at least one shape memory support.
  • the method further comprises fluidly coupling an input port of the flexible blood bag with a blood source, wherein the input port is fitted with a hermetic seal and a valve configured to break the hermetic seal, and breaking the hermetic seal by releasing the valve to draw blood from the blood source which increases a fluid volume inside the flexible blood bag and at least partially transforms the at least one shape memory support to the second form, thereby accelerating the rate for drawing blood into the flexible blood bag.
  • a kit for a blood collecting apparatus comprising: a flexible blood bag configured to have at least a collapsed configuration enclosing a first volume and an expanded configuration enclosing a second volume, wherein the first volume is smaller than the second volume; and at least one shape memory support configured to be mechanically coupled with a first external side of the flexible blood bag, and mechanically decoupled from an opposite external side of the flexible blood bag, externally to the flexible blood bag, wherein the at least one shape memory support is configured to take on a first form and a second form, and wherein the shape of the opposite external side is configured to be secured, wherein transforming the at least one shape memory support from the first form to the second form applies a mechanical force on the flexible blood bag that increases the distance between the first external side and the opposite external side of the flexible blood bag; and wherein the increased distance transforms the flexible blood bag from the collapsed configuration to the expanded configuration, thereby reducing the pressure inside the flexible blood bag to accelerate the rate
  • the apparatus and kit further comprise at least one spring having a compressed configuration and a relaxed configuration.
  • the at least one spring is plate-shaped.
  • the at least one spring comprises a bi-stable element.
  • the at least one spring is a wire. ln some embodiments, the at least one spring is bar-shaped.
  • the compressed configuration is flat.
  • the compressed configuration is concave.
  • the relaxed configuration is convex. In some embodiments, the relaxed configuration is flat.
  • the at least one shape memory support comprises a first one of the at least one spring, wherein the first form of the at least one shape memory support corresponds to the compressed configuration of the first one of the at least one spring, and wherein the second form of the at least one shape memory support corresponds to the relaxed configuration of the first one of the at least one spring, wherein the first one of the at least one spring is mechanically coupled with the first external side of the flexible blood bag while the first one of the at least one spring is in the compressed configuration and the flexible blood bag is in the collapsed configuration.
  • the apparatus and kit further comprise an element configured to be mechanically coupled with the opposite external side of the flexible blood bag and mechanically decoupled from the at least one shape memory support, externally to the flexible blood bag, wherein the element is configured to secure the shape of the opposite external side to resist assuming the second form of the at least one shape memory support.
  • the element comprises a stiff plate.
  • the element comprises a second shape memory support.
  • the second shape memory support comprises a second one of the at least one spring.
  • the apparatus and kit further comprise a fastener configured to fasten the opposite external side of the flexible blood bag to a surface securing the shape of the opposite external side, wherein when the opposite external side of the flexible blood bag is fastened to the surface via the fastener, the surface is mechanically decoupled from the at least one second shape memory support, externally to the flexible blood bag, and supports the shape of the opposite external side to resist assuming the second form of the at least one shape memory support.
  • the apparatus and kit further comprise an input port fitted with a hermetic seal configured to constrain a fluid volume inside the flexible blood bag and prevent the at least one shape memory support from transforming to the second form, and a valve configured to break the hermetic seal, wherein releasing the valve when the input port is fluidly coupled to a blood source breaks the hermetic seal, thereby drawing blood from the blood source into the flexible blood bag which increases a fluid volume inside the flexible blood bag and at least partially transforms the at least one shape memory support to the second form.
  • a hermetic seal configured to constrain a fluid volume inside the flexible blood bag and prevent the at least one shape memory support from transforming to the second form
  • a valve configured to break the hermetic seal
  • Figure 1 illustrates a conventional cord blood bag, known in the art and intended for use in a sterile environment
  • FIGS. 4A-4B taken together, illustrate an apparatus for an expandable blood bag, constructed and operative in accordance with a further exemplary embodiment of the disclosed technique
  • FIGS. 5A-5D taken together, illustrate an apparatus for an expandable blood bag, constructed and operative in accordance with another exemplary embodiment of the disclosed technique
  • FIGS. 5E-5F taken together, illustrate a profile view of an apparatus constructed and operative in accordance with a further embodiment of the disclosed technique
  • Figures 7A-7C, taken together, illustrate an apparatus for an expandable blood bag, constructed and operative in accordance with a further exemplary embodiment of the disclosed technique
  • FIGS. 8A-8D taken together, illustrate an apparatus for an expandable blood bag, constructed and operative in accordance with another exemplary embodiment of the disclosed technique
  • Figure 9 is a schematic illustration of a first method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique
  • Figure 10 is a schematic illustration of a second method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with another embodiment of the disclosed technique
  • FIGS 11A-11B taken together, illustrate an apparatus for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique
  • Figures 11C-11G, taken together, illustrate an apparatus for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with another embodiment of the disclosed technique
  • Figures 11 H-11 J, taken together, illustrate an apparatus for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique
  • FIGS 11K-11L taken together, illustrate an apparatus for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with another embodiment of the disclosed technique
  • Figure 12 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique
  • Figure 13 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with another embodiment of the disclosed technique
  • FIGS 14A-14H taken together, illustrate implementations for an apparatus for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique
  • FIGS. 15A-15B taken together, illustrate an apparatus for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with another embodiment of the disclosed technique
  • Figure 16 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique.
  • Figure 17 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with another With reference to Figures 11 C-11 F, embodiment of the disclosed technique.
  • the disclosed technique overcomes the disadvantages of the prior art by providing a flexible blood bag that can transform from a collapsed configuration to an expanded configuration, thereby increasing the volume inside the bag.
  • the increased volume creates a vacuum relative to the ambient pressure, which accelerates the rate for drawing cord blood into the bag.
  • the configuration transformation from collapsed state into expanded state is implemented via at least one shape memory support that is mechanically coupled to areas on the external surface of a sealed blood bag. Actuating the at least one shape memory support transforms it from a first form to a second form, which serves to expand the volume of the bag when sealed thus creating a pressure differential.
  • the shape memory supports may be designed to comply with regulatory requirements governing blood bags and accommodate a label for recording details. In this manner, cord blood may be harvested efficiently in a process that demands less time and effort from nursing staff, while complying with regulation standards.
  • shape memory support as used herein is understood to be a structure capable of supporting the shape of a flexible material.
  • the shape memory support of the disclosed technique is deformable and can take on multiple discrete forms. At least one of the discrete forms is “relaxed”.
  • the shape memory support “remembers” the relaxed form in the sense that it tends to revert to the relaxed form (i.e. , a loaded spring would tend to release back to its relaxed form) by itself, regardless of any external mechanical force that would be applied.
  • the shape memory support of the disclosed technique may include one or more coil springs, plate-shaped springs, flat or curved wire-shaped springs, bar-shaped springs, bi-stable structures, and the like. This list is not intended to be limiting.
  • the springs may be made of an alloy of multiple substances, such as a bi-stable material, or alternatively may be made of a single substance, such a metal or plastic.
  • shape memory support of the disclosed technique may include one or more elastic elements, it may include additional elements for supporting a given shape, such as bars, panels, hinges, and the like.
  • the flexible blood bag of the disclosed technique is a blood bag that has passed regulatory requirements, for example the prior art blood bag of Figure 1.
  • the shape memory supports are coupled to areas on the external surface of the blood bag, and thus do not affect the sterility of the bag.
  • the shape memory supports are implemented using purely mechanical means, precluding the need for an external pump or power supply.
  • the shape memory supports of the disclosed technique do not significantly affect the size or shape of the blood bag when not in use, and thus the blood bag of the present invention is substantially the same size and shape as a conventional blood bag, allowing the blood bag of the present invention to be stored and transported while incurring minimal to no adjustments.
  • FIGS 2A-2FI illustrate an apparatus for an expandable blood bag, generally referenced 100, constructed and operative in accordance with an exemplary embodiment of the disclosed technique.
  • apparatus 100 is shown in two possible configurations from a two-point perspective.
  • Figure 2A shows apparatus 100 in the collapsed configuration
  • Figure 2B shows apparatus 100 in the expanded configuration.
  • Apparatus 100 includes a flexible blood bag 102, multiple shape memory supports 104- 1 , 104 2 , and 104 3 , a tube 106, and a blood collecting needle 108.
  • Blood bag 102 is further provided with at least an inlet port 110, and optionally, one or more additional ports, such as an outlet port 112 and an injection port 114.
  • Ports 110, 112 and 114 may be fitted with a hermetic seal to maintain sterility and prevent contamination.
  • Blood bag 102 is made of flexible, high molecular weight PVC that has undergone a validated sterilization process in accordance with regulatory standards.
  • blood bag 102 stores an amount of anticoagulant, for example an amount of CPD solution, and has a capacity to store a predetermined amount of umbilical cord blood, i.e. 200ml.
  • Tube 106 is fluidly coupled to inlet port 110 of blood bag 102.
  • Blood collecting needle 108 is fluidly coupled to tube 106. Blood collecting needle 108 is shown inserted into a vein of umbilical cord 116, fluidly coupling the flow of blood from umbilical cord 116 to the sterile interior of blood bag 102 via tube 106 and inlet port 110.
  • Shape memory support 104i is mechanically coupled to the left side of blood bag 102 at left corner sections 118 (top front), 120 (top rear), 122 (bottom front) and 124 (bottom rear).
  • Shape memory support 104 2 is mechanically coupled to the right side of blood bag 102 at right sections 126 (bottom front), 128 (bottom rear), 130 (top front) and 132 (top rear).
  • Shape memory support 104 3 is mechanically coupled to the bottom base of blood bag 102 at bottom sections 122 (front left), 124 (rear left), 126 (front right) and 128 (rear right).
  • Shape memory supports 104i, 104 2 , and 104 3 may be coupled to blood bag 102 using any suitable technique, such as via an adhesive, a suction, mechanical clips, hooks, Velcro® and the like.
  • Shape memory supports 104- 1 , 104 2 , and 104 3 may be made of any suitable material, such as plastic (e.g. acrylic or polyethylene plastic), metal (e.g. steel), or a combination thereof.
  • shape memory supports 104i, 104 2 , and 104 3 are made of a shape memory alloy, such as Nitinol.
  • Each of shape memory supports 104- 1 , 104 2 , and 104 3 includes a pair of crossed rods 112i, 112 2 , and 112 3 , coupled to expandable frames 114i, 114 2 , and 114 3 respectively.
  • Frames 114i and 114 3 share a side at sections 122 and 124 of blood bag 102, and frames 114 2 and 114 3 share a side at sections 126 and 128 of blood bag 102.
  • Crossed rods 112-i, 112 2 , and 112 3 are arranged to form an expandable “X-shape” within each of expandable frames 114-i, 114 2 , and 114 3 , such that opening each “X-shape” expands frames 114i, 114 2 , and 114 3.
  • Shape memory supports 104i, 104 2 , and 104 3 further include one or more compression springs integrated within expandable frames 114i, 114 2 , and 114 3 , allowing opposing sides of frames 114i, 114 2 , and 114 3 to lengthen when the compression springs are released.
  • springs 134 and 136 are integrated within frame 114i
  • springs 138 and 140 are integrated within frame 114 3
  • springs 136 and 140 are integrated within frame 114 3. It is to be noted that in the example shown, springs are integrated to widen blood bag 102, however the springs may be additionally or alternatively integrated to lengthen blood bag 102.
  • Spring 134 allows frame 114i to widen between top left sections 118 (front) and 120 (rear), and spring 136 allows frame 114- 1 to widen between bottom left sections 122 (front) and 124 (rear).
  • Spring 138 allows frame 114 2 to widen between top right sections 130 (front) and 132 (rear), and spring 140 allows frame 114 2 to widen between bottom right sections 126 (front) and 128 (rear).
  • Spring 136 allows frame 114 3 to widen between bottom left sections 122 (front) and 124 (rear), and spring 140 allows frame 114 3 to widen between bottom right sections 126 (front) and 128 (rear). Releasing springs 134, 136,
  • At least one release is provided to actuate shape memory supports 104i, 104 2 , and 104 3 by releasing springs 134, 136, 138, and 140, which expands frames 114-i , 114 2 , and 114 3.
  • springs 134, 136, 138, and 140 are released to accelerate the drawing of blood from umbilical cord 110. This actuates shape memory supports 104i, 104 2 , and 104 3 and transforms these from the collapsed form of Figure 2A to the expanded form of Figure 2B.
  • the transformation applies a mechanical force on blood bag 102 that increases the average distance between sections 118 and 120, 122 and 124, 126 and 128, and 130 and 134 of blood bag 102 from D1 (Figure 2A) to D2 ( Figure 2B), where D1 is smaller than D2.
  • the increased average distance, D2-D1 transforms blood bag 102 from the collapsed configuration ( Figure 2A) to the expanded configuration ( Figure 2B).
  • blood bag 102 In the collapsed state, blood bag 102 encloses a first, smaller volume, corresponding to D1 , whereas in the expanded state, blood bag 102 encloses a second, larger volume, corresponding to D2.
  • ports 110, 112, and 114 of blood bag 102 are sealed, the increased volume reduces the internal pressure relative to the ambient pressure.
  • the pressure gradient induces a suction which accelerates the flow of cord blood from umbilical cord 116, via tube 106 and inlet port 110 into the interior of blood bag 102.
  • a greater volume of cord blood may be collected in a shorter period of time.
  • apparatus 100 further includes a control release 122 (not shown) coupled to release 120.
  • Control release 122 allows controlling the rate at which blood bag 102 transforms from the collapsed configuration to the expanded configuration, and thus control the rate for drawing cord blood from umbilical cord 116. This is to avert the possibility of the soft bodily tissue of umbilical cord 116 from being suctioned around blood collecting needle 108, which may clog the opening of needle 108 and block the flow of the cord blood into blood bag 102.
  • FIGS 2C-2D show the bottom face of blood bag 102 of Figures 2A-2B, in the collapsed configuration ( Figure 2C) and the expanded configuration ( Figure 2D), constructed and operative in accordance with an embodiment of the disclosed technique.
  • Frame 114 3 of shape memory support 104 3 is coupled to the bottom corner sections 122 (bottom front left), 124 (bottom rear left), 126 (bottom front right) and 128 (bottom rear right) of blood bag 102.
  • Crossed rods 112 3 are coupled to frame 114 3 at the corners, corresponding to corner sections 122, 124, 126 and 128 of blood bag 102.
  • FIGS 2E-2F show the left face of blood bag 102 of Figures 2A-2B, in the collapsed configuration ( Figure 2E) and the expanded configuration ( Figure 2F), constructed and operative in accordance with an embodiment of the disclosed technique.
  • Frame 114i of shape memory support 104i is coupled to left corner sections 118 (left front top), 120 (left rear top), 122 (left front bottom) and 124 (left rear bottom), of blood bag 102.
  • Crossed rods 112i are coupled to frame 114i at the corners, corresponding to left corner sections 118, 120, 122 and 124.
  • FIGS 2G-2FI show the right face of blood bag 102 of Figures 2A-2B, in the collapsed configuration ( Figure 2G) and the expanded configuration ( Figure 2H), constructed and operative in accordance with an embodiment of the disclosed technique.
  • Frame 114 2 of shape memory support 104 2 is coupled to right corner sections 126 (right front bottom), 128 (right rear bottom), 130 (right front top) and 132 (right rear top) of blood bag 102.
  • Crossed rods 112 2 are coupled to frame 114 2 at the corners, corresponding to left sections 126, 128, 130 and 132.
  • FIG. 2A-2FI are intended to illustrate the general concept of the disclosed technique, and do not limit the present invention to a specific implementation.
  • apparatus 100 may include more or fewer shape memory supports than the shape memory supports shown.
  • the shape memory supports may be non-rectangular to accommodate the geometry of typical, non-cuboid blood bags, and may be coupled at sections further towards the center to accommodate blood collections bags having flat sealed edges that are non-expandable.
  • Apparatus 200 is substantially similar to apparatus 100 of Figures 2A-2FI with the notable exception of the addition of one or more stiffening means coupled to the shape memory supports and middle sections of blood bag 202, to prevent the middle sections of blood bag 102 from collapsing due to the induced suction.
  • the stiffening means are implemented as support bars 250, 252 positioned on the front face of blood bag 202 and drawn with solid lines, and support bars 254 and 256 positioned on the rear face of blood bag 202 and drawn with dashed lines.
  • Support bars 250, 252, 254, and 256 may be made of a suitable stiff material, such as plastic acrylic, epoxy, polystyrene and the like, or metal such as steel or aluminum. Similar to apparatus 100 above, apparatus 200 includes a blood bag 202, having ports 210, 212 and 214. Port 210 is fluidly coupled to a tube 206, which is fluidly coupled to an umbilical cord 216 via a needle 208. Three shape memory supports 204- 1 , 204 2 and 204 3 are mechanically coupled to the right section, left section and bottom section of blood bag 102, corresponding to shape memory supports 104i, 104 2 , and 104 3 of Figures 2A-2G, respectively.
  • a suitable stiff material such as plastic acrylic, epoxy, polystyrene and the like, or metal such as steel or aluminum.
  • apparatus 200 includes a blood bag 202, having ports 210, 212 and 214. Port 210 is fluidly coupled to a tube 206, which is fluidly coupled to an umbilical cord
  • shape memory supports 204- I , 204 2 , and 204 3 include frames 214-i, 214 2 , and 214 3 mechanically coupled to bars 212i, 212 2 , and 212 3 arranged in X-shapes, and springs 234, 236, 238, and 240, respectively, coupled to at least one release 220 (not shown).
  • Support bars 250, 252 are coupled to front facing sections of shape memory supports 204- I and 204 2 and to front middle sections 260, 262, 264, and 266 of blood bag 202, such as via an adhesive, hooks, Velcro® and the like.
  • Rear-facing support bars 254, 256 are coupled to rear facing sections of shape memory supports 204i and 204 2 and to rear middle sections 268, 270, 272 , and 274 of blood bag 202.
  • Upper front middle section 260 is opposite to upper rear middle section 268, upper front middle section 262 is opposite to upper rear middle section 270, lower front middle section 264 is opposite to lower rear middle section 272, and lower front middle section 266 is opposite to lower rear middle section 274.
  • shape memory supports 204i, 204 2 , and 204 3 Prior to actuating shape memory supports 204i, 204 2 , and 204 3 , the distance between opposing sections 260 and 268, 262 and 270, 264 and 272, and 266 and 274, is D1. Once shape memory supports 204- I , 204 2 , and 204 3 have been actuated to release springs 234, 236, 238, and 240, and expand the “X-shape” formed by crossed bars 212i , 212 2 , and 212 3, frames 214i , 214 2 , and 214 3 , expand accordingly.
  • Support bars 224i, 224 2 , 224 3 , and 224 4 exert a mechanical force on opposing middle sections 260 and 268, 262 and 270, 264 and 272, and 266 and 274 to increase their average distance to approximately D2 from D1 , allowing for some distortions due to the flexibility of blood bag 202.
  • support bars 250, 252, 254, and 256 are but an exemplary implementation for a stiffening means to prevent the middle portions of blood bag 102 from collapsing due to the induced suction, and that other shapes may be used, such as longitudinally oriented bars, or a flat plate accommodating a label, such as label 14 of Figure 1.
  • the distances between sections of blood bag 202 are shown as uniform, i.e. D1 for the collapsed state and D2 for the expanded state, this is merely intended to simplify the description, and the invention may accommodate distortions, i.e. for non-cuboid bags. Additional embodiments may allow for variations in the respective distances, in keeping with the overall goal that the distances between corresponding sections of the blood bag of the present invention are greater in the expanded state than in the collapsed state, and the overall average distance is greater.
  • apparatus 300 includes a blood bag 302, having ports 310, 312, and 314.
  • Inlet port 310 is fluidly coupled to a tube 306, which is fluidly coupled to an umbilical cord 316 via a needle 308.
  • Apparatus 300 further includes multiple expandable ring-shaped shape memory supports, i.e. expandable rings 304i and 304 2 , encircling blood bag 302.
  • Expandable rings 304- I and 304 2 are configured to take on a first, collapsed form having a smaller diameter, and a second expanded form having a larger diameter. Although two shape memory supports are shown in Figures 4A-4B, it is to be noted that more or fewer shape memory supports may be used.
  • Figure 4A shows shape memory supports 304i and 304 2 in the collapsed form before actuation
  • Figure 4B shows shape memory support 304i and 304 2 in the expanded form, after actuation.
  • Shape memory supports 304i and 304 2 are mechanically coupled to multiple sections of blood bag 302.
  • Shape memory support 304i is mechanically coupled to sections 318, 320, 322, 324, 326, and 328 forming an upper ring encircling blood bag 302.
  • Shape memory support 304 2 is mechanically coupled at sections 330, 332, 334, 336, 338, and 340, forming a lower ring encircling blood bag 302.
  • Section 318 (front-left-top) is opposite from section 320 (rear-left- top).
  • Section 328 (front-middle-top) is opposite from section 322 (rear-middle- top).
  • Section 326 (front-right-top) is opposite from section 324 (rear-right-top).
  • Shape memory supports 304i and 304 2 may be made of an elastic material that operates as a spring mechanism, such as composites made from aluminum, steel, copper, plastic, and the like. The spring mechanism can alternatively take on a collapsed form ( Figure 4A) and an expanded form ( Figure 4B). Alternatively, shape memory supports 304 ! and 304 2 are rings with overlapping sections for tightening the rings to span a smaller diameter. Releasing the overlapping sections opens rings 304i and 304 2 to span a larger diameter.
  • Apparatus 500 is substantially similar to those described herein above with the notable difference that shape memory supports are implemented with a bi-stable element, such as one or more bi-stable plates 504 affixed to the surface of the blood bag.
  • Bi-stable plates 504 are made of a bi-stable material having two relaxed modes, or configurations. Each of bi-stable plates 504 operates on the side of the bag coupled therewith, independently of the other side. Applying an external force transform the bi-stable material from one relaxed mode to the other.
  • each of bi-stable plates 504 may operate as a reference plate to the action of the other one of bi-stable plates 504, by resisting to assume the relaxed configuration of the other bi-stable plate 504 as the other bi-stable plate is transformed by an external force.
  • Apparatus 500 includes a blood bag 502 having an input port 510, an output port 512, and an injection port 514, a non-expandable, flat sealed perimeter 520, a front middle section 522, indicated as a solid star, and an opposing rear middle section 524, shown as a dashed star.
  • Blood bag 502 is expandable at least between front middle section 522 and opposing rear middle section 524.
  • blood bag 502 is a standard, commercially available cord blood bag.
  • Apparatus 500 further includes a bi-stable plate 504 F (front) coupled with the front face of blood bag 502 at least at flexible front middle section 522 and another bi-stable plate 504 R (rear) coupled with the rear face of blood bag 502 at least at flexible rear middle section 524.
  • Bi-stable plates 504 F and 504 R are made of any suitable bi-stable material as is known in the art, such as plastic or metal layers that are combined to alternately take on a flat form or a convex form when subjected to mechanical stress. In some embodiments, bi-stable plates 504 F and 504 R may assume a concave form.
  • Figures 5A-5B show blood bag in the collapsed configuration from a front view (Figure 5A) and profile view ( Figure 5B), with bi-stable plates 504 F and 504 R in the flat form.
  • the distance between front middle section 522 and rear middle section 524 is D1.
  • Figures 5C- 5D show blood bag in the expanded configuration from a front view ( Figure 5C) and profile view ( Figures 5D) after a mechanical stress has been applied to transform bi-stable plates 504 F and 504 R towards the convex form.
  • the distance between front middle section 522 and rear middle section 524 has increased to D2 from D1, with the internal volume increasing accordingly to induce a suction.
  • a nurse may apply an external force to blood bag 502 to transform bi-stable plates 504 F and 504 R to the convex form, thereby inducing a suction which accelerates the flow of cord blood into blood bag 502.
  • bi-stable plates 504 F and 504 R may be transformed by fluidly coupling blood bag to a blood flow, as describes herein below.
  • Apparatus 530 is substantially similar to apparatus 500 described above, with the notable difference that only one bi-stable plate is provided.
  • Apparatus 530 includes blood bag 532 having at least one port 534 and a flat sealed perimeter 536 where blood bag 532 is not expandable.
  • One face 538 of blood bag 532 is flexible and the opposite face 540 is made of a sufficiently stiff material, such as hard plastic, acrylic, or metal, to resist a subsequently induced suction, and thus serving as a reference surface.
  • a bi-stable plate 542 is mechanically coupled with flexible face 538 of blood bag 532, e.g. at least at middle section 544, positioned opposite to middle section 546 of stiff face 540.
  • blood bag 532 is a conventional blood bag and the stiffness of face 540 is achieved by attaching a stiff plate opposite to bi-stable plate 542 (i.e. on the rear face) to serve as a reference plate.
  • face 540 may be fastened to a surface, such as a table with a double-sided adhesive, Velcro® and the like, serving as a reference surface.
  • the reference (plate or surface) resists assuming the shape of bi-stable plate 542 when bi-stable plate 542 is transformed towards the other relaxed mode (e.g. the convex shape), thereby increasing average distance between the opposing sides, increasing the internal volume inside blood bag 532 and inducing the suction.
  • FIG. 5E shows blood bag in the collapsed configuration from a profile view.
  • Bi-stable plate 542 is flat, and the distance between section 544 on the flexible face 538 and section 546 on the stiff face 540 of blood bag 532 is D1.
  • Figure 5F shows blood bag 532 in the expanded configuration from a profile view after a mechanical stress has been applied to transform bi-stable plate 542 to the convex form, pulling section 544 away from section 546, and increasing the average distance there between to D3. The increased average distance increases the internal volume, which induces and promotes the flow of cord blood into blood bag 532.
  • bi-stable plate 542 may accommodate a label for recording data relating to the collection of the cord blood.
  • Apparatus 600 is substantially similar to the embodiments described herein above with the notable difference that the one or more shape memory supports are implemented as frame supports integrated with at least one hinge and a corresponding catch.
  • the hinge allows the frame supports of the blood bag to pivot with respect to each other, causing the faces to slide with respect to each other. This motion transforms the blood bag from a flat, collapsed configuration to an expanded configuration having a larger volume.
  • the corresponding catch locks at least one of the hinges to secure the frame supports in the expanded configuration, and prevent a return pivoting and sliding motion that would transform the blood bag back to the collapsed configuration once the increased volume induces a suction.
  • Apparatus 600 includes a blood bag 602 mechanically coupled to multiple shape memory supports including multiple frame supports 606, multiple hinges 608 and at least one corresponding catch (not shown). The corresponding catch locks the respective hinge when frame supports 606 are pivoted by a predefined angle, securing the resulting configuration for shape memory supports 604.
  • Frame supports 606 are configured as multiple stiff rods that are mechanically coupled to sections of blood bag to define an front face 610, a rear face 612, side faces 614 (left) and 616 (right), a top face 620, and a bottom face 622 for blood bag 602.
  • Hinges 608 mechanically couple tips of different frame supports 606 to each other, enabling frame supports 606 to pivot with respect to each other. The pivoting motion of frame supports 606 enables front face 610 and rear face 612 to slide horizontally with respect to each other.
  • blood bag 602 When blood bag 602 is in the collapsed configuration ( Figures 6A- 6B), blood bag 602 is similar to a flattened box. Front face 610 and rear face 612 are not vertically aligned, but rather, are shifted sideways with respect to each other; side faces 614 and 616 are substantially parallel to front face 610 and rear face 612, to form a substantially flat surface; and top and bottom faces 618 and 620 are substantially collapsed in a slanted shape.
  • Actuating shape memory supports 604 transforms blood bag 602 to the expanded configuration ( Figures 6C-6D).
  • Frame supports 606 pivot about hinges 608 to unflatten the box.
  • the pivot motion rotates side faces 614 and 616 until these are substantially perpendicular to front face 610 and rear face 612, and shifts front face 610 with respect to rear face 612 until these are substantially aligned (i.e. one on top of the other); and further expands bottom and top faces 618 and 620 to an un slanted shape until these are substantially perpendicular with respect to front and rear faces 610 and 612, such that blood bag 602 has a box-like shape. Consequently, the interior volume of blood bag 602 increases, inducing a suction.
  • the at least one catch locks at least one of hinges 608, preventing any further pivoting of frame supports 606, or shifting of upper face 610 and lower face 612, in order to stabilize blood bag 602 in the expanded configuration and preventing a return to the collapsed configuration.
  • Faces 610, 612, 614, 616, 618 and 620 of blood bag 602 are made of a sufficiently stiff material to resist collapse due to the induced suction. It is to be noted that the cuboid shape of Figures 6A-6D is for illustrative purposes only, and not to limit the invention.
  • Apparatus 700 is substantially similar to those described herein above with the notable difference that the multiple shape memory supports are implemented as an accordion mechanism integrated with the blood bag.
  • Apparatus 700 includes a blood bag 702, multiple shape memory supports 704 including multiple stiff rods 706 arranged in an accordion-like configuration, a latch 708, and at least one compression spring 714.
  • Shape memory supports 704 are mechanically coupled to sections of blood bag 702, such as to sections 710 and 712, at the front and rear ends of blood bag 702.
  • blood bag 702 is shown in the collapsed configuration, before actuating shape memory supports 704.
  • Latch 708 secures compression spring 714 in its compressed state, which secures shape memory supports 704 in the collapsed form to maintain a distance of D1 between sections 710 and 712 of blood bag 702.
  • blood bag 702 is shown in the expanded configuration after releasing latch 708 of Figures 7A-7B.
  • the actuation decompresses compression spring 714, which opens blood bag 702 like an accordion. Consequently, the average distance between different sections of blood bag 702 coupled to shape memory supports 704 increases. For example the distance between sections 710 and 712 increases to D2 from D1, where D2 is greater than D1.
  • the increase in average distance between the different sections of blood bag 702 increases the internal volume, which induces a suction.
  • the stiffness of rods 706 together with the at least one compression spring resists the induced suction and secures blood bag 702 in the expanded configuration.
  • the suction can be applied to accelerate the inflow of cord blood into blood bag 702.
  • Apparatus 800 is substantially similar to apparatus 500 described above with respect to Figures 5A-5D with the notable difference that the shape memory supports are implemented with magnetic coatings that exert a repulsive magnetic force with respect to each other.
  • Apparatus 800 includes a blood bag 802 having an input port 810, an output port 812, and an injection port 814, a non-expandable, flat sealed perimeter 820, a front middle section 822 (solid) and an opposing rear middle section 824 (dashed).
  • Apparatus 800 further includes two magnetic plates 804 F and 804 R and a strap 826.
  • Blood bag 802 is expandable at least between front middle section 822 and opposing rear middle section 824.
  • blood bag 802 is a standard, commercially available cord blood bag.
  • Magnetic plates 804 F and 804 R are magnetically repellant with respect to each other.
  • Magnetic plate 804 F is mechanically coupled at least to front middle section 822 and magnetic plate 804 F is mechanically coupled at least to rear middle section 824.
  • Strap 826 is configured to be mechanically coupled to blood bag 802, and become easily detached.
  • strap 826 may be a plastic strip that can be torn off, or an adhesive strip that can be peeled off.
  • blood bag 802 is shown in the collapsed configuration from a front view ( Figure 8A) and profile view ( Figure 8B).
  • Strap 826 is mechanically coupled to blood bag 802 and squeezes magnetic plates 804 F and 804 R together, resisting the repellant magnetic force exerted by magnetic plates 804 F and 804 R , thereby holding blood bag 802 in the collapsed configuration.
  • the distance between front middle section 822 and rear middle section 824 is D1.
  • blood bag 802 is shown in the expanded configuration from a front view (Figure 8C) and profile view ( Figures 8D).
  • Strap 826 has been removed, allowing the repellant magnetic force to pull magnetic plates 804 F and 804 R apart, increasing the average distance from at least front middle section 822 and rear middle section 824.
  • the distance between front middle section 822 and rear middle section 824 is increased to D2, where D2 is greater than D1.
  • Figure 9 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique.
  • a flexible blood bag is provided.
  • the flexible blood bag is configured to have a first, collapsed configuration enclosing a first volume and a second, expanded configuration enclosing a second volume, where the first volume is smaller than the second volume.
  • flexible blood bag 102 is shown in the collapsed configuration enclosing the first volume.
  • the first volume corresponds to the distance D1 between sections 116E and 116F.
  • flexible blood bag 102 is shown in the expanded configuration enclosing the second volume.
  • the second volume corresponds to the distance D2 between sections 116E and 116F. Since distance D1 is smaller than distance D2, the first volume enclosed by blood bag 102 in Figure 2A is smaller than the second volume enclosed by blood bag 102 in Figure 2B.
  • at least one shape memory support is provided.
  • the at least one shape memory support is configured to take on a first form and a second form.
  • shape memory support 104 3 is shown in a collapsed form (Figure 2A) and an expanded form (Figure 2B).
  • the at least one shape memory support is mechanically coupled to at least a first section and a second section of the flexible blood bag.
  • shape memory support 104 3 is mechanically coupled to sections 116C and 116D of flexible blood bag 102.
  • actuating the at least one shape memory support transforms the at least one shape memory support from the first form to the second form. This transformation applies a mechanical force on the flexible blood bag that increases the distance between the at least first section and the at least second section of the flexible blood bag.
  • shape memory support 104 3 is shown in the collapsed form (Figure 2C), and in the expanded form ( Figure 2D).
  • Actuating shape memory support 104 3 transforms shape memory support 104 3 from the collapsed form of Figure 2C to the expanded form of Figure 2D. This transformation applies a mechanical force on flexible blood bag 102 that increases the distance between sections 116C and 116D of flexible blood bag 102 from D1 ( Figures 2A, 2C) to D2 ( Figures 2B, 2D).
  • the increased distance transforms the flexible blood bag from the collapsed configuration enclosing the first volume to the expanded configuration enclosing the second volume, thereby reducing the pressure inside the flexible blood bag and inducing a suction.
  • the increased distance between sections 116C and 116D of flexible blood bag 102 transforms flexible blood bag 102 from the collapsed configuration of Figure 2A, enclosing the first volume, to the expanded configuration of Figure 2B, enclosing the second volume. This reduces the pressure inside flexible blood bag 102 and induces a suction.
  • the at least one shape memory support includes a first rod coupled, at a first section of the first rod, to the first section of the flexible blood bag, and a second rod coupled, at a second section of the second rod, to the second section of the flexible blood bag. Transforming the at least one shape memory support from the first form to the second form increases the distance between the first section of the first rod and the second section of the section rod, thereby increasing the distance between the first and second sections of the flexible blood bag, and transforming it from the collapsed to the expanded configuration.
  • shape memory support 104i includes a frame 114i, coupled to multiple rigid rods 112- 1 , arranged in an X-shape.
  • the bottom tip of the first one of rods 112i is coupled to bottom -front-left section 116C of blood bag 102.
  • the bottom tip of the second one of rods 112i is coupled to bottom -rear-left section 116D of blood bag 102.
  • Transforming shape memory support 104i from the first form (Figure 2E) to the second form ( Figure 2F) increases the distance between the bottom tips 116C and 116D of rods 112 -i from D1 ( Figures 2A and 2E) to D2 ( Figures 2B and 2F), i.e. the X-shape widens, increasing the distance at the base of the X- shape from D1 to D2. This increases the distance between sections 116C and 116D of blood bag 102, and transforms it from the collapsed configuration (Figure 2A) to the expanded configuration ( Figure 2B).
  • the multiple rigid rods are oriented longitudinally along the flexible blood bag.
  • rigid rods 112i are oriented longitudinally along the left side of blood bag 102, forming an X-shape.
  • the multiple rigid rods are oriented horizontally across the flexible blood bag.
  • support rods 112 3 are oriented horizontally across the base of blood bag 102.
  • the at least one shape memory support includes an expandable ring encircling the flexible blood bag, where the diameter of the ring, corresponding to the first form of the at least one shape memory support, is smaller than the diameter of the ring corresponding to the second form of the at least one shape memory support.
  • shape memory support 304i is an expandable ring encircling blood bag 302.
  • the diameter of ring 304i at sections 316C and 316D, corresponding to the first form of shape memory support 304i, is D1 ( Figure 4A) which is smaller than D3, which is the diameter of ring 304- I at sections 316C and 316D, and corresponding to the second form of shape memory support 304- I ( Figure 4B).
  • the flexible blood bag has a sterile interior volume, where transforming the flexible blood bag from the collapsed configuration to the expanded configuration preserves the sterile interior volume.
  • ports 102A, 102B and 102C of blood bag 102 are fitted with a hermetic seal to maintain sterility and prevent contamination.
  • Shape memory supports 104i, 104 2 , and 104 3 are mechanically coupled to the external surface of blood bag 102, such that actuating shape memory supports 104i, 104 2I and 104 3 to transform flexible blood bag 102 from the collapsed configuration (Figure 2A) to the expanded configuration ( Figure 2B) can be effected without affecting the hermetic seal or the internal volume of blood bag 102, to preserve the sterile interior volume.
  • Figure 10 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with another embodiment of the disclosed technique.
  • a flexible blood bag is obtained.
  • the flexible blood bag is configured to have a first, collapsed configuration enclosing a first volume and a second, expanded configuration enclosing a second volume, where the first volume is smaller than the second volume.
  • flexible blood bag 102 is shown in the collapsed configuration enclosing the first volume.
  • the first volume corresponds to the distance D1 between corresponding sections 116A and 116B, 116C and 116D, 116E and 116F, and 116G and 116H of blood bag 102.
  • flexible blood bag 102 is shown in the expanded configuration enclosing the second volume.
  • the second volume corresponds to the distance D2 between corresponding sections 116A and 116B, 116C and 116D, 116E and 116F, and 116G and 116H of blood bag 102. Since distance D1 is smaller than distance D2, the first volume enclosed by blood bag 102 in Figure 2A is smaller than the second volume enclosed by blood bag 102 in Figure 2B.
  • At least one shape memory support is obtained.
  • the at least one shape memory support is configured to take on a first form and a second form.
  • shape memory support 114 3 is shown in a first form ( Figure 2C) and a second form ( Figure 2D).
  • the at least one shape memory support is mechanically coupled to at least a first section and a second section of the flexible blood bag.
  • shape memory support 114 3 is mechanically coupled to sections 116C and 116D of flexible blood bag
  • the at least one shape memory support is actuated to transform the at least one shape memory support from the first form to the second form.
  • actuating a shape memory support via release 120 releases at least one spring 118 3 , which transforms shape memory support 114 3 from the first form of Figure 2C to the second form of Figure 2D.
  • a mechanical force is applied to the flexible blood bag that increases the distance between the at least first section and the second section of the flexible blood bag as a result of transforming the at least one shape memory support from the first form to the second form.
  • the increased distance transforms the flexible blood bag from the collapsed configuration enclosing the first volume to the expanded configuration enclosing the second volume, thereby reducing the pressure inside the flexible blood bag and inducing a suction.
  • the suction accelerates the flow of blood from the umbilical to the blood bag.
  • the transformation of shape memory supports 104-i, 104 2 , and 104 3 from the collapsed form (Figure 2A) to the expanded form ( Figure 2B) applies a mechanical force on flexible blood bag 102 that increases the average distance between corresponding sections 116A and 116B, 116C and 116D, 116E and 116F, and 116G and 116H of blood bag 102 from D1 ( Figure 2A) to D2 ( Figure 2B).
  • the increased average distance transforms flexible blood bag 102 from the collapsed configuration of Figure 2A enclosing the first volume to the expanded configuration of Figure 2B enclosing the second volume. This reduces the pressure inside flexible blood bag 102 and induces a suction which accelerates the blood flow into blood bag 102 from umbilical cord 110 via tube 106 and inlet port 102A.
  • characteristics of the pressure coefficients of one or more fluids occupying the inner volume of a blood bag are exploited to accelerate the flow of cord blood into the blood bag.
  • compressing and expanding air is relatively easy, whereas compressing and expanding a liquid is difficult. Consequently, air enclosed within a blood bag is readily expandable, such as in response to the release of one or more expansion springs mechanically coupled to the external surface of the blood bag, whereas a liquid volume enclosed within the blood bag is not readily expandable.
  • a liquid volume such as an anti-coagulant fluid supplied in advance with a hermetically sealed blood bag, will resist an expansive force exerted by an expansion spring externally coupled to the blood bag, and will maintain the expansion spring in a compressed state, such as until the hermetic seal is broken.
  • Apparatus 1100 includes a flexible blood bag 1102 and an expansion spring 1104 coupled to external sections 1128 and 1129 of blood bag 1102. Expansion spring 1104 is shown encircling blood bag 1102, with the rear portion of expansion spring 1104, coupled to the back side of blood bag 1102 indicated with a dashed line. The distance between the front and back of blood bag 1102 is negligible. Blood bag 1102 is provided with an input port 1114 fitted with a hermetic seal 1118 that maintains sterility and prevent the inflow of fluid (e.g.
  • Input port 1114 is configured to fluidly couple an external fluid flow, such as a blood flow of an umbilical cord 1116, to the interior volume of blood bag 1102 in an air-tight manner via a tube 1106 and a blood collecting needle 1108 mechanically coupled thereto.
  • input port 1114 is provided with a valve 1120 mechanically coupled to hermetic seal 1118 to control the fluid flow.
  • Valve 1120 may be any suitable valve, such as a pinch valve, a faucet valve, a lure lock, or a spring activated valve, to name but a few options.
  • valve 1120 and hermetic seal 1118 are shown mechanically coupled to input port 1136 this is but an exemplary implementation that is not intended to limit the invention.
  • Valve 1120 and hermetic seal 1118 may alternatively be positioned anywhere along tube 1144, between input port 1136 and needle 1146. When valve 1120 is closed, hermetic seal 1118 is intact, preventing the inflow of fluid into blood bag 1102 via input port 1114. Releasing valve 1120 breaks hermetic seal 1118, allowing the inflow of fluid into blood bag 1102 via input port 1114.
  • Blood bag 1102 is made of flexible, high molecular weight PVC that has undergone a sterilization process, and has a capacity to store a predetermined volume of fluid, such as umbilical cord blood, i.e. 200 ml. Blood bag 1102 is configured to have a collapsed configuration enclosing a smaller volume of fluid, and an expanded configuration enclosing a larger volume of fluid.
  • a predetermined volume of fluid such as umbilical cord blood, i.e. 200 ml.
  • Blood bag 1102 is configured to have a collapsed configuration enclosing a smaller volume of fluid, and an expanded configuration enclosing a larger volume of fluid.
  • Blood bag 1102 may be provided with a volume (V1) of an anticoagulant 1122, for example CPD solution. Additionally, blood bag 1102 is provided with a negligible volume of air already contained therein. Blood bag 1102 is compressed to its collapsed configuration prior to applying hermetic seal 1118 to evacuate all but a negligible amount of air remaining. Thus, volume V1 retained in blood bag 1102, while in the compressed state, includes only a negligible amount of air. Consequently, blood bag 1102 cannot be expanded in any substantial manner while hermetic seal 1118 remains intact. This is due to the fluid mechanical properties of the anticoagulant solution stored therein and the negligible volume of air remaining.
  • V1 volume of an anticoagulant 1122
  • expansion spring 1104 is mechanically coupled to sections on the external surface of blood bag 1102 while expansion spring 1104 is compressed, and while blood bag 1102 is in the collapsed configuration enclosing the negligible amount of air, with hermetic seal 1118 intact.
  • expansion spring 1104 exerts an expansive force on blood bag 1102
  • expansion spring 1104 remains compressed due to the negligible amount of expandable fluid (e.g. air) present inside hermetically sealed blood bag 1102.
  • Valve 1120 and seal 1118 are configured to withstand the pressure difference realized between the pressure Pi in the section of apparatus 1130 from valve 1120 towards the needle and the pressure P 2 in the section of apparatus 1130 between the valve and the bag, where typically P-i ⁇ P 2.
  • tube 1106 is mechanically coupled to inlet port 1114 of blood bag 1102 in an air-tight manner, while valve 1126 remains closed, keeping hermetic seal 1118 intact.
  • Blood collecting needle 1108 is inserted into a vein of umbilical cord 1116, thereby mechanically coupling input port 1114 to umbilical cord 1116 via tube 1106.
  • cord blood will not flow from cord 1116 into blood bag 1102 due to hermetic seal 1118.
  • valve 1120 and hermetic seal 1118 are applied just prior to inserting needle 1108 into the vein of umbilical cord 1116.
  • releasing valve 1120 breaks hermetic seal 1118 of Figure 11 A, fluidly coupling the flow of cord blood in umbilical cord 1116 to the interior of blood bag 1102 via needle 1108, tube 1106 and inlet port 1114, thereby drawing the cord blood from umbilical cord 1116 into flexible blood bag 1102.
  • the inflow of cord blood into blood bag 1102 increases the volume enclosed by flexible blood bag 1102 by an amount corresponding to the drawn blood since the air-tight coupling between tube 1106 and inlet port 114 prevents the inflow of air.
  • the increase in volume releases expansion spring 1104, at least partially, from its compressed state (Figure 11 A) to an expanded state ( Figure 11 B).
  • FIG. 11C-11G illustrate an apparatus, generally referenced 1130, for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with another embodiment of the disclosed technique.
  • Figures 11C-11D show apparatus 1130 in a collapsed configuration in a front view ( Figure 11 C) and profile view (11 D).
  • Figures 11E-11G show apparatus 1130 in an expanded configuration in a front view ( Figure 11 E) and top view ( Figure 11 F) and profile view ( Figure 11 G).
  • Two shape memory supports are provided as two plate shaped springs 1134 F (front) and 1134 R (rear).
  • Apparatus 1130 is similar to apparatus 1100 of Figures 11A-11B, with the notable difference that expansion spring 1104 is implemented with two plate-shaped springs 1134 F (front) and 1134 R (rear).
  • Plate-shaped spring 1134 F is mechanically coupled to the front face of blood bag 1132
  • plate-shaped spring 1134 R is mechanically coupled to the rear face of blood bag 1132, with plate shaped spring 1134 F and 1134 R being mechanically decoupled from each other, other that via (i.e.
  • Plate-shaped springs 1134 F and 1134 R are configured to take on a relaxed convex configuration when released, and capable of being elastically deformed to a flat or concave form when compressed.
  • a label (not shown) may be affixed to plate-shaped spring 1134 F via an adhesive to allow recording data relating the collected blood. Compressing plate-shaped springs
  • I 134 F and 1134 R converts the shape of plate-shaped spring 1134 F and 1134 R to a flat form ( Figures 11C-11D).
  • Releasing plate-shaped springs 1134 F and 1134 R converts the shape of plate-shaped springs 1134 F and 1134 R to the relaxed convex form ( Figures 11 E-11 G).
  • Apparatus 1130 includes a blood bag 1132, provided with an input port 1136 fitted with a hermetic seal 1138.
  • Input port 1136 is provided with a valve 1140 mechanically coupled to hermetic seal 1138 to control a fluid flow, as described above with respect to valve 1126 and seal 1120.
  • Input port 1138 is configured to fluidly couple an external fluid flow, such as a blood flow of an umbilical cord 1142, to the interior volume of blood bag 1132 in an air-tight manner via a tube 1144 and a blood collecting needle 1146 mechanically coupled thereto ( Figures 11 A and 11 C).
  • Plate shaped spring 1134 F is mechanically coupled to the external front surface of blood bag 1132 and plate shaped spring 1134 R is mechanically coupled to the external rear surface of blood bag 1132 while plate shaped springs 1134 F and 1134 R are compressed (i.e. flat), and while blood bag 1132 is in the collapsed configuration with hermetic seal 1136 intact.
  • Plate shaped springs 1134 F and 1134 R are mechanically decoupled from each other externally to blood bag from 1132, i.e. there is no physical connection between them other than the blood bag to which they are attached. Plate-shaped springs
  • I I 34 F and 1134 R exert an expansive force on blood bag 1132 but remain compressed due to hermetic seal 1136.
  • tube 1144 is mechanically coupled to inlet port 1136 of blood bag 1132 in an air-tight manner, while valve 1140 remains closed, keeping hermetic seal 1138 intact.
  • Blood collecting needle 1146 is inserted into a vein of umbilical cord 1142, thereby mechanically coupling input port 1136 to umbilical cord 1142 via tube 1144.
  • cord blood cannot flow from cord 1142 into blood bag 1132 due to hermetic seal 1138.
  • releasing valve 1140 breaks hermetic seal 1138 of Figures 11 C-11 D, fluidly coupling the flow of cord blood in umbilical cord 1142 to the interior of blood bag 1132 via needle 1146, tube 1144 and inlet port 1136, thereby drawing the cord blood into blood bag 1132.
  • the inflow of cord blood increases the volume enclosed by blood bag 1132 by an amount corresponding to the drawn blood, since the air-tight coupling between tube 1144 and inlet port 1136 prevents the inflow of air.
  • the increase in volume releases plate-shaped springs 1134 F and 1134 R , at least partially, from the flat, compressed form (Figures 11C-11D) to the relaxed convex form ( Figures 11E- 11 G).
  • Each one of plate-shaped springs 1134 F and 1134 R thus acts as a reference plate to the other, by resisting assuming the relaxed convex form of the opposing spring when released.
  • the mechanical force exerted by plate- shaped springs 1134 F and 1134 R increases the internal volume of blood bag 1132, creating a suction which promotes an additional flow of cord blood from umbilical cord 1142 into blood bag 1132 via needle 1146, tube 1144, and inlet port 1136, until blood bag 1132 reaches the expanded configuration.
  • the average distance between the front and rear sides of blood bag 1132 is no longer negligible but increases to D2, owing to the convex shape of plate shaped springs 1134 F and 1134 R , and resulting in a larger volume enclosed by blood bag 1102.
  • system 1130 may be implemented with only one plate-shaped spring affixed to one face
  • the shape of the opposing face e.g. the rear face
  • the opposing face may be fastened to a flat surface, such as a table with a double-sided adhesive, Velcro® and the like, serving as a reference surface that resists assuming the convex shape of the plate-shaped spring coupled with the opposite external side.
  • plate-shaped springs 1134 F and 1134 R may be replaced with one or more flat bar-shaped springs that are flat when compressed and convex when released.
  • FIGS 11H-11J taken together illustrate an apparatus, generally referenced 1150, for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with another embodiment of the disclosed technique.
  • Apparatus 1150 is shown from a front view ( Figure 11 FI), profile contracted view (Figure 111) and profile expanded view (Figure 11 J).
  • Apparatus 1150 is substantially similar to apparatus 1130 of Figures 11C-11F with the noted different that plate-shaped springs 1134 F and 1134 R are replaced with bar-shaped springs 1154, 1156, 1158 (front) and 1160, 1162, 1164 (back). Bar-shaped springs 1154, 1156, 1158 (front) and 1160, 1162, 1164 may have varying thicknesses, from elongated plates to wires.
  • FIGS 11K-11L taken together illustrate an apparatus, generally referenced 1170, for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with another embodiment of the disclosed technique.
  • Apparatus 1170 is shown from a front view ( Figure 11 K), and a profile contracted view ( Figure 11 L).
  • Apparatus 1150 is substantially similar to apparatus 1130 of Figures 11C-11F with the noted different that plate-shaped springs 1134 F and 1134 R are replaced with two bar-shaped springs 1174 and 1176 arranged in an X-shape on one face of the blood bag (e.g.
  • bar-shaped springs 1178, 1180, 1182, 1184, and 1186 arranged horizontally on the opposite face (e.g. the rear face) of the blood bag.
  • the specific implementations illustrated are not intended to be limiting, but rather to illustrate various configurations for implementing the disclosed technique.
  • bar-shaped springs 1174, 1176, 1178, 1180, 1182, 1184, and 1186 may have varying thicknesses, from elongated plates to wires. It is to be appreciated that any suitable combination of the implementations described herein may be used, such as replacing any of the bar-shaped or wire-shaped springs by fastening the opposing face to a surface, such as a table or wall as a reference.
  • FIG. 12 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique.
  • procedure 1200 a flexible blood bag configured to have at least a collapsed configuration enclosing a first volume and an expanded configuration enclosing a second volume, is obtained, where the first volume is smaller than the second volume.
  • the flexible blood bag is provided with an input port configured to fluidly couple a blood flow from an umbilical cord to the interior volume of the flexible blood bag in an air-tight manner via a tube mechanically coupling the input port with the umbilical cord.
  • a flexible blood bag 1102 is shown in a collapsed configuration ( Figure 11 A) and in an expanded configuration ( Figure 11 B).
  • the first volume (V1) of coagulant fluid 1132 enclosed by flexible blood bag 1102 in the collapsed configuration ( Figure 11 A) is smaller than the second volume 1134 (V2) enclosed by flexible blood bag 1102 in the expanded configuration ( Figure 11B).
  • the second volume 1134 includes coagulant fluid 1132 as well as an amount of cord blood collected from umbilical cord 1116.
  • Flexible blood bag 1102 is provided with input port 1114 configured to fluidly couple a blood flow from umbilical cord 1116 to the interior volume of flexible blood bag 1102 in an air tight manner via tube 1106 mechanically coupling input port 1114 with umbilical cord 1116.
  • the flexible blood bag is compressed to the collapsed configuration by evacuating all but a negligible volume of air.
  • blood bag 1102 is collapsed to the collapsed configuration and all but a negligible volume of air has been evacuated.
  • a volume V1 of liquid coagulant solution is contained within flexible blood bag 1102.
  • the input port integrated with the flexible blood bag is fitted with a hermetic seal mechanically coupled to a valve that is configured to break the seal.
  • input port 1114 integrated with flexible blood bag 1102 is fitted with a hermetic seal 1120 mechanically coupled to valve 1126, where valve 1126 is configured to break hermetic seal 1120.
  • a least one spring is mechanically coupled to external sections of the flexible blood bag while the expansion spring is compressed, and while the flexible blood bag is in the collapsed configuration enclosing the negligible amount of air with the hermetic seal intact.
  • expansion spring 1104 is mechanically coupled to external sections of flexible blood bag 1102, while flexible blood bag 1102 is in the collapsed configuration enclosing the negligible volume of air, and while hermetic seal 1120 is intact (Figure 11A).
  • releasing the valve breaks the hermetic seal and fluidly couples the blood flow of the umbilical cord to the interior of the flexible blood bag when the input port is mechanically coupled to the umbilical cord via the tube in the gas tight manner. This action draws blood into the flexible blood bag, increasing the first volume to the second volume.
  • releasing valve 1126 breaks hermetic seal 1120, thereby fluidly coupling the blood flow of umbilical cord 1116 to the interior of flexible blood bag 1102 when input port 1114 is mechanically coupled to umbilical cord 1116 via tube 1106 in the gas-tight manner, thereby drawing blood into blood bag 1102 and increasing the first volume V1 to the second volume V2.
  • increasing the first volume at least partially releases the at least one spring, to exert an expansive force on the flexible blood bag that promotes an additional drawing of blood until the flexible blood bag reaches the expanded configuration enclosing the second volume.
  • increasing the first volume V1 at least partially expands expansion spring 1104, thereby exerting an expansive force on flexible blood bag 1102 that promotes an additional drawing of blood until flexible blood bag 1102 reaches the expanded configuration enclosing the second volume V2 ( Figure 11 B).
  • Figure 13 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with another embodiment of the disclosed technique.
  • a flexible blood bag is obtained.
  • the flexible blood bag is configured to have at least a collapsed configuration enclosing a first volume and an expanded configuration enclosing a second volume, where the first volume is smaller than the second volume.
  • the flexible blood bag is obtained in the compressed (i.e. , collapsed) configuration, enclosing only a negligible volume of air, where an input port of the flexible blood bag is fitted with a hermetic seal.
  • the flexible blood bag is obtained with at least one expansion spring mechanically coupled to external sections of the flexible blood bag with the expansion spring compressed. Referring to Figures 11A-11B, flexible blood bag 1102 is obtained.
  • Flexible blood bag 1102 is configured to have at least a collapsed configuration enclosing a first volume V1 ( Figure 11A) and an expanded configuration enclosing a second volume V2 ( Figure 11 B), where volume V1 is smaller than volume V2.
  • Flexible blood bag 1102 is obtained in the compressed, collapsed configuration, enclosing all but a negligible volume of air, with input port 1114 integrated with flexible blood bag 1102 fitted with hermetic seal 1120.
  • Flexible blood bag 1102 is obtained with at least one spring 1104 mechanically coupled to external sections of flexible blood bag 1102 with expansion spring 1104 compressed.
  • the input port of the flexible blood bag is mechanically coupled to an umbilical cord in an air-tight manner via a tube.
  • input port 1114 of flexible blood bag 1102 is mechanically coupled to umbilical cord 1116 in an air-tight manner via tube 1106.
  • valve 1126 provided with input port 1114 and mechanically coupled to hermetic seal 1120, is released.
  • hermetic seal 1120 ( Figure 11 A) is broken, thereby fluidly coupling the blood flow of umbilical cord 1116 to the interior of flexible blood bag 1102.
  • blood is drawn into the flexible blood bag to increase the first volume.
  • Increasing the first volume at least partially releases the at least one spring, thereby accelerating an additional drawing of blood from the umbilical cord until the flexible blood bag reaches the expanded configuration enclosing the second volume.
  • FIG 11 B blood is drawn into the flexible blood bag 1102 thereby increasing the first volume V1 ( Figure 1A).
  • Increasing the first volume at least partially expands expansion spring 1104, thereby accelerating an additional drawing of blood from umbilical cord 1116 until flexible blood bag 1102 reaches the expanded configuration enclosing the second volume V2 ( Figure 11 B).
  • Figures 14A-14H which taken together, illustrate implementations for an apparatus for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique.
  • the embodiments shown in Figures 14A-14F are intended to add clarity to the techniques described above, particularly with respect to Figures 5A-5F and 11C-11 F.
  • a flexible blood bag apparatus 1400 is shown from a top view in a collapsed configuration enclosing a first (i.e. smaller) volume ( Figure 14A), and in an expanded configuration enclosing a second (i.e. larger) volume ( Figure 14B).
  • Blood bag apparatus 1400 includes a blood bag 1408 with a shape memory support comprising a plate-shaped spring 1402 mechanically coupled with one side (e.g. the front face) of blood bag 1408.
  • Plate-shaped spring 1402 can take on a relaxed convex configuration when released and may be elastically deformed to a flat form when compressed. Plate-shaped spring 1402 is compressed to the flat shape (Figure 14A) to support blood bag 1408 in the collapsed configuration.
  • Plate-shaped spring 1402 is released to assume the relaxed convex form ( Figure 14B) to support blood bag 1408 in the expanded configuration.
  • the shape of the opposite face of blood of blood bag 1408 is secured in a manner that is separate and mechanically decoupled from the shape memory support coupled to the front face of blood bag 1408, other than via the blood bag 1408 itself.
  • blood bag apparatus 1400 additionally includes an element mechanically coupled with the rear external face of blood bag 1408 as a shape support.
  • the element is mechanically decoupled from the shape memory support coupled to the front face, externally to blood bag 1408 itself.
  • the element supports the shape of the rear external face, and prevents the rear face from assuming the shape of the front face of blood bag 1408.
  • the shape support is configured as a rigid plate 1404 mechanically coupled to the opposite face (e.g. the rear face) of blood bag 1408 securing the shape of the opposite face.
  • rigid plate 1404 is mechanically decoupled, externally to blood bag 1408, from plate shaped spring 1402, (e.g. there is no mechanical connection other than blood bag 1408 that couples plate-shaped spring 1402 and rigid plate 1404).
  • Rigid plate 1404 assumes the flat shape of plate-shaped spring 1402 when compressed, and resists the convex shape of plate-shaped spring 1402 when plate-shaped spring 1402 is released.
  • Rigid plate 1404 thus acts as a reference that resists conforming to the shape of plate-shaped spring 1402 when plate shaped spring 1402 is released, thereby maintaining the increased average distance between the two opposing sides of blood bag 1408, which increases the internal volume and induces a suction.
  • rigid plate may be replaced by adhering the opposite (i.e. rear) face of blood bag 1408 to a suitably stiff surface, such as a table, or wall, with a fastener, with the surface functioning as the reference.
  • Plate-shaped spring 1402 transforms plate-shaped spring 1402 from the flat shape ( Figure 14A) towards the relaxed convex shape ( Figure 14A).
  • the convex shape applies a mechanical force to the one face of blood bag 1408 (e.g. the front face), independent from the opposite face (e.g. the rear face) to which the reference, e.g. rigid plate 1404 or the rigid surface, is coupled.
  • the mechanical force is directed towards increasing the average distance between the front and rear faces of blood bag 1408, since the flat shape of the rear face is sustained by the rigid surface, e.g. rigid plate 1404, as the reference.
  • a flexible blood bag apparatus 1410 is shown from a top view in a collapsed configuration enclosing a first (i.e. smaller) volume ( Figure 14C), and in an expanded configuration enclosing a second (i.e. larger) volume ( Figure 14D).
  • Blood bag apparatus 1410 is substantially similar to blood bag apparatus 1400 ( Figures 14A-14B) with the noted difference that plate-shaped spring 1402 and rigid plate 1404 are replaced with a plate-shaped spring 1412 and a rigid plate 1414, respectively, attached to a flexible blood bag 1418.
  • Plate-shaped spring 1412 is concave when compressed, and convex when released to its relaxed configuration.
  • Rigid plate 1414 assumes the concave shape of plate-shaped spring 1412 when compressed ( Figure 14C), and thus constrains the volume inside blood bag 1418.
  • Rigid plate 1414 acts as a reference plate which resists assuming the convex shape of plate-shaped spring 1412 when plate-shaped spring 1412 is released ( Figure 14D), increasing the internal volume of blood bag 1418.
  • a port 1416 of blood bag 1418 is hermetically sealed, the pressure inside is reduced, inducing a suction for promoting the drawing blood.
  • rigid plate 1414 may be replaced by any sufficiently rigid surface, such as contoured surface, to which the rear side of blood bag 1418 is affixed, to serve as a reference surface that resists conforming to the shape of the opposing side of the blood bag 1418 when plate-shaped spring 1412 is released.
  • Bag 1418 may be thus be provided with a fastener, such as a sticky surface, Velcro® or other suitable affixing means to affix the rear face of blood bag 1418 to the surface.
  • a flexible blood bag apparatus 1420 is shown from a top view in a collapsed configuration enclosing a first (i.e. smaller) volume ( Figure 14C), and in an expanded configuration enclosing a second (i.e. larger) volume ( Figure 14D).
  • Blood bag apparatus 1420 is substantially similar to blood bag apparatus 1400 ( Figures 14A-14B) with the noted difference that a blood bag 1428 is provided with two plate-shaped springs 1422 and 1424, where plate-shaped spring 1424 replaces rigid plate 1404.
  • Plate-shaped spring 1422 is coupled to one face of blood bag 1428, and is flat when compressed and convex when released (i.e. relaxed).
  • Plate-shaped spring 1424 is coupled to the opposite face of blood bag 1428, and is mechanically decoupled from plate-shaped spring 1424, externally to blood bag 1428.
  • Plate shaped spring 1424 assumes the flat form of plate-shaped spring 1422 when compressed, and a convex form opposite (i.e. mirrored) to the convex form of plate-shaped spring 1422 when released.
  • releasing plate-shaped spring 1424 is directed to increase the average distance between the two opposing faces of blood bag 1428, independently of the action of plate-shaped spring 1422.
  • the convex forms of plate-shaped springs 1422 and 1424 need not be identical, e.g.
  • plate-shaped springs 1422 and 1424 acts as a reference to the other, by resisting the released shape of the other, thereby increasing the average distance therebetween, to increase the internal volume of blood bag 1428 and induce a suction. The combined release of both plate-shaped springs 1422 and 1424 doubles the distance there between.
  • a flexible blood bag apparatus 1430 is shown from a top view in a collapsed configuration enclosing a first (i.e. smaller) volume ( Figure 14G), and in an expanded configuration enclosing a second (i.e. larger) volume ( Figure 14H).
  • Blood bag apparatus 1430 is substantially similar to blood bag apparatus 1420 ( Figures 14E-14F) with the noted difference that a blood bag 1440 is provided with four plate-shaped springs 1432, 1434, 1436, and 1438. Two plate-shaped springs 1432 and 1434 are coupled to one face of blood bag 1440, and two plate-shaped springs 1436 and 1438 are coupled to the opposite face of blood bag.
  • Plate-shaped springs 1436 and 1438 are mechanically decoupled from plate-shaped springs 1432 and 1434 external to blood bag 1440 (e.g. there is no connector external to blood bag 1440 coupling springs 1432 and 1434 with springs 1436 and 1438). Plate shaped springs 1432 and 1434 act as references to plate-shaped springs 1436 and 1438, each resisting the released shape of the opposing pair, to increase the internal volume of blood bag 1440 and induce a suction.
  • FIGS 15A-15D illustrate additional implementations for an apparatus 1500 for accelerating the flow of cord blood into a blood bag, constructed and operative in accordance with another embodiment of the disclosed technique.
  • a flexible blood bag 1508 is shown in a collapsed configuration ( Figure 15A) and an expanded configuration ( Figure 15B).
  • Blood bag 1508 is provided with a shape support 1502 coupled to one face (e.g. front) of blood bag 1508, and a bi-stable element, such as a bi-stable plate 1504 coupled to the opposing face (e.g. rear) of blood bag 1508.
  • Shape support 1502 is mechanically decoupled from bi-stable plate external to blood bag 1508.
  • shape support 1502 is a plate-shaped spring. In other embodiments, shape support 1502 is rigid. Bi-stable plate 1504 can take on two relaxed forms: a concave form (Figure 15A) and a convex form (Figure 15B). Shape support 1502 acts as a reference to bi-stable plate 1504 by resisting to conform to the second relaxed configuration of bi-stable plate 1504 when actuated to expand blood bag 1508. Referring to Figure 15A, when blood bag 1508 is in the collapsed state, shape support 1502 and bi-stable plate 1504 assume a similar shape, i.e.
  • bi-stable plate 1504 is concave (facing downwards), and the reverse, thereby enclosing the smaller volume.
  • FIG 15B to transform blood bag 1508 towards the expanded state ( Figure 15B), an external force is applied to bi-stable plate 1504 that transforms bi-stable plate 1504 to the convex form.
  • Shape support 1502 is sufficiently stiff to maintain its form of Figure 15A, which is now a reflection of the convex form (downward facing) of bi-stable plate 1504 in Figure 15B.
  • shape support 1502 acts as a reference to bi-stable plate 1504.
  • Transforming bi- stable plate 1504 from the concave to the convex form applies a mechanical force on blood bag 1508 increases the average distance between the two opposing faces. The increased average distance corresponds to the larger volume. When port 1506 is hermetically sealed, this reduces the pressure inside blood bag 1508 accelerate the rate for drawing blood therein. It is to be appreciated that the embodiments disclosed herein above provide a simple and elegant solution for promoting the drawing of blood into a sterile blood bag, without necessitating an external vacuum source or pump. In particular, the techniques disclosed in Figures 5A-5F, 8C-8D, 11C-11L, 14A- 14H, and 15A-15B illustrating multiple independent shape supports (e.g.
  • a shape support coupled to the front face of the blood bag is mechanically decoupled from the shape support coupled to the rear face of the blood bag.
  • the shape supports thus operate only on the side of the bag they are coupled to, and thus provide a simple and elegant solution for accelerating the collection of blood. Furthermore, mechanically decoupling the shape supports attached to opposing sides of the blood bag facilitates the assembly of the blood collecting apparatus.
  • the term “convex” as used herein is not intended to limit the invention to a curved shape, but rather to any protruding shape, such as square, triangular, and the like.
  • the shape supports described herein e.g. plate-shaped spring, bar-shaped spring, wire-shaped spring, rigid plate, rigid, wire, rigid bar, bi-stable plate, etc.
  • any suitable technique such as but not limited to, glue, Velcro, hooks, one or more pockets configured with the blood bag, and the like.
  • the specific examples given are intended for clarity only, and do not limit the invention. Thus, any suitable combination of the examples described herein may be used.
  • Figure 16 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with a further embodiment of the disclosed technique.
  • a flexible blood bag configured to have a first, collapsed configuration enclosing a first, smaller volume and a second, expanded configuration enclosing a second, larger volume.
  • a flexible blood bag 1130 is provided having a collapsed configuration enclosing a smaller volume ( Figure 11 D), and an expanded configuration enclosing a larger volume ( Figure 11 E-11 F).
  • at least one first shape support is provided that is configured to have at least a first relaxed configuration and is capable of being elastically deformed away from the first relaxed configuration. The at least one first shape support is mechanically coupled with a first external side of the flexible blood bag.
  • a first shape support includes a plate-shaped spring 1134 F.
  • Plate-shaped spring 1134 F can take on a flat form ( Figure 11 DO and a convex form ( Figures 11E-11G).
  • the first shape support includes a bi-stable plate (e.g. Figures 5A- 5F and 15A-15B).
  • the first shape support includes a bar shaped spring.
  • the bar-shaped spring may have any suitable width (thickness), and may be implemented with a wire (Figure 11 H-11 L).
  • the first shape support comprises multiple supports, e.g. Figures 11 H-11 L, and 14G-14H.
  • a reference surface coupler configured to be mechanically coupled with the flexible blood bag at an opposite external side to the first external side, and mechanically decoupled from the at least one first shape support externally to the flexible blood bag.
  • the reference surface coupler is configured to couple the opposite external side of the blood bag to a reference surface, where the reference surface is mechanically decoupled from the at least one first shape support externally to the flexible blood bag, and where the reference surface is configured to resist assuming the first relaxed configuration of the at least one first shape support when the at least one first shape support is transformed towards the first relaxed configuration.
  • the first shape support operates independently from the reference surface coupled to the opposite side of the blood bag.
  • Transforming the at least one first shape support from the first form towards the relaxed form applies a mechanical force on the flexible blood bag that increases the average distance between the two opposing faces of the blood bag.
  • the increased average distance transforms the flexible blood bag from the collapsed configuration towards the expanded configuration, which reduces the pressure inside the flexible blood bag and induces a suction.
  • a reference surface coupler such as an adhesive, is provided for affixing a reference surface (e.g. plate-shaped spring 1134 R ) to the rear face of blood bag 1132.
  • Plate-shaped spring 1134 R is coupled to blood bag 1132 via the adhesive and acts as a reference surface which resists assuming the expanded form of plate-shaped spring 1134 R.
  • the second shape support includes a rigid plate (e.g. Figures 14A-14B), or multiple plate-shaped springs (Figures 11 H-11 L and 14G- 14H).
  • the second shape support includes a bar-shaped spring.
  • the bar-shaped spring may have any suitable width (thickness), and may be implemented with a wire ( Figure 11 H-11 L).
  • the reference surface is a table or wall.
  • Blood bag 1132 may be provided with a two- sided adhesive (the reference surface coupler), such as a two-sided sticker or Velcro® for affixing the rear face of the blood bag to the table or wall.
  • a hermetic seal is provided with a valve fitted on an input port of the flexible blood bag.
  • the hermetic seal is configured to constrain a fluid volume inside the flexible blood bag and prevent the at least one plate-shaped spring from releasing.
  • the valve is configured to break the hermetic seal when the input port is fluidly coupled to a blood source, thereby drawing blood from the blood source into the flexible blood bag. This increases a fluid volume inside the flexible blood bag and at least partially releases the at least one first shape support.
  • hermetic seal 1138 is provided with valve 1140 fitted on input port 1136 of blood bag 1132.
  • Figure 17 is a schematic illustration of a method for accelerating the rate for drawing blood into a flexible blood bag, constructed and operative in accordance with another embodiment of the disclosed technique.
  • a flexible blood bag configured to have a first, collapsed configuration enclosing a first, smaller volume and a second, expanded configuration enclosing a second, larger volume is obtained.
  • a flexible blood bag 1130 is provided having a collapsed configuration enclosing a smaller volume ( Figure 11 D), and an expanded configuration enclosing a larger volume ( Figure 11 E-11 F).
  • a first shape support mechanically coupled with a first external side of the flexible blood bag is obtained.
  • the at least one first shape support is configured to have at least a first relaxed configuration, and is capable of being elastically deformed away from the first relaxed configuration
  • a first shape support is provided as a plate-shaped spring 1134 F.
  • Plate-shaped spring 1134 F has a relaxed convex form (Figures 11E-11G) and is capable of being elastically deformed to a flat form ( Figure 11 D), i.e. compressed.
  • the first shape support is a bi-stable plate (e.g. Figures 5A-5F and 15A-15B).
  • the first shape support comprises multiple supports, e.g.
  • a reference surface coupler configured to be mechanically coupled with the flexible blood bag at an opposite external side to the first external side, and mechanically decoupled from the at least one first shape support externally to the flexible blood bag.
  • the reference surface coupler is configured to couple the opposite external side of the blood bag to a reference surface, where the reference surface is mechanically decoupled from the at least one first shape support externally to the flexible blood bag, and wherein the reference surface is configured to resist assuming the first relaxed configuration of the at least one first shape support when the at least one first shape support is transformed towards the first relaxed configuration.
  • a reference support is provided as plate-shaped spring 1134 R , e.g., coupled to blood bag via an adhesive serving as a reference surface coupler.
  • Plate-shaped spring 1134 R resists assuming the relaxed convex form of plate-shaped spring 1134 R when plate shaped spring 1134 R is released.
  • the reference surface is a rigid plate (e.g. Figures 14A-14B).
  • the reference surface is a wall or table.
  • the reference surface coupler may be two-sided adhesive, such as a sticker or Velcro®, and the like.
  • the method further comprises coupling the opposite external side of the blood bag to the reference surface via the reference surface coupler.
  • the reference surface coupler may be the rough Velcro® side (e.g. the hooks), where a wall adjacent to the umbilical cord may be provided with the soft Velcro® side (e.g. the loops).
  • the practitioner affixes the rear side of the blood bag to the wall by pressing the two Velcro® sides together. In this manner, the wall provides the reference surface for the blood bag that resists conforming to the shape of the plate-shaped spring affixed to the opposite (e.g. front) side of the blood bag.
  • an input port of the flexible blood bag is coupled to a blood source while the flexible blood bag is in the collapsed configuration, and while the input port sealed hermetically, constraining a fluid volume inside.
  • an input port 1136 is coupled to umbilical cord 1142 while blood bag 1132 is in the collapsed configuration ( Figure 11 C), and while hermetic seal 1138 is fitted with input port 1136.
  • the hermetic seal is broken, thereby drawing blood from the blood source into the blood bag which increases the volume inside and at least partially transforms said at least one first shape support from the first form to the second form.
  • hermetic seal 1138 of Figure 11 C is broken, drawing blood from umbilical cord 1142 into blood bag 1132, which increases the volume therein, and at least partially transforms spring 1134 F from the flat from to the convex form.
  • the at least one first shape support is transformed from the first form to the second form, thereby applying a mechanical force on the flexible blood bag that is directed to increase the average distance between the two sides and transforms the flexible blood bag from the collapsed configuration towards the expanded configuration, thereby reducing the pressure inside and inducing a suction.
  • plate-shaped spring 1134 F is transformed from the flat from to the convex form, transforming blood bag 1132 from the collapsed configuration ( Figure 11 D) to the expanded configuration.
  • the blood prior to breaking the hermetic seal, the blood is trapped in the blood source, and after breaking said hermetic seal, the at least partial transforming of the at least one first shape support at least partially unconstrains the fluid volume inside the flexible blood bag, thereby untrapping the blood from said blood source and promoting the drawing of blood into the flexible blood bag.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un appareil de collecte de sang comprenant : une poche de sang flexible configurée pour avoir une configuration repliée renfermant un volume plus petit et une configuration étendue renfermant un volume plus grand ; et un support à mémoire de forme couplé mécaniquement à un premier côté de la poche de sang flexible et configuré pour prendre une première forme et une seconde forme, et découplé mécaniquement d'un côté opposé de la poche de sang flexible, à l'extérieur de la poche de sang flexible, avec la forme du côté opposé fixée, où la transformation du support à mémoire de forme de la première à la seconde forme applique une force mécanique sur la poche de sang flexible qui augmente la distance entre le premier côté et le côté opposé, la distance accrue transformant la poche de sang flexible de la configuration repliée à la configuration déployée, ce qui permet de réduire la pression à l'intérieur pour accélérer la vitesse de prélèvement de sang.
PCT/IL2021/050193 2020-02-19 2021-02-18 Appareil de collecte de sang extensible WO2021165967A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IL272785 2020-02-19
IL272785A IL272785A (en) 2020-02-19 2020-02-19 Expandable blood collecting apparatus
US202163140885P 2021-01-24 2021-01-24
US63/140,885 2021-01-24

Publications (1)

Publication Number Publication Date
WO2021165967A1 true WO2021165967A1 (fr) 2021-08-26

Family

ID=77391739

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2021/050193 WO2021165967A1 (fr) 2020-02-19 2021-02-18 Appareil de collecte de sang extensible

Country Status (1)

Country Link
WO (1) WO2021165967A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070219531A1 (en) * 2006-03-08 2007-09-20 Nippon Sherwood Medical Industries Ltd. Suction Fluid Collector for Medical Applications
US20090234330A1 (en) * 2002-11-28 2009-09-17 Sumitomo Bakelite Company Limited Body fluid suction reservoir
US9682220B2 (en) * 2011-08-29 2017-06-20 Coloplast A/S Assembly for urinary drainage

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090234330A1 (en) * 2002-11-28 2009-09-17 Sumitomo Bakelite Company Limited Body fluid suction reservoir
US20070219531A1 (en) * 2006-03-08 2007-09-20 Nippon Sherwood Medical Industries Ltd. Suction Fluid Collector for Medical Applications
US9682220B2 (en) * 2011-08-29 2017-06-20 Coloplast A/S Assembly for urinary drainage

Similar Documents

Publication Publication Date Title
US3115138A (en) Evacuator
AU625556B2 (en) High-frequency transvalvular axisymmetric blood pump
JP5452812B2 (ja) 血液産物移送システム
US4443220A (en) Blood collection and transfer apparatus
US4902291A (en) Collapsible artificial ventricle and pumping shell
US9375168B2 (en) Apparatus and method for collecting cord blood
US10321675B2 (en) Suspendable organ transplant system and method of use
US20090069763A1 (en) Flat Expandable Effusion Drain
KR20160014640A (ko) 첨가제와 생체 표본을 혼합하기 위한 혼합 시스템
JPH05505546A (ja) 平たく横たえたサンプル貯蔵器を有する血液容器
WO2021165967A1 (fr) Appareil de collecte de sang extensible
US8157774B1 (en) Apparatus for stem cell collection and methods thereof
JP2002541930A (ja) 血液を個々の成分および／または血液成分のグループに分離するための装置
EP3275377A1 (fr) Champ de fixation de champ opératoire
US9492598B2 (en) Equipment that makes it possible to apply a determined pulsatile pressure to a medical device
CN114557745B (zh) 一种连发用结扎夹
JP2800585B2 (ja) 血液循環補助装置
ES2321384T3 (es) Aparato paara recoger sangre.
JPH07502689A (ja) すすぎチャンバーバッグを用いて体液を濾過するための方法
AU2002304670A1 (en) Blood collection apparatus
CA2280719A1 (fr) Systeme de prelevement du sang et son procede d'utilisation
CN211834661U (zh) 一种标本取物装置
US20240009400A1 (en) Sterile sampling methods and devices for automated cell engineering systems
CN214512126U (zh) 一种导管固定吊瓶支架
WO2024172668A1 (fr) Dispositif de maintien pour équipement médical

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21756664

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21756664

Country of ref document: EP

Kind code of ref document: A1