EP0935481A1 - Ensemble de connecteur pour collecter des fluides - Google Patents

Ensemble de connecteur pour collecter des fluides

Info

Publication number
EP0935481A1
EP0935481A1 EP97937569A EP97937569A EP0935481A1 EP 0935481 A1 EP0935481 A1 EP 0935481A1 EP 97937569 A EP97937569 A EP 97937569A EP 97937569 A EP97937569 A EP 97937569A EP 0935481 A1 EP0935481 A1 EP 0935481A1
Authority
EP
European Patent Office
Prior art keywords
vessel
tube
assembly according
umbilical cord
cord
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97937569A
Other languages
German (de)
English (en)
Inventor
Valter Paderni
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CRB Nederland BV
Original Assignee
CRB Nederland BV
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
Application filed by CRB Nederland BV filed Critical CRB Nederland BV
Publication of EP0935481A1 publication Critical patent/EP0935481A1/fr
Withdrawn legal-status Critical Current

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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/14—Female reproductive, genital organs
    • A61M2210/1433—Uterus
    • A61M2210/1466—Umbilical cord

Definitions

  • the present invention relates to a connector assembly for collecting fluids.
  • the connector assembly is a ⁇ apted to connect the cut end portion of the umbilical cord, or of vessels, or of a hollow tube, having a variable cross-section with soft and elastic walls having a loose and easily collapsible consistency, to a container for collecting blood, or other fluids, from the placenta or another organ or part of an organ or another container, as stated in the main claim.
  • the assembly according to the invention is used mainly in the biological, medical and veterinary field both for diagnostic and therapeutic purposes and for research purposes, for the collection of blood or other fluids from the placenta or another organ or part of an organ or other container, to be used subsequently as a source of cells, molecules or other.
  • the blood is useful since it contains stem cells, which are hematopoietic precursor cells, i.e., cells which are capable of reconstituting the hematopoietic system and therefore can be used, if the need arises, for transplanting to the same donor or to another compatible recipient.
  • stem cells which are hematopoietic precursor cells, i.e., cells which are capable of reconstituting the hematopoietic system and therefore can be used, if the need arises, for transplanting to the same donor or to another compatible recipient.
  • Placental blood from the umbilical cord is collected because it contains hematopoietic stem cells which can be used for transplants.
  • the following conditions must be met: 1. the largest possible amount of blood, i.e., the highest possible number of cells, must be recovered; 2. the collected blood, which is fetal in origin, must not be contaminated by foreign cell populations, such as for example maternal cells; 3. during collection, contact of the blood with the outside (air or other potentially contaminated objects) must be minimized, or the collection procedure must occur in sterile conditions, possibly in a closed environment; 4. the possibility of human error must be minimized. Steps of collection a. Before expulsion of the placenta.
  • Blood is currently extracted from the placenta in the medical field, both for diagnostic and therapeutic purposes and for research purposes, as follows: during childbirth, directly after the expulsion of the newborn child, the umbilical cord is closed (clamped) in two points and cut in a point which is intermediate between the two closure points. After cutting, the cut end of the umbilical cord which is connected to the placenta protrudes freely from the mother's vagina and is available for collection operations. Typically, blood is collected in the period between the cutting of the umbilical cord and expulsion of the placenta. During this period, the flow of blood is ensured by the pressure generated by uterine contractions, which by compressing the placenta facilitate the outflow of blood through the umbilical cord, b. After expulsion of the placenta.
  • a second advantage is that the three vessels which are present n the umbilical cord are simultaneously pervious.
  • Another advantage of the system is the possibility to express the umbilical cord during collection. Disadvantages
  • This collection system furthermore exposes the blood to the air of the outside environment, thus facilitating contaminations by microorganisms which are present in the outside environment.
  • “Closed-circuit” systems entail handling needles and therefore expose the operators to the r sk of accidental punctures.
  • the needle inserted in the umbilical vein is not stably fixed to it and can easily come loose, also in view of the highly dynamic nature of childbirth; this problem is particularly felt if collection is continued even after expulsion of the placenta. Accordingly, the continuous presence of an operator is required to ensure the correct placement of the needle during the various steps of collection.
  • the flow of blood is furthermore hindered by the sudden decrease in cross-section (the needle, no matter how large, can never have the same cross-section as the umbilical vein) .
  • the needle is inserted in an intermediate segment of the umbilical cord, upstream of the closure region; stasis of the blood downstream of the insertion point, with a consequent tendency to clotting, is thus inevitable; moreover, the blood which remains downstream of the insertion point is not recovered. Disclosure of the Invention
  • An aim of the present invention is to provide a connector assembly for collecting fluids that overcomes the drawbacks of the cited prior art.
  • An further aim of the invention is to provide a connector assembly adapted to connect, in a sterile, practical and quick manner, the end portion of the umbilical cord or of vessels or of a hollow tube having a variable cross-section, with soft and elastic walls and having a loose and easily collapsible consistency, to a collection container by means of a closed system, which optionally contains anticoagulant or another liquid or is connected to another container and/or dispenser of anticoagulant or other liquid, such that the blood or other fluid drained from the umbilical cord or vessel or tube passes into the collection container in sterile conditions, without making contact with the outside.
  • FIG. 1 is a side view of an anchoring device for anchoring the cut end portion of the umbilical cord, or of vessels, or a hollow tube, shown in an inactive position;
  • FIG. 2 is a side view of an anchoring device for anchoring the cut end portion of the umbilical cord, or of vessels, or a hollow tube, shown in an active position;
  • FIG. 3 s a side elevated view of the central body for accommodating and locking the cut end portion of the umbilical cord or of vessels or of a hollow tube;
  • FIG. 4 is a top view of the central body of FIG. 3;
  • FIG. 5 is a section view according to the section line V-V of FIG. 4;
  • FIG. 6 is a side view of the cutting device for cutting the umbilical cord, or vessels, or hollow tube;
  • FIG. 7 is a section view according to the section line II-VII of
  • FIG. 8 is a side view of a disinfecting and cleaning device
  • FIG. 9 is a section view according to the section line IX-IX of FIG. 8;
  • FIGs. 10-12 are side views of the assembly according to the invention shown in three successive steps of the operation of the assembly;
  • FIG. 13 is a schematic side elevated view of a system for applying pressure to the placenta and optionally to the umbilical cord, using the connector assembly according to the present invention.
  • the collector assembly according to the invention globally designated by the reference numeral 100, comprises six elements.
  • the anchoring device 200 has the purpose of anchoring the cut end portion of the umbilical cord or other vessel or tube and conveying it through the central body of the connector assembly according to the invention for subsequent positioning and locking.
  • the anchoring system is constituted by four optionally pointed curved elements 1 which are fixed to one end of an element 3 which passes through the central body and has, at the opposite end, a tip 4 which can be grasped by a hand.
  • a sheath 2 can slide along the longitudinal axis of the system and modifies the position of the curved elements from an inactive position, which allows to accommodate the end portion of the cord between said curved elements, to a "closed" position, which allows to fix and firmly anchor the end portion of the umbilical cord or other vessel or tube. In the inactive position (FIGs.
  • the anchoring system passes through the central body of the connector assembly, so that the anchoring elements protrude from the end from which the cord enters the central body and so that the tip that can be grasped protrudes from the opposite end portion 31.
  • the umbilical cord is conveyed through the central body of the connector assembly according to the invention for subsequent positioning and locking.
  • a central body 300 for accommodating and locking the cut end portion of the umbilical cord.
  • the central body 300 has the function of locking the end portion of the umbilical cord or other vessel or tube once it has been positioned by means of the above described anchoring system.
  • the central body can optionally have an access path leading to the internal space for connection to another container and/or dispenser of anticoagulant or other liquid or an access path for drawing part of the blood or fluid during collection.
  • the central body is composed of a hollow cylinder 5 which has appropriately selected length and diameters so as to allow the passage of the umbilical cord or other vessel or tube.
  • Orientated means 6 protrude from the inner walls and allow the cord or vessel or tube to slide freely in one direction but lock it if it is pulled in the opposite direction.
  • said means are represented by pointed metallic structures which protrude from the inside walls of the cylinder toward the center of said cylinder and are orientated toward the outlet with a suitable angle.
  • the orientated means can be constituted by solid or hollow needles or by a hollow truncated cone with a saw-toothed edge or other.
  • the locking means can optionally be arranged at right angles to the cord, so as to allow positioning of the cord and therefore so that they are activated appropriately in order to lock the cord in both directions. Flow is ensured by the appropriate choice of the dimensions of the locking means.
  • Said coupling device is constituted by a coupling system of the conical or screw or ring or other type between the central body and a collecting container constituted by a pouch, syringe, flask, collection tube or other.
  • the coupling device s an element 7 which has a conical coupling with the central body and can be connected to a collection pouch.
  • Other systems can be adopted for the connection of other containers.
  • a sealing device 8 for hermetically sealing the umbilical cord and the outer surface of the central body.
  • the function of the sealing device is to isolate from the outside environment the cut end portion of the umbilical cord, which is locked inside the central body. Said isolation is produced by virtue of sealing elements which adhere to the cord, optionally proximate to the point where the cord enters the central body, and thus ensure sterility inside the central body.
  • This device also allows to contain any anticoagulants or other substances introduced in the central body. The device does not entail significant decreases in cross-section or capacity of the umbilical cord or flow resistances of any other kind.
  • the sealing device 8 comprises a cylindrical or conical sheath made of elastic material (rubber, silicone, polymers or other material suitable for the purpose), which is shaped and sized so that the walls of one end adhere to a preset portion of the umbilical cord without compressing it but also ensure a hermetic seal, whilst the other end adheres to the outer surface of the central body or is coupled or mated to it by gluing, rings, conical coupling or other means.
  • the sealing means which are given appropriate dimensions and studied appropriately, can also ensure pressure tightness.
  • a cutting device 400 for cutting the umbilical cord can optionally comprise a cutting device for cutting the umbilical cord or vessel or tube.
  • the cutting device 400 of FIGs. 6 and 7 comprises a metallic element 9 which has a sharp end, with a central slot whose size and shape are suitable for the flow of blood (and which optionally corresponds to the inside diameter of the central body) and one end, which is opposite to the sharp one and has a radiused surface 10 which is suitable to be pushed by the operator.
  • Said metal element is located in the central body in suitable guides 11 which allow its sliding (guillotine).
  • the metal element after cutting the end portion of the umbilical cord or vessel or tube, ensures the outflow of the blood through the system by means of the slot provided in the body of said metal element.
  • the cutting system can optionally be connected to the central body only temporarily and can be disconnected after cutting 12: in this case, it is a metal element such as the one described n the previous hypothetical case; however, the presence of the slot required for the flow of blood after cutting is optional.
  • a disinfection and cleaning device 500 for disinfecting and cleaning the umbilical cord is an element which is suitable to appropriately clean and disinfect the cord or vessel or tube practically, quickly, effectively and without risks for the operator.
  • the device 500 shown m FIGs. 8 and 9, comprises a cylinder, which contains an element 13 which is made of elastic material which is optionally spongy and cylindrical and has a central hole 14, or of two half cylinders which are mutually coupled so as to obtain a cylinder and contain two half cylinders provided with a central longitudinal groove.
  • Said central element made of optionally spongy elastic material and having appropriate dimensions so as to allow the accommodation and sliding of the umbilical cord or vessel or tube, is impregnated with disinfectant, which makes contact with the outer surface of the cord or vessel or tube while passing through the cylinder.
  • two elements made of elastic material and having appropriate dimensions 15 ensure clamping upstream of the disinfection area.
  • FIGs. 10-12 schematically show the operational steps of the assembly according to the invention.
  • the description of the assembly given hereinafter is a non-limitative example of the invention and relates to its application to the withdrawal of placental blood from the umbilical cord during childbirth.
  • the invention can of course be used to collect blood or other liquids drained from other vessels or tubes.
  • the umbilical cord is closed in two points and then cut in a point which is intermediate between the two closure points. The end of the cord which is connected to the placenta remains available for coupling to the connector assembly.
  • the connector assembly which is sterilized beforehand, is in the illustrated configuration 31: the umbilical cord anchoring system passes through the central body.
  • the operator must couple the anchoring system to the maternal end portion of the umbilical cord, sliding the sheath along the guiding element. Once the end portion of the cord has been anchored, the operator, by pulling the end that can be grasped, pulls the umbilical cord through the central body 32.
  • the umbilical cord is in the position deemed optimum, it is cut with the cutting system included in the invention or with a pair of scissors 32.
  • the umbilical cord is cut, the operator pulls the umbilical cord in reverse with respect to the entry direction; in this manner, the umbilical cord is fixed inside the central body by the needles or by other means or suitable locking elements.
  • the umbilical cord is locked, the operator can connect the central body to the collection container 33, optionally after removing the cutting system.
  • a variation of the cord connector assembly provides for the application of said system immediately after the expulsion of the neonate, before cutting the umbilical cord.
  • the system in this case, in order to be applied to the umbilical cord which is still joined to the child, is constituted so that it can be applied around the cord without requiring a cut and free end.
  • the system according to the invention combines the advantages of the systems currently used for this purpose and eliminates their shortcomings, since it is a closed system in which the umbilical cord portion, once disinfected and connected, is isolated from the outside; sterile collection, suitable for use for a transplant, is ensured because the risk of contamination of the collected blood with microorganisms present in the environment is eliminated and contamination with maternal blood, which usually abundantly flows along the outer surface of the cord, is also prevented; it does not produce resistances to the flow of blood and allows collection from all three vessels of the umbilical cord; since the umbilical cord, once it has been connected, is firmly placed in the central body of the system, no particular care in movements is required and optional expression is facilitated; it does not use needles or other exposed pointed objects and therefore the operators are not exposed to the risk of accidental punctures; the constant presence of an operator is not required; the system can be used by health operators, even non-medical ones, since it does not require particular experience
  • the connector assembly according to the invention can be an integral part of a procedure which provides for the connection of the umbilical cord or vessel or tube to the collection container by means of the invention and for the subsequent application of pressure to the placenta by virtue of a suitable apparatus.
  • the placenta is placed on a supporting membrane
  • the umbilical cord which protrudes from the fetal surface of the placenta, is accommodated, in its initial portion, in a hollow cylindrical element of appropriate size 22, whilst the end portion, which has an appropriate length, is connected to a collection container by means of the invention.
  • the maternal surface of the placenta is separated from a hermetic chamber 16 by means of a membrane made of elastic material: the pressure applied by the membrane in the inactive position or the pressure generated by a pneumatic, electric or other system inside the hermetic chamber is transmitted to the upper surface of the placenta by virtue of the elastic membrane 17.
  • an appropriate mechanical pressure, generated by the rotary motion of a spiral conical element 26, is optionally applied to the fetal surface of the placenta.
  • the cut end portion of the umbilical cord or vessel or tube optionally after disinfection, is inserted in the central body of the system, optionally by means of a guiding element, arranged as necessary, and locked by appropriate locking means without squeezing, compressing or choking or in any case compromising the capacity of said vessel; is isolated from the outside environment with appropriate sealing elements which adhere to said cord; and is finally connected to a collection container, thus allowing collection, in sterile conditions, of the blood or other fluid drained from the umbilical cord or vessel or tube.
  • the above described assembly is non- 1 imitative , exemplifies one of the possible embodiments of the invention and relates to its application to the collection of placental blood from the umbilical cord, but it can of course be used to collect blood or other fluids drained from one or more vessels or from a hollow tube which has a variable cross-section with soft and elastic walls which have a loose and easily collapsible consistency.

Abstract

L'invention concerne un ensemble de connecteur pour collecter des fluides. Cet ensemble comprend un corps creux central (300) adapté pour recevoir et bloquer la partie d'extrémité coupée du cordon ombilical ou de tout autre vaisseau ou tube. L'invention concerne aussi un dispositif d'accouplement (7) pour coupler, de manière hermétique, le corps central (300) à un appareil de collecte. L'invention traite aussi d'un dispositif de scellement (8) pour sceller le cordon, le vaisseau ou le tube et une surface extérieure du corps central (300).
EP97937569A 1996-08-16 1997-08-12 Ensemble de connecteur pour collecter des fluides Withdrawn EP0935481A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT96UD000160A IT1288974B1 (it) 1996-08-16 1996-08-16 Sistema di raccordo per la raccolta di fluidi
ITUD960160 1996-08-16
PCT/EP1997/004383 WO1998007466A1 (fr) 1996-08-16 1997-08-12 Ensemble de connecteur pour collecter des fluides

Publications (1)

Publication Number Publication Date
EP0935481A1 true EP0935481A1 (fr) 1999-08-18

Family

ID=11422176

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97937569A Withdrawn EP0935481A1 (fr) 1996-08-16 1997-08-12 Ensemble de connecteur pour collecter des fluides

Country Status (4)

Country Link
EP (1) EP0935481A1 (fr)
AU (1) AU4014897A (fr)
IT (1) IT1288974B1 (fr)
WO (1) WO1998007466A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NO338751B1 (en) * 2015-03-25 2016-10-17 Terje Eide Devices for introducing and maintaining a port in an umbilical vessel
ES2896764T3 (es) * 2016-11-18 2022-02-25 The Hospital For The Relief Of Poor Lying In Women Dublin Commonly Called The Rotunda Hospital Un dispositivo de extracción de sangre de cordón

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4187848A (en) * 1977-07-18 1980-02-12 The Kendall Company Adapter assembly
US4405312A (en) * 1981-08-31 1983-09-20 Abbott Laboratories Connecting device for medical liquid containers
US5114672A (en) * 1990-08-27 1992-05-19 Cryo-Cell International, Inc. Method for preserving blood fluid
DE4100837A1 (de) * 1991-01-14 1992-07-16 Volker Bertram Adaptor mit trachealtubus
US5342328A (en) * 1993-03-22 1994-08-30 Grossman Michael D Medical body fluid sampler device and method
US5372581A (en) * 1993-07-21 1994-12-13 Minneapolis Children's Services Corporation Method and apparatus for placental blood collection

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9807466A1 *

Also Published As

Publication number Publication date
IT1288974B1 (it) 1998-09-25
WO1998007466A1 (fr) 1998-02-26
AU4014897A (en) 1998-03-06
ITUD960160A1 (it) 1998-02-16

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