DE1138186B - Infusion device for collecting and administering medical fluids - Google Patents

Description

The invention relates to an infusion device for collecting and administering medical Liquids, especially blood, with a storage and collection container made of flexible plastic and an inlet device also made of flexible plastic.

There are numerous problems and requirements in the extraction and handling of therapeutic Fluids, especially blood. In the case of whole blood need coagulation, clumping and chemical change in the fluid can be prevented or minimized. This requires devices that are sterile, air and blood only Present inert impermeable, inherently repellent surfaces.

There are so-called blood packs known that have a storage bag made of plastic with a have connected to it plastic hose, with inlet and discharge devices on these parts, ζ. Β. can be coupled by a plug connection.

When collecting blood, ζ. Β. for blood banking, testing or sampling of the blood is generally required, e.g. B. for blood group determination, typing, mixing, cross or cultural purposes. It is therefore used in conjunction with Collecting and storing all of the blood is usually a separate sample (pilot sample) of the particular one Donation made.

The invention aims to provide a device for collecting and administering medical Liquids, such as blood, which simultaneously with the collection and storage of the liquid in Easily samples can be taken, with the identity of the bulk of the liquid and the sample is guaranteed in each case and no mutual interference with the collection or administration of the liquid takes place through the production or removal of the sample.

According to the invention, the device is provided with an inlet device in front of the storage or collecting container in one piece via a branch line connected sample collection chamber opposite the Inlet means having a closure member, characterized.

In the branch line an externally operable device, e.g. B. a blood-repellent pearl or ball, for opening and closing the sample collection chamber.

The sample collection chamber can consist of a flexible plastic bag, one end of which

and administering medical

liquids

Applicant:

Fenwal Laboratories, Incorporated,
Framingham, Mass. (V. St. A.)

Representative: Dr. E. Wiegand,

Munich 15, Nussbaumstr. 10,

and Dipl.-Ing. W. Niemann, Hamburg 1,

Patent attorneys

Claimed priority:
V. St. v. America 23 Jan 1956 (No. 560 675)

David Bellamy, Framingham, Mass.,

and Carl Waldemar Walter,

Houston, Mass. (V. St. A.),

have been named as inventors

wall in one piece with the inlet device consisting of a flexible plastic tube is connected and contains the branch line.

The invention ensures that the main or donor liquid and the sample liquid via a ge ^ obtain and use common inlet in a single closed, sealed system, without the need for sterile, hermetically sealed storage through the collection or delivery of the one quantity the other set, d. H. the main quantity or the sample, is impaired or damaged. The invention also makes it possible for the sample to be collected first and then the main amount is accepted, with these operations in a unified system, together with the collection the sample. Finally, when using the invention, the identity of main set and The sample is always flawlessly guaranteed.

The invention is explained in more detail below, for example with reference to the drawing.

Fig. 1 is a view of the entire device according to the invention before it is used;

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3 4

Fig. 2 is an enlarged scale chuk or plastic enclosed. To the view the bag for the sample, a part of which can end a reaction with the blood inside has broken away in order to have a blood-repellent film for the connection with the donor needle 22, the hose to show; the z. B. from a dilute aqueous dispersion

Fig. 3 is a section along line 3-3 of Fig. 2.5 obtained from dicocodimethylammonium chloride. In Fig. 1 is an embodiment of an infusion tube 21 is a control valve device according to the invention for collecting, erecting device, and specifically in the vicinity of the Preserve and dispense a blood donation and an inlet of the container 10, which is preferably the shape Blood sample shown, which has a reservoir or sam- a ball 24 made of stainless steel, which in Mel container 10, a collecting device 20 and a hose 21 inserted and a little overdimensio sample collection chamber or a bag 30. is ned. This valve ball 24 can be similar The container 10, the collecting device 20 and the way as the needle 22 with a blood-repellent Bags 30 are in the form of an integral film coated.

arranged sterile closed system, the one-piece flexible, collapsible

Device 20 as an inlet for the donation container 15, hose 21 can be connected to one or more additional 10 and as both inlet and outlet for the borrowed points between its length with different sample collection chamber 30 serves. Furthermore, all of the closing means, e.g. B. by a hose or at least the blood-containing and pre-clamps or by knotting the tube, or elements of the system made of polyvinyl chloride by dielectric or other welding or other flexible, sterilizable plastic 20 ßung provided its opposite walls be of suitable strength and light weight. In this way it can be a whole Toughness produced, the only inert, impermeable, forming series of separate sections 25 gevon self-repellent surfaces against which are formed (see. Fig. 1). In these sections 25 Offering blood. can take additional separate samples of the blood that

The container 10 has a flexible body 25 is mainly stored in the container 10, samer wall and can in particular be made of one, and these additional samples can be used to Sleeve or tube or folded or identification, e.g. B. by printing or doubled Sheet consist, the opposite bring suitable double characters 26, on the Forms walls and be marked on the sides and / or ends of hose 21.

is flattened and welded, as in the case of the 30. The sample collection chamber 30 is integral with the Welds 11 and 12 is indicated. The loading collecting device 20 is connected in such a way that In this way, holder 10 provides a collapsible inlet and outlet through the hose 21 Bag which is evacuated before use, which is also in connection with the container 10 can be; he can have a capacity of can stand. The sample collection chamber 30 may be similar. B. have 500 ecm. 35 high like the container 10, a body with more flexible

The container 10 has one or more liquid wall have the z. B. from a sleeve or Keitsauslasst, which is preferably tubular in front of a hose or of folded or cracked Form 13, which is formed for coupling with liquid double sheet layers, their opposite administration devices (not shown) lying walls on their sides and / or are suitable. The outlet projections 13 are tightly spaced 40 ends are connected in one piece. Closing the sample pack A pair of protruding chambers 30 can be cut in the embodiment shown or separable tabs in the form of a bag that is smaller than the or strips 14 wrapped, the container 10 outside of the container, but has a similar structure, so 10 are welded together and sealed so that it also has a collapsible evacuation bag for the projections 13 form. Forms 45 baren container in use; this sample bag can be a these strips 14, the separate handle ends capacity of z. B. have 10 ecm, The sample collection chamber 30 in particular is cut off or pulled apart

gene to open the pockets and the connection formed by the fact that one or the free end of the the liquid administration devices are closed to form bags, e.g. B. by the flattened equip. 50 pieces or the weld 31, and his other

The container 10 can be partitioned off at one of the end 32 so that it can in this way welds 11, 12 with an eye ring or a parallel, flat opposite wall part 33, other opening 15 may be provided in which support 34 has (Fig. 3). These wall parts 33, 34 are or hanging means can engage, e.g. Storage, collection or dispensing purposes 55 opposite over and around the hose geder Liquid. are clamped and sealed. You can with each other

The device 20 for collecting blood or on both sides of the tube and in close proximity therapeutic fluid has a conclusion to be associated with it, Appropriate length of flexible, collapsible If the sample collection chamber 30 consists of a single tube 21, which is made at one end with the 60 zig sheet, this is around the The container 10 is integrally joined by the welding point 11, the hose 21 is folded and welded and the chamber is bound and with the container in open connection completed by the fact that one at the preceding dung stands. The one-piece © device 20 has sides and ends welded. When the sample collector a needle 22 of known design from rust chamber is made of double sheets, who is free Steel or the like for taking blood or for blood 65 the opposite layers over the tube delivery on. This needle is guided with its holding part in 21 and welded to this, and the Kamdas free end of the tube 21 fitted, while mer 30 is made by welding the above their cannulas closed in a sealing sheath 23 made of chewing leaf pages and ends.

From Fig. 1 it can be seen that the sample collection chamber 30 desirably with the device 20 on or within one of the separable sections 25 is united, the designation 26 of which is visible through it; this can also be near the transparent strips 33, 34 can be provided and thus also identify the sample.

The sample collection chamber 30 is connected in one piece to the device 20. It can also be a short length of hose 35 can be welded to an opening in a junction in the hose 21. the End weld32 of the sample collection chamber also encompasses this hose junction, with the parts 33, 34 are laid flat and welded around them, or they can form part 35 and so too represent a cavity end wall which expires like a funnel.

Furthermore, according to the invention, a closure member 36 for closing off the one-piece sample collection chamber 30 may be provided by the device 20. The closure member can be different Way to be carried out, including by means of facilities that are applied from the outside, such. B. a hose clamp. In the illustrated embodiment, however, similar to the container 10, a stainless steel ball 36 'is used for the locking member 36, which ball can be treated in this way that it is blood-repellent, which is oversized for engagement with the branch hose 35 and the how the valve 24 of the container 10 is completely enclosed so that it can be handled from the outside can be.

The infusion device according to the invention is for use e.g. B. made ready for blood bank purposes, that an appropriate amount of anticoagulant solution is added to the cleaned system brings in.

The infusion device according to the invention can be used for receiving and delivering blood or other therapeutic Liquid can be prepared by making a loose turn-up knot 27 in the tube 21 underneath the sample collection chamber 30 made and the container 10 supported or in a desired manner is hung.

In order to obtain a supply of blood, a blood sampling or blood-letting site is first established at the donor prepared by washing and disinfecting the skin and z. B. by a tourniquet the desired Pressure applied. The protective sheath 23 is then pulled off the needle 22 and blood is drawn made by inserting the needle into the donor's vein. The flow of blood in the tube 21 and at least to the sample collection chamber 30 is then conveyed by connecting the hose 21 squeezes or expands the valve 24 to such an extent that a fluid passageway at the Ball 24 done over.

The first few cubic centimeters of blood that flows out of a vein opening is through a marked greater tendency to lump; this increased clumping ability may be desirable for the sample while it is detrimental to the main donation. Accordingly, the first flow is preferred of the blood is passed into the sample collection chamber 30. This way of collecting the first blood as a sample also ensures that the sample is obtained without entering the container 10, as required can be when the sample is finally collected,

z. B. if the donor's blood flow stops before the container is filled.

After the container 10 is closed by releasing the hose 21 around the ball 24, the device is actuated or squeezed in the area of the branch member 35 to open the sample collection chamber 30 and to create a passage past the valve ball 36 ', so that the Blood can flow to the sample collection chamber 30 and fill it, ίο The sample collection chamber 30 is then closed, e.g. B. by releasing the tube 35 for reclosing around the ball 36 'so that the following blood flow is directed into the tube 21. The ball 24 is then pressed into the container 10 so that the desired flow of blood can now ^{take place along the donor tube into the blood container 10 1 in} order to fill it.

During this loading or filling of the container 10, the blood can with the in it Anticoagulant solution z. B. by kneading the container walls both during and after Collection to be mixed.

When the collection is finished, the hose 21 is between the container 10 and the sample collection chamber 30 z. B. completed by tightening the knot 27 in the hose 21.

Furthermore, in the practical use of the device according to the invention, the sample can be used for redetermination of the blood group (re-typing), for mixing or for cultural purposes. In this case, the needle 22 can be connected to a vacuum device immediately after the completion of the blood sample. z. B. an evacuated hose with a pierceable stopper, applied, and the closure member 36, as stated above, can be opened to the desired flow from the sample collection chamber 30 to allow the hose provided with the plug. The described sampling can with several such vacuum devices to the limit of capacity the sample collection chamber 30 can be repeated.

It can also be seen that some blood is retained in the sample collection chamber 30 and the Dispenser tube 21 between the sample collection chamber 30 and the donor needle 22 for the purpose the redetermination or other subsequent use of the retained blood sample is completed can be.

Mixture, cross and culture samples can also be obtained from the one-piece tube 21 will. If one or more samples of the serum are desired, the tube 21 is merely as described above, closed between the sections 25, so that separately closed sections are formed.

When samples of citrated blood are required, the tube 21 is first operated so as to that the blood contained in it is drawn into the container 10. Then the hose 21 released to allow the resulting citrated blood to flow back into it. Finally, the hose is terminated or welded, as detailed above, to the desired to obtain individual separable sample sections.

From the foregoing it can be seen that the invention is a durable economical device of creates a light weight, which is a one-piece

closed fluid system, which is used for the safe, simple, sterile collection of a Donation and samples of whole blood or other fluid with a minimal physiological Disturbance of the dispenser is suitable and in which the main amount of the liquid or the Blood and the sample are protected from the action of air and stored in such a way that they are none Subject to deterioration or chemical change. All carrying or storing the blood Parts of the device are designed in such a way that no reaction with the blood or the like occurs can and that they can be sterilized and welded by conventional methods.

Claims (3)

PATENT CLAIMS: 1. Infusion device for collecting and administering medical fluids with a storage or collection container made of flexible plastic and one as well made of flexible plastic Letting device, characterized by a sample collection chamber (30) connected in one piece with the inlet device (Zl) in front of the storage or collecting container (10) via a branch line (35), which has a closure member (36) opposite the inlet device. 2. Infusion device according to claim 1, characterized in that in the branch line (35) an externally operable device such as a blood-repellent bead (36 ') for opening and Closing the chamber (30) is arranged. 3. Infusion device according to claim 1 or 2, characterized in that the sample collection chamber (30) consists of a flexible plastic bag, one end wall (32) of which with integrally connected to the inlet device (21) consisting of a flexible plastic tube and includes the branch line (35). Considered publications:
U.S. Patent Nos. 2702034, 2,698,619, 663,298, 2,597,715, 1,693,189. 1 sheet of drawings © 20 »677/12 10.62