EP4087632A1 - Insert de chambre de goutte-à-goutte pour un système de perfusion médical - Google Patents

Insert de chambre de goutte-à-goutte pour un système de perfusion médical

Info

Publication number
EP4087632A1
EP4087632A1 EP21706894.9A EP21706894A EP4087632A1 EP 4087632 A1 EP4087632 A1 EP 4087632A1 EP 21706894 A EP21706894 A EP 21706894A EP 4087632 A1 EP4087632 A1 EP 4087632A1
Authority
EP
European Patent Office
Prior art keywords
drip chamber
face
insert
chamber insert
overflow opening
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.)
Pending
Application number
EP21706894.9A
Other languages
German (de)
English (en)
Inventor
Torben Guhl
Uwe Erik Schneider
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.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
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 B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP4087632A1 publication Critical patent/EP4087632A1/fr
Pending 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1411—Drip chambers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16813—Flow controllers by controlling the degree of opening of the flow line
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids

Definitions

  • the invention relates to a drip chamber insert for use in a drip chamber connected to a medical infusion or transfusion device, which is designed as a hollow body with an at least partially open first end face, drainage openings in a second end face opposite the first end face and at least one overflow opening, the at least one Overflow opening are formed by the at least partially open first end face or lies within a lateral surface arranged between the first and the second end face.
  • a well-known infusion device is available from B. Braun under the name Intrafix Safeset. This is a special infusion device with an air barrier and ventilation function.
  • the infusion device has a drip chamber with - based on an installed functional state - a piercing spike in the area of an upper side for piercing an infusion solution container and in the area of an underside a drip chamber floor which merges into an outlet channel that is connected to a hose line.
  • a liquid filter that acts as an air barrier is positioned at a distance above the bottom of the drip chamber.
  • the hose line has a connection piece (patient connector) for connection to an infusion needle.
  • the connector On delivery, the connector is provided with a protective cap (PrimeStop) with an integrated, air-permeable, liquid-repellent membrane that prevents infusion solutions and bacteria from escaping, but can allow air to escape from the system.
  • the system must be primed in preparation for the infusion. This process is carried out in the following order. First the roller clamp is closed. The spike is then inserted into the infusion solution container. By repeatedly pressing the flexible lower part of the drip comb, the liquid level is set in the drip chamber. This is followed by opening the roller clamp in order to vent the hose line.
  • the object of the invention is to provide a drip chamber of the type mentioned at the beginning which can be used quickly and easily and which reduces the risk of incorrect handling by the user and nursing staff.
  • the drip chamber should be designed in such a way that the risk of air embolism when using the drip chamber in a medical infusion system in a patient is reduced and / or the uncontrolled leakage of the infusion solution from the patient connector when the roller clamp is open, possibly in combination with a PrimeStop cap for drip-free venting, is prevented.
  • the drip chamber insert according to the invention is used for use in a drip chamber that can be connected to a medical infusion or transfusion device.
  • the drip chamber insert is designed as a hollow body and has an at least partially open first end face, one or more drainage openings in a second end face opposite the first end face, and at least one overflow opening.
  • the at least one overflow opening is located laterally in any area of the lateral surface that extends from the first to the second end face; it is used to ensure that liquid in the drip chamber insert - in addition to the drain opening (s) in the second end face - can run out laterally.
  • the at least one overflow opening allows infusion or transfusion liquid to flow not only through the outflow openings in the second end face but at the same time through the at least one overflow opening.
  • the at least one overflow opening lies within a lateral surface arranged between the first and the second end face; preferably the distance from the second end face (S2) is at least 1/3 H, more preferably in the range 0.4 H to 0.8 H, where H is the height of the drip chamber insert (1) measured as the distance from the first to the second end face .
  • the at least one overflow opening is approximately halfway between the first and second end face, i.e. in the range of 0.5 H ⁇ 10%.
  • the at least one overflow opening is formed by the at least partially open first end face, and / or the at least one overflow opening is designed as an extension of the opening of the at least partially open first end face.
  • the opening located on the at least partially open first end face can extend into the jacket surface at one or more points along the circumference, so that at least one notch is located on the upper edge of the jacket surface (ie on the one adjoining the second front side Edge or edge located upstream in use).
  • the drip chamber insert is advantageously designed in shape and size in such a way that it can be used as an insert in conventional drip chambers, in particular in a lower region (lower part) of the conventional drip chamber based on an assembled functional state.
  • the first end face of the drip chamber insert is a top side (upstream in use) and the second end face is an underside (downstream in use).
  • To prepare the drip chamber insert for an infusion only the piercing part of a drip chamber with an integrated drip chamber insert according to the invention is pierced into an infusion solution container. As a result of gravity, the infusion solution flows through the opening in the first end face and collects in the drip chamber insert until the filling level reaches the at least one overflow opening.
  • the total area (drainage area) defined by the (ie all) drainage openings is smaller than the area (overflow area) defined by the at least one overflow opening.
  • overflow openings here is synonymous with “at least one overflow opening”.
  • the outflow rate from the drip chamber insert corresponds to the infusion rate of the infusion solution into the drip chamber insert.
  • the drainage openings cause the drip chamber to be completely emptied towards the end of the infusion.
  • the process of preparing the infusion can be made much simpler, more time-efficient and safer by eliminating most of the preparation steps.
  • the following steps for preparing the infusion device can be dispensed with: closing the roller clamp, pressing the flexible lower part of the drip chamber several times and opening the roller clamp.
  • the present invention considerably simplifies the handling of gravity-based (or drip-chamber-based) medical infusion and transfusion devices, standardizes the filling of the drip chamber and significantly reduces the risk of incorrect handling.
  • the invention achieves a maximum of patient safety.
  • the outflow openings are round and / or have a diameter of 0.5 to 3 mm, preferably 0.8 to 2 mm and in particular 1.0 to 1.5 mm.
  • the sieve-like design of the underside of the drip chamber insert is intended to ensure, on the one hand, a lower outflow rate in relation to the inflow rate and thus an increase in the filling level in the drip chamber insert. On the other hand, a complete emptying of the drip chamber including the drip chamber insert is guaranteed.
  • the overflow openings in the lateral surface are designed to be elongated.
  • the overflow openings are located within the jacket surface at the same height as the hollow body in the area between the first and the second end face.
  • it is slot-shaped overflow openings that the Allow infusion liquid to pass essentially unhindered without leading to a further increase in the level above the height of the overflow openings.
  • the overflow openings arranged within the jacket surface are spaced apart from the second end face, and the overflow openings may be spaced apart from the first end face. As a result of the spacing, the overflow openings lie within the lateral surface arranged between the first and the second end face.
  • the hollow body is designed in the shape of a cylinder.
  • the hollow body preferably tapers towards the second end face.
  • the outer geometry of the hollow body can have the shape of a cylinder, a cone or a truncated cone.
  • the hollow body has a height of 1 to 10 cm, preferably 2 to 8 cm and in particular 3 to 6 cm, measured as the distance from the first to the second end face, and / or has a height at the level of the first end face and / or outside diameter measured at the level of the second end face of 0.5 to 5 cm, preferably 1 to 4 cm and in particular 2 to 3 cm.
  • Such a drip chamber insert is modeled on drip chamber lower parts known in terms of geometry and dimensions and can thus be easily integrated into known drip chambers. It is also preferred that the hollow body is designed with regard to the drip chamber in such a way that there is a gap between the outer jacket surface of the drip chamber insert and the inner jacket surface of a lower region of the drip chamber (drip chamber lower part) and / or between the outer second end face of the drip chamber insert and the Forms the inside of the drip chamber base to ensure that the infusion solution flows out of the drip chamber unhindered.
  • the drip chamber insert according to the invention can be designed in one piece and / or made of plastic, in particular hard plastic. This enables simple production using a 2-jaw tool.
  • the drip chamber insert can be presented ready-to-use, in particular it can be packaged in one package with other infusion sets.
  • the administration is preferably sterile.
  • the object is also achieved by a drip chamber for a medical infusion or transfusion device with a drip chamber base, which has an outlet channel for connection to a hose line, and a drip chamber insert as described above, which is positioned in the drip chamber with the second end facing the drip chamber base.
  • the drip chamber has a liquid filter.
  • This is positioned in the drip chamber between the drip chamber base and the drip chamber insert, and preferably at a distance (for example by means of spacers) from the outlet channel.
  • the liquid filter is designed in particular as an AirStop, in that it prevents the escape of air bubbles from the drip chamber into the outlet channel and in this way additionally reduces the risk of an air embolism in the patient.
  • the liquid filter is preferably able to act as a particle filter to prevent particles from passing through.
  • the outer surface of the drip chamber insert is at least partially spaced from the inner surface of the drip chamber. It is further preferred that the drip chamber insert is positioned at a distance from the drip chamber floor or, if present, at a distance from the liquid filter in the drip chamber. For this purpose, spacers can be provided at the corresponding positions to be spaced apart. The distance can be, for example, 0.1 to 10 mm, preferably 0.2 to 5 mm and in particular 0.5 to 3 mm.
  • the drip chamber also has a hose line connected to the outlet channel with a connector for connection to an infusion or transfusion needle.
  • the connector is preferably provided with a closure cap which separates the interior of the hose line from the surroundings by means of an air-permeable and water-repellent membrane.
  • the drip chamber is preferably (also) cylindrical and / or the drip chamber tapers, if necessary, towards the outlet channel.
  • Another aspect of the present invention relates to the use of a drip chamber insert (as described here) or a drip chamber (as described here) to prepare a medical infusion or transfusion device without shutting off and reopening a connection to the drip chamber provided on the patient side and / or without external pressurization of the Inside the drip chamber.
  • a connection provided on the patient side is understood in particular to be the hose line connected to the outlet channel.
  • the term "without external pressurization of the interior of the drip chamber” means that, apart from the force of gravity acting on the infusion solution, no further forces on the infusion solution and in particular no forces on the drip chamber itself, for example through (multiple) compression (e.g. manual pressing) of the Drip chamber, are exercised.
  • FIG. 1 schematically shows a sectional view of a drip chamber according to the invention with a drip chamber insert in a preferred embodiment
  • FIG. 2 schematically shows a view of the drip chamber insert 1 from FIG. 1 in a plan view from below on the end face S2 in the section plane A-A of FIG. 1; and
  • FIG. 3 schematically shows a sectional view of a drip chamber according to the invention with a drip chamber insert in a further embodiment.
  • FIG. 1 is a sectional view of a drip chamber according to the invention with a drip chamber insert according to a preferred embodiment of the invention.
  • the drip chamber is a conventional cylindrical drip chamber 10 composed of lower part 6 and upper part 7 Outlet channel 4 tapers conically.
  • the upper part 7 is shown here with a round or hemispherical tapering upper end with a concentrically arranged piercing spike 8.
  • a liquid filter 5 is located on the drip chamber floor and preferably at a distance from the drip chamber floor Drip chamber insert 1 and inner surface of the lower part 6 and between the bottom (outside) of the drip chamber insert 1 and the bottom (inside) of the drip chamber 10 fills. In other words, an intermediate space to the drip chamber, in which infusion liquid can flow, is formed at the side and downwards.
  • the size and shape of the drip chamber insert 1 is adapted to the lower part 6 of the drip chamber 10, ie it corresponds to the geometry of the lower part 6 and is preferably slightly smaller.
  • the drip chamber insert 1 has slot-shaped overflow openings 3 in its outer surface, in this embodiment preferably approximately halfway up.
  • a plurality of drainage openings 2 is provided in the bottom of the drip chamber insert 1.
  • FIG. 2 shows a view of the drip chamber insert 1 from FIG. 1 (ie without showing the drip chamber 10) from below, specifically a plan view from below on the end face S2 in the section plane AA in FIG. 1, but on a slightly larger scale than in FIG 1.
  • the bottom of the drip chamber insert 1 has a large number of drainage openings 2 (shown here round), preferably in a sieve structure.
  • the sieve-like base enables a low flow rate due to the relatively small outflow openings 2.
  • the slot-shaped overflow openings 3 located in the outer surface - approximately halfway up the conical / truncated spherical housing profile of the drip chamber insert 1 - are also shown.
  • the overflow openings 3 allow a relatively high flow rate due to relatively large holes.
  • FIG. 3 is a sectional view of another embodiment of the drip chamber of the present invention showing a modification of the drip chamber insert of FIG.
  • the drip chamber is constructed in the same way as in FIG. 1, with the difference that the overflow openings 3 are not located in the lateral surface between the first and second end faces S1, S2, but rather extend away from the opening of the first end face S1 Shape of notches extending downwards. Otherwise, the reference symbols denote the same as in the embodiment according to FIG. 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un insert de chambre de goutte-à-goutte destiné à être introduit dans une chambre de goutte-à-goutte (10) à raccorder à un dispositif médical de perfusion ou de transfusion. L'insert de chambre de goutte-à-goutte (1) est réalisé sous la forme d'un corps creux et comprend : une première face d'extrémité au moins partiellement ouverte (S1), des ouvertures d'évacuation (2) dans une seconde face d'extrémité (S2) opposée à la première face d'extrémité, et au moins une ouverture de trop-plein (3), la ou les ouvertures de trop-plein (3) étant formées dans la zone de la surface latérale du corps creux qui s'étend de la première face d'extrémité à la seconde face d'extrémité. L'insert de chambre de goutte-à-goutte peut être introduit dans la chambre de goutte-à-goutte. La chambre de goutte-à-goutte (10) est adaptée à un dispositif médical de perfusion ou de transfusion et comprend, en plus de l'insert de chambre de goutte-à-goutte, une base de chambre de goutte-à-goutte dotée d'un canal de vidange (4) destiné à être relié à une conduite tubulaire. L'insert de chambre de goutte-à-goutte (1) est positionné dans la chambre de goutte-à-goutte (10) de telle sorte que la seconde face d'extrémité (S2) fait face à la base de chambre de goutte-à-goutte. L'insert de chambre de goutte-à-goutte ou la chambre de goutte-à-goutte peut être avantageusement utilisé pour préparer le fonctionnement d'un dispositif médical de perfusion ou de transfusion sans fermeture et réouverture d'un raccordement côté patient à la chambre de goutte-à-goutte et/ou sans application externe d'une pression à l'intérieur de la chambre de goutte-à-goutte.
EP21706894.9A 2020-02-19 2021-02-18 Insert de chambre de goutte-à-goutte pour un système de perfusion médical Pending EP4087632A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020202123.6A DE102020202123A1 (de) 2020-02-19 2020-02-19 Tropfkammereinsatz für ein Infusionsgerät eines medizinischen Infusionssystems
PCT/EP2021/053942 WO2021165352A1 (fr) 2020-02-19 2021-02-18 Insert de chambre de goutte-à-goutte pour un système de perfusion médical

Publications (1)

Publication Number Publication Date
EP4087632A1 true EP4087632A1 (fr) 2022-11-16

Family

ID=74672314

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21706894.9A Pending EP4087632A1 (fr) 2020-02-19 2021-02-18 Insert de chambre de goutte-à-goutte pour un système de perfusion médical

Country Status (5)

Country Link
US (1) US20230338642A1 (fr)
EP (1) EP4087632A1 (fr)
CN (1) CN115151286A (fr)
DE (1) DE102020202123A1 (fr)
WO (1) WO2021165352A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE8101247L (sv) 1981-02-26 1982-08-27 Haessle Ab Lekemedelsadministrationsanordning
DE29921086U1 (de) * 1999-12-01 2001-04-12 Braun Melsungen Ag Infusionsgerät
US8523829B2 (en) * 2004-01-29 2013-09-03 Becton, Dickinson And Company Intravenous delivery system
KR100609608B1 (ko) * 2006-05-24 2006-08-08 허승환 수액 투여기용 역류방지장치
WO2012057602A1 (fr) * 2010-10-29 2012-05-03 Hian Khim Francis Then Système d'administration de liquide intraveineux
US10874806B2 (en) * 2014-02-14 2020-12-29 Ailnh, Llc Gas removal apparatus and related methods

Also Published As

Publication number Publication date
CN115151286A (zh) 2022-10-04
US20230338642A1 (en) 2023-10-26
DE102020202123A1 (de) 2021-08-19
WO2021165352A1 (fr) 2021-08-26

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