INFUSION SET FOR AN INFUSION DEVICE
Patent Information
- Authority / Receiving Office
- MX · MX
- Patent Type
- Patents
- Current Assignee / Owner
- YPSOMED AG
- Filing Date
- 2021-04-22
- Publication Date
- 2026-05-19
Smart Images
Figure MX433659B0
Abstract
Description
FIELD OF INVENTION The invention relates to an infusion set for an infusion device. Infusion sets are used to deliver a liquid product, in particular a liquid medication, from an infusion device into a patient's body. The term “medicinal drug” herein encompasses any fluid medicinal formulation suitable for controlled administration by a means such as a cannula or hollow needle, for example, a formulation comprising a liquid, solution, gel, or suitable suspension containing one or more active medicinal ingredients. The medicinal product may be a single-agent composition or a pre-mixed or co-formulated multi-agent composition in a single container.Drugs include drugs such as peptides (e.g., insulins, drugs containing insulin, containing or derived from GLP-1 or analogous preparations), proteins and hormones, biologically obtained or active ingredients, hormone-based active ingredients or genes, nutritional formulations, enzymes and other substances in both solid (suspended) and liquid form, but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies, as well as suitable basic, auxiliary and carrier substances. For patients with a regular need for liquid medication, the required amount can be administered in liquid form via a cannula inserted into the subcutaneous tissue over an extended period. For this purpose, an infusion set with a cannula made of either a soft or rigid material is attached to the patient's skin, allowing the cannula to penetrate the skin and reach the subcutaneous tissue. The required amount of medication is administered in liquid form from an infusion device, preferably an automatic infusion pump, through a delivery line to the patient via the delivery cannula of the infusion set. BACKGROUND OF THE INVENTION Infusion sets are known from prior art. US patents 8152769B2, EP1694385B1, and EP1984044B1 describe infusion sets that have a base with a cannula. The cannula is inserted through the skin into the subcutaneous tissue to administer a liquid medication to a patient. In addition, the infusion sets have a connector to which a delivery line, specifically tubing, is attached. The delivery line can be connected to an infusion device, specifically an infusion pump. The liquid medication can then be administered to the patient via the infusion device through the infusion set. The connector and base can be rotated relative to each other, specifically to any desired angle. This arrangement improves ease of use.The disadvantage of these infusion sets is that handling and / or operating these infusion sets becomes more difficult, as operational errors are possible. RQQfrnn / Lznz / B / Yi BRIEF DESCRIPTION OF THE INVENTION It is an objective of the invention to provide an alternative infusion set, the handling and / or operation of the infusion set being made easier to avoid incorrect operation. This problem is resolved by the subject matter of the independent claims. Advantageous modalities are defined in the dependent claims. In the case of the infusion set according to the invention, the distant direction means the side to which an adhesive bandage can be attached to secure the infusion set to a patient's skin. In the case of the infusion set according to the invention, the near direction means the side that cannot be connected to an infusion device. The infusion set according to the invention can be attached to an infusion device, particularly an infusion pump, and preferably an automatic infusion pump. The infusion devices can be used for the continuous administration of infusions, particularly drugs in liquid form. The infusion device can be a reusable infusion device, consisting of a new container pre-filled with a liquid drug that is inserted into the reusable infusion device. Alternatively, the infusion device can be a single-use infusion device, in which case the pre-filled container of liquid drug is empty. The infusion set can comprise a base portion for attaching to a patient's skin, wherein the base portion can have a proximal and a distal side. Furthermore, the base portion can have a cannula for delivering the liquid drug into the patient's body.The cannula may be provided on the far side of the base. Furthermore, the infusion set may include a connector with a supply line, in particular a tube. The connector may have a near side and a far side. The supply line may be used for connection to the infusion device. Additionally, the supply line may be used to connect to the base via a piercing cannula to form a fluid path between the connector and the base. Furthermore, the infusion set may include a cap for storing the infusion set by the patient or by means of an insertion device or piercing aid, wherein the cap may have a far side and a near side.The infusion set can be equipped, in a first modality, with a soft cannula, where the cannula can be formed from a soft material, in particular a polymer, or, in a second modality, with a rigid cannula, where the cannula is formed from steel or an alternative rigid material. In a first embodiment of the infusion set, the cap portion of the infusion set may have a rigid needle, which may be made of steel or an alternative rigid material. The cap portion may be hinged or detachably connected to the base portion. The connection may preferably be designed as a snap-fit connection. Alternative connections may be provided. The cap portion may be connected, in particular, snapped, to the base portion such that the rigid needle can be arranged concentrically within a soft cannula of the base portion. The soft cannula can be used to deliver liquid medication into a patient's body. The cap portion may be positioned on the proximal side of the base portion. The concentric arrangement of the soft cannula and the rigid needle can serve to guide the soft cannula when the soft cannula of the base portion is inserted into the patient's skin.The distal end of the rigid needle may protrude beyond the distal end of the soft cannula. Additionally, an adhesive bandage may be applied to the distal side of the base. The adhesive bandage can be used to attach the infusion set to the patient's skin. To attach the infusion set to the patient's skin, the base, connected to the cap, is secured in place. A protective film is removed from one side of the adhesive bandage beforehand. The soft cannula, with its fixed needle, can then penetrate the patient's skin and into the subcutaneous tissue. To connect the infusion set to an infusion device, the cap with the needle is first removed from the base, and a connector, which may include a delivery line (specifically tubing and an adapter), is then attached to the base of the infusion set.The connection between the base and connector portions can be designed as a snap-fit connection. Alternative connections are available. One end of the supply line can be soldered and / or bonded to the adapter. The other end of the supply line can be soldered and / or bonded to the connector portion. Preferably, the supply line can be bonded to the adapter and / or connector portion, preferably with an adhesive that can be cured by exposure to UV light. This means that solvents used during soldering can be dispensed with. The use of solvents may be undesirable because a solvent can enter the fluid path and contaminate the liquid medication to be dispensed. The connector portion adapter can be detachably attached to a corresponding connection element of the infusion device.The connector adapter can be attached to the infusion device using a bayonet, Luer, or other type of locking mechanism. A fluid path can then be created from the infusion device through the infusion set to the patient. The connector adapter may include a valve. The valve may be designed to open and close. The valve may be designed as a check valve, particularly a diaphragm check valve. The valve may include a liquid inlet and a liquid outlet for the liquid medication. The valve can also be designed to open when the pressure of the liquid medication at the inlet exceeds a predetermined threshold. This prevents uncontrolled release of the liquid medication. The valve can also be designed so that the liquid medication can only flow in one direction, from the liquid inlet to the liquid outlet. This can prevent the liquid medication to be dispensed from flowing backward. In a second embodiment of the infusion set, the infusion set may comprise a cap portion. The base portion may comprise a rigid cannula. The rigid cannula can be used to deliver a liquid medication into a patient's body. The cap portion may be hinged or detachably connected to the base portion. The connection may preferably be designed as a snap-fit connection. Alternative connections may be provided. The base portion may be disposed at the far end of the cap portion. On the far side of the base portion, an adhesive bandage may be provided for attaching the infusion set to the patient's skin. To attach the infusion set to the patient's skin, the base portion connected to the cap portion, particularly when fitted in place, may be attached to the patient's skin by means of adhesive bandages, a protective film of which is removed beforehand from one adhesive side of the bandage.The rigid cannula of the base can penetrate the patient's subcutaneous tissue. The cap portion can be removed from the base portion to loosely connect a connector portion to the base portion. The connector portion may comprise a supply line, in particular a tube and an adapter, for loosely connecting the infusion set to an infusion connection. The connection between the base portion and the connector portion may be designed as a snap-fit connection. Alternative connections may be provided. The supply line may be soldered and / or glued to the adapter at one end and soldered and / or glued to the connector portion at the other end. Preferably, the supply line may be glued to the adapter and / or the connector portion, preferably with an adhesive that can be cured by exposure to UV light. This means that the solvents used during soldering can be dispensed with.The use of solvent may be undesirable because a solvent can enter the fluid path and contaminate the liquid medication being dispensed. The connector adapter can be detachably attached to a corresponding connection element of the infusion device. The connector adapter can be attached to the infusion device using a bayonet, Luer, or other type of locking mechanism. A fluid path can then be created from the infusion device through the infusion set to the patient. The connector adapter may include a valve. The valve may be designed to open and close. The valve may be designed as a check valve, particularly a diaphragm check valve. The valve may include a liquid inlet and a liquid outlet for the liquid medication. The valve can also be designed to open when the pressure of the liquid medication at the inlet exceeds a predetermined threshold value. This prevents uncontrolled release of the liquid medication. The valve can also be designed so that the liquid medication can only flow in one direction, from the liquid inlet to the liquid outlet. This can prevent the liquid medication to be dispensed from flowing backward. The first and second types of infusion sets may preferably include a removable protective element. This protective element may serve to protect against puncture wounds from the rigid cannula or rigid needle of the corresponding infusion set. The protective element may preferably be designed in the form of a sleeve. Alternative configurations of the element may be provided. One or more longitudinal protrusions may preferably be provided on an outer protective surface of the protective element for improved grip.Therefore, before the infusion set is applied to the patient's skin, the patient can simply remove the protective element from the base. After removing the infusion set from the patient's skin, the protective element can be easily placed back onto the rigid cannula of the base or the rigid needle of the cap, where the patient is protected from needlestick injuries. The protective element can be loosely connected to the base and / or cap with a force adjustment and / or a form adjustment to protect the patient from needlestick injuries. The base portion of the first and second infusion set may preferably be flat. To guide and / or position the base portion relative to the cap and / or connector portion, a base cylinder may be provided on the proximal side of the base portion of the first and second infusion set. The base cylinder may extend from the proximal side of the base portion in the proximal direction. The base cylinder may be cylindrical. The base cylinder may be arranged concentrically for the soft or rigid cannula of the corresponding infusion set. Furthermore, an opening may be provided in the base of the first and second types of infusion set. The opening may be designed as a blind hole. The opening may be located on the far side of the base and may be provided in the base cylinder. The opening may be arranged concentrically for the soft or rigid cannula of the corresponding infusion set. The opening may be designed so that it can only receive the protective element, in particular, by force fit. Alternatively, the opening and the protective element may be designed so that the protective element can be received in the opening by form fit. Additionally, a cannula cylinder may preferably be provided at the far end of the base portion of the first and second infusion sets. The cannula cylinder may be cylindrical. The cannula cylinder may be provided at the opening of the base portion. The cannula cylinder may extend from the far side of the base portion in the far direction. The soft or rigid cannula may be attached to the corresponding cannula cylinder, particularly in a passage provided in the cannula cylinder, and extend from the corresponding cannula cylinder in the far direction to deliver the liquid medication to the patient. Before the corresponding infusion set is attached to the patient's skin, the protective element can be detachably connected to the base unit with a tension adjustment. This allows the protective element to protect the patient from a puncture wound caused by the rigid cannula or needle of the corresponding infusion set. The protective element can be pressed freely or pressed into the opening of the base unit, subjecting it to compression. This compression force on the protective element can lead to less damage, particularly cracking, than if the protective element is positioned within the cannula cylinder of the base unit and thus subjected to tensile stress.Additionally, the diameter of the protective element can be larger so that the patient can better grip it when removing it from or placing it on the base. This design can also reduce pressure on the cannula cylinder, preventing damage such as cracking or denting. Alternatively, the base portion may have one or more recesses into which one or more pin-shaped elements provided in the protective element can be pressed. RQQfrnn / Lznz / E / YL freely or be pressed into the recess or plurality of recesses to protect the patient from puncture wounds. Alternatively, the recess or plurality of recesses and the pin-shaped element or plurality of pin-shaped elements may be designed such that the recess or plurality of recesses can receive the pin-shaped element or plurality of pin-shaped elements in a form-fit manner. The cap portion of the first and second infusion setting is preferably designed in the shape of a cap. A cap cylinder may be provided within the cap portion's cover. The cap cylinder may be cylindrical. The cap cylinder may be formed in one piece or in several pieces. The cap cylinder may be designed as a hollow cylinder. The cap cylinder may extend from the inside of the cover in the distant direction. The cap cylinder may be arranged in the cap portion such that when the cap portion is connected, in particular fitted, to the base portion, the cap cylinder can be arranged concentrically to the base cylinder of the base portion. When the base portion is connected to, in particular fitted into, or removed from the base portion, the base cylinder may be in a guide coupling with the cap cylinder, in particular a sliding coupling.The cap cylinder of the cap portion can be positioned outside the base cylinder of the base portion. The cap portion can be positioned so that it moves about its axis relative to the base portion when connected, in particular fitting into the base portion and / or releasing from the base portion. The connector portion of the first and second infusion set configurations may preferably be designed in the form of a cap. Additionally, a connector cylinder may be provided within the cover of the connector portion. The connector cylinder may be cylindrical. The connector cylinder may extend from the inside of the cover in a distant direction. The connector cylinder may be arranged within the connector portion such that when the connector portion is connected, or in particular fitted, to the base portion, the connector cylinder is concentric with the cannula cylinder of the base portion. The connector cylinder of the connector portion may be positioned outside the base cylinder of the base portion. The connector cylinder may be formed in one piece or in several pieces.The connector cylinder can be designed as a hollow cylinder, in which a drilling cannula is arranged concentrically and / or coaxially with the connector cylinder inside the connector cylinder. The drilling cannula can be designed as a separate part, particularly as a separate steel cannula, or as part of the connector part. The drilling cannula can be connected to the supply line, particularly to the tubing. When the connector part is connected to the base part, particularly when it is fitted into place, or removed from the base part, the base cylinder can be in a guide coupling, particularly a sliding coupling, with the connector cylinder. If the connector cylinder is arranged concentrically with the base cylinder, the connector part can rotate relative to the base part, particularly through any desired angle.The connector part and the base part can be arranged to move and rotate axially relative to each other, in particular to rotate through any desired angle. In the first modality of the infusion set, the rigid cannula can be inserted to the correct length into the base part, specifically into the cannula cylinder, and an adhesive can be used to fix the rigid cannula to the base part. RQQfrnn / Lznz / E / YL of the fluid path, particularly between the rigid cannula and the cannula cylinder of the base. Therefore, contamination of the liquid drug to be dispensed by the adhesive can be excluded. Preferably, an adhesive that can be cured by exposure to UV light for solvent dispensing may be used. Alternative means of fixation may be provided to secure the rigid cannula to the base. In the second embodiment, the infusion set, the soft cannula of the correct length can be inserted into the base portion, specifically into the cannula cylinder of the base portion, or it can be cut to the correct length while already inserted. A connecting piece can be used for connection, particularly for securely attaching the soft cannula to the base portion. The connecting piece can preferably be tubular at the far end and funnel-shaped at the near end. Other designs of the connecting piece are available. The connecting piece can be made of a rigid material, particularly steel. The connecting piece can be referred to as an "eyelet." The "eyelet" can serve to guide the rigid needle that is positioned in the cap portion. To insert the soft cannula into the base portion, the soft cannula can first be joined to or pushed into or over the "eyelet," particularly over the far portion of the "eyelet."The soft cannula can be positively connected to the eyelet, specifically by pressing it in. The eyelet connected to the soft cannula can be pressed into the passage provided in the cannula cylinder. The eyelet connected to the soft cannula can be positively connected to the base. The proximal portion of the eyelet can be positioned on the proximal side of the cannula cylinder, and the distal portion of the eyelet can be positioned on the distal side of the cannula cylinder. In addition, a septum may be provided in the cannula cylinder of the first and second infusion set configurations. In the first infusion set configuration, the septum may be provided at the near end of the rigid cannula to close the passage of the cannula cylinder. In the second infusion set configuration, the septum may be provided at the near end of the "eyelet" to close the passage of the cannula cylinder. The septum may also serve to close the base portion to prevent unwanted fluid flow. The piercing cannula of the connector portion may pierce the septum of the base portion, particularly if the connector portion is connected to the base portion, especially if it is tightly fitted, to form a fluid connection. The delivery line, in particular the tubing for the first and second modes of the infusion set, may preferably comprise an outer material and an inner material. The outer material may preferably comprise polyurethane (PU), in particular Elastollan® 1185 A 10FC. The inner material may preferably comprise high-density polyethylene (HDPE), in particular SABIC® HDPE B5429, or polypropylene (PP), in particular Bormed™ SC820CF-11. An alternative outer and / or inner material may be provided. In one embodiment of the delivery line, particularly the tubing, the delivery line, particularly the tubing of the infusion set, may consist of an outer material and an inner material. The outer material may preferably consist of polyurethane (PU), particularly Elastollan® 1185 A 10FC. The inner material may preferably consist of high-density polyethylene (HDPE), particularly SABIC® HDPE B5429, or polypropylene (PP). RQQhnn / ιζηζ / Β / γι particular Bormed ™ SC820CF-11. The two-layer tube may be produced by a co-extrusion process, then cooled in a water bath, wound onto a roll, and cut to an appropriate length. The adhesion of the two layers may result from a chemical and / or physical process during the co-extrusion process. The two-layer tube may not include an adhesive layer between the two layers. By dispensing with an adhesive layer between the two layers, contamination of the liquid medication to be dispensed by a substance absorbed into the adhesive layer may be prevented. In one type of supply line, specifically the pipe, the outer diameter of the outer material can be between 1.47 mm and 1.57 mm. The inner diameter of the outer material can be approximately 0.6 mm. The inner diameter of the inner material can be approximately between 0.26 mm and 0.34 mm. In another configuration of the supply line, specifically the pipe, the outer diameter of the outer material can be approximately between 1.47 mm and 1.57 mm. The inner diameter of the outer material can be approximately 0.8 mm. The inner diameter of the inner material can be approximately between 0.46 mm and 0.54 mm. The wall thickness of the inner material can be reduced so that less of the inner material is used to manufacture the tube. Therefore, less preservative, such as pheno or m-cresol, can be absorbed by the inner material of the tube, thus increasing the shelf life of the liquid medication dispensed through it. The choice of material for the outer material may preferably have good tensile strength or good wear resistance, resistance to hydrolysis, low temperature flexibility and / or resistance to microorganisms. The base portion of the first and second embodiments may have an uneven surface on the far side. One, or in particular a plurality of, cams (or flanges) may be provided on the far side of the base portion. The plurality of cams may be arranged in a uniformly distributed manner on the far side of the base portion. Alternatively, the plurality of cams may be arranged in an irregularly distributed manner on the far side of the base portion. The cams may preferably be approximately pyramidal or conical in shape. The cams may preferably be attached to the adhesive plaster, in particular by fusion. The cams of the base portion may preferably be fused to the adhesive plaster by ultrasonic welding using a sonotrode.When the base portion is attached to the patient's skin, this arrangement can result in improved ventilation of the soft or rigid cannula of the infusion set in the patient's skin, as air can circulate between the base portion and the adhesive plaster. The base portion of the first and second forms may preferably have a rebate. The rebate may be provided on the near side of the base portion. A plurality of rebates may preferably be provided. The rebate or plurality of rebates may be arranged on an edge of the base portion. The base portion may preferably comprise a projection and a rebate, in particular a plurality of projections and a plurality of rebates. The projection and the rebate, in particular a plurality of projections and a plurality of rebates, may be provided on the near side of the base portion. Furthermore, the projection and the rebate, in particular a plurality of projections and RQQbnn / ί7Π7 / E / YI The plurality of rebates may be arranged on the edge of the base part. Particularly preferable, the base part may have a projection and a rebate arrangement. The rebate, in particular the plurality of rebates, may be part of the projection and rebate arrangement. The projection and rebate arrangement may be provided on the near side of the base part. The projection and rebate arrangement may be provided on the edge of the base part. The projection and rebate arrangement may preferably be formed continuously. In addition, the base portion may have an annular notch. The annular notch may be located on the far side of the base portion. Preferably, the annular notch of the base portion may be formed continuously. The base of the first and second options can preferably be circular. Other configurations are possible. The base part of the first and second modality can be connected to the lid part to hold the infusion set by a patient or by an insertion device or puncture aid can be connected, in particular in a rotatable manner, to the connector part with a supply line for connection with an infusion device. The base part of the first and second modalities connected to the cap part can be attached to or removed from the patient's skin. The connector portion of the first and second configurations may preferably be circular. The connector portion may preferably be designed in the shape of a cap. Additionally, the connector portion may preferably be designed to be elastic. Other configurations are possible. The connector portion may include a projection on its far side. The projection may be provided on an edge of the connector portion. The projection may be arranged on an inner surface of the cap-shaped connector portion. The projection of the connector portion may extend from the inner surface of the cap at any angle to the axis of rotation, particularly radially inward. Preferably, two projections may be provided on the connector portion. The two projections may preferably be arranged on the connector portion, offset from each other by 180°. In addition, a guide groove for guiding an edge of the base portion may be provided on the connector portion. The guide groove is arranged close to the projection on the connector portion. Preferably, two guide grooves may be provided on the connector portion. Particularly preferably, each guide groove may have a projection.A gripping element may be provided on an outer surface of the connector portion. Furthermore, the gripping element may preferably be offset by 90° from the guide groove and / or the projection, or from both guide grooves and / or the two projections, on the outer surface of the connector portion. The gripping element may preferably be located on the edge and on the outer surface of the connector portion. The connector portion may preferably have two gripping elements. The gripping element may serve to improve the grip of the connector portion. The gripping element may preferably be flange-shaped. The gripping element may be designed and / or arranged on the connector portion such that the patient can connect the connector portion to the base portion, in particular, position it, and remove the connector portion from the base portion. «ααπηη / 1 zoz / e / yl To freely connect the connector portion to the base portion, and specifically to position it correctly, the connector portion can be placed into the base portion. The piercing cannula located inside the connector portion's cover can be inserted through the septum of the base portion to create a fluid connection between the connector portion and the base portion. The base portion and connector portion can then be rotated together to deliver liquid medication from the infusion device to the patient. The connector part may be incorrectly or incompletely connected to the base part; in particular, it may be improperly fitted into place. The connector portion's projection can be designed to engage with the projection and recess arrangement of the base such that, upon relative rotation between the connector portion and the base, an audible and / or tactile signal is generated to indicate that the connector portion has been incorrectly or incompletely connected to the base. With relative rotation between the connector portion and the base, the connector portion's projection can slide over the projection and recess arrangement of the base. An incorrect or incomplete connection, particularly a faulty fit, can mitigate the risk of inadequate medication delivery, as medication is administered to the patient from the connector portion through the base. The connector part can be connected, in particular properly or completely fitted, to the base part. The projection of the connector portion can be made to engage with the annular notch of the base portion in such a way that the connector portion can be rotated relative to the base portion silently and / or without generating a tactile signal to indicate that the connector portion has been correctly or completely connected to the base portion. Furthermore, the edge of the base part can be coupled with the guide slot provided on the connector part, in particular with the two guide slots provided on the connector part. The lid portion of the first and second versions may preferably be circular. The lid portion may preferably be designed in the shape of a lid. Additionally, the lid portion may preferably be designed to be elastic. Other configurations are possible. The cap portion may have ratchet teeth (or a locking mechanism). The ratchet teeth may be provided on an edge of the cap portion. The ratchet teeth may be arranged on the inside of the cap portion's cover. The ratchet teeth of the cap portion may extend from the inner surface of the cover at any angle to the axis of rotation, particularly radially inward. The ratchet teeth can be formed in any shape that fits the recess, particularly one of the various recesses in the base. The ratchet teeth can be engaged, particularly in an engagement configuration, with the recess, specifically one of the various recesses in the base, to form a non-rotating connection between the base and the cap. Preferably, two ratchet teeth may be provided on the lid portion. The two ratchet teeth may preferably be arranged on the lid portion, offset from each other by 180°. In addition, a guide notch for securing the rim of the base portion may be provided on the lid portion. The guide notch may be arranged on the lid portion at a distance from the ratchet teeth. Preferably, two guide notches may be provided on the lid portion. Particularly preferably, ratchet teeth may be provided from each guide notch. The lid portion may, particularly preferably, have a support element. The support element may preferably be arranged on an outer surface of the lid portion. The support element may extend from the surface of the lid portion, preferably in the near direction.Preferably, two parallel support elements may be provided on the outer surface of the lid portion. The support element may preferably be arranged approximately in axial alignment with the guide notch and / or ratchet teeth. The support element may be designed and / or arranged on the lid portion such that the patient can connect the lid portion to the base portion, in particular, place it in position, and remove the lid portion from the base portion. The lid portion may preferably include a handle portion. The handle portion may preferably be arranged on the outer surface of the lid portion and in the center of the lid portion. The handle portion may extend from the surface of the lid portion, preferably in the proximal direction.In the first embodiment of the infusion set, the handle portion can hold the rigid needle, which extends from the inner surface of the cap portion in a distal direction. The handle portion can also be used to position the cap portion, connected to the base portion and secured in place, onto an insertion device or puncture aid. The soft or rigid cannula of the infusion set can be inserted directly into the skin using the insertion device or puncture aid and held in place with adhesive tape. When the cap portion is connected to the base portion and secured in place, the ratcheting teeth of the cap portion can engage with the recess of the base portion to prevent rotation.The engagement between the ratchet teeth of the cap and the recess of the base prevents the cap from rotating relative to the base. This anti-rotation device between the cap and base allows the patient to more easily remove the protective film of the adhesive plaster from the base. Ideally, a first anti-rotation block can be formed between the handle of the cap and a receptacle of the insertion device or puncture aid, and a second anti-rotation block can be formed between the ratchet teeth of the cap and the recess of the base. These two anti-rotation blocks assist the patient in more easily removing the protective film of the adhesive plaster from the base when the infusion set is inserted into the insertion device or puncture aid. The lid portion may also have a groove between the handle portion and the support element. The groove may preferably be parallel to the support element and / or the guide notch in the lid portion. The groove may be continuous or solid. The groove may facilitate better attachment of the lid portion to the base portion and easier removal of the lid portion from the base portion. BRIEF DESCRIPTION OF THE FIGURES The invention is described below with reference to the various FIGURES. The features described herein, RQQfrnn / Lznz / E / Yl, each advantageously develop the invention individually and in any combination thereof. The FIGURES show: FIGURE 1 shows an exploded view of the first modality of the infusion set according to the invention, a lid part and a base part of the infusion set that is visible. FIGURE 2 shows a longitudinal cross-sectional view of the infusion set according to FIGURE 1, the lid part connects, in particular fits, to the base part. FIGURE 3 shows a longitudinal cross-sectional view of the infusion set according to FIGURE 1, a connector part is connected, in particular fitted, to the base part. FIGURE 4 shows an exploded view of the second modality of the infusion set according to the invention, a lid part and a base part of the infusion set that is visible. FIGURE 5 shows a longitudinal cross-sectional view of the infusion set according to FIGURE 4, a lid part is connected, in particular fitted, to the base part. FIGURE 6 shows a longitudinal cross-sectional view of the infusion set according to FIGURE 4, a connector part is connected, in particular fitted, to the base part. FIGURE 7 shows a plan view of the base part of the first and second modes of the infusion set. FIGURE 8 shows a longitudinal cross-sectional view of an edge of the base portion of the infusion set along section line AA according to FIGURE 7. FIGURE 9 shows a longitudinal cross-sectional view of the lid portion of the infusion set according to FIGURE 1. FIGURE 10 is a perspective view of the section of the lid part identified in FIGURE 9. FIGURE 11 is a side view of the connector for the first and second modes of the infusion set. FIGURE 12 is a longitudinal sectional view of the connector along section line BB according to FIGURE 11. FIGURE 13 is a perspective view of the connector according to FIGURE 12. DETAILED DESCRIPTION OF THE INVENTION FIGURE 1 is an exploded view of an infusion set according to a first embodiment of the present invention, in which a lid part and a base part of the first embodiment of the invention can be seen. The infusion set comprises a circular, cap-shaped cap (3) with a rigid needle (3a). The cap (3) is designed to be flexible. The rigid needle (3a) is preferably made of steel or an alternative material. The needle (3a) is securely connected to the cap (3). One, or in particular two, support elements (3d) and a handle (3e) are provided on an outer surface of the cap (3). The support element (3d) is used to support the infusion set, and the handle (3e) is used to insert the infusion set into an insertion device or puncture aid. In addition, one, or in particular two, continuous grooves (3f) are provided on the cap (3). A proximal end of the rigid needle (3) connects to the handle (3e) of the cap (3). RQQfrnn / ίζηζ / Ε / γι of cover. The infusion set also comprises, in particular, a flat base portion (1). A protective element (1e) may be provided on the base portion (1) to protect against needlestick injuries (3a). A plurality of projections (1i) and a plurality of recesses (1j) are arranged on a near side and on the edge of the base portion (1). The base portion further comprises a cylindrical base cylinder (1n). The base cylinder (1n) is arranged on the near side of the base portion and projects in the near direction. A passage (FIGURE 2; 1o) is provided in the base cylinder. An eyelet (11) is inserted into the passage (FIGURE 2; 1o) of the base cylinder (1n) for connecting a soft cannula (1a) to the base portion (1). The soft cannula (1a) is preferably made of a soft material. The passage (FIGURE 2; 1st) is closed with a septum (1m), the septum (1m) is arranged at the near end of the “eyelet” (11).The cams (or flanges) (FIGURE 2; 1h) are provided on a distant side of the base portion. The cams (FIGURE 2; 1h) are fused with an adhesive plaster (1c) of the base portion (1) so that the adhesive plaster is bonded to the base portion (1). The adhesive plaster (1c) is used to attach the infusion set to the patient's skin. A distant side of the adhesive plaster (1c) may be covered with a protective film (1d). Before applying the infusion set to the patient's skin, the patient removes the protective film 1(d) from the adhesive plaster (1c). Figure 2 shows a longitudinal cross-sectional view of the infusion set according to Figure 1. The cap portion connects to the base portion and is secured in place. The rigid needle (3a) of the cap portion is received into the soft cannula (1a) of the base portion such that a distant end of the needle (3a) of the cap portion protrudes over a distant end of the soft cannula (1a) of the base portion. The concentric arrangement of the soft cannula (1a) and the rigid needle (3a) is used to guide the soft cannula (1a) when the soft cannula (1a) of the base portion (1) is inserted into the patient's skin. The soft cannula (1a) is positively connected to the eyelet (11) and is pressed into the passage (1o) of the base cylinder (1n). The protective element (1e) is pressed freely into an opening (1g) provided at a distant end of the base cylinder (1n) of the base part (1). The cap part (3) fits onto the base part (1).The edge of the cap part (3) has a guide notch (3c) that receives an edge of the base part (1). Additionally, a ratchet tooth (3b), provided on an inner surface of the cap part (3), projects into a recess (1j) arranged at the far end of the base part (1). As can be seen in FIGURE 7 and FIGURE 8, the recess (1j) is arranged on the edge of the base part (1). The recess (1j) is also part of a projection (1i) and the recess arrangement (1j) of the base part (1). As can be seen in FIGURE 9 and FIGURE 10, the ratchet tooth (3b) of the cap part (3) projects radially inward from the interior of the cover of part (3). The ratchet teeth (3b) of the cap part (3) can be engaged, in particular in a coupling form with the recess (1j) of the base part (1), to establish a non-rotating connection between the base part (1) and the cap part (3).The anti-rotation connection between the cap part (3) and the base part (1) allows the patient to remove the protective film (1d) from the adhesive plaster (1c) more easily from the base part (1). To attach the infusion set to the patient's skin, the patient removes the protective element (1e) from the base (1). The patient removes the protective film (1d) from the adhesive cast (1c). The cap (3) fitted to the base (1) is placed on the patient's skin. The soft cannula (1a) of the base (1) RQQbnn / 1 7P7 / E / YILI base with the rigid needle (3a) of the cap portion received therein penetrates through the skin and into the subcutaneous tissue. The cams (or flanges) (1h) of the base portion (1) separate the base portion (1) from the patient's skin and serve to circulate air between the base portion and the patient's skin. The cap portion (3) is removed from the base portion (1) by the patient pressing the two support elements (3d) inward, releasing the tightening connection between the cap portion (3) and the base portion (1). The protective element (1e) may preferably be placed over the rigid needle (3a) provided in the cap portion (3) to protect the patient from puncture wounds. Particularly preferable, a support provided on the inner surface of the cap portion (3) may be provided for this purpose. A connector portion (2) with a tube (2d) is then attached to the base portion (1). The tube (2d) includes an adapter for loose connection to an infusion device, in particular an infusion pump. The tube (2d) of the connector portion (2) is connected to the adapter by means of an adhesive that hardens when exposed to UV light. Figure 3 shows a longitudinal cross-sectional view of the infusion set according to Figure 1. A connector portion is connected, in particular fitted, to the base portion. The tubing (2d) of the connector portion (2) is connected to the base portion (2) by means of an adhesive that cures upon exposure to UV light. The tubing (2d) is in fluid connection with a piercing cannula (2e) disposed on an inner surface of the cover. The tubing (2d) is preferably disposed offset by 90° with respect to the piercing cannula (2e) in the connector portion, as shown in Figure 12. The piercing cannula (2e) of the connector portion (2) penetrates the septum (1m) provided in the base portion (1) and preferably exits at the eyelet (11), in particular at the portion closest to the eyelet (11) of the base portion (1).A connector cylinder (2f) provided on the inner surface of the connector part (2) receives the base cylinder (1n) from the base part (1), which projects in the near direction. The connector cylinder (2f) is in a guide coupling with the base cylinder (1n), specifically a sliding coupling. The connector part (2) is rotatable relative to the base part (1), specifically rotating through any desired angle between them. The drug to be dispensed is administered into the patient's body by the infusion device via the connector part (2) and the base part (1). With the correct or complete fit between the connector part (2) and the base part (1), as shown in FIGURE 3, the edge of the base part (1) engages a guide groove (2b) provided in the connector part (2). Additionally, a projection (2a) on the inside of the connector part (2) cover engages an annular notch (1k) provided in the base part (1). The projection (2a) of the connector part (2) engages with the annular notch (1k) of the base part (1). With relative rotation between the connector part (2) and the base part (1), the projection (2a) of the connector part (2) slides silently and / or without generating any audible feedback into the annular notch (1k) of the base part (1). In the event of an incorrect or incomplete connection, particularly a faulty fit between the connector part (2), the projection (2a) of the connector part (2) engages the projection (1i) and the recess arrangement (1j) of the base part (1). The projection (2a) of the connector part (2) engages with the projection (1i) and the recess arrangement (1j) of the base part (1). With relative rotation between the connector part (2) and the base part (1), the projection (2a) of the connector part (2) slides over the projection (1i) and the recess arrangement (1j) of the base part (1). In the event of a relative rotation between the connector part (2) and the base part (1), an acoustic and / or tactile signal is preferably generated to indicate that the connector part (2) is not connecting correctly or completely to the base part (1), in particular it is coupling incorrectly.An incorrect or incomplete connection, particularly a faulty fit, carries the risk of inadequate medication delivery, which is fed to the patient from the connector part through the base part. To remove the connector part (2) from part (1), the patient grasps the two gripping elements (2c) provided on the connector part (2) inwards, as shown in FIGURE 11 and FIGURE 13. The adjustment connection between the connector part (2) and the base part (1) is released. To remove the base part (1) from the patient's skin, the patient peels off the adhesive cast (1c) and removes the base part (1). Alternatively, the patient can connect the base part (1) to a cap part that does not have a rigid needle (3a). The patient is then able to remove the cap part (3) connected to the base part (1) from the patient's skin and dispose of the infusion set. FIGURE 4 shows an exploded view of a second modality of the infusion set according to the invention, a lid part (3') and a base part (1') of the infusion set that is visible. The infusion set has a circular, lid-shaped portion (3'). The lid portion (3') comprises one, or in particular two, support elements (3d') and a handle portion (3e') attached to an outer surface of the lid portion (3'). In addition, one, or in particular two, continuous grooves (3f') may be provided in the lid portion (3'). The infusion set also has, in particular, a flat base portion (1'). A rigid cannula (1b') is attached to a passage (FIGURE 5; 1o') of a cylindrical base (1n') of the base portion (1'). To fix the rigid cannula (1b') to the base portion (1'), an adhesive is applied between the rigid cannula (1b') and the cylindrical cannula (1f), in particular an adhesive that hardens when exposed to UV light. A protective element (1e') may be provided on the base portion (1') to protect against puncture wounds caused by the rigid cannula (1b). A plurality of projections (1i') and a plurality of recesses (1j) are arranged on a near side and on the edge of the base portion (1'). The passage (FIGURE 5; 1o) is closed with a septum (1 m'), the septum (1mj) being provided at a near end of the rigid cannula (1b'). The cams (FIGURE 5; 1 h') are arranged on a distant side of the base portion.The cams (FIGURE 5;1h') are fused with an adhesive plaster (1c') of the base portion (1') so that the adhesive plaster bonds to the base portion (1'). The adhesive plaster (1c') is used to attach the infusion set to the patient's skin. A distant side of the adhesive plaster (1c') may be covered with a protective film (1d'). Before attaching the infusion set to the patient's skin, the patient removes the protective film (1d') from the adhesive plaster (1c'). Figure 5 shows a longitudinal cross-sectional view of the infusion set according to Figure 4. The cap part (3') is connected, in particular fitted, to the base part (1'). The second embodiment of the infusion set differs from the first embodiment in that the cap part (3') does not have a rigid needle. Furthermore, instead of a soft cannula, the rigid cannula (1b) is fixed to the base part (1'). The septum (1m') closes the proximal end of the rigid cannula (1b'), which is glued to the base cylinder (1n'). Due to an adhesive connection between the rigid cannula (1b') and the base cylinder (1n'), it can be dispensed with a connecting element, in particular an eyelet. FIGURE 6 shows a longitudinal sectional view of the infusion set according to FIGURE 4, a connector part (2') is connected, in particular fitted, to the base part (T). The second modality of the infusion set differs from the first modality in that a piercing cannula (2e') provided in the connector part (2') penetrates through the septum (1m') of the base part (1') and forms a fluid connection to the base part (1'). Reference number: ; 1 ' base part 1st soft cannula 1b rigid cannula 1c; 1c' adhesive plaster d; 1 d' protective film 1e; 1e' protective element f; 1 f' cannula cylinder g; 1 g' opening 1h; 1h' lever (rim) 1i; 1 ¡' projection 1j; 1j' rebate k; 1k' annular notch eyelet 1m; 1m' septum 1n; 1 n' base cylinder 1st; 1st passage, 2nd connector part 2a; 2a' projection 2b; 2b' guide slot 2c; 2c' gripping element 2d;2d' tube 2e; 2e' drilling cannula 2f; 2f' connector cylinder 3; 3' lid part 3rd rigid needle 3b; 3b' ratchet 3c; 3c' guide notch 3D; 3D support elements 3e; 3e' part of mango 3f; 3f' slot 3g; 3g' cap cylinder
Claims
1. An infusion set comprising - a base portion for attachment to a patient's skin, the base portion having a proximal and a distant side and a cannula on the distant side of the base portion provided for delivering a liquid drug into the patient's body and a projection and recess arrangement provided on the proximal side of the base portion;- a connector portion with a supply line for connection to an infusion device, the connector portion having a near and a far side and a projection provided on the far side, - wherein the base portion and the connector portion are rotatably connected to each other to administer liquid medication from the infusion device to the patient, characterized in that it comprises - the projection of the connector portion that can engage with the projection and recess arrangement of the base portion such that, upon relative rotation between the connector portion and the base portion, an acoustic and / or tactile signal is generated to indicate that the connector portion was incorrectly or incompletely connected to the base portion.
2. An infusion set comprising: - a base portion for attachment to a patient's skin, the base portion having a proximal and a distant side and a cannula on the distant side of the base portion provided for delivering a liquid medication into the patient's body, and an annular notch provided on the proximal side of the base portion; - a connector portion with a supply line for connection to an infusion device, the connector portion having a proximal and a distant side and a projection provided on the distant side; - wherein the base portion and the connector portion are rotatably connected to each other to deliver the liquid medication from the infusion device to the patient.characterized in that it comprises - a projection of the connector portion that can engage with the annular notch of the base portion such that the connector portion rotates relative to the base portion silently and / or without generating a tactile signal to indicate that the connector portion has been correctly or completely connected to the base portion.
3. The infusion set according to claim 1 or 2, further characterized in that the base part is circular.
4. The infusion set according to one of the preceding claims, further characterized in that the projection and the recess arrangement are arranged on an edge of the base part.
5. The infusion set according to any one of the preceding claims, further characterized in that the connector portion is cap-shaped and the projection is provided on an inner surface of the connector portion. «ααπηη / Lznz / E / Yi 6. The infusion set according to one of the preceding claims, further characterized in that the connector part is circular.
7. The infusion set according to one of the preceding claims, further characterized in that the projection is arranged on an edge of the connector portion.
8. The infusion set according to one of the preceding claims, further characterized in that the cannula is designed with a rigid or soft cannula.
9. The infusion set according to one of the preceding claims, further characterized in that the connector part has a guide groove, in particular two guide grooves for fixing an edge of the base part.
10. A method for assembling an infusion set comprising the following steps: - providing a connector portion with a supply line for connection to an infusion device, the connector portion having a proximal and a distant side and a projection provided on the distant side, - providing a base portion for attachment to a patient's skin, the base portion having a proximal and a distant side and a cannula on the distant side provided for delivering a liquid medication into the patient's body and a projection and recess provided on the proximal side, - connecting the connector portion to the base portion for delivering the liquid medication from the infusion device to the patient, characterized in that it comprises - the projection of the connector portion mating with the projection and recess of the base portion such that,After relative rotation between the connector part and the base part, an acoustic and / or tactile signal is generated to indicate that the connector part was incorrectly or incompletely connected to the base part.
11. A procedure for assembling an infusion set comprising the following steps: - providing a connector part with a supply line for connection to an infusion device, the connector part having a proximal and a distant side and a projection provided on the distant side, - providing a base part for attachment to a patient's skin, the base part having a proximal and a distant side and a cannula on the distant side provided for delivering liquid medication into the patient's body and an annular notch provided on the proximal side, - connecting the connector part to the base part to deliver the liquid medication from the infusion device to the patient,characterized in that it comprises - the projection of the connector portion that engages with the annular notch of the base portion so that the connector portion can be rotated relative to the base portion silently and / or without a tactile signal being generated to indicate that the connector portion has been correctly or completely connected to the base portion.
12. The Method according to claim 10 or 11, further characterized in that a guide slot provided in the connector part, in particular two guide slots provided in the connector part, engages or are engaged with an edge of the base part.