Infusion set for an infusion device
Patent Information
- Application Number
- EP2024711522
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-03-30
- Filing Date
- 2024-03-12
- Publication Date
- 2026-02-11
Smart Images
Figure EP2024056502_03102024_PF_FP_ABST
Abstract
Description
[0001] Infusion set for an infusion device
[0002] 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 the body of a patient.
[0003] The term "medicine" as used herein includes any flowable medicinal formulation suitable for controlled administration through a means such as a cannula or a hollow needle, for example, comprising a liquid, a solution, a gel, or a fine suspension containing one or more medicinally active ingredients. A medicament may be a composition with a single active ingredient or a premixed or co-formulated composition with multiple active ingredients from a single container. Medication includes drugs such as peptides (e.g.Insulins, insulin-containing medicines, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically derived or active ingredients, active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances in solid (suspended) or liquid form, but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable base, excipient and carrier substances.
[0004] For patients who regularly require liquid medication, the required amount of medication can be delivered to the body in liquid form using a cannula placed in the subcutaneous tissue for an extended period. For this purpose, an infusion set with a cannula made of a soft or hard material is attached to the patient's skin in such a way that the cannula penetrates the skin into the subcutaneous tissue. The required amount of medication in liquid form is thus administered by an infusion device, in particular an infusion pump, particularly preferably an automatic infusion pump, via a supply line to the patient, with the cannula placed in the infusion set supplying the patient with the liquid medication.
[0005] Infusion sets are known from the prior art. Document W02020 / 084374A1 discloses an infusion set comprising a base portion with a soft cannula, the cannula being used to penetrate the skin into the subcutaneous tissue to administer a liquid medication to a patient. Furthermore, the infusion set comprises a cap portion, the cap portion serving to hold the infusion set by the patient or by an insertion device or puncture aid, so that the base portion connected to the cap portion can be applied to the patient's skin. This cap portion comprises a hollow needle arranged within the cannula to guide the cannula. A disadvantage of this infusion set is that it is difficult to handle.
[0006] It is an object of the invention to provide an alternative infusion set, wherein the handling of the infusion set is facilitated.
[0007] This object is achieved by the subject matter of the independent claim. Advantageous embodiments are defined in the dependent claims.
[0008] In the inventive infusion set, the distal direction refers to the side to which an adhesive plaster can be applied to secure the infusion set to a patient's skin. In the inventive infusion set, the proximal direction refers to the side that can be connected to an infusion device.
[0009] The infusion set according to the invention can be connected to an infusion device, in particular to an infusion pump, particularly preferably to an automatic infusion pump. Infusion devices can be used for the continuous administration of infusions, in particular of medications in liquid form. The infusion device can be a reusable infusion device, wherein a new container prefilled with a liquid medication can be inserted into the reusable infusion device. Alternatively, the infusion device can be a single-use infusion device, wherein the infusion device is discarded when a container prefilled with a liquid medication is empty. The infusion set can comprise a base part for application to the skin of a patient, wherein the base part can have a proximal side and a distal side.Furthermore, the base part can have a cannula for delivering the liquid medication into the patient's body. The cannula is designed as a hollow needle, allowing liquid medication to be administered into the patient's body.
[0010] Particularly preferably, the cannula is designed as a soft cannula. The soft cannula can be made of a soft material, in particular a polymer. The cannula can be provided on the distal side of the base part.
[0011] Furthermore, the infusion set can comprise a connector part with a supply line, in particular a tube. The connector part can have a proximal side and a distal side. The supply line can serve for connection to the infusion device. Furthermore, the supply line can serve for connection to the base part by means of a piercing cannula in order to form a fluid path between the connector part and the base part. Furthermore, the infusion set can comprise a cap part for holding the infusion set by the patient or by an insertion device or puncture aid, wherein the cap part can have a distal side and a proximal side. The cap part can be cap-shaped.
[0012] The cap portion of the infusion set contains a needle. The needle is made of solid material. The advantage of a solid needle is that it has greater flexural rigidity than a cannula with the same outer diameter, making it less susceptible to deformation.
[0013] In addition, the needle according to the invention has a conical tip. The conical tip of the needle has the advantage that the cannula is not damaged by the tip of the needle when the needle of the cap part is pushed or inserted into the cannula of the base part during assembly of the infusion set.
[0014] The needle tip can be straight or obliquely conical. Particularly preferred is a straight conical tip. This design has the advantage that the needle of the cap part can be pushed or inserted into the cannula of the base part particularly easily and without damaging the cannula. Furthermore, it ensures that no transverse forces act on the needle when the needle is inserted into the skin or subcutaneous tissue, preventing the needle from being deformed and allowing the cannula to be positioned more precisely in the subcutaneous tissue.
[0015] The cap part can be or be detachably connected to the base part. The connection can preferably be designed as a snap connection. Alternative connections can be provided. The cap part can be connected to the base part in such a way, in particular snapped, that the needle can be arranged concentrically in the cannula of the base part. The cannula can be used to deliver a liquid medication into the body of a patient. The cap part can be or be arranged on the proximal side of the base part. The concentric arrangement of the cannula and the needle can serve to guide the cannula when the cannula is inserted into the skin or subcutaneous tissue of the patient. At least the distal tip of the needle can protrude beyond the distal end of the cannula, with the needle of the cap part being arranged within the cannula of the base part.The needle is arranged inside the cannula when the base part is connected to the cap part, or when the base part and the cap part are connected. Furthermore, an adhesive plaster can be arranged on the distal side of the base part. The adhesive plaster can serve to secure the infusion set to the patient's skin. In order to attach the infusion set to the patient's skin, the base part, which is connected to the cap part, in particular by snapping it, can be adhered to the patient's skin using an adhesive plaster. A protective film can be removed from one adhesive side of the adhesive plaster beforehand. The cannula, held by the needle, can then penetrate the skin and into the patient's subcutaneous tissue.
[0016] The conical tip of the needle preferably has an opening angle (W) greater than or equal to 10° and less than or equal to 35°, preferably between 14° and 30°, particularly preferably approximately 20°. This configuration of the opening angle (W) ensures that when the cannula is inserted into the skin or subcutaneous tissue of the patient, with the needle arranged within the cannula and at least the distal tip of the needle protruding beyond the distal end of the cannula, the skin or subcutaneous tissue of the patient is injured as little as possible. Furthermore, by using the needle according to the invention, the patient's skin is penetrated in such a way that the skin or subcutaneous tissue heals as quickly and scar-free as possible after the insertion.
[0017] To minimize irritation or allergic reactions to the patient's skin or subcutaneous tissue during insertion of the needle, particularly when the distal end of the needle extends beyond the distal end of the cannula, the entire needle or at least part of the needle, particularly preferably the tip of the needle, is preferably made of metal, ensuring high needle strength. The use of stainless steel, particularly stainless steel according to ISO 15510 or a biocompatible steel grade as defined by ISO 10993, is particularly suitable for preventing irritation or allergic reactions upon penetration of the patient's skin or subcutaneous tissue.
[0018] Alternatively, the needle can be made of another metal, including iron, copper, bronze, aluminum, magnesium, or an alloy, particularly a steel alloy. However, it can also be made of plastic.
[0019] At least the part of the needle that comes into contact with the skin or subcutaneous tissue should be made of the material mentioned above in order to avoid irritation or allergic reactions of the patient's skin or subcutaneous tissue.
[0020] To connect the infusion set to an infusion device, the cap part with the needle can first be removed from the base part, and a connector part, which can comprise a supply line, in particular a tube and an adapter, can be attached to the base part of the infusion set. The connection between the base part and the connector part can be designed as a snap connection. Alternative connections can be provided. A first end of the supply line can be welded and / or glued to the adapter. A second end of the supply line can be welded and / or glued to the connector part. The adapter of the connector part can be detachably attached to a corresponding connecting element of the infusion device. The adapter of the connector part can be connected to the infusion device by means of a bayonet lock, Luer lock, or another closure.This allows a fluid path to be created from the infusion device via the infusion set to the patient.
[0021] The infusion set can preferably have a detachable protective element. The protective element can serve to protect against puncture injuries caused by the needle of the cap part of the infusion set. The protective element can preferably be sleeve-shaped. Alternative designs of the protective element can be provided. One or more longitudinal ribs can preferably be provided on an outer surface of the protective element to improve grip on the protective element. This allows the patient to simply remove the protective element from the base part before applying the infusion set to the patient's skin and, after removing the infusion set from the patient's skin, simply replace it over the needle of the cap part, whereby the patient can thus be protected from puncture injuries.The protective element can be releasably connected to the base part and / or the cap part with a force fit and / or a form fit in order to protect the patient from puncture injuries.
[0022] The base part of the infusion set can preferably be flat. For guiding and / or positioning the base part relative to the cap part and / or the connector part, a base cylinder can be provided on the proximal side of the base part of the infusion set. For this purpose, a corresponding cap cylinder and / or connector cylinder can also be provided on the cap part and / or connector part, in particular on the distal side of the cap part and / or connector part. The base cylinder can protrude from the proximal side of the base part in the proximal direction. The base cylinder can be cylindrical. The base cylinder can be arranged concentrically to the cannula of the infusion set.
[0023] Furthermore, a cannula cylinder can preferably be provided on the distal side of the base part of the infusion set. The cannula cylinder can be cylindrical. The cannula cylinder can protrude from the distal side of the base part in the distal direction. The cannula can be secured in the corresponding cannula cylinder, in particular in a passage provided in the cannula cylinder, and protrude from the corresponding cannula cylinder in the distal direction in order to deliver the liquid medication to the patient.
[0024] The length (L) of the needle protruding from the distal side of the base part is preferably greater than or equal to 10 mm and less than or equal to 40 mm, preferably between 20 mm and 30 mm, particularly preferably approximately 24.4 mm when the needle is arranged within the cannula. The length (L) of the needle is preferably measured from the distal side of the cannula cylinder of the base part to the distal end of the needle tip. These needle lengths (L) are particularly suitable for a cannula of approximately 5 mm to 10 mm, measured from the distal end of the cannula cylinder. The selection of the length (L) of the needle depends on the length (L) of the cannula, whereby the needle is arranged within the cannula and at least the distal tip of the needle should protrude beyond the distal end of the cannula. Preferably, at least the distal tip of the needle protrudes beyond the distal end of the cannula. Particularly preferably, the entire tip of the needle and at least part of a shaft of the needle extend beyond the distal end of the cannula.This arrangement ensures that the cannula can be inserted into the patient's skin or subcutaneous tissue as painlessly as possible and without causing major injuries to the skin or subcutaneous tissue.
[0025] Particularly preferably, the diameter (D) of the needle is greater than or equal to 0.2 mm and less than or equal to 0.55 mm, preferably between 0.26 mm and 0.5 mm, and particularly preferably approximately 0.36 mm. The diameter (D) of the needle is measured along the straight shaft of the needle. This diameter (D) is particularly suitable for a cannula with a diameter (D) of 0.2 mm to 0.6 mm. The diameter (D) of the needle is matched to the diameter (D) of the cannula so that the cannula can be guided smoothly and, in particular, inserted painlessly and without injury into the patient's skin or subcutaneous tissue.
[0026] The base part and / or the cap part of the infusion set can preferably be circular and / or elastic. This design ensures that the base part can be firmly and flushly attached to the patient's skin, and that the cap part can be easily connected and detached from the base part. Other designs may be provided.
[0027] Particularly preferably, the base part and the cap part are connected to each other in a rotationally fixed manner. For this purpose, a locking tooth can be provided on the cap part, which can engage with a projection and recess arrangement of the base part to form an anti-rotation device.
[0028] When the cap part is connected to the base part, in particular snapped together, the locking tooth of the cap part can engage in the recess of the projection and recess arrangement of the base part to form an anti-twist device. The anti-twist device between the cap part and the base part allows the patient to more easily remove the protective film of the adhesive plaster from the base part. To do so, the patient grasps a handle provided on the cap part to remove the protective film of the adhesive plaster from the base part snapped to the cap part. The handle part is preferably provided on an outer surface of the cap part. The handle element can extend from the outer surface of the cap part, preferably in the proximal direction. The handle element can hold the needle, wherein the needle can extend from the inner surface of the cap part in the distal direction.In addition, the handle element can be designed to facilitate insertion of the infusion set into an insertion device or a puncture aid. Alternatively, the handle element can be designed to allow the patient to better grip the handle element in order to place or secure the base part connected to the cap part onto the patient's skin.
[0029] Particularly preferably, the cap part can have a retaining element. The retaining element can preferably be arranged on an outer surface of the cap part. The retaining element can extend from the outer surface of the cap part, preferably in the proximal direction. Particularly preferably, two parallel retaining elements can be provided on the outer surface of the cap part. The retaining element can be designed and / or arranged on the cap part in such a way that the patient can connect the cap part to the base part, in particular snap it together, and can detach the cap part from the base part.
[0030] The retaining element can further serve to hold the cap part, which is connected to the base part and is particularly snapped into place, in an insertion device or a puncture aid. The cannula of the infusion set can be placed directly into the skin or subcutaneous tissue using the insertion device or puncture aid and held in place with the adhesive plaster. Furthermore, by pressing the two parallel retaining elements together, the cap part can be released from the base part. The two retaining elements can be pressed toward each other or pre-tensioned inward, releasing the connection, particularly the snap connection, between the cap part and the base part.
[0031] The invention is described below with reference to several figures. The features disclosed herein advantageously further develop the invention, both individually and in any combination of features. They show:
[0032] Figure 1 is an exploded view of the infusion set according to the invention, showing a cap part (2) and a base part (1) of the infusion set.
[0033] Figure 2 is a longitudinal sectional view of the infusion set according to Figure 1, wherein the cap part (2) is connected, in particular snapped, to the base part (1).
[0034] Figure 3 is a longitudinal sectional view of a needle (2a) of the cap part (2) according to Figure 1.
[0035] Figure 4 is a perspective view of the needle (2) of the cap part (2) according to Figure 2, wherein the needle (2a) is arranged within the cannula (1a) of the base part (1) and at least a distal tip of the needle (2b) projects beyond a distal end of the cannula (1a).
[0036] Figure 1 shows an exploded view of an infusion set according to the present invention, showing a cap part (2) and a base part (1) of the infusion set. The infusion set comprises a circular and cap-shaped cap part (2) with a needle (2a). The cap part (2) is elastic. The needle (2a) comprises a conical tip (2b) and a shaft (2c), wherein the needle is formed from solid material. The needle (2a) formed from solid material has the advantage that the needle (2a) has greater flexural rigidity than a hollow needle with the same outer diameter and is therefore less easily deformed.
[0037] Preferably, the needle (2a) can be made of metal, in particular of stainless steel, particularly preferably of stainless steel according to ISO 15510 or a biocompatible steel grade as defined by ISO 10993. The use of these materials prevents irritation or allergic reactions upon penetration of the patient's skin or subcutaneous tissue.
[0038] Alternatively, the needle may be formed from another metal comprising iron, copper, bronze, aluminum, magnesium or an alloy, in particular a steel alloy.
[0039] The needle (2a) is firmly connected to the cap part (2). One, in particular two, holding elements (2f) and a grip part (2e) are provided on an outer surface of the cap part (2). The holding element (2f) can be used to hold the infusion set, and the grip part (2e) can be used to insert the infusion set into an insertion device or a puncture aid.
[0040] The infusion set further comprises a circular, in particular flat, base part (1). To protect against puncture injuries caused by the needle (2a), a protective element (1f) can be provided on the base part (1). The base part further comprises a cylindrical base cylinder (1d). The base cylinder (1d) is arranged on the proximal side of the base part (1) and protrudes in the proximal direction. A cannula (1a) is provided in the base cylinder (1d) via a passage. The cannula (1a) is preferably designed as a soft cannula (1a) and is thus made of a soft material. An adhesive plaster (1b) for securing the infusion set to a patient's skin is provided on the distal side of the base part (1). The distal side of the adhesive plaster (1b) can be covered with a protective film (1c). Before applying the infusion set to the patient’s skin, the patient removes the protective film (1c) from the adhesive plaster (1b).
[0041] Figure 2 shows a longitudinal sectional view of the infusion set according to Figure 1, wherein the cap part (2) is connected, in particular snapped, to the base part (1).
[0042] The needle (2a) of the cap part (2) is received in the cannula (1a) of the base part (1) such that at least the distal tip of the needle (2b) of the needle (2a) of the cap part (2) protrudes beyond a distal end of the cannula (1a) of the base part (1). The concentric arrangement of the cannula (1a) and the needle (2a) serves to guide the cannula (1a) when the cannula (1a) of the base part (1) is inserted into the patient's skin. The protective element (1f) is detachably pressed into the base cylinder (1d), wherein the protective element (1f) is arranged between the base cylinder (1d) and the cannula cylinder (1e). The cap part (2) is snapped onto the base part (1). For this purpose, a cap cylinder (2d) provided on the cap part (2) is in engagement with the base cylinder (1d) provided on the base part (1).Preferably, an anti-twist device can be provided between the base part (1) and the cap part (2), whereby the patient can more easily remove the protective film (1c) of the adhesive plaster (1b) from the base part (1).
[0043] To apply the infusion set to the patient's skin, the patient removes the protective element (1f) from the base part (1). The patient then peels off the protective film (1c) from the adhesive plaster (1b). The cap part (2), which is snapped onto the base part (1), is placed on the patient's skin. The cannula (1a) of the base part (1), with the needle (2a) of the cap part (2) accommodated therein, penetrates the skin into the subcutaneous tissue. The cap part (2) is then removed from the base part (1) by the patient pre-tensioning the two holding elements (2f) inwards or pressing them towards each other, whereby the snap connection between the cap part (2) and the base part (1) is released. The needle (2a) is thus withdrawn from the subcutaneous tissue and the cannula (1a). The protective element (1f) can preferably be placed over the needle (2a) provided on the cap part (3) in order to protect the patient from puncture injuries.
[0044] A connector part with a tube is then attached to the base part (1). The tube includes an adapter for detachable attachment to an infusion device, in particular to an infusion pump.
[0045] Figure 3 shows a longitudinal sectional view of the needle (2a) of the cap part (2) according to Figure 1. Furthermore, Figure 4 shows a perspective view of the needle (2) of the cap part (2) according to Figure 2, wherein the needle (2a) is arranged within the cannula (1a) of the base part (1) and at least the distal tip of the needle (2b) projects beyond the distal end of the cannula (1a).
[0046] The conical tip of the needle (2b) can be straight or oblique. Preferably, the conical tip of the needle (2b) is straight. The conical tip of the needle (2b) preferably has an opening angle (W) greater than or equal to 10° and less than or equal to 35°, preferably between 14° and 30°, particularly preferably approximately 20°, as shown in Figure 3. This ensures that when the cannula (1a) is inserted into the skin or subcutaneous tissue of the patient, the skin or subcutaneous tissue of the patient is injured as little as possible. Furthermore, by using the needle according to the invention, the patient's skin is penetrated in such a way that the skin or subcutaneous tissue heals as quickly and scar-free as possible after the insertion.Furthermore, the length (L) of the needle (2a) projecting from the distal side of the base part (1) is preferably greater than or equal to 10 mm and less than or equal to 40 mm, preferably between 20 mm and 30 mm, particularly preferably approximately 24.4 mm. The length (L) of the needle (2a) is preferably measured from the distal side of the cannula cylinder (1d) of the base part (1) to the distal end of the tip of the needle (2b). These lengths (L) of the needle (2a) are particularly suitable for a cannula (1a) of approximately 5mm to 10mm, measured from the distal end of the cannula cylinder (1e), so that at least the distal tip of the needle (2b) or the entire tip of the needle (2b) or at least part of the shaft of the needle (2c) projects beyond the distal end of the cannula (1a) when the needle (2b) is arranged within the cannula (1a), as shown in Figure 4.This arrangement ensures that the cannula (1a) can be inserted into the patient's skin or subcutaneous tissue as painlessly as possible and without causing major injuries to the skin or subcutaneous tissue.
[0047] In addition, the diameter (D) of the needle (2a) is preferably greater than or equal to 0.2 mm and less than or equal to 0.55 mm, preferably between 0.26 mm and 0.5 mm, and particularly preferably approximately 0.36 mm. The diameter (D) of the needle (2a) is measured on the straight shaft of the needle (2c). This diameter (D) is particularly suitable for a cannula (1a) with a diameter of 0.2 mm to 0.6 mm. The diameter (D) of the needle (2a) is matched to the diameter of the cannula (1a) so that the cannula can be easily guided and, in particular, inserted into the patient's skin or subcutaneous tissue without pain or injury.
[0048] Reference symbol:
[0049] 1 base part
[0050] 1a cannula
[0051] 1b adhesive plaster
[0052] 1c protective film
[0053] 1d base cylinder
[0054] 1e Cannula cylinder
[0055] 1f protective element
[0056] 2 cap part
[0057] 2a needle
[0058] 2b Tip of the needle
[0059] 2c Shaft of the needle
[0060] 2d cap cylinder
[0061] 2nd handle part
[0062] 2f holding element
[0063] L length
[0064] D Diameter
[0065] W opening angle
Claims
Patent claims 1. Infusion set with a base part (1) for application to the skin of a patient, wherein the base part (1) has a proximal side and a distal side, wherein a cannula (1 a) for supplying a liquid medication into the body of the patient is provided on the distal side of the base part (1), -a cap part (2) for holding the infusion set by the patient or by an insertion device or puncture aid, wherein the cap part (2) has a proximal and a distal side and wherein a needle (2a) is provided on the distal side, -wherein the base part (1) and the cap part (2) are connectable to each other in order to apply the base part (1) connected to the cap part (2) to the skin of the patient, wherein the needle (2a) is arranged within the cannula (1a) and at least one distal tip of the needle (2b) projects beyond the distal end of the cannula (1a), characterized in that -the tip of the needle (2b) is conical and the needle (2a) is made of solid material.
2. Infusion set according to claim 1, characterized in that the tip of the needle (2b) is straight or obliquely conical.
3. Infusion set according to claim 1 or 2, characterized in that the cannula (1 a) is designed as a soft cannula (1 a).
4. Infusion set according to one of the preceding claims, characterized in that the base part (1) and the cap part (2) are connected to one another in a rotationally fixed manner.
5. Infusion set according to one of the preceding claims, characterized in that the diameter (D) of the needle (2b) is greater than or equal to 0.2 mm and less than or equal to 0.55 mm, preferably between 0.26 mm and 0.5 mm, particularly preferably approximately 0.36 mm.
6. Infusion set according to one of the preceding claims, characterized in that the length (L) of the needle (2b) projecting from the distal side of the base part (1) is greater than or equal to 10 mm and less than or equal to 40 mm, preferably between 20 mm and 30 mm, particularly preferably approximately 24.4 mm.
7. Infusion set according to one of the preceding claims, characterized in that the conical tip (2b) of the needle (2a) has an opening angle (W) greater than or equal to 10° and less than or equal to 35°, preferably between 14° and 30°, particularly preferably approximately 20°.
8. Infusion set according to one of the preceding claims, characterized in that the needle (2a) is made of metal.
9. Infusion set according to claim 8, characterized in that the needle (2a) is made of stainless steel, in particular of stainless steel according to ISO15510.
10. Infusion set according to one of claims 1 to 7, characterized in that the needle (2a) is made of iron, copper, bronze, aluminum, magnesium or an alloy, in particular a steel alloy.