INFUSION SET FOR AN INFUSION DEVICE

Abstract

An infusion set includes a base having a cannula for delivering a liquid medicament on a distal side for placing on a patient and a projection and recess and/or an annular groove on a proximal side. A connector for connection to an infusion device includes a protrusion on a distal side. The base and the connector are rotatably connectable to each other. The protrusion of the connector may be engaged with the projection and recess of the base such that, upon relative rotation between the connector and base, an acoustic and/or tactile signal indicates that the connector is connected incorrectly to the base; and/or the protrusion of the connector may be brought into engagement with the annular groove of the base such that the connector is rotatable relative to the base without causing noise and/or a tactile signal to indicate that the connector is connected correctly to the base.

Claims

1. An infusion set, comprising: a base part configured for attaching to skin of a patient, the base part comprising a proximal side and a distal side, wherein a cannula is provided on the distal side of the base part and is configured for supplying a liquid medicament into the patient, and wherein a projection and recess arrangement is provided on the proximal side of the base part; a connector part comprising a supply line configured for connecting to an infusion device, the connector part comprising a proximal and a distal side, wherein a projection is provided on the distal side, wherein the base part and the connector part are rotatably connected to one another in order to administer the liquid medicament from the infusion device to the patient, and wherein when the connector part is incorrectly or incompletely connected with the base part, the projection of the connector part is in an engagement with the projection and recess arrangement of the base part such that relative rotation between the connector part and the base part generates an acoustic and/or a tactile signal to thereby indicate the connector part is incorrectly or incompletely connected with the base part.

2. The infusion set according to claim 1, wherein the base part is circular.

3. The infusion set according to claim 1, wherein the projection and recess arrangement is arranged on an edge of the base part.

4. The infusion set according to claim 1, wherein the connector part is cap-shaped and the projection is provided on an inner surface of the connector part.

5. The infusion set according to claim 1, wherein the connector part is circular.

6. The infusion set according to claim 1, wherein the projection is arranged on an edge of the connector part.

7. The infusion set according to claim 1, wherein the cannula is configured as a rigid cannula or as a soft cannula.

8. The infusion set according to claim 1, wherein the connector part comprises one or more guide slots for fastening to an edge of the base part.

9. An infusion set, comprising: a base part configured for attaching to skin of a patient, the base part comprising a proximal side and a distal side, wherein a cannula is provided on the distal side of the base part and is configured for supplying a liquid medicament into the patient, and wherein an annular groove is provided on the proximal side of the base part; a connector part comprising a supply line configured for connecting to an infusion device, the connector part comprising a proximal and a distal side, wherein a projection is provided on the distal side, wherein the base part and the connector part are rotatably connected to one another in order to administer the liquid medicament from the infusion device to the patient, and wherein when the connector part is correctly or completely connected to the base part, the projection of the connector part is in an engagement with the annular groove of the base part such that the connector part rotates relative to the base part without generating noise and/or without generating a tactile signal to thereby indicate the connector part is correctly or completely connected to the base part.

10. The infusion set according to claim 9, wherein the base part is circular.

11. The infusion set according to claim 9, wherein a projection and recess arrangement is arranged on an edge of the base part.

12. The infusion set according to claim 9, wherein the connector part is cap-shaped and the projection is provided on an inner surface of the connector part.

13. The infusion set according to claim 9, wherein the connector part is circular.

14. The infusion set according to claim 9, wherein the projection is arranged on an edge of the connector part.

15. The infusion set according to claim 9, wherein the cannula is configured as a rigid cannula or as a soft cannula.

16. The infusion set according to claim 9, wherein the connector part comprises one or more guide slots for fastening to an edge of the base part.

17. A method for assembling an infusion set, comprising the steps of: providing a connector part comprising a supply line for connection to an infusion device, the connector part comprising a proximal side and a distal side, wherein a projection is provided on the distal side; providing a base part for attachment to skin of a patient, the base part comprising a proximal side and a distal side, wherein and a cannula is provided on the distal side for supplying a liquid medicament into the patient, and wherein a projection and recess arrangement is provided on the proximal side; and connecting the connector part to the base part in order to administer the liquid medicament from the infusion device to the patient, wherein when the connector part is incorrectly or not completely connected to the base part, the projection of the connector part is in an engagement with the projection and recess arrangement of the base part such that relative rotation between the connector part and the base part generates an acoustic and/or a tactile signal to thereby indicate the connector part is incorrectly or not completely connected to the base part.

18. The method of claim 17, wherein the connector part comprises one or more guide slots, and the one or more guide slots is in an engagement with an edge of the base part.

19. A method for assembling an infusion set, comprising the steps of: providing a connector part comprising a supply line for connection to an infusion device, the connector part comprising a proximal and a distal side, wherein a projection is provided on the distal side; providing a base part for attachment to skin of a patient, the base part comprising a proximal side and a distal side, wherein and a cannula is provided on the distal side for supplying a liquid medicament into the patient, and wherein an annular groove is provided on the proximal side; and connecting the connector part to the base part in order to administer the liquid medicament from the infusion device to the patient, wherein when the connector part is correctly or completely connected to the base part, the projection of the connector part is in an engagement with the annular groove of the base part such that the connector part rotates relative to the base part without generating noise and/or without generating a tactile signal to thereby indicate the connector part is correctly or completely connected to the base part.

20. The method of claim 19, wherein the connector part comprises one or more guide slots, and the one or more guide slots is in an engagement with an edge of the base part.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Implementations of the present disclosure are described below with reference to several figures. The features disclosed advantageously develop the implementations individually and in any combination of features.

[0055] FIG. 1 shows an exploded view of a first embodiment of an infusion set according to implementations of the present disclosure, with a cap part and a base part of the infusion set being visible.

[0056] FIG. 2 shows a longitudinal sectional view of the infusion set according to FIG. 1, with the cap part being connected, e.g., snapped, to the base part.

[0057] FIG. 3 shows a longitudinal sectional view of the infusion set according to FIG. 1, with a connector part being connected, e.g., snapped, to the base part.

[0058] FIG. 4 shows an exploded view of a second embodiment of the infusion set according to implementations of the present disclosure, with a cap part and a base part of the infusion set being visible.

[0059] FIG. 5 shows a longitudinal sectional view of the infusion set according to FIG. 4, with a cap part being connected, e.g., snapped, to the base part.

[0060] FIG. 6 shows a longitudinal sectional view of the infusion set according to FIG. 4, a connector part being connected, e.g., snapped, to the base part.

[0061] FIG. 7 shows a plan view of the base part of the first and the second embodiment of the infusion set.

[0062] FIG. 8 shows a longitudinal sectional view of an edge of the base part of the infusion set along the section line A-A according to FIG. 7.

[0063] FIG. 9 shows a longitudinal sectional view of the cap part of the infusion set according to FIG. 1.

[0064] FIG. 10 is a perspective view of the section of the cap part identified in FIG. 9.

[0065] FIG. 11 is a side view of the connector of the first and second embodiment of the infusion set.

[0066] FIG. 12 is a longitudinal sectional view of the connector along the section line B-B according to FIG. 11.

[0067] FIG. 13 a perspective view of the connector according to FIG. 12.

DETAILED DESCRIPTION

[0068] FIG. 1 shows an exploded view of an infusion set according to a first embodiment of the present disclosure, in which a cap part and a base part of the first embodiment of the infusion set are shown.

[0069] The infusion set comprises a circular and cap-shaped cap part (3) with a rigid needle (3a). The cap part (3) may be configured to be elastic or flexible. The rigid needle (3a) may be made of steel or an alternative material. The rigid needle (3a) may be firmly connected or affixed to the cap part (3). One or more holding elements (3d), e.g., two, and a handle part (3e) may be provided on an outer surface of the cap part (3). The holding element (3d) may be used to hold the infusion set and the handle part (3e) may be used to insert the infusion set into an insertion device or a puncture aid. Furthermore, one or more continuous slots (3f), e.g., two, may be provided in the cap part (3). A proximal end of the rigid needle (3) may be connected to the handle part (3e) of the cap part (3).

[0070] The infusion set may also comprise a circular base part (1), which may be configured to be flat. A protective element (1e) may be provided on the base part (1) to protect against puncture injuries caused by the rigid needle (3a). A plurality of projections (1i) and a plurality of recesses (1j) may be arranged on a proximal side and on the edge of the base part (1). The base part may further include a base cylinder (1n) which may be cylindrical. The base cylinder (1n) may be arranged on the proximal side of the base part and protrude in the proximal direction. A passage (FIG. 2; 1o) may be provided in the base cylinder. An “eyelet” (1l) may be inserted in the passage (FIG. 2; 1o) of the base cylinder (1n) in order to connect a soft cannula (1a) to the base part (1). The soft cannula (1a) may be made of a soft material. A cannula cylinder (1f) may protrude from the distal side of the base part (1) in the distal direction. The soft cannula (1a) may be fastened in the corresponding cannula cylinder (1f), for instance in a passage provided in the cannula cylinder (1f), and may protrude from the cannula cylinder (1f) in the distal direction in order to deliver the liquid medicament to the patient. The passage (FIG. 2; 1o) may be closed with a septum (1m), and the septum (1m) may be arranged at the proximal end of the “eyelet” (1l). Cams (or ridges) (FIG. 2; 1h) may be provided on a distal side of the base part. The cams (FIG. 2; 1h) may be fused to an adhesive layer (1c) of the base part (1) so that the adhesive layer may be connected to the base part (1). The adhesive layer (1c) may be used to attach the infusion set to the patient's skin. A distal side of the adhesive layer (1c) may be covered with a protective film (1d). Before applying the infusion set to the patient's skin, the patient takes the protective film (1d) off the adhesive layer (1c).

[0071] FIG. 2 shows a longitudinal sectional view of the infusion set according to FIG. 1, with the cap part (3) being connected to the base part (1), for instance by being snapped into place. The rigid needle (3a) of the cap part (3) may be received in the soft cannula (1a) of the base part (1) in such a way that a distal end of the rigid needle (3a) of the cap part (3) protrudes over a distal end of the soft cannula (1a) of the base part (1). The concentric arrangement of the soft cannula (1a) and the rigid needle (3a) may be used to guide the soft cannula (1a) when the soft cannula (1a) of the base part (1) is pierced into the patient's skin. The soft cannula (1a) may be positively connected to the “eyelet” (1l), for instance by being pressed and pressed into the passage (1o) of the base cylinder (1n). The protective element (1e) may be releasably pressed into an opening (1g) provided on a distal side of the base cylinder (1n) of the base part (1). The cap part (3) may be snapped onto a proximal side of the base part (1). The edge of the cap part (3) may include a guide groove (3c), which receives an edge of the base part (1). Furthermore, a ratchet tooth (3b) or a locking tooth may be provided on an inner surface of the cap part (3) and may protrude into a recess (1j) arranged on the distal side of the base part (1). When the cap part (3) is connected to the base part, a cap cylinder (3g) may be arranged concentrically to the base cylinder (1n) of the base part (1). As shown in FIG. 7 and in FIG. 8, the recess (1j) may be arranged on the edge of the base part (1). The recess (1j) may also form a part of a projection (1i) and recess arrangement (1j) of the base part (1). As shown in FIG. 9 and in FIG. 10, the ratchet tooth (3b) or locking tooth of the cap part (3) may protrude radially inward from the inside of the casing of the cap part (3). The ratchet tooth (3b) of the cap part (3) may be brought into an engagement, for instance, may form an engagement with the recess (1j) of the base part (1), in order to establish a non-rotatable connection between the base part (1) and the cap part (3). The non-rotatable connection between the cap part (3) and the base part (1) may enable the patient to remove the protective film (1d) of the adhesive layer (1c) more easily from the base part (1).

[0072] In order to attach the infusion set to the patient's skin, the patient may remove the protective element (1e) from the base part (1). The patient may then pull the protective film (1d) off the adhesive layer (1c). The cap part (3) snapped onto the base part (1) may be placed on the patient's skin. The soft cannula (1a) of the base part (1) with the rigid needle (3a) of the cap part received therein may penetrate through the skin and into the subcutaneous tissue. The cams (or ridges) (1h) of the base part (1) may space the base part (1) from the patient's skin and may enable air to circulate between the base part and the patient's skin. The cap part (3) may then be removed from the base part (1) by the patient pretensioning the two holding elements (3d) inward, releasing the snap connection between the cap part (3) and the base part (1). The protective element (1e) may be placed over the rigid needle (3a) provided on the cap part (3) in order to protect the patient from puncture injuries. For instance, a holder provided on the inner surface of the cap part (3) may be provided for this purpose.

[0073] Then, turning to FIG. 3, a connector part (2) with a tube (2d) may be attached to the base part (1). The tube (2d) may include an adapter for releasable attachment to an infusion device, such as an infusion pump. The tube (2d) of the connector part (2) may be connected to the adapter by using of an adhesive which hardens when exposed to UV light.

[0074] FIG. 3 shows a longitudinal sectional view of the infusion set according to FIG. 1, a connector part (2) being connected, e.g., snapped, to the base part (1). The tube (2d) of the connector part (2) may be connected to the connector part (2) by an adhesive which cures by exposure to UV light. The tube (2d) may be in fluid connection with a piercing cannula (2e) arranged on an inner surface of the jacket. The tube (2d) may be arranged offset by 90° with respect to the piercing cannula (2e) in the connector part, as shown in FIG. 12. The piercing cannula (2e) of the connector part (2) may penetrate the septum (1m) provided on the base part (1) and may protrude into the “eyelet” (1l), for instance into the proximal part of the “eyelet” (1l) of the base part (1). A connector cylinder (2f) may be provided on the inner surface of the connector part (2) and may receive the base cylinder (1n) of the base part (1), which protrudes in the proximal direction. The connector cylinder (2f) may be in a guide engagement with the base cylinder (1n), for instance in a sliding engagement, with the connector part (2) being rotatable relative to the base part (1), for instance being rotatable through any desired rotational angle relative to one another. The drug to be dispensed may be administered into the patient's body by the infusion device via the connector part (2) and the base part (1).

[0075] With correct connection or complete snap action between the connector part (2) and the base part (1), as shown in FIG. 3, the edge of the base part (1) enters a guide slot (2b) provided on the connector part (2). Furthermore, a projection (2a) arranged on the inside of the casing of the connector part (2) protrudes into an annular groove (1k) provided on the base part (1). The projection (2a) of the connector part (2) may thus be in an engagement with the annular groove (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 a tactile signal generating in the annular groove (1k) of the base part (1).

[0076] In the event of an incorrect or incomplete connection, such as a faulty snap between the connector part (2) and the base part (1), the projection (2a) of the connector part (2) enters the projection (1i) and recess arrangement (1j) of the base part (1). The projection (2a) of the connector part (2) is in engagement with the projection (1i) and 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 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 a tactile signal may be generated to indicate that the connector part (2) is not correctly or not completely connected to the base part (1), for instance is engaged incorrectly. An incorrect or incomplete connection, such as a faulty snap, harbors the risk of an inadequate supply of medication, which may be delivered to the patient from the connector part via the base part.

[0077] In order to detach the connector part (2) from the base part (1), the patient grips two gripping elements (2c) provided on the connector part (2) and presses inwards, as shown in FIG. 11 and FIG. 13. The snap connection between the connector part (2) and the base part (1) may thereby be released.

[0078] To remove the base part (1) from the patient's skin, the patient detaches the adhesive layer (1c) from the patient's skin and removes the base part (1) from the skin. Alternatively, the patient may connect the base part (1) to a cap part (3) which does not have a rigid needle (3a), and the patient may then be able to pull the cap part (3) connected to the base part (1) out of the patient's skin and dispose of the infusion set.

[0079] FIG. 4 illustrates an exploded view of a second embodiment of the infusion set according to implementations of the present disclosure, with a cap part (3′) and a base part (1′) of the infusion set being shown. Reference elements in the second embodiment labeled with an apostrophe (′), e.g., base part (1′), include similar configurations and functions as the same numbered reference elements discussed in the first embodiment without the apostrophe, e.g., base part (1), unless otherwise described, and those similarities are not repeated for purposes of clarity.

[0080] The infusion set may have a circular and cap-shaped cap part (3′). The cap part (3′) may include one or more holding elements (3d′), e.g., two, and a handle part (3e′), which may be attached to an outer surface of the cap part (3′). Furthermore, one or more continuous slots (3f′), e.g., two, may be provided in the cap part (3′).

[0081] The infusion set may also include a circular base part (1′), which may be flat. In a passage (FIG. 5; 1o′) of a base cylinder (1n′) of the base part (1′), a rigid cannula (1b) may be attached. To fix the rigid cannula (1b) in the base part (1′), an adhesive may be applied between the rigid cannula (1b) and the cannula cylinder (1P), such as an adhesive which hardens when exposed to UV light. A protective element (1e′) may be provided on the base part (1′) to protect against puncture injuries caused by the rigid cannula (1b). A plurality of projections (1i′) and a plurality of recesses (1j′) may be arranged on a proximal side and on the edge of the base part (1′). The passage (FIG. 5; 1o′) may be closed with a septum (1m′), the septum (1m′) being provided at a proximal end of the rigid cannula (1b). Cams (or ridges) (FIG. 5; 1h′) may be arranged on a distal side of the base part. The cams (FIG. 5; 1h′) may be fused with an adhesive layer (1c′) of the base part (1′) so that the adhesive layer may be attached to the base part (1′). The adhesive layer (1c′) may be used to attach the infusion set to the patient's skin. A distal side of the adhesive layer (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 layer (1c′).

[0082] FIG. 5 shows a longitudinal sectional view of the infusion set according to FIG. 4, the cap part (3′) being connected, for instance snapped, 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 attached to the base part (1′). The septum (1m′) may close the proximal end of the rigid cannula (1b), which may be attached to the base cylinder (1n′). Due to the adhesive connection between the rigid cannula (1b) and the base cylinder (1n′), a connecting element, such as an “eyelet”, may be unnecessary.

[0083] FIG. 6 shows a longitudinal sectional view of the infusion set according to FIG. 4, with a connector part (2′) being connected, for instance snapped, to the base part (1′). The second embodiment of the infusion set differs from the first embodiment in that a piercing cannula (2e′) provided on the connector part (2′) penetrates through the septum (1m′) of the base part (1′) to form a fluid connection with the base part (1′).

REFERENCE NUMBER

[0084] 1; 1′ base part [0085] 1a soft cannula [0086] 1b rigid cannula [0087] 1c; 1c′ adhesive layer [0088] 1d; 1d′ protective film [0089] 1e; 1e′ protective element [0090] 1f; 1f′ cannula cylinder [0091] 1g; 1g′ opening [0092] 1h; 1h′ cam (ridge) [0093] 1i; 1i′ projection [0094] 1j; recess [0095] 1k; 1k′ annular groove [0096] 1l eyelet [0097] 1m; 1m′ septum [0098] 1n; 1n′ base cylinder [0099] 1o; 1o′ passage [0100] 2, 2′ connector part [0101] 2a; 2a′ projection [0102] 2b; 2b′ guide slot [0103] 2c; 2c′ gripping element [0104] 2d; 2d′ tube [0105] 2e; 2e′ piercing cannula [0106] 2f; 2f′ connector cylinder [0107] 3; 3′ cap part [0108] 3a rigid needle [0109] 3b; 3b′ ratchet tooth [0110] 3c; 3c′ guide groove [0111] 3d; 3d′ holding elements [0112] 3e; 3e′ handle part [0113] 3f; 3f′ slot [0114] 3g; 3g′ cap cylinder