Assembly Comprising Inserter, Cannula Part and Base Part
The invention relates to an assembly comprising—an inserter ( 10 ) for insertion of a penetrating member ( 7 ) into a patient,—a penetrating member attached to the inserter ( 10 ) before use,—a base part comprises a position shaped to receive the penetrating member where the penetrating member can be attached to the base part during use and fastening means ( 2 ) which can provide for the base part to be attached to the patient, where the inserter ( 10 ) comprises inserter attachment means ( 14 ) locking the inserter ( 10 ) to the base part before and during insertion of the penetrating member ( 7 ) which inserter attachment means can be unlocked so that the inserted can be removed from the base part after insertion of the penetrating member ( 7 ), the inserter attachment means comprise at least one protruding part and at least one corresponding opening. Either the at least one protruding part or the at least one corresponding opening part is positioned on a surface of the base part and a corresponding part either comprising a protruding part or an opening is positioned on a surface of the inserter.
1 . An assembly comprising
an inserter ( 10 ) for insertion of a penetrating member ( 7 ) into a patient,
a penetrating member ( 7 ) attached to the inserter ( 10 ) before use which penetrating member ( 7 ) is provided with a through going opening forming a fluid connection between delivery means ( 8 ) and a patient when the penetrating member ( 7 ) is inserted,
a base part comprises a position shaped to receive the penetrating member ( 7 ) where the penetrating member ( 7 ) can be attached to the base part during use and fastening means ( 2 ) which can provide for the base part to be attached to the patient,
where the inserter ( 10 ) comprises inserter attachment means ( 14 ) locking the inserter ( 10 ) to the base part before and during insertion of the penetrating member ( 7 ) which inserter attachment means ( 14 ) can be unlocked so that the inserted can be removed from the base part after insertion of the penetrating member ( 7 ), the inserter attachment means ( 14 , 14 A, 14 B, 14 PR/R, 14 PL/L) comprise at least one protruding part and at least one corresponding opening,
characterized in that either the at least one protruding part or the at least one corresponding opening part is positioned on a surface of the base part and a corresponding part either comprising a protruding part or an opening is positioned on a surface of the inserter ( 10 ).
2 . An assembly according to claim 1 , characterized in that the inserter ( 10 ) is released from the base part i.e. the inserter attachment means ( 14 ) are disengaged, by the interaction between a moving part ( 38 ) of the inserter ( 10 ) which moving part guides the insertion of the penetrating member ( 7 ) from a first to a final position and a stationary part ( 29 , 115 , 14 A) of the base part during insertion.
3 . An assembly according to claim 2 , characterized in that the moving part ( 38 ) of the inserter ( 10 ) moves forward in a direction which is approximately perpendicular i.e. 90°±45°, normally 90°±15° to the direction of insertion of the penetrating member ( 7 ).
4 . An assembly according to any preceding claim, characterized in that the penetrating member ( 7 ) is attached by a tube shaped connection ( 16 ) to the base part before and during insertion.
5 . An assembly according to claim 4 , characterized in that the connection ( 16 ) comprises a flexible material.
6 . An assembly according to any preceding claim, characterized in that the inserter ( 10 ) is released from the base part by applying a force to the inserter ( 10 ) or a part of the inserter ( 10 ) in a direction different from the direction of insertion of the penetrating member ( 7 ).
7 . An assembly according to claim 5 , characterized in that the force is applied in a direction which is approximately perpendicular i.e. 90°±45°, normally 90°±15° to the direction of insertion of the penetrating member ( 7 ).
8 . An assembly according to any preceding claim, characterized in that the release of the inserter ( 10 ) from the base part is at least partly provided by the release of a force in direction towards the base part.
9 . An assembly according to claim 8 , characterized in that the released force is provided by a spring unit ( 45 ) exercising a force directed to a proximal surface of the inserter housing and a distal surface of the base part ( 1 ).
10 . An assembly according to claim 9 , characterized in that the spring ( 36 ) is a leaf spring which at one end is fastened unreleasably to a part of the inserter and at the other end will touch the upper surface of the base part before the inserter is released from the base part.
11 . An assembly according to any of the preceding claims, characterized in that the attachment means ( 14 ) of the inserter ( 10 ) comprise at least one protruding part ( 14 PR, 14 PL) corresponding to an opening ( 14 R, 14 L) in the base part.
12 . An assembly according to claim 11 , characterized in that the at least one protruding part ( 14 PR, 14 PL) is inserted into the corresponding opening ( 14 R, 14 L) in a direction approximately parallel to the upper surface of the base part.
13 . An assembly according to any of the preceding claims, characterized in that the attachment means ( 14 ) comprise at least one hook attached to a hinged part ( 14 ) formed by a part of the housing of the inserter ( 10 ).
14 . An assembly according to claim 13 , characterized in that the at least one hook is turned inward i.e. the hook is placed on an inner surface of the housing of the inserter and turned toward the centre of the housing.
15 . An assembly according to claim 14 , characterized in that the at least one hook faces at least two protruding parts ( 14 PR, 14 PL) which are placed on a surface of the housing opposite the at least one hook.
16 . An assembly according to claim 15 , characterized in that the at least one hook is placed between the two protruding parts.
17 . An assembly according to any of the preceding claims, characterized in that the penetrating member ( 7 ) is provided with attachment means ( 23 ) assuring that the penetrating member ( 7 ) is unreleasably attached to the base part after insertion.
18 . An assembly according to any of the preceding claims, characterized in that either the penetrating member ( 7 ) or the base part or both is/are provided with sealing means ( 18 ) forming a fluid tight connection between the base part and the penetrating member ( 7 ) and the base part is further provided with sealing means ( 17 ) forming a fluid connection to the delivery means ( 8 ).
19 . An assembly according to any of the preceding claims, characterized in that the position shaped to receive the penetrating member ( 7 ) is formed as a longitudinal opening ( 12 A) extending from the upper surface of the connection part ( 3 ) of the base part to the lower surface of the connection part ( 3 ) of the base part, which opening ( 12 A) corresponds to the profile of at least the non-penetrating end of the penetrating member ( 7 ).
20 . An assembly according to claim 19 , characterized in that an outlet of a fluid path ( 12 ) opens into the wall of the opening ( 12 A) and when the penetrating member ( 7 ) is inserted, an inlet to a fluid path of the penetrating member ( 7 ) corresponds to the outlet ( 12 ) of the fluid path.
21 . An assembly according to any of the preceding claims, characterized in that one penetrating member ( 7 ) comprises a cannula part having a body made of a hard material to which a soft or cutting cannula ( 22 ) is unreleasably attached.
22 . An assembly according to claim 21 , characterized in that the body ( 24 ) of the cannula part has an inner opening from which inner opening fluid is led to the cannula ( 22 ) and this inner opening has at least one inlet ( 20 , 21 ) through which fluid or a needle can enter the inner opening.
23 . An assembly according to any of the preceding claims, characterized in that at least one penetrating member ( 7 ) comprises a sensor part.
24 . An assembly according to any of the preceding claims, characterized in that the assembly is delivered to the user in a sterile state where the penetrating member ( 7 ) is in a retracted position in the inserter ( 10 ) and the inserter ( 10 ) is attached to the base part.