SEALING BETWEEN A CANNULA PART AND A FLUID PATH

20210283331 · 2021-09-16

    Inventors

    Cpc classification

    International classification

    Abstract

    The application relates to an infusion part comprising a cannula part (7) and a fluid path, whereby a sealing (18) is positioned between the cannula part and the inlet/outlet opening (12) of the fluid path when the cannula part is in position for use in order to keep the fluid path to the cannula tight. The sealing (18) is surrounding the inlet/outlet opening (12) and/or the distance di between a centre line c of the cannula part and a point on the outer surface of the cannula part positioned at or above the upper edge of the sealing (18) is larger than the distance 02 between the centre line c of the cannula part and a point on the outer surface of the cannula part positioned at or below the lower edge of the sealing.

    Claims

    1. An infusion part comprising: a base part attachable to a patient's skin in use of the infusion part, the base part defining a fluid path and including at least one base part opening; a cannula part sized to be received by the base part in use of the infusion part, the cannula part including a body and a cannula coupled to the body, the body having at least one body opening formed in a surface thereof that is in fluid communication with the at least one base part opening in use of the infusion part; and an elastic sealing part to provide a fluid-tight connection between the cannula part and the base part when the cannula part is received by the base part in use of the infusion part.

    2. The infusion part of claim 1, wherein the cannula is arranged along a center line of the cannula part, and wherein an angle defined between the center line and a line parallel to the surface is 90 degrees.

    3. The infusion part of claim 2, wherein a tube fluidly coupling the cannula part to a reservoir at least partially defines one opening of at least one base part opening.

    4. The infusion part of claim 3, wherein the reservoir includes an inlet having a membrane arranged to at least partially close off the inlet to protect the reservoir from contamination.

    5. The infusion part of claim 1, wherein the body of the cannula part has a frustoconical shape.

    6. The infusion part of claim 5, wherein the base part includes a cannula cavity shaped to receive the body of the cannula part, and wherein the cannula cavity has a frustoconical shape complementary to the shape of the body of the cannula part.

    7. The infusion part of claim 6, wherein the elastic sealing part is permanently affixed to the body of the cannula part.

    8. The infusion part of claim 7, further comprising a second elastic sealing part, wherein each of the elastic sealing part and the second elastic sealing part is permanently affixed to the body of the cannula part, and wherein the elastic sealing part and the second elastic sealing part are spaced apart from one another along a longitudinal center line of the cannula part.

    9. The infusion part of claim 1, wherein the at least one base part opening includes two fluid path openings, and wherein the elastic sealing part is provided in a round track surrounding at least one of the two fluid path openings.

    10. The infusion part of claim 9, wherein the two fluid path openings are integrally formed with the base part.

    11. The infusion part of claim 1, wherein the cannula part is provided separately from, and is detachable from, the base part, and wherein the cannula part is connectable to the base part with an inserter.

    12. An infusion assembly comprising: a plate to be positioned adjacent a patient's skin; a connector part coupled to the plate, the connector part including a fluid path that extends from a cannula cavity of the connector part to an access opening of the connector part; a cannula part sized to be received at least partially by the cannula cavity in use of the infusion assembly, the cannula part comprising: a body having at least one body opening formed in a surface thereof that is in fluid communication with the access opening in use of the infusion assembly; and a cannula coupled to the body that is arranged along a center line of the cannula part such that an angle defined between the center line and a line parallel to the surface is 90 degrees; and an elastic sealing part to provide a fluid-tight connection between the cannula part and the connector part when the cannula part is received by the cannula cavity in use of the infusion assembly.

    13. The infusion assembly of claim 12, wherein a tube fluidly coupling the cannula part to a reservoir at least partially defines an opening of the connector part.

    14. The infusion assembly of claim 13, wherein the reservoir includes an inlet having a membrane arranged to at least partially close off the inlet to protect the reservoir from contamination.

    15. The infusion assembly of claim 12, wherein the body of the cannula part has a frustoconical shape.

    16. The infusion assembly of claim 15, wherein the cannula cavity has a frustoconical shape complementary to the shape of the body of the cannula part.

    17. An infusion assembly comprising: a plate to be positioned adjacent a patient's skin; a connector part coupled to the plate, the connector part including a fluid path that extends from a cannula cavity of the connector part to an access opening of the connector part; a cannula part sized to be received at least partially by the cannula cavity in use of the infusion assembly, the cannula part comprising: a body having at least one body opening formed in a surface thereof that is in fluid communication with the access opening in use of the infusion assembly, the body having a frustoconical shape; and a cannula coupled to the body that is arranged along a center line of the cannula part; and an elastic sealing part to provide a fluid-tight connection between the cannula part and the connector part when the cannula part is received by the cannula cavity in use of the infusion assembly.

    18. The infusion assembly of claim 17, wherein the cannula cavity has a frustoconical shape complementary to the shape of the body of the cannula part.

    19. The infusion assembly of claim 18, further comprising a second elastic sealing part, wherein each of the elastic sealing part and the second elastic sealing part is permanently affixed to the body of the cannula part, and wherein the elastic sealing part and the second elastic sealing part are spaced apart from one another along the center line of the cannula part.

    20. The infusion assembly of claim 19, wherein an angle defined between the center line and a line parallel to the surface is 90 degrees.

    Description

    [0028] Embodiments of the invention will now be described with reference to the figures in which:

    [0029] FIG. 1 shows a first embodiment of an infusion part according to the invention.

    [0030] FIG. 2 shows a second embodiment of an infusion part according to the invention.

    [0031] FIG. 2A shows another view of the second embodiment of the infusion part.

    [0032] FIG. 3 shows the same embodiment of an infusion part as FIGS. 2 and 2A.

    [0033] FIG. 4A shows a cannula part which can be used in connection with the invention.

    [0034] FIG. 4B shows another view of the cannula part depicted in FIG. 4A.

    [0035] FIG. 4C shows yet another view of the cannula part depicted in FIG. 4A.

    [0036] FIG. 5 shows a front view of an inserter which can be used in connection with the invention.

    [0037] FIG. 6 shows a view from the proximal side of the inserter of FIG. 5.

    [0038] FIG. 7 shows a connector part which can be part of an infusion part according to the invention.

    [0039] FIG. 8 shows the same connector part as FIG. 7 without the bubble membrane covering the inlet.

    [0040] FIG. 9A shows a cannula part having an inclined contact surface.

    [0041] FIG. 9B shows another view of the cannula part depicted in FIG. 9A.

    [0042] FIG. 10A shows an enlargement of the contact between the cannula part and the cannula opening of the connection part.

    [0043] FIG. 10B is another view of an enlargement similar to that depicted in FIG. 10A.

    [0044] FIG. 10C is yet another view of an enlargement similar to that depicted in FIG. 10A.

    [0045] FIG. 10D is yet another view still of an enlargement similar to that depicted in FIG. 10A.

    [0046] FIG. 11A shows an embodiment of a base part provided with a fluid path mainly constructed of a tube.

    [0047] FIG. 11B shows another view of the embodiment depicted in FIG. 11A.

    [0048] FIG. 11C shows yet another view of the embodiment depicted in FIG. 11A.

    [0049] FIG. 12 shows an embodiment of an infusion part having an angle d=90° between insertion direction and tangent to contact surface.

    [0050] FIG. 13 shows a cannula part which can be used in connection with the invention.

    [0051] FIG. 1 shows an embodiment of an infusion part comprising a cannula part and a fluid path according to the invention. This embodiment comprises a surface plate 1 attached to a contact surface. The surface plate 1 is in this embodiment is constructed of a molded plastic material and the contact surface can be the proximal side of a mounting pad 2 which mounting pad 2 is unreleasably fastened to the surface plate 1 during manufacturing of the device. The mounting pad 2 of this embodiment has the same area as the surface plate 1 but it could be of an area larger or smaller than the surface plate 1.

    [0052] A connector part 3 is positioned on the surface plate 1. The connector part 3 provides for the contact between the base part and some kind of delivery means. According to one embodiment the surface plate 1 and at least an outer cover of the connector part 3 is simply molded in one piece during manufacturing of the device. The internal parts of the connector part 3 form a fluid path between e.g., a reservoir of medication or a reservoir for liquid collected from the patient and a cannula part 7. Therefore the connector part 3 is provided with at least two openings, one opening at each end of the fluid path where the first opening 13 is an inlet or outlet opening receiving or delivering fluid to a not shown reservoir and the second opening is an inlet or outlet opening 12 receiving or delivering fluid to a cannula part 7. The connection part 3 might be provided with extra openings e.g., for inserting the cannula part, for injection of a second medication or nutrient or for letting the fluid in the fluid path get in contact with a sensor.

    [0053] In the following the first opening 13 will be referred to as “inlet” and the second opening will be referred to as “outlet” although the direction of the flow through the fluid path is not significant for the invention.

    [0054] The embodiment of FIG. 1 is provided with two guiding means 4 in the form of two right angled L-shaped profiles in the form: ┐, ┐, which profiles are protruding from the surface plate 1 of a base part having a lower or proximal side which is fastened to the skin of the patient. The guiding means 4 correspond to guiding means on a delivery part or a cover or connecting means which are to be fastened to the base part during use. Such corresponding means can e.g., be formed as one or more hooks having an L-shaped profile in the form: and ┘ ┘ corresponding to the profiles on the base part.

    [0055] The fluid path of the connection part 3 of this embodiment is very short and the inlet 13 of the connection part 3 is placed in a centre position in relation to the guiding means 4. The top of an inserted cannula part 7 is shown inserted into the connection part 3.

    [0056] The connection part 3 is further provided with a cannula cavity 12A which accurately fits around a cannula part 7 i.e., the cannula cavity 12A has the same 3-dimensional shape or profile as the cannula part 7 and is just big enough to let the cannula part 7 pass through and then fit into the opening. In FIG. 1 the cannula part 7 is shown in a position where the cannula part 7 is fully inserted. When the cannula part 7 is fully inserted, then the upper surface i.e. the distal surface of the cannula part 7 is normally at level with or at a lower level than the outer surface of the connection part 3 around the cannula cavity 12A.

    [0057] When the cannula part 7 has been fully inserted into the connection part 3, an opening 20 in a side surface of a body 24 of the cannula part 7 corresponds to the opening 12 of the fluid path of the connection part 3 and fluid can flow from one part to the other. The opening 12 might in the following be referred to as an “outlet” although the direction of the flow is not significant to the invention.

    [0058] FIGS. 2 and 3 show a second embodiment of an infusion part according to the invention. A delivery part corresponding to this embodiment could be joined to the base part by pushing the delivery part down toward the guiding means 4 which in this case is a longitudinal raised platform having a magnet 5 fastened to the top surface. The delivery part would be provided with a corresponding magnet e.g., of a smaller or different size than the magnet 5 which is placed in such a way e.g., in a track corresponding to the raised platform 4, that the corresponding magnet of the delivery part can slide along the magnet 5 on the raised platform 4 of the base part in the longitudinal direction. When the delivery part arrives at its working position, two release handles can engage respectively with two protruding parts 15 protruding from the upper surface of the surface plate 1. When the delivery part is in its working position it is locked in any horizontal direction by the release handles and in the direction perpendicular to the surface plate 1 by the two corresponding magnets of respectively the delivery part and the base part. These locking mechanisms make it possible to fasten and release the delivery device from the base part as often as needed i.e., a single-use base part can be combined with a multi-use delivery part.

    [0059] In FIGS. 2 and 2A the base part is shown without the cannula part 7 and in FIG. 3 the base part is shown having the cannula part 7 in a position reached just before insertion of the cannula part 7, normally the cannula part 7 would at this stage of insertion still be placed inside an inserter and it would not be visible.

    [0060] Normally an inserter 10 holds the cannula part 7 before insertion and the insertion can be initiated by pushing a handle 11. FIGS. 5 and 6 shows the direction the handle 11 has to be pushed in, in order to initiate insertion of the cannula part 7. After insertion a not shown insertion needle can be retracted to the inside of the inserter 10 and the inserter 10 is removed from the base part, leaving an inserted cannula 22 fastened to the surface plate 1. If the cannula 22 of the cannula part 7 is a hard self-penetrating cannula there will be no separate insertion needle and therefore no need to retract the insertion needle.

    [0061] In FIGS. 2 and 2a the connection part 3 is shown with an outer cover provided by the molded surface plate 1. The outer cover shown in this embodiment is not an independent unit but is attached unreleasably to or simply made as a part of the surface plate 1 e.g., by a molding process. The outer cover is provided with a cannula cavity 12A for the cannula part 7 and an access opening 13 for e.g., a reservoir thereby allowing access to the fluid path of the connection part 3 by the reservoir and the cannula part 7. The cannula cavity 12A allows the cannula part 7 to be inserted sub- or transcutaneous into the patient within the circumference of the hard surface plate 1 and the contact surface 2 of the base part which in this embodiment is provided by a mounting pad is also provided with an opening 12B which allows for the cannula to be inserted (see FIGS. 7 and 8). This opening 12B is not necessary if the contact surface 2 is constructed of such a material and thickness that it can be penetrated by at least the cannula 22 of the cannula part 7.

    [0062] In FIGS. 7 and 8 the connection part 3 is shown without the outer cover provided by the molded surface plate 1. In order to secure a fluid tight connection between the outlet opening 12 in the connection part 3 and the cannula part 7 the outlet opening 12 of the connection part 3 is provided with an elastic sealing 18 around the outlet opening 12. When the cannula part 7 is inserted it will be press fitted into the cannula opening 12 and the elastic sealing 18 will provide a completely fluid tight gasket around the corresponding openings 12 and 20. In order to improve the press-fitting and thereby the fluid tight connection between the cannula part 7 and the outlet of the fluid path, the cannula cavity 12A can be provided with a decreasing cross-section in a plane parallel to the cannula 22 when inserted and perpendicular to the surface where the outlet of the fluid path is positioned. The cannula part 7 will have a corresponding decreasing cross-section.

    [0063] In order to secure a fluid tight connection between the inlet opening 13 in the connection part 3 and the reservoir 6, a bubble shaped membrane 17 has been positioned around the first opening 13. The membrane 17 completely covers the inlet opening 13 and prevents contamination of the internal of the connection part 3. When a reservoir or connecting parts for a reservoir is pressed towards the connection part 3, a connector needle 19 will penetrate the membrane 17 and provide a completely fluid tight transfer of fluid between the connection part 3 and the reservoir.

    [0064] That the membrane 17 is bubble shaped means that it is attached around the opening—normally around the edge of the opening—it protects and the membrane 17 protrudes from the planed formed by the edge of the opening and forms a dome in a distance from the edge which distance normally corresponds to the length of a connector needle 19.

    [0065] In FIG. 8 the connector needle 19 is shown as being a part of the connection part 3 i.e. it is attached to the connection part 3 but it might just as well be a part of the reservoir.

    [0066] According to one embodiment the connection part 3 is provided with both a connector needle 19 and a bubble shaped self-closing membrane 17 and the reservoir is also provided with a bubble shaped self-closing membrane. As both parts are provided with self-closing membranes it will be possible to separate the two units from each other and rejoin them at a later time without the internal fluid path of the connection part 3 and thereby the patient being contaminated.

    [0067] FIGS. 4A, 4B and 4C shows an enlargement of a cannula part 7 which can be used in connection with the invention. This embodiment comprises a body 24 provided with a cannula 22 and with a protruding front 25 having a flat surface. The surface of the cannula part 7 having an opening need not be flat; it can actually have any desired shape as long as it is possible to create a corresponding surface on the connection part 3 facing the cannula part 7. In one embodiment the front 25 is inclined in such a way that the cross-section at the upper i.e., distal end is larger than the cross-section at the proximal end, i.e., the end closest to the patient after insertion, of the front in at least one dimension. The front 25 is provided with an opening 20 through which liquid can exit or enter the cannula part 7. The body 24 is further provided with a top opening 21 which opening can be covered with a self-closing membrane. The opening 21 need some kind of entrance protection as it is facing an outer surface which is in contact with the surroundings. The top opening 21 is primarily used when inserting the cannula part 7 if the cannula 22 is a soft cannula. That the cannula 22 is soft means that is made of a relatively soft material which can not penetrate the patient's skin, in this case it is necessary to use a pointy insertion needle of a relatively hard material when inserting the cannula and this pointy needle can be inserted through the top opening 21, pass through an inner through-going opening in the body 24 of the cannula part and further pass through the full length of the cannula 22 in such a way that the pointy end of the insertion needle stick out of the open end of the hollow cannula 22. After insertion i.e., after the cannula 22 has been placed sub- or transcutaneous in the patient, then the insertion needle is retracted and the cannula 22 is left inside the patient.

    [0068] The cannula part 7 is also provided with fastening means 23 which fastening means 23 lock the cannula part 7 to the base part at the time where it is fully inserted. The fastening means 23 of this embodiment comprises outward hooks that can pivot around an axe close to the body 24 of the cannula part 7 in such a way that the diameter formed by the outermost edge of the hooks can be reduced when the hooks are pressed inward i.e., towards the centre of the cannula part 7. When the pressure is removed the hooks will return to their original position due to the flexibility of the material. The hooks will be pushed inwards when they pass an opening such as e.g., the opening 12B or a corresponding opening in the surface plate having a cross-section which at least in one dimension is smaller than the outer edge of the hooks and as the hooks return to their original position after having passed through the opening, the hooks will lock the cannula part 7 in the inserted position.

    [0069] FIGS. 5 and 6 show an inserter that can be used to position the cannula part 7 in the base part. The inserter comprises a housing 10 provided with an internal opening where the cannula part 7 can be moved from a retracted position to a forward position. In the retracted position the cannula 22 is not in contact with the patient and in the forward position the cannula 22 is inserted into the patient. The inserter further comprises an actuator handle 11 which is to be activated when the cannula part 7 is to be inserted and it comprises fastening means 14 which means can lock the inserter to the base part before and during insertion. Normally the inserter should be fastened to the base part under sterile conditions or the joined base part and inserter should be sterilized after fastening of the inserter in order to prevent contamination of the cannula cavity 12A, and in order to reduce the amount of material placed on the patient's skin it is desirable to be able to remove the whole of or at least part of the inserter after the cannula part 7 has been inserted.

    [0070] FIGS. 9A and 9B show an enlargement of a second embodiment of a cannula part 7. FIG. 9A shows the cannula part 7 in a state just before insertion and FIG. 9B shows the cannula part 7 inserted into the cavity 12A in the base part.

    [0071] This embodiment also comprises a body 24 provided with a cannula 22 and with a protruding part 25 having a flat surface provided with an opening 20. According to this embodiment the protruding part 25 is inclined in such a way that the pressure between the opening 20 and the sealing 18 around the second opening 12 of the connection part 3 is increased, also the sealing 18 is subjected to less tear during insertion. The inclination of the inclined part 25 is defined by the angle d between the centre line c of the cannula 22 (the centre line c is parallel to the insertion direction) and a line parallel to the surface around the opening 20. If the surface around the opening 20 is not straight, then the line parallel to the surface would be the tangent to the surface around the opening 20. The angle d will be larger than 0° and smaller than or equal to 90°, normally d c [0°, 30° ] depending on the diameter or the protrusion of the sealing 18 or [60°, 90° ]. The distance d1 measured at the distal end of the surface of the protruding inclined part 25 where the distal end is the end of the cannula part 7 which is furthest away from the patient after insertion, between the surface of the protruding inclined part 25 and the centre c of the cannula part 7 is larger than the distance d2 between the surface of the protruding part 25 at the proximal end i.e., the end closest to the patient after insertion, and the centre c of the cannula part 7. Normally the distance d2 will be so small that the proximal end of the protruding inclined part 25 does not touch the sealing 18 of the connection part 3 during insertion.

    [0072] In one embodiment (not shown) the angle d is close to 90° i.e. d=90°, such an embodiment would in a drawing corresponding to FIGS. 9A and 9B appear to have an upward opening 12 of the connection part 3 fitting to a downward opening 20 of the cannula part 7. This means that the force pushing the cannula part 7 toward the sealing 18 will be close to perpendicular to the contact surface of the sealing 18 and this will prevent that the sealing is distorted during insertion of the cannula part 7 by the cannula part 7 sliding along the sealing 18.

    [0073] In another embodiment (shown in FIGS. 4A-C and in FIGS. 10A-B) d=0° as the protruding part 25 and the centre line c are parallel. According to this embodiment the cannula part 7 will be in sliding contact with the protruding sealing 18 which can cause the sealing to be distorted.

    [0074] The protruding front 25 of the cannula part 7 need not be flat; it can actually have any desired shape e.g., partly spherical as long as it is possible to create a corresponding surface on the connection part 3 facing the cannula part 7. Also the opening 20 of the protruding front 25 can behave as an inlet or an outlet depending on the purpose of the cannula part 7. In FIGS. 9A and 9B which is a cut-through view it is shown how the top opening 21 of the body 24 is covered with a self-closing membrane 21A. As according to the embodiment of FIG. 4A-C the top opening 21 is primarily used when inserting the cannula part 7 if the cannula 22 is a soft cannula but the top opening 21 can also be used to inject medication or nutrients other than the primary medication which could be e.g. insulin which the patient receive via the opening 20.

    [0075] This embodiment of the cannula part 7 is also provided with fastening means 23 and in this embodiment the fastening means 23 has the form of a protruding part 23 on the cannula part 7 which corresponds to a flexible part 23A on the stationary base part. The flexible part 23A can be pushed outward as indicated with an arrow at FIG. 9A when the protruding part 23 on the cannula part 7 passes during insertion of the cannula part 7. After insertion the upward surface of the protruding part 23 of the cannula part 7 will be locked by the downward surface of the flexible part 23A of the base part and it will not be possible to detach the cannula part 7 from the base part.

    [0076] The cannula part 7 of FIGS. 9A and 9B is provided with a soft cannula 22 which soft cannula 22 together with a bushing 29 provides a cannula assembly. This assembly is normally fastened inside the body 24 of the cannula part 7 by an interference fit i.e. it is only the friction between the body 24 and the cannula assembly which keeps it in the correct position. In order to prevent the cannula assembly from sliding back through the upper larger opening in the body 24 of the cannula part 7, the body 24 of the cannula part 7 can be provided with a ring shaped recess encircling the exit for the soft cannula 22. As the recess creates an open space around the soft cannula 22, the soft cannula 22 can form a small bulk i.e. a ring shaped bulk which prevents the soft cannula from sliding back.

    [0077] FIG. 10 illustrates how the unrestricted openings between the cannula part 7 having the body 24 and the fluid path having the inlet/outlet opening 12 slide into place. FIGS. 10A and 10B show an embodiment where d=0° and FIGS. 10C and 10D show and embodiment where d is around 15°, normally between 8-22°. According to the embodiment of FIGS. 10A and 10B the body 24 of the cannula part 7 is provided with an inclined edge in order to reduce distortion or tearing of the sealing. In both embodiments the shown sealing 18 is a circular or cylindrical silicone unit which is placed in a round track around the inlet/outlet opening 12 in the connection part 3. The wall where the sealing or gasket 18 has been placed is provided with an adjacent expansion room 28. After positioning of the cannula part 7 the sealing 18 can occupy this room. In the embodiment of FIGS. 10C and 10D is not only the sealing face angled, the whole cylindrical sealing part 18 is angled in order to allow uniform sealing deformation. The cylindrical sealing 18 does not form the walls of the inlet/outlet opening 12, the wall or surfaces of this opening is formed by the material which the connection part 3 is formed of in order to provide a pipe which cannot be deformed. In order to create the necessary pressure between the seal and the seal face i.e. the surface which the sealing 18 touches when in a sealing position, the sealing face can be provided with a small continuous protrusion protruding from the sealing face and having the same shape as the sealing which would e.g. be circular if the sealing has the cylindrical shape shown in FIG. 10A-D.

    [0078] FIGS. 11A-11C show one embodiment of a connection part 3. FIG. 11A show the embodiment of the connection part 3 in an exploded view where the internal holding parts 61 for a tube 60 providing a fluid path is shown. FIG. 11B shows a cut through the internal holding part 61 according to which it is possible to the position of the tube 60. FIG. 11C shows an enlargement of the encircled part of FIG. 11A.

    [0079] According to the present embodiment the connection part 3 and the surface plate 1 is molded in one piece of a plastic material, the connection part is provided with several openings, one opening is the cavity 12A which is prepared for fitting in the cannula part 7 and another opening is prepared for fitting in the internal parts of the connection part 3. The internal parts of the connection part 3 according to this embodiment comprises one tube which at two positions are bent in 90° i.e. both the inlet and the outlet end of the tube 60 points in the same direction perpendicular to the connecting part of the tube 60 where the connecting part of the tube 60 forms the fluid path between the two bending parts.

    [0080] At one end the tube 60 is protected by a bubble shaped membrane 17 and at the other end the tube 60 is open and unprotected, but the open tube end is surrounded by a sealing 18 which is attached unreleasably to a holding part 61. When the internal parts have been placed in the corresponding opening in the connection part 3 a cover 62 accurately fitting in the opening is placed in level with the surface of the connection part 3 in such a way that the user experience a smooth surface which cannot be tampered with.

    [0081] The embodiment of the base part shown in FIG. 11A is provided with guiding means 26 placed inside the cavity 12A of the connection part 3. The two opposing ribs 26 which constitute the guiding means correspond to closely fitting openings 27 in the cannula part 7. The guiding means 26 and the corresponding parts 27 on the cannula part can have other forms, the important feature is that they correspond to each other and make it possible for the cannula part 7 to slide into use position.

    [0082] FIG. 11B shows an enlargement of the internal parts of the connection part 3. The holding parts 61 comprise a single molded part which is providing a stable embedment of the tube 60. The open end of the tube 60 opens into a space surrounded by the sealing 18. The closed end of the tube 60 is completely surrounded by a soft membrane. “Completely surrounded” means that the there is no free access to the surroundings, “soft membrane” means that the membrane can be penetrated by a needle, especially the connector needle 19 which is provided by the end of the tube 60 and which is embedded inside the soft membrane. The end of the tube 60 which constitutes the connector needle 19 is in this embodiment not actually in touch with the surrounding membrane 17. The connector needle 19 is surrounded by air, and the internal space surrounding the connector needle 19 has a cylindrical or conical shape i.e. a circular cross-section. The walls of the membrane 17 will deform by bending inwards or outwards when the length of the membrane is reduced as a result of the applied pressure.

    [0083] FIG. 11C shows an enlargement of the enclosed field marked in FIG. 11A.

    [0084] FIG. 12 shows an embodiment of an infusion part where the angle d=90°. The inlet/outlet opening 12 is constructed as a pointy end of a tube 60 which provide for the fluid path or connection between the reservoir 6 and the cannula part 7. A membrane e.g., self-closing protects the entrance to the reservoir 6 which means that microorganisms cannot access the reservoir 6 when the reservoir is removed from the connection part 3.

    [0085] FIG. 13 shows yet an embodiment of a cannula part 7 which can be used with an infusion part according to claim 1. The body 24 of the cannula part 7 has the shape or profile of a truncated cone i.e., in each horizontal (according to FIG. 13) cross-section of the body it is round having varying diameters. The body 24 is provided with two permanently attached circular sealings or gaskets 18. Between these two gaskets 18 is the opening 20 positioned which opening 20 allows for fluid to enter the inner through going opening of the cannula part 7. The cannula part 7 is to be placed in a below illustrated connection part 3 provided with a corresponding cavity 12A also having the shape of a truncated cone. The cavity 12A has an inlet/outlet opening 12 for fluid flowing to or from the cannula 22.