Field of the invention The invention relates to connector devices for fluidly connecting different units of an ambulatory infusion pump system, and connector parts of such connector devices, according to the preamble of the independent claims.

Background of the invention Infusion pumps are used for parenterally providing patients with liquid medicaments over longer time periods. Nowadays, infusion pumps with very small dimensions are available that can be carried by the patient on the body. Such small-sized ambulatory infusion pumps are particularly useful for metering small doses of highly effective liquid medicaments, such as insulin for the treatment of diabetes, or analgesics for pain therapy, which are conveyed through a cannula into the tissue of a patient. The treatment of diabetes for example comprises the repeated metering of small doses in the range of nanoliters.

In one approach, an infusion pump, carried somewhere on the body, e.g. attached to a belt, is fluidly connected via flexible tubing to an infusion site interface, also called insertion head, that is attached to the body of the patient. The infusion site interface comprises a cannula unit with a cannula to be inserted into the body tissue, a housing to which the cannula is mounted, and connector means for f luidly connecting the cannula with the flexible tubing connected to the upstream infusion pump. The tubing can be repeatedly connected and disconnected from the infusion site interface. The connector means may for example comprise a septum sealingly closing the fluid system of cannula and housing. The septum can be penetrated by a hollow connector needle, for reversibly establishing a fluid connection. The cannula can be realized as a rigid or semi-rigid cannula with a pointed end that is stiff enough for being inserted into the body tissue on its own, similar to an injection needle. Alternatively, the cannula may be made of a flexible material. Such flexible cannulas are more comfortable during use. Since flexible cannulas cannot be inserted directly into the tissue, an additional piercing device, e.g. in the form of a rigid piercing needle made from metal, is arranged inside the flexible cannula. A pointed end of the piercing device protrudes from the proximal end of the cannula, the cannula that will be open toward the interstitial fluid. After inserting the piercing device and the stabilized cannula into the body tissue, the piercing device is removed from the cannula. The cannula is now flexible, and remains in the body tissue. Generally, a piercing needle is arranged in such a way that it penetrates a septum, which after withdrawal of the piercing needle sealingly closes the distal end of the now open cannula fluid path. Examples of such infusion site interfaces and insertion heads are shown in WO 02/07804 A1 , US 2008/02881 44 A1 , and US 201 2/296290 A1 , the disclosure of which is hereby included by reference in their entirety In another approach, the infusion pump device is directly fluidly connected with the infusion site interface (so called patch pumps). Examples of such embodiments are shown in WO 2007/056504 A1 , the disclosure of which is hereby included by reference in its entirety. The infusion site interface may comprise a base plate adhesively connected to the body surface of the patient. The infusion pump unit is then mounted the base plate, for example with a suitable locking mechanism. The fluid connection between infusion pump and cannula is established by a hollow connector needle of the pump, reversibly penetrating a septum of the cannula unit that sealingly closes the distal end of the cannula fluid path. Advantageously, the pump can be repeatedly connected and disconnected from the infusion site interface. For example may a pump unit be replaced by another pump unit, using the same infusion site interface, or the same pump unit may be used with a further infusion site interface mounted at another location of the patient's body.

Figure 1 schematically shows a cannula unit of an infusion site interface as it is known from the prior art. The cannula unit comprises a housing body 2, made from a suitable thermoplastic polymer material. In an infusion site interface, the housing body will be suitably mounted on the rest of the interface, e.g. on a base plate (not shown) .

The housing body 2 is provided with a passageway along a longitudinal axis of the body, connecting two opposite ends of the body. On one end, a pierceable septum 3 is arranged in a corresponding septum seat 3a, thereby sealingly closing this end of the passageway. On the opposite end, a distal end of an infusion cannula 7 is embedded in the housing body 2. The passageway between septum 3 and cannula 7 defines a conical fluid chamber 4 and a fluid conduit 5. A hollow connector needle 6 of an infusion pump, or of an infusion tubing connected to an infusion pump, penetrates septum 3. A flow path between the infusion pump (not shown) and the proximal end of the infusion cannula (not shown) is established, via needle conduit 6a, fluid chamber 4, fluid conduit 5, and cannula conduit 7a, through which during operation liquid medicament is conveyed, as symbolically indicated by dashed arrows.

Such a cannula unit is particularly useful in combination with flexible cannulas, since for insertion of the cannula into the tissue of a patient, a piercing needle can be arranged in the cannula, with a pointed end protruding from the distal end of the cannula, and a distal end penetrating the septum 3. After insertion, the piercing needle is withdrawn from the cannula. The flow path is then f luidly connected to the tissue of the patient, while the septum sealingly separates the fluid chamber from the environment, thereby keeping the inner volume of the cannula unit sterile. The septum can now be used for establishing a fluid connection with an infusion pump, by penetrating the septum with a hollow connector needle 6 shown in Figure 1 .

In alternative embodiments, separate septums may be used for sealing the flow path after withdrawal of the piercing needle, and for connecting the infusion site interface to the infusion pump. A dedicated connector septum may for example be arranged in a lateral wall of the body in such a way that the connector needle penetrates the connector septum perpendicular to the longitudinal axis defined by the cannula. Similar infusion site interfaces are shown in Figure 1 D of US 201 2/0296290 A1 . If such a variant is combined with a rigid infusion cannula, without the need for a piercing needle, a septum for the piercing needle may be dispensed with.

In prior art cannula units as discussed above, a fluid chamber 4 with a diameter larger than the fluid conduit 5 and the subsequent cannula conduit 7a is needed, for preventing a pointed end 6b of a connector needle 6 accidentally cutting into the inner volume wall of the body 2, which can produce chips of polymer material that may occlude the cannula passageway, or may be conveyed into the tissue of the patient, which is both not acceptable. Furthermore, a collision of the needle 6 and the inner wall of the body 3 may distort the connector needle, which can cause leakage of the septum 3.

While a conical fluid chamber 4 as shown in Figure 1 in combination with suitable guiding of the movement of the connector needle can solve the above-mentioned problem, it inevitably comprises a considerable volume that is not accessible, and though which no liquid is conveyed. Several microliters of air may be trapped 8 in such a dead volume. Large volumes in an infusion pump fluid system are detrimental for the precision of repeated metering of doses in the nanoliter range, because gases are very elastic compared to liquids. Larger air volumes may further hinder timely detection of occlusions, since the trapped air can be considerably compressed before system pressure increases above a certain warning threshold. Furthermore, temperature changes also lead to a considerable change of the volume of trapped gas, which may cause unwanted dosing of liquid medicament, or sucking of body fluid back into the cannula, which both may cause metering errors.

Thus, infusion site interfaces applying a septum for establishing a fluid connection to the infusion pump will inevitably limit the achievable precision of metering to a certain limit, although the infusion pump may actually be far more precise.

A further disadvantage of using a pierceable septum and a hollow needle for coupling two fluid systems is the restricted number of coupling/decoupling steps that can be carried out. Each time a hollow coupling needle pierces a septum, the polymer matrix of the elastic septum material is cut. After a while, the elastic material of the septum may be damaged to such an extent that it cannot properly close any longer the bores produced by the needle. The septum starts to leak. In addition, after too may piercing steps, the hollow needle may even cut out particles of the septum material, which may cause occlusions, or which may be conveyed into the tissue of the patient. There is an ongoing need for improvement in the field of connectors for releasably connecting infusion site interfaces with infusion pumps, or with flexible tubing connected to an infusion pump. Objectives of the Invention

It is an overall objective of this invention to provide advantageous connector devices for connecting components of an ambulatory infusion pump system that overcome one or more of the above-mentioned and other problems. Another object of the invention is to provide advantageous connector parts for such connector devices.

Such connector devices should have a reduced trapped air volume. If possible the overall dead volume should also be reduced. Furthermore, the connector device should be able to reliably establish a connection and release the connection for a large number of cycles without decrease of the functionality, particular without the risk of leakages or other functional failures.

Such connector devices and connector parts should be reliable, and cost efficient in large scale manufacture.

A further object of the invention is to provide ambulatory infusion pump devices and components of ambulatory infusion pump devices that comprise such connector devices and/or connector parts.

These and other objects are substantially achieved through the features of the independent claims. In addition, further advantageous embodiments follow from the dependent claims and the description. Summary of the invention

The present invention may comprise one or more of the features recited in the attached claims, and/or one or more of the following features and combinations thereof.

A first connector part according to the invention for establishing a fluid connection with a second connector part according to the invention, as described further below, comprises a valve with a valve seat, a valve member, and a resilient element. The valve seat comprises a valve chamber, and a circular opening with a circumferential sealing lip. The valve member is provided in the valve chamber, and is able to sealingly close the circular opening of the valve seat when being pushed against the circular opening. The resilient element sub- jects the valve member to a bias force pushing the valve member against the circular opening of the valve seat. The valve member further comprises a circumferential wall around the circular opening, located on the side of the circular opening opposite to the valve chamber. The circumferential wall forms a concave receptacle for receiving a corresponding connection cone of a second connector part, the concave receptacle having the shape of a truncated cone and facing away from the valve chamber, the circular opening being located in the centre of the concave receptacle.

Advantageously, the valve seat is made of an elastomeric polymer.

In an advantageous embodiment of such a first connector part according the invention, the valve member is a valve ball. Advantageously, in the first connector part the resilient element is an elastic structure made of an elastomeric polymer, or is a helical spring. The first connector part according to the invention advantageously further comprises an infusion cannula fluidly connected to the valve chamber. In such an embodiment, it is particularly advantageous when the first connector part further comprises a septum arranged at a distal end of the infusion cannula. Even more advantageously, such a first connector part further comprises a piercing needle for temporarily stiffening the infusion cannula, arranged inside the infusion cannula and penetrating the septum. Advantageously, the valve member and the septum are one single piece.

A second connector part according to the invention for establishing a fluid connection with a first connector part according to the invention, as described further above, comprises a right circular truncated cone for being received in a corresponding concave receptacle of a first connector part; a recess at the tip of the truncated cone for actuating a valve member of a first connector part; and a fluid feed conduit. The fluid feed conduit has one or more outlets opening at least partially toward the shell surface of the cone.

In an advantageous embodiment of a second connector part according to the invention, the surface of the recess has the shape of an inverted cone, or forms a section of a hollow sphere.

Alternatively or in addition, the fluid feed conduit has an outlet located on the recess, and one or more notches extending from the outlet across the recess surface to the shell surface of the cone.

In an even more advantageous embodiment of a second connector part according to the invention, the surface of the recess comprises two or more separated areas.

A connector device according to the invention comprises a first connector part according to the invention, and a second connector part according to the invention. Advantageously, a connector device according to the invention further comprises means for pressing together with a certain force the first connector part and the second connector part.

Alternatively, or in addition, an advantageous embodiment of a connector device according to the invention further comprises means for aligning and/or orienting the first connector part and the second connector part in relation to each other.

Alternatively, or in addition, an advantageous embodiment of a connector device according to the invention further comprises means for releasably fixating the first connector part and the second connector part in a certain defined position relative to each other.

In an advantageous embodiment of such a connector device according to the invention, with the truncated cone of the concave receptacle of the first connector part having a first cone angle a in regard to a longitudinal axis of the cone, and with the right circular truncated cone of the second connector part having a second cone angle β in regard to a longitudinal axis of the cone, the first cone angle a is larger or equal the second cone angle β, and the difference between first cone angle a and second cone angle β is smaller or equal about 20°, advantageously smaller or equal about 1 5°, and more advantageously lies between about 5° and about 1 5°.

An ambulatory infusion pump unit according to the invention comprises a second connector part according to the invention, or a first connector part according to the invention.

An infusion site interface according to the invention comprises a first connector part according to the invention, or a second connector part according to the invention. An ambulatory infusion pump unit with a second connector part according to the invention can then be coupled with an infusion site interface with a first connector part according to the invention. An ambulatory infusion pump unit with a first connector part according to the invention can be coupled with an infusion site interface with a second connector part according to the invention.

An infusion tubing according to the invention for use with an ambulatory infusion pump comprises a first connector part according to the invention, and/or a second connector part according to the invention.

Said infusion tubing according to the invention can then be coupled with an infusion site interface according to the invention, and/or an ambulatory infusion pump unit according to the invention.

An ambulatory infusion pump system according to the invention comprises a connector device according to the invention.

An adapter according to the invention comprises a hollow connector needle, a fluid transfer conduit fluidly connected to the hollow transfer needle, and a first connector part according to the invention, or a second connector part according to the invention, wherein the fluid transfer conduit is fluidly connected to the fluid system of the first connector part or second connector part.

Another adapter according to the invention comprises a connector septum, a fluid chamber sealingly closed by the connector septum, a fluid transfer conduit fluidly connected to the fluid chamber, and a first connector part according to the invention, or a second connector part according to the invention, wherein the fluid transfer conduit is fluidly connected to the fluid system of the first connector part or second connector part. The above-mentioned adapters according to the invention allow to connect elements and devices such as ambulatory infusion pump units, infusion site interfaces, and infusion tubing equipped with prior art connector parts such as hollow connector needles, and/or sep- tums to be penetrated by said hollow connector needles to be operationally interconnected with ambulatory infusion pump units, infusion site interfaces, or infusion tubing equipped with first connector parts according to the invention and/or second connector parts according to the invention.

Brief description of the drawings In order to facilitate a fuller understanding of the present invention, reference is now made to the appended drawings. These references should not be construed as limiting the present invention, but are intended to be exemplary only.

Figure 1 schematically shows a longitudinal section of a cannula unit according to the prior art as discussed further above. Figure 2 schematically shows a longitudinal section of an embodiment of a connector device according to the disclosure, with (a) the female connector part of the connector device, the valve being closed; (b) the male connector part of the connector device approaching the female connector part during the connecting step; (c) the two connector parts in the connected stated, the valve being open; (d) the flow path of liquid medicament conveyed by an infusion pump through the connector device, shown by arrows; and (e) a perspective view of the female connector part. Figure 3 schematically shows in a perspective view and partial cross section a patch pump system according to the disclosure, comprising an infusion pump unit, an infusion site interface, and the connector device of Figure 2 for connecting the fluid system of the infusion pump unit to the cannula of the infusion site interface; (a) in the uncoupled state, and (b) in the coupled state.

Figure 4 schematically shows the patch pump system of Figure 3 in a perspective view, with (a) the infusion site interface mounted on the body surface, after insertion of the stiffened infusion cannula into the body tissue; (b) after removal of the piercing needle, the infusion site interface now being operative; (c) the infusion pump unit in a partial bottom view; and (d) the infusion pump unit just before being coupled to the infusion site interface.

Figure 5 schematically shows different advantageous embodiments of female connector parts of connector devices according to the disclosure, in a bottom view; (a) with an arrangement of notches and fluid feed conduit similar to the embodiment of Figure 2; and (b) to (f) with alternative arrangements of notches and fluid feed conduit.

Figure 5 schematically shows a longitudinal section of two further advantageous embodiments of male connector parts of connector devices according to the disclosure. Detailed description of the invention

The examples provided hereinafter serve as an improved illustration of the present invention, but are not suited for restricting the invention to the features disclosed herein. Components that are identical, or that are identical at least in terms of their function, are des- ignated below by identical or at least comparable reference numbers, e.g. 2, 1 02, 302, 402.

An advantageous embodiment of a connector device according to the invention is disclosed in Figures 2 (a) - (e) . The connector device comprises a first, female connector part 1 1 0 and a second, male connector part 1 50. In the unconnected state, the fluid system of the separate female connector part 1 1 0 is sealed against the environment. When the two connector parts are aligned and are pressed onto each other with a certain force, they establish a fluid connection between their respective fluid systems, while the fluid system remains sealed against environment.

The first, female connector part 1 1 0 of a connector device 1 70 is shown alone, before the removal of the piercing needle 1 09, in Figure 2 (a) . The first connector part 1 1 0 comprises a housing body 1 02, in the given example protruding from a base plate 1 01 of an infusion site interface. The housing body 1 02 is limited by perpendicular walls 1 1 9, and has an outer shape (not shown) that is not rotationally symmetric, in order to ensure proper alignment with a second connector part 1 50, as will be discussed further below. In the housing body 1 02, a flexible infusion cannula 1 07 is mounted, with a first, distal end being fixed to the body. A middle section and a second, proximal end protrude from an underside of the base plate 1 01 opposite to the first connector part 1 1 0. A cannula chamber 1 04 is defined by the volume between distal end of cannula 1 07 and septum 1 03 , upstream of the inner conduit of the cannula 1 07. A piercing needle 1 09 is arranged inside the cannula 1 07, with a pointed end (not shown) protruding from the proximal end of the cannula. The piercing needle 1 09 further penetrates a septum 1 03 for sealing the fluid system after removal of the piercing needle from the infusion cannula. With the piercing needle 1 09 inserted in the flexible cannula 1 07, cannula and needle can be inserted into the tissue of the patient.

The actual connector part 1 1 0 comprises a concave connection cone 1 1 8 and a valve 1 1 1 . The connection cone 1 1 8 is intended to be pressed against a corresponding connection cone 1 5 1 of a second connector part 1 50, thereby establishing a sealed connection. As long as no connection with a second connector part is established, the connector valve 1 1 1 sealingly closes the fluid system of the first connector part against environment. The valve 1 1 1 comprises a valve seat 1 1 2 with a circumferential sealing lip 1 1 4, and a valve member 1 1 3 having the shape of a ball. The ball member is mounted on a resilient element 1 1 5, which presses with a certain bias force the valve member ball 1 1 3 against the circumfer- ential sealing lip 1 14, thereby sealingly closing the valve. The valve seat 1 1 2, the valve member 1 1 3 and the resilient element 1 1 5 define an inner volume of the valve, the valve chamber 1 1 6. A narrow transfer conduit 1 1 7 connects the valve chamber 1 1 6 with the cannula chamber 1 04 upstream of the inner conduit of the cannula 1 07. The shown embodiment has a dead volume that is very small compared to a prior art cannula unit, as for example shown in Figure 1 . No voluminous cannula chamber is needed to prevent damages by connector needles. Furthermore essentially the complete fluid system is in the flow path of the liquid medicament, such that no air bubbles can accumulate and the amount of trapped air is minimal.

Housing body 1 02 and base plate 1 01 are made from a suitable rigid polymer material, for example a thermoplastic polymer such as polypropylene. The valve member 1 1 2 and the connection cone 1 1 8, as well as the septum 1 03 are realized as one single element, made from a suitable elastomeric polymer material, for example rubber, silicone elastomers, thermoplastic elastomers, and the like. The spherical valve member 1 1 3 is made from a rigid, hard material such as for example hard, non-elastic polymers, steel, glass, ceramics etc, and advantageously has a smooth surface. The resilient element 1 1 5 is made from a suitable elastomeric polymer material, similar as discussed above for the valve seat 1 1 2, connection cone 1 1 8, and septum 1 03. The elastic material should be able to provide the necessary bias force of the valve member 1 1 3 against sealing lip 1 1 4. All materials that come into contact with liquid medicament or body tissue must be acceptable for that pur- pose. A skilled person knows which materials are suitable for the intended function of the various elements.

For manufacturing the first connector part 1 1 0, the various elements 1 02, 1 1 2/1 1 8/1 03, 1 1 5, 1 07, 1 09 may be assembled in different order, depending on the specific manufacturing method. In one possible approach, for example, a piercing needle 1 09 threaded on the cannula 1 07 is provided, and is partially embedded in the polymer matrix of the housing body 1 02 and the base plate 1 01 during the manufacture of housing body and base plate, using suitable injection moulding tooling. A resilient element 1 1 5 is mounted on the base plate, or is produced together with the housing body/base plate using two-component injection moulding techniques. Then the valve ball 1 1 3 is placed on the resilient ele- ment 1 1 5. A single component including valve seat, connection cone and septum, is produced e.g. by injection moulding, and is finally inserted in a corresponding seat 1 25 in the form of a cavity in the housing body 1 02. During this insertion step, advantageously the distal end of the piercing needle penetrates the septum, arriving at the connector part shown in Figure 2 (a ) . In a further step, the distal end of the piercing needle may be equipped with a handle for easing removal of the needle. The second, male connector part 1 50 of the connector device 1 70 in the unconnected state can be seen in Figu res 2 (b) and (e), as well as in Figure 5 (a). A connection cone 1 51 is arranged at the bottom of a cavity 1 57 with perpendicular walls 1 55. A spherically shaped recess 1 53 is located in the centre of the cone 1 51 . The radius of the spherical recess 1 53 is essentially identical to the radius of the valve member 1 1 3 , since it has the purpose of keeping the valve member ball aligned when the valve is opened, as will be explained further below. In the centre of the recess, a fluid feed conduit 1 52 opens toward the outside. The fluid feed conduit 1 52 is connected to the fluid system downstream of an infusion pump, or to an infusion tubing. Two notches 1 54 extending radially from the fluid conduit outlet 1 58 are provided. The depth of the notches 1 54 is chosen such that they extend into a central zone of the cone surface around the spherical recess 1 53, but not into an outer zone of the cone surface that will come into contact with the surface counter cone 1 1 8 of a first connector part for establishing. In Figure 5 (a ), these two zones are schematically made visible by a dashed circle defining the inner zone and the outer zone of the cone surface.

The second connector part 1 50 is preferably made of a rigid, hard polymer material, such as for example a suitable thermoplastic polymer. Other hard materials such as metal, glass or ceramic material would also be possible, although more expensive and more difficult to manufacture. A connector device advantageously comprises primary guiding structures that ensure proper orientation and alignment of the two connector parts. In the given embodiment, such primary guiding structures are provided in the form of interacting guiding elements 1 1 9, 1 55. The guiding element 1 1 9 of the first connector part 1 1 0 is realized as an outer wall 1 1 9 of the housing body 1 02, extending perpendicularly from the base plate 1 01 . The guiding element 1 55 of the second connector part 1 50 is realized as an inner wall 1 55 of a cavity 1 57, extending perpendicularly from the bottom of the cavity, at the bottom of which the connector components are arranged (cf. Figure 2 (e) ). The two guiding walls 1 1 9, 1 55 are shaped in such a way that proper orientation of the two connector parts 1 1 0, 1 50 is given during the connecting process. In other words, the two connector parts can only be assembled in one, correct orientation. In the given example, a rotationally non- symmetric, egg-shaped form of the walls 1 55 of the cavity 1 57 and the outer walls 1 1 9 of the housing body 1 02 allows a coupling only with the two connector parts 1 1 0, 1 50 properly aligned to a coupling axis 1 61 , in one specific rotational arrangement of the two connector parts 1 1 0, 1 50. The situation during the connection process is shown in Figure 2 (b) , just before the connection of the two connector parts 1 1 0, 1 50 of the disclosed connector device 1 70 is established. The infusion cannula has been inserted into the body tissue 1 91 of a patient, and the base plate 1 01 of the infusion site interface has been attached to the body surface. The piercing needle has been removed. The two connector parts 1 1 0, 1 50 are properly aligned along axis 1 71 and correctly oriented to each other. The outer guiding wall 1 1 9 has been inserted into the corresponding cavity 1 57 with inner guiding walls 1 55. During the connection movement of the two connector parts 1 1 0, 1 50, symbolized by an arrow, the guiding walls 1 1 9, 1 55 glide along each other along coupling axis 1 71 .

Figure 2 (c) shows the connector device 1 70 with established connection between the two connector parts 1 1 0, 1 50. The connection cone 1 51 is pressed with a certain force into the concave connection cone 1 1 8. Since the concave connection cone 1 1 8 is made of an elastomeric polymer material, while the connection cone 1 55 is made of a hard, inelastic material, the elastic, resilient cone 1 1 8 will be deformed in the zone the two cones come into contact, thereby establishing a reliable fluidly sealed connection between the first and the second connector part. Advantageously, the inclination angle of the connection cone 1 55 in regard to its longitudinal axis is chosen slightly larger than the corresponding inclination angle of its counter cone 1 1 8, which results in a circumferential contact zone between the two cones extending from the centre axis 1 71 radially outwards, with the highest contact pressure close to the centre axis. Such an embodiment prevents air being present between the surfaces of the two contacting cones of being pressed into the fluid system. The air is safely squeezed outwards toward atmosphere.

During the coupling process, just before the two connection cones 1 1 8, 1 51 start to touch, the spherical recess 1 53 will touch down on the ball valve member 1 1 3. During the remaining forward movement of the cone 1 51 , during which the cones start to abut to each other and cone 1 18 is slightly compressed in the contact zone, the valve member 1 1 3 will be pushed downwards toward the base plate, against the bias force of resilient element 1 1 5 (shown as dashed arrow). As a result, the valve member ball 1 1 3 no longer abuts the sealing lip 1 14, and the connector valve 1 1 1 is open. Thus, in the disclosed embodiment of a connector device, the connection cone 1 51 of the second connector device 1 50 acts as an actuator for the valve member 1 1 3 of valve 1 1 1 of the first connector device 1 1 0. Since both cone 1 51 /spherical recess 1 53 and valve member 1 1 3 consist of a hard, inelastic material, while cone 1 1 8 is resilient, the movement of the valve member 1 1 3 by cone 1 51 is precise.

For being properly connected and operative, the two connector parts of a connector device as discussed above, particularly their respective connection cones 1 51 and 1 1 8, need to be brought into and hold in a certain, defined position in regard to each other. In this position, a sealingly tight connection between the two cones is achieved, and the valve is kept open by holding the valve ball in its open position against the closing bias force of the re- silient element. The correct positioning of the two connector parts can be achieved by suitable guiding and locking means that correctly align the two connector parts and keep them in a certain distance to each other. Such guiding and locking means may be provided directly in the connecting device, or may be provided in a higher-level system, for example by the means for locking a patch infusion pump on an infusion site interface. Corresponding technologies are well known to a skilled person, e.g. releasable clamp mechanisms, bayonet couplings, etc.

Liquid medicament can now be conveyed downstream from the infusion pump into the infusion cannula toward the body tissue 1 91 of the patient, as schematically shown as ar- rows in Figure 2(d ). Liquid flows downstream through fluid feed conduit 1 52, toward the outlet 1 58 of the conduit. Since the outlet 1 58 is blocked by valve ball 1 1 3, the fluid flows through two conduits between spherical recess 1 53 and valve member 1 1 3, provided by the two notches 1 54, into the now accessible valve chamber 1 1 5. In the valve chamber 1 1 5, the liquid flows between valve seat 1 1 2 and valve member 1 1 3 downward, around the resilient element 1 1 5, through the transfer conduit 1 1 7 into the cannula chamber 1 04. From the cannula chamber, the liquid finally flows through cannula conduit 1 07a towards the proximal end of the cannula, into the tissue 1 91 of the patient.

For releasing the connection between the two connector parts 1 1 0, 1 50, the connecting process is reversed. When the second connector part 1 50 is moved upwards, away from the first connector part, the valve member ball 1 1 3 will also move upwards, driven by the biasing force of the resilient element 1 1 5, until it reaches the sealing lip 1 14 of the valve member 1 1 2. The valve 1 1 1 is now sealingly closed again, protecting the fluid system against environment. During the closing movement of the valve member, the compressed elastic cone 1 1 8 expands, but keeping its cone surface abut the cone surface of cone 1 5 . A further upward movement of second part 1 50 separates the two cones. The two connector parts are decoupled.

The shown embodiment of a connector device can be used as an advantageous alternative to known septum/needle connector devices, and may be applied for infusion site inter- faces intended for being connected to infusion tubing connector, as well as for being directly coupled to an infusion patch pump unit. Figures 3 and 4 shows such a patch pump system, using the connector device of Figure 2.

The patch pump system comprises an infusion pump unit 1 60 and a corresponding infusion site interface 1 61 . The infusion site interface 1 61 comprises a base plate 1 01 , which is attachable with its flat underside to a body surface of a patient, e.g. in the region of an upper arm, a thigh, or the abdomen. Suitable attaching methods are known from the prior art, for example using adhesive layers provided on the underside of the base plate. The infusion site interface further comprises a first connector part 1 1 0, like the one disclosed in Figure 2 , a cannula 1 07, and a piercing needle 1 09 ( not shown in Figure 3 ). The infusion pump unit 1 60 comprises a second connector part 1 50 located in cavity 1 57, similar to the one disclosed in Figure 2. Since portable infusion pumps that can be integrated in a patch pump 1 60 are known from the prior art, no details are shown regarding the pump system upstream of fluid feed conduit 1 52. The infusion pump unit 1 60 can be releasably mounted to the upper side of the infusion site interface 1 61 , with suitable locking means. Locking means that can be used for such a purpose, e.g. releasable catch lock mechanisms or the like, are known to the skilled person and are not shown in detail. The locking means, in addition to securely mounting the infusion pump unit to the base plate of the infusion site interface, have two additional purposes. On one hand the locking means act as secondary guiding elements for the connector device, which ensure a correct orientation of the two connector parts before the guiding walls 1 1 9, 1 55 as the primary guiding elements abut each other and ensure a precise alignment during the connection step. On the other hand, the locking means will hold the infusion pump unit and the infusion site interface tightly fixed to each other, thereby constantly holding the pressing force on the two connector parts.

For setting the patch pump system in operation, in a first step shown in Figure 4(a ) , the infusion site interface 1 61 is placed on the body surface of the patient. In the shown embodiment, the temporarily stiffened infusion cannula 1 07 is inserted into the tissue during manually placing the base plate 1 01 on the body. So called inserter devices are known that allow in a first step attaching a base plate on the body, and in a second step automatically inserting a stiffened cannula into the body tissue, fixedly attaching a cannula hub to the base plate, and subsequently withdrawing the piercing needle. Such technologies can also be applied for connector devices as disclosed. In such a case, a hub comprising the housing body with the cannula and the first connector device would be fixedly attached to the base plate after insertion of the temporarily stiffened cannula.

In the shown embodiment, however, the piercing needle 1 09 is removed manually, and one arrives at the now operative infusion site interface 1 61 in Figure 4(b). The infusion pump device 1 60 is prepared for being attached to the infusion site interface 1 61 ( Figure 4(c) ), and is mounted to the base plate ( Figure 4(d ) ) .

As has been shown, in order to establish a fluid connection between the fluid feed conduit of a second connector part and the fluid system of a first connector part, the liquid has to pass the abutting spherical recess and valve member ball. In the embodiment of a connector device as discussed above, this has been achieved by two notches extending from the feed conduit outlet in the centre of the spherical recess to the inner zone of the cone that is not in contact with the cone of the first connector part. Such an arrangement is also shown in Figure 5 (a ) .

Figures 5(b) to (f) show further, alternative arrangements of the various elements on the connecting cone of a second connector. Dotted circles mark the borderline between the outer zone of the cone 251 , which contacts the counter cone of the other connector part, and the inner zone, which faces toward the valve chamber once the valve is opened. Figure 5 (b) shows an alternative embodiment where only one notch 254 extends from the outlet 258, thus representing a minimum variant. Figure 5 (c) shows a further embodiment, with three notches 254, providing an increased flow cross section. Similarly, the amount of notches can be further increased, and/or the geometry of the notches can be changed to more complex forms. Essentially, the area of the spherical recess may be reduced to a very minimum as long as it allows a precise and reliable actuation of the valve member. An embodiment with strongly reduced spherical recess area is depicted in Figure 5 (d ) . The notches have been extended to a circular plane 254d perpendicular to the coupling axis, into which the outlet 258 opens. The spherical recess has been reduced to four segment shaped protrusions extending from the plane 254d, having a front face 253d that repre- sents a section of the same spherical shape. In such an embodiment, a valve ball of a first connector part will only be in contact with the front faces 253d of the three protrusions, while the liquid can flow through the free volume between the circular plane 254d and the valve ball surface.

A further embodiment of a connector cone, which does not make use of notches, is shown in Figure 5 (e) . The fluid feed conduit and its outlet 258e have an oblong cross-section, which extends from the centre of the spherical recess 253 into the inner zone of the cone 251 . As a result, the two outer areas of the outlet 258e that are not within the circular area of the spherical recess 253 open directly toward the valve chamber, once the valve is open. A similar approach is applied in the embodiment disclosed in Figure 5 (f) . The fluid feed channel and its outlet 258f are not aligned to the coupling axis, but are located off-centre. At least a part of the outlet cross-section lies in the inner zone of the cone surface of cone 251 . This area of the outlet 258f directly opens toward the valve chamber, once the valve is open.

Further embodiments of a first connector part of a connector device are shown in Figure 6. The functional principle of the first connector parts 31 0, 41 0 is essentially the same as for the first connector part shown in Figure 2.

The embodiment 3 1 0 as shown in Figure 6(a) differs from the previously discussed first connector part in that the bias force pressing the valve member 3 1 3 against sealing lip 31 8 of valve seat 3 2 is generated with a helical spring 31 5. Furthermore, valve member 31 2 with connection cone 31 8 does not include a septum for the piercing needle. The septum (not shown) is either realized as a separate element, or is dispensed with, for example when rigid cannulas are used.

In the embodiment of a first connector part 41 0 as shown in Figure 6(b) , the ball shaped valve member has been replaced by an essentially cylindrical valve member 41 3. One end of this cylinder is arranged inside the helical spring 41 5, thereby ensuring the alignment of valve member 41 3 and spring 41 5, and reducing the volume of the valve chamber. Another end of the valve member, facing toward the sealing lips 41 4 of the valve member 41 2, is realized as a half sphere. The helical spring 41 5 is supported on a circumferential edge of the cylinder. In the embodiments discussed so far, the fluid feed conduit of the second connector part has opened in an outlet that is the connected state is at least partially blocked by the valve member of the first connector part. Such components can be efficiently produced, e.g. with injection moulding techniques. However, principally it would also be possible to dispense with the outlet, and to provide a fluid connection between a fluid feed conduit in the form of a blind hole and the inner zone of the cone surface with one or more dedicated conduits branching off from the fluid feed conduits.

The present invention is not to be limited in scope by the specific embodiments described herein, indeed, various modifications of the present invention, in addition to those de- scribed herein, will be apparent to those skilled in the art from the foregoing description and accompanying drawings. Thus, such modifications are intended to fall within the scope of the appended claims. Additionally, various references are cited throughout the specification, the disclosures of which are each incorporated herein by reference in their entirety.

List of Reference Numerals

2 housing body

3 connector septum

3a septum seat

4 fluid chamber

5 fluid conduit

6 connector needle

6a needle conduit

6b pointed end of needle

7 infusion cannula

7a cannula conduit

8 trapped air

10 first connector part

50 second connector part

70 connector device

100 insertion head

101 base plate

102 housing body

103 septum

104 cannula chamber

107 infusion cannula

109 piercing needle

110 first connector part, female connector part

111 connector valve

112 valve seat

113 valve member, valve ball

114 sealing lip

115 resilient element

116 valve chamber

117 fluid transfer conduit

118 concave connection cone guiding element, guiding wall

cavity for valve seat and septum

second connector part, male connector part connection cone

fluid feed conduit

spherical recess

notch

guiding element, guiding wall

cavity

outlet of fluid feed conduit

infusion pump unit

infusion site interface

connector device

coupling axis

body surface

body tissue

second connector part

connection cone

spherical recess

d spherical front face of a protrusione spherical recess

f spherical recess

notch

d circular plane

outlet of fluid feed conduit

e outlet of fluid feed conduit

f outlet of fluid feed conduit

housing body

first connector part

valve

valve seat

valve member, ball 314 sealing lip

315 spring element

316 valve chamber

317 fluid transfer conduit

318 concave connection cone

402 housing body

410 first connector part

411 valve

412 valve seat

413 valve member

414 sealing lip

415 spring element

416 valve chamber

417 fluid transfer conduit

418 concave connection cone