In the following the invention will be described in further details with reference to the figures.
FIG. 1 shows one embodiment of an infusion set where the infusion part and the connector are unified.
FIG. 2 shows one embodiment of the infusion set where the infusion part and the connector are separated.
FIG. 3 shows the same embodiment of the separated infusion set as in FIG. 2 from a different angle.
FIG. 4 shows a second embodiment of a separated infusion set from a first angle.
FIG. 5 shows the second embodiment of the infusion set from a different angle.
FIG. 6 shows a first embodiment of an injector device separated from the infusion part.
FIG. 7 shows the first embodiment of the injector device joined with the infusion part.
FIG. 8 shows the first embodiment of the injector device joined with the infusion part.
FIG. 9 shows the first embodiment of the injector device where the pivoting member is embracing the needle after insertion.
FIG. 10 shows the first embodiment of the injector device in the loaded and secured position before insertion.
FIG. 11 shows the first embodiment of the injector device in the loaded and secured position before insertion from a second angle.
FIG. 12 shows a second embodiment of the injector device in a loaded and secured state before insertion.
FIG. 13 shows the second embodiment of the injector device in a ready to use state.
FIG. 14 shows the second embodiment of the injector device after insertion of the needle and before removing the injector from the infusion part.
FIG. 15 shows the second embodiment of the injector device after separating the injector from the infusion part.
FIG. 16 shows the second embodiment of the injector device after the pivoting arm has been positioned to embrace the used needle.
FIG. 17 shows the second embodiment of the injector device after the pivoting arm has been positioned to embrace the needle seen from another angle.
FIG. 18 shows an infusion set placed on the skin.
FIG. 19 shows the second embodiment of the injector device together with a credit card.
FIG. 20 shows a third embodiment of the injector device.
FIG. 21 A-D shows assembling of the infusion part and injector device according to the third embodiment.
FIG. 22 A-B shows the third embodiment of the injector device prepared for insertion.
FIG. 23 A-B shows the adhesive support of the infusion part hooked to the slidable member.
FIG. 24 A shows the injector device after insertion with an infusion part and
FIG. 24 B shows the injector device after insertion without the infusion part.
FIG. 25 shows the third embodiment of the injector device after insertion and embracing the needle.
FIG. 26 A-D shows the different steps when injecting the infusion part.
FIGS. 35 and 36A-D shows the different steps when using a fifth embodiment of the injector device for injecting the infusion part.
FIG. 1-3 illustrates an embodiment of an infusion set. The infusion set comprises an infusion part (0B) and a connector (0A). The infusion part (0B) comprises a base part (2) having a main plane which, when the infusion set is attached to a patient, is essentially parallel with the skin of the patient. Said base part (2) comprises a first set of guiding means (13) which in this case has the form of two stabilizing fins. The base part further comprises two retention devices (4) extending from the upper surface of the base part in this case in form of two steps. Mounted on the inner surface of the infusion part is an adhesive support (1) which in this case is a plaster. A cannula (5) is extending from the base part (2) and is penetrating the adhesive support (1) being in fluid communication with a central cavity (3). The cannula (5) is preferably a soft cannula but could also be made of metal. The cavity (3) optionally being covered by a membrane is adapted to receive a cannula (6) extending from the connector. In the embodiment shown in FIG. 2-5 the cannula (6) is extending from the central part of the connector and is placed in a retracted position relative to the front of the central part. In this embodiment the base part (2) has two cuttings (12) creating two flaps on which the retention devices (4) are mounted. The connector (0A) comprises two arms (9) having four carvings (10) adapted to fit with the retention devices (4). The connector (0A) is symmetrical around the main plane and around the plane perpendicular to the main plane and parallel to the main axis thus allowing the connector to match with the base part in two ways. The cannula (6) is in fluid communication with the tube (7) which provides the connection to a medical device such as an insulin pump. In this embodiment the central part of the connector has a second set of guiding means (8) in form of two grooves placed symmetrically around the main plane of the connector. In this embodiment the connector further has gripping means (11) in form of recesses. The gripping means 11 are optional and can be selected from the group consisting of rims, grooves, recesses or a roughened surface optionally of another material than the connector itself
FIGS. 4 and 5 show another embodiment of the invention where the connector has two grooves (14) which in this case are placed symmetrically around the main plane of the connector. However it is not necessary for the grooves to be places symmetrically around the main plane since they are not coupling with the infusion part.
Whether the infusion set is intended to be inserted manually or by an injector the infusion part (0B) and the connector (0A) are delivered to the user as two separate units in sterile packages. If inserted manually the infusion part (0B) will at delivery be combined with a needle unit with the same locking and guiding means (8) as the connector. The needle unit is provided with an insertion needle extending from the central front which insertion needle at delivery extends through and beyond the end of the cannula (5). The needle unit's only function will be to penetrate the user's skin where after the needle unit is removed and replaced with the connector (0A) leaving the cannula (5) subcutaneous.
The connector (0A) can be connected to a luer coupling member through the tube (7). Through the luer coupling it is possible to administer a suitable therapeutical substance, such as insulin from a pump. The connector can also be a sort of closing part with a suitable entrance for the inserting needle of a syringe. Such a closing part can stay in position for up till three days while the user can have medication, e.g. insulin injected through the entrance in order to reduce trauma to the skin.
It is important for the user that it is easy to change i.e. to engage and to disengage the infusion part (0B) and the connector (0A) even when the user has reduced dexterity of hands and fingers. The present infusion set complies with this purpose as the movement used to unlock the infusion part (0B) from the connector (0A) is pressing the connector between the first finger and the thumb which is a simple and easily performed movement. Also the oppositely directed forces from respectively the first finger and the thumb pushing toward each other, are not only used to unlock the device but is also used when pulling the connector away from the infusion part (0B). In order to make it easier to disengage the connector (0A) the arms (9) can be made very flexible, either by choosing a soft and flexible material or by making the fastening of the arms (9) to the central part more or less rigid e.g. by varying the size of the grooves (14) on the shoulder of the connector (0A).
Although the arms (9) are very flexible the danger of accidently releasing and pulling the connector away from the infusion part, when positioned on the skin of the user, is quite small as the device has to be exposed to a simultaneous pressure from both sides.
FIG. 6-11 shows a first embodiment of an injector device (29) which can be used for injection of the infusion part (0B) of the infusion set. In FIG. 6 the injector device is separated from the infusion part (0B) and FIGS. 7 and 8 show the same injector device (29) joined with an infusion part (0B). The injector device comprises a housing (30) with two longitudinally extending guiding means (31) formed as grooves in this embodiment and a longitudinally slidable member (32) having guiding means (31a), in this embodiment a rim, corresponding to the guiding means (31). A penetrating needle (35) is extending from the front part of the slidable member (32), and the needle (35) is at the end where it is fastened to the slidable member (32) surrounded by guiding means corresponding to the guiding means (13) on the infusion part (0B). The slidable member (32) is capable of moving from a retracted position to a forward position, and is driven from the retracted position to the forward position by a spring (34). The spring is located between the slidable member (32) and the back (33) of the housing. Optionally there is a spring support (37) (FIG. 8) which fits with the back of the housing thereby minimizing the risk of a malfunctioning spring. The injector device further comprises locking means (38) for maintaining the spring in a compressed state and release means (39) for disengaging the locking means. When the locking means (38) are disengaged, the spring (34) drives the slidable member (32) to its forward position, thus introducing the cannula positioned at the front end of the infusion part (0B) into the patient by means of the needle (35). After the introduction of the cannula, the injector device including the insertion needle (35) is withdrawn from the infusion part (0B) leaving the insertion needle in an exposed position. The pivoting member (36) can then be swung into a position where it embraces the needle (35) as shown in FIG. 9.
FIG. 10 and FIG. 11 show the same embodiment of the injector device in a loaded and secured position. Part of the pivoting member (36) acts as locking means (38). In FIG. 10 it can be seen how the needle (35) fits into the cannula (5) of the infusion part. The needle (35) will bring the cannula (5) with it during the skin penetration. After penetrating the skin the needle (35) secured to the injector will be withdrawn leaving the cannula inserted in the patient. In FIG. 11 the locking means are shown said locking means are disengaged when the tab (38) is pushed over the edge of the outer side of the back (33) of the housing.
FIGS. 12 to 17 show a second embodiment of the injector device according to the invention where the pivoting member (36) is fastened centrally in relation to the slidable member (32). FIG. 12 shows the injector device in a state where the pivoting member (36) protects the needle prior to injection of the cannula (5) of the infusion part (0B). The figure shows the housing (30) with another type of longitudinally extending guiding means (31), in this case a bar. The housing further has gripping means (40), preferably in the form of recesses, as means for getting a better grip of the injector device.
Centrally positioned release means (39) is shown on one of the main faces of the injector device. The advantage of a one button release mechanism is that the risk of a slanting injection reduced.
In FIG. 13 is shown an injector device prepared for insertion of the needle. The pivoting member is positioned away from the embracing position in an angle v≈90° in relation to the main axis of the injector device where the main axis is coincident with the insertion needle. The adhesive support (1) is positioned in such manner that the cannula (5) of the infusion part (0B) and the therein positioned needle (35) penetrates the adhesive support through an opening in the release liner. When the pivoting member is positioned essentially perpendicular to the main plane of the injector device it can provide a helping mean for achieving essentially vertical injection of the needle. Further FIG. 13 shows the needle (35) of the injector device inside the cannula (5). In FIG. 14 the injector device is in a released state where the needle (35) would have penetrated the skin. The housing in the embodiment of FIG. 14 has a stopping tab (43) corresponding to a protrusion on the slidable member that keeps the slidable member (32) within the housing (30) thereby making it easier to withdraw the needle since there is no risk that the slidable member slides out of the housing. In FIG. 15 the injector device has been withdrawn, leaving the cannula (5) of the infusion part (0B) inserted in the patient. In FIGS. 16 and 17 the pivoting member (36) is in a position where it embraces the needle (35) thereby protecting the surroundings from coming into contact with the used needle (35). In FIG. 18 the infusion part (0B) has been brought from the essentially vertical insertion position to a position essentially parallel to the skin.
FIG. 19 shows the injector device together with a credit card to illustrate the size of the injector device.
In FIG. 20 is shown a third embodiment of the injector device together with an infusion part (0B). This embodiment also has a housing (30) with longitudinally extending guiding means (31) and a longitudinally slidable member (32) of a different construction compared to the two first embodiments. Also the pivoting arm (36) and the spring (34) can be seen in this figure. In this embodiment the stopping tab (43) is placed centrally and has the form of a protrusion raising form the lower side of the housing (30). The release means (39) comprises two buttons placed on each side of the housing (30).
In FIG. 21 A-D it is shown how the infusion part (0B) along with the slidable member (32) and the spring (34) of the third embodiment fit into the housing (30). The unit (?) shown between the pivoting arm (36) and the insertion part (0B) is an adapter which makes it possible to use a standard injector for different guiding means (13) on the infusion part (0B).
In FIG. 22 A-B is shown fixing means (44) placed on the pivoting member (36). It is possible to temporarily attach a part of the adhesive support (1) to the fixing means in order to secure the position of the adhesive support in such a way that the adhesive surface of the support (1) will be turned towards the skin of the patient. Further release means (39) in the form of two buttons, one on each side of the housing (30), can be seen as well as the protruding stopping tab (43).
FIG. 23 A-B shows in further details and without the housing how the adhesive support (1) is hooked to the fixing means (44) due to at least one cutting (46) in the adhesive support (1).
FIG. 24 A shows the third embodiment of the injector device with an infusion part after insertion and 24 B shows the injector device after insertion and after the injector device has been removed from the insertion part (0B).
In FIG. 25 the pivoting member (36) of the injector device is in a position embracing the needle. A locking tab (45) fixes the pivoting arm in this position. This makes certain that the needle stays embraced by the pivoting arm and thereby minimizes the risk of somebody getting hurt by the needle.
In FIG. 26 A-D the cycle of use for the injector device is illustrated:
When the infusion set is delivered to the patient together with the injector device, the infusion part (0B) and the connector (0A) are packed separately and under sterile conditions, and the infusion part (0B) is placed in the injector device (FIG. 26 A). When the user wants to insert the infusion part (0B), the user pulls the pivoting arm and turns the arm perpendicularly to the housing (30) (FIG. 26 B). In this position the needle (35) placed on the slidable member (32) is exposed and the adhesive support is bend backwards with the adhesive surface turned towards the users skin. The user then pushes the buttons (39) on each side of the housing which releases the spring and pushes the slidable member (32) towards the user's skin (FIG. 26 C). The needle (35) will in this position penetrate the skin and place the cannula of the infusion part (0B) subcutaneous. After placing the infusion part (0B) the injector device is removed, and in order to protect the surroundings from the used needle (35) the pivoting arm (36) is turned approximately 180° to an angle w≈90° perpendicular to the main axis of the injector device, where it embraces the needle and make it safer to dispose of the device.
FIGS. 35A-E and 36A-E illustrates the cycle of use of the injector device seen respectively from the upper (FIG. 35) and the lower (FIG. 36) side of the injector device.
In FIGS. 35A and 36A the device is in a first state, which is the state the device would normally be delivered to the patient in, under sterile conditions. In this state the pivoting arm (36) is in a position where it embraces the needle (35) and the angle v between the main plane of the injector device and the pivoting arm is approximately 0°, if the release means (39) should unintentionally be pressed in this situation two protruding tabs (48) will prevent the slidable member (32) from being pushed forward.
In FIGS. 35B and 36B the device is prepared for use by lifting the pivoting arm (36) backwards thereby exposing the insertion needle (35) and also in this embodiment lifting the part of the release liner (41) which is attached to the pivoting arm (36), exposing the underlying adhesive support (1). In this position the pivoting arm (36) allows for insertion of the needle and is in an angle v to main plane of the injector device where 90°≦v≦180°, and in this position the injector device would be placed against the patient's skin.
In FIGS. 35C and 36C the release means (39) has been pressed and has released the spring (34). The spring has pushed the slidable member (32) forward until the slidable member was stopped by two stopping tabs (43). In this position the insertion needle (35) has penetrated the patient's skin and a part (this part covers an area around the needle in the full breadth of the adhesive support) of the adhesive surface of the adhesive support (1) is in contact with the patient's skin. In FIG. 36C it is shown how the second part (42) of the release liner is attached to the housing (30) and still covers the adhesive surface when the slidable member (32) is pushed forward.
In FIGS. 35D and 36D it is shown what happens when the injector device is removed from the patient, leaving the infusion part (0B) inserted subcutaneously. The user frees the first part (41) of the release liner from the pivoting arm (36) and then when pulling the injector device away the second part (42) of the release liner is also pulled away, exposing the adhesive surface of the adhesive support (1) and making it possible for the user to press the adhesive support towards the skin and thereby securing the infusion part (0B).
Finally after withdrawal of the insertion needle which in this embodiment is attached to the slidable member (32) in the injector device, it is shown in FIGS. 35E and 36E how the pivoting member (36) is placed in a position where it is embracing the needle thereby protecting the surroundings from getting stung. In order to get into this position the pivoting arm (36) is turned approximately 180° from the position in FIGS. 35D and 36D, and the angle w between the main plane of the injector device and the pivoting arm (36) is approximately 90°.
Patent Application
20080039794
