Source: https://patents.google.com/patent/US20100198157A1/en
Timestamp: 2019-07-22 05:19:08
Document Index: 643181090

Matched Legal Cases: ['arts 9', 'arts 7', 'art 9', 'arts 11', 'art 9', 'art 9', 'art 9', 'art 9', 'arts 11', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'art 9', 'arts 11', 'art 9', 'art 1', 'art 9', 'arts 11', 'arts 11', 'art 1', 'arts 11', 'art 9']

US20100198157A1 - Cannula and Delivery Device - Google Patents
US20100198157A1
US20100198157A1 US12/598,825 US59882507A US2010198157A1 US 20100198157 A1 US20100198157 A1 US 20100198157A1 US 59882507 A US59882507 A US 59882507A US 2010198157 A1 US2010198157 A1 US 2010198157A1
US12/598,825
Tenna M. Pedersen
2007-12-06 Application filed by Unomedical AS filed Critical Unomedical AS
2007-12-06 Priority to US12/598,825 priority patent/US20100198157A1/en
2010-01-07 Assigned to UNOMEDICAL A/S reassignment UNOMEDICAL A/S ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MATHIASEN, ORLA, GYRN, STEFFEN, PEDERSEN, TENNA M.
2010-08-05 Publication of US20100198157A1 publication Critical patent/US20100198157A1/en
The present invention relates to a base part comprising a cannula device for use in delivery devices delivering medication to a patient under controlled conditions, and an inserter device for insertion of the cannula device in the base part. The base part comprises a receiving portion (7) for a cannula device (1), a portion (9) which can be placed on the skin of a patient and attachment parts (11) for a delivery part comprising at least a reservoir (13). The base part further has a connection transferring fluid from the reservoir (13) to the base part which connection can be provided at different angles relative to the base part (9).
The present invention relates to a base part comprising a cannula device for use in delivery devices delivering medication to a patient under controlled conditions, and an inserter device for insertion of the cannula device in the base part.
US 2003/0176852A1 discloses a delivery device in which a base part comprises a pivoting member, said base part comprising a cannula for insertion into a patient and pivoting member has an inner cavity with one receiving end adapted to receive an inserter needle or a connector cannula and two connecting ends (3161 and 320) for further connection with the cannula of the base part. During insertion the pivoting member is positioned orthogonal to the base part and an inserter needle penetrates a membrane in the receiving end and the needle passes through a canal and through the first connecting end into the cannula which then can be inserted. After insertion the needle is removed and the pivoting member is connected with a connector. The connector and the pivoting member are connected from the same direction as the connection between the pivoting member and the inserter. The pivoting member is then turned in order for the second connecting end to align with the cannula. This device has the drawback that it is very sensitive to movement of the pivoting member since a small movement will close of the delivery of drugs.
In one embodiment the cannula device comprise a body showing a smooth outer surface and having an inner cavity, the inner cavity is at the distal end covered with a wall such as a membrane or a septum which can be penetrated by a needle such as a connector needle or a syringe and at the proximal end of the inner cavity a cannula is embedded, the outer proximal surface of the body, i.e. a surface of the body facing the receiving portion during injection of the cannula device, is provided with means for unreleasably attaching the device to a receiving portion. The smooth outer surface can e.g. have a round or oval circumference and the wall covering the distal end of the inner cavity can be penetrated either by a pointy or by a blunt needle which ever might be preferred.
According to another aspect of the invention another base part is provided. This base part comprises a receiving portion for a cannula device, a portion which can be placed on the skin of a patient and attachment parts for a delivery part comprising at least a reservoir. The delivery part which can be connected to this base part has more than one position relative to the attachment parts. In a first position parts of the delivery part corresponding to the attachment parts of the base part is/are brought into contact with the attachments parts, after contact is made the parts of the delivery part corresponding to the attachment parts of the base part slides along a track or a surface towards a second position where a fluid connection between the delivery part and the cannula device) is formed. The tracks or surface can be a continuous opening in an upright wall as shown e.g. in FIG. 5 or 8, or it can be the outer/upper of a protruding surface leading towards the receiving portion. If the tracks or surface is a continuous opening in an upright wall, then the corresponding parts of the delivery part could be protruding parts engaging the openings. If the tracks or surface is a band then the corresponding parts of the delivery part are corresponding sliding parts.
FIG. 14 shows two views of the same embodiment of a cannula according to the invention mounted in an inserter which inserter is joined to a receiving portion of a base part;
FIG. 15 shows a base part having a close fit square receiving section for a square cannula device with two access openings;
FIG. 16 shows a cannula device with two access openings placed in an inserter positioned in contact with a base part:
FIG. 17 shows a base part having a centrally positioned receiving portion adapted to a cannula device having to access openings.
FIGS. 1A and B show a first embodiment of the present invention. In this embodiment, the cannula device includes a housing 1 a, 1 b and a wall in the form of e.g. a membrane 4 which together define an inner cavity adapted to receive a piercing member 6 extending from e.g. a connector or a syringe. The housing 1 a, 1 b is normally made of a relatively hard molded plastic material.
The cannula device can also be constructed with an angular profile e.g. a quadrangular profile as shown in FIG. 1C. This figure shows two embodiments of the cannula device: a device having a round profile (upper) and a device having a square profile (lower). This profile shows when the cannula device is seen from above along the line A-A shown in FIG. 2. Whether the profile of the cannula device is round or angular it might have a loose fit or a close fit in the receiving portion where a loose fit and transporting means for transferring fluid from the reservoir normally indicates that the receiving section is provided with guiding means for the inserter and the cannula device is placed in correct position when the inserter is placed according to the guiding means and when the inserter is removed from the receiving section an empty space corresponding to the walls of the inserter can appear around the cannula device. A close fit means that the receiving section of the base part is provided with a room closely corresponding to the form or the profile of the cannula device and the cannula device is positioned inside the room, e.g. by an inserter, which room has walls closely corresponding to the outer walls of the cannula device.
The cannula device shown in FIG. 1D has two access openings covered with one membrane 4, in another (not shown) embodiment each access opening could be covered with separate non-connected membranes at different surface positions (e.g. respectively 4 a and 4 b). Such a cannula device can be fed with medication from two different angles via the surface 4 a or the surface 4 b. Such a device provides the possibility of having an extra access for medication if a corresponding opening is provided in the receiving portion 7 or alternatively the cannula device could be a standard device for two different types of base parts 9 provided with different openings in the receiving portion 7.
FIG. 2 shows the same embodiment of the cannula device as in FIG. 1, where the cannula device is positioned in the receiving portion 7. The receiving portion 7 is provided with essentially vertically positioned walls covering the side section of the cannula device and a bottom part formed by the protruding parts 7 a on which the cannula device rests when locked in the receiving portion 7. The essentially vertical walls which encircle or surround the cylindrical space 8 around the cannula device can create a guiding mean for an inserter. The cannula device is in this embodiment fully covered by a lower cylindrical part of the inserter and when the user wants to inject the cannula device, the cylindrical lower part of the inserter is placed in the space 8 formed by the receiving portion 7 and then the cannula device is pushed in position by a plunger being moved forward inside the cylindrical lower part of the inserter.
FIG. 3 shows an upper view of a base part 9 provided with a receiving portion 7 and with attachment parts 11 for a delivery part. A delivery part might comprise both transporting means and a reservoir for medication but at least the reservoir. The transporting means normally have the form of a pump which provides for the controlled transport of medication from the reservoir to the patient. The control can be predefined in relation to the patient before the device is positioned on the patient e.g. the device can be programmed to deliver a constant amount prime unit, to deliver a certain dose at defined intervals or the delivering can be defined continuously by administering an amount or dose defined as a result of sensor measurements monitoring one or more components in the patients blood.
The base part 9 will normally be fastened to the patient by an adhesive surface or surface parts provided at the proximal side of the base part 9 or by a separate adhesive part or layer, but any kind of mounting which will make the base part stick to the patient without allowing the device to move can be used. A separate adhesive part or layer can be fastened to the base part 9 by glue, Velcro, molding or the like.
PCT applications PCT/DK2006/000737 and PCT application PCT/DK2006/000472 both filed on 22 Dec. 2006 relates to delivery devices of the described type having delivery parts comprising both reservoir and transporting means placed in joined relation to the base part. The delivery devices having base parts and delivery parts as shown and described in these two PCT applications are hereby incorporated by reference in the present application.
FIG. 4 shows an upper view of the same base part 9 as shown in FIG. 3 also provided with a receiving portion 7 and with attachment parts 11 for a delivery part but in FIG. 4 a cannula device has been positioned in the receiving portion 7.
FIG. 5 shows an upper view of another embodiment of a base part 9. FIG. 5 shows a centrally placed receiver 7 having a square profile in which a cannula device 1 having a square profile is placed. The receiving section 7 of this base part 9 has a square inner room and a cannula device 1 a having an outer square profile is placed in the receiving section 7.
FIG. 6 shows an upper view of a base part 9 as shown in FIG. 3, 4 or 5 but in FIG. 6 the base part 9 has been provided with a cover 12 in which a delivery part comprising a reservoir 13 for medication and means for transporting of the medication from the reservoir to the patient are embedded.
FIG. 7 shows a cut-through view of the device shown in FIG. 6. FIG. 7 shows a receiving portion 7 positioned on a base part 9 which base part 9 has an underlying mounting pad 10. A cannula device has been inserted in the receiving portion 7 and the cannula 3 of the cannula device is inserted subcutaneously in a patient. The cannula device and the receiving portion 7 could be either square or round. The cover 12 is mounted releasably on the base part 9, and a connector needle 6 forms a fluid connection between the reservoir 13 which is attached to the inside of the cover 12 and the cannula device by penetrating the septum 4 of the cannula device. The transporting means are not shown.
FIGS. 9 and 10 shows other embodiments of a delivery device. The embodiment of FIG. 9 is provided with a cylindrical cannula device (round profile) placed in a square or rectangular receiving portion 7. This embodiment provides a loose fit for the cannula device. The embodiment of FIG. 10 is provided with a square or rectangular cannula device placed in a square or rectangular receiving portion 7. This embodiment also provides a loose fit for the cannula device where the upright walls of the receiving portion 7 can provide the guiding means for an inserter.
In FIG. 9 the peripheral placed receiver has a square profile in which a cannula device 1 having a round profile is placed. In order to position this cannula device 1 correctly in the base part 9 an injection device having a square outer and a round inner profile is needed or at least an inserter which have parts or surfaces adapted to fit into an outer square space formed by the receiver and have parts or surfaces which can provide a space in which a round cannula holding device can slide.
In FIG. 10 the peripheral placed receiver has a square profile in which a cannula device 1 having a square profile is placed. In order to position this cannula device 1 correctly in the base part 9 an injection device having a square outer and a square inner profile is needed or at least an inserter which have parts or surfaces adapted to fit into an outer square space formed by the receiver and have parts or surfaces which can provide a space in which a square cannula holding device can slide.
FIG. 11 shows a centrally placed receiver without upright walls guiding the inserter into position. Instead the slightly raised circumference of the central plate 9 a of the base part 9 corresponding to a part of the proximal end of the inserter indicates the correct position of the inserter during insertion of the cannula device 1.
FIG. 12 shows a base part 9 having a centrally placed receiver having upright walls which walls provide the receiver 7 with a square profile. The base part 9 is shown before the cannula device 1 inserted.
FIGS. 13 and 14 illustrates an inserter which can be used when inserting the cannula device in a base part of a delivery device with a receiving portion 7 shown in FIG. 3-10. Such an inserter should have outer walls providing a profile corresponding to a part e.g. the walls of the receiving portion 7 and inner walls providing a profile corresponding to the cannula device in question in order for the inserter to guide the cannula device into the correct position.
A detailed description of the specific inserter shown in FIGS. 8 and 9 and a description of how this inserter functions can be found in DK application PA200601028 filed on 2 Aug. 2006. This inserter is hereby incorporated by reference.
FIG. 15 shows an embodiment of a delivery device similar to the embodiments shown in FIGS. 9 and 10 but in the embodiment of FIG. 15 the receiver portion 7 has been changed in order to make it possible to inject liquid from to different angles. The cannula device has as shown in FIG. 1D two access openings but in the cannula device of FIG. 15 each opening is covered by a separate membrane 4 b and 4 a. The opening covered by the first membrane 4 a can e.g. be used when applying the cover 12 inside which a fluid connection is formed to a reservoir 13 while the second access covered by the second membrane 4 b e.g. can be used when another medication or a higher dose than the one flowing through the fluid connection from the reservoir 13, has to be injected. In this situation the cover 12 could be provided with a corresponding opening which would make it possible to inject extra or other kinds of medication without removing the cover.
FIG. 16 shows an embodiment of a cannula device intended for a base part 9 having a centrally positioned receiving portion 7. The cannula device 1 is placed in an inserter, it is held in position inside the inserter by the friction between the insertion needle 3 a which is unreleasably connected to the inserter and the cannula 3 of the cannula device. That the insertion needle 3 is unreleasably connected means that it can be molded into the plunger of the inserter. The cannula device of FIG. 16 has two access openings, the insertion needle is placed through the first access opening covered by the membrane at position 4 a and the second access opening is placed perpendicular to the first access opening and covered by the membrane at position 4 b. When the cannula device is inserted into the base part 9 it will be possible to access both openings as the receiving portion 7 has been provided with an opening corresponding to the second opening of the cannula device.
FIG. 17 shows a base part 9 which can be used in combination with the cannula device of FIG. 16 i.e. the base part 9 provides several access openings for the delivery part. In FIG. 17 one access is provided in a direction approximately perpendicular to the upper surface of the base part 9, according to the shown embodiment approximately would mean ±10° to perpendicular of the upper surface of the base part 9. The possible insertion angle is defined both by the position of the membrane but also by the angle of the walls of the inner cavity in the cannula device 1 therefore the connector needle 6 of the delivery part does not need to be exactly perpendicular to the upper surface of the base part 9. The second access opening is provided in a direction approximately parallel to the upper surface of the base part 9 i.e. the direction of the connection needle need not be exactly parallel to the upper surface of the base part 9 but could deviate ±10° from parallel or as much as the walls of the inner cavity of the cannula device allow. In this embodiment the first connection angle, i.e. the connection through the first access opening, and the second connection angle, i.e. the connection through the second access opening, deviate from each other by around 90°, i.e. between 70° and 110°.
FIG. 18 shows a base part 9 of similar type as the one shown in FIG. 17 but in this embodiment the base part 9 is of the form and size of a credit card without a separate mounting pad. The base part 9 can be made by molding without a separate mounting pad and provided with an adhesive on the proximal side which secures the device to the user after mounting.
The openings of the attachment parts 11 are inclined towards the receiving portion in order for the delivery part to approach the receiving portion 7 in a correct angle. Actually the surfaces need not be inclined; they can have any form or direction directing the delivery part to connect with the base part 9 or the cannula part 1 in a desired way. When joining the delivery part to the base part 9, the delivery part is first positioned on the attachments parts 11 in a position away from the receiving portion and then the delivery part slides along the attachment parts 11 until the final position is reached and a fluid connection is made between the delivery part and the cannula part 1. According to a similar embodiment the attachment parts 11 could comprise a single longish central part instead of two separate parts placed near the sides of the base part 9.
1. A base part comprising a receiving portion (7) for a cannula device (1), a portion (9) which can be placed on the skin of a patient and attachment parts (11) for a delivery part comprising at least a reservoir (13), characterized in that a connection transferring fluid from the reservoir (13) to the base part can be provided at different angles relative to the base part (9).
2. A base part according to claim 1, characterized in that the delivery device further comprises transporting means for transferring fluid from the reservoir (13) to the patient.
3. A base part according to claim 1, characterized in that the transferring means are a pump.
4. A base part according to claim characterized in that at least two connection angles deviates from each other by at least 40°, preferably by at least 60°.
5. A base part according to any of claims 1-2, characterized in that the cannula device (1) is provided with more than one access opening to an inner cavity.
6. A base part according to any of claims 1-5 characterized in that the cannula device is provided with means (5) for attaching the device to the base part (9) on the proximal side of the device.
7. A base part according to claim 6 characterized in that the means (5) for attaching the device to the base part (9) comprise mechanical features cooperating with corresponding means (7 a) on the base part (9).
8. A base part according to claim 6 characterized in that the means for attaching the device to the base part (9) comprise parts (5) extending from a proximal surface of the cannula device which parts (5) can pivot and thereby temporarily reduce the diameter formed by the edges of the parts (5) in at least one position.
9. A base part according to claim 6 characterized in that the means (5) for attaching the device to the base part (9) comprise an adhesive surface on a proximal surface of the cannula device adhering to a corresponding surface of the base part (9).
10. A base part according to claim 1 characterized in that the cannula device is provided with guiding means corresponding to an inserter device (14) which guiding means secure a well-defined motion of the cannula device when being moved towards the base part (9).
11. A base part according to claim 10 characterized in that the cannula device is inserted with an inserter device (14) provided with a covering part (15) covering the full length of the cannula device.
12. A base part according to any preceding claim characterized in that the device comprise a body (1 b) showing a smooth outer surface and having an inner cavity, the inner cavity is at the distal end covered with a wall (4) which can be penetrated by a needle (6) and at the proximal end of the inner cavity a cannula (3) is embedded, the outer proximal surface of the body (1 b) is provided with means (5) for unreleasably attaching the device to a receiving portion (7).
13. A base part according to any preceding claim characterized in that the smooth outer surface of the cannula device (1) has a round, angular e.g. rectangular or oval circumference.
14. A base part according to any preceding claim characterized in that the wall (4, 4 a, 4 b) covering the access openings of the inner cavity can be penetrated by a pointy or blunt needle (6).
15. A base part according to claim 6 characterized in that an unreleasable attachment between the receiving portion (7) and the cannula device is formed automatically as the cannula device is pushed against the receiving portion (7).
16. A base part comprising a receiving portion (7) for a cannula device (1), a portion (9) which can be placed on the skin of a patient and attachment parts (11) for a delivery part comprising at least a reservoir (13), characterized in that the delivery part has more than one position relative to the attachment parts and in a first position parts of the delivery part corresponding to the attachment parts (11) of the base part (9) is/are brought into contact with the attachments parts (11) and then the parts of the delivery part corresponding to the attachment parts (11, 11 a) of the base part (9) slides along a track or a surface towards a second position where a fluid connection between the delivery part and the cannula device (1) is formed.
17. An inserter device for insertion of a cannula device in a base part according to claims 1-16, said device comprising a first insertion part and a second insertion part, and an injection needle where
the second insertion part is connected to the injection needle and the injection needle is releasably combined with the cannula of the cannula device,
the first insertion part covers the injection needle in a non-activated position,
the guiding means of the first and the second insertion part allows the injection needle to project beyond the first insertion part when the insertion device is activated.
18. An inserter device according to claim 18, where the cannula device has a retracted position inside the first insertion device and a forward position inside the first insertion device, and in the forward position the cannula (3) of the cannula device extends beyond the open proximal end of the first insertion device.
19. An inserter device according to claim 17, where the first insertion part is provided with guiding means which means can be combined with means of a base part (9) being secured to the patient in order to create a well-defined insertion point and angle.
US12/598,825 2007-05-07 2007-12-06 Cannula and Delivery Device Abandoned US20100198157A1 (en)
US12/598,825 US20100198157A1 (en) 2007-05-07 2007-12-06 Cannula and Delivery Device
US20100198157A1 true US20100198157A1 (en) 2010-08-05
US12/598,825 Abandoned US20100198157A1 (en) 2007-05-07 2007-12-06 Cannula and Delivery Device
RU2468828C2 (en) 2012-12-10
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GYRN, STEFFEN;MATHIASEN, ORLA;PEDERSEN, TENNA M.;SIGNING DATES FROM 20091202 TO 20091208;REEL/FRAME:023746/0024