Source: https://patents.google.com/patent/WO2009007287A1/en
Timestamp: 2018-10-18 10:51:19
Document Index: 750671322

Matched Legal Cases: ['art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'arts 6', 'arts 15', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'arts 6', 'arts 6', 'art 10', 'art 10', 'arts 15', 'arts 15', 'arts 6', 'art 10']

WO2009007287A1 - Inserter having two springs - Google Patents
Inserter having two springs Download PDF
WO2009007287A1
WO2009007287A1 PCT/EP2008/058512 EP2008058512W WO2009007287A1 WO 2009007287 A1 WO2009007287 A1 WO 2009007287A1 EP 2008058512 W EP2008058512 W EP 2008058512W WO 2009007287 A1 WO2009007287 A1 WO 2009007287A1
PCT/EP2008/058512
The invention relates to an inserter for a medical device e.g. an infusion set or the likefor intermittent or continuous administration of a therapeutical substance, such as e.g. insulin. The inserter comprises a needle hub comprising an insertion needle and two elastic elements assuring automatic insertion and automatic retraction of the insertion needle. Activation of the first elastic element (11) cause a penetrating member (6A) to be inserted sub-or transcutaneously into the skin of a patient, and the secondelastic element (12) cause the penetrating member (6A) to be retracted from the skin of the patient. The first elastic element (11) is in an unloaded state before activation and upon activation the first elastic element (11) energizes the second elastic element (12).
The invention relates to an inserter for a medical device e.g. an infusion set or the like for intermittent or continuous administration of a therapeutical substance, such as e.g. insulin. The inserter comprises a needle hub comprising an insertion needle and two elastic elements assuring automatic insertion and automatic retraction of the insertion needle.
WO 2005/046780 (fig. 97 - 102) describes a device used for automatic insertion of a cannula of an infusion device into the skin of a patient, and afterwards automatic retraction of the insertion needle. The insertion device has the form of an oblong cylinder which is open in one end (1984) and provided with means for activation at the other end (1952). When the infusion set has been loaded onto the needle (1968) the lock member (1962) is moved in direction of the end provided with means for activation by the patient using projections (1974) until barbs (1956) of the lock member (1962) engage an outer surface of the housing (page 26, I. 24-27). The projections (1974) are accessible through a slot (1976) of the housing. Then the open end (1984) is placed against the skin of the patient and the means for activation (1952) is activated. When activated shoulders (1954) on the means for activation engage, the barbs (1956) are pushed toward each other in order to disengage the barbs from the housing. When the barbs are clear of the housing the lock member, the needle hub, the retainer body and the associated infusion device are moved by a first spring in direction of the open end (1984). The inserter device moves the infusion device towards the skin of the patient thereby inserting the needle and the cannula of the infusion device. As the cannula is fully inserted, barbs (1964) of the needle hub (1965) engage ramped surfaces (1972) of the sleeve (1982), causing the barbs (1964) to be forced toward one another. When the barbs (1964) have been forced sufficiently inwardly to clear ends (1988) of the main body (1980), the second spring (1966) then moves the needle hub (1965) in the direction of the activation means (1952). Thus the needle is removed from the infusion device leaving the infusion device in place on the skin while the retainer body remains in a position adjacent the open end of the sleeve so that once the insertion device is removed from the skin of the patient, the retainer body protects the patient from further contact with the needle.
The object of the invention is to provide a simple, non-expensive inserter for an infusion device which inserter would be easy and safe for the user to handle during use and safe to dispose of after use.
The invention concerns an inserter for a medical device comprising two elastic elements where activation of the first elastic element cause a penetrating member to be inserted sub- or transcutaneous^ into the skin of a patient, and the second elastic element cause the penetrating member to be retracted from the skin of the patient wherein the first elastic element is in an unloaded state before activation and upon activation the first elastic element energizes the second elastic element. That the first elastic element is in an unloaded state means that it is un-biased or slightly biased, and only upon activation the first elastic element will be loaded. This assures that the first elastic element does not decay during storing before use.
According to one embodiment of the invention the first elastic element is a spring having a spring constant ki.
According to one embodiment of the invention the spring constant ki of the first elastic element is larger than the spring constant k2 of the second elastic element, normally the spring constant ki > 2*k2.
According to one embodiment the spring constant ki > 0.2 and the spring constant k2 > 0.09.
According to one embodiment the first elastic element and/or the second elastic element are/is a helical spring. According to one embodiment of the invention the inserter comprises
- a stationary part (10) being stationary in relation to the patient during insertion and resting against the patients skin,
- activation means (1 ), - a carrier body (2) which carrier body (2) has a forward and a retracted position relative to the stationary part (10) and -a needle hub (6) connected with a penetrating member (6A),
- first locking means (4) locking the carrier body (2) in a retracted position,
- first release means (13A) unlocking the carrier body (2) from a retracted position,
- second locking means (8, 9) locking the needle hub (6) in a forward position relative to the carrier body (2),
- second release means (15A) unlocking the needle hub (6) from the forward position, wherein the first elastic element (11 ) apply force to a surface of the house (1 ) and to a surface of the carrier body (2) and the second elastic element (12) apply force to a surface of the needle hub (6) and to a surface of the stationary part (10).
According to this embodiment a first integrated part comprising the first elastic element can be separated from a second integrated part comprising the second elastic element and the penetrating needle e.g. the first integrated part is reusable and the second integrated part is disposable. The invention also relates to use of an inserter as described above e.g. for sub- or transcutaneous^ positioning of a unit for metering a substance e.g. the glucose content of the blood and/or sub- or transcutaneous^ positioning of an infusion part of an infusion set for delivering of a drug e.g. insulin to the patient and/or sub- or transcutaneous^ positioning of a gateway for replacing multiple injections.
Fig. 1A and 1 B show a side view of the embodiment where the carrier body and the medical device are in a retracted position before insertion, fig. 1 C shows a spatial side view of the same position;
Fig. 2A and 2B show a side view of the embodiment where the carrier body and the medical device are in a retracted position before insertion, fig. 2C shows a spatial side view of the same position;
Fig. 3A and 3B show a side view of the embodiment where the carrier body and the medical device are in a fully forward position, fig. 3C shows a spatial side view of the same position;
Fig. 4A and 4B show a side view of the embodiment where the carrier body is in a forward position and the medical device is in a retracted position; fig. 4C shows a spatial side view of the same position; Fig. 5A and 5B show a side view of the embodiment where the carrier body and the medical device are in a retracted position after insertion, fig. 5C shows a spatial side view of the same position;
Fig. 6 shows a top view of a medical device which can be used with the inserter device. The embodiment of the inserter device of fig. 1A, 1 B and 1 C is shown in a state before insertion of the medical device. The embodiment comprises a house 1 , a carrier body 2, a stationary part 10 which is stationary in relation to the patient during use and a needle hub 6 provided with a penetrating member 6A. Further the inserter device comprises two elastic elements in the form of two spring units, an inserter spring 11 having a spring constant ki and a retraction spring 12 having a spring constant k2.
The house 1 has a cylindrical body with a closed distal end and an open proximal end, and the house 1 is provided with two longitudinal openings 13 on opposite sides of the body of the house 1 ; the openings are limited towards the distal end by an edge 13A and towards the proximal end by and edge 13B. Further the house 1 is provided with four slots 13C, one on each side of each longitudinal opening 13, extending from the proximal edge of the house 1.
The lower or proximal side of the protruding parts on the arms 5 provides a stop for the relative movement between the stationary part 10 and the house 1 , i.e. it is not possible to pull the stationary part 10 out of the house 1 when the oppositely placed arms 5 are in a relaxed position. When the arms 5 are pushed towards each other the arms 5 are in a tensioned position and it is possible to pull the stationary part 10 out of the house 1 and replace the stationary part 10 with a new e.g. unused part or e.g. with a part having another function or having a different medical device attached. The slots 13C allow an increment of the diameter of the house 1 which increment makes it possible to remove the stationary part 10 from the shown embodiment of the house 1 without destroying the house 1. After use the carrier body 2 of the embodiment shown in the figures will be stuck inside the stationary part 10, and therefore the carrier body 2 will be removed together with the stationary part 10.
The carrier body 2 also comprises a cylindrical body, where the distal end of the cylindrical body has an increased diameter compared to the proximal end of the cylindrical body. The distal part of the cylindrical part of the carrier body has a surface against which the inserter spring 11 rests, also the outward arms 4 of the stationary part 10 rest against a surface of the carrier body 2. The carrier body 2 is provided with two longitudinal openings 7 on opposite positions on the proximal part of the cylindrical body which openings functions as guiding means for protruding parts 6B of the needle hub 6. The longitudinal openings assure that the needle hub 6 can only travel a certain distance corresponding to the openings 7 inside the carrier body 2. The carrier body 2 also is provided with a closed proximal exit having an opening which is just large enough to allow the penetrating member to pass through.
Such a nearly closed end prevents access to the contaminated penetrating member after use. The embodiment shown in the figures also has two openings 7A perpendicular to the openings 7 and extending from the proximal end of the cylindrical body of the carrier body 2. The protruding parts 15A of the protruding circular edge 15 of the stationary part 10 extend into these openings 7A and are guided along the openings 7A when the carrier body 2 moves in relation to the stationary part 10. The proximal end surface of the carrier body 2 touches the patient's skin when the carrier body 2 is in a most forward position relative to the stationary part 10. When the carrier body 2 is in a most retracted position relative to the stationary part 10 - which is the state shown in fig. 1A, 1 B and 1 C -, inward protruding parts of the outward arms 4 of the stationary part 10 rest against a surface of the distal part of the cylindrical body of the carrier body 2.
The needle hub 6 is before use placed inside the distal part of the cylindrical body of the carrier body 2. The distal end of the needle hub 6 is provided with two protruding parts 6B which are placed on opposite positions on the cylindrical body of the needle hub 6 (shown in fig. 1 B) and as mentioned above the longitudinal openings 7 assure that the needle hub 6 can only travel a certain distance inside the carrier body 2 corresponding to the length of the openings 7. The needle hub also comprises pivotally mounted arms 8 having hooks which in the retracted position are in contact with proximal turned surfaces 9 of the carrier body 2. This proximal turned surface 9 is the distal edge of the opening 7A.
Fig. 2A, 2B and 2C show the inserter device in a state where the inserter spring 11 is compressed and therefore biased but before the carrier body 2 and the needle hub 6 is brought forward.
The downward movement of the combined carrier body and needle hub 6 brings the inserter device to the state illustrated in fig. 3A, 3B and 3C.
Fig. 3A, 3B and 3C shows the needle hub 6 in a position where the penetrating member 6A is fully inserted in the patients skin. The retraction spring 12 has been compressed and thereby energized as the spring constant k2 of the retraction spring 12 which pushes upward on the protruding parts 6B of the needle hub 6 is smaller than the spring constant ki of the inserter spring 11 which pushes downward on the carrier body 2. Normally the spring constant ki of the inserter spring 11 is equal to or larger than 0.25 N/mm and the spring constant k2 of the retraction spring 12 is equal to or larger than 0.1 N/mm. After the distal part of the cylindrical body of the carrier body 2 has passed between the outward arms 4 of the stationary part 10, the outward arms 4 return to their position and the distal part of the carrier body 2 is now between the arms 4 instead of above the arms 4 as shown in fig. 2. The carrier body 2, the stationary part 10 and the house 1 are at this position all at a level where they touch the patients skin. The pivotally mounted arms 8 of the needle hub 6 which have an inclined surface have in this position been forced inwards by the protruding parts 15A of the protruding circular edge 15. The inward movement is a result of the stationary protruding parts 15A touching the pivotally mounted arms 8 when the arms 8 move downwards. Fig. 4A, 4B and 4C shows the inserter device in a state where the needle hub 6 is in a position where the penetrating member 6A is fully retracted from the patients skin. The retraction spring 12 has pushed the needle hub 6 as far upwards and away from the patient as possible, the needle hub 6 can only move to the upper end of the proximal part of the carrier body 2 as the protruding parts 6B of the needle hub 6 at this position will come into contact with a surface of the distal part of the carrier body 2.
Fig. 5A, 5B and 5C shows the inserter device in a state where the needle hub 6, the carrier body 2 and the stationary part 10 are positioned as in fig. 4, but in fig. 5 the user has released the pressure on the house 1 and therefore the house has jumped back into the same position as in fig. 1 where the inserter spring 11 is relaxed.
If the medical device is not provided with a cannula, then the medical device can be fastened to the patients skin before insertion. The cannula will then - irrespective of whether this is a hard self-penetrating or a soft cannula - be provided together with the needle hub 6 e.g. as a separate cannula part (1 b) as shown in PCT application no. PCT/DK2006/000737. If the medical device is provided with a soft cannula, the medical device will be delivered to the patient as an integrated part of the inserter device. When the inserter device has been unpacked and is ready for use the release layer is removed from the mounting pad 20 and then the medical device joint to the inserter device is placed against the skin of the patient. The user then activates the insertion procedure by pushing the house 1 of the inserter device towards the patients skin. This one push causes the needle hub and the hereto joint medical device and penetrating member 6A to be inserted subcutaneously and afterwards the penetrating member 6A is automatically being retracted and placed inside the carrier body 2. The user can then remove the inserter device from the medical device leaving the medical device fully functional on the patients skin.
The inserter can be used for sub- or transcutaneously positioning of a unit for metering a substance e.g. the glucose content of the blood and/or for sub- or transcutaneously positioning of an infusion part of an infusion set for delivering of a drug e.g. insulin to the patient and/or sub- or transcutaneously positioning of a gateway for replacing multiple injections, such a gate way is e.g. known from the international patent application PCT/DK2006/050005 and this gateway is incorporated in the present application by reference. The inserter can also be used for inserting a cannula device as known from PCT/DK2006/00737 e.g. figures 32-36, such a cannula device is hereby incorporated in the present application by reference.
1. An inserter for a medical device comprising two elastic elements (11 , 12) where activation of the first elastic element (11 ) cause a penetrating member (6A) to be inserted sub- or transcutaneous^ into the skin of a patient, and the second elastic element (12) cause the penetrating member (6A) to be retracted from the skin of the patient characterized in that the first elastic element (11 ) is in an unloaded state before activation and upon activation the first elastic element (11 ) energizes the second elastic element (12).
2. An inserter for a medical device according to claim 1 , wherein the first elastic element is a spring (11 ) having a spring constant ki.
3. An inserter for a medical device according to claim 1 or 2, wherein the second elastic element is a spring (12) having a spring constant k2.
4. An inserter for a medical device according to claim 1 , wherein the spring constant ki of the first elastic element is larger than the spring constant k2 of the second elastic element.
5. An inserter for a medical device according to claim 4, wherein the spring constant ki > 2k2.
6. An inserter for a medical device according to claim 4, wherein the spring constant ki > 0.2 and the spring constant k2 > 0.09.
7. An inserter for a medical device according to claim 1 , wherein the first elastic element and/or the second elastic element are/is a helical spring.
8. An inserter for a medical device according to claim 1 , comprising - a stationary part (10) being stationary in relation to the patient during insertion and resting against the patients skin, - activation means (1 ),
- a carrier body (2) which carrier body (2) has a forward and a retracted position relative to the stationary part (10) and
-a needle hub (6) connected with a penetrating member (6A), - first locking means (4) locking the carrier body (2) in a retracted position,
- second locking means (8, 9) locking the needle hub (6) in a forward position relative to the carrier body (2), - second release means (15A) unlocking the needle hub (6) from the forward position, wherein the first elastic element (11 ) apply force to a surface of the house (1 ) and to a surface of the carrier body (2) and the second elastic element (12) apply force to a surface of the needle hub (6) and a surface of the stationary part (10).
9. An inserter for a medical device according to claim 8, wherein the house (1 ) is the activation means (1 ) and inside the house (1 ) the carrier body (2) moves from a retracted to a forward position when the first elastic element (11 ) is activated.
10. An inserter for a medical device according to claim 8, wherein the second release means (15A) automatically releases the needle hub (6) from the carrier body (2) when it passes a certain position.
11. An inserter for a medical device according to claim 10, wherein the release means (15A) are part of the stationary part (10).
12. An inserter for a medical device according to claim 8, wherein a first integrated part (1 , 11 ) comprising the first elastic element (11 ) can be separated from a second integrated part (2, 6, 10, 12) comprising the second elastic element (12) and the penetrating needle.
13. An inserter for a medical device according to claim 12, wherein the first integrated part (1 , 11 ) is reusable and the second integrated part (2, 6, 10,
12) is disposable.
14. Use of an inserter according to claim 1 -13 for sub- or transcutaneous^ positioning of a unit for metering a substance e.g. the glucose content of the blood and/or sub- or transcutaneous^ positioning of an infusion part of an infusion set for delivering of a drug e.g. insulin to the patient and/or sub- or transcutaneous^ positioning of a gateway for replacing multiple injections.
PCT/EP2008/058512 2007-07-10 2008-07-02 Inserter having two springs WO2009007287A1 (en)
US95913407 true 2007-07-10 2007-07-10
US60/959,134 2007-07-10
JP2010515472A JP2011509097A (en) 2007-07-10 2008-07-02 Inserter with two springs
CN 200880023933 CN101790394B (en) 2007-07-10 2008-07-02 Inserter having two springs
DE200860005153 DE602008005153D1 (en) 2007-07-10 2008-07-02 Inserter with two feathers
DK08774646T DK2173410T3 (en) 2007-07-10 2008-07-02 Inserter having two springs
EP20080774646 EP2173410B1 (en) 2007-07-10 2008-07-02 Inserter having two springs
US12667926 US8486003B2 (en) 2007-07-10 2008-07-02 Inserter having two springs
CA 2704909 CA2704909A1 (en) 2007-07-10 2008-07-02 Inserter having two springs
WO2009007287A1 true true WO2009007287A1 (en) 2009-01-15
PCT/EP2008/058512 WO2009007287A1 (en) 2007-07-10 2008-07-02 Inserter having two springs
EP (1) EP2173410B1 (en)
WO2007020090A1 (en) * 2005-08-17 2007-02-22 L + N Plast Vertriebs Gmbh Automatic injector device
EP1569852B1 (en) * 2002-12-10 2009-06-10 Rapid Action Packaging Limited Carton for diagonally cut sandwiches
US20100228226A1 (en) 2010-09-09 application
CN101790394B (en) 2012-10-17 grant
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