Source: http://www.google.com/patents/US7867200?dq=Donato+M.+Fraioli
Timestamp: 2017-09-20 01:12:57
Document Index: 292656280

Matched Legal Cases: ['§371', 'arts 10', 'arts 10', 'arts 10', 'art 30', 'art 30', 'art 24', 'art 30', 'arts 10', 'art 24', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 40', 'art 40', 'art 40', 'art 40', 'art 41']

Patent US7867200 - Inserter - Google Patents
The invention relates to an inserter for an infusion set for intermittent or continuous administration of a therapeutical substance such as e.g. insulin. The inserter comprises a needle unit comprising a needle hub (2) and a carrier body (4), and a cannula housing (3). The cannula housing and the needle...http://www.google.com/patents/US7867200?utm_source=gb-gplus-sharePatent US7867200 - Inserter
Publication number US7867200 B2
Application number US 11/721,263
PCT number PCT/DK2005/050010
Also published as CA2589693A1, CN101072597A, CN101072597B, EP1824537A2, US7867199, US20060161108, US20090306596, WO2006061027A2, WO2006061027A3
Publication number 11721263, 721263, PCT/2005/50010, PCT/DK/2005/050010, PCT/DK/2005/50010, PCT/DK/5/050010, PCT/DK/5/50010, PCT/DK2005/050010, PCT/DK2005/50010, PCT/DK2005050010, PCT/DK200550010, PCT/DK5/050010, PCT/DK5/50010, PCT/DK5050010, PCT/DK550010, US 7867200 B2, US 7867200B2, US-B2-7867200, US7867200 B2, US7867200B2
Inventors Lasse W. Mogensen, Magnus W. Göransson
Patent Citations (470), Non-Patent Citations (7), Classifications (11), Legal Events (6)
US 7867200 B2
The invention relates to an inserter for an infusion set for intermittent or continuous administration of a therapeutical substance such as e.g. insulin. The inserter comprises a needle unit comprising a needle hub (2) and a carrier body (4), and a cannula housing (3). The cannula housing and the needle hub are releasably connected and when they are connected, the insertion needle (6) is placed inside the cannula (5). The carrier body guides the movement relative to the set housing between a retracted and an advanced position. When released the needle unit and the cannula housing are forced by a spring unit (13) to an advanced position where the needle and cannula are placed subcutaneously. The object of the invention is to provide a disposable inserter for an infusion set which inserter is easy and safe for the user to handle during use and to dispose of after use.
1. An inserter for an angled infusion set comprising:
a set housing, the set housing being provided with first guiding means on an internal surface of the set housing and a lower base of the set housing including a projecting part, the projecting part forming an angle with respect to the body for indicating a correct insertion angle for the user during insertion;
a carrier body, the carrier body being provided with second guiding means on an external surface of the carrier body, the second guiding means for guiding movement of the carrier body relative to the first guiding means of the set housing between a retracted and an advanced position, the second guiding means comprising at least one protruding part, the at least one protruding part positionable at least partially within the first guiding means for movement between the retracted and the advance position, the at least one protruding part releasably lockable to an end portion of the first guiding means to releasably lock the carrier body in the retracted position;
a needle hub, the needle hub comprising an insertion needle for piercing of the skin, the needle hub and the carrier body being unreleasably connected;
a cannula housing, the cannula housing comprising a soft cannula to be placed subcutaneously, the cannula housing and the needle hub being releasably connected to each other, and the insertion needle being adjoined to the cannula when the cannula housing and the needle hub are connected; and
a spring unit connected to a release means, wherein upon activation of the release means, the cannula housing, the needle hub and the carrier body are forced by the spring unit to the advanced position where the needle and cannula can be placed subcutaneously.
2. An inserter according to claim 1, wherein the needle hub comprises a plurality of openings in a part of the needle hub and the carrier body is provided with a plurality of projections corresponding to the plurality of openings in the needle hub, wherein a portion of the set housing covers the plurality of openings.
3. An inserter according to claim 1, wherein the needle hub and the carrier body can be placed in a retracted position after insertion.
4. An inserter according to claim 1, wherein the inserter further comprises a stopper on the set housing.
5. Inserter as claimed in claim 1, wherein the set housing forms at least a part of a delivery packing for the inserter.
6. Inserter as claimed in claim 1, wherein the set housing is provided with a cover.
7. Inserter as claimed in claim 1, wherein the spring unit is fastened to the set housing in a first position and to the carrier body or the needle hub in a second position, and the first position is situated closer to a front end of the set housing than the second position when the spring unit is unbiased.
8. Inserter as claimed in claim 1, wherein the spring unit is an elastic O-ring.
9. Inserter as claimed in claim 1, wherein the spring unit is fastened to the set housing in a first position and fixed to the carrier body or the needle hub in a second position, and the first position is situated closer to a back end of the set housing than the second position when the spring unit is unbiased.
10. Inserter as claimed in claim 1, wherein the spring unit is a flat spring placed between a back end of the set housing and a needle unit.
11. Inserter as claimed in claim 10, wherein the spring unit comprises two convex curved portions placed on each side of the needle unit, and that each curved portion is fixed to the needle unit at one end and to the set housing behind the fixation to the needle unit at another end in the unbiased state.
12. Inserter as claimed in claim 1, wherein a part of the projecting part is positioned above an insertion axis for the insertion needle and another part of the projection part is positioned below the insertion axis.
13. The inserter of claim 1, wherein the second guiding means comprises a rectangular plate.
14. The inserter of claim 1, wherein the first guiding means comprises a pair of L-shaped protrusions forming an opening for reception of the second guiding means.
15. The inserter of claim 1, wherein the spring unit comprises a pair of flat springs.
16. The inserter of claim 1, wherein the spring unit comprises a first convex curve and a second convex curve.
17. The inserter of claim 1, wherein the spring unit comprises a first end connected to the carrier body.
18. An inserter for an angled infusion set comprising:
a set housing, the set housing comprising a first guide on an internal surface of the set housing and the set housing comprising a lower base including a projecting part, the projecting part forming an angle with respect to the body for indicating a correct insertion angle for the user during insertion;
a carrier body, the carrier body comprising a second guide on an external surface of the carrier body, the second guide comprising at least one protruding part positionable at least partially within the first guide for movement of the carrier body relative to the set housing between a retracted position and an advanced position, the at least one protruding part releasably lockable to an end portion of the first guiding means to releasably lock the carrier body in the retracted position;
a needle hub connected to the carrier body, the needle hub comprising an insertion needle for piercing of the skin;
a cannula housing, the cannula housing comprising a soft cannula to be placed subcutaneously, the cannula housing and the needle hub being releasably connected to each other, the insertion needle extending at least partially through the cannula when the cannula housing and the needle hub are connected; and
a spring unit connected to the carrier body, the spring unit biasing the needle hub and the carrier body to the advanced position where the needle and cannula can be placed subcutaneously when the protruding part is released from the end portion of the first guide.
19. The inserter of claim 18, further comprising a release member, the release member being activatable to allow the carrier body to move to the advanced position.
20. The inserter of claim 18, wherein the spring comprises a flat spring.
This application is a 35 U.S.C. §371 national stage application of International Application No. PCT/DK2005/050010, filed Dec. 9, 2005, which is a continuation-in-part of Danish Patent Application No. PA 200401914, filed Dec. 10, 2004 and which claims the benefit of U.S. application Ser. Nos. 60/634,940, filed Dec. 10, 2004; 60/679,453, filed May 9, 2005 and 60/699,472, filed Jul. 15, 2005, these references are incorporated herein in their entirety.
US 2002/0077599 A1 concerns an inserter for a low-profile, angled infusion set which inserter comprises an inserter housing having a bottom wall, a retainer slidably connected to the inserter housing for movement between retracted and extended positions in a direction substantially parallel with the bottom wall. The inserter also comprises a base member connected to the outer surface of the inserter housing. The retainer is adapted to releasably receive a cannula housing. When used the retainer 30 moves forward and causes the needle 27 and the cannula 26 to pierce the skin at a proper angle and enter into the subcutaneous layer at a proper distance. The cannula housing 28 can then be released from the inserter assembly 10 by depressing the release button 66. Afterwards the mounting pad 80 is secured to the skin and the needle 27 is removed, thus leaving the cannula 26 in place.
The end of the projecting part should preferably pass beyond the line formed by the needle/cannula in front of the end of the insertion needle when the needle unit is in a retracted position. This makes it necessary to provide an opening in the prolongation in order for the needle/cannula to be able to pass through. According to the embodiment of FIGS. 1-3 this is obtained by separating the projecting part into two legs. In this embodiment the projecting part is formed as a mathematical continuous curvature but it could also be noncontinuous, i.e. being provided with one or more breaks.
In yet another embodiment the set housing is formed of a single U-shaped piece of material. The set housing is U-shaped which means that it is constructed of a rectangular or elliptic piece of flat material which is bent in such a way that the ends of the material—seen from the side—forms two substantial parallel legs connected in one end with a straight or arched line, where the legs are not necessarily of the same length. The material is of a bend form which does not mean that it is constructed by bending; it could e.g. be molded in a bend form. When the set housing is U-shaped the part called the lower leg is the leg in contact with the user when the inserter is in position for insertion of the infusion device.
FIGS. 9 a and b show an exploded view of the third embodiment;
FIG. 12 shows the needle unit combined with the spring unit of the fourth embodiment seen from above/behind;
FIG. 12A shows a spring unit similar to the fourth embodiment seen from above/front;
FIG. 13 shows a fifth embodiment with a circular spring seen from the side A, from above B and from behind C;
FIG. 13A shows a secondary embodiment with a circular spring seen from the side;
FIG. 15 shows a seventh embodiment with a coiled spring unit seen from the side in (A) a forward position and (B) a retracted position;
FIG. 16 shows an eighth embodiment with a flat spring in A: a forward position seen from the side, B: a forward position seen from the behind, C: a retracted position seen from the side, D: a retracted position seen from above.
FIG. 17 shows a ninth embodiment with a spring unit fastened to opposite sides of the set housing and the embodiment is shown in (A) a forward position seen from the side, (B) a retracted position seen from the side, (C) a forward position seen from above, (D) a retracted position seen from above.
FIG. 18 shows a tenth embodiment of the inserter with a spiral spring unit;
FIG. 21 shows an infusions set which can be inserted with the inserter of the invention.
At the end of the lower leg 1 b two upwardly bend parts 10 are formed. These parts 10 indicate the correct insertion angle for the user when the user inserts the cannula. Also the parts 10 will assure that a mounting pad 14 placed in connection with the cannula housing 3 will be in correct and ready position when the cannula 5 is inserted.
In FIG. 8 it is shown how this embodiment could be delivered: the needle unit 2, 4 is in a relaxed, i.e. non-biased or just slightly biased forward position and the needle is covered with a hard case top 20 which has to be removed from the device before use. The set housing 1 is formed as a piece of pipe with an oval cut-through profile. Opposite the hard case top 20 the set housing 1 is covered with a removable flat cover 21. The flat cover can be provided with an adhesive for assuring the tight closure between the cover 21 and the set housing 1 or it can be welded to the set housing, and any kind of cover which at the same time has the necessary strength to resist transportation and can provide hermetical sealing of the device will do. The needle unit 2, 4 is unreleasably connected to a handle 22 which handle on the lower side is provided with a projection 23 for fastening of a spring unit 13 (see FIGS. 9 a and 9 b). The upper side of the carrier body 4 is provided with guiding means 9 d having the form of a rectangular plate, the guiding means 9 d of the carrier body 4 fit into guiding means 9 b of the set housing 1 having the form of downward L-profiles.
The combination of the L-profiles and the rectangular plate assures that the carrier body has limited possibilities for moving up and down, and is lead along the wall of the set housing 1 in a very controlled manner. The spring unit 13 in this embodiment consists of elastic in the form of an O-ring. The spring is fastened to the lower front part of the set housing 1 at the position p1 and the lower part of the carrier body 4 at position p2. In this embodiment the spring unit 13 is fastened behind—and beyond—the carrier part of the carrier body 4 which causes the carrier body 4 to get into a slightly tilted position when the spring is biased as only the lower part of the carrier body 4 is pulled forward by the spring unit 13, and this tilted position can lock or support the locking of the carrier body 4 in the retracted position as the guiding means 9 d are provided with a protruding part 30 (see FIG. 12, 15, 19, 20) on the rearmost half. When the spring unit 13 is biased, this protruding part 30 will be influenced by a downward force created because the carrier body 4 is being pulled forward at a low point.
When the user is going to apply the device the needle unit 2, 4 is brought to a retracted position (see FIG. 10) by pulling the handle 22 either (1) until the projection 23 on the lower side of the handle passes a raised part 24 on the inside of the lower part of the set housing 1 or (2) until the protruding part 30 on the guiding means 9 d passes the end of or an opening in the L-profiled guiding means 9 b of the set housing 1. Then the user places the upwardly bend parts 10 against the skin and release the needle unit 2, 4.
When the user wants to release the needle unit 2, 4 from the retracted position the user can push the two pressure points 7 together if the needle unit is locked by (1) or the user can push down at 7 a if the needle unit is locked by (2). Preferably there will be indicated pressure points 7 a on both upper and lower side of the set housing 1 in order for the user to apply oppositely directed finger pressures. When the to points 7 are pushed toward each other the diameter of the housing perpendicular to a line between the pressure points is increased, and as the guiding means 9 d on the upper side of the carrier body 4 are caught in the inward L-profiles the projection 23 is lifted free of the raised part 24. This activates the spring unit 13 and causes the needle unit 2, 4 and the attached cannula housing 3 to move forward to an advanced position. When pushing down at 7 a the user pushes down the front end of the guiding means 9 d and disengage the protruding parts at the rear end of the guiding means 9 d from the means 9 b of the set housing 1, this activates the spring unit 13 and causes the needle unit 2, 4 and the attached cannula housing 3 to move forward to an advanced position.
In FIGS. 11 and 12 is shown a fourth embodiment with a different kind of spring unit 13. The spring unit 13 of this embodiment is made of two flat springs and each of them is formed as a C when the spring unit is unbiased. That the flat springs are formed as a C means that they comprise only one convex curve, how the springs are shaped and fastened at each end, 13 a and 13 b, of the curve will depend on the material and the form chosen for the springs. The flat springs 13 are fastened to the bottom wall of the set housing 1 in such a way that the back end 13 a of the C-formed spring units 13 are stationary in relation to the set housing 1. The front end 13 b of the flat springs rests against a surface 4 a of the needle unit 2, 4 or is fastened to the needle unit 2, 4. In this embodiment the C-formed spring units 13 are placed between the back end of the needle unit 2, 4 and the back end of the set housing 1 and when the handle 22 is pulled back, the spring units 13 are biased, the two ends of the C-formed spring units, 13 a and 13 b, are brought closer together. When the release button 17 is activated the spring units 13 will return to the unbiased form and the needle unit 2, 4 will be pushed forward.
In FIG. 12A is shown an embodiment of the flat springs 13 are fastened to the top wall of the set housing 1 in such a way that the back end 13 a of the slightly C-formed spring units 13 are stationary in relation to the set housing 1. The front end 13 b of the flat springs rests against a surface of the needle unit 2, 4 or is fastened to the needle unit 2, 4 but the front end 13 b is in this embodiment fastened to the front part of the needle unit 2, 4 below the needle level.
FIG. 13 shows a fifth embodiment of the inserter where the spring unit 13 is formed of a circular spring. The rearmost part 13 a of the circular spring unit 13 is stationary to the set housing 1 and the front part 13 b of the circular spring 13 is fastened to the needle unit 2, 4 or to the handle 22 or is simply resting against the movable needle unit 2, 4 or handle 22 in a slightly biased state. The spring unit 13 might be formed with a prolonged part 13 c lying along the bottom wall of the set housing 1. Such a prolonged part 13 c could be fastened anyway along its length but preferably at a position p1 close to the front of the set housing 1.
FIG. 13A shows an embodiment where the rearmost part 13 a of the circular spring unit 13 is resting against the upper part (above needle level) of the set housing 1 and the front part 13 b of the circular spring 13 is fastened to the handle 22 by simply resting a specially formed part against the handle 22 in a slightly biased state.
FIG. 15 shows a seventh embodiment of the inserter where the spring unit 13 is formed of a coiled spring. The rearmost part 13 a of the coiled spring unit 13 is stationary to the set housing 1 and the front part 13 b of the coiled spring 13 is fastened to the needle unit 2, 4 or to the handle 22 or is simply resting against a part of the movable needle unit or handle in a slightly biased state. The spring unit 13 might be partly enclosed in a trail lying along the bottom wall of the set housing 1. Such a trail would preferably be made of the same material as the set housing 1. The trail can consist of to walls rising from the bottom wall of the set housing 1, and the walls might be parallel, rounded inwards or inclined toward each other. A part of the needle unit 2, 4 is formed as reaching downwards, and this part reaches down into and slides inside the trail. The front end 13 b of the spring unit 13 is fastened to or rest against this part. When the handle 22 is brought to the retracted position, this part will assure that the spring unit 13 inside the trail is biased by pushing the movable end 13 b of the spring unit 13 towards the stationary end 13 a.
FIG. 16 shows an eighth embodiment of the inserter where the spring unit 13 is a circular or rectangular leaf spring. The back end 13 a of this flat spring 13 is stationary to the set housing 1, and the back end 13 b is fastened or rest against a part of the top wall of the set housing 1. The front end 13 b is fastened to the lower side of the needle unit 2, 4 e.g. at a position p2 (see FIGS. 9 a and 9 b).
FIG. 17 shows a ninth embodiment of the inserter where the spring unit 13 is fastened to opposite walls of the set housing 1. In FIG. 17 the front ends 13 b of the spring unit 13 is fastened to the side walls of the set housing 1, and the rearmost part 13 a of the spring unit 13 is fastened to or rests against the movable needle unit 2, 4 at a position p3. In this embodiment the spring unit 13 forms a loop around a low part of the needle unit 2, 4, and does not actually touch the position p3 when the spring unit is in an unbiased state. When the handle 22 is pulled back biasing the spring unit 13, the loop will be deformed and tightened around the low part of the needle unit 2, 4, and when the release button is activated the needle unit 2, 4 will be pulled forward by the spring unit 13 as the loop will return to its original form. Preferably this embodiment would be made of a metal wire or another material with similar characteristics.
It would also be possible to construct the spring unit 13 of a flat spring where the foremost part is resting against the position p3 and indicated in FIGS. C and D with a thin black line, and the rearmost part is fastened to the side walls of the set housing 1 at the rear position of the side walls. In this case the flat spring could be made of metal or plastic.
FIG. 18 shows an inserter with a spiral spring 13 where one end 13 a of the spring is fixed to a bottom part of the needle unit 2, 4, and the other end 13 b is fixed to a hook or similar at the front part of the set housing 1. When retracting the needle unit 2, 4 the spiral spring is uncoiled, and when releasing the retainer the spring coils up and moves forward, causing the needle and cannula to pierce the skin at a proper angle and enter into the subcutaneous layer at a proper distance.
In FIGS. 19 and 20 is shown an eleventh embodiment the spring unit 13 is made of two flat springs and each of them is formed as a slightly bend S. That the flat springs are formed as an S means that they comprise two convex curves. The flat springs 13 are fastened to the top wall of the set housing 1 in such a way that the back end 13 a of the S-formed spring units 13 are stationary in relation to the set housing 1. The front ends 13 b of the flat springs are fastened to the needle unit 2, 4. In this embodiment the S-formed spring units 13 are placed between the front end of the needle unit 2, 4 and the back end of the set housing 1 and when the handle 22 is pulled back, the spring units 13 are biased, the two ends of the S-formed spring units, 13 a and 13 b, are brought closer together. When the release button 17 is activated the spring units 13 will return to the unbiased form and the needle unit 2, 4 will be pushed forward.
FIG. 21 shows an infusions set which can be inserted with the inserter of the invention. The infusion set comprises an infusion part which will be inserted with the inserter and a connector part which after insertion can form the connection between e.g. an insulin pump and the infusion part. In this embodiment the connector part is symmetrical around the plane formed by the two arms.
FIG. 21 shows an infusion set comprising a connector part 40 and cannula housing 3. The cannula housing 3 can be inserted with the inserter according to the claims. After insertion the insertion needle 6 of the inserter is removed together with the inserter and the connector part 40 is placed in the shown position. In this embodiment the connector part 40 is symmetrical around the plane which is parallel to the needle and comprises the two arms 41 of the connector part 40. This connector part 41 also comprises a connector needle 42 which needle penetrates a barrier layer in the cannula housing 3.
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1 Advisory Action mailed Oct. 20, 2009 for U.S. Appl. No. 11/298,259.
2 International Preliminary Report on Patentability dated Mar. 20, 2007 for International Application No. PCT/DK2005/050010.
3 International Search Report from DK 200401914 dated Sep. 5, 2005.
4 International Search Report mailed Aug. 8, 2006 for International Application No. PCT/DK2005/050010.
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U.S. Classification 604/164.12, 604/181, 604/164.01
International Classification A61M5/178, A61M5/00
Cooperative Classification A61M5/158, A61M2005/1585, A61M25/0612, A61M2005/1587
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MOGENSEN, LASSE W.;GORANSSON, MAGNUS W.;REEL/FRAME:019810/0130;SIGNING DATES FROM 20070705 TO 20070804
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MOGENSEN, LASSE W.;GORANSSON, MAGNUS W.;SIGNING DATES FROM 20070705 TO 20070804;REEL/FRAME:019810/0130