Source: https://insight.rpxcorp.com/pat/US7867200B2
Timestamp: 2019-10-20 00:52:18
Document Index: 697553357

Matched Legal Cases: ['arts 10', 'arts 10', 'arts 10', 'art 1', 'art 30', 'art 30', 'art 24', 'art 30', 'arts 10', 'art 24', 'art 25', 'art 25', 'art 25', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 13', 'art 25', 'art 13', 'art 13', 'art 13']

Patent US 7,867,200 B2
Medical device inserter
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FIGS. 9a and b show an exploded view of the third embodiment;
FIGS. 1-3 and 5-7 show an embodiment of the invention wherein the set housing 1 is U-shaped having an upper leg 1a and a lower leg 1b. In this embodiment the upper and the lower leg are parallel and connected in one end through a piece of material approximately of the same length as the height of the needle unit 2, 4. The distance between the upper and the lower leg 1a, 1b will depend on height and general shape of the needle unit 2, 4 connected with the cannula housing 3 and also the distance between the upper and lower leg 1a, 1b should be sufficient to comprise the guiding means 9a, 9b, 9c which keep the needle unit 2, 4 and cannula housing 3 in place during traveling between the retracted and advanced position.
The guiding means of the set housing in FIGS. 1-3 comprises two opposite and outward L-profiles 9a standing up from the lower leg 1b, flanges 9b extending downwardly from the upper leg 1a and flanges 9b extending inwardly from side parts of the upper leg 1a being in contact with the sides 9e of the needle unit 2, 4. The corresponding guiding means on the needle unit 2, 4 comprise at the bottom side of the needle unit 2, 4 two inward L-profiles (not shown in figures) which profiles correspond to the outward L-profiles on the set housing 1, see FIG. 5, and on the upper side of the needle unit 2, 4 two flanges 9d are standing up from the top side keeping contact with the upper leg 1a and the flanges 9b.
At the end of the lower leg 1b 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.
The essentially triangular profile 11 extending from the lower leg 1b is provided for facilitating handling as the total functional inserter set is quite small and else can be difficult to handle if the user has reduced dexterity.
The spring unit 13 that pushes the needle unit 2, 4 forward when the release button 7 is activated, is shown in FIGS. 6 and 7. The spring unit 13 is placed between the set housing 1 and the needle unit 2, 4 at the closed end of the U-shaped set housing 1. The spring unit 13 is fastened to a protrusion 18a at the back end of the needle hub 2 and to a protrusion 18b on the inside of the set housing 1. The spring unit 13 may be any suitable spring but in this embodiment the spring unit 13 is preferably a coil spring which pushes the needle unit 2, 4 away from the set house ending.
In order to control the forward movement of the needle unit 2, 4 when the release button 7 is used, the lower leg 1b of the set housing 1 is provided with a stopper 12. In the embodiment in FIGS. 1-3 the needle unit 2, 4 stops moving forward when a corresponding protrusion on the needle unit 2, 4 hits the stopper 12. In the embodiment in FIGS. 5-7 two flanges 9f move in tracks 19 formed as grooves in the lower leg 1b and the stopper 12a is provided as the flanges 9f touches the end of one or both of the tracks 19.
In another preferred embodiment the stopper 12 is created by the ends of the upper and lower legs 1a and 1b of a U-shaped set housing 1. When both or one of the ends of the legs 1a and 1b are turned inwardly, the leg ends restrict the distance between the upper and the lower leg 1a, 1b at the open end of the U-shaped set housing. When this distance is restricted to less than the height of the needle unit 2, 4, the inwardly turned leg ends perform as a stopper 12.
In FIG. 5 the needle hub 2 is shown detached from the cannula housing 3 and the carrier body 4. In this preferred embodiment the needle hub 2 comprises two openings 15 in the rear half which openings 15 correspond to two projections 16 on the carrier body 4. When the projections 16 are placed in the openings 15, the needle hub 2 and the carrier body 4 are locked relatively to each other in the horizontal plane (in this embodiment the horizontal plane is the plane perpendicular to the contact surfaces between the openings of the needle hub 2 and the projections of the carrier body 4). When the needle unit 2, 4 comprising the joined needle hub 2 and carrier body 4 is placed in the set housing 1, the legs 1a and 1b of the set housing 1 cover the needle unit 2, 4 on two opposite sides and prevent movements in the vertical direction.
When the inserter set is produced and prepared for use, it will normally be delivered to the user in packed, set and sterilized condition being ready for use. When the user opens the package, the needle unit 2, 4 is connected to the cannula housing 3 forming the infusion set, and the infusion set is in a retracted position. A mounting pad 14 is placed on the lower side of the cannula housing 3 and the sticky side of the mounting pad is covered with release paper. The user removes the release paper from the mounting pad and places the base part 1b, 10 of the inserter against the skin in an adequate angle; where after the user pushes the release button 7.
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. 9a and 9b). The upper side of the carrier body 4 is provided with guiding means 9d having the form of a rectangular plate, the guiding means 9d of the carrier body 4 fit into guiding means 9b 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 9d 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 9d passes the end of or an opening in the L-profiled guiding means 9b 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 7a if the needle unit is locked by (2). Preferably there will be indicated pressure points 7a 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 9d 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 7a the user pushes down the front end of the guiding means 9d and disengage the protruding parts at the rear end of the guiding means 9d from the means 9b 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, 13a and 13b, 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 13a of the C-formed spring units 13 are stationary in relation to the set housing 1. The front end 13b of the flat springs rests against a surface 4a 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, 13a and 13b, 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 13a of the slightly C-formed spring units 13 are stationary in relation to the set housing 1. The front end 13b 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 13b is in this embodiment fastened to the front part of the needle unit 2, 4 below the needle level.
How the flat springs are fastened to the set housing 1 at 13a will depend on which material they are made of as this influence the form—particularly the thickness—they are made in. If the flat springs are made of a plastic material the material where they are fastened to the housing 1 can take almost any form if they e.g. are produced by molding. If the material is of an adequate thickness a protruding part 25 of the flat spring can be squeezed into an opening in the set housing 1. If the flat springs are made of e.g. metal it would be more expensive to form a protruding part 25 on the flat spring, in this case it would in stead be efficient to cut e.g. a three-sided rectangular slit in the flat spring which is to be fastened to the set housing 1 and form a cut-out 26. This slit makes it possible to bend the cut-out 26 out of the surface of the flat spring and let it rest against the set housing 1. When the flat springs are fastened to the set housing 1 either by a protruding part 25 or by a cut-out 26 it will not be necessary to perform further fastening of the springs to the housing e.g. by welding, gluing or the like.
FIG. 13 shows a fifth embodiment of the inserter where the spring unit 13 is formed of a circular spring. The rearmost part 13a of the circular spring unit 13 is stationary to the set housing 1 and the front part 13b 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 13c lying along the bottom wall of the set housing 1. Such a prolonged part 13c 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 13a of the circular spring unit 13 is resting against the upper part (above needle level) of the set housing 1 and the front part 13b 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. 14 shows a sixth embodiment with a spring unit 13 formed as an S and constituted of a flat spring made of metal or plastic. The front part 13b of the S-formed spring is fastened to or rests against a surface 4a of the needle unit preferably in a slightly biased state when the needle unit 2, 4 is in its foremost position; the rearmost end of the S-formed spring is fastened to the bottom of the set housing 1. Preferably the rearmost end is fastened to the housing by a prolonged part 13c which can be placed in a trail formed by two opposite and inward turned, upright L-profiles, fastened at the rear end e.g. by a protruding part 25 of the spring unit 13 being pressed into an opening in the set housing 1, and at the front by a three-sided rectangular slit 26 in the prolonged part forming a cut-out which can catch the front edge of the set housing 1. When the handle and the needle unit are pulled back the two ends of the S are pressed together biasing the spring, and when the release button is activated the spring pushes the needle unit 2, 4 forward.
FIG. 15 shows a seventh embodiment of the inserter where the spring unit 13 is formed of a coiled spring. The rearmost part 13a of the coiled spring unit 13 is stationary to the set housing 1 and the front part 13b 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 13b 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 13b of the spring unit 13 towards the stationary end 13a.
FIG. 16 shows an eighth embodiment of the inserter where the spring unit 13 is a circular or rectangular leaf spring. The back end 13a of this flat spring 13 is stationary to the set housing 1, and the back end 13b is fastened or rest against a part of the top wall of the set housing 1. The front end 13b is fastened to the lower side of the needle unit 2, 4 e.g. at a position p2 (see FIGS. 9a and 9b).
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 13b of the spring unit 13 is fastened to the side walls of the set housing 1, and the rearmost part 13a 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.
FIG. 18 shows an inserter with a spiral spring 13 where one end 13a of the spring is fixed to a bottom part of the needle unit 2, 4, and the other end 13b 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 13a of the S-formed spring units 13 are stationary in relation to the set housing 1. The front ends 13b 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, 13a and 13b, 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.
Mogensen, Lasse W., Göransson, Magnus W.
604/164.04, 604/164.08, 604/164.12, 604/165.04, 604/288.01, 604/288.04, 604/181
Current Assignee: Unomedical A/S
Sponsoring Entity: Unomedical A/S