Source: http://www.freepatentsonline.com/y2007/0016129.html
Timestamp: 2020-05-26 04:47:32
Document Index: 183340373

Matched Legal Cases: ['arts 202', 'art 202', 'art 424', 'art 605', 'art 605', 'art 605']

Insertion Device for Infusion Sets - Liniger, Jurg
United States Patent Application 20070016129
Roethlisberger, Mark (Hasle-Rueegsau, CH)
11/427437
A61M31/00; A61M5/158
Download PDF 20070016129 PDF help
20080294109 Illumination Instrument for an Infusion Pump November, 2008 Estes et al.
20080215016 Medical Tubes September, 2008 Igarashi et al.
FIG. 8, including FIGS. 8a, 8b and 8c, shows a variant of the device of FIG. 3.
FIG. 9, including FIGS. 9a and 9b, show the device of FIG. 8 in a released state.
FIG. 10, including FIGS. 10a, 10b and 10c, shows another embodiment of the present invention.
FIG. 12, including FIGS. 12a and 12b, shows another embodiment of the present invention.
FIG. 13, including FIGS. 13a and 13b, shows another embodiment of the present invention.
FIG. 14, including FIGS. 14a to 14c, shows further views of the embodiment of FIG. 13.
FIG. 15, including FIGS. 15a to 15c, shows further views of the embodiment of FIG. 13.
In use, movement of grip elements 17a, 17b in the direction of the release button 10 tensions the displacement mechanism 4 and engages the locking lug 11 in the holding fixture 12. Actuation of the release button 10 leads to a sideward movement of the locking lug 11 and, consequently, to release from the holding fixture 12 and thus to release of the displacement mechanism 4 from a tensioned to a non-tensioned position. When the cannula 33 is arranged under the skin, renewed actuation of the release button 10 causes a slight axial movement of the ejector device 15 and thus, via cams (not shown), an axial movement to the infusion set 30 held by frictional engagement in the receiving element 9. This movement suffices to eject the infusion set 30 from the receiving element 9.
FIGS. 3 to 7 show a second exemplary insertion device according to the present invention which likewise is based on the principle of a lever mechanism. FIG. 3 shows the insertion device without infusion set in the tensioned state. FIG. 3 indicates a spring 213 which is visible at its ends 213a, 213b. One end 213a bears on an abutment 214 which is connected to the housing 202a in a positionally fixed manner. The other end of the leg spring 213 presses against the leg lever 205 and seeks to press this downward in FIG. 3. The spring is prevented from doing this by the latch 211 which, with a hook, is engaged on a rib 212 at the upper end of the housing. The rib 212 is connected to the housing 202 in a positionally fixed manner. The leg lever 205 is connected to another leg lever 208, arranged below it, via a rotary connection member (axle) 241 which ensures a rotation of the leg levers 205 and 208 about the common axle 241. A further rotary connection member 242 is arranged at the upper end of the leg lever 205. The rotation axle of the connection member 242 is positionally fixed, in contrast to the rotation axle 241. Arranged on the axle of the connection member 242 is a toothed wheel 243 which rotates together with the upper end of the leg lever 205. The toothed wheel 243 meshes with a toothed wheel 244 which rotates about a rotary connection member 245 or an axle 245. This toothed wheel 244 is connected to the upper end of the leg lever 206 in such a way that it co-rotates with the latter. Thus, a rotation movement of the leg lever 205 about the axle 242 causes, via the meshing toothed wheels, a corresponding rotation movement of the leg lever 206 in the opposite direction about the axle 245. A second leg spring is provided whose one leg is likewise supported on the housing, while the other one forces the leg lever 206 downward. A rotation movement about the axle 245 caused by this is likewise transmitted via the toothed wheels 244 and 243 to the leg lever 205.
Grip elements 217a and 217b are connected fixedly to the hammer head 224. The hammer head 224 extends through elongate slits 218 located on both sides of the housing, and specifically in a manner free of contact, so as to have no friction losses. In the position shown in FIG. 3, the hammer head is at its uppermost end.
A recess or receiving element 235 serves to receive an infusion set, as can be seen in FIG. 4. The housing is designed in two parts, namely with parts 202a and 202b, and the part 202b can be pushed downward, as will be discussed later in connection with FIG. 5.
FIG. 5 now shows the insertion device in a ready for use state. The insertion device is charged or loaded with the infusion set. The protective sleeve 233 has been removed, so that the cannula 237 now projects freely. The lower housing half 202b has been drawn out and thus surrounds and protects the exposed cannula 237. The lower ends 202c of the housing 202b may be generally flat to ensure a good placement of the housing on the skin.
FIG. 6 shows the insertion device after the release button 210 has been actuated and the cannula has penetrated into the skin. As will be seen, the liner 232 protrudes below the housing, as of course does the cannula or needle 237, such that the latter can penetrate into the skin unimpeded by the housing. The leg levers 205 and 206 have been forced downward by the relaxing of the leg spring 213 and by another leg spring (not shown) after the locking lug 211 has been released from the rib 212 by way of the release button 210. The leg levers 205, 206, 207 and 208 are now in the extended state and have turned about the respective connection members. By this means, the hammer head 224 has been driven down in its drive direction. By virtue of the sufficiently widely dimensioned gap 218, the hammer head has also been moved forward without friction and without contact in this gap, and the grip elements 217a and 217b are now located in their lower end state.
FIG. 7 now shows the insertion device in a state before it is tensioned again and in a state in which no infusion set has yet been introduced. By pressing the grip elements 217a and 217b up toward the spring 213, the hammer head 224 is brought back up to its charged position.
The holding fixture for the infusion set on the housing can be configured in different ways. For example, the upper end of the infusion set can be held with force-fit between two receiving elements 235 serving as clamping fixtures. One clamping fixture 235 is mounted on one wall of the housing 202a, and the other lies opposite it. The distance between the clamping fixtures is greater than the width of the hammer head 224, so that the latter can pass without contact between two opposite clamping fixtures 235 and can carry the infusion set with it and release it from the clamping fixture.
As will be seen from FIG. 8b, the receiving elements 235 press laterally against the infusion set so as to securely clamp it. The pressing action is effected by means of the elastic elements 251 which, for example, are helical springs. FIG. 8c shows a plan view of FIG. 8b. If the hammer head 224 now strikes against the upper end of the infusion set 230, the receiving elements 235 are forced back counter to the spring force of the springs 251, and the infusion set flies downward, freely accelerated by the force of the impacting hammer. FIG. 8b is a sectional view along the line A-A in FIG. 8a.
The protective sleeve (needle guard) and the protective paper may be removed after the infusion set has been secured in its starting position, that is to say in the tensioned position shown in FIG. 8. By virtue of the secure clamping of the infusion set and locking by the locking lug 211, this can be done without danger. The insertion device is now ready to apply the infusion set. For this purpose, the infusion set is placed onto the skin at the intended site. To release it, all that has to be done is to actuate the button 210. By this means, the locking lug (snap-in hook) is deflected and the snap-fit connection thus released. The pretensioned mechanism is then accelerated downward, and the hammer head strikes against the infusion set after a free flight (without contact with the housing). The hammer head exerts on the infusion set a downward vertical force component which transmits laterally to the receiving elements 235 (thrust pins). By this means, the springs are compressed, leading to release of the infusion set. The infusion set is now applied into the body by the spring force of the pretensioned levers. The distance “d2” shown in FIG. 9a between hammer head and infusion set after release does not have to be defined. Depending on the curvature of the skin at the application site, the infusion set is in contact or not in contact with the hammer. After the puncturing procedure, the insertion device can be removed from the application site and the application procedure is completed.
FIG. 9 also illustrates the principle of the present invention, with identical reference numbers designating the same parts as in the embodiment described above. The variant of the second embodiment described with reference to FIGS. 8 and 9 is similar to this. Referring to FIG. 9, a lateral introduction of the infusion set into the inserter or insertion device is described. The insertion set 230 is pushed laterally in the direction E1 into the insertion device. The distance between the hammer head 224 and the upper end 238 of the infusion set is designated by “d1”. This distance can be 0 or greater than 0 as in the previous embodiment. A guide 250 serves as abutment surface for the infusion set in order to orient the latter correctly with respect to the hammer 224. Correspondingly, in the second embodiment, the rear wall 236 shown in FIG. 4 can be designed to guide the infusion set when it is introduced into the insertion device. The lateral introduction of the infusion set can also be provided in the other embodiments. For example, in the sixth embodiment (FIGS. 13 to 16), a gap 612 at the side (FIG. 13a) is provided for this purpose.
FIG. 10 shows a further embodiment of the present invention, in which an elastic means serves both as a guide for the drive endpiece and also as a drive mechanism. In the embodiment shown in FIG. 10, the elastic means is formed from an elastic material and assumes an elongate shape, with constant cross section in the longitudinal direction, so that, in the released state, its distance from the housing is constant along the entire longitudinal extent. The elastic means may be formed from any suitable elastic material, for example, a foam, rubber, etc. FIG. 10a shows the infusion set which, in FIG. 10b, is inserted into the receiving element 335. The receiving element serves to hold the infusion set, for example by frictional engagement or with a force fit. The grips 317a and 317b extend in a longitudinal slit of the housing and are used for charging the insertion device, by the elastic means 313 being brought from a released state (FIG. 10b) to a tensioned state (FIG. 10c). In this process, the cam 311 engages in the release button 312. The ejector 352 is entrained in this movement. If the release button 312 is now moved away from the cam 311 in FIG. 10c, the energy stored in the elastic means 313 discharges and drives the drive endpiece 335, at the same time designed as receiving element, in the drive direction. After the infusion set has thus been applied to the skin, the ejector 352 serves to release the infusion set from the receiving element 335.
FIG. 11 shows another embodiment of the present invention in which a drive endpiece is designed in the form of a punch or an inverted T. The drive endpiece has a lower end 424a onto which an infusion set can be fitted, or which is designed to strike the latter out of a holding fixture which, for example, is secured on a housing wall. The drive endpiece also has a part 424b which extends in the drive direction and which is here referred to as connecting rod. Pivot bearings 448 and 447 are mounted on this connecting rod and each serve as rotary connection members for levers 408, 407 and 417, 418, respectively. The rotary connection members 421, 422, 423 and 425 are not fixedly connected to the connecting rod 424, but only via the levers 407, 408, 417 and 418. These rotary connection members are in turn connected in each case via leg levers 405, 406, 415 and 416 to rotary connection members or pivot bearings 401, 402, 411, 412 on the housing wall. The embodiment shown permits guidance of the connection endpiece along a lemniscate curve and may, therefore, also be referred to as a lemniscate guide. The connecting rod is guided at least substantially vertically by this. The elastic tensioning means and the locking mechanism and release mechanism can be designed analogously to the other described embodiments. The elastic means can be connected to the connecting rod and/or to one or more of the leg levers so as to pretension these in such a way that the connection endpiece is accelerated downward when the tension of the elastic means is released.
FIG. 12 shows a further embodiment of the invention. A leg lever 505 is attached at one end on the housing wall 502 via a rotary connection member 542. An infusion set 530 is secured at the opposite end of the leg lever. The leg lever can be tensioned against the housing wall 502 via a spring 513 as is shown in FIG. 12b. If a locking mechanism (not shown) is released, the leg lever 505 is forced downward by the spring 513, as is shown in FIG. 12a. If a free end of the leg lever strikes against an abutment 503, the infusion set 530 can be released, for example from a frictional connection, and, after a short free flight, can penetrate the skin.
FIGS. 13 to 16 show another embodiment of the present invention. FIG. 13a shows the insertion device in the tensioned state, that is to say the charging grip 601 is drawn upward. The release mechanism 602 is located to the left and right of the charging grip. These are pressed inward for release. The housing is designated by 603 and surrounds a drive endpiece 604, which can be seen in FIG. 13b. An elastomer part 605 is located at the lower end of the housing 603 and may be suitably connected, including integrally connected, to the latter. This elastomer part 605 is guided round a sleeve 606 at the lower end of the insertion device, as can be seen from FIG. 13b. The elastomer part bears on the lower inside wall of the sleeve 606 at a location designated by 605a. From there, it branches upward in the form of a band 605b. FIG. 13b also shows the tensioned state.
FIG. 14 shows the non-tensioned state in which the charging grip 601 has moved downward after the release mechanisms 602 have been actuated. A needle tip 630 can be seen at the bottom protruding downward from the insertion device. FIG. 14b corresponds to FIG. 13a. FIG. 14c shows the state of FIG. 14a with the infusion needle 630 and the liner or plaster 631. The drive endpiece 604 is located at the lower end of its path of movement. The lowermost end of the drive endpiece 604 lies at least approximately in the plane of the lower end of the elastomer part 605. As can be seen from FIG. 14c, there is a space between the lower end 605 of the elastomer part and the drive endpiece 604.
FIG. 15a shows, in cross section, the non-tensioned state from FIG. 14a. The infusion set 632 is mounted in the drive endpiece 604. Hooks 610 are engaged with the drive endpiece 604 and define the deepest position of the path of movement of the drive endpiece.
As will be seen from FIG. 15b, the band 605b of the elastomer part is guided round a top end of the drive endpiece, such that the band is stretched when the drive endpiece is moved upward. The upward movement is effected with the aid of the charging grip 601. At its lower end, this charging grip has two hooks 601a and 601b which are locked in engagement with a correspondingly designed projection 604a of the drive endpiece. This locked engagement can be released by the release mechanisms 602 because, when the charging grip 601 is drawn out, they act on extensions 601c which can be seen in FIG. 15a.
FIG. 15c shows the tensioned state in cross section. The band 605b is tensioned, and the insertion device is ready for application, the drive endpiece 604 being moved downward until extensions 604a strike against the hook-shaped ends 610a.
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