Source: http://www.google.fr/patents/US20040230216
Timestamp: 2018-01-21 15:00:44
Document Index: 62177896

Matched Legal Cases: ['art 126', 'art 28', 'art 28', 'art 60', 'art 60', 'art 60', 'art 28', 'art 60', 'art 28', 'art 60', 'art 28', 'art 30', 'art 30', 'art 262', 'art 262', 'art 304', 'art 342', 'art 344', 'art 342']

Brevet US20040230216 - Blood sampling device - Google Brevets
A device for sampling and/or analyzing blood or other body fluid of a subject. A housing contains a plurality of lancets and optionally includes test elements to take up a sample of blood, an evaluation system and a display. A complete system that can be handled as a single device, for example in the...http://www.google.fr/patents/US20040230216?utm_source=gb-gplus-shareBrevet US20040230216 - Blood sampling device
Numéro de publication US20040230216 A1
Autre référence de publication CA2477089A1, CA2477089C, CA2477104A1, DE10208575C1, DE20213607U1, DE50300685D1, EP1476070A1, EP1476070A4, EP1485021A1, EP1485021B1, US7150755, US7883473, US8870903, US20050015020, US20060178600, US20070088377, WO2003070099A1, WO2003071940A1, WO2003071940A8
Numéro de publication 10737016, 737016, US 2004/0230216 A1, US 2004/230216 A1, US 20040230216 A1, US 20040230216A1, US 2004230216 A1, US 2004230216A1, US-A1-20040230216, US-A1-2004230216, US2004/0230216A1, US2004/230216A1, US20040230216 A1, US20040230216A1, US2004230216 A1, US2004230216A1
Cessionnaire d'origine Levaughn Richard W., Kennedy Gwenn E., Ruf Christopher J., Mitchell Solis, Robbins Avi M., Heath Jason R., Wolfgang Ostertag, Armin Lohrengel, Herbert Stohr
Citations de brevets (46), Référencé par (187), Classifications (41), Événements juridiques (14)
US 20040230216 A1
1-68. (Cancelled).
69. A lancet cartridge for a lancing device comprising:
a spring biasing the protective cap of each of said plurality of lancets out of the plane.
70. The lancet cartridge of claim 69, wherein the protective cap of each lancet comprises a pair of recesses on opposed sides thereof, and wherein the carrier comprises a guide member engaged in each of said recesses to constrain the protective cap to motion along a path out of said plane.
71. The lancet cartridge of claim 70, wherein the carrier comprises a recess for receiving the protective cap of each of said plurality of lancets upon separation of the cap from the lancet and retaining said protective cap out of the path of travel of the lancet.
72. The lancet cartridge of claim 69, wherein the carrier comprises a pair of upright walls bounding the sides of each of said plurality of lancets to define the path of travel of the lancets.
73. The lancet cartridge of claim 69, wherein each spring comprises a loop having a pair of legs and a cross-member extending between the legs, said cross-member engaging the protective cap of each of said plurality of lancets.
74. The lancet cartridge of claim 69, wherein the carrier is a generally circular disk, and wherein the plurality of lancets are arranged generally radially about the perimeter of the carrier.
75. The lancet cartridge of claim 69, wherein each lancet comprises at least one cantilevered spring element for engagement with said carrier to bias the lancet toward a retracted position.
76. A lancet cartridge comprising:
at least one lancet having a protective cap removably mounted thereon, said at least one lancet constrained to a generally linear path of travel;
a spring for biasing the protective cap of each lancet out of the path of travel upon separation of the protective cap from the lancet.
77. The lancet cartridge of claim 76, further comprising at least one guide member in engagement with the protective cap to guide the protective cap out of the path of travel of the lancet under the influence of the spring.
78. The lancet cartridge of claim 76, wherein said spring comprises a flat section in engagement with the protective cap of each said lancet.
79. The lancet cartridge of claim 76, wherein each lancet is slidably mounted on a carrier, said carrier comprising walls defining a path of travel for each lancet.
80. The lancet cartridge of claim 79, wherein each spring comprises a generally U-shaped member having a pair of legs straddling said walls, and a cross-member extending between the pair of legs, and wherein the path of travel of each lancet extends through said generally U-shaped member.
81. The lancet cartridge of claim 79, wherein each lancet comprises a resilient tongue for engagement with said carrier to bias the lancet toward a retracted position.
82. The lancet cartridge of claim 79, wherein the carrier is a generally circular disk, and wherein the plurality of lancets are arranged generally radially about a central axis of the disk.
83. A lancet cartridge for replaceable insertion in a lancing device, said cassette comprising:
a disk-shaped carrier having a first face comprising a series of teeth for cooperative engagement with an advancing mechanism of the lancing device and a second face comprising walls defining a plurality of radial paths; and
a plurality of lancets, each lancet translationally mounted in one of said radial paths.
84. The lancet cartridge of claim 83, further comprising a spring for biasing a separable endcap portion of each lancet out of a plane defined by the plurality of radial paths.
85. The lancet cartridge of claim 84, wherein the separable endcap portion of each lancet defines at least one groove extending along a side face thereof, and wherein said carrier comprises a guide member in engagement with each said groove to guide the end cap in a direction generally perpendicular to the plane defined by the plurality of radial paths upon separation of said end cap from the lancet.
86. The lancet cartridge of claim 83, further comprising a cantilevered arm comprising a locating finger for alignment within a cartridge alignment recess of the lancing device.
87. The lancet cartridge of claim 83, further comprising a cartridge stop for preventing re-use of the plurality of lancets.
88. The lancet cartridge of claim 83, wherein said series of engagement teeth permit advancement in a first direction and prevent advancement in a second direction opposite the first direction.
89. A method of obtaining a sample of body fluid using a lancing device, said method comprising:
cocking the lancing device to engage a first lancet with a drive mechanism, arm the drive mechanism, separate a protective cap from said first lancet, and remove the protective cap from a path of travel of the first lancet; and
actuating the lancing device to drive the first lancet along the path of travel.
90. The method of claim 89, further comprising again cocking the lancing device to engage a second lancet with the drive mechanism, arm the drive mechanism, separate a protective cap from said second lancet, and remove the protective cap from a path of travel of the second lancet.
[0065]FIG. 1 shows a perspective view of a sampling device according to one example embodiment of the invention.
[0066]FIG. 2 shows a plan view of the sampling device of FIG. 1.
[0067]FIG. 3 shows an exploded view of the sampling device of FIG. 1 having an open housing.
[0068]FIG. 4 shows an exploded representation of a carrier with lancets and test elements of the sampling device of FIG. 3.
[0069]FIG. 5 is a view along a sectional plane through arrows A-A of FIG. 2.
[0070]FIG. 6 is a view along a sectional plane through arrows B-B of FIG. 2.
[0071]FIG. 7 is a plan view of a sampling device according to another example embodiment of the invention.
[0072]FIGS. 8 and 9 show a cassette of penetration elements and a detailed view of a lancet according to an example embodiment of the invention.
[0073]FIGS. 10-13 show a cassette of lancets according to another embodiment of the invention.
[0074]FIG. 14 shows an example drive mechanism for the lancets of FIGS. 10-13, according to an example embodiment of the invention.
[0075]FIGS. 15 and 16 show a cassette of lancets according to yet another embodiment of the invention.
[0076]FIGS. 17a-d show a sequence of operation of removal of a protective cap from a lancet, according to an example embodiment of the invention.
[0077]FIG. 18 shows an activation and release mechanism portion of a sampling device according to an example embodiment of the invention.
[0078]FIGS. 19-21 show an exploded representation and top and bottom views of a sampling device and lancets according to an embodiment of the present invention.
[0079]FIGS. 22-28 show a sequence of operation of an actuation cycle of the sampling device of FIGS. 19-21.
[0080]FIG. 29 shows a partial internal view of a sampling device according to another embodiment of the invention.
[0081]FIGS. 30-32 show a sequence of operation of the device of FIG. 29.
[0082]FIG. 33 shows a perspective view of another embodiment of the sampling device of the present invention.
[0083]FIG. 34 shows a partial interior view of the sampling device of FIG. 33.
[0084]FIGS. 35 and 36 show exploded views of components of the sampling device of FIG. 33.
[0085]FIGS. 37 and 38 are detailed views of an example embodiment of a lancet of the sampling device of the present invention.
[0086]FIGS. 39a-c show a process for producing a lancet according to an example embodiment of the invention.
[0087]FIG. 40 is a perspective view of a lancet carrier according to an example embodiment of the present invention.
[0088]FIG. 41 is a perspective view of a retainer ring according to an example embodiment of the invention.
[0089]FIGS. 42 and 43 are perspective views of the carrier and lancets of a sampling device before and after use, respectively, according to an example embodiment of the present invention.
[0090]FIGS. 44 and 45 are partial perspective views of the housing of a sampling device, according to an example embodiment of the invention.
[0091]FIG. 46 is a perspective view of a piston or plunger element of the sampling device, according to an example embodiment of the present invention.
[0092]FIG. 47 is a perspective view of a release element of the sampling device, according to an example embodiment of the invention.
[0093]FIG. 48 is a perspective view of a tensioning or arming wheel element of the sampling device, according to an example embodiment of the present invention.
[0094]FIG. 49 is a bottom view of the sampling device, with the lower cover removed, according to an example embodiment of the invention.
[0096]FIGS. 1 and 2, as a perspective and plan view respectively, show a blood analysis device according to one example embodiment of the invention, which as a whole is designated by the reference number 2. The blood analysis device comprises a housing 4, which contains a blood withdrawal system 6 comprising at least one, and preferably a plurality of lancets 8; and at least one, and preferably a plurality of test elements 10. Unused lancets 8 and test elements 10 are stored in the housing 4, used, and, after use, removed again to be discarded or disposed of. The blood analysis device 2 preferably further comprises an evaluation system 12, preferably comprising an electronic evaluation system and a display 14, preferably in the form of a visually readable display to show the result of an evaluation, such as for example the display of the quantity of an analyte such as blood sugar content. The depicted embodiment is an “all-in-one” device, comprising lancing features and sample collection and analysis features. In alternate embodiments of the invention, the invention is a lancing device, comprising only the lancing features, substantially as described, and omitting the sample collection and analysis features. In other alternate embodiments, the invention is a sampling device, comprising only the sample collection and analysis features, and omitting the lancing features.
[0106]FIGS. 8 and 9 show a lancing cassette according to another embodiment of the present invention. A plurality of lancet elements are mounted on a band or belt 102. In the depicted embodiment, the lancets are radially arranged in spaced locations about the circumference of a continuous ring-shaped belt 102, in the form of a closed circle. Alternatively, a plurality of lancet elements are mounted along the length of a strip-like belt. Each lancet element comprises a piston 106 translationally mounted within a cylinder or sleeve 100. The piston 106 carries the sharp lancet tip 114 at one end. At least one resilient tongue 108 (two are shown) is mounted to the other end of the piston. Upon actuation, the piston 106 of a lancet element is driven outward, in the direction of arrow 110. The sharp tip 114 of the lancet projects outwardly of the sleeve 100, to pierce the skin at the sampling site. The resilient tongue(s) 108 are deformed and thereby exert a retraction force to withdraw the piston 106 a sufficient distance to shield the lancet tip 114 within the sleeve 100 after lancing. The lancing cartridge preferably further comprises a cover 112, for example in the form of a section of thin film, sealing the open ends of the sleeves 100 to maintain sterility of the lancet tip 114 prior to use, and to prevent inadvertent sticks. The cover 112 can either be penetrated by the lancet during lancing, or the cover can be removed partially or completely immediately before the lancing process is carried out.
[0107]FIG. 9 shows an enlarged cross-sectional view of a lancet element according to the embodiment of FIG. 8. Between the inner cylindrical wall 116 of the sleeve 100 and the piston 106 there is preferably a seal in the form of an annular protuberance 118 from the wall 116 and an abutting protuberance 120 from the piston 106. When the piston means 106 is driven outwardly in the direction of the arrow 100, the annular protuberance 120 slides over the annular protuberance 118 under the resilient action of the cylinder wall 116. Before the lancing process is carried out, the two annular protuberances 118, 120, form a seal for the cylindrical space within the sleeve, so that the lancet tip 114 is held under sterile and sealed conditions. On the other side, the cylindrical space is sealed off by the film 112.
[0108]FIGS. 10-13 show another embodiment of a lancing cassette according to the present invention, in which a plurality of lancets 122 are held in hemispherical depressions 124 in a disk-shaped carrier part 126, and are driven in the axial direction (i.e., parallel to the axis of rotation 70 of the carrier 126) upon actuation of the lancing device, as depicted in FIG. 14. The carrier 126 preferably comprises a ring of teeth 130 along one face 128, serving as an end gear for rotating the carrier 126 within a lancing device. Alternatively, a depression defining internal gearing is formed in the face 128 of the carrier. As can be seen from the detailed drawing of FIG. 13, each lancet 122 is mounted, as by injection-molding, potting, or the like, into a carriage lug 132, which is preferably integrally formed with the material of the hemispherical wall 133 forming the dome-shaped depression 124. The depressions 124 are preferably covered over by a film 134, which hermetically seals the enclosed space to surrounding the lancet tip 122 to preserve sterility and prevent inadvertent needle-sticks. The walls of the hemispherical depressions are preferably formed of a deformable and resilient material, and optionally further comprise annular weakening slots 136 for increased wall flexibility. FIG. 14 shows an example drive mechanism for a lancing device for use with this embodiment of lancing cartridge. A transversely-driven plunger 138 is arranged radially relative to the lancing cartridge. The plunger 138 comprises a wedge-shaped ramp 140 for impacting the carriage lug 132 and deflecting the dome-shaped depression to drive the lancet tip 122 in the axial direction. After lancing, the ramp 140 retracts, and the resilient wall of the carrier 126 returns to its dome shape, withdrawing the lancet tip away from the sample site.
[0109]FIGS. 15 and 16 show perspective and exploded views, respectively, of another embodiment of a lancing cartridge for use in connection with a lancing device and/or a combined lancing and sample analysis device, according to the present invention. A plurality of lancet elements are arranged on a rotatable carrier disk 142. The lancet elements each comprise a lancet tip 140 and a lancet body 144, and are preferably arranged generally radially on the carrier disk, and are preferably formed of injection-molded plastic. One or more resilient tongues 146 (two are shown) extend from the lancet body 144, to retract the lancet tip 140 away from the sampling site after lancing and prevent forward movement of lancet after firing. The carrier disk 142 preferably comprises guide projections projecting from its face to hold and act as a guide bearing for radial sliding movement of the lancet body 144 as it traverses a path between a retracted position and an extended position during the lancing operation. The lancets tips 140 are preferably injection-molded into the lancet body 144, and are preferably encapsulated by a protective cap 147, which provides a sterility and safety barrier for the lancet tip 140.
A spring member 148 is affixed to the carrier disk 142, serving as a guide allowing the lancet body 144 to translate back and forth in the radial direction, but preventing its loss or removal from the cassette. An extension arm 150 of the spring member 148 extends over each protective cap 147, and exerts downward pressure in the axial direction on the protective cap 147 toward the carrier disk 142. The lancet body 144 is retracted radially inward prior to actuating the lancing operation, for example in a cocking step, as shown in FIG. 17b. The protective cap 147 is constrained by the guide projections of the carrier disk 142 to ensure smooth travel of the lancet cap out of the firing position, and to prevent radial retraction of the cap, thereby separating the cap 147 from the lancet body 144 and exposing the lancet tip 140. As shown in FIGS. 17c and 17 d, the extension arm 150 of the spring member 148 then presses the separated protective cap 147 into a depression 152 formed in the carrier disk 142, and out of the path of movement of the lancet. During the lancing operation, the lancet tip 140 is driven outwardly, through a passage in the extension arm 150, to pierce the skin at the sampling site, and is thereafter retracted away from the sampling site by the resilient tongues 146 and the retraction spring in the drive mechanism.
[0111]FIG. 18 shows schematically the means of activating a lancing device, according to an example embodiment of the invention. A drive mechanism 44 comprises a piston or plunger 154 that is preferably generally coaxial with the centerline of the lancet which can be driven longitudinally, in the radial direction relative to a disk-shaped lancing cartridge, and withdrawn again by means of a tension and compression spring 156. The plunger mechanism can be armed by actuating a pivotal cocking means 158 comprising a radially projecting cam 160. The cam 160 engages with a cooperating projection 161 on the piston 154 so that the piston is moved against the compression force of the drive spring 156 such that it is held in an armed state by a catch mechanism or trigger 162, holding the drive spring in tension. The positioning means 158 with the cam 160 can then return back to its starting position as for example under spring force. The trigger catch is then manually released, causing the piston 154 to be driven longitudinally in the radial direction under the force of the spring, so that the free end of the piston 154 strikes the inner end of the lancet or of a holder which carries the lancet, and that likewise projects outward. Alternatively, the end of the piston 154 comprises a clip or other engagement feature for engaging the lancet, and the lancet is carried along the traverse of the piston as it is cocked and released. Then the piston returns to its starting position as shown in FIG. 18 under the influence of the spring 156, and/or the lancet is withdrawn into the housing under the action of the resilient tongue(s) as described above.
FIGS. 19 to 29 depict an example embodiment of a lancing device according to the present invention. FIG. 19 shows an exploded view of a lancet cassette, which is shown in its assembled state from the top in FIG. 20 and from the bottom in FIG. 21. The lancet cassette comprises a carrier disk with a plurality of lancet elements 172 arranged radially thereon, each lancet having a sharp tip covered by a protective cap 174, in similar fashion to the embodiment of FIG. 15. The cassette further comprises a ring-shaped spring means 176 which interacts with each protective cap 174, substantially as described above in connection with FIGS. 17a-17 d. These components are inserted into a housing mechanism base having a cylindrical wall region 180 extending upward. This mechanism base has in its center an opening 182 projecting into the interior, forming a housing for a plunger or piston 184, which is radially movable within it. Between a radial inner end 186 of the plunger 184 and a wall of the opening 182 which forms the housing, there is a first drive spring 188. A return spring 192 is provided between a ring collar 190 of the plunger 184 and he opening 182.
[0118]FIG. 25 shows the maximally rotated position of the control lever 202 or the plunger 184, in which the plunger 184 is held in this stressed position by a holding mechanism, which in this case is made up of the clamp spring 196 and the circular slot on plunger means 184. When the control lever 202 is turned back as shown in FIG. 26, the plunger 184 remains in its tensioned position. Now the protective cap 174 is moved out of the path of movement of the lancet 232 by the axially acting spring means 176. Finally, FIG. 27 shows the completed puncture process, in which the plunger 184 moves rapidly outward in the radial direction due to actuation of the holder in the form of spreading the clamp spring 196. It strikes the end of the holding plunger 172 and forces it outward along with the lancet 232. In the next moment, the withdrawal spring 192 produces a withdrawal movement of the plunger 184 back to the starting position, as shown in FIG. 28, in which the lancet tip is withdrawn inside the housing.
[0119]FIGS. 29-32 show details of a drive means or plunger mechanism for a lancing device, according to another embodiment of the present invention. These figures also explain the activation (tensioning) of the drive means for the lancets and the further rotation of the carrier by means of a single control element 238 which is formed, as an example, from the cover part already discussed. (This is independent of the arrangement and formation of the lancets on a rotatable carrier.) FIG. 29 shows a perspective view of the carrier components of this embodiment of the analytical device, with the components that make up the housing omitted. However, one can see the cover part 28 which has, at its inner side 36, not only the sliding guide rail 38 discussed in connection with FIG. 2 but also an arrangement of teeth 240 similar to a gear rack which follows the inner side 36. These teeth 240 engage with the gearing of a first gear wheel 242 in the plane of movement of the cover part 28. This first gear wheel 242 is arranged so that it is fixed on a shaft 244 extending perpendicularly to the plane mentioned. It has a second gear wheel 246 at its other end, the drive end. This second gear wheel can be moved into and out of mesh with an internal gear 82 of a carrier part 60. (Reference numbers corresponding to those in FIGS. 1 to 6 are used here.) The shaft 244 can be moved in a slot 248 in the specified plane of movement. When the cover element 28 is turned in the direction to open the application position discussed with FIG. 1, the shaft 244 is forced into the position shown in FIG. 29 at one end of the slot 248, in which the second gear wheel 246 meshes with the internal gear 82 of the carrier part 60 so that when the gear and shaft arrangement of carrier part 60 is rotated, and the arrangement of lancets is rotated clockwise. When the cover part 28 is slid or turned back to its initial position, then the gear wheel and shaft arrangement is forced to the opposite end of the slot 248, so that the teeth of the second gear wheel 246 come out of contact with the internal gear 82 of carrier part 60, thereby preventing reverse rotation of the arrangement of lancets 8.
In a later outward movement of the cover part 28 the second gear wheel 246 not only turns the carrier part 60 farther, but it also pivots the leaf spring holder 258, thus moving the leaf spring 252 to a tensioned state. By actuation of the button 264, the other leaf spring holder 260 is likewise pivoted by the lever arrangement 256 so that the leaf spring 252 is suddenly released from its stable tensioned state past a dead point and the plunger 48 suddenly projects radially outward. That, in turn, likewise moves the lancet involved rapidly radially outward to carry out the puncture process. This course of the movement is shown in FIGS. 30, 31, and 32. Each of these figures shows a view from above (view b) and from below (view a) of the components of interest here inside the housing. FIG. 30 shows the drive means 250 of the blood withdrawal device in the non-activated initial state. The leaf spring 252 has a bowed shape between the leaf spring holders 258 and 260. Now, if as can be seen in FIG. 31, the cover part 28 is moved in the direction to open the application position 30, the carrier part 30, the shaft 244, and gear wheel 248 and the internal gear 82 of the carrier part 30 are rotated along with it by the gear wheel 242. At the same time, as shown in FIG. 31a, the leaf spring holder 258 at the second gear wheel 246 moves counterclockwise, and the leaf spring 252 takes on a form bent in an S shape. While this is going on, the leaf spring holder 260 and the position of the pivotable part 262 remain unchanged. The drive means 250 and its leaf spring 252 are now in the tensioned activated state. Now, if a user actuates the initiating means 254 by pressing the button 264 to start the puncture process, the lever arrangement 256 rotates the pivotable part 262 into the position shown in FIG. 32a. Thus the leaf spring 252 is moved past a dead point and the spring energy stored in the spring, tensioned in the S shape, is suddenly released. The spring returns again to its bowed shape as shown in FIG. 32a, but with curvature opposite that shown in FIG. 29a. Due to the coupling of the leaf spring 252 with the plunger 48 of the plunger mechanism 244, it is likewise projected suddenly outward.
[0122]FIGS. 33 and 34 show perspective views of a lancing device 302 for drawing a sample of blood from human or animal bodies for analysis, according to another embodiment of the invention. A cover part 304, which is preferably connected so that it can pivot, shown in FIG. 33, is omitted in FIG. 34. Inside a housing 306 a multiplicity of concentrically and radially arranged lancets 308 can be seen. A plunger system 310, which defines a plunging or puncturing direction 312, is visible in the center of the concentric arrangements.
[0123]FIGS. 35 and 36 show exploded views of the components housed within the housing 306. The lancets 308, which will be described in more detail below, can be seen. They have a protective cover or cap. FIG. 35 shows their radial arrangement. They can slide in radial directions on a carrier 314, preferably in the form of a circular disk, in guide paths or guide slots 316 of the carrier 314. FIG. 35 shows a circular disk 318 of spring steel above the lancet 308. It holds the lancets 308 in a manner that will be described in more detail below in the guide slots 316 of the carrier 308 so that they cannot be lost but can be slid radially.
[0125]FIG. 36 shows the housing 306, which has a baseplate 332 with a cylindrical marginal section 334 projecting upward like a collar and a disk or dome-shaped elevation 336 in the center with sections with circular periphery 338. At the lower side of the baseplate 332 there is a disk-shaped part 342, with an actuating lever 340 which protrudes radially outwardly therefrom, and which can be rotated manually by a user. It is held at the bottom side of the baseplate 332 of the housing 306 by a cover part 344 on the baseplate side, so that it can be rotated. A retraction means in the form of a return spring 346 is also shown. The disk-shaped part 342 makes up a tensioning means 348 for the plunger system 310.
[0127]FIG. 37 shows an enlarged perspective view of a lancet 308 with a protective covering. This covering involves a lancet body 362 of plastic or similar material, which is preferably injection-molded to cover the metal needle lancet 308 (which comprises the sharpened lancet tip 365), and a protective cap 364 in the region of the tip 365. In the injection-molding process, the lancet 308 is preferably held into the injection mold through an opening 366 left open in the body 362. Additionally, the lancet needle shaft may be flattened or otherwise deformed along its length to ensure capture and retention by the injection molding process. The body 362 and the protective cap 364 are preferably injection-molded in a single process. The body 362 and the protective cap 364 meet at a thin-walled transition region 368, which forms an area of weakening 370. This weakened area can be further weakened by cutting or otherwise forming a slit almost through the plastic. In alternate embodiments, the body 362 and the protective cap 364 are formed as separate components. An opening 372 is preferably formed in the transition region 368, which promotes development of the thin-walled area of weakening 370. This opening 372 can, for instance, be produced in the injection-molding process by another holder for the lancet 308.
A resilient tongue or pin 374 projects from the holder 362 at an oblique angle, for example of about 400 to the longitudinal direction of the lancet 308, and preferably is integrally formed with the body 362, and has a rounded free end 376. The tongue 374 can be spread apart or is elastically and resiliently deformable in the direction of the double arrow 378 with respect to the body 362 for the lancet 308. The tongue 374 assures stabilization in the plane of application for the body 362 and, for example, prevents tilting about the longitudinal direction. The tongue can also serve to minimize oscillation of the lancet. After a plunger process has been carried out, it can initiate a withdrawal force into the holder, entering the lancet 308 and withdrawing it. It also makes sure that the lancet does not slip out of the guide slots 316 of the carrier 314. A post 369 keeps the lancet from falling inward after use by abutting against a cooperating lip or projection on the carrier. The protective cap 364 preferably has an H-shape in the plan view, having guide slots on both sides, with which it is held immovably in the longitudinal direction of lancet 308 (i.e., in the radial direction, on carrier 314), but it can slide transversely, perpendicular to the longitudinal direction of lancet 308, with respect to the carrier. FIGS. 38a-c show additional detail of the lancet with the holder and protective cap. In its longitudinal direction, including the holder 362 and protective means 364, the lancet is preferably about 12.5 mm long. FIGS. 39a-c show example processes of production for separating the lancets 308 covered by the body 362 and protective capping means 364 during production. The end of the body 362 distal from the protective cap 364 preferably comprises at least one shoulder or flange 418 projecting transversely outward from a side of the body, and has a step or recess 382. More preferably, a pair of opposed flanges project from opposite sides of the body 362 for engagement with the drive mechanism, to withdraw the lancet along its longitudinal axis without misalignment during cocking. The lancet needle 308 is cut off from a length of wire or tube by upper and lower knives 384, 386 shown. The upper knife 384 is placed nearly in contact with the step 382 so that its position can be defined with respect to the holder 362 and the lancet 308, and the lancet needle 308 is cut off substantially flush with the lancet body 362.
[0129]FIGS. 40-43 show the arrangement of the lancets 308 together with the bodies 362 and protective caps 364 on the carrier 314. The carrier 314 is preferably a generally circular disk having a raised pattern molded on its upper face. In the depicted embodiment, the carrier comprises ten radial guide channels, each channel bounded by a supporting wall 388 in the plane of the disk and two lateral guide walls 390 which are perpendicular to the disk and radially oriented. A lancet 308, with holder 332 and protective cap 364, is translationally slidable within each radial guide channel. The individual lancets 308 are inserted into the guide depressions from above, i.e., in the axial direction. Then they take up the positions shown in FIGS. 34 and 42. It can be seen that there is no lancet 308 in one arc segment 391 of the carrier. When the carrier is inserted from above into the housing 306, the carrier 314 is positioned so that the arc segment 391 is oriented above the plunger system 310, such that the radial outer end of the plunger system 310 extends into this circle segment 391. Then the plunger means 350 is arranged within the circle segment 391 as if between two adjacent lancets, the first and last lancets. A positioning aid in the form of an arrow-shaped profile of the circular disk 318 is preferably provided to assist in the installation.
[0132]FIGS. 44-45 show the housing 306 with and without the components involved with the drive system 310. It can be seen that the dome-shaped elevation 336 in the housing 306 forms a holder for the plunger 350, the plunger spring 352 and the withdrawal spring 354. The cover 358 holds these components so that they cannot be lost and can be slid longitudinally into the holder, in the radial direction. FIG. 46 shows, in a greatly enlarged presentation, the plunger 350, which is designed as a piston or a ram. Its outside diameter is stepped down, so that it has an axial step 408 that supports one end of the withdrawal spring 354. The other end of the withdrawal spring 354 is supported against one face 410 of the dome-shaped elevation 336. The plunger spring 352 is supported at the end with the greater diameter 412, with the other end supported against a face 412 of the dome-shaped elevation 336. The plunger means 358 further comprises a coupling region 416, which is open in the direction of plunger movement, as well as in the peripheral direction. This coupling region 416 is complementary to a rear gripping region 418.(see FIG. 37) of the lancet body 362 and can hold that region so that the body 362 can be coupled to the plunger 350, forming a secure engagement with the plunger 350. For the orientation of the plunger means 350 seen in FIG. 45, a holder 362 for a lancet 308 can be rotated into this coupling region 316 by rotating the carrier 314, as can be seen in FIG. 34. If the plunger 350 is drawn back radially inward, locked together with a lancet body 362 for a lancet 308, so that the plunger spring 352 is tensioned, then the protective cap 364, which is constrained against motion in the radial direction, cannot follow, and there is a break in the region of weakening 370 between them. As soon as the free sharp end 365 of the lancet 308 comes free of the protective cap 364, the cap is moved into the disposal position 403, as described previously, under the action of the loop-shaped spring tongue 398. The lancet 308 along with the body 362 follows the tensioning movement of the plunger 350 during this operation. Now the puncture system 310 is in the activated or armed state, and can be actuated or triggered to carry out the puncture process by pressing the release 356.
US7913838 * 21 mars 2006 29 mars 2011 Bayer Healthcare Llc Packaging container for test sensors
US7927345 * 2 nov. 2006 19 avr. 2011 Agamatrix, Inc. Lancet cartridges and lancing devices
US9517027 * 28 sept. 2010 13 déc. 2016 Facet Techonologies, Llc Advancement mechanism for cartridge-based devices
US20120046529 * 10 août 2011 23 févr. 2012 Sony Corporation Physiologically active substance collecting device
US20130085415 * 9 oct. 2012 4 avr. 2013 Roche Diagnostics Operations, Inc. Method for producing a membrane ring or test strip ring and ring magazine
US20150150496 * 26 sept. 2014 4 juin 2015 Roche Diagnostics Operations, Inc. Reuse Protection for Lancet System
CN103829953A * 6 mars 2014 4 juin 2014 无锡华平医疗科技有限公司 One-step type integrated blood glucose meter
EP1743577A1 * 23 juin 2005 17 janv. 2007 Roche Diagnostics GmbH Hand-held apparatus for the analysis of bodily fluids
EP1868920A2 * 7 mars 2006 26 déc. 2007 Stat Medical Devices Inc. Cartridge with lancets and testing device using the cartridge
EP1868920A4 * 7 mars 2006 31 mars 2010 Stat Medical Devices Inc Cartridge with lancets and testing device using the cartridge
EP2604186A1 18 mars 2009 19 juin 2013 Panasonic Corporation Blood collecting puncture device and magazine used for the same
WO2006096707A2 * 7 mars 2006 14 sept. 2006 Stat Medical Devices, Inc. Cartridge with lancets and testing device using the cartridge
WO2006096707A3 * 7 mars 2006 4 juin 2009 Stat Medical Devices Inc Cartridge with lancets and testing device using the cartridge
WO2013089917A1 * 18 oct. 2012 20 juin 2013 Facet Technologies, Llc Latch mechanism for preventing lancet oscillation in a lancing device
WO2014172245A1 * 14 avr. 2014 23 oct. 2014 Becton, Dickinson And Company Biological fluid sampling device