Patent Application
20080255598
The present invention relates generally to medical devices and procedures and, more particularly, to lancing devices for collecting samples of blood or other bodily fluid.
Many medical procedures require puncturing of the skin, and sometimes underlying tissues, of an animal or human subject. For example, a sharp lancet tip is commonly used to puncture the subject's skin at a lancing site to obtain a sample of blood, interstitial fluid or other body fluid, as for example in blood glucose monitoring by diabetics, and in blood typing and screening applications. In some instances, a person must periodically sample their blood for multiple testing throughout the day or week. Because re-use of a lancet can result in infection or spread of bloodborne contaminants, persons requiring repeated testing often must carry multiple lancets with them. This can be inconvenient and lead to reduced compliance with a prescribed test regimen. Accordingly, it can be seen that needs exist for a convenient, compact multi-use lancing device.
Various devices are known for sampling blood and other body fluids for analysis of the condition of a human or other animal subject. For example, U.S. Pat. No. 5,971,941 is understood to show a cassette with test strips for placement by a slider. A lancet pierces the skin surface so that blood can be obtained for analysis. The lancets are integrated on a test strip, and are positioned together with the test strip. Another embodiment is understood to show a disposable cylindrical insert having a lancet and a test membrane with an aperture for the lancet. The insert is inserted in a mounting cavity of a plunger or piston, which forces the lancet outward for blood withdrawal. DE 198 19407 A1 is understood to show a multiplicity of test strips with integrated lancets for insertion into an analysis device.
U.S. Pat. No. 4,787,398 is understood to show a device with a plunger for directing a lancet outward, and has an evaluation system and a display system. A replaceable unit is applied to the device for each measurement. The replaceable unit comprises the lancet and a test strip, which is wetted with blood. This replaceable unit is thrown away after each use. EP 0 449 525 A1 is understood to show a blood withdrawal system wherein a new lancet is inserted manually into a release device before each use. A test strip is then inserted into the device. U.S. Pat. No. 4,627,445 is understood to show a device for measuring blood sugar, with an integrated blood withdrawal unit. A new replaceable lancet and test elements must be installed to the device for testing, and afterward disassembled. U.S. Pat. No. 5,951,492 is understood to show a disposable unit with a capillary tube and a test strip, to which sampled blood taken is applied. The capillary tube includes a lancet. A new disposable unit is attached and removed before and after each measurement.
EP 0877250 A2, EP 0949506 A2 and EP 811843 A2 are understood to show devices having a multiplicity of test elements arranged on a rotatable disk carrier. The test elements are brought successively into a working position and pushed out of the housing to be wetted with blood. U.S. Pat. No. 6,228,100 and U.S. Pat. No. 4,794,926 are understood to show lancets arranged on a carrier, which is rotated with respect to a housing.
German Application DE 100 57 832 C1 is understood to show a lancing device of a known form. Other lancing devices understood to include multiple lancets are shown, for example, in U.S. Patent App. Serial No. 2002/0087056 A1 and WO 02/36010 A1. EP 0589186 B1 is understood to show a lancet with a removable protective cap. WO 01/66010 A1 is understood to include a multiplicity of lancets in a magazine, with an opening of the chamber closed by an elastic material, which is penetrated in the puncture process.
Known sampling devices have, however, not proven fully satisfactory to all users for a variety of reasons. Accordingly, it is to the provision of an improved sampling device that the present invention is primarily directed.
Generally described, the present invention includes several innovative features of a lancing device and a replaceable multi-lancet carousel for use therewith. In the embodiments described herein, the carousel has a carrier and a series of lancets that are carried by the carrier. The lancets each have a body and a puncturing tip projecting from the body. And the lancing device has a housing that holds the carousel so that the user can easily remove and replace carousels as needed. Several of the innovative features can, however, be implemented on a single-use lancing device, if desired.
In one aspect, the invention is a lancing device that includes at least one shutter mechanism. Preferably, there is one shutter mechanism coupled to the carrier for each lancet. The shutter mechanisms each include a shutter that moves between an open position not retaining the lancet from moving to a puncturing position and a closed position retaining the lancet in a retracted position. In the puncturing position, the lancet tip sticks out of the housing, and in the retracted position, the lancet tip is returned to safely within the housing. The shutter moves from the open position to the closed position in response to the lancet being actuated to puncture the skin. Preferably, the shutter mechanism includes a shutter release member that moves from an engaged position where it holds the shutter in the open position, to a release position not retaining the shutter in the open position when the lancet is rotationally actuated to lance the skin.
In another aspect, the invention is a lancing device that includes at least one charging mechanism. Preferably, there is one charging mechanism for each lancet. The charging mechanisms each have two or another number of loading recesses and two or another number of loading tabs that are rotated into and retained in the loading recesses when the lancet is moved from a charged position to a charged and set position. In the charged position, the lancet is charged for launching, and in the charged and set position, the lancet is charged and retained in place. In addition, the loading tab is rotated out of the loading recess when the lancet is moved from the charged and set position to the charged position, which frees the lancet for launching to the puncturing position.
In yet another aspect, the invention is a lancing device that includes at least one actuator mechanism. Preferably, there is one actuator mechanism rotationally coupled to the carrier for actuating all of the lancets. The actuator mechanism includes an actuator arm that can be operably aligned with and moved into engagement with each of the lancets to rotate the lancets from the charged and set position to the charged position, thereby freeing the lancets to be launched. Preferably, there is a cam surface on the lancets or on the actuator arm that is configured to cause the lancets to rotate when they are engaged by the actuator arm.
In still another aspect, the invention is a lancing device that includes a carousel with a carrier that is adapted for carrying the lancets in a non-radial, preferably a tangential, configuration. In addition, the housing preferably has a generally wedge-shaped protrusion corresponding to each lancet, with the protrusions each having a surface generally perpendicular to a puncturing stroke direction of a corresponding one of the lancets, and the housing having lancet tip openings in those perpendicular surfaces. Furthermore, the lancing device preferably has at least one lock mechanism including at least one key-tabbed member and at least one keyed opening that matingly receives the key-tabbed member so that the carousel can be rotated into a locked position in which it is secured to the housing.
In still another aspect, the invention is a lancet carousel that is replaceable in the housing of a lancing device. The carousel includes a plurality of lancets and a carrier that carries the lancets in a non-radial, preferably a tangential, configuration. Preferably, the carousel has at least one shutter mechanism including at least one shutter that moves between an open position not retaining the lancet from moving to the puncturing position and a closed position retaining the lancet in the retracted position. In addition, the carousel preferably has at least one charging mechanism including at least one loading recess and at least one loading tab that rotates into and is retained in the loading recess when the lancet moves from the charged position to the charged and set position. Furthermore, the carousel preferably has at least one actuator mechanism including at least one actuator arm that moves into engagement with the lancets to rotate the lancets from the charged and set position to the charged position to free the lancets for launching.
And in yet another aspect, the invention is a method of lancing skin, preferably using a lancing device and/or lancet carousel including one or more of the innovative features described herein. An example method includes the steps of providing a lancing device having a housing and a lancet carousel, the lancet carousel including a plurality of lancets carried by a carrier in a non-radial configuration. In addition, the method includes the steps of inserting the carousel in the housing, charging one of the lancets, launching the charged lancet, advancing the actuator mechanism from one of the lancets to a next one of the lancets, repeating these steps until all the lancets are actuated, and removing the carousel. The step of charging one of the lancets may include, for example, grasping a sterility cap of one of the lancets, pushing the lancet inward so that at least one loading tab is guided by a track to guide the lancet to a charged position, and rotating the lancet so that the loading tab is received in at least one loading recess to retain the lancet in a charged and set position. The step of launching the charged lancet may include, for example, actuating an actuator mechanism to rotate the lancet back to the charged position so that the loading tab is removed from the loading recess and the charged lancet is free to be launched. And the step of advancing the actuator mechanism may include, for example, rotating an actuator arm of the actuator mechanism from operable alignment with the one lancet to operable alignment with the next lancet.
Accordingly, it can be seen that the present invention, in its various aspects as described herein, provides ease of use in a compact carrying unit to lessen the difficulty and inconvenience associated with typical lancing equipment. With these improvements, users are more likely to stick with a blood testing regimen to monitor their health conditions.
The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be unnecessarily limiting of the claimed invention. Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.
With reference now to the drawing figures,
In a typical commercial embodiment, the housing 12 has a first or top section 20 and a second or bottom section 22 that are hingedly coupled together in a clamshell arrangement for movement between the open position of
In addition, the housing 12 has at least one opening 26 through which the lancets 18 extend to a fully extended puncturing position for puncturing the skin. Preferably, there are a plurality of the openings with a dedicated opening 26 for each lancet 18, and the actuator mechanism 14 rotates into alignment with each lancet for launching it through its opening. Alternatively, the housing may have only one opening (or another number of openings) for all the lancets and a rotary carousel for sequentially aligning the lancets with the opening.
Referring additionally to
Referring now to
In an alternative embodiment shown in
Referring still to
Accordingly, after the last one of the lancets 18 has been actuated, the user resets the lancing device 10 by turning the actuator mechanism 14 back to the first one of the lancets. Because all of the lancets 18 have been used, all of the lancets caps have been removed and the lancets retracted onto the housing (not shown), as will be described in more detail below. The lancing device 10 may include a structure (not shown) for rotating the carousel 16 along with the actuator mechanism 14 when resetting the actuator mechanism from the last to the first lancet 18. The carrier 17 is rotated to the position shown in
Referring now to
With the lancets 18 so configured, the housing 12 preferably has a protrusion 25 for each lancet, with each protrusion 25 having a surface 27 generally perpendicular to the longitudinal puncturing stroke direction (which is thus non-radial) of a corresponding one of the lancets (see
In an alternative embodiment, the lancets are arranged in a radial configuration. In this embodiment, the carousel 16 may further include a shield member 42 that blocks the lancets 18 from interfering with the actuator mechanism 14 or the oppositely positioned lancet. It will be understood that the shield member 42 may also be included with the non-radial configured lancets 18, as is depicted in the figures.
In addition, the lancing device 10 preferably includes one or more shutter mechanisms for retaining the lancets 18 in a retracted position with the lancet tips in the housing 12 after puncturing the skin in the puncturing position. The shutter mechanisms dampen lancet vibrations, prevent lancet re-strikes after once puncturing the skin, and prevent reuse of the of the lancets after being used once. The shutter mechanisms each include at least one shutter 44 that moves from an open position in which the corresponding lancet 18 can be actuated to a closed position retaining the lancet in the housing. The shutter 44 may be a panel, arm, frame, or another flat, curved, or otherwise configured structure for retaining the lancet in the housing. Preferably, the shutter 44 moves from the open position to the closed position automatically in response to the corresponding lancet 18 being actuated to puncture the skin.
In a typical commercial embodiment, each shutter mechanism includes a spring element, for example, a torsion spring 46 mounted on posts 48 on the carrier 17, and at least one shutter release, for example, a shutter release tab 50 extending longitudinally from a front end 53 of the body 52 of the lancet 18. The spring element 46 biases the shutter 44 to rotate about the post 48 to the closed position. But the shutter release tab 50 holds the shutter 44 in the open position when the lancet 18 is in a charged and set position ready for launching to the puncturing position (e.g., see lancet 18c). When the user operates the actuator mechanism 14, it actuates the lancet 18 by rotating it, thereby also rotating the shutter release tab 50 from blocking the shutter 44. Preferably, the lancet 18 and the shutter 44 rotate about perpendicular axes. So now the shutter 44 presses against the lancet body 52 while the lancet 18 is launched to puncture the user's skin (e.g., see lancet 18b). But when the lancet 18 is retracted back into the housing 12, the shutter release tab 50 is no longer there to block open the shutter 44, so it swings closed to retain the lancet tip 54 in the housing (e.g., see lancet 18d).
In alternative embodiments, the shutter mechanisms include shutters that are coupled to the housing, that slide up or laterally into the closed position, and/or that are biased by coil or other types of spring elements. In these or other alternative embodiments, the shutter mechanism includes shutters that are retained in the open position by catches or other shutter release structures that are pushed, pulled, or otherwise moved out of the way by the lancet launching movement. And in these or other alternative embodiments, the shutter mechanisms include shutters that catch and retain the back or side of the lancet instead of blocking its path of travel.
Referring now to
The charging mechanism includes structures for retaining the lancet 18 in the charged and set position of lancet 18c of
To actuate the charged lancet, the user operates the actuator mechanism 14 as described below, thereby rotating the lancet back to the position of lancet 18a of
In an alternative embodiment, the charging mechanisms include a ramped, curved, helical, and/or otherwise configured track assembly for rotating the lancet as it is pushed in to the charged position. In another alternative embodiment, the charging mechanisms include an automatic charging assembly for charging the next lancet automatically upon launching of the preceding lancet. In still another alternative embodiment, the charging mechanisms include another number and type of operating spring elements. In a further alternative embodiment, the charging mechanisms have the loading tabs extending from the carrier into a longitudinal track in the lancet body, and the lancet is rotated into a locked position with the tabs bearing on the front face of the lancet body. And in yet other alternative embodiments, the charging mechanisms include other structures for retaining the lancet in the charged position such as a latch, hook, catch, detent, and/or a spring-biased member, and/or the charged position and the charged and set position are the same, that is, the lancet is retained in place in the charged position.
Referring now to
Each lancet body 52 has a cam surface 78 extending therefrom or formed therein that is engaged by the outwardly moving actuator arm 72. For example, the cam surface 78 may be formed on a wedge-shaped member 80 extending from the lancet body 52. Because of the shape of the cam surface 78, as the actuator arm 72 is further extended outwardly it rotates the lancet body 52 in the direction of arrow 79. As described above, when a charged lancet 18 is rotated, the loading tabs 60 are moved from engagement and retention by the loading recess 62, freeing the lancet to be launched by the charged operating spring 56. The actuator mechanism 14 is rotationally mounted to the central portion of the carrier 17 so that the user can rotate the actuator arm 72 into alignment with the peripherally arranged lancets 18 one at a time. Alternatively, the actuator mechanism may be rotationally mounted to the housing, instead of the carrier, so that it can be reused with multiple carousels.
In order to align the actuator mechanism 14 with a desired one of the lancets 18 for launching, one of several actuator alignment features may be provided. In a typical, commercial embodiment, the actuator alignment features include a detent mechanism for snap-locking the actuator arm 72 into operational alignment with the cam surface 78 of the lancet 18 to be actuated. For example, the alignment detent mechanism may include a series of bumps 82 on the housing 12 (see
In an alternative embodiment, the actuator arm includes the detent and flag, in other words, the features of the alignment arm are combined onto the actuator arm. In another alternative embodiment, the actuator alignment mechanism includes an automatic alignment mechanism for advancing and aligning the actuator mechanism with the next lancet automatically upon launching of the preceding lancet. And in yet another alternative embodiment, the actuator alignment mechanism includes another structure for securing the lancet in the proper alignment, such as a flexible or curved one-way catch and/or a spring-biased member.
To use the lancing device 10, the user inserts a fresh one of the carousels 16 into the housing 12, charges one of the lancets 18, actuates the charged lancet, and advances the actuator mechanism 14 to the next lancet. The charging, launching, and actuator advancing steps are repeated until all the lancets 18 of the carousel 16 have been used. Then the user removes and disposes of the spent carousel 16 and repeats the entire process.
The depicted exemplary embodiment is a lancing device comprising only lancing features. In alternate embodiments of the invention, the device includes sample collection features and/or sample analysis features. Accordingly, the invention includes an “all-in-one” device, comprising lancing features combined with both sample collection and analysis features.
In addition, the various features shown and described herein have all been presented in a single exemplary embodiment. It will be understood, however, that each of these features can be provided by themselves or in any combination in the lancing device described herein or in another multi-lancet or single-lancet lancing device.
While the invention has been described with reference to preferred and example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions, and deletions are within the scope of the invention, as defined by the following claims.
This application claims the priority benefit of U.S. Provisional Patent Application Ser. No. 60/496,844, filed Aug. 20, 2003, the content of which is hereby incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US2004/026971 | 8/19/2004 | WO | 00 | 6/26/2008 |
| Number | Date | Country | |
|---|---|---|---|
| 60496844 | Aug 2003 | US |
