|Publication number||US20060241669 A1|
|Application number||US 11/397,058|
|Publication date||Oct 26, 2006|
|Filing date||Apr 4, 2006|
|Priority date||Apr 4, 2005|
|Also published as||DE602006015295D1, EP1868502A2, EP1868502B1, US8574255, US20100160831, WO2006107914A2, WO2006107914A3|
|Publication number||11397058, 397058, US 2006/0241669 A1, US 2006/241669 A1, US 20060241669 A1, US 20060241669A1, US 2006241669 A1, US 2006241669A1, US-A1-20060241669, US-A1-2006241669, US2006/0241669A1, US2006/241669A1, US20060241669 A1, US20060241669A1, US2006241669 A1, US2006241669A1|
|Inventors||Jeffrey Stout, Avi Robbins, David Buenger|
|Original Assignee||Stout Jeffrey T, Robbins Avi M, Buenger David R|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (40), Classifications (10), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/667,958, filed Apr. 4, 2005; which application is incorporated herein by reference in its entirety for all purposes.
The present invention relates generally to lancing devices for medical sampling of blood or other body fluids of a human or animal subject. More particularly, the invention relates to a miniature lancing device having components arranged in a compact planar configuration allowing the device to have a narrow profile relative to typical lancing devices.
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 or other body fluid, as for example in blood glucose monitoring by diabetics and in blood typing and screening applications. A lancing device having a spring-loaded or otherwise energized drive mechanism is often used to carry the lancet along a path of travel, between a retracted or shielded position and an extended position wherein the lancet tip punctures the skin.
Various forms of lancing devices are known. Many users, however, have found known lancing devices to be too bulky and inconvenient to carry and stow in a pocket or bag. Also, some users find it inconvenient to carry multiple separate components for sampling and testing, such as a lancing device and a meter. Perceived inconvenience can lead to non-compliance with a prescribed testing regimen, potentially adversely affecting the subject's health.
Thus it can be seen that needs exist for improvements to lancing devices to provide a smaller and thinner lancing device. Needs further exist for a lancing device that can be attached to a blood glucose meter for convenience and to avoid loss. It is to the provision of an improved lancing device meeting these and other needs that the present invention is primarily directed.
In example forms, the present invention relates to a miniature lancing device having a thin profile, for easy and convenient stowage. Optionally, the lancing device is configured to be provided as an original component of, or to be attached as a retrofit component onto a glucose test meter. For example, an example embodiment of the invention is a miniature lancing device configured to be used in place of a battery compartment cover of a glucose test meter. This allows the device to be retrofitted on existing meters, or provided as original equipment on a new meter, thereby providing an integrated device.
In one aspect, the present invention is a lancing device, preferably including a housing having a narrow profile and a slotted opening through a proximal end thereof. The lancing device preferably also includes a lancet carrier translationally mounted to slide along a path of travel within the housing, and having a pair of engagement fingers for releasably receiving a lancet therebetween. The lancing device preferably also includes an energizing member translationally mounted to slide within a lengthwise channel in the housing, generally parallel to the path of travel of the lancet carrier. The lancing device preferably also includes a release member translationally mounted to slide within a transverse channel in the housing, generally perpendicular to the path of travel of the lancet carrier.
In another aspect, the invention is the combination of a body fluid testing meter having a battery cover opening, and a lancing device configured for engagement with the meter over the battery cover opening.
In still another aspect, the invention is a lancet, preferably including a body portion having a sharp lancing tip projecting therefrom, and along at least a portion of its length having a flattened profile with a first dimension substantially larger than a second dimension. The lancet preferably also includes a sterility cap detachable from the body portion, and along at least a portion of its length having a flattened profile with a first dimension substantially larger than a second dimension. Prior to detachment of the sterility cap from the body portion, the flattened profile portion of the sterility cap is unaligned with the flattened profile portion of the body portion.
In another aspect, the invention is a lancing device including a lancet carrier translationally mounted within a housing and movable along a path of travel between a retracted position and an extended position, at least one drive spring engaged between the lancet carrier and the housing, a charging mechanism for moving the lancet carrier into the retracted position and energizing the at least one drive spring, and a release mechanism for holding the lancet carrier in the retracted position until actuated to release the lancet carrier to move along the path of travel under the influence of the at least one drive spring toward the extended position. The lancet carrier, the at least one drive spring, the charging mechanism and the release mechanism are all intersected by a single reference plane containing the path of travel.
In another aspect, the invention is a lancing device having an overall thickness of less than 0.25″ (0.6 cm).
In another aspect, the invention is the combination of a blood glucose test meter having a battery compartment, and a lancing device for releasable coupling to the blood glucose test meter over the battery compartment.
In still another aspect, the invention is a lancing device including a housing having a slotted lancet opening with a first opening dimension greater than a second opening dimension thereof, and a lancet releasably engagable with said lancing device. The lancet has a lancet body with a sharp lancet tip projecting therefrom and a cap removably covering the sharp lancet tip. The lancet body has a first lancet body dimension less than the first opening dimension but greater than the second opening dimension, and has a second lancet body dimension less than the second opening dimension. In this manner, the lancet body resists rotation within the slotted lancet opening upon twisting of the cap to detach the cap from the lancet body.
And in another aspect, the invention is a lancet including a lancet body having a sharp lancet tip projecting therefrom, and a protective cap removably covering the sharp lancet tip. The protective cap includes a release member for releasing the lancet body from engagement with a lancing device.
These and other aspects, features and advantages of the invention will be understood with reference to the drawing figures and detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following brief description of the drawings and detailed description of the invention are exemplary and explanatory of preferred embodiments of the invention, and are not restrictive of the invention, as claimed.
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 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 to
The lancet carrier 20 preferably comprises a pair of resilient fingers or forks 22 for releasably engaging a miniature lancet 40. The lancet 40 is preferably inserted and removed through a slotted opening 32 in the proximal end of the housing 30. The slotted opening 32 has a length considerably greater than its width, most preferably having a length at least twice its width. The lancet carrier 20 preferably also comprises slots 24 and/or contact faces for receiving and/or engaging one or more drive springs 50 and/or one or more retraction springs 52 for advancing and retracting the lancet carrier along its path of travel within the housing 30 to carry the lancet along its lancing stroke. In the depicted embodiment, two drive springs 50 and one retraction spring 52 are included in the form of coil springs, positioned within separate slots extending generally parallel to one another within the carrier 20. In alternate embodiments, a single drive spring is provided, having a substantially greater stiffness than the return spring, and/or torsion springs, leaf springs, or other forms of drive mechanisms are provided. The drive and return springs 50, 52 are preferably captured in compression or otherwise engaged between the contact faces of the lancet carrier 20 and lugs 34 or other surface features, recesses or projections of the housing 30. The walls of the slots and the sidewalls of the housing assist in maintaining the various biasing springs of the lancing device aligned and in place.
An energizing or charging member 60 is preferably translationally mounted to slide within a lengthwise channel 36 in the housing 30, generally parallel to the path of travel of the lancet carrier 20. A gripping pad or surface 62 preferably projects from the energizing member 60, outwardly of the housing, to facilitate actuation by a user. A tooth or pawl 64 projects laterally from the energizing member 60, for engagement with a cooperating projection 26 or other surface feature of the lancet carrier 20. An energizing member return spring 66 is preferably engaged in compression between the energizing member 60 and the housing 30, to bias the energizing member 60 toward the proximal end of the lancing device.
A release member 70 is preferably translationally mounted to slide within a transverse channel 38 in the distal end of the housing 30, generally perpendicular to the path of travel of the lancet carrier 20. The release member 70 preferably includes a release button 72 projecting outwardly from the housing 30 to facilitate user actuation. A release member return spring 74 is preferably engaged in compression between the release member 70 and the housing 30, to bias the release member 70 in the direction of the release button 72. The release member 70 preferably also comprises a sear 76 or other surface feature for releasably engaging a cooperating portion of the lancet carrier 20, to retain the lancet carrier retracted in its energized position until released by the user actuating the release button 72. The lancet carrier 20, the energizing member 60, and the release member 70 are all preferably intersected by a single common reference plane R, are relatively thin in the direction normal to the reference plane, and have generally flat and contiguous side faces lying parallel to the reference plane. Additionally, the associated biasing members 50, 52, 66 and 74 preferably each have their axes of bias along the reference plane R or closely parallel thereto. And the line or path of travel of the lancet 40 preferably also lies in the reference plane R. The thin and planar arrangement of components in this manner allows the overall device 10 to be contained within a very compact and narrow-profile external housing, as seen in example form in
The lancet 40 of the present invention preferably comprises a small and lightweight lancet body portion 42, preferably having a sharp lancet tip 43 projecting therefrom in the form of a metal needle or blade. Preferably, the lancet body 42 is a molded plastic member having a shank portion of the needle or blade 43 securely embedded therein. The lancet body 42 preferably has a flattened profile along at least a proximal portion of its length, having a first dimension (height) substantially larger than a second dimension (width), and configured to pass freely through the slotted opening 32 in the housing 30 when aligned therewith, but to prevent rotation of the lancet body within the slotted opening of the housing. Notches or recesses in the sides of the lancet body 42 are preferably provided to receive and releasably engage cooperating projections formed on the resilient fingers 22 of the lancet carrier 20. The lancet 40 preferably further comprises a removable sterility cap 44. The sterility cap 44 is preferably co-molded with the lancet body portion 42, and the two are connected at a narrow or notched neck portion for ease of separation upon removal of the sterility cap. The sterility cap 44 is preferably relatively large or oversized, as compared to the lancet body 42, to facilitate easier handling and loading of the lancet into the lancing device, which is of particular advantage to users having reduced visual acuity and/or reduced manual dexterity. The sterility cap 44 optionally has a flared or T-shaped configuration for better gripping during insertion of the lancet and removal of the cap. The sterility cap 44 preferably has a flattened profile along at least a distal portion of its length, generally matching the flattened profile of the proximal portion of the lancet body portion, but initially oriented generally perpendicularly or obliquely relative thereto. The sterility cap 44 preferably also has a release finger 46 projecting therefrom, to assist in release of a used lancet from the fingers or forks of the lancet carrier, as detailed below.
In use, the user loads a lancet 40 into the lancing device 10 by inserting the lancet body 42 into the slotted opening 32 of the housing, until the flattened profile of the lancet's sterility cap 44 contacts the proximal face of the housing 30, with the profile of the sterility cap being oriented generally crosswise to the slotted opening (
The user then actuates the energizing member 60 by sliding the gripping pad 62 rearwardly, away from the end of the housing 30 having the slotted opening 32 therein. Engagement of the pawl 64 of the energizing member 60 with the projection 26 of the lancet carrier 20 as the energizing member is operated retracts the lancet carrier and energizes the drive springs 50. Alternatively, pushing the lancet further into the housing energizes the drive spring(s). As the lancet carrier 20 moves into its retracted position, the lancet carrier contacts an inclined surface of the sear 76 of the release member 70, depressing the release member against the bias of the release member return spring 74. Upon reaching its fully retracted position, the sear 76 of the release member 70 snaps upwardly into engagement with the lancet carrier 20 under the influence of the release member return spring 74, to retain the lancet carrier retracted in its energized position (
The sterility cap 44 is removed, and the slotted proximal face of the housing is placed against the subject's skin at the intended lancing site. The user presses the release button 72 of the release member 70, releasing the sear 76 from engagement with the lancet carrier 20. The lancet carrier 20 is propelled forward into its advanced position under the influence of the drive springs 50, driving the sharp lancet tip through the slotted opening 32 and outwardly of the housing 30, to penetrate the subject's skin at the lancing site (
After use, the lancet body 42 is preferably removed from the lancing device 10, for replacement with a fresh lancet for subsequent use. The release finger 46 of the sterility cap 44 is inserted into a hole 39 in the housing, extending between the forks 22 of the lancet carrier, and behind the lancet body 42 (
One or more guides or limit members 28 are optionally provided on the lancet carrier 20, moving within one or more corresponding guide channels formed in the housing 30, to maintain transverse alignment of the lancet carrier (i.e., limiting up-and-down movement of the carrier and lancet perpendicular to the lancet stroke), and to provide a forward stop to limit the stroke of the lancet in the forward axial direction thereby more precisely controlling the depth of penetration of the lancet into the skin. The forks 22 of the lancet carrier 20 are preferably guided between a pair of retaining panels 35 at the proximal end of the housing adjacent the slotted opening 32 as the lancet carrier 20 moves into its advanced or lancing position, preventing the forks from spreading apart and potentially releasing the lancet 40 during the lancing operation (
Another example embodiment of a lancing device 210 according to the present invention is shown in
In the example embodiment of the present invention depicted in
Another example embodiment of a lancing device 410 having a hinged access door 480 in the housing 430 is shown in
Due to the compact size and narrow profile of example embodiments, the lancing device of the present invention is suitable for mounting or attachment to a blood glucose test meter or other device or carrier. Preferably, the lancing device of the present invention is mountable on or in place of a removable portion or component of the meter, removal or alteration of which does not negatively impact the meter's operation. For example, various forms of the invention can be mounted to or in place of the removable battery cover of a blood glucose test meter, such that the lancing device is carried with the meter for greater convenience and ease of use. The lancing device can be provided as original equipment as a detachable or integral part of a new meter, and/or can be provided as an upgrade or retrofit component for backwards-compatible attachment to an existing meter, such as for example the Bayer Ascensia Contour™ blood glucose meter sold by Bayer Healthcare LLC of Mishawaka, Ind.; the BD Logic Meter; the Lifescan OneTouch Ultra Meter, and/or the Abbott FreeStyle Flash Meter. The housing of the lancing device is preferably similar in size and shape to the battery cover of the particular blood-glucose testing meter to which it is intended to be mounted, and the narrow profile of the lancing device does not significantly alter the overall external geometry of the meter. The housing of the lancing device preferably comprises external surface features substantially conforming to the attachment clips, channels, tabs, slots and/or other corresponding coupling members of a battery cover, whereby the lancing device can be snapped or clipped onto a meter in place of the standard battery cover. Preferably, one or more of the actuator components and/or the lancet opening of the lancing device project beyond or adjacent the outer peripheral edges of the meter or other object to which the device is mounted, for easier access during use.
For example, as shown in
In an another example form of the present invention shown in
In other embodiments, the lancing device of the present invention is integrally formed with or mountable onto a meter elsewhere other than the battery cover, as by integral molding, adhesive attachment, snap-fitting connection or other attachment means. In further alternate embodiments, the lancing device of the present invention is integrally formed with or mountable onto a carrier other than a blood glucose meter. For example, the lancing device can comprise a clip allowing it to be mounted or attached onto a purse, belt or other item, similar to a pen, a tie-clip or a small pager. Alternatively or additionally, the lancing device includes a ring or loop for attachment to key-ring or other object, in similar fashion to a key-fob.
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.
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7648468||Dec 31, 2002||Jan 19, 2010||Pelikon Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7666149||Oct 28, 2002||Feb 23, 2010||Peliken Technologies, Inc.||Cassette of lancet cartridges for sampling blood|
|US7674232||Dec 31, 2002||Mar 9, 2010||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7682318||Jun 12, 2002||Mar 23, 2010||Pelikan Technologies, Inc.||Blood sampling apparatus and method|
|US7699791||Jun 12, 2002||Apr 20, 2010||Pelikan Technologies, Inc.||Method and apparatus for improving success rate of blood yield from a fingerstick|
|US7713214||Dec 18, 2002||May 11, 2010||Pelikan Technologies, Inc.||Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing|
|US7717863||Dec 31, 2002||May 18, 2010||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7731729||Feb 13, 2007||Jun 8, 2010||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7822454||Jan 3, 2005||Oct 26, 2010||Pelikan Technologies, Inc.||Fluid sampling device with improved analyte detecting member configuration|
|US7833171||Feb 13, 2007||Nov 16, 2010||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7841992||Dec 22, 2005||Nov 30, 2010||Pelikan Technologies, Inc.||Tissue penetration device|
|US7850621||Jun 7, 2004||Dec 14, 2010||Pelikan Technologies, Inc.||Method and apparatus for body fluid sampling and analyte sensing|
|US7850622||Dec 22, 2005||Dec 14, 2010||Pelikan Technologies, Inc.||Tissue penetration device|
|US7862520||Jun 20, 2008||Jan 4, 2011||Pelikan Technologies, Inc.||Body fluid sampling module with a continuous compression tissue interface surface|
|US7874994||Oct 16, 2006||Jan 25, 2011||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7892183||Jul 3, 2003||Feb 22, 2011||Pelikan Technologies, Inc.||Method and apparatus for body fluid sampling and analyte sensing|
|US7901362||Dec 31, 2002||Mar 8, 2011||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7909774||Feb 13, 2007||Mar 22, 2011||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7909775||Jun 26, 2007||Mar 22, 2011||Pelikan Technologies, Inc.||Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge|
|US7909777||Sep 29, 2006||Mar 22, 2011||Pelikan Technologies, Inc||Method and apparatus for penetrating tissue|
|US7909778||Apr 20, 2007||Mar 22, 2011||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7914465||Feb 8, 2007||Mar 29, 2011||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7938787||Sep 29, 2006||May 10, 2011||Pelikan Technologies, Inc.||Method and apparatus for penetrating tissue|
|US7988644||Aug 2, 2011||Pelikan Technologies, Inc.||Method and apparatus for a multi-use body fluid sampling device with sterility barrier release|
|US8109960 *||Jan 8, 2008||Feb 7, 2012||“HTL-Strefa” Spolka Akcy Jna||Patient's skin puncturing device|
|US8114029 *||Nov 16, 2009||Feb 14, 2012||Roche Diagnostics Operations, Inc.||Test system for measuring the concentration of an analyte in a body fluid|
|US8308748 *||Sep 29, 2011||Nov 13, 2012||Abbott Diabetes Care Inc.||Collapsible lancing device|
|US8460330 *||Aug 14, 2008||Jun 11, 2013||Owen Mumford Limited||Lancing devices|
|US8574255||Mar 2, 2010||Nov 5, 2013||Facet Technologies, Llc||Narrow-profile lancing device|
|US9072842||Jul 31, 2013||Jul 7, 2015||Sanofi-Aventis Deutschland Gmbh||Method and apparatus for penetrating tissue|
|US9089294||Jan 16, 2014||Jul 28, 2015||Sanofi-Aventis Deutschland Gmbh||Analyte measurement device with a single shot actuator|
|US9089678||May 21, 2012||Jul 28, 2015||Sanofi-Aventis Deutschland Gmbh||Method and apparatus for penetrating tissue|
|US20100249820 *||Jun 20, 2008||Sep 30, 2010||Owen Mumford Limited||Lancing devices|
|US20100318172 *||Jun 10, 2010||Dec 16, 2010||Ulrich Schaefer||Guide wire and method for its use|
|US20120010641 *||Aug 14, 2008||Jan 12, 2012||Owen Mumbord Limited||Lancing devices|
|US20120022565 *||Jan 26, 2012||Abbott Diabetes Care Inc.||Collapsible lancing device|
|US20130276521 *||May 8, 2011||Oct 24, 2013||Labstyle Innovation Ltd.||Fluids testing apparatus and methods of use|
|EP2298172A1 *||Mar 4, 2010||Mar 23, 2011||EPS Bio Technology Corp.||Blood lancing device|
|WO2008085071A1 *||Jan 8, 2008||Jul 17, 2008||Htl Strefa Spolka Akcyjna||Patient's skin puncturing device|
|WO2009022138A1||Aug 14, 2008||Feb 19, 2009||Owen Mumford Ltd||Lancing devices|
|U.S. Classification||606/182, 606/181|
|Cooperative Classification||A61B5/1411, A61B2560/04, A61B5/14532, A61B5/15186|
|European Classification||A61B5/145G, A61B5/14B2, A61B5/151S|
|Jun 28, 2006||AS||Assignment|
Owner name: FACET TECHNOLOGIES, LLC, GEORGIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:STOUT, JEFFREY T.;ROBBINS, AVI M.;BUENGER, DAVID R.;REEL/FRAME:017853/0639
Effective date: 20060515
|Sep 8, 2006||AS||Assignment|
Owner name: SILVER POINT FINANCE, LLC,CONNECTICUT
Free format text: PATENT SECURITY AGREEMENT;ASSIGNOR:FACET TECHNOLOGIES, LLC;REEL/FRAME:018230/0151
Effective date: 20060726
|Sep 11, 2006||AS||Assignment|
Owner name: BLACKROCK KELSO CAPITAL CORPORATION,NEW YORK
Free format text: SECURITY AGREEMENT;ASSIGNOR:FACET TECHNOLOGIES, LLC;REEL/FRAME:018230/0417
Effective date: 20060726
|Jan 10, 2011||AS||Assignment|
Owner name: TOWER THREE CAPITAL PARTNERS LLC, CONNECTICUT
Free format text: PATENT ASSIGNMENT - SUCCESSOR COLLATERAL AGENT;ASSIGNOR:SILVER POINT FINANCE, LLC;REEL/FRAME:025609/0349
Effective date: 20110104