Source: http://www.google.com/patents/US20070142854?ie=ISO-8859-1
Timestamp: 2015-03-06 18:43:34
Document Index: 338694896

Matched Legal Cases: ['arts 2000', 'arts 2000', 'art 3000', 'art 2000', 'art 2000', 'art 3000', 'art 2000']

Patent US20070142854 - Double-ended lancet, method and lancet device using the double-ended lancet ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsDouble-ended lancet unit for a lancet device. The unit includes a lancet body having a first end and a second end. A first lancet needle projects from the first end and a second lancet needle projects from the second end. The lancet device utilizes the double-ended lancet unit and includes a body and...http://www.google.com/patents/US20070142854?utm_source=gb-gplus-sharePatent US20070142854 - Double-ended lancet, method and lancet device using the double-ended lancet, and method of assembling and/or making the double-ended lancetAdvanced Patent SearchPublication numberUS20070142854 A1Publication typeApplicationApplication numberUS 11/312,433Publication dateJun 21, 2007Filing dateDec 21, 2005Priority dateDec 21, 2005Also published asCN101522113A, EP1968462A2, US8303614, WO2007117329A2, WO2007117329A3Publication number11312433, 312433, US 2007/0142854 A1, US 2007/142854 A1, US 20070142854 A1, US 20070142854A1, US 2007142854 A1, US 2007142854A1, US-A1-20070142854, US-A1-2007142854, US2007/0142854A1, US2007/142854A1, US20070142854 A1, US20070142854A1, US2007142854 A1, US2007142854A1InventorsSteve SchragaOriginal AssigneeStat Medical Devices, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (1), Referenced by (1), Classifications (10), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetDouble-ended lancet, method and lancet device using the double-ended lancet, and method of assembling and/or making the double-ended lancet
DETAILED DESCRIPTION OF THE PRESENT INVENTION The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the present invention may be embodied in practice. FIGS. 1-10 show a first non-limiting embodiment of a lancet assembly or double-ended lancet unit LA. The unit LA includes a main body portion 1, a first end portion 2 and a second end portion 3. The first and second end portions 2, 3 are oriented in opposite directions. Each end portion 2, 3 also includes a cap 4 to protect a lancet needle, as will be described later on. The main body 1 can have any desired cross-sectional shape such as polygonal, circular, or oval, and preferably is either triangular, square or circular in order to fit snugly into existing holding members of existing lancet devices. In the embodiment shown in FIGS. 1-10, the main body 1 has a generally cylindrical shape having a length of between approximately 0.25 inches and approximately 1 inch and a diameter of between approximately 0.05 inches and approximately 0.3 inches. The particular size and shape of the lancet unit LA can, of course, be adapted to the particular size and shape requirements of the lancet device. The first and second end portions 2 and 3 have portions which frictionally engage with an inside opening 1 a. Preferably, the opening 1 a is sized and shaped so that the end portions 2 and 3 can be prevented from being removed once they are positioned therein. This connection can be effectuated by any desired connection such as a press-fit connection, an adhesive connection, or an ultrasonic welding connection, etc,. The caps 4 can have any desired shape and are preferably removably connected to the first and second end portions 2, 3 (or the main body 1). In the embodiment shown in FIGS. 1-10, the caps 4 can be generally cylindrical in shape. By way of non-limiting example, the caps 4 can have a diameter which substantially corresponds to that of the main body and a length which is between about 0.1 inches long and about 0.3 inches long. The caps 4 are also preferably made of synthetic resin (and preferably of the same material used for conventionally known lancets) and of the same material as the main body 1 and end portions 2, 3. Most preferably, the left side cap 4 is made to have a color that corresponds to the color of the first end portion 2 and the right side cap 4 is made to have a color that corresponds to the color of the second end portion 3 with the colors of the end portions 2 and 3 being different. For example, the left side cap 4 can be made to have a blue color that corresponds to a blue color of the first end portion 2 and the right side cap 4 can be made to have a red color that corresponds to the red color of the second end portion 3. The benefits of such an arrangement is as follows: a user installs the lancet unit LA onto a holding member of the lancet device (in a similar manner to that shown in FIG. 29) with, e.g., the red end 3 projecting out from the holding member. Then, he or she removes the red cap 4 and uses the lancet device to prick the skin. Then, instead of discarding the lancet unit LA (as is the case with the prior art lancets), he or she removes the lancet unit LA from the holding member and removes the blue cap 4 from the blue end 2, installs the blue cap 4 on the red end 3. Then, he or she re-installs the lancet unit LA into the holding member with the blue end 2 projecting from the holding member. The user is now free to prick the skin with another clean needle. After use, the user will know that the lancet unit LA is used up because, once removed from the holding member, the user will see that red cap 4 is installed on the blue end 2-indicating that that needle has been used already. He or she can then install the blue cap 4 on the red end 3 and discard the lancet unit LA. This process doubles the useful file of the lancet. As can be seen in FIGS. 2 and 3, the caps 4 have an inner surface 4 b which can be cylindrical which slides over and onto the projecting portions 2 b, 3 b of the end portions 2, 3. Although not shown in FIGS. 1-10, the invention contemplates some sort of mechanical connection between the caps 4 and the end portions 2, 3. In this regard, various non-limiting connection arrangements are shown in the drawings which can be used in this embodiment. Preferably, for the embodiment shown in FIGS. 1-10, a connection arrangement of the type shown in FIGS. 17 and 18 is used in this embodiment. Most preferably, a connection system similar to that of FIGS. 32-35 is used in the embodiment of FIG. 1-10. Each cap 4 also has a closed end 4 c which is preferably spaced from the end of the needle N in order to prevent injury to the needle N. The end portions 2, 3 have a shoulder or flange portion 2 a, 3 a, which can be of any size and shape and preferably correspond to that of the main body 1. The flange portion 2 a of the first end portion 2 is preferably arranged to abut (or to be slightly spaced therefrom) the first end 1 b of the main body 1 and the flange portion 3 a of the second end portion 3 is preferably arranged to abut (or to be slightly spaced therefrom) the second end 1 c of the main body 1. As can be seen in FIGS. 6-8, the first end portion 2 and the second end portion 3 are generally identical in configuration. Each portion 2, 3 includes a flange portion 2 a, 3 a (as described above) as well as a front portion 2 b, 3 b which supports the needle N and whose front surface SS contacts the cap of the lancet device in order to define the penetration depth (see e.g., FIG. 31). Each portion 2, 3 further includes a rear portion 2 c, 3 c which is sized and shaped to connect with the inner opening 1 a of the main body 1. The length of generally cylindrical portion 2 c and 3 c can be any desired length and is preferably between 0.03 inches and 0.2 inches. Each portion 2 and 3 is preferably made as a one piece synthetic resin member that is formed with a metal needle N installed therein, e.g., in the same way that conventional lancets are formed. Preferably, the needle N projects from the stop surface SS by an amount that is typical of conventional lancets. FIGS. 11-13, 15 and 16 show a second non-limiting embodiment of a lancet assembly or double-ended lancet unit LA′. Unlike the previous embodiment using three-piece body, the unit LA′ of this embodiment does not utilize a main body portion, and instead utilizes only a first end portion 20 and a second end portion 30. The first and second end portions 20, 30 are oriented in opposite directions. Each end portion 20, 30 also includes a cap 40 to protect a lancet needle, as will be described later on. The first portion 20 can have any desired cross-sectional shape such as polygonal, circular, or oval, and preferably is either triangular, square or circular in order to fit snugly into existing holding members of existing lancet devices. In the embodiment shown in FIGS. 11-13, 15 and 16, the outer portion 20 has a generally cylindrical shape having a length of between approximately 0.25 inches and approximately 1 inch and a diameter of between approximately 0.05 inches and approximately 0.3 inches. The particular size and shape of the lancet unit LA′ can, of course, be adapted to the particular size and shape requirements of the lancet device as is the case with the previous embodiment. The first end portion 20 has an inner opening 20 a which frictionally engages with an outer surface 30 c. Preferably, the opening 20 a and the correspondingly shaped cylindrical portion 30 c are sized and shaped so that the end portions 20 and 30 can be prevented from being removed or disconnected from each other once they are connected. This connection can be effectuated by any desired connection such as a press-fit connection, an adhesive connection, or an ultrasonic welding connection, etc,. The caps 40 can have any desired shape and are preferably removably connected to the first and second end portions 20, 30. In the embodiment shown in FIGS. 11-13, 15 and 16, the caps 40 can be generally cylindrical in shape. By way of non-limiting example, the caps 40 can have a diameter which substantially corresponds to that of the portions 20, 30 and a length which is between about 0.1 inches long and about 0.3 inches long. The caps 40 are also preferably made of synthetic resin (and preferably of the same material used for conventionally known lancets) and of the same material as the end portions 20, 30. Most preferably, the left side cap 40 is made to have a color that corresponds to the color of the first end portion 20 and the right side cap 40 is made to have a color that corresponds to the color of the second end portion 30 with the colors of the end portions 20 and 30 being different. For example, the left side cap 40 can be made to have a blue color that corresponds to a blue color of the first end portion 20 and the right side cap 40 can be made to have a red color that corresponds to the red color of the second end portion 30. The benefits of such an arrangement is as follows: a user installs the lancet unit LA′ onto a holding member of the lancet device (in a similar manner to that shown in FIG. 29) with, e.g., the red end 30 projecting out from the holding member. Then, he or she removes the red cap 40 and uses the lancet device to prick the skin. Then, instead of discarding the lancet unit LA′ (as is the case with the prior art lancets), he or she removes the lancet unit LA′ from the holding member and removes the blue cap 40 from the blue end 20, installs the blue cap 40 on the red end 30. Then, he or she re-installs the lancet unit LA′ into the holding member with the blue end 20 projecting from the holding member. The user is now free to prick the skin with another clean needle. After use, the user will know that the lancet unit LA′ is used up because, once removed from the holding member, the user will see that red cap 40 is installed on the blue end 20�indicating that that needle has been used already. He or she can then install the blue cap 40 on the red end 30 and discard the lancet unit LA′. This process doubles the useful file of the lancet. As can be seen in FIGS. 11 and 12, the caps 40 have an inner surface 40 b which can be cylindrical which slides over and onto the projecting portions 20 b, 30 b of the end portions 20, 30. Although not shown in FIGS. 11-13,15 and 16, the invention contemplates some sort of mechanical connection between the caps 40 and the end portions 20, 30. In this regard, various non-limiting connection arrangements are shown in the drawings which can be used in this embodiment. Preferably, for the embodiment shown in FIGS. 11-13, 15 and 16, a connection arrangement of the type shown in FIGS. 17 and 18 is used in this embodiment. Most preferably, a connection system similar to that of FIGS. 32-35 is used in the embodiment of FIG. 11-13, 15 and 16. Each cap 40 also has a closed end 40 c which is preferably spaced from the end of the needle N in order to prevent injury to the needle N. The second end portion 30 has a shoulder or flange portion 30 a which can be of any size and shape and preferably correspond to a maim portion of the first portion 20. The right end 20 c of the first end portion 20 is preferably arranged to abut (or to be slightly spaced therefrom) the flange 30 a of the second end portion 30. As can be seen in FIGS. 13,15 and 16, the first end portion 20 and the second end portion 30 are not identical in configuration as was the case in the previous embodiment. Instead, the second portion has been combined with the main portion in order to form a one-piece or integrally formed first portion 20. Portion 30 includes a flange portion 30 a (as described above) as well as a front portion 30 b which supports the needle N and whose front surface SS contacts the cap of the lancet device in order to define the penetration depth (see e.g., FIG. 31). Portion 30 further includes a rear portion 30 c which is sized and shaped to connect with the inner opening 20 a of the first portion 20. The length of generally cylindrical portion 30 c and opening 20 a can be any desired length and is preferably between 0.03 inches and 0.2 inches. Each portion 20 and 30 is preferably made as a one piece synthetic resin member that is formed with a metal needle N installed therein, e.g., in the same way that conventional lancets are formed. Preferably, the needle N projects from the stop surface SS by an amount that is typical of conventional lancets. FIG. 14 shows a third non-limiting embodiment of a lancet assembly or double-ended lancet unit LA″. This two-piece embodiment is similar to that of the previous embodiment shown in FIGS. 11-13, 15 and 16 except that a single lancet needle member is utilized having two projecting portions N. The unit LA″ of this embodiment does not utilize a main body portion, and instead utilizes only a first end portion 200 and a second end portion 300. The first and second end portions 200, 300 are oriented in opposite directions. Each end portion 200, 300 also includes a cap (not shown but similar to caps 4, 40) to protect a lancet needle N, as will be described later on. The first portion 200 can have any desired cross-sectional shape such as polygonal, circular, or oval, and preferably is either triangular, square or circular in order to fit snugly into existing holding members of existing lancet devices. In the embodiment shown in FIG. 14, the first or outer portion 200 has a generally cylindrical shape having a length of between approximately 0.25 inches and approximately 1 inch and a diameter of between approximately 0.05 inches and approximately 0.3 inches. The particular size and shape of the lancet unit LA″ can, of course, be adapted to the particular size and shape requirements of the lancet device as is the case with the previous embodiment. The first end portion 200 has an inner opening 200 a which frictionally engages with an outer surface of portion 300 c. Preferably, the opening 200 a and the correspondingly shaped cylindrical portion 300 c are sized and shaped so that the end portions 200 and 300 can be prevented from being removed or disconnected from each other once they are connected. This connection can be effectuated by any desired connection such as a press-fit connection, an adhesive connection, or an ultrasonic welding connection, etc,. As with the previous embodiment, the first and second portions 200 and 300 are preferably made of materials having different colors such as, e.g., blue and red and whose caps have substantially corresponding colors. FIG. 17 shows one non-limiting way in which the cap C (which can be used on any of the embodiment disclosed herein) can be installed on either the front end portion FE or the second end portion SE (or both) of the lancet unit of the invention. In this embodiment, the cap C is substantially similar to that of the previous embodiments except that it includes a projecting portion PP which is frictionally received in a recess R formed on the first and/or second end portions FE, SE. Instead of a continuous ring-shaped projecting portion PP, the cap C can also use a plurality of partial projections (i.e., non-continuous or spaced apart) or even equally spaced circular projections to engage with the recess R. The projection PP preferably has a circular or outwardly curved end which is received in the correspondingly shaped recess R. This allows the cap C to removably connected to the first and/or second end portions FE, SE and to remain locked onto the lancet unit until removed by the user to expose the needle N. Removal of the cap C requires overcoming the frictional engagement of the projection PP and recess R and can be accomplished by pulling the cap C along a direction away from the lancet unit and generally parallel to an axis of the needle N. FIG. 18 shows another non-limiting way in which the cap C′ (which can be used on any of the embodiment disclosed herein) can be installed on either the front end portion FE′ or the second end portion SE′ (or both) of the lancet unit of the invention. In this embodiment, the cap C′ is substantially similar to that of the previous embodiments except that it includes a projecting portion PP′ formed ion the first and/or second end portions FE′, SE′ which frictionally engages with a recess R′ formed in the cap C′. Instead of a continuous ring-shaped projecting portion PP′, the first and/or second portions FE′, SE′ can also use a plurality of partial projections (i.e., non-continuous or spaced apart) or even equally spaced circular projections to engage with the recess R′. The projection PP′ preferably has a circular or outwardly curved end which is received in the correspondingly shaped recess R′. This allows the cap C′ to removably connected to the first and/or second end portions FE′, SE′ and to remain locked onto the lancet unit until removed by the user to expose the needle N. Removal of the cap C′ requires overcoming the frictional engagement of the projection PP′ and recess R′ and can be accomplished by pulling the cap C′ along a direction away from the lancet unit and generally parallel to an axis of the needle N. FIGS. 19-24 show another non-limiting way in which the cap C″ (which can be used on any of the embodiment disclosed herein) can be installed on either the front end portion FE″ or the second end portion SE″ (or both) of the lancet unit of the invention. In this embodiment, the cap C″ is similar to that of the previous embodiments except that it is of a two-piece configuration (made up of rear part C1 and front part C2) which pieces are connected together via a wrapped connecting tape CT. The connecting tape CT provides a breakable connection allowing the front portion C2 of the cap C″ to be separated from the rear portion C1 and removed to expose the needle N. The projecting portion or engaging member EM formed on the inner part C1 frictionally engages with an engaging recess ER formed in the cap C″. The engaging portion EM is slofted (i.e., has at least two equally spaced slots SL) in order to allow the cap C″ to be installed onto the recess ER. Instead of a continuous ring-shaped projecting portion EM, the portion or member EM can also be a plurality of partial projections (i.e., non-continuous or spaced apart) or even equally spaced circular projections to engage with the recess ER. The projection EM preferably has a tapered end and a shoulder which is non-removably received in the recess ER. This allows the rear portion C1 of the cap C″ to be non-removably connected to the first and/or second end portions FE″, SE″ and to remain locked onto the lancet unit even after the front portion C2 is removed by the user (i.e., by breaking the tape CT) to expose the needle N. Removal of the front portion C2 of the cap C″ requires overcoming the tension of and ripping of the wrapped connecting tape CT and can be accomplished by pulling the cap C″ along a direction away from the lancet unit and generally parallel to an axis of the needle N (see FIGS. 23-24). The connecting tape CT, which overlaps substantially equal portions of the parts C1 and C2 and is attached thereto with, e.g., a pressure sensitive adhesive, can be of any desired material and is preferably of a material which tears with less than a few ounces of pulling force. Preferably, the tape CT is wrapped in a recess of the cap C″ so that it cannot be inadvertently removed. FIGS. 25 and 26 show another non-limiting way in which the cap C111 (which can be used on any of the embodiment disclosed herein) can be installed on either the front end portion FE″ or the second end portion SE″ (or both) of the lancet unit of the invention. In this embodiment, the cap C111 is similar to that of the previous embodiments except that it is of a two-piece configuration (made up of rear part C1 and front part C2) which pieces are connected together via a connecting ring CR. The connecting ring CR provides a breakable connection along the breakable perforations BP allowing the front portion C2 of the cap C111 to be separated from the rear portion C1 and removed to expose the needle N. The projecting portion or engaging member EM formed on the inner part C1 frictionally engages with an engaging recess ER formed in the cap C111. The engaging portion EM is slotted (i.e., has at least two equally spaced slots SL as in the previously described embodiment) in order to allow the cap C111 to be installed onto the recess ER. Instead of a continuous ring-shaped projecting portion EM, the portion or member EM can also be a plurality of partial projections (i.e., non-continuous or spaced apart) or even equally spaced circular projections to engage with the recess ER. The projection EM preferably has a tapered end and a shoulder which is non-removably received in the recess ER. This allows the rear portion C1 of the cap C111 to be non-removably connected to the first and/or second end portions FE″, SE″ and to remain locked onto the lancet unit even after the front portion C2 is removed by the user (i.e., by breaking the connecting ring CR) to expose the needle N. Removal of the front portion C2 of the cap C111 requires overcoming the tension of and ripping of the connecting ring CR along the perforations BP and can be accomplished by pulling the cap C111 along a direction away from the lancet unit and generally parallel to an axis of the needle N (in the same was as FIGS. 23-24). The connecting ring CR, which overlaps substantially equal portions of the parts C1 and C2 and is attached thereto with, e.g., a end projections that engage with correspondingly shaped recesses, can be of any desired material and is preferably of a material which tears or breaks along the perforations BP with less than a few ounces of pulling force. Preferably, the ring CR is arranged in a recess of the cap C111 so that it cannot be inadvertently removed. FIG. 27 illustrates one non-limiting slot configuration for the caps shown in FIGS. 19-26. This exemplary configuration uses four equally spaced slots SL. However, the invention contemplates using as few as one and as many as e.g., 12. Since the purpose of the slots SL is to ensure easy installation of the caps onto the lancet unit, one should provide as many slots SL as is needed for this purpose. FIG. 28 shows another embodiment of the lancet unit LA111 of the invention. This embodiment is similar to that of FIGS. 1-10 except that it additionally includes a generally centrally disposed projecting flange F. The flange F is preferably sized and shaped in a manner which allows the lancet unit to be properly installed/mounted to the holding member of the lancet device. FIG. 29 shows, by way of non-limiting example, an enlarged partial view of a lancet device LD having a lancet holding member HM which can support or retain the lancet unit LA111. Of course, the lancet device LD can also be fitted with any of the lancet units disclosed and/or claimed herein. This Figure shows the lancet unit of FIG. 28 installed on the holding member HM only by way of example. FIG. 30 shows an enlarged partial view of FIG. 29 with the lancet device cap LC installed on the front end of the lancet device LD. The lancet cap LC is installed after the cap is removed from the lancet unit LA111 to expose the needle N. FIG. 31 shows an enlarged partial view of FIG. 30 after the lancet needle N projects past the skin engaging surface SES and after the holding member HM has moved to the fully extended position. FIGS. 32-35 show still another embodiment of the lancet unit LAIV of the invention. This embodiment is similar to that of FIG. 1 except that it uses different connections between the first or left side cap FC and the left end of the lancet body LB and between the second or right side cap SC and the right end of the lancet body LB. As a result of this arrangement, the right side cap SC can be removed from the right end and installed onto the left end of the lancet body LB and is thereafter prevented from be removed therefrom. FIG. 33 shows the embodiment of FIG. 32 with the left side cap FC removed from the left end. This allows the left side lancet needle to be used in a lancet device. FIG. 34 shows the embodiment of FIG. 32 with the right side cap SC removed from the right end and installed on the left end in a manner which prevents its removal therefrom. FIG. 35 shows the embodiment of FIG. 32 with the right side cap FC non-removably installed on the left end and with the left side cap FC removably installed on the right end. The benefits of such an arrangement is as follows: a user installs the lancet unit LAIV onto a holding member of the lancet device (in a similar manner to that shown in FIG. 29) with, e.g., the blue first cap FC projecting out from the holding member. Then, he or she removes the blue cap FC and uses the lancet device to prick the skin. Then, instead of discarding the lancet unit LAIV (as is the case with the prior art lancets), he or she removes the lancet unit LAIV from the holding member and removes the red cap SC from the blue body LB, installs the red cap SC on the end which previously has the blue cap FC. Then, he or she re-installs the lancet unit LAIV into the holding member with the right end projecting from the holding member. The user is now free to prick the skin with another clean needle. After use, the user will know that the lancet unit LAIV is used up because, once removed from the holding member, the user will see that red cap SC is installed on the blue left end-indicating that that needle has been used already. He or she can then install the blue cap FC on the right end (see FIG. 35) and discard the lancet unit LAIV. This process doubles the useful file of the lancet. By way of non-limiting examples, the lancet unit can be used with a lancet device (i.e., any of the lancet devices disclosed herein) which includes an adjustable tip or front cap of the type described in any one of the following documents: U.S. Pat. No. 6,811,557 to SCHRAGA, U.S. Pat. No. 6,530,937 to SCHRAGA, U.S. Pat. No. 6,322,575 to SCHRAGA, and U.S. Pat. No. 5,613,978 to HARDING, the disclosures of which are hereby expressly incorporated by reference in their entireties. By way of non-limiting examples, the lancet unit can also be used with a lancet device (i.e., any of the lancet devices disclosed herein) which includes a non-adjustable tip or front cap (see FIG. 30) of the type described in any one of the following documents: U.S. Pat. No. 6,156,051 to SCHRAGA, U.S. Pat. No. 6,022,366 to SCHRAGA, U.S. Pat. No. 5,908,434 to SCHRAGA, U.S. Pat. No. 5,797,942 to SCHRAGA, U.S. Pat. No. 5,628,764 to SCHRAGA, and U.S. Pat. No. 5,464,418 to SCHRAGA, the disclosures of which are hereby expressly incorporated by reference in their entireties. The above noted tips, as well as any of the tips known in the prior art, can also be used with any of the lancet devices described herein such as the ones shown in FIGS. 29-31. Additionally, the tip or front cap can be secured (e.g., non-removably secured or removably secured) to the lancet devices disclosed herein by any conventionally known arrangements such as threads, a snap connection (see FIGS. 30-31), etc,. The portions other than the needles of the lancet units can be made of any conventional material of which conventional lancets are made such as, e.g., synthetic resin. They can also be made by any conventional lancet making techniques including, e.g., injection molding, extrusion, etc,. The lancet needles can also be of the same material, types and sizes as are used in conventional lancets. By way of non-limiting example, each lancet unit can also range in axial length between approximately �″ and approximately �″. FIGS. 29-31 illustrate one non-limiting way in which the unit can be mounted to a lancet holding member of a lancet device. Generally speaking, most lancet devices utilize a lancet holding member. The lancet holding member is typically movably mounted within the lancet device and is usually moved and/or biased by one or more springs. In many lancet devices, the lancet holding member retains a replaceable lancet at a front location. Examples of such devices are disclosed in the following documents: U.S. Pat. No. 6,811,557 to SCHRAGA, U.S. Pat. No. 6,530,937 to SCHRAGA, U.S. Pat. No. 6,346,114 to SCHRAGA, U.S. 6,190,398 to SCHRAGA, U.S. Pat. No. 6,156,051 to SCHRAGA, U.S. Pat. No. 6,022,366 to SCHRAGA, U.S. Pat. No. 5,908,434 to SCHRAGA, U.S. Pat. No. 5,797,942 to SCHRAGA, U.S. Pat. No. 5,628,764 to SCHRAGA, U.S. Pat. No. 5,464,418 to SCHRAGA, and U.S. Pat. No. 5,613,978 to HARDING, the disclosures of which are hereby expressly incorporated by reference in their entireties. According to one non-limiting example, the lancet holding member of one or more of the devices disclosed in these documents is modified so as to use the unit disclosed herein. This can occur by redesigning the lancet holding member of these devices so as to be hollow or tubular to allow for axial insertion of the unit in a manner similar to that shown in the lancet device of, e.g., FIGS. 29-31. FIGS. 36-39 show another non-limiting embodiment of the double-ended lancet. The lancet unit has a two-piece body 1000 made up of body parts 2000 and 3000 (similar to those of FIG. 14), and two end caps 4000A and 4000B. The caps 4000A and 4000B can be attached to the body 1000 using any of the mechanisms disclosed herein. A freely movable lancet needle LN is able to slide axially back and forth between the positions shown in FIGS. 37 and 38. The movement of the lancet needle LN is limited between these axial positions by a movable stop MS (which can be molded synthetic resin cylindrical member) that is axially fixed to the lancet needle LN. In this embodiment, two different size caps 4000A and 4000B are utilized. The benefits of such an arrangement is as follows: a user installs the lancet unit shown in FIG. 36 onto a holding member of the lancet device (in a similar manner to that shown in FIG. 29) with, e.g., the first cap 4000A projecting out from the holding member. Then, he or she removes the cap 4000A (see FIG. 37) and uses the lancet device to prick the skin. Then, instead of discarding the lancet unit (as is the case with the prior art lancets), he or she removes the lancet unit from the holding member and removes the second cap 4000B from the body 1000, installs the second cap 4000B on the end which previously has the first cap 4000A (see FIG. 38). Because the lancet needle LN is freely movably mounted in body parts 2000 and 3000, installing the cap 4000B on the left end causes the lancet needle LN to move to the position shown in FIG. 38. Then, he or she re-installs the lancet unit into the holding member with the right end projecting from the holding member. The user is now free to prick the skin with another clean needle. After use, the user will know that the lancet unit is expended because, once removed from the holding member, the user will see that second cap 4000B is installed on the left end�indicating that that needle has been used already. This indication will clear because the first cap 4000A is made to have the substantially same color as part 3000 (e.g., red) and the second cap 4000B is made to have substantially the same color as the other part 2000 (e.g., blue). He or she can then install the red cap 4000A on the blue end (see FIG. 39) and discard the lancet unit. Thus, when fully used, the red cap 4000A will be installed on the blue part 2000 and the blue cap 4000B will be installed on the red part 3000. This process doubles the useful file of the lancet. FIGS. 40-43 show another non-limiting embodiment of the double-ended lancet. The lancet unit is substantially similar to the embodiment shown in FIGS. 36-39 except that the freely movable lancet needle LN'has a bent portion BP instead of a molded movable stop. The bent portion BP functions to limit the axial movement of the lancet needle LN'between the axial positions shown in FIGS. 41. FIGS. 44 and 45 show another non-limiting embodiment of the double-ended lancet. The lancet unit is substantially similar to the embodiment shown in FIGS. 36-39 except that the movable stop MS'is lockable in the positions shown in FIGS. 38 and 39. The locking occurs between a snap or lock ring LR arranged on the movable stop MS′ and a locking groove LG formed in the body part 2000. A similar locking arrangement may also be provided on the embodiment shown in FIGS. 40-43. The lancet devices can preferably made transparent and/or translucent so that a user will clearly be able to see the inner workings of the device and note how much of the unit has already been utilized. Of course, the invention is not limited to a body design which is transparent and/or translucent. All the parts of the lancet device, with the exception of the springs and needles (which can respectively be made of spring steel and stainless steel), may be made from plastic materials and can be formed using conventional injection molding techniques or other known manufacturing methods. However, when practical, other materials and manufacturing processes may also be utilized. In each of the disclosed embodiments, the lancets which make up the multi-lancet unit can be formed individually (e.g., by injection molding) and then connected together as described above. However, the invention also contemplates forming the multi-part lancet unit (e.g., by injection molding) as a one-piece member. In this latter case, the lancet needles can be placed (e.g., at predetermined locations) within the mold(s) which will form the multi-lancet unit. Then, the mold(s) is filled with the melted plastic material. Of course, provision is made in the mold(s) for producing the breakable connections will allow the lancets to be separated from the unit. It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims. Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS20060174592 *Feb 7, 2005Aug 10, 2006Chan Frank ALancet protective cap* Cited by examinerReferenced byCiting PatentFiling datePublication dateApplicantTitleUS8734365Aug 18, 2011May 27, 2014Roche Diagnostics Operations, Inc.Test element magazine having covered test fieldsClassifications U.S. Classification606/181International ClassificationA61B17/32Cooperative ClassificationA61B5/15146, A61B5/151, A61B5/1427, A61B5/1411European ClassificationA61B5/14B8, A61B5/14B2, A61B5/151M, A61B5/151Legal EventsDateCodeEventDescriptionDec 21, 2005ASAssignmentOwner name: STAT MEDICAL DEVICES, INC., FLORIDAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SCHRAGA, STEVEN;REEL/FRAME:017401/0980Effective date: 20051216RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services