CA2592979A1

CA2592979A1 - Multi-lancet unit, method and lancet device using the multi-lancet unit, and method of assembling and/or making the multi-lancet unit

Info

Publication number: CA2592979A1
Application number: CA002592979A
Authority: CA
Inventors: Steven Schraga
Original assignee: Stat Medical Devices, Inc.; Steven Schraga
Current assignee: Stat Medical Devices Inc
Priority date: 2005-01-28
Filing date: 2006-01-27
Publication date: 2006-08-10
Also published as: CN101163452A; WO2006083676A3; WO2006083676A2; EP1841370A4; AU2006211171A1; US9282918B2; CN100591292C; US9289161B2; EP1841370A2; US20060173478A1; US20060241668A1

Abstract

Multi-lancet unit (LA) for a lancet device (LD). The unit (LA) includes a plurality of lancets (L1, L2, Ln..,) arranged in a row. Each lancet (L1, L2, Ln..,) has a front end, a needle (LN) which extends from the front end, and a rear end. The front end of at least one of the plurality lancets (L1, L2, Ln..,) is removably connected to the rear end of another of the plurality of lancets (L1, L2, Ln..,). The lancet device (LD) utilizes the multi-lancet unit (LA) and includes a body (UH/LH) and a holding member (LHM) which houses the multi-lancet unit (LA).

Description

,.
TM~JLT~~~~ET UNIT, METHOD AND LANCET DEVICE USING THE
MULTI-LANCET UNIT, AND METHOD OF ASSEMBLING AND/OR MAKING
THE MULTI-LANCET UNIT

CROSS-REFERENCE TO RELATED APPLICATIONS

The instant application is based upon the U.S. priority Patent Application No.
11/044,008, filed January 28, 2005, the disclosure of which is hereby expressly incorporated by reference thereto, and the priority of which is hereby claimed under 35 U.S.C. 120.

BACKGROUND OF THE INVENTION
1. Field of the Invention [0001] The invention relates to a multi-unit lancet in which a plurality of lancets are arranged in series and/or one in front of the other. The lancets are removably connected to each other and can be disconnected from each other by twisting, pulling, bending, and/or any coinbination of these movements. The invention also relates to a method of assembling and/or forming the multi-unit lancet assembly by individually forming each lancet, arranging them in a row and connecting the lancets together in order to form a multi-lancet unit. The invention further relates to a lancet device which uses the multi-lancet unit and to a method of using the lancet device to puncture a user's skin.

2. Discussion of Background Information [0002] Lancet devices are commonly used to prick the skin of the user so that one or more drops of blood may be extracted for testing. Some users, such as diabetics, for example, may have to test their blood sugar levels several times a day. This may be accomplished by the user using a simple needle. However, this procedure is often problematic for the user since the needle may be difficult to handle. Additionally, many users simply cannot perform the procedure owing to either a fear of needles or because they lack a steady hand. As a result, lancet devices have been developed which allow the user to more easily and reliably perform this procedure.

VJi I~ ,~ 1i.I_ ji".il SUIVTIVIA ~.~Y OF THE INVENTION

[0003] According to one illustrative aspect of the invention there is provided a multi-lancet unit for a lancet device, wherein the unit preferably comprises a plurality of lancets arranged in a row. Each lancet preferably comprises a front end, a needle which extends from the front end, and a rear end. Preferably, the front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets.

[0004] The plurality of lancets may comprise at least two lancets. The plurality of lancets may comprise at least three lancets. The plurality of lancets may be between five lancets and twenty lancets. The plurality of lancets may be between eight lancets and twelve lancets.
Each of the plurality of lancets may comprise a generally cylindrical portion.
Each of the plurality of lancets may comprise a non-circular cross-section when viewed perpendicular to a center axis of the plurality of lancets. Each of the plurality of lancets may comprise a locking mechanism. The locking mechanisms may be generally equally spaced.
Each of the plurality of lancets may comprise a locking recess.

[0005] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body and a holding member which houses the multi-lancet unit.

[0006] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body, a trigger, and a movable holding member which houses the multi-lancet unit.

[0007] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body, a trigger, a movable holding member which houses the multi-lancet unit, and a mechanism for moving the holding meinber to a retracted trigger-set position.

[0008] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body, a holding member which houses the multi-lancet unit, and a mechanism for moving the multi-lancet unit within the holding member.

[0009] The invention also provides a method of puncturing a surface of skin using the lancet device described above, wherein the method comprises placing or arranging the lancet device ~(:::t? ~!.=:: v:.l~ ; , ~~..f~ 151 tl..~ 11.~ U
adjacerit against a user9s skin triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

[0010] The invention also provides a multi-lancet unit for a lancet device, wherein the unit comprises a plurality of lancets arranged in a row. Preferably, each lancet comprises a front end, a needle which extends from the front end, a rear end, an opening extending into the rear end, and a locking mechanism. Preferably, the front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets.

[0011] The plurality of lancets may comprise at least two lancets. The plurality of lancets may comprise at least three lancets. The plurality of lancets may be between five lancets and twenty lancets. The plurality of lancets may be between eight lancets and twelve lancets.
Each of the plurality of lancets may coniprise a generally cylindrical portion. Each of the plurality of lancets may comprise a non-circular cross-section when viewed perpendicular to a center axis of the plurality of lancets. The locking mechanism may comprise a tapered recess. The locking mechanisms may be generally equally spaced. The locking mechanism may comprise a locking recess.

[0012] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body and a holding member which houses the multi-lancet unit.

[0013] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body, a trigger, and a movable holding member which houses the multi-lancet unit.

[0014] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body, a trigger, a movable holding member which houses the multi-lancet unit; and a mechanism for moving the holding member to a retracted trigger-set position.

[0015] The invention also provides a lancet device utilizing the multi-lancet unit described above, wherein the lancet device comprises a body, a holding member which houses the multi-lancet unit, and a mechanism for moving the multi-lancet unit within the holding member.

('F;;:<< iL., ':~I" ,:= 11;jq ;i:;;{r 1~:,_~i If::u :{~~ li_'ni: ~' .a r õ ini [0016] The iriventiori aiso provi,4 jdes a method of puncturing a surface of skin using the lancet device described above, wherein the method comprises arranging the lancet device adjacent against a user's skin and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

[0017] The invention also provides a method of making the multi-lancet unit described above, wherein the method comprises forming each of the plurality of lancets and arranging the plurality of lancets in a row to form the multi-lancet unit.

[0018] The invention also provides a multi-lancet unit for a lancet device, wherein the unit comprises a plurality of lancets arranged in a row. Each lancet comprises a front end, a needle which extends from the front end, a rear end, an opening extending into the rear end, and a locking mechanism. A plurality of brealcable and/or separable connections is utilized.
Each breakable or separable connection is arranged to connect an adjacent pair of lancets..

[0019] Other exemplary embodiments and advantages of the present invention may be ascertained by reviewing the present disclosure and the accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein:

Figure 1 shows a side view of one embodiment of a multi-lancet unit. The unit includes four removably connected lancets arranged one in front of the other.
Each lancet includes a lancet needle;

Figure 2 shows an enlarged view of the second lancet shown in the unit of Figure 1;
Figure 3 shows a top view of the lancet shown in Figure 2;
Figure 4 shows a cross-section view of an end portion one embodiment of a lancet holding member;

Figure 5 shows a side view of Figure 4;
Figure 6 shows a top view of the retaining member used on the embodiment shown in Figures 4 and 5;
Figure 7 shows a side view of the retaining member shown in Figure 6;

<< 4~ '~~~~ ~
Figure ~ shows a sid' e view of the lancet holding member shown in Figure 5 with the retaining member removed;
Figure 9 shows another side view of the lancet holding member shown in Figure 5.
The view is rotated 90 degrees from that shown in Figure 8;
Figure 10 shows a cross-section view of the lancet holding member shown in Figures 4, 5, 8 and 9 with the multi-lancet unit installed therein. The lancets are not shown in cross-section;
Figure 11 shows a view similar to that of Figure 10 witll the multi-lancet unit being moved and/or advanced partially forward and out of the lancet holding member;
Figure 12 shows a view similar to that of Figure 11 with the multi-lancet unit being moved and/or advanced forward and out of the lancet holding member until the retaining member engages the next lancet thereby temporarily locking the multi-lancet unit in the next position;
Figure 13 shows a view similar to that of Figure 12 with the front most lancet being removed from the multi-lancet unit;
Figure 14 shows a cross-section of an end portion of another embodiment of a lancet holding member which can be used with the multi-lancet unit;
Figure 15 shows a side view of Figure 14 rotated 90 degrees;

Figure 16 shows a side view of Figure 14 and illustrates deflection of the retaining members while the multi-lancet unit advances forward and out of the lancet holding member;
Figure 17 shows a side view of one embodiment of a lancet device which can include the multi-lancet unit and the lancet holding member shown above;
Figure 18 shows a cross-section view of the lancet device shown in Figure 17;
Figure 19 shows a side view of another embodiment of a multi-lancet unit which can be used on the lancet device shown in Figures 17 and 18;
Figure 20 shows the multi-lancet unit of Figure 19 installed within the lancet device shown in Figures 17 and 18. The lancet device is shown in the armed/trigger set position;
Figure 21 shows the multi-lancet unit of Figure 19 installed within the lancet device shown in Figures 17 and 18. The lancet device is shown in the extended/triggered position;
Figure 22 shows a partial end view of another embodiment of the lancet device, lancet holding member, and multi-lancet unit. This embodinient is similar to that of Figures 20 and 1"exceptth~a~e''lance's itlie Tarcet holding member and guide flanges of the lancet device include arrangements for linearly and non-rotatably guiding movement of the hold'uig member within the lancet device and for linearly and non-rotatably guiding movement of the multi-lancet unit within the lancet holding member;
Figure 23 shows a partial end view of another embodiment of the lancet device, lancet holding member, and multi-lancet unit. This embodiment is similar to that of Figures 20 and 21 except that the lancets, the lancet holding member and guide flanges of the lancet device include arrangements and/or an external shape for linearly and non-rotatably guiding movement of the holding member within the lancet device and for linearly and non-rotatably guiding movement of the multi-lancet unit within the lancet holding member;
Figure 24 shows a side view of one embodiment of the multi-lancet unit which can be used in the lancet devices shown in Figures 22 and 23;

Figure 25 shows a side view similar to that of Figure 24 rotated 90 degrees;
Figure 26 shows anotlier embodiment of a lancet device which can utilize the multi-lancet unit described above. This device is similar to that shown in Figures 20 and 21 except that it additionally includes a mechanism for re-setting and/or moving the lancet holding member back into the trigger set/armed position;
Figure 27 shows another non-limiting way in which the lancets can be removably connected to each other. In this Figure, a single wrap of connecting tape is used to connect two adjacent lancets;
Figure 28 shows a partial end view of another einbodiment of the lancet device, lancet holding member, and multi-lancet unit. This embodiment is similar to that of Figures 20 and 21 except that the lancets, the lancet holding member and guide flanges of the lancet device include arrangements and/or an external shape for linearly and non-rotatably guiding movement of the holding member within the lancet device and for linearly and non-rotatably guiding movement of the multi-lancet unit within the lancet holding member;
Figure 29 shows five views of another embodiment of the lancet device wherein the lancet devices uses a system for advancing the multi-lancet unit. The mechanism has the form of a slide button. This multi-lancet unit advancing system can be used on any of the lancet devices disclosed herein;

Figure 30 shows an enlarged view of the multi-lancet unit advancing system shown in Fig. 29; and Figure 31 schematically shows a lancet device with a front cap.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0021] The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present ulvention 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 forins of the present invention may be embodied in practice.

[0022] Figs. 1-3 show a first non-limiting embodiment of a lancet assembly or multi-lancet unit LA. The unit LA includes a plurality of lancets L1, L2, L3 and a terminatiuig or rear end lancet which is made up of a last lancet LL and a dummy lancet DL. These rear lancet members LL and DL are preferably non-removably connected to each other. The last lancet LL and the lancets L1-L3 (or Ll-LN depending on the desired number N of lancets in a unit LA) are generally identical in size, shape and configuration with the exception that the last lancet LL need not be provided with the comiecting members CM. Instead, the last lancet LL and the dummy lancet DL can be formed as a one-piece member. As can be seen in Fig.
2, each lancet, e.g., lancet Ll, has body portion CBP which can be generally cylindrical. As can be seen in Fig. 3, a rear end of each lancet, e.g., lancet Ll, includes a plurality of connecting projections or members CM and a generally centrally arranged lancet needle opening LNO which is sized to receive therein a lancet needle LN of an adjacent rear lancet, e.g., lancet L2. The particular number, size, shape and arrangement of the connecting members CM is not of particular importance provided that a stable yet breakable connection is ensured between the adjacent lancets. In this regard, the connection should be strong enough to allow a user pull the unit LA out of the lancet holding member LHM
(see Figs. 11 and 12) until the unit LA reaches the next locking or retaining position to allow for the use of If ;.T :sl~ 41 }f a new fancet, e.g., the next adjacent lancet L2. The connection should also be weak enough to allow the user to break off (see Fig. 13) the front lancet, e.g., to allow the user to break off the lancet Ll from the rear adjacent lancet L2. In this regard, the invention contemplates that the connection can be fornled by any convenient and/or practical arrangement such as, e.g., adhesively bonding or ultrasonically welding, the members CM to the contact surfaces CS.
The connection can also be made breakable in any desired way provided that a user can cause separation of the lancets in a simple way by, e.g., twisting and/or bending.
As can be seen in Fig. 13, breaking off the front lancet Ll exposes the lancet needle LN of the rear adjacent lancet L2. As a result, the lancet needle LN of the rear adjacent lancet L2 remains protected within the opening LNO of the front lancet Ll while the front lancet L1 is connected to the rear adjacent lancet L2.

[0023] Each lancet, e.g, lancet Ll, also includes a front end from which the lancet needle LN
extends or projects. A locking or retaining recess LR and a shoulder SP whose front surface forms a contact surface CS is also provided on each lancet. By way of non-limiting example, the locking recess LR can be a tapered recess and can be specifically designed to engage with a locking or retaining menlber RM of a lancet holding member LHM of a lancet device (see Figs. 4-13). Of course, other mechanisms, other than a locking recess, can be utilized to ensure that the lancet unit LA is indexed or advanced in generally equal increments within the lancet holding member LHM. The invention contemplates that the particular location, size and configuration of the retaining mechanism of each lancet can be specifically configured to a particular lancet holding member LHM of a particular lancet device.

[0024] The contact surface CS can be designed to contact an inner surface IS
(which can be a movable/adjustable surface) of a lancet device tip (see e.g., Fig. 31). By way of non-limiting examples, the unit LA can be used with a lancet device (i.e., any of the lancet devices disclosed herein) which includes an adjustable tip or front cap FC (see Fig.
31) of the type described in any one of the following documents: US 6,811,557 to SCHRAGA, US
6,530,937 to SCHRAGA, US 6,322,575 to SCBRAGA, and US 5,613,978 to IIARDING, the disclosures of which are hereby expressly incorporated by reference in their entireties. By way of non-limiting examples, the unit LA 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 FC (see 't1R#A ~{...u == S~ =..' r I~.,.{' ~t ~l:..~- ~~~~.(f ~.'r lt..=4~ {{.,.iF
:','= {~'~~ I~~A
Fig. 31) of the type ldf escribed in any one of the following documents: US
6,156,051 to SCHRA.GA, US 6,022,366 to SCHRAGA, US 5,908,434 to SCHRAGA, US 5,797,942 to SCHRAGA, US 5,628,764 to SCFfRAGA, and US 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 witli any of the lancet devices described herein such as the ones shown in Figs. 17, 18, 20-23, 26 and 28-30.
Additionally, the tip or front cap FC 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, etc,.

[0025] The body CBP of the lancets Ll, L2, L3, LL and DL 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 malcing techniques including, e.g., injection molding, extrusion, etc,. The lancet needles LN can also be of the sanie material, types and sizes as are used in conventional lancets. The number of lancets ui a particular unit LA can also vary depending on the desired number required for a unit LA. It will also depend on the desired overall axial length of the unit LA. Preferably, the overall unit LA has an axial length of between approximately 1" and approximately 5" depending on the number of lancets in a unit LA and the length of each lancet. By way of non-limiting example, each lancet can also range in axial length between approximately 1/4" and approximately 3/4". In order to provide a visual indicator to a user, the last lancet LL, and optionally also lancet DL, can be made of different color than the lancets Ll-L3. In this way, when the user uses the unit LA in a lancet device (see e.g., Figs. 17-19), upon seeing and using the last lancet LL, the user will be able to note that it is time to change the unit LA with a new unit LA.

[0026] Figs. 4-13 illustrate one non-limiting way in which the unit LA can be mounted to a lancet holding member LHM 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: US
6,811,557 to SCHRAGA, US 6,530,937 to SCHRAGA, US 6,346,114 to SCHRAGA, US 6,190,398 to SC ~I~2AG~TA!'i;756;0'ST~~~o'ei1RAGA, US 6,022,366 to SCHRAGA, US 5,908,434 to SCHRAGA, US 5,797,942 to SCHRAGA, US 5,628,764 to SCHRAGA, US 5,464,418 to SCHRAGA, and US 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 LA 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 LA in a manner similar to that shown in the lancet device of, e.g., Fig. 20.

[0027] Again with reference to Figs. 4-13, it can be seen that the lancet holding member LHM, which uses the unit LA, has a front end from which a lancet L1 extends and through which the unit LA moves through. In order to ensure that the unit LA advances and/or indexes out of the front end one lancet at a time, the lancet holding member LHM includes a retaining mechanism RM. In the embodiment shown in Figs. 4-13, the retaining mechanism RM has the form of a C-shaped clip (see Fig. 6). The retaining mechanism RM
mounted to front end of the lancet holding member LHM via oppositely arranged slots SL, which are sized slightly larger in width than the retaining member RM in order to loosely receive therein the retaining meinber RM. In order to ensure that the retaining member RM remains mounted to the lancet holding member LHM, the retaining member RM includes four retaining projections RP which are designed to prevent the retaining member RM
from sliding out of engagement with the slots SL. The retaining member RM includes tapered and/or angled inner edges AIE which utilize an angle which is generally complementary to that of the retaining recesses LR (see Fig. 10). As can be seen when comparing Figs. 10-12, the retaining member RM is made of a resilient or spring-like material which can be deflected outwards (see Fig. 11) when the unit LA is moved out of the front end of the lancet holding member LHM. The angles of the edge AIE and the recess LR are such that they facilitate outward deflection of legs of the retaining member RM when the unit LA is moved in the direction shown in Fig. 11. However, because the retaining member RM
has the properties of a natural spring, when the unit LA is advanced out by the length of a lancet, the edges AIE again engage with another retaining recess LR thereby locking the unit LA in the next position (see Fig. 12).

;j'r' 1~:.. =t,~~:.: o.: }k..(1si i; i;I:.1[ fl :u 11:11 ~::" a' rt'!E

[0028] According to this embodiment, the used lancet Ll can the be separated and/or broken off from the unit LA (see Fig. 13) using either a twisting motion and/or a bending motion.
At this point, the lancet needle LN of the next or new lancet L2 is ready for use. The user can then install the tip of the lancet device and use it to pierce the skin.
In this embodiment, the user grips the used lancet L1 and pulls on the used lancet Ll (Fig. 11) to cause the unit LA to advance forward. The retaining member RM, by virtue of its angled inner edge AIE, prevents the unit LA from moving back into the lancet holding member LIiM even if the user desired it to so move, which functions as a safety feature. Of course, pulling of the lancet Ll has the possibility of pricking the user because the lancet needle LN is exposed.
Accordingly, it is preferred that the lancet device, which uses the lancet holding member LHM shown in Figs. 4-13, also use a system for advancing the unit LA that does not require the user to handle the lancets during pulling, even tliough it may be necessary to do so to disconnect the lancet Ll from the lancet L2. By way of non-limiting example, Figs. 29 and 30 show one such a system which can be used with any of the lancet holding members described herein. The details of Figs. 29 and 30 will be described later on.

[0029] Figs. 14-16 illustrate another non-limiting way in which the unit LA
can be mounted to a lancet holding member LHM' of a lancet device. Examples of lancet devices which can use the lancet liolding member LHM' are disclosed in the following documents:
US
6,811,557 to SCHRAGA, US 6,530,937 to SCHRAGA, US 6,346,114 to SCHRAGA, US
6,190,398 to SCI-iRAGA, US 6,156,051 to SCHRAGA, US 6,022,366 to SCI-B2AGA, US
5,908,434 to SCHRAGA, US 5,797,942 to SCHRAGA, US 5,628,764 to SCHRAGA, US
5,464,418 to SCI-B2.AGA, and US 5,613,978 to HARDING, the disclosures of which are hereby expressly incorporated by reference in their entireties.

[0030] Again with reference to Figs. 14-16, it can be seen that the lancet holding member LHM' has a front end from which a lancet L 1 extends and through which the unit LA moves through. In order to ensure that the unit LA advances and/or indexes out of the front end one lancet at a time, the lancet holding member LHM' includes oppositely arranged retaining members or mechanisms RM'. In the embodiment shown in Figs. 14-16, the retaining mechanisms RM' are integrally formed with the lancet holding member LHM' (see Fig. 15).
The retaining nlechanisms RM' are arranged on the front end of the lancet holding member 4tLI~M an'd'are ~1c pable 'detlecfing outwards when the unit LA is moved outwardly (see Fig. 16). The retaining members RM' include tapered and/or angled inner edges AIE' which utilize an angle which is generally complementary to that of the retaining recesses LR (see Fig. 14). As can be seen when comparing Figs. 14 and 16, the retaining members RM' are made of a resilient or spring-like material which can be deflected outwards (see Fig. 16) when the unit LA is moved out of the front end of the lancet holding member LHM'. The angles of the edge AIE' and the recess LR are such that they facilitate outward deflection of the retaining members RM' when the unit LA is moved in the direction shown in Fig. 16.
However, because the retaining members RM' have the properties of a natural spring, when the unit LA is advanced out by the length of a lancet, the edges AIE' again engage with another retaining recess LR thereby locking the unit LA in the next position.

[0031] Figs. 17-21 illustrate one non-limiting preferred embodiment of a unit LA and a lancet device LD which can utilize the unit LA. The lancet device LD utilizes a two part body made of an upper housing UH and a lower housing LH which can be connected to each other by, e.g., snap connection, adhesive bonding, or ultrasonic welding. The housing parts UH
and LH can be made of the same conventional materials as are used in conventional lancet devices and are preferably made of synthetic resin. A trigger button TB is mounted to the body and functions to cause the lancet holding member LHM to move to an extended position when it is activated. Examples of lancet devices which can use similar trigger buttons are disclosed in the following documents: US 6,811,557 to SCHRAGA, US
6,346,114 to SCHRA.GA, US 6,156,051 to SCHRA.GA, US 5,908,434 to SCHRAGA, US
5,797,942 to SCI-flZA.GA, US 5,628,764 to SCHRAGA, US 5,464,418 to SCHRAGA, and US 5,613,978 to HARDING, the disclosures of which are hereby expressly incorporated by reference in their entireties.

[0032] As can be seen when comparing Figs. 18 and 20, the lancet holding member LHM of the lancet device LD is hollow and/or tubular and is sized to receive therein the unit LA.
The lancet device LD has a rear opening RO which is aligned with the opening of the lancet holding member LHM. This opening RO allows the user to insert that unit shown in Fig. 19 into the lancet holding member LHM from the rear end of the lancet device LD.
Once installed therein (see Fig. 20), the protective cap RC can be removed. After the tip is .
914 ' 3 installed (not s~own) ori t~'e lancet device LD, the lancet device LD will then be ready for use in pricking a user's skin. After use, the user simply removes the tip, pulls on the used lancet LI until the unit LA advances to the next lancet L2. The user will then be able to break off the used lancet (see e.g., Figs. 12 and 13) thereby exposing the next new lancet L2.
The lancet device LD will then be ready for use once again after replacement of the tip on the lancet device LD. Fig. 21 shows how the lancet holding member LHM moves to the extended position under the action of the spring S once the trigger button TB
is activated. In order to ensure that the lancet holding member LHM is guided within the lancet device LD
in a generally linear manner without also rotating to a significant extent, the lancet device LD
uses two or more spaced apart guiding flanges GF. In order to ensure that the spring S also biases the lancet holding inember LHM back into the lancet device LD after it has moved to the extended position, the spring S has one end coupled to the body and another end coupled to the lancet holding member LHM. Since the use of springs and trigger buttons, as well as the interaction of the trigger button with the lancet holding member, on lancet devices is well kmow, the details of such devices and arrangements will not be discussed in detail herein.

[0033] Fig. 22 illustrates one non-limiting optional configuration in order to ensure that the lancet holding meinber LHM" of the lancet device LD is linearly guided within the lancet device LD without rotating. The arrangement uses an elongated guiding projection that is integrally formed with the lancet holding member LHM" and which acts to linearly guide the movement of the lancet holding member LHM" within the lancet device LD by engaging with grooves arranged on the guiding flanges GF'. The arrangement also uses guiding projections GP integrally formed with the lancets (see Figs. 24 and 25). The projections GP
act to linearly guide the movement of the unit LA' within the lancet holding member LHM"
when the unit LA' is advanced between positions. As is evident from Fig. 22, the projections GP slide within a groove formed in an inside cylindrical surface of the lancet holding member LHM".

[0034] Fig. 23 illustrates another non-limiting optional configuration in order to ensure that the lancet holding member LHM'" of the lancet device LD is linearly guided within the lancet device LD without rotating. The arrangement uses a polygonal-shaped, e.g., square or rectangular, lancet holding member LHM'" which moves within a slightly larger but +:
correspondiriglyshapediiopenirig in the guiding flanges GF". The arrangement also uses guiding projections GP integrally formed with the lancets (see Figs. 24 and 25). The projections GP act to linearly guide the movement of the unit LA' within the lancet holding member LHM'" when the unit LA' is advanced between positions. As is evident from Fig.
23, the projections GP slide within a groove formed in an inside cylindrical surface of the lancet holding member LHM"'.

[0035] Fig. 26 illustrate another non-limiting preferred embodiment of a unit LA and a lancet device LD' which can utilize the unit LA. The lancet device LD' is similar to that shown in Figs. 17, 19, 20 and 21 except that it also includes a trigger setting mechanism TSM. The lancet holding member LHMr''' is similar to the one used in the embodiment shown in Figs.
17, 19, 20 and 21 except that the rear end portion includes a flange which can be gripped and/or engages by the trigger setting mechanism TSM. The use of such mechanisms on lancet devices are well know and the invention is not limited to any particular type of trigger setting mechanism. Examples of lancet devices which can use similar trigger setting arrangements are disclosed in the following documents: US 6,156,051 to SCHRAGA
and US
6,022,366 to SCHRAGA, the disclosures of which are hereby expressly incorporated by reference in their entireties.

[0036] Fig. 27 illustrate another non-limiting way in which the lancets can be connected iulstead of and/or in addition to the connecting members CM. In this embodiment, the lancets of the unit LA" are connected with one or more wraps of connecting tape CT
which includes a breakable perforation line PL in order to allow the user to separate the lancets from each other. The connecting tape CT preferably is sufficiently thin so as not to cause the unit LA"
to become stuck within the lancet holding member LHM.

[0037] Fig. 28 illustrates another non-limiting optional configuration in order to ensure that the lancet holding member LHM'v of the lancet device LD is linearly guided within the lancet device LD without rotating. The arrangement uses a polygonal-shaped, e.g., square or rectangular, lancet holding member LHMn' which moves within a slightly larger but correspondingly shaped opening in the guiding flanges GF". The arrangement also uses a polygonal-shaped, e.g., square or rectangular, unit LA'" which moves with a slightly larger but correspondingly shaped openings in the lancet holding member LHMn'.

~~"[403~8] Figs'im~g'~ ~anc~ 3~'l~iYYustrate" another non-limiting embodiment of a lancet device LD"
which uses another embodiment of a lancet holding member LI3M . The device is similar to that shown in Figs. 17, 18, 20 and 21 except that it also includes a lancet advancing system LAS. The system LAS includes s slot formed on the lancet device body, a slot formed in the lancet holding member LHMv, and a push-button slide member UAM which is biased by a spring SP and which slides moves inwards to engage one of the retaining recess LR, slides forwardly to cause advancing movement of the unit LHMV. The user can then move the member UAM manually back to an initial position in order to engage the unit LA" again.
This arrangement for manually moving the unit can be used on any of the lancet device embodiments disclosed herein. Moreover, the invention is not limited to the particular arrangement shown herein and can utilize other arrangements for more safely advancing the unit within the lancet holding member.

[0039] 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 inuch of the unit has already been utilized. Of course, the invention is not limited to a body design which is transparent and/or translucent.

[0040] 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 'uijection molding tecliniques 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-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 producuig the breakable connections will allow the lancets to be separated from the unit.

[0041] 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 yPõT~ (yM,,: =,:.{+::: ,+- ~1...~~ iti=.~4 ~l,,,1,! I'~."','j! r'. ff. f'~v~f =.o,~i~= i{õ.~~ r~.~i present invention has been d'escribed 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 einbodiments, 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.

Claims

1. A multi-lancet unit for a lancet device, the unit comprising:
a plurality of lancets arranged in a row; and each lancet comprising a front end, a needle which extends from the front end, and a rear end;
wherein the front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets.

2. The unit of claim 1, wherein the plurality of lancets comprises at least two lancets.

3. The unit of claim 1, wherein the plurality of lancets comprises at least three lancets.

4. The unit of claim 1, wherein the plurality of lancets is between five lancets and twenty lancets.

5. The unit of claim 1, wherein the plurality of lancets is between eight lancets and twelve lancets.

6. The unit of claim 1, wherein each of the plurality of lancets comprises a generally cylindrical portion.

7. The unit of claim 1, wherein each of the plurality of lancets comprises a non-circular cross-section when viewed perpendicular to a center axis of the plurality of lancets.

8. The unit of claim 1, wherein each of the plurality of lancets comprises a locking mechanism.

9. The unit of claim 8, wherein the locking mechanisms are generally equally spaced.

10. The unit of claim 1, wherein each of the plurality of lancets comprises a locking recess.

11. A lancet device utilizing the multi-lancet unit of claim 1, the lancet device comprising:
a body; and a holding member which houses the multi-lancet unit.

12. A lancet device utilizing the multi-lancet unit of claim 1, the lancet device comprising:
a body;

a trigger; and a movable holding member which houses the multi-lancet unit.

13. A lancet device utilizing the multi-lancet unit of claim 1, the lancet device comprising:
a body;

a trigger;
a movable holding member which houses the multi-lancet unit; and a mechanism for moving the holding member to a retracted trigger-set position.

14. A lancet device utilizing the multi-lancet unit of claim 1, the lancet device comprising:
a body;
a holding member which receives therein the multi-lancet unit; and a mechanism for moving the multi-lancet unit within the holding member.

15. A method of puncturing a surface of skin using the lancet device of claim 11, the method comprising:
arranging the lancet device adjacent against a user's skin; and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

16. A method of puncturing a surface of skin using the lancet device of claim 12, the method comprising:
arranging the lancet device adjacent against a user's skin; and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

17. A method of puncturing a surface of skin using the lancet device of claim 13, the method comprising:
arranging the lancet device adjacent against a user's skin; and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

18. A multi-lancet unit for a lancet device, the unit comprising:
a plurality of lancets arranged in a row; and each lancet comprising a front end, a needle which extends from the front end, a rear end, an opening extending into the rear end, and a locking mechanism;
wherein the front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets.

19. The unit of claim 18, wherein the plurality of lancets comprises at least two lancets.

20. The unit of claim 18, wherein the plurality of lancets comprises at least three lancets.

21. The unit of claim 18, wherein the plurality of lancets is between five lancets and twenty lancets.

22. The unit of claim 18, wherein the plurality of lancets is between eight lancets and twelve lancets.

23. The unit of claim 18, wherein each of the plurality of lancets comprises a generally cylindrical portion.

24. The unit of claim 18, wherein each of the plurality of lancets comprises a non-circular cross-section when viewed perpendicular to a center axis of the plurality of lancets.

25. The unit of claim 18, wherein the locking mechanism comprises a tapered recess.

26. The unit of claim 18, wherein the locking mechanisms are generally equally spaced.

27. The unit of claim 18, wherein the locking mechanisms comprises a locking recess.

28. A lancet device utilizing the multi-lancet unit of claim 18, the lancet device comprising:
a body; and a holding member which houses the multi-lancet unit.

29. A lancet device utilizing the multi-lancet unit of claim 18, the lancet device comprising:
a body;

a trigger; and a movable holding member which houses the multi-lancet unit.

30. A lancet device utilizing the multi-lancet unit of claim 18, the lancet device comprising:
a body;
a movable holding member which houses the multi-lancet unit;

a mechanism for moving the holding member to a retracted trigger-set position;
and at least one of:
a front cap arrangement connected to the body;
a front tip assembly coupled to a front end of the body;
a front assembly removably coupled to a front end of the body; and a tip assembly adjusting a penetration depth of a lancet needle being coupled to a front end of the body.

31. A lancet device utilizing the multi-lancet unit of claim 18, the lancet device comprising:
a body;

a holding member which houses the multi-lancet unit; and a mechanism for moving the multi-lancet unit within the holding member.

32. A method of puncturing a surface of skin using the lancet device of claim 29, the method comprising:
arranging the lancet device adjacent against a user's skin; and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

33. A method of puncturing a surface of skin using the lancet device of claim 30, the method comprising:
arranging the lancet device adjacent against a user's skin; and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

34. A method of puncturing a surface of skin using the lancet device of claim 31, the method comprising:

arranging the lancet device adjacent against a user's skin; and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user's skin.

35. A method of making the multi-lancet unit of claim 1, the method comprising:
forming each of the plurality of lancets;
arranging the plurality of lancets in a row to form the multi-lancet unit.

36. A method of making the multi-lancet unit of claim 18, the method comprising:
forming each of the plurality of lancets;
arranging the plurality of lancets in a row to form the multi-lancet unit.

37. A multi-lancet unit for a lancet device, the unit comprising:
a plurality of lancets arranged in a row;
each lancet comprising a front end, a needle which extends from the front end, a rear end, an opening extending into the rear end, and a locking mechanism; and a plurality of breakable and/or separable connections, wherein each breakable or separable connection is arranged to connect an adjacent pair of lancets.