TW201722355A - Lancet device - Google Patents

Abstract

The present invention provides a blood sampling device 10 having body 12 having an opening 20 therein for receiving a retractable needle holder 14. A mechanism is provided for biasing the holder 14 and any needle contained therein to a position in which it projects from the body 12 such as to cause the taking of a sample of blood from a user. The mechanism includes a re-latchable spring biasing system.

Description

Blood collection device

The present invention relates to a blood collection device, and in particular to a micro blood collection device that can be carried, for example, by a patient who needs to obtain a small blood sample for testing purposes. These devices are typically used to pierce the skin of a user to allow access to a blood sample without the need for medical assistance from an expert.

Blood collection devices are well known and generally comprise a form of releasable retractable lancet needle holder and spring loaded activation mechanism housed within a housing or body portion, the spring load activation mechanism enabling the lancet needle holder after external activation Any blood collection needle contained therein and any part of the body is injected at a predetermined distance from the body portion and injected into the skin of the user for collecting blood samples for subsequent analysis. One example of such a device is shown in US 5,908,434, which includes a body having an interior for receiving a retractable needle holder, the needle holder having a first retracted position and a second deployed position. The needle holder houses the needle containing the blood collection needle and is spring loaded under the action of the releasable latch to allow the needle to be driven into the skin of the user when the latch is released. The device itself is a "single shot" device because there is no facility to re-lock the retractable needle holder.

US 8,828,038 discloses a versatile releasable retractable blood collection device having a body portion with a cocking mechanism at one end of the device and a release mechanism at the other end of the device. Can activate the stab mechanism and release multiple times Both mechanisms are placed to allow the user to use the device to collect multiple samples. The body includes two halves that are secured together and are used to house the lancet needle holder, the latch mechanism, and the activation mechanism. Before the two halves of the body are fixed together, the lancet needle holder and the latch mechanism are assembled on one half of the body, and the release mechanism includes a spring loaded button that extends into the body itself and holds the needle The latch on the device engages such that pressing the button releases the latch and allows deployment of the lancet and access to the blood sample. The torsion mechanism extends axially from the body such that in the position to be stabbed, the torsion mechanism extends the length of the device itself. Although this device does provide a sufficient sampling mechanism, the complexity of the design necessitates the need for multiple body portions to facilitate the retrieval of the needle holder and the latch, and the length of the device is greatly increased when the device is to be stabbed. This may make the device slightly larger than it is intended.

It is an object of the present invention to provide a blood sampling or blood collection device that reduces and possibly eliminates the disadvantages of the configurations mentioned above.

According to a first aspect of the present invention, there is provided a blood sampling device comprising: a body having a longitudinal axis X and having an exterior having an exterior surface, an interior having an interior surface therein and having therein a first end of the opening; a retractable needle holder in the interior of the body for receiving a blood collection needle, the needle holder having a first retracted position R and a second deployed position D, And the lancet has a first end and a second end, and has a needle protruding from the first end; a biasing member for biasing the needle holder to the deployment position D, at the position In D, the needle protrudes through the opening in the first end; a retractor mechanism for retracting the needle holder from the deployment position D to the retracted position R and having an extension to the outside of the body a latching mechanism for latching the needle holder from the retracted position R in a releasable manner; and a release mechanism for releasing from the latched retracted position R The needle holder; wherein the body includes one or more slots extending between the inner surface and the outer surface and extending axially between a closed end and an openable end, The slot receives the portion of the retraction mechanism and has one or more end stops toward the open end for restricting movement of the portion into the slot (during normal operation); and wherein the open end is Moving between a first closed position C and a second open position O, in which the end flaps are in close proximity to one another and prevent partial insertion into or removal from the slot, In this position O, the portion can pass between the end stops and be inserted into or removed from the one or more slots.

Those skilled in the art will appreciate that the above described apparatus is configured to allow for simple insertion of the needle holder mechanism into the body without the need for the body to include multiple portions.

Preferably, the body comprises a top portion and a bottom portion, two sides, and two slots each positioned on each side and opposite to each other, the joint portion and the top portion having an elastically flexible material And a portion of the bottom portion to permit reversible opening of the openable end, the top portion being joined to the bottom portion at the closed ends of the slots.

Advantageously, the top portion and the bottom portion include spaced apart axially extending portions, the extended portion extending away from the engaging portion in a direction opposite the direction in which the slots extend, and the top portion and the bottom portion A lever is formed to allow the top portion and the bottom portion to pivot about the engagement portion after applying a radially inward pressure to the axially extending portions.

The arrangement can include a locking feature on the outer surface of each of the top portion and the bottom portion, and the device further includes a locking ring that includes the locking feature and is coupled to the locking features to Preventing the top portion and the bottom portion from moving radially outward A locking feature of the movement. Advantageously, the locking feature can comprise a stop and the locking feature on the locking ring can comprise a dimple.

In a preferred configuration, the openable end includes mutually facing surfaces that are used to close the openable end when the slot is in a closed position, but in one of the open positions of the slot They are spaced apart from each other. Advantageously, the mutually facing surfaces comprise wedge-shaped leading edges opposite one another on one of the slots, the slots permitting insertion of the needle holder into the interior of the body in operation Then open the slots.

Advantageously, the retractor mechanism includes one or more axial projections between the needle holder and the (etc.) outer portion of the retractor mechanism, and wherein the (equal) axially extending projections are included for The wedge-shaped leading edge of the slots is opened after the needle holder is inserted into the opening of the body.

Advantageously, the slot includes an interior surface and the one or more axial projections comprise an elongated outer surface for sliding engagement with the interior surfaces of the slot.

Preferably, the one or more axial projections comprise an end surface for engaging the closable end of the slot when the needle holder is in its second deployment position D.

Advantageously, the body includes one or more recesses on the outer surface, and wherein the outer portions of the retraction mechanism are moveable between a first (deployed) position and a second (retracted) position, In the first (deployed) position, the outer portions are substantially outside the recess, and in the second (retracted) position, the outer portions are substantially within the recesses to allow the fingers to be in close proximity to hold the The needle is moved from the second deployed position to the first retracted position. Preferably, the recess comprises a wedge-shaped recess.

Preferably, the device includes a pair of outer portions, each of the outer portions being One of the bodies has opposite sides and each has a finger engaging portion.

Advantageously, the body includes an axially extending aperture extending through the body, and the latching mechanism includes one of the latchable members on the retractable needle holder and one of the body portions Release the latch.

Preferably, the latchable member includes an undercut wedge-shaped convex member having an undercut bottom surface and a wedge-shaped top surface positioned on a protruding portion of the needle holder, and the latch mechanism includes An inclined surface and a return surface and one of the bodies on the body corresponds to an undercut spring load ramp portion.

Preferably, the device includes a flexible member having a proximal end and a free distal end attached to the body, and wherein the latchable member is mounted to the flexible end toward the free end On and off the sex component.

Advantageously, the body includes an engagement portion and the proximal end is attached to the engagement portion.

Preferably, the latchable member includes a double-sided undercut male member having a wedge-shaped upper portion on each of the two sides and having a one on each of the two sides Undercut, and wherein the releasable latch includes one of an inclined ramp surface and a return surface pair of undercut spring load ramp portions, one such ramp portion being on each side of the latchable member.

The device can also include a movement limiting baffle to limit axial movement of the retractable needle holder toward a deployed position. Preferably, the moving baffle includes a protrusion on a proximal end of one of the flexible members.

Also described herein is a blood sampling device comprising: a body, a telescoping lancet needle holder, and a latch mechanism, the body including an axially extending aperture, the aperture extension Extending through the body, and the latching mechanism includes a latchable member on the retractable lancet needle holder and a releasable latch on the body portion; wherein the latchable member includes one An undercut wedge-shaped convex member on the bottom surface of the undercut and a wedge-shaped top surface positioned on a protruding portion of the lancet needle holder, and the latch mechanism includes an inclined surface and a return surface and is located on the body One of the upper ones corresponds to the undercut spring load ramp portion.

Also described herein is a blood sampling device comprising: a body having an interior surface and an exterior surface and having one or more slots extending between the interior surface and the exterior surface and Extending axially between a closed end and an openable end, the slot receiving the portion of the retraction mechanism and having one or more end stops toward the open end for restricting the portion into the slot Moving; and wherein the open end is movable between a first closed position C and a second open position O, in which position the end stops are in close proximity to one another and prevent partial insertion into the slot Or removed from the slot, in which position the portion can pass between the end stops and be inserted into or removed from the one or more slots, a telescoping lancet needle holder and a retractor mechanism, wherein the retractor mechanism includes one or more axial projections between the needle holder and the (etc.) outer portion of the retractor mechanism, and wherein the (etc.) The axially extending projections are included for After insertion into the opening in the body of the leading edge of such a wedge to open the slot.

Also described herein is a blood sampling device comprising: a body having an interior surface and an exterior surface and having one or more slots extending between the interior surface and the exterior surface and Extending axially between a first end and a second end, a telescoping lancet needle holder and a retractor mechanism having one or more outer portions external to the body, wherein the retractor The mechanism is in the needle holder and the retractor mechanism One or more radial projections are included between the outer portions, wherein the one or more radial projections pass through the (equal) slot, and wherein the body includes one or more recesses on the outer surface, And wherein the outer portions of the retraction mechanism are moveable between a first (deployed) position and a second (retracted) position in which the outer portions are in the recess Externally, in the second (retracted) position, the outer portions are substantially within the recesses to allow a finger to be moved to move the needle holder from the second deployment position D to the first retracted position R .

It will be appreciated that the features of the present invention can be used in conjunction with each other to form a single product, and that the elements claimed in the appended claims can be used independently, without relying on the features protected by the scope of the claims, and Features that are described in the detailed description but are not claimed. It is also understood that the elements shown in the figures may be used in a reasonable manner and are claimed individually, without relying on the other elements shown in the drawings.

The invention will now be described more particularly hereinafter with reference to the accompanying drawings in which: FIG. 1 is a perspective view of a blood sampling device incorporating the features of the present invention; FIG. 2 is an exploded view of the sampling device of FIG. Figure 3 is a partially exploded view of the sampling device of Figure 1; Figure 4 is a perspective view of the main portion of the sampling device of Figure 1; Figure 5 is a side view of the body portion shown in Figure 4; Figure 6 is in Figure 4 and Figure 7 is a plan view of the main body portion shown in Figures 4 to 6; Figures 8a and 8b are a side view and a plan view of the sampling device in a preset position; Figures 8c and 8d are in the directions of arrow AA and arrow BB in Figures 8a and 8b, respectively. Cross-sectional view; Figures 9a and 9b are side and top views of the sampling device in the pre-start position; Figures 9c and 9d are cross-sectional views along the direction of arrow AA and arrow BB in Figures 9a and 9b, respectively. 10A and 10B are a side view and a plan view of the sampling device when the start button has been pressed; FIGS. 10c and 10d are cross-sectional views taken along the directions of arrow AA and arrow BB in FIGS. 10a and 10b, respectively; FIG. Figure 11b is a side view and a plan view of the sampling device in the activated position; Figures 11c and 11d are cross-sectional views along the direction of arrow AA and arrow BB in Figures 11a and 11b, respectively; and Figure 12 is Figure 3 A cross-sectional view of a portion 76 of the same, and showing wedge leading edges 761 and 762.

Referring now generally to the drawings, but specifically to Figures 1 through 3, the blood sampling device schematically illustrated at 10 includes a body portion 12 having an outer surface 14e and an interior 16 (in Figures 2 and 3) The best seen in the middle), and the inner surface 16i. The first end 18 is provided with an opening 20 through which the needle described later herein can be deployed in operation. A telescoping lancet needle holder 14 is disposed within the interior 16 of the body 12 for receiving a lancet 22 having a needle 24 disposed therein and extending therefrom. The lancet 22 has a first end 22f for engagement in the needle holder 14 and a second end 22s for receiving the needle 24. A biasing member 25 is provided in the form of, for example, a compression spring 25 to bias the needle holder 14 toward a deployment position D in which the needle 24 protrudes from the opening 20 in the first end 18 to allow stab The user's skin is broken and blood samples are collected in a procedure described in more detail below. Displayed roughly at 26 A retractor mechanism is provided for retracting the needle holder 14 from the deployed position D to the retracted position R and includes a portion 26e that extends to the exterior of the body 12 and that is slidable by a user's thumb or finger. A latching mechanism, shown as an example under reference numeral 28, can be provided for latching the needle holder 14 from the retracted position R in a releasable manner. A release mechanism, shown as an example under reference numeral 30, can be provided for releasing the needle holder 14 from the latched retracted position R in a manner as described in detail below. The body 12 includes one or more slots 40a, 40b extending between the inner surface 16i and the outer surface 14e and extending axially between the closed end 42 and the openable end 44. The one or more slots 40a, 40b receive an outer portion 26e of the retraction mechanism 26, and each slot has a direction toward the openable end 44 for moving the portion 26e into the slot during normal operation Or a plurality of end stops 46. The openable end 44 is moveable between a first closed position C and a second open position O, in the first closed position C, the end stops 46 are in close proximity to each other and the prevention portion 26e is inserted into the slot 40 or Removed from the slot 40, in a second open position O, the portion 26e can pass between the end stops 46 and be inserted into or from the one or more slots 40 Remove. The moving facility can be implemented by placing the body in a material that has a degree of flexibility sufficient to allow the material of the needle holder 12 on each side of the slot 40 to flex around the closed end 42 and Allow opening to open the end 44. An example of a suitable material is Acetel plastic, but other plastics such as high density PTFE can also be used.

In a preferred configuration, the body 12 of the above configuration may include a top portion 12t and a bottom portion 12b, two side edges 12e and 12f, and two slots 40a each positioned on each of the side edges 12e, 12f and opposite to each other. , 40b, by the joint portion 50 and the top portion 12t having the elastically flexible material and the bottom portion 12b (as mentioned above) to allow insertion of the needle holder 14 The openable end 44 is opened, and the top portion 12t is joined to the bottom portion 12b at the closed end 42 of the slots 40a, 40b. This configuration provides a slot on each side of the body 12 and is thus capable of supplying a dual outer retractor mechanism portion 26, as best seen in Figures 2 and 3. In a preferred configuration, the top portion 12t and the bottom portion 12b include spaced apart axially extending portions 52, 54 that are remote from the engaging portion in a direction opposite the direction in which the slots 40a, 40b extend. 50 extends along axis X, and top portion 12t and bottom portion 12b form a lever to allow top portion 12t and bottom portion 12b to engage around after application of radially inward pressure P to said axially extending portions 52, 54 Part 50 pivots.

An optional configuration in the form of a locking mechanism generally shown at 58 can be provided to ensure that the openable end 44 is prevented from opening when the lancet needle holder 14 has been inserted into the body 12. This configuration may include first locking features 58a, 58b on the outer surface 14e of each of the top portion 12t and the bottom portion 12b and toward the openable end 44, and this configuration further includes a locking ring having the second locking feature 62 60. A second locking feature 62 surrounds the first locking features 58 and is interconnectably engageable to the locking features 58a, 58b to prevent the top portion 12t and the bottom portion 12b from moving radially outward. In the particular configuration shown, the locking features 58a, 58b include one or more stops 58b and the locking ring 60 includes indentations.

The openable end 44 preferably includes mutually facing surfaces 70a, 70b on the projection 70, the surfaces 70a, 70b being used to close the openable end 44 when the slots 40 are in the closed position, but in the slots The 40's open position is spaced from each other. The mutually facing surfaces 70a, 70b include wedge-shaped leading edges 72a, 72b opposite each other on the outer side OS of the slots 40, the slots 40 permitting insertion of the needle holder 14 into the body 12 during operation. The slot 40 is opened after the interior 16 is in the interior. The trailing edges 72c, 72d of the surface 70 are steep surfaces, and the steep surface is used to prevent self-operation in operation. The body 12 removes the needle holder 14.

The retractor mechanism 26, best seen in FIG. 3, includes one or more axial projections 76 between the needle holder 14 and the outer portion 26e of the retractor mechanism 26. Preferably, the axially extending projections 76 include wedge-shaped leading edges 76L for opening the slots 40 after the needle holder 14 is inserted into the opening 20 of the body. The projection 76 extends between the needle 14 and the one or more outer portions 26e to allow the needle holder 14 to move integrally with the outer portions 26e. The axial projection 76 can comprise an elongated outer surface 76s having a length L along the longitudinal axis X that is greater than its measured width W perpendicular to the axis X. This configuration promotes greater stability of the needle holder within the body 12 because the protrusion 76 will have a relatively long contact surface that contacts the slot 40 of the body portion 12 for internalization with the one or more slots 40. The sliding engagement of the surface 40i. The end surface 80 is disposed on one or more axial projections 76 for engaging the openable end 44 of the slot 40 when the needle holder 14 is in the second deployed position. This effectively defines the maximum range of travel of the needle holder 14 within the body 12, and its position helps define the reference position provided by the back surface 28bs, from which the person can define the total axial projection of the needle from the device, As discussed in more detail below. Although it should be understood that only one protrusion 76 and one outer portion 26e may be provided, it has been found that providing two such configurations (each having each of the two sides of the device 10) is readily accessible. The advantage of shrinking mechanism. If two such configurations are provided, preferably such configurations are provided on opposite sides of the body 12 to provide a sense of balance to the user and to allow easy manipulation by the thumb and fingers of the user's hand.

Referring now more specifically to Figures 1, 3 and 4, when the outer portion 26e of the retraction mechanism 26 is available in a first (deployed) position (shown as a dotted line in Figure 1) and a second (retracted) When moving between positions (shown fully in Figure 1), the body 12 can be adjacent to the outer portion 26e The outer surface 12e, 12f of the trajectory includes one or more recesses 82, 84 in which the outer portion is external to the recesses 82, 84, and in the second (retracted) position, the outer portion Portions are generally within the recesses 82, 84. This configuration is provided through the edges 82e, 84e of the recesses that are wedge-shaped in height with respect to the bottom portions 82b and 84b of the recesses to provide a wedge-shaped recess. This configuration allows the finger to easily abut the outer portion 66e when needed to move the needle holder 14 from the second deployment position D to the first retracted position R, but when in the retracted position R, or When the position is to be stabbed, the retraction mechanism 26 is shielded in the recess. The edges 82e, 84e of the recess also help define the edges of the top portion 12t and the bottom portion 12b, the top and bottom portions being used to hold the device during handling of the device and prior to release of the needle from the latch, as described herein.

Referring more specifically to FIG. 3, the body 12 includes an axially extending aperture 88 extending along a longitudinal axis X of the needle holder 14. In the particular configuration of the figures, the latch mechanism 28 includes a latchable member 28a on the retractable needle holder 14 and a releasable latch 28b on the body portion 12, in Figures 5 and 8. Shown in more detail. The apertures 88 allow the needle holder 14 to be inserted into the body 12 such that the latch 28b and the latching member 28a can engage each other when positioned properly adjacent to each other. In a preferred configuration, the latchable member 28a includes an undercut wedge shaped male member 28a having an undercut bottom surface 28bs and a tapered top surface 28t positioned on the raised portion 90 of the needle holder 14, and the latching mechanism 28b includes a corresponding undercut spring load ramp portion 28b having an inclined surface 28ss and a return surface 28rs and positioned on the body 12. The arrangement can also include a flexible member 102 having a proximal end 102p and a free distal end 102d attached to the body 12, wherein the latchable member 28a is mounted to the flexible member toward the free end 102 and can move with it. The body 12 includes an engagement portion 50 to which the proximal end 102p of the flexible member 102 is attached to allow for flexing around the portion. In a particularly preferred configuration, the latch can be latched The component 28a comprises a double-sided undercut male component 28a having a wedge-shaped upper portion 28tu on each of the two sides A, B and an undercut 28uc1 on each of the two sides A, B 28uc2, and the releasable latch 28b includes an undercut spring load ramp portion 28ur having an inclined ramp surface 29a and a return surface 29b, one ramp portion on each side A, B of the latchable member 28a . This configuration allows the latchable component to be sandwiched between the two latches and improves the latch when two latches are provided, but the release of the two latches can be achieved by the same mechanism, as discussed below. The operation of the latch mechanism will be described in detail below with reference to FIGS. 8 through 11.

The latch mechanism can also include a movement limiting baffle 122 having an inclined surface 120a and a generally radially extending surface 120b for limiting telescoping by engaging one or more undercuts 28uc1, 28uc2 The needle holder 14 moves axially toward the deployment position D, as best seen in Figure 9D. Although it will be appreciated that any of a number of baffle configurations can be used, a convenient configuration includes a baffle 122 on the proximal end of the flexible member 102, the proximal end extending inwardly such that the radially extending surface 120b The latches are undercut 28uc1, 28uc2 when the undercuts 28uc1, 28uc2 of the latchable portion have passed. In this regard, it will be appreciated that the flexibility of the flexible member 102 will allow the baffle to be moved radially inwardly and outwardly, and the inclined surface 120s is provided for insertion of the needle holder 14 to move the restriction flap 122 When it is outside the path, it interacts with the wedge portion 28tu of the needle holder 14. In effect, this baffle prevents unintentional removal of the needle holder 14 from the body 12. The position of the baffles described in this paragraph and above may be selected to ensure that the needle holder 14 has a desired degree of axial movement sufficient to produce any desired penetration of the needle into the skin of the user. In practice, this may mean that the restriction flap 122 does not engage in normal use because the needle holder 14 can first engage the stop surface of the closable end 44.

The release mechanism 30 can include one or more portions for separating the latch mechanism 28 Any of a number of devices, but it has been found that it is most convenient to provide the release mechanism 30 in the form of a release button 30 for self-engaging portions of the latch after being recessed along the axis X Separation. The button 30 is best seen in Figure 2, but its operation is best seen in Figures 8D, 9D, 10D and 11D, when discussing the latch and release procedure steps, reference will be made to Figures 8D, 9D below. , each of FIG. 10D and FIG. 11D. The button 30 is provided with one or more surfaces 30f that are operatively configured to engage the corresponding inclined surface 120f on the inner side 120i of the one or more flexible members 120 such that the recess of the button 30 along the axis X Surface contact is caused and the inclined surface 120f is displaced radially outward. This movement is set sufficient to cause the self-latching portion 28b to release the latchable portion 28a and to allow the needle holder to be deployed under the influence of the biasing member 25 and to cause any of the needles within the needle holder 14 to protrude beyond the body 12 itself. The outer surface 102x of the flexible member 102 is provided with a baffle 102s having an engaging surface 102e facing the engaging portion 50. A spring 140 is disposed between the engaging portion 50 and the baffle 102s, and the spring 140 is engaged with the bottom surface 28bs of the latchable portion 28 to bias the spring 140 and the needle holder 14 in the direction of the arrow R in FIG. . The strength of the spring 140 is less than the strength of the spring 25 such that the spring 25 can cause the needle to protrude from the outlet 20 when released by the mechanism 30, but after the needle 24 has penetrated the skin of the patient or user, the combined force of the spring is used to maintain the needle Within the body 12, in the body 12, the needle does not have any possible interaction with the user until the device 10 has been restarted by the user.

Reference will now be made in general to the drawings, but the assembly of the above-described devices is discussed with particular reference to Figures 8-11. First, the spring 25 is inserted into or around the needle holder 14 before the needle holder 14 is placed up against the openable end of the body 12 to introduce the wedge leading edges 761 and 762 to the surfaces 72a, 72b. The needle holder 14 is then pushed in the direction of the arrow R in FIG. This action causes the surfaces 761, 762 to move the surfaces 72a, 72b apart and allow the needle holder 14 to be inserted into the main In the body 12, in the body 12, the axial projections 76 are retained within the slots 40a, 40b but are slidable along the slots 40a, 40b. When the needle holder passes into the aperture in the body 12, the latchable member 28a passes toward the latch 28b and the tapered leading edge of the latch 28a engages the wedge surface 28ss of the latch such that the body of the wedge surface The interaction causes the flexible member 102 to flex away from the latchable member and allows the latchable member to pass over the wedge surface 28ss to allow the flexible member 102 to return to its previous position and to allow the latchable portion 28a The rear surface 28bs of the head engages the return surface 28rs of the latch 28b to latch the needle holder 14 in the "to be stabbed" or "pre-start" position as best seen in Figure 9D. If not attached prior to pre-start, the locking ring 60 can now be attached to the openable end 44 to prevent the locking ring 60 from being disposed therein with the first end 18 having the aperture 20 attached to the locking ring to define the surrounding device 10 The chamber of any of the needles 24 is previously opened. Spring 140 can pass over flexible portion 102 and is positioned to engage between engagement portion 50 and baffle 102s. The button 30 can then be placed over the assembled latch portion to abut the latch and allow the surface 30f to contact the surface 120f.

The operation of the assembled device 10 will now be described with reference to Figures 8-11.

Figure 8 illustrates the device in a preset position in which the needle 24 is securely received within the device 10 and the needle holder 14 is between the engagement portion 50 and the back surface 28bs of the latchable portion 28 The action of the active spring 140 is held in the preset position. The spring 25 acts between the engagement portion 50 and the engagement surface 14e of the needle holder 14 and serves to align the spring 140 and retain the needle holder and needle in a secure "preset" position. The device is preactivated by moving the needle holder 14 in the direction of the arrow P in Fig. 9 such that the tapered leading edge 28tu of the latchable portion 28 engages the tapered surface 28ss of the flexible member 102 and causes it to deviate from the exit path In addition, to allow the portion 28a to pass over the wedge surface 28ss and allow the rear surface 28bs and the flexible portion 102 The surface 28rs is then engaged or held by the rear surface 28rs to latch the needle holder in the "pre-start" position. This movement can be achieved by the user sliding one or the other or both of the portions 26e in the direction of the arrow R in FIG. In this position, the spring 25 is fully compressed and the spring 140 is fully deployed. In order to release the needle holder 14 and the needle 24a, we only need to press the button 30 to engage the surface 30f with the surface 120f and cause the flexible member 120 to be displaced outwardly to disengage the surfaces 28bs and 28rs from each other and allow The needle holder moves rapidly in the direction of the arrow D in each of Figs. 2 and 11 under the influence of the previously compressed spring 25. The quick release spring 25 temporarily deploys the needle 24 beyond the outlet 20 to pierce the user's skin as the outlet 20 is positioned against the skin of the user. After this initial activation, the combined effect of the two springs 25 and 140 causes the needle holder 14 to return to the preset position shown in Figure 8, in which the needle 24 is safely within the device itself, up to I will be needed next time.

Claims (20)

A blood sampling device 10 comprising: a) a body 12 having a longitudinal axis X and having an outer portion 14 including an outer surface 14e, an inner portion 16 including an inner surface 16i, and an opening 20 therein. a first end 18; b) a retractable needle holder 14 that is received within the interior 16 of the body 12 for receiving a lancet 22 having a first retracted position R and a second deployment position D, and the lancet 22 has a first end 22f and a second end 22s and has a needle 24 protruding from the first end; c) a biasing member 25 for The needle holder 14 is biased to the second deployment position D, in which the needle 24 protrudes through the opening 20 in the first end 18; d) a retractor mechanism 26 For retracting the needle holder 14 from the second deployment position D to the first retracted position R, and having a portion 26e extending to the outside of the body 12; e) a latch mechanism 28 for self The first retracted position R releases latches the needle holder 14; and f) a release mechanism 30 for releasing the latched latch from the first retracted position R a needle holder 14; wherein the body 12 includes one or more slots 40a, 40b extending between the inner surface 16i and the outer surface 14e and between a closed end 42 and a An axial extension between the open ends 44, the slot 40 receiving the portion 26e of the expander mechanism 26 and having one or more end stops 46 facing the openable end 44 for restricting the portion 26e to Movement within the slot And wherein the openable end 44 is movable between a first closed position C and a second open position O, in which the end stop 46 prevents the portion 26e from being inserted into the In or removed from the slot 40, in the second open position O, the portion 26e can pass between the end stops 46 and be inserted into the one or more slots 40 or Removed from the slots. The device 10 of claim 1, wherein the body 12 includes a top portion 12t and a bottom portion 12b, two side edges 12e and 12f, and are respectively positioned on the respective side edges 12e, 12f and opposite to each other. Two slots 40a, 40b, by engaging the portion 50 with the top portion 12t and the bottom portion 12b having an elastically flexible material to allow the openable end 44 to be reversibly opened, the top portion 12t and the bottom portion 12b The ends are closed at the closed ends 42 of the slots 40a, 40b. The device 10 of claim 2, wherein the top portion 12t and the bottom portion 12b include spaced apart axially extending portions 52, 54 that are in contact with the slots 40a, 40b extends in a direction opposite to the direction away from the joint portion 50, and the top portion 12t and the bottom portion 12b form a lever to apply a radially inward pressure P to the axially extending portions 52, 54 The top portion 12t and the bottom portion 12b are then allowed to pivot about the joint portion 50. The device 10 of any one of claims 1 to 3, comprising a first locking feature 58a, 58b on the outer surface 14e of each of the top portion 12t and the bottom portion 12b. And the device 10 further includes a locking ring 60 that includes the first locking features 58 and is coupled to the first locking features 58a, 58b to prevent the top portion A second locking feature 62 is moved 12t and the bottom portion 12b is moved radially outward. The device 10 of claim 4, wherein the first locking feature 58a, 58b includes a stop and the second locking feature 62 on the locking ring 60 includes a dimple. The device 10 of any one of claims 1 to 5, wherein the openable end 44 includes mutually facing surfaces 70a, 70b, when the slots 40 are in a closed position, the surface 70a 70b is used to close the openable end, but is spaced from each other in one of the slots 40 in an open position. The device 10 of claim 6, wherein the mutually facing surfaces 70a, 70b comprise wedge-shaped leading edges 72a, 72b opposite each other on one of the outer sides OS of the slots 40, the slots 40 The slots 40 are allowed to open after insertion of the needle holder 14 into the interior 16 of the body 12 during operation. The device 10 of any one of claims 1 to 7, wherein the retractor mechanism 26 includes one or more between the needle holder 14 and the outer portion 26e of the retractor mechanism 26. An axial projection 76, and wherein the one or more axial projections 76 include a wedge-shaped leading edge 761 for opening the slots 40 after the needle holder 14 is inserted into the opening 20 of the body 12, 762. The device 10 of claim 8 wherein the slots 40 include an interior surface 40i and the one or more axial projections comprise elongated members for sliding engagement with the interior surfaces 40i of the slots 40. External surface 76s. The device 10 of claim 8 or 9, wherein the one or more axial projections 76 are included for the slot 40 when the needle holder 14 is in its second deployment position D The openable end 44 engages one of the end surfaces 80. The device 10 of any one of clauses 1 to 10, wherein the body 12 includes one or more recesses 82, 84 on the outer surface 12e, 12f, and wherein the retractor mechanism 26 The outer portion 26e is moveable between a first (deployed) position and a second (retracted) position in which the outer portions 26e are substantially external to the recesses 82, 84, In the second (retracted) position, the outer portions 26e are generally within the recesses 82, 84 to allow the fingers to abut to move the needle holder 14 from the second deployment position D to the first back Shrink position R. The device 10 of claim 11, wherein the recesses 82, 84 comprise wedge-shaped recesses. A device 10 according to any one of claims 1 to 12, and comprising a pair of outer portions 26e each on an opposite side of the body 12 and each having a finger engaging portion 26FE . The device 10 of any one of claims 1 to 13, wherein the body 12 includes an axially extending aperture 88 extending through the body 12 and the latching mechanism 28 is included One of the latchable members 28a on the retractable needle holder 14 and one of the body portions 12 can release the latch 28b. The device 10 of claim 14, wherein the latchable member 28a includes an undercut wedge-shaped male member 28a having an undercut bottom surface 28bs and a projection portion 90 positioned on the needle holder 14. A wedge-shaped top surface 28t, and the latch mechanism 28b includes a bottom surface spring load ramp portion 28b having an inclined surface 28ss and a return surface 28rs and positioned on the body 12. The device 10 of claim 14 and including a flexible member 102 having a proximal end 102p and a free distal end 102d attached to the body 12, and The latchable member 28a is mounted to the flexible member 102 toward the free end and is movable therewith. The device 10 of claim 16 wherein the body 12 includes an engagement portion 50 and the proximal end 102p is attached to the engagement portion 50. The device 10 of any one of claims 14 to 17, wherein the latchable member 28a comprises a double-sided undercut male member 28a on the two sides A, B Each has a wedge-shaped upper portion 28tu and has an undercut 28uc1, 28uc2 on each of the two sides A, B, and wherein the releasable latch 28b includes a sloped ramp surface 29a and a return One of the surfaces 29b is paired with the undercut spring load ramp portion 28ur, one such ramp portion being on each side A, B of the latchable member 28a. The device 10 of any one of claims 14 to 18, and including a movement limiting baffle 120 to limit axial movement of the retractable needle holder 14 toward a deployment position D. The device 10 of claim 19, wherein the moving baffle 120 includes a protrusion 122 on a proximal end of the flexible member 102.