Blood pricking device

Abstract

The present invention relates to a single use lancing device, the single use lancing device comprising: a housing defining a cavity; the needle assembly comprises a needle and a needle holder, and the needle assembly is located in the cavity; a release member, the release member comprising: a body portion having an aperture through the body portion along a central longitudinal axis of the release member from a rear opening to a front opening; and a holding arm; a release member cap configured to be received by the rear opening such that the release member cap fits at least partially within the aperture; and a spring arranged to bias the needle assembly in a forward direction relative to the release member.

Description

Technical Field

[0001] The present invention relates to a lancing device, and more particularly to a disposable lancing device having a lancet that retracts to a shielded position after use. Background Art

[0002] Lancing devices are commonly used in both medical facilities and private individuals to obtain a blood sample from a subject by piercing the subject's skin. Lancets are used when only a small amount of blood is needed. Subjects suffering from diseases such as diabetes regularly use blood tests to monitor blood glucose levels, and many other diseases and conditions require the collection of a small blood sample, for example for monitoring or diagnostic purposes. Obtaining a sample of blood typically involves pricking the skin on a finger or other suitable body part with a lancet or a needle. Given blood-borne diseases, it is important that after use of the lancet, the portion of the lancet that has come into contact with blood does not subsequently come into contact with other people. Thus, an important aspect of a lancing device involves preventing the lancet or needle from injuring another person after the patient's skin has been pierced. Therefore, after use of the device, the lancet should be shielded to prevent accidental injury to another person. In addition, the lancing device should be disposable to reduce the likelihood of disease transmission due to subsequent use of the device on other people. In this regard, the lancet should preferably be a single-use device having features to prevent reuse.

[0003] Contact-activated lancets are known in the art. These devices have a needle holder and a trigger device that encloses the lancet structure. They are held in a standby position to be actuated by pressure on the trigger device. Disadvantages of known lancing devices include the problem of accidentally triggering the lancet because the lancing device is designed to be triggered upon contact with the skin, or because the trigger device is accidentally actuated by the user before the lancet is properly positioned on the skin. Many single-use lancets are wasted because they are actuated before they are in the correct position and thus cannot adequately pierce the skin to obtain a suitable blood sample.

[0004] Several prior art lancing devices attempt to overcome the problem of accidental triggering by including a complex arrangement for holding and releasing the lancet within the structure of the lancing device. These complex arrangements require the lancing device to be composed of many parts. Thus, these lancing devices are often expensive and are therefore not suitable for mass market use. These arrangements are also complex to manufacture. Typically, when the lancet is assembled, the trigger device functions to force the lancet apart. For example, a spring-actuated trigger mechanism may be difficult to keep in place during assembly.

[0005] Therefore, it is desirable to provide a robust, disposable lancing device having a simple structure and assembly that effectively reduces the likelihood of accidental triggering of the lancet. Summary of the Invention

[0006] According to a first aspect of the present invention, there is provided a single-use lancing device. The lancing device comprises: a housing defining a cavity; a needle assembly including a needle and a needle holder, the needle assembly being located within the cavity; and a release member. The release member includes: a body portion having an aperture extending longitudinally through the body portion from a rear opening to a front opening along a central longitudinal axis of the release member; and a retaining arm. The lancing device further comprises: a release member cap configured to be received by the rear opening such that the release member cap is at least partially received within the aperture; and a spring arranged to bias the needle assembly in a forward direction relative to the release member.

[0007] The release member cap may include a latching mechanism configured to engage with the release member such that when the release member cap is received by the rear opening, removal of the release member cap via the rear opening is prevented.

[0008] The release member and / or the release member cap may further include a stop mechanism configured to prevent the release member cap from advancing through the aperture beyond a desired position.

[0009] The latching mechanism and the stop mechanism may include a protrusion on an inner surface of the release member aperture and a corresponding recess on an outer surface of the release member cap. The release member protrusion may be received by the recess of the release member cap such that when the cap is positioned at a desired location within the release member, forward and backward movement of the cap relative to the release member is prevented. Alternatively, the cap may be provided with a protrusion received by a recess in the inner wall of the aperture.

[0010] The latching mechanism may include a protrusion or latch on the release member cap configured to engage with a portion of the release member. The protrusion or latch may be located on the cap such that when the cap passes through the aperture to a desired position, the latch advances past the forward opening and thus engages with the front face of the release member body to prevent the cap from moving backward through the aperture.

[0011] The stop mechanism may include a tapered portion of the aperture, or a portion of the aperture having a diameter smaller than the diameter at the rear opening. The release member cap or a portion thereof may be dimensioned such that it cannot advance through the aperture from the rearward direction beyond the desired position. Alternatively or additionally, the release member cap may be tapered; the front end of the cap has a smaller diameter than the rear end.

[0012] The release member cap may further include at least one guide rib, and the aperture of the release member may include at least one corresponding guide rail such that when the release member cap is received by the aperture, the guide rib slides movably along the guide rail. Alternatively, the cap may include a guide rail and the aperture may include a guide rib.

[0013] The release member cap can be configured to seal the orifice. The release member cap can be a solid piece having an outer diameter that is substantially the same as the inner diameter of the orifice. Alternatively, the release member cap may not completely seal the orifice from the rear. The release member cap can be hollow or have an orifice that extends through the length of the cap.

[0014] The orifice of the release member can be configured to allow the needle assembly and spring to pass through the orifice from the rear opening to the front opening. Providing a release member having an orifice and a cap can advantageously provide for easier assembly of the lancing device as compared to devices without these features. The orifice of the release member body can allow the needle assembly and spring to pass through the orifice to an assembled position where the needle assembly is positioned between the retaining arms. The orifice can be used to align the needle assembly with the arms and must ensure that the device is correctly assembled. In devices without an orifice and a cap, the needle assembly needs to be inserted into the retaining arms from the front or side of the release member. This can involve prying open the retaining arms or having to manually align the retaining arms with the surface of the needle assembly.

[0015] The lancing device of the present invention can be assembled in a housing. The release member can be inserted into the housing, and then the needle assembly and spring can "drop through" via the orifice. The release member cap can then be inserted into the orifice to hold the components. This configuration can further simplify the assembly of the device. The housing can also be used to align the components or hold the needle assembly between the retaining arms. Such an assembly is not possible in devices where the needle assembly must be inserted into the release member from the front or side.

[0016] The needle assembly can include at least one guide rib, and the orifice of the release member can include at least one corresponding guide rail such that when the needle assembly passes through the orifice, the needle assembly guide rib slidably moves along the guide rail. Alternatively, the needle assembly can include a guide rail and the orifice can include a guide rib.

[0017] The release member cap and the needle assembly can be configured to cooperate with the same guide rib or guide rail of the orifice. For example, both the cap and the needle assembly can include guide ribs, and the orifice can include a guide rail configured to cooperate with both the guide rib of the cap and the guide rib of the needle assembly.

[0018] The release member can be movable relative to the housing between a cocked position and a deployed position, in the cocked position, the retaining arms are arranged to cooperate with the housing to hold the needle assembly in the cocked position, and in the deployed position, the retaining arms are arranged to release the needle assembly to deploy the needle.

[0019] According to a second aspect of the present invention, there is provided a single-use lancing device. The lancing device comprises: a housing defining a cavity; a needle assembly including a needle and a needle holder, the needle assembly being located within the cavity; a release member; and a spring arranged to bias the needle assembly in a forward direction relative to the release member. The release member includes a retaining arm and is movable relative to the housing between a cocked position and a deployed position. In the cocked position, the retaining arm is arranged to cooperate with the housing to hold the needle assembly in the cocked position. In the deployed position, the retaining arm is arranged to release the needle assembly to deploy the needle. The release member further includes a main latch protrusion arranged to prevent the release member from moving in a rearward direction when the release member is in the cocked position, such that the release member cannot be removed from the housing.

[0020] The lancing device may further include a secondary latch protrusion configured to allow the release member to move from the cocked position to the deployed position. The secondary latch protrusion may be located on one of the retaining arms of the release member. Preferably, a pair of secondary latch protrusions is provided, which may be located on retaining arms opposite each other. The secondary latch protrusion may be provided on each retaining arm of the release member.

[0021] The secondary latch protrusion may be arranged to prevent the release member from moving back from the deployed position to the cocked position and optionally prevent the release member from being disassembled from the housing. Both the main latch protrusion and the secondary latch protrusion may work in combination to prevent the release member from moving back from the deployed position to the cocked position and / or prevent the release member from being disassembled from the housing.

[0022] It may be preferred or advantageous for the lancing device to include a main latch protrusion and a secondary latch protrusion.

[0023] Providing a main latch protrusion and a secondary latch protrusion may allow for better optimization of their respective functions compared to a device that includes only one protrusion performing both functions. That is, the main latch protrusion prevents the release member from being removed from the housing, and the secondary latch protrusion may prevent the release member from returning from the deployed position to the cocked position.

[0024] The main latch protrusion may be held in a first receiving portion of the housing in both the cocked and deployed positions. Thus, the main latch protrusion may only need to slide past the lip of the housing at the rear opening (and not past the body portion separating the receiving portions). Thus, compared to a device with only one protrusion, the main latch protrusion may be made larger or more resilient. This may make the device more difficult to disassemble.

[0025] The secondary latch protrusion may not be required to prevent disassembly (since the primary latch protrusion provides this). Thus, the secondary latch protrusion may only cooperate with the housing when in the deployed position and may prevent the release member from returning from the deployed position to the cocked position. Alternatively, the reliance on the secondary latch protrusion to prevent disassembly may be reduced. Thus, the secondary latch protrusion may be made smaller, less resilient, more flexible, or rounder compared to a device having only one protrusion (i.e., only the primary protrusion). This may mean that actuation of the device (movement from the cocked position to the deployed position) may be easier and the retaining arm may flex better upon release.

[0026] In embodiments where the secondary latch protrusion is not required to prevent disassembly (i.e., since the primary latch protrusion provides this function), the "secondary latch protrusion" may alternatively be referred to as the "secondary protrusion", i.e., since it may not require a latching function.

[0027] The primary latch protrusion and / or the secondary latch protrusion may be provided as a pair. For example, a pair of primary latch protrusions and / or a pair of secondary latch protrusions. Thus, in one embodiment, there may be at least four latch protrusions which may prevent the release member from being disassembled from the housing and / or prevent return from the deployed position to the cocked position. In another embodiment, there may be at least two latch protrusions (i.e., two primary latch protrusions) and at least two secondary protrusions, the at least two latch protrusions may prevent the release member from being disassembled from the housing and / or prevent return from the deployed position to the cocked position, and the at least two secondary protrusions are arranged to control the retaining arm during deployment of the needle assembly from the retaining member.

[0028] A pair of primary latch protrusions may be located on opposite surfaces of the release member. Additionally or alternatively, a pair of secondary latch protrusions may be located on opposite surfaces of the release member, such as on opposite retaining arms.

[0029] The housing may include: a first receiving portion configured to receive the primary latch protrusion when the release member is in the cocked position; a second receiving portion configured to receive the secondary latch protrusion when the release member is in the cocked position; and a third receiving portion configured to receive the secondary latch protrusion when the release member is in the deployed position.

[0030] The first receiving portion, the second receiving portion, and the third receiving portion may be apertures or windows through the body of the housing. Alternatively, the receiving portions may be indentations or recesses on the inner surface of the housing body.

[0031] When the release member is in the deployed position, the main latch protrusion can be received by the first receiving portion. Alternatively, when the release member is in the deployed position, the main latch protrusion can be received by the second receiving portion or the third receiving portion. The main latch protrusion can be arranged to prevent the release member from moving back from the deployed position to the armed position.

[0032] In embodiments including pairs of main latch protrusions and / or secondary latch protrusions, the housing can include corresponding receiving portions for each of the respective latch protrusions.

[0033] The lancing device can further include a removable safety member configured to prevent the release member from moving from the armed position to the deployed position. The removable safety member can include a collar configured to circumferentially engage a portion of the release member, wherein a main end of the collar is connected to a second end of the collar via a weakened shear portion. The collar can be configured to engage around the body of the release member near the rear end.

[0034] The weakened shear portion can include an overlapping region between a first end and a second end of the collar. The weakened shear portion can include at least one protrusion, tab, or conical protrusion connecting the first end and the second end of the collar at the overlapping region.

[0035] When the collar is fitted to the release member, the first end and the second end can overlap radially such that one end is located outside the other end relative to the lancing device. Alternatively, when the collar is mounted to the release member, the first segment and the second end can overlap longitudinally such that one end is located in front of the other end relative to the lancing device.

[0036] The needle assembly can further include a needle cap integrally formed with the needle holder, wherein there is a shear portion between the needle holder and the needle holder such that the needle cap can be removed from the needle and the needle holder.

[0037] When the release member is in the armed position, a portion of the cap can protrude through a hole in the front end of the housing.

[0038] The hole can have a diameter sufficient to allow the needle assembly to pass through. The hole can have a diameter of at least 2.5 mm or at least 3 mm or at least 3.2 mm. The hole can preferably have a diameter of 3.2 mm. The diameter of the hole can be within ±5% or ±10% or ±20% of the preferred diameter.

[0039] Rotating the cap relative to the needle holder can break the shear portion and allow the cap to be removed from the needle.

[0040] When the needle assembly is in the ready-to-fire position, the spring can be held in a compressed state. The spring can have a relaxed or natural state in which the needle is fully retained within the housing. The spring can be arranged such that upon deployment of the needle, the spring moves to an extended state in which the needle projects from the front end of the housing. The spring can then return to the relaxed state to retract the needle back into the housing.

[0041] The housing can further include a retaining surface arranged to hold the retaining arm in a retaining position when the release member is in its ready-to-fire position. The housing can have an opening into which the retaining arm can move to release the needle assembly when the release member is in the deployed position. The opening can be an aperture window through the housing body or a recess / depression on the inner surface of the housing body.

[0042] The release member can include at least one guiding rib and the housing can include at least one corresponding guiding rail such that when the release member moves relative to the housing, the guiding rib moves slidably along the guiding rail. Alternatively, the release member can include a guiding rail and the housing can include a guiding rib.

[0043] The features of the first aspect can be applied to the device of the second aspect and vice versa. For example, the lancing device of the first aspect can further include a main latch projection arranged to prevent the release member from moving in a backward direction when the release member is in the ready-to-fire position, such that the release member cannot be removed from the housing. Detailed Description

[0044] Embodiments of the present invention will be described by way of example only with reference to the accompanying drawings, in which:

[0045] Figure 1 An exploded view of a lancing device according to an embodiment of the present invention is shown;

[0046] Figure 2 Shows Figure 1 A perspective view of the lancing device;

[0047] Figure 3 Shows Figure 1 A further view of the lancing device;

[0048] Figure 4 Shows the release member forming part of the lancing device; Figure 1

[0049] Figure 5 Shows the needle assembly forming part of the lancing device; Figure 1

[0050] Figure 6 Shows Figure 1 A perspective view of the lancing device in the ready-to-fire position; ​​

[0051] Figure 7 shows Figure 1 a lancet device in an extended position in a perspective view;

[0052] Figure 8 shows a needle cap attached to Figure 5 the needle assembly;

[0053] Figure 9 shows Figure 8 a perspective view of the needle cap;

[0054] Figure 10 shows a part of a lancet device having a needle covering according to an embodiment of the present invention;

[0055] Figure 11 shows a removable safety member;

[0056] Figure 12 shows Figure 11 a further view of the removable safety member;

[0057] Figure 13 shows the lancet device in a cocked position as shown in Figure 6 with the needle cap and the removable safety member attached.

[0058] See Figure 1 , Figure 2 and Figure 3 , which show the lancet device 1 in a semi - disassembled state. The lancet device includes a release member 100, and the release member 100 includes a body portion 110 and retaining arms 120a, 120b. The body portion 110 has a rear opening 102 and a front opening 104. The body portion 110 may be generally hollow and cylindrical and have an aperture 106 that can be accessed at either end of the release member body via the rear opening 102 and the front opening 104.

[0059] The lancet device 1 further includes a release member cap 150. The release member cap 150 is configured to be received by the rear opening 102 of the release member body 110 such that the cap 150 at least partially fits within the aperture 106 within the release member body 110.

[0060] The lancet device further includes a needle assembly 200. The needle assembly 200 includes a needle 202 supported in a needle holder 204. The needle holder 204 may be made of a plastic material and molded onto the base of the needle 202. The needle assembly 200 is configured to be at least partially positioned between the retaining arms 120. The retaining arms 120 may include tapered end portions 122 configured to engage a portion of the needle holder 204. Prior to use, the needle 202 may be sterilized, for example, using Y - radiation.

[0061] The lancing device 1 further includes a housing 300. The housing 300 includes a housing body 302 which may be generally hollow and cylindrical, having a cavity 306. The cavity 300 is connected to a hole 308 in the front end of the housing body 302 and has a rear opening 304 at the rear end of the housing body 302. The rear opening 302 may be large relative to the diameter of the housing body 302 such that the housing 300 is substantially open at the rear end. The hole 308 may be smaller than the rear opening 304. The hole 308 may be configured such that a user cannot easily access the cavity 306 via the hole 308 (e.g., small enough such that a person cannot insert a finger through the hole 308). The front end of the housing 300 and the hole 308 may be configured for contact with the patient's skin. The housing body 302 may have ribs, deformations or formed portions 303. The formed portion 303 may strengthen the housing 300 or may provide a gripping surface for the user.

[0062] The lancing device 1 further includes a spring 250. The spring 250 is for deploying the needle assembly 200 during use, as discussed in detail later. The needle holder 204 may include a spring mount 206. The first end of the spring 250 may be fitted onto the needle holder spring mount 206, as Figure 2 shown. The release member cap 150 may also include a spring mount 156. The spring 250 may be held by the two spring mounts such that when in the assembled configuration, lateral movement of the spring is prevented. The spring 250 may be a helical spring as shown or any other type of spring.

[0063] Figure 1 、 Figure 2 and Figure 3 FIGs. show the lancing device 1 in a semi-assembled state. The release member 100 and the needle assembly 200 are separate components and are assembled to form the arrangement shown. The rear opening 102, the front opening 104 and the orifice 106 of the release member body 110 may be configured such that the needle assembly 200 and the spring 250 can pass through the orifice 106 from the rear. To position the needle assembly 200 within the holding arm 120 as shown, the needle assembly 200 may be pushed through the orifice 106 from the rear. The needle assembly 200 may then be further advanced in the forward direction such that the forward portion of the needle holder 204 advances beyond the tapered portion 122 of the holding arm 120. The needle assembly 200 may be advanced to a position where the rear portion of the needle holder 204 having a larger diameter abuts the tapered portion 122 of the holding arm 120, and the tapered portion 122 prevents further advancement of the needle assembly 200. The holding arm 120 may be flexible and elastic.

[0064] The spring 250 can also pass through the opening 106 from the rear direction such that it is positioned between the retaining arms 120 as shown. The spring 250 can be attached to the spring mount 206 of the needle assembly 200 before passing through the opening 106 (such that the needle assembly 200 and the spring 250 are positioned simultaneously). Alternatively, the needle assembly 200 can be positioned first, and then the spring 250 passes through the opening 106 such that it mates with the needle mount 206.

[0065] After the needle assembly 200 and the spring 250 are inserted, the release member cap 150 can be inserted into the opening 106 from the rear direction. When the release member cap 150 is inserted into the release member 100, the second end of the spring 250 can mate with the cap spring mount 156.

[0066] The release member 100, the release member cap 150, the needle assembly 200, and the spring 250 can be inserted into the housing 300 via the rear opening 304 of the housing body 302. The release member 100, the release member cap 150, the needle assembly 200, and the spring 250 can be assembled as described above before being inserted into the housing 300. Alternatively, the release member 100 can be inserted into the housing 300 first. Subsequently, as described above, the release member cap 150, the needle assembly 200, and the spring 250 can be inserted into the release member 100 / housing 300 via the rear opening 102 of the release member 100.

[0067] The release member body 110 can include guide ribs 112, and the housing 300 can include guide rails 310 within the cavity 306. The guide ribs 112 can be protrusions that extend at least partially along the outer surface of the release member body 110. The guide rails 310 can be notches in the inner surface of the housing body 302 that extend at least partially along the length of the cavity 306. The guide ribs 112 and the guide rails 310 can be configured such that when the release member 100 is received within the housing 300, the guide ribs 112 are slidably received within the guide rails 310.

[0068] The needle assembly 200 can include guide ribs 210 and the release member body 110 can include guide rails 120 within the opening 106. The guide ribs 210 can be protrusions that extend at least partially along the outer surface of the needle holder 204. The guide rails 120 can be notches in the inner surface of the release member body 110 that extend at least partially along the length of the opening 106. The guide ribs 210 and the guide rails 120 can be configured such that when the needle assembly 200 is received within the release member 100, the guide ribs 210 are slidably received within the guide rails 120.

[0069] The release member cap 150 may include guide ribs. The guide ribs may be protrusions that extend at least partially along the outer surface of the release member cap 150. The guide ribs may be configured such that when the release member cap 150 is inserted into the release member 100, the guide ribs are slidably received within the guide rails 120. The guide rails of the release member cap 150 may be configured to be received by the same guide rails 120 as the needle assembly 200. Alternatively, the release member body 110 may include additional guide rails for the guide ribs of the release member cap 150.

[0070] Each guide rib may include a pair of guide ribs disposed on opposite sides of the respective body / component. Each guide rail may correspondingly include a pair of guide rails disposed on opposite sides of the release member body 110 or the housing 300. The guide ribs and guide rails may facilitate the assembly of the various components. The guide ribs and guide rails may ensure proper alignment of the components during assembly. Once assembled, the guide ribs and guide rails may prevent rotation of the components.

[0071] The release member cap 150 may include a latching mechanism 152 and a stop mechanism 154 to assist in positioning the release member cap 150 within the release member body 110.

[0072] The release member 100 may include a neck portion 114, a primary latching protrusion 116, and a secondary latching protrusion 124. The housing 300 may include a first receiving portion 320, a second receiving portion 330, a third receiving portion 332, and a release aperture 340. These receiving portions / apertures may be defined by body portions 322, 334, 336, 342. The latching protrusions may be configured to engage the receiving portions / apertures when the release member 100 is received by the housing 300. The functions of the various latching protrusions and corresponding receiving portions / apertures will be described in more detail later.

[0073] See Figure 4 , an example of the release member 100 is shown. The release member includes a body 110. The body 110 has a front opening 104 that leads to an aperture within the release member body 110. As previously discussed, the aperture extends through the release body portion along the central longitudinal axis of the release member from a rear opening to the front opening 104. The release member body 110 may include a flared neck portion 114 that has a greater diameter than the body 110. The release member body 110 may further include guide ribs 112 on the outer surface of the body 110. The guide ribs 112 may extend along the length of the body 110 from the neck portion 114 to the front end of the body 110.

[0074] The release member 100 may include a pair of retaining arms 120 having tapered ends 122. The retaining arms 120 may extend forward from the body 110.

[0075] The release member 100 may have a main latch projection 116. The main latch projection 116 may be located where the retaining arm 120 is coupled to the body 110. The release member 100 may further include a secondary latch projection 124. The secondary latch projection 124 may project from the outer surface of the retaining arm 120.

[0076] See Figure 5 , an example of a needle assembly 200 is shown. The needle assembly 200 includes a needle 202 coupled to a needle holder 204. The needle holder 204 may include a retaining surface 208. The retaining surface 208 may include a flat portion and an angled portion configured to correspond to the tapered portion 122 of the retaining arm 120. When the needle assembly 200 is positioned within the release member 100 (as Figure 1 shown), the tapered retaining arm 120 may engage the retaining surface 208 such that the needle assembly 200 cannot be further advanced in the forward direction. The angled portion of the receiving surface 208 may abut the corresponding tapered portion 122 of the retaining arm 120. The body of the needle holder 204 may include a spring mount 206 as described previously. The spring mount 206 may include a projection or flange 207. The rear side of the flange 207 may be tapered such that the spring 250 can be pushed onto the flange from the rear. The front side of the flange 207 may be 90° relative to the spring mount 206 such that once the spring 250 is pushed onto the flange 207, the spring 250 cannot be easily removed. The spring mount 206 can thus hold the end of the spring 250 in a longitudinal position relative to the needle assembly 200. The spring mount 156 of the release member cap 150 (as Figure 2 shown) may have a similar flange for holding the opposite end of the spring 250 in a longitudinal position relative to the release member 100.

[0077] See Figure 6 , a lancing device 1 in the ready-to-fire position is shown. The lancing device 1 may include the features described in the previous figures.

[0078] In the ready-to-fire position, the needle 202 is received within the cavity 306 of the housing 300. The needle holder 204 is held between the retaining arms 120. The spring 250 is in compression.

[0079] The release member cap 150 can be held in a position that is partially within the release member body 110. The release member body 110 can include a retaining protrusion 108. The protrusion 108 can be a retaining ring that projects into the orifice 106 around the circumference at the forward opening 104. The release member cap can include a latching mechanism 152. The latching mechanism 152 can have a tapered front surface such that the latching mechanism can advance forward from the rear past the retaining ring 108. The latching mechanism 152 can have a rear surface that is 90° to the cap 150 such that once the latching mechanism has advanced past the retaining ring 108, the release member cap 150 cannot be pulled back into the orifice 106.

[0080] The release member cap 150 can further include a stop mechanism 154. The stop mechanism 154 can include a protruding ring near the rear end of the release member cap. The stop mechanism 154 can prevent the release member cap 150 from advancing relative to the release member 100 beyond a position (i.e., the protruding ring can not advance past the retaining ring 108). The latching mechanism 152 and the stop mechanism 154 can cooperate to hold the release member cap 150 in a desired position once the cap 150 has been fully advanced forward through the orifice 106 from the rear.

[0081] In the latched position, the retaining arm 120 can engage the needle holder 204. The tapered portion 122 can engage the retaining surface 208. In the armed position, the retaining arm 120 can be held by the body portion 342 of the housing 300. The body portion 342 can prevent the retaining arm 120 from deforming outwardly, thereby preventing the needle holder 204 from advancing forward past the tapered portion 122.

[0082] In this configuration, with the release member cap 150 held in the desired position within the release member body 110 and the needle assembly 200 prevented from moving forward by the retaining arm, the spring 250 is held compressed. The spring mounts 156, 206 can prevent the spring 250 from moving laterally.

[0083] The release member 100 can include a main latching protrusion 116. When the lancing device 1 is in the armed position, the main latching protrusion 116 can be received in the first receiving portion 320. The main latching protrusion 116 can have a tapered front surface, and the housing opening 304 and / or the body portion 322 can have a tapered inner surface such that the release member 100 can be inserted into the housing 300. The main latching protrusion 116 can have a rear surface that is 90° to the release member body 110 such that when the release member 100 is inserted into the housing 300, the release member 100 cannot be pulled back through the opening 304. Thus, once the lancing device 1 is arranged in the armed position, the main latching protrusion 116 can prevent the disassembly of the lancing device 1.

[0084] The release member 100 may further include a secondary latch protrusion 124. When the lancing device is in the cocked position, the secondary latch protrusion 124 may be received in the second receiving portion 320. The secondary latch protrusion 124 may have a tapered front surface such that the release member 100 may slide forwardly within the housing 300. The central portion of the retaining arm 120 (on which the secondary latch protrusion 124 is formed) may flex inwardly to allow the secondary latch protrusion 124 to slide forwardly within the housing. The primary latch protrusion 124 may have a rear face that is 90° to the retaining arm 120, and the retaining arm 120 may engage against the body portion to prevent the release member 100 from sliding backward.

[0085] As Figure 6 shown, the secondary latch protrusion 124 may not engage the body portion 334. Alternatively, the secondary latch protrusion 124 may engage the body portion 334 such that the secondary latch protrusion 124 abuts the body portion 334 to prevent the release member 100 from sliding backward.

[0086] See Figure 7 , the lancing device 1 is shown in the deployed or fired position. The lancing device 1 may include the features described in the previous figures.

[0087] The lancing device 1 may be moved from the cocked position to the deployed position by advancing the release member 100 relative to the housing 300. This may be accomplished by the user pushing on the rear end of the release member 100.

[0088] When the release member 100 advances from the cocked position to the deployed position, the front portion of the retaining arm 120 advances past the body portion 342. The release aperture 340 may allow the retaining arm 120 to deform outwardly such that the widest portion of the needle holder 204 may pass between the tapered ends 122 of the retaining arm 120. The force of the compression spring 250 is sufficient to push the needle holder 204 forward relative to the release member 100. The angled portion of the needle holder engagement surface 208 may assist in prying open the retaining arm 120. The retaining arm 120 may have an indentation 126 that may assist in deforming the retaining arm 120 outwardly.

[0089] The force of the spring 250 is sufficient to push the needle holder 204 past the tapered portion 122 of the deformed retaining arm 120 and accelerate the needle assembly 200 until the spring 250 reaches its natural or relaxed length (as Figure 7As shown. The momentum of the needle holder 204 is sufficient to carry the needle 202 beyond this natural length such that the end of the needle 202 projects through the hole 308 at the front of the housing 300. The needle holder 204 and the hole 308 may be configured such that the needle holder 204 contacts the housing body 302 to prevent the needle holder 204 from leaving the cavity 306. As the needle 202 projects from the hole 308, the spring 250 is fully extended. Even when fully extended, the spring 250 may remain on the spring mounts 156, 206 such that the spring does not become loose.

[0090] The extended spring 250 then returns to its natural length, thereby retracting the needle 202 to Figure 7 the deployed position shown. In the deployed position, the needle 202 is received within the cavity 306 of the housing 300. This prevents the needle 202 from contacting people outside after use.

[0091] By the neck portion 114 abutting the housing body portion / open lip 322, the release member 100 can be prevented from advancing further beyond the deployed position.

[0092] In the deployed position, the secondary latch projection 124 can be received by the third receiving portion 332. The rear of the secondary latch projection 124 can abut the body portion 336 to prevent the release member 100 from sliding backward from the deployed position to the ready position. This prevents the release member 100 from being pulled backward, thereby preventing reuse of the device.

[0093] The combination of the neck 114 and the secondary latch projection 124 can prevent the release member 100 from moving substantially forward or backward relative to the housing, thereby substantially locking the lancing device 1 in its current use. The lancing device 1 can then be discarded.

[0094] In the deployed position, the primary latch projection 116 can be received by the first receiving portion 320, as Figure 6 shown. Alternatively, the primary latch projection 116 can be received by the second receiving portion 330, where the body portion 334 further prevents the release member 100 from being pulled backward.

[0095] Refer to Figure 8 and Figure 9, the needle assembly 200 is shown as further including a needle cap 220. The needle cap 220 may be made of the same material as the needle holder 204 and may be formed by overmolding onto the needle 202 simultaneously with the needle holder 204. In fact, the needle holder 204 and the cap 220 may be integrally formed with each other, with a shear portion 224 formed therebetween, and the shear portion 224 may be broken to separate them and remove the cap 220 from the needle 202. The needle cap 220 may have a cylindrical body and project forward from the front end of the needle 202. The front end of the needle cap body may be flattened to form a gripping portion 222, which can be easily gripped by the user such that the user can apply a torsional torque to the needle cap 220. The cam surface 224a on the needle holder 204 and the cam protrusion 224b on the cap 220 may be arranged to cooperate during rotation of the cap 220 relative to the needle holder 204 to push the cap 220 forward away from the needle holder 204, thereby assisting in separating the cap 220 from the needle holder 204.

[0096] Reference Figure 10 , an assembly including a release member 100, a release member cap 150, and a needle assembly 200 is shown. The release member 100, the release member cap 150, and the needle assembly 200 may include any of the features described in the previous examples (e.g., as Figure 1 and Figure 2 shown). The needle assembly 200 includes a needle cap 220. The cap 220 and the handle 222 are configured such that they can pass through the orifice 106 of the release member body 110. The needle assembly 200 (including the cap 220), the spring 250, and the release member cap 150 may thus be inserted into the release member 100 for assembly as discussed previously.

[0097] Reference Figure 11 and Figure 12 , an example of a removable safety member 400 is shown. The safety member 400 includes a handle or tab portion 402 and a collar portion 404. The collar portion 404 may be configured to circumferentially fit around a portion of the release member 100, e.g., circumferentially around the release member body 110 adjacent the neck 114 at the rear end.

[0098] The collar portion 404 may include a first end portion 406 and a second end portion 408. The first end 406 and the second end 408 may overlap and be joined to each other by a weakened tearable shear portion 410. The shear portion 410 may include a plurality of ribs, protrusions, or cones, each having a thickness less than the thickness of the main collar 404. When the collar is assembled around the release member body 110, the shear portion 410 may be broken by a user pulling on the handle 402. As the shear portion 410 breaks, the first end 406 and the second end 408 are no longer attached, and the collar 404 may be removed from the release member 100. The collar 404 may include one or more ribs 412 on the inner circumference of the collar 404. The ribs 412 may mean that less material is required to form the collar 404 compared to a solid collar having the same thickness at the ribbed collar 404. The ribs 412 may also allow the collar 404 to flex more around the entire circumference compared to a solid collar contacting the release member body 110. This additional flexing may allow the shear portion 410 to be torn more easily.

[0099] See Figure 13 , which shows an example of the lancing device 1. Figure 13 The lancing device in may include any of the features presented in the foregoing examples (e.g., as Figure 6 and Figure 7 shown). The lancing device 1 is provided with a needle cap 220 and a removable safety member 400 such that the lancing device 1 is in a safe or storage configuration. The release member 100 is in the armed position.

[0100] The collar 404 of the safety member 400 fits circumferentially around the body 110 of the release member 100. The collar 404 may fit at a location near the neck 114 of the release member 100. The collar 404 may prevent the release member 100 from advancing through the housing body 302 by being positioned between the neck 114 and the housing body portion / lip 322, thereby keeping the neck 114 and the housing body 302 separated by a fixed distance.

[0101] The user may actuate the lancing device 1 by twisting the needle cap handle 222 such that the cap 220 is separated from the needle holder 204. The user may then remove the cap 220 from the housing body 302 via the aperture 308. The user may then pull on the safety member tab 402 to remove the collar 404 from the release member body 110. After these two steps, the lancing device should be configured in the armed position and ready for use, as Figure 6 shown.

[0102] When in a storage configuration, the lancing device 1 is inactive. The removable safety member 400 prevents the release member 100 from advancing from the cocked position to the deployed position. The main latch protrusion 116 of the release member 100 and the latch mechanism 152 of the release member cap 150 prevent disassembly of the device. The housing body 302 and the cover 220 hide the needle 202, which can prevent damage, contamination, and accidental user contact of the needle. The example presented shows a device that has generally dual symmetry through a plane extending along the longitudinal axis of the device (e.g., the release member 100 has two opposing retaining arms 120, the housing 300 has opposing receiving portions / apertures 320, 330, 332, 340, different guide rails and ribs are shown in opposing pairs, etc.). However, the device can include any number of these features and the features may not be symmetrically arranged. It may not be necessary to have the same number of each feature (as long as the cooperating features can still cooperate). For example, the device can include three retaining arms and three sets of housing receiving portions, but only one release member guide rib and one housing aperture guide rail.

[0103] Although exemplary embodiments have been described, these embodiments are not intended to limit the scope of the invention, which should be determined with reference to the appended claims.

Claims

1. A single - use lancing device, comprising: a housing that defines a cavity; a needle assembly including a needle and a needle retainer, the needle assembly being located within the cavity; a release member including: a body portion having an aperture that extends through the body portion from a rear opening to a front opening along a central longitudinal axis of the release member; and a retaining arm; a release member cap configured to be received by the rear opening such that the release member cap is at least partially received within the aperture; and a spring arranged to bias the needle assembly in a forward direction relative to the release member.

2. The lancing device according to claim 1, wherein, the release member cap includes a latching mechanism configured to engage with the release member such that when the release member cap is received by the rear opening, removal of the release member cap via the rear opening is prevented.

3. The lancing device according to claim 2, wherein, the release member and / or the release member cap includes a stop mechanism configured to prevent the release member cap from advancing through the aperture beyond a desired position.

4. The lancing device according to any one of the preceding claims, wherein, the release member cap includes at least one guiding rib and the aperture of the release member includes at least one corresponding guide rail such that when the release member cap is received by the aperture, the guiding rib is slidably movable along the guide rail.

5. The lancing device according to any one of the preceding claims, wherein, the release member cap is configured to seal the aperture.

6. The lancing device according to any one of the preceding claims, wherein, the aperture of the release member is configured to allow the needle assembly and the spring to pass through the aperture from the rear opening to the front opening.

7. The lancing device according to claim 6, wherein, the needle assembly includes at least one guiding rib and the aperture of the release member includes at least one corresponding guide rail such that when the needle assembly passes through the aperture, the guiding rib of the needle assembly is slidably movable along the guide rail.

8. The lancing device according to any one of the preceding claims, wherein, the release member is movable relative to the housing between a cocked position and a deployed position, in the cocked position, the retaining arm is arranged to cooperate with the housing to hold the needle assembly in the cocked position, and in the deployed position, the retaining arm is arranged to release the needle assembly to deploy the needle.

9. A single - use lancing device, comprising: a housing that defines a cavity; a needle assembly including a needle and a needle retainer, the needle assembly being located within the cavity; a release member; and a spring arranged to bias the needle assembly in a forward direction relative to the release member; Wherein, the release member includes a holding arm and is movable relative to the housing between a ready position and a deployed position. In the ready position, the holding arm is arranged to cooperate with the housing to hold the needle assembly in the ready position. In the deployed position, the holding arm is arranged to release the needle assembly to deploy the needle; and further includes a main latch protrusion arranged to prevent the release member from moving in a backward direction when the release member is in the ready position, such that the release member cannot be removed from the housing.

10. The lancing device according to claim 9, further comprising a secondary latch protrusion configured to allow the release member to move from the ready position to the deployed position.

11. The lancing device according to claim 10, wherein, the secondary latch protrusion is arranged to prevent the release member from moving back from the deployed position to the ready position.

12. The lancing device according to claim 10 or 11, wherein, the housing includes: a first receiving portion configured to receive the main latch protrusion when the release member is in the ready position; a second receiving portion configured to receive the secondary latch protrusion when the release member is in the ready position; and a third receiving portion configured to receive the secondary latch protrusion when the release member is in the deployed position.

13. The lancing device according to any one of claims 8 to 12, further comprising a removable safety member configured to prevent the release member from moving from the ready position to the deployed position.

14. The lancing device according to claim 13, wherein, the removable safety member includes a collar configured to circumferentially fit around a portion of the release member, wherein a first end of the collar is connected to a second end of the collar via a weakened shear portion.

15. The lancing device according to claim 14, wherein, the weakened shear portion includes an overlapping area located between the first end and the second end of the collar.

16. The lancing device according to any one of claims 8 to 15, further comprising a needle cap integrally formed with the needle holder by a shear portion between the needle cap and the needle holder, such that the needle cap can be removed from the needle tip and the needle holder.

17. The lancing device according to claim 16, wherein, when the release member is in the ready position, a portion of the cap protrudes through a hole in the front end of the housing.

18. The lancing device according to claim 16 or 17, wherein, rotating the cap relative to the needle holder breaks the shear portion and allows the cap to be removed.

19. The lancing device according to any one of claims 8 to 18, wherein, When the needle assembly is in the to-be-fired position, the spring is held in a compressed state, and the spring has a relaxed state in which the needle is fully held within the housing.

20. The lancing device according to claim 19, wherein, the spring is arranged such that when the needle is deployed, before returning to the relaxed state to retract the needle into the housing, the spring moves to an extended state in which the needle projects from the front end of the housing.

21. The lancing device according to any one of claims 8 to 20, wherein, the housing includes a retaining surface arranged to hold the retaining arm in a retaining position when the release member is in the to-be-fired position of the release member; and the housing defines an opening into which the retaining arm can move to release the needle assembly when the release member is in the deployed position.

22. The lancing device according to any one of the preceding claims, wherein, the release member includes at least one guiding rib, and the housing includes at least one corresponding guiding rail such that when the release member moves relative to the housing, the guiding rib can slidably move along the guiding rail.

Images