Skin penetration device

The present invention relates to devices penetrating the skin and in particular, but not exclusively, lancing devices. As will be explained, certain features disclosed herein can be used in applications other than lancing devices, e.g. in injection devices.

[0002] There are many cases in which it is necessary to puncture the skin to take capillary blood, e.g. to measure blood glucose levels in diabetics. It is very important that such instruments work accurately and that they can be quickly assembled during production. A significant benefit lies in reducing the number of components and thus facilitating their production and assembly. At the same time, it is necessary to ensure safe and reliable use by the end user.

[0003] In one aspect, a plurality of lancing devices are designed to be used with a disposable lancet, wherein the lancing device itself is reusable. Prior to making the incision, the new lancet is usually placed in the lancet holder in the device, which is then stretched and fired. After use, the used lancet, which is now contaminated with blood, must be removed to discard it. The connection between the lancet holder and the lancet must be suitable to securely hold the lancet in use. Usually for this purpose, an interference fit with a delicate form of action of the catch is used. In order to release said lancet, a pusher arrangement is usually provided which pushes the lancet, releasing it from the holder to remove it. There is a risk in this step that pushing out the used lancet to release it from the holder can cause inadvertent needle injury. In addition, there is a risk that the pressure on the lancet, after releasing it from the holder, will cause it to be thrown or shot forward. Thus, a system is designed in which the lancet holder can securely hold or grip the lancet, but which can be released in such a way that the used lancet can fall out of it without having to push out the lancet.

[0004] A further aspect of such lancing devices in which the lancet remains

When the lancet is inserted into the lancet holder and is held there by friction or a detent, the insertion force is required to place the lancet. This may be problematic because the user may inadvertently remove the protective cover prior to use, which usually covers the tip of the lancet, thereby exposing or bending the tip, both of which should be avoided. By providing a system in which the socket in the lancet holder can be extended means that the lancet can be placed in the lancet holder at virtually no insertion force, and yet can be safely maintained after insertion.

[0005] In our previous Autolet device^® The Life Clinisafe wedge element is transversely driven to flare adjacent wall edges in the lancet holder. This transverse wedging operation results in severe restrictions in the design of the device. US2006 / 0247670, US2009 / 0043326 and WO2006 / 096539 disclose systems in which the lancet holder is extended by laterally placing a protuberance or wedge in the slot in the slit-shaped sleeve of the lancet holder. Other lancing devices are known for example from WO2009022144; WO2009002131, EP1074219; WO2009136171 and WO2009002136.

[0006] Accordingly, according to an aspect of the invention, a lancing device according to claim 1 is provided.

[0007] In some embodiments, a lancing device may be provided having:

a housing;

a lancet holder movably mounted in said housing for providing movement in the lancing direction, wherein the lancet holder has a front portion defining a seat for partial surrounding and holding when using the rear lancet portion, the socket being expandable to allow insertion and / or removal of said lancet , and a lancet releasing element movable in a direction generally parallel to said lancing direction between a rest position and a releasing position to move said socket from the state of holding the lancet to an expanded state.

[0008] The movement of the release member in a direction generally parallel to the direction

As a result of the notch, it can allow a longer travel stroke and therefore less force than in the devices in which the wedge is placed transversely.

[0009] Preferably, said seat is defined by a generally cylindrical wall of elastically deformable material having a gap to allow expansion and / or shrinkage. The cylindrical wall can be provided with radially outward projections spaced from both sides of said slot, said release element having corresponding cam surfaces co-mating with said projection, wherein the movement of the release member in a direction generally parallel to the cutting direction causes the seat to move between the condition of maintaining the lancet and its expanded state. By positioning the lancet release member in a manner permitting longitudinal movement means that the release action performed by the release member does not mean protruding or getting into the interior of the seat. Means,

[0010] Preferably, the seat wall is shaped, and the projections are placed at an angle to ensure "overlap" in such a way that to expand the seat, the protrusions are squeezed together to expand the seat, although arrangements are possible in which to extend the slot, the protrusions are spaced apart. Preferably, the seat wall has a slot comprising front and rear angularly offset longitudinally extending portions to provide an ambient or overlap effect. The nose can ensure that the lancet in use is kept in a safer manner to counteract lateral displacement during placement and removal. Preferably, said lancet releasing means is further movable to pull the lancet holder.

[0011] In devices such as those described above and in fact in the devices in which the lancet is actively pushed out, we have found that possible difficulties occur when the lancet holder moves forward during operation.

Release. Thus, a system is designed in which, when the lancet releasing device is moved to release the lancet, its displacement is also useful to stop or restrict forward movement.

[0012] In some instances, a lancing device is provided having: a housing;

a lancet holder movably mounted in said housing, the lancet holder having a front portion in which the used lancet is placed, and a lancet releasing member that moves to release the lancet from said lancet holder, the movement of said lancet releasing device to release the lancet; at least, either inhibiting or limiting the forward movement of said lancet holder.

Preferably, said housing or element connected thereto comprises a lancet holder constraining member movable between a position in which it locks forward movement of said lancet holder and a free position in which the forward movement of the lancet holder is not blocked by it. Said lancet releasing member may comprise a control surface which, when said lancet releasing member slides to release the lancet, engages said blocking element to move it to its locking position.

[0014] In the case where the lancing device includes a trigger system that operates in such a way as to latch or release said lancet holder when driven by the drive spring, said lancet holder limiting member is preferably part of said lancet system.

[0015] In the general design of many cutting devices, there is provided a housing which has a removable front end to enable loading and removal of the lancet, with a portion of the head providing contact with the skin surface and having a small opening through which the tip of the lancet protrudes after launching. In devices where there is also an active or passive function of releasing the lancet, it is important that the head portion be removed before the lancet is released, otherwise the user may

Inadvertently release the lancet leaving it loose in the lancet housing, with the risk of being moved again by sliding its tip through the housing, leading to contamination; alternatively, the non-maintained lancet may fall out of the housing at the next opening, before the user is prepared to throw it away. Thus, a system is designed that ensures that the effective release operation is at least suppressed until the head portion is removed.

[0016] In some instances, a lancing device may be provided having:

a housing including a portion of the main body and a front portion of the head that is removable and removable to allow insertion and removal of the lancet during use;

a lancet holder mounted movably in said housing and having a front portion in which the used lancet is inserted;

a lancet releasing element movable between a resting position and a releasing position, wherein the movement of said lancet releasing element into its releasing position is suppressed by said front portion of the head when it is connected to said main body portion.

[0017] In one embodiment, the presence of the front portion of the head effectively blocks the movement of the lancet releasing element into its release position, because it is not possible to force the disconnection of the head portion from the device due to the pressure applied to the lancet releasing member. In a further embodiment, the device may be designed such that when an attempt is made to move the lancet-releasing element to its releasing position with the head part mounted, a part of the head is released. Releasing the head portion may be the intended operation before releasing the lancet, or it may be communicated to the user as incorrect use.

[0018] Preferably, said lancet dis- place is movable longitudinally and comprises an elongated extension adapted to cooperate with said head portion to counteract movement.

[0019] In devices penetrating the skin, such as lancets and instruments

In order to achieve this, it is often necessary to adjust the penetration depth of the penetrating element depending on the thickness of the skin and in particular penetration. It is common to provide, for example in lancing devices, a housing with a threaded portion of the head that can be tightened or unscrewed in order to adapt its axial position relative to a reference position, e.g. a stopping position of the lancet holder (or the farthest position). Elements of such devices are usually injection molded and the formation of screw threads on the interacting surfaces of the elements requires the use of complex molds. Furthermore, after forming, the assembly of the elements requires tightening to one another, which again requires angling and more complex assembly operations. Thus an alternative layout was designed,

[0020] Thus, in one aspect, the present invention provides a skin penetration device comprising:

a housing;

a movable insertable element provided in said housing, which has a sharp point and which is adapted to be inserted into the skin of a patient;

a deep penetrating system comprising a relatively constant portion forming a portion of said housing or attached thereto, and a depth adaptation portion which is attached so as to allow its angular movement about an axis on said relatively solid portion;

wherein the relatively constant or depth adjusting portion has a cam track defined by the dotted cam surface, and the second of the elements has a cam follower adapted to cooperate with said cam track, wherein the relative rotation of said depth adaptation portion and said fixed portion changes their relative axial position .

[0021] Preferably, said relatively constant part and said skin-contacting part align with one another.

[0022] Preferably, said relatively solid part and said skin-contacting part comprise corresponding hooking elements to provide

The operation of the latch at remote angular positions. Preferably, the stop surface is connected to said cam surface in order to limit the relative rotation of said relatively movable element. Said intermittent cam surface can follow a generally helical path with respect to the axis, the cam surface comprising alternating facing cam surface elements that together define said cam track for said pusher.

[0023] Preferably, the cam surface elements have a smaller circumferential extent than said pusher.

[0024] Preferably, at least one of the cam surface and said pusher is resiliently deformable to allow said pusher to be inserted into said cam track by applying an axial load during an interference operation. Although both solutions are possible, the pusher is preferably provided on said depth adaptation portion, and said cam track is provided on said relatively solid portion.

[0025] It is desirable to ensure that after the lancing device is locked, the inserted lancet is not removed until the device is launched. Thus, a device is designed in which, when the lancet is in a stretched state, the lancet releasing mechanism is held until the device is launched.

[0026] Thus, in a further aspect, a lancing device is provided having: a housing;

a lancet holder mounted removably in said housing, the lancet holder having a front portion in which the used lancet is placed;

a lancet releasing element that is removed to release the lancet from said lancet holder;

a trigger system which operates in such a way as to latch or release said lancet holder to be displaced by a driving spring, said trigger arrangement including a trigger element,

Which, during or after latching of said handle, moves to the loaded position ready for firing, and wherein, when the lancet holder is latched, with the trigger system in its loaded position, the trigger system blocks the effective movement of said lancet releasing element. .

Advantageously, said trigger element protrudes from the surface of said housing in a charged state and the lancet releasing element comprises an external controlled manually operated control element, and the trigger element in its armed position is located on the protruding path of the control element.

[0028] In each of the above aspects, the forward movement of the lancet holder can be limited in various ways. In one preferred arrangement, the lancet holder may have a stop surface at or in the direction of its rear end that moves until it contacts the abutting surface on the housing or component or attached thereto to determine the furthest position of the lancet holder.

[0029] While the invention has been described above, it also extends to other inventive combinations of the features described above, or presented in the following description or drawings. It should be understood that the features associated with various aspects of the invention can be adapted to various aspects to provide innovative combinations.

[0030] The invention can be made in various ways and, by way of example only, various embodiments of the lancing device according to the present invention and its modifications will now be described, with reference being made to the accompanying drawings in which:

Figure 1 is a general perspective view of an embodiment of a lancing device according to the invention;

Figure 2 is an exploded view of the apparatus of Figure 1;

Figure 3 is a longitudinal section through the device of Figure 1;

Figures 4 (a) and 4 (b) are a detailed perspective view of the detail in the lancet releasing mechanism with the blade component removed in the assembly

A slider for greater clarity;

Figure 5 is a view of a ram assembly, a lancet holder and a trigger unit to represent the locking action of the lancet holder;

Figure 6 is a cross-sectional view through the arrangement of Figure 5 in a larger scale before blocking the lancet;

Figure 7 is a view similar to that of Figure 6, however, showing the lancet holder in the locked state;

Figure 8 is a detailed cross-sectional view of the front end of the device with the slider in the forward position;

Figure 9 is a perspective view of a slider assembly with the thumb button removed;

Figure 10 is a view of the depth regulator assembly that is assembled;

Figure 11 is an exploded view of the depth regulator assembly;

Figures 12 (a), 12 (b) and 12 (c) are enlarged views showing the shape of the cam track at the rear portion of the depth regulator assembly;

Figure 13 is a cross-sectional view through the front and rear of the depth regulator assembly;

Figure 14 is a perspective view in partial section of a second embodiment of the present invention, wherein the ram assembly is deflected by integrally molded spring portions, and

Figures 15 (a) and (b) are a side view through a third embodiment of the lancing device of the invention, respectively in the loaded and fired state.

[0031] Referring first to Figures 1 and 2, the lancing device according to the present embodiment comprises a main casing 10, to the front end of which the depth regulator assembly 12 is detachably attached. A thumb button 14 of the slide assembly extends from the upper surface of the main housing 10, the main part of it is in the housing. The thumb push button 14 moves in the opposite direction (away from the depth regulator assembly) to prepare or strain the device before use, and

It then moves forward, after use, to release the used lancet from the front of the housing, after removing the depth regulator assembly. The device is fired after pressing the firing button 16 which protrudes from the housing when the device is stretched.

[0032] As can be seen in Figure 2, the main housing 10 is made of a rear portion of the body 18 and the front portion of the body 20 that connect to each other. A main drive spring 22 is located in the rear portion of the body 18, which acts on its rear interior surface, and the front end of which is placed in the cylindrical cavity in the rear portion of the lancet holder 24. The lancet holder 24 is provided at its front end with an integral resiliently deformable finger latch trigger 26 (shown enlarged in Figures 3 and 8). When the lancet holder 24 is moved back from the position shown in Figure 3 by pressing the thumb button 14 back, the trigger latch finger 26 latches behind the protrusion 28 on the inner surface of the housing to snap in behind it, and after snapping, pushes the trigger button 16 so that it protrudes from the case. At the front end of the lancet holder 24, a generally cylindrical seat 30 is integrally formed, in which a lancet (not shown) is placed. As can be seen more clearly in Figures 4 (a) and (b), the L-shaped slit extends downwardly and circumferentially on one side of the cylinder to provide a movable front and rear flap of the wall that can be bent or partially bent to expand the actual the internal diameter of the seat 30. As can also be seen in Figures 4 (a) and (b), the two cam lobes 34, 36 protrude radially from the outer wall of the seat, one, 34 being placed on the front flap of the wall and the other 36, it is placed on the smaller, rear side of the wall. These protrusions 34, 36 are offset from each other, as shown both angular and longitudinally. They coincide with the guide slot 38 in the longitudinal projection 40 of the slide assembly 42, whose thumb button 14 is an integral part. The walls of the projection 40 defining the inspection slot 38 are also longitudinally adjustable, and each comprises a chamfered focusing surface 44.

[0033] The slider assembly 42 is limited to provide linear sliding back and forth movement relative to the position shown on

Figures 1 and 3 under the influence of front and rear pressure spring 46, respectively,

48. Moving the forward slider assembly connects the protrusions 34 and 36 at the same time

In this way, it partially "flares" parts of the wall of the socket to expand it to locate or remove the lancet using a minimum inserting or removing force, respectively.

[0034] The socket 30 also has outer protruding spring seats 50 in which one end of a compression fender spring 52 is placed, the other end of which is arranged in the inner annular arm in the front portion of the body 20. In the front part of the body 20, in opposition to the longitudinal movement there is a trigger 54, which resiliently holds the firing button 16 with two hinges 17, the cast enclosing the front end of the lancet holder 24. As can be seen more clearly in Figures 5 and 7, the trigger cast has two flexible locking arms 56, wherein on their outer surfaces there are two ramp profiles 58. The locking arms 56 are designed to cooperate with diametrically opposite opposite arms of the slider 60 having chamfered leading edges 62.The slider arms 60 form an integral part of the slider assembly 42. The lancet holder 24 has a reduced width portion located downstream of the lancet receiving seat 30, which defines two locking arms 64 towards each other. Moving the slider assembly 42 forward from the position shown in Figure 6 merges of the arms of the slider 60 with ramp profiles 58 in the locking arms 56 and setting them in the central position shown in Figure 7, in which they lock forward movement of the lancet holder 24.Sliding the slider assembly 42 forward from the position shown in Figure 6 causes the slider arms 60 to engage the ramp profiles 58 in the locking arms 56 and align them in the central position shown in Figure 7, where they lock forward movement of the lancet holder 24.Sliding the slider assembly 42 forward from the position shown in Figure 6 causes the slider arms 60 to engage the ramp profiles 58 in the locking arms 56 and align them in the central position shown in Figure 7, where they lock forward movement of the lancet holder 24.

[0035] The slider assembly 42 includes a protrusion or blade member 65 at the base that projects forward on one side of the projection 40, and which extends beyond the spool 54 and terminates from the front of the front face of the front portion of the body 20 when the spool assembly 42 is in the rest position. The blade 65 is designed in such a way that the slider assembly 42 can not be moved forward from its rest position to release the lancet until the depth regulator assembly 12 is disconnected.

[0036] Referring in particular to Figures 10 to 13, the depth controller 12 consists of a relatively fixed rear portion 66 that removably connects the front portion of the front portion of the body by means of snapping or the like in one angular position, and which, as explained, blocks traffic to

At the front of the blade 65 when it is connected. Within the rear portion 66 there are intermittent, forward facing cam surfaces 61 and 63, respectively, which define a helical cam track acting as a thread. A hole 68 in the rear part allows the indication 69 to be seen on the front portion of the depth regulator 70. In the center, the wall portion adjacent to said opening is locally thickened to provide stoppers in a clockwise and anti-clockwise direction 71, 72, in to limit the rotation of the front portion 70. The cam surfaces 61, 63 are alternating and do not overlap each other axially and this means that the rear portion 62 can be formed in such a way that it opens and closes axially without the threaded portion which needs to be threaded. on the cast. The rear portion 62 also includes an inner cylindrical sleeve 74 that generally surrounds the seat 30 in the lancet holder. On the outer cylindrical wall there is a latching projection 76 with two slots 78 formed to allow elastic flexing of the latch protrusion.

[0037] A portion of the depth regulator 70 includes a frusto-conical member terminated with a transverse wall 80 with an opening for a lancet 82 surrounded by spaced apart projections 84 designed to disorient the nerve endings. The remaining portion of the front portion of the depth adjuster has grooves in the center 86 that co-operate with the latching projection 76 on the rear portion to provide a meshing or snap action when the depth control is rotated. On the rear edge of the front portion 70, a pusher portion 88 is formed, which is chamfered, as shown in Figures 11 and 13, to engage behind one or more cam surfaces 61, 63 on rear portion 64. This means that the front and back portions 66, 70 in the depth regulator assembly 12 can be easily mounted by axial thrusting into one another, and there is no need to rotate. The meshing operation is designed in such a way that it is solid enough and that after assembling the two parts can not easily separate. After assembly, the front portion of the depth adjuster can be rotated by approximately 270 °, with the rotation gradually adjusting the relative axial position, thereby altering the actual depth of penetration during the cutting operation.

[0038] During operation of the device, after setting the depth regulator assembly 12 to obtain the desired penetration, the depth regulator assembly is disconnected from the front end of the device and the slide assembly 42 moves forward under the pressure of the thumb on the thumb button 14 in to release the used lancet (if present) by expanding the seat 30 in the lancet holder by operating the protrusions 34, 36 that gather in the slot 38 of the projections 40. In the extended position, a new lancet can be placed in the lancet holder without using a significant axial force. After inserting the lancet, the slider returns to its rest position and the socket returns to its unexpanded shape, thus causing the lancet to be gripped. The depth regulator assembly 12 is then re-applied to the front of the instrument, and the device is stretched by sliding back the slider. The slider assembly meshes the lancet holder and moves it backward against the force of the drive spring 22 until the resiliently deformable finger 26 engages behind the projection 28 on the housing to engage, and by this push the trigger button 16 upward. The user then applies the device to the penetration point and fires the lancet by pressing button 16.

In the modified solution, not shown, the thumb button 14 can extend forward so that in its rest position its leading edge is just behind the opening in which the trigger button 16 is placed. In this way, when the device is stretched and when the trigger button 16 is pushed out of the housing by latching the lancet holder, the lancet button locks the forward movement of the thumb button 14 and it is not possible to move the slider forward until the device is launched.

[0040] In the second embodiment shown in Figure 14, the forward and rear deflection yokes 46 and 48, which deflect the slider assembly, can be replaced by integrally molded spring parts 46¹48¹, thus reducing the number of elements.

[0041] Referring now to the third embodiment, it is similar to the previous embodiments and similar elements have the same reference numbers and will not be discussed in detail again. In the first and second embodiments, when the device is fired, the forward movement of the lancet holder 24 is limited by the forward facing surface

A protrusion of the protrusion on the lancet holder is in contact with the rearwardly directed surface of the projection on the housing or element connected thereto. In a third embodiment, the forward movement of the lancet holder 24 is limited by the forward facing surface of the projection 90 on the element 92 at the rear end of the lancet holder 24, meshing with a rearwardly directed arm 94 projecting toward the center from the wall of the housing.

EP 2 907 449 B1