FIELD OF INVENTION

The present invention relates to a novel lancing device. The lancing device is compact and is particularly well suitable for use in or with compact products. In particular, the lancing device can be included as part of an integrated blood glucose meter.

GENERAL DESCRIPTION OF THE ART

Lancing devices are necessary for the collection of blood samples. Such devices can be stand alone lancing devices which produce a blood sample to be used by another device. Alternatively, lancing devices can be incorporated in to testing devices themselves.

One of the most frequent uses for lancing devices is to produce blood samples for measuring the blood glucose level of a patient. There are numerous products available which enable users to test and monitor their own or someone else's blood glucose levels.

When using a lancing device to obtain a blood sample it is necessary to puncture a user's skin. This action usually involves a level of discomfort for the user. As users who monitor their blood glucose levels typically test their blood several times per day, it becomes advantageous to reduce the level of discomfort for the user.

Testing a patients' blood glucose level typically requires two basic steps, obtaining a blood sample and testing the sample. The two steps can be performed by separate devices but it is often preferable to combine the two steps in a single integrated device.

Additionally, since users often desire to carry their blood glucose monitors with them, it is advantageous to provide more compact and reliable monitors. One way of reducing overall size is to incorporate a lancing device for obtaining a blood sample within a testing apparatus. In order to reduce the overall size of such integrated devices it is further advantageous to reduce the size of the lancing portion of the device.

In some cases traditional lancing devices can induce vibrations or not a well defined movement of the lancing needle, which may result to increased discomfort and pain during the lancing. Existing lancing devices thus have several typical problems. Certain types of lancing devices are large or bulky. Others, by design, inflict an unnecessary amount of discomfort upon a patient. Therefore, there exists a need in the art to provide a compact lancing device which, through its design, inflicts less discomfort to the user during use.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a novel lancing device which overcomes at least some of the disadvantages found in the art.

In particular, the advantageous portions of the present device will be found in the characterizing portions of the independent claims.

More specifically, it is an object of the present invention to provide a novel lancing device which is at least, and preferably all of, compact, inflicts a minimal amount of discomfort and is partially modular.

The present invention achieves the compactness by having a separate hammer means, and a moving lancing means, which together perform the function of lancing. The separation and design of the components enables the device to be very small in size.

The lancing device of the present invention can be realized as a stand-alone type lancing device or integrated in to a more complex device such as an integrated testing or monitoring device.

More specifically, the invention is defined in the independent claims.

Preferred embodiments are described by what is mentioned in the dependent claims.

The lancing device of the present invention will now be described in more detail with the aid of the drawings and exemplary embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows an expanded embodiment of the lancing device in perspective. Figure 2 shows the lancing device of Figure 1 from a top view. Figure 3 shows a lancing device in a loaded position in perspective. Figure 4 shows the lancing device of Figure 3 from a top view.

Figure 5 shows a lancing device in an engaged position in perspective.

Figure 6 shows the lancing device of Figure 5 from a top view.

Figure 7 shows a lancing device in a neutral position.

Figure 8 shows the lancing device of Figure 5 in an alternative perspective

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

An exemplary embodiment of the present lancing device is shown in a partially expanded view in Figures 1 and 2. Figure 1 shows the three basic components of the lancing device 10. The lancing device 10 is contained within, or at least partially within, a housing 12. The three basic parts of the lancing device are an actuator assembly, the actuator assembly being preferably the hammer assembly 14, the lancet holder assembly 16, and the lancet needle 18.

The three basic parts 14, 16 and 18, can be combined in to less than three parts. For example, the hammer assembly and the lancet holder assembly could be connected, merged in to a single assembly or both can be wholly or partially integral with the housing. However, there are distinct benefits to having them at least partially separate.

One of the benefits is that having the hammer assembly and the lancet holder assembly separate allows the two assemblies to be designed separately. The separate designs of the assemblies enable to reduce the size of the assemblies to a minimum required as well as optimizing their operation for performing the appropriate functions. For example, the actuator means can thus be efficient for storing and releasing of energy, and the lancet holder can be capable of well-defined and precise movement.

Additionally, this allows for easy repair and replacement of smaller portions of the system. Furthermore, it allows for keeping the hammer assembly intact while exchanging the lancet holder assembly to accommodate different lancets. Other benefits will be described later. Providing the whole apparatus as a combination of separate subassemblies is herein defined as designing or building the apparatus as a modular assembly.

In this exemplary enbodiment, during operation the lancet needle 18 is removably attached to the lancet holder assembly which controls its movements. After operation, or at any time between operations, the lancet needle 18 can be removed so that a new lancet needle can be placed in the lancet holder for the next operation of the lancet device. Thus, the lancet can be changed as often as necessary.

In the present embodiment the lancet needle 18 is inserted through the opening in the housing 12 prior to operation and is removably attached to the lancet holder assembly. However, the housing 12 can contain a plurality of lancet needles which are moved into place without direct contact from a user. The lancet needle can be any appropriate piece capable of producing a blood, or bloody sample from a user which is combatable with the lancet holder assembly.

The lancet holder assembly 16 comprises two basic parts, the lancet holder 23 and (return) spring element(s) 21. The spring element(s) 21 are attached to the lancet holder 23 and some other fixed portion of the device 10, preferably a portion of the housing 12. The spring element(s) 21 are preferably springs but can be any known means which is capable of reliably and repeatedly causing the lancet holder 23 to return to a predefined neutral position, preferably automatically, after engagement.

The lancet holder 23 is configured to hold a lancet needle 18 during operation. This can be accomplished through any known holding means including but not limited to: friction, mild adhesive, mechanical locking, electrical locking, magnetic locking, etc or combination thereof. Furthermore, it is preferable that the lancet holder assembly is positioned, or positionable, so that when in a neutral position and holding a lancet needle the tip of the lancet needle does not protrude from the opening in the housing, as shown in figures 3, 4 and 7.

The lancet holder assembly can further comprise additional elements or it can be limited to the two basic elements. Additional elements can aid in the placement or removal of lancet needles, the adjustment of the position of the lancet holder or of the opening so as to ensure that the tip of the lancet needle does not protrude from the opening prior to engagement, or a base plate to receive the impact of the hammer assembly. Additional elements could also be electrical, mechanical or electro-mechanical sensors for any number of appropriate measurements pertaining to the lancet holder assembly or lancet needle. An adjustable cap to control the penetration depth can also be used. The hammer assembly in the most general form includes a moving hammer component, and means for moving the hammer to set the lancet holder component in motion, and thus together perform the lancing function. The hammer or means for performing the hammerlike action can be arranged to be connected to the device by a pivot and arranged to rotate essentially in the same plane with the axis of movement of the lancet holder, thus enabling a thin profile design and efficient transfer of potential energy.

The hammer assembly 14 comprises three basic parts: the hammer head 27, the hammer lever 25, and the hammer pivot 29. The hammer head 27 is aligned with a portion of the lancet holder assembly 16 so that when the hammer head is engaged it will strike the portion of the lancet holder assembly 16 causing the lancet needle tip to exit the opening of the housing. Typically, the hammer assembly is loadable and comprises a potential energy storage element , such as a spring wire 28.

The hammer head 27 is attached to the hammer lever 25. The hammer head and lever can be separate and removably or fixedly attached. Alternatively they can be a single integral piece. The hammer lever is then secured to the lancing device 10 via the hammer pivot 29. The hammer pivot 29 can be a simple structure which allows the hammer lever 25 and hammer head 27 to pivot around a point.

The hammer pivot 29 can allow unrestricted movement of the hammer assembly, wherein the movement of the hammer assembly can then be limited by another portion of the lancing device 10. In the present embodiment of the figures the hammer pivot 29

comprises a means for controlling the motion of the hammer head and lever. The means can be a motor, spring or other mechanical device which controls the necessary motion of the hammer assembly.

The necessary motion of the hammer assembly includes maintaining a neutral position, moving to a loaded position, moving to an engaged position, engaging and then moving back to a neutral position. Additionally, there can be maintaining an engaged position. Figures 1 and 2 show the hammer assembly in a neutral position. Preferably, in a neutral position, the hammer head is not in contact with any portion of the lancet holder assembly. However, it is conceivable that the hammer head 27 would be in contact with the lancet holder assembly 16 without deforming the spring element(s) 21 or deforming them slightly but without allowing the tip of a lancing needle from protruding from the device 10 in the neutral position.

From the neutral position, the hammer assembly 14 is moved to a loaded position, as shown in figures 3 and 4. Preferably, the hammer assembly 14 is moved in to a loaded position and maintained in that position for a period of time before engagement. The hammer assembly 14 can be electrically or mechanically loaded and then held in place by the hammer pivot 29 or by another portion of the device 10. The moving to loaded position typically tensions a spring or another means for storing the potential energy, which can be released to facilitate the movement of the hammer. An exemplary energy storage means is the spring 28. Other means such as torsion springs are known to those skilled in the art. The loaded hammer assembly may be held in place and then released by several methods (e.g. latches, buttons, switches) known to those skilled in the art. In a preferred embodiment the holding and release is accomplished by a latch that lets the arm 25 move past it to the loaded position, and then moves in front of the arm, keeping the arm in the loaded position. The latch may be released by the user pressing a button on the outside cover of the device. This pressing of the button moves a latch out of the way of the hammer and thus allows the hammer to move based on the release of the potential energy from the energy storage means.

Once the hammer assembly 14 is loaded and released, the hammer assembly moves to engage the lancet holder assembly 16 and causes the tip of the lancet needle 18 to exit the opening in the housing 12. This is shown in figures 5, 6 and 8. In an embodiment where the hammer pivot 29 contains the means for controlling the movement of the hammer assembly 14, the means allows for the dissipation of the stored energy of the loaded hammer lever 25 and hammer head 27 more or less completely to the lancet holder assembly 16. Preferably no additional energy is added to the hammer assembly between the release and the point when the hammer head 27 contacts the lancet holder assembly 16.

Discomfort to a user when obtaining a blood sample is often caused by unnecessary force being applied to a needle once the needle has already contacted or penetrated the skin of a user. In the present lancing device, by loading the hammer and then releasing it, the maximum force transferred to the user or patient is when the tip of the lancet needle exits the device and contacts the users skin, which is when the most force is needed. From that point forward the amount of force applied to the user is dissipated until there is no outward force and the lancet needle tip begins to reverse back in to the device from the force exerted by the spring element(s) 21.

As shown in the figures, the hammer assembly 14 follows through on its path until the lancet needle is fully engaged. At that point the spring element(s) 21 return both the lancet holder assembly 16 and the hammer assembly 14 to their respective neutral positions. Additionally, or instead of this, the hammer assembly may be returned to its neutral position by the force exerted by energy storage element 28 in reaching its equilibrium (non-loaded) position.

Alternatively, the hammer assembly does not need to follow through to the fully engaged position. The hammer assembly movement can be restricted, by the hammer pivot 29 or another portion of the device, so that the hammer head 27 contacts the lancet holder assembly 16 causing the lancet holder assembly to continue to the fully engaged position while the hammer assembly 14 remains, or moves back to its neutral position having transferred its stored potential energy to the lancet holder assembly. In this alternative embodiment the hammer may only set the lancet holder assembly in motion, and the holder may accomplish the lancing action in whole or in part by inertia and controlled by the return springs.

Alternatively, or in combination with a movement means within the hammer pivot 29, the device can further comprise an element for loading the hammer assembly 14. One example is to have a loader lever and or loader spring, attached to or separate from the hammer assembly, which moves the hammer assembly from the neutral to loaded position. Such an element can maintain the hammer assembly in the loaded position or the there can be a further element capable of holding and selectively releasing the hammer assembly from the loaded position.

In addition to the above mentioned parts, the hammer assembly 14 may comprise further elements. Such elements can be for maintaining the neutral position, maintaining the loaded position, selectively loading the hammer assembly, selectively releasing the loaded assembly, etc. or combination thereof. Additional elements could also be electrical, mechanical or electro-mechanical sensors for any number of appropriate measurements pertaining to the hammer assembly and its movement or position.

The present embodiment represented in figures 1 -8 is a basic form of the present novel lancing device. The housing is shown as a generic box with an opening and the overall lancing device 10 is shown with a minimal number of components. However, as has been described above, the lancing device of the present invention can be more complex, it can be contained in a smaller, compact housing or it can be a portion of a more complex device such as an integrated monitoring or testing device.

The following is an example of the normal operation of a lancing device according to the present invention. A lancet 18 is placed in to the lancet holder 23. If necessary, the depth of the lancet is adjusted to a desired setting. This can be accomplished by a separate lancet cap / depth adjustment part placed on top of the lancet. The depth setting can also be set by other means such as through manipulation of position of the lancet holder assembly 16 and/or the spring element(s) 21 B.

Before, after or concurrently with preparing the lancet, the device must be armed.

Numerous methods of arming the device can be used. In one example, the lancing device 10 includes a cover which covers the hole in the housing 12. When the cover is moved to reveal the opening it automatically arms the device. In another example, there can be either an external lever which allows for mechanically loading the hammer assembly 14 or an electrical button or switch which causes the hammer assembly to be loaded.

Regardless of how the hammer assembly is loaded, it is brought to a loaded position and maintained there.

Once the lancet is prepared and the hammer assembly is loaded, then the user can press or select a release button or switch which enables the hammer assembly to travel and impact the portion of the lancet holder assembly. The lancet holder then travels, for instance on rails, so that the lancet tip is briefly outside the device and then retracts via the spring element(s).

When the lancing device is placed against or near the skin of a user then the lancet tip will punch a hole in the user's skin causing blood, or a bloody sample to be taken from the wound. The sample can automatically placed on a test strip or can be collected at a later time.

The present invention of a novel lancing device should not be limited to the explicit embodiments and figures described herein. One of ordinary skill in the art will recognize numerous variations of the described embodiments which do not part from the scope of the present invention. For example, the definition "hammer assembly" is herein used to denote all actuator assemblies capable of rapid actuating movement.