WO2014037011A1

WO2014037011A1 - Blood sampling needle incorporating measuring capabilities

Info

Publication number: WO2014037011A1
Application number: PCT/DK2013/050257
Authority: WO
Inventors: Michael AHLEFELDT
Original assignee: Aqm Maxval A/S
Priority date: 2012-09-05
Filing date: 2013-08-02
Publication date: 2014-03-13

Abstract

Disclosed is a needle for obtaining a sample of body fluid and generating a first signal indicative of a physiological parameter in said sample of body fluid, wherein said needle comprises: a needle tip for obtaining said sample of body fluid; an open duct for transporting said sample of body fluid towards said detection element, and a detection element for generating said first signal. The needle is configured to directly transfer said sample of body fluid to said detection element, allowing said detection element to generate said first signal without additional process steps.

Description

BLOOD SAMPLING NEEDLE INCORPORATING MEASURING CAPABILITIES

Field The present disclosure relates to a needle for obtaining a sample of body fluid and generating a signal indicative of a physiological parameter.

Additionally, the present disclosure relates to a needle storage device, and a medical handheld device. Background

Measurements of physiological parameters in body fluids are important for diagnosis and proper treatment of a large number of diseases. Examples of body fluids are blood, saliva, gale, and urine. By studying the measured physiological parameters the diagnosis of the patient can be determined. This information may be used to administrate the proper treatment.

One group of patients that have an especially high need for measuring physiological parameters are diabetics. A diabetic has at least partly lost the ability to properly control the level of blood glucose. This may be due to reduced insulin production and/or reduced insulin sensitivity. To avoid log- term complications the blood glucose level of the diabetic must be kept within a narrow range by an intake of insulin. The amount of insulin necessary is determined by the uptake of sugar by the digestive system of the patient, which can be estimated by measuring the diabetic's blood glucose level. Thus to be properly controlled a diabetic may need to make a number of blood glucose measurements each day.

Traditionally blood glucose is measured by firstly puncturing the skin with a lancing device to obtain a sample of blood, secondly transferring the sample of blood to a test strip, and finally inserting the test-strip in a blood glucose measurement apparatus, wherein the apparatus on a display shows the determined blood glucose level. However, the individual steps of the method must be carried out properly and in the correct order to obtain a usable blood glucose measurement.

This may be challenging especially for special patient groups such as children and the elderly population.

Another example of a special patient group is diabetics suffering from

Hypoglycaemia. Hypoglycaemia is a dangerous state that diabetics risk to experience. It is caused by a drop in blood glucose below a particular level, typically around 65 mg/dl. If hyperglycaemia is not discovered and properly treated it can result in severe brain damage or even death. Milder cases of hyperglycaemia can easily be treated by orally increasing the intake of sugar. Thus if hyperglycaemia is discovered timely it is only of little threat to the diabetic.

Hyperglycaemia can easily be discovered by a blood glucose measurement. Unfortunately the first symptom of hyperglycaemia is reduced cognitive ability. This may result in that the diabetic suffering from hyperglycaemia experience the traditional methods of measuring blood glucose as extremely complex.

There is therefore a need for a simpler way of measuring blood glucose.

WO03082091 discloses an integrated sample-testing meter comprising a single modular housing carrying: a puncture means; a drive train for driving the puncture means between an extended position and a retracted position; and a test strip cartridge containing a plurality of test strips. In use, after the puncture has been made, the user moves the meter to a second position where the sample-receiving area of the test strip is located in the drop and receives a sample from the fluid drop. The sensor then analyzes the sample.

However, the above method may for particular patient groups still be perceived as too complicated increasing the risk of maltreatment or even death.

EP1961381 discloses a sensor/lancet integrated device, including a lancet including a needle part for puncturing skin, and a sensor including a reagent part. The lancet is integrally molded with the needle part. The device preferably further includes a capillary for supplying to the reagent part.

Preferably, the needle part is formed to a hollow form, and has the interior communicated to an introduction port. US201 1 137143 discloses a fine needle having a channel formed therein including a fine needle portion of resin provided with a channel for sucking body fluid, a liquid sump portion, connected with the channel, pooling the body fluid, a sensor portion for detecting a specific component contained in the body fluid pooled in the liquid sump portion, a cover portion, in which the sensor portion is arranged, arranged to cover the liquid sump portion and an air hole connected with the channel formed in the fine needle portion through the liquid sump portion.

By providing an integrated sampling and sensor device the process of measuring blood glucose may be simplified.

However, it is a problem that the integrated sensor necessitates a large sampling device to make space for a sampling reservoir comprising the sensor.

It may further be complicated to make repeated measurements. Thus there is a need for a smaller sampling device having an sensor integrated.

There is further a need for devices and / or methods for making repeated measurements of physiological parameters simpler.

Summary

According to a first aspect, the invention relates to a needle for obtaining a sample of body fluid and generating a first signal indicative of a physiological parameter in said sample of body fluid, wherein said needle comprises:

• a needle tip for obtaining said sample of body fluid;

• a detection element for generating said first signal;

• a body comprising a sampling cavity; and

· a duct for transporting said sample of body fluid from said needle tip towards said detection element

wherein said needle is configured to directly transfer said sample of body fluid to said detection element, allowing said detection element to generate said first signal, wherein_said detection element is positioned at the bottom of the sampling cavity, said needle further comprises a ramp connecting said duct with said sampling cavity, and wherein the width of the sampling cavity at the part where the detection element is positioned is larger than the average width of the duct and the height of the sampling cavity at the part where the detection element is positioned is larger than the average height of the duct.

Consequently, by providing a ramp connecting the duct with the sampling cavity, where the sampling cavity is both wider and deeper than the duct, a sufficient sampling cavity may be obtained while still providing a needle with a relative narrow body. This allows the needle to be further miniaturized making the needle more suitable for being stored in a needle storage device. Additionally, a thicker needle body may provide increased structural stability with less material i.e. the needle may be less prone to bend up and down.

In a preferred embodiment, the duct is an open duct.

Consequently, by having an open duct the frictional forces acting on the sample of body fluid may be reduced allowing a smaller needle to be used. This may significantly reduce the discomfort felt by the patient. The needle tip may be suitable for obtaining any type of body fluid e.g.

amniotic fluid, bile, blood, cerebrospinal fluid, chyle, gastric juice,

mucus, peritoneal fluid, saliva, sweat, tears or urine. The physiological parameter may be any measurable physiological parameter such as concentration of glucose, oxygen saturation, acidity etc. The detection element may be provided as part of the needle tip or distal to the needle tip. The needle may be made of a rigid material making the needle suitable for penetrating tissue. Alternatively the needle may be made of a flexible material in order to avoid unwanted tissue damage e.g. if the needle is used to sample body fluids such as sweat or tears. The needle may be made of a plastic material and/or stainless steel. All elements of the needle may be permanently connected in a single unified body.

The detection element may be configured to generate any type of signal e.g. an electrical signal, an optical signal and / or an acoustic signal.

In some embodiments, the width of the sampling cavity at the part where the detection element is positioned is at least 1.5 times larger than the width of the open duct, and the height of the sampling cavity at the part where the detection element is positioned is at least 1.5 times larger than the height of the open duct. In some embodiments, the width of the sampling cavity at the part where the detection element is positioned is at least 2 times larger than the width of the open duct, and the height of the sampling cavity at the part where the detection element is positioned is at least 2 times larger than the height of the open duct.

In some embodiments, the width of the sampling cavity at the part where the detection element is positioned is at least 3 times larger than the width of the open duct, and the height of the sampling cavity at the part where the detection element is positioned is at least 3 times larger than the height of the open duct.

In some embodiment, the angle between the central axis of the open duct and the central axis of the ramp is between 95 degrees and 175 degrees.

In some embodiment, the angle between the central axis of the open duct and the central axis of the ramp is between 1 10 degrees and 170 degrees.

In some embodiment, the angle between the central axis of the open duct and the central axis of the ramp is between 130 degrees and 170 degrees.

Consequently, by providing a gently sloping ramp, the body fluid may be efficiently guided from the open duct to the sampling cavity i.e. the overall flow resistance may be lowered. This may reduce the required capillary pressure necessary to make a sample, thereby allowing the size of the needle tip to be further lowered, whereby the discomfort for the user, especially when the needle is used to puncture the skin, is correspondingly reduced. The central axis of the open duct is an axis positioned at the centre of the bottom of the open duct and being perpendicular with the flow direction in the open duct. Correspondingly, the central axis of the ramp is an axis positioned at the centre of the bottom of the ramp and being perpendicular with the flow direction in the ramp. The angle is defined as the smaller of the two possible angles measurable between two lines.

In some embodiments, the bottom of the open duct is positioned in a first plane, and the bottom of the sampling cavity is positioned in a second plan, said second plane being perpendicular with said first plane, wherein the distance between said first plane and said second plane is at least X, wherein X is 15%, 25%, 35% or 40% of the height of the body.

By providing a difference in elevation between the open duct and the sampling cavity, a deep sampling cavity is provided allowing enabling a narrower body.

In some embodiments, the average width of the open duct at the top of the open duct is at least 50%, 65%, 80% or 100% of the average depth of the open duct. In some embodiments, the needle tip comprises a non-planar outer surface, wherein said non-planar outer surface comprises an outer edge for penetrating the skin and an inner edge interfacing with the open duct, wherein the non-planar outer surface is configured so that, in use, the outer edge comes into contact with the skin of a user before the inner edge comes into contact with the skin of a user independently of the relative orientation between the skin and the needle tip.

This may allow the needle to make a cleaner cut, and thereby induce less pain on the user. Additionally, the non-planar outer surface may assist in guiding the flow of blood into the open duct. A non-planar outer surface is a surface that can not entirely be positioned in a 2 dimensional plane.

In some embodiments, the average width of the open duct at the top of the open duct is between 0.05 mm and 5mm, between 0.05 mm and 2 mm, between 0.1 mm and 1 mm or between .15 mm and 0.6 mm.

In some embodiments, the average depth of the open duct is between 0.05 mm and 5mm, between 0.05 mm and 2 mm, between 0.08 mm and 1 mm or between .1 mm and 0.5 mm.

In some embodiments, the length of the open duct is between 0.05 mm and 5 cm, between 0.1 mm and 2 cm, between 0.5 mm and 1 cm, between 1 mm and 8 mm or between 1 .5 mm and 5mm.

In some embodiments, the needle has a length between 1 mm and 10 cm, between 2mm and 7 cm, between 5mm and 5cm, or between 8mm and 3 cm. In some embodiments, said open duct is at least partly covered with a coating for reducing the frictional force induced by the walls of the open duct on the sample of body fluid.

The entire internal surface of the open duct may be covered with a coating for reducing the frictional force. The coating may be a silicone based coating.

In some embodiments, a cross-section of said body along a plane being perpendicular to a longitudinal axis of said needle has a polygonal shape e.g. a triangular, a rectangular, pentagonal, or hexagonal shape.

This may make it easier for another device to grip said needle. In some embodiments, said needle further comprises a ramp for transporting said sample of body fluid from said open duct to said detection element. Consequently, the amount of body fluid necessary to make a measurement may be lowered.

In some embodiments, said needle tip is a needle tip for penetrating the skin of a person.

In some embodiments, said body fluid is blood.

Consequently, the needle may be used for determining physiological parameters in blood such as blood glucose, oxygen saturation, pH, blood alcohol content, cholesterol levels in blood etc.

In some embodiments, said physiological parameter is blood glucose and wherein said detection element is a blood glucose detection element. In some embodiments, said open duct has a wedge shape at its distal end forming said needle tip allowing said sample of body fluid to flow inside said open duct directly from said needle tip to said detection element.

In some embodiment, said detection element is configured to generate a second signal indicating that said detection element is ready to receive said sample of body fluid and generate said first signal.

The detection element may be configured to generate said second signal in response to being supplied with power. In some embodiment, said detection element is configured to generate a third signal indicating that said detection element has been supplied with a sufficient amount of body fluid for generating said first signal. In some embodiments, said needle further comprises a first electrical contact unit for transferring said first signal to another device.

Consequently, complicated processing and display units of another device may be used to process and display the first signal. This may reduce the complexity and cost of the needle.

In some embodiments, said first electrical contact unit is positioned with a distance to said detection element, and wherein said detection element is electrically connected to said first electrical contact unit.

In some embodiments, said first electrical contact unit comprises a first electrical contact and a second electrical contact.

The first electrical contact and the second electrical contact may be used to transfer said first signal to another device and / or supply a charge to the sensor.

In some embodiments, said first electrical contact is a first electrical contact plane, and said second electrical contact is a second electrical contact plane arranged on said body.

In some embodiments, said first electrical contact plane, and said second electrical contact plane are arranged on different surfaces of said body.

As the electrical contact resistance between the needle and the other device is correlated with electrical contact area, the minimum size of the electrical contact planes are determined by the required electrical contact resistance between the needle and the other device. Thus, by providing the contact planes on different surfaces of the needle body a relative narrow body may be provided as contact planes may also be positioned on the side. As mentioned previously this allows the needle to be further miniaturized.

Additionally, the risk of short circuiting the first electrical contact unit is decreased.

In some embodiments, said first electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

The third electrical contact may be used to transfer said second signal to another device (the signal that indicates that said detection element is ready to receive said sample of body fluid) and said fourth electrical contact may be used to transfer said third signal (the signal that indicates that the detection element has been supplied with a sufficient amount of body fluid to generate said first signal) to another device.

In some embodiments, said third electrical contact is a third electrical contact plane, and said fourth electrical contact is a fourth electrical contact plane arranged on said body.

In some embodiments, said first electrical contact plane, said second electrical contact plane, said third electrical contact plane, and said fourth electrical contact plane are arranged on different surfaces of said body.

In some embodiments, said detection element comprises a reactant for reacting with said sample of body fluid to generate said first signal. The reactant may be configured to generate any type of signal. The reactant may generate an electrical signal indicative of the physiological parameter. Alternatively, the reactant may generate an optical signal indicative of the physiological parameter e.g. the reactant may change colour dependent on the physiological parameter. In some embodiments, said reactant is an electrochemical reactant that when it comes into contact with said sample of body fluid generates an electrical signal indicative of a physiological parameter.

In some embodiments, said detection element is a detection element having a limited reusability e.g. it is a detection element that can be used to make at most 50 distinct measurements, 20 distinct measurements, 5 distinct measurements, or it is a single use detection element.

In some embodiments, said needle has a shape and size configured to fit a socket of a needle storage device allowing said needle to be temporarily connected to said needle storage device.

In some embodiments, said first electrical contact unit is configured to allow a non permanent electrical connection to be made to a second electrical contact unit of a needle storage device so that said needle can be detached from said needle storage device.

Consequently, said needle storage device may comprise a plurality of needles.

According to a second aspect the invention relates to a needle storage device for storing a plurality of needles, wherein said needle storage device comprises a first element comprising a plurality of sockets for receiving and / or storing a needle and wherein a first socket of said plurality of sockets comprises a first electrical contact unit for aligning with an electrical contact unit of said needle for generating a non-permanent electrical connection with said needle allowing said needle to transfer an electrical signal to said needle storage device and further be discharged after use from said needle storage device. Thus a needle storage device is provided capable of storing a plurality of needles having integrated sensors, where an electrical signal generated by the needle may be processed and display using processing and display units of the needle storage device or a device connected to the needle storage device. Consequently, repeated measurements of physiological parameters are made simpler.

In some embodiments, said first socket is configured to hold a needle in a storage position (P1 ) and an activated positioned (P2), wherein said electrical contact unit of the needle is unaligned with the first electrical contact unit of the socket in said storage position (P1 ), and wherein the electrical contact unit of the needle is aligned with the first electrical contact unit of the socket in said activated position (P2) allowing said needle to transfer an electrical signal to said needle storage device. In some embodiments, said first electrical contact unit comprises a first electrical contact and a second electrical contact.

In some embodiments, said first electrical contact is arranged on a first surface of the first socket and the second electrical contact is arranged on a second surface of the first socket,

In some embodiments, the first surface and the second surface of the first socket is configured to establish a frictional fit with said needle. Consequently, the needle may be prevented from unwanted sliding out of the socket when its electrical contact unit is aligned with the electrical contact unit of the needle storage device. In some embodiments, said first electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

In some embodiments, said third electrical contact is arranged on a third surface of the first socket and the fourth electrical contact is arranged on a fourth surface of the first socket.

In some embodiments, the first surface, the second surface, the third surface and the fourth surface of the first socket is configured to establish a frictional fit with said at least one needle.

In some embodiments, each of the plurality of sockets is of a similar type as the first socket.

In some embodiments, said first element of said needle storage device comprises a first end for advancing and discharging said at least one needle, and a second end for interacting with a mechanical actuator for advancing and / or discharging said at least one needle.

In some embodiments, said second end of said first element comprises an opening for receiving said mechanical actuator allowing said mechanical actuator to directly or indirectly push said at least one needle.

In some embodiments, said first element of said needle storage device further comprises a second electrical contact unit for aligning with an electrical contact unit of another device and/or another element of said needle storage device, said second electrical contact unit is electrically connected with said first electrical contact unit allowing said first element of said needle storage device to transfer an electrical signal from said at least one needle to said other device and/or other element of said needle storage device.

In some embodiments, said second electrical contact unit comprises a first electrical contact and a second electrical contact.

In some embodiments, said second electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

In some embodiments, said first element comprises a plurality of sockets for receiving and / or storing needles, wherein each of the plurality of sockets comprises a first type of electrical contact unit for aligning with an electrical contact unit of a needle.

In some embodiments, said needle storage device further comprises a plurality of second type electrical contact units for aligning with electrical contacts of another device and/or another element of said needle storage device, wherein each of the first type electrical contact units is exclusively electrically connected to a single second type electrical contact unit allowing each of said second type of electrical contact units to transfer a signal to another device and/or another element of said needle storage device originating from a single specific needle.

In some embodiments, said needle storage device further comprises a needle stored in said first socket wherein said needle comprises an electrical contact unit for aligning with the first electrical contact unit of said first socket. In some embodiments, said stored needle is movable arranged in said first socket between a storage position (P1 ) and an activated position (P2), wherein said electrical contact unit of said needle is unaligned with the first electrical contact unit of said first socket and further the needle is completely contained in said first socket when the needle is positioned in said storage position (P1 ), and wherein said electrical contact unit of said needle is aligned with the first electrical contact unit of said first socket and further the needle tip of said needle protrudes from said first socket when said needle is positioned in said activated position (P2) thereby allowing the needle to obtain a sample of body fluid, generate a first signal indicative of a

physiological parameter and transfer said first signal to said fist socket when said needle is positioned in said activated position (P2).

The needle may be moved from said storage position (P1 ) to said activated position (P2) by a mechanical actuator. In some embodiments, said first element further comprises a plurality of needles stored in a plurality of sockets.

Each of the plurality of needles may be movable arranged between a storage position (P1 ) and an activated position (P2).

In some embodiments, said first element of said needle storage device comprises a first end for advancing and discharging said at least one needle, wherein said first end comprises a protective covering, wherein said protective covering covers the socket / sockets thereby protecting the needle/ needles stored in said socket / sockets, and wherein said stored needle is configured to penetrate said protective covering when it is advanced at least partly out of said socket.

Consequently the needle stored may be efficiently protected. In some embodiments, said needle storage device is further configured to fit a socket of a medical handheld device allowing said needle storage device to temporally engage with said medical handheld device. In some embodiments, said needle storage device further comprises a second electrical contact unit for aligning with an electrical contact unit of said medical handheld device and/or another element of said needle storage device, wherein said first electrical contact unit and said second electrical contact unit are electrically connected so that an electrical signal generated by said at least one needle can be transferred to said medical handheld device and/or another element of said needle storage device through said first element of said needle storage device.

Consequently, complicated processing and display units the medical handheld device may be used to process and display the first signal, thereby reducing the complexity and cost of the needle storage device. This may allow the needle storage device to be disposed after all needles stored therein have been used. In some embodiments, said needle storage device further comprises a second element, wherein said second element has a tubular body and surrounds said first element, and wherein said second element comprises a first electrical contact unit arranged to align with the second electrical contact unit of said first element, and wherein said second element further comprises a second electrical contact unit for aligning with an electrical contact unit of another device, wherein said first electrical contact unit and said second electrical contact unit are electrically connected allowing said second element to transfer an electrical signal from said first element to said other device. In some embodiments, said first element is rotatably mounted in said second element. Consequently said other device may interface with the non-movable second element. This may make the connection between the needle storage device and the other device more secure.

In some embodiments, said second electrical contact unit of said second element comprises a first electrical contact and a second electrical contact.

In some embodiments, said first electrical contact and said second electrical contact of said second electrical contact unit of said second element are formed by a first and a second conductive rod respectively.

In some embodiments, said second element of said needle storage device is configured to fit a socket of a medical handheld device allowing said needle storage device to temporally engage with said medical handheld device.

In some embodiments, said second electrical contact unit of said second element is configured to aligning with an electrical contact unit of said medical handheld device so that an electrical signal generated by said at least one needle can be transferred to said medical handheld device through said needle storage device.

According to a third aspect the invention relates to a handheld medical device for measuring a physiological parameter comprising a socket for receiving and holding needle storage device for storing one or more needles, wherein said handheld medical device comprises a first electrical contact unit for aligning with an electrical contact unit of said needle storage device allowing said needle storage device to transfer a first signal indicative of a physiological parameter measured in a sample of body fluid and wherein said handheld medical device further comprises a display for displaying

information related to said first signal. The socket may be configured to non-permanently receive said needle storage device, whereby a used needle storage device may exchanged with a new needle storage device thereby allowing the handheld medical device to be re-used with a plurality of needle storage devices.

In some embodiments, said needle storage device is a needle storage device as describe in relation to the second aspect of the invention. In some embodiments, said handheld medical device further comprises a processing unit connected to said first electrical contact unit and said display, wherein said processing unit is configured to determine a physiological parameter by processing said first signal and further control said display to display said determined physiological parameter.

In some embodiments, said socket is configured to hold said needle storage device at different positions, allowing a user to set different needle puncture depths. In some embodiments, said handheld medical device further comprises a communication unit for communicating with another device.

The communication unit may a wired communication unit or a wireless communication unit e.g. a blue tooth, WIFI, GSM or UMTS based

communication unit.

In some embodiments, said handheld medical device further comprises a mechanical actuator for advancing a needle from said needle storage device. In some embodiments, said mechanical actuator comprises a first elongated member and a second elongated member mechanically coupled, wherein both said first elongated member and said second elongated member are configured to enter an opening of a socket of a needle storage device, and wherein said first elongated member is configured to entirely discharge a needle stored in a socket of a needle storage device and said second elongated member is configured to advance a needle stored a socket of a needle storage device partly out of said socket.

This allows the mechanical actuator in a single operation to both discharge an old needle and further prepare a new needle for use.

Said first member may be longer than said second member.

In some embodiments, said handheld medical device further comprises a needle storage device as disclosed in relation to the second aspect of the invention, wherein said needle storage device is arranged in said socket.

In some embodiments, said needle storage device comprises a needle as disclosed in relation to the first aspect of the invention. In some embodiments, said handheld medical device further comprises a speaker operable connected to the processing unit, wherein said processing unit is configured to control said speaker to generate one or more audible signal/s for indicating the state of the medical handheld device. In some embodiments, the processing unit is configured to control the speaker to generate a first audible signal indicating that the medical handheld device comprises a needle being ready to receive a sample of body fluid and generating a signal indicative of a physiological parameter in said sample of body fluid. In some embodiments, the processing unit is configured to control the speaker to generate said first audible signal in response to having received a signal from a needle stored in the needle storage unit i.e. the processing unit is configured to control the speaker to generate said first audible signal in response to having received said second signal generated by a sensor of the needle.

In some embodiments, the processing unit is configured to control the speaker to generate a second audible signal indicating that the medical handheld device comprises a needle having received a sufficient sample of body fluid to generate a signal indicative of a physiological parameter in said sample of body fluid.

In some embodiments, the processing unit is configured to control the speaker to generate said second audible signal in response to having received a signal from a needle stored in the needle storage unit i.e. the processing unit is configured to control the speaker to generate said second audible signal in response to having received said third signal generated by a sensor of the needle.

According to a fourth aspect the invention relates to use of a needle as disclosed in relation to the first aspect of the invention for measuring a physiological parameter. According to a fifth aspect the invention relates to a method of measuring a physiological parameter on a person comprising the steps of:

• puncturing the skin of said person using a needle as disclosed in relation to the first aspect of the invention;

• obtaining an amount of body fluid using said needle;

wherein said needle generates a first signal indicative of said physiological parameter without the need of additional method steps. In some embodiments, the step of puncturing the skin further comprises arranging the surface of the skin to face approximately downwards allowing gravitational forces to assist in securing a flow of blood within said needle.

The skin is punctured on a location and with a depth securing that it does not result in a substantial health risk especially when carried out with the required expertise. According to a sixth aspect, the invention relates to a needle for obtaining a sample of blood, wherein said needle comprises an open duct and a needle tip, wherein the average width of the open duct at the top of the open duct is at least 25% of the average depth of the open duct. Consequently, a needle having a low flow resistance is provided. This allows smaller needles to be used, reducing the discomfort for the user.

In some embodiments, the average width of the open duct at the top of the open duct is at least 50%, 65%, 80% or 100% of the average depth of the open duct.

In some embodiments, the needle tip comprises a non-planar outer surface, wherein said non-planar outer surface comprises an outer edge for penetrating the skin and an inner edge interfacing with the open duct, wherein the non-planar outer surface is configured so that, in use, the outer edge comes into contact with the skin of a user before the inner edge comes into contact with the skin of a user independently of the relative orientation between the skin and the needle tip.

This may allow the needle to make a cleaner cut, thereby inducing less pain on the user. A non-planar outer surface is a surface that can not entirely be positioned in a 2 dimensional plane. In some embodiments, the average width of the open duct at the top of the open duct is between 0.05 mm and 5mm, between 0.05 mm and 2 mm, between 0.1 mm and 1 mm or between .15 mm and 0.6 mm.

In some embodiments, the length of the open duct is between 0.05 mm and 5 cm, between 0.1 mm and 2 cm, between 0.5 mm and 1 cm, between 1 mm and 8 mm or between 1 .5 mm and 5 mm.

In some embodiments, the needle has a length between 1 mm and 10 cm, between 2 mm and 7 cm, between 5 mm and 5 cm, or between 8 mm and 3 cm.

Here and in the following, the terms 'processing means' and 'processing unit' are intended to comprise any circuit and/or device suitably adapted to perform the functions described herein. In particular, the above term comprises general purpose or proprietary programmable microprocessors, Digital Signal Processors (DSP), Application Specific Integrated Circuits

(ASIC), Programmable Logic Arrays (PLA), Field Programmable Gate Arrays (FPGA), special-purpose electronic circuits, etc., or a combination thereof

The different aspects of the present invention can be implemented in different ways including as individual devices e.g. a needle, a needle storage device or a handheld medical device, combinations of devices e.g. any combinations of a needle, a needle storage device or a handheld medical device, or Use / methods for measuring physiological parameters as described above and in the following: each yielding one or more of the benefits and advantages described in connection with at least one of the aspects described above, and each having one or more preferred embodiments corresponding to the preferred embodiments described in connection with at least one of the aspects described above and/or disclosed in the dependant claims.

Furthermore, it will be appreciated that embodiments described in connection with one of the aspects described herein may equally be applied to the other aspects.

Brief description of the drawings The above and/or additional objects, features and advantages of the present invention, will be further elucidated by the following illustrative and non- limiting detailed description of embodiments of the present invention, with reference to the appended drawings, wherein: Fig. 1 a-c show a needle according to an embodiment of the present invention. Fig. 1 a shows a top view, Fig. 1 b shows a side view, and Fig. 1 c shows a bottom view.

Fig. 2 shows a cross-section of a needle according to an embodiment of the present invention.

Fig. 3a shows a perspective view of a needle according to an embodiment of the present invention.

Fig. 3b shows a perspective view of a needle tip of a needle according to an embodiment of the present invention.

Fig. 4a-d show a needle storage device according to an embodiment of the present invention. Fig. 4a shows a top view, Fig. 4b shows a side view, Fig. 4c shows a bottom view, and Fig. 4d shows perspective view. Fig. 5a-c show a needle storage device according to an embodiment of the present invention. Fig. 5a shows a top view, Fig. 5b shows a side view, Fig. 5c shows a perspective view.

Fig. 6 shows a perspective view of a handheld medical device according to an embodiment of the present invention.

Fig. 7 shows a perspective view of a handheld medical device according to an embodiment of the present invention.

Fig. 8a-c show a needle according to an embodiment of the present invention. Fig. 8a shows a top view, Fig. 8b shows a side view, and Fig. 8c shows a bottom view.

Fig. 8d shows a perspective view of a needle tip of a needle according to an embodiment of the present invention.

Fig. 9a-d show a needle storage device according to an embodiment of the present invention. Fig. 9a shows a top view, Fig. 9b shows a side view, Fig. 9c shows a bottom view, and Fig. 9d shows perspective view.

Detailed description In the following description, reference is made to the accompanying figures, which show by way of illustration how the invention may be practiced.

Fig. 1 a-c show a needle according to an embodiment of the present invention. Fig. 1 a shows a top view, Fig. 1 b shows a side view, and Fig. 1 c shows a bottom view. The needle comprises a needle tip 101 for obtaining a sample of body fluid, and a detection element 105 for generating a first signal indicative of a physiological parameter. The needle further comprises an open duct 102 connecting the needle tip 101 to the detection element 105. This arrangement allows the sample of body fluid to run directly within the open duct 102 from the needle tip 101 to the detection element 105. By using an open duct compared to a traditional hollow tube the frictional forces induced by the walls on the sample of body fluid may be reduced. This allows smaller needles to be used. The needle 100 comprises a ramp. The needle 100 further comprises a body 104 comprising a sampling cavity 107, wherein the detection element 105 is arranged at the bottom of the sampling cavity 107. Fig. 1 a additionally shows a longitudinal axis of the needle 106. The body 104 has shape so that a cross-section being perpendicular the longitudinal axis 106 of the needle 100 has polygonal shape i.e. a rectangular shape. The needle 100 is configured to transfer a sample of body fluid obtain by the needle tip 101 directly to the detection element 105 so that the detection element 105 can generate the first signal, indicative of a

physiological parameter in the sample. The detection element 105 is configured to generate an electrical signal indicative of a physiological parameter. The body further comprises an electrical contact unit 130 that can be used to transfer an electrical signal generated by the detection element 105 to another device e.g. a needle storage device. The electrical contact unit 130 comprises a first electrical contact 1 10, a second electrical contact 1 1 1 , a third electrical contact 1 12 and a fourth electrical contact (not shown). Each of the electrical contacts 1 10 1 1 1 1 12 of the electrical contact unit 130 are electrically connected to the detection element 105 through electrical wires 120 121 122 123. Each of the electrical contacts 1 10 1 1 1 1 12 1 13 are arranged on different surfaces of the body 104 and are formed as electrical contact planes configured establish a non permanent electrical connection with electrical contacts of another device. The needle has a length 190. Fig. 2 shows a cross-section of the needle 200 shown in Fig. 1 a-c along the longitudinal axis 106 shown in Fig. 1 a. The needle 200 comprises a needle tip 201 , an open duct 202, a body 204, and a detection element 205. The open duct 202 further comprises a ramp 203. The detection element 205 is arranged in a sampling cavity 207 in the body 204. In the embodiment shown in Fig. 1 a-c and Fig. 2, the width 150 of the sampling cavity 207 107 at the part where the detection element 205 105 is positioned is larger than the average width of the open duct 153 and the height of the sampling cavity 151 at the part where the detection element 205 105 is positioned is larger than the average height 152 of the open duct. Fig. 3a shows a perspective view of a needle 300 according to an

embodiment of the present invention. The needle 300 comprises a needle tip 301 an open duct 302, a body 304, a detection element 305 and an electrical contact unit 330. The open duct further comprises a ramp 303. The detection element is arranged in a sampling cavity 307 in the body 304. The electrical contact unit 330 comprises a first electrical contact 310, a second electrical contact 31 1 , a third electrical contact (not shown) and a fourth electrical contact (not shown). Each of the electrical contacts 310 31 1 of the electrical contact unit 330 are electrically connected to the detection element 305 through electrical wires 320 321 .Each of the electrical contacts 310 31 1 are arranged on different surfaces of the body 104 and are formed as electrical contact planes configured establish a non permanent electrical connection with electrical contacts of another device.

Fig. 3b shows a close up of the open duct 302 of the needle shown in fig. 3a. The open duct has wedge shape at it distal end forming the needle tip 301 . This allows the duct to transport a sample of body fluid directly from the needle tip 301 to the detection element 305.

Fig. 4a-d show a needle storage device according to an embodiment of the present invention. Fig. 4a shows a top view, Fig. 4b shows a side view, Fig. 4c shows a bottom view, and Fig. 4d shows perspective view. The needle storage device 400 comprises a first element 450. The first element 450 comprises six sockets 401 -406 for receiving and / or storing a needle. Each socket 401 -406 comprises a first type electrical contact unit (not shown) for aligning with an electrical contact unit of a needle for generating a non- permanent electrical connection with the needle. This allows the needle to transfer an electrical signal to the needle storage device and further allows the needle to be discharged after use from the needle storage device

The first element 450 of the needle storage device 400 comprises a first end 410 for advancing and discharging the needles and a second end 41 1 for interacting with a mechanical actuator (not shown). The second end comprises six openings 431 -436, one for each socket 401 -406, for receiving the mechanical actuator allowing the mechanical actuator to directly or indirectly push the needles stored in the sockets. The first end 410 may be fitted with a protective covering (not shown) wherein the needles stored in the needle storage device 400 is configured to penetrate the protective covering when they are advanced out of their socket. The first element of the needle storage device 450 further comprises a plurality of second type electrical contact units 421 - 423, one for each socket 401 -406, wherein the second type electrical contact units 421 -423 are electrically connected to the first type electrical contact units allowing the first element 450 to transfer an electrical signal from a needle to another device and / or element of the needle storage device 400. Fig. 5a-c show a needle storage device according to an embodiment of the present invention. Fig. 5a shows a top view, Fig. 5b shows a side view, Fig. 5c shows a perspective view. In this embodiment the needle storage device 500 comprises a first element 501 and a second element 502. The second element 502 has a tubular body and surrounds the first element 501 . The first element 501 may be of similar type as the first element of the needle storage device shown in Fig. 4a-d. The first element 501 is rotatably mounted in the second element 502. The second element 502 comprises a first electrical contact unit (not shown) arranged to align with a second electrical contact unit (not shown) of the first element 501 . The second element 502 further comprises a second electrical contact unit 561 -564 electrically connected to first electrical contact unit of the second element, thereby allowing the second element 502 to transfer an electrical signal from a needle stored in a socket of the first element 501 to another device. The second electrical contact unit 561 -564 of the second element 502 comprises a first conductive rod 561 , a second conductive rod 562, a third conductive rod 563, and a fourth conductive rod 564.

Fig. 6 shows a perspective view of a handheld medical device 600 for measuring a physiological parameter, according to an embodiment of the present invention. The handheld medical device comprises a body 601 , a cap 602, a display 603 and a mechanical actuator 604.

Fig. 7 shows a perspective view of a handheld medical device 700 for measuring a physiological parameter, according to an embodiment of the present invention. The handheld medical device 700 comprises a socket for receiving and holding a needle storage device, a display 703, two batteries 705 706, a processing unit 708, a communication unit 707, a mechanical actuator 704, and a speaker (not shown). The handheld medical device further comprises a needle storage device 710 fitted in the socket. The needle storage device comprises a needle 720 protruding from a first end of the needle storage device 710. The needle storage device 710 may be a needle storage device as described in relation the second aspect of the invention and / or Figs. 4 or 5. The needle 720 may be a needle as described in relation the first aspect of the invention and / or Figs. 1 -3. Fig. 8a-c show a needle according to an embodiment of the present invention. Fig. 8a shows a top view, Fig. 8b shows a side view, and Fig. 8c shows a bottom view. The needle 800 comprises an open duct 801 and a needle tip 802, wherein the width 803 of the open duct at the top of the open duct 805 is at least 25% of the average depth of the open duct 801. The open duct has a length 804. Fig. 8d shows a perspective view of a needle tip of a needle according to an embodiment of the present invention. The needle tip 802 comprises a non- planar outer surface 810. The non-planar outer surface 810 comprises an outer edge 81 1 for penetrating the skin and an inner edge 812 interfacing with an open duct, wherein the non-planar outer surface 810 is configured so that, in use, the outer edge 81 1 comes into contact with the skin of a user before the inner edge 812 comes into contact with the skin of a user independently of the relative orientation between the skin and the needle tip. This may allow the needle to make a cleaner cut, thereby inducing less pain on the user.

Fig. 9a-d show a needle storage device according to an embodiment of the present invention. Fig. 9a shows a top view, Fig. 9b shows a side view, Fig. 9c shows a bottom view, and Fig. 9d shows perspective view. The needle storage device 900 comprises a first element 950. The first element 950 comprises six sockets 901 -906 for receiving and / or storing a needle. Each socket 901 -906 comprises a first type electrical contact unit (not shown) for aligning with an electrical contact unit of a needle for generating a non- permanent electrical connection with the needle. This allows the needle to transfer an electrical signal to the needle storage device and further allows the needle to be discharged after use from the needle storage device

The first element 950 of the needle storage device 900 comprises a first end 910 for advancing and discharging the needles and a second end 91 1 for interacting with a mechanical actuator (not shown). The second end comprises six openings 931 -936, one for each socket 901 -906, for receiving the mechanical actuator allowing the mechanical actuator to directly or indirectly push the needles stored in the sockets. The first end 910 may be fitted with a protective covering (not shown) wherein the needles stored in the needle storage device 900 is configured to penetrate the protective covering when they are advanced out of their socket. The first element of the needle storage device 950 further comprises a plurality of second type electrical contact units 921 - 923, one for each socket 901 -906, wherein the second type electrical contact units 921 -923 are electrically connected to the first type electrical contact units allowing the first element 950 to transfer an electrical signal from a needle to another device and / or element of the needle storage device 900.

Fig. 10 shows a cross section of the front part of a needle 1000 according to an embodiment of the present invention. The needle 1000 comprises an open duct 1012 positioned in a first plane 1002 and a sampling cavity 1017 positioned in a second plane 1003, wherein the distance between the first plane 1002 and the second plane 1003 is more than 25% of the height 1005 of the body. In the embodiment shown the distance between the first plane 1002 and the second plane 1003 is approximately 44% of the height 1005 of the body 1001 .

Fig. 1 1 shows a cross section of the front part of a needle 1 100 according to an embodiment of the present invention. The needle 1 100 comprises an open duct 1 1 12, a ramp 1 1 18 and a sampling cavity 1 1 17. In the

embodiment shown the angle 1 104 between the central axis 1 102 of the open duct and the central axis 1 103 of the ramp 1 1 18 is between 130 degrees and 175 degrees. More particular the angle 1 104 is approximately 155 degrees. It should be noted that the angle 1 104 is defined as the smaller of the two possible angle measurable between two lines.

Although some embodiments have been described and shown in detail, the invention is not restricted to them, but may also be embodied in other ways within the scope of the subject matter defined in the following claims. In particular, it is to be understood that other embodiments may be utilised and structural and functional modifications may be made without departing from the scope of the present invention. In device claims enumerating several means, several of these means can be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims or described in different embodiments does not indicate that a combination of these measures cannot be used to advantage.

It should be emphasized that the term "comprises/comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

Further embodiments of the invention are disclosed in the following enumerated items.

Enumerated items

1 . A needle for obtaining a sample of body fluid and generating a first signal indicative of a physiological parameter in said sample of body fluid, wherein said needle comprises:

• a needle tip for obtaining said sample of body fluid; and

· a detection element for generating said first signal;

wherein said needle is configured to directly transfer said sample of body fluid to said detection element, allowing said detection element to generate said first signal.. 2. A needle according to item 2, wherein said needle further comprises an open duct for transporting said sample of body fluid towards said detection element.

3. A needle according to item 2, wherein said open duct is at least partly covered with a coating for reducing the frictional force induced by the walls of the open duct on the sample of body fluid.

4. A needle according to any of items 2 or 3, wherein said needle further comprises a body comprising said detection element, and wherein said open duct connects said needle tip with said body.

5. A needle according to any of items 2 to 5, wherein a cross-section of said body along a plane being perpendicular to a longitudinal axis of said needle has a polygonal shape e.g. a triangular, a rectangular, pentagonal, or hexagonal shape. 6. A needle according to item 3, wherein said open duct further comprises a ramp for transporting said sample of body fluid from said open duct to said detection element. 7. A needle according to item 4, wherein said detection element is positioned in a sampling cavity in said body.

8. A needle according to any of items 1 to 7, wherein said needle tip is a needle tip for penetrating the skin of a person.

9. A needle according to any of items 1 to 8, wherein said body fluid is blood.

10. A needle according to any of items 1 to 9, wherein said physiological parameter is blood glucose and wherein said detection element is a blood glucose detection element.

1 1 . A needle according to any of items 1 to 10, wherein said open duct has a wedge shape at its distal end forming said needle tip allowing said sample of body fluid to flow inside said open duct directly from said needle tip to said detection element.

12. A needle according to any of items 1 to 1 1 , wherein said needle further comprises a first electrical contact unit for transferring said first signal to another device.

13. A needle according to item 12, wherein said first electrical contact unit is positioned with a distance to said detection element, and wherein said detection element is electrically connected to said first electrical contact unit. 14. A needle according to any of items 12 to 13, wherein said first electrical contact unit comprises a first electrical contact and a second electrical contact. 15. A needle according to item 14, wherein said first electrical contact is a first electrical contact plane, and said second electrical contact is a second electrical contact plane arranged on said body.

16. A needle according to item 15, wherein said first electrical contact plane, and said second electrical contact plane are arranged on different surfaces of said body.

17. A needle according to any of items 14 to 16, wherein said first electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

18. A needle according to item 17, wherein said third electrical contact is a third electrical contact plane, and said fourth electrical contact is a fourth electrical contact plane arranged on said body.

19. A needle according to item 18, wherein said first electrical contact plane, said second electrical contact plane, said third electrical contact plane, and said fourth electrical contact plane are arranged on different surfaces of said body.

20. A needle according to any of items 1 to 18, wherein said detection element comprises a reactant for reacting with said sample of body fluid to generate said first signal. 21 . A needle according to item 20, wherein said reactant is an

electrochemical reactant that when it comes into contact with said sample of body fluid generates an electrical signal indicative of a physiological parameter.

22. A needle according to any of items 1 to 21 , wherein said detection element is a detection element having a limited reusability e.g. it is a detection element that can be used to make at most 50 distinct

measurements, 20 distinct measurements, 5 distinct measurements, or it is a single use detection element.

23. A needle according to any of items 1 to 22, wherein said needle has a shape and size configured to fit a socket of a needle storage device allowing said needle to be temporarily connected to said needle storage device.

24. A needle according to any of items 12 to 19, wherein said first electrical contact unit is configured to allow a non permanent electrical connection to be made to a second electrical contact unit of a needle storage device so that said needle can be detached from said needle storage device.

25. A needle storage device for storing at least one needle, wherein said needle storage device comprises a first element wherein said first element comprises a first socket for receiving and / or storing a needle, said first socket comprises an first electrical contact unit for aligning with an electrical contact unit of said needle for generating a non-permanent electrical connection with said needle allowing said needle to transfer an electrical signal to said needle storage device and further be discharged after use from said needle storage device.

26. A needle storage device according to item 25, wherein said first socket is configured to hold a needle in a storage position (P1 ) and an activated positioned (P2), wherein said electrical contact unit of the needle is unaligned with the first electrical contact unit of the socket in said storage position (P1 ), and wherein the electrical contact unit of the needle is aligned with the first electrical contact unit of the socket in said activated position (P2) allowing said needle to transfer an electrical signal to said needle storage device. 27. A needle storage device according to any of items 25 to 27, wherein said first electrical contact unit comprises a first electrical contact and a second electrical contact.

28. A needle storage device according to item 27, wherein said first electrical contact is arranged on a first surface of the first socket and the second electrical contact is arranged on a second surface of the first socket,

29. A needle storage device according to item 28, wherein the first surface and the second surface of the first socket is configured to establish a frictional fit with said needle.

30. A needle storage device according to any of items 27 to 29, wherein said first electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

31 . A needle storage device according to item 30, wherein said third electrical contact is arranged on a third surface of the first socket and the fourth electrical contact is arranged on a fourth surface of the first socket. 32. A needle storage device according to item 31 , wherein the first surface, the second surface, the third surface and the fourth surface of the first socket is configured to establish a frictional fit with said at least one needle.

33. A needle storage device according to any of items 25 to 32, wherein the needle storage device further comprises a plurality of sockets for receiving and / or storing a needle. 34. A needle storage device according to item 33, wherein each of the plurality of sockets are of a similar type as the first socket. 35. A needle storage device according to any of items 25 to 34, wherein said first element of said needle storage device comprises a first end for advancing and discharging said at least one needle, and a second end for interacting with a mechanical actuator for advancing and / or discharging said at least one needle.

36. A needle storage device according to item 35, wherein said second end of said first element comprises an opening for receiving said mechanical actuator allowing said mechanical actuator to directly or indirectly push said at least one needle.

37. A needle storage device according to any of items 25 to 36, said first element of said needle storage device further comprises a second electrical contact unit for aligning with an electrical contact unit of another device and/or another element of said needle storage device, said second electrical contact unit is electrically connected with said first electrical contact unit allowing said first element of said needle storage device to transfer an electrical signal from said at least one needle to said other device and/or other element of said needle storage device. 38. A needle storage device according to item 37, wherein said second electrical contact unit comprises a first electrical contact and a second electrical contact.

39. A needle storage device according to item 38, wherein said second electrical contact unit further comprises a third electrical contact and a fourth electrical contact. 40. A needle storage device according to any of items 25 to 36, wherein said first element comprises a plurality of sockets for receiving and / or storing needles, wherein each of the plurality of sockets comprises a first type of electrical contact unit for aligning with an electrical contact unit of a needle.

41 . A needle storage device according to item 40, wherein said needle storage device further comprises a plurality of second type electrical contact units for aligning with electrical contacts of another device and/or another element of said needle storage device, wherein each of the first type electrical contact units is exclusively electrically connected to a single second type electrical contact unit allowing each of said second type of electrical contact units to transfer a signal to another device and/or another element of said needle storage device originating from a single specific needle.

42. A needle storage device according to any of items 25 to 36, wherein said needle storage device further comprises:

• a needle stored in said first socket; and / or

• a needle according to any on items 1 to 24 stored in said first socket; wherein said stored needle comprises an electrical contact unit for aligning with the first electrical contact unit of said first socket.

43. A needle storage device according to item 42, wherein said stored needle is movable arranged in said first socket between a storage position (P1 ) and an activated position (P2), wherein said electrical contact unit of said needle is unaligned with the first electrical contact unit of said first socket and further the needle is completely contained in said first socket when the needle is positioned in said storage position (P1 ), and wherein said electrical contact unit of said needle is aligned with the first electrical contact unit of said first socket and further the needle tip of said needle protrudes from said first socket when said needle is positioned in said activated position (P2) thereby allowing the needle to obtain a sample of body fluid, generate a first signal indicative of a physiological parameter and transfer said first signal to said fist socket when said needle is positioned in said activated position (P2). 44. A needle storage device according to any of items 42 to 43, wherein said first element further comprises a plurality of needles stored in a plurality of sockets.

45. A needle storage device according to any of items 42 to 44, wherein said first element of said needle storage device comprises a first end for advancing and discharging said at least one needle, wherein said first end comprises a protective covering, wherein said protective covering covers the socket / sockets thereby protecting the needle/ needles stored in said socket / sockets, and wherein said stored needle is configured to penetrate said protective covering when it is advanced at least partly out of said socket.

46. A needle storage device according to any of items 25 to 45, wherein said needle storage device is further configured to fit a socket of a medical handheld device allowing said needle storage device to temporally engage with said medical handheld device.

47. A needle storage device according to item 46, wherein said needle storage device further comprises a second electrical contact unit for aligning with an electrical contact unit of said medical handheld device and/or another element of said needle storage device, wherein said first electrical contact unit and said second electrical contact unit are electrically connected so that an electrical signal generated by said at least one needle can be transferred to said medical handheld device and/or another element of said needle storage device through said first element of said needle storage device. 48. A needle storage device according to any of items 25 to 47, said needle storage device further comprises a second element, wherein said second element has a tubular body and surrounds said first element, and wherein said second element comprises a first electrical contact unit arranged to align with the second electrical contact unit of said first element, and wherein said second element further comprises a second electrical contact unit for aligning with an electrical contact unit of another device, wherein said first electrical contact unit and said second electrical contact unit are electrically connected allowing said second element to transfer an electrical signal from said first element to said other device.

49. A needle storage device according to item 48, said first element is rotatably mounted in said second element. 50. A needle storage device according to any of items 48 to 49, wherein said second electrical contact unit of said second element comprises a first electrical contact and a second electrical contact.

51 . A needle storage device according to item 50, wherein said first electrical contact and said second electrical contact of said second electrical contact unit of said second element are formed by a first and a second conductive rod respectively.

52. A needle storage device according to any of items 48 to 52, wherein said second element of said needle storage device is configured to fit a socket of a medical handheld device allowing said needle storage device to temporally engage with said medical handheld device.

53. A needle storage device according to item 52, wherein said second electrical contact unit of said second element is configured to aligning with an electrical contact unit of said medical handheld device so that an electrical signal generated by said at least one needle can be transferred to said medical handheld device through said needle storage device.

54. A handheld medical device for measuring a physiological parameter comprising a socket for receiving and holding a needle or a needle storage device for storing one or more needles, wherein said handheld medical device comprises an first electrical contact unit for aligning with an electrical contact unit of said needle storage device or needle allowing said needle storage device or needle to transfer a first signal indicative of a physiological parameter measured in a sample of body fluid and wherein said handheld medical device further comprises a display for displaying information related to said first signal.

55. A handheld medical device according to item 54, wherein said needle storage device is a needle storage device as describe in any of items 25 to 53.

56. A handheld medical device according to any of items 54 to 55, wherein said handheld medical device further comprises a processing unit connected to said first electrical contact unit and said display, wherein said processing unit is configured to determine a physiological parameter by processing said first signal and further control said display to display said determined physiological parameter. 57. A handheld medical device according to any of items 54 to 56, wherein said socket is configured to hold said needle storage device at different positions, allowing a user to set different needle puncturing depths.

58. A handheld medical device according to any of items 54 to 57, wherein said handheld medical device further comprises a communication unit for communicating with another device. 59. A handheld medical device according to any of items 54 to 58, wherein said handheld medical device further comprises a mechanical actuator for advancing a needle from said needle storage device.

60. Handheld medical device according to any of items 54 to 59, wherein said medical handheld device comprises a needle storage device according to any of items 25 to 53 arranged in said socket. 61 . Use of a needle according to any of items 1 to 24 for measuring a physiological parameter.

62. A method of measuring a physiological parameter on a person

comprising the steps of:

· puncturing the skin of said person using a needle according to any of items 1 to 24;

• obtaining an amount of body fluid using said needle;

wherein said needle generates a first signal indicative of said physiological parameter without the need of additional method steps.

63. A method according to item 62, wherein the step of puncturing the skin further comprises arranging the surface of the skin to face approximately downwards allowing gravitational forces to assist in securing a flow of blood within said needle.

64. A needle for obtaining a sample of blood, wherein said needle comprises an open duct and a needle tip, wherein the average width of the open duct at the top of the open duct is at least 25% of the average depth of the open duct. 65. A needle according to item 64, wherein the average width of the open duct at the top of the open duct is at least 50%, 65%, 80% or 100% of the average depth of the open duct. 66. A needle according to any of items 64 to 65, wherein the needle tip comprises a non-planar outer surface, wherein said non-planar outer surface comprises an outer edge for penetrating the skin and an inner edge interfacing with the open duct, wherein the non-planar outer surface is configured so that, in use, the outer edge comes into contact with the skin of a user before the inner edge comes into contact with the skin of a user independently of the relative orientation between the skin and the needle tip.

67. A needle according to any of items 64 to 66, wherein the average width of the open duct at the top of the open duct is between 0.05 mm and 5mm, between 0.05 mm and 2 mm, between 0.1 mm and 1 mm or between .15 mm and 0.6 mm.

68. A needle according to any of items 64 to 67, wherein the average depth of the open duct is between 0.05 mm and 5mm, between 0.05 mm and 2 mm, between 0.08 mm and 1 mm or between .1 mm and 0.5 mm.

69. A needle according to any of items 64 to 68, wherein the length of the open duct is between 0.5 mm and 5 cm, between 0.1 mm and 2 cm, between 0.5 mm and 1 cm, between 1 mm and 8 mm or between 1 .5 mm and 5 mm.

70. A needle according to any of items 64 to 69, wherein the needle has a length between 1 mm and 10 cm, between 2mm and 7 cm, between 5 mm and 5 cm, or between 8 mm and 3 cm.

Claims

Claims:

• a needle tip for obtaining said sample of body fluid;

• a detection element for generating said first signal;

• a body comprising a sampling cavity; and

• a duct for transporting said sample of body fluid from said needle tip towards said detection element

wherein said needle is configured to directly transfer said sample of body fluid to said detection element, allowing said detection element to generate said first signal, characterized in that said detection element is positioned at the bottom of the sampling cavity, said needle further comprises a ramp connecting said duct with said sampling cavity, and wherein the width of the sampling cavity at the part where the detection element is positioned is larger than the average width of the duct and the height of the sampling cavity at the part where the detection element is positioned is larger than the average height of the duct.

2. A needle according to claim 1 , wherein the duct is an open duct.

3. A needle according to claim 2, wherein the width of the sampling cavity at the part where the detection element is positioned is at least 1 .5 times larger than the average width of the open duct, and the height of the sampling cavity at the part where the detection element is positioned is at least 1 .5 times larger than the average height of the open duct.

4. A needle according to claims 2 or 3, wherein the bottom of the open duct is positioned in a first plane, and the bottom of the sampling cavity is positioned in a second plan, said second plane being perpendicular with said first plane, wherein the distance between said first plane and said second plane is at least X, wherein 15%, 25%, 35% or 40% of the height of the body.

5. A needle according to any one of claims 2 to 4, wherein the angle between the central axis of the open duct and the central axis of the ramp is between 95 degrees and 175 degrees.

6. A needle according to any one of claims 2 to 5, wherein said open duct is at least partly covered with a coating for reducing the frictional force induced by the walls of the open duct on the sample of body fluid.

7. A needle according to any one of claims 1 to 6, wherein a cross-section of said body along a plane being perpendicular to a longitudinal axis of said needle has a polygonal shape e.g. a triangular, a rectangular, pentagonal, or hexagonal shape.

8. A needle according to any of claims 1 to 7, wherein said needle tip is a needle tip for penetrating the skin of a person.

9. A needle according to any of claims 1 to 8, wherein said body fluid blood.

10. A needle according to any of claims 1 to 9, wherein said physiological parameter is blood glucose and wherein said detection element is a blood glucose detection element.

1 1 . A needle according to any of claims 1 to 10, wherein said open duct has a wedge shape at its distal end forming said needle tip allowing said sample of body fluid to flow inside said open duct directly from said needle tip to said detection element.

12. A needle according to any of claims 1 to 1 1 , wherein said needle further comprises a first electrical contact unit for transferring said first signal to another device.

13. A needle according to claim 12, wherein said first electrical contact unit is positioned with a distance to said detection element, and wherein said detection element is electrically connected to said first electrical contact unit.

14. A needle according to any of claims 12 to 13, wherein said first electrical contact unit comprises a first electrical contact and a second electrical contact.

15. A needle according to claim 14, wherein said first electrical contact is a first electrical contact plane, and said second electrical contact is a second electrical contact plane arranged on said body.

16. A needle according to claim 15, wherein said first electrical contact plane, and said second electrical contact plane are arranged on different surfaces of said body.

17. A needle according to any of claims 14 to 16, wherein said first electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

18. A needle according to claim 17, wherein said third electrical contact is a third electrical contact plane, and said fourth electrical contact is a fourth electrical contact plane arranged on said body.

19. A needle according to claim 18, wherein said first electrical contact plane, said second electrical contact plane, said third electrical contact plane, and said fourth electrical contact plane are arranged on different surfaces of said body.

20. A needle according to any of claims 1 to 19, wherein said detection element comprises a reactant for reacting with said sample of body fluid to generate said first signal.

21 . A needle according to claim 20, wherein said reactant is an

22. A needle according to any of claims 1 to 21 , wherein said detection element is a detection element having a limited reusability e.g. it is a detection element that can be used to make at most 50 distinct

23. A needle according to any of claims 1 to 22, wherein said needle has a shape and size configured to fit a socket of a needle storage device allowing said needle to be temporarily connected to said needle storage device.

24. A needle according to any of claims 12 to 19, wherein said first electrical contact unit is configured to allow a non permanent electrical connection to be made to a second electrical contact unit of a needle storage device so that said needle can be detached from said needle storage device.

25. A needle storage device for storing a plurality of needles, wherein said needle storage device comprises a first element comprising a plurality of sockets for receiving and / or storing a needle and wherein a first socket of said plurality of sockets comprises a first electrical contact unit for aligning with an electrical contact unit of said needle for generating a non-permanent electrical connection with said needle allowing said needle to transfer an electrical signal to said needle storage device and further be discharged after use from said needle storage device.

26. A needle storage device according to claim 25, wherein said first socket is configured to hold a needle in a storage position (P1 ) and an activated positioned (P2), wherein said electrical contact unit of the needle is unaligned with the first electrical contact unit of the socket in said storage position (P1 ), and wherein the electrical contact unit of the needle is aligned with the first electrical contact unit of the socket in said activated position (P2) allowing said needle to transfer an electrical signal to said needle storage device.

27. A needle storage device according to any of claims 25 to 27, wherein said first electrical contact unit comprises a first electrical contact and a second electrical contact.

28. A needle storage device according to claim 27, wherein said first electrical contact is arranged on a first surface of the first socket and the second electrical contact is arranged on a second surface of the first socket,

29. A needle storage device according to claim 28, wherein the first surface and the second surface of the first socket is configured to establish a frictional fit with said needle.

30. A needle storage device according to any of claims 27 to 29, wherein said first electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

31 . A needle storage device according to claim 30, wherein said third electrical contact is arranged on a third surface of the first socket and the fourth electrical contact is arranged on a fourth surface of the first socket.

32. A needle storage device according to claim 31 , wherein the first surface, the second surface, the third surface and the fourth surface of the first socket is configured to establish a frictional fit with said at least one needle.

33. A needle storage device according to claims 29 or 32, wherein the frictional fit has a strength securing that the needle does not slide out of the first socket unintentionally.

34. A needle storage device according to any of claims 25 to 33, wherein each of the plurality of sockets are of a similar type as the first socket.

35. A needle storage device according to any of claims 25 to 34, wherein said first element of said needle storage device comprises a first end for advancing and discharging said at least one needle, and a second end for interacting with a mechanical actuator for advancing and / or discharging said at least one needle.

36. A needle storage device according to claim 35, wherein said second end of said first element comprises an opening for receiving said mechanical actuator allowing said mechanical actuator to directly or indirectly push said at least one needle.

37. A needle storage device according to any of claims 25 to 36, wherein said first element of said needle storage device further comprises a second electrical contact unit for aligning with an electrical contact unit of another device and/or another element of said needle storage device, said second electrical contact unit is electrically connected with said first electrical contact unit allowing said first element of said needle storage device to transfer an electrical signal from said at least one needle to said other device and/or other element of said needle storage device.

38. A needle storage device according to claim 37, wherein said second electrical contact unit comprises a first electrical contact and a second electrical contact.

39. A needle storage device according to claim 38, wherein said second electrical contact unit further comprises a third electrical contact and a fourth electrical contact.

40. A needle storage device according to any of claims 25 to 36, wherein said first element comprises a plurality of sockets for receiving and / or storing needles, wherein each of the plurality of sockets comprises a first type of electrical contact unit for aligning with an electrical contact unit of a needle.

41 . A needle storage device according to claim 40, wherein said needle storage device further comprises a plurality of second type electrical contact units for aligning with electrical contacts of another device and/or another element of said needle storage device, wherein each of the first type electrical contact units is exclusively electrically connected to a single second type electrical contact unit allowing each of said second type of electrical contact units to transfer a signal to another device and/or another element of said needle storage device originating from a single specific needle.

42. A needle storage device according to any of claims 25 to 36, wherein said needle storage device further comprises:

· a needle stored in said first socket; and / or

• a needle according to any on claims 1 to 24 stored in said first socket; wherein said stored needle comprises an electrical contact unit for aligning with the first electrical contact unit of said first socket.

43. A needle storage device according to claim 42, wherein said stored needle is movable arranged in said first socket between a storage position (P1 ) and an activated position (P2), wherein said electrical contact unit of said needle is unaligned with the first electrical contact unit of said first socket and further the needle is completely contained in said first socket when the needle is positioned in said storage position (P1 ), and wherein said electrical contact unit of said needle is aligned with the first electrical contact unit of said first socket and further the needle tip of said needle protrudes from said first socket when said needle is positioned in said activated position (P2) thereby allowing the needle to obtain a sample of body fluid, generate a first signal indicative of a physiological parameter and transfer said first signal to said fist socket when said needle is positioned in said activated position (P2).

44. A needle storage device according to any of claims 42 to 43, wherein said first element further comprises a plurality of needles stored in a plurality of sockets.

45. A needle storage device according to any of claims 42 to 44, wherein said first element of said needle storage device comprises a first end for advancing and discharging said at least one needle, wherein said first end comprises a protective covering, wherein said protective covering covers the socket / sockets thereby protecting the needle/ needles stored in said socket / sockets, and wherein said stored needle is configured to penetrate said protective covering when it is advanced at least partly out of said socket.

46. A needle storage device according to any of claims 25 to 45, wherein said needle storage device is further configured to fit a socket of a medical handheld device allowing said needle storage device to temporally engage with said medical handheld device.

47. A needle storage device according to claim 46, wherein said needle storage device further comprises a second electrical contact unit for aligning with an electrical contact unit of said medical handheld device and/or another element of said needle storage device, wherein said first electrical contact unit and said second electrical contact unit are electrically connected so that an electrical signal generated by said at least one needle can be transferred to said medical handheld device and/or another element of said needle storage device through said first element of said needle storage device.

48. A needle storage device according to any of claims 25 to 47, said needle storage device further comprises a second element, wherein said second element has a tubular body and surrounds said first element, and wherein said second element comprises a first electrical contact unit arranged to align with the second electrical contact unit of said first element, and wherein said second element further comprises a second electrical contact unit for aligning with an electrical contact unit of another device, wherein said first electrical contact unit and said second electrical contact unit are electrically connected allowing said second element to transfer an electrical signal from said first element to said other device.

49. A needle storage device according to claim 48, said first element is rotatably mounted in said second element.

50. A needle storage device according to any of claims 48 to 49, wherein said second electrical contact unit of said second element comprises a first electrical contact and a second electrical contact.

51 . A needle storage device according to claim 50, wherein said first electrical contact and said second electrical contact of said second electrical contact unit of said second element are formed by a first and a second conductive rod respectively.

52. A needle storage device according to any of claims 48 to 52, wherein said second element of said needle storage device is configured to fit a socket of a medical handheld device allowing said needle storage device to temporally engage with said medical handheld device.

53. A needle storage device according to claim 52, wherein said second electrical contact unit of said second element is configured to aligning with an electrical contact unit of said medical handheld device so that an electrical signal generated by said at least one needle can be transferred to said medical handheld device through said needle storage device.

54. A handheld medical device for measuring a physiological parameter comprising a socket for receiving and holding needle storage device for storing one or more needles, wherein said handheld medical device comprises a first electrical contact unit for aligning with an electrical contact unit of said needle storage device allowing said needle storage device to transfer a first signal indicative of a physiological parameter measured in a sample of body fluid and wherein said handheld medical device further comprises a display for displaying information related to said first signal.

55. A handheld medical device according to claim 54, wherein said needle storage device is a needle storage device as describe in any of claims 25 to 53.

56. A handheld medical device according to any of claims 54 to 55, wherein said handheld medical device further comprises a processing unit connected to said first electrical contact unit and said display, wherein said processing unit is configured to determine a physiological parameter by processing said first signal and further control said display to display said determined physiological parameter.

57. A handheld medical device according to any of claims 54 to 56, wherein said socket is configured to hold said needle storage device at different positions, allowing a user to set different needle puncturing depths.

58. A handheld medical device according to any of claims 54 to 57, wherein said handheld medical device further comprises a communication unit for communicating with another device.

59. A handheld medical device according to any of claims 54 to 58, wherein said handheld medical device further comprises a mechanical actuator for advancing a needle from said needle storage device.

60. Handheld medical device according to any of claims 54 to 59, wherein said medical handheld device comprises a needle storage device according to any of claims 25 to 53 arranged in said socket.

61 . Use of a needle according to any of claims 1 to 24 for measuring a physiological parameter.

62. A method of measuring a physiological parameter on a person comprising the steps of:

• puncturing the skin of said person using a needle according to any of claims 1 to 24;

• obtaining an amount of body fluid using said needle;

63. A method according to claim 62, wherein the step of puncturing the skin further comprises arranging the surface of the skin to face approximately downwards allowing gravitational forces to assist in securing a flow of blood within said needle.

64. A needle for obtaining a sample of blood, wherein said needle comprises an open duct and a needle tip, wherein the average width of the open duct at the top of the open duct is at least 25% of the average depth of the open duct.

65. A needle according to claim 64, wherein the average width of the open duct at the top of the open duct is at least 50%, 65%, 80% or 100% of the average depth of the open duct.

66. A needle according to any of claims 64 to 65, wherein the needle tip comprises a non-planar outer surface, wherein said non-planar outer surface comprises an outer edge for penetrating the skin and an inner edge interfacing with the open duct, wherein the non-planar outer surface is configured so that, in use, the outer edge comes into contact with the skin of a user before the inner edge comes into contact with the skin of a user independently of the relative orientation between the skin and the needle tip.

67. A needle according to any of claims 64 to 66, wherein the average width of the open duct at the top of the open duct is between 0.05 mm and 5mm, between 0.05 mm and 2 mm, between 0.1 mm and 1 mm or between .15 mm and 0.6 mm.

68. A needle according to any of claims 64 to 67, wherein the average depth of the open duct is between 0.05 mm and 5mm, between 0.05 mm and 2 mm, between 0.08 mm and 1 mm or between .1 mm and 0.5 mm.

69. A needle according to any of claims 64 to 68, wherein the length of the open duct is between 0.5 mm and 5 cm, between 0.1 mm and 2 cm, between 0.5 mm and 1 cm, between 1 mm and 8 mm or between 1 .5 mm and 5 mm.

70. A needle according to any of claims 64 to 69, wherein the needle has a length between 1 mm and 10 cm, between 2mm and 7 cm, between 5 mm and 5 cm, or between 8 mm and 3 cm.