FR3131684A1 - Secure blood glucose meter - Google Patents

Abstract

The present invention relates to a sample collection device, from a septum (100), comprising a hollow body (4) receiving a needle (2) fixedly mounted on a support (20) and a reservoir (3) internal connected to said needle (2) facing a first end (40) of said body (4), gripping means (5) located at an opposite end of said body (4); characterized in that at least said support (20) is placed inside said body (4), said needle (2) being entirely contained inside said body (4) which comprises at its first end (40), an open housing (41) providing an interior space for receiving said septum (100), said needle (2) communicating with said interior space of said housing (41).The invention also relates to the use of the sampling device (1) according to the invention, to take a sample from a septum (100), advantageously to measure and quantify a compound present in said sample taken. Figure 3

Description

Secure blood glucose meter

The subject of the present invention is a medical device and its use in vitro in the examination of fluid samples from the human body, in particular blood samples.
Technical field of the invention

The present invention enters the medical field of taking samples of bodily fluids, in particular blood samples.

The invention will find a preferential application, but in no way limiting, in the measurement and quantification in vitro of a compound present in said sample taken, such as the blood sugar level.

The invention preferably aims at taking samples from a septum. Such a septum may be present on an extracorporeal circuit, or connected to another medical system, such as for example a urinary catheter.

Let us recall, within the meaning of the present invention, the term “septum” corresponds to a self-sealing membrane, generally made of silicone material, hermetically separating and preserving from the external atmosphere, the interior of a circuit connected to the human body. , particularly to its vascular system. The material and thickness of such a septum allow it to be pierced by a needle, and above all to maintain its airtight nature once the needle is removed. Thus, it is possible in an aseptic manner to administer solutions and, more particularly, to take samples, in particular blood samples.

Such a septum can be mounted along an extracorporeal circuit in the form of sheaths, or directly at one end of a catheter.

In this context, currently, blood sampling, several milliliters, from an extracorporeal circuit is carried out by a caregiver using a needle mounted on a syringe. It may be a transfer trocar, commonly referred to as a “pink trocard” (because of its distinctive color differentiating the use for sampling, compared to other colors intended for injection), or even “ trocard G18” (with regard to the dimensions of its gauge, namely the unit expressing the external diameter of a medical device). It can also be an “orange” needle, also called a “G25 needle”.

Once the sample has been taken by piercing the septum, the caregiver places a droplet of blood on a suitable support, such as a blood sugar test strip intended to be analyzed in vitro by a dedicated device.

Such a practice presents significant risks for both the caregiver and the patient.

First of all, for the caregiver, there is a risk of skin breakage by pricking themselves with the protruding needle, during its handling, particularly when the needle must be uncapped manually, or after sampling when it is pier. It is also possible to accidentally prick the patient.

Furthermore, when depositing the droplet of blood, especially by means of a syringe, there is a risk of blood splashing, particularly in contact with mucous membranes, such as the eyes, likely to induce contamination.

This medical procedure therefore presents a clear lack of safety for the caregiver, without certainty ensuring the asepsis of such a medical procedure.

In addition, the quantity of blood collected, several milliliters (symbol “ml”), is much greater than the actual requirements for the measurements and quantifications envisaged, namely a simple drop of blood of the order of 1/20 ml.
Presentation of the invention

The aim of the invention is to overcome the drawbacks of the state of the art by proposing a device for taking a sample from a septum. Such a sampling device is intended to ensure safety avoiding any risk of involuntary prick, by means of a needle provided retracted inside a body of said sampling device.

In addition, the needle is mounted movable from an inactive position enclosed inside said body, to a protruding active position with a view to taking the sample, while always being entirely contained in said body, and vice versa.

To do this, the sampling device includes:
- a needle mounted on a support,
- an internal reservoir connected to said needle,
- a hollow body receiving said support and said reservoir, said needle being oriented towards a first end of said body,
- gripping means located at an opposite end of said body.

Advantageously, said sampling device is characterized in that at least:
- said support is placed inside said body, said needle being entirely contained inside said body, and
- said body comprising at its first end, an open housing, said housing providing an interior space for receiving said septum, said needle communicating with said interior space of said housing.

According to additional, non-limiting characteristics, said support is mounted movable relative to said body, from an inactive position of said needle retracted relative to said housing, towards a protruding active position inside the interior volume of said housing, and vice versa.

According to one embodiment, said support is slidably mounted inside said body.

According to one embodiment, said support is actuated by movement in support of said gripping means provided movable relative to said opposite end of said body, the movement of said gripping means taking place simultaneously by application of pressure against said opposite end and a traction of said gripping means towards said opposite end, relatively to each other.

According to one embodiment, said reservoir forms said opposite end of said sampling device.

According to one embodiment, said sampling device comprises a member mounted inside said reservoir, like a piston actuated by said gripping means.

According to one embodiment, said sampling device comprises elastic return means from the active position to the inactive position.

According to one embodiment, said body comprises a window, while said tank comprises a through orifice, said window and said orifice being located opposite each other in the active position or in the inactive position.

Furthermore, in the protruding position, the needle communicates with a reservoir making it possible to recover a dedicated quantity of the sample taken, said reservoir being accessible through a window provided through said body. This communication avoids any risk of contact for the caregiver with the sample taken, as well as preventing any external contamination.

The invention also relates to the use of the sampling device according to the invention, to take a sample from a septum present on an extracorporeal circuit or on another medical system, such as a probe, preferably, to measure and quantifying a compound present in said sample taken, more preferably to measure the blood glucose level.

In particular, the invention relates to the use of the sampling device to collect a sample of body fluid from a septum.

According to a non-limiting embodiment, the invention aims at the use for taking a blood sample from a septum present on an extra-corporeal circuit.

According to one embodiment, the use aims to measure and quantify a compound present in said blood sample taken.

According to one embodiment, the use aims to measure the blood sugar level in said blood sample taken.

According to another embodiment, the use aims to measure the hemoglobin level in said blood sample taken.

Thus, the sampling device according to the invention improves the care of patients, by promoting a clean and sterile medical procedure, without any risk of accident, including for the caregiver, avoiding for example the risks of work accidents. Virus Exposure (AEV) or Blood Exposure Accidents (AES).

Furthermore, in the context of a sample for the purpose of quantifying blood sugar, the invention complies with the standards in force for capillary blood glucose, authorizing the use of capillary blood sugar diagnostic devices.
Presentation of the drawings

Other characteristics and advantages of the invention will emerge from the detailed description which follows of the non-limiting embodiments of the invention, with reference to the appended figures, in which:

schematically represents a perspective view of one embodiment of a sampling device according to the invention, in the active position, showing in particular a slot formed in the body of said device;

schematically represents a perspective view of another embodiment of said sampling device, in the inactive position;

schematically represents an exploded perspective view of the , showing in particular the different parts of said sampling device;

schematically represents a view in a longitudinal median section of an embodiment of the sampling device, showing in a partially exploded manner the different separate elements of said sampling device;

schematically represents a view in a longitudinal median section of an embodiment of the sampling device, in the inactive position;

schematically represents a view similar to the , in active position; And

schematically represents a simplified view in a longitudinal median section of said sampling device, in active position in cooperation with a septum of an extra-corporeal circuit, showing in particular the flow of blood from said circuit to a reservoir.
detailed description

The invention relates to a device 1 for collecting a body fluid sample, in particular a blood sample, also called a “sampler”.

The invention specifically targets a sampling device 1 made from a septum 100. Such a septum 100 equips a medical system, such as an extra-corporeal circuit 101, or even a probe, as mentioned above. Such a septum 100 is visible in the example of implementation of the .

Advantageously, the sampling device 1 comprises a needle 2 mounted for fixing on a support 20. The needle 2 is therefore integral with its support 20.

More precisely, in a non-limiting manner, the needle 2 is attached to one face of the support 20, called the “lower face” relative to the orientation of the sampling device 1 during its use, namely downwards in reference to Figures 4 to 7. Needle 2 is hollow, in the form of a tube. The needle 2 extends projecting from this lower face and passes through the wall of said lower face. The protruding end 200 of said needle 2 includes a bevel, giving it a perforating or pricking capacity. The opposite end 201 of the needle 2 therefore opens out on the other side of the support 20 with respect to the lower face, namely on the side of the so-called “upper” face.

Said needle 2 can be of any type, preferably hypodermic, suitable for taking samples. According to one embodiment, the needle 2 is identical to that of a transfer trocar or "trocar" or even "trocard", commonly referred to as "pink trocard" (because of its distinctive color differentiating the use for sampling , compared to other colors intended for injection), or even “G18 trocard” (with regard to the dimensions of its gauge, namely the unit expressing the external diameter of a medical device).

According to another particularly preferred embodiment, needle 2 is identical to that of an “orange needle”, also designated “G25 needle”.

According to another particularly preferred embodiment, the needle 2 is a heparinized or anticoagulated needle, making it possible to leave the secure sampling device 1 in place for a few hours on the extracorporeal circuit.

Furthermore, said support 20 can have any shape. According to the embodiment visible in the figures, said support 20 preferably has a generally cylindrical shape, with a circular section. The lower face has a step 21, within which the needle 2 is sealed over part of its length, ensuring its maintenance.

According to one embodiment, the needle 2 and its support 20 form a removable tip relative to the sampling device 1, allowing it to be replaced for and according to each use.

The sampling device 1 also includes an internal reservoir 3, designed to collect the sample taken. To do this, the internal reservoir 3 is connected to said needle 2.

More precisely, in a non-limiting manner, said internal reservoir 3 comprises walls delimiting a planned interior volume 30 communicating with the needle 2. In particular, the opposite end 201 of the needle 2 is connected to the interior volume 30 of said reservoir 3 via a channel 31 provided within the corresponding wall of said reservoir 3, namely the wall located on the side of said tip (needle 2 and support 20), or even the wall located lower. Furthermore, the interior of the channel 31 is dimensioned to receive said end 201 of the needle 2, namely with an internal diameter greater than or substantially equal to the clearance relative to the external diameter of said needle 2.

According to one embodiment, in particular visible in Figures 4 to 7, the reservoir 3 comprises a distal part 32 shaped to cooperate in nesting with a complementary space 22 provided within said support 20. Thus, the support 20 can be engaged on the reservoir 3, ensuring removable maintenance of one relative to the other, as well as the connection of the needle 2 to the interior volume 30 for the circulation of the sampling fluid.

Further, the sampling device 1 comprises a hollow body 4 receiving said support 20 and said reservoir 3. In addition, the shape and internal dimensions of said body 4 are provided complementary, with respect to the external dimensions of said reservoir 3, as well as the tip.

Said body 4 can have any shape, preferably a cylindrical shape. The body 4 has an opening at its opposite end, namely the upper end or located upwards. This opening allows the insertion of the other elements inside the sampling device 1.

Furthermore, once positioned inside, said needle 2 is oriented towards a first end 40 of said body 4, namely its lower end or located downwards. In other words, the insertion of the reservoir 3 and the tip is carried out so as to orient the pointed end 200 of the needle 2 towards said first end 40.

According to an advantageous characteristic, the sampling device 1 provides at least that when said support 20 is placed inside said body 4, said needle 2 is entirely contained inside said body 4. In short, no part of the needle 2 does not protrude beyond the walls delimiting said body 4, in particular its sharp end 200. Thus, it is not possible for a user to inadvertently prick themselves, ensuring a clean and sterile medical procedure, without any risk of accident, for both the caregiver and the patient.

Further forward, the sampling device 1 comprises gripping means 5 located at an opposite end of said body 4. Said gripping means 5, located on the proximal side of the body 4, allow the caregiver to hold it with a view to removing it. use of the sampling device 1.

Said gripping means 5 can have any shape. As visible in the example of realization of the , the gripping means 5 can be in the form of a simple ring, while they can include fins 50, as visible in the example of embodiment of the .

According to an advantageous characteristic, the sampling device 1 provides at least that said body 4 comprises at its first end 40, an open housing 41. In addition, said housing 41 provides an interior space for receiving said septum 100. In other words, said housing 41 has a shape complementary to that of the septum 100, namely preferably generally cylindrical. In addition, the internal dimensions of the housing 41 are shaped complementary to the external dimensions of said septum 100, so as to allow the sampling device 1 to be positioned on the septum 100, encompassing said septum 100 partially within said housing 41, in the body 4. Such a configuration of the sampling device 1 on the septum 100 is particularly visible on the .

In addition, said needle 2 communicates with said interior space of said housing 41. In short, the housing 41 comprises a passage allowing the needle 2, in particular its perforating end 200, to penetrate inside.

Such a passage can be in the form of a hole 42 provided passing through the bottom 43 of said housing 41. Furthermore, said hole 42 is shaped complementary to receive the end piece, in particular the step 21 of the support 20 located inside said body 4.

Thus, the needle 2 communicating inside the housing 41, said needle 2 can perforate the septum 100 introduced within said housing 41, until reaching the interior of the extra-corporeal circuit 101, allowing the fluid from the sample to circulate up to the internal volume 30 of said tank 3, as in particular visible on the .

According to a preferred embodiment, said support 20 is mounted movable relative to said body 4, from an inactive position of said needle 2 retracted relative to said housing 41, towards a protruding active position inside the interior volume of said housing 41, and vice versa. In short, said support 20 moves inside the body 4, along a path extending from said inactive position to said active position.

Furthermore, in the inactive position, as visible in the example of the , the perforating end 200 is essentially contained inside the hole 42 passing through the housing 41, its tip being flush with said bottom 43. Due to the dimensions of said housing 41, it is then not possible to introduce there by inadvertently a body part likely to enter, such as the distal phalanx of a finger.

In active position, as visible in the example of the , the needle 2 is deployed, but still contained inside the body 4, not protruding outside the housing 41. It is then not possible to inadvertently prick an essentially flat body part, such as the caregiver's skin or the patient.

According to one embodiment, said support 20 is slidably mounted inside said body 4. In fact, as the end piece is mounted on the reservoir 3, said reservoir 3 is jointly slidably mounted inside said body 4 .

In particular, the external dimensions of said tank 3 correspond, to the nearest clearance, to the internal dimensions of said body 4, ensuring sliding of one relative to the other. In short, said body 4 forms a sheath for guiding the translation of said tank 3 in its stroke, namely a downward vertical translation from the inactive position to the active position (from top to bottom), and conversely an upward vertical translation from the active position to inactive position (from bottom to top).

Further, the actuation of the sampling device 1 is carried out by pressing on the reservoir 3, manually allowing the support 20 to be moved jointly from the inactive position to the active position.

According to one embodiment, this support can be provided by the application of the sampling device 1 in contact with the septum 100, at the time of its insertion into said housing 41. In short, the septum 100 forms a stop at the time of application of said sampling device 1, blocking the body 4, only allowing the movement of said reservoir 3 under the action of said support.
Preferably, said support 20 is actuated by movement in support of said gripping means 5 provided to move relative to the opposite end of said body 4.

In addition, the movement of said gripping means 5 takes place simultaneously by applying pressure against said opposite end and traction of said gripping means 5 towards said opposite end, relative to each other. other. In short, a pinching gesture between the gripping means 5 and the opposite end of said body 4, reflects a thrust pressing against the reservoir 3, which then moves in translation from the inactive position to the active position.

According to one embodiment, said reservoir 3 forms said opposite end of said sampling device 1, namely the upper end or located upwards. In short, the tank 3 protrudes from the body 4 at this upper end.
In particular, as visible in the figures, the sampling device 1 comprises a cover 6 ensuring the closure of the body 4, in particular by covering the corresponding end of said reservoir 3. It is then advantageously against said cover 6 that the support takes place, as well as possibly pinching of said gripping means 5.

Such a cover 6 can have any shape, in particular an ergonomic shape, for example with a concave external face, allowing in particular the support of the pulp of the thumb, while the rest of the body 4, in particular the gripping means 5, are held by the other fingers of the caregiver's hand.

Further forward, the gripping means 5 can have a vertical section generally shaped like a T, with lateral branches 51 connected to a middle part 52. From then on, the reservoir 3 internally receives the gripping means 5.
In addition, the reservoir 3 comprises laterally perforated walls 33, allowing the movement of the lateral branches 51 of the gripping means 5. Such perforated walls 33 are provided in a complementary manner with respect to said branches 51, authorizing their vertical movement during the movement induced on said gripping means 5.

According to one embodiment, the sampling device 1 comprises a member 7 mounted inside said reservoir 3, in the manner of a piston actuated by said gripping means 5. The member 7 is therefore mobile relative to said reservoir 3, in particular in a vertical translation.

Furthermore, the member 7 can have any shape, in particular a cylindrical shape with a vertical section generally shaped in a U, complementary to internally receiving the middle part 52 of said gripping means 5.

Further forward, the member 7 may comprise a ring 70, ensuring its closure in the open upper part of its U-shape. This ring 70 fits onto the distal ends of the branches of the U-shape.

In addition, said ring 70 is crossed by the middle part 52 of the gripping means 5, while the branches 51 remain outside.

According to a preferred embodiment, the ring 70 has an annular shape with an oblong hole, allowing the passage of the distal end of the middle part 52, shaped complementary to a lug 53. This lug 53 projects laterally, on both sides. other of said middle part 52.

Thus, combined with the complementary oblong hole of the ring 70, the shape of the lug 53 ensures in an angular configuration the insertion of the middle part 52 inside said member 7, as well as its blocking in another angular configuration , like a key. In said other angular configuration, the gripping means 5 therefore find themselves entangled with the member 7, the lug 53 being retained by the lower face of said ring 70, preventing their disassembly of these elements one from the other . This other configuration nevertheless allows the sliding of the middle part 52 and therefore of the gripping means 5 relative to the member 7. In particular, as visible in the example of the , in the inactive position, the gripping means 5 are in the low position, the middle part 52 finding itself abutting in the bottom of said member 7, while after support, in the active position, the lug 53 abuts against the ring 70, as visible in the example of the . At this moment, the member 7 moves within the reservoir 3, applying a positive pressure to the fluid of the sample taken, due to joint movement of the needle 2. This is how the movements of the assembly of these elements are similar to the operation of a piston.

In particular, the piston effect makes it possible to create a positive pressure within the reservoir 3, necessary at the start of sampling when the needle 2 is plunged through the septum 100, to attract the fluid, for example blood, towards the tank 3.

Further, the return from the active position to the inactive position can be carried out in any case, in particular manually. In particular, it is possible to dismantle the elements of the sampling device 1, with a view to cleaning and sanitizing it, as well as replacing the tip, namely the needle 2 secured to its support 20.

According to one embodiment, not shown, the sampling device 1 comprises elastic return means from the active position to the inactive position. Such elastic return means can be of any type, in particular a spring, preferably compression; said spring is then positioned, between at least two corresponding elements within the sampling device 1, to be compressed when moving to the active position and ensure the automatic return to the inactive position.

Preferably, the return to the inactive position can take place by the positive pressure applied inside the reservoir 3 when it contains the fluid of a sample taken.

Once the sample has been taken, the sampling device 1 allows an in vitro test to be carried out on the sample taken.

To do this, a measuring means 102 is positioned to allow contact with the sample taken and contained in the sampling device 1. Such measuring means 102 can be of any type, in particular in the form of a paper dedicated to the absorption of said fluid from the sample, such as for example a test strip, in particular a blood sugar or rate test strip. hemoglobin, intended to be analyzed by a dedicated device.

Further, the deposit of part of the sample taken can be carried out via the perforating end 200 of the needle 2, by positioning the measuring means 102 under the sampling device 1 and applying pressure on the upper end, allowing the deposit of one or more droplets of blood on said measuring means 102.

According to a preferred embodiment, said body 4 comprises a window 44, while said tank 3 comprises a through orifice 34. In addition, said window 44 and said orifice 34 are located opposite each other in the active position or in the inactive position, preferably in the active position. In short, the window 44 and the orifice 34 find themselves aligned in an active or inactive position of the sampling device 1, providing a communication path between the internal volume 30 of said reservoir 3 and the exterior of said body 4.

Thus, it is possible to bring the measuring means 102 near the window 44, so that it comes into contact with the fluid of the sample taken, contained in the reservoir 3 and accessible via the orifice 34.

Such operation limits the risks of contact with the sample taken, in particular Virus Exposure Accidents (AEV) or Blood Exposure Accidents (AES).

The invention also relates to the use of the sampling device 1, according to one or other of the aforementioned embodiments, to take a sample of body fluid from a septum 100, preferably a blood sample. from a septum 100 present on an extra-corporeal circuit 101.

According to one mode of implementation, the use makes it possible to measure and quantify in vitro a compound present in said sample taken, preferably in said blood sample taken.

According to one mode of implementation, the use makes it possible to measure the blood sugar level in said blood sample taken.
In the context of a sample for the purpose of quantifying blood sugar, the use of the sampling device 1 complies with the standards in force for capillary blood glucose, authorizing the use of capillary blood glucose diagnostic devices.

According to another embodiment, the use makes it possible to measure the hemoglobin level in said blood sample taken.

Thus, the sampling device 1 according to the invention improves patient care, by promoting a clean and sterile medical procedure, with easy and risk-free handling.

In addition, the quantity of fluid, preferably blood, collected is minimal and perfectly suited to the intended uses.

Claims (12)

Device (1) for taking a sample, from a septum (100), comprising:
- a needle (2) mounted to fix on a support (20),
- an internal reservoir (3) connected to said needle (2),
- a hollow body (4) receiving said support (20) and said reservoir (3), said needle (2) being oriented towards a first end (40) of said body (4),
- gripping means (5) located at an opposite end of said body (4);
characterized in that at least:
- said support (20) is placed inside said body (4), said needle (2) being entirely contained inside said body (4), and
- said body (4) comprising at its first end (40), an open housing (41), said housing (41) providing an interior space for receiving said septum (100), said needle (2) communicating with said interior space of said housing (41). Sampling device (1) according to claim 1, characterized in that said support (20) is mounted movable relative to said body (4), from an inactive position of said needle (2) retracted relative to said housing (41), towards a protruding active position inside the interior volume of said housing (41), and vice versa. Sampling device (1) according to claim 2, characterized in that said support (20) is slidably mounted inside said body (4). Sampling device (1) according to one of the preceding claims, characterized in that said support (20) is actuated by movement in support of said gripping means (5) provided movable relative to said opposite end of said body (4), the movement of said gripping means (5) taking place simultaneously by applying pressure against said opposite end and traction of said gripping means (5) towards said opposite end, in a relative manner relative to the 'other. Sampling device (1) according to one of the preceding claims, characterized in that said reservoir (3) forms said opposite end of said sampling device (1). Sampling device (1) according to one of the preceding claims, characterized in that it comprises a member (7) mounted inside said reservoir (3), in the manner of a piston actuated by said means ( 5) gripping. Sampling device (1) according to one of claims 2 to 6, characterized in that it comprises elastic return means from the active position to the inactive position. Sampling device (1) according to one of claims 2 to 7, characterized in that said body (4) comprises a window (44), while said reservoir (3) comprises a through orifice (34), said window ( 34) and said orifice (44) located opposite each other in the active position or in the inactive position. Use of the sampling device (1) according to one of the preceding claims, for taking a sample of body fluid from a septum (100). Use according to claim 9, for taking a blood sample from a septum (100) present on an extracorporeal circuit (101). Use according to claim 10, for measuring and quantifying a compound present in said collected blood sample. Use according to claim 11, for measuring the blood sugar level or hemoglobin in said blood sample taken.