Blood venous puncture head for automatic or semi-automatic blood sampling device

Abstract

The present invention relates to a blood piercing head (8) for a mechatronic assembly, such as a robotically controlled arm of an automated or semi-automated blood sampling device, configured to enable movement of the mechatronic assembly under a patient's limb, said piercing head comprising a frame (10) with removable mounting means (11) for moving the piercing head from the frame to the mechatronic assembly, a holder (12) for a collection needle, means for linearly moving the needle holder (16), an electric device (25) for fluidly connecting the needle attached to the needle holder with the collection tube, and electromechanical devices (21, 22) configured to enable, on command, the withdrawal of the collection needle from the patient's arm.

Description

Technical Field

[0001] The present invention relates to a blood puncture head intended to be equipped in an automatic or semi-automatic blood sampling device. The present invention also relates to an automatic or semi-automatic blood sampling device comprising the blood puncture head according to the present invention.

Background Art

[0002] In medical institutions, a very large number of blood tests are performed every day. These operations are time-consuming, repetitive, and potentially dangerous for both nursing staff and patients. These risks must be considered, for example, in relation to the risks of injury associated with the swaying, fatigue, inexperience of nursing staff, and incorrect movements or reflexes of patients when the needle is guided into a vein.

[0003] Furthermore, some patients have veins that are not suitable for blood sample collection, or veins that require multiple attempts at puncture by nursing staff before a reachable vein for blood collection can be found. Such repeated attempts are painful for patients and can cause injury, so the sampling operation for these patients becomes increasingly complicated. US 2012 / 190981 is an autonomous intravenous insertion system comprising a robotic arm, one or more sensors rotatably fixed to the robotic arm for collecting information related to potential insertion sites on the subject's arm, a medical device rotatably fixed to the robotic arm, and a controller. The controller communicates with the sensors and the robotic arm, receives sensor information regarding the potential insertion sites by the controller, selects a target insertion site by the controller, and instructs the robotic arm to insert the medical device into the target insertion site.

[0004] Furthermore, the global health crisis of the coronavirus requires the development of systems that limit contact between patients and care staff and / or enable mass screening of the public.

[0005] Therefore, in WO2015158978, the applicant proposed an apparatus for automatically puncturing a vein of a patient, comprising means for infrared imaging of the patient's arm, means for detecting veins in the captured image, a device for holding the detected veins, a needle, and means for inserting the needle into the detected vein.

[0006] Thus, such an apparatus enables automation of the blood sampling operation.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0008] However, for some operations required for blood sampling, such as the application of dressings, the control of collection tubes, and the confirmation of samples, the presence of a person and / or additional equipment are always required.

[0009] Therefore, the applicant attempts to improve the proposed apparatus and, in particular, provides an autonomous puncture head intended to be provided in a mechatronics assembly (mechatronics assembly), such as a robotic arm of an automatic or semi-automatic blood sampling device.

[0010] Throughout the text, it is intended that an automatic or semi-automatic device is a device that can operate without human intervention, except for the loading operation of the device, the startup of the device, and / or the checking of the device.

Means for Solving the Problems

[0011] Object of the Invention The present invention is intended to provide a blood puncture head that is intended to be provided in a mechatronics assembly such as a robotic arm of an automatic or semi-automatic puncture device.

[0012] The present invention is intended to provide an autonomous blood puncture head that can be provided in any type of mechatronics assembly, particularly in a robotic arm or the like of any type of automatic or semi-automatic blood sampling device.

[0013] Also, in at least one embodiment of the present invention, the present invention is intended to provide a blood puncture head that can mount a sampling needle and can automatically establish a fluid connection between the sampling needle and a tube for receiving the blood sample.

[0014] Also, in at least one embodiment of the present invention, the present invention is intended to provide a blood puncture head that can be mounted on a collection tube intended to collect the blood sample.

[0015] Also, in at least one embodiment of the present invention, the present invention is intended to provide a blood puncture head that can prove the presence of blood in the collection tube.

[0016] Also, in at least one embodiment of the present invention, the present invention is intended to provide a blood puncture head that can automatically prove the filling of the collection tube.

[0017] Also, in at least one embodiment of the present invention, the present invention is intended to provide a puncture head that can automatically change the collection tube.

[0018] Also, in at least one embodiment of the present invention, the present invention is intended to provide a blood puncture head that can correctly position the bevel of the needle away from the skin of the patient's limb to be punctured.

[0019] Furthermore, in at least one embodiment of the present invention, the present invention is intended to provide a blood puncture head capable of automatically applying a dressing to a patient's skin following a sampling operation.

[0020] Furthermore, in at least one embodiment of the present invention, the present invention is intended to provide a blood puncture head capable of interrupting a blood puncture operation in the event of an abnormality being detected, and in particular, capable of removing the needle from a patient's limb in the event of a power failure.

[0021] Furthermore, in at least one embodiment of the present invention, the present invention is intended to provide a puncture head enabling automatic disinfection of the puncture zone.

[0022] Ultimately, the present invention is intended to provide an automatic or semi-automatic blood sampling device comprising a puncture head according to the present invention.

[0023] Statement of the Invention

[0024] To achieve this, the present invention relates to a blood puncture head intended to be provided in a mechatronics assembly, such as a robotic arm, of an automatic or semi-automatic blood sampling device configured to enable movement of the head above a limb of a patient to be punctured.

[0025] A blood puncture head according to the present invention, comprising a frame provided with means for removably fixing the frame to the mechatronics assembly, a bevel portion intended to pierce the skin of a limb of a patient to be punctured and carried by the frame, and a needle holder adapted to receive a needle having a rear portion intended to enable collected blood to flow into a collection tube.

[0026] The blood puncture head according to the present invention further comprises linear displacement means of the needle holder configured to actuate the puncture head from the perspective of inserting the needle into the limb of the patient, once the needle holder is provided with the needle, so that a blood sample can be obtained according to a command from the mechatronics assembly; a device for fluidly connecting the rear portion of the needle attached to the needle holder to a collection tube intended to collect blood taken from the limb of the patient; and an electromechanical device for deactivating the head of the needle and for the emergency removal of the needle from the limb of the patient, configured to enable the mechanical removal of the puncture needle solely from the limb of the patient according to a command.

[0027] The blood puncture head according to the present invention has a needle holder, means for moving the needle holder, a device, for example an automated device, for fluidly connecting the needle to a collection tube (which may be attached to the head as described above or may be arranged remotely from the head and connected to the needle using connecting means such as a flexible tube), and a device for deactivation and emergency removal, thereby ensuring automatic blood collection in the limb of a patient (the upper limb of the patient, hereinafter also referred to as the patient's arm, or the lower limb of the patient). In other words, the various elements necessary for collecting a blood sample from the patient move with the puncture head, so that these elements can be immediately accessed by the head without the need to move the mechatronics assembly towards additional items of the device or the intervention of an operator. Thus, the puncture head according to the present invention can be equipped on any robotic arm to form an automatic or semi-automatic puncture device.

[0028] Throughout the text, the term "robotic arm" refers to a mechatronics assembly configured to enable movement of the head carried by this mechatronics assembly above the limbs of the patient to be punctured. In this way, such a robotic arm is formed, for example, by a shaft articulated along six axes and controlled by digital control (thus having the appearance of such an arm), or comprises actuators (such as cables, electric motors, thrusters, supports, slides, etc.) and can be carried by any automatic system capable of moving the load carried by this system, based on a command, towards the limb to be punctured (in this example, the puncture head), and can be formed by any automatic system.

[0029] Throughout the text, the term "needle" is intended to refer to an elongated rod having a beveled portion adapted to penetrate the patient's skin and a rear portion adapted to be placed in fluid communication with a blood collection tube or any consumable capable of collecting a blood sample. Such a needle in the context of the present invention may itself be a sampling needle, but is not limited thereto, and may be any item of equipment that can be used for sampling even though it was not initially intended for such sampling. For example, a needle in the context of the present invention may be a cannula needle, a catheter, a microinfuser, etc. whose initial function is not blood sampling, but which can nevertheless be used for such sampling. Throughout the text, the term "sampling needle" must be interpreted as a needle in the context of the present invention.

[0030] In addition, the puncture head according to the present invention comprises a device for fluidly connecting the rear portion of the needle attached to the needle holder to a collection tube intended to collect the blood taken from the limbs of the patient.

[0031] Such a device for fluidly connecting the rear portion of the needle to the collection tube may be a flexible tube that fluidly connects the puncture head to a collection tube disposed spaced apart from the rear portion of the sampling needle, or, as will be described later, a collection tube directly related to means for fixing or releasing the collection tube to or from the rear portion of the needle, or a connecting member between the collection tube and a hose carried by the rear portion of the needle.

[0032] In the event that the collection tube is not attached to the puncture head, the fluid connection device comprises, for example, means for receiving a hose attached to the rear portion of the sampling needle. This receiving means may be in the form of a cannula, for example, fixed to the rear portion of the needle and intended to be fitted into a hose connected to a collection tube disposed away from the sampling device to which the puncture head according to the invention is attached. This fitting is effected, for example, by electric means.

[0033] The puncture head according to the invention also comprises a needle holder configured to receive a needle and linear displacement means for the needle holder, whereby, by operating the mechatronics assembly, the head can be brought into an operating state in response to a command to insert the needle into a patient's limb.

[0034] Thus, the insertion of the needle into the patient's limb is performed in two consecutive steps. In the first step, the puncture head is brought into an operating state and the needle is positioned at the puncture position by the moving means of the needle holder. In the second step, the mechanical assembly moves the head in a linear manner in a determined direction in the region of the determined puncture position.

[0035] The operation for removing the needle is also, in normal situations, carried out in two steps. In the first step, until the head is separated from the patient's limb, the head is moved in a direction opposite to the puncture direction. In the second step, once the needle has been separated from the patient's limb, an electromechanical removal device is activated to deactivate the head.

[0036] In the event of an emergency, the removal of the needle is carried out in a single step that includes activating the electromechanical removal device to ensure the removal of the needle. The removal of the needle is ensured solely by mechanical means and this emergency removal can be carried out even in the event of a power failure.

[0037] Therefore, the electromechanical device has a dual function for deactivating the head and for emergency removal. That is, the same means are used both for the removal of the needle in the normal state and for stopping the removal in the event of an emergency.

[0038] Furthermore, According to the present invention, the fluid connection device is electrically driven and comprises a device for loading and dispensing blood collection tubes, the device comprising at least one housing for receiving the collection tubes and at least one fixing / releasing actuator for the at least one collection tube to / from the rear part of the needle attached to the needle holder, the fixing / releasing actuator being configured to move the collection tube from the receiving housing to the rear part of the needle or vice versa.

[0039] In this way, the collection tube can be fitted into the head and moved from the receiving housing at the rear part of the needle by the fixing actuator.

[0040] In other words, a plurality of the collection tubes are fitted into the head and fluid connection is automatically ensured by fixing the collection tubes to the rear part of the collection tubes.

[0041] Advantageously, according to the invention, the device for loading and dispensing the sampling tubes comprises the barrel having a plurality of housings for receiving the sampling tubes distributed around the axis of rotation of the barrel, the axis of rotation extending parallel to the axis of the sampling needle once the needle is attached to the needle holder and being spaced from this axis by a distance equal to the distance separating the axis of rotation of the barrel from each of the housings for receiving the sampling tubes, each sampling tube being aligned with the needle by the rotation of the barrel and being fixed at the rear of the needle under the action of the fixed actuator (28) formed by a linear actuator for moving the sampling tube received in the receiving housing aligned with the needle.

[0042] According to an advantageous variant, the barrel is attached to the frame so that, by rotating the barrel, the housing for receiving the sampling tubes can extend on the side opposite the sampling needle.

[0043] The needle in the context of the present invention is preferably formed by a bevel venous needle intended to enter the vein of the limb of the patient to be punctured (which thus forms the bevel portion of the sampling needle) and a stopper piercing needle extending in the direction of the axis of the bevel needle and intended to extend into the sampling tube for transporting the blood collected therein (therefore, it forms the rear portion of the sampling needle).

[0044] In this method, the puncture head according to this variant of the invention can fill a plurality of collection tubes without the need to move the head to find a new tube. This is because after each filling of the tube, the filled tube can be separated from the stopper piercing needle and rearranged within the barrel. This barrel can be rotated by a predetermined angle to place an empty tube on the opposite side of the needle, and the barrel does not need to retract the venous needle from the patient's limb. Further, it is fixed to the rear portion of the stopper piercing needle to enable collection of a second sample of the collected blood and the like for all the collection tubes of the barrel without the intervention of an external operator.

[0045] Advantageously, according to this variant, the housing for receiving the collection tube arranged at the outer peripheral edge of the barrel for loading and dispensing is in the form of a loop for clip-fitting the collection tube.

[0046] According to this variant, the collection tube is attached in an electric loading and dispensing barrel for a blood collection tube by means of a clip-fitting loop. This facilitates the loading of the collection tube and also enables the collection tube to be unobstructed (except for the portion of the tube clamped within the clip-fitting loop). According to an advantageous variant, the receiving housing is arranged in a regular manner around the central axis of rotation of the barrel.

[0047] Advantageously, according to the present invention, the head further comprises an electric dressing holder with a suction cup plate for holding the dressing, the plate being such that the suction cup can contact a dressing dispenser outside the head so as to suck up the dressing by placing the hollow shaft under reduced pressure, a dressing loading position; and when pulling the needle out of the patient's limb, the hollow shaft is put under atmospheric pressure, thereby releasing the dressing so that the dressing carried by the suction cup can be pressed against and contacted with the skin of the patient's limb in the region of the puncture zone, a dressing application position, between which positions the dressing is carried by a hollow shaft rotatable with respect to the frame.

[0048] The puncture head according to this advantageous variant of the invention makes it possible to automatically apply a dressing in the area of the puncture zone while creating a compression position that prevents any risk of internal or external bleeding. This dressing applicator comprises a suction cup configured to be able to suck the dressing provided by a dressing dispenser (located outside the head and arranged in the area of the patient to be punctured) by placing a hollow tube carrying the suction plate under reduced pressure. For this purpose, preferably, the suction cup comprises a plurality of holes arranged on its upper surface in fluid communication with the hollow tube, and placing the hollow tube under reduced pressure can, as a result of the pressure difference, move the suction cup to the loading position, thereby drawing in the dressing placed in contact with the upper surface of the suction cup. Preferably, the dressing dispenser is loaded with a roll of dressing formed by a substrate on which dressings are arranged at a predetermined distance from each other. Of course, other forms are possible without calling into question the principle of this variant. The suction cup comes into contact with the dressing and sucks the dressing, and the dressing applicator is in a state where it can be used. The dressing dispenser is preferably automated so that after sucking the dressing, the dressing dispenser rotates by a predetermined angle to present a dressing available for the next puncture. Preferably, the dressing is non-porous and rigid with respect to the substrate to facilitate suction by the suction cup.

[0049] The hollow shaft of the dressing applicator is rotatably mounted with respect to the frame between a position for loading the dressing and a position for applying the dressing. In this way, the dressing applicator can apply a predetermined pressure to the patient's limb by slightly increasing the rotation of the hollow shaft in the position for applying the dressing. The position for applying the dressing is determined, for example, by the degree of the resistance torque in the area of the electric actuator that ensures the rotation of the hollow shaft.

[0050] According to an advantageous variant of the invention, the upper surface of the suction cup may have a recess that allows the passage of the needle during the application of the dressing. Thus, according to this variant, the operations for applying the dressing and removing the needle can be carried out simultaneously.

[0051] Preferably, the suction cup is rotatable relative to the tube so as to be able to adapt to the curvature of the limb of the patient through which the tube is punctured, independently of the rotation and / or tilting of the puncture head.

[0052] Advantageously, according to the invention, the frame comprises a fixed part provided with means for removably fixing it to the mechatronics assembly, and a movable part carrying at least the needle holder and the fluid connection device, and the electromechanical device for emergency withdrawal comprises an electromagnet and a return means extending between the fixed part of the frame and the movable part of the frame and configured to ensure the return of the movable part of the frame towards the fixed part of the frame when no current is supplied to the electromagnet anymore.

[0053] Thus, the electromechanical device of the head according to this variant forms a safety device that allows the needle to be immediately withdrawn from the patient's arm in the event of an emergency.

[0054] During normal operation, at the end of the puncture operation, the needle is withdrawn from the patient's skin by actuating the moving means of the needle holder. Then, the electromechanical device is actuated to deactivate the head.

[0055] In the event of an emergency, the movement of the movable part of the frame relative to the fixed part of the frame caused by the electromagnet ensures the withdrawal of the needle, and the actuation of the return spring causes the complete detachment of the needle.

[0056] Advantageously, according to the present invention, the head further comprises means for determining the filling level of the sampling tube fluidly connected to the sampling needle.

[0057] This advantageous variant makes it possible to determine the filling level of the sampling tube, and the advantageous variant in particular enables real-time monitoring of the sampling tube. These means for determining the filling level may be formed, for example, by optical means for detecting the presence of blood in a filling tube in fluid communication with the sampling needle. These means may also be formed by means for weighing the sampling tube, which also makes it possible to determine the amount of blood present in the sampling tube from knowledge of the empty weight of the sampling tube. These means may also be formed by means for calculating the filling time, whereby the amount of blood present in the sampling tube can be estimated from the puncture time and information representing the flow rate of the blood collection operation. Of course, other means may be used to determine the filling level of the sampling tube.

[0058] Also, this variant can detect the filling of the sampling tube and thus perform control to change the filled sampling tube to an empty sampling tube to be filled as soon as the filling level reaches a predetermined level.

[0059] Particularly advantageously, the means for determining the filling level of the sampling tube is configured to be able to trigger automatic exchange of the sampling tube.

[0060] For example, if the head comprises a barrel for loading and dispensing the collection tube, detecting a specific filling level of the collection tube fixed to the needle causes movement of the collection tube filled in its receiving housing, rotation of the barrel to align an empty collection tube in a straight line with the rear portion of the needle, and then movement of this empty collection tube to secure it to the rear portion of the needle. Thereby, blood sampling can be continued using a new collection tube without any external intervention. This method can be repeated for all the collection tubes provided for the tests to be performed.

[0061] In other words, according to this modification, detection of a predetermined filling level in the collection tube controls the fixing / releasing actuator of the collection tube at the rear portion of the needle attached to the needle holder and controls the replacement of the collection tube (rotation of the barrel if the collection tube loading device comprises a barrel).

[0062] Advantageously, according to the invention, the head further comprises means for detecting entry of the needle attached to the needle holder into the vein of the patient to be punctured.

[0063] According to this advantageous modification, the movement of the needle in the limb of the patient to be punctured can be controlled, and in particular, the time the needle is in the vein to be punctured can be determined.

[0064] Advantageously, according to the invention, the head further comprises a sensor arranged in the region of the needle holder and configured to detect an abnormal presence of blood in this region.

[0065] These sensors are, for example, resistive, capacitive, or inductive sensors and are configured to detect the presence of blood in the region of a zone that should not be affected by blood during nominal operation. These zones are adjacent to the liquid blood collection circuit.

[0066] Advantageously, according to the present invention, the needle holder comprises means for screwing, clip-fitting or magnetizing the sampling needle on the needle holder for fixing.

[0067] In the case of the screwing means, they are formed, for example, by a double screw nut, and each screw is adapted to the pitch of the screw of a needle of a type available on the general market. In this way, the head according to the present invention can receive different types of needles, which are distinguished from each other especially by the shape of the screw.

[0068] Preferably, the needle holder further comprises a system for releasing the rotation of the needle about its own axis so that the bevel portion of the needle can be directed away from the skin of the limb of the patient to be punctured.

[0069] Thanks to this advanced feature, the bevel can be correctly directed in order to facilitate the insertion of the needle into the skin of the limb of the patient.

[0070] Advantageously, according to the present invention, the head further comprises means for automatically disinfecting the puncture zone.

[0071] These automatic disinfection means comprise, for example, a spray to be attached to the head, a system for placing a cotton pad impregnated with a disinfectant, or other equivalent means.

[0072] The present invention also relates to an apparatus for automatic or semi-automatic blood sampling of a patient's limb, comprising a mechatronics assembly, a control unit of the mechatronics assembly, and a system for capturing and processing an image of the patient's limb configured to determine an optimal puncture zone, and further, the apparatus is characterized in that it comprises a puncture head according to the present invention attached to the mechatronics assembly.

[0073] The device according to the invention makes it possible to automate blood sampling on a patient's limbs. In addition to the puncture head according to the invention, this device comprises a mechatronics assembly such as a robotic arm, a control unit capable of controlling the position of the robotic arm, and a system for capturing and processing images configured to define an optimal puncture position. And this optimal puncture position is supplied to the control unit of the robotic arm and the control unit of the puncture head so that the needle can be inserted into the patient's arm in the area of the optimal puncture zone determined by the image processing system. This image processing system is, for example, the one described in application WO2015158978 in the name of the applicant of the present application.

[0074] The image processing system can also be directly adapted to the puncture head according to the invention carried by the frame, for example, to acquire the limbs of the patient to be punctured and to be able to determine an optimal puncture zone. According to this variant, all the functions required for the puncture can be provided in the head, and the main function of the blood sampling machine is to control the movement of the mechatronics assembly carrying the puncture head.

[0075] The above-mentioned advantages and effects described in relation to the puncture head are applied to the sampling device according to the invention with the necessary modifications.

[0076] The invention also relates to a puncture head and an automatic or semi-automatic blood sampling device characterized by combining all or some of the features mentioned above or below.

[0077] Other objects, features and advantages of the invention will be understood from the following description, given purely by way of non-limiting example and with reference to the accompanying drawings.

Brief Description of the Drawings

[0078]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Mode for Carrying Out the Invention

[0079] In the figures, the scale and ratio are not strictly adhered to for the purpose of illustration and clarification. Referring to the figures, throughout the following detailed description, unless otherwise indicated, each element of the puncture head according to the present invention is described as in the state when the head is attached to a mechatronics assembly such as a robot arm of an automatic sampling device. However, for the purpose of clarity, the robot arm is not shown in Figures 1 to 4. The arm is schematically shown in Figure 5.

[0080] Furthermore, the same reference numerals are assigned to all identical, similar, or comparable elements in all the figures.

[0081] Finally, the terms longitudinal, lateral, vertical, and variations thereof are used in a non-limiting exemplary manner with reference to the three-sided bodies L, T, V as shown particularly in Figure 1. The longitudinal direction (indicated by L in the figure) corresponds to the main direction of the puncture head, and further, the longitudinal direction coincides with the direction along which the blood sampling needle extends particularly when the blood sampling needle is attached to the needle holder. The vertical direction (indicated by V in the figure) is the direction defined by gravity, and the lateral direction (indicated by T in the figure) is the direction orthogonal to the longitudinal direction and the vertical direction.

[0082] The blood puncture head according to the embodiment of the figure includes a frame 10, and the frame 10 is provided with means 11 for removably fixing the frame 10 to a robot arm of an automatic blood sampling device not shown in FIGS. 1 to 4 for the purpose of clarity. These fixing means 11 can be of any type and depend on the robot arm to which the puncture head is attached.

[0083] The previous puncture head also includes a sampling needle holder 12 carried by the frame 10 and configured to receive a needle 13 such as a blood sampling needle. This needle holder 12 is shown in more detail in FIG. 4, which also shows a collection tube 14 fixed to the rear portion of the needle. The sampling needle 12 has a bevel-shaped portion (obliquely cut portion) 13a intended to enter a vein in the limb (arm or leg) of the patient to be punctured, and a stopper piercing portion 13b that extends in the axial direction of the bevel-shaped portion 13a and passes through a stopper 15 so as to extend into the blood collection tube 14. The bevel-shaped portion 13a and the stopper piercing portion 13b may be formed from one and the same needle, or may be formed from two needles connected to each other.

[0084] In the remaining part of this text, reference is made to a bevel needle and a stopper piercing needle, but it is understood that these may be manufactured by one and the same needle as described above. The bevel needle 13a and the stopper piercing needle 13b are in fluid communication such that the blood removed by the bevel needle 13a flows to the stopper piercing needle 13b and then to the blood collection tube 14 fixed to the rear portion of this stopper piercing needle.

[0085] The sampling needle 13 is attached to the needle holder 12 by means of screwing, clip fitting or magnetization.

[0086] According to one embodiment of the present invention, the needle holder 12 also comprises means for detaching the needle 13, and the means for detaching the needle 13 enables the bevel portion of the needle, which facilitates its insertion into the limb of the patient to be punctured, to be oriented away from the skin of the patient being punctured, thereby enabling the needle 13 to be rotated about its spindle.

[0087] This detachment is effected, for example, by means of a screw of the needle holder which is pivotally mounted about the axis of the needle and is pressed against a retaining plate by a spring. The force of this spring, its tension, and the nature of the material used are configured to produce a controlled friction, thereby obtaining an appropriate screwing torque to ensure an optimal block for screwing in the needle, guaranteeing the correct positioning of the bevel portion of the needle, and enabling a rotational drive of the screw that guarantees no movement of the needle when it is inserted.

[0088] The needle holder 12 is fixedly joined to the head frame 10 using any possible mechanical means.

[0089] The puncture head also comprises linear displacement means 16 of the needle holder 12, and if this needle holder 12 comprises a sampling needle 13, it is configured such that the head can be brought into an operative state to insert this needle into the limb of the patient to be punctured.

[0090] These linear displacement means of the needle holder are preferably formed by the robotic arm that carries the puncture head when the needle is inserted into the limb of the patient, and by the robotic arm and an electromechanical release system (or trigger system) when the needle is removed.

[0091] This electromechanical trigger system is schematically shown in FIG. 2. In particular, it comprises an electromagnet 21 and a return spring 22 configured to ensure the return of the needle holder along the slide 24 when the supply of current to the electromagnet 21 is interrupted.

[0092] During normal operation, a current is supplied to the magnetic adsorption cup forming the electromagnet, and the return spring 22 is held in an extended state. The trigger system is maintained in this configuration throughout the entire puncture operation. To start the system, at the end of the puncture operation, in the event of an emergency removal, or in the event of a power outage, the magnetic adsorption cup releases the movable part of the head, and the movable part of this head is then displaced along the slide by the force of the spring 22 to the damping stop.

[0093] According to an embodiment of the present invention not shown, the needle holder 12 may be provided with a needle presence sensor adapted to detect the presence of a needle on the needle holder. Such a sensor may be, for example, an optical sensor, a mechanical sensor, a magnetic sensor, or any equivalent means.

[0094] According to other embodiments not shown, the frame comprises a fixed part provided with means for removably fixing to the robot arm, and a movable part carrying the needle holder, the movable part being configured to be movable relative to the fixed part by commands from a control unit and associated actuators to ensure the insertion / removal of the needle carried by the needle holder on the limbs of the patient, and the movable part thus forms the linear displacement means of the needle holder.

[0095] According to the embodiment of the figure, the puncture head also comprises a powered barrel 25 for loading and dispensing the blood collection tube 14.

[0096] This barrel 25 comprises a plurality of housings 27 for receiving the tubes 14 arranged around the axis of rotation 26 of the barrels forming the star-shaped barrel. Each receiving housing 27 is formed by an elastic clip-fitting handle. According to other embodiments, each receiving housing may be formed by a double clip-fitting that improves retention and makes it possible to ensure the alignment of the tubes.

[0097] The rotation axis 26 of the barrel extends parallel to the axis of the sampling needle 13 after the sampling needle is attached to the needle holder 12, but is offset with respect to the axis of the needle. This rotation axis 26 is rotationally driven by an electric motor that cannot be seen in the figure. This electric motor is preferably housed in the rotation axis 26. Of course, other electromechanical means may be used to ensure this rotation of the rotation axis 26 of the barrel 25.

[0098] By rotating the barrel 25 about the rotation axis 26, each sampling tube 14 housed in the receiving housing 27 can be sequentially positioned on the axis of the needle 13. Once the sampling tube 14 is within the axis of the needle 13, the sampling tube is moved toward the rear portion of the needle 13 under the action of a bidirectional linear actuator 28 in order to be fixed in place. After the sampling tube is fixed to the rear of the needle 13, blood sampling can be started. Since the linear actuator 28 is bidirectional, after filling the sampling tube, removal of the sampling tube can be ensured to replace it with another tube of the barrel 25.

[0099] The puncture head 8 according to the embodiment of the figure also includes an electric dressing applicator 30 that includes a suction cup plate 31 for holding a dressing carried by a hollow shaft 32 that pivots relative to the frame 10. Such a bidirectional actuator is, for example, a rack and pinion actuator.

[0100] By rotating the hollow shaft 32 to put the hollow shaft 32 in a decompressed state so that dressing can be sucked, the suction cup plate can be displaced between a dressing loading position where it can contact a dressing dispenser outside the head, and a dressing application position where the dressing carried by the suction cup contacts the skin of the patient's limb in the area of the puncture zone. When the needle 13 is withdrawn from the patient's limb, the dressing is released by bringing the hollow shaft 32 to atmospheric pressure so that the dressing can be applied to the patient's limb.

[0101] The rotation of the hollow shaft 32 is ensured, for example, by an electric motor that rotationally drives a gear washer that meshes with a gear washer fixedly joined to the hollow shaft 32. Of course, other electromechanical means may be used to ensure the rotation of the hollow shaft from the position for drawing in the dressing to the position for applying the dressing to the patient's limb.

[0102] According to an embodiment of the present invention (not shown), the dressing applicator 30 may include a sensor for detecting the dressing. Such a sensor may be, for example, an optical sensor, a mechanical sensor, a decompression sensor, or equivalent means.

[0103] Preferably, as shown in FIG. 3, the puncture head also includes means 40a, 40b for controlling the filling, presence, and positioning of the collection tube. According to the embodiment of the figure, these filling control means 40a, 40b include an optical sensor configured to detect the presence of blood in the collection tube 14 and the filling level of the collection tube. Therefore, it is possible to monitor the progress of blood sampling in real time. These sensors also make it possible to detect the presence and nominal position of the collection tube before puncture. Any type of optical sensor can be used to detect the blood in the collection tube and the filling level of the collection tube. According to the embodiment of the figure, the filling means 40a is arranged on the output side of the collection tube, and the filling means 40b is arranged on the receiving side of the collection tube.

[0104] The puncture head according to the embodiment of the figure also includes a resistive sensor arranged in the region between the needle holder 12 and the barrel 25 for loading and dispensing the collection tube, and configured to detect the abnormal presence of blood in this region.

[0105] In addition, the puncture head, together with the mechatronics assembly, includes a control unit configured to receive data and / or measurements of various sensors and actuators of the puncture head that enable the control of the operation and movement of the puncture head.

[0106] The present invention also relates to an automatic blood sampling device very schematically illustrated in FIG. 5. According to the illustrated embodiment, this device consists of a robotic arm 50, a control unit 51 of the robotic arm, a system 52 for capturing and processing an image of a patient's limb configured to determine an optimal puncture zone, and a puncture head 8 according to the embodiments of FIGS. 1 to 4. The system 52 for capturing and processing an image includes, for example, a camera (not shown) capable of acquiring (capturing) the limb of the patient 9 to be punctured. Then, this image is transmitted to an image processing module configured to detect an optimal puncture vein. The method for identifying the optimal vein is, for example, the method described in Application WO2015158978 in the name of the same applicant. After the optimal vein is detected, the control unit 52 transmits movement information items of the needle holder to the actuator of the robotic arm 50 and the actuator of the puncture head 8 so that the needle 13 can be inserted into the limb of the patient 8 to be sampled.

[0107] Before the blood sampling operation, the puncture head according to the present invention is loaded with the collection tube required for a specific analysis of the patient. The collection tube is inserted into the rotating barrel, which preferably has the same number or more collection tube receiving housings than the number of collection tubes required for the tests to be performed on the patient.

[0108] Next, the head is loaded with a dressing. As described above, this dressing loading is performed by the displacement of the hollow arm 32 that transports the suction cup plate 31 to the position where the dressing is loaded, where the suction cup plate can contact the dressing dispenser.

[0109] According to another variant, the dressing dispenser may be replaced by an operator so as to directly place the dressing on the suction cup plate 31. Similarly, the operations for loading the collection tube, assembling the needle, or disinfection may, according to the variant, be performed by an operator.

[0110] As soon as the system for capturing and processing an image defines the optimal puncture position, the puncture head is placed at the sampling position by the robotic arm. The puncture head advances towards the limb of the patient to be punctured, and the needle penetrates the skin according to a predetermined angle through the image processing module or through an additional device or means until the needle reaches the target vein. Then, a first collection tube compliant with regulations is inserted into the stylet needle with a stopper according to the mechanism described above.

[0111] When the filling (injection) of the collection tube is performed and a predetermined filling level (detected by means for controlling the filling of the collection tube) is achieved, the filled collection tube is exchanged with the empty tube of the barrel. This cycle of operations is repeated until the sample intended for the patient in question is completed.

[0112] After all sample collections have been performed, the needle is withdrawn from the patient's limb, and the dressing present in the suction cup is applied to the patient's limb in the area of the puncture position.

Claims

Claim 1 The blood puncture head intended to be provided in a mechatronics assembly of an automatic or semi-automatic blood sampling device configured to allow movement of the blood puncture head above the limbs of a patient to be punctured, The frame (10) provided with means (11) for removably fixing the frame to the mechatronics assembly, A needle holder (12) adapted to receive a needle (13) comprising a beveled portion (13a) intended to pierce the skin of the limbs of the patient to be carried by the frame (10) and pierced, and a rear portion (13b) intended to allow the collected blood to flow into a collection tube, The blood puncture head further comprises, Once the needle holder is provided with a needle, linear displacement means (16) of the needle holder configured to be able to operate the blood puncture head from the perspective of inserting the needle (13) into the limbs of the patient so that a blood sample can be obtained by a command from the mechatronics assembly, A device for fluidly connecting the rear portion of the needle (13) attached to the needle holder (12) to a collection tube intended to collect blood taken from the limbs of the patient, wherein the device for fluidly connecting is automated and further comprises a device (25) for loading and dispensing the collection tube, the device comprising at least one housing (27) for receiving the collection tube (14) and at least one fixing actuator (28) of the collection tube to the rear portion of the needle attached to the needle holder, the fixing actuator (28) being configured to move the collection tube (14) from the housing to the rear portion of the needle or vice versa, the device, An electromechanical device (21, 22) configured to be able to mechanically remove the needle exclusively from the limbs of the patient by a command, a blood puncture head comprising. Claim 2 Said device (25) for loading and distributing the sampling tubes comprises said barrel provided with a plurality of housings for receiving the sampling tubes distributed around the axis of rotation (26) of the barrel, said axis of rotation (26) extending parallel to the axis of said needle (13) once said needle has been attached to said needle holder and being spaced from this axis by a distance equal to the distance separating the axis of rotation of the barrel from each of said housings for receiving the sampling tubes, each of said sampling tubes being aligned with said needle by the rotation of the barrel and being fixed at the rear of said needle under the action of said fixed actuator (28) for moving the sampling tube received in said housing aligned with said needle. The blood puncture head according to claim 1.

3. The housing for receiving the sampling tubes formed on the outer periphery of the barrel for loading and distributing comprises a loop portion for clipping the sampling tubes. The blood puncture head according to claim 2.

4. Furthermore, it comprises an electric dressing holder (30), said electric dressing holder being such that a suction cup plate (31) can contact a dressing dispenser outside the blood puncture head in a dressing loading position so that the dressing can be sucked up by placing a hollow shaft under vacuum, and a dressing holding position in which the dressing carried by said suction cup plate is pressed against and contacted with the skin of the patient's limb at the level of the puncture zone while the needle is withdrawn from the patient's limb so that the dressing can be released by venting the hollow shaft and attached to the patient's limb. The suction cup plate (31) for holding the dressing carried by the hollow shaft (32) rotating with respect to the frame between the two positions is provided. The blood puncture head according to any one of claims 1 to 3.

5. The suction cup plate (31) of said dressing holder comprises a recess allowing the passage of said needle during the attachment of the dressing. The blood puncture head according to claim 4.

6. The suction cup plate (31) is rotatable with respect to the hollow shaft (12) so as to be adaptable to the bending of the patient's limbs during puncture, independently of the rotation and / or inclination of the blood puncture head, according to claim 4 or 5.

7. The frame (10) comprises a fixed part provided with means for removably fixing to the mechatronics assembly, and a movable part carrying at least the needle holder and the device for fluid connection thereto. The electromechanical device comprises an electromagnet and a return means extending between the fixed part of the frame and the movable part of the frame and configured to ensure the return of the movable part of the frame to the fixed part of the frame when no current is supplied to the electromagnet any more, according to any one of claims 1 to 6.

8. Furthermore, it comprises means (40a, 40b) for determining the filling level of the sampling tube fluidically connected to the needle for sampling, according to any one of claims 1 to 7.

9. The means for determining the filling level of the sampling tube is configured to be able to cause an automatic exchange of the sampling tube, according to claim 8.

10. Furthermore, it comprises means for detecting the entry of the needle attached to the needle holder into the vein of the patient to be punctured, according to any one of claims 1 to 9.

11. The needle holder (12) comprises means for fixing the needle to the needle holder by screwing, clipping or magnetization, according to any one of claims 1 to 10.

12. The needle holder (12) further comprises a system enabling the rotation of the needle itself so that the beveled part of the needle can be directed away from the skin of the patient's limb to be punctured, according to claim 11.

13. Furthermore, it comprises means for automatic disinfection of the puncture zone, according to any one of claims 1 to 12.

14. A device for automatically or semi-automatically puncturing a patient's limb, a mechatronics assembly (50), a control unit (52) of the mechatronics assembly, A system configured to capture and process an image of a patient's limb to determine an optimal puncture zone, and An apparatus, further comprising the blood puncture head (8) according to any one of claims 1 to 13 attached to the mechatronics assembly.

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