BLOOD PRICKING HEAD FOR AN AUTOMATIC OR SEMI-AUTOMATIC BLOOD COLLECTION MACHINE

Abstract

The invention relates to a blood pricking head (8) for a mechatronic assembly such as a robot-controlled arm of an automatic or semi-automatic blood collection machine configured to enable movement of the mechatronic assembly below the limb of a patient, the pricking head comprising: a frame (10) provided with removable attachment means (11) that can be moved from the frame to the mechatronic assembly; a holder (12) for collection needles, means (16) for linearly moving the needle holder; a motorised device (25) for fluidically linking the needle mounted on the needle holder with a collection tube; and an electromechanical device (21, 22) configured to enable, on command, withdrawal of the pricking needle from the patient's arm.

Claims

1. A blood puncture head intended to equip a mechatronic assembly such as a robotic arm, of an automatic or semi-automatic blood sampling machine configured to allow movement of said head above a limb of a patient to be punctured, said blood puncture head comprising: a frame equipped with means for removably fixing the frame to said mechatronic assembly, and a needle holder carried by said frame and adapted to receive a needle comprising a beveled portion intended to pierce the skin of the patient's limb to be punctured and a rear portion intended to allow the flow of collected blood to a collection tube, wherein said blood puncture head further comprises: linear displacement means of said needle holder configured to allow, once equipped with a needle, to arm the puncture head with a view to inserting, on command from said mechatronic assembly, this needle in said limb of said patient in order to be able to take a blood sample, a device for fluidically connecting said rear portion of said needle mounted on said needle holder with a collection tube adapted to collect the blood taken from said patient's limb, and an electromechanical device for disarming the head and emergency removal of said needle from said patient's limb configured to allow, on command, an exclusively mechanical removal of said needle from said patient's limb.

2. The puncture head according to claim 1, wherein said fluidically connecting device is motorized and further comprises a device for loading and distributing blood collection tubes comprising at least one housing for receiving a collection tube and at least one securing actuator of this collection tube to the rear of a needle mounted on said needle holder, said securing actuator (being configured to move said collection tube from the receiving housing to the rear portion of said needle and vice versa.

3. The puncture head according to claim 2, wherein said device for loading and distributing sampling tubes comprises a barrel comprising a plurality of housings for receiving tubes distributed around an axis of rotation of said barrel, said axis of rotation extending parallel to the axis of said needle, once the needle is mounted on said needle holder, and separated from this axis by a distance equal to the distance which separates said axis of rotation of said barrel from each of said housings for receiving said tubes, so that each tube can be aligned with said needle, by rotation of said barrel, and secured at the rear of said needle, under the effect of said securing actuator formed by a linear actuator for moving the tube housed in the receiving housing aligned with said needle.

4. The puncture head according to claim 3, wherein said housings for receiving the sampling tubes formed at the periphery of said loading and dispensing barrel comprise loops for clipping said tubes.

5. The puncture head according to claim 1, wherein it further comprises a motorized dressing holder comprising a suction cup plate for holding a dressing carried by a hollow shaft pivoting relative to said frame between a position for loading a dressing in which said suction cup can come into contact with a dressing dispenser outside said head in order to be able to suck up a dressing by placing said hollow shaft under vacuum, in a position for placing the dressing, in which said dressing carried by said suction cup comes into pressed contact with the skin of said patient's limb at the level of the puncture zone, during withdrawal of said needle from said patient's limb in order to be able to affix said dressing on said patient's limb by venting said hollow shaft, thereby releasing said dressing.

6. The puncture head according to claim 5, wherein said suction cup plate of the dressing holder comprises a recess allowing the passage of the needle during the fitting of the dressing.

7. The puncture head according to claim 5, wherein said suction plate is pivotable with respect to the hollow shaft so as to be able to adapt to the curvature of the patient's limb at puncture, independent of the rotation and/or inclination of the puncture head.

8. The puncture head according to claim 1, wherein said frame comprises a fixed part fitted with means for removable fixing to said mechatronic assembly and a mobile part carrying at least said needle holder and said fluidic connection, and in that said electromechanical device for disarming and emergency withdrawal comprises an electromagnet and a return means extending between the fixed part of said frame and said movable part of said frame, and configured to ensure the return of the movable part of said frame to the fixed part of said frame when said electromagnet is no longer supplied with current.

9. The puncture head according to claim 1, wherein it further comprises means for determining the filling level of the collection tube in fluidic connection with said sampling needle.

10. The puncture head according to claim 9, wherein said means for determining the filling level of the collection tube are configured to be able to trigger an automatic change of the sampling tube.

11. The puncture head according to claim 1, wherein it further comprises means for detecting the entry of said needle mounted on said needle holder into a vein of the patient to be punctured.

12. The puncture head according to claim 1, wherein said needle-holder comprises means for fixing by screwing, clipping or magnetization of said puncture needle on said needle-holder.

13. The puncture head according to claim 12, wherein said needle holder further comprises a system for disengaging the rotation of said needle so as to allow rotation of the needle on itself in order to be able to orient the bevel said needle away from the skin of the patient's limb to be punctured.

14. The puncture head according to claim 1, wherein it also comprises means for the automatic disinfection of said puncture zone.

15. A machine for automatic or semi-automatic puncture of a patient's limb comprising a mechatronic assembly, a control unit of said mechatronic assembly, a system for capturing and processing images of the patient's limb configured to determine an optimal puncture zone, wherein the machine further comprises a puncture head mounted on said mechatronic assembly, the puncture head comprising: a frame equipped with means for removably fixing the frame to said mechatronic assembly, and a needle holder carried by said frame and adapted to receive a needle comprising a beveled portion intended to pierce the skin of the patient's limb to be punctured and a rear portion intended to allow the flow of collected blood to a collection tube, wherein said blood puncture head further comprises: linear displacement means of said needle holder configured to allow, once equipped with a needle, to arm the puncture head with a view to inserting, on command from said mechatronic assembly, this needle in said limb of said patient in order to be able to take a blood sample, a device for fluidically connecting said rear portion of said needle mounted on said needle holder with a collection tube adapted to collect the blood taken from said patient's limb, and an electromechanical device for disarming the head and emergency removal of said needle from said patient's limb configured to allow, on command, an exclusively mechanical removal of said needle from said patient's limb.

Description

LIST OF FIGURES

[0080] Other objectives, features and advantages of the invention will be appreciated from a reading of the following description, given purely by way of non-limiting example and with reference to the appended Figures, in which:

[0081] FIG. 1 shows a schematic, perspective front view of a puncture head according to an embodiment of the invention,

[0082] FIG. 2 shows a schematic, perspective view according to another orientation of the puncture head according to the embodiment of FIG. 1,

[0083] FIG. 3 shows a schematic, perspective view according to another orientation of the puncture head of the embodiment of FIGS. 1 and 2,

[0084] FIG. 4 shows a schematic side view of a needle holder which is equipped with a puncture needle of a puncture head according to an embodiment of the invention,

[0085] FIG. 5 shows a schematic view of an automatic blood sampling machine according to an embodiment of the invention.

DETAILED DESCRIPTION OF AN EMBODIMENT OF THE INVENTION

[0086] In the Figures, the scales and proportions are not strictly complied with for the purposes of illustration and clarity. In the entire detailed description which follows with reference to the Figures, unless indicated otherwise, each element of the puncture head according to the invention is described as it is when the head is mounted on a mechatronic assembly such as a robotic arm of an automatic sampling machine. The robotic arm is not, however, illustrated in FIGS. 1 to 4 for the purposes of clarity. The arm is illustrated schematically in FIG. 5.

[0087] Furthermore, elements which are identical, similar or comparable are given the same reference numerals in all the Figures.

[0088] Finally, the terms longitudinal, transverse, vertical and the variants thereof are used by way of non-limiting example with reference to the trihedron L, T V, as illustrated in particular in FIG. 1. The longitudinal direction (designated L in the Figures) corresponds to the main direction of the puncture head and coincides in particular with the direction along which the blood sampling needle extends when it is mounted on the needle holder. The vertical direction (designated V in the Figures) is the direction defined by gravitational force and the transverse direction (designated T in the Figures) is the direction perpendicular to the longitudinal direction and the vertical direction).

[0089] The blood puncture head according to the embodiment of the Figures comprises a frame 10 which is provided with means 11 for removably fixing the frame 10 to a robotic arm of an automatic blood sampling machine which is not illustrated in FIGS. 1 to 4 for the purposes of clarity. These fixing means 11 may be of any type and are dependent on the robotic arm on which the puncture head is mounted.

[0090] The puncture head also comprises a sampling needle holder 12 which is carried by the frame 10 and which is configured to receive a needle 13, such as a blood sampling needle. This needle holder 12 is illustrated in greater detail in FIG. 4, which also illustrates a collection tube 14 which is secured to the rear of the needle. The sampling needle 12 is formed by a bevelled portion 13a which is intended to enter the vein of the limb of the patient to be punctured and a stopper-piercing portion 13b which extends in the axis of the bevelled portion 13a and which passes through a stopper 15 in order to extend into the collection tube 14. This bevelled portion 13a and this stopper-piercing portion 13b may be formed from one and the same needle or two needles which are connected to each other.

[0091] In the remainder of the text, reference is made to a bevelled needle and a stopper-piercing needle, it being understood that they may be produced by one and the same needle as indicated above. The bevelled needle 13a and stopper-piercing needle 13b are in fluidic communication so that the blood removed by the bevelled needle 13a flows to the stopper-piercing needle 13b, then to the collection tube 14 which is secured to the rear of the stopper-piercing needle.

[0092] The sampling needle 13 is mounted on the needle holder 12 by means of screwing, clip-fitting or magnetisation.

[0093] According to one embodiment of the invention, the needle holder 12 also comprises means for disengaging the needle 13 which enable the needle 13 to be pivoted about the main axis thereof in order to enable the bevel of the needle to be orientated away from the skin of the patient to be punctured which facilitates the insertion thereof into the patient's limb to be punctured.

[0094] This disengagement is, for example, carried out by means of a thread of the needle holder which is pivotably mounted about the axis of the needle and which is held pressed against a retention plate by a spring. The force of this spring, the tension thereof and the nature of the materials used are configured to generate a controlled friction, which enables an adequate screwing torque to be obtained in order to ensure an optimum blocking in order to screw the needle, a rotational driving of the thread which ensures the correct positioning of the bevel of the needle and the absence of movement of the needle when the needle is inserted.

[0095] The needle holder 12 is fixedly joined to the frame 10 of the head using any possible mechanical means.

[0096] The puncture head also comprises linear displacement means 16 of the needle holder 12 which are configured, once the needle holder 12 is equipped with a sampling needle 13, to enable the head to be armed in order to insert this needle into the limb of a patient to be punctured.

[0097] These linear displacement means of the needle holder are preferably formed by the robotic arm which carries the puncture head when the needle is inserted into the limb of the patient and the robotic arm and an electromechanical disarming system (or triggering system) when the needle is removed.

[0098] This electromechanical triggering system is illustrated schematically in FIG. 2. It comprises in particular an electromagnet 21 and a return spring 22 which is configured to ensure the return of the needle holder along slides 24 when the electromagnet 21 is no longer supplied with current.

[0099] During normal operation, a magnetic suction cup which forms the electromagnet is supplied with current so that the return spring 22 is held in a stretched state. The triggering system is kept in this configuration for the entire duration of the puncture operation. In order to start the system, at the end of the puncture operation, in the event of emergency removal or in the event of a power failure, the magnetic suction cup releases the movable portion of the head which is then displaced by the force of the spring 22 along the slides as far as a damping stop.

[0100] According to one embodiment of the invention which is not illustrated in the Figures, the needle holder 12 may also comprise a needle presence sensor which is adapted to detect the presence of a needle on the needle holder. Such a sensor may, for example, be an optical sensor, a mechanical sensor, a magnetic sensor, or any equivalent means.

[0101] According to another embodiment which is not illustrated in the Figures, the frame comprises a fixed portion which is equipped with means for removably fixing to the robotic arm and a movable portion which carries the needle holder, the movable portion being configured to be able to be moved, on command from a control unit and associated actuators, relative to the fixed portion in order to ensure the insertion/removal of the needle carried by the needle holder in the limb of the patient, the movable portion thus forming the linear displacement means of the needle holder.

[0102] According to the embodiment of the Figures, the puncture head also comprises a motorised barrel 25 for loading and distributing blood collection tubes 14.

[0103] This barrel 25 comprises a plurality of housings 27 for receiving tubes 14 which are distributed about a rotation axis 26 of the barrel which forms a star-like barrel. Each receiving housing 27 is formed by a resilient clip-fitting handle. According to other embodiments, each receiving housing may be formed by a dual clip-fitting which enables the retention to be improved and the alignment of the tubes to be ensured.

[0104] The rotation axis 26 of the barrel extends parallel with the axis of the sampling needle 13, after the needle has been mounted on the needle holder 12, but is offset relative to the axis of the needle. This rotation axis 26 is rotationally driven by an electric motor which cannot be seen in the Figures. This electric motor is preferably accommodated in the rotation axis 26. Of course, other electromechanical means may be used in order to ensure this rotation of the rotation axis 26 of the barrel 25.

[0105] The rotation of the barrel 25 about the rotation axis 26 enables each collection tube 14 which is accommodated in a receiving housing 27 to be positioned in turn in the axis of the needle 13. Once the collection tube 14 is in the axis of the needle 13, the tube is moved, under the action of a bidirectional linear actuator 28, towards the rear of the needle 13 in order to be secured at that location. After the tube has been secured to the rear of the needle 13, the blood sampling can begin. The linear actuator 28 being bidirectional, it can also ensure the removal of the collection tube, after it has been filled, in order to be replaced with another tube of the barrel 25.

[0106] The puncture head 8 according to the embodiment of the Figures also comprises a motorised dressing applicator 30 which comprises a suction cup plate 31 for holding a dressing carried by a hollow shaft 32 which pivots relative to the frame 10. Such a bidirectional actuator is, for example, a rack and pinion actuator.

[0107] The pivoting of the hollow shaft 32 enables the suction cup plate to be displaced between a position for loading a dressing in which the suction cup may come into contact with a dressing distributor outside the head in order to be able to suck a dressing by placing the hollow shaft 32 under reduced pressure, and a position for applying the dressing, in which the dressing carried by the suction cup comes into contact with the skin of the limb of the patient in the region of the puncture zone, when the needle 13 is withdrawn from the limb of the patient in order to be able to apply the dressing to the limb of the patient by placing the hollow shaft 32 at atmospheric pressure, thus releasing the dressing.

[0108] The pivoting of the hollow shaft 32 is ensured, for example, by an electric motor which rotationally drives a gear washer which meshes with a gear washer which is fixedly joined to the hollow shaft 32. Of course, other electromechanical means may be used in order to ensure the pivoting of the hollow shaft from the position for drawing in the dressing to the position for applying the dressing to the limb of the patient.

[0109] According to one embodiment of the invention which is not illustrated in the Figures, the dressing applicator 30 may also comprise a sensor for detecting a dressing. Such a sensor may, for example, be an optical sensor, a mechanical sensor, a reduced pressure sensor or any equivalent means.

[0110] The puncture head preferably also comprises, as illustrated in FIG. 3, means 40a, 40b for controlling the filling, the presence and the positioning of the tubes. These filling control means 40a, 40b comprise, according to the embodiment of the Figures, optical sensors which are configured to detect the presence of blood in the collection tubes 14 and the filling level of the tubes. It is thus possible to monitor in real time the progress of the blood sampling. These sensors also enable the presence and the nominal positioning of the tube to be detected before puncture.

[0111] All types of optical sensors may be used to carry out this detection of blood in the tube and the filling level of the tube. According to the embodiment of the Figures, a filling means 40a is arranged at the output side of the tubes and a filling means 40b is arranged at the receiving side of the tubes.

[0112] The puncture head according to the embodiment of the Figures also comprises resistive sensors which are arranged in the region of the needle holder 12 and the barrel 25 for loading and distributing the tubes and which are configured to detect an abnormal presence of blood in this region.

[0113] The puncture head also comprises a control unit which is configured to receive the data and/or measurements of the various sensors and actuators of the head which, together with the mechatronic assembly, enable the operation and the movement of the puncture head to be controlled.

[0114] The invention also relates to an automatic blood sampling machine which is illustrated very schematically in FIG. 5. This machine comprises, according to the embodiment illustrated, a robotic arm 50, a control unit 51 of the robotic arm, a system 52 for capturing and processing images of the limb of the patient which is configured to determine an optimum puncture zone, and a puncture head 8 according to the embodiment of FIGS. 1 to 4. The system 52 for capturing and processing images comprises, for example, a camera which is not illustrated in the Figures and which is capable of carrying out the acquisition of the limb of the patient 9 to be punctured. The images are then transmitted to an image processing module which is configured to detect an optimal puncture vein. The method for identification of the optimal vein is, for example, the method described in the application WO 2015158978 in the name of the same Applicant. After the optimum vein has been detected, the control unit 52 transmits to the actuators of the robotic arm 50 and to the actuators of the puncture head 8 the movement information items of the needle holder in order to enable the insertion of the needle 13 into the limb of the patient 8 to be sampled.

[0115] Prior to the blood sampling operation, the puncture head according to the invention is loaded with the collection tubes necessary for the specific analysis of the patient. The tubes are inserted into the rotating barrel, which preferably comprises a number of tube receiving housings which is greater than or equal to the number of tubes required for the examination carried out on the patient.

[0116] The head is then loaded with a dressing. As explained above, this loading of the dressing may be carried out by the displacement of the hollow arm 32 which carries the suction cup plate 31 to the position for loading a dressing, in which the suction cup may come into contact with the dressing distributor.

[0117] According to another variant, the dressing distributor may be replaced by an operator who places the dressing directly on the suction cup plate 31. In the same manner, the operations for loading tubes, assembling needles or disinfection may, according to a variant, be carried out by an operator.

[0118] As soon as the system for capturing and processing images has defined the optimum puncture location, the puncture head is placed in a sampling position by the robotic arm. The head advances towards the limb of the patient to be punctured and the needle penetrates the skin in accordance with a predetermined angle, either via the target vein. The first collection tube conforming to the regulations is then inserted in the stopper-piercing needle in accordance with the mechanism described above.

[0119] The filling of the tube is carried out and when a predetermined filling level is reached (detected by the means for controlling the filling of the tubes), the filled tube is replaced with an empty tube of the barrel. This cycle of operations is repeated until the intended samples have been completed for the patient in question.

[0120] After all the samples have been carried out, the needle is withdrawn from the limb of the patient and the dressing present on the suction cup is applied to the limb of the patient in the region of the puncture location.