CANNULA INSERTION SYSTEM

Abstract

A cannula insertion system to insert a cannula into a human or animal body, includes: one or more sensors to determine a suitable location for insertion of the cannula, a cannula insertion device configured to insert the cannula into the human or animal body, a cannula insertion device positioning system to support and position the cannula insertion device, and a control device arranged to control the positioning system to position, on the basis of the determined location for insertion of the cannula, the cannula insertion device in a suitable position to insert the cannula into human or animal body, where the cannula insertion system includes a blood collection system to collect blood in one or more blood collection tubes supported by the blood collection system, where the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device.

Claims

1. A cannula insertion system to insert a cannula into a human or animal body, comprising: one or more sensors to determine a suitable location for insertion of the cannula, a cannula insertion device configured to insert the cannula into the human or animal body, a cannula insertion device positioning system to support and position the cannula insertion device, and a control device arranged to control the positioning system to position, on the basis of the determined location for insertion of the cannula, the cannula insertion device in a suitable position to insert the cannula into human or animal body, wherein the cannula insertion system comprises a blood collection system to collect blood in one or more blood collection tubes supported by the blood collection system, wherein the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device.

2. The cannula insertion system of claim 1, wherein the blood collection system is mounted on the cannula insertion device positioning system to at least partly follow movements of the cannula insertion device.

3. The cannula insertion system of claim 1, wherein the cannula insertion device positioning system is arranged to move the cannula insertion device between an operating position from which a cannula may be inserted into the human or animal body, and a retracted position.

4. The cannula insertion system of claim 1, wherein the cannula insertion device positioning system comprises at least one movable stage, wherein the blood collection system is mounted on the at least one stage.

5. The cannula insertion system of claim 1, wherein the cannula insertion system comprises a blood collection tube exchange system to exchange blood collection tubes between a blood collection tube input device and the blood collection system.

6. The cannula insertion system of claim 5, wherein the blood collection system comprises an actuator to invert and/or rotate a blood collection tube during or after being filled with blood from the human or animal body.

7. The cannula insertion system of claim 1, wherein each cannula comprises a patient needle to be inserted into a patient, a tube needle to be inserted in a blood collection tube and a conduit connecting the patient needle and the tube needle.

8. The cannula insertion system of claim 3, wherein, in the retracted position, the blood collection tube exchange system may exchange one or more blood collection tubes supported by the blood collection system

9. The cannula insertion system of claim 1, wherein the cannula insertion system comprises a cannula exchange system to exchange a cannula held by the cannula insertion device, and wherein the cannula exchange system is arranged to dispose a used cannula in a cannula disposal container.

10. The cannula insertion system of claim 3, wherein, in the retracted position, the cannula exchange system may exchange a cannula with the cannula insertion device.

11. The cannula insertion system of claim 9, wherein the cannula exchange system is arranged to select the cannula from a cannula supply comprising multiple cannulas.

12. The cannula insertion system of claim 1, wherein the suitable location is located on or in an arm of a human, and wherein the one or more sensors are arranged to determine a shape of the arm and/or a location of an elbow pit of the human.

13. The cannula insertion system of claim 1, wherein the cannula insertion system comprises an end-effector supporting the one or more sensors and the cannula insertion device.

14. The cannula insertion system of claim 1, wherein the cannula insertion system is arranged to insert a cannula into a vein of the human or animal body.

15. The cannula insertion system of claim 14, wherein the one or more sensors provide at least one sensor signal, and wherein the control device is arranged to create on the basis of the at least one sensor signal an image of the vein suitable for insertion of the cannula.

16. The cannula insertion system of claim 1, wherein the cannula insertion system comprises a pressure applicator arranged to apply pressure on the insertion location after removal of the cannula from the insertion location.

17. The cannula insertion system of claim 16, wherein the pressure applicator comprises a bandage support to support a bandage with which pressure is exerted on the insertion location.

18. The cannula insertion system of claim 1, wherein the system comprises a patient or treatment identification device.

19. The cannula insertion system of claim 1, wherein the cannula insertion system comprises a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient.

20. The cannula insertion system of claim 19, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the holding force is within a predefined holding force range, and to abort the cannula insertion procedure if the holding force is outside the predefined holding force range.

21. The cannula insertion system of claim 19, wherein the hand grip, or at least a part thereof, is movable between a stand-by position and an activated position, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the hand grip or the movable part thereof is arranged in the activated position, and to abort the cannula insertion procedure if the hand grip or the movable part thereof is arranged in the stand-by position.

22. The cannula insertion system of claim 1, wherein the cannula insertion system comprises a tourniquet device, wherein the tourniquet comprises a safety release device to release the tourniquet from a patient's arm or to release the tourniquet from the cannula insertion system if a pulling force exceeds a pulling force threshold.

23. The cannula insertion system of claim 1, wherein the blood collection tube exchange system comprises a blood quantity sensor arranged to provide a blood quantity signal representative for a quantity of blood present in a blood collection tube.

24. The cannula insertion system of claim 1, wherein the one or more sensors are arranged to determine one or more locations of nerves, and wherein the control device is arranged to prevent the insertion of the cannula into the nerves.

25. The cannula insertion system of claim 1, wherein the cannula insertion system comprises a blood presence sensor located near, on or in the cannula arranged to determine the presence of blood in the cannula.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0088] Further characteristics and advantages of the cannula insertion system of the invention will now be explained by description of an embodiment of the invention, whereby reference is made to the appended drawings, in which:

[0089] FIG. 1 shows schematically a first part of a cannula insertion system according to an embodiment of the invention comprising an end-effector supporting a contact sensor and a cannula insertion device;

[0090] FIG. 2 shows schematically a second part of the cannula insertion system according to an embodiment of the invention comprising a pressure applicator and arm rest;

[0091] FIG. 3 shows schematically a third part of the cannula insertion system according to an embodiment of the invention comprising a cannula exchange system;

[0092] FIG. 4 shows schematically a fourth part of the cannula insertion system according to an embodiment of the invention comprising a blood collection tube exchange system; and

[0093] FIGS. 5 and 6 show an embodiment of a cannula insertion system according to an embodiment of the invention; and

[0094] FIG. 7 shows an embodiment of a blood collection system according to an embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0095] FIGS. 1-4 show parts of a cannula insertion system, generally denoted by reference numeral 1. FIGS. 1-4 are used to show different parts of a cannula insertion system 1 to describe/show different elements/devices of the cannula insertion system 1 and explain their function. In practice, the different devices/element may be arranged close to each other and would be visible in the different Figures. Thus, some parts shown in one or more of the figures are deliberately not shown in other Figures. Also, not all devices/elements are drawn to scale with respect to the other devices/elements shown in the same or other Figures.

[0096] The cannula insertion system 1 is configured to autonomously insert a cannula 2, for example a needle into a blood vessel V of a human or animal. The cannula insertion system 1 as shown in FIG. 1 is in particular configured to autonomously draw blood from a blood vessel. In alternative embodiments, the cannula insertion system 1 may be configured to arrange a cannula in a blood vessel V for intravenous medication and/or infusions.

[0097] To draw blood from the blood vessel V, the cannula insertion system 1 may be arranged to determine a location of a blood vessel underneath the skin S of the human or animal, insert a cannula 2 into the blood vessel V and draw blood from the blood vessel V without direct interaction of an operator of the cannula insertion system 1.

[0098] The cannula insertion system 1, shown on FIG. 1, comprises an ultrasound transducer 3 to obtain one or more sensor signals that are representative for the location of a blood vessel V in the human or animal. The ultrasound transducer 3 is a contact sensor. During use contact between the ultrasound transducer 3 and the skin S is required in order to obtain relevant data with respect to the location of the blood vessel V. The ultrasound transducer may be guided along the skin S of the human or animal in a target area T. This target area T is an area of the skin S underneath which the presence of a blood vessel V suitable for insertion of a cannula 2 is expected and which is examined by the ultrasound transducer 3. A control device 5 controls the position of the ultrasound transducer 3.

[0099] The target area T may be determined by obtaining images of the skin of a human or animal, for example using NIR (near infrared), infrared or visible light sensors 15, and determining on the basis of the images an area in which it is likely that a blood vessel suitable for insertion of a cannula will be found. The cannula insertion system 1 has multiple fixed sensors, i.e. sensors mounted at a fixed location, such as sensor 15. These multiple fixed sensors may be used to determine the target area, i.e. an approximate location of a blood vessel that can be used for insertion of the cannula 2. In an alternative embodiment, one or more of these NIR or visible light sensors may be arranged on a movable end-effector 4.

[0100] In addition, or as an alternative the fixed sensors 15 may be used to determine a location of the elbow pit of the arm and/or the shape of the arm. The sensors 15 could also be used to detect areas which should not be used for venipuncture, like birthmarks and wounds.

[0101] Once a target area T is determined, the ultrasound transducer 3 may be used to provide a sensor signal representative for a location of the blood vessel V within the target area T. The sensor signal is fed into a processing device 6 which is arranged to process the sensor signal. The control device 5 and the processing device 6 may be comprised in a single processer 7, such as a PC.

[0102] On the basis of the sensor signal provided by the ultrasound transducer 3, an image of the vein may be created by the processing device 6. This image may be based on multiple 2D images along a line in a certain direction, 3D coordinates and direction, 6D coordinates or may be a 3D image.

[0103] The processing device 6 determines on the basis of the sensor signal, or sensor signals, the location of a blood vessel V suitable for the insertion of the cannula 2. On the basis of this location, the processing device 6 may determine an insertion path for insertion of the cannula 2 into the blood vessel V. The processing device 6 may also locate nerves and prevent from penetrating those nerves, when selecting an insertion path for the cannula 2.

[0104] If no suitable location for insertion of the cannula 2 can be found, the cannula insertion system 1 may request the patient to place the other arm in the cannula insertion system 1.

[0105] The cannula 2 is arranged on a cannula insertion device 8. The cannula 2 is held by a cannula holder 10. The cannula 2 can be taken out of the cannula holder to facilitate exchange of cannulas 2.

[0106] The cannula insertion device 8 is arranged to insert the cannula 2 in an insertion direction ID through the skin S and into the blood vessel V along the insertion path determined by the processing device 6. The cannula insertion device comprises a rotation actuator to adjust an insertion angle of the cannula 2 to align a longitudinal axis of the cannula 2 with the insertion direction ID. A linear actuator is provided to translate the cannula 2 along an insertion path in the insertion direction ID.

[0107] The insertion path of the cannula 2 may be adapted to anatomical structures in the arm of the patient. By adapting the position of the cannula insertion device 8 during insertion of the cannula 2, the cannula 2 may also be moved along a non-linear insertion path.

[0108] The cannula insertion device 8 may be provided with a force sensor with which the axial force exerted on the cannula 2 may be measured. By measuring the axial force exerted on the cannula 2, it can be determined when the wall of a vein is penetrated by the cannula 2. Further, this axial force on the cannula 2 may be compared with a maximum allowable axial force. Insertion of the cannula 2 may be stopped or at least the insertion speed may be lowered when this axial force exceeds this maximum allowable axial force.

[0109] The cannula insertion device 8 may comprise a safety device arranged to retract the cannula 2 or to release the cannula 2 from the cannula insertion device 8 when a force exerted on the cannula 2 in a direction perpendicular to the insertion direction ID results in exceeding a respective safety threshold value. The release of the cannula 2 from the cannula insertion device 8 may be a complete release or a release in a limited number of degrees of freedom, for example one or two rotation directions. The safety device may for example allow to freely rotate in the rotation direction in which a torque is exerted on the cannula when this torque exceeds a safety threshold value in order to follow an inadvertent movement of the human or animal body.

[0110] The cannula insertion device 8 is supported by a positioning system 9, for example a robot arm, that is arranged to bring the cannula insertion device 8 in a position from which the cannula insertion device 8 may move the cannula 2 along the insertion path. The cannula insertion device 8 and the positioning system 9 are controlled by the control device 5.

[0111] In some cases, a vein positioned below the ultrasound transducer 3 may displace due to the pressure exerted with the ultrasound transducer 3. This may also be referred to as a ‘rolling vein’. When this occurs, this may be determined on the basis of the measurements of the ultrasound transducer 3. The cannula insertion system 1 may be configured to control the cannula insertion device 8 to actively follow the movement of the vein. In addition, or as an alternative, a mechanism may be provided to prevent displacement of the vein, for example by arranging two mechanical elements on the skin surface at opposite sides of the vein. Also, it is possible to abort the cannula insertion procedure when displacement of the vein is measured by the ultrasound transducer 3.

[0112] In the embodiment shown in FIG. 1, the ultrasound transducer 3 and the cannula insertion device 8 are mounted on a single end-effector 4. This ensures a fixed spatial relationship between the ultrasound transducer 3 and the cannula insertion device 8. The positioning system 9 is therefore used for positioning of both the ultrasound transducer 3 and the cannula insertion device 8. In an alternative embodiment, the ultrasound transducer 3 may be held in a fixed spatial relationship with the cannula 2, such that the tip of the cannula 2 can be tracked very accurately.

[0113] The cannula insertion system 1 comprises a patient or treatment identification device 20. The patient or treatment identification device 20 is configured to read an identification of the patient. Such identification may for example be an identity card, token or chip, a passport, a hospital identity card, token or chip or a letter with barcode, or an insurance card. The patient or treatment identification device 20 may comprise any suitable reader or scanner to read/scan the information provided by the identification of the user. The patient or treatment identification device 20 may be connected with a central information system, such as an electronic patient file, a laboratory information system (LIS) or other system and may receive all data required for that patient for carrying out a cannula insertion procedure. After the identity of a patient has been determined, the identity of the patient may be confirmed, for example by providing an audible or readable output to the patient that has to confirmed by the patient.

[0114] The cannula insertion system 1 may comprise an emergency button that can be operated by the operator and/or the patient. When this emergency button is operated, the cannula insertion system will start abort procedure, in which the cannula insertion process is safely stopped.

[0115] The cannula insertion system 1 may further comprise a patient interface, for example a display device that can be seen by the patient.

[0116] The patient interface can be used to provide instructions to the patient, for example to reposition an arm, to provide information with respect to the cannula insertion procedure, such as the remaining time of the procedure, and/or display media, such as a video, that may distract the patient from the procedure. The patient interface may also be used for patient input. For example, the patient may be requested to respond to questions, such as the confirmation of the identity of the patient, the use of anticoagulation, etc.

[0117] Similarly, the cannula insertion system 1 may comprise an operator interface, such as a display device or communication device to provide relevant information with respect to the cannula insertion procedure to the operator. This operator interface may for example provide a sound or visual alarm system to inform the operator that the patient request help. This operator interface may comprise a digital communication device that sends data to a remote device, e.g. a smart watch or tablet device.

[0118] FIG. 2 shows a second part of the cannula insertion system 1. The cannula insertion system 1 comprises an arm rest 21 on which the patient can place his arm. The armrest 21 may be adjustable in height based on the length/size of the patient. This height adjustment may be automatically or manually.

[0119] A hand grip 22 to be held by a hand of a patient is arranged on the armrest 21. The hand grip 22 is configured to measure a holding force with which the hand grip 22 is held by the patient. The hand grip 22 comprises a holding force sensor 23 with which this holding force can be measured. This holding force can be used to monitor the patient's well-being during the insertion of a cannula into the patient. It may be possible that a patient faints during the cannula insertion procedure.

[0120] To monitor the patient's well-being, the patient is requested to hold the hand grip 22 with a minimum holding force. This holding force is measured by the holding sensor 23. As long as the holding force is within a predefined holding force range, the procedure may be continued. As soon as the holding force is outside the predefined holding force range, i.e. below a lower threshold holding force or above an upper holding force threshold, the cannula insertion procedure may be aborted. In an alternative embodiment, one or more warning signals may first be provided to the patient to increase or decrease the holding force. When the holding force within a certain predefined time interval is not increased/decreased by the patient to a holding force within the predefined holding force range, the cannula insertion procedure may be aborted. In an alternative embodiment, the cannula insertion system may only provide warning signals when the holding force is outside the predefined holding force range.

[0121] In addition, or as an alternative, the hand grip 22 can be movable, for example slidable, between a standby-position (shown in solid lines) and an activated position (shown in dashed lines). The hand grip 22 may be biased, for example by a biasing spring, to the stand-by position. At the start of the procedure the patient is requested to move the hand grip 22 to the activated position. In this position, the cannula insertion system 1 may carry out a cannula insertion procedure. When the hand grip 22 is moved back into the stand-by position, for example when the patient faints and the biasing spring pushes the hand grip 22 back to the stand-by position, the cannula insertion system 1 is arranged to abort the cannula insertion procedure. Instead of the whole hand grip 22, it is also possible that only a part of the hand grip 22 is movable between a stand-by position and an activated position.

[0122] In an embodiment, the hand grip 22 could also comprise a humidity sensor arranged to measure humidity between the hand grip 22 and a hand of a patient in order to measure sweating of a patient. When increased sweating is determined by this humidity sensor a warning signal could be provided to the operator to check the patient.

[0123] Also, a camera can be provided in the cannula insertion system 1 to monitor the patient, for example to detect his face with for example face recognition. On the basis of face recognition, it may for example be determined that the patient faints. As soon as this is determined, a warning signal may be provided and/or the cannula insertion procedure may be aborted. Further, the cannula insertion system 1 may comprise one or more cameras or other sensors arranged to detect an object intruding into the workspace of the positioning system, for example a hand of a child and the cannula insertion system 1 may be arranged to abort the cannula insertion procedure when such intrusion is detected. Cameras or other sensors may also be arranged to detect the position of the arm of a patient. If the position of the arm of the patient is not correct, i.e. needs to be repositioned, a corresponding instruction can be provided to the patient or operator.

[0124] The cannula insertion system 1 further comprises a tourniquet device 24 to hold the upper arm of a patient during the cannula insertion procedure. The tourniquet device comprises a strap or band 25 which may be manually or automatically tightened on the upper arm of a patient. The pressure with which the tourniquet device 24 is automatically tightened around the upper arm of the patient may be made dependent on the patient itself, on the basis of the identification of the patient by the patient or treatment identification device 20 shown in FIG. 1.

[0125] The tourniquet device 24 may also comprise an inflatable cuff that is tightened around the upper arm of a patient. In such embodiment, the inflatable cuff may also be used to measure a blood pressure of the patient.

[0126] The tourniquet device 24 may comprises a safety release device to release the tourniquet from a patient's arm or to release the tourniquet from the cannula insertion system if a pulling force on the tourniquet device 24 exceeds a pulling force threshold.

[0127] The safety release device could further be configured to release the upper arm when the time period in which the tourniquet device 24 is tightened around the upper arm of the patient exceeds a predefined maximum time period and/or when the pressure which is exerted by the tourniquet device 24 exceeds a predefined maximum pressure. This predefined maximum time period and/or predefined maximum pressure may be patient specific.

[0128] The safety release device may be configured to reduce the pressure exerted on the upper arm by loosening the strap or band 25, or by releasing the pressure in the inflatable cuff. Any other way or device to reduce the pressure within a short time period may also be applied.

[0129] The tourniquet device 24, or at least its band or strap 25 may be detachable so that it can be replaced and potentially be cleaned separately from the cannula insertion system 1. In an alternative embodiment, the strap or band 25 may be provided in a roll. The roll may be used to use for each patient a new strap or band 25 which is rolled from the roll. The tourniquet device 24 may also have a cleaning device to clean the tourniquet device 24 between two patients.

[0130] After retraction of the cannula 2 from the human or animal body, it may be needed to apply pressure on the penetration location where the cannula 2 has penetrated the skin to stop bleeding caused by the introduction of the cannula into the human or animal body. The cannula insertion system 1 comprises a pressure applicator 26 arranged to apply pressure on the penetration location of the cannula 2 after retraction of the cannula 2 from the insertion location. The pressure applicator 26 comprise a pressure element 27 which has a cylindrical shape wherein the longitudinal axis of the cylindrical shape is arranged substantially parallel to the skin surface on which a pressure should be exerted. In other embodiments the pressure element may be plate shaped or have any other suitable shape. The pressure applicator 26 is advantageously configured to automatically place, using the positioning system 28 the pressure element 27 at the penetration location and exert a suitable force with this pressure element 27.

[0131] In an alternative embodiment the pressure applicator 26 may be mounted on the end-effector 4 together with the cannula insertion device 8 and/or the ultrasound transducer 3.

[0132] The pressure applicator 26 comprises a bandage support to support a bandage 29 with which pressure is exerted on the insertion location. The pressure element 27 will press the bandage 29 against the skin at the penetration location to stop bleeding of the patient.

[0133] The use of a bandage 29 has the advantage that the pressure element may not have to be cleaned each time when the pressure element is used to exert a pressure on the skin. Since the bandage 29 will act as a barrier between the pressure element 27 and the insertion location in the arm of patient.

[0134] Furthermore, the bandage support, in this embodiment in the form of a carrier film 30 may be configured to hold the bandage 29 until the pressure applicator 26 is used to apply the pressure on the skin and then release the bandage 29. The bandage 29 may remain on the skin of the human or animal body to be used to further stop bleeding.

[0135] In an embodiment, the bandage may be a self-sealing bandage that is arranged on the skin surface before the insertion of the cannula into the patient. The cannula may be introduced into the patient through the bandage. After removal of the cannula, the bandage will seal the opening made by the cannula and seal the insertion location.

[0136] The carrier film 30 with releasable bandage 29 is rolled from a roll held by the pressure applicator 26. The carrier film 30 will be rolled up on another roll supported by the pressure applicator 26 after the bandage 29 is released from the carrier film 30. The bandage 29 may be made of any suitable material such as cotton of other known bandage material.

[0137] In an alternative embodiment, the roll with releasable bandage may be provided at any other suitable location of the cannula insertion system 1.

[0138] The pressure applicator 26 may be configured to apply the pressure during a predetermined time period. This may be a fixed time period, or a time period dependent on factors such as patient characteristics, such as age and anticoagulation factors, and other factors such as needle diameter. These factors may be known from the input at the patient or treatment identification device 20, or may be based on manual input from the patient or the operator.

[0139] FIG. 3 shows a part of the cannula insertion system 1 comprising a cannula exchange system 31 to exchange a cannula 2 held by the cannula insertion device 8. For each insertion of a cannula 2 into a human or animal body a new disposable cannula 2 should be used. The cannula exchange system 31 comprises a cannula supply 32 in which multiple cannulas 2 are stored and a cannula disposal container 33 in which used cannulas 2 may be disposed.

[0140] The cannula exchange system 31 comprises a displacement device 34, for example a robotic arm, to take a cannula 2 from a supply area at or near the cannula supply 32 where a cannula 2 is taken from the cannula supply 32 to a loading area where the cannula is loaded on the cannula insertion device 8 by coupling the cannula 2 to the cannula holder 10. After the cannula 2 is used the displacement device may take the cannula 2 from the cannula holder 10 to a discharge area where the cannula 2 may be discharged into the cannula disposal container 33.

[0141] The displacement device 34 is a separate movement device. In practice, the displacement device may have two robotic arms or other manipulators, one for taking a cannula 2 from the cannula supply 32 and coupling the cannula 2 on the cannula holder 10, and one for discharging the cannula 2 from the cannula holder into the cannula disposal container 33. One of the robotic arms or manipulators may be formed by the cannula insertion device positioning system.

[0142] In another embodiment, the positioning system 9 is used to move the cannula insertion device 8 to a suitable location to take a cannula 2 from a supply area at or near the cannula supply 32 and to discharge a used cannula 2 into the cannula disposal container 33. In such embodiment, the displacement 34 may be omitted.

[0143] The cannula disposal container may be any container suitable to receive cannulas after their use. The cannula disposal container may be disposable itself, so that it can be disposed together with the used cannulas, or the cannula can be emptied and placed back into the cannula insertion system, preferably after cleaning and disinfection.

[0144] The cannula supply 32 may comprise multiple types of cannulas 2 as shown in FIG. 3, such as cannulas having different needle diameters or needle lengths. The cannula exchange system 31 is configured to select a cannula of a desired type. This selection may for example depend on the basis of an identity of a person in which the cannula 2 will be inserted, and an associated type of cannula 2. The selection of the cannula 2 may also depend on the size and location of the vein in which the cannula 2 will be inserted.

[0145] The cannula supply 32 may also comprise cannulas 2 that comprise at or near its distal end a blood contact sensor. Such blood contact sensor can be used to determine the actual entrance of the cannula into a blood vessel. By determining the actual entrance of the cannula into the blood vessel, this actual entrance can be compared with the expected entrance of a blood vessel on the basis of the cannula insertion path as determined by the control device of the cannula insertion system.

[0146] This confirmation of the entrance of the blood vessel can be used to determine whether the cannula insertion path is correctly followed. When there is a large difference between the actual entrance of a blood vessel as measured with a blood contact sensor and the expected entrance of a blood vessel on the basis of the cannula insertion path, the cannula insertion procedure may be stopped as a safety measure.

[0147] FIG. 4 shows a blood collection tube exchange system 40 that can be used in the cannula insertion system 1 to exchange blood collection tubes 41.

[0148] During blood drawing of blood from a patient a blood collection tube 41 is connected to the cannula 2. The blood collection tube 41 is for example held by a tube holder 43 of a blood collection system.

[0149] A blood quantity sensor 45 may be arranged to provide a blood quantity signal representative for a quantity of blood present in the blood collection tube 41. With the blood quantity sensor 45 it can be determined whether the blood collection tube 41 is filled with blood to a desired filling level. The blood quantity sensor 45 may be an optical sensor that can determined a blood level in the blood collection tube 41. Other types of sensors may also be used to determine the quantity of blood in the blood collection tube 41.

[0150] During blood withdrawal, it may be desirable that multiple blood collection tubes are filled with blood.

[0151] The blood collection tube exchange system 40 is configured to select the respective blood collection tubes from a blood collection tube storage 42 in which multiple types of blood collection tubes 41 may be stored. The blood collection tube storage 42 may also function as a blood collection tube input device into which blood collection tubes are manually introduced.

[0152] It may be desirable that, for a specific patient, blood collections tubes of a set of pre-selected blood collections tubes 41 are subsequently filled with blood drawn from a blood vessel of one patient. The set of pre-selected blood collections tubes 41 may be arranged in a cartridge 46. The cartridge 46 may define one or more holding positions for holding the one or more pre-selected blood collection tubes 41. The cartridge 46 may be designed in such a way that the one or more blood collection tubes can manually be easily arranged in the cartridge 46, but that it relatively hard to take the blood collection tubes manually out of the cartridge 46. This may prevent that a person may advertently or inadvertently one or more blood collection tubes 41 out of the cartridge 46. A blood collection tube removal device 47 may be provided in the cannula insertion system 1 to remove the blood collection tube 41 out of the cartridge once place in the cannula insertion system 1. The blood collection tube removal device 47 may comprise one or more pushers that are capable of pushing a blood collection tube 41 out of the cartridge 46.

[0153] In an embodiment, the blood collection tube exchange system 40 may further be configured to couple a selected blood collection tube 41 to the cannula to fill the blood collection tube to a desired filling level.

[0154] When the blood collection tube 41 is sufficiently filled, the blood collection tube 41 may be transferred to a blood collection tube release device 48, where the blood collection tube 41 can be taken out of the cannula insertion system 1.

[0155] The blood collection tube exchange system comprises a manipulator 44 to take a blood collection tube 41 out of the blood collection tube storage 42. In this embodiment, the manipulator 44 is arranged to couple the selected blood collection tube 41 to the cannula 2 by placing it in the tube holder 43. After the blood collection tube 41, is filled with blood to the desired level, the manipulator 44 may take the blood collection tube 41 from the tube holder 43 and transport it to blood collection tube release device 48. In practice, the blood collection tube storage 42 and the blood collection tube release device 48 may be integrated in a single device.

[0156] In another embodiment, the blood collection tube exchange system 40 and its manipulator 44 are used to load and unload the blood collection tubes 41 in and out a blood collection system as described with respect to the embodiment of FIGS. 5-7. In this embodiment, another device may be used to connect the cannula 2 to the respective blood collection tube 41.

[0157] The tube exchange system 40 may also be configured to invert, when desired, the filled blood collection tube 41 in order to mix a coagulant present in the blood collection tube 41 with the blood.

[0158] In an alternative embodiment, the positioning system 9 may be used to manipulate the blood collection tubes 41, for example to take a blood collection tube 41 out of the blood collection tube storage 42 and couple the selected blood collection tube 41 to the cannula 2 and/or, after filling, to take the blood collection tube 41 from the tube holder 43 and transport it to blood collection tube release device 48. In such embodiment, the manipulator 44 may be omitted.

[0159] The blood collection tube release device 48 may be arranged to label the blood collection tube 41. The blood collection tube release device 48 may also be configured to mix the content of blood tubes in a standardized way and/or to centrifuge the blood tube to separate serum and plasma from blood after blood draw so the time period until blood analysis is performed can be extended. The blood collection tube release device 48 may also be configured to resolve any remaining pressure difference of the filled blood collection tubes with the environment, in order to maintain the blood quality and prevent hemolysis.

[0160] The blood collection tube release device 48 may further be configured to perform blood test analysis after the blood is drawn at point-of-care. For example, a HIL test on Hemolysis, Icterus and Lipemia can be performed to determine sample quality.

[0161] In an embodiment, the blood collection tube release device 48 can be connected to a tube system (blood tube transportation system, e.g. pneumatic) that is directly connected with a laboratory.

[0162] In an embodiment, the filled blood collection tubes 41 can be placed back into the cartridge 46.

[0163] For hygienic reasons, the end-effector 4 and/or the ultrasound transducer 3 may be placed in a cover to protect against blood and bodily fluids. The cover could be a plastic cover, a bandage or a special fabricated shield. The cannula insertion system 1 may be arranged to automatically arrange the cover on the end-effector 4 and/or the ultrasound transducer 3 and to dispose it when desired.

[0164] Sensors, e.g. the cameras are able to check if the procedure is according plan and they can check if there are no blood drips on the armrest before the procedure starts/after the procedure.

[0165] In case of blood drips on arm rest, the device can signal to the operator that cleaning and disinfection is required.

[0166] The device can clean and disinfect itself, in particular the parts touching the patient at the venipuncture location, especially in the case of contact sensors

[0167] This cleaning can be done by automated brushing, washing, or wiping of (part of) the end-effector.

[0168] After cleaning, the parts can be dried to prepare for disinfection, for example through blowing of air or heating.

[0169] Disinfection may occur through closed UV-C chamber for a predetermined amount of time; alternatively, disinfection occurs through automated spraying, wiping and/or soaking.

[0170] FIGS. 5 and 6 show an alternative embodiment of a positioning system 60 for positioning of the end-effector 4. The positioning system 60 comprises a first stage 61 to move the end-effector 4 in x-direction, a second stage 62 to move the end-effector 4 in y-direction and a third stage 63 to move the end-effector in z-direction, wherein the x-direction, y-direction and z-direction are orthogonal directions. The positioning system 60 further comprising a connection arm 64 comprising three rotation actuators to rotate the end-effector 4 about each of the x-direction, y-direction and z-direction. This results in end-effector 4 being movable in six degrees of freedom to optimally position the end-effector 4 with respect to a human or animal body, for example a patient's arm.

[0171] The first stage 61 has a relatively long stroke that can be used to move the end-effector 4 between an operating position (FIG. 5) from which a cannula 2 may be inserted into the human or animal body, and a retracted position (FIG. 6). In dashed lines a housing 70 of the cannula insertion system 1 is shown. This housing 70 comprises a recess in which the cannula insertion device may at least partially be placed. During the insertion of the cannula 2 into a patient, the first stage 61 may be arranged in the operating position in which the end-effector 4 extends at least partially outside the housing 70. After blood withdrawal is finished, the end-effector 4 including the cannula insertion device 8 may be moved to the retracted position so that the cannula insertion device 8 no longer extends from the housing 70. In the retracted position, within the housing 70, the cannula insertion system 1 may exchange disposable parts such as a cannula and blood collection tubes filled during blood withdrawal. Also, new disposable parts may be provided to facilitate blood withdrawal of a subsequent patient. For example, in the retracted position of the end-effector 4, the cannula 2 and the blood collection tubes 41 may be exchanged.

[0172] The cannula 2 comprises a patient needle 71 to be inserted into a patient, a tube needle 72 to be inserted in a blood collection tube 41 and a conduit 73 connecting the patient needle 71 and the tube needle 72. The cannula 2 is provided as a disposable part. To fill a blood collection tube 41 with blood the tube needle 72 is inserted into the blood collection tube 41 and the patient needle 71 into a blood vessel of the human or animal body. Advantageously, the conduit 73 between the patient needle 71 and the tube needle 72 is relatively short so that a relatively low volume of blood is needed to fill the conduit 73. For this reason, the blood collection tubes 41 are held by a blood collection system 75 which is mounted on the first stage 61 of the positioning system 60. As a result, the blood collection system 75 will move together with the end-effector 4 between the operating position and the retracted position and will stay relatively close to the end-effector 4.

[0173] The blood collection system 75 comprises a carousel 76 comprising multiple holding locations each arranged to hold a blood collection tube 41 and a tube needle insertion device 77 to insert the tube needle 72 in a blood collection tube 41 aligned with the and pull the tube needle out of the blood collection tube 41 after the blood collection tube 41 has been filled with blood. The carousel 76 is rotatable about an axis of rotation extending in z-direction. By rotation about the axis of rotation a selected one of the holding locations can be aligned with the tube needle insertion device 77 to allow the tube needle 72 to be inserted into the blood collection tube held in the selected one of the holding locations. When the blood collection tube 41 is filled, the tube needle insertion device 77 may retract the tube needle 72 out of the blood collection tube 41 and a new holding location and blood collection tube 41 held therein may be aligned with the tube needle insertion device 76 by rotation of the carousel 76. When arranged in this position the tube needle insertion device 76 may insert the tube needle 72 into this new blood collection tube 41. To determine whether a blood collection tube is sufficiently filled a sensor may be provided that is capable of providing a level signal representative for sufficient filling of the blood collection tube 41. This sensor is for example a level sensor that can measure whether a predetermined level of blood in the blood collection tube 41 has been reached, for example by using a light beam.

[0174] FIG. 7 shows an actual embodiment of a blood collection system 75 that can be mounted on the first stage 61. The blood collection system 75 comprises a carousel 76 and a needle insertion device 77. The carousel 76 comprises multiple holding locations each arranged to hold a blood collection tube. The tube needle insertion device 77 comprises an actuator 78 to insert and withdraw the tube needle 72 into and from the blood collection tube 41 aligned with the needle insertion device 77. The tube holding locations are formed by tube holders 79 that are mounted tiltable on the carousel 76. To properly align the blood collection tubes 41 with the tube needle insertion device 77 of this embodiment, the tube holders 79 and the blood collection tubes 41 held therein are tilted with their top ends radially outwardly with respect to the axis of rotation of the carousel 76.

[0175] In an embodiment, the blood collection system 75 may comprise an actuator to invert and/or rotate a blood collection tube during or after being filled with blood from the human or animal body.

[0176] Again referring to FIGS. 5 and 6, in the retracted position of the end-effector 4, the cannula exchange system 31 is provided to exchange a cannula 2 held by the cannula insertion device 8 and a blood collection tube exchange system 40 to exchange blood collection tubes 41 held by the blood collection system 75. The cannula exchange system 31 may for example be embodied as described with respect to FIG. 3. The blood collection tube exchange system 40 may for example be embodied as described with respect to FIG. 4.

[0177] Embodiments of different aspects of the invention can be described as follows:

[0178] 1. A cannula insertion system to insert a cannula into a human or animal body, comprising:

[0179] one or more sensors to determine a suitable location for insertion of the cannula,

[0180] a cannula insertion device configured to insert the cannula into the human or animal body,

[0181] a cannula insertion device positioning system to support and position the cannula insertion device, and

[0182] a control device arranged to control the positioning system to position, on the basis of the determined location for insertion of the cannula, the cannula insertion device in a suitable position to insert the cannula into human or animal body.

[0183] 2. The cannula insertion system of embodiment 1, wherein the cannula insertion system comprises a blood collection system to collect blood in one or more blood collection tubes supported by the blood collection system,

[0184] wherein the blood collection system is movably arranged to at least partly follow movements of the cannula insertion device,

[0185] wherein the blood collection system for example is mounted on the cannula insertion device positioning system to at least partly follow movements of the cannula insertion device.

[0186] 3. The cannula insertion system of embodiment 1 or 2, wherein the cannula insertion device positioning system is arranged to move the cannula insertion device between an operating position from which a cannula may be inserted into the human or animal body, and a retracted position.

[0187] 4. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion device positioning system comprises at least one movable stage, wherein the blood collection system is mounted on the at least one stage.

[0188] 5. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system comprises a blood collection tube exchange system to exchange blood collection tubes between a blood collection tube input device and the blood collection system.

[0189] 6. The cannula insertion system of embodiment 5, wherein the blood collection system comprises an actuator to invert and/or rotate a blood collection tube during or after being filled with blood from the human or animal body.

[0190] 7. The cannula insertion system of any of the preceding embodiments, wherein each cannula comprises a patient needle to be inserted into a patient, a tube needle to be inserted in a blood collection tube and a conduit connecting the patient needle and the tube needle.

[0191] 8. The cannula insertion system of embodiment 3 and 5, wherein, in the retracted position, the blood collection tube exchange system may exchange one or more blood collection tubes supported by the blood collection system.

[0192] 9. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system comprises a cannula exchange system to exchange a cannula held by the cannula insertion device, and wherein the cannula exchange system is arranged to dispose a used cannula in a cannula disposal container.

[0193] 10. The cannula insertion system of embodiment 3 and 9, wherein, in the retracted position, the cannula exchange system may exchange a cannula with the cannula insertion device.

[0194] 11. The cannula insertion system of any of the embodiments 9-10, wherein the cannula exchange system is arranged to select the cannula from a cannula supply comprising multiple cannulas.

[0195] 12. The cannula insertion system of any of the preceding embodiments, wherein the suitable location is located on or in an arm of a human, and wherein the one or more sensors are arranged to determine a shape of the arm and/or a location of an elbow pit of the human.

[0196] 13. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system comprises an end-effector supporting the one or more sensors and the cannula insertion device.

[0197] 14. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system is arranged to insert a cannula into a vein of the human or animal body.

[0198] 15. The cannula insertion system of the preceding embodiment, wherein the one or more sensors provide at least one sensor signal, and wherein the control device is arranged to create on the basis of the at least one sensor signal an image of the vein suitable for insertion of the cannula.

[0199] 16. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system comprises a pressure applicator arranged to apply pressure on the insertion location after removal of the cannula from the insertion location.

[0200] 17. The cannula insertion system of the preceding embodiment, wherein the pressure applicator comprises a bandage support to support a bandage with which pressure is exerted on the insertion location.

[0201] 18. The cannula insertion system of any of the preceding embodiments, wherein the system comprises a patient or treatment identification device.

[0202] 19. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system comprises a hand grip to be held by a hand of a patient, wherein the hand grip is configured to measure a holding force with which the hand grip is held by the patient and/or a holding position in which the hand grip is held by the patient.

[0203] 20. The cannula insertion system of the preceding embodiment, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the holding force is within a predefined holding force range, and to abort the cannula insertion procedure if the holding force is outside the predefined holding force range.

[0204] 21. The cannula insertion system of embodiment 19 or 20, wherein the hand grip, or at least a part thereof, is movable between a stand-by position and an activated position, wherein the cannula insertion system is arranged to carry out a cannula insertion procedure if the hand grip or the movable part thereof is arranged in the activated position, and to abort the cannula insertion procedure if the hand grip or the movable part thereof is arranged in the stand-by position.

[0205] 22. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system comprises a tourniquet device, wherein the tourniquet comprises a safety release device to release the tourniquet from a patient's arm or to release the tourniquet from the cannula insertion system if a pulling force exceeds a pulling force threshold.

[0206] 23. The cannula insertion system of any of the preceding embodiments, wherein the blood collection tube exchange system comprises a blood quantity sensor arranged to provide a blood quantity signal representative for a quantity of blood present in a blood collection tube.

[0207] 24. The cannula insertion system of any of the preceding embodiments, wherein the one or more sensors are arranged to determine one or more locations of nerves, and wherein the control device is arranged to prevent the insertion of the cannula into the nerves.

[0208] 25. The cannula insertion system of any of the preceding embodiments, wherein the cannula insertion system comprises a blood presence sensor located near, on or in the cannula arranged to determine the presence of blood in the cannula.