NL2035285B1

NL2035285B1 - Cannula insertion system

Info

Publication number: NL2035285B1
Application number: NL2035285A
Authority: NL
Inventors: Gerardus Leonardus Hoevenaars Antonius; Gerhard Daniël Karssen Johannes; Robert Joseph Brian; Houdijn Beekhuis Johan; Olaf Overbeeke Toon; Cornelis Jonker Arris
Original assignee: Vitestro Holding B V
Priority date: 2023-07-06
Filing date: 2023-07-06
Publication date: 2025-01-13
Also published as: WO2025008532A1

Abstract

The present technology provides a cannula insertion system to insert a cannula into a patient, comprising: a cannula insertion device configured to insert the cannula at an insertion location into the patient, and a bandage applicator configured to arrange a bandage on the skin of the patient, wherein the bandage applicator comprises at least one bandage holder to releasably hold the bandage and wherein the bandage applicator is arranged to place a bandage at or 10 near the insertion location before complete retraction of the cannula from the insertion locaﬁon.

Description

P36257NLO0/MVM

Cannula insertion system

The present technology relates to a cannula insertion system for inserting a cannula into a body part of a patient.

WO21140116 A1 discloses a cannula insertion system. In an embodiment, the cannula insertion system comprises a pressure applicator arranged to apply pressure on the insertion location after retraction of the cannula from the insertion location. The pressure applicator may comprise a pressure element, such as a pressure plate or pressure body which is pressed on the skin at the insertion location.

The pressure applicator of WO21140116 A1 may comprise a bandage support to support a bandage with which pressure is exerted on the insertion location. The pressure element may press a bandage which is arranged between the pressure element and the insertion location against the skin at the insertion location to stop bleeding of the patient. The use of a bandage 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. Furthermore, the bandage support may be configured to hold the bandage until the pressure applicator is stopped to apply the pressure on the skin and then release the bandage. The bandage may remain on the skin of the body of the patient to be used to stop further bleeding.

It is an object of the present technology to provide a cannula insertion system with an improved pressure applicator and/or bandage applicator, or at least to provide an alternative.

The present technology relates to a cannula insertion system to insert a cannula into a patient, comprising: a cannula insertion device configured to insert the cannula at an insertion location into the patient, and a bandage applicator configured to arrange a bandage on the skin of the patient, wherein the bandage applicator comprises at least one bandage holder to releasably hold the bandage and wherein the bandage applicator is arranged to place a bandage at or near the insertion location before complete retraction of the cannula from the insertion location.

The bandage applicator is arranged to position the bandage supported by the bandage applicator at or near the insertion location before complete retraction of the cannula from the insertion location, i.e. the cannula being arranged at least partially in the body of the patient. At or near the insertion location means that the bandage is arranged close to the skin such that the bandage at least partially covers the insertion location to shield and/or absorb any potential blood, such as blood splatters, to prevent blood from contacting any other part of the cannula insertion system.

Additionally, in some embodiments, any pressure exerted on the insertion location by the bandage applicator may avoid preventing the cannula from being retracted from the insertion location and/or may avoid applying pressure on the cannula that could result in pain or damage of the skin or blood vessels of the patient due to the cannula still being partially present in the insertion location.

The bandage applicator of the present technology does therefore not have the drawback of the pressure applicator of WO21140116 A1 that the pressure applicator with an associated bandage can only be placed on the insertion location after the cannula has been completely retracted from the body of the patient with the associated result that any blood that will come from the body, for example due to retraction of the cannula from the insertion location, which provides a substantial risk of contamination of the cannula insertion system.

Advantageously, the bandage applicator may be arranged to place a bandage in contact with the skin at or near the insertion location before complete retraction of the cannula without exerting a substantial pressure on the bandage at the insertion location. As a result, the insertion location can be effectively shielded for preventing transfer of any blood present at the insertion location and/or on the cannula, for example blood spatters that result from retraction of the cannula.

In an alternative embodiment, the bandage applicator may be arranged to place a bandage almost in contact with the skin, e.g., holding the bandage less than 10 mm above the skin at the insertion location, for example less than 5 mm above the skin at the insertion location. Since the bandage is not pressed on the insertion location, for example by the pressure exerted by a pressure element, the bandage can still provide an option to allow a retracting movement of the cannula out of the body of the patient. Additionally or alternatively, the bandage applicator may be arranged to move the bandage directly after retraction of the cannula from the insertion location, to the skin of the patient to shield the insertion location and/or to absorb any blood at the insertion location, for example at a high speed.

The bandage to be used in combination with the cannula insertion system of the present technology may be any bandage suitable to be placed by the bandage applicator of the present technology on the skin of the patient.

In some embodiments, the bandage comprises: a flat bandage body comprising at least one fluid impermeable layer, an adhesive layer arranged on a skin side of the bandage body at at least two opposite regions of the bandage body to stick the bandage to the skin of the patient, and 2 a padding arranged on the skin side of the bandage body between the two opposite regions.

The bandage body may comprise one or more layers of material. The fluid impermeable layer of the bandage body prevents fluid, such as blood, from passing through the bandage from the skin side to the other side of the bandage. The fluid impermeable layer may also be advantageous to hold the bandage, for example when using a vacuum suction force. The fluid impermeable layer (and/or other suitable layer in the bandage body) may be non-transparent (e.g., opaque) such that that any blood present at the skin side of the bandage, for example in the padding, cannot be seen through the bandage body when the bandage is placed on the skin of the patient.

The padding may include any material capable of absorbing blood, such as cotton or cotton wool. The padding may be arranged in a central part of the skin side of the bandage body such that the padding is placed on the wound at the insertion location that is created by penetration of the cannula through the skin of the patient.

The adhesive layer may be arranged on the surface of the skin side of the bandage body at least at two opposite regions of the bandage. As a result, the padding will be arranged between the two adhesive regions having an adhesive layer. These two regions may be separate areas with an adhesive material, for example separated by a region of padding that runs from one edge of the bandage body to an opposite edge of the bandage body, between the two adhesive regions. As an alternative the two regions having an adhesive layer may be joined to one another, such as formed by one adhesive layer arranged on the skin side of the bandage body. For example, the padding may be in a central part of the bandage and completely surrounded by an adhesive layer. If the padding runs up to one edge of the bandage body, the adhesive layer may be arranged in a C-shape around the padding.

The bandage is generally a flat object having a rectangular, square, round, oval, hexagonal, or other suitable shape.

As an alternative for the above bandage, the bandage may not have any adhesive layers at its skin side to adhere the bandage to the skin of the patient. Such non-adhesive bandage cannot be adhered to the skin of the patient by the bandage applicator. Instead, the bandage applicator may be configured to hold the bandage after pressing it on the insertion location and dispose it in a disposal contained after use. The bandage may also stay on the skin of the patient. The bandage may for example be taped to the skin by an operator or the patient may be instructed to hold the bandage after the procedure is ended, for example in combination with applying manual pressure on the insertion location. The bandage without adhesive layer may for example be a cotton or cotton wool pad. 3

Further, the bandage applicator, or more generally, the cannula insertion system, may be arranged to apply a topical hemostatic agent at the insertion location. Such a hemostatic agent may cause vasoconstriction and/or promote platelet aggregation In order to help stop bleeding at the insertion location. In some embodiments, the topical hemostatic agent may be applied on the skin side of the bandage before the bandage is applied to the skin of the patient. This may be done in the cannula insertion system or at a bandage production facility.

Additionally or alternatively, the cannula insertion system, for example the bandage applicator, may comprise a hemostatic agent applicator to apply a topical hemostatic agent on the insertion location before a bandage is applied to the skin of a patient. The hemostatic agent applicator may for example include a sprayer configured to spray a topical hemostatic spray on the insertion location.

The topical hemostatic agent may also be used as an alternative for the bandage. A cannula insertion system without having a bandage applicator may comprise an applicator to apply a topical hemostatic agent, for example a sprayer configured to spray a topical hemostatic spray, on the insertion location to stop bleeding. This topical hemostatic agent may be applied in combination with a pressure element pressing on the insertion location to stop bleeding.

In some embodiments, the bandage applicator is arranged to place the bandage at or near the insertion location before complete retraction of the cannula from the insertion location such that during retraction of the cannula, the cannula is at least partially swiped along the bandage to remove or absorb any blood from the cannula.

When the cannula is retracted from the body of the patient, for example out of an arm of the patient, blood may be present on or in the distal end of the cannula. The risk that any blood present on or in the distal end of the cannula may contaminate the cannula insertion system or will drip on a body part of the patient is undesirable. To prevent this, the cannula may be swiped along the bandage when the cannula is retracted from the insertion location.

This swiping along the padding results in that blood present on or in the tip of the cannula may be absorbed by the padding. For example, the cannula may be moved in contact with and along a bandage that is held stationary, a bandage may be moved in contact with and along the cannula that is held stationary, or both the cannula and the bandage may be moved in contact with and along each other.

In an embodiment, the bandage applicator may be arranged to apply the bandage to the skin of the patient before the cannula is inserted into the body of the patient. In some embodiments in which the bandage is applied before insertion of the cannula, the cannula may be inserted into the body of the patient through the bandage. The bandage may be adapted to facilitate insertion of the cannula through the bandage. Such bandage could for example have a self-sealing layer, e.g., a layer in the bandage that becomes fluid tight after 4 retraction of the cannula from the insertion location and out of the bandage. This prevents that the bandage will leak through the puncture hole in the bandage created by the cannula.

In some embodiments, the bandage applicator may be arranged to apply part of the bandage to the skin of the patient, such as by applying one adhesive region of the bandage at the insertion location adjacent to the site of cannula insertion (e.g., without covering the exact point where the cannula is to be inserted) to facilitate insertion of the cannula without requiring insertion of the cannula through the bandage. In such embodiments, at least a portion of the bandage may be adapted to bend or fold backwards (e.9g., in a direction away from the skin-facing surface of the bandage) to provide more room for manipulating the cannula in and around the insertion location. For example, the bandage may include flexible materials and/or scoring to help facilitate bending or folding in a direction opposite the skin- facing surface of the bandage, such as away from the skin-adhering side or the padding.

In an embodiment, the bandage applicator is arranged to releasably hold a single bandage. By holding a single bandage by the at least one bandage holder of the bandage applicator, the dimensions of the bandage applicator can generally be smaller than an embodiment in which multiple bandages are held by the bandage applicator. Furthermore, a bandage applicator with multiple bandages may have an increased risk of contamination of a bandage to be used for a future application, for example a subsequent venipuncture, as this bandage will typically be arranged close to the bandage being applied to the insertion location. The single bandages can be supplied by a bandage supply unit having a supply of bandages, wherein the bandage applicator is arranged to pick a single bandage from the supply of bandages. The bandage supply unit may be arranged at any suitable location, for example at a location where also other consumables of the cannula insertion system are stored, such as cannulas.

In some embodiments, the at least one bandage holder comprises one or more vacuum cups, each vacuum cup being arranged to releasably hold the bandage by a vacuum force. Vacuum cups can efficiently be used to releasably hold a bandage. A vacuum source may be provided to create a vacuum space in the interior of the vacuum cups. This vacuum space can be used to apply a suction force on a bandage that is held against the respective vacuum cup. In this application, a vacuum space is not necessarily a space with an absolute vacuum, but a vacuum space may be any space in which the pressure is substantially lower than atmospheric pressure. When the bandage held by the one or more vacuum cups is placed on the skin of the user, the vacuum source may be turned off or disconnected from the one or more vacuum cups such that a suction force is no longer applied by the one or more vacuum cups on the bandage in order to release the bandage from the one or more vacuum cups. 5

Additionally or alternatively, the at least one bandage holder can releasably couple to and hold a bandage in other suitable manners. The bandage holders may for example comprise a fastener such as a hook and loop fastener connection between the bandage holder and the bandage, a static electricity clamp or other static electricity connection between the bandage holder and the bandage, and/or an adhesive connection between the bandage holder and the bandage. In some embodiments, the fastener, static electricity connection, and/or adhesive used for such coupling to the bandage holder can be advantageously less strong than adhesive layers of the bandage that are used to adhere the bandage to the skin of a patient. The adhesive of the adhesive connection may be arranged on the bandage, the bandage holder or on both. In yet further embodiments, the bandage can include one or more projecting features (e.g., a textured surface, ribs, tab, etc.) such that the at least one bandage holder can include pincers or a suitable grasping mechanism configured to couple to one or more such projecting features to hold the bandage. Additionally or alternatively, the bandage and the bandage holder(s) can have complementary mating features that are configured to engage with each other such that the bandage holder(s) can hold the bandage.

The bandage holder may be configured to be aligned with an adhesive layer of the bandage such that the bandage holder can be used to adhere the bandage on the skin of a patient. The bandage holder is arranged to place the bandage on the skin of the user. The bandage holder may be used to apply a pressure on the bandage when placed on the skin to push the adhesive layer against the skin of the patient.

In an embodiment, the bandage applicator comprises two bandage holders, each bandage holder being arranged to releasably hold the bandage. The bandage holders may be spaced with respect to each other such that the bandage holders can hold two opposite regions of the bandage leaving a middle part of the bandage between the opposite held regions free. This middle part of the bandage can be brought into contact with the skin of the patient at the insertion location without exerting any substantial pressure on the bandage.

This may in particular be advantageous when the cannula is at least partially arranged within the body of the patient at the insertion location when the bandage is placed on the skin of the patient.

Furthermore, the two opposite regions of the bandage may be provided with an adhesive layer at their skin side, i.e. the side to be placed on the skin of the patient, such that the bandage holders can also be used to adhere the bandage on the skin of the patient.

In some embodiments, the bandage applicator comprises a pressure element to apply pressure on the insertion location after complete retraction of the cannula from the insertion location. To stop bleeding from the wound created by the penetration of the cannula into the body of the patient, it is advantageous to apply a pressure on the insertion location with the pressure element. The pressure element may be any object having a substantially flat or 6 slightly rounded surface that can effectively be used to apply a pressure force on the insertion location, such as through the bandage. The pressure element may be a part of the bandage holder or may be provided as a separate component of the bandage applicator.

The pressure element may be aligned with a padding provided on the bandage which padding is configured to absorb blood. During the application of pressure with the pressure element, the padding may be pressed on the wound at the insertion location to absorb any blood. After retraction of the pressure element, the padding may still continue to absorb blood present at the insertion location.

In some embodiments, the pressure element is arranged at least partially between the two bandage holders. In this configuration, the two bandage holders may be aligned with the adhesive layers at opposite ends of the bandage and the pressure element may be aligned with the padding on the middle part of the bandage. Other configurations of pressure element and bandage holders and associated locations of adhesive layer and paddings may also be applied. It is also possible that the pressure element or another element is used to press the adhesive layers on the skin of a patient.

In some embodiments, the two bandage holders define a bandage holding plane along which the bandage holder(s) hold the bandage, and the pressure element comprises a pressure surface to be pressed on the bandage, wherein the bandage holding plane can be spaced with a distance from the pressure surface such that the bandage can be arranged at or near the insertion location, for example in contact with the skin, without the pressure surface contacting the bandage. While the pressure surface does not contact the bandage, the bandage has some flexibility to move towards and/or away from the skin. This flexibility can be used to arrange the bandage at or near the insertion location without hindering or complicating the retraction of the cannula from the insertion location. During the retraction of the cannula the cannula can be swiped along the bandage, for example along the padding of the bandage to remove blood from the cannula.

In some embodiments, the bandage holders are movable or compressible to move the bandage holding plane, such as to decrease the distance between the bandage holding plane and the pressure surface to enable the pressure element to be pressed on the bandage. To enable the pressure element to be pressed on the bandage to apply a pressure on the insertion location, the bandage holders may be movable or compressible.

In addition or as an alternative embodiment, the pressure element may be movable with respect to the bandage holders to decrease the distance between the bandage holding plane and the pressure surface to enable the pressure element to be pressed on the bandage, such as to apply a pressure on the insertion location to stop bleeding.

In some embodiments, the cannula insertion system comprises: 7 a cannula insertion device positioning system to support and position the cannula insertion device, a bandage applicator positioning system to support and position the bandage applicator, and a control device arranged to control the cannula insertion device positioning system and the bandage applicator positioning system to position the cannula insertion device and the bandage applicator in a desired position, respectively.

In some embodiments, the control device is arranged to control: the cannula insertion device positioning system to position the cannula insertion device in a suitable location to insert and retract the cannula into and from the patient, and the bandage applicator positioning system to position the bandage applicator in a suitable position to at least partially swipe the cannula along the bandage held by the bandage applicator during retraction of the cannula to remove or absorb any blood from the cannula and/or to cover the insertion location to shield and/or absorb any potential blood present at the insertion location.

In some embodiments, the control device is arranged to control: the bandage applicator positioning system to position the bandage applicator in a suitable position to apply with a pressure element pressure on the insertion location after complete retraction of the cannula from the insertion location and/or to adhere the bandage to the skin of the user with the bandage holder.

The cannula insertion device positioning system and the bandage applicator positioning system may be provided as part of a single positioning system. For example, the cannula insertion device and the bandage applicator may be mounted on a single end effector that is connected to a positioning system. The end effector can, for example, be attached to an actuatable robotic arm and allow for positioning of one or more imaging devices (e.g., an ultrasound transducer) and/or the cannula insertion device. The cannula insertion device may have a first actuator to change the insertion angle of the cannula and a second actuator to control movement of the cannula in its longitudinal direction for introduction of the cannula into and retraction of the cannula from the body of the patient.

The bandage applicator may comprise an actuator, for example a linear actuator to move the at least one bandage holder towards and away from the skin of the patient to place a bandage on the skin of the patient. The bandage applicator may also comprise one or more actuators to move the at least one bandage holder in one or more directions substantially parallel to the skin surface of the patient in order to align the bandage with the insertion location of the cannula. In addition or as an alternative, the bandage is designed to cover a large range of potential insertion locations, such that a single position of the bandage can be used for this range of potential insertion locations. 8

In some embodiments, the cannula insertion device and the bandage applicator may each have their own positioning system.

In some embodiments, the cannula insertion system comprises a bandage supply unit comprising multiple bandages, wherein the bandage applicator is arranged to take and releasably hold a single bandage from the multiple bandages.

In some embodiments, the bandage supply unit comprises: a carrier strip carrying multiple bandages, and a bandage release device to release a single bandage from the carrier strip, while being held by the bandage applicator.

In some embodiments, the bandage supply unit comprises two or more carrier strips, each carrier strip carrying multiple bandages. The two or more carrier strips can include a first carrier strip carrying multiple bandages of a first type, and a second carrier strip carrying multiple bandages of a second type.

To reliably pick up a bandage from a bandage supply unit, the bandages may be provided on a carrier strip that moves along the bandage release device that presents a bandage to the bandage applicator. The carrier strip may comprise an adhesive with which the bandages are adhered to the carrier strip. It is also possible that the adhesive layer of the bandage is used to adhere the separate bandages to the carrier strip. In some embodiments, the bandage supply unit can include a storage of multiple bandages that is separate from the end effector. However, in some embodiments, the bandage supply unit can be incorporated or included in the end effector, the positioning system (e.g., robotic arm), or within the range of motion of the end effector {e.g., within at least one degree of freedom with which the end effector is moves), and/or other suitable component of the cannula insertion system.

Once a bandage is held by the at least one bandage holder of the bandage applicator, for example by creating a suction force with a vacuum cup of the bandage holder, the bandage release device may be actuated to release the single bandage from the carrier strip.

The present technology further provides a bandage to be used in combination with a cannula insertion system as described herein, wherein the bandage comprises: a flat bandage body comprising at least one fluid impermeable layer, an adhesive layer arranged on a skin side of the bandage body at at least two opposite regions of the bandage body to stick the bandage to the skin of the patient, and a padding arranged on the skin side of the bandage body between the two opposite regions.

In some embodiments, the bandage body may be non-transparent.

The bandage is generally a flat object having a rectangular, square, round, oval, hexagonal, or other suitable shape. 9

The bandage may have a self-sealing layer.

According to another aspect of the present technology, a cannula insertion system to insert a cannula into a patient comprises: a cannula insertion device configured to insert the cannula at an insertion location into the patient, the cannula comprising an internal channel having a distal end and a proximal end, and a vacuum source in fluid connection to a proximal end of the cannula arranged to suck at least during retraction of the cannula blood present at the distal end of the internal channel towards the proximal end of the internal channel.

By providing a vacuum source in fluid connection to the proximal end of the internal channel of the cannula, any blood present at the distal end of the internal channel can be sucked into the cannula. Therewith, risk of contamination of the cannula insertion system with blood dripping from the distal end of the cannula after the cannula is retracted from the insertion location may be reduced or prevented.

In some embodiments, a blood collection container having an internal pressure below atmospheric pressure may be used as the vacuum source. To collect blood taken from a patient via a cannula inserted into the body of the patient, blood collection containers may be provided. These blood collection containers may be provided with an internal pressure below atmospheric pressure to facilitate drawing of blood from the patient through a cannula inserted into the patient and connected to the blood collection container. At the end of the blood drawing process, the relatively low internal pressure in the blood collection container may also be used to draw blood into the internal channel of the cannula.

Further characteristics and advantages of the cannula insertion system of the present technology will now be explained by the following description, whereby reference is made to the appended drawings, in which:

Figure 1 shows schematically an example embodiment of a cannula insertion system comprising a bandage applicator in accordance with the present technology;

Figures 2a and 2b show schematically an example embodiment of a bandage to be used in combination with the bandage applicator;

Figure 3 shows an example embodiment of a bandage to be used in combination with the bandage applicator;

Figure 4 shows an example embodiment of a bandage to be used in combination with the bandage applicator; 10

Figures 4a-4g show example embodiments of a bandage to be used in combination with the bandage applicator;

Figure 5 shows an embodiment of a bandage applicator in a retracted position;

Figure 6 shows the bandage applicator of Figure 5 in an extended position;

Figure 7 shows the cannula insertion system of Figure 1 in which the bandage applicator is arranged to place a bandage at or near the insertion location before complete retraction of the cannula from the insertion location;

Figures 8a-8e show the bandage applicator shown in Figure 5 in subsequent steps of placing a bandage on the skin of a user;

Figure 9 shows an example embodiment of the cannula insertion system comprising a bandage applicator;

Figures 10-12 show an example embodiment of a bandage supply unit arranged to supply a bandage to the bandage applicator;

Figures 13a and 13b show example embodiments of a portion of a bandage supply unit;

Figures 14a and 14b show example embodiments of pressure elements in a bandage applicator; and

Figure 15 shows an example embodiment of a bandage supply unit with multiple bandage supply rolls.

Figure 1 shows schematically a cannula insertion system, generally denoted by reference numeral 1. Further details of the cannula insertion system are for example described in WO2021140118, the contents of which are herein incorporated by reference.

The cannula insertion system 1 is configured to autonomously insert a cannula 2, for example a needle into a blood vessel V of a patient. The patient may be any human or animal that uses the cannula insertion system 1 to insert a cannula into the body of the patient. The cannula insertion system 1 as shown in Figure 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 other suitable purposes such as intravenous medication and/or infusions.

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 patient, 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.

The cannula insertion system 1, shown in Figure 1, comprises an ultrasound transducer 3 to obtain one or more sensor signals that are representative for the location of a 11 blood vessel V in the patient. The ultrasound transducer 3 is a contact sensor. During use, contact between the ultrasound transducer 3 and the skin S enables the acquisition of relevant data with respect to the location of the blood vessel V. The ultrasound transducer may be guided along the skin S of the patient 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.

The target area T may be determined by obtaining images of the skin of patient, for example using NIR (near infrared), infrared and/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.

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.

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, or among a distributed network of multiple processors.

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.

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 the cannula 2 from penetrating those nerves, when selecting an insertion path for the cannula 2.

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 (e.g., by displaying written and/or graphical instructions on a display device or other patient interface, providing audible instructions from a speaker device, etc.). 12

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.

The cannula insertion device 8 is arranged to insert the cannula 2 in an insertion direction ID through the skin S at an insertion location 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.

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.

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 onthe 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 threshold value. 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 threshold value.

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 the cannula 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 patient.

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.

In some cases, a vein positioned below the ultrasound transducer 3 may become displaced (e.g., laterally displaced) due to the pressure exerted by the ultrasound transducer 3. This may also be referred to as a ‘rolling vein’. When this occurs, this may be determined at least in part 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 13 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.

In the embodiment shown in Figure 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.

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 patient. 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 may be confirmed by the patient.

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 an abort procedure, in which the cannula insertion process is safely stopped.

The cannula insertion system 1 may further comprise a patient interface, for example adisplay device 19 that can be seen by the patient.

The patient interface can be used to provide instructions to the patient, for example to reposition an arm or other body part, to place a different arm or other body part in the cannula insertion system 1, 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 to provide confirmation of the identity of the patient, the use of anticoagulation, etc. 14

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 requests 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.

The cannula insertion system 1 comprises a bandage applicator 30 configured to arrange a bandage 50 on the skin S of the patient. The bandage applicator 30 comprises two vacuum cups 31 as bandage holders to releasably hold the bandage 50. In alternative embodiments clamps, grippers or other bandage holders can be used to releasably hold a bandage.

The bandage applicator 30 is configured to hold a single bandage 50. By holding a single bandage it may avoided that, while applying a first bandage, other bandages held by the bandage applicator 30 will be contaminated by any blood that is present at the insertion location. Furthermore, by holding only one bandage, the bandage applicator may have a more compact design compared to a bandage applicator supporting multiple bandages.

The cannula insertion system 1 may comprise a bandage supply unit (not shown) comprising multiple bandages 50, wherein the bandage applicator 30 is arranged to take and releasably hold a single bandage 50 from the multiple bandages. The bandage supply unit can, in some embodiments, be incorporated or included in the end-effector 4, and/or in the path or range of motion in which the end-effector moves (e.g., along a degree of freedom in which the end-effector moves).

The bandage applicator 30 is mounted on the end-effector 4 such that the bandage applicator 30 is moved by the positioning system 9 together with the ultrasound transducer 3 and the cannula insertion device 8. In other embodiments, a completely separate positioning system may be provided for positioning the bandage applicator 30.

The bandage applicator 30 comprises a pressure element 32 to apply pressure on the insertion location after complete retraction of the cannula 2 from the insertion location.

The bandage applicator 30 further comprises a linear actuator 33 to move the vacuum cups 31 and the pressure element 32 between a retracted position as shown in Figure 1 and an extended position in which a bandage 50 can be placed on the skin S of the patient. The bandage applicator 30, or its positioning system, may also comprise one or more actuators to move the at least one bandage holder in one or more directions substantially parallel to the skin surface of the patient in order to align the bandage 50 with the insertion location of the cannula. In addition or as an alternative, the bandage 50 is designed to cover a large range of 15 potential insertion locations, such that a single position of the bandage can be used for this range of potential insertion locations.

A vacuum source 34 is provided to provide a vacuum, i.e, a lower pressure than atmospheric pressure, in the vacuum cups 31 to exert a suction force on the bandage 50 to hold the bandage 50. When the vacuum source 34 is switched off, disconnected from the vacuum cups 31, or otherwise controlled to increase pressure in the vacuum cups 31 until the pressure in the vacuum cups 31 is equal to or greater than atmospheric pressure, the bandage applicator 30 may release the bandage 50. The linear actuator 33 and the vacuum source 34 are controlled by the control device 5. In some embodiments, the pressure in the vacuum cups 31 may be increased gradually {e.g., incrementally) until the bandage applicator 30 releases the bandage 50.

In some embodiments, the cannula insertion system 1 further comprises a hemostatic agent applicator in the form of a hemastatic sprayer 60 configured to spray a topical hemostatic spray on the insertion location. Such hemostatic spray or another hemostatic agent may cause vasoconstriction and/or promote platelet aggregation in order to help stop bleeding at the insertion location. The topical hemostatic agent may be sprayed on the skin before the bandage is applied on the skin of the patient. In some embodiments, the hemostatic spray is applied before insertion of the cannula into the patient.

In the shown embodiment, the hemostatic sprayer 60 is mounted on the cannula insertion device 8. In other embodiments, the hemostatic sprayer 60 may be mounted at any suitable location to spray, or more generally apply a hemostatic agent on the skin of the patient at the insertion location. The hemostatic sprayer 60 may for example be mounted on the bandage applicator 30, the end-effector 4, or the ultrasound transducer 3. In the embodiment of Figure 1, the hemostatic sprayer 60 is shown in combination with a bandage applicator 30. The hemostatic sprayer 60 may also be applied in an embodiment of a cannula insertion system 1 that does not comprise a bandage applicator 30.

Figures 2a and 2b show a bottom view and a side view of a bandage 50 to be used in combination with the cannula insertion system 1. The bandage 50 comprises a flat bandage body 51 having a skin side and an opposite upper side of the bandage 50. Figure 2a shows the skin side of the bandage 50 to be placed on the skin S of the patient. The bandage body 51 comprises at least one fluid impermeable layer 52. The fluid impermeable layer prevents the passage of blood from the skin side to the upper side. The fluid impermeable layer also facilitates the holding of the bandage 50 by the vacuum cups 31, since the fluid impermeable layer will prevent that air from passing through the bandage.

At the skin side of the bandage 50 a padding 53 is provided at the middle part of the bandage body 51. The padding 53 is made of fluid absorbent material, such as cotton or cotton wool to absorb any blood that comes into contact with the padding 53. At the two 16 opposite ends of the bandage body 51, adhesive layers 54 are provided at the skin side such that the bandage can be adhered to the skin S of the patient.

The bandage body 51 may be non-transparent to prevent blood absorbed by the padding 53 from being seen through the bandage body 51 when the bandage is adhered to the skin S of a patient.

Figures 3 and 4 show alternative embodiments of a bandage 50. In the bandage 50 of

Figure 3 the padding 53 runs to only one end of the bandage body 51 such that the padding 53 is partially surrounded by a C-shaped adhesive layer 54. In the embodiment of Figure 4 the padding 53 is completely surrounded by an adhesive layer 54.

Furthermore, in various embodiments, the bandage may have another shape, such as round (Figure 4a), oval (Figure 4b), pentagonal (Figure 4c) hexagonal (Figure 4d), etc. The padding 53 can be centered within the outline shape of the bandage 50, or can be off-center.

Furthermore, the padding 53 can have a shape similar to the outline shape of the bandage 50 (e.g., Figure 4A, Figure 4d), or different from the outline shape of the bandage 50 (e.g.,

Figure 4b, Figure 4c). In yet further embodiments, the bandage 50 can include one or more regions of adhesive layer 54 that are arranged on strips extending from the padding 53. For example, Figures 4e and 4f illustrate bandages 50 having two strips of adhesive layer 54 arranged on opposite sides of the padding 53, where the length of each strip of adhesive layer 54 is longer than the length of the padding 53. In Figure 4e, the bandage 50 includes strips of adhesive layer 54 that are generally straight or rectangular (e.g., an “H’-shaped bandage), while in Figure 4f, the bandage 50 includes strips of adhesive layer 54 that are generally curved or arcuate (e.g., semi-circular), though the strips of adhesive layer 54 can have any suitable shape.

In some embodiments, the bandage 50 can include padding 53 whose perimeter is partially surrounded by region(s) of the adhesive layer 54. In such embodiments, the region(s) of the adhesive layer 54 can continuous (e.g., as shown in Figure 3) or discontinuous (e.g., as shown in Figure 4g). Discontinuous regions of the adhesive layer 54 can be equally distributed around the padding 53, or unequally distributed around the padding 53. For example, discontinuous regions of the adhesive layer 53 can be arranged around the padding 53 in a radially symmetric manner (e.g., as shown in Figure 4g, with arcuate segments of the adhesive layer 54 arranged equally around a central or circular padding 53). As another example, discontinuous regions of the adhesive layer 54 can be bilaterally symmetrical (e.g., as shown in Figures 4e and 4f). It should also be understood that bandages of any suitable shape (including those shown in Figures 24-49), the perimeter of the padding 53 can be either partially or fully surrounded by an adhesive regions of adhesive layer 54 Figure 5 shows a side view of the bandage applicator 30 as indicated with A-A in Figure 1. In this view it can be seen that the the bandage applicator comprises two vacuum cups 31 as bandage 17 holders arranged to releasably hold two opposite ends of the bandage 50. The vacuum cups 31 are aligned with the regions having an adhesive layer 54 of the bandage 50 such that the vacuum cups can be used to press the adhesive layers 54 on the skin S of the patient to adhere the bandage 50 to the skin S.

The pressure element 32 is arranged between the two vacuum cups 31 such that the pressure element 32 can be used to exert a pressure through the bandage 50 on the insertion location. This insertion location is the location where the cannula 2 penetrated the skin S of the patient. By exerting a pressure on this insertion location, bleeding of the wound where the cannula entered the body of the patient can be stopped. The pressure element 32 comprises a pressure surface 36 to be pressed on the bandage 50. The pressure surface 36 can, for example, include a rigid or semi-rigid surface (e.g., with less compliance than tissue of the patient at the insertion location) that is large enough to extend sufficiently over the area of the insertion location (e.g., point of cannula insertion plus some margin of additional surface area). The pressure surface 36 can, in some embodiments, be generally flat or be contoured to the geometry of the insertion location. The padding 53 of the bandage 50 is aligned with the pressure element 32 such that the pressure surface 36 of the pressure element 32 will be pushed on the padding 53 and therewith the padding 53 on the wound at the insertion location |.

In some embodiments, the bandage applicator 30 can include a sensor 37 configured to provide information indicative of the force or pressure with which the pressure element 32 is pressing on the insertion location |. Measurements from the sensor 37 can, for example, be used to help modulate the actuation of the pressure element 32 so as to apply sufficient pressure to help stop bleeding of the wound, without applying excessive pressure that may risk bruising or otherwise injuring the patient. The sensor 37 can, for example, include a force sensor measuring the force with which the pressure element 32 is pressing on the insertion location |, and/or a displacement sensor measuring the distance that the pressure element 32 moves while pressing on the insertion location |. As shown in Figure 1, the sensor 37 can, in some embodiments, be arranged at or near an attachment point where the linear actuator 33 is coupled to the end effector 4. At this attachment point, for example, the sensor 37 can measure a reactive force that is correlatable to the force or pressure with which the pressure element 32 is pressing on the insertion location. Additionally or alternatively, the sensor 37 can be located on or near the pressure surface 36.

In some embodiments, the force or pressure with which the pressure element 32 is pressing on the insertion location | can be controlled at least in part with a spring element that is coupled to the pressure element 32 and configured to provide a constant force for displacing the pressure element 32. 18

Additionally or alternatively, in some embodiments, the sensor 37 can include a displacement or position sensor configured to measure the displacement or position of a system component. Such displacement or position can, for example, be indicative of the force or pressure with which the pressure element 32 is pressing on the insertion location. In some embodiments, for example, the sensor 37 can include a displacement or position sensor arranged in or on the end effector 4 to measure the curvature in a robotic arm of the positioning system 9. Additionally or alternatively, the sensor 37 can include a displacement or position sensor configured to monitor the movement of the cannula. Furthermore, the sensor 37 can additionally or alternatively include a sensor (e.g., range finder sensor) configured to determine the displacement, position, and/or location of the bandage 50 itself during or after bandage application.

The two vacuum cups 31 define a bandage holding plane 35 in which the bandage 50 is held. In the state shown in Figure 5, the bandage holding plane 35 is spaced with a distance from the pressure surface 36. Due to this spacing the bandage 50 can be arranged onthe skin S of a patient without the pressure surface 36 contacting the bandage 50.

The vacuum cups 31 are compressible to decrease the spacing distance between the bandage holding plane 35 and the pressure surface 36 to enable the pressure element 32 to be pressed on the bandage 50. The vacuum cups 31 may for example be provided with a biasing element, such as a spring construction arranged in the wall or inside of the vacuum cups, that biases the vacuum cups 31 to the state shown in Figure 5. When a force is exerted on the vacuum cups 31, the vacuum cups 31 may be compressed against the biasing force.

Figure 6 shows, as an example, the bandage applicator 30 of Figure 5 when the bandage applicator 30 is pressed onto a flat surface (not shown). It can be seen that the vacuum cups 31 have been brought into a compressed state and that the pressure surface 36 is now arranged in the same plane as the bandage holding plane 35. Due to the compression of the vacuum cups 31, the vacuum cups 31 also exert a pressure on the ends of the bandage which facilitates adhering the adhesive layers 54 to the skin S of the patient.

As an alternative for providing compressible vacuum cups, it is also possible to provided linearly movable vacuum cups 31 and/or a linearly movable pressure element 32 to change the spacing distance between the bandage holding plane 35 and the pressure surface 36.

Furthermore, while the pressure element 32 is shown in Figures 5 and 6 as being located between two bandage holders 31, other components can additionally or alternatively provide pressure on the bandage 50 to help facilitate bandage application to the skin of the patient. For example, in some embodiments, a bandage 50 can be held by one or more bandage holders 31 (e.g., a bandage holder 31 located over the padding of the bandage 50), and a pressure element 32 can be located inside the bandage holder 31 and selectively 19 operated such that a pressure surface 36 on the pressure element 32 can be actuated to apply pressure to the wound through the padding, similar to that described above. The pressure element 32 can, for example, be located within the cavity of the vacuum cup(s), and/or be embodied in the wall of the vacuum cup(s) itself such as through a reinforcement structure.

Additionally or alternatively, the bandage holders can releasably couple to and hold a bandage in other suitable manners. The bandage holders may for example comprise a fastener such as a hook and loop fastener connection between the bandage holder and the bandage, a static electricity clamp or other static electricity connection between the bandage holder and the bandage, and/or an adhesive connection between the bandage holder and the bandage.

In some embodiments, the bandage applicator 30 can include one or more sensors configured to confirm whether the bandage holder(s) are presently holding a bandage 50 in the proper manner. If it is determined that the bandage holder(s) are holding a bandage 50 properly, the bandage applicator 30 can continue in operation including applying the bandage 50 to skin of the patient. However, if it is determined that the bandage holder(s) are not holding a bandage 50 properly (e.g., the bandage 50 is not present or the bandage 50 is askew, such as being held by only one of two bandage holders), then a notification may be provided to an operator (e.g., monitoring operator or patient, etc.) for corrective action.

For example, in embodiments in which the bandage holder(s} include one or more vacuum cups, a sensor in the vacuum source 34 can be configured to measure the amount of pressure in the vacuum cups, which can be correlated to a determination of whether a bandage 50 is being held by the vacuum cups. For example, if a negative pressure or vacuum is sustained at a substantially stable level (e.g., variation of pressure below a predetermined threshold) for a vacuum cup this can indicate that a bandage 50 is being held by the vacuum cup. However, if a negative pressure or vacuum is not sustained at a substantially stable level for a vacuum cup this can indicate a lack of a pressure seal between the bandage 50 and the vacuum cup. In some embodiments, a sufficiently sustained level of vacuum by at least one vacuum cup may be interpreted as indicating that the bandage 50 is present and ready for application to skin of a patient. In some embodiments, the confirmation that the bandage 50 is present can be reliant upon determining that there is a sufficiently sustained level of vacuum by all vacuum cups (not just one).

In addition or as an alternative to assessing vacuum level to determine whether the bandage 50 is present, in some embodiments the bandage applicator 30 can include an optical sensor, ultrasound sensor, and/or other suitable sensor(s) to detect the presence of the bandage 50 on the bandage holders. 20

The construction of the bandage applicator 30 allows the bandage applicator 30 to arrange a bandage 30 at or near the insertion location before complete retraction of the cannula 2 from the insertion location.

Figure 7 shows a position of the bandage applicator 30 in which the bandage 30 is arranged at a position at or near the insertion location | before complete retraction of the cannula 2 from the insertion location 2. The bandage applicator 30 has been moved by the linear actuator 33 into a position in which the bandage 50 contacts the skin S of the patient.

The pressure surface 36 of the pressure element 32 is still spaced from the bandage holding plane such that the middle part of the bandage 50 where the padding 53 is positioned has some flexibility. The cannula 2 lifts partially the middle part of the bandage 50.

When the cannula 2 is retracted from the insertion location, the cannula 2 will at least partially be swiped along the bandage 50, in particular the padding 53, to remove or absorb any blood from the cannula 2. This has the advantage that this blood cannot contaminate other parts of the cannula insertion system 1.

The placement of the bandage 50 at or near the insertion location |, for example in contact with the skin S, may have the further advantage that the insertion location can be effectively shielded for any blood present at the insertion location and/or on the cannula. This shielding may prevent that blood will come into contact with the ultrasound transducer 3 and/or other parts of the cannula insertion system 1.

This blood may be absorbed by the padding 53 of the bandage 50.

Figures 8a-8e show an example process of placing a bandage 50 on the skin of a patient using the bandage applicator 30. The control device 5 may be arranged to control the linear actuator 33 and the vacuum source 34 to carry out this process.

Figure 8a shows the bandage applicator 30 in a retracted position. The vacuum cups 31 hold a bandage 50 using a vacuum provided by the vacuum source 34. A cannula 2 is inserted into the skin at the insertion location |. While fluid transfer occurs (e.g., while blood is drawn from the patient or fluid is infused into the patient), the bandage applicator 30 may stay in this position. When the blood drawing or other fluid transfer process has almost finished, but the cannula is still within the body of the patient, the bandage applicator 30 may be moved to an extended position (Figure 8b) in which the bandage 50 is placed at or near the insertion location I, but in which the pressure element 32 is still spaced from the bandage 30.

Figure 8b shows this position which corresponds with the position of the bandage applicator 30 shown in Figure 7. In this position of the bandage applicator 30, the cannula 2 may be retracted from the patient and swiped along the padding 53 of the bandage 50 to remove any blood present on or in the distal end of the cannula 2. At the same time, the bandage 30 covers the insertion location | to shield the insertion location and to absorb any blood, for example coming from the wound created by the cannula 2. In an alternative 21 embodiment, the bandage applicator may be arranged to move the bandage simultaneously with or directly after retraction of the cannula from the insertion location, to the skin of the patient to shield the insertion location and/or to absorb any blood at the insertion location.

This movement is advantageously carried out at a relatively high speed.

Figure 8c shows the bandage applicator 30 in the same position as Figure 8b but with the cannula 2 retracted from the body of the patient. The insertion location |, in particular the wound created by the cannula 2 is still covered by the bandage 50 and blood coming from the wound may be absorbed by the padding 53 of the bandage 50. Since the cannula 2 is retracted from the patient, the pressure element 32 can now be pressed on the insertion location | without the risk of causing any pain or injury due to the presence of the cannula 2.

Figure 8d shows the bandage applicator 30 moved by the linear actuator 33 to a further extended position. For example, in this position, the pressure element 32 can be advanced to further decrease the distance between the pressure surface 36 and the bandage holding plane. In this position, the pressure element 32 is pressed with its pressure surface 36 against the bandage 30 in order to stop bleeding of the wound. At the same time the vacuum cups 31 are compressed and as a result press the opposite ends of the bandage 30 against the skin S of the patient. This causes the adhesive layers 54 of the bandage 50 to adhere to the skin S of the patient. The distal ends of the vacuum cups 31 are flexible such that they can adapt the holding position of the bandage 50 to the surface of the skin S. In this position the vacuum provided by the vacuum source 34 may be switched off such that the vacuum cups no longer hold the bandage 34 (or the level of vacuum may be otherwise sufficiently reduced such that the attachment strength between the vacuum cups and the bandage 34 is lower than the attachment strength between the bandage 34 and the skin S of the patient). When a desired period for pressing on the wound has passed , the bandage applicator 30 may be moved back to the retracted position. Such a desired period for pressing on the wound can range, for example, between about 1 second and about 60 seconds (e.9g., between about 10 seconds and about 50 seconds, or between about 20 seconds and about 40 seconds, or about 30 seconds), about 60 seconds, or greater than about 80 seconds (e.qg., 75 seconds, 90 seconds, etc.).

Figure 8e shows the bandage applicator 30 back in the retracted position. The bandage 50 remains on the skin S of the patient. The bandage applicator 30 may be moved to a bandage loading position in which a new bandage 50 may be loaded on the bandage applicator 30. Once a new bandage 50 is loaded on the bandage applicator 30, the bandage applicator 30 is ready for a new blood draw procedure as shown in Figure 8a.

As an alternative for the subsequent steps shown in Figures 8a-8e, in some embodiments, it is also possible to apply the bandage 50 before insertion of the cannula 2 into the body of the patient. The cannula may be inserted through the bandage into the body 22 of the patient. Furthermore, in some embodiments, the bandage 50 can be partially applied to the skin of the patient (e.g., adjacent to the point of cannula insertion) in a manner that allows the cannula 2 to be inserted into the body of the patient without passing the cannula 2 through the bandage. For example, one side or end of the bandage 50 can be applied to the skin of the patient, and a free portion of the bandage can be manipulated (e.g., rolled, folded, bent, etc.) away from the insertion location to expose the point where the cannula is inserted.

After the cannula has been inserted and is ready to be removed, the free portion of the bandage can be manipulated so its skin facing surface approaches the skin (e.g., rolled, folded, bent, etc. toward the skin). Accordingly, one portion of the bandage 50 can be applied prior to cannula insertion while another portion of the bandage 50 can be applied after cannula insertion {(e.qg., while the cannula is being removed).

Figure 9 shows an example embodiment of the cannula insertion system 1 similar to that shown in Figure 7, but with an additional vacuum line 60 connected between the vacuum source 34 and a proximal end of the cannula 2. The vacuum connection with vacuum line 60 is arranged to suck at least during retraction of the cannula 2 blood present at the distal end of an internal channel of the cannula 2 towards the proximal end of the internal channel of the cannula 2.

By providing the vacuum source 34 in fluid connection to the proximal end of the internal channel of the cannula, any blood present at the distal end of the internal channel can be sucked into the cannula 2. Therewith, the risk of contamination of the cannula insertion system 1 with blood dripping from the distal end of the cannula 2 after the cannula is retracted from the insertion location | may be reduced or prevented.

The vacuum line 60 can be provided in addition to or as an alternative for the placement of a bandage at or near the insertion location before complete retraction of the cannula 2.

In some embodiments, a blood collection container (or other fluid collection container) having an internal pressure below atmospheric pressure may be used as the vacuum source.

These blood collection containers are used to collect blood from a patient and provided with an internal pressure below atmospheric pressure to facilitate drawing of blood from the patient. At the end of the blood drawing process, the relatively low internal pressure in the blood collection container may also be used to draw blood into the internal channel of the cannula. The tube between the blood collection container and the cannula used for blood collection then also serves as vacuum line 80 during the retraction of the cannula from the patient.

While Figures 5, 6, and 8a-8e generally relate to a bandage applicator 30 configured to apply a bandage 50 to an insertion location through linear (e.q., generally vertical, as shown in the Figures) movement of the pressure element 32, it should be understood that in 23 some embodiments the pressure element 32 can apply pressure to the bandage 50 (and/or the insertion location) in other motions. For example, as shown in Figure 14a, the pressure element 32 can include a pressure surface 36 configured to apply pressure to the bandage 50 with a sliding motion along the bandage 50 (e.g., the pressure surface 36 can be curved with arounded shape and/or can include a low-friction or lubricious material, etc.). As another example, as shown in Figure 14b, the pressure element 32 can include a roller with a pressure surface 36 configured to apply pressure to the bandage 50 with a rolling motion along the bandage 50. The roller can, for example, include a wheel or at least a partial spherical surface (or other suitable curved surface approximating at least a partial spherical surface) configured to apply pressure. The path of the sliding or rolling motion of the pressure surface 36 can be linear (e.g., left and right in the perspective shown in Figures 14a and 14b, and/or in and out of the page in the perspective shown in Figures 14a and 14b), circular, or any suitable path.

Figure 10 shows an example bandage supply unit 100 arranged to supply a single bandage 50 to the bandage applicator 30 of a cannula insertion system 1.

The bandage supply unit 100 comprises a housing 101. In the housing 101 a bandage supply roll 102 is rotatably mounted on a rotation axis 103. The bandage supply roll 102 comprises a carrier strip 104 supporting multiple bandages 50 (bandages on the wound roll are not shown) on its surface. For example, the multiple bandages 50 can be attached to the surface of the carrier strip 104 via adhesive, static electricity, other suitable fasteners, and/or in any suitable manner. The bandages 50 can be generally equally spaced apart on the carrier strip by a predetermined spacing distance, or unequally spaced apart. The carrier strip 104 is guided along a carrier strip path via a first guiding roller 105a, a clamping device 106, a second guiding roller 105b, a bandage release device 107 and a third guiding roller 105c to a carrier strip disposal spindle 108. Although Figure 10 depicts an embodiment with three guiding rollers arranged in a particular manner to provide a certain shape of carrier strip path, it should be understood that the bandage supply unit 100 can include any suitable number of guiding rollers arranged in any suitable manner to provide a carrier strip path of any suitable shape. The carrier strip disposal spindle 108 can be actuated by a rotation actuator 109 in rotation direction R to wind the carrier strip 104 on the carrier strip disposal spindle 108.

The bandage supply unit 100 further comprises an alignment sensor 110 arranged to determine whether a bandage 50 is properly aligned with a pick-up location for a pick-up by the bandage applicator 30. For example, the alignment sensor 110 can be aligned with the pick-up location itself. Additionally or alternatively, an alignment sensor 110 can be arranged to provide information to enable the system to anticipate when the bandage 50 will be properly aligned with the pick-up location. For example, an alignment sensor 110 can be arranged at a known location offset along the carrier strip path relative to the pick-up location, 24 but given a known speed at which the carrier strip 104 moves along the carrier strip path, information from the alignment sensor 110 can be used to calculate when an upcoming bandage 50 will be aligned with the pick-up location by the bandage applicator 30.

The alignment sensor 110 can include any suitable kind of sensor. For example, in some embodiments, the alignment sensor 110 can include an optical sensor. For example, as shown in Figure 13a, the alignment sensor 110 can include an optical sensor positioned adjacent a first surface of the carrier strip 104 and in line with the pick-up location, and a light source (e.g., visible light) can be located adjacent a second surface of the carrier strip 104 opposite the first surface such that the light source emits light toward the alignment sensor 110. The carrier strip 104 can be translucent or otherwise configured to permit the light from the light source to pass through the carrier strip 104 while the bandages 50 themselves are opaque to the light from the light source. Accordingly, in these embodiments, when the optical sensor fails to detect light passing through the carrier strip 104, it may indicate that a bandage 50 is located at the pick-up location (or other known location, as described above).

As another example, as shown in Figure 13b, in some embodiments, the alignment sensor 110 can include an optical sensor positioned adjacent to the carrier strip 104 and configured to detect one or more fiducial markers 117 on the carrier strip 104. The fiducial markers 117 can include graphical symbols (e.g., dots, numbers, letters, etc.) and/or a computer-readable code (e.g., QR code, bar code, etc.) that is identifiable by the alignment sensor 110. The fiducial markers 117 can have a known position on the carrier strip 104 relative to the bandages 50 (e.g., on a surface of the carrier strip directly underneath each bandage 50, on a surface of the carrier strip spaced apart from each bandage 50 by a predetermined distance, etc.). Accordingly, in these embodiments, when the optical sensor detects a fiducial marker 117 on the carrier strip 104, it may indicate that a bandage 50 is located at the pick-up location {or other known location, as described above). Additionally or alternatively, the fiducial markers can provide further information regarding the bandage supply unit 100. For example, in some embodiments, the fiducial markers can include numbers or information encoded in a computer-readable code that indicate the number of bandages 50 that have been removed from the carrier strip, the number of bandages 50 that remain on the carrier strip, type of bandages 50 that are on the carrier roll, lot number, and/or the like. The fiducial markers can be printed, stamped, etched, embossed, and/or formed in any other suitable manner on the carrier strip 104 and/or bandages 50.

In some embodiments, the bandage supply unit 100 can optionally include at least one bandage type sensor 114 configured to detect the kind of bandage (e.g., size, shape, thickness, absorbency, color, adhesive strength or type, other material property, etc.) that is on the carrier strip 104. The bandage type sensor 114 can include, for example, an optical sensor. The bandage type sensor 114 can be configured to directly sense a property of the 25 bandage 50 on the carrier strip 104, and/or directly sense a serial code or other identifying information that is present on the carrier strip 104 and/or bandage 50 and associated with the type of bandage 50. In some embodiments, the bandage type sensor 114 can be the same sensor as the alignment sensor 110, as described above, or can include one or mare sensors separate from the alignment sensor 110.

In some embodiments, the bandage supply unit 100 can optionally include at least one bandage count sensor 115 configured to detect the number of bandages that have been removed from the carrier strip 104 and/or the number of bandages that remain on the carrier strip 104. The bandage count sensor 115 can, for example, include an optical sensor that can detect one or more symbols on the carrier strip 104 as it moves along the carrier strip path, where the one or more symbols can be correlated to number of removed bandages and/or remaining bandages. For example, such symbols can include numbers, letters, and/or other graphical symbols, and can be located on the carrier strip 104 and/or the bandages 50. The symbols can be printed, stamped, etched, embossed, and/or formed in any suitable manner on the carrier strip 104 and/or bandages 50. In some embodiments, the bandage count sensor 115 can be the same sensor as the alignment sensor 110 and/or the same sensor as the bandage type sensor 114, and/or include one or more sensors separate from the alignment sensor 110 and the bandage type sensor 114.

The bandage supply unit 100 also comprises an alignment element 111, for example an alignment pin on which the end effector 4 can be docked in order to align the bandage applicator 30 with the bandage supply unit 100. In other embodiments, such alignment element 111 to align the bandage supply unit 100 with the end-effector 4 may not be required.

To pick up a single bandage 50 with the bandage applicator 30, the rotation actuator 109 is actuated to displace (e.g., advance) the carrier strip along the carrier strip path to place a bandage 50 at the pick-up location. When the alignment sensor 110 determines that the bandage 50 is arranged at the pick-up location, the rotation actuator 109 is stopped and the bandage holders, e.g., the vacuum cups 31, may be placed on the bandage 50 to hold the bandage 50.

In Figure 10, the end-effector 4 is shown before the end-effector 4 is docked on the alignment element 111. Thus, in this situation, the end-effector 4 can be docked on the alignment element 111 before the vacuum cups 31 can be arranged on the bandage 50 at the pick-up location. It is also possible that end-effector 4 is first docked on the alignment element 111 before the bandage 50 is placed at the pick-up location, or that these actions are performed at the same time.

Figure 11 shows the bandage supply unit 100, where the end-effector 4 is docked on the alignment element 111 and the vacuum cups 31 of the bandage applicator 30 are arranged on the bandage 50. By activating the vacuum source of the bandage applicator 30, 26 the vacuum cups 31 may hold the bandage 50, but the bandage 50 will still be adhered with its adhesive layer to the carrier strip 104.

To peel the bandage 50 from the carrier strip 104, the clamping device 106 and the bandage release device 107 are provided.

The clamping device 106 comprises a clamp which is movable between a non- clamping position (Figure 10) and a clamping position (Figure 11). In the clamping position, the carrier strip 104 is held by the clamping device 108 and in the non-clamping position the carrier strip 104 may freely move through the clamping device 108.

The bandage release device 107 is pivotable about a pivot axis 112 between a first position (Figure 11) and a second position (Figure 12). The bandage release device 107 can be biased into the first position by a biasing element, for example a spring. In this first position a support plate 113 of the bandage release device 107 supports the carrier strip 104 and the bandage 50 at the pick-up location to facilitate the vacuum cups 31 to hold the bandage 50.

When the bandage 50 is held by the vacuum cups 31, the clamping device 106 may be activated to clamp the carrier strip 104. By clamping the carrier strip 104 in the clamping device 106 and simultaneously actuating the rotation actuator 109 to wind the carrier strip 104 on the carrier strip disposal spindle 108, the length of the part of the carrier strip 104 between the clamping device 106 and the carrier strip disposal spindle 108 will become shorter. As a result, the bandage release device 107 will be pulled from the first position towards the second position as shown in Figure 12. Due to this movement, the bandage 50 will be peeled from carrier strip 104 as the bandage 50 is held stationary by the vacuum cups 31 and the carrier strip 104 is pulled away from the bandage 50. To facilitate peeling the bandage 50 from the carrier strip 104, the support plate 113 is provided with a sharp edge.

When the bandage 50 is completely peeled from the carrier strip 104, the clamping device 106 may be moved back to the non-clamping position. If the clamping device 106 is in the non-clamping position, the carrier strip 104 with bandages from the bandage supply roll 102 is free to move through the clamping device 108. As a result, the bandage release device 107 can move back to the first position due to the biasing force of the biasing element.

As soon as the alignment sensor 110 determines that a new bandage 50 is arranged atthe pick-up location, the rotation actuator 109 may be stopped such that the new bandage 50 is ready to be picked up by the bandage applicator 4.

The bandage supply unit 100 is therefore arranged to supply single bandages 50 from the carrier strip 104 to the bandage applicator 30 in a reliable manner.

In other embodiments of the cannula insertion system 1, other embodiments of a bandage supply unit 100 may be provided to supply single or multiple bandages 50 to a bandage applicator 30 of the cannula insertion system 1. 27

For example, as shown in Figure 15, in some embodiments, the bandage supply unit 100 can include multiple bandage supply rolls 102 (e.g., two, three, four or more bandage supply rolls 102). A bandage supply unit 100 with multiple bandage supply rolls 102 can have multiple advantages. For example, multiple bandage supply rolls 102 allows for redundancy in the system, such that in the event that one bandage supply roll 102 fails (e.g., fails to properly rotate on the rotation axis 103, has a carrier strip 104 that fails to properly advance, etc.}, a second bandage supply roll 102 can be accessed to still supply bandages. Additionally, multiple bandage supply rolls 102 can improve ease of maintenance for the bandage supply unit 100, in that multiple bandage supply rolls can increase bandage capacity | the bandage supply unit 100 and thus reduce the frequency with which the bandage supply unit 100 must be resupplied (e.g., by an operator) with new bandage supply rolls 102. Furthermore, in some embodiments, a bandage supply unit 100 can include bandage supply rolls 102 having different types of bandages located thereon (e.g., different size, shape, thickness, color, absorbency, adhesive strength or type, etc.), and a different selected type of bandage can be removed from the appropriate bandage supply roll 102 based on certain circumstances, such as patient type or wound type. For example, a selected bandage supply roll 102 can include bandages 50 that are particularly suited for patients with a certain kind of skin that may benefit from a bandage 50 having a certain kind of adhesive (e.g., a patient with sensitive skin may benefit from a bandage 50 with a weaker or other suitable kind of adhesive). As another example, a selected bandage supply roll 102 can be include bandages 50 of a desired size {e.g., smaller bandages for pediatric patients, larger bandages for adult patients) and/or color (e.g., bright colors or cartoon graphics for pediatric patients, etc.). Such selection of bandage supply roll 102 can be based on, for example, patient information transmitted to the system (e.g., patient age, predetermined bandage preference, etc.), and/or based on patient selection (e.g., selection of a desired bandage type on a display screen or other suitable user interface device, etc.).

Two or more bandage supply rolls 102 can be arranged proximate to each other in the bandage supply unit 100, such that the carrier strip 104 of each bandage supply roll 102 can be easily accessed within the bandage supply unit 100. For example, as shown in Figure 15, two or more bandage supply rolls 102 can be coaxial and arranged axially adjacent to one another, such as on rotation axis 103.

In some embodiments, the bandage pick-up location can be adjusted to be associated with a selected bandage supply roll 102 (e.g., selected from multiple bandage pick-up locations, where each bandage pick-up location is associated with a respective bandage supply roll 102). Additionally or alternatively, multiple bandage supply rolls 102 can be arranged in any suitable manner such that a second bandage supply roll 102 can be mounted above, below, or otherwise proximate to a first bandage supply roll 102, and the 28 second bandage supply roll 102 can be moved to replace the first bandage supply roll 102 (e.g., on the rotation axis 103).

Additionally or alternatively, in some embodiments, the bandage supply unit 100 can be similar to that described above with respect to Figures 10-12, except that the support plate 113 can be stationary. In these embodiments, the carrier strip 104 can be advanced over the stationary support plate 113 (e.g., over the sharp edge of the support plate 113) while the bandage holder(s) 31 couple to and hold a bandage 50. Accordingly, the bandage 50 that is held by the bandage holder(s) 31 can be removed from the carrier strip 104 as the carrier strip 104 is advanced over the support plate 113. Furthermore, in some embodiments, both the support plate 113 and the carrier strip 104 can move relative to each other while the bandage holder(s) 31 hold a bandage 50, in order to remove the held bandage 50 from the carrier strip 104.

As another example, in some embodiments, the bandage supply unit 100 can include a carrier strip including a continuous strip of bandage material. The continuous strip of bandage material can be advanced along a carrier strip path similar to that shown in Figures 10-12, or can be unrolled from a coiled configuration in any suitable manner. In some embodiments, individual bandages 50 can be removed from the carrier strip with an actuatable cutting element {e.g., blade, scissors, etc.), tearing individual bandages 50 across a sharp edge such as an edge of support plate 113, applying tension across perforations in the continuous strip of band, and/or in any suitable manner. Individual bandages 50 can be captured by bandage holders 31, similar to that described herein.

Conclusion

Although many of the embodiments are described above with respect to systems, devices, and methods for inserting a cannula for blood draw, the technology is applicable to other applications and/or other approaches, such as intravenous medication delivery or fluid infusion. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to Figures 1-14b.

The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are 29 presented in a given order, alternative embodiments may perform steps in a different order.

The various embodiments described herein may also be combined to provide further embodiments.

As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.

Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such alist is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or ({c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology.

Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CONCLUSIONS

1. A cannula insertion system for inserting a cannula into a patient, comprising: a cannula insertion device configured to insert the cannula into an insertion site in the patient, and a patch applicator configured to apply a patch to the skin of the patient, the patch applicator comprising at least one patch holder for releasably holding the patch and the patch applicator configured to position a patch at or near the insertion site before fully withdrawing the cannula from the insertion site.

2. The cannula insertion system of claim 1, wherein the patch applicator is configured to place a patch at or near the insertion site prior to fully withdrawing the cannula from the insertion site, such that during withdrawal of the cannula, the cannula is at least partially swept across the patch to remove or adsorb blood from the cannula.

3. The cannula insertion system of claim 1 or 2, wherein the patch applicator is configured to releasably hold a single patch.

4. A cannula delivery system according to any one of claims 1 to 3, wherein the patch delivery device comprises one or more vacuum cups, each vacuum cup being adapted to releasably hold the patch by means of a vacuum force.

5. A cannula insertion system according to any one of claims 1 to 4, wherein the patch applicator comprises two patch holders, each patch holder being adapted to releasably hold the patch.

6. A cannula insertion system according to any preceding claim, wherein the patch applicator comprises a pressure element for applying pressure to the insertion site after the cannula has been fully withdrawn from the insertion site.

7. Cannula insertion system according to claims 5 and 6, wherein the pressure element is arranged at least partly between the two plaster holders.

8. A cannula insertion system according to claim 7, wherein the two patch holders define a patch holding surface and wherein the pressing element comprises a pressing surface to be pressed onto the patch, wherein the patch holding surface can be positioned at a distance from the pressing surface such that the patch can be placed onto the skin without the pressing surface coming into contact with the patch.

9. The cannula insertion system of claim 8, wherein the patch holders are movable or compressible to reduce the distance between the patch holding surface and the pressing surface so that the pressing element can be pressed onto the patch.

10. A cannula insertion system according to claim 8 or 8, wherein the pressing element is movable relative to the plaster holders to reduce the distance between the plaster holding surface and the pressing surface so that the pressing element can be pressed onto the plaster.

11. A cannula insertion system according to any preceding claim, wherein the cannula insertion system comprises: a cannula insertion device positioning system for supporting and positioning the cannula insertion device, a plaster applicator positioning system for supporting and positioning the plaster applicator, and a control device configured to control the cannula insertion device positioning system and the plaster applicator positioning system to position the cannula insertion device and the plaster applicator, respectively, in a desired position.

12. The cannula insertion system of claim 11, wherein the control device is configured to control: the cannula insertion device positioning system to position the cannula insertion device in a suitable location for inserting and withdrawing the cannula into and from the patient, and the patch applicator positioning system to position the patch applicator in a suitable location to at least partially sweep the cannula held by the patch applicator during withdrawal of the cannula to remove or absorb any blood from the cannula and/or to cover the insertion site to shield and/or absorb any blood at the insertion site.

13. The cannula insertion system of claim 12, wherein the control device is configured to control: the patch applicator positioning system to position the patch applicator in a suitable location to apply pressure to the insertion site with a pressure element after the cannula has been fully withdrawn from the insertion site and/or to adhere the patch to the user's skin.

14. A cannula insertion system according to any one of claims 11 to 13, wherein the cannula insertion device positioning system and the patch applicator positioning system are part of a single positioning system.

15. A cannula insertion system according to any preceding claim, wherein the cannula insertion system comprises a patch supply unit comprising a plurality of patches, the patch applicator being configured to grasp and releasably hold a single patch of the plurality of patches.

16. The cannula delivery system of claim 15, wherein the patch delivery unit comprises: a carrier strip carrying a plurality of patches, and a patch release device for releasing a single patch from the carrier strip while being held by the patch applicator.

17. The cannula insertion system of claim 16, wherein the patch supply unit comprises two or more carrier strips, each carrier strip carrying a plurality of patches.

18. The cannula insertion system of claim 17, wherein the two or more carrier strips comprise a first carrier strip having a plurality of patches of a first type and a second carrier strip having a plurality of patches of a second type.

19. A patch for use in combination with a cannula insertion system according to any preceding claim, the patch comprising: a flat patch body having at least one fluid-impermeable layer, an adhesive layer on a skin side of the patch body on at least two opposed regions of the patch body for adhering the patch to the patient's skin, and a padding disposed on the skin side of the patch body between the two opposed regions.

20. The plaster according to claim 19, wherein the plaster body is opaque.