VASCOSCOPE

Abstract

The present invention is in the field of an improved device for assisting entry of a needle into a vein or a shunt using ultra-sound, also referred to as a vascoscope, a kit of parts comprising said vascoscope, and a method of entering a needle in a vein or shunt, comprising use of said vascoscope. The present vascoscope is especially suited for use in dialysis and is aimed at preventing damage such as in repetitive use applications.

Claims

1. A device for assisting entry of a needle comprising a probe comprising at least one array of n*m ultrasound electro-acoustical elements, for forming an ultrasound depth image, a holder (0) for the probe, the probe holder adapted to provide rotation of the probe over at least ±45°, wherein a bottom of the holder is higher than a bottom of the probe, a fixator attached to both sides of the holder for maintaining the holder in a spatial position, and also adapted to provide translational repositioning of the holder and probe of at least 1 mm in at least one direction parallel to a bottom probe plane, wherein the holder and fixator are configured to leave a space directly adjacent to the front side of the probe free for entry of the needle and for tactile control of a vein or shunt, a display for providing an ultrasound image of the probe, a controller, the controller being capable of addressing the electro-acoustical elements and receiving signals from the electro-acoustical elements, the controller in use providing input to the display, and an input for an electrical power source for providing power to at least one of the probe, controller and display.

2. The device according to claim 1, wherein at least one array of electro-acoustical elements is adapted to form an ultrasound image under an angle of 40-90° relative to the bottom plane of the probe, and wherein the probe can be removably attached to the probe holder, and wherein a size of the holder at a front side is less than 1 cm more than a size of the probe, and wherein the fixator is adapted to provide translational repositioning of the holder and probe of at least 1 mm in at least one direction parallel to a bottom probe plane movement in any direction parallel to the bottom probe plane, and wherein the fixator is removably attached to the probe holder, and wherein the space is larger than 1 cm in a direction perpendicular to the front side and larger than 3 cm parallel to a tangential of the front side.

3. The device according to claim 1, wherein the fixator is rotatably attached to the holder, a rotation axis thereof being substantially parallel to the bottom probe plane.

4. The device according to claim 1, wherein the fixator comprises at least one distance piece, the distance piece in combination with the rotation configured for maintaining a distance of 1-5 mm of the fixator from an object to be imaged, and a ball bearing wherein balls extend partly outwards from the bearing.

5. The device according to claim 1, wherein the display is integrated in the probe, or wherein the display is in a wireless connected device, or wherein the display is in a video glasses, wherein the video glasses cover an eye image field for less than 50%, allowing at least one eye to obtain images from above and below the glasses, or is in an augmented reality glasses, or is a combination thereof.

6. The device according to claim 1, wherein the fixator comprises two side portions, the side portions each individually comprising at least one high density material, the side portions being made of a flexible material, and wherein the side portions form an O-ring.

7. The device according to claim 1, wherein the controller is connected to the probe by a wire, or is wireless connected, or is integrated in the probe.

8. The device according to claim 1, wherein the probe is connected to the display by a wire, or is wireless connected.

9. The device according to claim 1, wherein the fixator comprises a resilient bridge, two legs attached to either side of the bridge, each leg comprising a clamp section, wherein the holder comprises an elastic material, wherein the holder is attached by a holder attachment to the fixator.

10. The device according to claim 1, wherein the device is transportable.

11. The device according to claim 1, wherein the probe holder and probe comprises an indentation in a central portion thereof, therewith allowing a portion of underlying material to remain visible.

12. The device according to claim 1, wherein the probe holder and probe comprises needle guider.

13. The device according to claim 1, wherein the probe forms 3D images.

14. The device according to claim 1, wherein the probe comprises at least one of a receiving element for a display, wherein the display is integrated in the probe, a metal shield, a backing material, an acoustic absorber, a piezo electric element, and an acoustic lens.

15. The device according to claim 1, wherein in the array of electro-acoustical elements comprises n*m electro-acoustical elements, wherein n∈[1,10] and m∈[2,2.sup.10], and at least one second array of electro-acoustical elements located under an angle of 45-90° with respect to the at least one first array of electro-acoustical elements.

16. The device according to claim 1, wherein at least one first electro-acoustical element has a centre frequency of 20 kHz-50 MHz, an active area of 4*10.sup.−4-2000 mm.sup.2, and a near field length of 0.1-50 mm.

17. The device according to claim 1, wherein at least one electro-acoustical element comprises at least one MEMS, the MEMS comprising at least one piezoelectric element, a cavity, and one or more of an ultrasound absorbing layer, a quarter lambda reflecting (multi)layer, and an ultrasound reflecting layer, wherein the MEMS comprises a stack of layers, the stack comprising (i) at least two piezoelectric elements poled in a same direction, each piezoelectric element comprising a top electrode layer, a piezoelectric layer, and a bottom electrode layer, wherein the top electrode covers the piezoelectric layer completely or partially, and wherein the piezoelectric layer covers the bottom electrode completely or partially.

18. The device according to claim 1, comprising a transceiver for communication between the device and an external supporting device, and comprising stored on the device and stored on the external supporting device software and gathered data, and wherein the holder or the probe comprises a pivot, and wherein the holder comprises a slit receiving element and the probe comprises a slit.

19. A kit of parts, comprising a device according to claim 1 or at least one part thereof, and a box for storing said device.

20. (canceled)

21. (canceled)

22. (canceled)

23. (canceled)

Description

SUMMARY OF FIGURES

[0064] FIGS. 1a-d and 2a-f show schematical layouts of the present vascosope.

[0065] FIGS. 3a-c show a use of the present vascosope.

[0066] FIGS. 4a-d show layouts of the present MEMS.

[0067] FIG. 5 shows a layout of the probe.

[0068] FIGS. 6-8 show further details of the invention.

[0069] FIGS. 9a-d show an alternative embodiment of the present fixator and holder.

DETAILED DESCRIPTION OF FIGURES

[0070] In the figures: [0071] 1 device [0072] 10 probe [0073] 11 array of transducers [0074] 12 bottom of probe [0075] 13 metal shield [0076] 14 damping material [0077] 15 display receiving element [0078] 16 slit [0079] 17 acoustic absorber [0080] 18 piezo electric element [0081] 19 acoustic lens [0082] 20 probe holder [0083] 22 bottom of holder [0084] 23 side of holder [0085] 24 front side of holder (may be void) [0086] 25 pivot (axis) [0087] 26 probe receiver [0088] 27 indentation [0089] 28 optical needle guider [0090] 29 holder attachment [0091] 30 fixator [0092] 31 distance piece [0093] 32 hinge [0094] 33 fixator leg [0095] 34 fixator clamp [0096] 35 central portion fixator [0097] 36 side portion fixator [0098] 37 adjustment element [0099] 38 fixator bridge [0100] 39 fixator foot [0101] 40 display [0102] 41 video glasses [0103] 71 top/bottom electrode layer [0104] 72 piezoelectric layer [0105] 73 stiff layer [0106] 74 dielectric layer [0107] 81 wire [0108] 91 video glasses [0109] 92 computer [0110] 93 software [0111] 94 beamformer [0112] 95 exemplary probe [0113] 96 exemplary fixator

[0114] FIG. 1a shows the present probe 10, with a wire 81, a probe holder 20, an indentation 27 at a front end, a needle guider in the form of a light source (LED) and a slit providing a visual line on a skin, a side 23 of the holder, a void front side of the holder, a hinge 32, a fixator 30 (strap), and distance piece 31 in the form of ball bearings.

[0115] FIG. 1b shows a side view of FIG. 1a, with further an array of transducers 11, a bottom of the probe 12 located lower than a bottom 22 of the probe holder (indicated with arrows).

[0116] FIG. 1c shows the device taken apart into the various elements thereof, and FIG. 1d shows a top view.

[0117] FIGS. 2a-f show alternative embodiments.

[0118] FIG. 2a shows a probe 10, a probe holder 20, a fixator 30, and a front side 24 of the probe holder that is void, leaving space for image forming and entering a needle.

[0119] FIG. 2b shows a side view and FIG. 2c an aerial view.

[0120] FIG. 2d shows the device taken apart, with the probe 10, probe holder 20, and fixator 30, and further a pivot 25 for rotating the probe in the holder, the holder comprising a pivot receiving element.

[0121] FIG. 2e shows a slit 16 for removably attaching the probe to holder 20, with a slit receiving element 26 in the holder.

[0122] FIG. 2f shows an alternative fixator which comprises a side portion 36, and may comprise a central portion 35, and a flat extension spring 37.

[0123] FIG. 3a shows an overview of the present device attached to an arm, with a probe 10 and display 40. A needle is entered.

[0124] FIG. 3b shows a caretaker using the present device with video glasses (or likewise AR glasses) 42, taking a vein between thumb and index finger of the left hand and entering a needle with the right hand.

[0125] FIG. 3c schematically shows the process of (1) using a pressure wrap to make a vein visible, (2) using the present device to identify a location of a vein (dark coloured part in bottom part of the figure), (3) fixing the device to the arm for holding the device in position, (4) tightening the fixator, (5) entering a needle (indicated with an arrow) under ultrasound image guidance, and (6) entering the needle (indicated with an arrow) under ultrasound image guidance in the vein.

[0126] In FIG. 4a a basic piezoelectric element is shown. Therein, from top to bottom, a top electrode layer 71, a piezoelectric layer 72, a bottom electrode 71, also functioning as a top electrode layer 71, a piezoelectric layer 72, and a bottom electrode 71 are shown. To the top electrode a first voltage may be applied, to the middle electrode a second potential, and to the bottom electrode a third potential, such as +50 V, 0 V, −50 V, and 100 V, 50 V and 0V, respectively. A voltage may be provided as such, or as a split voltage from one source.

[0127] In FIG. 4b, in addition to FIG. 1a, a stiff layer 73 is present, such as a SiN layer. The layer may be at the bottom, it may be at the top, and both. Further a stiff layer may be present in between the bottom electrode 71 of the top piezoelectric layer, and the top electrode 71 of the bottom electrode layer, in which case the bottom and top electrode are not the same.

[0128] In FIG. 4c, compared to FIG. 1a, a dielectric layer 74 in between the bottom electrode 71 of the top piezoelectric layer, and the top electrode 71 of the bottom electrode layer, is present.

[0129] In FIG. 4d four piezoelectric elements, each comprising a top electrode layer 71, a piezoelectric layer 72, and a bottom electrode layer 71, with in between a dielectric layer 74, and a stiff layer 73 is present. Each piezo-electric layer may have a voltage of e.g. 50 V, which may be a split voltage from one single source. A total voltage over the layers would then be 200 V.

[0130] FIG. 5 shows a schematic layout of the present probe 10. Therein a coaxial wire 81, a metal shield 13 essentially surrounding a bottom part and leaving the bottom open, an acoustic lens 19, such as an array of holes or a path-length refractor, a piezo electric element 18, acoustic absorber 17, typically a layer, such as a foam layer, such as a urethane layer, and a damping material 14, such as a layer, e.g. a layer of tungsten loaded epoxy, such as araldite, are shown. Typically also a ground electrode is present.

[0131] In FIG. 6 schematics of operation are shown. Cedexis Jena video glasses are in connection with a computer. On the computer software for addressing transducers, processing ultrasound signals, forming ultrasound images, communication between various elements of the present device, and so on, is stored. The ultrasound images are formed with a Micrus EXT-1 h beamformer (shown to the right of the computer). The beamformer is incorporated in the present ultrasound probe, which is custom made by Telemed. Also the fixator is custom made by MTKF. Connections are indicated with capital letters A-K, and elements are indicated with numbers 91-96.

[0132] FIG. 7 shows an exemplary embodiment wherein the probe 10 can move relative to the holder 20. The fixator 30 can be attached to a patient at one specific location and still providing movement of the probe in two directions.

[0133] FIG. 8 shows an elliptical, symmetrical, oblique probe.

[0134] An elliptical shaped probe provides both stability of and available space of a narrow variant. The symmetrical shaped probe and holder provide that both the front and the back can be pricked. Very practical when the shunt must be punctured from 2 sides, the whole system does not have to be removed and turned over. A sloping edge of the probe (narrow from the top, wide from the bottom) is also provided. So that the nurse, even when looking at the probe, can see exactly where the line on the front is exactly on the skin. This means that the caretaker knows exactly where the transducer is located and where it needs to be pinned.

[0135] FIGS. 9a-d show an alternative embodiment of the present fixator and holder. In FIG. 9a the elastic holder 20, fixator 30 with bridge 38, legs 33, clamps 34, and feet 39 are shown. The holder is at a lower part of the fixator attached to the fixator by attachment 29. FIG. 9b shows opening of the present fixator by a thumb and finger action. The device can then be positioned on e.g. a human arm. In FIG. 9c the present probe can be rotated and slid and if required the device can be repositioned, such as up or down the arm, or towards a side of the arm, or both. In FIG. 9d a needle is entered into a vein using the present device.

[0136] Further details of the figures are given throughout the description.

EXAMPLES

[0137] Measurement Procedure

[0138] With reference to FIG. 3c. 1: The shunt and skin are inspected. Then a tourniquet is applied. As a preparation ultrasound gel is applied to the probe. And for imaging video glasses are placed on the caretaker's head. 2: The probe with holder is placed on the arm. Then the shunt-traject is inspected using the ultrasound image formed by the probe. The best place for first shunt access is then selected. 3,4: The probe is fixed to the arm and on the specified place by connecting the tourniquet-system band and pulling the band slightly. This enables proper fixation and prevents indentation of the shunt. 5,6: The needle is pushed through the skin and underlying tissue into the shunt, guided by the ultrasound image. Next a blood line is connected. Finally the probe and holder are disconnected and may be moved to a second access location.

[0139] The invention although described in detailed explanatory context may be best understood in conjunction with the accompanying examples and figures.