WO2010029521A2 - Vein locator and associated devices - Google Patents

Vein locator and associated devices Download PDF

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Publication number
WO2010029521A2
WO2010029521A2 PCT/IB2009/054028 IB2009054028W WO2010029521A2 WO 2010029521 A2 WO2010029521 A2 WO 2010029521A2 IB 2009054028 W IB2009054028 W IB 2009054028W WO 2010029521 A2 WO2010029521 A2 WO 2010029521A2
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WO
WIPO (PCT)
Prior art keywords
apparatus
catheter
body part
unit
vein
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Application number
PCT/IB2009/054028
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French (fr)
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WO2010029521A3 (en
Inventor
Moshe Ben Chorin
Nir Weiss
Guy Levin
Ori Levin
Original Assignee
Moshe Ben Chorin
Nir Weiss
Guy Levin
Ori Levin
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Publication date
Priority to US9687808P priority Critical
Priority to US61/096,878 priority
Application filed by Moshe Ben Chorin, Nir Weiss, Guy Levin, Ori Levin filed Critical Moshe Ben Chorin
Publication of WO2010029521A2 publication Critical patent/WO2010029521A2/en
Publication of WO2010029521A3 publication Critical patent/WO2010029521A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4887Locating particular structures in or on the body
    • A61B5/489Blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters

Abstract

A single-enclosure mobile apparatus for blood vessel location including an illumination unit configured to shine light on a body part, a light detection unit configured to receive light coming from the body part, a processing unit configured to process signals from the light detection unit thereby locating blood vessels in the body part. Related apparatus and methods are also described.

Description

VEIN LOCATOR AND ASSOCIATED DEVICES

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. Provisional Application Serial No. 61/096,878 filed September 15, 2008.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to a mobile vein locator and associated devices, and, more particularly, but not exclusively, to a handheld vein locator and associated devices such as a vein cannulation device, a vein printer, and a display.

A need for free access to the blood system is common in many and diverse medical procedures, such as blood tests, blood donation, intravenous lines (for liquid infusions and medications), hemodialysis and others. While these situations differ from each other in most aspects they all involve vein cannulation, also known as percutaneous venous puncture, which is a puncturing of a vein by a sharp tip of a hollow needle, which is inserted into the vein to provide access to the blood flow.

The diversity of situations in which vein cannulation is performed in order to achieve access to blood flow makes it a common invasive medical procedure. As such it requires presence of trained medical staff, such as doctors, nurses, phlebotomists, or paramedics. Absence of such staff may delay treatment, reduce treatment efficiency, and in certain cases, particularly in trauma cases, may even endanger a patient's life. The situation may become critical in cases of mass catastrophes or major accidents when many people require urgent medical attention during a short period of time, and where medical staff on scene is usually insufficient to answer all needs. In a case where a vein is collapsed, cannulation requires people even more experienced than cannulation in a regular situation.

Many methods have been developed to improve detection of veins. Some methods are based on optical detection, and some on ultra-sound imaging. Ultrasound vein detection methods are described in US patent 4,527,569 to KoIb, US patent 6,068,599 to Saito et al, and US patent 6,132,379 to Patacsil et al. Optical methods to detect veins have been developed. These methods attempt to increase visibility of veins, by increasing contrast between a vein and its surrounding tissue. The methods rely on blood having an increased absorption, relative to surrounding tissue, in IR and red wavelength regime. Therefore, under IR or deep red illumination, veins appear darker with respect to their surroundings. The same phenomenon causes the veins to appear bluish with respect to their surround under visible, white, light. An advantage of IR and deep red light is their longer wavelength, which results in less absorption and scattering in body tissue and provides better contrast with respect to that obtained in the visible range. In order to locate veins in a human, for example for taking blood samples or inserting an intravenous needle, lighting is used in order to improve contrast between veins and the flesh through which they pass.

Several companies, such as Sharn (www.sharn.com). Venoscope (www.venoscope.com) and VeinLite (www.veinlite.com) have developed various light sources based mostly on Light Emitting Diodes (LEDs), in the red region of the spectrum. The light sources are used to trans-illuminate tissue, thus improving visibility of veins.

A Venoscope® II trans-illuminator, available from Venoscope, L. L. C, 1018 Harding Street, Suite 104, Lafayette, LA 70503, USA, is used to localize veins, as described in www.venoscope.com. It utilizes an array of high intensity LED lights to trans- illuminate a patient's subcutaneous tissue, thereby highlighting veins which absorb the light rather than reflecting it. This particular combination of lights, with different wavelengths, allows light to penetrate deeper into the subcutaneous tissue and to create the contrast necessary so that the blood veins stand out as dark lines within the illuminated orange tissue. Veinlite also use trans-illumination to localize veins, as described in www.veinlite.com.

A FotoFinder Veinscope, available through FotoFinder Systems, Inc., at 9693 Gerwig Lane, Suite S, Columbia, MD 21046, USA, uses polarized light to enhance contrast between veins and surroundings. An integrated LED ring light and an optional floodlight compensate for even poor light conditions. A special lens FotoFinder VeinScope provides macro and close up images. The FotoFinder VeinScope captures redness, blood vessels (couperose, spider veins), acne, wrinkles, scars or tattoos. The FotoFinder VeinScope has a continuously adaptable filter setting which can be adjusted between cross and parallel polarization. This enables a user to either take images without any reflections, where redness comes out stronger, or to use extreme sidelight in order to reinforce unevenness of a patient's skin. An opaque metal tube of the VeinScope permits consistent illumination of the viewing field.

Persons may use an illuminator for detection, and then forego using the illuminator while performing the puncturing. The insertion procedure with the illuminator becomes more complex than without. Furthermore, because detection is done by the human visual system, IR light, which has a better penetration into the dermis, and thus a better contrast, cannot be used, since it is not visible to a human eye.

The human visual system is also not very sensitive to the red light used, compared to its sensitivity to ambient illumination. Therefore, in most handheld battery driven illuminators, light intensity is not strong enough, and detection is preferably done in a darkened room. For more intense light sources power is taken from utility lines, and portability of the illuminator is severely curtailed.

IR light is better suited for detection, but cannot be viewed by an unaided eye. Therefore, in a certain system, termed Vein Contrast Enhancer, also termed Vein Viewer, by Luminetx (www . luminetx .com) an image of the IR illuminated skin is captured by a camera and presented on a display. This provides an image that can be viewed by humans, and assist them in detecting veins. The Vein Viewer sends out infrared light which is reflected back differently from the vein compared to surrounding tissue. The reflected light is then converted to an image of the veins and projected back onto the patient's skin allowing the nurse or the doctor to view the image with relation to the area in which the puncturing should take place. Vein Viewer is said by the manufacturer to work equally well in dark and light skinned individuals. Vein Viewer is described in www.luminetx.com. The disadvantage of the method is that it usually requires relative large distance for the imaging (and the projection), and tight registration of the captured and projected image.

A publication named "Combining near-infrared illuminants to optimize venous imaging", by Vincent Pacquit, Jeffery R. Price, Fabrice Meriaudeau, Kenneth W. Tobin, and Thomas L. Ferrel, Proc. SPIE vol. 6509, p. 65090H (2007), describes a system in which the surface to be punctured is imaged in the IR to obtain vein structure, and in parallel a laser beam scans the surface to obtain three-dimensional map. This approach allows correlating the position of veins with the bulging of the skin above veins.

Another publication named "Near-infrared imaging and structured light ranging for automatic catheter insertion", by Vincent Pacquit, Jeffery R. Price, Fabrice Meriaudeau, Rubye H. Farahi, Kenneth W. Tobin, and Thomas L. Ferrel, Proc. SPIE vol. 6141, p. 6141 IT-I (2006), describes an illumination system for vein imaging using LEDs of different wavelengths. The system allows estimation of a spectral image of the veins and the surrounding tissues.

A publication named "Dual wavelength laser diode excitation source for 2D photoacoustic imaging" by Thomas J. Allen and Paul C. Beard, published in Proc. SPIE vol. 6437, p. 6437 IU (2007) describes the use of short duration IR pulses to excite ultrasonic signals, when absorbed inside the blood and other tissues. The temporal dependence of the ultra-sonic signals is interpreted to provide information about the IR absorption below the skin surface. Several peaks are detected, and one of them is attributed to absorption of the IR in the blood in the vessels. This provides information about vein depth below skin surface.

A publication named "An optical detection system for biomedical photoacoustic imaging", by P. C. Beard and T. N. Milles, published in Proc. SPIE vol. 3916, p. 100 (2000) describe a method for the detection of the ultra-sonic signals, using optical methods.

There are several other products specifically designed for vein localization: Vena- vue uses liquid crystal thermography to detect the warmth of blood flowing through veins, as described in www.kiyota-intl.com;

Additional background art includes: US published patent application 2006/0020212 of Tianning;

US published patent application 2003/0060716 of Heidrich;

US published patent application 2005/0101912 of Faust et al;

US patent 5,954,701 to Matalon;

US patent 5,678,555 to O'Connel; PCT published patent application WO 06/064433 of Ayati et al;

PCT published patent application WO 06/120619 of Sieglinde et al;

PCT published patent application WO 06/123282 of Schwach et al; PCT published patent application WO 06/069066of Marcotte et al; and EP patent 1894524 to Miura et al.

SUMMARY OF THE INVENTION The present invention, in some embodiments thereof, relates to a mobile vein locator and associated devices, and, more particularly, but not exclusively, to a single- enclosure mobile vein locator and associated devices such as a vein cannulation device, a vein printer, and a display.

Exemplary embodiments of the invention include a mobile handheld device for automatically detecting veins, and associated devices. Some of the associated devices include a device for automatically directing a needle into a detected vein; a device for printing a vein map on a scanned body part; a device for printing a puncture point and a puncture direction on a scanned body part; and a device for displaying veins and/or displaying a puncture point and a puncture direction. According to an aspect of some embodiments of the present invention there is provided a single-enclosure, hand-held mobile apparatus for blood vessel location including an illumination unit configured to shine light on a body part, a light detection unit configured to receive light coming from the body part, a processing unit configured to process signals from the light detection unit thereby locating blood vessels in the body part.

According to some embodiments of the invention, the apparatus dimensions are less than 420mm x 150mm x 100mm. According to some embodiments of the invention, the apparatus fits into a hand-carryable bag. According to some embodiments of the invention, the apparatus weight is less than 5 kilogram. According to some embodiments of the invention, the apparatus is further configured to be powered by batteries included within the single enclosure.

According to some embodiments of the invention, the light detection unit scans the body part. According to some embodiments of the invention, the light detection unit scans the body part while in contact with the body part. According to some embodiments of the invention, the processing unit is additionally configured to identify whether a blood vessel is a vein, and if a vein is located, to judge the suitability of the vein for cannulation. According to some embodiments of the invention, the processing unit is additionally configured to select a vein and plan a puncture point and direction for performing cannulation of the vein.

According to some embodiments of the invention, the apparatus further includes a catheter insertion unit configured to position a catheter unit including a puncture needle and a catheter tube so that a point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation. According to some embodiments of the invention, the catheter insertion unit further includes a catheter holder configured to translate, relative to the apparatus, along three perpendicular directions, and rotate around at least two perpendicular axes. According to some embodiments of the invention, the catheter insertion unit further includes a catheter holder configured to translate, relative to the apparatus, along two perpendicular directions, and rotate around one axis.

According to some embodiments of the invention, the configured to position includes having a user interface for guiding an operator to place the apparatus so that a point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation. According to some embodiments of the invention, the configured to position includes automatically moving the catheter insertion unit so that a point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation. According to some embodiments of the invention, the catheter insertion unit is configured to automatically insert the catheter unit into the selected vein.

According to some embodiments of the invention, an operation cycle including scanning to locate blood vessels in the body part and puncturing to automatically insert the catheter unit into a selected vein draws less than 300 milliamperes. According to some embodiments of the invention, the apparatus further includes a unit for automatically taping the catheter tube to the body part. According to some embodiments of the invention, the apparatus further includes means for disinfecting the body part.

According to some embodiments of the invention, the catheter insertion unit is configured to position the catheter unit so that the point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation, and the catheter insertion unit is configured for manual insertion by an operator.

According to some embodiments of the invention, the catheter insertion unit is configured to puncture the selected vein at a first angle between the puncture needle and the vein, and to insert the catheter unit into the selected vein at a second angle between the puncture needle and the vein.

According to some embodiments of the invention, the catheter insertion unit includes a catheter holder including two parts, a needle gripper and a catheter tube gripper, and the two parts are configured to move relative to each other. According to some embodiments of the invention, the needle gripper is further configured to withdraw the puncture needle from the body part.

According to some embodiments of the invention, the light detection unit is slidingly affixed to a rail. According to some embodiments of the invention, the light detection unit includes a linear array of light detectors. According to some embodiments of the invention, the catheter insertion unit is slidingly affixed to a rail.

According to some embodiments of the invention, at least one side of the single- enclosure is configured to conform to a shape of the body part, thereby enabling to place a large portion of the at least one side of the single enclosure in contact with the body part. According to some embodiments of the invention, the apparatus is configured to measure a position of the catheter insertion unit relative to the light detection unit and provide the measurement to the processing unit.

According to some embodiments of the invention, the apparatus is further configured for affixing the apparatus to the body part. According to some embodiments of the invention, the apparatus further includes one or more straps for affixing the apparatus to the body part. According to some embodiments of the invention, a side of the apparatus for placing next to the body part is shaped to conform to the body part. According to some embodiments of the invention, a side of the apparatus for placing next to the body part includes a flexible flange for closing gaps between the apparatus and the body part. According to some embodiments of the invention, the flange is inflatable.

According to some embodiments of the invention, the apparatus further includes a tourniquet. According to some embodiments of the invention, the apparatus further includes a counter-plate hingedly affixed to the single-enclosure, and means for attaching the counter- plate to the single-enclosure, thereby configured to envelop the body part in a clamshell form. According to some embodiments of the invention, the illumination unit is included in the counter-plate.

According to some embodiments of the invention, the apparatus further includes a cannulation detection module configured to detect presence of blood in the catheter tube, and in which the catheter insertion unit is further configured to remove the puncture needle from the body part if blood has been detected in the catheter tube after insertion of the catheter unit, and to remove the entire catheter unit from the body part if blood has not been detected after insertion of the catheter unit.

According to some embodiments of the invention, the apparatus further includes a catheter unit cartridge configured to store a plurality of the catheter units, and the catheter insertion unit is further configured to automatically load a catheter unit from the catheter unit cartridge.

According to some embodiments of the invention, the catheter unit cartridge stores a plurality of catheter units of different sizes, the apparatus is configured to receive a catheter unit selection signal from a user, and the catheter insertion unit is configured to removably connect a catheter holder to a selected one of the catheter units according to the catheter unit selection signal.

According to an aspect of some embodiments of the present invention there is provided a vein location and cannulation method including using a single-enclosure mobile apparatus for illuminating a body part, receiving light coming from the body part, automatically processing the received light thereby locating blood vessels in the body part, identifying whether a blood vessel is a vein, if one or more veins are located, selecting a vein and planning a puncture point and direction for performing cannulation of the vein, and inserting a catheter unit into the selected vein, along the selected direction, in the body part.

According to some embodiments of the invention, the method further includes affixing the apparatus to the body part. According to some embodiments of the invention, the affixing is done using straps. According to some embodiments of the invention, the method further includes affixing the apparatus to the body part using a counter-plate hingedly affixed to the single-enclosure, thereby enveloping the body part in a clamshell form. According to some embodiments of the invention, the apparatus is affixed to the body part single-handedly. According to some embodiments of the invention, after the inserting a needle gripper withdraws the needle from the selected vein, thereby leaving the catheter tube inserted in the selected vein.

According to some embodiments of the invention, the method further includes detecting presence of blood in the catheter tube, and removing the puncture needle from the body part if blood has been detected after the inserting, and removing the catheter unit from the body part if blood has not been detected after the inserting. According to some embodiments of the invention, the method further includes automatically loading the catheter unit from a catheter unit cartridge which stores a plurality of catheter units.

According to some embodiments of the invention, the method further includes receiving a cannulation type indication from a user, selecting a catheter type based, at least partly, on the cannulation type indication, and inserting a catheter unit of the selected catheter type into the selected vein.

According to some embodiments of the invention, the apparatus further includes a printing module for printing onto the body part. According to some embodiments of the invention, the apparatus further includes a pen for printing onto the body part. According to some embodiments of the invention, the printing module is configured to print using one or more materials of the group consisting of colored dye, colored ink, permanent ink, and fluorescent ink.

According to some embodiments of the invention, the apparatus further includes a printing module configured to print the puncture point and the direction for performing cannulation onto the body part. According to some embodiments of the invention, the processing unit is configured to select more than one vein, plan more than one puncture point, and plan a direction for performing cannulation corresponding to each selection point, and the printing module is configured to print more than one puncture point and a direction for performing cannulation corresponding to each selection point. According to some embodiments of the invention, the printing module is configured to print a map of at least one type of blood vessel onto the body part. According to some embodiments of the invention, the printing module is configured to print a map of more than one type of blood vessel onto the body part, and to print different types of blood vessel using different symbols. According to some embodiments of the invention, the printing module is configured to print the map using different inks corresponding to different types of blood vessel. According to an aspect of some embodiments of the present invention there is provided a vein location and printing method including illuminating a body part, receiving light coming from the body part, processing the received light thereby locating blood vessels in the body part, identifying a type of a blood vessel, and printing onto the body part. According to some embodiments of the invention, the method further includes selecting a type of blood vessel which is a vein, planning a puncture point and direction for performing cannulation of the vein, and printing the puncture point and the direction for performing cannulation onto the body part.

According to some embodiments of the invention, the method further includes printing a map of at least one type of blood vessel onto the body part.

According to some embodiments of the invention, the apparatus further includes a display configured to display graphical information about the blood vessels in the body part. According to some embodiments of the invention, the graphical information includes a map of the blood vessels in the body part. According to some embodiments of the invention, the graphical information includes a map of the blood vessels in the body part and a selected puncture point and cannulation direction.

According to an aspect of some embodiments of the present invention there is provided a vein location and display method using a single-enclosure mobile apparatus including illuminating a body part, receiving light coming from the body part, processing the received light thereby locating blood vessels in the body part, and displaying graphical information about the blood vessels located in the body part.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.

For example, hardware for performing selected tasks according to embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a flash disk and/or removable media, for storing instructions and/or data. Optionally, a network connection may be provided as well. A display and/or a user input device such as a keyboard or mouse may optionally be provided as well.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings: Fig. IA is a simplified illustration of a typical prior art catheter unit;

Fig. IB which is a simplified illustration of the catheter unit of Fig. IA, in which the puncture needle is drawn back from the catheter tube; Fig. 2A is a simplified illustration of a single-enclosure apparatus constructed and operative according to an exemplary embodiment of the invention;

Fig. 2B is a simplified flow chart illustration of a method of cannulation operational according to an exemplary embodiment of the invention; Fig. 3 A is a simplified illustration of an exemplary embodiment of the apparatus of

Fig. 2A, attached by straps to a patient's forearm;

Fig. 3B is a simplified illustration of an exemplary embodiment of the apparatus of Fig. 2 A, having a clamshell form factor;

Fig. 4 is a simplified illustration of some parts of the apparatus of Fig. 2A; Fig. 5A is a simplified block diagram illustration of an exemplary configuration of the light detection unit and the illumination unit in the apparatus of Fig. 2A;

Fig. 5B is a simplified block diagram illustration of an alternative exemplary configuration of the light detection unit and the illumination unit in the apparatus of Fig. 2A; Fig. 5C is a simplified flow chart illustration of an exemplary method of blood vessel selection in the apparatus of Fig. 2A;

Fig. 5D is a series of images corresponding to stages in the exemplary method of Fig. 5C;

Figs. 6A, 6B, and 6C, are simplified top, side, and frontal view illustrations respectively, of the catheter insertion unit of the apparatus of Fig. 2A;

Fig. 7 is a simplified illustration of the catheter insertion unit of the apparatus of Fig. 2A;

Fig. 8 is a simplified illustration of the vertical rotator of the apparatus of Fig. 2A;

Fig. 9 is a simplified drawing of an optional catheter unit cartridge of the apparatus of Fig. 2A;

Figs. 1OA and 1OB are simplified illustrations of a side and a top view, respectively, of an alternative embodiment of the catheter insertion unit of the apparatus of Fig. 2A;

Fig. 1OC is a simplified and partial illustration of the side view of the alternative embodiment of the catheter insertion unit of the apparatus of Fig. 2 A;

Fig. 11 is a simplified illustration of apparatus for printing constructed and operative according to an alternative exemplary embodiment of the invention; Fig. 12 is a simplified flow chart illustration of a method of printing operational according to the alternative embodiment of Fig. 11;

Fig. 13 is a simplified flow chart illustration of an alternative method of printing operational according to yet another alternative exemplary embodiment of the invention; and

Fig. 14 is a simplified illustration of apparatus for display constructed and operative according to still another alternative exemplary embodiment of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION The present invention, in some embodiments thereof, relates to a mobile, handheld vein locator and associated devices, and, more particularly, but not exclusively, to a single- enclosure vein locator and associated devices such as a vein cannulation device, a vein printer, and a display.

Exemplary embodiments of the invention include a single-enclosure mobile apparatus including a device for automatically detecting veins, and one or more additional associated devices. The associated devices include a device for automatically inserting a catheter into a detected vein; a device for automatically directing an operator to orient and insert a catheter into a detected vein; a device for printing a blood vessel map on a scanned body part; a device for printing a puncture point and a puncture direction on a scanned body part; and a device for displaying veins and/or displaying a puncture point and a puncture direction.

It is noted that a mobile apparatus for cannulation potentially provides operational advantages. Moving the mobile apparatus around between patients, whether in a hospital, clinic, or outside of such institutions, for example at a patient's home or at a location of medical need, may be more convenient and faster than bringing a patient to a non-mobile apparatus for cannulation.

The mobile apparatus, in some embodiments thereof, can optionally be attached to the patient's body. It is noted that apparatus for cannulation which can optionally be attached to a body potentially provides operational advantages. Attaching the mobile apparatus to the body maintains registration of the apparatus relative to the body, and overcomes possible movement of the body. The attaching enables use in non-stable situation such as, by way of a non-limiting example, a moving vehicle, and/or other causes for patient movement.

The mobile apparatus, in some embodiments thereof, can optionally be mounted on a patient's bed, with and/or without attaching to the patient's body. The mobile apparatus, in some embodiments thereof, performs a linear scan of light collected off a patient's body, producing a map of blood vessels, and specifically veins, in the body part scanned. Veins are automatically detected, and one or more puncture locations are automatically selected, as well as a direction of cannulation for the puncture locations. The mobile apparatus, in some embodiments thereof, performs automatic detection and insertion of a catheter, enabling less-skilled operators to use the apparatus, possibly at home, or in locations away from more-skilled medical personnel. The automatic insertion of the catheter is optionally performed by a mechanical manipulator, which grips a catheter, guides a tip of the catheter's needle to a puncture point, pushes the needle into a patient's vein, and withdraws the needle, leaving the catheter tube in the vein.

The mobile apparatus, in some embodiments thereof, supports one-handed use, including one-handed attachment to a patient's body, automatic detection of a puncture location and cannulation direction, and automatic insertion of the catheter.

The mobile apparatus, in some embodiments thereof, performs automatic detection of a puncture location and cannulation direction, and optionally guides an operator, using a suitable user interface, to locate and insert of a catheter, enabling optional use of less- skilled operators for cannulation.

The mobile apparatus, in some embodiments thereof, performs automatic detection of blood vessels, and/or specifically veins, and/or puncture locations and associated cannulation directions, and prints a map of some or all of the blood vessels, arteries, veins, puncture locations, and/or associated cannulation directions, on a patient's body.

The mobile apparatus, in some embodiments thereof, performs automatic detection of blood vessels, and/or specifically veins, and/or puncture locations and associated cannulation directions, and displays some or all of the above on a display built into the apparatus. Other embodiments of the apparatus display blood vessels, and/or specifically veins, and/or puncture locations and associated cannulation directions by shining a light, optionally a laser, onto a patient's body. As will be seen below, the apparatus, in exemplary embodiments thereof, is designed to be built using low cost components, thereby lowering total cost. A lower total cost enables proliferation, which is useful in cases such as, by way of a non-limiting example, locations of catastrophe, where large numbers of people need to be treated efficiently; home blood sampling; veterinary blood sampling; military infusion and/or medication kits.

In some cases an autonomous system able to detect veins and automatically insert catheters into the veins is provided, thus opening blood access optionally without intervention of medical staff, except possibly for an initiation of the process. For purposes of better understanding some embodiments of the present invention, as illustrated in Figs. 2A-14 of the drawings, reference is first made to the construction and operation of a typical vein catheter unit as illustrated in Figs IA and IB.

Reference is now made to Fig. IA, which is a simplified illustration of a typical prior art catheter unit 10. The catheter unit 10 includes a puncture needle 15 to which a catheter tube 20 is attached. The catheter tube 20 is a flexible plastic tube, typically having at one end a connection hub 25 to an intravenous drip (not shown). Initially, plastic of the catheter tube 20 envelops the puncture needle 15. At one, distal, end of the catheter unit 10 a sharp tip of the puncture needle 15 protrudes from the catheter tube 20 and at another, proximal, end the puncture needle 15 is connected to a holder 30 which is removably attached to the connection hub 25.

After insertion of the puncture needle 15 with the catheter tube 20 into a vein, a portion of the catheter unit 10 including the puncture needle 15 is drawn back, and a portion of the catheter unit 10 including the catheter tube 20 is left inside the vein.

A present day manual vein puncture procedure involves several stages. A manual process for inserting an intravenous catheter is now described; however, many of the steps and devices used are similar to other processes involving vein cannulation, such as drawing blood. It is noted that different processes involve using different catheters, for example catheters having different sized needles. It is noted that different processes involve cannulation in different body parts. For example, intravenous catheters are typically inserted into arm veins in adults, yet foot veins in infants.

In a first stage of an insertion procedure a suitable vein, close to the skin's surface, is identified. Detection of the vein is done by using visual cues and by feeling a patient's skin using fingers to locate surface veins. A tourniquet is often applied in order to increase vein blood volume and improve detection.

In a second stage of an insertion procedure skin is disinfected in an area of intended penetration, and the puncture needle 15 carrying the catheter tube 20 is inserted into a vein. After blood is observed in the catheter tube 20, the puncture needle 15 is drawn back, leaving the catheter tube 20 inside the vein.

In a final stage the catheter tube 20 is fixed in its position and is ready for use. In many cases, repeated trials are required before success in cannulation is achieved. These are mostly due to failure in the detection of a suitable vein, especially when the vein is not clearly visible. Therefore, the insertion procedure may be time consuming, and painful for the patient.

Reference is now additionally made to Fig. IB, which is a simplified illustration of the catheter unit of Fig. IA, in which the puncture needle is drawn back from the catheter tube. Fig. IB depicts how the portion of the of the catheter unit 10 which includes the puncture needle 15 can be removed from the portion of the catheter unit 10 which includes the catheter tube 20.

It is noted that two openings 27 28 for intravenous drips are present in the connection hub 25. One of the openings 27 is depicted as uncapped in Figs. IA and IB, and the other opening 28 is depicted as capped in Figs. IA and IB.

It is noted that catheter units 10 come in various sizes. Of especial importance are outside and inside diameters of the puncture needle 15. Obviously, the outside diameter of the puncture needle 15 determines the inside diameter of the catheter tube 20.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Overview of an exemplary embodiment

Reference is now made to Fig. 2A, which is a simplified illustration of a single- enclosure apparatus 90 constructed and operative according to an exemplary embodiment of the invention. The apparatus 90 includes a vein detection unit 100, and a catheter insertion unit

200, both optionally slidingly affixed to an optional main rail 300.

An enclosure 400 is attached to the main rail 300.

In some embodiments of the invention the main rail 300 is a mechanical base upon which other elements move, as will be further described below. In other embodiments of the invention the enclosure 400 is the mechanical base upon which the other elements move, as will be further described below.

It is noted that in some embodiments of the invention the enclosure 400 is optionally shaped to fit a suitable body part. An enclosure 400 shaped for placing on a large body part may be larger than an enclosure 400 shaped for placing on a smaller body part. An enclosure 400 shaped for placing on a flat body part may be shaped differently from an enclosure 400 shaped for placing on a cylindrical body part such as a limb. By way of a non-limiting example, an enclosure 400 shaped for placing on a limb is optionally curved on the side placed next to the limb.

By way of a non-limiting example, an enclosure 400 shaped to fit a forearm is curved on the side placed next to the forearm, a curve which conforms to the forearm. For example, an enclosure 400 shaped to fit an infant's foot is more curved than the enclosure

400 shaped to fit an adult forearm. An enclosure 400 shaped to fit on an abdomen, for example to be used for intravenous feeding, is much less curved than the enclosure 400 shaped to fit the forearm. The enclosure 400 may be shaped to fit a neck being less curved than the enclosure 400 shaped to fit the forearm.

In some embodiments of the invention the enclosure 400 has one form factor, and an extension to the enclosure 400 (not shown) is fitted onto the side of the enclosure 400 next to the patient's skin, the extension being shaped to conform to the body part.

In some embodiments of the invention the open side of the enclosure 400 includes a flange, made of rubber or other flexible material, to overcome variations in limb and/or other body part shapes. In some embodiments of the invention the flexible flange is inflatable, allowing for a fit with some pressure, fitting the enclosure 400 to a specific shape, and preventing sliding of the apparatus.

In some embodiments of the invention, the inflatable flange is connected to an inflatable sleeve and/or strap which are placed around the patient's arm, so that when the flange is inflated, the sleeve is also inflated, acting as a tourniquet and aiding cannulation.

An example mode of operation of exemplary embodiments of the apparatus is now described. Once a vein cannulation is judged necessary, the enclosure 400 is placed by a user onto a suitable region of a patient's body. A typical body part selected for cannulation is a limb. The main rail 300 optionally operates as a structural frame, holding components of the apparatus, and acting as a positional reference frame for the components, and, being attached to the enclosure 400, which is attached to the limb, also as a positional reference frame for the limb. The vein detection unit 100 and the catheter insertion unit 200 are both configured to slide along the main rail 300 attached to the enclosure 400.

The vein detection unit 100 optionally scans the body part, optionally illuminating the body part, receiving light from the body part, and processing the light received to detect blood vessels. A processing unit, optionally included within the vein detection unit

100, processes the received light, optionally determines which of the detected blood vessels is a vein, and selects a puncture point and trajectory for cannulation. The catheter insertion unit 200 inserts a catheter into the vein, and withdraws the needle of the catheter from the vein, while leaving the catheter tube in the vein.

It is noted that by having the vein detection unit 100 scan the body part from a close distance, and/or by contact scanning, a large area of body surface is mapped while having a compact apparatus 90. If an optical system with a relatively large focal length and field of view were used in the vein detection unit 100, the optical system would require placing the vein detection unit 100 a large distance from the surface, not enabling the apparatus 90 to be compact, and interfering with portability.

Using a low power consumption illuminating unit and light detection unit in the vein detection unit 100 enables prolonged battery operation, and improves mobility and portability of the apparatus 90. Overview of operation

Reference is now additionally made to Fig. 2B, which is a simplified flow chart illustration of a method of cannulation operational according to an exemplary embodiment of the invention. The body part intended to be cannulated is placed under the apparatus 90 of Fig.

2A. The apparatus is optionally attached to the body part, as will be discussed further below with reference to Fig. 3 A.

The body part is illuminated (305), using an illumination unit.

Light coming from the body part is received (310), using a light detection unit. The received light is optionally automatically processed by the processing unit, locating blood vessels in the body part (315). Optionally, the blood vessels located are then further identified as arteries or veins (320).

If one or more veins have been located (325), a vein is optionally selected, and a puncture point and a direction for performing cannulation of the vein are planned (330). Once a puncture point and a direction for performing cannulation of the vein have been planned, a catheter unit is optionally inserted into the selected vein (335), along the selected direction, in the body part.

In some embodiments of the invention alcohol, or some other suitable disinfectant, is sprayed onto the puncture point before inserting the catheter unit into the selected vein. Some alternative configurations of the apparatus of Fig. 2A will now be described, after which components of the apparatus of Fig. 2 A will be described in greater detail.

Some alternative configurations

It is noted that in some embodiments of the invention, the enclosure 400 is affixed to the suitable region of a patient's body by using straps. The straps optionally use suitable fasteners to lock the straps in place, and the length of the straps is optionally adjustable. The straps may use a Velcro-like fastening to lock the straps in place.

Reference is now additionally made to Fig. 3A, which is a simplified illustration of an exemplary embodiment of the apparatus of Fig. 2A, attached by straps 405 to a patient's forearm 410. The exemplary embodiment of the apparatus 90 has two straps 405 attached to the enclosure 400. The straps 405 serve to attach the enclosure 400 to the forearm. The straps may optionally be connected to the main rail 300, not necessarily to the enclosure 400.

There may be more than two straps 405, or only one strap 405. The number of straps, and/or the width and/or lengths of the straps may be different in different embodiments of the invention, optionally according to the size of the body part to which the apparatus 90 is to be attached.

In some embodiments of the invention, the enclosure 400 is affixed to the suitable region of a patient's body by having an additional rigid or semi rigid section of an enclosure, termed herein a counter-plate, the counter-plate intended for placing on an opposite side of the body part. The enclosure 400 and the counter-plate optionally form together a form factor termed a clamshell.

Reference is now made to Fig. 3B, which is a simplified illustration of an exemplary embodiment of the apparatus of Fig. 2A, having a clamshell form factor. The clamshell form factor of the apparatus 90 includes, in addition to the enclosure 400, a counter plate 420. The counter plate 420 is connected to the enclosure 400 by one or more hinges 425 of some suitable type. The hinges may be, by way of a non-limiting example, simple straps providing rotation of the counter plate 420 relative to the enclosure 400; may be one or more long piano hinges; and may be one or more standard hinges. Some embodiments of the invention include a spring acting to close the counter plate 420 against the enclosure 400. Some embodiments of the invention include a ratchet mechanism (not shown) with the hinges 425, which permits closing of the counter plate 420 and acts against opening the counter plate 420, until the ratchet mechanism is released.

An edge 430 of the counter plate 420 opposite to the hinge 425 optionally includes a fastener (not shown) to fasten the edge 430 to the enclosure 400. The fastener may be, by way of some non-limiting examples, a flexible fastener such as one or more straps using Velcro and/or buckles to attach to the enclosure 400; and a rigid fastener, optionally including a ratchet mechanism, and/or optionally including a spring to add flexibility to the rigid fastener.

The exemplary embodiments of Fig. 3B enable one-handed operation of the apparatus 90. In some of the embodiments of the invention having a clamshell form factor, not shown in Fig. 3B, an illumination unit (not shown) is optionally placed in the counter-plate 430, and light shines through the body part enveloped by the apparatus 90.

In alternative embodiments of the invention the illumination unit placed in the counter plate 430 is in addition to an illumination unit (not shown, see Fig. 4) in the enclosure 400. In other embodiments of the invention the illumination unit placed in the counter plate 430 is instead of the illumination unit placed in the enclosure 400.

In alternative embodiments of the invention, an illumination unit is placed in the counter plate 430, either in a fixed position, and/or able to translate along the counter plate 430. In alternative embodiments of the invention, the translation is optionally controlled by the processing unit, and/or the translation is mechanically connected to a translation of a light detection unit included in the vein detection unit 100.

The flexible flange, mentioned above with reference to Fig. 2A, may optionally be attached to the edge of the enclosure 400 and/or to the edge of the counter plate 420. The flexible flange may be inflatable, as described above, and may be attached to the inflatable sleeve and/or strap acting as a tourniquet.

In some embodiments of the invention the enclosure 400 is transparent, and/or partially transparent, enabling viewing of the patient's body through the enclosure 400.

The vein detection unit 100 Reference is now additionally made to Fig. 4, which is a simplified illustration of some parts of the apparatus of Fig. 2A. Fig. 4 depicts the vein detection unit 100, the catheter insertion unit 200, and the main rail 300. Additional details of the vein detection unit 100 are depicted in Fig. 4 and also described below.

The vein detection unit 100 optionally includes a light detection unit 101, an illumination unit 102, and a processing unit (not shown).

It is noted that the components of the vein detection unit 100 which are depicted and/or described in the exemplary embodiment of Fig. 4 as housed within the vein detection unit 100, may be housed in different units.

By way of a non- limiting example, in some embodiments the illumination unit 102 is housed separately from the vein detection unit 100. The illumination unit 102 may or may not be slidingly affixed to the main rail 300 or the enclosure 400, and may or may not slide along. By way of another non-limiting example, in some embodiments the processing unit is housed separately from the vein detection unit 100, and may or may not be slidingly affixed to the main rail 300 or the enclosure 400, and may or may not slide along.

In such cases the light detection unit 101 optionally slides along the main rail 300 and optionally takes positional reference from the main rail 300, the illumination unit may also optionally slide along the main rail 300 and may optionally take positional reference from the main rail 300, while the processing unit need not necessarily slide along or take positional reference from the main rail 300.

In some embodiments of the invention the vein detection unit 100 optionally scans the body part rather than imaging the body part as a single exposure. When the light detection unit 101 is a linear detector, capture of light from body tissues is line by line. The vein detection unit 100 is optionally placed in close proximity to a surface of the patient's body. In some embodiments of the invention the light detection unit 101 actually touches the skin.

In some embodiments of the invention the light detection unit 101 optionally has no imaging optics.

It is to be appreciated that when the light detection unit 101 scans the skin in contact with the skin, and/or in close proximity to the skin, there need be no optics used, or the optics may be very simple and inexpensive, such as micro-lenses. The micro-lenses may be one per detection element, and may even be formed as part of the detection element.

In some embodiments of the invention, alcohol or some other suitable disinfectant is sprayed and/or swabbed by the light detection unit as it scans the patient's body.

In some embodiments of the invention the light detection unit 101 is optionally curved, to more closely match curvature of the scanned body part. In some embodiments of the invention the illumination unit 102 is optionally curved, to more closely match curvature of the scanned body part.

The light detection unit 101

In the embodiment of the invention depicted in Figs. 2A and 4 the light detection unit 101 is a linear light sensitive array. The light detection unit 101 is optionally a light sensitive CCD detector, a CMOS based detector, or a light-sensitive diode or transistor, optionally sensitive at deep-red and near Infra Red (IR) wavelengths, by way of a non- limiting example 800nm to lOOOnm wave length. In some embodiments of the invention the light detection unit 101 is optionally sensitive at thermal infrared wavelengths, for example 8-12 microns.

In some embodiments of the invention the light detection unit 101 samples light at different wavelengths. In some embodiments, the light detection unit 101 uses a Foveon light detection array, which samples at three wavelength ranges simultaneously.

In some embodiments of the invention, the illumination unit 102 illuminates at different wavelengths (colors), switching between the different wavelengths, to enable the light detection unit 101 to sample the different wavelengths.

The resolution needed for the light detection unit depends on the accuracy required by the apparatus 90. By way of a non-limiting example, since accuracy of approximately

0.1 mm is enough for cannulation, the resolution of the light detector can be 0.1 mm. By way of a non-limiting example, a linear array detector providing 10 pixels per millimeter is enough, and is typically lower than resolution provided by off the shelf light detection components. A typical, off the shelf, exemplary linear array detector of 2048 elements per 4 cm, when used in a 1 :1 magnification, and/or a scanning mode, provides a resolution of approximately 0.02 mm, which is approximately 5 times the above mentioned resolution.

In some embodiments of the apparatus 90 the light detection unit 101 optionally samples light at a plurality of wavelengths. The processing unit then analyses spectral differences between tissue, veins, and arteries. Since the different tissues, veins, and arteries absorb differently at different wavelengths, differentiating between them is possible by comparing the absorption at different wavelengths.

It is noted that some detectors, such as the detectors described above, are presently inexpensive, enabling production of inexpensive embodiments of the invention. Producing embodiments of the invention at as low cost as possible supports having a wide distribution of many low cost embodiments of the invention, for example in use in homes, or stored in emergency stores for use in states of emergency.

By way of a non-limiting example a low cost 320 Kbit CMOS sensor light detection unit 101 is optionally found, drawing a peak current of 12mA, at a cost of approximately $0.60. It is noted that by having the light detection unit 101 scan the body part from a close distance, and/or by contact scanning, a large area of body surface is mapped while having a compact apparatus 90. If an optical system with a relatively large focal length and field of view were used, the optical system would require placing the light detection unit 101 a large distance from the surface, not enabling the apparatus 90 to be compact, and interfering with portability.

In some embodiments of the invention the light detection unit 101 includes a single detector, or a few detectors, in place of a linear detector.

In some embodiments of the invention collection of reflected light is improved by using optics, such as, by way of a non-limiting example, using micro-lenses placed on the light detection unit 101 to focus collected light on the light detection unit 101. By changing a focal plane of the optics, scattered light originating mainly from one optical focus plane is collected, thereby providing information regarding the depth from which data is collected.

In some embodiments of the invention, in which an area illuminated is but a small spot, a motor scans the light detection unit 101 along an axis perpendicular to the direction of the detection unit movement. The illumination unit 102

In some embodiments of the invention the illumination unit 102 includes a linear array of illumination units. The linear array optionally provides an approximately uniform lighting of the area scanned by the light detection unit 101.

In some embodiments of the invention the illumination unit 102 includes a single LED, or a few LEDS, in place of a linear array of illumination units.

In some embodiments of the invention, light emitted from the illumination unit 102, by way of a non-limiting example, from a linear array of IR LEDs, passes through a diffuser, in order to homogenize the illumination.

In other embodiments of the invention, light emitted from the illumination unit 102 is focused using optics, such as, by way of a non-limiting example, a cylindrical lens or a micro-lens array. The focusing enables better definition of the area from which light is collected. In any case the focusing is optionally not better than required based on scattering properties of relevant tissues.

In some embodiments of the invention LEDs of different wavelength are used, and information about spectral properties of the collected light is optionally derived.

In some embodiments of the invention, the illumination unit 102 illuminates at different wavelengths (colors) using a prism and/or a diffraction grating. Different wavelengths are produced at different angles, and picked up at different locations by the light detection unit 101. The processing unit compensates for the different wavelengths sampled at different locations.

Reference is now made to Fig. 5A, which is a simplified block diagram illustration of an exemplary configuration of the light detection unit 101 and the illumination unit 102 in the apparatus 90 of Fig. 2A.

The illumination unit 102 shines light 110 onto a patient's body part. The light 110 is reflected 120 off the patient's skin 238, and some of the light 110 penetrates the body and is scattered 121 from below the skin 238. Some of the light is absorbed by the veins. The reflected 120 and the scattered 121 light are collected by suitable optics 103, which concentrates light 130 onto the light detection unit 101. The amount of light arriving to each detector pixel provides a basis for detecting existence of a blood vessel beneath the skin.

In some embodiments of the invention the reflected 120 and the scattered 121 light are collected without use of optics. Especially and specifically when the light detection unit 101 uses a linear array of light detectors, and when the linear array of light detectors is close to the skin 238, there is no need to use the optics 103.

Reference is now made to Fig. 5B, which is a simplified block diagram illustration of an alternative exemplary configuration of the light detection unit 101 and the illumination unit 102 in the apparatus 90 of Fig. 2A.

The alternative exemplary configuration depicted in Fig. 5 B has the illumination unit 102 placed so that it shines light 110 through the patient's body. One such configuration is the clamshell form factor described above. The light 110 is transmitted through and scattered in the patient's body. Transmitted light 122 is collected by suitable optics 103, which concentrates light 130 onto the light detection unit 101.

In some embodiments of the invention the transmitted light 122 is collected without use of optics. Especially and specifically when the light detection unit 101 uses a linear array of light detectors, and when the linear array of light detectors is close to the skin 238, there is no need to use the optics 103. In some embodiments of the invention the light detection unit 101 and/or the illumination unit 102 are placed remotely elsewhere than next to the patient's skin. The light is optionally transmitted via optic fibers, and/or optionally collected via fiber optics. Simplified description of scanning and processing

Part of the operation of the apparatus is now described again, with additional detail. The illumination unit 102 optionally includes a set of IR LEDs, arranged linearly along the sides of the light detection unit 101. The vein detection unit 100 is translated along the main rail 300, using, by way of a non-limiting example, a linear DC motor (not shown), a screw transmission rotated by a stepper motor (not shown), or other actuator. It is noted that in some embodiments of the invention the actuators are designed to be low powered actuators, suitable for mobile, not connected to a power cord, use. It is noted that such actuators are inexpensive, supporting construction of an inexpensive embodiment. For example, a 4mm DC Micro Motor which draws 7OmA has been found at a cost of approximately $1.50. An example LS 7290 motor controller for controlling up to four motors draws 2mA and costs approximately $1.15. An example bridge driver L6201 for motor control applications draws 2mA during operation, 15mA at peak, and costs approximately $5.00. Upon starting operation, the vein detection unit 100 optionally translates to a start position, optionally to an end of the mail rail 300, optionally to an edge detector (not shown). The initial position optionally sets a zero position before scanning. The position of the vein detection unit 100 with respect to an optional edge detector may be determined by a linear encoder placed along the main rail 300, or by a similar method. It is to be appreciated that in embodiments of the invention in which there is a fixed spatial relationship between the light detection unit 101 and the catheter insertion unit 200, setting a zero position is not required.

The processing unit (not shown) monitors the position of the vein detection unit 100, and controls the movement of the vein detection unit 100. Light from the illumination unit 102 illuminates an examined tissue, and returning light is collected by the detectors of the light detection unit 101, producing electronic signals. The electronic signals are optionally sampled by an A/D converter, and resulting digital data is optionally stored in an appropriate position in a frame buffer memory (not shown) in the processing unit (not shown), for optional further processing. A position at which digital data is stored is optionally determined by the position of the vein detection unit 100 with respect to the start, or zero, position. In some embodiments of the invention, the illumination unit 102 / light detection unit 101 combination is calibrated by using a standard diffusive reflector surface, such as a reflective reference patch. The patch is optionally installed inside the apparatus 90, optionally at the zero position of the vein detection unit 100. Prior to scanning, a reading of the light detection unit 101 of the reflected light from the patch is optionally stored. The reading is a reference reading, and is optionally used to calibrate response of the reflectance of a combination of the illumination unit 102 and the light detection unit 101.

The frame buffer memory optionally stores a map and/or an image of the scanned area. The map is optionally further processed to generate a vein location map, for use to define a suitable puncture position and direction for cannulation.

The processing unit

In some embodiments of the invention the processing unit optionally includes a micro-processor and/or a DSP unit running suitable software.

In other embodiments of the invention the processing unit optionally includes dedicated electronic hardware, in FPGA or ASIC.

An example inexpensive processing unit, by way of a non-limiting example, is an NXP 32-bit ARM9 MCU, which draws 80mA in use, and costs about $7.00.

In yet other embodiments of the invention the processing unit optionally includes a combination of the above components. Image processing and decision making

The processing optionally includes image improvement; vein detection; decision making; cannulation path determination.

Image improvement optionally includes noise removal, optionally by unsharp mask filtering, a Fast Noise Reduction method, median filtering, adaptive Wiener filtering and/or other methods; and normalization.

The unsharp masking is optionally followed by a background reflectance normalization, by which global variation of reflectance of background tissue, varying due in part to changes in curvature of the background tissue, is reduced. Noise reduction may be done before or after background removal. Both noise reduction and background removal can optionally be done on an entire image, or line by line during scanning.

The normalization optionally uses a light distribution recorded on a reference surface, optionally at a beginning of the scan. Alternatively, the normalization is optionally performed by removal of high frequency features by low pass filtering, followed by sampling at a low resolution, then interpolating to obtain a global illumination reflection map. Alternatively, a low order polynomial regression can be applied to fit a measured reflectance. The polynomial fit may be done on an entire image, or line by line. Optionally, only some of the lines are regressed, after which a 2D structure is obtained by interpolating and/or regressing between the regressed lines. The global illumination reflection map is used to normalize a de-noised image.

A curvature correction algorithm is optionally applied.

Contrast enhancement and thresholding is optionally applied in order to separate absorbing veins from background tissue.

Dilation and hole-filling are also optionally used to further define vein structure, and boundaries between veins and surrounding tissue are optionally found using edge detection.

Detection of veins is also optionally performed by selecting large blobs, or objects. Large objects in an image are the blood vessels, differentiated from possible noise, which is likely to show up as small spots, or a blob appearing in a small area of an image.

Separation of veins from arteries is optionally performed. The separation is optionally based on spectral differences. The spectral differences are caused by blood in veins and blood in arteries being oxygenated at different levels. Different levels of oxygenation in the blood cause different absorption at different wavelengths, enabling distinguishing between veins and arteries by comparing absorption at different wavelengths.

Categorization of veins into different types is optionally performed. The categorization of veins includes separating veins suitable for cannulation from veins less suited for cannulation, and categorizing large veins, mid-sized veins, and small veins.

Detection of straight regions of veins suitable for cannulation is optionally performed using feature extraction methods such as, by way of a non-limiting example, a Hough transform. Alternatively, the vein edges are approximated by piecewise linear lines, and the longer portions are selected. The above image processing operations optionally produce a vein map.

The vein map is used in order to identify and classify veins. A three dimensional position, direction, length, and width of vein sections are optionally identified. Decision making with reference to vein selection and a location to be punctured is optionally performed by the processing unit, using the above mentioned features collected about veins.

A selection of a vein and a location optionally takes into account several pre defined properties, such as, by way of a non-limiting example, one or more of a minimum width, a minimum length, a straight line stretch, an effective depth.

Reference is now made to Fig. 5C, which is a simplified flow chart illustration of an exemplary method of blood vessel selection in the apparatus of Fig. 2A. The method of Fig. 5C includes some of the image processing procedures mentioned above. Detected light 505, from the light detection unit 101, is input into the processing unit. An estimation of background light 510 is also optionally input into the processing unit. The estimation of background light 510 may optionally be present in memory in the processing unit, and not need to be input. Alternatively, the processing unit optionally computes the estimation of background light 510, based on one of the methods discussed above with reference to background light, or by a combination of the above-mentioned methods. The estimation of background light 510 optionally serves for compensating for various known and measured non-uniformities in light detection, such as, by way of a non- limiting example, non-uniformities caused by non-uniform lighting and by non-uniform detection element responses, and non-uniform reflectance properties of the body part. The estimation of background light 510 is optionally subtracted from the detected light 505 (515).

Next, the result is optionally processed to filter out noise (520).

Next, contrast enhancement is optionally performed (525), optionally followed by thresholding (530). After thresholding, a hole-filling procedure is optionally used (535).

As a result of the above image processing, an image now contains connected objects. Objects which may have been separated by small spaces have optionally been unified.

A list is made of connected objects and some of their parameters, such as, by way of a non-limiting example, size, eccentricity (ratio of length to width), and orientation (direction of length) (540).

The largest objects having suitable parameters are optionally selected (545). Edges of the selected objects are optionally found (550).

The edges found are optionally approximated by piecewise linear straight lines (555), and a list is optionally made of the straight lines and some of their parameters, such as, by way of a non-limiting example, parent object, length, and direction (560). Reference is now made to Fig. 5D, which is a series of images corresponding to stages in the exemplary method of Fig. 5C.

A first image 565 of the detected light 505 of Fig. 5 C is depicted.

Next, a second image 570 depicts the detected light 505 after subtracting the estimation of background light 510 (515 of Fig. 5C). A third image 575 depicts the result of noise filtering (520 of Fig. 5C).

A fourth image 580 depicts the result after thresholding (530 of Fig. 5C).

A fifth image 585 depicts the result after object selection (545 of Fig. 5C).

A sixth image 590 depicts the result after approximation of edges by piecewise linear straight lines (555 of Fig. 5C). A decision is made concerning vein selection, puncture location and direction is optionally performed by giving each vein section a grade based on its estimated properties, and sorting a list of graded vein sections from a most appropriate to a least appropriate based on the grade.

For a chosen vein section, a puncture point, a final target point, and a trajectory are optionally determined. The puncture point, the final target point, and the trajectory are at least part of a basis for calculating a motion of the catheter unit 10. The puncture point and the final target point are calculated based on certain assumptions made regarding a vein cross section and a required penetration.

In some embodiments, the vein is optionally assumed to have an elliptical cross section with an eccentricity within a certain range. Therefore, a thickness of the vein is optionally estimated to be within a certain range, based on the width of the vein as calculated by the processing unit.

The catheter insertion unit 200

Reference is now additionally made to Figs. 6A, 6B, and 6C, which are simplified top, side, and frontal view illustrations respectively, of the catheter insertion unit 200 of the apparatus of Fig. 2A. The catheter insertion unit 200 optionally includes a cross rail 210, a cross rail slider 220, a horizontal rotator 230, a vertical rotator 240, and a catheter holder 250.

Reference is now additionally made to Fig. 7, which is a simplified illustration of the catheter insertion unit of the apparatus of Fig. 2A. Several additional features of the catheter insertion unit 200 are now described.

The catheter insertion unit 200 optionally includes a main rail rider 201, a θ rotation stage 203, a vertical z-translation unit 204, a φ rotation stage 205, a cannulation translation stage 206, and a grip mechanism 207.

The cross rail 210 is slidingly attached to the main rail 300 by the main rail rider 201, optionally providing translation of the catheter holder 250 along a body part to which the enclosure 400 is attached.

The cross rail slider 220 is slidingly attached to the cross rail 210, optionally providing translation of the catheter holder 250 along the cross rail 210, perpendicularly to a direction of the translation provided by the main rail rider 201. The horizontal rotator 230 is rotatingly attached to the cross rail slider 220 by the θ rotation stage 203, optionally providing horizontal rotation to the catheter holder 250.

The vertical rotator 240 is rotatingly attached to the horizontal rotator 230 by the φ rotation stage 205, optionally providing horizontal rotation to the catheter holder 250. The vertical rotator 240 is also slidingly attached to the horizontal rotator 230, by the vertical z- translation unit 204, optionally providing translation of the catheter holder 250 in a third direction, perpendicular to the direction of the translation provided by the cross rail 210 and perpendicular to a direction of the translation provided by the cross rail slider 220.

Figs. 6A, 6B, and 6C depict an exemplary catheter unit 10 (See Figs. IA, IB) held by the catheter insertion unit 200. The catheter insertion unit 200 includes translation and rotation axes, with motion along and/or around each axis being controlled by a dedicated motor.

It is noted that use herein of the terms horizontal and vertical axes and rotations refer to a right-side-up orientation of the apparatus 90. As a matter of fact, the apparatus 90 may be oriented in a different orientation, depending on how the apparatus 90 is placed on a body part. The terms "horizontal" and "vertical" in all their grammatical forms are used throughout the present specification and claims in a sense of being perpendicular to each other, and not relatively to the Earth's surface. A base horizontal x-y translation stage consists of the main rail 300 (x-axis) attached to the enclosure 400, and a cross rail 210 (y-axis) perpendicular to the main rail

300. The cross rail 210 is configured to move along the main rail 300, facilitating motion along the x-axis. The cross rail slider 220 is configured to move along the y-axis cross rail 210, carrying the vertical rotator 240.

The horizontal rotator 230 is attached to the cross rail slider 220, configured to facilitate rotation in a horizontal x-y plane (θ direction). The x-y movement is used to place the rotation center of the horizontal rotator 230 at a required position, so that a projected track of cannulation will match a vein direction. On the horizontal rotator 230 the vertical rotator 240 is attached, which also has a φ rotation axis perpendicular to the θ rotation axis. By using z-translation and the φ rotation axis, in addition to the x-y and the θ motions, it is possible to define a direction in space going through a specific point in three-dimensional space. The specific point corresponds to a puncture location, and the direction corresponds to a cannulation direction.

Finally, the vertical rotator 240 is attached to the catheter holder 250. The puncture needle 15 is configured to move the catheter unit 10 in a direction parallel to the puncture needle 15 of the catheter unit 10, in order to puncture a vein. The vein puncturing direction is termed a cannulation axis or cannulation direction. Some embodiments of the apparatus 90 use fewer degrees of freedom of three dimensional movement of the catheter holder 250 relative to the enclosure 400 and/or the main rail 300. Such embodiments are described below, with reference to embodiments of the invention with a catheter insertion unit 200 having fewer degrees of freedom relative to the enclosure 400 and/or the main rail 300. Reference is now additionally made to Fig. 8, which is a simplified illustration of the vertical rotator 240 of the apparatus of Fig. 2A.

The vertical rotator 240 includes the catheter holder 250, a needle gripper 251, and a catheter tube gripper 252.

The puncture needle 15 is optionally attached onto the catheter holder 250 using a gripper mechanism. The gripper mechanism optionally includes a separate needle gripper 251, and a separate catheter tube gripper 252. In some embodiments of the invention the needle gripper 251 and the catheter tube gripper 252 optionally use a spring to grip the puncture needle 15 and the catheter tube 20.

In some embodiments of the invention (not shown), the needle gripper 251 and the catheter tube gripper 252 optionally use electromagnetic force to attach the puncture needle 15 and the catheter tube 20.

In some embodiments of the invention (not shown), the needle gripper 251 and the catheter tube gripper 252 optionally use a mix of a spring and electromagnetic force to attach the puncture needle 15 and the catheter tube 20. By way of a non- limiting example, the catheter tube 20 is attached by electromagnetic force, and the puncture needle 15 is attached both by electromagnetic force and by a spring. Alternatively, the grippers 251 252 may be spring loaded, so that attachment of the puncture needle 15 and/or the catheter tube 20 is done against spring force, and release is done by electromagnetic force operating against the spring.

Fig. 8 also depicts a catheter unit 10, in order to show an example of the catheter unit 10 being held by the catheter holder 250. An enlarged portion 600 of Fig. 8 more clearly depicts the catheter tube 20 being gripped by the catheter tube gripper 252, and the puncture needle 15 being gripped by the needle gripper 251.

It is noted that, for purpose of clarity, Fig. 8 does not actually depict the puncture needle 15 being gripped by the needle gripper 251. The puncture needle 15 is depicted in a position slightly pulled back from the catheter tube 20, and so not actually gripped by the needle gripper 251. The depiction is in order to clearly define between the puncture needle 15 and the catheter tube 20, and the needle gripper 251 is to be understood as gripping the puncture needle 15.

The needle gripper 251 and the catheter tube gripper 252 are configured to translate separately along the catheter holder 250, so that after puncturing of a vein, the puncture needle 15 can be drawn backwards, while the catheter tube 20 is left within the vein.

Simplified description of cannulation

Upon starting operation, the catheter insertion unit 200 optionally translates to a start position, optionally to an edge detector (not shown). The initial position optionally sets a zero position for the catheter insertion unit 200. The position of the catheter insertion unit 200 with respect to an optional edge detector may be determined by a linear encoder placed along the main rail 300, or by a similar method. In some embodiments the location of the catheter insertion unit 200 and/or of a location of the puncture needle 15 is optionally found by the vein detection unit 101. The vein detection unit 101 collects light and identifies the location of the catheter insertion unit 200 and/or of the location of the puncture needle 15. The processing unit (not shown) controls the movement of the catheter insertion unit 200.

Based on the processing unit having decided on a puncture position and direction for cannulation, the processing unit instructs the catheter insertion unit 200 to move to a position and direction suitable for puncturing a vein. The vein puncture is performed by moving the catheter holder 250 forward along the cannulation direction.

It is noted that the direction of the cannulation direction may be changed around any point during the puncture process using a combined control of z-translation and the φ rotation axis. The change may be helpful for starting a puncture at an angle of about 30° and then changing the puncture needle 15 angle to about 10° with respect to the surface of the vein, in order to be able to move a longer distance within the vein.

Given locations of the catheter insertion unit 200 and the light detection unit 101 with respect to their zero position, three dimensional coordinates of a point of the puncture needle 15, and an orientation of the puncture needle 15 with respect to a reference coordinate system of the main rail 300 is easily calculated. The x-y position of a puncture on the body part and the required puncture direction are also given within the reference coordinate system.

To optionally find a z-coordinate of the skin at the puncture position a distance between the catheter insertion unit 200 and the skin is optionally measured. Some embodiments of the invention use a mechanical spring loaded gauge touching the skin, some embodiments use an optical rangefmder, some embodiments optically focus on the skin and/or on a blood vessel in order to measure distance, and some embodiments use ultrasound ranging.

Puncturing of the skin is optionally detected by monitoring the force applied during motion along the cannulation direction. An increase in applied force necessary for movement is optionally measured as the skin is touched. Measuring the force is optionally done by an optional piezoelectric sensor included in the catheter insertion unit 200. After the skin is penetrated the puncture needle 15 is moved towards a point in space determined by the processing unit as indicating successful vein penetration. A second increase in the applied force necessary for movement is optionally measured as the vein is punctured.

It is to be appreciated that sensing when the puncture needle 15 touches the skin optionally serves for indicating a beginning of a cannulation trajectory. The cannulation trajectory is optionally limited in length. If the cannulation trajectory is measured to have extended up to a threshold, the puncture needle 15 is not pushed forward any more, as the puncture needle 15 is judged to have exceeded a safe penetration distance.

In some embodiments of the invention the z-coordinate of the skin at the puncture position is not used. The catheter unit 10 is moved along the cannulation direction, and punctures the skin on its way.

The puncture of the vein is optionally also confirmed by an increase in the applied force followed by a reduction of the force when the needle is inside the vein.

In alternative embodiments of the invention, entry of blood into the catheter tube 20 is monitored, by optical or other means. Optical transmission across the catheter tube 20 may be monitored, by placing a light source on one side and checking a signal on a photo- detector on the other side.

In yet other alternative embodiments of the invention, changes in the color of reflected light from the catheter tube 20 are monitored, optionally by checking a relation between light reflection in a red part of the spectrum and light reflection over the whole spectrum.

In still other alternative embodiments of the invention, changes in pressure in the catheter tube 20 optionally indicate penetration into a blood vessel, for example, using the method described in US patent 5,954,701. Operation of the mobile apparatus

Operation of the apparatus 90 is now described again. An operator, be it a doctor, paramedic, nurse, certified operator of the device, or even an untrained operator, identifies a possible area of a body for cannulation.

A typical area for cannulation is usually a limb, and during the present description the limb will be referred to, without intention of limiting body parts.

A sterile catheter unit 10 is inserted by the operator to the catheter insertion unit 200, and is secured by the gripper mechanism of the catheter holder 250. The catheter insertion unit 200 the optionally retracts, protecting the operator against injury from the sharp point of the puncture needle 15.

The operator optionally disinfects the area of cannulation, and places the apparatus 90 on the limb, attaching the enclosure 400 firmly to the limb. The attachment may be done by Velcro strips, as described above, tightened around the limb. In some embodiments of the invention, disinfection is performed automatically as part of the procedure, either by the light detection unit 101 additionally swabbing skin while scanning, or by the catheter insertion unit 200 spraying alcohol before catheter insertion.

Preferably, the operator also places a tourniquet above the cannulation area to improve vein detection. The tourniquet is optionally part of the apparatus 90.

Following the above described preparation stage, the operator presses a button and/or otherwise initiates start of automatic operation. The catheter insertion unit 200 and the vein detection unit 100 each optionally move to an end of the main rail 300 inside the enclosure 400, and the illumination unit 102 is optionally switched on. Optionally, when the units reach their edge detectors their reference zero position is defined.

At the vein detection unit 100 zero position the LEDs light is optionally recorded reflecting from a reference reflective surface for calibration purpose. The vein detection unit 100 starts to scan the limb and measurements of the collected light are recorded, normalized and processed to obtain a map. After the scan, the LEDs are optionally switched off in order to save power.

The map is analyzed by the processing unit and a decision regarding a cannulation trajectory is provided, from which motion of the different axes of the catheter insertion unit

200 is derived. Following that, the catheter insertion unit 200 moves along the main rail

300, and also moves in the y-axis, to achieve the right position. The needle is also rotated in an x-y plane to the required θ direction.

A cannulation direction actuator is optionally shifted to its back position, and then the axis is rotated in the φ direction to an angle of about 30°. The catheter holder 250 is driven forward along the cannulation direction until vein penetration is confirmed, such as, without limiting generality, by detecting blood entrance into the catheter, and/or by a change in resistance force felt by sensors (not shown) in the apparatus 90. Alternatively the forward motion along the cannulation direction is not done by a cannulation direction actuator, but by a combined and correlated motion of the other actuators of the apparatus 90.

Optionally, after skin penetration is detected, a combined shift of the z-translation axis and φ rotation is optionally applied, in order to reduce the penetration angle to about 10°. The catheter tube is optionally driven further forward, until a predefined target position is reached.

Optionally, blood in the catheter tube is confirmed.

Next, the needle gripper 251 is translated back from the catheter tube gripper 252, so as to remove the puncture needle from the vein while leaving the catheter tube 20 inserted in the vein. The catheter tube gripper 252 is optionally released, before additional backward translation of the needle gripper 251.

When the needle gripper 251 is translated slightly back from the catheter tube gripper 252, the sharp tip of the puncture needle 15 is withdrawn into the catheter tube. Further backward translation of the needle gripper 251 may withdraw the puncture needle 15 from the vein, and from the body. The needle gripper 251 may be limited in backward movement, in which case the entire catheter insertion unit 200 is translated back along the cannulation direction, in order to withdraw the puncture needle 15 from the vein.

The grippers supporting the catheter tube 20 are released, and the z-translation stage moves upwards to remove the catheter insertion unit 200, still holding the puncture needle 15, away from the skin, and success is indicated to the operator.

The operator then releases the enclosure 400 and lifts the apparatus 90 from the limb, and affixes the catheter tube 20 to the limb.

It is to be appreciated that if cannulation success is not confirmed, for example by blood in the catheter tube, the catheter unit 10 is withdrawn from the body, and such failure is indicated via the user interface. Additionally a limit is set on an amount of translation beyond puncturing of the skin, in order not to seek the vein any deeper than necessary. By way of a non-limiting example, the limit is the smaller of a maximum depth and the depth at which the vein was detected. In an alternative embodiment of the invention the catheter insertion unit 200 and the vein detection unit 100 are configured to translate together at a fixed distance from each other, optionally by a mechanical connection. The apparatus 90 operates in a similar manner to that described above, except that after an initial scan and determination of a cannulation trajectory, a second scan is performed. During the second scan, measurements are compared with the initial scan in order to determine the position of the vein detection unit 100 and the catheter insertion unit 200. It is noted that the comparison is optionally done, by way of a non-limiting example, by correlations between the initial scan and the second scan. An advantage of this method is that it does not require accurate registration and relative positioning of the vein detection unit 100 and the catheter insertion unit 200.

Alternatively, a suitable puncture position is detected during the initial scan, and the catheter insertion unit 200 cannulates at the suitable puncture position based on instructions provided by the processing unit, based on the fixed positional relation of the vein detection unit 100 to the catheter insertion unit 200.

In some embodiments of the invention the catheter tube 20 is automatically taped to the patient's skin. In some embodiments of the invention the bottom of the enclosure includes a sticky film, which sticks to the patient's skin. When the apparatus 90 is removed from the patient's body, the sticky film remains stuck to the patient's skin, taping the catheter tube

20 in place.

A catheter unit cartridge Reference is now additionally made to Fig. 9, which is a simplified drawing of an optional catheter unit cartridge 610 of the apparatus of Fig. 2A.

The catheter unit cartridge 610 contains one or more slots 615. Each of the slots 615 optionally contains one catheter unit 10.

Some embodiments of the invention include the catheter unit cartridge 610, which contains a plurality of catheter units 10. The plurality of catheter units 10 may be all of the same type of catheter unit 10, or different types of catheter units 10.

In embodiments of the invention having the catheter unit cartridge 610, the catheter unit cartridge 610 is optionally mounted to the enclosure 400 or to the main rail 300.

The catheter unit cartridge 610 is optional disposable, and/or optionally sterile. The catheter unit cartridge 610 is optionally opened when inserted into the apparatus 90. The apparatus 90 may also be kept sterile as a unit, optionally containing a first sterile catheter unit cartridge 610. Persons skilled in the art will appreciate that catheters come in different forms, for different uses. Different catheter units 10 may have different sized puncture needles 15, different types of catheter tubes 20, and different types of connection hubs 25. By way of some non-limiting examples, cannulation in children is optionally performed with smaller puncture needles 15 than cannulation in adults; cannulations for transfusions are optionally performed with larger puncture needles 15 than cannulations for drawing blood; cannulations in larger veins are optionally performed with larger puncture needles 15 than cannulations in smaller veins; cannulations in large animals are optionally performed with larger puncture needles 15 than cannulations in smaller animals. It is to be appreciated that using catheter unit cartridges 610 provides advantages by enabling disposable cartridges combined with a re-usable apparatus 90 and by reducing a risk of needle injuries when loading the apparatus 90.

Operation of embodiments of the apparatus 90 which include a catheter unit cartridge are similar to the operation described above. Some differences in operation are described below.

The catheter unit cartridge may optionally be loaded with catheter units before operation. The catheter units may be pre-loaded by a manufacturer, may be loaded by the operator, and may combine a mixture of both options, such as the apparatus 90 being preloaded by the manufacturer, and after depletion of the pre-loaded catheter units, the operator may load additional catheter units. A fully loaded catheter unit cartridge may be loaded into the apparatus 90.

The catheter insertion unit 200 optionally starts with automatically loading a catheter unit from the catheter unit cartridge. If the catheter insertion unit 200 also performs a zero reference registration when beginning operation, the loading may be performed either after the zero reference registration or before the zero reference registration.

In embodiments of the apparatus 90 which use a catheter unit cartridge which contains a plurality of catheter units of different types, the catheter insertion unit 200 optionally loads a catheter unit 10 of the right type based on one of several options. The operator may indicate which catheter type is to be loaded using some form of interface. The operator may indicate which cannulation type is to be performed, such as, by way of a non-limiting example, infant/young/adult, or blood sampling/infusion/medication, and the processing unit may decide which catheter type is to be loaded according to a decision based on several criteria. The criteria include, by way of a non-limiting example: a measured size of the vein, a user-indicated type of cannulation, including, by way of a non- limiting example infusion, blood drawing, medication, type of medication, long term or short term cannulation.

It is noted that selection of a catheter unit from a catheter unit cartridge which contains a plurality of catheter units of different types is optionally done in any one of the following ways: the processing unit may include a list of catheter unit cartridge types and which catheter units are loaded into what location within the catheter unit cartridge, and/or the catheter units may be differentiated according to markings on the catheter units, and/or according to color, and/or according to gauge, and/or according to shape.

In some embodiments of the invention the catheter unit cartridge 610 is shaped as a revolving cartridge, similarly to a revolver cylinder (not shown). The revolving embodiment of the catheter unit cartridge 610 is optionally positioned partly within the enclosure 400, placed for convenient pickup of the catheter units 10, and exposing at least one catheter unit slot outside the enclosure 400, thereby enabling loading catheter units 20 into the catheter unit cartridge 610.

A user interface

The apparatus 90 optionally includes a user interface. Different embodiments of the mobile apparatus 90 have different user interfaces.

A simple user interface may optionally include a single button for starting operation, and an indicator for indicating end of operation.

A more elaborate interface may optionally include separate indications for indication a success or failure at end of operation. Embodiments of the apparatus 90 which include the catheter unit cartridge optionally have means for input of catheter unit selection, and/or input of data relevant for catheter unit selection by the processing unit, such as, by way of a non-limiting example: age of patient; size of patient; type of cannulation, such as, by way of a non-limiting example infusion, blood drawing, medication, short term, long term; and type of catheter unit cartridge.

Some embodiments of the user interface include one or more buttons, one or more indicator lights, and/or one or more tone producers for indication purposes. Some embodiments of the user interface include a display, optionally an inexpensive display such as an LCD or an OLED.

Some embodiments of the user interface include a touch screen display.

Some embodiments of the user interface include an external user interface, such as, by way of a non-limiting example, a laptop computer, a mobile computer, and a Personal Digital Assistant.

It is noted that a display included in the user interface can optionally serve as a distraction for patients. Some patients are squeamish about seeing the cannulation procedure, and watching the display may serve as a distraction, which may lower the perceived pain associated with cannulation. The above is especially useful for pediatric use.

It is contemplated that the display may also serve for displaying a distracting animation and/or movie while the apparatus 90 is operating, thereby distracting children and/or squeamish persons from the cannulation procedure. Embodiments of the invention having fewer degrees of freedom

Cannulation requires the puncture needle 15 to be located at a puncture point, inclined at a shallow angle relative to the patient's skin, and aligned along a cannulation direction.

An alternative embodiment of the apparatus 90 has the catheter holder 250 attached to the enclosure 400 and/or the main rail 300 at such a fixed angle that the puncture needle 15 is inclined at the shallow angle relative to the patient's skin. Cannulation using the embodiment requires that the puncture needle 15 be located at the puncture point and aligned along the cannulation direction. Location and alignment of the catheter holder 250 are achieved, in the above embodiment, not by rotating the catheter holder 250, but indicating to an operator, via a user interface, how to move the enclosure 400 so that the catheter holder 250 be located at the puncture point and aligned along the cannulation direction.

Since the operator moves the enclosure 400 relative to the patient's body, registration is lost between the blood vessel map and the patient's body. In some embodiments of the invention, the processing unit uses the vein detection unit 100 to collect light and produce the blood vessel map with an image of the puncture needle 15, and guides the puncture needle 15 to the puncture point and the cannulation direction.

In other embodiments of the invention, after the operator moves the enclosure 400, the processing unit rescans the patient's body with light detection unit 101, produces a blood vessel map, and verifies that the catheter holder 250 is correctly positioned at the puncture point and correctly aligned along the cannulation direction.

The verification may be done by having specific coordinates at which the puncture point should be, relative to the enclosure 400, and/or by producing an image of the puncture needle 15 together with the blood vessel map, and verifying that the puncture needle 15 is at the puncture point and aligned in the cannulation direction.

When the puncture needle 15 is at the puncture point and aligned in the cannulation direction, the catheter unit 10 is moved forward along the catheter holder 250, puncturing the skin, then puncturing the vein. The moving forward may be done manually by the operator, in an embodiment in which the catheter insertion unit 200 has no motorized movement at all. In another embodiment the catheter unit 10 is moved forward along the catheter holder 250 by a motor, as described above with reference to Fig. 8.

When cannulation is detected, by any of the methods described above with reference to the simplified description of cannulation, in some embodiments the catheter holder 250 optionally rotates and pushes the catheter unit 10 into the vein at a shallower angle than was used for puncturing.

In embodiments in which the catheter holder 250 does not have an ability to rotate, after the cannulation the catheter tube 20 is optionally pushed into the vein, and the puncture needle 15 is optionally withdrawn. The puncture needle 15 is withdrawn immediately after cannulation, without pushing further into the vein, in order not to cause an inadvertent additional puncture to the vein.

In yet other embodiments of the invention, the light detection unit 101 is fixed relative to the enclosure 400 and/or main rail 300. In some embodiments of the invention, there are no moving parts at all, except the catheter holder 250 which serves for inserting the catheter. The operator, before optionally attaching the enclosure 400 to the patient's body, scans the patient's body by moving the enclosure 400. The light detection unit 101 collects light from the body and the processing unit produces a blood vessel map. The processing unit then guides the operator, via the user interface, to a suitable puncture point and direction. The operator optionally attaches the enclosure 400 to the patient's body.

The processing unit optionally verifies the position of the puncture needle 15 relative to the puncture point and cannulation direction, as described above. The verification may be done either before, or after the attaching, or both before and after.

Having described embodiments of the invention in which the catheter holder 250 does not move relative to the enclosure 400, and embodiments in which the light detector

101 does not move relative to the enclosure 400, it should be clear how a combination of moving and non-moving components of the apparatus 90 may be put together and operated to achieve cannulation.

Embodiments of the invention can have a catheter insertion unit 200 immovable relative to the enclosure 400, as described above, and movable with many degrees of freedom, as described above with reference to Figs. 2A, 4, 6A-C, and 7. Embodiments of the invention can have fewer degrees of freedom than described above with reference to Figs. 2A, 4, 6A-C, and 7. Having fewer degrees of freedom can save parts in producing the apparatus 90, and optionally lower costs.

An embodiment of the invention having an intermediate number of degrees of freedom is now described.

Reference is now additionally made to Figs. 1OA and 1OB, which are simplified illustrations of a side and a top view, respectively, of an alternative embodiment 270 of the catheter insertion unit of the apparatus of Fig. 2A.

The side view of the alternative embodiment 270 depicted in Fig. 1OA depicts an alternative form of a horizontal rotator 235, in which the catheter holder 250 is held at a fixed shallow angle suitable for having the puncture needle 15 puncture a vein. The alternative form of the horizontal rotator 235 is slidingly mounted on the cross rail 210, which itself is slidingly mounted on the main rail 300.

The top view of the alternative embodiment 270 depicted in Fig. 1OB depicts the alternative form of the horizontal rotator 235, showing that the horizontal rotator 235 can rotate at a horizontal angle 237. The alternative form of the horizontal rotator 235 is slidingly mounted on the 210, and can translate back and forth along the 210, in the direction 212. During operation of the embodiment having the alternative embodiment 270 of the catheter insertion unit the puncture needle is constantly held at the fixed shallow angle, yet the catheter unit can be moved with two degrees of freedom to any puncture location, and the puncture needle 15 can be rotated horizontally to align the puncture needle with the cannulation direction.

Reference is now additionally made to Fig. 1OC, which is a simplified and partial illustration of the side view of the alternative embodiment 270 of the catheter insertion unit of the apparatus of Fig. 2 A.

The catheter holder 250 is slidingly connected to the alternative form of a horizontal rotator 235. When the puncture needle 15 reaches the puncture location and is aligned along the cannulation direction, the catheter holder 250 translates along the alternative form of a horizontal rotator 235, pushing the needle 15 at the shallow angle suitable for puncturing skin 238 and vein (not shown).

In some embodiments of the invention, having either the alternative embodiment 270 of the catheter insertion unit or the embodiment of the catheter insertion unit 200 depicted in Fig. 2A, the catheter unit 10 is pushed forward, and punctures skin and vein, by a motor. In other embodiments of the invention, having either the alternative embodiment

270 of the catheter insertion unit or the embodiment of the catheter insertion unit 200 depicted in Fig. 2 A, the catheter unit 10 is pushed forward, and punctures skin and vein, manually by an operator.

Use scenarios and further features

Embodiments of the apparatus 90 described herein use relatively low power, and the power is optionally supplied by one or more batteries. The batteries may be rechargeable, and may or may not be built into the apparatus 90. Some embodiments of the apparatus 90 are cordless.

Some embodiments of the apparatus 90 are for mobile use.

It is noted that actuators used in the mobile apparatus 90, such as the linear DC motor or screw transmission rotated by a stepper motor mentioned above with reference to the vein detection unit 100 are optionally selected to be low powered actuators, suitable for mobile, cordless, use.

It is noted that the mobile apparatus 90 supports single handed use. On part of an operator the operation involves placing the mobile apparatus 90 on a body part, securing the mobile apparatus 90 on the body part, interfacing with a user interface, and removing the mobile apparatus 90 from the body part. All of the above are actions which can be performed using one hand.

It is noted that occasionally there is a need to perform more than one cannulation. The apparatus 90 is configured to perform more than one cannulation. The processing unit is optionally configured to decide on more than one puncture point and cannulation trajectory, into a same vein and/or nearby veins. Embodiments of the apparatus 90 including a catheter unit cartridge enable performing the more than one cannulation without removing the apparatus 90 from the patient. It is noted that descriptions of the invention have been made with reference to use on humans. Use on animals other than human is also contemplated. In fact, cannulation by non-experts using the apparatus 90 is likely to occur quite often, in situations where an animal veterinary is not present.

Size and power consumption Based on example light detectors, illumination sources, and actuators described herein, weight and power consumption of the invention are optionally held low.

Based on the optical configuration of the light detection unit 101 described above, especially of the scanning configuration, dimensions of the invention are optionally kept compact. The size and weight of the apparatus 90 for cannulation described above, and even more so the apparatus for printing and apparatus for display which are described below, are such that the apparatus is easily mobile, portable, and easily carried by hand.

Example embodiments of the invention are compact enough to fit within 420mm x 150mm x 100mm. The weight of the above-mentioned example embodiments is less than 5kg.

Example instances of Advanced Life Support (ALS) bags and Trauma bags are presently offered at three sizes, with dimensions: 24.5" x 8.5" x 11", 18.5" x 8" x 8.5", and 17" x 6" x 9.5". The above-mentioned example embodiments of the invention fit into any one of the example bags. Power consumption of example embodiments of the invention is brought forth in Table 1 below.

Mode of operation Operation duration (Sec) Total current (mA) Scanning 10 450

Puncturing 10 300

Standby » 10

Off » 0 Table 1 - Power consumption per mode of operation

In some embodiments of the invention peak power consumption is kept to a minimum.

During a scan cycle: a single LED provides illumination, drawing approximately 100 mA, as described above with reference to illumination; a scanning motor draws approximately 70 mA as described above with reference to motors; a light detector draws approximately 12 mA, as described above with reference to light detectors; and a processing unit draws approximately 80 mA, as described above with reference to the processing unit. The scan cycle therefore draws approximately 262 mA. A puncturing draws approximately 300 mA, as described above in Table 1.

Therefore, in the above-mentioned embodiments of the invention, a scanning and puncturing cycle, when performed serially, that is, scanning and locating blood vessels first, then puncturing, is performed using no more than approximately 300 mA.

Based on the power consumption as detailed in Table 1 , a duration of usefulness and/or readiness to function of the apparatus is detailed in Table 2 below. The duration is dependent on battery capacities and on a number of uses of the apparatus during the duration, and without recharging the batteries. It is noted that the batteries may be disposable batteries and they may be rechargeable batteries. Number of uses

Battery capacity 1 5 10 20 50 75 100

80O mAH 3.23 2 .81 2 .29 1.25

1000 mAH 4.06 3 .65 3 .13 2.08

1200 mAH 4.90 4 .48 3 .96 2.92

1400 mAH 5.73 5 .31 4 .79 3.75

160O mAH 6.56 6 .15 5 .63 4.58 1.46

180O mAH 7.40 6 .98 6 .46 5.42 2.29

2000 mAH 8.23 7 .81 7 .29 6.25 3.13

2400 mAH 9.90 9 .48 8 .96 7.92 4.79 2.19

Table 2 - Duration of apparatus readiness, in days, as a function of battery capacity and of a number of uses during the duration, with the apparatus at standby and without battery recharging.

Several modes of operation of the apparatus affect power consumption.

The actuators moving the catheter unit 10 may operate serially, each at a separate time, so as to lower the maximum current drawn, they may operate together, in parallel, in order to have the catheter unit 10 move into place more rapidly. A combination of the above methods may be used, for example by operating some actuators in parallel, while limiting a maximum of current drawn.

The illuminating unit 102 optionally illuminates using different wavelengths. The illumination at different wavelengths is optionally performed one wavelength at a time, so that the calculated power consumption of the different illumination sources is optionally less than the sum of the power consumption of all the illumination sources.

A printer device

Some embodiments of the invention include components used in the apparatus for cannulation, associated with additional useful devices, such as a printer. Reference is now made to Fig. 11 , which is a simplified illustration of apparatus for printing 930 constructed and operative according to an alternative exemplary embodiment of the invention.

The apparatus for printing 930 includes an enclosure 935, a vein detection unit (not shown) similar to the vein detection unit 100 of Fig. 2A, and a processing unit, similar to the processing unit of the embodiment of Fig. 2 A, and a printer for printing on a body part. In some embodiments of the invention the apparatus may include straps for attaching to the body part, as depicted in Fig. 3A, and/or be of a clamshell configuration, as described above with reference to Fig. 3A.

In some embodiments of the invention a transparent window 940 allows an operator to view the section of the patient's body which is being scanned.

In some embodiments of the invention a part 945 of the enclosure is removable from the rest of the enclosure 935, for placing and replacing batteries for operation of the apparatus for printing 930.

The enclosure 935 of Fig. 11 and the enclosure 400 of Fig. 2A are shaped differently. It is to be appreciated that the different shapes are interchangeable. The enclosures are but packages into which the components are packaged. As long as the enclosures enable moving components within the enclosure to move, all suitable shapes are contemplated, and considered part of the invention. Some embodiments do not have moving components, as described above with reference to embodiments of the invention having fewer degrees of freedom.

The printing on the body part optionally includes one or more of printing a blood vessel map, an artery map, a vein map, a puncture point, a cannulation direction, and/or combinations of the above. Contemplated uses of the printing include, by way of a non- limiting example, teaching anatomy; teaching cannulation; and planning cannulation. The apparatus for printing scans a body part using the vein detection unit, similarly to the scanning performed by the apparatus for cannulation.

Reference is now made to Fig. 12, which is a simplified flow chart illustration of a method of printing operational according to the alternative embodiment of Fig. 11. The apparatus for printing starts operation 705 by performing a scan 710. A processing unit of the apparatus for printing processes scanned data 715, and optionally produces a map of blood vessels. The blood vessels are optionally chosen to be veins, similarly to the blood vessels mapped by the apparatus for cannulation. An alternative embodiment of the apparatus for printing enables a user input to optionally define what blood vessel map should be produced: veins, arteries, and/or both. The printer, optionally translationally mounted on a main rail similar to the main rail 300, prints a printout 720 in a user requested format. It is noted that the printer may optionally use a droplet-emitting head such as an inkjet head, optionally moving perpendicularly to the main rail, along a cross rail similar to the cross rail 210 of the apparatus 90. Other embodiments of the printer may optionally use a linear array of droplet-emitters. Other embodiments of the printer use a pen, such as, by way of a non-limiting example, a felt pen.

In other embodiments of the apparatus for printing the printer moves together with the vein detection unit, and prints either on a first scan, or on a second scan, as described above in the section describing the operation of the mobile apparatus.

Reference is now made to Fig. 13, which is a simplified flow chart illustration of an alternative method of printing operational according to yet another alternative exemplary embodiment of the invention.

The alternative method optionally includes two scans, by way of a non-limiting example a first scan to process data and optionally produce a blood vessel map, and a second scan for further processing and printing. The apparatus for printing starts operation 805 by performing a first scan 810.

The processing unit performs a first processing of scanned data 815, and optionally produces a map of blood vessels. The scanned data, and/or the processed data, is sent to a frame buffer 820 optionally comprised in the processing unit.

The first processing 815 optionally processes an entire vein map, and optionally decides on a puncture point and trajectory.

A second scan 825 is then optionally performed, during which the vein detection unit again detects the same blood vessels, and a second processing 830 is optionally performed. The second processing optionally tracks the second scan, and at appropriate locations optionally instructs the printer to print out the puncture point 835 and the trajectory and/or other information.

Optionally, during the second processing 830 the apparatus for printing displays an indication of the processing 840, such as when the puncture point 835 and the trajectory are approached and being printed, and optionally of an end of processing.

A printout according to the above-described methods optionally includes a puncture point, a cannulation direction, and a vein map. The printout may optionally include a blood vessel map, including veins, arteries, or both. The veins and the arteries, are classified by the processing unit, and optionally printed with different colored inks. The printout may be done using permanent ink, for long term marking and/or tattooing. Such marking may be useful for repeat cannulation patients such as dialysis patients. The printout may be done using a fluorescent ink, so as to be less discernible unless illuminated with UV light, or in order to enhance visibility under low light conditions by illuminating with UV light.

In some embodiments of the invention, the printout includes printing an orientation mark on the body. The orientation mark optionally serves as the zero position mentioned above, and can be detected by the vein detection unit 100.

A display device Some embodiments of the invention include components used in the apparatus for cannulation, associated with additional useful devices. Such embodiments include an apparatus for displaying detected blood vessels of a body part on which the apparatus for display is placed.

The apparatus for display scans the body part, using a vein detection unit, similarly to the scanning performed by the apparatus for cannulation, and displays a map of some or all of the blood vessels in the body part, and/or a suggested puncture point and cannulation direction.

Reference is now made to Fig. 14, which is a simplified illustration of apparatus for display 900 constructed and operative according to still another alternative exemplary embodiment of the invention.

The apparatus for display 900 comprises an enclosure 905, a vein detection unit (not shown), and a processing unit (not shown), all similar to corresponding components of the apparatus for cannulation, and a display 910.

The apparatus for display 900 may be attached to a body part 950 with straps, or in a two-enclosure clamshell configuration as described above, with reference to the apparatus 90. However, since exact registration of the display to the body part 950 may not be needed, the apparatus for display 900 is optionally not attached to the body part 950.

Some non- limiting exemplary embodiments of the display 910 include an LCD display, and an OLED display. Operation of the display optionally includes pressing a start button 915, and scanning the body part 950 while viewing the display. The processing unit optionally processes collected light and produces a graphical display of information. The graphical display of information includes, by way of a non-limiting example, a blood vessel map; a vein-only map; an artery only map; a puncture point and/or a cannulation direction with a blood vessel map or a vein-only map.

Some embodiments of the apparatus for display 900 have the same form factor as the apparatus 90, and the vein detection unit scans along the body part, building a blood vessel map. At the same time, or after the scan has ended, the display 910 displays the blood vessel map.

Some embodiments of the apparatus for display 900 have a different from factor than the apparatus 90, having an enclosure 400 shaped as a hollow frame, in which the vein detection unit 100 is contained. The vein detection unit 100 scans the body part on which the apparatus for display 900 is placed, and the apparatus for display 900 shines light in order to display the graphical display. By way of a non-limiting example, the apparatus for display 900 displays a point of light to mark the puncture point, and another point of light, and/or a line of light, to mark the cannulation direction. Other embodiments of the apparatus for display 900 include a vein detection unit

100 of approximately the same length as the display 910, and operate by having an operator drag the apparatus for display along the body part 950. The display 910 displays a display corresponding to a section of the body part 950 which is directly beneath the apparatus for display 900, optionally at a scale of 1 : 1. In some embodiments of the apparatus for display 900 the display 910 is transparent. The user sees the patient's body through the display, and the graphical display is overlaid over the view of the patient's body. Some non- limiting example uses contemplated for the transparent display are learning and teaching location of blood vessels in the body, and planning cannulation. The exemplary embodiment depicted in Fig. 14 displays on the display 910. Other embodiments of the apparatus for display 900 include a transparent window, instead of the display 910. After the scan has ended, the apparatus for display 900 displays the graphical display by shining a light on the body. The light may optionally be a laser, controlled so that the display optionally lights only the puncture point and the direction of cannulation, thereby displaying the puncture point and the direction of cannulation on the patient's body. It is expected that during the life of a patent maturing from this application many relevant catheter units, puncture needles, catheter tubes, displays, and light detectors will be developed, and the scope of the terms catheter units, puncture needles, catheter tubes, displays, and light detectors is intended to include all such new technologies a priori. As used herein the terms "about" and "approximately" refer to ± 20 %.

The terms "comprises", "comprising", "includes", "including", "having" and their conjugates mean "including but not limited to".

The term "consisting of means "including and limited to".

The term "consisting essentially of means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a unit" or "at least one unit" may include a plurality of units, including combinations thereof.

As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing and/or reversing the progression of a condition, substantially ameliorating clinical and/or aesthetical symptoms of a condition and/or substantially preventing and/or delaying the appearance of clinical and/or aesthetical symptoms of a condition. The word "exemplary" is used herein to mean "serving as an example, instance or illustration". Any embodiment described as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.

The word "optionally" is used herein to mean "is provided in some embodiments and not provided in other embodiments". Any particular embodiment of the invention may include a plurality of "optional" features unless such features conflict.

Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases "ranging/ranges between" a first indicate number and a second indicate number and "ranging/ranges from" a first indicate number "to" a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween. It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

CLAIMS WHAT IS CLAIMED IS:
1. A single-enclosure, hand-held mobile apparatus for blood vessel location comprising: an illumination unit configured to shine light on a body part; a light detection unit configured to receive light coming from the body part; a processing unit configured to process signals from the light detection unit thereby locating blood vessels in the body part.
2. The apparatus of claim 1 in which the apparatus dimensions are less than 420mm x 150mm x 100mm.
3. The apparatus of claim 1 in which the apparatus fits into a hand-carryable bag.
4. The apparatus of claim 1 in which the apparatus weight is less than 5 kilogram.
5. The apparatus of claim 1 and further configured to be powered by batteries comprised within the single enclosure.
6. The apparatus of claim 1 in which the light detection unit scans the body part.
7. The apparatus of claim 6 in which the light detection unit scans the body part while in contact with the body part.
8. The apparatus of claim 1 in which the processing unit is additionally configured: to identify whether a blood vessel is a vein; and if a vein is located, to judge the suitability of the vein for cannulation.
9. The apparatus of claim 1 in which the processing unit is additionally configured to select a vein and plan a puncture point and direction for performing cannulation of the vein.
10. The apparatus of claim 9 and further comprising a catheter insertion unit configured to position a catheter unit comprising a puncture needle and a catheter tube so that a point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation.
11. The apparatus of claim 10 in which the catheter insertion unit further comprises a catheter holder configured to translate, relative to the apparatus, along three perpendicular directions, and rotate around at least two perpendicular axes.
12. The apparatus of claim 10 in which the catheter insertion unit further comprises a catheter holder configured to translate, relative to the apparatus, along two perpendicular directions, and rotate around one axis.
13. The apparatus of claim 10 in which the configured to position comprises having a user interface for guiding an operator to place the apparatus so that a point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation.
14. The apparatus of claim 10 in which the configured to position comprises automatically moving the catheter insertion unit so that a point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation.
15. The apparatus of claim 10 in which the catheter insertion unit is configured to automatically insert the catheter unit into the selected vein.
16. The apparatus of claim 15 in which an operation cycle including scanning to locate blood vessels in the body part and puncturing to automatically insert the catheter unit into a selected vein draws less than 300 milliamperes.
17. The apparatus of claim 15 and further comprising a unit for automatically taping the catheter tube to the body part.
18. The apparatus of claim 1 in and further comprising means for disinfecting the body part.
19. The apparatus of claim 10 in which the catheter insertion unit is configured to position the catheter unit so that the point of the puncture needle is at the puncture point and the puncture needle is aligned along the selected direction for performing cannulation, and the catheter insertion unit is configured for manual insertion by an operator.
20. The apparatus of claim 15 in which the catheter insertion unit is configured to puncture the selected vein at a first angle between the puncture needle and the vein, and to insert the catheter unit into the selected vein at a second angle between the puncture needle and the vein.
21. The apparatus of claim 10 in which the catheter insertion unit comprises a catheter holder comprising two parts, a needle gripper and a catheter tube gripper, and the two parts are configured to move relative to each other.
22. The apparatus of claim 21 in which the needle gripper is further configured to withdraw the puncture needle from the body part.
23. The apparatus of claim 1 in which the light detection unit is slidingly affixed to a rail.
24. The apparatus of claim 1 in which the light detection unit comprises a linear array of light detectors.
25. The apparatus of claim 10 in which the catheter insertion unit is slidingly affixed to a rail.
26. The apparatus of claim 1 in which at least one side of the single-enclosure is configured to conform to a shape of the body part, thereby enabling to place a large portion of the at least one side of the single enclosure in contact with the body part.
27. The apparatus of claim 1 configured to measure a position of the catheter insertion unit relative to the light detection unit and provide the measurement to the processing unit.
28. The apparatus of claim 1 and further configured for affixing the apparatus to the body part.
29. The apparatus of claim 1 and further comprising one or more straps for affixing the apparatus to the body part.
30. The apparatus of claim 1 in which a side of the apparatus for placing next to the body part is shaped to conform to the body part.
31. The apparatus of claim 1 in which a side of the apparatus for placing next to the body part comprises a flexible flange for closing gaps between the apparatus and the body part.
32. The apparatus of claim 31 in which the flange is inflatable.
33. The apparatus of claim 1 and further comprising a tourniquet.
34. The apparatus of claim 1 and further comprising a counter-plate hingedly affixed to the single-enclosure, and means for attaching the counter-plate to the single- enclosure, thereby configured to envelop the body part in a clamshell form.
35. The apparatus of claim 34 in which the illumination unit is comprised in the counter-plate.
36. The apparatus of claim 1 and further comprising a cannulation detection module configured to detect presence of blood in the catheter tube, and in which the catheter insertion unit is further configured: to remove the puncture needle from the body part if blood has been detected in the catheter tube after insertion of the catheter unit; and to remove the entire catheter unit from the body part if blood has not been detected after insertion of the catheter unit.
37. The apparatus of claim 1 and further comprising a catheter unit cartridge configured to store a plurality of the catheter units, and the catheter insertion unit is further configured to automatically load a catheter unit from the catheter unit cartridge.
38. The apparatus of claim 37 in which: the catheter unit cartridge stores a plurality of catheter units of different sizes; the apparatus is configured to receive a catheter unit selection signal from a user; and the catheter insertion unit is configured to removably connect a catheter holder to a selected one of the catheter units according to the catheter unit selection signal.
39. A vein location and cannulation method comprising using a single- enclosure mobile apparatus for illuminating a body part; receiving light coming from the body part; automatically processing the received light thereby locating blood vessels in the body part; identifying whether a blood vessel is a vein; if one or more veins are located, selecting a vein and planning a puncture point and direction for performing cannulation of the vein; and inserting a catheter unit into the selected vein, along the selected direction, in the body part.
40. The method of claim 39 and further comprising affixing the apparatus to the body part.
41. The method of claim 40 in which the affixing is done using straps.
42. The method of claim 39 and further comprising affixing the apparatus to the body part using a counter-plate hingedly affixed to the single-enclosure, thereby enveloping the body part in a clamshell form.
43. The method of claim 39 in which the apparatus is affixed to the body part single-handedly.
44. The method of claim 39 in which after the inserting a needle gripper withdraws the needle from the selected vein, thereby leaving the catheter tube inserted in the selected vein.
45. The method of claim 44 and further comprising detecting presence of blood in the catheter tube, and: removing the puncture needle from the body part if blood has been detected after the inserting; and removing the catheter unit from the body part if blood has not been detected after the inserting.
46. The method of claim 39 and further comprising automatically loading the catheter unit from a catheter unit cartridge which stores a plurality of catheter units.
47. The method of claim 46 and further comprising: receiving a cannulation type indication from a user; selecting a catheter type based, at least partly, on the cannulation type indication; and inserting a catheter unit of the selected catheter type into the selected vein.
48. The apparatus of claim 1 and further comprising a printing module for printing onto the body part.
49. The apparatus of claim 1 and further comprising a pen for printing onto the body part.
50. The apparatus of claim 48 in which the printing module is configured to print using one or more materials of the group consisting of: colored dye; colored ink; permanent ink; and fluorescent ink.
51. The apparatus of claim 8 and further comprising a printing module configured to print the puncture point and the direction for performing cannulation onto the body part.
52. The apparatus of claim 51 in which: the processing unit is configured to select more than one vein, plan more than one puncture point, and plan a direction for performing cannulation corresponding to each selection point; and the printing module is configured to print more than one puncture point and a direction for performing cannulation corresponding to each selection point.
53. The apparatus of claim 48 in which the printing module is configured to print a map of at least one type of blood vessel onto the body part.
54. The apparatus of claim 48 in which the printing module is configured to print a map of more than one type of blood vessel onto the body part, and to print different types of blood vessel using different symbols.
55. The apparatus of claim 53 in which the printing module is configured to print the map using different inks corresponding to different types of blood vessel.
56. A vein location and printing method comprising: illuminating a body part; receiving light coming from the body part; processing the received light thereby locating blood vessels in the body part; identifying a type of a blood vessel; and printing onto the body part.
57. The method of claim 56 and further comprising: selecting a type of blood vessel which is a vein; planning a puncture point and direction for performing cannulation of the vein; and printing the puncture point and the direction for performing cannulation onto the body part.
58. The method of claim 56 and further comprising printing a map of at least one type of blood vessel onto the body part.
59. The apparatus of claim 1 and further comprising a display configured to display graphical information about the blood vessels in the body part.
60. The apparatus of claim 59 in which the graphical information comprises a map of the blood vessels in the body part.
61. The apparatus of claim 59 where the graphical information comprises a map of the blood vessels in the body part and a selected puncture point and cannulation direction.
62. A vein location and display method using a single-enclosure mobile apparatus comprising: illuminating a body part; receiving light coming from the body part; processing the received light thereby locating blood vessels in the body part; and displaying graphical information about the blood vessels located in the body part.
PCT/IB2009/054028 2008-09-15 2009-09-15 Vein locator and associated devices WO2010029521A2 (en)

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