WO2008081438A1 - Système et procédé d'accès vasculaire - Google Patents

Système et procédé d'accès vasculaire Download PDF

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Publication number
WO2008081438A1
WO2008081438A1 PCT/IL2007/001627 IL2007001627W WO2008081438A1 WO 2008081438 A1 WO2008081438 A1 WO 2008081438A1 IL 2007001627 W IL2007001627 W IL 2007001627W WO 2008081438 A1 WO2008081438 A1 WO 2008081438A1
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WO
WIPO (PCT)
Prior art keywords
needle
blood vessel
puncture system
puncture
vein
Prior art date
Application number
PCT/IL2007/001627
Other languages
English (en)
Inventor
Gil Shetrit
Asher Bennett
Hagai Aran
Ofer Sela
Original Assignee
Gil Shetrit
Asher Bennett
Hagai Aran
Ofer Sela
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gil Shetrit, Asher Bennett, Hagai Aran, Ofer Sela filed Critical Gil Shetrit
Publication of WO2008081438A1 publication Critical patent/WO2008081438A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/427—Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4887—Locating particular structures in or on the body
    • A61B5/489—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Definitions

  • the present invention is directed to providing an automated system for inserting needles into veins for infusions, injections, blood sampling, blood donating, insulin injecting and the like.
  • Vascular access is one of the most commonly performed invasive medical procedures. It has been estimated that over 1.4 billion vascular access or venipuncture procedures are performed annually in the US alone. Inserting a needle cleanly into a vein first time around is not easy however, and it has been estimated that some 28% of needle insertions are performed badly, where the patient is an adult. Furthermore, some 23% to 28% of needle insertions result in extravasations or infiltrations.
  • NIR near infra red
  • PCT Publication Number WO06073869 titled "System and Method for Inserting a Needle into a Blood Vessel" and incorporated herein by reference, describes a needle insertion system that includes an imaging system and a needle.
  • the imaging system includes at least one infrared emitter an infrared detector, a computing unit, a display device, and a power source.
  • the method includes the steps of preparing a body target area, putting on a headset, powering up the system, locating a target blood vessel, picking up the needle, aligning the needle with the target blood vessel, inserting the needle, advancing the needle until a sufficient depth of penetration has been reached, and withdrawing the needle.
  • the system includes at least one infrared emitter an infrared detector, a computing unit that enhances images and outputs enhanced images in substantially real time, a display device for displaying enhanced images, and a power source.
  • the method also includes the steps of preparing a body target area, putting on a headset, powering up the system, locating a target blood vessel, inserting a needle into the target blood vessel, and performing the medical procedure.
  • Japanese Publication Number JP2006130201 titled "Device and Method for Presenting Positions of Blood Vessel and Syringe Needle” and incorporated herein by reference, relates to a blood vessel / needle position presentation apparatus for a doctor / nurse that comprises display of mark and blood vessel emphasis images specifying positions of needle and blood vessel simultaneously.
  • a device is described for presenting the positions of a blood vessel and a syringe needle, by which the position and direction of a vein which is not easily viewed are confirmed, piercing is performed with excellent precision, and relation between the point of the syringe needle after piercing and the position/direction of the vein is confirmed.
  • the blood vessel projector provides a blood vessel projector which allegedly enables an unpracticed operator to puncture a needle infallibly and can be used not only for puncturing the needle including blood drawing but for detecting and observing a foreign body or a lesion under the skin.
  • the blood vessel projector comprises a blood vessel detector and a blood vessel indicator.
  • the blood vessel detector has an infrared laser generator and a reflected infrared wave measuring means
  • the blood vessel indicator has a visible light laser generator.
  • a directing apparatus for venous blood vessel piercing which is a venous blood vessel image-forming system comprising a rectangular near-infrared transmitting tube, a cylindrical near infrared ray receiver, a square monitor and a DC power source. During real time operation, the image signals can be transmitted to the monitor.
  • United States Patent Number US 6,353,753 titled “Optical Imaging of Deep Anatomic Structures” and incorporated herein by reference, provides an apparatus and means for visualizing blood vessels and subsurface anatomic structures during surgery and in Real Time, with improved optical imaging and minimized trauma to the patient. More specifically, the technology described therein provides a method for imaging a deep anatomic tissue of interest, comprising the steps of: emitting radiant energy to the surface of said tissue; enhancing contrast of said radiant energy; and detecting reflected radiant energy from said tissue surface, wherein the reflected radiant energy provides imaging information of the tissue.
  • Infrared Imager for Subcutaneous Puncture and Study of Vascular Network describes a novel three-dimensional infrared imager for study of the vascular network so as to cause blood vessels to be visualized for accurate subcutaneous puncture during insertion of a hypodermic needle.
  • the technology described uses the properties of near infrared light as it is absorbed and reflected by the human body, allowing the user to visualize the tissues a few millimeters below the skin's surface.
  • the use of infrared light permits the manipulation of the acquired information to a grade of sensed visualization, which is impossible to reach with visible light.
  • the technology imitates the human three- dimensional perception by use of a stereoscopic infrared viewer, and is designed to be user-friendly, allowing the health care professional to work in his usual manner.
  • a double image is superimposed on the viewer and the user wears blue-red eyeglasses to create the three-dimensional image from the double image on the viewer.
  • the depth perception provided by the three-dimensional image the user can accurately penetrate the vein on the initial attempt, thereby lowering the fear of venous puncture and causing the patient to be at ease, while lowering the incidence of medical complications associated with inaccurate puncture.
  • a liquid crystal display (LCD) mounted in a frame is provided on the upper surface of the apparatus.
  • Sensitive, charge-coupled devices which develop images and deliver them to a microprocessor which synchronizes the images and allows the user to manipulate the images as desired, controlling effects such as brightness, contrast, sharpness and edge enhancement.
  • the inventive imaging system incorporates the use of a contrast agent to enhance the image and allow for study of the vascular system.
  • the imaging system incorporates the use of a coherent source of light, such as an infrared laser.
  • United States Patent Number US 5,947,906 titled “Apparatus for Enhanced Visual Venous Examination” and incorporated herein by reference, relates to an apparatus for aiding in performing operations requiring location of blood vessels such as intravenous injections or drawing blood in which a charge coupled device camera is focused on an area of the body such as the arm that is illuminated by a light source which emits light that is partly in the infrared range and partly in the ultraviolet range but from which light having a wavelength in the visible range has been substantially eliminated.
  • the useful range of wavelengths may be provided by any one of several methods including having an infrared source and an ultra violet source or an incandescent source emitting wavelengths extending from the infrared to the ultra violet and having a filter for removing the range of visible light.
  • the headpiece also supports an infrared sensitive video camera and monitor screen in front of one eye and an opaque shield over the other eye. The lines of sight of the one eye viewing the screen is coincident with the line of sight of the camera and both lines of sight are directed toward the vein of the patient.
  • each camera and monitor can be positioned with line of sight coincident with the line of sight of the respective eye.
  • the apparatus is mounted on the head of the user.
  • the device is mounted on a floor stand.
  • the apparatus is equipped with an image intensif ⁇ er.
  • a mirror is provided that enables the user to view the selected area and the image simultaneously.
  • a video camera for producing a video image and immediately overlying monitor for displaying the video image is utilized to look at the flesh. The camera is sensitive to infrared radiation.
  • a video display results in which infrared absorbing or scattering contrasting portions of the flesh are highlighted, for example, hard to find veins for insertions of needles.
  • a contrast enhancing circuit is included which discloses amplifying the video information with high contrast enhancement of the video. Adaptation of the disclosed circuit to conventional TV charge-coupled device cameras and monitors is illustrated with compensation of horizontal sweep to even image background, intensity averaging line to line for vertical image uniformity and display of image contrasts on a log amplification format.
  • the teleoperator system comprises a surgical system suited for endoscopic surgery.
  • the surgical system includes a surgical instrument, a servomechanism and a controller.
  • the surgical includes an insertion section and a control section.
  • the insertion section comprises a forearm, a wrist and an end effector in the form of a surgical instrument head selected from the group consisting of retractors, electrosurgical cutters, electrosurgical coagulators, forceps, needle holders, scissors, blades and irrigators.
  • the control section comprises a plurality of motors and linkages which operate to insert and retract the forearm, rotate the forearm, pivot the forearm, and pivot the wrist link about the wrist joint.
  • the surgeon actively manipulates the surgical tool albeit remotely. In other systems, the relative position of surgical tool and body tissue are calculated or imaged.
  • Appropriate image pairs can then be used to locate and track any other feature such as a medical instrument, in the workspace, so long as the cameras remain fixed in their positions relative to the workspace.
  • the computations are desirably performed with a computer workstation including computer graphics capability, image processing capability, and providing a real-time display of the workspace as imaged by the video cameras.
  • the 3D framework of the workspace can be aligned with the 3D framework of any selected volume scan, such as MRI, CT, or PET, so that the instrument can be localized and guided to a chosen feature. No guidance arc or other apparatus need be affixed to the patient to accomplish the tracking and guiding operations.
  • an instrument guide unit includes an instrument guide for guiding a surgical instrument into the body of a patient and a base unit operative to be secured to the body in an area in which surgery is to occur.
  • the base unit is coupled to the instrument guide.
  • An adjustment mechanism coupled to the base unit and the instrument guide, is operative to adjust the instrument guide in lateral directions with respect the surface of the area.
  • the adjustment mechanism is operative to adjust the instrument guide in x and y directions.
  • the adjustment mechanism includes an x direction control mechanism for adjusting the instrument in an x direction and a y direction control mechanism for adjusting the instrument in a y direction.
  • the y direction control mechanism may be coupled to the x direction control mechanism.
  • the positional movement of the surgical instrument in the z direction may be tracked by sensing the location of a transducer coupled to the surgical instrument.
  • United States Patent Number US 6,490,467 titled "Surgical navigation systems including reference and localization frames" and incorporated herein by reference, describes a system for use during a medical or surgical procedure on a body.
  • the system generates an image representing the position of one or more body elements during the procedure using scans generated by a scanner prior or during the procedure.
  • the image data set has reference points for each of the body elements, the reference points of a particular body element having a fixed spatial relation to the particular body element.
  • the system includes an apparatus for identifying, during the procedure, the relative position of each of the reference points of each of the body elements to be displayed.
  • the system also includes a processor for modifying the image data set according to the identified relative position of each of the reference points during the procedure, as identified by the identifying apparatus, said processor generating a displaced image data set representing the position of the body elements during the procedure.
  • the system also includes a display utilizing the displaced image data set generated by the processor, illustrating the relative to the system are also disclosed. Also described are devices for use with a surgical navigation system having a sensor array which is in communication with the device to identify its position.
  • the device may be a reference frame for attachment of a body part of the patient, such as a cranial reference are frame for attachment to the head or a spine reference are frame for attachment to the spine.
  • the device may also be a localization frame for positioning an instrument relative to a body part, such as a localization biopsy guide frame for positioning a biopsy needle, a localization drill guide assembly for positioning a drill bit, a localization drill yoke assembly for positioning a drill, or a ventriculostomy probe for positioning a catheter.
  • a localization biopsy guide frame for positioning a biopsy needle
  • a localization drill guide assembly for positioning a drill bit
  • a localization drill yoke assembly for positioning a drill
  • a ventriculostomy probe for positioning a catheter.
  • a base is fixed in relation to the subject.
  • An imaging probe is configured to scan the subject and provide scan images of the subject.
  • An array of receivers is in communication with the base and the imaging probe.
  • a first plurality of reference points is fixed in relation to the base and in communication with the array.
  • a second plurality of reference points is fixed in relation to the imaging probe and in communication with the array.
  • a processor in communication with the imaging probe and the array calculates the position in the scan images corresponding to the position of the imaging probe relative to the subject.
  • NIR imaging for mapping veins
  • systems for remote manipulation of surgical tools combined with imaging systems are very costly and sophisticated and are typically only appropriate for precision brain surgery and the like.
  • NIR imaging has been used for mapping / imaging veins
  • the medical practitioner wishing to inject or extract fluid into a vein has had to manually insert the needle, relying on his / her skill and experience to penetrate the needle tip into the vein, but not to exit the vein on the other side.
  • NIR near infra red
  • a puncture system for insertion of a needle into a blood vessel.
  • the puncture system comprises: (a) detection means for locating a subcutaneous blood vessel in body tissue; (b) an alignment means for aligning a needle with the detected subcutaneous blood vessel; (c) a driving means for driving the needle into the body tissue for insertion into the detected subcutaneous blood vessel, and (d) a means for ensuring the needle is not inserted too far.
  • the blood vessel is typically a vein but may be an artery.
  • the puncture system further comprises a means of attachment for attaching to a limb.
  • the limb is a forearm.
  • the means of attachment comprises a sleeve.
  • the means of attachment comprises straps.
  • the detection means comprises a near infra red detector for detecting near infra red emissions from the vein from above.
  • the means for ensuring the needle is not inserted too far comprises a second near infra red detector for detecting near infra red radiation emitted sideways from the blood vessel.
  • the means for ensuring the needle is not inserted too far comprises a pressure sensor for detecting change of pressure as needle enters said vein.
  • the present invention is directed to providing a method of inserting a needle into a subcutaneous blood vessel comprising the steps of:
  • Fig. 1 is a schematic illustration of a vein map of an arm
  • Fig. 2 is a near infra red image of the back of a hand, showing the blood vessels in clear contrast with surroundings;
  • Fig. 3 is a functional block diagram of an automated puncture system
  • Fig. 4 is a schematic illustration of one embodiment of the invention consisting of a sleeve, a needle insertion apparatus and a pair of infra red cameras;
  • Fig. 5 shows the needle insertion apparatus and pair of NIR cameras of Fig. 3, without the sleeve;
  • Fig. 6 shows how needle is inserted into the needle box
  • Fig. 7 is a flowchart showing a novel automated puncture method.
  • the present invention relates to an automated puncture system, typically for venipuncture, i.e. for catheter placement, blood sampling, blood donating, infusions, injections and the like.
  • the system uses NIR radiation from a limb to enable mapping of blood vessels therein, for the automated insertion of a needle into a vein or artery. It can also be used to map blood vessels to ensure that a needle is inserted into tissue away from and does not puncture blood vessels.
  • Fig. 1 the vein map of a typical arm is shown.
  • three large diameter, straight, long peripheral veins 2A, 2B, 2C run through the flesh 4 of the anterior forearm 6. These are known as the cephalic 2 A, antebrachial 2B and basilica 2C veins.
  • these large veins are optimal insertion locations.
  • physicians rarely use this area for venipuncture.
  • a set of orthogonal axes is used.
  • the direction of blood flow along the arm is referred to henceforth as the +-Y direction.
  • the axis across the arm as shown is known hereinafter as the X direction, and the direction into the tissue is known hereinafter as the Z direction.
  • near infra red imaging techniques provide contrast between blood vessels and surrounding tissue.
  • Preferred embodiments of the present invention use tried and tested near infra red imaging systems to locate veins running through the subcutaneous region selected for venipuncture.
  • the puncture system 100 serves to drive a needle 10 (Fig. 4) into a blood vessel, typically a vein 2 (Fig. 1) located within the flesh 4 (Fig. 1) of a limb, such as the forearm 6 (Fig. 1), for example.
  • the venipuncture system 100 consists of a detection means 102, an alignment means 104, a driving means 106, and a means 108 for ensuring that a needle 10 is not inserted too far.
  • the puncture system 100 includes an attachment means 110 for attaching to the limb.
  • the attachment means 110 may include straps, for example, and may be tied onto the limb, or a sleeve that may slid over the limb, or wrapped there around. Typically a quick closed fastening means is used, such as Velcro or pressed studs are used, for example.
  • an inflatable annular bladder 112 is provided that allows pressure to the veins 2 A, 2B, 2C to be increased, causing them to dilate, aiding the needle 10 insertion procedure by making it more difficult for the needle 10 to be inserted too far.
  • the detection means 102 includes a near infra red detector 114 that detects a subcutaneous vein 2 (or artery, if preferred) and then the alignment means 104 aligns the needle 10 with the detected subcutaneous vein 2 in the XY plane.
  • the driving means 106 drives the needle 10 into the vein 2 and the means 108 for ensuring the needle 10 is not inserted too far prevents the needle 10 from penetrating too far in the Z direction and puncturing the far side of the vein 2.
  • Fig. 4 a schematic illustration of one embodiment of the invention is shown.
  • the needle 10 is situated within a needle box 12 which further comprises the driving means 106.
  • the aligning means 104 moves the whole box in the X-X direction, thereby aligning the needle 10 with the vein 2.
  • the means 108 for ensuring that the needle 10 is not inserted too far includes a second near infra red detector sensor 116 that maps veins in the Z direction.
  • a sleeve 110 is shown with attachment straps 111 that may be elastic rings, or may include inflatable annular bladder 112 is provided that allows pressure to the veins 2A, 2B, 2C to be increased, causing them to dilate, aiding the needle 10 insertion procedure by maldng it more difficult for the needle 10 to be inserted too far.
  • the needle 10 is inserted at a very shallow angle ⁇ , and since large diameter veins 2A 5 2B, 2C are preferably used, there is a relatively large distance and time interval between when the needle tip 11 pierces the outermost surface of the vein and when it reaches the innermost surface of the vein 2.
  • the means 108 for ensuring the needle 10 is not inserted too far comprises a pressure sensor such as a load cell or stress gauge that indicates that the needle 10 tip 11 has punctured the vein
  • a pressure sensor system essentially emulates the human operator who uses the lowered resistance to know that the needle has entered a vein.
  • the drop in needle 10 insertion force 9F automatically deactivates the driving means 106 and stops further motion of the needle 10, thereby preventing the needle being inserted too far.
  • Fig. 5 shows the needle 10 box 12, aligning means 104, driving means 106 and pair of NIR cameras 114, 116 of Fig. 3, without the sleeve 110.
  • the basic system can be configured as particular embodiments for special applications, such as providing an epidural in a maternity ward, for example.
  • FIG. 6 shows how a sterilized needle 10 may be unwrapped from its packaging and inserted into the needle box 12. Since needle 10 is fully enclosed, the likelihood of accidents is minimized. For battle field applications and for use by emergency personnel at car crashes, train derailments and the like, a needle 10 can be pre-inserted into the needle box 12.
  • Embodiments of the equipment for the military may be designed and fabricated to meet the various applicable military specifications and will have rugged construction. Different versions may be optimized for different end users that include, inter alia, general practitioner clinics, hospital casualty units and special wards for cancer patients, pediatrics, and the like. As shown in Fig. 7, a novel automated venipuncture method is proposed.
  • the method comprises the steps of: (a) attaching the puncture system described above over a distal limb via the attachment means; (b) locating a vein; (c) aligning the needle with the vein in plane of skin surface; (d) inserting the needle into the limb at a shallow angle to a depth where needle punctures outer surface of vein, and (e) detecting that needle tip is within vein and stopping further insertion.
  • the Z dimensions of the vein are determined by a second NIR sensor. The needle is prevented from penetrating too far, by mapping the position of the needle onto the position of the vein.
  • a pressure sensor in the needle driving means indicates that a vein has been punctured by a sudden, noticeable drop in the force required to drive the needle further into the tissue.
  • the needle is inserted into the veins or arteries that are physiologically most suitable for injection, rather than those most easily seen and accessed by the physician.
  • Local anesthetic can be used since the fact that anaesthetizing tends to make veins less visible to the human eye is irrelevant. This can further reduce pain to patients.
  • the needle is not generally exposed, reducing accidental stabbing.
  • the system can be used by non-trained personnel.
  • Diabetics and other home users can inject into themselves without flinching. They can even inject themselves or do acupuncture, ensuring that arteries and veins are not punctured.
  • Venipuncture can be accomplished in conditions of poor visibility, such as at night, in the field.
  • the system described above can be used, perhaps with application specific optimized embodiments, for insulin injection by diabetics, treating end-stage renal failure, injections and IV drips for cancer patients, treating cardiovascular illnesses, multiple sclerosis, the obese, HTV/ Aids sufferers, children, trauma victims at car crashes and on the battle field.

Abstract

La présente invention concerne un système de ponction destiné à insérer une aiguille dans un vaisseau sanguin sous-cutané, comprenant : (a) des moyens de détection destinés à localiser le vaisseau sanguin sous-cutané dans un tissu corporel ; (b) des moyens d'alignement destinés à aligner une aiguille dans le tissu corporel pour une insertion dans le vaisseau sanguin ; (c) des moyens de commande destinés à entraîner l'aiguille dans le tissu corporel pour une insertion dans le vaisseau sanguin, et (d) des moyens destinés à assurer que l'aiguille n'est pas insérée trop loin, et un procédé préféré d'insertion d'une aiguille dans le vaisseau sanguin, comprenant les étapes consistant à : fixer un manchon d'un système de ponction tel que celui qui est décrit précédemment sur un membre distal ; localiser un vaisseau sanguin ; aligner l'aiguille avec le vaisseau sanguin dans le plan de la surface de la peau ; insérer l'aiguille dans le membre selon un angle peu profond jusqu'à une profondeur où l'aiguille perce la surface extérieure du vaisseau sanguin ; détecter que le bout de l'aiguille est dans le vaisseau sanguin et arrêter une insertion plus lointaine.
PCT/IL2007/001627 2006-12-31 2007-12-31 Système et procédé d'accès vasculaire WO2008081438A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL180469A IL180469A0 (en) 2006-12-31 2006-12-31 Vascular access system and method
IL180469 2006-12-31

Publications (1)

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WO2008081438A1 true WO2008081438A1 (fr) 2008-07-10

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