WO2008120137A1 - Laser guide for percutaneous biopsy interventions on a rotational x-ray device - Google Patents

Laser guide for percutaneous biopsy interventions on a rotational x-ray device Download PDF

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Publication number
WO2008120137A1
WO2008120137A1 PCT/IB2008/051118 IB2008051118W WO2008120137A1 WO 2008120137 A1 WO2008120137 A1 WO 2008120137A1 IB 2008051118 W IB2008051118 W IB 2008051118W WO 2008120137 A1 WO2008120137 A1 WO 2008120137A1
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WO
WIPO (PCT)
Prior art keywords
positioning
ray
alignment
needle
biopsy
Prior art date
Application number
PCT/IB2008/051118
Other languages
French (fr)
Inventor
Robert Johannes Frederik Homan
Drazenko Babic
Original Assignee
Koninklijke Philips Electronics N.V.
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Filing date
Publication date
Application filed by Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2008120137A1 publication Critical patent/WO2008120137A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/12Devices for detecting or locating foreign bodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A61B90/13Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints guided by light, e.g. laser pointers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/306Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers

Definitions

  • the present invention relates to the field of a laser guide for percutaneous biopsy interventions on a rotational X-ray device.
  • distance holders are used for percutaneous biopsy interventions at an operating X-ray system, such that a doctor is not irradiated by X- rays. Otherwise a X-ray tube has to be switched off, when a doctor wants to inject a needle at a patient without a distance holder. In both cases it is to be prevented that an operator is irradiated by X-rays during an injection of the needle.
  • a percutaneous biopsy device wherein the device comprises a positioning device, an illumination device and an alignment device, wherein the alignment device comprises a X-ray absorbing material, wherein the alignment device is attachable to the positioning device, and wherein light from the illumination device is transmittable through the alignment device.
  • a percutaneous biopsy device is preferably a device, which allows an adequate alignment of a biopsy device, e.g.
  • a needle by means of an illumination device such as a laser and a X-ray system, between an operating X-ray tube and detector of a X-ray system, such that the X-ray system can be switched off during a needle is injected into a patient, and thus an operator can handle the biopsy device without being irradiated by X-rays.
  • an illumination device such as a laser and a X-ray system
  • a positioning device is preferably understood the part of the percutaneous biopsy device, which allows to bring a needle into an operating X-ray system, i.e. a X-ray system, which is emitting X-rays.
  • a positioning device has an architecture, which allows an accommodation of an appropriate illumination device, like a laser, and an accommodation of an alignment device, like a tube, cross hairs or rings for positioning or aligning the percutaneous biopsy device.
  • the positioning device consists of several elements, which are connected together by one or several appropriate connection elements. Further it is preferred that the positioning device is connected with the illumination device, i.e. the laser or laser hardware with appropriate connection elements. By means of several connection elements a plurality of positioning devices can be connected such that the advantage is achieved that the length of the positioning device can be regulated or different laser systems can be connected with the positioning device.
  • an illumination device is understood a part of the percutaneous biopsy device, which is used to illuminate a position on a body, preferably a human body, which shall be medically treated by a needle, especially a biopsy needle.
  • This is called an so-called "entry-point view", where the needle will be later injected.
  • an illumination device comprises a laser and an optical fiber or light-guiding fiber.
  • a laser is preferably a helium-neon-laser (HeNe- laser) or any other laser, like a point laser, aligned laser or cross-hair laser, which is adapted to illuminate a position on a body without occurring any damages to this body. Further it is preferred that the laser is automatically aligned by the laser hardware, which comprises preferably an adequate laser control and optics.
  • An optical fiber is preferably a fiber, which allows a transmittance of laser light from the laser to the end of the positioning device, especially to a lens, which is focusing the laser light into the alignment device or onto the biopsy needle, especially on the back of the biopsy needle.
  • an alignment device is a device, which can be attached to the end of the positioning device by suitable fitting means or a holder.
  • the alignment device comprises a X-ray absorbing material, such that later, when the alignment device is brought into the space of the operating X-ray tube and the X-ray detector a projection of the cross-section of the alignment device is detected by the X-ray detector, as will be described later on.
  • a material can be aluminium, steel, iron or any other X-ray absorbing material, but also a combination of these materials.
  • the alignment device is a hollow tube, or a device consisting of two cross hairs or two rings.
  • the advantage is achieved that with the hollow alignment device, a circle or ring is projected by the X-rays on the X- ray detector when the alignment device is brought with the positioning device into the space between an operating X-ray tube and a detector.
  • an operator knows by the form of a circle or ring that the alignment device is correctly positioned relatively to the emitted X-rays such at the beginning of a surgery to the patient the needle is injected with the wished angle into the body when the X-ray system is switched off. Therefore, when the X-ray-system is switched off a doctor is not irradiated by X-rays when positioning the biopsy needle at an laser-projected entry point on the body of the patient.
  • the entry point is the point where the laser light of the illumination device shines as a spot on the body of the patient.
  • an operator i.e. a doctor
  • injects the needle into the body of a patient as the correct entry point of the needle is given by the projected laser light on the body of the patient.
  • a correct positioning of the needle is possible as the biopsy device is aligned with the operating X-ray-system and the percutaneous biopsy device.
  • the doctor can change the orientation of the needle until the laser light shines on the back of the needle. Then the needle can be inserted into the patient, keeping the light on the back of the needle.
  • the alignment device is attachable to the positioning device.
  • the tube, cross hairs or rings is attachable by a suitable holder to the positioning device.
  • the alignment device is attachable at an angle of 90°, i.e. perpendicular to the positioning device.
  • the X-ray system is switched off and the needle can be injected e.g. under an angle of 90° or under any other angle into the body of the person to be medically treated.
  • the percutaneous biopsy device it is possible to determine the depth of an injected needle into the body of a patient. This can be achieved e.g.
  • the origin position is the position, where the X-ray tube is situated at the highest point of the C-arm system.
  • this view is called a "progressive view”.
  • the line of vision is perpendicular to the orientation of the biopsy needle, i.e. the C-arm is rotated 90° relative to the (rotation)angle of the needle.
  • the X-ray- system can be switched on and the C-arm-system can be brought into a "progressive view".
  • the "progressive view” it is possible to see the depth of the biopsy needle in the patient as the biopsy needle is viewed from the side under an angle of 90° to the direction of the needle.
  • the doctor can now plan and determine the further way of the biopsy needle in the patient. If he/she has decided for the further way the X-ray system is switched off. Now the doctor can guide the needle again into the right angle and depth into the body of the patient as the light of the laser light on the body shows the right angle for guiding the needle and from the former "progressive view" the doctor knows how deep the biopsy needle may be inserted into the patient.
  • the doctor has a secure way and method of performing an exact biopsy treatment at a patient as determination of a correct angle and depth of injection of the biopsy device by means of the percutaneous biopsy device and X-ray-system are possible.
  • the C-arm system is brought from a vertical position, where the X-ray tube is in its highest position of the C-arm system to a horizontal position, where X-ray tube and X-ray detector are arranged at the same height of the system.
  • the exact penetration and depth of the needle into the body of the patient i.e. how deep the needle was injected into the patient.
  • an operator i.e. a doctor, can plan a path of the needle in the body of a patient.
  • a planned path in 3D wherein so-called volume data are e.g. available from CT, can be followed with the tip of the needle, as the C-arm system, e.g. Allura FD-20 (XperGuide), is moving into a predetermined position (vertical or horizontal, or any other angle), such that the path of the needle can be followed by the X-ray- system and the operator of the X-ray system by means of the X-ray detector.
  • the C-arm system e.g. Allura FD-20 (XperGuide)
  • the positioning device preferably comprises a tube.
  • a tube is preferably a hollow rod or hollow cylinder.
  • the tube can have two closed ends.
  • the advantage is achieved that in its inner part further components like optical fibers, etc. can be accommodated.
  • the positioning device can comprise a material out of the group: Perspex, plastics.
  • Perspex is the trading name for PMMA (polylmethylmethacrylate), which is a transparent plastics. Further the positioning device can comprise plastics.
  • the illumination device preferably comprises a laser.
  • a laser is preferably a helium-neon- laser (HeNe- laser) as already mentioned above or any other suitable laser, which allows an adequate illumination of the wished position of the biopsy needle without the risk of damaging or hurting the body of a patient by the laser radiation.
  • HeNe- laser helium-neon- laser
  • the illumination device preferably comprises an optical fiber.
  • An optical fiber is preferably an element by means of which a transmittance of light from the laser to the alignment device is possible such as to illuminate the body of a patient in a proper way.
  • the illumination device comprises a lens.
  • a lens is preferably understood a device by means of which a focusing of the light from the illumination device in the alignment device is possible.
  • the lens is an optical lens.
  • the illumination device i.e. the laser light of the laser
  • the light is transmitted from the lens through the inner part of the alignment device, i.e.
  • the optical fiber is preferably arranged in the inner part of the positioning device. It is preferably understood that the optical fiber is positioned in the hollow part of the tube.
  • the alignment device is substantially arranged at the end of the positioning device.
  • the alignment device is arranged at the part of the positioning device, which is located at the outermost part of the positioning device and which is exposed to the X-ray beam.
  • the alignment device is held by an appropriate holder on the positioning device.
  • the alignment device is preferably arranged perpendicular to the positioning device.
  • the alignment device is attached to the positioning device at an angle of 90°.
  • the alignment device comprises preferably at least one element out of the group: tube, cross hair, ring.
  • a tube is preferably understood a hollow rod.
  • the tube can comprise aluminium, steel, iron, X-ray absorbing material or any other combination of these materials.
  • the tube has dimensions, which allow an adequate projection of the tube on an X-ray detector when the X-ray system is running.
  • cross hairs and a ring is preferably understood a device, by means of which an alignment of the alignment device relative to X-rays, emitted by the X-ray tube, is possible.
  • the material of the alignment device i.e. the tube, cross hairs or the ring is absorbing X-rays.
  • the projected image of the alignment device can be seen on the X-ray detector.
  • the light of the laser is illuminated directly to the biopsy needle without being transmitted over the alignment device, i.e. the laser light is transmitted outside the positioning device.
  • the laser light is transmitted from the laser via an optical fiber to the biopsy needle.
  • a method for positioning a percutaneous biopsy device comprises the steps of switching on an illumination device of the percutaneous biopsy device, positioning an alignment device of the percutaneous biopsy device between an operating X-ray tube and a X-ray detector, rotating the positioning device until a wished optical projection of the alignment device is detected by the X-ray detector, switching off the operating X-ray tube and X-ray detector.
  • the laser of the percutaneous biopsy device is switched on.
  • laser light is transmitted over an illumination device, which comprises an optical fiber, to the lens of the percutaneous biopsy device and an illumination of the alignment device, i.e. the tube and/or needle is possible.
  • the later position of the entry of a biopsy needle can be illuminated, when the X-ray system is switched off. Later, when the alignment device can be removed from the positioning device and the exact point of entry of the biopsy needle is aligned by the laser the biopsy needle can be injected at the desired position and the desired angle into the body of the patient.
  • the percutaneous biopsy device is brought with its side, which comprises the alignment device, between the operating X-ray tube and the X-ray detector.
  • the X-ray system can be switched off. Now a doctor can see the entry point of the later biopsy needle as the laser light of the illumination device is projected on the body of the patient, as already described above. After the doctor has injected the biopsy needle the X-ray system can be switched on to see in a "progression view" as already described above the deep of injection of the biopsy needle.
  • the percutaneous biopsy device is brought into a translational or rotational displacement until the cross-section of the tube and/or the biopsy needle are/is projected by the X- rays in form of a circle on the X-ray detector.
  • the position of the point of entry of the biopsy needle is projected on the body of the person to be operated.
  • the angle of the biopsy needle is entering perpendicularly the body of the patient under an angle of 90° or any other desired angle.
  • the path of the needle can also be seen by the projection of the HeNe- laser when the X-ray system is switched off.
  • the X- ray tube is stopped in the way that a further emission of X-rays is not possible such that a doctor is not irradiated by X-rays when he/she is inserting a biopsy needle into the body of a patient.
  • the alignment device can be separated from the positioning device.
  • the alignment device is removed from the holder on the positioning device.
  • a ball joint for supporting the device is used.
  • a device by means of which the percutaneous biopsy device can by supported and held in a preferred position, such as to support an adequate alignment of the percutaneous biopsy device during a biopsy intervention.
  • the ball joint is connected with a joint knee, by means of which it is possible to guide the ball joint in preferred way, preferably in a way toward the patient or away from the patient.
  • the positioning device with the alignment device can be fixed in its rotational and translational position by the ball joint.
  • the percutaneous biopsy device with the positioning device and alignment device is no longer possible.
  • the advantage is achieved that a precise positioning of the needle or biopsy needle on the body of a patient can be achieved.
  • a doctor can align and position the illumination device, i.e. the laser light, without bringing his hands into the X-rays of an operating X-ray-system. After the laser light is positioned on the body of a patient the doctor can insert a biopsy needle into the patient when the X-ray-system is switched off.
  • the illumination device i.e. the laser light
  • Fig. 1 shows a graphical illustration of the percutaneous biopsy percutaneous biopsy device.
  • Fig. 2 shows a detailed graphical view of the percutaneous biopsy device.
  • Fig. 3 shows the application of the percutaneous biopsy device on a target of a human body.
  • Figure 1 shows a graphical illustration of the percutaneous biopsy device
  • the percutaneous biopsy device 10 thereby comprises a positioning device 1, an illumination device 2 and an alignment device 3.
  • the positioning device 1 is a hollow tube, which is made of Perspex.
  • the illumination device 2 comprises a laser, an optical fiber 5 and an optical lens 4.
  • the alignment device 3 is a hollow aluminium tube and is fixed at the end 6 of the positioning device 1 of the percutaneous biopsy device 10.
  • the percutaneous biopsy device 10 is supported by a ball joint 12, wherein the ball joint is fixed on a table 30 on which a patient (not shown) can lie.
  • the percutaneous biopsy device 10 with the alignment device 3 is brought into the space between an operating X-ray tube 21 and a X-ray detector 22 of a C-arm X-ray system 20.
  • the X-ray tube 21 and X-ray detector 22 are arranged in a vertical position, i.e. the X-ray tube is situated at the highest position of the C-arm system.
  • the X-ray tube 21 is operated, i.e. X-rays are emitted by the X-ray tube, the cross-section of the aluminium tube is projected on the body of a patient (see Fig.
  • This cross-section which is in the ideal case a circle or ring, can be varied by rotating and translating the positioning device 1 together with the alignment device 3 relative to the X-rays emitted by the X-ray system. If the outer surface of the aluminium tube 3 is parallel to the X-rays 23, which are emitted by the X-ray tube, a circle is projected on the body of the patient (not shown), see Fig. 3.
  • the alignment device is arranged in a way that the aluminium tube is vertically (perpendicular) positioned to the surface of the body of a patient, i.e. the angle is 90°. Further with the light of the HeNe- laser also the position of the alignment device is projected on the body of the patient.
  • the X-ray system is switched off and the alignment device is removed from the positioning device a concrete point of entry of the biopsy needle 9 is projected by the HeNe-laser on the patient.
  • the doctor knows where the biopsy needle has to be injected under the correct angle into the body of the patient as the laser- light of the illumination device is projected on the body of the patient.
  • the back of the biopsy needle is illuminated by the beam 13 of the HeNe-laser and projected to the body of the patient. So it is known, at which position the needle 9 will be later injected into the body of a patient.
  • the X-ray system is switched on and the C-arm system is brought from a vertical position, where the X-ray tube is in its highest position of the C-arm system to a horizontal position (not shown), where X-ray tube and X-ray detector are arranged at the same height of the system.
  • a planned path in 3D can be followed with the needle as the C-arm system, e.g. Allura FD-20 (XperGuide), is moving into the wished position, i.e. horizontal, vertical or any other position relative to the patient, such that the path of the needle can be followed by the X-ray-system.
  • the C-arm system e.g. Allura FD-20 (XperGuide)
  • XperGuide XperGuide
  • the tip of the biopsy needle is projected on the body of the patient (not shown) by the X-rays, see Fig. 3.
  • the advantage is achieved that a precise aligning of a biopsy needle on a body of a patient is achieved without the risk that an operator, i.e. a doctor, is irradiated by X-rays of an operating X-ray system.
  • Fig. 2 shows a more detailed view of the percutaneous biopsy device.
  • the percutaneous biopsy device 10 comprises an illumination device 2 with a HeNe-laser, a positioning device 1, which is a hollow tube made of Perspex, a connection element 7 for connecting the illumination device 2 with the positioning device 1 and a holder 8 for holding the alignment device 3 (not shown).
  • the projection 101 of the hollow alignment device 3 on the body 100 of a patient can be seen.
  • the projection 101 which can be seen on the X-ray detector, has the form of a ring or circle.
  • the alignment device has this projected form on the X-ray detector, as the outer surface of the alignment device, which is in this case a hollow aluminium tube, is parallel to the X-rays 23 and wherein the aluminium absorbs the X-rays, which are emitted by the X-ray tube.
  • the cross-section of the biopsy needle 9 as a point 102 is projected by the X-rays.
  • the point 102 shows the exact position, where at a later moment of time, the biopsy needle 9 can be injected, when the X-ray system is switched off, as the tip of the needle is also illuminated by the HeNe-laser and thus projecting a point 102 on the body of the patient to be medically treated at a later moment of time.
  • a percutaneous biopsy device is provided with which an alignment of a laser beam of a planned path is obtained such as to guide a needle on this path without the help of X-rays, such that a doctor is not irradiated by X-rays when inserting a biopsy needle into a body of a patient.

Abstract

It is described a percutaneous biopsy device (10), wherein the device comprises a positioning device (1), an illumination device (2) and an alignment device (5), wherein the alignment device comprises a X-ray absorbing material, wherein the alignment device (3) is attachable to the positioning device (1) and wherein light from the illumination device (2) is transmittable through the alignment device (3). It is further described a method for positioning the percutaneous biopsy device (10), wherein the method is comprising the steps of switching on an illumination device (2) of the percutaneous biopsy device (10), positioning an alignment device (3) of the percutaneous biopsy device (10) between an operating X-ray tube (21) and a X-ray detector (22), rotating the positioning device (1) until a wished optical projection of the alignment device is detected by the X-ray detector (22), switching off the operating X- ray tube (21) and removing the alignment device (3) from the positioning device (1). With the percutaneous biopsy device and method it is possible to determine an exact point of entry of a biopsy device when a X-ray system is switched off and to guide the biopsy needle on a predetermined 3D-way in the body of a patient, such that an operator of the percutaneous biopsy device and when injecting a biopsy needle into a body of a patient is not exposed to X-rays.

Description

LASER GUIDE FOR PERCUTANEOUS BIOPSY INTERVENTIONS ON A ROTATIONAL X-RAY DEVICE
FIELD OF INVENTION
The present invention relates to the field of a laser guide for percutaneous biopsy interventions on a rotational X-ray device.
ART BACKGROUND
In the state of the art distance holders are used for percutaneous biopsy interventions at an operating X-ray system, such that a doctor is not irradiated by X- rays. Otherwise a X-ray tube has to be switched off, when a doctor wants to inject a needle at a patient without a distance holder. In both cases it is to be prevented that an operator is irradiated by X-rays during an injection of the needle.
However, when a X-ray tube is switched off, it is difficult to bring a needle for biopsy into the right position and "correct", respectively desired angle if no further precise aligning of the needle is done before the injection.
Thus, there may be a need for a guide for percutaneous biopsy interventions on a X-ray device, which allows to overcome those problems of the state of the art.
SUMMARY OF THE INVENTION
This need may be met by the subject matter according to the independent claims. Advantageous embodiments of the present invention are described by the dependent claims.
According to a first aspect of the invention there is provided a percutaneous biopsy device, wherein the device comprises a positioning device, an illumination device and an alignment device, wherein the alignment device comprises a X-ray absorbing material, wherein the alignment device is attachable to the positioning device, and wherein light from the illumination device is transmittable through the alignment device. Herein a percutaneous biopsy device is preferably a device, which allows an adequate alignment of a biopsy device, e.g. a needle, by means of an illumination device such as a laser and a X-ray system, between an operating X-ray tube and detector of a X-ray system, such that the X-ray system can be switched off during a needle is injected into a patient, and thus an operator can handle the biopsy device without being irradiated by X-rays.
As a positioning device is preferably understood the part of the percutaneous biopsy device, which allows to bring a needle into an operating X-ray system, i.e. a X-ray system, which is emitting X-rays. Preferably such a positioning device has an architecture, which allows an accommodation of an appropriate illumination device, like a laser, and an accommodation of an alignment device, like a tube, cross hairs or rings for positioning or aligning the percutaneous biopsy device. By positioning the alignment device in the X-rays a projection is achieved on a X-ray detector, such that can be seen if the alignment device is optimally aligned for a later medical treatment of a biopsy device.
It is further preferred that the positioning device consists of several elements, which are connected together by one or several appropriate connection elements. Further it is preferred that the positioning device is connected with the illumination device, i.e. the laser or laser hardware with appropriate connection elements. By means of several connection elements a plurality of positioning devices can be connected such that the advantage is achieved that the length of the positioning device can be regulated or different laser systems can be connected with the positioning device.
Preferably by an illumination device is understood a part of the percutaneous biopsy device, which is used to illuminate a position on a body, preferably a human body, which shall be medically treated by a needle, especially a biopsy needle. This is called an so-called "entry-point view", where the needle will be later injected. Thus, the advantage is achieved that once the aligned position of the later needle injection is fixed by rotating and translating the positioning device until the wished cross-section of the alignment device can be seen under the projection of the X-rays, the positioning device is fixed by means of a ball joint, the alignment device is removed from the positioning device, the laser light further shows the later entry point for injection of the biopsy needle when the X-ray-system is switched off.
It is preferred that such an illumination device comprises a laser and an optical fiber or light-guiding fiber. A laser is preferably a helium-neon-laser (HeNe- laser) or any other laser, like a point laser, aligned laser or cross-hair laser, which is adapted to illuminate a position on a body without occurring any damages to this body. Further it is preferred that the laser is automatically aligned by the laser hardware, which comprises preferably an adequate laser control and optics.
An optical fiber is preferably a fiber, which allows a transmittance of laser light from the laser to the end of the positioning device, especially to a lens, which is focusing the laser light into the alignment device or onto the biopsy needle, especially on the back of the biopsy needle.
It is preferred that an alignment device is a device, which can be attached to the end of the positioning device by suitable fitting means or a holder. The alignment device comprises a X-ray absorbing material, such that later, when the alignment device is brought into the space of the operating X-ray tube and the X-ray detector a projection of the cross-section of the alignment device is detected by the X-ray detector, as will be described later on. Such a material can be aluminium, steel, iron or any other X-ray absorbing material, but also a combination of these materials. It is especially preferred that the alignment device is a hollow tube, or a device consisting of two cross hairs or two rings. Thus, the advantage is achieved that with the hollow alignment device, a circle or ring is projected by the X-rays on the X- ray detector when the alignment device is brought with the positioning device into the space between an operating X-ray tube and a detector. Thus, an operator knows by the form of a circle or ring that the alignment device is correctly positioned relatively to the emitted X-rays such at the beginning of a surgery to the patient the needle is injected with the wished angle into the body when the X-ray system is switched off. Therefore, when the X-ray-system is switched off a doctor is not irradiated by X-rays when positioning the biopsy needle at an laser-projected entry point on the body of the patient. Therein, the entry point is the point where the laser light of the illumination device shines as a spot on the body of the patient. Thus, it is possible to bring the needle into the right position of the body when the X-ray-system is switched off and when an operator, i.e. a doctor, injects the needle into the body of a patient as the correct entry point of the needle is given by the projected laser light on the body of the patient. A correct positioning of the needle is possible as the biopsy device is aligned with the operating X-ray-system and the percutaneous biopsy device. Later on when the X-ray-system is switched off such that the doctor can treat the patient without being irradiated by X-rays he knows from the projected laser light on the patient the exact entry point for the needle. Then the doctor can change the orientation of the needle until the laser light shines on the back of the needle. Then the needle can be inserted into the patient, keeping the light on the back of the needle.
Under the expression that the alignment device is attachable to the positioning device is preferably understood that the tube, cross hairs or rings is attachable by a suitable holder to the positioning device. Preferably the alignment device is attachable at an angle of 90°, i.e. perpendicular to the positioning device. Thus, the advantage is achieved that at a later moment, when the position of a later injected needle is selected by the operator by means of the biopsy device, the X-ray system is switched off and the needle can be injected e.g. under an angle of 90° or under any other angle into the body of the person to be medically treated. It is further preferred that with the percutaneous biopsy device it is possible to determine the depth of an injected needle into the body of a patient. This can be achieved e.g. by rotating a C-arm of the X-ray system, preferably by moving the C- arm X-ray system by an angle of 90° to its origin position. Thereby the origin position is the position, where the X-ray tube is situated at the highest point of the C-arm system. When starting from this highest position for an angle of 90°, such that X-ray tube and detector are horizontally positioned, this view is called a "progressive view". Therein the line of vision is perpendicular to the orientation of the biopsy needle, i.e. the C-arm is rotated 90° relative to the (rotation)angle of the needle.
After injecting or introducing the biopsy needle for a certain distance and under the wished angle into the body of the patient the X-ray- system can be switched on and the C-arm-system can be brought into a "progressive view". In the "progressive view" it is possible to see the depth of the biopsy needle in the patient as the biopsy needle is viewed from the side under an angle of 90° to the direction of the needle.
The doctor can now plan and determine the further way of the biopsy needle in the patient. If he/she has decided for the further way the X-ray system is switched off. Now the doctor can guide the needle again into the right angle and depth into the body of the patient as the light of the laser light on the body shows the right angle for guiding the needle and from the former "progressive view" the doctor knows how deep the biopsy needle may be inserted into the patient.
Thus, by a repetition of switching on and off of the X-ray system the doctor has a secure way and method of performing an exact biopsy treatment at a patient as determination of a correct angle and depth of injection of the biopsy device by means of the percutaneous biopsy device and X-ray-system are possible.
The detailed operation with the X-ray-system and C-arm system is as follows: the C-arm system is brought from a vertical position, where the X-ray tube is in its highest position of the C-arm system to a horizontal position, where X-ray tube and X-ray detector are arranged at the same height of the system. Thus, it is possible to see the exact penetration and depth of the needle into the body of the patient, i.e. how deep the needle was injected into the patient. From the knowledge, where the needle is injected, how deep the needle is injected and in which direction, i.e. under which angle, the needle is injected, an operator, i.e. a doctor, can plan a path of the needle in the body of a patient. Thus, a planned path in 3D, wherein so-called volume data are e.g. available from CT, can be followed with the tip of the needle, as the C-arm system, e.g. Allura FD-20 (XperGuide), is moving into a predetermined position (vertical or horizontal, or any other angle), such that the path of the needle can be followed by the X-ray- system and the operator of the X-ray system by means of the X-ray detector.
This aspect of the invention is based on the idea that with the percutaneous biopsy device by means of a X-ray projection of the alignment device on the X-ray detector it is possible to align the later position and precise angle of an injecting needle as the laser light shows the correct position for injecting the biopsy needle into the body of the patient when the X-ray-system is switched off. Thus, the doctor can inject the needle under a correct angle and at the right position without being irradiated by X-rays. According to a further embodiment of the invention the positioning device preferably comprises a tube.
A tube is preferably a hollow rod or hollow cylinder. The tube can have two closed ends. Thus, the advantage is achieved that in its inner part further components like optical fibers, etc. can be accommodated.
According to a further embodiment of the invention the positioning device can comprise a material out of the group: Perspex, plastics.
Perspex is the trading name for PMMA (polylmethylmethacrylate), which is a transparent plastics. Further the positioning device can comprise plastics.
Because of the used materials a secure and easy to handle positioning device can be obtained.
According to a further embodiment of the invention the illumination device preferably comprises a laser. A laser is preferably a helium-neon- laser (HeNe- laser) as already mentioned above or any other suitable laser, which allows an adequate illumination of the wished position of the biopsy needle without the risk of damaging or hurting the body of a patient by the laser radiation.
According to a further embodiment of the invention the illumination device preferably comprises an optical fiber. An optical fiber is preferably an element by means of which a transmittance of light from the laser to the alignment device is possible such as to illuminate the body of a patient in a proper way. Thus the advantage is achieved that the laser can be situated at any suitable position of the positioning device in order not to be exhibited to X-rays of the X-ray system.
According to a further embodiment of the invention the illumination device comprises a lens.
As a lens is preferably understood a device by means of which a focusing of the light from the illumination device in the alignment device is possible. Preferably the lens is an optical lens. Thus, the advantage is achieved that a focusing of the transmitted laser light to the alignment device is possible and thus a more precise alignment of a needle is achieved as the later position of injection of the biopsy needle is shown by the illumination device, i.e. the laser light of the laser, on the body of the patient when the X-ray system is switched off. It is further preferred that the light is transmitted from the lens through the inner part of the alignment device, i.e. the optical axis of the light emitted from the laser and through the lens lies on the middle axis of the alignment device, wherein it is preferred that this alignment of the optical axis and the middle axis of the alignment device is automatically done by the laser hardware. According to a further embodiment of the invention, the optical fiber is preferably arranged in the inner part of the positioning device. It is preferably understood that the optical fiber is positioned in the hollow part of the tube. Thus, the advantage is achieved that the percutaneous biopsy device is constructed in a volume- saving way as the optical fiber is placed in the tube. Further arises the advantage that the optical fiber is protected in the inner part of the tube such that it can not be easily damaged.
According to a further embodiment of the invention the alignment device is substantially arranged at the end of the positioning device. By the expression substantially at the end of the positioning device is preferably understood that the alignment device is arranged at the part of the positioning device, which is located at the outermost part of the positioning device and which is exposed to the X-ray beam. Preferably the alignment device is held by an appropriate holder on the positioning device.
According to a further embodiment of the invention the alignment device is preferably arranged perpendicular to the positioning device. By the expression arranged perpendicular to the positioning device is preferably understood that the alignment device is attached to the positioning device at an angle of 90°.
According to a further embodiment of the invention the alignment device comprises preferably at least one element out of the group: tube, cross hair, ring. By a tube is preferably understood a hollow rod. The tube can comprise aluminium, steel, iron, X-ray absorbing material or any other combination of these materials. Preferably the tube has dimensions, which allow an adequate projection of the tube on an X-ray detector when the X-ray system is running.
By a tube, cross hairs and a ring is preferably understood a device, by means of which an alignment of the alignment device relative to X-rays, emitted by the X-ray tube, is possible. The material of the alignment device, i.e. the tube, cross hairs or the ring is absorbing X-rays. Thus, the projected image of the alignment device can be seen on the X-ray detector.
According to a further embodiment of the invention, the light of the laser is illuminated directly to the biopsy needle without being transmitted over the alignment device, i.e. the laser light is transmitted outside the positioning device. Preferably, the laser light is transmitted from the laser via an optical fiber to the biopsy needle.
There is further suggested a method for positioning a percutaneous biopsy device, wherein the method comprises the steps of switching on an illumination device of the percutaneous biopsy device, positioning an alignment device of the percutaneous biopsy device between an operating X-ray tube and a X-ray detector, rotating the positioning device until a wished optical projection of the alignment device is detected by the X-ray detector, switching off the operating X-ray tube and X-ray detector.
Under the step of switching on an illumination device of the device is preferably understood that the laser of the percutaneous biopsy device is switched on. Thus, laser light is transmitted over an illumination device, which comprises an optical fiber, to the lens of the percutaneous biopsy device and an illumination of the alignment device, i.e. the tube and/or needle is possible.
In this way the later position of the entry of a biopsy needle can be illuminated, when the X-ray system is switched off. Later, when the alignment device can be removed from the positioning device and the exact point of entry of the biopsy needle is aligned by the laser the biopsy needle can be injected at the desired position and the desired angle into the body of the patient.
Under the step of positioning an alignment device of the device between an operating X-ray tube and a X-ray detector, is preferably understood that the percutaneous biopsy device is brought with its side, which comprises the alignment device, between the operating X-ray tube and the X-ray detector.
Later, when the wished path of the needle is illuminated by the laser and projected to the body of a patient, the X-ray system can be switched off. Now a doctor can see the entry point of the later biopsy needle as the laser light of the illumination device is projected on the body of the patient, as already described above. After the doctor has injected the biopsy needle the X-ray system can be switched on to see in a "progression view" as already described above the deep of injection of the biopsy needle.
Under the step of rotating the device until a wished optical projection of the alignment device is detected by the X-ray detector, is preferably understood that the percutaneous biopsy device is brought into a translational or rotational displacement until the cross-section of the tube and/or the biopsy needle are/is projected by the X- rays in form of a circle on the X-ray detector. By the additional laser beam the position of the point of entry of the biopsy needle is projected on the body of the person to be operated. Thus, it is possible that the angle of the biopsy needle is entering perpendicularly the body of the patient under an angle of 90° or any other desired angle. As a further advantage the path of the needle can also be seen by the projection of the HeNe- laser when the X-ray system is switched off.
Under the step of switching off the X-ray tube is understood that the X- ray tube is stopped in the way that a further emission of X-rays is not possible such that a doctor is not irradiated by X-rays when he/she is inserting a biopsy needle into the body of a patient.
Under the step of removing the alignment device from the positioning device is preferably understood that the alignment device can be separated from the positioning device. Preferably it is understood that the alignment device is removed from the holder on the positioning device.
According to a further embodiment of the invention, preferably a ball joint for supporting the device is used.
Under a ball joint is preferably understood a device, by means of which the percutaneous biopsy device can by supported and held in a preferred position, such as to support an adequate alignment of the percutaneous biopsy device during a biopsy intervention.
Preferably, the ball joint is connected with a joint knee, by means of which it is possible to guide the ball joint in preferred way, preferably in a way toward the patient or away from the patient.
Further, it is preferred that once the wished alignment or positioning of the alignment device is achieved, i.e. a circle or ring as a projection of the alignment device by X-rays is projected on the X-ray detector, the positioning device with the alignment device can be fixed in its rotational and translational position by the ball joint.
Thus, a further movement of the percutaneous biopsy device with the positioning device and alignment device is no longer possible. Thus, the advantage is achieved that a precise positioning of the needle or biopsy needle on the body of a patient can be achieved.
Especially a doctor can align and position the illumination device, i.e. the laser light, without bringing his hands into the X-rays of an operating X-ray-system. After the laser light is positioned on the body of a patient the doctor can insert a biopsy needle into the patient when the X-ray-system is switched off.
In the following there will be described exemplary embodiments of the present invention with reference to a percutaneous biopsy device. It has to be pointed out that of course any combination of features relating to different subject matters is also possible.
It has to be noted that embodiments of the invention have been described with reference to different subject matters. In particular, some embodiments have been described with reference to apparatus type claims wherein other embodiments have been described with reference to method type claims. However, a person skilled in the art will gather from the above and the following description that, unless other notified, in addition to any combination of features belonging to one type of subject matter also any combination between features relating to different subject matters, in particular between features of the apparatus type claims and features of the method type claims is considered to be disclosed with this application. The aspects defined above and further aspects of the present invention are apparent from the examples of embodiment to be described hereinafter and are explained with reference to the examples of embodiment. The invention will be described in more detail hereinafter with reference to examples of embodiment but to which the invention is not limited. BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 shows a graphical illustration of the percutaneous biopsy percutaneous biopsy device.
Fig. 2 shows a detailed graphical view of the percutaneous biopsy device.
Fig. 3 shows the application of the percutaneous biopsy device on a target of a human body.
DETAILED DESCRIPTION
The illustration in the drawings is schematically. It is noted that in different figures, similar or identical elements are provided with the same reference signs or with reference signs, which are different from the corresponding reference signs only within the first digit. Figure 1 shows a graphical illustration of the percutaneous biopsy device
10 for percutaneous biopsy.
The percutaneous biopsy device 10 thereby comprises a positioning device 1, an illumination device 2 and an alignment device 3. The positioning device 1 is a hollow tube, which is made of Perspex. The illumination device 2 comprises a laser, an optical fiber 5 and an optical lens 4.
The alignment device 3 is a hollow aluminium tube and is fixed at the end 6 of the positioning device 1 of the percutaneous biopsy device 10.
The percutaneous biopsy device 10 is supported by a ball joint 12, wherein the ball joint is fixed on a table 30 on which a patient (not shown) can lie.
When using the percutaneous biopsy device for percutaneous biopsy, the percutaneous biopsy device 10 with the alignment device 3 is brought into the space between an operating X-ray tube 21 and a X-ray detector 22 of a C-arm X-ray system 20. Therein the X-ray tube 21 and X-ray detector 22 are arranged in a vertical position, i.e. the X-ray tube is situated at the highest position of the C-arm system. In the case that the X-ray tube 21 is operated, i.e. X-rays are emitted by the X-ray tube, the cross-section of the aluminium tube is projected on the body of a patient (see Fig. 3) when the alignment device 3 is positioned between the X-ray tube 21 and the body of the patient (not shown) and the body of the patient is positioned between the alignment device 3 and the detector of the X-ray system 22. Thus, when an imaginary line can be drawn between the X-ray tube 21 and the X-ray detector 22, the X-ray tube 21, the middle of the aluminium tube 3, the position of the body to be medically treated and the X-ray-detector are arranged on this line.
This cross-section, which is in the ideal case a circle or ring, can be varied by rotating and translating the positioning device 1 together with the alignment device 3 relative to the X-rays emitted by the X-ray system. If the outer surface of the aluminium tube 3 is parallel to the X-rays 23, which are emitted by the X-ray tube, a circle is projected on the body of the patient (not shown), see Fig. 3.
Thus the alignment device is arranged in a way that the aluminium tube is vertically (perpendicular) positioned to the surface of the body of a patient, i.e. the angle is 90°. Further with the light of the HeNe- laser also the position of the alignment device is projected on the body of the patient. Thus, when the X-ray system is switched off and the alignment device is removed from the positioning device a concrete point of entry of the biopsy needle 9 is projected by the HeNe-laser on the patient. Thus, the doctor knows where the biopsy needle has to be injected under the correct angle into the body of the patient as the laser- light of the illumination device is projected on the body of the patient.
The back of the biopsy needle is illuminated by the beam 13 of the HeNe-laser and projected to the body of the patient. So it is known, at which position the needle 9 will be later injected into the body of a patient.
Further a precise and easy to handle alignment is possible with the ball joint 12 and the knee joint 11, wherein a downward-directed or upward-directed movement and also vertical or horizontal movement is possible with the knee joint 11 and ball joint 12. By rotating the C-arm system with an angle of 90° from the vertical position into a horizontal position, which is indicated by the curved arrow in Fig. 1, it is further possible to determine the depth of a needle, which is injected into the body of a patient. In order to see the depth of the injected needle on a X-ray detector, the X-ray system is switched on and the C-arm system is brought from a vertical position, where the X-ray tube is in its highest position of the C-arm system to a horizontal position (not shown), where X-ray tube and X-ray detector are arranged at the same height of the system.
Thus, it is possible to see the exact depth of the needle in the body of the patient, i.e. how deep the needle was injected into the patient. Thus, from a repetition of switching on and off the X-ray-system and injecting and guiding the needle repeatedly into the body of the patient, i.e. from the knowledge, where the needle is injected, how deep the needle is injected and in which direction, i.e. under which angle, the needle is injected, an operator, i.e. a doctor, can plan a path of the needle in the body of a patient.
Thus, a planned path in 3D can be followed with the needle as the C-arm system, e.g. Allura FD-20 (XperGuide), is moving into the wished position, i.e. horizontal, vertical or any other position relative to the patient, such that the path of the needle can be followed by the X-ray-system.
Further, also the tip of the biopsy needle is projected on the body of the patient (not shown) by the X-rays, see Fig. 3.
Thus, with the percutaneous biopsy device, the advantage is achieved that a precise aligning of a biopsy needle on a body of a patient is achieved without the risk that an operator, i.e. a doctor, is irradiated by X-rays of an operating X-ray system.
Fig. 2 shows a more detailed view of the percutaneous biopsy device. In this embodiment the percutaneous biopsy device 10 comprises an illumination device 2 with a HeNe-laser, a positioning device 1, which is a hollow tube made of Perspex, a connection element 7 for connecting the illumination device 2 with the positioning device 1 and a holder 8 for holding the alignment device 3 (not shown).
Finally, in Fig. 3, the projection 101 of the hollow alignment device 3 on the body 100 of a patient can be seen. In this graphical image, the projection 101, which can be seen on the X-ray detector, has the form of a ring or circle. The alignment device has this projected form on the X-ray detector, as the outer surface of the alignment device, which is in this case a hollow aluminium tube, is parallel to the X-rays 23 and wherein the aluminium absorbs the X-rays, which are emitted by the X-ray tube. In Fig. 3 also the cross-section of the biopsy needle 9 as a point 102 is projected by the X-rays. The point 102 shows the exact position, where at a later moment of time, the biopsy needle 9 can be injected, when the X-ray system is switched off, as the tip of the needle is also illuminated by the HeNe-laser and thus projecting a point 102 on the body of the patient to be medically treated at a later moment of time.
Thus, it is for the doctor or surgeon possible to align the later point of injection of the needle or biopsy needle without coming into the operating X-ray system and thus without being irradiated by X-rays. It should be noted that the term "comprising" does not exclude other elements or steps and the "a" or "an" does not exclude a plurality. Also elements described in association with different embodiments may be combined. It should also be noted that reference signs in the claims should not be construed as limiting the scope of the claims. In order to recapitulate the above described embodiments of the present invention one can state that a percutaneous biopsy device is provided with which an alignment of a laser beam of a planned path is obtained such as to guide a needle on this path without the help of X-rays, such that a doctor is not irradiated by X-rays when inserting a biopsy needle into a body of a patient.
LIST OF REFERENCE SIGNS:
1 positioning device
2 illumination device
3 alignment device
4 lens
5 optical fiber
6 end of positioning device
7 connection element
8 holder for alignment device
9 biopsy needle
10 percutaneous biopsy device
11 knee joint
12 ball joint
13 beam of laser
20 C-arm system
21 X-ray tube
22 X-ray detector
23 X-rays
30 table for patient
100 body of a patient
101 projection of alignment device
102 projection of needle

Claims

CLAIMS:
1. A percutaneous biopsy device (10), comprising: a positioning device (1); an illumination device (2); and an alignment device (3), wherein the alignment device (3) comprises a X-ray absorbing material; wherein the alignment device (3) is attachable to the positioning device (1); and wherein light from the illumination device (2) is transmittable through the alignment device (3).
2. The device (10) according to claim 1, wherein the positioning device (1) comprises a tube.
3. The device (10) according to any of the previous claims, wherein the positioning device (1) comprises a material out of the group: Perspex, plastics.
4. The device (10) according to any of the previous claims, wherein the illumination device (2) comprises a laser.
5. The device (10) according to any of the previous claims, wherein the illumination device (2) further comprises an optical fiber (5).
6. The device (10) according to claim 5, wherein the optical fiber (5) is arranged in the inner part the positioning device (1).
7. The device (10) according to any of the previous claims, wherein the illumination device (2) further comprises a lens (4).
8. The device (10) according to any of the previous claims, wherein the alignment device (3) is substantially arranged at one end of the positioning device (1).
9. The device (10) according to any of the previous claims, wherein the alignment device (3) is arranged perpendicular to the positioning device (1).
10. The device (10) according to any of the previous claims, wherein the alignment device (3) comprises at least one element out of the group: tube, cross hair, ring.
11. The device (10) according to any of the previous claims, wherein the positioning device (1) comprises at least one connection element (7).
12. The device (10) according to any of the previous claims, wherein the positioning device (1) comprises at least one holder (8), which is arranged for holding the alignment device (3) at the positioning device (1).
13. A method for positioning a percutaneous biopsy device (10) according to any of the previous device claims, comprising the steps of: - switching on an illumination device (2) of the percutaneous biopsy device (10); positioning an alignment device (3) of the percutaneous biopsy device (10) between an operating X-ray tube (21) and a X-ray detector (22); rotating the positioning device ( 1 ) until a wished optical proj ection (101, 102) of the alignment device (3) is detected by the X-ray detector (22); switching off the operating X-ray tube (21) and removing the alignment device (3) from the positioning device (1).
14. The method according to claim 13, wherein a ball joint (12) for supporting the device (10) is used.
PCT/IB2008/051118 2007-03-30 2008-03-26 Laser guide for percutaneous biopsy interventions on a rotational x-ray device WO2008120137A1 (en)

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EP07105307 2007-03-30

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