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EP1653867A1 - Dispositif destine a la manipulation de tissus et d'organes - Google Patents

Dispositif destine a la manipulation de tissus et d'organes

Info

Publication number
EP1653867A1
EP1653867A1 EP04762651A EP04762651A EP1653867A1 EP 1653867 A1 EP1653867 A1 EP 1653867A1 EP 04762651 A EP04762651 A EP 04762651A EP 04762651 A EP04762651 A EP 04762651A EP 1653867 A1 EP1653867 A1 EP 1653867A1
Authority
EP
European Patent Office
Prior art keywords
tissue
attachment
organ
detection means
pressure
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP04762651A
Other languages
German (de)
English (en)
Inventor
Heinz Rupp
Bernhard Maisch
Ekkehard SCHÜLER
Michael Koch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Philipps Universitaet Marburg
Original Assignee
Philipps Universitaet Marburg
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 Philipps Universitaet Marburg filed Critical Philipps Universitaet Marburg
Publication of EP1653867A1 publication Critical patent/EP1653867A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3478Endoscopic needles, e.g. for infusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00269Type of minimally invasive operation endoscopic mucosal resection EMR
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/0046Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable
    • A61B2017/00473Distal part, e.g. tip or head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/30Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • A61B2017/306Surgical pincettes, i.e. surgical tweezers without pivotal connections holding by means of suction
    • 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
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • 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
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • A61B2090/373Surgical systems with images on a monitor during operation using light, e.g. by using optical scanners
    • 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
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • A61B2090/378Surgical systems with images on a monitor during operation using ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Definitions

  • the invention relates to a device for puncturing or other manipulation of the human or animal tissue, the attachment of the tissue being reliably recognized and signaled.
  • the device according to the invention enables access to the pericardium after piercing the pericardium.
  • US Pat. No. 5,972,013 A describes a device which allows minimally non-invasive access to the pericardium of the heart of a human or an animal.
  • This device includes a penetrating body located in a lumen of a steering tube.
  • the steering tube has at its distal end a deflection mechanism for deflecting the distal end of the penetrating body.
  • the steering tube has at its distal end a head with a lateral opening for receiving the tissue to be punctured.
  • a negative pressure source is connected to the steering tube, which can also be made of plastic, that is to say flexible, but which only allows the pericardium to be sucked into the same opening if the head or the opening is correctly positioned relative to the pericardium.
  • US Pat. No. 5,931,810 A also describes an apparatus and a method for accessing the pericardium.
  • the device described here consists of a body with a distal and proximal end. This body has a through hole.
  • the proximal end has several jaws that are opened and can be closed. At least one of the jaws is movable.
  • the distal end has a handle that is partially connected to the movable jaw, so that the jaw can be opened or closed at any time to a desired degree.
  • a needle for tissue puncture is housed in the jaws and can be moved within the through hole. It is also linked to a mechanism that limits its movements.
  • the two devices mentioned above have the problem that the attachment of the body tissue or an organ to the apparatus is not reliably recognized and signaled. Recognizing the attachment is the prerequisite for a successful puncture or other manipulation. Even with the help of the devices described above, it cannot be reliably recognized whether this is to be punctured
  • Tissue or organ in the right place on the head e.g. attached to the side opening. This creates the danger that the important organs or tissues, e.g. to injure the heart muscle during manipulation.
  • the object of the invention is therefore to create a device which fulfills the requirements for a successful puncture or other manipulation of the human or animal tissue.
  • the object is achieved according to the invention by a device for use in medicine and veterinary medicine according to claim 1.
  • the device according to the invention can be used for any human or animal tissue or organ, especially in the context of minimally invasive surgery, where there is no direct visual inspection and where it must be ensured that a tissue or organ is manipulated for a specific one Arrangement, for example, is attached to a device for puncturing.
  • the developed device consists of a negative pressure source, a suction head with a recess, at least one penetrating body, which is accommodated in at least one guide body with at least one lumen, and an attachment detection and display device.
  • the tack detection device may include one or more detection means, including acoustic, optical and pressure dependent.
  • detection means including acoustic, optical and pressure dependent.
  • Signals detected by the tack detection device are converted into display signals.
  • FIG. 1 shows all components of the device according to the invention.
  • Fig. 2 shows a side view of the suction head (7).
  • Fig. 3 shows the control device (4).
  • FIG. 4 shows the suction head (7) from FIG. 2 from above.
  • 5A + B shows the tissue or organ (10) sucked into the device according to the invention, the attachment detection device (12) optical detection means, in the form of intrusion detection means, e.g. in the form of a light barrier (13a) and / or endoscope (13b).
  • Fig. 6 shows the suction head (7) with an ultrasonic transmitter and receiver (14) as a detection means.
  • 7 shows a complete exemplary embodiment which can be used in the patient and has a rigid guide body.
  • Fig. 8 shows the (replaceable) head part of an embodiment with a flexible guide body.
  • Fig.1 shows all components of the device according to the invention.
  • the guide body (6) with the penetrating body (1), e.g. a needle, scissors, pliers or electrode or other manipulating body, the control device (4) for the penetrating body ends at its proximal end with a suction head (7).
  • the vacuum source (5), the attachment detection device (12) and the display device (16) are connected to the device.
  • the attachment detection device (12) and the display device (16) are connected to the device.
  • Attachment detection device (12) has a pressure sensor (15), with the aid of which attachment is recognized.
  • the guide body (6) has a distal and a proximal end.
  • the suction head (7) is located at its proximal end.
  • the suction head (7) has a recess (2) with a lateral opening into which the tissue or organ to be punctured is sucked.
  • the pressure sensor can be arranged inside the suction head (7), inside the vacuum source (5) or at any point of the vacuum channel between the suction head (7) and the vacuum source (5).
  • the penetrating body (1) In order to enable the puncture or other manipulation (e.g. radiation), the penetrating body (1), e.g. be advanced, pushed back and rotated by means of a control device (4) in the direction of its longitudinal axis within the guide body (6).
  • the penetrating body e.g. be advanced, pushed back and rotated by means of a control device (4) in the direction of its longitudinal axis within the guide body (6).
  • a locking device is provided which prevents the penetrating
  • the penetrating body (1) can be inserted into the tissue to reliably detect the attachment of the tissue or the organ.
  • the locking device can be in the form of a simple mechanical device, for example in the form of a clamp.
  • a continuously suction pump (without readjustment of the pressure when there is a change in pressure) or a vacuum source that works continuously with constant power is preferably used as the vacuum source (5) in order to compensate for any leaks during attachment.
  • the attachment is recognized by prior calibration or calibration using pressure measurement with the suction head closed.
  • a pressure-dependent detection means e.g. a pressure sensor (15) measures the changes in pressure. It is preferably located outside the device according to the invention, the measuring line having a minimal dead space volume.
  • the pressure sensor (15) has a high temporal resolution in order to be able to register the pressure changes. As long as there is no attachment, the vacuum source is released. An increase in the negative pressure indicates that the tissue or organ (10) to be punctured lies at the vacuum opening (11) in the suction head (7), which is the prerequisite for successful manipulation. This can be detected by various means using an attachment detection device (2).
  • All signals which are detected by detection means e.g. Pressure, light (see Fig. 5) etc., converted into display signals. These can be a light, an acoustic, an odor or a taste signal or a tactile signal.
  • Fig. 2 shows - in a side section - the suction head (7) with a penetrating body, for example a needle (1), which by means of a control device (4) in its longitudinal axis can be pushed forward, pushed back and turned and locked.
  • the recess with the lateral opening (2) in the suction head (7) is elongated in this embodiment.
  • the proximal end of the suction head (7) is designed obliquely.
  • the vacuum opening (11) in the suction head (7) completely encompasses the puncture needle.
  • the vacuum channel within the guide body (6) tapers preferably on the way to the vacuum opening (11) in the suction head (7). In addition to the vacuum opening (11), there may be further vacuum openings in the suction head.
  • Fig. 3 shows the control device (4) e.g. in the form of a one-piece bracket, with the aid of which the penetrating body (1) is advanced, pushed back and rotated or also locked.
  • a simple clamping is provided as a locking device.
  • the control device (4) is pushed into a tapering slot of the guide body (6) until it is clamped.
  • Fig. 4 shows the suction head (7) with a penetrating body, e.g. a needle (1), from Fig.2 from above.
  • 5 shows the tissue or organ (10), which by means of
  • the attachment detection device (12) being an optical detection means, e.g. has a light barrier (13a).
  • the tissue (10) is sucked into the recess (2) by means of a vacuum source (5), the attachment of which is detected by a light barrier (13a).
  • a light barrier 13a
  • FIG. 6 shows the suction head (7), the attachment of the tissue or organ (10) sucked into the recess (2) using an ultrasound sensor and a reflector or an ultra- sound transmitter and receiver (14) is detected, which has the attachment detection device (12) as detection means.
  • ultrasound is transmitted by an ultrasound transmitter and received by an ultrasound receiver. As soon as the tissue or organ gets between these two, the intensity of the received signal is changed.
  • Fig. 7 shows a further embodiment with a rigid guide body (6).
  • the guide body has, in addition to the lumen for guiding the penetrating body (1) and for conveying the negative pressure to the suction head (7), a further bore or a further lumen in order to have an endoscope (13b) as an optical attachment detection means to take.
  • This additional hole is shown in the upper drawing above.
  • the lumen for guiding the penetrating body and for conveying the negative pressure between the suction head and the additional pressure-dependent detection means (not shown) provided here is located underneath and has its exit at the identification “5/12”.
  • the endoscope can advantageously also be used for detection the optimal attachment parts are used.
  • the (middle) sub-picture below shows a connecting part (27) which connects the guide body (6) to the control device (4) for the penetrating body (1).
  • the connecting part (27) is designed to maintain and convey a negative pressure between the suction head and the negative pressure source and is preferably repeatably removable from the guide body and, in a particularly preferred embodiment (not shown), has adapters for attaching negative pressure hoses (below) and
  • Optical fibers for the optical detection means in the form of a light barrier or an endoscope which is known to consist essentially of optical fibers.
  • An exemplary embodiment of a control device (4) is shown in the lower partial image.
  • the penetrating body (1) is connected to a guide shaft (25) or a guide wire (28), the control device (4) being otherwise provided with a guide part (17) for rotary movements and various stop and guide screws (18 , 19, 20, 23, 24) with seals (21), for example made of silicone and with a pressure roller (22), so that the penetrating body (1) can be pushed back and forth approximately parallel to the guide body and rotated ,
  • the attachment detection means are in the form of means for detecting the pressure or pressure changes
  • the control device (4) must be coordinated with the pressure-sensitive detection means in such a way that the movement of the penetrating body results in only slight pressure changes, so that none "False positive" attachment is displayed.
  • FIG. 8 shows the (exchangeable) head part of an exemplary embodiment with a flexible guide body using a controllable endoscope, in which a pressure-dependent detection means and an optical detection means (in this case an endoscope (13b)) are used.
  • a pressure-dependent detection means and an optical detection means in this case an endoscope (13b)
  • Exemplary embodiments for the penetrating body are (Fig. 8B) a screw electrode, (Fig. 8C) scissors and (Fig. 8D) a needle.
  • a stiff tissue (10) is only attached to the head in a controlled manner for manipulation.
  • an elastic tissue is attached to the recess, the penetrating body being a needle, e.g. for access to the pericardium.
  • the guide body in addition to the lumen for conveying the negative pressure between the source and the suction head and the lumen for guiding the optical detection means of an endoscope (13b) has a further lumen for guiding a further penetrating body (in the exemplary illustration a screw electrode).
  • a further penetrating body in the exemplary illustration a screw electrode.
  • the third lumen (for guiding a further penetrating body) can of course also be provided within a second guiding body which is detachably connected to the first.
  • Such optical means e.g. in the form of optical fibers, in which the optical materials have electrical conductivities, so that electrical monitoring and identification of the adhering tissue is possible in parallel with the optical monitoring of the attachment.
  • the simplest form is by attaching electrodes that penetrate the tissue easily. By applying a voltage and a subsequent impedance measurement between the electrodes (in the form of easily penetrating bodies), an identification of the attached tissue is then easily possible.
  • Very simple, non-penetrating electrodes can of course also be used as the detection means. Identification of tissue using electrical or combined electrical and optical measurements is then possible both with the penetrating and non-penetrating electrodes. of impedance difference can be recognized. It is also possible to monitor organ functions with electrical detection means or with penetrating electrodes if they send out or require electrical signals.
  • the display device is an optical display means has, for example LEDs, with the aid of which the signal from the attachment detection device (12) is converted into an optical signal.
  • a sound source is provided as the display means.
  • the signal from the attachment detection device (12) is converted into an acoustic signal, a higher voltage corresponding, for example, to a higher or louder tone.
  • the advantage is that the examiner is not distracted by observing the pressure meter, in the event that a pressure sensor is provided as the detection means. The same is achieved if, for example, a vibrator (tactile signal) is used as the display device.
  • Penetrating body e.g. needle
  • 'needle not visible
  • recess

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne un dispositif servant à ponctionner ou à manipuler un tissu humain ou animal, tout en permettant de détecter et de signaler si le tissu est bien attaché. En particulier, le dispositif selon l'invention permet l'accès dans le péricarde après avoir percé ce dernier. Le dispositif selon l'invention peut être utilisé pour tout tissu ou organe humain ou animal, principalement dans le cadre d'une chirurgie minimale invasive, pour laquelle il n'existe aucun contrôle visuel direct et où l'on doit s'assurer qu'un tissu ou organe destiné à être manipulé sur un dispositif spécial est bien attaché, par exemple, à un dispositif à ponctionner. L'invention n'est pas limitée à un tissu ou organe vivant.
EP04762651A 2003-08-14 2004-08-12 Dispositif destine a la manipulation de tissus et d'organes Withdrawn EP1653867A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10337813A DE10337813A1 (de) 2003-08-14 2003-08-14 Vorrichtung für eine Gewebe- und Organmanipulation
PCT/DE2004/001806 WO2005016157A1 (fr) 2003-08-14 2004-08-12 Dispositif destine a la manipulation de tissus et d'organes

Publications (1)

Publication Number Publication Date
EP1653867A1 true EP1653867A1 (fr) 2006-05-10

Family

ID=34177659

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04762651A Withdrawn EP1653867A1 (fr) 2003-08-14 2004-08-12 Dispositif destine a la manipulation de tissus et d'organes

Country Status (4)

Country Link
US (1) US20070198041A1 (fr)
EP (1) EP1653867A1 (fr)
DE (1) DE10337813A1 (fr)
WO (1) WO2005016157A1 (fr)

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WO2008118737A1 (fr) 2007-03-22 2008-10-02 University Of Virginia Patent Foundation Cathéter à électrode permettant d'effectuer une ablation et procédé associé
EP2134253B1 (fr) 2007-03-19 2022-01-26 University Of Virginia Patent Foundation Dispositif de détection par pression pour aiguille d'accès
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Also Published As

Publication number Publication date
US20070198041A1 (en) 2007-08-23
DE10337813A1 (de) 2005-03-10
WO2005016157A1 (fr) 2005-02-24

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