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WO2006131388A1 - Materiel de biopsie - Google Patents

Materiel de biopsie Download PDF

Info

Publication number
WO2006131388A1
WO2006131388A1 PCT/EP2006/005545 EP2006005545W WO2006131388A1 WO 2006131388 A1 WO2006131388 A1 WO 2006131388A1 EP 2006005545 W EP2006005545 W EP 2006005545W WO 2006131388 A1 WO2006131388 A1 WO 2006131388A1
Authority
WO
WIPO (PCT)
Prior art keywords
slider
pin
mandrel
coupling
slit
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.)
Ceased
Application number
PCT/EP2006/005545
Other languages
English (en)
Inventor
Armando Belluomo
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.)
H S Hospital Service SpA
Original Assignee
H S Hospital Service SpA
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 H S Hospital Service SpA filed Critical H S Hospital Service SpA
Publication of WO2006131388A1 publication Critical patent/WO2006131388A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms

Definitions

  • the present invention relates to a biopsy device, of the so-called “guillotine” type, namely a device for taking samples of organic tissue, in particular for the diagnosis and the treatment of tumours or other pathologies .
  • biopsy devices are known of the so-called "guillotine" type, consisting of a substantially cylindrical mandrel, near the tip of which a housing is obtained, - for example obtained by making a flattening along a portion of the mandrel - suitable for receiving the sample to be taken, and of a hollow needle with a cutting tip, slidingly coupled externally to said spindle.
  • the housing has dimensions that are such as to receive a sample of tissue of sufficient size for the histiological examinations to be conducted thereupon.
  • the device In order to conduct the biopsy, the device is introduced into the body of the patient, with the mandrel retracted inside the hollow needle so that only the tip thereof protrudes.
  • the mandrel When the tip of the mandrel has reached the zone of the body of the patient from which the sample has to be taken the mandrel is made to emerge from the needle by reciprocal axial sliding. In this way a portion of the tissue surrounding the mandrel penetrates the housing obtained on the mandrel.
  • the hollow needle is moved until it covers said housing in such a way that the cutting tip of the hollow needle separates, with a guillotine action, the portion of tissue that has penetrated into the aforementioned housing from the surrounding area.
  • Biopsy devices are known in which the movements of the mandrel and of the hollow needle are achieved through thrust means, for example elastic thrust means, that is operatable by the operator.
  • a biopsy device comprising a case provided with a hole that extends along a longitudinal axis of the casing and a track that extends parallel to the hole and along which a proximal slit and a distal slit are made in the wall of the casing, which are parallel to said longitudinal axis.
  • the device furthermore comprises a mandrel that is provided, near a tip thereof, with a housing for receiving a tissue sample, and a hollow needle, or cannula, that is coaxial to the spindle and is slidable upon it and inside said longitudinal hole; a guiding element is slidingly coupled in the aforementioned track and is provided with a longitudinal proximal slit provided with a notch at an end thereof and a longitudinal distal slit, which is also provided with a notch at an end thereof; the mandrel is provided with a guiding pin for coupling with the guiding element, the guiding pin extending in a direction that is perpendicular to the longitudinal axis of the mandrel through the proximal slit of the casing and the proximal slit of the guiding element; the hollow needle is also provided with a guiding pin that extends in a direction perpendicular to the longitudinal axis of the needle through the distal slit of the casing and the dis
  • Manoeuvring the guiding element by the operator may be difficult with the risk of diverting the tip of the mandrel from the point in which it was inserted.
  • biopsy devices which are also called “biopsy guns", in which the movements of the mandrel and of the cannula are obtained by means of elastic elements, such as, for example, springs.
  • biopsy guns in which the movements of the mandrel and of the cannula are obtained by means of elastic elements, such as, for example, springs.
  • These devices are in general very complex and cumbersome, not easy to handle and to drive .
  • the object of the present invention is to provide a biopsy device in which the advance of the mandrel and of the hollow needle are controlled automatically, that is relatively easy to construct and easy to handle and drive.
  • a biopsy device comprising a mandrel provided at a distal end thereof with a seat for receiving a sample of tissue, a hollow needle arranged concentrically outside said spindle, said spindle and said hollow needle being movable with respect to one another in a direction that is substantially parallel to the respective longitudinal axes, characterised in that said spindle and said hollow needle are drivable to slide in said direction through automatic driving means, said automatic driving means shifting in sequence first the mandrel and, subsequently, the hollow needle between a respective first position and a respective second position.
  • the steps for conducting a biopsy are conducted automatically, the only task that the operator conducting the biopsy has to perform is to activate the automatic driving means. This enables the operator to be able to easily maintain the device in the correct position whilst conducting the biopsy, not having to perform manual tasks to make the needle and the cannula advance .
  • Figure 1 is a longitudinal section of a device according to the invention, in a first operating position
  • Figure 2 is a detail of Figure 1;
  • Figure 3 is a longitudinal section of a device according to the invention, in a second operating position;
  • Figure 4 is a detail of Figure 3;
  • Figure 5 is a longitudinal section of a device according to the invention, in a third operating position;
  • Figure 6 is a detail of Figure 5 ;
  • Figure 7 is a raised side view of a device according to the invention, without spindle and hollow needle;
  • Figure 8 is the view from the right of Figure 7;
  • Figure 9 is a view like the one in Figure 7, from the side opposite the one in Figure 7 ;
  • Figure 10 is a view from the right of Figure 9;
  • Figure 11 is the enlarged section XI-XI of Figure 7 ;
  • Figure 12 is a longitudinal section of a support and guide element of the spindle and of the hollow needle
  • Figure 13 is a longitudinal section of the upper part of the support and guide element of the Figure 12;
  • Figure 14 is a longitudinal section of the lower part of the support and guide element of Figure 12 ;
  • Figure 15 is a view from above of the support and guide element in Figure 12;
  • Figure 16 is the section XVI-XVI of Figure 15;
  • Figure 17 is a view from below of the support and guide element in Figure 12 ;
  • Figure 18 is the section XVIII-XVIII of figure 17;
  • Figure 19 is a plan view of a driving element of the mandrel and of the hollow needle
  • Figure 20 is a longitudinal section of the driving element of Figure 19;
  • Figure 21 is a view like the one in Figure 15, with the driving element inserted into the support and guide element, in a first operating condition;
  • Figure 22 is a view like the one in Figure 21, with the driving element in a second operating condition
  • Figure 23 is a view like the one in Figure 21, with the driving element in a third operating condition
  • Figure 24 is a view like the one in Figure 2, in which the position of the driving element has been highlighted;
  • Figure 25 is a view like the one in Figure 4, in which the position of the driving element has been highlighted;
  • Figure 26 is a view like the one in Figure 6, in which the position of the driving element has been highlighted;
  • Figure 27 is a raised view of a slide that drives the driving element of the mandrel and of the hollow needle;
  • Figure 28 is a view like the one in Figure 27, but on the opposite side of the slide means.
  • FIG. 1 shows a device according to the invention, comprising an internally hollow body 2, in the upper part of which through a movable cover 2a, a support and guide element 3 is insertable with which a mandrel 4 and a hollow needle or cannula 5 are slidingly coupled, the cannula 5 being externally coaxial to the mandrel 4.
  • the mandrel 4 is fixed, at a proximal end thereof to a first slider 6 that is slidable inside the support and guide element 3.
  • the first slider 6 is provided with an upper guiding pin 7, slidingly coupled in a first longitudinal slit 8 made in the upper part 9 of the support and guide element 3, and with a lower pin 10, slidingly coupled in a second longitudinal slit 11, made in the lower part 12 of the support and guide element 3.
  • the cannula 5 is fixed, at a proximal end thereof, to a second slider 13, that is slidable inside the support and guide element 3.
  • the second slider 13 is provided with an upper guiding pin 14 slidingly coupled in a third longitudinal slit 15, made in the upper part 9 of the support and guide element 3 , aligned with the first slit 8, but separated from it.
  • the second slider 13 is furthermore provided with a lower pin 16 slidingly coupled in said second longitudinal slit 11.
  • the lower pin 10 of the first slider 6 and the lower pin 16 of the second slider 13 are coupled with a driving element 17 (Figures 19 e 20) slidingly coupled with the lower part 12 of the support and guide element 3.
  • the driving element 17 is provided, at the proximal end thereof, with a recess 18, intended to be coupled with the lower pin 10 of the first slider 6.
  • the entrance 19 to the recess 18 has a width that is less than the diameter of said lower pin 10, so that the latter can enter and exit the recess 18 only through forcing.
  • the driving element 17 is furthermore provided with a hole 20 intended to be coupled with a dragging pin that will be disclosed below.
  • the driving element 17 is provided with a longitudinal groove 21, in which it is intended to slidingly couple the lower pin 16 of the second slider 13.
  • the recess 18, the hole 20 and the groove 21 are aligned along the longitudinal axis of the dragging element 17.
  • the groove 21 is provided, near a proximal end 23 thereof, with a narrowing 22 having a lesser width than the diameter of said lower pin 16, so that the lower pin 16 can be retained at the proximal end of the groove 21.
  • the dragging element 17 is driven by a slide 24 that is slidable on a shaft 25 and is provided with a pin 26 that protrudes above from the slide 24 and is suitable for engaging in the hole 20 of the dragging element 17 for moving it in a direction parallel to the longitudinal axis of the device 1.
  • the slide 24 is coupled with a spring 24a that opposes the movement of the slide 24, when the latter is moved from a distal end-of-stroke position shown in Figure 5, to a proximal end-of-stroke position, shown in Figure
  • Dragging of the first slider 5 by the dragging element 17 is ensured by the fact that the lower pin 10 of the first slider 5 is inserted into the proximal end 23 of the groove 21 of the dragging element 17 and cannot emerge from said end through the effect of the narrowing 22.
  • the first slider 6 When the slide 24 reaches an intermediate position, shown in Figure 3, the first slider 6 reaches the proximal end-of- stroke position, with the upper pin 7 at the proximal end of the first slit 8. In this position, the hollow needle 5 leaves a distal end portion of the mandrel 4 uncovered, in which a seat 4a is obtained that is intended to receive a sample of organic tissue ( Figure 4). If the slide 24 is moved to the proximal end-of-stroke position, the lower pin 10 of the first slider 6 is forced to pass through the narrowing 22 and can then slide freely- inside the slit 21. Simultaneously, the lower pin 16 of the second slider 13 engages in the seat 18 obtained at the proximal end of the driving element 17, crossing the narrowing 19.
  • the second slider 13 is then dragged by the driving element 17, thus following the movement of the slide 24, until it reaches the proximal end-of-stroke position.
  • the movement of the second slider 17 causes the mandrel 4 to be withdrawn inside the hollow needle 5, from which, at the end, only the the tip of the mandrel 4 protrudes, whilst the seat 4a is completely inside the hollow needle 5.
  • the spring 24a is loaded. In this condition, the device according to the invention is arranged for conducting a biopsy, as will be disclosed below.
  • the dragging slide 24 is provided with a longitudinal through hole 24b in which it couples the shaft 25 with play; furthermore, on each of the sides 27, 28 thereof parallel to the longitudinal axis of the shaft 25, the slide 24 is provided with a respective slit 29, 30 that extends in a direction substantially parallel to said longitudinal axis.
  • the upper side 31 of the slit 29 and the lower side 32 of the slit 30 are shaped as a cam profile.
  • the shaft 25 is provided with a transverse pin 33 that, during sliding of the slide 24 engages, with the ends thereof, the cam profiles 31 and 32.
  • This rotation can be obtained by acting on a second pin 36 that protrudes from the proximal end of the shaft 25, in a direction substantially perpendicular to both the axis of the shaft 25 and the pin 33.
  • an operating stem 37 acts that is arranged perpendicularly to the pin 36 and is drivable by means of a pushbutton 38. By pressing the pushbutton 38 the operating stem 37 pushes the pin 36 causing rotation of the shaft 33 around the longitudinal axis thereof.
  • a locking device consisting of a pawl 39 that can rotate around an axis 40 parallel to the longitudinal axis of the shaft 25 and is driven by a lever 41.
  • the pawl 39 is movable between an active position in which it prevents rotation of the pin 36 and therefore of the shaft 25 and a neutral position in which it does not interfere with the pin 36.
  • the rotation of the shaft 25 for disengaging the ends of the pin 33 from the cam profiles 31 and 32 can also be obtained by means of a lever 42 that acts on the distal end of the shaft 25.
  • the slide 24 can be driven to run along the shaft 25 to load the spring 24a by means of a slider 43 that is slidable in the lower part of the body 2.
  • the slider 43 is provided, at the distal end thereof with a lever 44 pushed upwards by a spring 45 and suitable for engaging in seats 46, 47 obtained in the lower part of the slide 24.
  • a first seat 46 is used for sliding the slide from the distal end-of-stroke position to the intermediate position whereas the second seat 47 is used to slide the slide 24 from the intermediate position to the proximal end-of-stroke position.
  • the slider 43 is provided with a recess 48 and with a protrusion 49 for facilitating the driving of the slider by an operator.
  • the zone of the slider 43 in which the recess 48 and the protrusion 49 are obtained is accessible from outside the body 2 through a window 50 made in the lower part of the body 2.
  • the operator acts on the slider 43 to move the slide 24 from the distal end-of-stroke position to the proximal end-of-stroke position, in which the hollow needle 5 covers the mandrel 4 leaving only the tip of the mandrel 4 ( Figure 1) protruding therefrom.
  • the operator introduces the spindle and the cannula into the body of the patient until it reaches the zone in which the biopsy has to be carried out.
  • the hollow needle 5 is made to advance covering again the flattening 4a and separating from the surrounding tissue the portion of tissue that had penetrated the aforementioned flattening.
  • the materials, the dimensions and the constructional details may be different from those indicated but be technically equivalent thereto without falling outside the realm of legal protection of the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un matériel (1) de biopsie qui comporte un mandrin (4) situé à son extrémité distale, avec un siège (4a) pour recevoir un échantillon de tissu, une aiguille creuse (5) disposée concentriquement à l'extérieur dudit mandrin (4), ledit mandrin (4) et ladite aiguille creuse (5) étant mobiles l'un par rapport à l'autre dans un sens qui est sensiblement parallèle à leurs axes longitudinaux respectifs, ledit mandrin (4) et ladite aiguille creuse (5) pouvant être entraînés pour glisser dans ledit sens par un moyen d'entraînement automatique (17, 24, 24a), ledit moyen d'entraînement automatique (17, 24, 24a) entraînant consécutivement à la fois le mandrin (4) et l'aiguille creuse (5).
PCT/EP2006/005545 2005-06-10 2006-06-09 Materiel de biopsie Ceased WO2006131388A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMO2005A000143 2005-06-10
IT000143A ITMO20050143A1 (it) 2005-06-10 2005-06-10 Dispositivo per biopsia.

Publications (1)

Publication Number Publication Date
WO2006131388A1 true WO2006131388A1 (fr) 2006-12-14

Family

ID=36922078

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/005545 Ceased WO2006131388A1 (fr) 2005-06-10 2006-06-09 Materiel de biopsie

Country Status (2)

Country Link
IT (1) ITMO20050143A1 (fr)
WO (1) WO2006131388A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0429390A1 (fr) * 1989-11-24 1991-05-29 Medical Device Technologies, Inc. Appareil jetable pour la biopsie de tissus mous
EP0448222A1 (fr) * 1990-03-16 1991-09-25 Ryder International Corporation Instrument pour prélever des échantillons de tissu
US5507298A (en) * 1994-09-23 1996-04-16 M3 Systems, Inc., D/B/A/ Manan Medical Products, Inc. Forward-fired automatic tissue sampling apparatus
US5538010A (en) * 1994-10-05 1996-07-23 Proact Ltd. Biopsy needle device
EP0925759A2 (fr) * 1997-12-26 1999-06-30 Mitaka Kohki Co., Ltd. Dispositif de biopsie et dispositif de commande à distance associé
US5993399A (en) * 1996-07-31 1999-11-30 C.R. Bard, Inc. Automated tissue sampling device
US20040068231A1 (en) * 2002-10-03 2004-04-08 Jerome Blondeau Device for taking a sample from a body
US20040249278A1 (en) * 2003-06-04 2004-12-09 Krause William R. Biopsy and delivery device

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0429390A1 (fr) * 1989-11-24 1991-05-29 Medical Device Technologies, Inc. Appareil jetable pour la biopsie de tissus mous
EP0448222A1 (fr) * 1990-03-16 1991-09-25 Ryder International Corporation Instrument pour prélever des échantillons de tissu
US5507298A (en) * 1994-09-23 1996-04-16 M3 Systems, Inc., D/B/A/ Manan Medical Products, Inc. Forward-fired automatic tissue sampling apparatus
US5538010A (en) * 1994-10-05 1996-07-23 Proact Ltd. Biopsy needle device
US5993399A (en) * 1996-07-31 1999-11-30 C.R. Bard, Inc. Automated tissue sampling device
EP0925759A2 (fr) * 1997-12-26 1999-06-30 Mitaka Kohki Co., Ltd. Dispositif de biopsie et dispositif de commande à distance associé
US20040068231A1 (en) * 2002-10-03 2004-04-08 Jerome Blondeau Device for taking a sample from a body
US20040249278A1 (en) * 2003-06-04 2004-12-09 Krause William R. Biopsy and delivery device

Also Published As

Publication number Publication date
ITMO20050143A1 (it) 2006-12-11

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