WO2002078560A1 - Methode et moyens permettant de localiser et d'indiquer une lesion non palpable dans des tissus mous - Google Patents

Methode et moyens permettant de localiser et d'indiquer une lesion non palpable dans des tissus mous Download PDF

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Publication number
WO2002078560A1
WO2002078560A1 PCT/IB2002/000926 IB0200926W WO02078560A1 WO 2002078560 A1 WO2002078560 A1 WO 2002078560A1 IB 0200926 W IB0200926 W IB 0200926W WO 02078560 A1 WO02078560 A1 WO 02078560A1
Authority
WO
WIPO (PCT)
Prior art keywords
tip
needle
soft tissue
lesion
means according
Prior art date
Application number
PCT/IB2002/000926
Other languages
English (en)
Inventor
Jacopo Nori
Original Assignee
H.S. Hospital Service S.P.A.
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 S.P.A. filed Critical H.S. Hospital Service S.P.A.
Publication of WO2002078560A1 publication Critical patent/WO2002078560A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3908—Soft tissue, e.g. breast tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3987—Applicators for implanting markers

Definitions

  • the present invention relates to a method and means for identifying and indicating lesions in soft tissue, in particular non-palpable breast lesions.
  • identifying and indicating non- palpable lesions in soft tissue by inserting a cannula needle, i.e. a hollow needle, into the tissue and identifying the position of the needle through known display techniques such as mammography, radiography, etc.
  • a metal wire is fed through the needle until the wire reaches the previously identified lesion and the metal wire is left in position whereas the cannula needle is extracted, whereby the wire is a reference for a surgeon, who must then operate on the lesion.
  • the end of the wire in contact with the identified lesion generally has fixing means which remain fixed to the tissue in the zone of said lesion.
  • This system has the drawback that the wire may break or be moved due to movements of the patient's body which cause the tissue to move in the zone in which the wire was inserted thus making said wire useless as a reference.
  • the metal wire inside the soft tissue may be made visible by mammography but cannot be detected by other types of examination such as echography or magnetic resonance . This makes the use of the metal wire as a reference not very versatile.
  • the metal wire is disagreeable to the patient and for this reason it can be left in position only for short periods; the metal wire therefore has to be inserted only shortly before a surgical intervention.
  • Another system used to indicate a lesion identified in soft tissue provides progressively extracting a hollow needle and simultaneously injecting a preparation containing sterile carbon, after identification of the lesion and positioning of a hollow needle with its tip in the lesion.
  • the sterile carbon injected along the needle route as far as the identified lesion helps the surgeon to more easily visually identify the route to follow to surgically reach said lesion. Marking with sterile carbon, has the advantage of remaining for a long time and of not causing the patient discomfort, so that it can be carried out considerably in advance of the surgeon' s intervention.
  • marking with active carbon is visible only to the naked eye and cannot be detected through imaging methods such as mammography, echography, magnetic resonance, etc.
  • imaging methods such as mammography, echography, magnetic resonance, etc.
  • active carbon when active carbon is injected great care has to be taken to inject it uniformly, whilst the cannula needle is being withdrawn, to avoid the risk that a major portion of the route of the cannula needle is not marked with the active carbon, which would make the marking substantially unusable.
  • Tecnezio radiological contrast means
  • This system involves numerous organisational problems inasmuch as Technezio has to be injected shortly before the surgical intervention and also requires close coordination between the department of Nuclear Medicine and the departments of Radiology and Surgery. This system cannot therefore be used if a certain time, for example, a few days, must elapse between marking and the surgical intervention.
  • Tecnezio marking can be detected only by an appropriate probe but cannot be seen with the naked eye or with imaging methods.
  • the object of the present invention is to provide a method and means for identifying non-palpable lesions in soft tissue which enable certain identification and marking of said lesion which is clear, lasting, visible to the naked eye and which can be detected by any imaging method.
  • a method for identifying and indicating a non-palpable lesion in soft tissue comprising inserting a hollow needle into said soft tissue, identifying the position of the needle in said soft tissue, further inserting said needle until the tip of the needle reaches said lesion, extracting the needle from said soft tissue, injecting marker means, during said extraction, characterised in that said marker means comprise a macromolecular substance detectable by echography or magnetic resonance.
  • means for identifying and indicating a non-palpable lesion in soft tissue comprising marker means injectable into said soft tissue along a route leading to said lesion, characterised in that said marker means comprise a macromolecular substance detectable by echography or magnetic resonance.
  • the marker means can also comprise a colouring substance such as active carbon and/or contrast means which can be detected by radiological examination.
  • a durable trace is left along the route of the needle through the tissue to the zone affected by the lesion, in particular due to the presence of the colouring means and the macromolecular substance, said trace being detectable both by the naked eye and by all imaging methods.
  • a needle usable for identifying and indicating a non-palpable lesion in soft tissue comprising an internally hollow cylindrical body, characterised in that said hollow cylindrical body ends in a tip which is releasably connected to the hollow cylindrical body and is provided with fixing means suitable for being fixed onto said soft tissue.
  • the needle according to the invention significantly facilitates execution of the so-called sentinel lymph node technique which is used in surgical interventions on breast tumours in women.
  • This technique consists of injecting, before the surgical intervention, contrast means which can be detected radiologically, for example a Tecnezio solution, on the tumour lesion to identify, by means of a mammoscintigraphy, the axillary lymph node through which the tumour is drained. After identifying the lymph node, the surgeon removes it so that it can be analysed in order to identify the type of tumour and to decide whether the other axillary lymph nodes have to be removed too.
  • contrast means which can be detected radiologically, for example a Tecnezio solution
  • the use of the needle according to the invention enables the removable tip of the needle to be left inside the lesion when the breast lesion is identified because when the needle is removed from the patient' s body the tip has been positioned inside said lesion and the fixing means of the tip of the needle ensure that the tip remains fixed to the tissue and detaches itself from the needle when the needle is extracted, said tip thus remains inside the patient' s body at the identified lesion and thus acts as an accurate reference for injection of the radiological contrast means when the sentinel lymph node technique is carried out.
  • Figure 1 is a longitudinal schematic section of a needle according to the invention:
  • Figure 2 is a section like the one of Figure 1, which shows the tip detached from the body of the needle;
  • Figure 3 is a section like the one of Figure 2, which shows a variation of the needle according to the invention
  • Figure 4 is a longitudinal schematic section like the one of Figure 1, which shows a construction variation of the tip of the needle according to the invention
  • Figure 5 is a section like the one of Figure 4, which shows the tip detached from the body of the needle;
  • Figure 6 is a section like the one of Figure 3 which shows the application of said construction variation of the tip of the needle to the variation of the needle shown in Figure 3.
  • the method for identifying and indicating a non-palpable lesion in soft tissue comprises inserting a hollow needle into said soft tissue, identifying the position of the needle in said soft tissue, further inserting said needle until the tip of the needle reaches said lesion, extracting the needle from said soft tissue, during said extracting the needle, injecting marker means which comprise a macromolecular substance detectable by echography or magnetic resonance.
  • the macromolecular substance is preferably a synthetic human albumen.
  • the colouring means may be sterile carbon.
  • the marker means may also comprise contrast means which can be detected radiologically.
  • a macromolecular substance in said marker means possibly in conjunction with a colouring substance and contrast means which can be detected radiologically, enables certain identification of the route which the surgeon has to follow to reach said lesion.
  • the macromolecular substance in fact leaves a durable trace along the route of the needle inserted as far as the zone of said lesion, which trace can easily be detected by imaging methods such as echography and magnetic resonance.
  • said route can be easily seen, also because the macromolecular substance facilitates the persistence of the colouring substance along said route.
  • said marker means also comprise contrasting means which can be detected radiologically said route can, if necessary, be detected by a radiological examination.
  • a needle is shown which can be used to carry out the method according to the invention and which is particularly suitable for performing the sentinel lymph node technique, described above.
  • the reference 1 indicates the hollow cylindrical body of the needle according to the invention ending in a tip 2 comprising a shank 3 suitable for being inserted into the cavity 4 of the cylindrical body 1.
  • the shank 3 comprises a cavity 5, communicating, at one end thereof, with the cavity 4 of the cylindrical body 1 and, at the other end, with the inside of the tip 2, said tip being also hollow.
  • the tip 2 comprises holes 6 which enable the hollow interior of the tip 2 to communicate with the exterior.
  • the tip 2 also has fixing means comprising elastic tabs 7 which are connected at one end thereof to the side surface of the tip 2. When the needle is inserted into soft tissue inside the patient's body the elastic tabs 7 are compressed by said tissue against the side surface of the tip 2 of the needle.
  • the tabs 7 fix onto the surrounding tissue and are spread out towards the exterior to prevent the tip 2 from being extracted together with the needle.
  • the shank 5 of the tip 2 is extracted from the cavity 4 of the cylindrical body 1 and the tip 2 separates from the cylindrical body 1 and remains trapped inside the patient' s body in the position in which it was inserted.
  • FIG 3 a variation of the needle according to the invention is shown, in which a tube 8, preferably in radioopaque material, is associated to the shank 5 of the tip 2.
  • a tube 8 preferably in radioopaque material
  • the length of the tube 8 is such that after the body 1 of the needle has been extracted from the patient's body an end of the tube 8 protrudes and can be used to inject, for example, contrast means which can be detected radiologically for performing the sentinel lymph node technique, at the tumour lesion in which the tip 2 of the needle has been inserted.
  • the tip 2 of the needle is preferably made with biologically compatible material, i.e. with a material which does not cause undesirable irritations or allergic reactions with the patient's tissues; e.g. the tip 2 of the needle can be made from a titanium steel alloy known under the commercial name "Nitinol" or from AINSI 304 biocompatible steel alloy.
  • the tip 2a of the needle is shown. According to this construction variation, the internally hollow tip 2a has elastic tabs 7a which are fixed at one end thereof to the base of the tip 2a.
  • tip 2a has holes 6, which enable the hollow interior of the tip 2 to communicate with the exterior.
  • the tip 2a can be released from the body 1 by pushing the tip 2a out of the body 1 through pusher means (not shown) insertable into said cavity 4. Owing to the thrust exerted on the tip 2a by said pushing means the tabs 7 protrude from the cavity 4 and elastically separate as shown in Figure 4 so anchoring the tip 2a to the surrounding tissue.
  • a needle according to the invention having a tip 2a, to the base of which a tube 8 in radioopaque material is fixed as already described with reference to Figure 3.
  • the tube 8 communicates with the hollow interior of the tip 2a and can also be used as a pusher to separate the tip 2a from the body 1 of the needle, after the latter has been inserted into the body of the patient.
  • the needle according to the invention can also be used, as it has already been said, to mark the route for reaching the tumour lesion.
  • the tip 2, 2a of the needle inserted into the patient's body has reached the zone affected by the tumour lesion
  • extraction of the body 1 of the needle is started and simultaneously the marker means are injected according to the invention.
  • said marker means can also be injected through a common hypodermic needle after the tip of the needle has reached the tumour lesion and during extraction of the needle.

Abstract

L'invention concerne une méthode conçue pour identifier et d'indiquer une lésion non palpable dans un tissu mou et consistant à injecter des moyens de marquage dans ledit tissu au moyen d'une aiguille creuse selon une trajectoire menant à ladite lésion, lesdits moyens de marquage comprenant une substance macromoléculaire détectable par échographie ou résonance magnétique. L'invention se rapporte également à des moyens destinés à identifier et indiquer une lésion non palpable dans un tissu mou et comportant des moyens de marquage injectables dans ledit tissu mou selon une trajectoire menant à ladite lésion, lesdits moyens de marquage comprenant une substance macromoléculaire détectable par échographie ou résonance magnétique. L'invention concerne en outre des moyens permettant d'identifier et d'indiquer une lésion non palpable dans un tissu mou, lesquels moyens comprennent des dispositifs d'aiguille pourvus d'un corps cylindrique creux (1) ainsi que d'une pointe (2) fixée de manière amovible à une extrémité dudit corps (1) et munie de moyens de fixation (7) conçus pour une fixation dans ledit tissu mou.
PCT/IB2002/000926 2001-03-30 2002-03-26 Methode et moyens permettant de localiser et d'indiquer une lesion non palpable dans des tissus mous WO2002078560A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMO01A000060 2001-03-30
IT2001MO000060A ITMO20010060A1 (it) 2001-03-30 2001-03-30 Metodo e mezzi per l'individuazione e la segnalazione di una lesione non palpabile in tessuti molli

Publications (1)

Publication Number Publication Date
WO2002078560A1 true WO2002078560A1 (fr) 2002-10-10

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PCT/IB2002/000926 WO2002078560A1 (fr) 2001-03-30 2002-03-26 Methode et moyens permettant de localiser et d'indiquer une lesion non palpable dans des tissus mous

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IT (1) ITMO20010060A1 (fr)
WO (1) WO2002078560A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7465279B2 (en) 2004-03-31 2008-12-16 Ethicon Endo-Surgery, Inc. Marker device and method of deploying a cavity marker using a surgical biopsy device

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4403789A1 (de) * 1994-02-03 1995-08-10 Schering Ag Mittel zur visuellen Markierung von Körpergewebe
WO1996008208A1 (fr) * 1994-09-16 1996-03-21 Biopsys Medical, Inc. Procedes et dispositifs pour delimiter et marquer des tissus corporels
US5517993A (en) * 1991-09-24 1996-05-21 Imarx Pharmaceutical Corp. Copolymers and their use as contrast agents in magnetic resonance imaging and in other applications

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5517993A (en) * 1991-09-24 1996-05-21 Imarx Pharmaceutical Corp. Copolymers and their use as contrast agents in magnetic resonance imaging and in other applications
DE4403789A1 (de) * 1994-02-03 1995-08-10 Schering Ag Mittel zur visuellen Markierung von Körpergewebe
WO1996008208A1 (fr) * 1994-09-16 1996-03-21 Biopsys Medical, Inc. Procedes et dispositifs pour delimiter et marquer des tissus corporels

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7465279B2 (en) 2004-03-31 2008-12-16 Ethicon Endo-Surgery, Inc. Marker device and method of deploying a cavity marker using a surgical biopsy device

Also Published As

Publication number Publication date
ITMO20010060A1 (it) 2002-09-30
ITMO20010060A0 (it) 2001-03-30

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