EP1653862A1 - Instrument a aiguille pour la biopsie transcutanee de tissus de la moelle osseuse - Google Patents

Instrument a aiguille pour la biopsie transcutanee de tissus de la moelle osseuse

Info

Publication number
EP1653862A1
EP1653862A1 EP04744036A EP04744036A EP1653862A1 EP 1653862 A1 EP1653862 A1 EP 1653862A1 EP 04744036 A EP04744036 A EP 04744036A EP 04744036 A EP04744036 A EP 04744036A EP 1653862 A1 EP1653862 A1 EP 1653862A1
Authority
EP
European Patent Office
Prior art keywords
cannula
stylet
distal end
needle instrument
section
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Withdrawn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
EP04744036A
Other languages
German (de)
English (en)
Inventor
Enrico Malagoli
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP1653862A1 publication Critical patent/EP1653862A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • A61B2010/0258—Marrow samples

Definitions

  • Needle instruments are particularly known, which comprise a hollow metal cannula with one end, the so-called proximal end, having a handle for manipulating the instrument and the other end, the so-called distal end, having a coring edge for cutting out a cylindrical tissue portion to be collected.
  • a stylet may be introduced in the cannula, and be manipulated by a handle fitted at the proximal end of the stylet, which has such a length that the stylet tip extends beyond the distal end of the cannula.
  • the stylet tip is used to pierce the skin, the adipose tissues and bundles of muscles interposed between the skin and the bone tissue, and the bone tissue itself.
  • the stylet further prevents tissues other than the sample to be collected from being introduced in the cannula during the piercing step.
  • the stylet is removed and the cannula is further advanced, to isolate and enclose therein a substantially cylindrical portion of tissue (the so- called "core”) which forms the biopsy sample to be collected.
  • the biopsy sample is still joined at its bottom to the underlying tissue, i.e. outside the needle.
  • the portion of tissue enclosed within the cannula must be detached from or torn off the underlying tissue. Only when the tissue in the cannula has been severed from the underlying tissue, the cannula may be extracted from the patient's body. The biopsy sample in the caimula is finally ejected by an ejector.
  • the resection of the portion of tissue enclosed in the cannula is a particularly critical step in the above described biopsy process. According to a first known approach, resection of the tissue in the cannula is obtained by imparting repeated rotary and oscillatory motions to the cannula.
  • the oscillatory motions imparted to the cannula for detaching the biopsy sample cause bone injuries and microfractures, increased pain to the patient and longer healing times. Also, this approach does not ensure a total detachment of the biopsy sample from the underlying tissue. If any portion of the biopsy sample falls out of the cannula while the latter is being extracted, the biopsy procedure must be repeated, thereby aggravating injury and pain to the patient.
  • the hollow distal portion of the cannula may have a tapered shape converging toward its end.
  • tissue sample securing members may include a pair of opposed curved blades, which are deformed due to the taper or an elastic blade having a cylindrical profile with a longitudinal slot. Thanks to these sample securing members, the sample may be removed from the underlying tissue by simply rotating the cannula, without having to impart any oscillatory motion thereto. The biopsy sample is thus more reliably removed.
  • a cannula that has an interiorly tapered distal end reduces the available volume for collection of the biopsy sample, whereby an increased diameter of the cannula is required, which causes higher injury to the patient.
  • the need of providing a cannula with an interiorly tapered distal end involves higher needle fabrication costs.
  • the need of providing tissue sample securing means further complicates the fabrication of the instrument and increases fabrication costs.
  • the step of inserting the securing means is a further complication for the operator.
  • the object of this invention is to obviate at least some of the drawbacks of prior art needle instruments, and particularly the above mentioned drawbacks.
  • This object is fulfilled by providing a needle instrument for transcutaneous biopsy of bone marrow tissues according to claim 1. Further advantages may be obtained thanks to the additional characteristics of the dependent claims.
  • FIG. 1 is a front view which shows the step of inserting the stylet in the cannula
  • - Figure 2 is a front view which shows the assembled needle and stylet combination
  • - Figures 3-5 show an operational sequence of a biopsy procedure by the instrument of Figures 1 and 2
  • - Figure 6 is a cross sectional view of Figure 5
  • - Figure 7 is an enlarged view of the tip of the needle instrument.
  • the reference numeral 1 denotes a needle instrument for transcutaneous biopsy of bone marrow tissues.
  • This instrument comprises a hollow cannula 2, having a substantially constant cross section all along its length, with a proximal end 3, having a handle 4 for manipulating the instrument 1, and a distal end 5 having a coring edge 6 which is adapted to penetrate bone marrow tissues in such a manner as to enclose a generally cylindrical biopsy sample 20.
  • the cannula 2 is made of metal, e.g. stainless steel.
  • the coring edge 6 has a plurality of teeth 6a, 6b, 6c, to facilitate the penetration of bone tissues.
  • a stylet 10 may be inserted in the cannula 2 of the needle instrument 1, and has a proximal end 11, fitted with a handle 12, and a sharp distal end 13.
  • the length of the stylet 10 is such that the distal end 13 of the stylet extends beyond the distal end 5 of the cannula 2.
  • the stylet 10 to be used may be a conventional stylet, therefore it will not be further described.
  • the handles 4, 12 are shaped in such a manner as to match complementarily and means 14, 15 may be provided for removably fastening the handle 12 of the stylet to the handle 5 of the cannula 2, thereby providing an easier penetration to the relevant tissues.
  • These fastening means 14, 15 are also known, therefore they will not be further described. It will be appreciated that the distal end 5 of the cannula 2 has a constant cross section, apart from any unavoidable processing and measurement tolerances.
  • the lack of tapered or narrowed profiles in the distal end 5 allows to optimize the volume of the collected biopsy sample 20, which makes the biopsy procedure less invasive.
  • the inner section of the coring edge 6 has not a circular shape. Thanks to this non-circular cross section of the coring edge 6, by rotating the cannula 2, the base 21 of the biopsy sample 20 is subjected to a twisting action, which causes the biopsy sample to be severed from the underlying tissue. Thanks to this characteristic, a highly reliable needle instrument may be obtained in a simple manner and at a low cost.
  • the inner cross section of the coring edge 6 is substantially or generally a polygon, e.g. a square or a triangle.
  • This design is particularly effective and is also easily achievable.
  • Those skilled in the art may obviously provide other cross sectional shapes for the coring edge 6.
  • a substantially and/or generally polygonal cross section a substantially and/or generally elliptical cross section may be used.
  • the non circular design of the coring edge 6 may be obtained, for instance, by using a cannula 2 having a circular coring edge 6 and by deforming the coring edge 6 with a substantially pyramidal tool.
  • the operation of the instrument is as follows. When performing a biopsy procedure, the operator holds the instrument 1 with the stylet 10 in the operating position and introduces the instrument 1 through adipose and muscular tissues into the bone tissue until he/she feels a reduced resistance, i.e.
  • the operator extracts the stylet from the cannula, and pushes the latter further into the bone marrow tissue, until it encloses a tissue portion, which forms the biopsy sample 20. Then the operator rotates the cannula 2, whereby the coring edge 6, due to its non circular cross section, imparts a twisting motion to the base 21 of the sample within the cannula 2, thereby detaching the sample from the underlying tissue. Finally, the cannula 2 is extracted and the collected biopsy sample 20 is extracted from the cannula by an ejector.

Abstract

La présente invention se rapporte à un instrument à aiguille (1) destiné à la biopsie transcutanée de tissus de la moelle osseuse, comportant une canule creuse (2) dotée d'une extrémité proximale (3) avec une poignée (4) permettant de manipuler la canule (2) et d'une extrémité distale (5), présentant une section transversale sensiblement uniforme sur toute sa longueur et munie d'un bord de perçage (6). Un stylet (10) conçu pour être introduit dans la canule (2) dudit instrument (1) présente une extrémité proximale (11) équipée d'une poignée (12) et une extrémité distale pointue (13). La longueur du stylet (10) est telle que son extrémité distale (13) dépasse l'extrémité distale (5) de la canule (2). L'instrument est caractérisé en ce que la section transversale interne du bord de perçage (6) n'est pas circulaire.
EP04744036A 2003-07-28 2004-07-26 Instrument a aiguille pour la biopsie transcutanee de tissus de la moelle osseuse Withdrawn EP1653862A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI20031540 ITMI20031540A1 (it) 2003-07-28 2003-07-28 Strumento ad ago per la biopsia transcutanea di tessuti osteomidollari
PCT/IB2004/002377 WO2005009246A1 (fr) 2003-07-28 2004-07-26 Instrument a aiguille pour la biopsie transcutanee de tissus de la moelle osseuse

Publications (1)

Publication Number Publication Date
EP1653862A1 true EP1653862A1 (fr) 2006-05-10

Family

ID=34090511

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04744036A Withdrawn EP1653862A1 (fr) 2003-07-28 2004-07-26 Instrument a aiguille pour la biopsie transcutanee de tissus de la moelle osseuse

Country Status (3)

Country Link
EP (1) EP1653862A1 (fr)
IT (1) ITMI20031540A1 (fr)
WO (1) WO2005009246A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9925068B2 (en) 2014-05-30 2018-03-27 Treace Medical Concepts, Inc. Bone harvester and bone marrow removal system and method

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7905857B2 (en) 2005-07-11 2011-03-15 Covidien Ag Needle assembly including obturator with safety reset
US7828773B2 (en) 2005-07-11 2010-11-09 Covidien Ag Safety reset key and needle assembly
US20060276747A1 (en) 2005-06-06 2006-12-07 Sherwood Services Ag Needle assembly with removable depth stop
US7731692B2 (en) 2005-07-11 2010-06-08 Covidien Ag Device for shielding a sharp tip of a cannula and method of using the same
US7654735B2 (en) 2005-11-03 2010-02-02 Covidien Ag Electronic thermometer
US8357104B2 (en) 2007-11-01 2013-01-22 Coviden Lp Active stylet safety shield
US9402602B2 (en) 2013-01-25 2016-08-02 Choon Kee Lee Tissue sampling apparatus
US9414815B2 (en) 2013-03-15 2016-08-16 Vidacare LLC Intraosseous needle sets and kits
KR20160104544A (ko) 2013-03-15 2016-09-05 비다케어 엘엘씨 골내 디바이스 핸들, 시스템, 및 방법
GB2528304B (en) * 2014-07-17 2020-05-13 Cambridge Univ Hospitals Nhs Foundation Trust Perineal prostate biopsy apparatus

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4838282A (en) * 1987-02-26 1989-06-13 Manan Manufacturing Co., Inc. Bone biopsy needle assembly
IT1317102B1 (it) * 2000-07-24 2003-05-26 Pietro Castellacci Ago del tipo da biopsia o per altri prelievi da organi umani o dianimali.
EP1476069B1 (fr) * 2001-10-25 2015-11-18 CareFusion 2200, Inc. Instrument de biopsie medullaire a retention amelioree de l'echantillon

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2005009246A1 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9925068B2 (en) 2014-05-30 2018-03-27 Treace Medical Concepts, Inc. Bone harvester and bone marrow removal system and method
US11020244B2 (en) 2014-05-30 2021-06-01 Treace Medical Concepts, Inc. Bone harvester and bone marrow removal system and method

Also Published As

Publication number Publication date
ITMI20031540A1 (it) 2005-01-29
WO2005009246A1 (fr) 2005-02-03

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