EP4626330A1 - Dispositif de biopsie avec marqueur intégré - Google Patents

Dispositif de biopsie avec marqueur intégré

Info

Publication number
EP4626330A1
EP4626330A1 EP22843579.8A EP22843579A EP4626330A1 EP 4626330 A1 EP4626330 A1 EP 4626330A1 EP 22843579 A EP22843579 A EP 22843579A EP 4626330 A1 EP4626330 A1 EP 4626330A1
Authority
EP
European Patent Office
Prior art keywords
marker
needle
retaining
retaining device
sample notch
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.)
Pending
Application number
EP22843579.8A
Other languages
German (de)
English (en)
Inventor
Koltin GLASPIE
Bryon E. Pelzek
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.)
Bard Peripheral Vascular Inc
Original Assignee
Bard Peripheral Vascular Inc
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 Bard Peripheral Vascular Inc filed Critical Bard Peripheral Vascular Inc
Publication of EP4626330A1 publication Critical patent/EP4626330A1/fr
Pending 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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • 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 specification generally relates to biopsy devices, assemblies, and methods, and, more particularly, to biopsy devices, assemblies, and methods including an integrated marker.
  • Biopsies are sometimes performed on patients to collect samples of tissue for analysis.
  • a biopsy is generally performed with a biopsy device that is insertable into a patient and configured to collect a tissue sample from the patient while inserted.
  • a marker is generally made from biocompatible materials that are visible under various modes of imaging, such as X-ray.
  • a separate applicator containing the marker is inserted into the biopsy device after the tissue sample has been collected. This separate applicator may then be used to deploy the marker into the biopsy site. This process may be cumbersome as it requires handling and inserting a separate applicator containing the marker. Accordingly, it may be beneficial to have a biopsy device with an integrated marker such that the marker is contained within and directly deployable from the biopsy device.
  • a biopsy device generally includes a needle, a cutting apparatus, a marker, and a marker retaining device.
  • the needle includes a needle tip and a needle body coupled to the needle tip.
  • the needle body defines a needle lumen extending therethrough and a sample notch in communication with the needle lumen.
  • the cutting apparatus is operable to cut a tissue sample disposed within the sample notch.
  • the marker retaining device is disposed within the needle lumen and is moveable between a retaining position and a deploying position. The marker may be retained in a distal portion of the needle lumen by the marker retaining device. Retraction of the marker retaining device from the retaining position to the deploying position is configured to deploy the marker through the sample notch.
  • FIG. 3 schematically depicts a cross-sectional view of the biopsy device of FIG. 1 in an intermediate configuration, according to one or more embodiments shown and described herein;
  • FIG. 7 schematically depicts a cross-sectional view of the biopsy device of FIG. 6 in an intermediate configuration, according to one or more embodiments shown and described herein;
  • FIG. 8 schematically depicts a cross-sectional view of the biopsy device of FIG. 6 in a deploying configuration, according to one or more embodiments shown and described herein.
  • the marker retaining device is disposed within the needle lumen and is moveable between a retaining position and a deploying position.
  • the marker may be retained in a distal portion of the needle lumen by the marker retaining device. Retraction of the marker retaining device from the retaining position to the deploying position is configured to deploy the marker through the sample notch. Accordingly, the marker may be retained within the biopsy device throughout collection of a biopsy sample and deployed directly from the biopsy device. Biopsy procedures are thereby improved by reducing complexity or need of devices used for marker delivery separate from the biopsy device.
  • proximal is used directionally to refer to the direction towards an operator of a biopsy device.
  • distal is used directionally to refer to the direction away from the operator of a biopsy device, such as toward to needle tip of the biopsy device.
  • the biopsy device 10 generally includes a needle 100 and a handle 20.
  • the handle 20 may be configured to house a driver assembly for powering and moving internal components of the biopsy device 10.
  • the needle 100 extends from the handle 20 to a needle tip 110 and is configured to retrieve a tissue or biopsy sample from a subject.
  • the needle 100 generally includes a needle tip 110 and a needle body 120 coupled to the needle tip 110 that extends between the needle tip 110 and the handle 20.
  • the needle tip 110 may be sharp to enable insertion into a subject’s tissue to a target location.
  • the needle body 120 may extend about a longitudinal axis L firom the needle tip 110.
  • the needle body 120 may be round in a cross-section taken normal to the longitudinal axis L.
  • the needle body 120 may be substantially hollow such that it has an inner surface 120a and a distal wall 112 defining a needle lumen 124.
  • the needle lumen 124 may extend through the needle body 120 along the longitudinal axis L.
  • the needle lumen 124 may be configured to receive a tissue sample.
  • the needle body 120 may define a sample notch 116 that extends along a portion of the circumference of the needle body 120 and along a portion of the length of the needle body 120 (e.g. in the direction defined by the longitudinal axis L).
  • the sample notch 116 provides a lateral window into the needle lumen 124.
  • the sample notch 116 may be selectively opened to allow for tissue at a biopsy site to move into the needle lumen 124, such as under vacuum pressure, for example.
  • a cutting apparatus 150 as will be described in greater detail below, may then be selectively actuated to extend across the sample notch 116 to sever tissue that has entered the needle lumen 124 through the sample notch 116.
  • positioned within the needle 100 may be a marker 140 housed within the distal portion 114 of the needle lumen 124, so as to be positioned distal to the sample notch 116.
  • the marker 140 has a cylindrical shape, though many other shapes are contemplated and possible.
  • the marker 140 may be made from a biocompatible material that is visible during imaging, such as titanium, stainless steel, or Nitinol.
  • the biopsy device 10 further includes a marker retaining device 130 housed within the needle lumen 124.
  • the marker retaining device 130 is configured to selectively retain the marker 140 in the distal portion 114 of the needle lumen 124.
  • the marker retaining device 130 may be translatable in a longitudinal direction defined by the longitudinal axis L and may be rotatable about the longitudinal axis L.
  • the marker retaining device 130 may include a longitudinally extending portion 132, a marker retaining wall 134 coupled to a distal end 133 of the longitudinally extending portion 132.
  • the marker retaining wall 134 may be disposed at the distal end 133 of the longitudinally extending portion 132.
  • the marker retaining wall 134 may have a rounded outer edge 138, so as to substantially extend acrossthe diameter of the needle lumen 124 and prevent the marker 140 from exiting the distal portion 114 of the needle lumen 124 prior to deployment.
  • the rounded outer edge 138 may be configured to abut or be positioned close proximate the inner surface 120a of the needle body 120.
  • the marker retaining device 130 may be made from a shapememory alloy, such as nickel-titanium, copper-aluminum-nickel, etc., to spring-load the marker retaining device 130, as will be described in greater detail below.
  • the marker retaining device 130 may be made from a spring material such as spring steel to springload the marker retaining device 130.
  • the marker retaining device 130 may be moveable between a retaining position, an intermediate position, and a deploying position. Referring specifically to FIG. 2, the marker retaining device 130 is depicted in the retaining position. In this position, the marker retaining device 130 may be advanced so that the marker 140 is retained in the distal portion 114 of the needle lumen 124. For example, the longitudinally extending portion 132 may be positioned opposite the sample notch 116.
  • the marker retaining device 130 when the marker retaining device 130 is in the retaining position, it may retain the marker 140 within the distal portion 114 of the needle lumen 124 such that the marker 140 is separated from the sample notch 116, and does not interfere with sample collection.
  • the marker retaining device 130 is shown in the intermediate position. In this position, the marker retaining device 130 is rotated about the longitudinal axis L relative to the retaining position. Accordingly, the marker retaining device 130, such as the longitudinally extending portion 132, may abut or be positioned adjacent the sample notch 116 in the intermediate position. The marker retaining wall 134 may remain at an angle relative to the longitudinal axis L such that the marker retaining device 130 continues to retain the marker 140 within the distal portion 114 of the needle lumen 124.
  • the second surface 134b of the marker retaining wall 134 faces away (such as is angled down) from the sample notch 116 and the first surface 134a is angled upward.
  • the marker contacting portion 136 may be oriented below the marker 140.
  • the marker retaining device 130 is shown in the deploying position. In this position, the marker retaining device 130 may be proximally retracted (e.g. in the direction defined by the longitudinal axis L) relative to the intermediate position and the retaining position. As noted above, the marker retaining device 130 may be formed via a shape memory or spring loaded material. Accordingly, as the longitudinally extending portion 132 is withdrawn, the marker retaining wall 134 may be allowed to flatten toward a relaxed orientation to extend inline (or angled above) the longitudinally extending portion 132. Accordingly, in embodiments the marker retaining wall 134 may be biased to aligned with or extend above the longitudinally extending portion 132, and both the marker retaining wall 134 and the longitudinally extending portion 132 may abut the sample notch 116.
  • the marker retaining wall 134 may continue to move to its relaxed orientation as a result of the bias of the marker retaining wall 134.
  • the marker contacting portion 136 may maintain contact with the marker 140 to move or “pull” the marker 140 proximally toward the sample notch 116. Accordingly, when the marker retaining device 130 is fully retracted to the deploying position, the marker 140 may be deployed from the sample notch 116 and into the biopsy site of the subject.
  • a method of using the biopsy device 10 may include positioning the needle 100 at a biopsy site.
  • the marker retaining device 130 may be in the retaining position during positioning of the needle 100 at the biopsy site.
  • the cutting apparatus 150 may also be extended distally over the sample notch 116, to prevent unwanted tissue collection through the sample notch 116. While the biopsy device 10 is positioned at the biopsy site, the cutting apparatus 150 may be withdrawn in the proximal direction from the sample notch 116. Once the sample notch 116 is exposed, tissue may enter the sample notch 116.
  • vacuum may be delivered through the sample notch 116, such as via the cutting apparatus 150 and/or the needle lumen 124, to draw tissue into the sample notch 116.
  • the cutting apparatus 150 may then be advanced distally past the sample notch 116 to cut the tissue sample.
  • the sample may be pulled, such as via vacuum through the cutting lumen to a sample collection container.
  • the marker retaining device 130 may remain positioned in the retaining position throughout sample collection.
  • the method of using the biopsy device 10 may include moving the marker retaining device 130 from the retaining position to the deploying position, thereby deploying the marker 140 from the needle lumen 124 through the sample notch 116.
  • moving the biopsy device 10 from the retaining configuration to the deploying configuration may include rotating the marker retaining device 130 (such as by manipulating the longitudinally extending portion 132 at the handle 20) from the retaining position to the intermediate position (such as depicted in FIG. 3).
  • the longitudinally extending portion 132 may be arranged to extend across the sample notch 116, thereby blocking at least a portion of the sample notch 116.
  • the marker retaining device 130 may be withdrawn in the proximal direction from the intermediate position to the deploying position, as depicted in FIG. 4.
  • the longitudinally extending portion 132 may be manipulated at the handle 20 to be pulled in the proximal direction.
  • the marker retaining device 130 is withdrawn proximally, the marker retaining wall 134 along with the marker contacting portion 136 may begin to flex toward the sample notch 116, thereby pushing the marker 140 toward and out of the sample notch 116.
  • distal wall 112’ of the needle 100 may include a curved or concave surface.
  • the distal wall 112’ may curve toward the needle lumen 124.
  • the distal wall 112’ may accordingly, aid in directing the marker 140 toward the sample notch 116 during movement from the retaining position to the deploying position described above.
  • the rounded geometry of the distal wall 112’ may prevent the marker 140 from rolling or falling off of the marker retaining device 130 as the marker retaining device 130 is moved from the retaining position to the deploying position.
  • the marker retaining device 130’ may be made from a shape-memory alloy, such as nickel-titanium, copper-aluminum-nickel, etc., to bias the marker contacting portion 136’ of the marker retaining device 130’ to the wound geometry depicted in FIGS. 6 and 7.
  • the marker retaining device 130’ may be made from a spring material such as spring steel to bias the marker contacting portion 136’ of the marker retaining device 130’.
  • the marker contacting portion 136’ may be wrapped or wound about the marker 140 when in the retaining position. Accordingly, the marker retaining device 130’ may retain the marker 140 within the distal portion 114’ of the needle lumen 124. In embodiments, the marker retaining device 130’ may separate at least a part 114a of the distal portion 114’ of the needle lumen 124 from the rest of the needle lumen 124. Accordingly, the marker 140 may not be in communication with the sample notch 116 of the needle lumen 124 when the marker retaining device 130’ is in the retaining position.
  • the marker contacting portion 136’ may contact an edge of the sample notch 116.
  • the contact between the edge of the sample notch 116 and the marker contacting portion 136’, may cause the marker contacting portion 136’ to unroll as the marker retaining device 130’ is pulled proximally, thereby deploying the marker 140 out of the sample notch 116 to the biopsy site.
  • a biopsy device for marking a location of a tissue biopsy, the biopsy device comprising: a needle comprising a needle tip and a needle body coupled to the needle tip, the needle body defining a needle lumen extending therethrough and a sample notch in communication with the needle lumen; a cutting apparatus operable to cut a tissue sample disposed within the sample notch; a marker retaining device disposed within the needle lumen and moveable between a retaining position (in a distal portion of the needle) and a deploying position (proximal to the retaining position); and a marker retained in a distal portion of the needle lumen by the marker retaining device (when in the retaining position), wherein (the biopsy device / marker retaining device is configured such that) retraction of the marker retaining device from the retaining position to the deploying position deploys the marker through the sample notch.
  • the marker retaining device comprises a marker contacting portion configured to pull the marker in a proximal direction from the distal portion of the needle lumen toward the sample notch (when moving from the retaining position to the deploying position).
  • biopsy device of any preceding clause, wherein the (biopsy device and/or the) marker retaining device is configured to separate / separates the distal portion of the needle lumen from a sample notch when in the retaining position.
  • biopsy device of any preceding clause, wherein the (biopsy device and/or the) marker retaining device is (configured to be) positioned in the retaining position during movement of the cutting apparatus to cut the tissue sample.
  • the marker retaining device is configured to be wound about the marker in the retaining position.
  • a biopsy device for marking a location of a tissue biopsy, the biopsy device comprising: a needle comprising a needle tip and a needle body coupled to the needle tip, the needle body defining a needle lumen extending therethrough and a sample notch in communication with the needle lumen; a cutting apparatus operable to cut a tissue sample disposed within the sample notch; marker retaining device disposed within the needle lumen and rotatable between a retaining position (in a distal portion of the needle) and a deploying position (proximal to the retaining position); and a marker retained in a distal portion of the needle lumen by the marker retaining device (when in the retaining position), wherein (the biopsy device / marker retaining device is configured such that) rotation of the marker retaining device from the retaining position to the deploying position deploys the marker through the sample notch.
  • biopsy device of any preceding clause, wherein the (biopsy device and/or the) marker retaining device is configured to separates / separates at least a part of the distal portion of the needle lumen from a tissue receiving region of the needle lumen when in the retaining position.
  • a method of using a biopsy device optionally the biopsy device of any of the preceding clauses, the biopsy device comprising: a needle comprising a needle tip and a needle body coupled to the needle tip, the needle body defining a needle lumen extending therethrough and a sample notch in communication with the needle lumen; a cutting apparatus operable to cut a tissue sample disposed within the sample notch; a marker retaining device disposed within the needle lumen and retractable from a retaining position and a deploying position; and a marker retained in a distal portion of the needle lumen by the marker retaining device; and moving the marker retaining device from the retaining position to the deploying position, thereby deploying the marker from the needle lumen through the sample notch.
  • a biopsy device that generally includes a needle, a cutting apparatus, a marker, and a marker retaining device.
  • the needle includes a needle tip and a needle body coupled to the needle tip.
  • the needle body defines a needle lumen extending therethrough and a sample notch in communication with the needle lumen.
  • the cutting apparatus is operable to cut a tissue sample disposed within the sample notch.
  • the marker retaining device is disposed within the needle lumen and is moveable between a retaining position and a deploying position. The marker may be retained in a distal portion of the needle lumen by the marker retaining device.
  • Retraction of the marker retaining device from the retaining position to the deploying position is configured to deploy the marker through the sample notch. Accordingly, the marker may be retained within the biopsy device while the tissue sample is cut by the cutting apparatus and may be deployed directly from the biopsy device. Biopsy procedures are thereby improved by reducing complexity or need of devices used for marker delivery separate from the biopsy device.

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  • 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)
  • Surgical Instruments (AREA)

Abstract

Dispositif de biopsie comprenant généralement une aiguille, un appareil de coupe, un marqueur et un dispositif de retenue de marqueur. L'aiguille comprend une pointe d'aiguille et un corps d'aiguille couplé à la pointe d'aiguille. Le corps d'aiguille définit une lumière d'aiguille s'étendant à travers celui-ci et une encoche d'échantillon en communication avec la lumière d'aiguille. L'appareil de coupe peut fonctionner pour couper un échantillon de tissu agencé à l'intérieur de l'encoche d'échantillon. Le dispositif de retenue de marqueur est agencé à l'intérieur de la lumière d'aiguille et est mobile entre une position de retenue et une position de déploiement. Le marqueur peut être retenu dans une partie distale de la lumière d'aiguille par le dispositif de retenue de marqueur. La rétraction du dispositif de retenue de marqueur de la position de retenue à la position de déploiement est conçue pour déployer le marqueur à travers l'encoche d'échantillon.
EP22843579.8A 2022-11-30 2022-11-30 Dispositif de biopsie avec marqueur intégré Pending EP4626330A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2022/080689 WO2024118097A1 (fr) 2022-11-30 2022-11-30 Dispositif de biopsie avec marqueur intégré

Publications (1)

Publication Number Publication Date
EP4626330A1 true EP4626330A1 (fr) 2025-10-08

Family

ID=84942869

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22843579.8A Pending EP4626330A1 (fr) 2022-11-30 2022-11-30 Dispositif de biopsie avec marqueur intégré

Country Status (2)

Country Link
EP (1) EP4626330A1 (fr)
WO (1) WO2024118097A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1552794B1 (fr) * 1996-08-12 2009-05-06 Ethicon Endo-Surgery, Inc. Appareil de marquage de tissus
US6220248B1 (en) * 1998-10-21 2001-04-24 Ethicon Endo-Surgery, Inc. Method for implanting a biopsy marker
US8267868B2 (en) * 2005-08-10 2012-09-18 C. R. Bard, Inc. Single-insertion, multiple sample biopsy device with integrated markers
US7761137B2 (en) * 2005-12-16 2010-07-20 Suros Surgical Systems, Inc. Biopsy site marker deployment device
US8529465B2 (en) * 2009-09-24 2013-09-10 Devicor Medical Products, Inc. Biopsy marker delivery devices and methods
CN114376739A (zh) * 2014-10-08 2022-04-22 Devicor医疗产业收购公司 活检标记物

Also Published As

Publication number Publication date
WO2024118097A1 (fr) 2024-06-06

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