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WO2025037297A1 - Séparateur de tissu - Google Patents

Séparateur de tissu Download PDF

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Publication number
WO2025037297A1
WO2025037297A1 PCT/IL2024/050781 IL2024050781W WO2025037297A1 WO 2025037297 A1 WO2025037297 A1 WO 2025037297A1 IL 2024050781 W IL2024050781 W IL 2024050781W WO 2025037297 A1 WO2025037297 A1 WO 2025037297A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
sampling portion
manipulator
inner lumen
sampling
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
PCT/IL2024/050781
Other languages
English (en)
Inventor
Assaf Klein
Hadar GILBOA
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.)
Limaca Medical Ltd
Original Assignee
Limaca Medical Ltd
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 Limaca Medical Ltd filed Critical Limaca Medical Ltd
Publication of WO2025037297A1 publication Critical patent/WO2025037297A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Clinical applications involving detecting or locating foreign bodies or organic structures for locating instruments

Definitions

  • the present invention in some embodiments thereof, relates to tissue sampling and, more particularly, but not exclusively, to sampling of soft tissue for biopsy.
  • a biopsy device comprising: a. a hollow sampling portion comprising an elongated body having a long axis, a proximal end, a distal end and an inner lumen within said body positioned along said long axis; wherein said sampling portion distal end comprises a distal opening, shaped and sized to allow entry of tissue into said inner lumen when the hollow sampling portion is axially advanced into body tissue; b. at least one movable tissue manipulator extending from a wall of said sampling portion body into said inner lumen and towards said sampling portion proximal end; wherein said at least one tissue manipulator is configured to move outwardly towards said wall, and inwardly towards the inner lumen.
  • Example 2 The device according to example 1, wherein said at least one movable tissue manipulator is shaped and sized to be pushed towards an inner surface of a wall of said sampling portion by said tissue entering into said inner lumen, and to move back towards said inner lumen and apply force on said tissue in said inner lumen.
  • Example 3 The device according to any one of examples 1 or 2, wherein said at least one tissue manipulator is configured to move back towards said inner lumen when said axially advancement of said hollow sampling portion is stopped.
  • Example 4 The device according to any one of examples 1-3, wherein said at least one tissue manipulator is an elastically deflectable tissue manipulator, configured to elastically deflect towards said wall inner surface by said tissue entering into said inner lumen through said distal opening, and to recover from said deflection when said axially advancement of said hollow sampling portion into said body tissue is stopped.
  • said at least one tissue manipulator is an elastically deflectable tissue manipulator, configured to elastically deflect towards said wall inner surface by said tissue entering into said inner lumen through said distal opening, and to recover from said deflection when said axially advancement of said hollow sampling portion into said body tissue is stopped.
  • Example 5 The device according to any one of examples 1-4, wherein said at least one tissue manipulator is a partial cut out portion of said sampling portion wall.
  • Example 6 The device according to any one of examples 1-5, wherein said at least one tissue manipulator is formed from a material of said wall.
  • Example 7 The device according to any one of examples 1-6, wherein said at least one tissue manipulator is formed by forming an arc-shaped cut across said wall, and wherein a width of said cut is between 0.005 mm and 0.05 mm.
  • Example 8 The device according to any one of examples 1-7, wherein said at least one tissue manipulator comprise a distal end coupled to said wall or integrated with said wall close to said sampling portion distal end, and a proximal end configured to be positioned in said inner lumen, and wherein said at least one tissue manipulator distal end is located a distance between 0.1 mm and 20 mm, from said sampling portion distal end or up to a distance from the sampling portion distal end which is 4 times an inner width of the sampling portion.
  • Example 9 The device according to any one of examples 1-8, wherein said distal end of said at least one tissue manipulator is located at a level of said hollow sampling portion wall and/or is aligned with the hollow sampling portion wall.
  • Example 10 The device according to any one of examples 1-9, wherein a radius of curvature of said at least one tissue manipulator between said distal end and said proximal end is a radius of curvature of said hollow sampling portion wall.
  • Example 11 The device according to any one of examples 1-10, wherein a radius of curvature of said at least one tissue manipulator between said distal end and said proximal end is smaller or larger in up to 30% relative to a radius of curvature of said hollow sampling portion wall.
  • Example 12 The device according to any one of examples 1-11, wherein said at least one tissue manipulator between said distal end and said proximal end is straight.
  • Example 13 The device according to any one of examples 1-12, wherein a pitch angle between said at least one tissue manipulator and a plane perpendicular to a long axis of said sampling portion is between 5 degrees and 30 degrees.
  • Example 14 The device according to any one of examples 1-13, wherein said at least one tissue manipulator is formed from a superelastic and/ or shape memory alloy.
  • Example 15 The device according to any one of examples 1-14, wherein said at least one tissue manipulator is configured to form a tissue separation region in said tissue by moving back towards said inner lumen and applying force against said tissue in said inner lumen, wherein said tissue separation region is a region which is more susceptible to tissue separation compared to other regions of said body tissue portion.
  • Example 16 The device according to any one of examples 1-15, wherein said at least one tissue manipulator is configured to form a tissue separation region in said tissue by moving back towards said inner lumen and penetrating into said tissue in said inner lumen, wherein said tissue separation region is a region which is more susceptible to tissue separation compared to other regions of said body tissue portion.
  • Example 17 The device according to any one of examples 1-16, wherein said hollow sampling portion applies forces on said tissue in said inner lumen which are sufficient to separate a tissue sample from said tissue at said tissue separation region, when said hollow sampling portion is rotated and/or retracted.
  • Example 18 The device according to any one of examples 15 to 17, wherein said hollow sampling portion is axially advanced into said body tissue while being rotated in a first direction, and wherein said at least one movable tissue manipulator is configured to form said tissue separation region when said hollow sampling portion is rotated in a second opposite direction when said axial advancement is stopped.
  • Example 19 The device according to any one of examples 1-18, wherein said at least one tissue manipulator comprises a tissue penetrating edge configured to contact tissue in said inner lumen and to form said separation region by forming at least a partial circumferential groove or at least a partial circumferential slit in said tissue when said hollow sampling portion is rotated.
  • Example 20 The device according to any one of examples 1-19, wherein said at least one tissue manipulator comprises at least two tissue manipulators, each having a tissue contacting end configured to contact said tissue in said inner lumen, wherein tissue contacting ends of said at least two tissue manipulators are positioned on a single plane which is substantially perpendicular to said long axis, when each of said at least two tissue manipulators fully extends into said inner lumen.
  • Example 21 The device according to any one of examples 1-20, comprising at least one actuator, and a shaft having a distal end and a proximal end, wherein said at least one actuator is coupled to said shaft proximal end and said hollow sampling portion is coupled to said shaft distal end, and wherein said shaft is configured to rotate and/or axially advance said hollow sampling portion within said body tissue.
  • Example 22 The device according to any one of examples 1-21, wherein said shaft rotates said sampling portion in a first direction while said sampling portion is axially advanced into said body tissue, and wherein rotation of said sampling portion by said shaft in a second opposite direction forms a tissue separation region by said at least one tissue manipulator and/or separates a tissue sample from tissue in said inner lumen.
  • Example 23 The device according to any one of examples 1-22, wherein said at least one actuator is configured to rotate said sampling portion in a tangential velocity between 2.5 and 1000 mm/second.
  • Example 24 The device according to any one of examples 1-23, wherein said at least one actuator is configured to axially advance said sampling portion in an axial velocity between 1 and 100 mm/second.
  • Example 25 The device according to any one of examples 1-24, wherein a ratio between axial velocity and tangential velocity of said sampling portion is between 1 and 10.
  • Example 26 The device according to any one of examples 1-25, wherein a ratio between axial velocity and tangential velocity of said sampling portion is between 2 and 5.
  • Example 27 The device according to any one of examples 1-26, wherein said shaft is a flexible shaft.
  • Example 28 The device according to any one of examples 1-27, wherein said sampling portion is shaped and sized to be advanced towards said body tissue within a working channel of an endoscope.
  • Example 29 The device according to any one of examples 1-28, wherein said hollow sampling portion comprises a sampling needle.
  • Example 30 The device according to any one of examples 1-29, wherein said sampling portion distal end is substantially perpendicular to said long axis of said sampling portion.
  • Example 31 The device according to any one of examples 1-30, wherein said sampling portion distal end comprises an internal and/or an external sharpened edge, surrounding said distal opening and configured to form a circular cut through body tissue during axial advancement and/or rotation of said sampling portion into said body tissue.
  • Example 32 A method for sampling tissue, comprising: a. axially advancing a sampling portion of a biopsy device into body tissue, wherein during said axially advancing a portion of said body tissue enters into an inner lumen of said sampling portion and pushes at least one tissue manipulator extending from a wall of said sampling portion into said inner lumen, outwardly towards said wall; b. applying forces by said at least one tissue manipulator on said body tissue portion when said at least one tissue manipulator returns back into said inner lumen; c.
  • tissue separation region is a region which is more susceptible to tissue separation compared to other regions of said body tissue portion in the inner lumen in response to application of a separating force on said body tissue portion; d. separating a tissue sample from said body tissue portion at said tissue separation region by applying said separating force on said body tissue portion.
  • Example 33 The method according to example 32, wherein said at least one tissue manipulator comprises two or more tissue manipulators, and wherein said applying comprises grasping said body tissue portion in said inner lumen by said two or more tissue manipulators when said two or more tissue manipulators return into said inner lumen.
  • Example 34 The method according to example 32 or 33, wherein forming said tissue separation region by said at least one tissue manipulator comprises forming at least a partially circumferential groove or slit in said body tissue portion by rotating said at least one tissue manipulator while applying said forces.
  • Example 35 The method according to any one of examples 32-34, comprising rotating said sampling portion and said at least one tissue manipulator during said forming to form said at least a partially circumferential groove or slit in said body tissue portion, while said at least one tissue manipulator applies said forces on said body tissue portion.
  • Example 36 The method according to any one of examples 32-35, wherein said axially advancing comprises axially advancing while rotating said sampling portion in a first direction relative to said body tissue, and wherein said forming comprises forming said tissue separation region by rotating said sampling portion and said at least one tissue manipulator in a second opposite direction while applying said forces on said body tissue portion by said at least one tissue manipulator.
  • Example 37 The method according to any one of examples 32-36, comprising stopping said axially advancing prior to said forming of said tissue separation region.
  • Example 38 The method according to any one of examples 32-37, wherein said separating comprises separating said tissue sample by applying shearing forces on said body tissue portion by rotating said sampling portion relative to said body tissue located outside said sampling portion.
  • Example 39 The method according to any one of examples 32-38, wherein said separating comprises separating said tissue sample by retracting said sampling portion from said body tissue and applying tearing forces on said body tissue portion.
  • Example 40 The method according to any one of examples 32-39, comprises repeating said axially advancing, said applying, said forming and said separating, for acquiring at least one additional tissue sample from said body tissue.
  • Example 41 The method according to any one of examples 32-40, wherein said axially advancing comprises axially advancing said sampling portion into said body tissue in an axial velocity between 1-100 mm/second.
  • Example 42 The method according to any one of examples 32-41, wherein said axially advancing comprises rotating said sampling portion during said axially advancing in a tangential velocity between 2.5-1000 mm/second.
  • Example 43 The method of example 42, wherein a ratio between said axial velocity and said tangential velocity is in a range between 3 and 5.
  • Example 44 A soft tissue biopsy device comprising: a. an elongated handle comprising a gripping member; b. an elongated flexible shaft mechanically comprising a hollow distal sampling portion with an internal lumen and a distal opening facing a soft tissue; c. at least one driving unit configured to rotate said sampling portion while axially advancing the sampling portion into said soft tissue; wherein a ratio between a tangential rotation velocity and the axial advancement velocity of the sampling portion is between a ratio of 1 and a ratio of 10.
  • Example 45 The device according to example 44, wherein said at least one driving unit rotates said elongated flexible shaft with a tangential velocity in a range between 2.5-1000 mm/second.
  • Example 46 The device according to any one of examples 44 or 45, wherein said at least one driving unit axially advances said sampling portion in an axial velocity in a range between 1- 100 mm/sec.
  • Example 47 The device according to any one of examples 44-46, wherein said distal opening is located at a distal end of said sampling portion, and wherein said sampling portion distal end is a flat straight end or is substantially perpendicular to a long axis of the sampling portion.
  • Example 48 The device according to any one of examples 44-47, wherein said ratio is between a ratio of 2 and a ratio of 5.
  • Figure la is a flow chart of a general process for generating a separation region in a tissue, according to some embodiments of the invention.
  • Figures Ib-le are schematic illustrations of a process for generating a separation region in a tissue, according to some embodiments of the invention.
  • Figure If is a flow chart of a process for tissue sampling, according to some embodiments of the invention.
  • Figure 2 is a schematic diagram showing changes in a position of a flexible cutter during a tissue sampling process, according to some embodiments of the invention
  • Figures 3a-3b are schematic illustrations of a sampling portion of a biopsy device when at least one cutter is aligned with a wall of the sampling portion (3A), and when the at least one cutter is inwardly extending into an inner lumen of the sampling portion (3B), according to some embodiments of the invention;
  • Figures 3c-3e are schematic illustrations showing an orientation of two cutters extending into an inner lumen of a sampling portion, according to some embodiments of the invention.
  • FIG. 3f is a block diagram of a tissue sampling device, according to some exemplary embodiments of the invention.
  • Figure 4 is a flow chart of a detailed process for tissue sampling, according to some embodiments of the invention.
  • FIGS. 5a-5h are schematic illustrations showing a tissue sampling process, according to some embodiments of the invention.
  • Figures 6a-6g are schematic illustrations showing extraction of tissue samples from an inner lumen of a sampling portion of a biopsy device, according to some embodiments of the invention
  • Figures 7a-7e are schematic illustrations of a sampling portion having cutters inwardly extending from a wall of the sampling portion into a sampling portion lumen, according to some embodiments of the invention.
  • FIGS 8a-8b are schematic illustrations of a tissue manipulator, for example cutter, according to some exemplary embodiments of the invention.
  • the present invention in some embodiments thereof, relates to tissue sampling and, more particularly, but not exclusively, to sampling of soft tissue for biopsy.
  • An aspect of some embodiments of the invention relates to separating a tissue sample from tissue within a biopsy device lumen using at least one tissue manipulator extending from a wall of the biopsy device into the lumen.
  • the at least one tissue manipulator is positioned in an inner lumen in an orientation suitable for forming a separation region, for example a separation plane in the tissue, for example by reducing a width, for example a diameter of said tissue or amount of said tissue in said separation region.
  • a separation region is a region in the tissue interconnecting two parts of the tissue on both sides of the separation region with a weakened force. In some embodiments, when shearing forces are applied on the tissue, a separation or a gap will be formed in the separation region or plane between the two parts of the tissue on both sides of the separation region.
  • the tissue manipulator manipulates the tissue inside the biopsy device lumen by at least one manipulator, forming a cut in the tissue, forming a groove in the tissue and/or grasping of the tissue by penetrating, for example threading, into the tissue.
  • the tissue manipulator forms a circumferential or an arc shape cut in the tissue, surrounding at least partly the tissue.
  • the tissue manipulator forms a circumferential or an arc shape groove in the tissue, surrounding at least partly the tissue.
  • the tissue manipulator comprises at least one movable extension, extending into a lumen of the biopsy device, for example from a wall of the biopsy device surrounding the lumen.
  • the movable extension comprises a cutter, which is optionally flexible, for example a cutting tooth, extending from a wall of the biopsy device into the lumen.
  • the at least one flexible cutter is a portion of the biopsy device wall, configured to inwardly bend into the biopsy device lumen, in a relaxed state.
  • the at least one flexible cutter is configured to move between a first state, in which a proximal end of the flexible cutter is substantially aligned with the biopsy device wall, or is substantially adjacent to the wall, and a second state in which the flexible cutter proximal end moves inwardly into the biopsy device lumen, optionally while a distal end of the flexible cutter remains coupled to the wall or is integrated with the wall.
  • a distal end of the tissue manipulator, for example cutter is located at a level of the sampling portion wall and/or is aligned with the hollow portion wall.
  • the penetrating tissue pushes the at least one movable extension, for example a proximal end of the movable extension, towards the wall, optionally to acquire the first state.
  • the at least one movable extension for example the proximal end of the movable extension moves or bends inwardly into the lumen and optionally penetrating into the tissue within the lumen.
  • the movable extension for example the flexible cutter
  • the flexible cutter is a partial cut out portion of the biopsy device wall, for example the wall of a sampling portion, for example a sampling needle, of the biopsy device.
  • an angle for example a pitch angle between the movable extension, for example the flexible cutter and a plane perpendicular to a long axis of the biopsy device is in a range between 5 degrees and 30 degrees, for example in a range between 10 degrees and 20 degrees, in a range between 10 degrees and 15 degrees, in a range between 12 degrees and 15 degrees, in a range between 12 degrees and 17 degrees, in a range between 13 degrees and 18 degrees, in a range between 12 degrees and 30 degrees, or any intermediate, smaller or larger pitch angle or range of pitch angles, towards a proximal end of the biopsy tube.
  • a distal end of the flexible cutter located away from a base of the flexible cutter comprises a cutting edge.
  • rotation of the flexible cutter in the direction of the distal end cutting edge cuts a tissue contacting the flexible cutter.
  • the at least one flexible cutter comprises at least two flexible cutters, extending into the biopsy device lumen from at least two locations on a circumference of the wall.
  • the two locations have a similar axial position along the length of the biopsy device.
  • the two locations are opposite locations on the circumference of the biopsy device wall.
  • the at least two flexible cutters have a similar orientation between a base and a distal end of each flexible cutter, for example along a rotation path of the biopsy tube.
  • An aspect of some embodiments of the invention relates to introducing tissue into a lumen of a biopsy device needle while rotating in a first direction, and forming a circumferential groove, for example a circumferential cut in the tissue inside the lumen, by rotating the needle in a second direction that is opposite to the first direction.
  • the tissue is shaped by a tissue manipulator extending into the lumen.
  • the tissue manipulator is a cutter extending into the lumen from a wall of the biopsy device needle, configured to cut the tissue when the biopsy tube is rotated in the second direction.
  • the circumferential cut or groove is formed in a single cutting plane, for example to reduce diameter of the tissue in the cutting plane.
  • the tissue manipulator is described herein as a cutter forming a cut in the tissue, it should be noted that the tissue manipulator can pinch or generate a partial or a complete groove, for example a circumferential groove or an arc shaped groove, in the tissue, and that a cut in the tissue is an example of a groove.
  • the groove forms a separation region, which is a region where the tissue is more likely to disconnect or separate.
  • rotation and/or retraction of the biopsy tube causes tearing of a tissue sample from the tissue in the biopsy tube inner lumen, optionally without forming a cut in the tissue.
  • the tissue manipulator is used for grasping the tissue, and therefore acting as a tissue grasper.
  • grasping of the tissue allows applying forces on the tissue by rotation and/or axial retraction of the sampling portion, for example, to separate the grasped tissue from tissue in the biopsy device lumen located distally to the tissue manipulator, when the biopsy device is retracted.
  • a potential advantage of having a separation region in a single plane may be that it enables to separate between a proximal tissue sample that continues to flow within the inner lumen of the sampling portion and a distal tissue that continue to be connected to the organ tissue.
  • tissue manipulators are not located at a similar axial position in the sampling portion, following tissue sample separation, tissue may be trapped by the tissue manipulators and block penetration of tissue into the sampling portion.
  • Additional potential advantage of having one or more tissue manipulators extending into the inner lumen of a sampling portion may be to reduce a cross-section area of the sampling portion, for example to prevent penetration of body fluids, for example blood, into the sampling portion and contamination of a tissue sample with the body fluids, specifically when optionally using sampling needles having an inner diameter larger than 0.4 mm.
  • An aspect of some embodiments relates to a biopsy device having a hollow distal sampling portion configured to separate a tissue sample from body tissue by axially advancing into the body tissue while being rotated in a fixed or varying rotation speed.
  • a ratio between the tangential rotation velocity and the axial advancement velocity of the sampling portion is between a ratio of 1 and a ratio of 10, for example between a ratio of 3.5 and a ratio of 4.5, for example between a ratio of 2 and a ratio of 5.
  • the axial advancement and rotation of the hollow sampling portion in the abovementioned ration applies forces on a portion of the body tissue poisoned within an inner lumen of the sampling portion that is sufficient to separate a tissue sample from the body tissue portion, for example as described in International Patent Application Publication Number WO2019155472A1, incorporated herein as a reference in its entirety.
  • the sampling portion is rotated with a tangential velocity in a range between 2.5-1000 mm/second (sec), for example 2.5-40 mm/sec, 30-40 mm/sec, 35-45 mm/sec, 30-50 mm/sec, 10-100 mm/sec, 50-500 mm/sec, 300-1000 mm/sec or any intermediate, smaller or larger range of values.
  • the sampling portion is axially advanced into the tissue in an axial velocity in a range between 1-100 mm/sec, for example in an axial velocity in a range of 1-10 mm/sec, 5-12 mm/sec, 5-15 mm/sec, 5-50 mm/sec, 10-100 mm/sec, or in any intermediate, smaller or larger range of values.
  • the biopsy device comprises at least one driving unit, for example a motor for rotating the sampling portion and/or for axially advancing the sampling portion.
  • the biopsy devices comprises at least two motors, at least one motor for rotating the sampling portion and at least one different motor for axially advancing the sampling portion.
  • the hollow distal sampling portion is coupled or integrated with a distal end of a shaft, for example a flexible shaft.
  • the shaft for example a proximal end of the flexible shaft is coupled to the at least one motor.
  • the shaft is configured to deliver power and/or force from the at least one motor to the sampling portion.
  • An example of the biopsy device is described in International Patent Application Publication Number WO2019155472A1, incorporated herein as a reference in its entirety.
  • the sampling portion comprises the at least one tissue manipulator described in this patent application, when axially advanced and rotated in the abovementioned ratio.
  • the sampling portion does not include the at least one tissue manipulator, when axially advanced and rotated in the abovementioned ratio.
  • the sampling portion is the sampling portion described in the application with or without the at least one tissue manipulator.
  • a potential advantage of rotating and axially advancing the sampling portion into the body tissue in the specific range of ratio values may be to prevent damage to body tissue outside the sampling portion while allowing efficient separation of long and intact one or more tissue samples from a portion of the body tissue located within the sampling portion inner lumen, by the biopsy device.
  • a biopsy device comprising a sampling portion includes at least one tissue manipulator extending into an inner lumen of the sampling portion.
  • the at least one tissue manipulator comprises two or more tissue manipulators.
  • the two or more tissue manipulators have a similar axial position along the sampling portion inner lumen length.
  • the at least one tissue manipulator is a movable tissue manipulator, configured to move between a first position, for example a first state, and a second position, for example a second state.
  • the movable tissue manipulator is an elastic tissue manipulator, for example an elastically deflectable tissue manipulator.
  • the elastically deflectable tissue manipulator is a tissue manipulator that is configured to move from a first position to a second position, for example when a force is applied on the tissue manipulator, and to return to the first position when the force application is stopped or when the force applied on the tissue manipulator decreases.
  • the at least one tissue manipulator is positioned and is shaped and sized to be threaded into a tissue penetrating into the inner lumen, for example when the sampling portion is rotated and axially advanced, optionally simultaneously, into body tissue.
  • the penetration of the at least one tissue penetrator into tissue inside the inner lumen forms a tissue separation region.
  • the tissue separation region is a region in the tissue that is susceptible for tissue separation. In some embodiments, applying forces, for example tearing or shearing forces on tissue at the tissue separation region, separates a tissue sample from the body tissue penetrated into the inner lumen.
  • body tissue is introduced into an inner lumen of a sampling portion of a biopsy device, at block 100.
  • the body tissue is introduced into the lumen while the sampling portion is axially advanced into the body tissue.
  • the body tissue is introduced into the lumen when the sampling portion is advanced into the body tissue while being rotated.
  • the body tissue is introduced into the lumen through a distal opening of the sampling portion.
  • At least one tissue manipulator penetrates into body tissue, at block 101.
  • the at least one tissue manipulator extends into an inner lumen of a sampling portion of a biopsy device.
  • the at least one tissue manipulator penetrates into body tissue entering into the inner lumen when the sampling portion is advanced into the body tissue.
  • the at least one tissue penetrates into the body tissue in the inner lumen when the sampling portion axially advances into body tissue outside the sampling portion, optionally while the sampling portion rotates.
  • the at least one tissue manipulator penetrates into body tissue within the inner lumen of the sampling portion when axial advancement of the sampling portion is stopped, optionally, when a force applied on the tissue manipulator decreases, allowing the tissue penetrator to recover from deflection.
  • the at least one tissue manipulator forms a separation region in the body tissue within the inner lumen, at block 105.
  • the separation region is a region of tissue where the tissue is more susceptible for separation in comparison to other regions of the tissue.
  • the at least one tissue manipulator forms the separation region by forming a cut in the body tissue, for example a circumferential cut or an arc-shaped cut, optionally surrounding at least partly the body tissue.
  • the at least one tissue manipulator forms the separation region by forming a groove in the body tissue, for example a circumferential groove or an arc-shaped groove, optionally surrounding at least partly the body tissue.
  • the at least one tissue manipulator forms the separation region by grasping the body tissue, for example by engaging or increasing an engagement of the at least one tissue manipulator and the body tissue, optionally by increasing friction or grasping force between the two.
  • a tissue sample is separated from the body tissue, at block 107.
  • the tissue sample is separated from the body tissue at the separation region.
  • the tissue sample is separated from the body tissue by applying forces, for example tearing and/or shearing forces on the tissue at the separation region.
  • the tissue sample is separated by rotating the sampling portion.
  • the tissue sample is separated by pulling or retracting the sampling portion out from the body tissue.
  • FIG. 1 depicting a tissue sampling process by formation of a separating region in a tissue, according to some exemplary embodiments of the invention.
  • At least one tissue manipulator for example tissue manipulators 109 and 111 penetrates into a portion 113 of body tissue 115 located within an inner lumen 117 of a sampling portion 119.
  • the tissue manipulator penetrates into the tissue 113 during axial and/or rotational movement of the sampling portion into the body tissue 115.
  • the tissue manipulator penetrates into the tissue 113 when movement, for example axial movement of the sampling portion 119 into the body tissue 115 is stopped.
  • movement of the tissue manipulator forms a separation region 121 in the tissue portion 113 located within the lumen 117, for example as shown in Figure 1c.
  • the formed separation region is a region in the tissue that is more susceptible to a force applied on the tissue, leading to a separation of the tissue 113 at the tissue separation region 121.
  • a width, for example diameter, of the tissue in the separation region 121 is smaller compared to width of the tissue distally and/or proximally to the region 121.
  • the separation region 121 is a region which concentrates forces applied on the tissue 113 within the sampling region, leading to tearing or separation between two parts of the tissue 113 at the separation region 121.
  • retraction and/or rotation of the sampling portion in rotation direction 139 while the tissue manipulators are located within the separation region applies forces, for example tearing and/or shearing forces on the tissue 113 at the separation region 121.
  • the applied forces lead to separation of a sample, for example a tissue sample 123 located within the lumen 117 and proximally to the manipulators 111 and 109, from the rest of the tissue 113 located within and outside the inner lumen 117.
  • the rest of the tissue 113 is located at the separation region and/or distally to the manipulators 109 and 111.
  • formation of the separation zone 121 allows, for example, to determine a location of a separation plane between a tissue sample 123 and the rest of the body tissue 113 located within the inner lumen 117.
  • Exemplary general tissue sampling process
  • a biopsy device is used for sampling soft tissue, for example for taking biopsy samples from soft tissue of the body, for example from tissue of a pancreas, a liver, at least one lymph node, a lung, a spleen, and/or a gland, for example a thyroid gland.
  • the biopsy device is used to sample tissue suspected as cancerous tissue.
  • a sampling portion of the biopsy device for example a sampling needle located at a distal section of the biopsy device is axially advanced while being rotated, in synchronization, and optionally in a specific ratio, into the tissue.
  • a tissue sample is separated from tissue entering the sampling portion, when the sampling portion is rotated in a direction that is opposite to a rotation direction used when penetrating into the tissue.
  • FIG. 1 depicting a process for sampling soft tissue, for example sampling a volume within soft tissue optionally including cancerous tissue or a tumor, according to some exemplary embodiments of the invention.
  • a biopsy device is advanced towards a target tissue, at block 102.
  • a flexible shaft terminating with a sampling portion for example a sampling needle, is advanced towards the target tissue.
  • the flexible shaft terminating with the sampling portion is advanced towards a target tissue within and/or via a working channel of an endoscope.
  • the sampling portion comprises at least one tissue manipulator, for example a cutter configured to extend into an inner lumen of the sampling portion.
  • the inner lumen is optionally blocked by a tissue penetrator.
  • a distal tip of the tissue penetrator extends at least partially through a distal opening of the sampling portion facing the tissue, and is configured to form a cut, for example a thin cut in a wall of the tissue, for example as described in W02022003691A1, incorporated herein as a reference in its entirety.
  • the tissue penetrator body in the inner lumen pushes the at least one tissue manipulator towards a wall, for example an inner surface of a wall of the sampling portion.
  • the tissue penetrator is optionally removed from the inner lumen, at block 103.
  • the tissue penetrator is removed by retracting the tissue penetrator from the inner lumen.
  • removal of the tissue penetrator unblocks the inner lumen of the sampling portion and optionally, allows the at least one tissue manipulator to move into the inner lumen, for example to recover from a deflection of the tissue manipulator caused by the tissue penetrator.
  • the sampling portion is axially advanced while being rotated around a long axis of the sampling portion, into body tissue, for example soft body tissue, at block 104.
  • the advancement of the sampling portion into the body tissue introduces body tissue into the inner lumen of the sampling portion.
  • the body tissue enters into the inner lumen through a distal opening of the sampling portion and optionally beyond or proximally to an axial position of the at least one tissue manipulator, for example the at least one cutter within the inner lumen.
  • stopping the movement comprises stopping axial and rotation movement of the sampling portion.
  • stopping movement comprises stopping axial movement of the sampling portion into the tissue, while optionally maintaining rotation of the sampling portion.
  • the sampling portion is rotated in an opposite direction, at block 108.
  • the sampling portion is rotated in a direction that is opposite to the rotation direction used at block 104 when axially advancing the sampling portion into the tissue.
  • the tissue manipulator generates a separating region in the body tissue, at block 110.
  • the tissue manipulator generates the separating region by forming a cut or a groove, for example a circumferential cut or a circumferential groove, in the body tissue inside the inner lumen, for example to separate a tissue sample from the body tissue, at block 110.
  • the tissue manipulator manipulates the tissue, for example cuts or forms a grove, and separates the tissue sample from the body tissue while the sampling portion is rotated at block 108.
  • the separated tissue sample is removed from the sampling portion inner lumen, at block 112.
  • the separated tissue sample is removed from the inner lumen via the distal opening of the sampling portion.
  • the separated tissue sample is removed via a proximal opening of the sampling portion, for example when the sampling portion is separated from a shaft used to rotate the sampling portion, or when the sampling portion is disassembled, for example to extract the separated tissue sample.
  • the sampling portion of a biopsy device comprises at least one inner cutter, extending from the wall of the sampling portion into an inner lumen into which tissue is introduced from the outside.
  • the inner cutter is integrated with the sampling portion wall, or is coupled to the sampling portion wall.
  • a portion of the body tissue is introduced through a distal opening of the sampling portion into the inner lumen, and contacts the at least one inner cutter.
  • the at least one inner cutter is a movable inner cutter, and is optionally a flexible inner cutter, configured to move between a first position where the inner cutter extends into the inner lumen, and a second position in which the inner cutter is pushed against the sampling portion wall.
  • the inner cutter is configured to extend into the inner lumen of the sampling portion in a relaxed state, for example when there is no mechanical force applied on the inner cutter. In some embodiments, when the inner cutter is pushed towards the sampling portion wall, the inner cutter penetrates at least partly into an opening, for example a cut out window in the sampling portion wall.
  • a sampling portion of a biopsy device is positioned next to a body tissue to be sampled, prior to penetration into the body tissue, at block 204.
  • the sampling portion position is stationary, and the body tissue is outside the sampling portion inner volume.
  • the at least one movable inner cutter is bent into the inner volume of the sampling portion.
  • the movable inner cutter is inwardly extends from the wall of the sampling portion into the inner volume, and is optionally in a relaxed state.
  • the sampling portion is advanced into the body tissue.
  • the sampling portion is axially advanced while being rotated around a long axis of the sampling portion.
  • body tissue enters into the inner lumen of the sampling portion while being attached to body tissue outside the sampling portion.
  • the body tissue entered into the inner lumen pushes the at least one inner cutter towards the wall of the sampling portion, for example towards an opening in the wall.
  • the at least one inner cutter is pushed towards the sampling portion wall, until the at least one inner cutter is at least partly substantially aligned with the wall, for example is positioned in an angle smaller than 7 degrees, for example smaller than 5 degrees, smaller than 3 degrees or any intermediate, smaller or larger angle, relative to the wall.
  • body tissue entering the inner lumen is advanced to a location within the inner lumen that is proximal to the at least one inner cutter, for example a location between the inner cutter and a proximal opening or a proximal end of the biopsy device.
  • the movement of the sampling portion into the body tissue is stopped, at block 208.
  • axial advancement of the sampling portion into the body tissue and/or movement of the body tissue within the inner lumen of the sampling portion is stopped. Additionally, rotation of the sampling portion is stopped at block 208.
  • at block 208 at least one elongated portion of body tissue is positioned in the inner lumen between a location proximal to the inner cutter and the distal opening of the sampling portion, and is optionally still connected to body tissue outside the sampling portion.
  • the cutter inwardly bends into the inner lumen and into the body tissue, for example soft body tissue, in the inner lumen.
  • an angle between the at least one inner cutter and the wall of the sampling portion is larger than 5 degrees, for example larger than 10 degrees, larger than 20 degrees, larger than 30 degrees, larger than 45 degrees, or any intermediate, smaller or larger angle value.
  • the angle between the inner cutter and the sampling portion wall is in a range between 5 degrees and 60 degrees, for example between 15 degrees and 50 degrees, between 20 degrees and 45 degrees, between 10 degrees and 30 degrees, or any intermediate, smaller or larger range of angles.
  • the sampling portion is rotated at block 210, optionally at a direction that is opposite the rotation direction when the sampling portion is advanced into the body tissue, at block 206.
  • the movable cutter cuts and separates, at least partly, a sample, from the body tissue positioned inside the inner lumen of the sampling portion.
  • rotation of the sampling portion rotates the inner cutter and forms a circumferential cut through the body tissue, separating at least partly a sample of tissue located proximally to the inner cutter from the body tissue positioned within the sampling portion.
  • a sampling portion of a biopsy device for example a sampling needle, has an elongated optionally tubular body with a distal opening to an inner lumen of the tubular body.
  • the body has a tapered distal end surrounding the distal opening, and is shaped and sized to allow penetration through tissue, for example soft tissue, of the body.
  • penetration of the distal end, for example the tapered distal end into the tissue forms a circular cut in the tissue allowing a portion of the tissue body to enter through the distal opening into the body inner lumen.
  • the sampling portion comprises at least one, for example 2, 3, 4, 5 6 or any larger number of tissue manipulators, for example inner cutters, extending from the wall of the sampling portion into the inner lumen.
  • the inner cutters are configured to form a cut in the body tissue portion positioned in the inner volume, causing at least a partial separation of a tissue sample from the body tissue portion.
  • FIG. 3a depicting a longitudinal cross-section of a sampling portion of a biopsy device which comprises at least one, for example at least two, inner cutters, according to some exemplary embodiments of the invention.
  • a biopsy device sampling portion for example sampling portion 302 comprises an elongated hollow body 304, having an inner lumen 306, a long axis 308, a distal end 310 and a proximal end 312.
  • the body comprises a distal opening 314 to the inner lumen 306, at the distal end 310.
  • the distal end is a flat straight end.
  • the distal end is substantially perpendicular to a long axis of the sampling portion.
  • substantially perpendicular means with a deviation of up to 5% from a 90 degrees angle.
  • the distal end is a beveled end.
  • the sampling portion body has a circular, oval or an ellipsoid transverse cross-section, for example at the distal end 310.
  • the sampling portion body is tubular, for example to allow passage of tissue through the distal opening 314 into the inner lumen 306.
  • the sampling portion comprises at least one tissue manipulator, for example at least two tissue manipulators.
  • the at least two tissue manipulators comprise at least two inner cutters 316 and 318.
  • the at least two cutters 316 and 318 are coupled to a wall 320 of the body 304 surrounding the inner lumen.
  • the at least two cutters 316 and 318 are partial cut out portions of the wall 320.
  • a coupling region between each of the cutters 316 and 318 and the wall for example coupling regions 315 and 317 respectively, is located at a distance 322 from the distal end 310 or the distal opening 314.
  • the coupling regions function as hinge regions.
  • the coupling regions allow for example the cutters 316 and 318 to elastically deflect towards the wall and to recover from the deflection, for example by bending inwardly, back into the inner lumen 306.
  • the distance 322, which is the axial distance from a distal end 310 of the sampling portion and an axial position of the one or more or all of the inner cutters is within a range between 0.1 mm and 50 mm, for example between 0.2 mm and 20 mm, between 2 mm and 15 mm, between 4 mm and 12 mm, or any intermediate, smaller or larger range of values.
  • the distance 322 is between 0.2- and 4 times of the inner width of the sampling portion 302, for example the diameter of the sampling portion 302, for example 0.2-1 times of the width, 0.5- 1.5 times of the width, 1-2 times of the width, 2-4 times of the width or any intermediate, smaller or larger value or range of values.
  • the cutters are located at a distance of 0 to 2 times of the width of the sampling portion following the inner sharpening, for example at a distance of 0 to 1 of the width, 0.5-1 of the width, or any intermediate, smaller or larger range of values following the inner sharpening.
  • the sampling portion comprises an outer sharpening surrounding at least part of the distal opening.
  • the inner and/or outer sharpening are configured to form a circular cut in the body tissue when the sampling portion axially advances into the body tissue
  • an inner cutter for example cutters 316 and 318 inwardly extends from the wall 320 into the inner lumen 306 in a direction of the proximal end 312, in a maximal angle 324 between a cutter and the wall 320.
  • the maximal angle value is in a range between 3 degrees and 90 degrees, for example in a range between 5 degrees and 45 degrees, in a range between 10 degrees and 30 degrees, or any intermediate, smaller or larger range of values.
  • the inner cutter for example cutters 316 and 318, is flexible and is configured to move between a first state, an extended state, where the cutter extends into the lumen 306 in the maximal angle 324, to a second state, where the cutter is substantially aligned with the wall, for example is in an angle 324 smaller than 5 degrees, for example smaller than 3 degrees, smaller than 2 degrees, or any intermediate, smaller or larger angle, with the wall 320.
  • the cutter for example cutters 316 and 318, are partly cut out portions of the wall 320, remain coupled to the wall 320 in the connection region, for example connection regions 315 and 317.
  • the cutter for example cutters 316 and 318, is integrated with the wall 320 and is optionally formed from the same material of the wall 320.
  • the cutter for example cutters 316 and 318 is thinner than the wall 320, and has a maximal thickness of up to 0.8 of the wall thickness, for example up to 0.6 of the wall thickness, up to 0.5 of the wall thickness, up to 0.3 of the wall thickness or any intermediate, smaller or larger value.
  • the cutter for example cutters 316 and 318 is formed from a superelastic material or a shape memory alloy material, for example Nitinol (Nickel Titanium), CuAlNi (Copper Aluminum Nickel), CuZnAl (Copper Zinc Aluminum), Fe-Mn-Si (Iron Manganese Silicon), NiTiCu (Nickel Titanium Copper), CuSnZn (Copper Tin Zinc), and TiPd (Titanium Palladium).
  • the material forming the cutter and/or the sampling portion is a biocompatible material.
  • the sampling portion 302 or body 304 is also formed from the shape memory alloy, or from a shape memory alloy or a material which is different from the material used for forming the cutter for example cutters 316 and 318.
  • the cutter is optionally elastic.
  • the cutter when the cutter is in a relaxed state, the cutter inwardly extends into the lumen 306, and acquires the extended state.
  • a force for example a mechanical force is applied on the cutter within the lumen 306 in a radial direction, for example in a direction towards the wall 320, the cutter is pushed towards the wall 320, for example as long as the mechanical force is applied on the cutter.
  • the tissue axial force applies force, for example bending moment, on the cutters that push the cutters in an outer radial direction.
  • the cutter when the application of the mechanical force is stopped, the cutter returns to a relaxed extended state into the lumen 306.
  • maximal angle 324 is acquired when the cutter is in a relaxed state.
  • the cutter for example one or more of the cutters 316 and 318 is coupled to the wall 320 via at least one hinge or a hinge portion.
  • the hinge portion is elastic, and is configured to allow inwardly bending of the cutter into the lumen 306, when the hinge portion is in a relaxed state.
  • Figure 3b showing one or more inner cutters substantially aligned with the wall of a sampling portion
  • Figure 3c showing the one or more inner cutters inwardly extending into an inner lumen of the sampling portion, according to some exemplary embodiments of the invention.
  • the at least one inner cutter for example cutters 316 and 318, is configured to move into an opening in the wall 320.
  • the at least one inner cutters moves into the wall, and is substantially aligned with the wall, when a mechanical force is applied on the cutter from within the lumen 306.
  • the force is applied on the cutter in a proximal and/or a radial direction, pushing the cutter into the opening in the wall.
  • the force pushes the cutter against the wall, for example against the inner surface of the wall, optionally attaching the cutter to the inner surface of the wall.
  • a tissue penetrator 340 positioned inside the lumen 306 extending through the distal opening 314 is used to penetrate through more rigid and/or elastic portions of a tissue wall, when advancing the sampling portion to a target soft tissue of the body.
  • the tissue penetrator 340 when the tissue penetrator 340 is in the lumen 306, it applies a mechanical force on the at least one cutter, for example cutters 316 and 318, pushing the cutter, at least partly into the wall.
  • the tissue penetrator pushes the cutter against the wall.
  • body tissue when body tissue enters the lumen 306 through the distal opening, it applies force on the cutter, pushing the cutter at least partly into the wall, or against the wall.
  • the cutter when there is no force applied on the cutter, for example cutters 316 and 318, from within the lumen 306, the cutter extends into the lumen 306, optionally in a maximal angle 324.
  • a cutter for example cutter 340 has a first end 342 coupled or integrated with the wall 320, and a second end 344 located at a distance from the wall 320.
  • the second end 344 is configured to be positioned within the inner lumen 306 when the cutter 340 inwardly extends into the lumen 306, for example when the cutter is relaxed from deflection or in a rest state.
  • the cutter comprises a cutting edge located in a region between the first end 342 and the second end 344.
  • the cutting edge is located at the second end 344.
  • two or more cutters are coupled to the wall 320, for example to the wall circumference.
  • the cutters 346 and 348 are coupled to the wall at opposite locations on the wall circumference.
  • each of the cutters 346 and 348 extend inwardly into the lumen 306 and are oriented such that a distal end of each cutter points toward a proximal end of the sampling portion.
  • each of the cutters is oriented in a similar angle relative to the wall 320.
  • the cutters for example cutters 346 and 348 are oriented such that a cutting edge of the at least some, or all of the cutters, for example cutters 346 and 348, have the same axial position relative to along axis of the sampling portion, for example to allow formation of a single cutting plane 350 in a tissue contacting the cutting edges.
  • the cutters 346 and 348 form the cutting plane 350 when the sampling portion and cutters 346 and 348 are rotated around the lone axis of the sampling portion body, and optionally, without axial movement of the sampling portions and the cutters 346 and 348.
  • a potential advantage of having a single cutting plane 350 is that it enables to separate between a proximal tissue sample that continues to flow within the inner lumen of the sampling portion and a distal tissue that continue to be connected to the organ tissue.
  • tissue may be trapped by the cutters blocking penetration of tissue into the sampling portion.
  • a biopsy device comprising a sampling portion with an inner cutter, for example a flexible inner cutter, is configured for removing tissue samples, for example biopsy samples, from a soft tissue.
  • the soft tissue includes tissue suspected as a tumor, and the device is configured to remove at least one sample from the suspected tissue.
  • the device cuts the tissue sample by rotating and axially advancing a sampling portion, for example a needle, at a distal end of the device into the tissue, for example soft tissue.
  • the device rotates the sampling portion at an opposite direction to allow separation of a tissue sample from tissue within the sampling portion, and/or to allow separation of consecutive tissue samples from the tissue without pulling the device completely out from the tissue after each tissue sampling.
  • FIG. 3f depicting a biopsy device, also termed herein as a biopsy system, according to some exemplary embodiments of the invention.
  • biopsy device for example a device 350 comprises a control unit 352 and a sampling portion 354, for example a needle, mechanically coupled to the control unit 352 via an elongated flexible shaft 356.
  • the flexible shaft 356 is a torque coil, for example a braided torque coil configured axially advance and rotate the sampling portion 354 in different directions.
  • the flexible shaft is formed from interwoven strands of wire coupled together, optionally in a helical formation.
  • control unit 352 comprises a control circuitry 356 functionally coupled to at least one actuator 358.
  • the at least one actuator comprises a motor, for example an electric motor.
  • the at least one actuator comprises a hydraulic or a pneumatic actuator.
  • the shaft 356 is functionally coupled to the at least one actuator 358.
  • control unit 352 comprises a memory circuitry 360, storing one or more movement parameters of the sampling portion, for example axial advancement velocity, rotation tangential velocity, a ratio between axial velocity and tangential velocity, rotation direction, axial advancement direction, and/or duration of the sampling portion movement.
  • control unit 352 comprises a user interface 362, configured to generate a human detectable indication and/or to receive input data from a user of the device 350, for example a physician, a surgeon, an expert or a technician.
  • input data comprises one or more of the movement parameters stored in the memory 360.
  • control circuitry 356 is configured to signal said actuator 358 to rotate and/or to axially advance the shaft 356 and the sampling portion 354, according to the movement parameters stored in the memory 360.
  • the control circuitry 356 signals the actuator to axially advance the shaft 356 and the sampling portion 354 at the distal end of the shaft 356. Additionally, the control circuitry 356 signals the actuator 358 to rotate the shaft 356 and the sampling portion 354 in a first direction, for example in direction 754 shown in Figure 7d, simultaneously and optionally in synchronization with the axial advancement.
  • tissue enters via a distal opening 354 of the sampling portion 354 into an inner lumen 366 of the sampling portion 354. In some embodiments, the tissue entering into the lumen push the inner cutters, for example cutter 368 towards a wall 370 of the sampling portion.
  • the control circuitry 356 signals the actuator 358 to stop the axial advancement of the shaft 356 and sampling portion 370. Additionally, in some embodiments, the control circuitry 356 signals the actuator 358 to stop rotation of the shaft and sampling portion in the first direction.
  • the control circuitry signals the actuator 358 to rotate the shaft 356 and the sampling portion in a second direction which is opposite to the first direction, for example in direction 746 shown in Figure 7d.
  • the control circuitry signals the actuator to rotate the shaft 356 and the sampling portion 354 in the second direction for a predetermined time period and/or with a different rotation angle and/or for a selected number of rotations.
  • the control circuitry 356 signals the actuator 358 to retract the shaft and the sampling portion, optionally in a predetermined distance, for example in a predetermined step. In some embodiments, retraction of the sampling portion is performed after rotation of the sampling portion.
  • retraction of the sampling portion allows to separate a tissue sample from tissue within the lumen 366, for example as shown in Figure 5g.
  • retraction is manual while axial forward advancement and/or rotation is motorized.
  • the control circuitry 356 signals the actuator to repeat a sequence of (1) axial advancement while rotating in the first direction, (2) stopping axial advancement, (3) rotating in the second direction, (4) retracting of the sampling portion, and optionally repeating in order to acquire additional tissue samples.
  • a tissue sampling device for example a biopsy device, is used to take long continues samples of soft tissue of the body for example tissue of, pancreas, liver, lymph nodes, spleen, lung, a gland, adrenal gland, kidney, esophagus wall, stomach wall, an organ of a gastrointestinal tract (GI) tract.
  • the biopsy device is used to cut and separate long tissues samples from body tissue, having a length of at least 1mm, for example at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm or any intermediate, smaller or larger length of a tissue sample.
  • the biopsy device is used to obtain several separated long tissue samples in a single passage of the device within the body tissue, and optionally without retracting the device out from the body tissue.
  • the tissue sample comprises tissue suspected to be cancerous tissue, or tissue of a tumor, or a tissue mass.
  • FIG. 4 depicting a flow chart of a sampling process, according to some exemplary embodiments of the invention.
  • a biopsy device is advanced towards a target tissue, at block 402.
  • the biopsy device comprises a flexible shaft terminating with a distal sampling portion, for example a hollow needle, at the distal end of the shaft.
  • the biopsy device comprises an elongated tissue penetrator, for example the tissue penetrator described in W02022003691A1 incorporated by reference herein in its entirety.
  • the elongated tissue penetrator pass within the shaft and the inner lumen of the sampling portion, and extends through a distal opening of the sampling portion.
  • the biopsy device is advanced, for example within a working channel of an endoscope, towards a wall of a tissue.
  • the biopsy device penetrates through the wall, optionally using the tissue penetrator, at block 404.
  • a distal end of the biopsy device penetrates through the tissue wall using the tissue penetrator that extends distally to the biopsy device distal end.
  • the tissue penetrator is retracted out from the sampling portion lumen, at block 406.
  • retraction of the tissue penetrator allows the one or more inner cutters to bend inwardly from a wall of the sampling portion, at block 408.
  • tissue penetrator there is no tissue penetrator within the biopsy device lumen or the sampling portion lumen, and the one or more inner cutters are already bended inwardly from the wall into the inner lumen during the advancement of the biopsy device.
  • the process shown in Figure 4 does not include blocks 404, 406 and/or 408.
  • the sampling portion is axially advanced while being rotated, into the tissue, at block 410.
  • rotation of the sampling portion refers to turning the sampling portion around its long central axis, optionally in a circular motion.
  • the sampling portion is rotated with a tangential velocity in a range between 2.5- 1000 mm/second (sec), for example 2.5-40 mm/sec, 30-40 mm/sec, 35-45 mm/sec, 30-50 mm/sec, 10-100 mm/sec, 50-500 mm/sec, 300-1000 mm/sec or any intermediate, smaller or larger range of values.
  • the sampling portion is axially advanced into the tissue in an axial velocity in a range between 1-100 mm/sec, for example in an axial velocity in a range of 1-10 mm/sec, 5-12 mm/sec, 5-15 mm/sec, 5-50 mm/sec, 10-100 mm/sec, or in any intermediate, smaller or larger range of values.
  • a ratio between the tangential rotation velocity and the axial velocity is between a ratio of 1 and a ratio of 10, for example between a ratio of 3.5 and a ratio of 4.5, for example between a ratio of 2 and a ratio of 5, or any intermediate, smaller larger range of values.
  • the ratio is fixed during the advancement of the sampling portion into the tissue.
  • the sampling portion is axially advanced forward into the tissue while being rotated in a direction where a distal end of the tissue manipulators, for example cutters, coupled to the wall, is the leading end which first faces the tissue entering into the sampling portion lumen.
  • tissue enters through a distal opening of the sampling portion into the sampling portion lumen, at block 412.
  • the tissue entering into the lumen remains connected to the tissue outside the sampling portion.
  • the tissue entering the sampling portion lumen is condensed due to the narrowed inner width of the sampling portion relative to the width of the distal opening at the tapered distal end.
  • the entering tissue pushes, for example outwardly pushes the cutters towards the wall of the sampling portion.
  • tissue moves proximally to the cutters at block 414.
  • advancement of the sampling portion into the tissue is stopped at block 416.
  • axial advancement and rotation of the sampling portion are stopped at block 416.
  • the inner cutters bend inwardly into tissue in the sampling portion lumen, at block 418.
  • the cutters are bent into the tissue in the inner lumen and increase contact and/or friction between at least one cutting edge of each cutter and the tissue in the inner lumen.
  • the sampling portion is rotated around the sampling portion long central axis, in a direction opposite to the direction used when the sampling portion advanced into the tissue at block 410. For example in a direction in which a proximal free end of the tissue manipulators is used as a leading edge faces the tissue during the rotation. In some embodiments, rotation of tissue manipulators at block 420 pushes the proximal free end of one or more tissue manipulator into the tissue.
  • tissue in the inner lumen is cut by the tissue manipulators for example cutters, at block 422.
  • at least one edge for example a cutting edge at a free proximal end of the cutters penetrates into the tissue when the sampling portion rotates at block 420, forming a circular cut optionally a circumferential cut or groove, in the tissue.
  • the sampling portion is retracted while the cutters are positioned inside the tissue.
  • a tissue sample is separated from the tissue in the sampling portion lumen, at block 424.
  • the tissue sample is separated from the tissue in the sampling portion at the cutting plane formed by the cutters at block 422.
  • rotation of the sampling portions during the cutting at block 422 applies forces, for example cutting, tearing and/or shearing forces at a cutting plane, for example at a plane between tissue distal to the cutting plane and tissue proximal to the cutting plane, leading to separation of the proximal tissue, now a tissue sample, from tissue distal to the cutting plane which remains coupled to the tissue outside the sampling portion.
  • the cutting place is located at a separation region formed by the cutters.
  • the tissue sample is separated from tissue in the sampling portion by tearing, for example by retracting the sampling portion after or during the cut formation at block 422
  • the sampling portion is rotated and is further axially advanced into the tissue, at block 410, for example to acquire at least one additional sample.
  • retraction of the sampling portion with or without rotation tears or separates the tissue sample from the rest of the tissue within the sampling portion.
  • the tissue sample is removed from the sampling portion lumen, at block 426.
  • the tissue sample is removed from the distal opening, for example through a lumen of an additional tube, for example a thin wall tube, inserted into the inner lumen of the sampling portion through the distal opening and pushes the cutters towards the sampling portion wall or against the wall.
  • the tissue sample is removed from a proximal opening of the sampling portion, for example after decoupling of the sampling portion from a flexible shaft.
  • the tissue sample is remove by cutting of the sampling portion, for example a sampling needle, to extract the tissue sample.
  • the tissue sample is flushed out from the sampling portion lumen, for example through a distal or a proximal opening, by introducing fluid, for example liquid or air into the lumen.
  • the tissue sample is removed from the sampling portion lumen by application of vacuum on the lumen through a distal or a proximal opening.
  • the tissue sample is removed from the sampling portion lumen by introduction of an elongated pushing element that is configured to push the sample out from the lumen through a distal or a proximal opening.
  • FIGS 5a-5f depicting a tissue sampling process using a biopsy device having a distal sampling portion, for example a needle, with at least one inner cutter, according to some exemplary embodiments of the invention.
  • a sampling portion 502 is advanced towards a target tissue 504, for example soft tissue, having a tissue wall 506, at least partially surrounding the target tissue 504.
  • a tissue penetrator 508 is positioned within an inner lumen 510 of the sampling portion and extends through the distal opening of the sampling portion 502.
  • the biopsy device including the sampling portion 502 and the tissue penetrator 508 is axially advanced towards the target tissue 504 within a working channel of an endoscope.
  • the axial advancement of the biopsy device in Figure 5a is manual, for example by manually pushing the biopsy device towards the target tissue 504.
  • the movement of the biopsy device in Figure 5a is motorized, and is optionally in steps.
  • the axial advancement of the biopsy device includes rotation or without rotation of the sampling portion of the biopsy device.
  • a length of each step is predetermined and is optionally equal.
  • the length of each step is determined based on a distance between the biopsy device and the target tissue or target tissue wall. For example, as the biopsy device gets closer to the target tissue or target tissue wall, the steps become shorter.
  • the advancement of the biopsy device for example the biopsy device sampling portion towards a target tissue is monitored using image processing based on one or more imaging modalities, for example using ultrasound imaging.
  • the at least one cutter when the tissue penetrator 508 is within the inner lumen 510, the at least one cutter, for example cutters 512 and 514, is attached, at least partly, to the wall 516, for example to the inner surface of the wall 516.
  • the at least one cutter is located, at least partly within an opening in the wall 516.
  • the biopsy device penetrates through the wall 506 using the tissue penetrator 508.
  • the tissue penetrator perform a thin cut in the tissue wall, for example as described in W02022003691A1 incorporated by reference herein in its entirety.
  • the tissue penetrator 508 is removed from the inner lumen 510 of the sampling portion 502.
  • the at least one cutter for example cutters 512 and 514 inwardly bend into the inner lumen 510 while remaining coupled to the wall 516.
  • the distal end of the sampling portion comprising the distal opening 520 face the target tissue 504.
  • the sampling portion 502 is now axially advanced into the target tissue 504, while being rotated around a central axis 522 of the sampling portion 502.
  • a circumferential cutting surrounding the distal opening 520 cuts through the target tissue.
  • following cutting and during the axial advancement a portion of the target tissue enters the inner lumen 510 via the distal opening 520 while remaining coupled to tissue outside the sampling portion 502.
  • tissue entering the lumen 510 push the cutters 512 and 514 towards the wall 516.
  • the cutters 512 and 514 are pushed at least partly into openings in the wall 516, where each cutter is pushed at least partly into a different opening in the wall 516.
  • the cutters 512 and 514 are pushed towards an inner surface of the wall 516.
  • tissue in the lumen 510 penetrates proximally to the cutters 512 and 514.
  • axial advancement of the sampling portion 502 into tissue 504 is stopped. Additionally, rotation of the sampling portion is also stopped.
  • the dynamic radial force applied by the tissue on the cutters 512 and 514 in the direction of the wall 516 is reduced, and the cutters 512 and 514 inwardly bend into the lumen 510 and into the tissue in the lumen.
  • the cutters 512 and 514 when a force applied on the cutters 512 and 514 by the tissue in the lumen 510 is reduced, the cutters 512 and 514, for example flexible and optionally elastic cutters, are allowed to return to a relaxed state and to bend into the lumen 510.
  • the cutters are elastically deflectable.
  • the cutters when the force applied by the tissue on the cutters is reduced the cutters recover from deflection, and at least a portion of the cutters inwardly bend into the tissue.
  • each cutter when the cutters 512 and 514 are bent into the tissue, a cutting edge of each cutter contacts the tissue.
  • the sampling portion is rotated.
  • the sampling portion is rotated in an opposite direction to the rotation direction applied during axial advancement onto the tissue as shown for example in Figures 5d and 5e.
  • rotation of the sampling portion moves the cutters around the tissue in the lumen, forming a circumferential cut, or a groove, in the tissue, optionally in a single cutting plane.
  • the sampling portion is retracted from the tissue.
  • retraction of the sampling portion tears, and/or twists, and/or applies shearing forces on the tissue inside the lumen at the single cutting plane, for example on tissue at the formed separation region, leading to separation of a tissue sample, for example tissue sample 530, located proximal to the cutting plane from tissue in the lumen located distally to the cutting plane, for example between the cutting plane and a distal opening of the sampling portion.
  • tissue sample for example tissue sample 530
  • the inwardly bended cutters 512 and 514 prevent movement of the tissue sample 530 distally to the cutters 512 and 514, acting as a one-way valve.
  • repeating the actions as shown for example in Figure 5e-5g allows to separate multiple tissue samples, for example tissue samples 530, 532, 534 and 536, without pulling the sampling completely out from the organ, for example from the tissue 504.
  • one or more tissue samples located within the sampling portion are extracted at the end of the tissue sampling procedure.
  • the one or more tissue samples are extracted from the sampling portion when the sampling portion is removed from the patient body.
  • the cutters are removed from the sampling portion lumen or are pushed against or into the sampling portion wall.
  • the cutters change orientation between a flexible state to a stable non-flexible plastic state based on a plastic to elastic transition temperature, for example the cutters are elastic in body temperature, and plastic in room temperature.
  • a cutters opener 602 is pushed into the lumen 510 via the distal opening 520.
  • the cutters opener 602 pushes the cutters 512 and 514 against the wall 516 or into openings in the wall 516.
  • the cutters 512 and 514 remain attached to the wall 516 or within the wall 516, by friction forces between the wall and each cutter, and/or by shifting the cutters from elastic to plastic configuration, for example based on the elastic to plastic transition temperature of the cutters.
  • the tissue samples are moved to the distal opening 520 and out from the distal opening 520 by application of vacuum from the distal opening or, for example as shown in Figure 6b, by pushing the tissue samples 606 and 608 out from the lumen 510 via the distal opening 520 by a pusher shaft 610, inserted into the sampling portion lumen through a proximal opening of the sampling portion.
  • fluid can be used to flush out the one or more tissue samples.
  • a tissue extraction tube for example tube 612 is pushed through the distal opening 520 and pushes the cutters 512 and 514 towards the wall 516.
  • the pusher shaft 610 pushes the tissue samples 606 and 608 into the tube 612 and out from the sampling portion.
  • the tissue extraction tube 612 has a beveled tip for example to allow easy insertion of the tube 612 into the sampling portion 502 via the distal opening 520.
  • the sampling portion 502 for example a sampling needle, is coupled to a flexible shaft 620.
  • the flexible shaft is configured to deliver rotation and/or axial force from at least one motor of the biopsy device and the sampling portion 502.
  • the flexible shaft is flexible enough to transmit rotation and/or axial movement when the shaft is at least partly within a working channel of an endoscope, for example within a working channel of a flexible endoscope.
  • the shaft 620 is coupled to the sampling portion 502 via at least one connector 622, for example a snap-fit connector, or a bayonet connector.
  • the connector is a circumferential connector.
  • the sampling portion 502 in order to extract tissue samples 606 and 608 from the sampling portion lumen, is released from the shaft 620, for example by releasing the sampling portion 502 and/or the shaft 620 from the connector 622, for example as shown in Figure 6f, or by cutting the sampling portion 502.
  • a proximal opening 624 of the sampling portion 502 allows access to the lumen 510 and/or to the tissue samples 606 and 608.
  • a pusher shaft 630 is inserted into the lumen 510 through the distal opening 520, moves the cutters 512 and 514 towards the wall 516 and pushes the tissue samples, for example samples 606 and 608 in the lumen 510 out from the sampling portion 502 via the proximal opening 624.
  • fluid for example saline
  • fluid is injected through the distal opening 520 to flush out the samples, for example samples 606 and 608 out from the sampling portion 502 through the proximal opening 624, and/or through a proximal opening of a shaft coupled to the sampling portion or through a proximal opening of a handle coupled to the shaft.
  • vacuum is applied to remove tissue via an opening at a proximal end of the sampling portion or biopsy device, or by pushing a shaft or a tube into the lumen and towards the proximal end.
  • each cutter for example each flexible or elastic cutter, is a portion of the sampling portion wall, partially cut out from the wall.
  • Figures 7a-7e depicting one or more cutters which are partial cut out portions of a biopsy device sampling portion, according to some exemplary embodiments of the invention.
  • a biopsy device sampling portion 702 comprises an elongated body 704 having a distal end 706 and a proximal end 708.
  • the body is a hollow body, having an inner lumen extending between the distal end 706 and the proximal end 708.
  • the body 704 is tubular.
  • the inner lumen of the body 704 comprises a distal opening 710 at the distal end 706.
  • the distal end 706 is a flat and straight distal end.
  • the sampling portion 702 comprises at least one tissue manipulator, for example least one cutter 714, which is optionally a flexible or elastically deflectable.
  • the cutter 714 is a cut out portion of a wall of the body, for example wall 716.
  • an arc-shaped cut, for example a U-shaped cut 718 is formed in the wall 716, at a distance 720 from the distal end 706.
  • a value of the distance 720 is within a range between 0.5 mm and 10 mm, for example within a range between 0.5 mm and 3 mm, within a range between 1 mm and 5 mm, or any intermediate, smaller or larger range of values.
  • the cutter 714 is formed and a long axis 717 of the cutter 714 is oriented in an angle 719 relative to a traverse axis 720 of the body 704, for example an axis that is perpendicular to a long axis 722 of the body 704.
  • the angle 719 value is within a range between 5 degrees and 20 degrees, for example within a range between 5 degrees and 12 degrees, within a range between 8 degrees and 15 degrees, within a range between 10 degrees and 14.5 degrees, within a range between 12 degrees and 14.5 degrees, or any intermediate, smaller or larger range of values.
  • the angle 719 (01) value depends and/or is determined based on a ratio between axial velocity and tangential velocity of the sampling portion, for example according to the below calculation:
  • Vtangential CD x 71 x D
  • the sampling portion comprises two spaced apart cutters, 714 and 730, which are partial cut out portions of the wall 716.
  • each of the cutters for example flexible and optionally elastic cutters is formed by forming a U-shaped cut across the wall.
  • the cutters are located at opposite sides of the wall. In some embodiments, the cutters are aligned in the same direction.
  • the distal end 706 is a tapered end, surrounding the distal opening 710.
  • the distal end has an internal and/or an external sharpened edge, for example to allow the distal end to cut through tissue as it axially advances into the tissue, for example as shown in Figures 5d and 5e.
  • a maximal inner width 740 as shown in Figure 7c, for example inner diameter, of the sampling portion at the distal end 706 is within a range between 0.4-10 mm, for example 0.4-5 mm, 0.5-2 mm, 0.5-3 mm, 1-5 mm, 3-10 mm or any intermediate, smaller or larger range of values.
  • a minimal inner width 742 for example inner diameter of the sampling portion at a narrow part of the sampling portion is within a range between 0.5-8 mm, for example 0.5-2 mm, 1-2 mm, 1.5-5 mm, 2-8 mm, or any intermediate, smaller or larger range of values.
  • a maximal thickness 744 of the wall 716 is within a range between 0.04-2 mm, for example 0.04-1 mm, 0.05-0.1 mm, 0.05-0.2 mm, 0.1-2 mm or any intermediate, smaller or larger range of values.
  • each cutter 714 and 730 are aligned in the same circumferential direction 746.
  • each cutter comprises a distal end, for example base region 750 coupled to the wall 716, optionally integrated with the wall 716, and a proximal free end 752 configured to be positioned within the lumen 729 of the sampling portion 702.
  • each cutter comprises at least one cutting edge between the base 750 and the proximal free end 752, and optionally at the proximal free end 752.
  • the distal end 750 of the tissue manipulator is closer to a distal end and/or a distal opening of the sampling portion, compared to the proximal end 752 of the tissue manipulator.
  • a radius of curvature of the tissue manipulator between the distal end 750 and the proximal end 752 is about the radius of curvature of the sampling portion wall.
  • the radius of curvature of the tissue manipulator is smaller or larger in up to 50%, for example up to 40%, up to 30%, up to 15% or any intermediate, smaller or larger percentage value from to the radius of curvature of the sampling portion wall.
  • the tissue manipulator between the distal end 750 and the proximal end 752 is straight.
  • the sampling portion is rotated in direction 754, in which a base 750 is a leading end of the cutter during the rotation.
  • tissue entering into the sampling portion lumen push each of the cutters towards and optionally into, an opening in the wall, for example cutter 714 is pushed towards and optionally into opening 718 shown in Figure 7b.
  • rotation in direction 754 pushes each of the cutters at least partly into the opening in the wall.
  • the sampling portion in order cut the tissue within the sampling portion lumen, for example as shown in Figure 5g, is turned in direction 746, which is an opposite direction to direction 754, such that the distal end 752 is a leading end of the cutter, cutting through the tissue.
  • Figure 8a shows a tubular body of a sampling portion in an open and planar form, according to some exemplary embodiments of the invention.
  • each cutter for example cutters 802 and 804 are formed and positioned at a distance 806 from a distal end 808 of a sampling portion body.
  • a value of the distance 806 is within a range between 0.1-15 mm from the distal end of the sampling portion, for example 0.1-5 mm, 1-4 mm, 2-10 mm or any intermediate, smaller or larger range of values.
  • a distance between the cutters and the inner sharpening region is in a range of 0-2 mm, for example 0-1 mm, 0.1 -1.5 mm or any intermediate, smaller or larger range of values.
  • the cutters 802 and 804 have the same axial position on the body 810.
  • each of the cutters 802 and 804 is formed by cutting an arc- shaped cut, for example a U-shaped cut, across the wall 816, for example cuts 812 and 814 respectively.
  • the cut, for example a laser cut has a width 825 in a range between 0.005 and 0.05 mm, for example in a range between 0.01 and 0.05 mm, in a range between 0.015 and 0.03 mm, or any intermediate, smaller or larger range of values.
  • Figure 8b is an enlarged view of section 820 shown in Figure 8a, according to some exemplary embodiments of the invention.
  • each cutter for example cutter 802 is oriented in an angle 822, for example angle 01 calculated above, relative to a traverse axis 824 of the sampling portion body.
  • the angle 822 is within a range between 5 degrees and 20 degrees, for example within a range between 5 degrees and 12 degrees, within a range between 8 degrees and 15 degrees, within a range between 10 degrees and 14.5 degrees, within a range between 12 degrees and 14.5 degrees, or any intermediate, smaller or larger range of values.
  • the angle 822 is determined based on a ratio between axial advancement velocity and tangential velocity of the sampling portion.
  • a length 826 between a base 828 and a tip 830 of each cutter is within a range between 0.4 mm and 8 mm, for example in a range between 0.4 mm and 3 mm, a range between 1 mm and 5 mm, or any intermediate, smaller or larger range of values.
  • the length is determined based in the number of cutters and according to a circumference length:
  • Length 826 [l/(2XNumber of cutters)] of the circumference. For example, for 2 cutters the length 826 is 1/4 of the circumference.
  • a width 832 of a base region 828 of each cutter coupling the cutter to the wall is within a range between 0.2 mm and 2 mm, for example in a range between 0.5 mm and 1 mm, in a range between 1 mm and 2 mm, or any intermediate, smaller or larger range of values. In some embodiments, a width 832 is about a 1/3 of the length 826.
  • sampling portion is intended to include all such new technologies a priori.
  • compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

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Abstract

L'invention concerne un dispositif de biopsie comprenant : une partie d'échantillonnage creuse comprenant un corps allongé ayant un axe long, une extrémité proximale, une extrémité distale et une lumière interne à l'intérieur dudit corps positionnée le long de l'axe long ; l'extrémité distale de la partie d'échantillonnage comprenant une ouverture distale, formée et dimensionnée pour permettre l'entrée de tissu à l'intérieur de la lumière interne lorsque la partie d'échantillonnage creuse est avancée axialement dans le tissu corporel ; au moins un manipulateur de tissu mobile s'étendant à partir d'une paroi dudit corps de partie d'échantillonnage à l'intérieur de la lumière interne et vers l'extrémité proximale de la partie d'échantillonnage ; ledit manipulateur de tissu étant conçu pour se déplacer vers l'extérieur vers la paroi, et vers l'intérieur vers la lumière interne.
PCT/IL2024/050781 2023-08-16 2024-08-05 Séparateur de tissu Pending WO2025037297A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363532930P 2023-08-16 2023-08-16
US63/532,930 2023-08-16

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WO2025037297A1 true WO2025037297A1 (fr) 2025-02-20

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Country Link
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120116249A1 (en) * 1997-07-24 2012-05-10 Mcguckin James F Jr Breast surgery method and apparatus
US20130197393A1 (en) * 1994-03-24 2013-08-01 Devicor Medical Products Methods and devices for biopsy and collection of soft tissue
US20210038202A1 (en) * 2018-02-08 2021-02-11 Limaca Medical Ltd. Biopsy device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130197393A1 (en) * 1994-03-24 2013-08-01 Devicor Medical Products Methods and devices for biopsy and collection of soft tissue
US20120116249A1 (en) * 1997-07-24 2012-05-10 Mcguckin James F Jr Breast surgery method and apparatus
US20210038202A1 (en) * 2018-02-08 2021-02-11 Limaca Medical Ltd. Biopsy device

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