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WO2008121145A1 - Outils de canule multifonctions - Google Patents

Outils de canule multifonctions Download PDF

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Publication number
WO2008121145A1
WO2008121145A1 PCT/US2007/065784 US2007065784W WO2008121145A1 WO 2008121145 A1 WO2008121145 A1 WO 2008121145A1 US 2007065784 W US2007065784 W US 2007065784W WO 2008121145 A1 WO2008121145 A1 WO 2008121145A1
Authority
WO
WIPO (PCT)
Prior art keywords
elongate tubular
tissue
tubular member
cannula tool
distal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/065784
Other languages
English (en)
Inventor
Eric J. Seibel
Charles David Melville
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.)
University of Washington
Original Assignee
University of Washington
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 University of Washington filed Critical University of Washington
Priority to PCT/US2007/065784 priority Critical patent/WO2008121145A1/fr
Publication of WO2008121145A1 publication Critical patent/WO2008121145A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32056—Surgical snare instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00685—Archimedes screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22039—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire eccentric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A61B2017/320008—Scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • Catheters are inherently more flexible and smaller in diameter than endoscopes, so regions previously unexplored by endoscopes can be accessed by guidewire-based tools. It would clearly be desirable to develop a variety of different types of catheter-based or guidewire-based tools for use in collecting samples from an internal site in a patient's body for cytopathological diagnosis.
  • a guidewire would be inserted into the body of a patient in a generally conventional manner advanced to a desired location where a biopsy of cells and tissue is to be taken.
  • the process of advancing the guidewire can be done purely by exercising the touch and feel of an experienced physician, or can be carried out with visualization technologies, such as fluoroscopy, X-ray or computed tomography (CT) imaging, magnetic resonance imaging (MRI), ultrasound imaging, optical tomography, etc.
  • CT computed tomography
  • MRI magnetic resonance imaging
  • ultrasound imaging optical tomography
  • a multifunction tool over the guidewire as a cannula, or otherwise couple the tool to the guidewire so that it can be advanced to the site over the guidewire and be employed to obtain a biopsy sample at the site.
  • the cannula tool system includes an elongate tubular member having at least one lumen that is sized and configured to slip longitudinally over a guide that has been inserted into a body of a patient.
  • the elongate tubular member can then be controllably advanced over the guide to a desired internal site within the body of the patient.
  • Means associated with the elongate tubular member are provided for dislodging a biopsy sample from a desired internal site within a body of a patient.
  • Also associated with the elongate tubular member are means for withdrawing the biopsy sample from a body of a patient for cytopathological evaluation.
  • the elongate tubular member generally extends between a proximal end and a distal end.
  • the means for withdrawing can include a pump that is coupled in fluid communication with a lumen formed within the elongate tubular member. This pump is configured for extracting the biopsy sample through the lumen, from the distal end of the elongate tubular member, for example, by drawing the biopsy sample along with a bodily fluid through the lumen. The biopsy sample and bodily fluid are thus drawn toward the proximal end of the elongate tubular member where the biopsy sample can be collected for further study or evaluation.
  • the elongate tubular member has an exterior surface
  • the means for dislodging comprises a plurality of outwardly extending abrasive points disposed at spaced-apart positions on the exterior surface of the elongate tubular member and proximate to its distal end. These abrasive points are provided for abrading cells from the internal site within a body of a patient, and the cells that are abraded free of the tissue comprise the biopsy sample.
  • the means for withdrawing can further include a plurality of orifices formed in the elongate tubular member, proximate to the spaced-apart positions where the plurality of outwardly extending abrasive point are disposed. These orifices provide fluid communication paths for cells conveyed with a bodily fluid, so that the cells pass into the lumen of the elongate tubular member and are drawn by the pump through the lumen toward the proximal end of the elongate tubular member.
  • An annular gap is formed between the guide and an interior surface of the lumen and comprises a fluid path, so that cells passing through the plurality of orifices are conveyed by the bodily fluid through the annular gap to the proximal end of the elongate tubular member.
  • the means for dislodging comprises a snare loop that extends generally distally of the distal end of the elongate tubular member.
  • the snare loop can be employed to cut free a biopsy sample from an internal site within a body of a patient, by snaring the tissue.
  • the snare loop is coupled to a power supply that is selectively activated to heat the snare loop with an electrical current to a temperature sufficiently high to cut through tissue, freeing the biopsy sample from adjacent tissue. The biopsy sample that is freed from the adjacent tissue is then drawn with bodily fluid into and through the lumen of the elongate tubular member.
  • the snare loop is coupled to one or more lines or wires that extend proximally of the elongate tubular member. These one or more lines are pulled to tighten the snare loop around tissue, so that the loop cuts the tissue free from adjacent tissue. The tissue that is freed from the adjacent tissue can then be drawn into and through the elongate tubular member toward the proximal end of the elongate tubular member, to serve as a biopsy sample.
  • the means for dislodging comprises a helical member having a cutting blade formed on its distal end.
  • the helical member is disposed in the lumen of the elongate tubular member, within an annular gap defined between an interior surface of the elongate tubular member and the guide. Rotation of the elongate tubular member about the guide causes the cutting blade to cut a piece of tissue free from adjacent tissue at an internal site within the body of a patient. The piece of tissue comprising the biopsy sample can then be drawn into and through the annular gap toward the proximal end of the elongate tubular member.
  • the cannula tool system can further include a prime mover and a rotational driver that is configured to drivingly couple with the elongate tubular member where it is exposed outside a body of a patient.
  • the prime mover causes the rotational -A-
  • a biopsy trap can be disposed between the pump and the proximal end of the elongate tubular member, and in fluid communication with both.
  • the biopsy trap serves to trap a biopsy sample that has passed through the lumen of the elongate tubular member.
  • the means for dislodging comprises a balloon that is disposed around an exterior of the elongate tubular member and adjacent to its distal end.
  • An outer surface of the balloon has an abrasive coating so that when the balloon is selectively inflated while the distal end of the elongate tubular member is disposed at an internal site with a body of a patient, and the elongate tubular member is then moved while the abrasive coating is in contact with tissue at the internal site, cells are dislodged from the tissue by the abrasive coating. These cells can then be drawn with bodily fluid into and through the elongate tubular member, e.g., through an annular gap defined between an interior surface of the elongate tubular member and the guide, and toward the proximal end by the pump.
  • the elongate tubular member can include a guide collar disposed proximate to the distal end of the elongate tubular member, attached to one side of the elongate tubular member.
  • the guide collar has a second lumen formed within it, and the second lumen is sized and configured to slide over the guide.
  • the guide can comprise an elongate flexible member such as an endoscope, a catheter, or a flexible guidewire.
  • the distal end of the elongate tubular member includes a sharp cutting edge that slices a piece of tissue comprising the biopsy sample free from adjacent tissue. This biopsy sample is conveyed by the pump into and through the lumen, toward the proximal end of the elongate tubular member.
  • FIGURE IA is a schematic block diagram of an exemplary multifunctional cannula tool system for collecting a biopsy sample from an internal site in a body of a patient;
  • FIGURE IB is an enlarged cut-away schematic view of an exemplary embodiment of a distal end of a cannula tool that includes an abrasive surface for abrading cells from adjacent tissue;
  • FIGURE 2 is an enlarged cut-away schematic view of a distal end of an exemplary embodiment of a cannula tool that includes a loop for snaring tissue that is cut away for a biopsy sample;
  • FIGURE 3 is an enlarged cut-away schematic view of a distal end of an exemplary embodiment of a cannula tool that includes a helical ribbon having a cutting edge for cutting away a piece of tissue for a biopsy sample;
  • FIGURE 4 is an exploded view of an exemplary rotational driver that is disposed externally and is configured to drivingly rotate a cannula tool about a longitudinal axis;
  • FIGURE 5 is a schematic view of an exemplary embodiment of a cannula tool having an inflatable balloon with an abrasive surface, within a body lumen, illustrating the inflatable balloon in a deflated state;
  • FIGURE 6 is a schematic view of the exemplary embodiment of FIGURE 5 after the balloon has been selectively inflated and either rotated or moved longitudinally so that the abrasive surface frees cells from tissue on the inner surface of the body lumen, enabling the cells to be drawn into an annular passage between a guidewire and inner surface of the cannula lumen;
  • FIGURE 7 is a schematic view of an exemplary embodiment of a cannula tool that includes a piggyback guide collar that is adapted to slide over a guidewire, and which has a cutting edge on a leading distal end of a lumen, so that a piece of tissue cut from tissue can be drawn into the lumen for collection at the proximal end of the cannula tool.
  • FIGURE IA illustrates an exemplary cannula tool system 8 that includes a first example of a cannula tool 18.
  • an elongate flexible tube 16 is illustrated extending through a dermal interface 10 and into a body 12 of a patient.
  • Elongate flexible tube 16 is guided to a desired location within body 12 by a flexible guide wire 14, which has been inserted through an incision or other opening in dermal interface 10 and has already been advanced to the desired location or site.
  • Elongate flexible tube 16 is then slid over flexible guide wire 14 and is thus guided to the desired location.
  • cannula tool 18 can be employed to carry out a plurality of functions. Specifically, cannula tool 18 is employed to dislodge cells or tissue at the desired location, and then facilitates withdrawal of the dislodged cells or tissue from the site as a biopsy sample, for collection to enable further processing or analysis. The dislodged cells or tissue are conveyed from the site at the distal end of the elongate flexible tube through an annulus formed between guide wire 14 and the interior surface of elongate flexible tube 16, toward the proximal end of the elongate flexible tube.
  • a port 20 is formed at or adjacent to the proximal end of elongate flexible tube 16, in fluid communication with the annulus, and is coupled to one end of a fluid line 22.
  • the other end of fluid line 22 is connected to a three-way valve 23, which selectively provides direct communication to a vacuum pump 28 for applying negative pressures or to a fluid pump 25 for applying positive pressures.
  • a biopsy trap 24 is disposed between the three-way valve and vacuum pump (or other source of a vacuum).
  • the vacuum pump 28 coupled through a fluid line 26 to the opposite side of biopsy trap 24 produces a negative pressure that draws the biopsy sample, e.g., along with a bodily fluid such as blood, mucus, or an introduced fluid (e.g., air or saline), into the biopsy trap.
  • a bodily fluid such as blood, mucus, or an introduced fluid (e.g., air or saline)
  • the biopsy sample can then be removed from the biopsy trap so that the processing and analysis can be carried out.
  • Fluid pump 25 can provide saline solution (from a source reservoir - not shown) to suspend the dislodged cells or tissue for easier retrieval.
  • the introduced fluid under positive pressure can help to dislodge cells, mucus, blood, or other body fluid from the tool, guidewire, or wall of the body lumen.
  • Cannula tool 18 which is disposed at the distal end of elongate flexible tube 16, includes a plurality of spaced-apart outwardly extending points 30 disposed around the exterior surface of the elongate flexible tube.
  • cannula tool 18 can instead be simply coupled to the distal end of elongate flexible tube 16 through an appropriate coupling mechanism (not shown).
  • Points 30 are shaped so that they tend to abrade cells from tissue adjacent to the outer surface on which the points are disposed when the elongate flexible tube is moved longitudinally back-and-forth a few centimeters (and/or rotated back and forth around) its longitudinal axis.
  • a plurality of orifices 32 are interspersed between the plurality of points providing a number of fluid communication paths through which the bodily fluid and cells dislodged from the adjacent tissue can be drawn into an annulus 36, which is disposed between the outer surface of guide wire 14 in the inner surface of elongate flexible tube 16.
  • the bodily fluid conveys the dislodged cells or tissue through annulus 36 from the distal end of the elongate flexible tube to the proximal end where port 20 is disposed, so that the cells or tissue comprising the biopsy sample can be drawn into biopsy trap 24 and collected.
  • a seal comprising annular rings 34a and 34b is disposed at the distal end of elongate flexible tube 16 to ensure that vacuum pump 28 draws the bodily fluid and dislodged cells or tissue through orifices 32, rather than simply drawing bodily fluid without the cells or tissue from around guide wire 14 at the distal end of the elongate flexible tube.
  • points 30 are intended to be exemplary and not in any way limiting, since it should be apparent that a number of other different shapes or configurations can be employed for such points comprising an abrasive surface, such as short bristles (e.g., a tubular brush).
  • cannula tool 40 is illustrated for use in connection with an elongate flexible tube 42.
  • This same outer tube can also be used to shield the internal tissues of the body from cannula tool 18 during insertion to the desired location within the body.
  • This outer elongate flexible tube or sheathing can then be withdrawn to reveal the biopsy tool distal tip when it is disposed at the desired biopsy site within the body.
  • cannula tool 40 is configured to be advanced to a desired site by sliding along guide wire 14.
  • Cannula tool 40 includes a wire loop 46 that extends distally of a ring 44, which is disposed just inside the distal end of elongate flexible tube 42. Loop 46 is sized to ensnare a biopsy sample of tissue, such as a polyp 54 growing from adjoining tissue 56 at the desired site, as shown in this Figure.
  • Two different techniques can be employed to cut away the piece of tissue comprising the biopsy sample from adjoining tissue.
  • One option is to supply an electrical current so that loop 46 is heated sufficiently to burn through adjacent tissue 56, freeing the biopsy sample, such as polyp 54.
  • the electrical current can be applied to loop 46 through conductive wires 48 and 50, which extend proximally of the elongate flexible tube 42 and are connected through a switch to a conventional electrical current supply (neither shown).
  • wires 48 and 50 can be pulled proximally of the proximal end of elongate flexible tube 42, which tightens loop 46 around the tissue sufficiently to cut through the tissue, freeing it from the adjacent tissue.
  • a vacuum can be applied within outer elongate flexible tube 42.
  • the biopsy sample Once the biopsy sample is freed, it can be drawn with bodily fluid into an annulus 52 formed between the outer surface of guide wire 14 and the inner surface of the elongate flexible tube 42.
  • vacuum pump 28 shown in FIGURE IA
  • This biopsy sample that has thus been freed and withdrawn from inside the body of a patient can then be collected for processing and analysis by medical personnel.
  • An exemplary embodiment of a cannula tool 60 shown in FIGURE 3 is also configured to be advanced to desired site within the body of the patient over guide wire 14.
  • Cannula tool 60 includes an outer elongate flexible tube 62 that extends between a distal end and a proximal end. The proximal end is disposed outside the body of the patient.
  • a middle flexible tube 65 Within the outer elongate flexible tube is disposed a middle flexible tube 65.
  • a helical coil 64 On the outer surface of the middle flexible tube, at its distal end, is affixed.
  • the helical coil is in contact with the inner surface of the outer elongate flexible tube and terminates on its leading end at a sharp cutting edge 66, which extends just beyond the distal end of elongate flexible tube 62.
  • Sharp cutting edge 66 is thus configured to slice a ribbon of tissue from the desired site as middle flexible tube 65 is rotated about its longitudinal axis in the appropriate direction with respect to outer elongate flexible tube 62 to bring the sharp cutting edge into the adjacent tissue.
  • This ribbon of tissue which comprises a biopsy sample, is carried between helical coils 64 and conveyed with bodily or introduced fluid through an annulus 68 formed between the outer surface of guide wire 14 and the inner surface of middle flexible tube 65.
  • a smaller annular gap 63 is provided between the outer surface of middle flexible tube 65 and the inner surface of outer elongate flexible tube 62, which may facilitate capture of the tissue ribbon when negative pressure is applied at the proximal end of the elongate flexible tube or may facilitate removal of the tissue ribbon from the helical coil with introduced fluid applied at the proximal end.
  • the vacuum pump shown in FIGURE IA can be used to draw the biopsy sample and bodily fluid through the annulus toward the proximal end of the elongate flexible tube, where the biopsy sample can be collected.
  • FIGURE 4 illustrates a rotational driver 70 that is configured to rotate a guidewire or endoscope 72 about a longitudinal axis of the device.
  • Attached to the distal end of the guidewire or endoscope can be one of the multifunctional cannula tools discussed herein.
  • the endoscope should be viewed as a specific type of "elongate flexible tube," which is used with each of the exemplary embodiments of the cannula tools discussed herein. However, this exemplary embodiment matches the ribbon cutting tool in FIGURE 3, which optionally can provide fluid communication in both annular gaps around the middle flexible tube. Note that an endoscope can also serve as a guide wire with eyes.
  • a prime mover 74 for example, an electric motor
  • a driven shaft 76 is included to rotate a driven shaft 76, thereby providing a rotational force that rotates and drives middle flexible tube 65, which holds the biopsy tool, forward and backward.
  • An outer sheath sleeve 78 is fitted over guidewire or endoscope 72. Sealing "O" rings 90 are provided on outer sheath sleeve 78, as well as on each side 88 of a driven gear 86, and on a guidewire or endoscope sleeve 80, which is near a proximal end 84 of the endoscope and attached to a strain relief boot 82.
  • End caps 92 and 94 are fitted over and sealingly engage "O" rings 90, when securely coupled to a bearing body 100 by fasteners 95.
  • End caps 92 and 94 include ports 96 and 98, to provide fluid paths in fluid communication with exposed portions of the endoscope. At each of these exposed portions, the elongate flexible tube is open for withdrawing or injecting either gases or liquids into one or two annular gaps formed in guidewire or endoscope with cannula tool 72.
  • port 98 can be used to withdraw a biopsy sample that is conveyed with a bodily or introduced fluid from the distal end of guidewire or endoscope with cannula tool 72, through annulus 68 formed between guide wire 14 and the inner surface of middle flexible tube 65.
  • Port 96 is in fluid communication with small annular gap 63 that is formed between the outer surface of middle flexible tube 65 and the inner surface of outer elongate flexible tube 62.
  • a vacuum can be applied to both ports 96 and 98 in FIGURE 4, which will help pull the tissue up against the cutting edge of the cannula tool in FIGURE 3.
  • the vacuum can be removed from only the outer annular gap, i.e., from port 96.
  • any tissue and cells within the helical coil can be flushed and then sucked into the larger inner annulus 68, with negative pressure applied to port 98, e.g., with vacuum pump 25 (FIGURE IA).
  • Driven shaft 76 is drivingly coupled to a drive gear 102, which is rotatably mounted in bearing block 100 and affixed to an end of driven shaft 76.
  • a gear slide fork 104 is mounted on the side of bearing block 100 and is configured to engage driven gear 86, so as to move the driven gear into meshing relationship with drive gear 102 when gear slide rod 106 is appropriate pushed (or pulled) longitudinally.
  • gear slide rod 106 By thus moving gear slide rod 106, a user can selectively engage driven gear 86 with drive gear 102 to apply a rotational force that begins turning driven gear 86, which is in mechanical communication with middle flexible tube 93, so that the middle flexible tube turns in one direction versus the opposite direction, about its longitudinal axis.
  • Rotational motion of the cannula tool shaft can be used either for abrading or cutting cells and tissue from adjacent tissue at a desired location in a body of a patient.
  • the rotational driver can be used to rotate a cannula tool having an abrasive surface, such as exemplary cannula tool 18, or can turn a cannula tool that has a sharp cutting edge, which is able to cut away a ribbon of tissue to form a biopsy sample, such as exemplary cannula tool 60.
  • a cannula tool 110 is illustrated and is disposed adjacent to the distal end of a flexible elongate tube 116.
  • flexible elongate tube 116 has an internal lumen that is sized to be guided over guide wire 14 to a desired site within a body of a patient.
  • guide wire 14 has been advanced through a body lumen 112 and has been used to guide elongate flexible tube 116 so that a balloon 118 (currently deflated) is advanced to a site where cells comprising a biopsy sample is to be taken.
  • Balloon 118 is sealingly attached to the outer surface of the flexible elongate tube at each end of the balloon (for example, by thermal bonding or using an appropriate adhesive).
  • a pressurized fluid tube 120 extends within an annulus formed between the outer surface of guide wire 14 and the inner surface of elongate flexible tube 116, from the proximal end of the flexible elongate tube to a port 122.
  • Port 122 provides an opening through elongate flexible tube 116 to add or remove fluid volume inside balloon 118.
  • the proximal end of the pressurized fluid tube is coupled to a pressurized fluid source, such as fluid pump 25, and to a negative pressure source, such as vacuum pump 28, both of which are shown in FIGURE IA.
  • Pressurized fluid provided by the pressurized fluid source can be selectively applied through pressurized fluid tube 120 and port 122 to inflate balloon 118, as shown in FIGURE 6.
  • an abrasive coating 124 that extends over the outer surface of balloon 118 comes into contact with tissue on the wall of body lumen 112.
  • the elongate flexible tube 116 is then rotated around its longitudinal axis or pushed/pulled longitudinally back-and-forth within body lumen 112, cells 126 are abraded from the tissue lining the body lumen by the abrasive coating.
  • the abraded cells and bodily fluid within body lumen 112 are together drawn into an annulus 128 formed between the inner surface of the lumen extending through elongate flexible tube 116 and the outer surface of guide wire 14, as shown in FIGURE 6. These cells, which comprise a biopsy sample, can be withdrawn from the annulus at the proximal end of flexible elongate tube 116, generally as explained above.
  • An elongate sheath 125 (shown in FIGURES 5 and 6 after the elongate sheath has been pulled back) can be disposed around the abrasive balloon during insertion and retraction and then pulled back or proximally to expose the abrasive surface of the balloon when the cannula tool is disposed at a desired site for taking a biopsy sample.
  • the proximal end of elongate sheath 125 is accessible outside the body of a patient and can be separately manipulated to move it longitudinally, relative to balloon 118 (or other embodiments of the cannula tool).
  • cannula tool it may be preferable to rotate elongate sheath about its longitudinal axis between first and second positions, so that an opening at its distal end (not shown) selectively either protects or exposes the portion of the cannula tool that is used to dislodge cells or tissue comprising the biopsy sample.
  • FIGURE 7 Yet another exemplary embodiment of a cannula tool 140 is illustrated in FIGURE 7.
  • Cannula tool 140 is intended to cut away a ribbon of tissue with a sharpened cutting edge 144, which is formed over at least a portion of the distal leading edge of the elongate flexible tube.
  • cannula tool 140 has a flexible elongate tube 142 with an internal lumen 146 that does not slide over guide wire 14.
  • Lumen 146 instead defines a passage through which a ribbon of tissue that is cut away by sharpened cutting edge 144 from adjacent tissue within the body of a patient can be drawn with bodily fluid toward the proximal end of the elongate flexible tube.
  • a protective cover can be provided that overlies sharpened cutting edge 144 until the distal end of the cannula tool is disposed where it is desired to cut away a ribbon of tissue as a biopsy sample.
  • a pull wire (not shown) that is coupled to the protective cover can then be pulled proximally, enabling the protective cover to be pulled away from the sharpened cutting edge and out through the proximal end of lumen 146.
  • flexible elongate tube 142 can be rotated so that cutting edge 144 is disposed close to the guidewire and away from the tissue, then rotated outwardly toward the tissue, to cut away the biopsy sample.
  • Piggyback collar 148 includes an internal open guide lumen that is sized to readily slide along guide wire 14, and thus, to be guided to a desired site within the body of a patient where a biopsy sample is to be taken.
  • Stanchion 150 may enable elongate tube 142 to rotate but prevent it from sliding longitudinally to enable cutting edge 144 to be turned away from the tissue during insertion and retraction of the tool through the body lumen.
  • Each of the exemplary embodiments of cannula tools discussed above is characterized by performing at least two functions.
  • the first function is to dislodge or cutaway cells or tissue from within the body of a patient.
  • the second function is to enable the cells or tissue that have been dislodged to be collected as a biopsy sample for further processing or analysis.
  • a multi-functional capability and relatively compact size of these cannula tools enable them to be readily used in many applications where conventional cannula tools cannot be.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne des outils de canule réalisant chacun de multiples fonctions. Chaque outil de canule est capable de déloger ou d'enlever par découpe un échantillon de biopsie d'un site souhaité dans le corps d'un patient, puis de collecter l'échantillon. L'outil de canule, qui est disposé à l'extrémité distale d'un tube flexible allongé est guidé vers le site souhaité sur un fil-guide. L'outil de canule soit érode les cellules provenant du tissu adjacent avec une surface abrasive, soit enlève par découpe un échantillon de tissu avec une arête tranchante vive ou avec une boucle qui est chauffée électriquement ou tirée pour aspirer l'échantillon. L'échantillon de biopsie est ensuite aspiré avec un fluide corporel ou un fluide introduit à travers un anneau entre le fil-guide et la surface interne du tube flexible allongé ou à travers une lumière, pour collecte au niveau de l'extrémité proximale du tube flexible allongé.
PCT/US2007/065784 2007-04-02 2007-04-02 Outils de canule multifonctions Ceased WO2008121145A1 (fr)

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WO2009089829A1 (fr) * 2008-01-17 2009-07-23 Miltenyi Biotec Gmbh Dispositif de prélèvement de matière biologique
JP2012512002A (ja) * 2008-12-17 2012-05-31 ザ スペクトラネティクス コーポレーション 偏心バルーンレーザーカテーテル
WO2016144834A1 (fr) * 2015-03-06 2016-09-15 Transmed7, Llc Dispositif et procédés d'ablation de tissu mou et de matière endovasculaire
US10722631B2 (en) 2018-02-01 2020-07-28 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
CN112804948A (zh) * 2018-07-23 2021-05-14 克劳斯贝医疗有限公司 用于活检和细胞学检查的子宫外翻导管的设备和方法
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US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
US12102815B2 (en) 2019-09-25 2024-10-01 Shifamed Holdings, Llc Catheter blood pumps and collapsible pump housings
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US12161857B2 (en) 2018-07-31 2024-12-10 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US12220570B2 (en) 2018-10-05 2025-02-11 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US12409310B2 (en) 2019-12-11 2025-09-09 Shifamed Holdings, Llc Descending aorta and vena cava blood pumps
US12465748B2 (en) 2019-08-07 2025-11-11 Supira Medical, Inc. Catheter blood pumps and collapsible pump housings

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Cited By (21)

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Publication number Priority date Publication date Assignee Title
WO2009089829A1 (fr) * 2008-01-17 2009-07-23 Miltenyi Biotec Gmbh Dispositif de prélèvement de matière biologique
JP2012512002A (ja) * 2008-12-17 2012-05-31 ザ スペクトラネティクス コーポレーション 偏心バルーンレーザーカテーテル
EP2346430B1 (fr) * 2008-12-17 2014-01-01 The Spectranetics Corporation Cathéter-laser à ballonnet excentrique
WO2016144834A1 (fr) * 2015-03-06 2016-09-15 Transmed7, Llc Dispositif et procédés d'ablation de tissu mou et de matière endovasculaire
US10219821B2 (en) 2015-03-06 2019-03-05 Transmed7, Llc Devices and methods for soft tissue and endovascular material removal
US11185677B2 (en) 2017-06-07 2021-11-30 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11717670B2 (en) 2017-06-07 2023-08-08 Shifamed Holdings, LLP Intravascular fluid movement devices, systems, and methods of use
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
US11229784B2 (en) 2018-02-01 2022-01-25 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US10722631B2 (en) 2018-02-01 2020-07-28 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
US12076545B2 (en) 2018-02-01 2024-09-03 Shifamed Holdings, Llc Intravascular blood pumps and methods of use and manufacture
CN112804948A (zh) * 2018-07-23 2021-05-14 克劳斯贝医疗有限公司 用于活检和细胞学检查的子宫外翻导管的设备和方法
US12161857B2 (en) 2018-07-31 2024-12-10 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US12220570B2 (en) 2018-10-05 2025-02-11 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US12465748B2 (en) 2019-08-07 2025-11-11 Supira Medical, Inc. Catheter blood pumps and collapsible pump housings
US12121713B2 (en) 2019-09-25 2024-10-22 Shifamed Holdings, Llc Catheter blood pumps and collapsible blood conduits
US12102815B2 (en) 2019-09-25 2024-10-01 Shifamed Holdings, Llc Catheter blood pumps and collapsible pump housings
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
US12409310B2 (en) 2019-12-11 2025-09-09 Shifamed Holdings, Llc Descending aorta and vena cava blood pumps

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