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WO2019140179A1 - Méthodes et dispositifs pour le traitement de troubles pulmonaires - Google Patents

Méthodes et dispositifs pour le traitement de troubles pulmonaires Download PDF

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Publication number
WO2019140179A1
WO2019140179A1 PCT/US2019/013177 US2019013177W WO2019140179A1 WO 2019140179 A1 WO2019140179 A1 WO 2019140179A1 US 2019013177 W US2019013177 W US 2019013177W WO 2019140179 A1 WO2019140179 A1 WO 2019140179A1
Authority
WO
WIPO (PCT)
Prior art keywords
arms
lung
hub
reduction device
arm
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/US2019/013177
Other languages
English (en)
Inventor
Lilip Lau
Mark Gelfand
Mark Leung
Qi Li
Sean Michael TOTTEN
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.)
Eolo Medical Inc
Original Assignee
Eolo Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eolo Medical Inc filed Critical Eolo Medical Inc
Publication of WO2019140179A1 publication Critical patent/WO2019140179A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device

Definitions

  • the field of the invention is lung reduction devices used to treat chronic obstructive pulmonary disease (COPD).
  • COPD chronic obstructive pulmonary disease
  • the invention relates to lung reduction devices configured to be delivered through the airway to the lung with minimally invasive techniques.
  • COPD is a lung disease that makes it hard to breathe. COPD is a major cause of disability and is the third leading cause of death in the United States. The symptoms and effects of COPD often worsen over time, such as over years, and can limit the ability of a person suffering from COPD to do routine activities. Current medical techniques offer no solution for reversing the damage to the airways and lungs associated with COPD.
  • COPD often does not affect all air sacs or alveoli equally in a lung.
  • a lung may have diseased regions in which the air sacs are damaged and unsuited for gas exchange.
  • the same lung may have healthy regions (or at least relatively healthy regions) in which the air sacs continue to perform effective gas exchange.
  • the diseased regions may be large, such as 20 to 30 percent or more of the lung volume.
  • the diseased regions of the lung occupy volume in the pulmonary cavity which could otherwise be occupied by the healthy portion of the lung. If the healthy regions(s) of the lung were allowed to expand into the volume occupied by the diseased regions, the healthy regions could expand and fill with air to allow the air sacs in the healthy region to exchange oxygen for carbon dioxide.
  • the inventors identified a need for lung reducing devices that are safe, easy to deploy, reliable and capable of cumulatively collapsing large diseased portions of a lung, for example at least fifteen to twenty percent (>15-20%) of the overall volume of the lung.
  • the inventors conceived of and disclose herein, implantable lung volume reducing devices and medical techniques for implanting lung volume reduction devices through the trachea and bronchi, using minimally-invasive deployment and surgical techniques.
  • the lung reducing devices may be used to reduce the volume of a lung, thereby increasing the elastic recoil of the remaining lung volume.
  • the invention may be embodied as a novel treatment for patients suffering from COPD comprising the application of a minimally invasive bronchoscopy technique to implant a lung reduction device into a lung airway of a patient.
  • the implantable lung reduction device which may be generally referred to as a“clip” comprises two or more arms that are positioned in branches of a bifurcation of an airway in the lung.
  • the arms of the device are connected or joined at the hub (which includes a vertex and stem) of the device.
  • the hub of the clip are positioned adjacent the bifurcation.
  • the lung tissue separating the two adjacent airways immediately downstream of the bifurcation of the airway into two or more branches of the airway passage is the airway septum.
  • the device applies a mechanical force to the branches that collapses the branches.
  • the device may bias the tissue of the septum together to collapse the branches together and thereby reduce the lung volume in the vicinity of the bifurcation.
  • the overall lung volume is reduced due to the collapse of the tissue at the septum.
  • Implanting several devices (such as 10, 15, 20 or more) in diseased region(s) of a lung provides a cumulative reduction that may amount to 10%, 20% or more of the volume of the lung.
  • the implantable lung reduction device may be a“twisted clip” formed as an integral and single piece component for example of a super-elastic and memory shape material, such as a nickel titanium (Nitinol) alloy.
  • the twist clip includes at least two arms each shaped as a helix and the arms together form a double (or multiple) helix.
  • the distal ends of the arms may be padded or rounded to reduce the risk of puncturing lung tissue as the arms are inserted into branches of a bifurcation of an airway in the lung.
  • the distal ends of the arms may flare outwards from an axis of the helical arms. The fares of the distal ends aid the movement of the arms into the branches.
  • the distal ends may each be floppy to impart atraumatic force to the airway wall surfaces as they are being advanced or while implanted.
  • floppy distal ends may be similar in fabrication and function to a guidewire such as a coil wrapped core, that is connected (e.g., welded, crimped, glued) to the distal ends of the arms.
  • the floppy ends may be flexible enough that when advanced into an airway wall they easily deform to take a path of least resistance into the lumens of the airways instead of puncturing the airway wall.
  • the arms of the device follow the floppy ends into the airway lumens such that the sides of the arms advances over the airway wall instead of the tip of the arms pushing into the airway wall.
  • the proximal ends of the arms are fixed to a hub (vertex) of the lung reduction device.
  • the arms are effectively cantilevered beams extending from the vertex to their distal ends. As the arms are bent or twisted, they apply forces resisting bending and twisting. These forces cause the branches and their associated lung tissue to collapse together in both lateral and radial directions.
  • the twisted clip may be deployed at a bifurcation of an airway passage by being advanced and simultaneously rotated towards the bifurcation.
  • the distal ends of the arms are moved into respective branches of the bifurcation of an airway passage due to the advancement and rotation of the twisted clip.
  • One arm may be longer than the other so that the longer arm may be first inserted into one branch and the shorter arm inserted into another branch.
  • the arms pull the branches together and may cause the branches to wrap around each other. This pulling and wrapping of branches reduces the lung tissue between the branches and at the septum.
  • the invention may be embodied as a lung reduction device including: a hub, a first arm having a proximal end fixed to the hub, and a second arm having a proximal end fixed to the hub, wherein the first and second arms each have, at least partially a helical shape and the first and second arms together form a multiple helix; wherein the first and second arms are each configured to extend into a respective one of airway branches of a bifurcation of an airway in the lung, and the hub is configured to seat upstream of a bifurcation, and wherein the first and second arms are configured to apply a bias force to the airway branches which compresses a lung tissue section between the airway branches.
  • the hub may include a locking mechanism, such as a key or slot, configured to releasably engage a delivery tool, wherein the key is configured to transfer a turn of the delivery tool as a torque to the hub, or to transfer axial translation of the delivery tool as axial translation to the hub.
  • a locking mechanism such as a key or slot
  • the first arm is longer than the length of the second arm.
  • the first arm may include a nub at a distal end of the first arm, and the nub may have an opening configured to receive a guide wire.
  • the hub and a distal end of the first arm may each include an opening configured to receive a guide wire.
  • the second arm may lack a hole or other means to engage a guide wire.
  • the first and second arms may each include a distal region which flares outward from a plane which is parallel to a majority of the lengths of the first and second arms.
  • the first and second arms may each have a width substantially greater than a thickness of the arm.
  • the first and second arms may be arc-shaped in cross section. Each of the first and second arms may be wide near the hub and the width of the arm reduces gradually from the hub towards a distal end of the arm.
  • the lung reduction device may be sized to have a diameter in a range of 0.5 to 3 millimeters (mm) when delivered and a length in a range of 1 to 15 mm.
  • the invention may be embodied as an assembly for a lung reduction device including: a sleeve configured to be deployed from a flexible shaft of a bronchoscope and into an air passage of a lung; a drive shaft extendible through the sleeve and having a distal end configured to advance longitudinally through the sleeve and to rotate within the sleeve; a lung reduction device housed within the sleeve and including a hub and arms extending distally from the hub, wherein the hub is configured to engage the distal end of the drive shaft such that the lung reduction device can be rotated and advanced with respect to the sleeve; wherein the arms each extend from the hub to a distal end, wherein each arm forms a cantilevered beam extending from the hub; wherein the arms are formed of a shape memory alloy and each of the arms is shaped, at least partially, as at least one of a helix or coil; wherein the arms are each configured to extend into a respective one of airway
  • the arms together may form a double helical shape.
  • the hub may include a locking mechanism, such as a key or slot, configured to releasably engage a delivery tool, wherein the key is configured to transfer a turn of the delivery tool as a torque to the hub.
  • a locking mechanism such as a key or slot, configured to releasably engage a delivery tool, wherein the key is configured to transfer a turn of the delivery tool as a torque to the hub.
  • At least one of the arms may be longer than another of the arms.
  • a distal end of one of the arms includes an opening configured to receive a guide wire.
  • the hub may have an opening configured to receive a guide wire.
  • Each of the arms may include a distal region which flares outward from an axis of the lung reduction device.
  • the lung reduction device may have a diameter in a range of 0.5 to 3 millimeters (mm) and a length in a range of 1 to 15 cm, the sleeve has an internal diameter in a range of 1 to 4 mm, and the drive shaft has an outer diameter in a range of 0.25 to 3 mm.
  • These lung reduction devices may also delay closure of the small airways in the lung during a breath and lower the Residual Volume (RV) in the lung. A reduction in RV results in less air trapped in the lung at the end of each breath and suppresses
  • RV Residual Volume
  • RV is an accepted index of disease severity and the benefit of a lung reduction therapy is generally accepted to be proportional to the reduction in RV.
  • Reduced thoracic gas compression and improved expiratory flow may translate to an improvement in chest wall and diaphragm configuration and mechanics, reduced dynamic hyperinflation and strain of breathing, and better cardiac performance.
  • FIGS. 1 to 6 show, sequentially, the introduction of a shaft of a bronchoscope into a lung, the placement of a lung reduction device deployed through the shaft at an airway bifurcation in the lung and the retraction of the bronchoscope after the lung reduction device has been permanently positioned (or at least positioned for an extended period) in the lung.
  • FIG. 7 illustrates a lung reduction device having arms arranged in a double helix.
  • FIGS. 8 to 10 illustrate the implantation of the lung reduction device into branches of a bifurcation of an airway passage.
  • FIGS. 11 and 12 illustrate another embodiment of a lung reduction device having arms arranged in a double helix.
  • FIGS. 13 and 14 illustrate proximal (Fig. 13) and distal (Fig. 14) ends of a drive shaft to move a lung reduction device longitudinally and rotationally with respect to a sleeve (lumen).
  • FIGS. 15 and 16 illustrate another embodiment of the implantation of the lung reduction device into branches of a bifurcation of an airway passage.
  • FIG. 17 is a view in cross section of an arm of the lung reduction device.
  • FIGS. 1 to 6 illustrate the insertion of a lung reduction device, such as a lung clip, into air passages of a lung 10.
  • a lung reduction device such as a lung clip
  • bronchoscope is inserted into the patient through the trachea 14 and into the air passages 16 of one of the lungs 10.
  • the arrows 18 show the advancement of the distal end 20 of the flexible shaft 12 of the bronchoscope into the lung.
  • a portion 19 of the lung may be diseased or otherwise unable to effectively exchange carbon dioxide for oxygen.
  • the techniques and devices disclosed herein may be used to reduce the volume of the diseased portion 19 of the lung. Reducing the volume of portion 19, allows the remaining portion of the lung to expand into the volume previously occupied by portion 19.
  • a physician manipulates the flexible shaft 12 of the bronchoscope to manipulate the distal end 20 and advance the distal end through the air passages of the lung, as shown in Figures 1 and 2.
  • a camera on the distal end 20 may be used to generate images of the air passages which are viewed by the physician manipulating the flexible shaft 12 of the bronchoscope.
  • the bronchoscope may also be shown on a display of images of the lung generated in real time of the lung, such as by using X-ray or CT scanning techniques. Virtual bronchoscopy mapping may be used to plan a procedure or deliver a lung reduction clip.
  • the distal end 20 of the bronchoscope is advanced to a selected bifurcation 22 of the airway passages in the diseased portion 19 of the lung.
  • the distal end 20 of the flexible shaft of the bronchoscope is positioned proximate to and upstream of an airway bifurcation 22 that splits into two or more branches 24 , 26.
  • the distal end 20 may be advanced as far as possible into a lobe, such as a left or right upper lobe, of the lung.
  • a lumen 28 is extended from the distal end 20 of the flexible shaft 12 of the bronchoscope.
  • the lumen 28 may be a hollow sleeve, such as a tube, that may be advanced (see arrow 30) into the airway passage beyond the distal end 20 of the bronchoscope.
  • the lumen has sufficient stiffness and structural strength to retain its general tubular shape as it extends from the distal end 20 and is advanced towards the bifurcation 22 of the airway passage.
  • the stiffness and structural strength of the lumen allow the lumen to retain its shape as the lung reduction device housed in the lumen is advanced from the lumen and turned during the advance.
  • the stiffness and structural strength of the lumen is helpful in supporting a delivery tool shaft that extends through the lumen and advances and turns the lung reduction device.
  • FIG. 4 shows a first arm 32 of a lung reduction device being slid out of the distal end of the lumen 28.
  • the lung reduction device may be formed of a super elastic and shape memory material, such as Nitinol (nickel titanium), which returns to its original shape after being deployed from the lumen.
  • the lung reduction device In the lumen, the lung reduction device is constrained by the inner walls of the lumen and deformed into a generally straight shaft like configuration.
  • the arms such as the first arm 32, elastically return to their original shape, which may be a helix, wave, coil, frog- leg, bowed or other shape configured to seat in a branch 24, 26 of an airway passage in the lung.
  • the arm may include a nub 34 at a distal end of the arm.
  • the nub may be flared, e.g., curved, to assist the nub in entering the branch.
  • the nub 34 may slide against the lung tissue forming the branch 26 as the arm 32 is advanced into the branch.
  • the lung reduction device is rotated 36 which rotates the first arm.
  • the rotation of the lung reduction device may be driven by rotation of the lumen or by a drive shaft within the lumen and coupled to the lung reduction device.
  • the lung reduction device may be rotated as it is deployed from the lumen (sleeve).
  • the lung reduction device may be pushed out of the lumen by a drive shaft and/or the lumen may be retracted to cause the lung reduction device to slide out of the lumen.
  • the rotation of the lung reduction device and the advancement of the device towards the bifurcation and its branches may be performed sequentially and/or
  • the advancement and rotation of the lung reduction device is controlled by a physician or other operator of the bronchoscope.
  • a camera 40 at the distal end 20 of the shaft 12 of the bronchoscope may be used to capture images, in real time, of the alignment between the first arm and the branch.
  • Other imaging techniques, such as X- rays or CT scans of the lung may be used to assist in turning and advancing the first am 32 of the lung reduction device into the branch 26 of the bifurcation 22 in the air passages of the lung, which may be particularly useful when a targeted septum 22 is out of visual range from the camera 40.
  • the lumen 28 may be retracted (arrow 30) and turned 42 to move the end of the lumen into alignment with the other branch 24.
  • a second arm 44 extends from the distal end of the lumen.
  • the second arm 44 is aligned with the branch 24 by advancing 41 and/or rotating 42 the lumen 28 which advances and rotates the second arm 44.
  • the flared nub 46 of the second arm 44 enters the branch 24 and may slide along lung tissue forming the branch 24 as the arm is advanced into the branch.
  • the second arm 44 may be shorter than the first arm 32 of the lung reduction device. Having the first arm longer than the second, assists in moving the first arm into the first branch 26 and thereafter moving the second arm into the second branch 24.
  • the first arm 32 may bend and otherwise deform in the first branch 26.
  • the length and shape, e.g., wavey, frog legged or helical, of the first arm assists in causing the first arm to remain in the first branch while the rest of the lung reduction device is retracted, advanced and/or rotated to move the second arm into the second branch. Both arms may have similar shapes.
  • FIG. 6 shows the lung reduction device 48, such as a lung clip, being fully extended out of the lumen 28 and positioned such that the first arm 32 is in the first branch 26 of the air passage bifurcation 22 and the second arm 44 is in the second branch 24.
  • the arms 32, 44 are fixed at their proximal ends to a hub (vertex) 50 of the device 48.
  • the hub may be cylindrical and have a key 54 configured to engage a distal end 56 of a delivery shaft 58.
  • the delivery shaft 58, while engaged with the key 54 and stem 52 of the device 48 may advance, retract and turn the arms 32, 44 of the device 48 to move the arms into their respective branches 24, 26.
  • the delivery shaft 58 may include, at its distal end 56, a clamp, jaws, threads or other gripping device 60 which engages the key 54 on the stem 52 of the device 48.
  • the gripping device 60 may be configured to securely grasp the key 54 while the distal end 56 and the stem 52 are within the sleeve of the lumen 28.
  • the gripping device may spread outward, be turned or otherwise maneuvered to disengage from the key 54 as the gripping device slides out the distal end of the lumen 28. This disengagement action by the gripping device releases the lung reduction device 48 from the delivery shaft and allows the device 48 to remain at the bifurcation 22.
  • the lumen 28 is then retracted into the shaft 12 of the bronchoscope and the shaft is pulled out of the lung tissue along the same airway passages as used to introduce the shaft into the lung.
  • the shaft 12 or lumen 28 may be repositioned in the lung to implant another lung reduction device.
  • the lung reduction device 48 while seated at the bifurcation applies a compressive force to tissue 22 between the branches 24, 26.
  • the arms form cantilevers attached to the hub (vertex) 50 and stem. The arms are spread apart by the branches. The elastic properties of the arms results in compressive forces 62 applied by the arms to their respective branches. The compressive forces may be applied by the arms laterally and radially to push and twist the branches together.
  • the compressive forces applied by the lung reduction device reduce the volume of the septum of lung tissue between the branches and adjacent the bifurcation of the airway passage.
  • these compressive forces applied by the lung reduction device to the branches reduce the volume of the lung in the diseased region 19.
  • FIG. 7 illustrates another embodiment of a lung reduction device 70 in a configuration where the device has not yet been implanted or constrained by a delivery lumen 88, which includes at least two arms 72, 74, wherein one arm 72 is longer than the other 74.
  • the distal ends (nubs) 76 of the arms may be rounded, padded or otherwise shaped or treated to avoid puncturing lung tissue at the surfaces of the branches of the airway passages.
  • the arms each have a helix, spiral or corkscrew shape.
  • the arms 72, 74 together may form a double-helix shape in which the arms remain generally parallel along their length.
  • the proximal ends of the arms 72, 74 are fixed to a hub (vertex) 78.
  • the arms extend from the vertex as cantilevered arms.
  • the hub provides structural support for the proximal ends of the arms such that the arms are biased to maintain their helical shape and resist being bent apart.
  • the structure and shape of the arms cause them to be biased to return to their double helical shape. This bias applies a mechanical compressive force that may compress and twist the branches together.
  • the branches are formed by a bifurcation of an air passage.
  • the device 70 is implanted at the bifurcation and the arms are each inserted into a respective one of the branches.
  • the branches are compressed together due to lateral and radial forces applied by the arms to the branches.
  • the arms may compress the branches and in some scenarios may twist the airway branches to some degree and thereby collapse the branches together.
  • the lung tissue near the branches is also collapsed which reduces the volume occupied by the lung tissue near the branches.
  • Other lung tissue (e.g., parenchyma) near the compressed lung tissue may expand, which may improve elastic recoil of airways and alveoli thus improving breathing mechanics in the diseased lung.
  • the hub and arms may be integral and form a single piece lung reduction device 70.
  • the device may be formed of a super elastic material such as Nitinol, an elastic material such as spring stainless steel or an elastic polymer such as PEEK or Pebax®, or a shape memory material such as shape memory Nitinol or shape memory polymer.
  • the device may be formed from a sheet of material or from a tube of material. A laser cutting device may be used to cut the sheet or tube to form the arms, hub and other portions of the lung reduction device 70.
  • the cut device 70 is rolled into a desired tubular shape such as shown in Figure 7 and subjected to a treatment, such as being heated to set the shape of the device as a tube with integral arms arranged as a double helix.
  • a treatment such as being heated to set the shape of the device as a tube with integral arms arranged as a double helix.
  • Other manufacturing options may include molding, machining, printing, etching or stamping.
  • the arms 72, 74 may be cut by a laser such that they are wider near the hub and become increasingly narrower along their length and towards the nubs 76. Due to being cut from a sheet or tube of material, the arms may have a width W, which is greater than their thickness t as shown in Figure 17. Similarly, the cross section of each arm may be arc-shaped. The wide and arc shaped arms tends to have greater stiffness in radial and circumferential directions, and thereby resist being bent outward more so than arms formed from wires. Similarly, the stiffness of the arms assists the device 70 in applying mechanical loads (forces) to lung tissue in lateral and radial directions to collapse the lung tissue between the branches into which the arms are inserted.
  • the lung tissue may be collapsed and in some scenarios may twist the airways to some degree.
  • the dimensions of the lung reduction device 70 are selected based on the air passage bifurcation and branches into which the device is to be implanted.
  • the length of the arms 72, 74 may be in the range of 10 to 150 millimeters (mm)
  • the length of the hub may be 2 to 5 mm
  • the diameter of the device may be 0.25 to 3 mm, such as 1.8 or 2.2mm.
  • the diameter of the device should be smaller than the inside diameter of the sleeve (lumen), e.g., about 90% of the lumen inner diameter, to allow the device to be advanced through the lumen.
  • the shorter arm 74 may be 50% to 80%, such as 60%, 70% and 75%, of the length of the longer arm 72.
  • the lung reduction device 70 may include a stem (hub) 80 which is proximal of the hub 78.
  • the stem (hub) 80 may have a lumen therethrough, which may allow the device to be delivered over a guidewire (not shown).
  • a guidewire may pass through the device 70 by passing along the central axis of the device through a lumen in the stem 80 and hub 78 and between both arms 72 and 74.
  • the guidewire may be positioned in one airway branch.
  • the guidewire may be retracted out of the device 70 for example once the device 70 is fixed onto the targeted septum.
  • the guidewire may optionally be left in the lung, for example in the diseased region of the lung following implantation of a first device and when to facilitate positioning of a second device to be implanted on a different airway bifurcation that may be in the diseased region.
  • a fixation coil 81 may extend from a distal end of the stem (hub).
  • the fixation coil may be a helically shaped extension which is substantially shorter than the arms 72, 74.
  • the fixation coil may be formed by laser cutting of the tube or sheet of material which is cut to form the hub and arms.
  • a fixation coil may be shaped (e.g., machined) from a separate piece of material and connected to a hub of a lung clip.
  • the fixation coil is configured to be implanted into the septum of lung tissue at the bifurcation of the air passages as shown in Figure 10. Implanting a fixation coil into the septum may further reduce a risk of a lung reduction clip from becoming dislodged.
  • the stem (hub) may include a locking mechanism 82 (key) that engages a distal end 84 of a driving shaft 86 that moves the device 70 longitudinally with respect to the shaft 86 and a sleeve (lumen) 88 that houses the device 70 before being positioned into the bifurcation.
  • the locking mechanism may be in the form of a T or L-shaped slot in the stem.
  • the distal end 84 of the shaft may be a post that fits within a hollow section of the stem 80 of the device.
  • a detent 90 on the side of the distal end 84 slidably engages the T or L-shaped slot of the locking mechanism 82.
  • the shaft 86 engages the device 70 and is able to move the device is both longitudinally and rotationally.
  • the distal end 84 is seated in the stem 80 as the device 70 is loaded into a sleeve 88 which may be carried by a lumen extending from the distal end of a flexible shaft of a bronchoscope or the sleeve may extend directly from the flexible shaft.
  • the shaft rotates the device to cause the longer arm 72 to enter one branch of the bifurcation and thereafter continues to push out and rotate the device 70 to cause the shorter arm 74 to enter another branch of the bifurcation.
  • the shaft 86 is used to maneuver the device until both arms are positioned in their respective branches and the hub 78 is adjacent the bifurcation. In the embodiment shown in Figure 7, while maneuvering the device 70, the shaft may only rotate in a single direction to ensure that the detent 90 does not slide out of a longitudinal portion of the T or L-shaped slot.
  • a distal end of a drive shaft 140 and the hub of a lung reduction clip 144 may have a coupling mechanism 156,158 that allows rotation in both directions and decoupling is done by releasing the coupling mechanism from a sheath 88.
  • the device 70 remains implanted at the bifurcation and functions to collapse lung tissue near the bifurcation.
  • the shaft 86 and sleeve 88 are retracted from the airway passages of the lung.
  • FIGS. 8 and 9 illustrate the helical arms 72, 74 of the lung reduction device 70 being deployed from a sleeve 88.
  • the delivery shaft 86 and the distal end 84 of the delivery shaft are engaged with the stem 80 of the device 70 and are housed within the sleeve immediately behind the device. While the device 70 is fully housed in the sleeve 88, as shown in Figure 8, the device 70 is constrained by the sidewalls of the sleeve 88 such that the arms are close to each other in a double helix configuration and symmetrical about an axis 89.
  • the sleeve with the device is advanced (arrow 90) through an air passage 16 in the lung towards a selected bifurcation 22.
  • the sleeve is retracted (or the device 70 may be advanced) to deploy the device 70 from the sleeve.
  • the arms 72, 74 of the device slide clear of the sleeve, one or both of the arms may flare outward as shown in Figure 9.
  • the flaring of the arm(s) may be limited to a distal region on one or both the two arms 72,74. Alternatively, the flaring may comprise a greater portion (e.g., distal 25%, distal 50%, distal 75%) of one or both arms bending outward from the axis of the device as the device slides from the sleeve.
  • the shaft 86 is turned (arrow 92) to cause the device 70 (arrow 94) to turn.
  • the device 70 is advanced and simultaneously turned by the distal end 84 of the shaft, as shown in Figure 9.
  • the advancement and turning of the device 70 causes the longer arm 72 to engage a branch 24 of the bifurcation 22.
  • the distal end 76 of the first arm 72 may be flared which assists in causing the end of the arm to enter the branch 24.
  • the arm remains in that branch, even while the arm is turned and bent by continued turning and advancement of the device 70.
  • the continued advancement and turning of the device is used to cause the distal end 76 of the shorter arm 74 to enter another branch 26 of the bifurcation.
  • the shaft 86 continues to advance and turn the device 70 towards the bifurcation As shown in FIG. 10, the continued turning of the device 70 may cause the branches 24, 26 to twist around each other.
  • the twisting of the branches around each other collapses the lung tissue in the region of the branches and bifurcation. This collapse of lung tissue reduces the volume of the diseased portion of the lung.
  • the device 70 After the device 70 has been implanted at the bifurcation 22 and the arms 72, 74 have twisted together the branches 24, 26 of the airway passage, the device 70 is detached from the distal end 84 of the shaft 86. Thereafter, the distal end and shaft are retracted into the sleeve 88 (see arrow 96). Once the shaft is retracted into the sleeve, the sleeve is retracted (see arrow 98) from the airway 16 in the lung and trachea, or alternatively repositioned to implant another lung clip on a different septum. [00059] An alternative version of how a device (e.g., device 70) behaves when implanted is shown in figure 16.
  • a device e.g., device 70
  • FIG 15 shows the device 70 prior to advancing it over a targeted septum 22 wherein the drive shaft 86 is coupled to the locking mechanism 82, a sleeve 88 is partially containing the device 70, and an optional guidewire 108 is positioned through the device 70, a lumen in hub 78 and stem 80, and a lumen 87 in the drive shaft.
  • the drive shaft 86 is advanced and rotated which causes the arms of device 70 to advance and rotate.
  • each arm is engaged in a respective airway branch 24 and 26, which causes each arm to separate from a common axis and become two separate helixes positioned in each airway branch 24,26 and connected to the hub 78.
  • the forces applied to the airway branches by the two arms compresses tissue in the septum 22.
  • each arm provides beneficial functions including gripping the tissue to reduce a risk of the device 70 becoming dislodged; facilitating a screw motion to advance the device on to the septum; imparting a combination of forces (e.g., force vectors that are orthogonal to the curved ribbon width in some positions and tangential to the ribbon width in some positions) that contribute to the cantilevering effect of the arms; moving with the compressed lung tissue during breathing motion.
  • Another beneficial feature of the configuration shown in figure 16 is that the two arms each in a separate helical formation in their respective airway branches may act similar to a stent to prevent the airways from occluding fully if they were to collapse for example by kinking.
  • a lumen of each helix may remain patent while the helical arms stop the airway walls from collapsing fully.
  • FIGS. 11 and 12 illustrate another type of lung volume reduction device 100 having a hub (vertex) 102 that attaches the arms 106,110 to a stem 114.
  • the device 100 may be formed of a super elastic material that, when deformed, applies a bias force to return to its original shape. The bias force is applied by the device to lung tissue to collapse the tissue.
  • the arms 106, 110 may be wires or strips having a width greater than their thickness.
  • the arms each form a helix and the arms together form a double helix that assists in twisting and collapsing branches of the airway into which the arms are implanted.
  • Figure 11 shows the device 100 as it would be housed in a sleeve.
  • Figure 12 shows the device 100 in a deployed state and out of the sleeve. While in the sleeve, the arms of the device are deformed to be generally straight by the inside walls of the sleeve. As the device 100 is pushed out of the sleeve, the arms spread outward as shown in Figure 12. The distal end of the shorter arm is flared outward which assist in inserting the arm into a branch of the bifurcation.
  • a hollow nub 104 is on the longer arm 106.
  • the hollow hub 102 and stem 114, and the hollow nub 104 are configured to receive a guide wire 108.
  • the guide wire is advanced from the distal end of a flexible shaft of a bronchoscope and through the airway and into a selected branch of the airway.
  • the guide wire 108 may be inserted into the branch with the aid of an imaging device such as a CT scanner or X-ray device that enables a physician to view on a display screen the position and movement of the guide wire in the air passages of the lung.
  • the device 100 slides from a sleeve and along the guidewire to position the longer arm 106 in the selected branch.
  • the device 100 is rotated to align the shorter arm 110 with another branch and to insert the nub 112 of the shorter arm 110.
  • a delivery tool may grasp the stem 114 of the device and rotate the device 100 about the guide wire to align the nub 112 of the shorter arm 110 with the branch that does not include the guide wire.
  • the turning of the device also may cause the arms to twist the branches together to compress tissue between the branches and reduce the volume of the lung tissue near the branches.
  • the guide wire 108 is retracted from the device 100 and from the lung and the patient or alternatively left in the lung to prepare for delivering another device to a different septum.
  • FIGS. 13 and 14 illustrate proximal (Fig. 13) and distal (Fig. 14) ends of a drive shaft 140 to move a lung reduction device longitudinally and rotationally with respect to a sleeve (lumen) 88.
  • the proximal end of the drive shaft 140 is connected to a handle 142 which allows a physician to move the drive shaft and a lung reduction device 144 coupled to the distal end of the drive shaft in both longitudinal and rotational directions.
  • the handle 142 may be cylindrical in shape and have a helical slot 146 extending at least partially along the length of the handle.
  • the handle may be hollow or have an internal passage to receive the proximal end of the drive shaft 140.
  • a T-shaped end 148 of the drive shaft extends into the slot 146 of the handle.
  • the T-shaped end is configured to slide through the slot when moved by a physician holding and moving a collar 150 which holds the lateral ends of the T-shaped end 148.
  • the slots 146 cause the T-shaped end to simultaneously advance forward (arrow 152) and turn (arrow 154) the drive shaft 140.
  • the physician may advance the drive shaft longitudinally, without turning the shaft, by holding or locking the collar in place with respect to the handle and pushing and pulling the drive shaft.
  • the collar 150 and T-shaped end 148 may be pulled rearward along the cylinder 142 to disengage the lung reduction device 144 from the key 156 on the distal end of the drive shaft 140.
  • the drive shaft key 156 may have a shape that seats in a corresponding key 158 of the hub of the lung reduction device 144.
  • the keys 158, 156 on the hub and drive shaft engage while the hub and end of the drive shaft are within the sleeve 88 to advance and turn the lung reduction device.
  • the key 156 of the drive shaft may disengage from the key 158 of the hub of the lung reduction device by rotational and/or longitudinal movement of the drive shaft.
  • the embodiment of a drive shaft and lung clip coupling mechanism that has key 156 and 158 as shown in Figure 14 may be applied to any of the various embodiments of clip arms or other clip features disclosed herein.
  • a drive shaft 140, key 156 and handle 142 may further comprise a guidewire lumen (not shown) configured to allow a guidewire to pass through the lumen and through one or more guidewire lumens of an implantable lung clip.
  • FIG. 17 shows in cross-section an arm 72, 74 of the lung reduction device 70.
  • the arm may taper from the vertex 78 towards the distal end of the arm.
  • the width (W) of the arm at the vertex gradually narrows (w) along the length of the arm and towards the distal end of the arm.
  • the amount of taper of the width may be from 10 percent to 75 percent, such as 20, 30, 40, 50 and 60 percent.
  • the cross section 79 of the arm may be an arch shape.

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

Abstract

L'invention concerne un dispositif de réduction pulmonaire (32, 48, 70, 100, 120, 144) comprenant : une embase (52, 80, 114, 128), un premier bras (32, 72, 106, 122) comportant une extrémité proximale reliée à l'embase, et un second bras (44, 74, 110, 123, 124) comportant une extrémité proximale reliée à l'embase, les premier et second bras se prolongeant à partir d'un même côté distal de l'embase, et chacun des premier et second bras comprenant, dans au moins une configuration du dispositif, une partie respective de forme non linéaire.
PCT/US2019/013177 2018-01-14 2019-01-11 Méthodes et dispositifs pour le traitement de troubles pulmonaires Ceased WO2019140179A1 (fr)

Applications Claiming Priority (2)

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US201862617255P 2018-01-14 2018-01-14
US62/617,255 2018-01-14

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013109784A1 (fr) * 2012-01-17 2013-07-25 Endoshape, Inc. Dispositif d'occlusion pour un lumen vasculaire ou biologique
US20150119905A1 (en) * 2013-10-29 2015-04-30 Entourage Medical Technologies, Inc. System for providing surgical access
WO2015153507A1 (fr) * 2014-03-31 2015-10-08 Spiration, Inc. Mécanismes et systèmes d'ancrage pour dispositifs endoluminaux
US20150342610A1 (en) * 2014-05-29 2015-12-03 Pulmonx Corporation Medical devices and methods for lung volume reduction

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013109784A1 (fr) * 2012-01-17 2013-07-25 Endoshape, Inc. Dispositif d'occlusion pour un lumen vasculaire ou biologique
US20150119905A1 (en) * 2013-10-29 2015-04-30 Entourage Medical Technologies, Inc. System for providing surgical access
WO2015153507A1 (fr) * 2014-03-31 2015-10-08 Spiration, Inc. Mécanismes et systèmes d'ancrage pour dispositifs endoluminaux
US20150342610A1 (en) * 2014-05-29 2015-12-03 Pulmonx Corporation Medical devices and methods for lung volume reduction

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