HK1217892B - Torque alleviating intra-airway lung volume reduction compressive implant structures - Google Patents

Abstract

A device for enhancing the breathing efficiency of a patient is provided. The implantable device may include a deployed configuration with one or more helical sections with proximal end in a stand-off proximal end configuration. The stand-off proximal end configuration may reduce migration of the deployed device and may preserve implant tissue compression. Alternative configurations may include two or more helical sections with a transition section disposed between the two or more helical sections. A device may include a right-handed helical section and a left-handed helical section and the transition section comprises a switchback transition section. The switchback section may provide greater control of the device during deployment by limiting recoiling forces of a device comprising a spring material. The deployed device may compress the lung to increase a gas filling resistance of the compressed portion of the lung, and/or increase tension and elastic recoil in other portions of the lung.

Description

Torque-reducing compression type implant structure for lung in airway

Related application

The present patent application claims the benefit of U.S. provisional patent application No.61/791,517 filed 3, 15, 2013, in accordance with 35USC § 119 (e). The entire disclosure of this provisional patent application is incorporated herein by reference for all purposes.

This patent application is generally related to U.S. patent application No.12/782,515 (approved) entitled "Cross-section modification During Deployment of an elongated Lung Volume Reduction Device" filed on 2010, 5, 18, which claims the benefit of U.S. provisional patent application No.61/179,306 filed on 2009, 5, 18, according to 35USC 119(e), each of which is incorporated herein by reference in its entirety.

This patent application is also generally related to U.S. patent application No.12/167,167 (now U.S. patent No.8,282,660) entitled "minimumy active Lung Volume Reduction Devices, Methods, and Systems" (Minimally Invasive Lung Volume Reduction Devices, Methods, and Systems) filed on day 7, month 2 of 2008, a continuation application of PCT patent application No. PCT/US07/06339 filed internationally on day 3, month 13 of 2007, a continuation application of U.S. patent application part No.11/422,047 (now U.S. patent No.8,157,837) filed on day 6, month 2 of 2006, and entitled "minimumy active Lung Volume Reduction Device and method", each of which is incorporated herein by reference in its entirety.

The present patent application also relates generally to U.S. provisional patent application No. 60/743,471 entitled "Minimally Invasive lung volume Reduction Device and Method" (Minimally Invasive lung volume Reduction apparatus and Method) filed on 13.3.2006; U.S. provisional patent application No. 60/884,804 entitled "Minimally Invasive Lung Volume reduction devices, Methods and Systems" (Minimally Invasive Lung Volume reduction devices, Methods, and Systems) filed on 12.1.2007; and a national provisional patent application 60/885,305 entitled "Minimally Invasive Lung volume reduction Devices, Methods and Systems" (Minimally Invasive Lung volume reduction Devices, Methods, and Systems) filed on 17.1.2007, each of which is incorporated herein by reference in its entirety.

This patent application also relates generally to U.S. patent application No.12/209,631 (now U.S. patent No.8,142,455) entitled "Delivery of Minimally Invasive Lung volume reduction Devices"; U.S. patent application No.12/209,662 (now U.S. patent No.8,157,823), entitled "Improved Lung Volume Reduction Devices, Methods and systems" (Improved minimally invasive Lung Volume Reduction Devices, Methods and systems), both of which were filed on 12/9/2008; and to U.S. patent application No.12/558,206 entitled "Improved and/or Long Lung Volume Reduction Devices, Methods, and Systems" (Improved and/or Longer minimally invasive Lung Volume Reduction Devices, Methods, and Systems); and U.S. patent application No.12/558,197 (now U.S. patent No.8,632,605) entitled "Elongated Lung Volume Reduction Devices, Methods, and Systems" (Elongated minimally invasive Lung Volume Reduction Devices, Methods, and Systems), each of which was filed on 11/9/2009, all of which are incorporated herein by reference in their entirety.

All publications and patent application publications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Background

Technical FieldDevices, systems, and methods for treating a lung are described. For patients with emphysema, the example devices, systems, and methods may, for example, improve quality of life and restore lung function. Embodiments of a system may include an implant and a delivery catheter. The implant may be advanced through tortuous anatomy and actuated to maintain a predetermined shape and stiffness. Additionally, the implant may include a shape memory material or a spring material, which may be constrained to a first configuration during delivery through tortuous anatomy and may subsequently be allowed to return to a second configuration during deployment. The deployed implant modifies the shape of the airway and locally compresses the lung parenchyma to cause a volume reduction and thereby tensions the lung parenchyma to recover elastic recoil. Also included are systems and devices for deploying and actuating implantable devices, and systems and devices designed for recapturing implantable devices.

The current medical literature describes emphysema as a chronic (long-term) lung disease that can be exacerbated over time. Which is usually caused by smoking. With emphysema is meant that some of the alveoli in the lungs are damaged, making breathing difficult. Some reports indicate that emphysema is the fourth leading cause of death in the united states, affecting estimates of 16-30 million U.S. citizens. Approximately 100,000 patients die from the disease each year. Smoking has been identified as the primary cause, but with increasing air pollution and other environmental factors that negatively affect lung patients; the number of people affected by emphysema is rising.

For patients with emphysema, the currently available solution is a surgical procedure known as Lung Volume Reduction (LVR) surgery, whereby the diseased lung is resected and lung volume is reduced. This allows the healthier lung tissue to expand into the volume previously occupied by the diseased tissue and allows the diaphragm to recover. High mortality and morbidity can be associated with such invasive procedures. There are several minimally invasive investigative treatments aimed at improving the quality of life and restoring lung function in patients with emphysema. These possible treatments include mechanical devices andand (4) carrying out biological treatment. Zephyr prepared from Emphasys (Redwood City, Calif.)^TMDevice and IBV prepared by Spiration (Redmond, WA)^TMThe device is a mechanical one-way valve device. The principle underlying these devices is to achieve absorptive atelectasis by preventing air from entering the diseased portion of the lung while allowing air and mucus to pass out of the diseased area through the device. The Watanabe tap is another mechanical device that may attempt to completely occlude the airway, thereby preventing air from entering and leaving the lungs. For such devices, collateral ventilation (preventing completely blocked interphalangeal and intrapolatal-porous flow paths) may prevent atelectasis. The absence of atelectasis or lung volume reduction can significantly reduce the effectiveness of such devices. Other mechanical devices include components that deploy anchors into the airway and physically deform the airway by pulling the anchors together via a cable.

Biological treatment utilizes tissue engineering, the purpose of which is to create scars at specific locations. Unfortunately, controlling scar formation and preventing uncontrolled scar proliferation can be difficult.

Summary of The Invention

The present invention generally provides improved medical devices, systems and methods, particularly for treating one or both lungs of a patient. Embodiments of the present invention generally use an elongated implant structure that can be introduced into an airway system to reach a target airway axial region. The target axial region may or may not include branches, and the implant may be deployed within the airway by bending or allowing the implant to bend such that the implant compresses adjacent lung tissue. Many embodiments may apply lateral bending and/or compressive forces to lung tissue from within the airway for extended periods of time. Exemplary embodiments may be placed in a lung to increase gas filling resistance in portions of the lung. Optionally, embodiments may be deployed within the lung to expand a previously collapsed airway or blood vessel. Embodiments may include a spring or shape memory material that is delivered to a target airway in a delivery configuration within a catheter and then released from the catheter to return to a deployed configuration within the airway. Exemplary embodiments may have configurations that provide a more controlled transition from a delivery configuration to a deployed configuration during release of the device from a catheter. In some embodiments, the proximal end of the device may be configured to facilitate recapturing of the device after it is deployed within the lung. This may be advantageous when the device is deployed to an undesirable location or orientation or when the implant is deemed unnecessary.

Exemplary embodiments include structures or features that can prevent tissue reactions that may otherwise allow portions of the device to eventually penetrate the airway wall. Various embodiments of the elongated device can increase the support area that bears laterally on tissue surrounding the airway cavity wall, particularly along the length of the device between the proximal end of the device and the distal end of the device. Embodiments may have features that increase the friction of the device with the airway to allow the device to grasp the surrounding airway when the device is deployed. This may be advantageous to prevent the device from sliding longitudinally within the airway and may increase the accumulation of damaged lung tissue together under compression. Maintaining the device within the airway may facilitate recapture of the device (in the delivery catheter or after full deployment and the device has been implanted, optionally capturing the implant with a separate device (separate grasper)) and may facilitate successful pulling of the device out of the lung. Infusing a suitable adhesive around the device in the lung (ideally by infusing pneusseal^TMAlbumin-glutaraldehyde adhesive) that can then be recaptured by pulling the device out of the sealant. To minimize or inhibit inflammation of the tissue, the device should include a material that is biocompatible and generally circular such that micro-motion between the device and the airway does not result in acceleration of tissue degradation. Contact with the device may advantageously cause beneficial tissue thickening. Some tissue ingrowth (stimulation of tissue growth) is induced to thicken the tissue base and the device is obtainedThe feature of better support may also be advantageous.

In an embodiment of the present invention, a lung volume reduction system for improving respiratory efficiency of a patient having an airway is provided. The system may include an implantable device configured to apply a compressive force to lung tissue. The implantable device can include a proximal end and a distal end, and can also have a first configuration and a second configuration. The second configuration of the implantable device may correspond to a pre-implant or post-implant configuration of the implantable device. The second configuration may include at least two helical segments (sometimes referred to herein as coil segments) and a transition segment disposed between the at least two helical segments. Optionally, the at least two helical segments comprise a right-handed helical segment and a left-handed helical segment. Additionally, the transition segment disposed between the at least two helical segments may comprise a back-cut transition segment when the implantable device is in the second configuration. In some embodiments, at least one of the at least two helical segments comprises a circular helical segment when the implantable device is in the second configuration. Optionally, when the implantable device is in the second configuration, two of the at least two helical segments comprise circular helical segments.

In some embodiments, the implantable device can further comprise a jacket covering a portion of the implantable device. The jacket can be configured to reduce erosion within the airway by the deployed implantable device. The jacket may cover the at least two helical segments and the transition segment disposed between the at least two helical segments. The jacket may also cover the distal end of the implantable device. Optionally, the jacket may comprise a polycarbonate polyurethane material. The polycarbonate material may have a hardness of at least 55D.

In some embodiments, the distal end of the implantable device can include an anchor for coupling with the airway. Optionally, the proximal end of the implantable device may be non-invasive. Preferably, the proximal end of the implantable device comprises a distal tail extending away from each axis of the at least two helical sections when the implant is in the second configuration. In some embodiments, the at least two helical segments each have a first axis and a second axis when the implantable device is in the second configuration, and the first and second axes are different. The first axis and the second axis may form an angle in a range of 190 ° to 230 ° when the implantable device is in the second configuration. Optionally, the implantable device comprises a spring element. The implantable device can include a metal including nickel and titanium. In some embodiments, the distal helical section may include more loops (i.e., complete helical turns) than the proximal helical section when the implantable device is in the second configuration. In some embodiments, the proximal helical section may comprise less than two loops when the implantable device is in the second configuration. Optionally, the distal helical section comprises at least one loop when the implantable device is in the second configuration. In some embodiments, the distal helical section may comprise at least four loops when the implantable device is in the second configuration.

Some embodiments of the present invention provide a lung volume reduction device for improving the respiratory efficiency of a patient having an airway. The device may comprise a proximal end and a distal end; and the device may comprise a first configuration and a second configuration, wherein the first configuration corresponds to the delivery configuration and the second configuration corresponds to the pre-implantation configuration or the post-implantation configuration. The second configuration of the device may include a first helical section having an axis, and the first helical section may be disposed between the proximal end and the distal end of the device. The proximal end may extend away from the axis of the first helical section when the device is in the second configuration. The second configuration may also include a second helical segment coupled with the first helical segment. The first and second helical segments may comprise right-handed and left-handed helical segments when the device is in the second configuration. The proximal end may extend away from the axis of the second helical section when the device is in the second configuration.

In some embodiments of the lung volume reduction device, the more distal helical section may comprise more loops than the proximal helical section when the device is in the second configuration. Optionally, the axis of the second helical section may be different from the axis of the first helical section when the device is in the second configuration. The device may further comprise a jacket covering at least the distal end and the first helical section. The jacket may comprise a polycarbonate polyurethane material having a hardness of at least 55D.

In another embodiment of the present invention, a method of increasing the respiratory efficiency of a patient having a lung with an airway is provided. The method may include advancing the implant distally through the airway to a portion of the patient's lung when the implant is in a delivery configuration; the implant has a proximal end and a distal end. The device may then be deployed in a portion of the lung by transitioning the implant from the delivery configuration to the deployed configuration; the deployed configuration of the implant includes at least two helical segments and a transition segment disposed between the at least two helical segments. The at least two helical segments may include a right-handed helical segment and a left-handed helical segment, and the transition segment disposed between the at least two helical segments may include a cut-back transition segment when the implant is in the deployed configuration. At least one of the at least two helical segments can comprise a circular helical segment when the implantable device is in the deployed configuration. Optionally, when the implant is in the deployed configuration, two of the at least two helical segments comprise circular helical segments. In some embodiments, the implant may further comprise a jacket covering a portion of the implant. The jacket may be configured to reduce implant erosion within the airway after the implant is deployed within the lung. The jacket may cover the at least two helical segments and the transition segment disposed between the at least two helical segments. The jacket may also cover the distal end of the implant. Preferably, the jacket comprises a polycarbonate polyurethane material having a hardness of at least 55D.

The distal end of the implant may include an anchor for coupling with the airway. The implant may be deployed in the portion of the lung by coupling the distal end of the implant to the lung tissue with the anchor before or during transitioning of the implant from the delivery configuration to the deployed configuration. The proximal end of the implant may be non-invasive. The proximal end of the implant may also include a pull-out proximal tail. The detached proximal tail may extend away from each axis of the at least two helical segments when the implant is in the deployed configuration. The at least two helical segments may have first and second axes, respectively, and the first and second axes may be different when the implant is in the deployed configuration. For example, the first axis and the second axis may form an angle in the range of 190 ° to 230 ° when the implant is in the deployed configuration. The implant may include a spring element and the implant may be constrained to a delivery configuration during delivery. Optionally, the implant may be configured to naturally revert from the constrained delivery configuration to the deployed configuration during deployment. The implant may comprise a metal comprising nickel and titanium. The distal helical section may include more loops than the proximal helical section when the implant is in the deployed configuration. In some embodiments, the proximal helical section comprises less than two loops when the implant is in the deployed configuration. The distal helical section may include at least one loop when the implant is in the deployed configuration. In some embodiments, the distal helical section may comprise at least four loops when the implant is in the deployed configuration.

In another embodiment of the present invention, another method of increasing the respiratory efficiency of a patient having a lung with an airway is provided. The method may include advancing the implant distally through the airway to a portion of a patient's lungs while the implant is in a delivery configuration; the implant has a proximal end and a distal end. The method may then include deploying the implant in the portion of the lung by transitioning the implant from the delivery configuration to a deployed configuration, the deployed configuration of the implant including a first helical section having an axis, the first helical section disposed between the proximal end and the distal end of the device, and wherein the proximal end extends away from the axis of the first helical section when the device is in the deployed configuration.

The deployed configuration may also include a second helical segment having an axis and the second helical segment may be coupled with the first helical segment. The first and second helical segments may include right-handed and left-handed helical segments when the implant is in the deployed configuration. The proximal end may extend away from the axis of the second helical section when the implant is in the deployed configuration.

The more distal helical section may include more loops than the proximal helical section when the implant is in the deployed configuration. Optionally, the axis of the second helical section is different from the axis of the first helical section when the device is in the deployed configuration. The implant may further comprise a jacket covering at least the distal end and the first helical section. The jacket may comprise a polycarbonate polyurethane material having a hardness of at least 55D.

Brief Description of Drawings

A better understanding of the features and advantages of the present invention will be obtained by reference to the accompanying documents that illustrate exemplary embodiments, in which the principles of the invention are utilized, and the accompanying drawings, of which:

1A-1C illustrate the anatomy of the respiratory system;

2A-2D illustrate a bronchoscope;

figure 3 shows a bronchoscope according to the present invention in combination with a delivery device for a lung volume reduction device;

figures 4A-4F illustrate a lung volume reduction device according to one aspect of the present invention;

figures 5A-5D illustrate a lung volume reduction device according to another aspect of the present invention;

figure 6 shows a lung volume reduction device according to another aspect of the present invention;

figure 7 shows a lung volume reduction device enclosed in a sheath;

figures 8A-8D illustrate a lung volume reduction device according to another aspect of the present invention;

9A-9B illustrate a segment suitable for use in constructing a lung volume reduction device, according to one aspect of the present invention;

FIG. 10 illustrates an exemplary apparatus in a pre-deployment state, in accordance with aspects of the present invention;

11A-11B illustrate a lung volume reduction device according to another aspect of the present invention;

12A-12C illustrate various device configurations having non-invasive tips;

figures 13A-13F illustrate a plurality of individual wires formed from a shape memory material that can be deployed to form a lung volume reduction device and a delivery device;

fig. 14 shows the device configuration;

FIG. 15 shows the device in a loading bay;

FIG. 16 shows an elongated device configuration;

fig. 17 shows a device configuration with a wire support frame;

FIG. 18 shows a device configuration with a cover;

FIG. 19 shows a device configuration with a perforated cover;

fig. 20 shows a device configuration with an attached wire support frame;

figure 21 shows a device configuration with attached frame and cover;

FIG. 22 shows a device configuration coupled to a second device;

fig. 23 shows the device configuration in the shape of a coil;

24A-24E illustrate a device having two helical segments and a transition segment;

fig. 25A-25D show the device of fig. 24A-E further comprising a jacket.

26A-26E illustrate another embodiment of a device having two helical segments and a transition segment;

FIGS. 27A-27D illustrate the device of FIGS. 26A-E further comprising a jacket;

fig. 28 shows the device in a delivery configuration during delivery within the airway;

fig. 29 shows the device of fig. 28 deployed in a deployed configuration within an airway;

FIGS. 30 and 31 are images of human lung tissue before or after compression of a portion of the lung tissue from within the airway by an embodiment of the implant;

FIGS. 32A-32C illustrate the device implanted in a lung;

FIG. 33A illustrates method steps for implanting a device;

FIG. 33B illustrates method steps for implanting a device;

FIG. 34 shows the system positioned in an airway, with the device ready for delivery;

fig. 35 shows a system of a delivery device in an airway;

FIG. 36 shows the system in an airway, where the device has been delivered;

fig. 37 shows a system with a bronchoscope, catheter, dilator and guidewire;

38A-38B illustrate delivery of a device;

FIG. 39 schematically illustrates selection from a plurality of alternative devices having different lengths and loading the device into a cartridge such that the device may be advanced into a delivery catheter; and is

Fig. 40A-40C illustrate delivery of a lung volume reduction device according to an embodiment of the invention.

Detailed Description

By way of background and to provide a context for the present invention, FIG. lA illustrates respiratory system 10 primarily located within the thoracic cavity 11. The description of the anatomy and physiology is provided to facilitate an understanding of the present invention. It should be understood by those skilled in the art that the scope and spirit of the present invention is not limited to the anatomical discussion provided. In addition, it should be understood that the anatomical features of individuals may differ due to a variety of factors not described herein. Respiratory system 10 includes an airway 12, which airway 12 allows air to enter a right main airway 14 and a left main airway 16 from either the nose 8 or mouth 9. Air enters the right lung 18 from the right main bronchus 14; air enters the left lung 20 from the left main bronchus 16. The right lung 18 and the left lung 20 together comprise lung 19. The left lung 20 consists of only two lobes and the right lung 18 consists of three lobes, which to some extent provides space for the heart, which is typically located to the left of the chest cavity 11 (also referred to as the pleural cavity).

As shown in more detail in fig. 1B, the main bronchus (e.g., left main bronchus 16) leading to the lung (e.g., left lung 20) branches into secondary bronchus 22, then further into tertiary bronchus 24, and further into small bronchus 26, terminal bronchus 28, and finally into alveoli 30. The pleural cavity 38 is the space between the lungs and the chest wall. The pleural cavity 38 shown in fig. 1C protects the lung 19 and allows the lung to move during breathing. As shown in fig. 1C, pleura 40 defines pleural cavity 38 and is composed of two layers (visceral pleura 42 and parietal pleura 44), with a thin layer of pleural effusion between the visceral and parietal pleura. The space occupied by the pleural effusion is referred to as the pleural space 46. Each of the two pleural layers 42, 44 is composed of a very porous interstitial serous membrane through which a small amount of interstitial fluid continuously permeates into the pleural space 46. The total amount of fluid in the pleural space 46 is typically small. Under normal conditions, excess fluid will typically be drawn from the pleural space 46 by the lymphatic vessels.

The lungs 19 are described in the current literature as elastic structures that float within the thoracic cavity 11. A thin layer of pleural effusion surrounding the lungs 19 lubricates the movement of the lungs within the thoracic cavity 11. The suction of excess fluid from the pleural space 46 into the lymphatic channels may maintain a slight suction between the visceral pleural surface of the lung pleura 42 and the parietal pleural surface of the pleural cavity 44. This slight suction creates a negative pressure that keeps the lungs 19 inflated and floating within the chest cavity 11. If no negative pressure is present, the lungs 19 collapse like a balloon and expel air through the trachea 12. Thus, the natural exhalation process is almost completely passive due to the elastic recoil of the lungs 19 and the thorax. Due to this physiological configuration, when the pleura 42, 44 is broken, the negative pressure holding the lung 19 in suspension disappears and the lung 19 collapses due to the elastic recoil effect.

When fully inflated, the lung 19 completely fills the pleural cavity 38 and parietal pleura 44 and visceral pleura 42 contact. During the expansion and contraction process of inhalation and exhalation, the lung 19 slides back and forth within the pleural cavity 38. A thin layer of mucoid fluid located in the pleural space 46 between the parietal pleura 44 and the visceral pleura 42 facilitates movement within the pleural cavity 38. As described above, when the alveoli in the lungs are damaged 32, such as with emphysema, breathing becomes difficult. Thus, isolating damaged alveoli to improve the elastic structure of the lungs may improve breathing. Similarly, locally compressing a region of lung tissue while maintaining the overall volume of the lung may increase the tension in other portions of lung tissue, which may increase overall lung function.

Conventional flexible bronchoscopes are described in U.S. patent No.4,880,015 to Nierman entitled "Biopsy Forceps". As shown in fig. 2A-D, bronchoscope 50 may be configured to have any suitable length, for example, a measured length of 790 mm. Bronchoscope 50 may also be constructed from two main parts, a working head 52 and an insertion tube 54. The working head 52 includes an eyepiece 56 (an eyepiece with a diopter adjustment ring 58); accessories for the suction pipe 60 and the suction valve 61 and for the cold halogen lamp sources 62 and 63; and an access port or biopsy inlet 64 through which various devices and fluids may be delivered into the working channel 66 and out the distal end of the bronchoscope. The working head is attached to an insertion tube, typically measuring 580mm in length and 6.3mm in diameter. The insertion tube may be configured to include a fiber optic bundle that terminates into the objective lens 30 at the distal tip 68, two light guides 70 and 70', and the working channel 66. The distal end of the bronchoscope can be bent forward and backward 72 to have an accurate angle of deflection depending on the instrument used. A common range of bending is 160 degrees forward to 90 degrees backward, for a total of 250 degrees. The bending can be controlled by the operator adjusting the angled locking and angulating levers on the working head. See also U.S. publication US 2005/0288550Al to Mathis entitled "Lung Access Device" and US 2005/0288549Al to Mathis entitled "Guided Access to Lung Tissue" which are incorporated herein by reference in their entirety.

Fig. 3 illustrates the use of a lung volume reduction delivery device 80, the lung volume reduction delivery device 80 being used for delivering a lung volume reduction device comprising an implantable device having a bronchoscope 50. As described in further detail below, the lung volume reduction system is adapted and configured to be delivered to a lung airway of a patient in a delivery configuration and subsequently transitioned to a deployed configuration. By deploying the device, tension can be applied to the surrounding tissue, which can facilitate recovery of lung elastic recoil. The device is designed to be used by an interventional specialist or surgeon.

Figures 4A-F illustrate a shaft or tubular member of a lung volume reduction device 110 that may be included in an implant according to one aspect of the invention, where figures 4B-F are cross-sections taken along lines B-B, C-C, D-D, E-E and F-F, respectively, of figure 4A. The lung volume reduction device 110 includes a member (e.g., a tubular member 112) with a c-shaped cut 114 or notch along its length to provide flexibility such that the device can flex away from the longitudinal axis a when deployed. In other words, the longitudinal axis of the implant shaft or body may generally change from a generally straight configuration suitable for distal insertion along axis a to a curved or deployed configuration. The curved or deployed implant may bend or reconfigure the surrounding airway in order to locally compress the lung tissue. For example, where the cuts are oriented parallel to each other along the length of the tubular member and have the same or similar depth D, the device will tend to bend uniformly about the axial point when deployed. Thus, the device preferentially curls or bends in a direction determined by the shape of the slot. Different types of notches or slots (width, depth, orientation, etc.) may be used to achieve different operational effects and configurations of the deployment device without departing from the scope of the present invention.

An actuation element 116 or pull wire is positioned within the lumen 113 of the tubular member 112. The actuating element may have a circumferential cross-section, as shown, or may have any other suitable cross-section. The actuating element 116 may be anchored at one end, e.g., the distal end, of the device 110 by a cap 119. A cap 119 can be incorporated into the device and a distal crimp can be provided to crimp the cap 119 into the pull wire 116. The cap 119 may be rounded as shown to make insertion of the device non-invasive. Alternatively, the cap 119 can be configured to include anchors configured to grasp adjacent airways during device deployment within the airways. The anchors may increase the amount of tissue compression and thus beneficial amount of tension in the lung by deploying the device. Such alternative anchors are discussed further below. An opposite end, such as a proximal end, may be adapted and configured to engage the mechanism 120. The mechanism 120 may be adapted to deploy the device. The additional mechanism 120 may be configured to lock the device 110 in the deployed configuration once it is deployed, or to unlock the device to facilitate its removal from the airway. The device 110 may be configured to be detachable from a delivery catheter adapted to deliver a lung volume reduction device. The delivery catheter and delivery of the device are discussed further below.

The mechanism 120 at the proximal end of the device may be adapted to include a retainer ring 122, the retainer ring 122 engaging a ratchet 124 that may be used to lock the device in place. The coupler 126 holds the ratchet 124 so that the ratchet locks the device in place once it is deployed. At the proximal end, a removal adaptor 130 is provided, for example, pulling a wire loop. The removal adaptor 130 may be adapted and configured to enable removal of the device at a later point in time during the procedure or during a subsequent procedure. The ratchet device may include a flange that may extend away from the central axis when the device is deployed to lock the device in place.

Fig. 5A-C illustrate another lung volume reduction device according to another aspect of the present invention, wherein fig. 5B-C are cross-sections taken along lines B-B and C-C, respectively, of fig. 5A. As illustrated in the present embodiment, the lung volume reduction device 310 includes a member, such as a tubular member 312, having c-shaped cuts 314 and 314' or notches along its length to provide flexibility such that the device may flex away from the longitudinal axis a in more than one direction upon deployment. In this embodiment, the notches are positioned on member 312 on opposite sides of the member when the member is in the plane. For example, where the cuts are oriented parallel to each other along the length of the tubular member and have the same or similar depth D, the device will tend to bend uniformly about the axial point when deployed. In this embodiment, when the actuation element 316 is pulled proximally (i.e., toward the user) for deployment, the configuration of the notch will result in an "s-shaped" deployed configuration.

Fig. 6 illustrates another lung volume reduction device 410 according to another aspect of the present invention. In this embodiment, the tubular member 412 has notches 414, 414', 414 "configured in a helical pattern along its length. Thus, when the actuation element 416 is pulled proximally towards the user, the device bends to form a helix, as will be shown below.

Figure 7 shows the lung volume reduction device 510 enclosed in a sheath 535. The jacket may be a polymer elastic mold, such as silicone. The sheath may prevent material from the body lumen from entering the lumen 513 of the tubular member 512. An actuation member 516 is provided within lumen 513 of tubular member 512.

Fig. 8A-D illustrate another lung volume reduction device 610 according to another aspect of the present invention, where fig. 8B-D are cross-sections taken along lines B-B, C-C and D-D of fig. 8A, respectively. The lung volume reduction device 610 in this embodiment is made up of individual segments 612, 612', 612 ". The segments may be configured, for example, to have the same asymmetric configuration such that a compressible space 614 is located between each segment prior to actuation of the device by activating the actuator element 616. Each of the segments further includes a detent on the first surface that opposes a mating indentation on a surface of an opposing segment. It should be understood that various components of the devices disclosed herein may be configured to provide a locking or mating mechanism to facilitate actuation and operation. When the actuating element 616 is activated, the compressible space is reduced and the opposing surfaces of two adjacent segments act together to reduce or eliminate the space between them depending on the desired result. In the case of segments having the same or nearly the same configuration, the device will form an arc uniformly around the axial point. Where the segments do not have the same configuration, multiple configurations may be achieved upon deployment, depending on the configuration of the selected segment and the orientation of the segments in the device. As with the previous embodiments, the actuator element 616 is secured at one end (e.g., the distal end) by a cap 619. The segments may be formed as hypotubes or may be formed as injection molded or solid blocks. The use of segments may avoid fatigue on the device as these surfaces contact each other during compression. The material selection may also prevent corrosion of the bio-metal. In addition, the segment design facilitates mass production and consistent maintenance of final shape and operation.

Fig. 9A-B illustrate segments 712, 712' suitable for use in constructing a lung volume reduction device in accordance with an aspect of the present invention. The segments as shown may be generally cylindrical with a pair of surfaces at either end being parallel or non-parallel to each other. To achieve the operation described above, the first surface 713 may be perpendicular to the elongated tubular side surfaces 715 of the elements, while the opposite surface 717 is not perpendicular to these side surfaces of the elements (or parallel to the opposite first surface). Detents 721 may be provided on one surface and configured to mate with indentations 723 on the second surface of another segment. Other configurations, such as a key: and (4) key groove combination. A central lumen 725 is provided through which an actuator element (as described above) extends. I is

Fig. 10 shows the device 2510 in a pre-deployment configuration according to the present invention. Fig. 10 illustrates a device 2510 having a longitudinal configuration (e.g., as it would assume prior to deployment). When the device is implanted and placed axially under compressive or tensile forces, the device will preferentially bend. The actual preferential bending will vary depending on the configuration of the device. For example, the location, depth and orientation of the slots shown in FIGS. 4-7; or the orientation of the walls of the segment of fig. 8. Upon reviewing this disclosure, one of skill in the artIt will be appreciated by the practitioner that other configurations can be achieved by, for example, changing the size and location of the c-shaped cut on the tubular member or by changing the configuration of the segments shown in fig. 8-9. Once the device preferentially bends, the device exerts a bending force on the lung tissue, which results in a reduction of the lung volume. It should be understood that the implant once reshaped has a shorter length than the deliverable implant configuration. Foreshortening occurs when, for example, the distance between the proximal and distal ends decreases. Typically, the deliverable shape of the device is such that it fits within a cylindrical space having a diameter of 18mm or less. Thus, the implant may contact greater than 10 per linear inch of implant length^-6Square inch of tissue. The reshaped or deployed implant may be configured in a variety of shapes to lie in a single plane or in any other suitable configuration so that it does not lie in a single plane. In addition, the device may have varying curvature along its length.

Turning to fig. 11A-B, a lung volume reduction device 210 is shown according to another aspect of the invention, where fig. 11B is a cross-section taken along line B-B of fig. 11A an actuating element 216 or pull wire is positioned within lumen 213 of tubular member 212 as described above, the actuating element may have a circumferential cross-section, as shown, or may have any other suitable cross-section as well.

Fig. 12A-C illustrate a device 2710 according to the present invention implanted, for example, within the bronchiole 26. The device 2710 shown in fig. 12A is configured to provide an atraumatic tip 2711 on either end of the device. When the device 2710 is actuated within the bronchiole 26, the device bends and applies bending forces to the lung tissue. Due to the bending pressure, the tissue bends and compresses itself to reduce the lung volume. In addition, deployment of the device can cause the airway to become curved. As shown in fig. 33C, the device can also be configured with a single atraumatic tip so that the deployment mechanism 2720 can be easily engaged with the proximal end of the device. Alternatively, the non-invasive tip 2711 can include a rounded tip similar to the tip shown in fig. 4A.

In another embodiment of the present invention, as shown in fig. 13A-F, device 810 includes a plurality of individual wires formed of a shape memory material that recover their shape when implanted. The wire may be heat treated to assume a particular shape, such as the C-shape described above. The wire is then implanted separately by the delivery system 850 such that when the first wire is implanted, the diameter of the wire may be small enough that the wire cannot overcome the forces exerted by the surrounding tissue to assume its pre-configured shape. However, when additional wires are implanted, the accumulation in the wires can be determined by the amount of strength to overcome the force exerted by the tissue and the wires together to achieve the desired shape (see fig. 13F). It will be apparent to those skilled in the art that the strength of the formed wire may vary depending on the amount of material used. For example, a formed wire having a larger cross-section will have a higher strength than a formed wire having a smaller cross-section. However, larger diameter wires may be more difficult to apply because they will be more difficult to straighten into a shape suitable for deployment. Where multiple small wires are used, each wire is individually more flexible and can be more easily deployed, but when a large number of wires are implanted, the combined strength increases. In some embodiments, it may be useful to configure the device 810 such that use of, for example, 50-100 wires will have strength to overcome the pressure applied by the tissue. Wires 810 may be deployed within a flexible polymer tube such that the wires are held in close proximity to one another.

Fig. 14 shows an example of an implantable device 3703 made of nitinol metal wire 3701. Nickel-titanium, stainless steel, or other biocompatible metals having memory shape characteristics, or materials that recover after being tensioned 1% or more, may be used to make such implants. Additionally, plastics, carbon-based composites, or combinations of these materials would be suitable. The device is shaped like a french number and may generally lie in a single plane. The end is formed into a shape that maximizes the surface area shown in the form of balls 3702 to minimize scraping or cutting of lung tissue. The balls may be prepared by melting back a portion of the wire, however, they may be additional components welded, pressed or glued to the end of the wire 3701.

Nitinol metal implants (such as the implant shown in fig. 14) can be configured to be elastic to return to a desired shape within the body (as with any other type of spring), or they can be prepared in a configuration that can be thermally actuated to return to a desired shape. The nitinol may be cooled to the martensite phase or heated to the austenite phase. In the austenitic phase, the metal returns to its programmed shape. The temperature at which the metal is fully converted to the austenite phase is referred to as the Af temperature (austenite finish). If the metal is adjusted so that the Af temperature is at or below body temperature, the material is considered elastic in the body and it will resemble a simple spring. The device can be cooled to induce a martensitic phase in the metal that will make the device flexible and very easy to deliver. When the device is allowed to heat, typically by body heat, the device will naturally resume its shape as the metal is positively transformed back to the austenite phase. If the device is tensioned to fit through the delivery system, it may also be sufficiently tensioned to additionally induce the martensite phase. This transformation may occur with as little as 0.1% strain. The strain-induced martensite phase device will still return to its original shape and transition back to the austenite phase after the constraint is removed. If the device is configured to have an Ar temperature above body temperature, the device can be heated to transform to the austenite phase and heat initiates its shape recovery within the body. All of these configurations will work well to actuate the device in the lung tissue of the patient. The body temperature in a typical human body is considered to be 37 degrees celsius.

Fig. 15 illustrates a cross-sectional view of the delivery cartridge system 3800 constraining the implant device 3703 in a deliverable shape. The device 3801 may be shipped to the intended user in such a system or it may be used as a tool to more easily load the implant into the desired shape prior to installation in a patient, bronchoscope, or catheter delivery device. The cartridge may be sealed or terminated with an open end or with one or more bushings (e.g., the illustrated luer lock bushing 3802). The implant should be constrained to a diameter equal to or less than 18mm diameter because any implant above this value will be difficult to advance through the vocal cord opening.

Fig. 16 shows another implant device 3901 shaped in the form of a three-dimensional shape similar to a baseball bat. The wire is shaped such that the proximal end 3902 extends somewhat straight and is slightly longer than the other end. This proximal end will be the end closest to the user and the straight portion will make recapturing easier. If it is curved, it can be driven into the tissue to make it difficult to access.

Fig. 17 is a schematic view of another implant system 4001. It is similar to that shown in fig. 16, except that a wire frame 4002 is added around the device. The wire frame may be used, for example, to increase the bearing area applied to lung tissue. By increasing the bearing area, the pressure carried by the tissue is reduced, while the propensity of the device to grow through lung structures or cause inflammation problems is reduced. Small wires that exert loads in the body tend to move, so it is believed that the device should be configured to have greater than 0.000001 (1) per linear inch of device length^-6Inch (L)²) Surface area of square inches. The frame is one of a number of ways to provide a large surface area to support on tissue.

Fig. 18 shows another example of an apparatus 4101 according to the invention. The device 4101 features a cover 4102 to increase the support area. In this example, main wire 3902 is covered by a wire frame and polymer cover 4102. The cover may be made of any biocompatible plastic, thermoplastic, fluoropolymer, or the like,Urethane, metal mesh, paint, silicone, or other elastomeric material that will reduce bearing pressure on lung tissue. The ends of the cover 4103 may remain sealed or open, as shown, to allow the user to flush antibiotics into and out of the cover.

Fig. 19 illustrates another configuration of an implant device 4201, showing a cover 4205 having perforations 4203 adapted and configured to allow the device to be washed. The end 4202 of the cover is sealed to the end of the device to hold the two components stationary and prevent slippage of one or the other during deployment. The cover may be heat bonded, glued or shrunk onto the close fitting.

Fig. 20 shows a device 4301 having a wire frame 4002 joined to a ball end 3702 at a joint 4302. The ball may be melted from the wire stock and the wire frame may be simultaneously incorporated into the ball. It may also be glued, pressed together, welded or mechanically locked together.

Fig. 21 shows another implant device 4401 having an attached wire frame 4302, main wire 4103, and cover 4102. The completed implant may include additional structures or materials that increase the ability of the implant to provide a therapeutic effect during long-term implantation, wherein multiple of these additional structures or materials provide a bearing surface or interface between the compression-inducing shaft of the device and the surrounding tissue lumen wall of the airway. These additional structures or materials may be any of those disclosed in U.S. patent application No.12/782,515 entitled "Cross-Sectional Modification During Deployment of an elongated lung Volume Reduction Device", filed on 2010, 5, 18, month, 2010, which is incorporated herein by reference.

Fig. 22 shows a system 4501 of one or more devices that can be hooked together. The device 3703 is configured such that both ends terminate, for example, with blunt spherical ends 3702. Device 4502 terminates at one end by an open cup and slot shape 4503, which open cup and slot shape 4503 allows these devices to be coupled together. These devices may be delivered together or coupled in situ. The device may be mounted within a single conduit in the lung or may be coupled together in different locations.

Fig. 23 shows another three-dimensional device 4601 fabricated in the form of a coil with non-invasive ball terminals 3702.

Figures 24A-24E illustrate another 100mm long device 900 in pre-and post-implantation configurations. In this configuration, the device 900 includes two helical segments 902, 904, with a transition/intermediate segment 906 disposed between the two helical segments 902, 904. Similar to the devices described above, the device 900 can have another configuration corresponding to the delivery configuration that it assumes during delivery to the treatment area within the airway. Each helical segment 902, 904 includes a respective helical shaft 906, 908. In the embodiment shown in fig. 24A-24E, the helical axis 906 is at an angle to the helical axis 908. In some embodiments, the angle between the helical axis 906 and the helical axis 908 can be between 190 ° and 230 °. In an alternative embodiment, the helical segments 902, 904 may share a helical axis.

In this particular embodiment, the device 900 comprises a shape memory material, however, one of ordinary skill will recognize that many of the methods described above may be used to construct the device such that it can be mechanically actuated and locked into a similar configuration. The device 900 shown in the figures includes a right-handed helical segment and a left-handed helical segment, and the transition segment 910 between the two helical segments includes a resection transition segment when the device is in a pre-implant or post-implant configuration. The resection transition segment may be defined as an intermediate segment in which the elongate body of the implant transitions between opposing helical configurations. In some embodiments, the switchback transition segment may reduce the spring back force during deployment of the device 900, providing higher control of the device 900 during deployment. In addition, the back-cut transition may reduce the movement of the implant after deployment and thereby preserve the tissue compression benefits of the device. As shown in fig. 24A-24E, the helical segments need not include the same number of loops or complete helical turns. In this embodiment, the distal helix 904 comprises more loops than the proximal helix 902. Alternatively, the device 900 may be configured such that the proximal helix 902 includes more loops than the distal helix 906. The helical segment can be configured to include a pitch of 0.078 ± 0.025 inches. In this particular embodiment, the two helical segments are circular helical segments. Other embodiments of the present invention may be configured to include spherical or conical helical segments when in the pre-implant and post-implant configurations.

Fig. 25A-25D show an apparatus 900 that further includes a jacket 916. The jacket 916 may increase the diameter of the device 900 to provide a greater area/unit force when deployed in an airway. For example, a jacket may increase the device diameter by a factor of 3.25 to provide a greater area per unit force. Thus, once the device 900 is deployed, the increase in diameter may reduce erosion within the airway wall. Jacket 916 may comprise 55D polycarbonate Polyurethane (PCU). PCU can reduce biofilms that promote bacterial growth, thereby limiting the incidence of infections. The jacket may cover the proximal helix, the distal helix, and a transition segment disposed between the helices. Additionally, a jacket can cover the distal portion of the device, as shown in fig. 25A-25D. In some embodiments, the proximal end is also covered by a jacket. Alternatively, the jacket may cover only certain portions of the device. The jacket may be secured to the device 900 by an adhesive (e.g., Loctite 3311).

The proximal end 912 and distal end 914 of the device 900 may be configured to be non-invasive. In the illustrated embodiment, the proximal and distal ends 912, 914 comprise balls having a diameter of about 0.055 ± 0.005 inches, which can be manufactured by melting back portions of the wire or can be additional components welded, pressed, or glued onto the ends of the wire. The non-invasive ball may have a smaller surface area to allow for a small catheter friendly profile or may have a larger ball to take advantage of the larger surface area to reduce tissue stress. In other embodiments, tissue penetrating anchors may be used to couple the proximal or distal end of device 900 to the airway wall during deployment of the device.

The distal end 912 may also be configured as a detached proximal tail that may extend beyond the outer boundary defined by the proximal coil, for example, as shown in FIG. 24B, the angle β may be 76 ° ± 20 °. in some embodiments, the detached proximal tail may extend away from the axis of the helical section when the device is in a pre-implant configuration or a post-implant configuration, as shown in FIG. 24D.

Fig. 26A-26E show a device 1000 similar to device 900. The device 1000 includes a proximal helical section 1002 and a distal helical section 1004. The transition segment 1006 is disposed between the two helical segments 1002, 1004. The proximal end 1012 and the distal end 1014 include atraumatic balls. The distal helical section 1004 includes 4.25 loops, but may include more. Fig. 27A-27D show device 1000 that also includes jacket 1016. The distal helical section may also compress portions of the lung when the device 1000 is deployed within the airway. Similar to device 900, other configurations of device 1000 are possible. For example, the device 1000 may be configured to include two right-handed helical segments or two left-handed helical segments. Optionally, the helical segments may share the same helical axis.

Figures 28 and 29 illustrate how the length of the device can be reduced when the device is deployed in situ. The device shown in delivery configuration 4802 in fig. 28 is also shown in deployment configuration 4803 in fig. 29. The distance a between the device ends 3702 is greater when the device is constrained by the constraining cartridge device 3801. Distance a is similar when the device is constrained by a loading cartridge, catheter or bronchoscope. Fig. 29 shows the same device in a deployed configuration 4803 in the airway 4801 that has been deformed by shape recovery of the implant device. Fig. 29 shows that the distance B between the device ends 3702 is significantly shorter after the device is deployed. Similarly, fig. 30 shows the device of fig. 26A-E deployed within an airway. As shown, an airway lining can be sandwiched between adjacent helical rings to provide advantageous tissue compression. In some embodiments, a 70% improvement in volume reduction may be obtained over existing LVRCs.

Fig. 30 and 31 show two photographs of a human lung in a chest simulator. Lungs are explanted from people who die from Chronic Obstructive Pulmonary Disease (COPD). The cavity is sealed with the main lung bronchi protruding through holes in the cavity wall. The bronchi have sealed to the holes so a vacuum can be applied to draw air out of the space between the inside of the cavity and the lungs. This allows the lungs to be pumped to a larger inflated state with a vacuum level at physiological conditions (e.g., 0.1 to 0.3psi, similar to a typical human chest). Fig. 30 shows a 175mm long implant that has been delivered to the distal end of the delivery catheter as described above. The catheter is significantly constraining the implant to a straightened delivery configuration.

Fig. 31 shows the implant with the catheter retracted from the implant to allow the implant to return to its relaxed configuration. The implant has returned to its original shape by elastic recoil and it is possible that the nitinol metal composite phase has changed substantially back to the austenitic phase. The delivery grasper has been unlocked to release the implant in the airway. By comparing the lung tissue in fig. 30 and 31, the region of the lung compressed by the implant during the shape recovery process (changing from the delivery shape to the deployed shape) can be identified. The compressed area can be displayed in a fluoroscopic image by a sharp increase in the darkness or darker gray shade of the image. Darker areas indicate denser areas and lighter areas indicate less dense areas. The implant may be observed to compress as it recovers to cause areas of the lung to become darker. Other areas may be observed to be tensioned or stretched and this may also be observed as areas that transition into lighter areas.

In an inspiratory COPD patient, these deteriorated regions are filled with air first, so that the region that may better assist the patient in losing air filling, as weakened tissue provides little or no resistance to gas filling, by implanting a device into these regions, so that the gas filling is in a region that may still effectively exchange components with the blood stream.

As with the previous embodiments, the embodiment shown in fig. 14-31 is adapted and configured to be delivered to a lung airway of a patient in a delivery configuration and to change to a deployed configuration to curve the lung airway. The device is characterized by a delivery configuration in which the device is resiliently bendable into a plurality of shapes, such as those shown in the figures. The design of the device may be such that the strain relief is advantageously located on both ends of the device. In addition, the ends of the device in the delivery or deployed state are relatively elastic.

The device may have any suitable length for treating the target tissue. However, the length is typically in the range of, for example, 2cm to 20cm, typically 5 cm. The diameter of the device may be in the range 1.00mm to 3.0mm, preferably 2.4 mm. The device may be used with a catheter having a working length of 60cm to 200cm, preferably 90 cm.

In operation, the devices shown in fig. 14-31 are adapted to be and configured to be minimally invasive, which facilitates ease of use in bronchoscopic procedures. Typically, during deployment, there is no incision and damage to the pleural space of the lung. In addition, collateral ventilation in the lung does not affect the efficacy of the implanted device. Thus, the device is applicable to both homogeneous and heterogeneous emphysema.

Each of the devices shown in fig. 14-31 is adapted and configured to apply a bending force to lung tissue. For example, a spring element may be provided that applies a bending force to the lung tissue as shown in fig. 14. The implantable spring element may be constrained to a shape that may be delivered to the airway, and may be unconstrained to allow the element to apply a bending force to the airway to cause the airway to buckle.

Embodiments of the lung volume reduction system may be adapted to provide an implant that is constrained in a first configuration to a relatively straightened delivery configuration and that allows for in situ return to a second configuration (which is a less straightened configuration). The device and implant may be made at least in part from a spring material that will fully recover after having been tensioned by at least 1%, suitable materials include metals such as metals including nickel and titanium. In some embodiments, the implant of the cooling lung volume reduction system is cooled to the delivery configuration below body temperature. In such embodiments, the cooling system may be controlled by a heat sensitive feedback loop and the feedback signal may be provided by a temperature sensor in the system. The device may be configured to have an Af temperature adjusted to 37 degrees celsius or less. Additionally, at least a portion of the metal of the device may be transformed to be in the martensite phase in the delivery configuration and/or may be in the austenite phase state in the deployed configuration.

Lung volume reduction systems (e.g., those shown in fig. 14-31) include an implantable device that is configured to be deliverable into a patient's lung and that is also configured to be reshaped to make lung tissue in contact with the device more curved. Increasing the curvature of the tissue helps to reduce the lung volume of diseased tissue, which in turn increases the lung volume of healthier tissue. In some cases, the device is configured to be reshaped into a durable second configuration. However, it will be understood by those skilled in the art that the device may also be adapted and configured to have a first shape and be configured to elastically strain to a deliverable shape.

It will be appreciated by those skilled in the art that the device shown in fig. 14-31 can be configured to be delivered into a patient's lung and can be configured to reshape lung tissue while allowing liquid to flow through the implant in both directions. A number of additional features (e.g., locking features, decoupler Systems, activation Systems, and extraction Systems) described in related U.S. patent application 12/558,206 entitled "Enhanced efficiency Lung Volume Reduction Devices, Methods, and Systems" may be used with certain aspects of the present invention. The entire disclosure of U.S. patent application 12/558,206 is incorporated herein by reference.

Fig. 32A-C illustrate a process of implanting a device into a lung. As shown, the device 2810 is advanced through the airway and into, for example, the bronchiole, in a configuration that adapts the device to the anatomy of the lung until it reaches a desired location relative to the damaged tissue 32. The device is then activated by engaging the actuation device, thereby causing the device to bend and pull the lung tissue toward the activated device (see fig. 32B). The device continues to be activated until the lung tissue has been retracted a desired amount, such as shown in fig. 32C. Those skilled in the art will appreciate that retracting tissue can be accomplished by, for example, bending and compressing a target section of lung tissue when one of the configurable devices disclosed herein is deployed. Once fully activated, the deployment device is withdrawn from the lung cavity.

Upon review of this disclosure, those skilled in the art will appreciate the various steps for performing the methods according to the present invention. However, for exemplary purposes, fig. 33A shows steps that include inserting device 3610; activating device 3620, for example by activating an actuator; bending the device into a desired configuration 3630 and locking the device into a deployed state. It will be appreciated that the step of bending the device may be achieved by activating the actuator (as described above), or by returning the implant to the pre-configured shape.

In one embodiment, the device operation comprises the steps of: a bronchoscope is inserted into a patient's lung, and then an intrabronchial device or a lung volume reduction device is inserted into the bronchoscope. The endobronchial device is then allowed to exit the distal end of the bronchoscope (where the device is pushed into the airway). Various methods may be used to verify the location of the device to determine if the device is in a desired location. Suitable verification methods include, for example, visualization by a visualization device, such as fluoroscopy, CT scan, or the like. The device is then activated by pulling the pull guidewire proximally (i.e., toward the user and toward the outside of the patient's body). At this point, another visual inspection may be made to determine if the device has been properly positioned and deployed. The device may then be fully actuated and the ratchet may be allowed to lock and hold the device in place. The implant is then separated from the delivery catheter and the delivery catheter is removed.

Fig. 33B illustrates another method of tensioning a lung, which illustrates the steps comprising: applying a bending load or force to tension the device from the first shape to a deliverable shape without plastically or permanently bending the device 3640, delivering the device into the patient with a bronchoscope or other delivery system component to hold the device in the deliverable shape 3650 when introduced, and then removing the constraint for holding the device to allow it to return to its first shape 3660. The elastic recovery of the device drives the device into a more curved state, thereby applying a force to the adjacent lung tissue. The bending force locally compresses the tissue near the implant and exerts a tensile force on the lung tissue in the surrounding area to restore lung recoil and improve breathing efficiency. The first shape is adapted to be resiliently constrained to a deliverable configuration by the delivery device, whereby removal of the delivery device allows the implant to rebound and reshape closer to its first shape.

Fig. 34 illustrates a system 4901 that can be used to deliver an implant device. Many components of the system may be required to guide bronchoscope 4902 to a site suitable for implant delivery. The airway guidewire has a distal floppy section 4913 that can be maneuvered into any desired airway by: by rotating the slight curve at the distal tip to the appropriate trajectory at the airway bifurcation. To apply torque to the wire, a device (e.g., locking proximal handle 4915) may be attached to the proximal end of wire 4912. The wire end may be blunt, such as the ball end 4914 shown. In some embodiments, the wire may be adapted and configured to pass through a dilator catheter 4909, said dilator catheter 4909 shaped to provide a smooth diameter transition from the wire diameter to the delivery catheter 4906 diameter. The distal tip 4911 of the dilator 4910 should be tapered as shown. The dilator prevents the open end of the delivery catheter 4906 from embedding into the lung tissue in an unintended manner. The dilator liner 4916 may be manufactured as a Y-fitting to allow the user to couple a syringe and inject radiopaque dye through the dilator lumen to increase the visibility of the airway, which facilitates the use of x-ray guidance systems, such as fluoroscopy or computed tomography. The delivery catheter may be used without the presence of a wire and dilator. Catheter 4906 is designed to constrain the device in a deliverable shape during advancement of the device through the system and into the patient. The distal end 4907 may be constructed of a softer polymer or braid than the proximal end 4906, and the distal tip may also include a radiopaque material associated (integral or adjacent) with the tip to identify the position of the tip relative to other anatomical sites (e.g., bone). Providing one or more radiopaque markers facilitates using an x-ray guidance system to position the distal end of the device in situ relative to the target anatomy. The proximal terminal end of the delivery catheter 4908 may also be adapted to incorporate a lockable liner to secure the loading cartridge 3801 with a smooth continuous lumen. Delivery catheter 4906 is shown introduced into bronchoscope side port 4905 and exiting the distal end 4917 of the endoscope. Camera 4903 is shown attached to the end of an endoscope having a cable 4904, or other delivery mechanism, to transmit image signals to a processor and monitor. The loading cartridge, delivery catheter, dilator, guidewire and guidewire nut may be made of any of the materials identified in this specification or known to be useful for similar products used by radiologists in the human vascular tract.

Figure 35 shows delivery system 5001 already placed in a human lung. Bronchoscope 4902 is located in airway 5002. Endoscopic camera 4903 is coupled to video processor 5004 by a cable 4904. The image is processed and transmitted to the monitor 5006 via the cable 5005. The monitor displays a typical visual orientation of the delivery catheter image 5008 directly in front of the optical element in the endoscope on screen 5007. The distal end of the delivery catheter 4907 extends out of the endoscope in the airway 5002 where the user will place the implant device 3703. The implant 3703 is loaded into the loading cartridge 3801, which loading cartridge 3801 is coupled to the proximal end of the delivery catheter by the locking hub connection 3802. The push rod gripper device 5009 is coupled to the proximal end of the implant 3703 with a gripper coupler 5010 that is locked to the implant with an actuation piston 5012, a handle 5011, and a pull wire extending through a central lumen in the push rod catheter. By releasably coupling the pusher bar to the implant device and advancing the pusher bar/grasper device 5009, the user can advance the implant to a location in the lung in the deployed configuration. If the delivery location is less than ideal, the user can observe the implant placement location and still be able to easily retrieve the implant into the delivery catheter. The device has not been delivered and the bottom surface 5003 of the lung is shown as generally flat and the airway is shown as generally flat. For a lung without an implant device, these configurations may be anatomically correct. If the delivery position is correct, the user can actuate plunger 5012 to release the implant into the patient.

Fig. 36 shows the substantially same system after the implant has been deployed into airway 5103. Implant 5102 and pushrod 5101 have been advanced through delivery catheter 4907 to a position distal to endoscope 4902. The push rod grasping jaw 5010 remains locked onto the proximal end of the implant 5102, but the implant has returned to the pre-programmed shape, which has also bent the airway 5103 into the folded configuration. By folding the airway, the airway structure is effectively shortened within the lung and lung tissue and between the portions of the implant that have been laterally compressed. Since the airway is well anchored within the lung tissue, the airway provides tension to the surrounding lung tissue, which is shown graphically by showing the stretched (inwardly curved) bottom surface 5104 of the lung. The image from camera 4903 is transmitted by signal processor 5004 to monitor 5006 to display the distal tip 5101 of the delivery catheter, the distal grasper 5010 of the pusher rod, and the proximal end 3703 of the implant. The grasper may be used to position, couple and remove a device that has been released in a patient. The implant acts on the airway and lung tissue without obstructing the entire lumen of the airway. This is beneficial because fluid or air can flow through the airway in any path across the implant device.

Fig. 37 shows a delivery system 5200 placed in a patient's body and in particular a human lung. The delivery system 5200 may be generally similar to the systems 4901 or 5001 described above. The distal end 5240 of bronchoscope 4902 extends into the airway system toward an airway portion or axial region 5002 (sometimes referred to as an axial segment). Endoscopic camera 4903 is coupled to video processor 5004 by a cable 4904. The image is processed and sent to monitor 5006 via cable 5005. Monitor 5006 displays a portion of delivery catheter image 5008 directly in front of the optical image capturing element in the endoscope on screen 5007. In some embodiments, the endoscope may be constrained by a relatively large cross-section, and thus may be advanced only to the "vicinity" of the lung adjacent to the main airway. Thus, the optical image has a field of view that extends only a limited distance along the airway system, and it is often desirable to implant some, most, or all of the implant outside of the field of view 5242 of the endoscope 4902.

The guidewire 5203 is threaded through the bronchoscope 4902 and through the airway system to reach (and pass through) the airway 5002. As described above, the guidewire 5203 can optionally have a cross-section that is substantially smaller than a cross-section of the endoscope and/or the delivery catheter. Alternative embodiments may utilize a relatively large diameter guidewire. For example, instead of relying on a tapered dilator between the guidewire and the delivery catheter, the guidewire may instead be large enough to substantially or significantly fill the lumen of the delivery catheter while still allowing sliding movement of the guidewire through the lumen. Suitable guidewires may have a cross-section in the range of about 5Fr to about 7Fr, desirably about 51/2Fr, while the delivery catheter may be between about 5Fr and 9Fr, desirably about 7 Fr. The distal end 5209 of the guidewire 5203 may be angled as described above to facilitate steering. In addition, other variations are possible, including delivering the implant directly through the working lumen of the endoscope (as well as using a separate delivery catheter). In particular, where the bronchoscope has a cross-sectional dimension that allows the endoscope to be advanced to the distal end of the target airway region, the bronchoscope itself may then be used as a delivery catheter, optionally in the absence of remote imaging.

A fluoroscopy system, an ultrasound imaging system, an MRI system, a Computed Tomography (CT) system, or some other remote imaging modality with a remote image acquisition device 5211 allows guidance of the guidewire so that the guidewire and/or the delivery catheter 5201 can be advanced out of the field of view of the bronchoscope 4902. In some embodiments, the guidewire may be advanced under remote image guidance without the use of an endoscope. Regardless, the guidewire is typically advanced completely across the proximal lung, with the distal end of the guidewire typically being advanced and/or passed through the middle lung, optionally toward or to the small airways of the distal lung. When using a relatively large guidewire (typically a guidewire of greater than 5Fr, such as 51/2 Fr), the cross-section of the guidewire may limit advancement to airway regions having a lumen size suitable for receiving the above-described implant. The guidewire may have atraumatic ends with exemplary embodiments having a guidewire structure that includes a core wire attached to a surrounding coil with an elastic or low column strength bumper extending from the coil, the bumper desirably formed by additional loops of the coil with spacing between adjacent loops to allow the bumper to flex axially and inhibit tissue damage. The rounded surface or ball at the distal end of the bumper also inhibits tissue damage. The distal end 5244 of the laterally flexible delivery catheter 5201 can then be passed through a lumen in the bronchoscope 4902 and advanced over the guidewire 5203 under guidance of the imaging system, ideally until the distal end of the delivery catheter is substantially aligned with the distal end of the guidewire.

The distal portion of the guidewire 5203 is provided with a length marking 5206 indicating the length along the guidewire from the distal end 5209. The markings may include scale numbers or simple scale markings, and the distal end 5244 of the catheter 5201 may have one or more corresponding high contrast markings, with the guidewire markings and catheter markings typically being visible with remote imaging systems. Thus, the remote imaging camera 5211 can identify, track, or image the indicia 5206 and thus provide the length (and relative position) of the portion of the guidewire extending between the distal end of the bronchoscope and the distal end 5209 of the guidewire 5203. The length indicia 5206 may include, for example, radiopaque or ultrasound markers and the remote imaging modality may include, for example, an x-ray or fluoroscopic guidance system, a Computed Tomography (CT) system, an MRI system, or the like. Exemplary indicia include indicia in the form of high contrast metal bands crimped at regular axial intervals to a core wire with a core disposed on the band, the metals typically including gold, platinum, tantalum, iridium, tungsten, and the like. Note that some of the guidewire markers are schematically shown passing through the distal portion of the catheter in fig. 37. The length indicia 5206 thus facilitates use of the guide system to measure the length of the airway 5002 or other portion of the airway system outside of the field of view of the endoscope, thereby allowing selection of an implant of an appropriate length.

The remote imaging modality 5221 is coupled to an imaging processor 5224 via a cable 5215. The imaging processor 5224 is coupled to a monitor 5226, which monitor 5226 displays an image 5228 on a screen 5227. Image 5228 shows the length markings 5205 and 5206 of the delivery catheter 5201 and guidewire 5203, respectively. As described above, when a small diameter guidewire is used, the dilator 5217 can be advanced through the lumen of the catheter such that the distal end of the dilator extends from the distal end of the delivery catheter 5201 as the catheter is being advanced. As the delivery catheter 5201 is advanced distally, the dilator 5217 atraumatically expands the opening of the airway system. The dilator 5217 tapers radially outward proximal to the distal tip of the guidewire 5203, facilitating advancement of the catheter distally to or through the intermediate lung to reach the distal lung. Once the catheter has been advanced to the distal end of airway portion 5002 for delivery (optionally between the distal end of the guidewire and the distal end of the bronchoscope, when a large diameter guidewire is used to identify the distal end of the target region of the implant, or optionally via the guidewire as long as the cross-section of the catheter allows the catheter to be safely extended via a smaller diameter guidewire). The dilator 5217 (if used) and the guidewire 5203 are typically withdrawn proximally from the delivery catheter 5201 to provide an open lumen of the delivery catheter from which a lung volume reduction device or implant can be deployed.

Fig. 38A and 38B illustrate an implant 5300 for treating an airway 5002 of a lung. As described above, airway 5002 comprises part of a branched airway system, and an airway intended for deployment will generally define airway axis 5340. Implant 5300 includes an elongate body 5301, a distal end 5303, and a proximal end 5305. The elongate body 5301 is biased to bend into a bent deployment configuration as described above and shown in fig. 38B. The push rod gripper device 5009 is coupled to the proximal end 5305 with a gripper coupler 5010 that locks to the implant 5300 with actuation skips 5012, a handle 5011, and a pull wire extending through a central lumen in the push rod catheter. Prior to deployment, the implant 5300 can be loaded into a tubular loading cartridge (e.g., cartridge 3801) and advanced from the loading cartridge into the lumen of the catheter 5301. Pusher-bar gripper apparatus 5009 can advance implant 5300 through delivery catheter 5201. As shown in fig. 38A, when constrained within the delivery catheter 5201, the elongate body 5301 is held in a straightened configuration that defines a long axis between the distal end 5303 and the proximal end 5305. As seen in fig. 38B, as pusher-bar gripper apparatus 5009 axially constrains implant 5300 and catheter 5201 is pulled proximally from airway axial region 5002, implant 5300 resiliently returns to the curved deployed configuration to curve airway 5002. More specifically, airway axis 5340 changes from a relatively straight configuration to a highly curved configuration in which lateral movement of the elongate body and surrounding airway structure compresses adjacent tissue. Once the catheter 5201 has been withdrawn from the elongate body 5301, deployment may be evaluated. If deployment does not appear satisfactory, the user can axially constrain the implant 5300 while axially advancing the guide 5201 to recapture the implant, or the user can actuate the plunger 5012 to release the implant 5300. The implant 5300 can be loaded into a tubular loading cartridge (e.g., cartridge 3801) and advanced from the loading cartridge into the lumen of the catheter 5301.

Fig. 39 shows a plurality of implants including implants 5300A, 5300B, and 5300C. Each of these implants may have different sizes, lengths and shapes from one another. When using the delivery system 5200, the guidewire 5203 can be advanced to a target area near the distal end of the airway system. The guidewire 5203 can be advanced distally until further distal advancement is limited by the distal end of the guidewire, which is being sufficiently engaged by the surrounding lumen of the airway system. The delivery catheter 5201 can then be advanced such that the distal end of the catheter 5201 is adjacent to the distal end of the guidewire. The distance along the length mark 5205 from the bronchoscope to the distal end of the guidewire 5203 can be used to select an implant having an elongated body 5301 of a desired length. The desired length may be shorter, longer, or substantially equal to the distance between the distal end of the delivery catheter 5201 and the distal end of the bronchoscope, as indicated by reference 5206. An elongated body 5301 of a selected length can be advanced and deployed within the lung via an airway system and with the pushrod gripper 5009 described above. To utilize a self-deploying elongate body (including utilizing an elastic material and/or utilizing a superelastic material (e.g., nitinol)^TMEtc.) to provide a desired implant shelf life and/or a desired deployment force for compressing tissue, it may be advantageous to store the various in a relaxed stateVarious implants of various sizes. Once the desired implant geometry or other characteristics have been identified, the push rod gripper apparatus 5009 can be utilized to load the selected implant 5300 into the loading cartridge 5401 (and subsequently into the lumen of the delivery catheter 5201). Pusher bar gripper apparatus 5009 can be tensioned proximally and/or loading cartridge 5401 can be pushed distally to cause elongate body 5301 to straighten axially. Loading cartridge 5401 and implant 5300 can then be coupled to other components of the delivery system and the implant advanced into the airway as described above.

In an exemplary embodiment, push rod gripper 5009 moves distally as catheter 5201 is retracted proximally from the implant during deployment. The length of the selected implant may be greater than the measured distance between the distal end of the guidewire (and thus the end of the delivery catheter) and the distal end of the endoscope. This can help accommodate recoil or movement of the implant ends toward each other during delivery so as to avoid applying excessive axial loads between the implant and the tissue. Distal movement of the pusher bar grasper 5009 and the proximal end of the implant during deployment also helps to keep the proximal end of the implant within the field of view of the bronchoscope and increases the volume of tissue compressed by the implant. Exemplary implants may be more than 10% longer than the measured length of the axial region of the target airway, typically 10% to about 30%, and ideally about 20%. Suitable implants may, for example, have total arc lengths of 125, 150, 175 and 200 mm.

Related U.S. patent application 12/558,206 describes exemplary methods for treating a patient and evaluating treatment, each of which may be used with certain aspects of the present invention. For example, a method of treatment may include delivering implants into the lungs and then evaluating patient respiration to determine if more implants are needed. Alternatively, multiple implants may be delivered into the patient's lungs prior to evaluation. The patient's lungs may be evaluated by measuring the patient's Forced Expiratory Volume (FEV), measuring/observing changes in tissue density at the implanted region, measuring/observing displacement of the diaphragm or lung fissure, and the like.

In some embodiments, a catheter (e.g., catheter 5201) is utilized to deploy the implant into a straightened configuration to include an implant of a generally straight shape. Alternative embodiments may use the working lumen of the bronchoscope directly, such that the bronchoscope functions as a delivery catheter. Upon removal of the constraining catheter, the implant springs back to a deployed shape that can be readily identified by the fact that the distance from one end to the second end is reduced. The proximal end of the implant can be grasped and held, for example, by a push rod grasper device 5009, such that as the length of the implant is gradually withdrawn (by proximally withdrawing the catheter), the distal end of the implant remains engaged on the desired airway tissue. If the proximal end of the implant remains in a fixed position throughout deployment, high tension can be created between the distal portion of the implant and the airway tissue as the implant is biased to spring or bring the ends closer together when released. However, it may be advantageous to allow the proximal end of the implant to advance distally during release, rather than keeping the implant from springing back, as these forces may be detrimental. For example, the distance between the distal end of the implant and the lung surface and the tissue thickness are short, there may be minimal strain relief on the tissue and the risk of rupture may be excessive. In addition, the implant may additionally tend to shorten after it is released by the grasper. When foreshortening occurs, the proximal end of the implant may travel distally out of the field of view of the bronchoscope, and it may be difficult for the user to reliably remove the implant.

Thus, as schematically illustrated in fig. 40A-40C, in some cases, an implant 5300 having a length greater than the target axial region 5505 may be selected for deployment. As noted above, the guidewire can be advanced distally from the bronchoscope until guidewire advancement is inhibited by engagement with the surrounding airway, wherein the guidewire optionally has a relatively large cross-section (such a guidewire has a dimension of between about 5F and 7F, desirably a dimension of about 51/2F). This allows the guidewire to be advanced to (but not excessively beyond) a target location for the distal end of the implant (which may have an atraumatic ball surface having a diameter of about 1 to about 3mm, desirably about 1.5 mm). As shown in fig. 40A, the catheter 5201 is advanced distally over the guidewire from the distal end of the bronchoscope 4902 until the distal end of the catheter 5201 aligns with the distal end of the guidewire or until the distal end of the catheter restricts further distal movement (as the distal end of the catheter 5201 is similarly sufficiently engaged by the surrounding lumen of the airway system 5002). The length 5505 of the target axial region of the airway is measured. The length 5505 may be the distance between the distal end of the pusher catheter 5201 and the distal end of the bronchoscope 4902, and the guidewire may be withdrawn proximally after the measurement. Implant 5300, having a length greater than measured length 5505, is selected and advanced distally through catheter 5201 using pusher bar grasper 5009 previously described. Implants having a length at least 10%, preferably about 20% or more, longer than the measured axial region of the target may be selected.

Fig. 40B illustrates deployment of the implant 5300. The implant 5300 is advanced through the lumen of the guide 5201 to adjacent its distal end and the guide 5201, the distal end of the implant being (at least initially) held axially in place and the guide being withdrawn proximally from the distal portion of the implant. As the catheter 5201 is withdrawn, the implant 5300 flexes laterally and compresses a portion of the airway 5002. As shown in fig. 40B, once the catheter 5201 is fully withdrawn such that it no longer constrains the implant 5300, the larger portion of the airway 5002 may be compressed by the implant 5300. As the catheter is gradually withdrawn, the proximal end of the implant moves distally relative to the surrounding bronchoscope and airway tissue. The proximal end of implant 5300 may also be released by push rod gripper 5009 after implant 5300 has been progressively shortened during its release (as measured along the axial center of the airway).

By utilizing a longer implant 5300, the proximal end of the implant 5300 can also be fed into the airway while the potential energy of the implant is free to perform work on the lung tissue (when the catheter is being pulled away from the implant). The lung airways may be distorted so that the airway cross section is pushed into a more elliptical shape. Longer implants may tend to zigzag repeatedly throughout the airway lumen so that implants significantly longer than the measured airway length can be introduced. For example, a 150mm long (arc length) implant may be deployed within a 100mm long airway. Longer length implants may minimize uncontrolled recoil, which when released may result in the proximal end being lost in the patient. The larger implant length may also allow the user to feed the implant into the patient without overstressing the lung tissue when the catheter is removed. In addition, if shortening of the longer implant occurs, the proximal end of the implant may remain within the field of view of the bronchoscope, and the user may thus maintain the ability to securely remove the implant. It should be appreciated that the ratio of the length of the implant to the diameter of the airway may be much greater than the schematic illustrations of fig. 40A-40C, the implant may have more complex three-dimensional curvature to affect volumetric compression of lung tissue, etc.

It will be appreciated by those skilled in the art that the device may be manufactured and deployed such that it may be delivered through a bronchoscope. When actuated, the device may be adapted and configured to bend or curl, which then distorts lung tissue in contact with the device. The lung tissue that can be advantageously distorted by the device is the airway, blood vessels, the tissue plane that has been cut for introduction of the device, or a combination of any of these tissues. In at least some instances, the device can cause an increase in elastic recoil and tension in the lung by compressing lung tissue. Additionally, in some cases, lung function may be at least partially restored regardless of the amount of collateral ventilation. Furthermore, in some cases, once a greater tension is created, the diaphragm may move upward, which enables the lung cavity to work more efficiently.

The device according to the invention has a small cross-section, typically less than 10F. The flexibility of the device prior to deployment facilitates advancement of the device through tortuous pulmonary anatomy. Once deployed, the device may remain rigid to secure and maintain the tissue deformation effect. In addition, the device design facilitates recapture, deactivation and removal, as well as proper adjustment.

Alternative materials for the devices and components described herein will be known to those skilled in the art and include, for example, suitable biocompatible materials such as metals (e.g., stainless steel, shape memory alloys, such nickel titanium alloys (nitinol), titanium and cobalt) and engineering plastics (e.g., polycarbonate). See, for example, U.S. patent No.5,190,546 to Jervis entitled "Medical Devices incorporating SIM Memory Alloy Elements" and U.S. patent No.5,964,770 to Flomenblit entitled "High Strength Medical Devices of shape Memory alloys". In some embodiments, other materials may be suitable for some or all of the components, for example, biocompatible polymers including Polyetheretherketone (PEEK), polyaramid, polyethylene, and polysulfone.

The polymers and metals used to make the implants and delivery systems may be coated with materials to prevent the formation and growth of granular tissue, scar tissue, and mucus. A variety of drugs used with the stent product after deployment of the metal stent to block smooth muscle cell proliferation in the blood vessel would be extremely effective for these devices. The slow release drug eluting polymer or solvent may be used to modulate the release of a drug, including any substance capable of producing a therapeutic or prophylactic effect in a patient. For example, the drug may be designed to inhibit the activity of smooth muscle cells. It can be used to inhibit abnormal or inappropriate migration and/or proliferation of smooth muscle cells to inhibit tissue mass accumulation. The drug may include a small molecule drug, a peptide, or a protein. Examples of drugs include antiproliferative substances such as actinomycin D, or its derivatives and analogs (manufactured by Sigma-Aldrich (Milwaukee, Wis.), or COSMEGEN available from Merck). Alternative names for actinomycin D include dactinomycin, actinomycin IV, actinomycin₁Actinomycin X₁And actinomycin C₁. Active agents may also fall into the categories of antineoplastic, anti-inflammatory, antiplatelet, anticoagulant, antifibrins, antithrombin, antimitotic, antibiotic, antiallergic and antioxidant substances. Examples of such antineoplastic and/or antimitotic agents include paclitaxel (e.g., from Bristol-Myers Squibb Co., Stamford, Conn.)) Docetaxel (e.g., available from Aventis s s.a. (Frankfurt, Germany))) Methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride (e.g., from Pharmacia)&Of Upjohn (Peapack N.J.)) And mitomycin (e.g., from Bristol-Myers Squibb)). Examples of such antiplatelet agents, anticoagulant agents, anti-fibrin agents, anti-thrombin agents include heparin sodium, low molecular weight heparins, heparinoids, hirudin, argatroban, forskolin, vapreotide, prostacyclin and prostacyclin analogs, dextran, D-phenylalanine-proline-arginine-chloromethyl ketone hydrochloride (synthetic antithrombin), dipyridamole, glycoprotein Hh/IIIa platelet membrane receptor antagonist antibodies, recombinant hirudin, and thrombin inhibitors (e.g., angiomax (tm)). Examples of such cytostatic or antiproliferative agents include angiopeptin, angiotensin converting enzyme inhibitors (e.g., captopril, e.g., from Bristol-Myers SquibbAnd) Cilazapril or Hsinopril (e.g., from Merck)&Of Co., Inc. (Whitehouse Station, NJ.)And) (ii) a Calcium channel blockers(e.g., nifedipine), colchicine, Fibroblast Growth Factor (FGF) antagonists, fish oil (omega-3 fatty acids), histamine antagonists, lovastatin (inhibitor of HMG-CoA reductase, cholesterol lowering drugs, from Merck)&Trade name of co) Other suitable therapeutic substances or agents include α -interferon, genetically engineered epithelial cells, tacrolimus, dexamethasone, and rapamycin, as well as structural derivatives or functional analogs thereof, such as 40-O- (2-hydroxy) ethyl-rapamycin (trade name EVEROLIMUS known from Novartis, New York), 40-O- (3-hydroxy) propyl-rapamycin, 40-O- [2- (2-hydroxy) ethoxy ] rapamycin]Ethyl-rapamycin, and 40-O-tetrazole-rapamycin.

Other polymers may be suitable in some embodiments, such as other grades of PEEK, such as 30% glass filled or 30% carbon filled, provided that such materials have been clearly indicated by the FDA or other regulatory bodies as being useful in implantable devices. The use of glass-filled PEEK would be desirable where it is desirable to reduce the expansion rate and increase the flexural modulus of PEEK, as glass-filled PEEK is known to be ideal for improving strength, stiffness or stability, while carbon-filled PEEK is known to enhance the compressive strength and hardness of PEEK and reduce its expansion rate. In addition, other suitable biocompatible thermoplastic and thermoplastic polycondensate materials may be suitable, including materials that have good memory, are flexible and/or pliable, have very low moisture absorption, and good wear and/or abrasion resistance, may be used without departing from the scope of the invention. These materials include Polyetherketoneketone (PEKK), Polyetherketone (PEK), Polyetherketoneetherketoneketone (PEKEKK), andpolyetheretherketone ketone (PEEKK), and in general polyaryletherketone. Other polyketones and other thermoplastic materials may be utilized. Reference to suitable polymers that may be used in the tool or tool component may be found in the documents below, which are incorporated by reference in their entirety. These documents include: PCT publication WO 02/02158Al entitled "Bio-Compatible Polymeric Materials" (biocompatible Polymeric Materials) to Victrex Manufacturing Ltd; PCT publication WO 02/00275Al entitled "Bio-Compatible Polymeric Materials" (biocompatible Polymeric Materials) to Victrex Manufacturing Ltd; PCT publication WO 02/00270Al entitled "Bio-Compatible Polymeric Materials", assigned to Victrex Manufacturing Ltd. Still other materials (e.g., available from Polymer Technology Group (Berkeley, Calif.))Polycarbonate polyurethane) may also be suitable for good oxidative stability, biocompatibility, mechanical strength, and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers may also be used in portions of the device where radiopacity is desired.

The implants described herein may be made of a metallic material or alloy, such as, but not limited to, a cobalt-chromium alloy (e.g., ELGILOY), stainless steel (316L), "MP3SN," "MP2ON," ELASTINITE (nitinol), tantalum-based alloys, nickel-titanium alloys, platinum-based alloys (e.g., platinum-iridium alloys), iridium, gold, magnesium, titanium-based alloys, zirconium-based alloys, or combinations thereof. Devices made from bioabsorbable or biostable polymers may also be used with embodiments of the present invention. "MP35N" and "MP2ON" are trade names of alloys of cobalt, nickel, chromium, and molybdenum available from Standard Press Steel Co. (Tenkintown, Pa.). "MP35N" comprises 35% cobalt, 35% nickel, 20% chromium and 10% molybdenum. "MP2ON" comprises 50% cobalt, 20% nickel, 20% chromium, and 10% molybdenum.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims be interpreted as defining the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims (16)

1. A lung volume reduction device for improving respiratory efficiency of a patient having an airway, the device comprising:

a proximal end and a distal end; and is

Wherein the device comprises a first configuration and a second configuration;

the first configuration corresponds to a delivery configuration;

the second configuration corresponds to a pre-implantation configuration or a post-implantation configuration, and the second configuration includes at least two helical segments and a transition segment disposed between the at least two helical segments;

wherein the at least two helical segments comprise a right-handed helical segment and a left-handed helical segment, and wherein the transition segment comprises a cut-back transition segment when the device is in the second configuration;

wherein adjacent helical loops of one of the at least two helical segments are configured to sandwich a lining of the airway between the adjacent helical loops, providing favorable tissue compression; and

wherein the distal helical section comprises more loops than the proximal helical section when the device is in the second configuration.

2. The lung volume reduction device of claim 1, further comprising a jacket covering a portion of the device, the jacket configured to reduce device erosion within the airway after deployment of the device.

3. The lung volume reduction device of claim 2, wherein the jacket covers the at least two helical segments and the transition segment disposed between the at least two helical segments.

4. A lung volume reduction device according to claim 3, wherein the jacket covers the distal end of the device.

5. The lung volume reduction device of any one of claims 2-4, wherein the jacket comprises a polycarbonate polyurethane material having a hardness of at least 55D.

6. The lung volume reduction device of claim 1, wherein the proximal and distal ends of the device are non-invasive.

7. The lung volume reduction device of claim 1, wherein the proximal end comprises a pull-off proximal tail.

8. The lung volume reduction device of claim 1, wherein the at least two helical segments have a first axis and a second axis, respectively, and wherein the first and second axes are different when the device is in the second configuration.

9. The lung volume reduction device of claim 8, wherein the first and second axes form an angle in the range of 190 ° to 230 ° when the device is in the second configuration.

10. The lung volume reduction device of claim 1, wherein the device comprises a shape memory material.

11. The lung volume reduction device of claim 1, wherein the device comprises a metal comprising nickel and titanium.

12. The lung volume reduction device of claim 1, wherein the proximal helical section comprises less than one loop when the device is in the second configuration.

13. The lung volume reduction device of claim 1, wherein the distal helical section comprises at least one loop when the device is in the second configuration.

14. The lung volume reduction device of claim 1, wherein the distal helical section comprises at least four loops when the device is in the second configuration.

15. The lung volume reduction device of claim 1, wherein the proximal and distal ends of the device comprise non-invasive balls.

16. The lung volume reduction device of claim 1, wherein the distal helical section comprises a first tapered helical section, and wherein the proximal helical section comprises a second tapered helical section.