Delivery methods and devices for implantable bronchial isolation devices

Disclosed is an apparatus for deploying a bronchial isolation device in a bronchial passageway in a lung of a patient. In one embodiment, the apparatus includes an outer shaft having a distal end. A housing is coupled to the distal end of the outer shaft and configured to receive the bronchial device. An inner shaft is slidably disposed within the outer shaft. A handle is adapted to move the outer shaft relative to both the inner shaft and the handle while the inner shaft remains fixed relative to the handle so as to eject the bronchial isolation device from the housing.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to methods and devices for use in performing pulmonary procedures and, more particularly, to devices and procedures for treating lung diseases.

2. Description of the Related Art

Certain pulmonary diseases, such as emphysema, reduce the ability of one or both lungs to fully expel air during the exhalation phase of the breathing cycle. Such diseases are accompanied by chronic or recurrent obstruction to air flow within the lung. One of the effects of such diseases is that the diseased lung tissue is less elastic than healthy lung tissue, which is one factor that prevents full exhalation of air. During breathing, the diseased portion of the lung does not fully recoil due to the diseased (e.g., emphysematic) lung tissue being less elastic than healthy tissue. Consequently, the diseased lung tissue exerts a relatively low driving force, which results in the diseased lung expelling less air volume than a healthy lung.

The problem is further compounded by the diseased, less elastic tissue that surrounds the very narrow airways that lead to the alveoli, which are the air sacs where oxygen-carbon dioxide exchange occurs. The diseased tissue has less tone than healthy tissue and is typically unable to maintain the narrow airways open until the end of the exhalation cycle. This traps air in the lungs and exacerbates the already-inefficient breathing cycle. The trapped air causes the tissue to become hyper-expanded and no longer able to effect efficient oxygen-carbon dioxide exchange.

In addition, hyper-expanded, diseased lung tissue occupies more of the pleural space than healthy lung tissue. In most cases, a portion of the lung is diseased while the remaining part is relatively healthy and, therefore, still able to efficiently carry out oxygen exchange. By taking up more of the pleural space, the hyper-expanded lung tissue reduces the amount of space available to accommodate the healthy, functioning lung tissue. As a result, the hyper-expanded lung tissue causes inefficient breathing due to its own reduced functionality and because it adversely affects the functionality of adjacent healthy tissue.

Lung reduction surgery is a conventional method of treating emphysema. However, such a conventional surgical approach is relatively traumatic and invasive, and, like most surgical procedures, is not a viable option for all patients.

Some recently proposed treatments for emphysema or other lung ailments include the use of devices that isolate a diseased region of the lung in order to modify the air flow to the targeted lung region or to achieve volume reduction or collapse of the targeted lung region. According to such treatments, one or more bronchial isolation devices are implanted in airways feeding the targeted region of the lung. The bronchial isolation device regulates fluid flow through the bronchial passageway in which the bronchial isolation device is implanted. The bronchial isolation devices can be, for example, one-way valves that allow flow in the exhalation direction only, occluders or plugs that prevent flow in either direction, or two-way valves that control flow in both directions.

The following references describe exemplary bronchial isolation devices: U.S. Pat. No. 5,954,766 entitled “Body Fluid Flow Control Device”; U.S. patent application Ser. No. 09/797,910, entitled “Methods and Devices for Use in Performing Pulmonary Procedures”; and U.S. patent application Ser. No. 10/270,792, entitled “Bronchial Flow Control Devices and Methods of Use”. The foregoing references are all incorporated by reference in their entirety and are all assigned to Emphasys Medical, Inc., the assignee of the instant application.

The bronchial isolation device can be implanted in a target bronchial passageway using a delivery catheter that is placed through the trachea (via the mouth or the nasal cavities) and to the target location in the bronchial passageway. It would be advantageous to develop improved methods and devices for delivering bronchial isolation devices into the lung of a patient.

SUMMARY

Disclosed is an apparatus for deploying a bronchial isolation device in a bronchial passageway in a lung of a patient, comprising an outer shaft having a distal end; a housing coupled to the distal end of the outer shaft and configured to receive the bronchial device; an inner shaft slidably disposed within the outer shaft; and a handle adapted to move the outer shaft relative to both the inner shaft and the handle while the inner shaft remains fixed relative to the handle so as to eject the bronchial isolation device from the housing.

Also disclosed is an apparatus for deploying a bronchial isolation device in a bronchial passageway in a lung of a patient, comprising an outer shaft having a distal end; a housing coupled to the distal end of the outer shaft and configured to receive the bronchial device; an ejection member movably disposed in the housing; and a handle adapted to cause relative movement between the housing and the ejection member so as to eject the bronchial isolation device from the housing. Relative movement between the housing and the ejection member is limited to prevent the ejection member from moving substantially outside of the housing.

Also disclosed is an apparatus for delivering a device into a body passageway, comprising a handle; an outer shaft movably coupled to the handle; an inner shaft slidably disposed within the outer shaft and fixedly coupled to the handle, the handle adapted to move the outer shaft relative to both the inner shaft and the handle while the inner shaft remains fixed relative to the handle; and a sheath attached to the handle and disposed over a portion of the outer shaft such that the outer shaft is free to slide within the sheath.

Also disclosed is a method of deploying a bronchial device in a bronchial passageway in a patient's lung, the method comprising: providing a delivery device having an outer shaft, an inner shaft and a handle; coupling the bronchial isolation device to a housing on a distal end of the outer shaft and a inner shaft; advancing the delivery catheter into the patient's lung with the housing carrying the bronchial device until the housing is positioned in the bronchial passageway; and moving the outer shaft in a proximal direction relative to the inner shaft and the handle while the inner shaft remains fixed relative to the handle to release the bronchial isolation device from the housing.

Also disclosed is a method of deploying a bronchial device in a bronchial passageway in a patient's lung, the method comprising providing a delivery device having an outer shaft, a housing coupled to a distal end of the outer shaft, and an ejection member movably disposed in the housing; advancing the delivery catheter into the patient's lung with the housing carrying the bronchial device until the housing is positioned in the bronchial passageway; and moving the ejection member relative to the housing to eject the bronchial isolation device from the housing, wherein the ejection member is substantially limited from moving outside of the housing.

Other features and advantages of the present invention should be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the invention.

DETAILED DESCRIPTION

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which the invention(s) belong. It should be noted that the various devices and methods disclosed herein are not limited to the treatment of emphysema, and may be used for various other lung diseases.

Disclosed are various devices and methods for delivering one or more bronchial isolation devices (which are sometimes referred to herein as flow control devices) to a location in a bronchial passageway. The bronchial isolation device is delivered to a target location in the bronchial passageway by mounting the bronchial isolation device in a housing at the distal end of a delivery catheter and then inserting the delivery catheter into the bronchial passageway. Once the housing is positioned at a target location in the bronchial passageway, the bronchial isolation device is ejected from the housing and deployed within the passageway. In the example shown inFIG. 1, the distal end of the delivery catheter110is inserted into the patient's mouth or nose, through the trachea, and down to a target location in the bronchial passageway517. For clarity of illustration,FIG. 1does not show the housing in which the device is contained.

The following references describe exemplary bronchial isolation devices and delivery devices: U.S. Pat. No. 5,954,766 entitled “Body Fluid Flow Control Device”; U.S. patent application Ser. No. 09/797,910, entitled “Methods and Devices for Use in Performing Pulmonary Procedures”; U.S. patent application Ser. No. 10/270,792, entitled “Bronchial Flow Control Devices and Methods of Use”; and U.S. patent application Ser. No. 10/448,154, entitled “Guidewire Delivery of Implantable Bronchial Isolation Devices in Accordance with Lung Treatment”. The foregoing references are all incorporated by reference in their entirety and are all assigned to Emphasys Medical, Inc., the assignee of the instant application.

Exemplary Lung Regions

Throughout this disclosure, reference is made to the term “lung region”. As used herein, the term “lung region” refers to a defined division or portion of a lung. For purposes of example, lung regions are described herein with reference to human lungs, wherein some exemplary lung regions include lung lobes and lung segments. Thus, the term “lung region” as used herein can refer, for example, to a lung lobe or a lung segment. Such nomenclature conform to nomenclature for portions of the lungs that are known to those skilled in the art. However, it should be appreciated that the term “lung region” does not necessarily refer to a lung lobe or a lung segment, but can refer to some other defined division or portion of a human or non-human lung.

FIG. 2shows an anterior view of a pair of human lungs210,215and a bronchial tree220that provides a fluid pathway into and out of the lungs210,215from a trachea225, as will be known to those skilled in the art. As used herein, the term “fluid” can refer to a gas, a liquid, or a combination of gas(es) and liquid(s). For clarity of illustration,FIG. 2shows only a portion of the bronchial tree220, which is described in more detail below with reference toFIG. 5.

Throughout this description, certain terms are used that refer to relative directions or locations along a path defined from an entryway into the patient's body (e.g., the mouth or nose) to the patient's lungs. The path of airflow into the lungs generally begins at the patient's mouth or nose, travels through the trachea into one or more bronchial passageways, and terminates at some point in the patient's lungs. For example,FIG. 2shows a path202that travels through the trachea225and through a bronchial passageway into a location in the right lung210. The term “proximal direction” refers to the direction along such a path202that points toward the patient's mouth or nose and away from the patient's lungs. In other words, the proximal direction is generally the same as the expiration direction when the patient breathes. The arrow204inFIG. 2points in the proximal or expiratory direction. The term “distal direction” refers to the direction along such a path202that points toward the patient's lung and away from the mouth or nose. The distal direction is generally the same as the inhalation or inspiratory direction when the patient breathes. The arrow206inFIG. 2points in the distal or inhalation direction.

The lungs include a right lung210and a left lung215. The right lung210includes lung regions comprised of three lobes, including a right upper lobe230, a right middle lobe235, and a right lower lobe240. The lobes230,235,240are separated by two interlobar fissures, including a right oblique fissure226and a right transverse fissure228. The right oblique fissure226separates the right lower lobe240from the right upper lobe230and from the right middle lobe235. The right transverse fissure228separates the right upper lobe230from the right middle lobe235.

As shown inFIG. 2, the left lung215includes lung regions comprised of two lobes, including the left upper lobe250and the left lower lobe255. An interlobar fissure comprised of a left oblique fissure245of the left lung215separates the left upper lobe250from the left lower lobe255. The lobes230,235,240,250,255are directly supplied air via respective lobar bronchi, as described in detail below.

FIG. 3is a lateral view of the right lung210. The right lung210is subdivided into lung regions comprised of a plurality of bronchopulmonary segments. Each bronchopulmonary segment is directly supplied air by a corresponding segmental tertiary bronchus, as described below. The bronchopulmonary segments of the right lung210include a right apical segment310, a right posterior segment320, and a right anterior segment330, all of which are disposed in the right upper lobe230. The right lung bronchopulmonary segments further include a right lateral segment340and a right medial segment350, which are disposed in the right middle lobe235. The right lower lobe240includes bronchopulmonary segments comprised of a right superior segment360, a right medial basal segment (which cannot be seen from the lateral view and is not shown inFIG. 3), a right anterior basal segment380, a right lateral basal segment390, and a right posterior basal segment395.

FIG. 4shows a lateral view of the left lung215, which is subdivided into lung regions comprised of a plurality of bronchopulmonary segments. The bronchopulmonary segments include a left apical segment410, a left posterior segment420, a left anterior segment430, a left superior segment440, and a left inferior segment450, which are disposed in the left lung upper lobe250. The lower lobe255of the left lung215includes bronchopulmonary segments comprised of a left superior segment460, a left medial basal segment (which cannot be seen from the lateral view and is not shown inFIG. 4), a left anterior basal segment480, a left lateral basal segment490, and a left posterior basal segment495.

FIG. 5shows an anterior view of the trachea325and a portion of the bronchial tree220, which includes a network of bronchial passageways, as described below. The trachea225divides at a lower end into two bronchial passageways comprised of primary bronchi, including a right primary bronchus510that provides direct air flow to the right lung210, and a left primary bronchus515that provides direct air flow to the left lung215. Each primary bronchus510,515divides into a next generation of bronchial passageways comprised of a plurality of lobar bronchi. The right primary bronchus510divides into a right upper lobar bronchus517, a right middle lobar bronchus520, and a right lower lobar bronchus422. The left primary bronchus415divides into a left upper lobar bronchus525and a left lower lobar bronchus530. Each lobar bronchus517,520,522,525,530directly feeds fluid to a respective lung lobe, as indicated by the respective names of the lobar bronchi. The lobar bronchi each divide into yet another generation of bronchial passageways comprised of segmental bronchi, which provide air flow to the bronchopulmonary segments discussed above.

As is known to those skilled in the art, a bronchial passageway defines an internal lumen through which fluid can flow to and from a lung or lung region. The diameter of the internal lumen for a specific bronchial passageway can vary based on the bronchial passageway's location in the bronchial tree (such as whether the bronchial passageway is a lobar bronchus or a segmental bronchus) and can also vary from patient to patient. However, the internal diameter of a bronchial passageway is generally in the range of 3 millimeters (mm) to 10 mm, although the internal diameter of a bronchial passageway can be outside of this range. For example, a bronchial passageway can have an internal diameter of well below 1 mm at locations deep within the lung. The internal diameter can also vary from inhalation to exhalation as the diameter increases during inhalation as the lungs expand, and decreases during exhalation as the lungs contract.

Bronchial Isolation Device Delivery System

As discussed above, the bronchial isolation device is deployed in the bronchial passageway using a delivery catheter110, which is inserted into the bronchial passageway through the patient's trachea. In one embodiment, the delivery catheter110is inserted directly into the trachea and bronchial passageway. In another embodiment, shown inFIG. 1, a bronchoscope120assists in the insertion of the delivery catheter110through the trachea and into the bronchial passageway. The method that uses the bronchoscope120is referred to as the “transcopic” method. According to the transcopic method, the delivery catheter110is inserted into the working channel of the bronchoscope120, which is deployed to the bronchial passageway517either before or after the delivery catheter has been inserted into the bronchoscope120.

As shown inFIGS. 1 and 6, in an exemplary embodiment the bronchoscope120has a steering mechanism125, a delivery shaft130, a working channel entry port135, and a visualization eyepiece140.FIG. 1shows the bronchoscope120positioned with its distal end at the right primary bronchus510. The delivery catheter110is positioned within the bronchoscope120such that the delivery catheter's distal end and the attached bronchial isolation device115protrude outward from the distal end of the bronchoscope120, as shown inFIG. 1.

FIG. 6shows an enlarged view of the bronchoscope120, including the steering mechanism125, delivery shaft130, working channel entry port135, and visualization eyepiece140. In addition, the bronchoscope can also include a fiber optic bundle mounted inside the length of the bronchoscope for transferring an image from the distal end to the eyepiece140. In one embodiment, the bronchoscope also includes a camera or charge-coupled device (CCD) for generating an image of the bronchial tree.FIG. 7shows an enlarged view of the distal portion of the bronchoscope120. A working channel710(sometimes referred to as a biopsy channel) extends through the delivery shaft130and communicates with the entry port135(shown inFIG. 6) at the proximal end of the bronchoscope120. The working channel710can sometimes be formed by an extruded plastic tube inside the body of the bronchoscope120. The bronchoscope120can also include various other channels, such as a visualization channel720that communicates with the eyepiece140and one or more illumination channels730. It should be appreciated that the bronchoscope can have a variety of configurations and is not limited to the embodiment shown in the figures. For example, in an alternative embodiment, the working channel710may be formed of a flexible material and temporarily or permanently attached to the outside of the delivery shaft130.

FIG. 8shows one embodiment of the delivery catheter110for delivering and deploying the bronchial isolation device115to a target location in a bronchial passageway. The delivery catheter110has a proximal end810and a distal end815that can be deployed to a target location in a patient's bronchial passageway, such as through the trachea. The catheter110has an elongated outer shaft820and an elongated inner shaft825that is slidably positioned within the outer shaft820such that the outer shaft820can slidably move relative to the inner shaft825along the length of the catheter, as described in more detail below.

The following references describe exemplary delivery devices: U.S. Pat. No. 5,954,766 entitled “Body Fluid Flow Control Device”; U.S. patent application Se. No. 09/797,910, entitled “Methods and Devices for Use in Performing Pulmonary Procedures”; U.S. patent application Ser. No. 10/270,792, entitled “Bronchial Flow Control Devices and Methods of Use”; and U.S. patent application Ser. No. 10/448,154, entitled “Guidewire Delivery of Implantable Bronchial Isolation Devices in Accordance with Lung Treatment”. The foregoing references are all incorporated by reference in their entirety and are all assigned to Emphasys Medical, Inc., the assignee of the instant application.

With reference still toFIG. 8, an actuation handle830, is located at the proximal end810of the catheter110. The actuation handle830can be actuated to slidably move the outer shaft820in a proximal direction relative to the inner shaft825with the inner shaft825remaining fixed relative to the actuation handle830. During such movement, the outer shaft820slides over the inner shaft825.FIG. 8shows a schematic view of the actuation handle830, which is described in more detail below. Generally, the handle830includes a first piece835and a second actuation piece840, which is moveable relative to the first piece835. The outer shaft820of the catheter110can be moved relative to the inner shaft825by moving the first piece835of the handle830relative to the second piece840.

The inner shaft825of the catheter110can include a central guidewire lumen (not shown) that extends through the entire length of the catheter110. The central guidewire lumen of the inner shaft825is sized to receive a guidewire, which can be used during deployment of the catheter110to guide the catheter110to a location in a bronchial passageway.

With reference still toFIG. 8, a housing850is located at or near a distal end of the catheter110for holding therein the bronchial isolation device115. In one embodiment, the housing850is attached to a distal end of the outer shaft820of the catheter110but not attached to the inner shaft825, which extends axially through the housing. The housing850defines an inner cavity that is sized to receive the bronchial isolation device115therein.

FIG. 9shows an enlarged, perspective view of the distal portion of the catheter110where the housing850is located.FIG. 10Ashows a plan, side view of the distal portion of the catheter110where the housing850is located. As shown inFIGS. 9 and 10A, the housing850is shaped to receive the bronchial isolation device therein and is open at a distal end and closed at a proximal end. The inner shaft825of the catheter110protrudes through the housing850and can slidably move relative to the housing850. An ejection member, such as a flange910, is attached at or near a distal end of the inner shaft825. The flange910is sized such that it can be received into the housing850so that the flange910can be withdrawn into the housing850to abut a proximal end of the housing.FIGS. 9 and 10Ashow the flange910positioned outside of the housing850.

As described below, the ejection member can be used to eject the bronchial isolation device115from the housing850. The housing can be manufactured of a rigid material, such as steel. The housing850can also be flexible or collapsible. Although the housing850is shown having a cylindrical shape, it should be appreciated that the housing850can have other shapes that are configured to receive the bronchial isolation device therein.

In one embodiment, a sizing element925is located at or near the housing850, as shown inFIGS. 10A and 10B. (For clarity of illustration,FIG. 10Bdoes not show the bronchial isolation device115mounted in the housing850and does not show the inner shaft825of the delivery catheter.) The sizing element925can be used to determine whether the bronchial isolation device115in the housing850will fit within a particular bronchial passageway in a working manner. The sizing element925comprises one or more extensions, such as first extensions930aand second extensions930bthat define distances L1and L2, respectively. That is, the opposed, outer tips of the extensions930aare separated by a distance L1and the opposed, outer tips of the extensions930bare separated by a distance L2. The distance L1corresponds to the diameter of the larger end of the functional diameter range of the bronchial isolation device115. That is, the distance L1is substantially equal to the largest possible diameter for a bronchial passageway in which the bronchial isolation device can be functionally deployed. The distance L2corresponds to the diameter of the lower end of the functional diameter range of the bronchial isolation device115. That is, the distance L2is substantially equal to the smallest possible diameter for a bronchial passageway in which the bronchial isolation device115can be functionally deployed. It should be appreciated that the extensions930can take on a variety of structures and shapes. For example,FIGS. 10A and 10Bshows the extensions930comprising elongate prongs that extend radially outward from the catheter or the housing850.

In another embodiment, shown inFIG. 9, the extensions930of the sizing element925comprise two or more loops931aand931b, which correspond to the extensions930aand930b, respectively. Each loop931forms an ellipse having a long axis of a predetermined length. In the illustrated embodiment, the loop931ahas a long axis of length L1that is greater than the length L2of the long axis of the second loop931b. Thus, the larger length L1of loop931acorresponds to the diameter of the larger end of the functional diameter range of the bronchial isolation device115. The shorter length L2of loop931bcorresponds to the diameter of the lower end of the functional diameter range of the bronchial isolation device.

As the delivery catheter110is inserted into the bronchial passageway, the sizing element925is used to determine whether or not the bronchial passageway is within the functional range of the bronchial isolation device115. For a bronchial passageway in which the sizing element is positioned, if the opposed tips of the longer extensions930a(e.g., the diameter loop931a) cannot simultaneously contact the wall of the bronchial passageway, then the bronchial isolation device115is too small to be implanted in that passageway. In other words, the bronchial passageway is too large for the bronchial isolation device if the tips of the longer extensions930acannot simultaneously contact the bronchial wall when the extensions930aare centrally positioned within the bronchial passageway. If the opposed tips of the shorter extensions930bcan simultaneously contact the wall of the bronchial passageway, then the bronchial isolation device115is too large to be implanted in the bronchial passageway in a working manner.

The extensions930, such as the loops931, can be constructed of various materials. In one embodiment, the extensions are constructed of wire, etched from a flat plate, or by other methods. The extensions930can be made of a flexible material, such as Nitinol, or a polymer or other flexible material, such that the extensions fold down when inserted into or retracted into the working channel of the bronchoscope. In one embodiment, the extensions are manufactured of Pebax, which is a polyether-block co-polyamide polymer. Other flexible resins can be used as well. Other configurations and shapes of the sizing element925are contemplated, such as standing struts rather than loops, etc.

In use, the bronchial isolation device115is first inserted into the housing850. The bronchial isolation device115can be inserted into the housing according to various methods and devices, some of which are described in U.S. patent application Ser. No. 10/270,792, entitled “Bronchial Flow Control Devices and Methods of Use”, which is assigned to Emphasys Medical, Inc., the assignee of the instant application. After the bronchial isolation device115is inserted into the housing, the distal end of the delivery catheter110is deployed into a bronchial passageway via the trachea such that the housing850is located at or near the target location in the bronchial passageway, as shown inFIG. 11A. Once the delivery catheter110and the attached bronchial isolation device115are located at the target location, an operator can eject the bronchial isolation device115from the housing850into the bronchial passageway.

This process is described with reference toFIG. 11A and 11B.FIG. 11Ashows a cross-sectional view of a bronchial passageway1110with the deliver catheter110positioned therein. The distal end of the delivery catheter110, including the housing850, is located at or near the target location L. Once the catheter is positioned as such, an operator actuates the catheter handle830to slidably move the outer catheter member820in a proximal direction relative to the location L, while maintaining the location of the bronchial isolation device115, inner shaft825, and flange910fixed with respect to the location L. The proximal movement of the outer shaft820causes the attached housing850to also move in a proximal direction, while the flange910prevents the bronchial isolation device115from moving in the proximal direction. This results in the housing850sliding away from engagement with the bronchial isolation device115so that the bronchial isolation device115is eventually entirely released from the housing850and implanted in the bronchial passageway at the target location L, as shown inFIG. 11B.

During actuation of the actuation handle830, the outer shaft820can undergo tension and the inner shaft825undergo compression due to the relative movement of the shafts and possible friction against the proximal movement of the outer shaft820. This can result in an axial shortening of the inner shaft825and an axial lengthening of the outer shaft820. In order to compensate for this and to allow the device115to be fully ejected from the housing850, the flange910can be configured to over-travel a distance Y beyond the distal end of the housing850, as shown inFIG. 11B. The over-travel of the flange910beyond the housing's distal end can create a potential problem during withdrawal of the delivery catheter110, particularly in situations where the delivery catheter110is deployed in a location that requires its distal end to bend at an acute angle.FIG. 12shows such a situation, where the bronchial isolation device115is deployed at a location in the bronchial tree220that requires the delivery catheter110to bend at an acute angle with the flange910withdrawn entirely from the housing850. In such situations, the flange910can catch on the tissue of the bronchial wall at a location1210inside the bend as the operator pulls the catheter110out of the bronchial passageway. This can make it difficult for an operator to remove the delivery catheter110from the bronchial passageway and can risk possible damage to the tissue if the operator continues to pull while the flange is caught on the bend.

This problem can be overcome by limiting the travel of the flange910relative to the housing850such that the flange910cannot move outward of the distal end of the housing850. One way this can be accomplished is by limiting the travel of the inner shaft825at the distal end of the catheter110.FIG. 13shows a cross-sectional view of the distal region of the catheter, showing the inner shaft825axially disposed in the outer shaft820. As mentioned, the flange910is attached to the inner shaft825and the housing850is attached to the outer shaft820. The inner shaft825has a step1405and the housing850or outer shaft820has a stop or ledge1410. The step1405is spaced from the ledge1410when the flange910is fully withdrawn in the housing850. As the outer shaft820moves in the proximal direction, the step1405eventually abuts the ledge1410, which acts as a stop to limit any further proximal movement of the outer shaft820relative to the inner shaft825. As shown inFIG. 14, the flange910is positioned just at the distal end of the housing850when the stop position is reached. Thus, the flange910and housing850have a relative range of travel therebetween.

In one embodiment, the flange910is limited from being distally positioned at all past a distal edge of the housing. In another embodiment, the flange910can be distally positioned past the distal end of the housing only to the extent that the flange will not catch onto tissue during withdrawal of the delivery catheter. Thus, referring toFIG. 11B, the distance Y is sufficiently small to prevent or greatly reduce the likelihood of bronchial wall tissue being caught or pinched between the flange910and the housing850during withdrawal of the delivery catheter110. This eliminates the possibility of the flange910catching or lodging on the bronchial tissue during removal of the delivery catheter110.

Actuation Handle

There is now described an actuation handle for the delivery catheter that can be used to slide the outer shaft820(and the attached housing850) relative to the inner shaft825while maintaining the inner shaft825stationary relative to the handle.FIG. 15shows a side view of an actuation handle1510. In the illustrated embodiment, the actuation handle1510has an elongate shape suitable for grasping within an operator's hand. It should be appreciated, however, that the shape of the actuation handle1510can vary. The actuation handle1510includes an actuation member, such as a slidable actuation slider1515, that can be actuated to slide the outer shaft820relative to the inner shaft825(the inner shaft is not shown inFIG. 15) during ejection of the bronchial isolation device115. The actuation member can be positioned on the handle1510such that an operator can grasp the handle with a single hand and also move the actuation member using a finger or thumb of the same hand. For example, in the embodiment shown inFIG. 15, the slider1515is positioned along the side of the actuation handle1510so that the operator's thumb can be used to move the slider1515. Other configurations can be used.

FIG. 16shows a cross-sectional view of the actuation handle1510, which includes an actuation system for moving the outer shaft relative to the handle. In one embodiment, the actuation system comprises a rack and pinion system for effecting movement of the outer shaft820relative to the inner shaft825. The actuation slider1515is coupled to the actuation system. The actuation slider1515is slidably positioned inside an elongate slot1605in the actuation handle1510. A distal end of the actuation slider1515abuts or is attached to a first rack1610that is also slidably mounted in the elongate slot1605. The first rack1610has a first edge with teeth that mesh with corresponding teeth on a first pinion1615. The first pinion1615is engaged with a second pinion1620having teeth that mesh with a second rack1625mounted in an elongate slot1628. The second rack1625is attached to the outer shaft820of the delivery catheter110such that movement of the second rack1625corresponds to movement of the outer shaft820. That is, when the second rack slidably moves in the proximal direction or distal direction, the outer shaft820also moves in the proximal or distal direction, respectively. The inner shaft825is fixedly attached to the handle1510, such as by using adhesive or through a friction fit. The first rack, second rack, first pinion, and second pinion collectively form a rack and pinion system that can be used to transfer distal movement of the actuation slider1515to proximal movement of the outer shaft820while the inner shaft825remains stationary relative to the handle1510, as described below.

The actuation slider1515can be positioned in an initial position, as shown inFIG. 16. When the actuation slider1515is in the initial position, the flange910is fully withdrawn inside the housing950(as shown inFIG. 13). In one embodiment, the actuation slider1515is at the proximal end of the handle when in the initial position, although it should be appreciated that the initial position can vary. When the actuation slider1515slidably moves in the distal direction (represented by the arrow1630inFIG. 16) from the initial position, the rack and pinion system causes the outer shaft820to slidably move in the proximal direction (represented by the arrow1635inFIG. 16), and vice-versa, while the inner shaft825remains stationary relative to the handle. More specifically, movement of the actuation slider1515in the distal direction1630moves the rack1610in the distal direction, which drives the first pinion1615and which, in turn, drives the second pinion1620. The gearing between the second pinion1620and the second rack1625causes the second rack1625to move in the proximal direction1635through the slot1628. As mentioned, the second rack1625is attached to the outer shaft820so that the outer shaft820moves in the proximal direction1635along with the second rack1625. During such movement, a distal region of the outer shaft820slides into the handle1510. While this occurs, the inner catheter825(which is fixed to the handle1510) remains stationary relative to the handle1510while the outer shaft820moves. Thus, when the operator moves the slider1515in the distal direction1630, the outer shaft820(and the attached housing850) slides in the proximal direction, with the inner shaft820and flange910remaining stationary relative to the handle. The handle can be fixed relative to the patient such that the handle, inner shaft, flange and bronchial isolation device remain fixed relative to the patient during ejection of the bronchial isolation device from the housing.

The gear ratio between the first pinion1615and second pinion1620can be varied to result in a desired ratio of movement between the actuation slider1515and the outer catheter820. For example, the first pinion1615can have a larger diameter than the second pinion1620so that the outer shaft820(and the attached housing850) are withdrawn in the proximal direction at a slower rate than the actuation slider1515is advanced in the distal direction. The gear ratio can also be varied to reduce the force required to move the actuation slider1515and thereby make it easier for an operator to control ejection of the bronchial isolation device115from the housing850. The ratio between the pinions can be altered to make the withdrawal of the outer shaft faster, slower, or the same speed as the actuation slider movement. In one embodiment, the rack and pinion system is configured such that a 2:1 force reduction occurs such that the actuator slider moves about twice the distance that the outer shaft820is moved. For example, if the slider is moved an inch in the distal direction, then the outer shaft and the attached housing moves about half an inch in the proximal direction, and vice-versa.

The handle1510can include a safety lock that retains the actuation slider1515(or any other type of actuation member) in the initial position until the operator applies a force to the actuation slider sufficient to disengage the safety lock. The safety lock prevents inadvertent deployment of the bronchial isolation device either by inadvertent movement of the actuation slider in the distal direction or by inadvertent movement of the outer shaft820in the proximal direction relative to the handle. Inadvertent proximal movement of the outer shaft820can possibly occur when the delivery catheter110is being advanced into the patient's trachea, which can cause resistance to be applied to the outer shaft820by an anesthesia adaptor valve, endotracheal tube, or the lung.

In one embodiment, the safety lock comprises one or more magnets positioned in the actuation handle1510.FIG. 17shows a partial, cross-sectional view of the proximal end of the handle1510with the actuation slider1515positioned distally of the initial position. A first magnet1710is located on the handle1510near the initial location of the actuation slider1515. A second magnet1715is located on or in the actuation slider1515. The magnets1710,1715are oriented such that an attractive magnetic force exists therebetween. When the actuation slider1515is in the initial position, the magnetic force between the magnets1710,1715retains the actuation slider1515in the initial position until the operator applies a force to the slider1515sufficient to overcome the magnetic force and move the slider1515out of the initial position.

It should be appreciated that configurations other than magnets can be employed as the safety lock. One advantage of magnets is that the attractive force between the magnets1710,1715automatically increases as the actuation slider moves toward the initial position. If the actuation slider happens to be out of the initial position when the bronchial isolation device is loaded into the housing850, the actuation slider1515is driven back toward the initial position as the bronchial isolation device is loaded into the housing850. The magnetic attraction between the first and second magnets1710,1715automatically engages the safety lock when the actuation slider1515moves into the initial position.

The safety lock can include an additional feature wherein the operator must depress the actuation slider1515in order to disengage the slider from the initial position. As shown inFIG. 17, the slot1605in the actuation handle1510has an opening1712. The actuation slider1515moves outward and sits in the opening1712when in the initial position. The operator must depress the slider1515to move the actuation slider1515out of the opening in order to disengage the slider from the initial position and slide the actuation slider1515in the distal direction.

Adjustment of Handle Position Relative to Bronchoscope

As discussed above, according to the transcopic delivery method, the bronchoscope120(shown in FIGS.1,6,7) is used in deploying the delivery catheter110into the bronchial passageway. Pursuant to this method, the delivery catheter110is inserted into the working channel710of the bronchoscope120such that the delivery catheter's distal end is aligned with or protrudes from the distal end of the bronchoscope120. The bronchoscope120, with the delivery catheter110positioned as such, is then inserted into the bronchial passageway via the patient's trachea such that the distal end of the delivery catheter is positioned at a desired location in the bronchial passageway, as shown inFIG. 1. It should be appreciated that the delivery catheter110can be inserted into the bronchoscope120either before or after the bronchoscope has been inserted into the bronchial passageway.

FIG. 18shows an enlarged view of the distal region of the bronchoscope120with the delivery catheter's distal end (including the housing850) protruding outward from the working channel710. The bronchial isolation device115is positioned within the housing850. The bronchial isolation device115is a distance D from the distal end of the bronchoscope120. Once the bronchoscope and delivery catheter are in the patient, the operator may desire to adjust the distance D to fine tune the location of the bronchial isolation device115. However, it can also be desirable or even required to hold the actuation handle1510, and thus the inner shaft825, stationary relative to the bronchoscope120. This way, the bronchoscope120can be fixed relative to the patient's body, thereby keeping the bronchial isolation device115fixed relative to the target location in the bronchial passageway.

FIG. 19shows another embodiment of the actuation handle, referred to as actuation handle1910, that can be used for transcopic delivery and that can be fixed relative to a bronchoscope while also allowing for adjustments in the distance D ofFIG. 18once the delivery device is positioned in the bronchoscope. The actuation handle1910includes an actuation member in the form of a button1915that can be depressed in the distal direction to move the outer shaft820of the delivery catheter in the proximal direction. The handle includes an adjustment mechanism that is used to adjust the position of the handle relative to the bronchoscope. The adjustment mechanism comprises an elongated bronchoscope mount1920that extends outwardly from the distal end of the actuation handle1910and extends at least partially over the catheter outer shaft820such that the outer shaft can slide freely within the bronchoscope mount1920. The bronchoscope mount1920extends outward from the handle a distance A. The bronchoscope mount1920is slidably moveable into or out of the handle1910such that it can be pushed into or pulled out of the handle1910along the axis of the mount1920in order to adjust the distance A. In one embodiment the bronchoscope mount1920is biased outward, for example with a spring, so that its tendency is to be fully extended outward from the handle1910. A locking mechanism includes a lock, such as a lever1925, that can be depressed to lock the bronchoscope mount1920relative to the handle1910when the distance A is adjusted to a desired amount, as described below. Once the distance A is at a desired amount, the operator can lock the bronchoscope mount1920relative to the handle to fix the bronchoscope mount1920relative to the handle1910.

With reference toFIG. 20, the bronchoscope mount1920has a size and shape that is configured to sit within the entry port135of the bronchoscope working channel. In use, an operator can insert the bronchoscope mount1920into the entry port135such that it abuts and sits within the entry port135. In this manner, the actuation handle1910is fixed relative to the bronchoscope120with the catheter's distal end protruding a distance D from the bronchoscope's distal end (as shown inFIG. 20). The operator can then adjust the distance A by moving the bronchoscope mount1920into or out of the handle1910, such as by pushing on the handle1910to decrease the distance A. By virtue of the outer and inner catheter shafts' attachment to the handle, adjustments in the distance A will correspond to adjustments in D. That is, as the operator decreases the distance A (FIG. 20), the catheter slides deeper into the bronchoscope so that the distance D (FIG. 18) increases, and vice-versa.

Once the desired distance A has been achieved, the bronchoscope mount1920is locked by depressing the lever1925. Thus, by adjusting the distance A, the operator also adjusts the distance D (shown inFIG. 18) between the distal end of the bronchoscope120and the bronchial isolation device115. This can be helpful where different brands or types of bronchoscopes have different length working channels. It also allows the operator to fine-tune the position of the housing850and bronchial isolation device in the bronchial passageway without moving the bronchoscope. Other mechanisms for locking the movement of the bronchoscope mount1920are possible such as depressing and holding the lever1925to release the movement of the bronchoscope mount1920, repositioning the bronchoscope mount1920, and releasing the lever1925to lock the bronchoscope mount1920in place.

Catheter Sheath

As discussed above, during use of the delivery catheter110it can be desirable to fix the location of the inner shaft825(and thus the bronchial isolation device in the housing850) relative to the patient's body while proximally withdrawing the outer shaft820and the housing850relative to the bronchial passageway to eject the bronchial isolation device, as shown inFIGS. 11A and 11B. Given that the outer shaft820moves proximally relative to the bronchial passageway during the foregoing process, the outer shaft820can encounter resistance to proximal movement due to friction with devices or body passageways in which the delivery device is positioned. For example, the outer surface of the outer shaft820can encounter frictional resistance against an anesthesia adaptor through which the outer shaft is inserted. The anesthesia adapter is a fitting that permits the bronchoscope and delivery catheter to be inserted into the lung without leakage of ventilated oxygen, anesthesia gases, or other airway gases. The adapter typically has a valve through which the delivery catheter or bronchoscope is inserted. The valve seals against the outer surface of the outer shaft820to prevent air leaks. This seal can provide resistance against proximal movement of the outer shaft820during ejection of the bronchial isolation device from the housing850. Such resistance to proximal movement of the outer shaft820is undesirable, as it can result in the bronchial isolation device115being deployed in a location distal of the target location in the bronchial passageway.

FIG. 21shows an embodiment of the delivery catheter110, which includes a deployment sheath2110that reduces or eliminates the resistance to proximal movement of the catheter outer shaft820during ejection of the bronchial isolation device115. The deployment sheath2110is a sheath having an internal lumen in which the outer shaft820is slidably positioned. The sheath2110is fixed at a proximal end2112to the actuation handle815.FIG. 21shows the actuation handle815, although the sheath2110can be used with any type of handle. Furthermore, it should be appreciated that the sheath2110is not limited to use with delivery catheters that deploy bronchial isolation devices, but can rather be used with various types of catheters. For example, the sheath configuration can be used in combination with catheters suitable for use in venous, arterial, urinary, billiary, or other body passageways. The sheath2110extends over the outer shaft820a distance X. The distance X can vary. In one embodiment, the distance X is long enough to extend to locations where the outer shaft is likely to encounter frictional resistance to movement, such as at the anesthesia adapter, if present. However, when used with a delivery catheter having a housing850, the distance X is such that the distal end of the sheath does not interfere with the housing850being fully withdrawn in the proximal direction.

The sheath2110can have a very thin wall to minimize its contribution to the overall diameter of the delivery catheter110. In one embodiment, the sheath2110has a wall thickness in the range of approximately 0.002 inches to approximately 0.004 inches. The sheath2110is manufactured of a material that is lubricous to minimize resistance to the outer shaft820sliding inside the sheath2110. The sheath material also has a stiffness that resists crumpling when a compressive load is placed along the length of the sheath (such as when the sheath is possibly pinched or grabbed to fix its position relative to the anesthesia adapter during ejection of the catheter from the housing, as described below). The compressive forces can come from the possibility that the outer shaft is pinched when the sheath is pinched, and thus when the handle is actuated and the outer shaft starts to move towards the handle, the sheath is compressed]. The sheath2110can be manufactured of various materials, such as, for example, polyimide, Teflon doped polyimide, PolyEtherEtherKetone (PEEK), etc.

In use, the delivery catheter110is positioned in the patient's lung through the trachea, such as described above. This can involve the delivery catheter110being positioned through a device such as a bronchoscope or through an anesthesia adapter2210, such as shown in the partial view ofFIG. 22. The sheath2110is located between the anesthesia adapter2210and the outer shaft820(not shown inFIG. 22) such that the sheath2110provides a lubricous shield between the outer shaft820and the anesthesia adapter. Thus, the outer shaft820can be proximally moved using the actuation handle without the outer shaft820encountering frictional resistance from contact with the anesthesia adapter (or any other object or device in which the sheath and outer shaft are positioned). If desired, the operator can grab or pinch the catheter110(as represented by the arrows2215inFIG. 22) through the sheath2110at the entrance of the anesthesia adapter2210to fix the location of the sheath2110(and thus the location of the handle and the inner shaft) relative to the patient and/or anesthesia adaptor. As the sheath2110is made of a relatively rigid and lubricous material, the outer shaft820is free to slide through the sheath in the proximal direction as the sheath is grabbed.

Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.