Lung access device

A pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a channel. The pulmonary access device further comprises a profiled stylet configured for being disposed in the working channel of the elongated shaft, the profiled stylet having a proximal stylet section with a first lateral stiffness profile, an intermediate stylet section having a second lateral stiffness profile less than the first lateral stiffness profile, a distal stylet section, wherein, when the profiled stylet is disposed in the working channel of the elongated shaft, the intermediate stylet section axially aligns with the bendable shaft section. The pulmonary access device further comprises a pull wire affixed to the distal shaft section, such that, when the pull wire is tensioned, the bendable shaft section bends, thereby deflecting the distal shaft section relative to the proximal shaft section.

FIELD

The present disclosure relates generally to surgical devices, and more specifically, to methods, systems, and devices for navigating to and biopsy lung nodules.

BACKGROUND

Early diagnosis of potentially cancerous tissue is an important step in the treatment of cancer, because the sooner that cancerous tissue can be treated, the better the patient's chances are for survival. Typical diagnostic procedures involve biopsying tissue at a site of interest. Biopsies are a group of medical diagnostic tests used to determine the structure and composition of tissues or cells. In biopsy procedures, cells or tissues are sampled from an organ or other body part to permit their analysis, e.g., under microscope. Generally, if an abnormality is found through superficial examination, such as palpation or radiographic imaging, a biopsy can be performed to determine the nature of the suspected abnormality.

Biopsies can be performed on a number of organs, tissues, and body sites, both superficial and deep, and a variety of techniques may be utilized depending on the tissue or body part to be sampled, the location, size, shape, and other characteristics of the abnormality, the number of abnormalities, and patient preference. Fine needle aspiration (FNA) is typically performed to sample deep tissues using a fine gauge needle (22 or 25 gauge) inserted percutaneously or through an endoscope under ultrasound guidance (EUS-FNA). By contrast, surgical biopsy is generally performed as an open procedure and can be either excisional (removal of an entire lesion) or incisional (removal of a piece of a lesion).

Surgical biopsies generally permit removal of more tissue than fine needle biopsies, and thus, are less prone to misdiagnosis. However, open surgical procedures are significantly more expensive than needle biopsies, require more time for recuperation, require sutures, can leave a disfiguring scar, require anesthesia, carry a small risk of mortality, and can result in bleeding, infection, and wound healing problems.

In contrast, fine needle biopsies carry risks of their own. For example, the relatively small quantities of tissue sampled may not be representative of the region of interest from which it is taken, particularly when that region of interest is very small or very hard. As another example, fine gauge needles are typically stiffer, and less prone to deflection. Thus, while it may be possible to guide the needle to the region of interest, it may not be possible to accurately sample the site of interest if the needle is too stiff to navigate the same path through the tissue.

The global lung cancer epidemic, combined with the adoption of lung cancer screening, may result in an increasing number of suspicious solitary pulmonary nodules (SPNs) found on chest computed tomography (CT) scans or other scans. Suspicious SPNs, which typically exist in the periphery of lungs, may be difficult to access and diagnose using current bronchoscopic technologies designed primarily for the central airway. Peripheral lung nodules, or SPNs, may be rounded benign or malignant masses that may range in size between 5-25 mm. When an SPN is identified, it may need to be diagnosed with a biopsy. Typically, FNA may be utilized to access and obtain a biopsy from identified SPNs with a transbronchial approach through a bronchoscope inserted through a patient's mouth and throat into the bronchial airways of a lung, or with a transthoracic approach though a patient's thoracic cavity. Generally, the transbronchial approach may be favored over the transthoracic approach as access to the SPNs may be gained through existing airways of the lung without puncturing body tissue, and furthermore, puncturing the outer lining of a lung, which may lead to a pneumothorax.

Existing systems may be constrained by difficulties in accessing lung nodules via the transbronchial approach, especially in the smaller peripheral airways that may be too narrow to accommodate larger catheters and biopsy apparatuses. Furthermore, as SPNs are often located in the deep periphery of the lungs, and in particular, within the parenchyma of the lungs away from any airways, it may be difficult or impossible to reach such SPNs through airways of the lungs. Further, biopsy needles used in typical transbronchial approaches normally are straight and relatively inflexible. Thus, it may be difficult to navigate these biopsy needles along small and tortuous peripheral airways. In this case, a transthoracic approach accessing an SPN by puncturing through a patient's thoracic cavity may need to be used.

In some instances, the material of the needle may inelastically yield, and thus may sustain exceedingly high stresses when negotiating tight turns in these small and tortuous peripheral airways. Thus, it is not uncommon that a needle will yield or “kink” with a very acute irreversible bend that permanently alters the distal end of the needle, and therefore, their distal trajectories. Such an event renders the needle useless and creates a hazard to safely removing the needle from the body via the bronchoscope.

In addition, a straight needle trajectory is dictated by the position and orientation of the distal end of the bronchoscope. Most needles are not capable of making adjustments to deviate from this trajectory towards SPNs or otherwise away from anatomical obstacles. Thus, straight biopsy needles obtain samples along an axis of the needle through back and forth motion of the needle. As a result, obtaining multiple samples from different regions of a single SPN can be difficult and can require repeated repositioning of the bronchoscope.

There exist steerable lung biopsy needles that are capable of articulating to provide access to SPNs for biopsy that are deeper in the bronchial airways of a lung. However, these steerable lung biopsy needles are not capable of puncturing the wall of airway, and thus, are not capable of accessing SPNs that are in the parenchyma of the lung outside the airway. There also exists a lung biopsy needle that is capable of puncturing a bronchial airway of a lung to access SPNs that are in the parenchyma of the lung. However, this lung biopsy needle is not capable of taking multiple samples from different regions of a single SPN in a controlled manner.

As a transthoracic approach may be viewed as more invasive than a transbronchial approach and may require more recovery time than a transbronchial approach, it is desirable to provide a lung biopsy needle that is capable of navigating the tortuous pathways of the deep or far periphery of the bronchial airways of the lungs, and taking multiple samples from different regions of an SPN located in the parenchyma of the lungs that could only be previously performed using a transthoracic approach.

SUMMARY

In accordance with a first aspect of the present inventions, a pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a channel. In one embodiment, the lateral stiffness profile of the distal shaft section is less than the lateral stiffness profile of the proximal shaft section, and the bendable shaft section is a transition shaft section that transitions the lateral stiffness profile of the distal shaft section to the lateral stiffness profile of the proximal shaft section, e.g., in a gradual fashion or a step-wise fashion. The proximal shaft section of the elongated shaft may have a 1:1 torque transmission.

The pulmonary access device further comprises a profiled stylet configured for being disposed in the working channel of the elongated shaft. The profiled stylet has a proximal stylet section with a first lateral stiffness profile, an intermediate stylet section having a second lateral stiffness profile less than the first lateral stiffness profile, a distal stylet section. When the profiled stylet is disposed in the working channel of the elongated shaft, the intermediate stylet section axially aligns with the bendable shaft section. The proximal stylet section has a first geometric profile, and the intermediate stylet section has a second geometric profile less than the first geometric profile. The profiled stylet has, e.g., a circular cross-section or a rectangular cross-section.

The pulmonary access device further comprises a pull wire affixed to the distal shaft section, such that, when the pull wire is tensioned, the bendable shaft section bends, thereby deflecting the distal shaft section relative to the proximal shaft section.

In one embodiment, the elongated shaft has a distal tip disposed on the distal shaft section, and the pull wire is affixed to the distal tip. The distal tip may be, e.g., a tissue-penetrating distal tip. In this case, the working channel terminates at a distal opening in the tissue-penetrating distal tip, and the distal stylet section is an atraumatic distal stylet section that blocks the distal opening in the tissue-penetrating distal tip. The tissue-penetrating distal tip may be symmetrical relative to a longitudinal axis of the elongated shaft. The distal tip may alternatively be an atraumatic distal tip, in which case, the working channel may terminate at a distal opening in the atraumatic distal tip, and the distal stylet portion may have a tissue-penetrating distal tip that extends from the distal opening in the atraumatic distal tip.

In still another embodiment, the elongated shaft further has a pull wire lumen that houses the pull wire. In yet another embodiment, the pulmonary access device further comprises a handle assembly including a handle body and a deflection control actuator affixed to the handle body. The deflection control actuator operably connected to the pull wire to tension the pull wire. In yet another embodiment, the pulmonary access device further comprises a rotational actuator affixed to the handle body. The rotational actuator is operably connected to the elongated shaft to rotate the elongated shaft relative to the handle body. In yet another embodiment, the pull wire is affixed to the distal shaft section, such that, when the pull wire is tensioned, the bendable shaft section bends, thereby deflecting the distal shaft section at least 180 degrees relative to the proximal shaft section.

In yet another embodiment, the pulmonary access device further comprises a steering plate affixed within the elongate shaft along the bendable shaft section and the distal shaft section. The pull wire may be affixed to the steering plate. The elongated shaft may comprise a first tube extending along the proximal shaft section, and a second tube extending along the bendable shaft section and the distal shaft section, the first tube having a third lateral stiffness profile, and the combination of the second tube and the steering plate having a fourth lateral stiffness profile along the distal shaft section less than the third lateral stiffness profile. The steering plate may have a geometric profile that tapers down in the distal direction along the bendable shaft section, such that the steering plate gradually transitions the first lateral stiffness profile of the proximal shaft section of the elongated shaft to the second lateral stiffness profile of the distal shaft section of the elongated shaft. The proximal shaft section may be, e.g., metallic

In yet another embodiment, the elongated shaft may comprise a first polymeric tube having a first durometer and extending along the proximal shaft section, a second polymeric tube having a second durometer less than the first durometer and extending along the bendable shaft section, and a third polymeric tube having a third durometer less than the second durometer and extending along at least a portion of the distal shaft section.

In accordance with a second aspect of the present inventions, a pulmonary biopsy system comprises the aforementioned pulmonary access device, and a bronchoscope having a working channel in which the pulmonary access device is disposed. In embodiment, the pulmonary biopsy system further comprises a biopsy device, the profiled stylet and the biopsy device configured for being interchangeably disposed in the working channel of the pulmonary access device.

In accordance with a third aspect of the present inventions, a method of using the aforementioned pulmonary access device to biopsy a solitary pulmonary nodule (SPN) located in parenchyma of a patient is provided, introducing the profiled stylet within the channel of the elongated shaft, navigating the pulmonary access device through a bronchial airway of the patient, puncturing the distal tip of the elongated shaft through a wall of the bronchial airway into the parenchyma, tracking the distal tip of the elongated shaft through the parenchyma to a first site of the SPN by tensioning the pull wire to actively deflect the distal shaft section while distally advancing the pulmonary access device, and taking a biopsy sample from the first site of the SPN.

One method further comprises repeating the introducing, navigating, puncturing, tracking, and taking steps for a second site of the SPN different from the first site of the SPN. Another method further comprises introducing a bronchoscope through the bronchial airway of the patient. Navigating the pulmonary access device through the bronchial airway of the patient may comprise introducing the pulmonary access device through the bronchoscope into the bronchial airway of the patient.

In still another method, taking the biopsy sample from the first site of the SPN comprises proximally retracting the profiled stylet within the channel of the elongated shaft, and coring the biopsy sample with a distal tip of the elongated shaft. Taking the biopsy from the first site of the SPN may comprise, while the biopsy sample is cored in the distal tip of the elongated shaft, repeatedly tensioning and relaxing the pull wire, thereby cyclically deflecting the distal shaft section until the biopsy sample is separated from the SPN. In yet another method, taking the biopsy sample from the first site of the SPN comprises removing the profiled stylet from the channel of the elongated shaft, introducing a biopsy device through the channel of the elongated shaft, and taking the biopsy sample from the first site of the SPN with the biopsy device. In yet another method, navigating the pulmonary access device through the bronchial airway of the patient comprises tensioning the pull wire to actively deflect the distal shaft section while distally advancing the pulmonary access device within the bronchial airway of the patient.

In accordance with a fourth aspect of the present inventions, a method of biopsying a solitary pulmonary nodule (SPN) located in parenchyma of a patient, the method comprising navigating a pulmonary access device through a bronchial airway of the patient, puncturing the pulmonary access device through a wall of the bronchial airway into the parenchyma, tracking a distal tip of the pulmonary access device through the parenchyma to a first site of the SPN by actively deflecting the distal tip of the pulmonary access device while distally advancing the pulmonary access device, and taking a biopsy sample from the first site of the SPN.

One method further comprises repeating the introducing, navigating, puncturing, tracking, and taking steps for a second site of the SPN different from the first site of the SPN. Another method comprises introducing a bronchoscope through the bronchial airway of the patient, in which case, navigating the pulmonary access device through the bronchial airway of the patient may comprise introducing the pulmonary access device through the bronchoscope into the bronchial airway of the patient. In yet another method, taking the biopsy sample from the first site of the SPN comprises coring the biopsy sample with a distal tip of the pulmonary access device. In yet another method, taking the biopsy from the first site of the SPN comprises, while the biopsy sample is cored in the distal tip of the pulmonary access device, cyclically deflecting the distal shaft section until the biopsy sample is separated from the SPN. In yet another method, taking the biopsy sample from the first site of the SPN comprises introducing a biopsy device through pulmonary access device, and taking the biopsy sample from the first site of the SPN with the biopsy device. In yet another method, navigating the pulmonary access device through the bronchial airway of the patient comprises actively deflecting the distal end of the pulmonary access device while distally advancing the pulmonary access device.

Other and further aspects and features of embodiments of the disclosed inventions will become apparent from the ensuing detailed description in view of the accompanying figures.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Referring toFIG. 1, one exemplary embodiment of a transbronchial pulmonary biopsy system10capable of accessing an identified solitary pulmonary nodule (SPN) in the parenchyma of a lung located remotely from a bronchial airway in the lung will be described. The transbronchial pulmonary biopsy system10generally comprises a flexible bronchoscope12and a pulmonary access device14.

The bronchoscope12is conventional in nature, and can take the form of, but not limited to, BF-P180 or endobronchial ultrasound bronchoscopy (EBUS) scope manufactured by Olympus. The bronchoscope12is configured for being inserted through the patient's mouth or nose and into the bronchial airways of the patient. The bronchoscope12comprises an elongated shaft16having a proximal end18and a distal end20, a working channel22extending through the elongated shaft16, a handle assembly24affixed to the proximal end18of the elongated shaft16, and an access port25leading to the working channel22within the elongated shaft16. The working channel22may conventionally have a diameter of 2.8 mm or a diameter of 2.65 mm. The access port25includes a coupling26configured for locking the pulmonary access device14within the working channel22of the bronchoscope12. In an optional embodiment, the access port25does not have a coupling26, in which case, the pulmonary access device14may be freely displaced relative to the working channel18of the bronchoscope12.

The bronchoscope12further comprises one or more lights (not shown) disposed at the distal end20of the elongated shaft16for illumination and optical fibers (not shown) extending through the elongated shaft16for capturing and transmitting images at the distal end20of the elongated shaft16. The handle assembly24comprises a handle body28affixed to the proximal end18of the elongated shaft16, and an eyepiece30affixed to the handle body26for viewing images at the distal end20of the elongated shaft16, thereby allowing a practitioner to observe the progress of the bronchoscope18through the patient on a monitor as the bronchoscope12is steered through the bronchial airways of the patient in proximity to an SPN. A camera (not shown) may be connected to the eyepiece30for porting images to a monitor (not shown). The handle assembly24further comprises a light adapter32to which a light cable (not shown) may be connected for optical coupling to the lights at the distal end20of the elongated shaft16.

The pulmonary access device14is configured for tracking through the working channel22of the bronchoscope12, being navigated through the tortuous pathways of the deep or far periphery of the bronchial airways of the lungs, puncturing out of a bronchial airway, traversing the parenchyma of the lung, and accessing a selected SPN in the parenchyma of the lung, such that biopsy samples can be taken at multiple sites of the selected SPN. In one variation, the pulmonary access device14serves as a biopsy device that takes the biopsy samples from the selected SPN. In another variation, the pulmonary access device14serves as a channel device that delivers commercially available or future developed biopsy tools (e.g., biopsy needles, brushes, forceps, etc.) to the selected SPN, which biopsy tools can then be operated to take the biopsy samples from the selected SPN.

Referring further toFIG. 2A-2C, one exemplary embodiment of the pulmonary access device14comprises an elongated shaft40having a steerable distal section. In the preferred embodiment, the elongated shaft40has compression resistance and is highly torqueable to provide the pulmonary access device14with steering fidelity, axial pushability, and SPN piercing force translation. The elongated shaft40may be constructed, such that it has a 1:1 torque transmission and a 1:1 axial transmission. In this manner, rotational and axial displacement at the distal end of the elongated shaft40will consistently track the rotational and axial displacement of the proximal end of the elongated shaft40, such that the distal tip of the elongated shaft40may traverse and change direction in the parenchyma to the SPN, and thus, be consistently and predictably located at the various sampling sites of a selected SPN, as will be described in further detail below. The torsional profile along the entire elongated shaft40is preferably uniform, whereas the lateral stiffness profile along the elongated shaft40preferably has a transition directly proximal to the steerable distal section of the elongated shaft40to facilitate tracking through the parenchyma.

To this end, the elongated shaft40has a proximal shaft section42, a bendable shaft section44, a distal shaft section46, a distal tip48, and a channel50(either a biopsy channel or a working channel) (shown inFIGS. 2D and 2E) extending through the proximal shaft section42, bendable shaft section44, and distal shaft section46, and terminating at a distal opening52in the distal tip48(shown best inFIGS. 7 and 8).

In this exemplary embodiment, the lateral stiffness profile of the distal shaft section46is less than the lateral stiffness profile of the proximal shaft section42, while the bendable shaft section44has a transitioning lateral stiffness profile that transitions the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46, as illustrated inFIGS. 3A and 3B. In this manner, the bendable shaft section44facilitates tracking of the distal tip48through the bronchial airways and parenchyma of the lung. That is, in the absence of the bendable shaft section44, the distal shaft section46may “snow plow” and not follow itself, possibly creating tissue damage and making it difficult to track the distal tip48to the SPN. Although the lateral stiffness profile of the distal shaft section46is less than the lateral stiffness profile of the proximal shaft section42, the lateral stiffness profile of the distal shaft section46is preferably high enough to provide stability to the distal shaft section46when locating the distal tip48at a sampling site of a selected SPN, and to facilitate taking of a biopsy at the sampling site of the selected SPN.

As will be described in further detail below, the lateral stiffness profiles of the proximal shaft section42, bendable shaft section44, and distal shaft section46may be accomplished using different techniques. Furthermore, the transition between the lateral stiffness profiles of the proximal shaft section42and the distal shaft section46may also be accomplished using different techniques.

In the exemplary embodiments illustrated inFIGS. 3A and 3B, the lateral stiffness profiles of the proximal shaft section42and the distal shaft section46are uniform, although in alternative embodiments, either or both of the lateral stiffness profiles of the proximal shaft section42and the distal shaft section46may be non-uniform. The transitioning lateral stiffness profile of the bendable shaft section44may either be gradual (FIG. 3A), such that it transitions the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46in a gradual fashion, or uniform (FIG. 3B), such that it transitions the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46in a gradual fashion in a step-wise fashion.

In an alternative embodiment illustrated inFIG. 3C, the bendable shaft section44does not transition the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46. Instead, bendable shaft section44has the same lateral stiffness profile as that of the distal shaft section46, and thus, the higher lateral stiffness profile of the proximal shaft section42is immediately transitioned to the lower lateral stiffness profiles of the bendable shaft section44and the distal shaft section46in a step-wise fashion.

In this exemplary embodiment, the distal tip48takes the form of a tissue-penetrating distal tip. In contrast to asymmetrical distal tips, which may create bias in steering when traversing tissue, and in this case, the parenchyma, the tissue-penetrating distal tip48is bi-laterally symmetrical relative to a longitudinal axis of the elongated shaft40, thereby facilitating uniform and predictable steering of the distal shaft section46through the parenchyma. For example, as best illustrated inFIGS. 4A and 4B, the tissue-penetrating distal tip48tapers to a point that is coincident with a longitudinal axis54of the elongated shaft40. Preferably, the taper of the tissue-penetrating distal tip48aligns perpendicularly to the plane of deflection of the distal shaft section46. In an alternative embodiment, the elongated shaft40has an atraumatic distal tip48′, as illustrated inFIG. 5.

The pulmonary access device14further comprises a profiled stylet56configured for being disposed in the working channel50of the elongated shaft40. As best shown inFIG. 6, the profiled stylet56has a proximal stylet section58, an intermediate stylet section60, and a distal stylet section62. As illustrated inFIGS. 2A-2C, the profiled stylet56further comprises a stylet hub63affixed to the end of the proximal stylet section58. One embodiment of a stylet56ahas a circular cross-section (FIG. 6A). Another embodiment of a stylet56bhas a rectangular cross-section (FIG. 6B). In this embodiment, the smaller dimension of the rectangular cross-section (i.e., the dimension with decreased bending stiffness) may be aligned with the steering directionality (in this case, of uni-directional or bi-directional steering), thereby facilitating bending of the bendable shaft section44in the proper steering plane. In this case, the stylet56bmay be keyed with the elongated shaft40to facilitate proper rotational orientation of the stylet56bwithin the channel50. In still another embodiment, the stylet56bmay have a generally rectangular cross-section with rounded edges (FIG. 6C). For example, the top and bottom surfaces of a cylindrical rod may be ground flat to achieve decreasing bending stiffness in the plane of bending.

As illustrated inFIG. 7, when the profiled stylet56is disposed in the working channel50of the elongated shaft40, the proximal stylet section58, intermediate stylet section60, and distal stylet section62respectively axially align with the proximal shaft section42, bendable shaft section44, and distal shaft section46. In the alternative embodiment where the elongated shaft40does not include a transition shaft section (seeFIG. 3C), the proximal stylet section58and intermediate stylet section60will be aligned with the distal shaft section46(e.g., the proximal stylet section58and intermediate stylet section60will collectively extend along the length of the distal shaft section46).

In the exemplary embodiment illustrated inFIG. 8A-8C, the distal stylet section62is atraumatic and blocks the distal opening52in the tissue-penetrating distal tip48. In this manner, the profiled stylet56serves as an obturator for pulmonary access device14. For example, when navigating through the bronchial airways, the distal stylet section62may extend distally past the tissue-penetrating distal tip48(seeFIG. 8A), thereby shielding the tissue along the bronchial airways from being damaged by the tissue-penetrating distal tip48. When puncturing through a bronchial airway into the parenchyma, and tracking the parenchyma to the SPN, the distal stylet section62may be slightly retracted within the tissue-penetrating distal tip48until the distal stylet section62is axially aligned with, or proximal to, the tissue-penetrating distal tip48(seeFIG. 8B), thereby allowing the tissue-penetrating distal tip48to puncture and traverse tissue, without coring the tissue. When taking a biopsy sample from the SPN, the distal stylet section62may be further retracted within the tissue-penetrating distal tip48(seeFIG. 8C), thereby creating sufficient displace in the distal end of the channel50for coring the SPN.

In the embodiment illustrated inFIGS. 9A-9C, wherein the elongated shaft40has an atraumatic distal tip48′, an alternative embodiment of a profiled stylet56′ has a tissue-penetrating distal stylet section62′. For example, when navigating through the bronchial airways, the distal stylet section62′ may be retracted within the tissue-penetrating distal tip48′ (seeFIG. 9A), thereby shielding the tissue along the bronchial airways from being damaged by the atraumatic distal tip48′. When puncturing through a bronchial airway into the parenchyma, and tracking the parenchyma to the SPN, the tissue-penetrating distal stylet section62′ may be distally extended from the atraumatic distal tip48′ (seeFIG. 9B), such that the tissue-penetrating distal stylet section62′ may puncture the tissue, and allow the atraumatic distal tip48′ to traverse tissue, without coring the tissue. When taking a biopsy sample from the SPN, the profiled stylet56′ may be completely removed from the channel50(seeFIG. 9C) and replaced with a separate biopsy tool (not shown) for taking a biopsy of the SPN.

In either of the embodiments illustrated inFIGS. 8A-8CorFIGS. 9A-9C, the lateral stiffness profile of the proximal stylet section58and distal stylet section62are the same, while the lateral stiffness profile of the intermediate stylet section60is less than the lateral stiffness profiles of the proximal stylet section58and distal stylet section62. In the exemplary embodiment illustrated inFIGS. 6 and 7, the intermediate stylet section60has a geometric profile that is less than the geometric profile of the proximal and distal stylet sections58,62, such that the lateral stiffness profile of the intermediate stylet section60is less than the lateral stiffness profiles of the proximal and distal stylet sections58,62. In this exemplary embodiment, the geometric profiles of the proximal stylet section58, intermediate stylet section60, and distal stylet section62are circular cross-sections, in which case, the diameter of the intermediate stylet section60is less than the diameters of the proximal and distal stylet sections58,62.

In the case where the pulmonary access device14serves as a biopsy needle, the profiled stylet56may be pulled back within the channel50(or alternatively, the pulmonary access device14may be distally advanced relative to the profiled stylet56), such that the distal tip48may core a biopsy sample from the SPN, which biopsy sample may be retained in the distal end of the channel50. The profiled stylet56may then be pushed back to dislodge the biopsy sample from the channel50, which can be subsequently analyzed. In the case where the pulmonary access device14serves as a channel device (e.g., the embodiment illustrated inFIG. 9C), the profiled stylet56may be completely removed from the channel50, such that a separate biopsy tool may be introduced through the channel50to take biopsy samples from the SPN.

Referring specifically toFIG. 2D, the pulmonary access device14further comprises a pull wire64affixed to the distal shaft section46. In the exemplary embodiment, the pull wire64is housed within a pull wire lumen66extending through the proximal shaft section42and bendable shaft section44, and into the distal shaft section46. Thus, when the pull wire64is tensioned, the bendable shaft section44bends, thereby deflecting the distal shaft section46relative to the proximal shaft section42, as illustrated inFIG. 2B. In an alternative embodiment illustrated inFIG. 2E, the pulmonary access device14comprises two pull wires64that are clocked from each other 180 degrees and affixed to the distal shaft section46. In the exemplary embodiment, the pull wires64a,64bare respectively housed within two pull wire lumens66a,66bextending through the proximal shaft section42and bendable shaft section44, and into the distal shaft section46. Thus, when the pull wire64ais tensioned, the bendable shaft section44bends, thereby deflecting the distal shaft section46relative to the proximal shaft section42in first direction. In contrast, when the pull wire64bis tensioned, the bendable shaft section44bends, thereby deflecting the distal shaft section46relative to the proximal shaft section42in the opposite direction.

In one embodiment, the maximum bend of the bendable shaft section44is at least 180 degrees, thereby deflecting the distal shaft section46a maximum of at least 180 degrees relative to the proximal shaft section42. In this manner, the deflection strength of the distal shaft section46, when in the tissue of the patient, and in this case when in the parenchyma of the lung, is increased, thereby increasing the number of sites that can be sampled. In alternative embodiments, the maximum bend of the bendable shaft section44is less than 180 degrees (e.g., 90 degrees), thereby deflecting the distal shaft section46a maximum of less than 180 degrees (e.g., 90 degrees) relative to the proximal shaft section42.

Significantly, since the intermediate stylet section60is aligned with the bendable shaft section44of the elongated shaft42when fully introduced into the channel50of the pulmonary access device14, as illustrated inFIG. 7, bending of the bendable shaft section44, and thus, deflection of the distal shaft section46, is facilitated by the relatively low lateral stiffness of the intermediate stylet section60. As will be described in further detail below, selective deflection of the distal shaft section46allows the pulmonary access device14to be actively steered to the SPN and located at various sites of the SPN, thereby maximizing the diagnostic yield of the biopsy. Furthermore, when coring the biopsy samples, deflection of the distal shaft section46allows a biopsy sample that is cored within the channel50to be sheer off (“bite-off”) or twist off the cored biopsy sample to separate it from the SPN. In contrast, a non-steerable distal tip must be cycled back and forth along an axis to core the sample, which may result in difficulty detaching the cored sample from the SPN.

Although the distal shaft section46has been described and illustrated as only being capable of deflecting in a single direction, such that the pulmonary access device14is enabled with uni-directional steerability, it should be appreciated that the pulmonary access device14may be modified to allow the distal shaft section46to be selectively deflected in one of a plurality of different directions. For example, the pulmonary access device14may comprise two pull wires and two associated pull wire lumens that are clocked 180 degrees from each other to allow the distal shaft section46to be deflected in opposite directions, thereby enabling the pulmonary access device14with bi-directional steerability. As another example, the pulmonary access device14may comprise two pull wires and two associated pull wire lumens that are clocked less than 180 degrees from each other (e.g., 90 degrees) to allow the distal shaft section46to be deflected out-of-plane to create complex curves.

Referring toFIGS. 2A-2C, the pulmonary access device14further comprises a handle assembly68affixed to the proximal shaft section42. The handle assembly68includes a handle body70, which is preferably shaped to be ergonomic for grasping with one hand by the physician. The handle body46may be composed of a suitable polymer, such as, e.g., acrylonitrile butadiene styrene (ABS), polyvinylchloride, polycarbonate, polyolefins, polypropylene, polyethylene, etc. The handle assembly68further includes a stylet port71through which the stylet56may be introduced into the channel50of the elongated shaft40. In one embodiment, the handle assembly68includes a luer connector (not shown) that can affix the stylet56relative to the elongated shaft40. Thus, the position of the stylet56within the channel50may be affixed by tightening the luer connector. In an optional embodiment, the stylet56may be removed from the channel50, and an aspiration/suction system can be connected in fluid connection with the channel50via the luer connector.

The handle assembly68further includes a deflection control actuator72affixed to the handle body70. The deflection control actuator72is operably connected to the pull wire64, such that the pull wire64may be alternately tensioned via manual manipulation of the deflection control actuator72, thereby bending the bendable shaft section44(seeFIG. 2C), and relaxed via manual manipulation of the deflection control actuator72, thereby allowing the resiliency of the elongated shaft40to straighten, or at least reduce the bend in, the bendable shaft section44(seeFIG. 2A).

The handle assembly68further includes a shaft displacement actuator74affixed to the handle body70. The shaft displacement actuator74is operably connected to the proximal shaft section42, such that the elongated shaft40may be rotated about its longitudinal axis54relative to the handle body70via manual manipulation of the shaft displacement actuator74, thereby rotating the deflected distal shaft section46about the longitudinal axis54. As a result, the distal tip48of the deflected distal shaft section46may be located at different circumferential positions about the longitudinal axis54. The shaft displacement actuator74is also operably connected to the proximal shaft section42, such that the elongated shaft40may be linear displaced along the longitudinal axis54relative to the handle body70via manual manipulation of the shaft displacement actuator74, thereby linearly translating the distal shaft section46along the longitudinal axis54. In this manner, the distal shaft section46may be alternately deployed from the distal end20of the elongated shaft16of the bronchoscope12(seeFIG. 2B) and retracted into the distal end20of the elongated shaft16of the bronchoscope12(seeFIG. 2A).

In the embodiment illustrated inFIG. 2A-2C, the deflection control actuator72takes the form of a dial that can be manually rotated about the arrow76by the thumb of the physician in one direction to tension the pull wire64, and either manually rotated by the thumb of the physician in the other opposite direction, or simply released, to relax the pull wire64, as illustrated inFIG. 10. The deflection control actuator72may be locked in one or more positions, such that the tension on the pull wire64, and thus the bend in the bendable shaft section44, is maintained when the physician releases the deflection control actuator72, and unlocked to relax the pull wire64and straighten the bendable shaft section44. In the embodiment illustrated inFIGS. 2A-2C, the shaft displacement actuator74takes the form of a collar that can be grasped between the thumb and finger of the physician and manually rotated about the arrow78to rotate the deflected distal shaft section46about the longitudinal axis54and/or linearly translated along the arrow80to linearly translate the distal shaft section46along the longitudinal axis54, as illustrated inFIG. 11.

As briefly discussed above, the pulmonary access device14may alternatively not be locked within the working channel22of the bronchoscope12, and thus, may be freely displaced relative to the working channel18of the bronchoscope12, as illustrated in handle assembly68′ ofFIG. 12. In this case, a shaft displacement actuator is not required, and instead, the handle body70may simply be rotated about arrow82relative to the bronchoscope12to rotate the deflected distal shaft section46about the longitudinal axis54and/or linearly displaced along the arrow84relative to the bronchoscope12to linearly displace the distal shaft section46along the longitudinal axis54, as illustrated inFIG. 13. In this alternative embodiment, the pulmonary access device14further includes a strain relief sleeve86affixed around the exposed region of the proximal shaft section42.

The handle assembly68′ in this alternative embodiment may include a deflection control actuator88that takes the form of a plunger that can be manually axially pulled with a finger of the physician to tension the pull wire64, and either manually axially pushed with the finger or thumb of the physician, or simply released, to relax the pull wire64. One variation of the deflection control actuator88illustrated inFIGS. 14A-14Cmay take the form of a finger ring88′ that can be manually axially pulled with a finger of the physician along the arrow90to tension the pull wire64(FIG. 14A) and manually axially pushed with the finger or thumb of the physician, or simply released, to relax the pull wire64(FIG. 14B).

Although the pulmonary access device14has been described as being capable of manually manipulated via the handle assembly68, it should be appreciated that the pulmonary access device14may form a portion of a robotic medical system, in which case, the elongated shaft40of the pulmonary access device14may be operably connected to a robotic actuation of the robotic medical system.

Referring now toFIGS. 15 and 16, one specific embodiment of a pulmonary access device14′ will be described. In this embodiment, the lateral stiffness profiles of the proximal shaft section42and the distal shaft section46are uniform (with the lateral stiffness profile of the distal shaft section46being less than the lateral stiffness profile of the proximal shaft section42), and the transitioning lateral stiffness profile of the bendable shaft section44is gradual, such that it transitions the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46in a gradual fashion, as illustrated inFIG. 3A.

The elongated shaft40of the pulmonary access device14′ comprises a proximal tube80extending along the proximal shaft section42, and a distal tube82extending along the bendable shaft section44and the distal shaft section46. The proximal tube80can be composed of a metal to facilitate axial and torque transmission along the proximal shaft section42. For example, the proximal tube80may be composed of a multi-strand wound stainless steel wire construction designed to maximize torque transmission in either rotational direction while maximizing axial compression resistance to enable efficient steering.

In contrast, the distal tube82can have a more flexible construction. In the illustrated embodiment, the distal tube82is composed of a very thin malleable polymeric material (e.g., expanded polytetrafluoroethylene (ePTFE)), thereby providing lateral flexibility along the bendable shaft section44and the distal shaft section46relative to the proximal shaft section42. Alternatively, the distal tube82may have a metallic construction (e.g., a metallic coil or a laser cut metallic tube). In an optional embodiment, the proximal tube80and distal tube82are radiopaque to enable visualization of the pulmonary access device14′ under fluoroscopy. For example, the metallic nature of the proximal tube80, and if applicable the distal tube82, inherently provides radiopaqueness to the pulmonary access device14′. In the case where the proximal tube80is polymeric, the polymer may be loaded within radiopaque particles, such as tungsten or bismuth.

The proximal tube80and distal tube82may be affixed to each other in any suitable manner. For example, the proximal tube80and distal tube82may be affixed to each other via a lap joint. In the illustrated embodiment, the distal end of the proximal tube80has a reduced diameter, such that the proximal end of the distal tube82may be fitted over the reduced distal end of the proximal tube80and bonded together.

In this embodiment, the distal tip48of the pulmonary access device14′ is a tissue-penetrating distal tip. To this end, the distal tip48of the pulmonary access device14′ takes the form of a coring needle84composed of a suitably rigid material, such as stainless steel, that is affixed to the distal end of the distal tube82. The pull wire lumen66extends through the walls of the proximal tube80and distal tube82, terminating at the coring needle84. The distal end of the pull wire64extending through the pull wire lumen66is attached to the coring needle84using suitable means, e.g., soldering or welding. In an alternative embodiment, the distal tip48of the pulmonary access device14′ may be an atraumatic distal tip, in which case, the distal end of the distal tube82may serve as the atraumatic distal tip48. In an alternative embodiment, the atraumatic metal distal tip is a distinct element that is affixed to the distal end of the distal tube82.

In this embodiment, the pulmonary access device14′ further comprises a steering plate86having a rectangular cross-section affixed within the elongate shaft40along the bendable shaft section44and distal shaft section46. The steering plate86may be composed, e.g., a high yield strength spring steer (17-7 PH®). In one embodiment, the steering plate86is embedded in the distal tube82. In an alternative embodiment, the steering plate86may reside within a separate polymeric tube. The lateral stiffness profile of the combination of the distal tube82and the steering plate86extending along the distal shaft section46is less than the lateral stiffness profile of the proximal tube80extending along the proximal shaft section42. As best illustrated inFIG. 17A, the steering plate86has a geometric profile along the longitudinal axis54of the elongated shaft40that tapers down in the distal direction along the bendable shaft section44, such that the steering plate86transitions the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46in a gradual manner, as illustrated inFIG. 3A.

Thus, as discussed above, the steering plate86transitions the higher lateral stiffness of the proximal shaft section42to the lower lateral stiffness of the distal shaft section46, thereby facilitating tracking of the distal tip48through the bronchial airways and parenchyma of the lung. In the illustrated embodiment, the pull wire64is affixed to the coring needle84circumferentially opposite to the steering plate86to minimize the steering force required to deflect the distal shaft region46of the elongated shaft40.

In an alternative embodiment illustrated inFIG. 17B, a steering plate86′ has a uniform geometric profile along its length, such that there is no transition between the higher lateral stiffness profile of the proximal shaft section42and the lower lateral stiffness profile of the distal shaft section46. In this case, the elongated shaft40does not have a transition section, but instead, the higher lateral stiffness profile of the proximal shaft section42is immediately transitioned to the distal shaft section42in a step-wise manner, as illustrated inFIG. 3C.

Referring now toFIGS. 18 and 19, another specific embodiment of a pulmonary access device14″ will be described. In this embodiment, the lateral stiffness profile of the proximal shaft section42is uniform, and the distal shaft section46is uniform (with the lateral stiffness profile of the distal shaft section46being less than the lateral stiffness profile of the proximal shaft section42), and the transitioning lateral stiffness profile of the bendable shaft section44is uniform, such that it transitions the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46in a step-wise fashion, as illustrated inFIG. 3B.

The elongated shaft40of the pulmonary access device14″ comprises a proximal polymeric tube90extending along the proximal shaft section42, an intermediate polymeric tube92extending along the bendable shaft section44, and a distal polymeric tube94extending along the distal shaft section46. The polymeric tubes90-94may be composed of, e.g., nylon, Pebax® elastomer, polyurethane, or a laminate design. In the illustrated embodiment the proximal polymeric tube90has a relatively high durometer (e.g., 90D), the intermediate polymeric tube92has a relatively medial durometer (e.g., 72D), and the distal polymeric tube94has a relatively low durometer (e.g., 55D). In one embodiment, the polymeric tubes90-94may be reinforced with a uniform braid (e.g., 0.001″×0.003″ flat wire composed of a stainless steel braid of 55 picks per inch (ppi)) to resist both compression and torsional loss.

Thus, the lateral stiffness profile of the distal polymer tube94extending along the distal shaft section46is less than the lateral stiffness profile of the proximal polymer tube90extending along the proximal shaft section42, while the transition polymer tube92transitions the higher lateral stiffness profile of the proximal shaft section42to the lower lateral stiffness profile of the distal shaft section46in step-wise manner, as illustrated inFIG. 3B. In an optional embodiment, the proximal polymer tube90, intermediate polymer tube92, and distal polymer tube94may be loaded with radiopaque particles, such as tungsten or bismuth, to provide radiopacity to the pulmonary access device14″.

The proximal polymer tube90, intermediate polymer tube92, and distal polymer tube94may be affixed to each other in any suitable manner. For example, the proximal polymer tube90, intermediate polymer tube92, and distal polymer tube94may be affixed to each other via lap joints. In the illustrated embodiment, the distal end of the proximal polymer tube90has a reduced diameter, such that the proximal end of the intermediate polymer tube92may be fitted over the reduced distal end of the proximal polymer tube80and bonded together. Likewise, the distal end of the intermediate polymer tube92has a reduced diameter, such that the proximal end of the distal polymer tube94may be fitted over the reduced distal end of the intermediate polymer tube92and bonded together. In an alternative embodiment, the proximal polymer tube90, intermediate polymer tube92, and distal polymer tube94may be affixed to each other via butt bonds.

In this embodiment, the distal tip80of the pulmonary access device14″ is tissue-penetrating distal tip. To this end, the pulmonary access device14′ takes the form of a coring needle84composed of a suitably rigid material, such as stainless steel, that is affixed to the distal end of the distal polymer tube84. The pull wire lumen66extends through the walls of the proximal polymer tube90, intermediate polymer tube92, and distal polymer tube94, terminating at the coring needle96. The distal end of the pull wire64extending through the pull wire lumen66is attached to the coring needle96using suitable means, e.g., soldering or welding. In an alternative embodiment, the distal tip80of the pulmonary access device14″ may be an atraumatic distal tip, in which case, the distal end of the distal polymer tube94may serve as the atraumatic distal tip80. In this embodiment, a compression coil96(e.g., a tightly wound steer coil) may be provided over the pull wire64to provide additional compression resistance to the proximal polymer tube90, intermediate polymer tube92, and distal polymer tube94.

In an alternative embodiment, the elongated shaft40of the pulmonary access device14″ does not have an intermediate polymer tube92, such that there is no transition between the higher lateral stiffness profile of the proximal shaft section42and the lower lateral stiffness profile of the distal shaft section46. In this case, the higher lateral stiffness profile of the proximal shaft section42will be immediately transitioned to the distal shaft section42in a step-wise manner, as illustrated inFIG. 3C.

Referring toFIGS. 20 and 21A-21H, one exemplary method100of using the transbronchial pulmonary biopsy system10to take biopsy samples from different sites of an SPN located in the parenchyma P of a patient will now be described. In this method, the pulmonary access device14serves as a biopsy needle comprising the elongated shaft40with a tissue-penetrating distal tip48, as illustrated inFIGS. 2A-2C, and a profiled stylet56as an obturator within the elongated shaft40, as illustrated inFIGS. 8A-8C.

First, the pulmonary access device14is assembled by introducing the profiled stylet56within the channel50of the elongated shaft40(e.g., by introducing the profiled stylet56through the stylet port71associated with the handle body70(shown inFIGS. 10-13), and into the working channel50along the elongated shaft40) until the distal stylet section62(obturator) is distal to the tissue-penetrating distal tip48of the elongated shaft40, as illustrated inFIG. 8A(step102).

Next, the pulmonary access device14is navigated through a bronchial airway BA of the patient. In particular, the bronchoscope12is navigated through the bronchial airway BA of the patient in a conventional manner (step104), as illustrated inFIG. 21A. The pulmonary access device14is then introduced through the working channel22of bronchoscope12(shown inFIG. 1) into the bronchial airway BA of the patient (step106), as illustrated inFIG. 21B. In the case where the bronchoscope12is provided with a coupling26, the pulmonary access device14may be locked within the working channel22of the bronchoscope12(shown inFIG. 1).

The pulmonary access device14is then navigated further into the bronchial airway BA of the patient by actively steering the distal shaft section46while distally advancing the pulmonary access device14within the bronchial airway BA of the patient until the tissue-penetrating distal tip48of the elongated shaft40is adjacent the access puncture point to the SPN (step108), as illustrated inFIG. 21C. In the exemplary embodiment, the pulmonary access device14is actively steered by tensioning the pull wire64via manipulation of the deflection control actuator72illustrated inFIGS. 10-11or via manipulation of the deflection control actuator88illustrated inFIGS. 12-14) to actively deflect the distal shaft section46, and the pulmonary access device14is distally advanced within the bronchial airway BA of the patient via linear displacement of the shaft displacement actuator74illustrated inFIGS. 10-11or via linear displacement of the handle body70illustrated inFIGS. 12-14).

Next, the profiled stylet56is proximally retracted slightly within the channel50of the elongated shaft40until the distal stylet section62(obturator) is aligned with or proximal to the tissue-penetrating distal tip48of the elongated shaft40, thereby exposing the tissue-penetrating distal tip48of the elongated shaft40(step110), as illustrated inFIG. 8BandFIG. 21D. Then, if the tissue-penetrating distal tip48of the elongated shaft40is not already pointed towards the SPN, the distal shaft section46is actively deflected and rotated about the longitudinal axis54of elongated shaft40, such that the tissue-penetrating distal tip48of the elongated shaft40points towards the SPN (step112). In the exemplary embodiment, the distal shaft section46is actively deflected by tensioning the pull wire64(e.g., via manipulation of the deflection control actuator72illustrated inFIGS. 10-11or the deflection control actuator88illustrated inFIGS. 12-14), and rotated via rotation of the shaft displacement actuator74illustrated inFIGS. 10-11or via rotation of the handle body70illustrated inFIGS. 12-14). The tissue-penetrating distal tip48of the elongated shaft40is then punctured through the wall of the bronchial airway PA into the parenchyma P by distally advancing the pulmonary access device14(step114), as illustrated inFIG. 21E. In the exemplary embodiment, the pulmonary access device14is distally advanced within the bronchial airway BA of the patient via linear displacement of the shaft displacement actuator74illustrated inFIGS. 10-11or via linear displacement of the handle body70illustrated inFIGS. 12-14).

Next, the tissue-penetrating distal tip48of the elongated shaft40is tracked through the parenchyma P to a selected one of a plurality of different sites of the SPN by actively deflecting the distal shaft section46while distally advancing the pulmonary access device14(step116), as illustrated inFIG. 21F. In the exemplary embodiment, the distal shaft section46is actively deflected by tensioning the pull wire64(e.g., via manipulation of the deflection control actuator72illustrated inFIGS. 10-11or the deflection control actuator88illustrated inFIGS. 12-14). As illustrated inFIG. 21G, any one of a plurality of different sites of the SPN may be selected by controllably deflecting the distal shaft section46. As such, multiple biopsies may be taken from various sites of the SPN, thereby maximizing the diagnostic yield of the biopsy.

Then, the profiled stylet56is proximally retracted further within the channel50of the elongated shaft40until a sufficient sampling space is created in the distal end of the channel50of the elongated shaft40for coring a biopsy sample of the SPN (step118), as illustrated inFIG. 8CandFIG. 21H. The biopsy sample at the selected site of the SPN is then cored with the tissue-penetrating distal tip48of elongated shaft40by distally advancing the pulmonary access device14, such that the cored biopsy sample is disposed within the sampling space of the channel50(step120), as illustrated inFIG. 21I. In the exemplary embodiment, the pulmonary access device14is distally advanced via linear displacement of the shaft displacement actuator74illustrated inFIGS. 10-11or via linear displacement of the handle body70illustrated inFIGS. 12-14).

While the biopsy sample is cored within the channel50of the elongated shaft40, the distal shaft section46is cyclically deflected until the cored biopsy sample is separated from the SPN (step122), as illustrated inFIG. 21J. In the exemplary embodiment, the distal shaft section46is cyclically deflected by repeatedly tensioning and relaxing the pull wire64(e.g., via manipulation of the deflection control actuator72illustrated inFIGS. 10-11or the deflection control actuator88illustrated inFIGS. 12-14).

The pulmonary access device14is then removed from the patient while leaving the bronchoscope12in place within the bronchial airway BA of the patient (step124), and the profiled stylet56is distally advanced within the channel50to dislodge the cored biopsy sample (step126). Steps106-124can then be repeated to take another biopsy sample from a different site of the SPN, except that, instead of puncturing through the wall of the bronchial airway BA of the patient into the parenchyma P in step114, the pulmonary access device14is reintroduced through the previously made puncture in the wall of the bronchial airway BA into the parenchyma P. In an optional method after the SPN has been completely biopsied, the profiled stylet56may be completely removed from the channel50, and an aspiration system (not shown) can be fluidly coupled to the channel50, and operated to aspirate any remaining loose cells from the SPN through the working channel50. The aspirate, along with the cells, may then be collected for analysis.

Referring toFIG. 22, another exemplary method150of using the transbronchial pulmonary biopsy system10to take biopsy samples from different sites of an SPN located in the parenchyma P of a patient will now be described. In this method, the pulmonary access device14serves as a channel device (as opposed to a biopsy needle) comprising the elongated shaft40with a tissue-penetrating distal tip48, as illustrated inFIGS. 2A-2C, and a profiled stylet56having an obturating distal stylet section62, as illustrated inFIGS. 8A-8C.

The method150is similar to the method100described above in that steps102-116are performed to track the tissue-penetrating distal tip48of the elongated shaft40through the parenchyma P to a selected one of a plurality of different sites of the SPN (step116). The method150differs from the method100in that, instead of proximally retracting the profiled stylet56further within the channel50of the elongated shaft40to create sufficient sampling space in the distal end of the channel50of the elongated shaft40for coring a biopsy sample of the SPN, the profiled stylet56is completely removed from the channel50of the elongated shaft40(e.g., from the stylet port71associated with the handle body70) (step152), and a separate biopsy device (not shown) is introduced within the channel50of the elongated shaft40(e.g., by introducing the profiled stylet56through the stylet port71associated with the handle body70(shown inFIGS. 10-13) until the operative end of the biopsy device is at the selected site of the SPN (step154).

The biopsy device is then operated in a conventional manner to take a biopsy sample from the SPN (step156), and if required, the distal shaft section46may be cyclically deflected until the biopsy sample is separated from the SPN (step158). The biopsy device is then completely removed from the channel50of the elongated shaft40(e.g., from the stylet port71associated with the handle body70) (step160), and the biopsy sample is obtained from the biopsy device (step162). The pulmonary access device14is then proximally retracted from the parenchyma P back into the bronchial airway BA of the patient (step164). In the exemplary embodiment, the pulmonary access device14is proximally retracted via linear displacement of the shaft displacement actuator74illustrated inFIGS. 10-11or via linear displacement of the handle body70illustrated inFIGS. 12-14).

The profiled stylet56is re-introduced within the channel50of the elongated shaft40until the distal stylet section62(obturator) is aligned with or just proximal to the tissue-penetrating distal tip48of the elongated shaft40(step166). The pulmonary access device14is then re-introduced through the puncture in the bronchial airway BA into the parenchyma P of the patient (step168), and steps116and152-162repeated to take another biopsy sample from a different site of the SPN.

Referring toFIGS. 23 and 24A-24J, still another exemplary method200of using the transbronchial pulmonary biopsy system10to take biopsy samples from different sites of an SPN located in the parenchyma P of a patient will now be described. In this method, the pulmonary access device14serves as a channel device comprising the elongated shaft40with an atraumatic distal tip48, as illustrated inFIG. 5, and a profiled stylet56′ having a tissue-penetrating distal stylet section62′, as illustrated inFIGS. 9A-9C.

First, the pulmonary access device14is assembled by introducing the profiled stylet56′ within the channel50of the elongated shaft40(e.g., by introducing the profiled stylet56′ through the stylet port71associated with the handle body70(shown inFIGS. 10-13), and into the working channel50along the elongated shaft40) until the tissue-penetrating distal stylet section62′ is aligned with or proximal to the atraumatic distal tip48′ of the elongated shaft40, as illustrated inFIG. 9A(step202).

Next, the pulmonary access device14is navigated through a bronchial airway BA of the patient. In particular, the bronchoscope12is navigated through the bronchial airway BA of the patient in a conventional manner (step204), as illustrated inFIG. 24A. The pulmonary access device14is then introduced through the working channel22of bronchoscope12(shown inFIG. 1) into the bronchial airway BA of the patient (step206), as illustrated inFIG. 24B. In the case where the bronchoscope12is provided with a coupling26, the pulmonary access device14may be locked within the working channel22of the bronchoscope12(shown inFIG. 1).

The pulmonary access device14is then navigated further into the bronchial airway BA of the patient by actively steering the distal shaft section46while distally advancing the pulmonary access device14within the bronchial airway BA of the patient until the atraumatic distal tip48′ of the elongated shaft40is adjacent the access puncture point to the SPN (step208), as illustrated inFIG. 24C. In the exemplary embodiment, the pulmonary access device14is actively steered by tensioning the pull wire64via manipulation of the deflection control actuator72illustrated inFIGS. 10-11or via manipulation of the deflection control actuator88illustrated inFIGS. 12-14) to actively deflect the distal shaft section46, and the pulmonary access device14is distally advanced within the bronchial airway BA of the patient via linear displacement of the shaft displacement actuator74illustrated inFIGS. 10-11or via linear displacement of the handle body70illustrated inFIGS. 12-14).

Next, the profiled stylet56is distally advanced within the channel50of the elongated shaft40until the tissue-penetrating distal stylet section62′ extends distally from the atraumatic distal tip48′ of the elongated shaft40(step210), as illustrated inFIG. 9BandFIG. 24D. Then, if the atraumatic distal tip48′ of the elongated shaft40is not already pointed towards the SPN, the distal shaft section46is actively deflected and rotated about the longitudinal axis54of elongated shaft40, such that the atraumatic distal tip48′ of the elongated shaft40points towards the SPN (step212). In the exemplary embodiment, the distal shaft section46is actively deflected by tensioning the pull wire64(e.g., via manipulation of the deflection control actuator72illustrated inFIGS. 10-11or the deflection control actuator88illustrated inFIGS. 12-14), and rotated via rotation of the shaft displacement actuator74illustrated inFIGS. 10-11or via rotation of the handle body70illustrated inFIGS. 12-14). The tissue-penetrating distal stylet section62′ is then punctured through the wall of the bronchial airway PA into the parenchyma P by distally advancing the pulmonary access device14(step214), as illustrated inFIG. 24E. In the exemplary embodiment, the pulmonary access device14is distally advanced within the bronchial airway BA of the patient via linear displacement of the shaft displacement actuator74illustrated inFIGS. 10-11or via linear displacement of the handle body70illustrated inFIGS. 12-14).

Next, the atraumatic distal tip48′ of the elongated shaft40is tracked through the parenchyma P to a selected one of a plurality of different sites of the SPN by actively deflecting the distal shaft section46while distally advancing the pulmonary access device14(step216), as illustrated inFIG. 24F. In the exemplary embodiment, the distal shaft section46is actively deflected by tensioning the pull wire64(e.g., via manipulation of the deflection control actuator72illustrated inFIGS. 10-11or the deflection control actuator88illustrated inFIGS. 12-14). As illustrated inFIG. 24G, any one of a plurality of different sites of the SPN may be selected by controllably deflecting the distal shaft section46. As such, multiple biopsies may be taken from various sites of the SPN, thereby maximizing the diagnostic yield of the biopsy.

Next, the profiled stylet56′ is completely removed from the channel50of the elongated shaft40(e.g., from the stylet port71associated with the handle body70) (step218), and a separate biopsy device90(e.g., biopsy forceps) is introduced within the channel50of the elongated shaft40(e.g., by introducing the profiled stylet56through the stylet port71associated with the handle body70(shown inFIGS. 10-13) until the operative end of the biopsy device is at the selected site of the SPN (step220), as illustrated inFIG. 24H.

The biopsy device is then operated in a conventional manner to take a biopsy sample from the SPN (step222), as illustrated inFIG. 24I, and if required, the distal shaft section46may be cyclically deflected until the biopsy sample is separated from the SPN (step224), as illustrated inFIG. 24J. The biopsy device is then completely removed from the channel50of the elongated shaft40(e.g., from the stylet port71associated with the handle body70) (step226), and the biopsy sample is obtained from the biopsy device (step228). The pulmonary access device14is then proximally retracted from the parenchyma P back into the bronchial airway BA of the patient (step230). In the exemplary embodiment, the pulmonary access device14is proximally retracted via linear displacement of the shaft displacement actuator74illustrated inFIGS. 10-11or via linear displacement of the handle body70illustrated inFIGS. 12-14).

The profiled stylet56′ is re-introduced within the channel50of the elongated shaft40until the distal stylet section62is distal to the tissue-penetrating distal tip48of the elongated shaft40(step232). The pulmonary access device14is then re-introduced through the puncture in the bronchial airway BA into the parenchyma P of the patient (step234), and steps216-228are repeated to take another biopsy sample from a different site of the SPN.

Although particular embodiments of the disclosed inventions have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the present inventions, and it will be obvious to those skilled in the art that various changes and modifications may be made (e.g., the dimensions of various parts) without departing from the scope of the disclosed inventions, which is to be defined only by the following claims and their equivalents. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The various embodiments of the disclosed inventions shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed inventions, which may be included within the scope of the appended claims.