CATHETER WITH MULTIPLE WORKING CHANNELS

A catheter includes a shaft portion defining a non-circular transverse cross-section. The shaft portion includes an exterior sidewall and an interior sidewall defining two or more asymmetrical working channels.

BACKGROUND

Technical Field

The present disclosure is generally related to catheters including multiple working channels, and more particularly, catheters including a shaft portion defining a non-circular transverse cross-section, the shaft portion including multiple working channels defined therein.

Description of Related Art

A wide variety of catheters, as well as surgical instruments designed to be used with such devices, have been developed. Of these known devices, each has certain advantages and disadvantages. However, there is an ongoing need to provide alternative catheters. For example, in some instances, some known catheters may only include one working channel configured to receive only one surgical instrument therein at a time. In surgical procedures requiring the use of multiple instruments, a catheter having only one working channel may require the removal and replacement of the various instruments throughout the procedure which may not only time consuming, but also may increase the likelihood of the catheter shifting out of position during removal and/or replacement of the various surgical instruments. In addition, a single circular working channel may prevent the use of two or more instruments at the same time. Thus, there exists a need to provide catheters having multiple working channels to provide access and/or use of multiple instruments simultaneously at a target tissue.

SUMMARY

The present disclosure describes catheters including multiple working channels. In some embodiments, the multiple working channels include two asymmetrical working channels.

The present disclosure also describes a catheter including a shaft portion defining a non-circular transverse cross-section. The shaft portion includes an exterior sidewall and an interior sidewall defining two or more asymmetrical working channels therein.

In some embodiments, the non-circular transverse cross-section of the catheter defines an elliptical transverse cross-section. The elliptical transverse cross-section of the shaft includes a major axis and a minor axis which cross at a central portion of the elliptical cross-section.

In some embodiments, the multiple working channels include a first and second working channel. In some embodiments, the first working channel generally defines a circular transverse cross-section and the second working channel generally defines a non-circular transverse cross-section. In some embodiments, the first working channel defines a generally reniform transverse cross-section and the second working channel defines a non-reniform transverse cross-section.

In some embodiments, the catheters described herein include a handle portion on a proximal end and a shaft portion on a distal end thereof. The shaft portion includes an exterior wall and an interior sidewall. The exterior sidewall defines an outer elliptical transverse cross-section and the interior sidewall defines a first and second working channel within the exterior wall. The first working channel defines a generally circular transverse cross-section and the second working channel defines a generally reniform transverse cross-section.

Use of the catheters described herein electromagnetic navigation systems for navigating through a luminal network of a patient, and particularly of a patient's lung, is also provided herein.

DETAILED DESCRIPTION

Aspects of the present disclosure are described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user.

The present disclosure is directed in part to a catheter including a shaft portion defining a non-circular transverse cross-section and including an exterior and interior wall combining to define two or more asymmetrical working channels defined therein. Each working channel being configured to receive and/or pass therethrough a surgical instrument. The shaft portion and/or the working channels being configured for navigation within a luminal structure of a patient.

FIG.1Adepicts a catheter70as described herein including a handle portion90on a proximal end thereof and a shaft portion80extending in a distal direction from the handle portion90. Any suitable handle portion configuration may be used with the shaft portion described herein. For example, the handle portion may be manually operated or power operated, both of which are generally known in the art.

In some embodiments, as shown inFIG.1A, the handle portion90may be manually operated and include at least one grip92and a telescopic connector94, which are operably connected to the shaft portion80. By rotating the grip92and translating the telescopic shaft94, the user is able to steer at least the distal end portion, if not a majority or all, of the shaft portion80to a target tissue using one or both hands. These movements of the handle90enable the user to navigate at least the distal end portion of the shaft portion80through the tortuous path of a luminal network such as the patient airways, and direct advancement of at least the distal end portion of the shaft portion80at each bifurcation. An example of such a handle90is currently manufactured and sold under the name EDGE™ by Covidien LP. The handle90may be ergonomically shaped to facilitate grasping and/or rotation of shaft portion80. In one embodiment, a plurality of rib portions (not explicitly shown) are provided along a length of the handle90to facilitate grasping and rotation of the shaft portion80.

FIG.1Bdepicts the shaft portion80defining a non-circular cross-section transverse to a longitudinal axis of the catheter70. The non-circular transverse cross-section of the shaft portion80may define any non-circular shape including but not limited to elliptical, hexagonal, pentagonal, heptagonal, octagonal, trapezoidal, etc. It is envisioned that the non-circular transverse cross-section may enhance the surgical instruments ability to travel through a selected luminal network which typically may be circular in cross-section.

In some embodiments, as further depicted inFIG.1B, the non-circular cross-section of the shaft portion80defines an elliptical transverse cross-section. An elliptical cross-section defines a major axis m and a minor axis n which cross at generally a center84of the elliptical transverse cross-section. The major axis m and the minor axis n define the elliptical cross-section into a first and second upper quadrant88a,88band a first and second lower quadrant88c,88dof the elliptical transverse cross-section. As particularly shown inFIG.1B, in some embodiments, the major axis m may be a lateral major axis and the minor axis n may be a vertical minor axis. However, it is envisioned that in some embodiments the major axis m may be a major vertical axis and the minor axis n may be a minor lateral axis.

FIG.1Bfurther depicts shaft portion80including an exterior sidewall81and interior wall83. The exterior sidewall81defines an outer perimeter of the shaft portion80. The interior sidewall83includes a first end portion83a, a second end portion83bopposite the first end portion83aand body portion83cpositioned therebetween. The first end portion83ais connected to a first portion81aof the exterior sidewall81and the second end portion83bis connected to a second portion81bof the exterior sidewall81. The body portion83cextends therebetween defining, along with the exterior sidewall81, the two or more asymmetrical working channels85,87. In some embodiments, the body portion83cof the inner sidewall83is curved and offset from the minor axis n.

By asymmetrical, the two or more working channels85,87define any combination of at least two different transverse cross-sectional shapes. For example, one working channel85may define a generally circular cross-section and another working channel87may define a non-circular cross-section. In some embodiments, the asymmetrical working channels85,87may further be arranged off-center, i.e., not equally distanced from a center of the non-circular transverse cross-section.

As further shown inFIG.1B, in some embodiments, the two asymmetrical working channels85,87may include a first and second working channels85,87. At least a portion of the first working channel85may extend across the center84of the non-circular, e.g., elliptical, transverse cross-section. In some embodiments, at least a portion of the first working channel85may extend across at least a portion of each of the first and second upper quadrants88a,88band the first and second lower quadrants88c,88dof the non-circular, e.g., elliptical, transverse cross-section. In some embodiments, at least a portion of the second working channel87may extend across only the second upper and lower quadrants88b,88dof the non-circular, e.g., elliptical, transverse cross-section. The two or more working channels85,87may further each be centered on the major axis m and not centered on the minor axis n.

FIG.1Bfurther illustrates that the first working channel85may define a circular transverse cross-section and/or the second working channel87may define a non-circular, e.g., reniform, transverse cross-section. It is envisioned that the non-circular transverse cross-section of the second working channel may be utilized with surgical instruments defining the same non-circular cross-section. For example, both the second working channel and a surgical instrument (e.g., a locatable guide, ultrasound probe, or camera) may define a non-circular, e.g., reniform, cross-section. In such an example, the mating of the two non-circular, e.g., reniform, cross-sections of the channel and the instrument can lock the instrument into a predetermined configuration relative to the other working channels because the instrument is unable to rotate within the channel, as is possible when both the instrument and the channel define a circular cross-section.

In some embodiments, a first thickness t1of the exterior sidewall81and a second thickness t2of the interior sidewall83may be generally equal, i.e., t1=t2, along the major axis m of the non-circular, e.g., elliptical, transverse cross-section and/or may be generally unequal along the minor axis n of the non-circular, e.g., elliptical, transverse cross-section. In some embodiments, the first thickness t1of the exterior sidewall81is generally uniform throughout, i.e., t1=t3, and/or a thickness of the interior sidewall is generally non-uniform throughout, i.e., t2is not equal to t4.

As further shown inFIG.1B, in some embodiments, the shaft portion80may further include one or more lumens86a,86bdefined therethrough. The lumens being smaller in dimension than the two or more working channels85,87. The working channels85,87being configured to accommodate a variety of surgical instruments and guides of varying dimensions. The lumens86a,86bbeing unable to accommodate the surgical instruments described herein. However, the lumens86a,86bmay be individually configured to provide suction therethrough, the ability to inject a substance therethrough, a light source therethrough, or even a guidewire therethrough for aiding in steering of the shaft portion80. The lumens86a,86bare shown defining a generally circular cross-section. However, other non-circular cross-section configurations may also be used.

The catheters described herein may include a handle portion on a proximal end and a shaft portion on a distal end thereof, the shaft portion including an exterior wall and an interior sidewall, the exterior sidewall defining a non-circular, e.g., elliptical, transverse cross-section and the interior sidewall defining a first and second working channel within the exterior wall, the first working channel defining a generally circular transverse cross-section and the second working channel defining a generally reniform transverse cross-section.

The catheters, and particularly the shaft portions of the catheters, described herein may be formed from any suitable biocompatible material, including but not limited to, rubbers and plastics acceptable for surgical and medical use. It is contemplated that a suitable material (not specifically shown) may include a braided support structure formed from metals, such as stainless steel, or alternatively one or more non-conductive fibrous materials such as Kevlar or other aramid fibers to provide additional resilience and to maintain one or more of the working channels in a generally open configuration to ease the passage of the multiple surgical instruments therethrough.

The catheters, and particularly the shaft portions of the catheters, described herein may be formed using any suitable method, including but not limited to, molding, extrusion, pressing, casting, and the like.

In addition, although not shown, in some embodiments, the handle portion of the catheters described herein may include one large channel configured to accommodate the multiple surgical instruments positioned with the working channels or alternatively the handle may include multiple channels configured to accommodate any combination of the multiple working channels therethrough.

The catheters as described herein are configured to be used with systems for visualizing a luminal network of a patient, and/or particularly a lung of a patient. The systems and/or catheters as described herein may use ultrasound (US) imaging technologies which provide a sufficient resolution to identify and locate a target for diagnostic, navigation, and treatment purposes. US imaging, particularly in conjunction with non-invasive imaging, can provide a greater resolution and enable luminal network mapping and target identification. Further, additional clarity is provided with respect to tissue adjacent the endoscope, catheter, or identified targets which can result in different treatment options being considered to avoid adversely affecting the adjacent tissue.

FIG.2illustrates an electromagnetic navigation (EMN) system2100, which is configured to augment CT, MRI, or fluoroscopic images, with US image data assisting in navigation through a luminal network of a patient's lung to a target. One such EMN system may be the ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY® system currently sold by Covidien LP. The system2100includes an endoscope assembly2010including an endoscope2020, a catheter2040as described herein including a shaft80with two or more asymmetrical working channels, multiple surgical instruments2060a,2060b, a computing device2120, a monitoring device2130, an EM board2140, a tracking device2160, and reference sensors2170. The endoscope2020is specifically a bronchoscope which is operatively coupled to the computing device2120and the monitoring device2130via wired connection (as shown inFIG.2) or wireless connection (not shown).

The bronchoscope2020is inserted into the mouth of the patient2150and captures images of the luminal network of the lung. In the EMN system2100, inserted into the bronchoscope2020is a catheter2040as described herein for achieving access to the periphery of the luminal network of the patient2150. The catheter2040includes a shaft portion80as described herein including two or more asymmetric working channels into which multiple surgical instrument2060a,2060bmay be inserted. A first surgical instrument2060a, such as a locatable guide including an electromagnetic (EM) sensor at the distal tip thereof, may be inserted into one of the two or more working channels to help navigate through the luminal network of the lung as described in greater detail below. Because the catheter includes at least a second working channel, a second surgical instrument2060b, such a cytology brush, biopsy needle, or ablation catheter, may be inserted into the a second of the two or more working channels and navigated through the luminal network of the lungs with the first instrument2060a. Therefore, upon arrival of a desired location in the lung, the locatable guide may not need to be removed from the working channel to and replaced with the second surgical instrument2060b. However, it is envisioned that the locatable guide may be removed and replaced with a third surgical instrument designed to work with the second surgical instrument to perform multiple steps of the procedure simultaneously.

The computing device2120, such as, a laptop, desktop, tablet, or other similar computing device, includes a display2122, one or more processors2124, memory2126, a network card2128, and an input device2129. The system2100may also include multiple computing devices, wherein the multiple computing devices2120are employed for planning, treatment, visualization, or helping clinicians in a manner suitable for medical operations. The display2122may be touch-sensitive and/or voice-activated, enabling the display2122to serve as both an input and output device. The display2122may display a two dimensional (2D) images or three dimensional (3D) model of a luminal network, such as found in the lung, to locate and identify a portion of the network that displays symptoms of disease, such as lung disease. The generation of such images and models is described in greater detail below. The display2122may further display options to select, add, and remove a target to be treated and settable items for the visualization of the network or lung. In an aspect, the display2122may also display the location of the catheter2040in the luminal network of the lung based on the 2D images or 3D model of the lung. For ease of description not intended to be limiting on the scope of this disclosure, a 3D model is described in detail below but one of skill in the art will recognize that similar features and tasks can be accomplished with 2D models and images.

The one or more processors2124execute computer-executable instructions. The processors2124may perform image-processing functions so that the 3D model of the lung can be displayed on the display2122. In embodiments, the computing device2120may further include a separate graphic accelerator (not shown) that performs only the image-processing functions so that the one or more processors2124may be available for other programs.

The memory2126stores data and programs. For example, data may be image data for the 3D model or any other related data such as patients' medical records, prescriptions and/or history of the patient's diseases. One type of programs stored in the memory2126is a 3D model and pathway planning software module (planning software). An example of the 3D model generation and pathway planning software may be the ILOGIC® planning suite currently sold by Covidien LP. When image data of a patient, which is typically in digital imaging and communications in medicine (DICOM) format, from for example a CT image data set (or image data set by other imaging modality) is imported into the planning software, a 3D model of the bronchial tree is generated. In an aspect, imaging may be done by CT imaging, magnetic resonance imaging (MRI), functional MRI, X-ray, and/or any other imaging modalities. To generate the 3D model, the planning software employs segmentation, surface rendering, and/or volume rendering. The planning software then allows for the 3D model to be sliced or manipulated into a number of different views including axial, coronal, and sagittal views that are commonly used to review the original image data. These different views allow the user to review all of the image data and identify potential targets in the images.

Once a target is identified, the software enters into a pathway planning module. The pathway planning module develops a pathway plan to achieve access to the targets and the pathway plan pin-points the location and identifies the coordinates of the target such that they can be arrived at using the EMN system2100in combination with any of the catheters described herein, and particularly the catheter2040and a first and second surgical instrument2060a,2060b. The pathway planning module guides a clinician through a series of steps to develop a pathway plan for export and later use in during navigation to the target in the patient2150. The term, clinician, may include doctor, surgeon, nurse, medical assistant, or any user of the pathway planning module involved in planning, performing, monitoring and/or supervising a medical procedure.

The memory2126may store navigation and procedure software which interfaces with the EMN system2100to provide guidance to the clinician and provide a representation of the planned pathway on the 3D model and 2D images derived from the 3D model. An example of such navigation software may be the ILOGIC® navigation and procedure suite sold by Covidien LP. In practice, the location of the patient2150in the EM field generated by the EM field generating device2145must be registered to the 3D model and the 2D images derived from the model. Such registration may be manual or automatic.

As further shown inFIG.2, the EM board2140is configured to provide a flat surface for the patient to lie down and includes an EM field generating device2145. When the patient2150lies down on the EM board2140, the EM field generating device2145generates an EM field sufficient to surround a portion of the patient2150. An EM sensor on a distal tip of the LG2060amay be used to determine the location of the LG2060ain the EM field generated by the EM field generating device2145.

In some embodiments, the EM board2140may be configured to be operatively coupled with the reference sensors2170which are located on the chest of the patient2170. The reference sensors2170move up and down following the chest while the patient2150is inhaling and move down following the chest while the patient2150is exhaling. The movement of the reference sensors2170in the EM field is captured by the reference sensors2170and transmitted to the tracking device2160so that the breathing pattern of the patient2150may be recognized. The tracking device2160also receives outputs of the EM sensor on the LG2060a, combines both outputs, and compensates the breathing pattern for the location of the LG2060a. In this way, the location identified may be compensated for so that the compensated location of the LG2060ais synchronized with the 3D model of the lung. Once the patient2150is registered to the 3D model, the position of the catheter2040described herein and particularly the LG2060aand the second surgical instrument2060b, can be tracked within the EM field generated by the EM field generator2145, and the position of the LG2060acan be depicted in the 3D model or 2D images of the navigation and procedure software.

When the endoscope2020or catheter2040, and the LG2060a, reaches a target tissue by following the pathway plan, the LG2060aincluding the EM sensor confirms its location at the target and a clinician may confirm the location at the target. Since the second instrument2060bwas included within the catheter2040, the general location of the second instrument2060bmay also be confirmed. The LG2060amay either remain in the catheter2040or be removed from the catheter2040after arriving at the target tissue. In some embodiments, the LG2060amay be withdrawn and replaced with a third surgical instrument (not shown) configured to work together with the second instrument2060bto treat the tissue or retrieve a sample of the target for confirmation of the disease.