Surgical access device with on-board balloon visualization module - Patent Application 20070122997

Abstract

The present invention relates to a surgical access device with an on-board balloon visualization module. When deployed, the balloon and visualization module may form part of a hybrid working channel. When retracted, the visualization module and balloon are fully retracted within the elongate body of the surgical access device. Embodiments of the surgical access device and balloon visualization system may be employed in a variety of medical procedures.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 376,049, filed September 16, 2022, U.S. Provisional Patent Application No. 63 / 384,372, filed November 18, 2022, and U.S. Provisional Patent Application No. 63 / 482,000, filed January 27, 2023, the entire contents of each of which are incorporated herein by reference.

[0002] Incorporation by Reference All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] Various alternative surgical access device embodiments relate to surgical devices with imaging capabilities. [Background technology]

[0004] Conventional surgical devices include visualization capabilities. However, one common drawback of conventional designs is that the visualization system occupies valuable space in the device's internal working channel, as shown in FIG. 1. Therefore, providing a visualization system creates a negative trade-off: the size of the working channel must be reduced or compromised. Therefore, an improved visualization system that can increase the size of the working channel while maintaining the desired surgical imaging capabilities is desirable. Summary of the Invention

[0005] In these and other embodiments, a surgical access device is provided that includes an elongate body having a working channel and a balloon visualization module disposed at a distal end of the elongate body, the balloon visualization module including a balloon and a camera module disposed within the balloon, the camera module being housed within an outer diameter of an access sheath in a stowed state, and the camera module being moved radially outward relative to a longitudinal axis of the elongate body and positioned substantially beyond the outer wall of the elongate body when deployed with the balloon inflated in use.

[0006] In some embodiments, the balloon visualization module fits completely within the working channel when retracted.

[0007] At least a portion of the distal surface of the balloon may form a contact visualization surface configured to contact a target tissue to enable visualization of the target tissue by the camera module.

[0008] In some embodiments, at least 90% of the distal surface of the balloon is within the field of view of the camera module when the camera module is in the deployed state, hi some embodiments, at least 95% of the distal surface of the balloon is within the field of view of the camera module when the camera module is in the deployed state.

[0009] The distal surface of the balloon may be rounded. In some embodiments, the balloon is made of an optically transparent material.

[0010] The camera module may be spaced approximately 8-13 mm from the distal surface of the balloon.

[0011] In some embodiments, the elongate body comprises multiple lumens. The elongate body may include a fluid lumen. In some embodiments, the diameter of the fluid lumen is about 0.4 to 0.6 mm. The elongate body may include a position tracking sensor.

[0012] In some embodiments, the camera module comprises an electronic connector extending proximally toward the proximal end of the elongate body. The camera module may include one or more lights. In some embodiments, the camera module is positioned generally parallel to a longitudinal axis of the elongate body. The camera module may be positioned generally parallel to a longitudinal axis of the elongate body. The camera module is positioned at an angle to the longitudinal axis of the elongate body. Some embodiments may further comprise a camera mount attached to the channel extension and configured to support the camera module.

[0013] The balloon visualization module may include a channel extension coupled to a distal end of the working channel. In some embodiments, the channel extension comprises a lumen having a cutout. The balloon may be configured, when inflated, to complete the lumen at least in part at the cutout. In some embodiments, the cutout occupies about 60-90% of the length of the channel extension. The channel extension may comprise a flexible tube. In some embodiments, the channel extension comprises an optically transparent material.

[0014] The balloon may include a balloon channel configured to surround the channel extension. In some embodiments, the balloon channel has a diameter of about 3 to 3.8 mm. The length of the balloon channel may be about 16 to 17.4 mm. In some embodiments, the device further comprises a camera mount attached to the balloon channel and configured to support the camera module. The balloon may have a thickness of about 0.1 mm or less. In some embodiments, the balloon has a durometer of about 80-90A on the Shore A scale.

[0015] The balloon may be asymmetric about the longitudinal axis of the channel extension. In some embodiments, a majority of the volume of the balloon is disposed above the channel extension. In some embodiments, more than 80% of the volume of the balloon is disposed above the channel extension.

[0016] The elongate body may have a diameter of about 12-16F.

[0017] In some embodiments, approximately 6-7 mm of the distal end of the channel extension is within the field of view of the camera module when the camera module is in the deployed position. In some embodiments, when the camera module is in the deployed position, about 2-3 mm of the bottom of the distal end of the channel extension is within the field of view of the camera module. The channel extension may include approximately the bottom third of the field of view of the camera module.

[0018] In some embodiments, the working channel has a diameter of about 8-9F. The working channel may extend beyond the distal end of the elongate body. In some embodiments, the balloon is made from one or a combination of polyurethane, silicone, Pebax®, nylon, polyester / PET. The proximal end of the balloon may be attached to the distal end of the elongate body. In some embodiments, the balloon height is about 12-14 mm.

[0019] The camera module may have a field of view in air of approximately 110°. The camera module may include an integrated lighting system.

[0020] In some embodiments, the refractive index of the fluid within the balloon is substantially the same as the refractive index of the balloon.

[0021] The balloon may be responsive to modulated pressure applied to the interior of the balloon. In some embodiments, the balloon, in response to modulated pressure applied to the interior of the balloon, becomes more compliant, less compliant, stiffer, more rigid, or develops one or more of the auxiliary shapes, surfaces, or portions supported by the balloon.

[0022] The surface of the balloon may include one or more electrodes, wiring, circuits, or components for mapping or ablation performed with the surgical access device.

[0023] In these and other embodiments, a surgical access device is provided comprising: an elongate body having a working channel; and a balloon visualization module disposed at a distal end of the elongate body, the balloon comprising a camera module, the camera module disposed within the balloon and spaced from a distal surface of the balloon, the camera module configured to be at least partially disposed within a path of the working channel in a stowed state, and when deployed with the balloon inflated in use, the camera module moves radially outward relative to a longitudinal axis of the elongate body and out of the path of the working channel such that at least 90% of the distal surface of the balloon is within a field of view of the camera module.

[0024] In these and other embodiments, there is provided a method of performing a medical procedure using the above-described surgical access device, which includes a handle, suitable connection, or configuration at its proximal end, and wherein the lighting, camera, and / or visualization components of the balloon visualization module, as part of an arthroscope, laparoscope, endoscope, robotic-assisted surgical instrument, or other surgical instrument, enhance visualization capabilities during the performance of the medical procedure.

[0025] In these and other embodiments, a method of performing a medical procedure on a patient is provided, the method including advancing a sheath to a desired location adjacent or proximate to a surgical site, removing a balloon visualization module from the sheath, transitioning the balloon visualization module to a visualization state, positioning a distal portion of the sheath adjacent to the surgical site using imaging from a camera in the balloon visualization module, performing one or more steps of an interventional procedure using a tool delivered using a working channel and a channel extension of a shaft, performing one or more steps of the interventional procedure by directly viewing the surgical site, the tool, or a surgical field using output from the camera in the balloon visualization module, transitioning the balloon visualization module from the visualization state, and returning the balloon visualization module to a retracted state within the sheath.

[0026] In some embodiments, in the method, moving the balloon visualization module from the sheath includes advancing a shaft coupled to the balloon visualization module relative to the sheath. Transitioning the balloon visualization module to a visualization state may include inflating a balloon of the balloon visualization module with a fluid. Transitioning the balloon visualization module to a visualization state may include inflating a balloon of the balloon visualization module with saline.

[0027] In some embodiments, the method further includes purging a balloon and / or fluid lines of the balloon visualization module, which may include continuously pumping fluid through the fluid lines and the balloon.

[0028] In some embodiments, the method includes transitioning the balloon visualization module to a visualization state including inflating a balloon of the balloon visualization module with fluid. Inflating the balloon of the balloon visualization module with fluid may occur until visual feedback confirms full inflation. Inflating the balloon of the balloon visualization module with fluid may occur until a predetermined amount of fluid has been pumped into the balloon. Inflating the balloon of the balloon visualization module with fluid may include active pressure control to provide one or more of constant balloon pressure, leak detection, and contact force sensing.

[0029] Transitioning the balloon visualization module into a visualization state may include inflating a balloon of the balloon visualization module with a fluid and moving the camera to a desired position.

[0030] In some embodiments, the method further includes withdrawing the sheath and the balloon visualization module from the patient.

[0031] The medical procedure may include ablation, left atrial appendage closure, minimally invasive mitral valve surgery, minimally invasive aortic surgery, coronary artery surgery, minimally invasive surgery for intrapericardial tumors, pacemaker lead removal, endocardial biopsy, transcatheter mitral valve repair, transcatheter mitral valve replacement, tricuspid valve repair, right ventricular reshaping, tether implants, closure of an atrial septal defect or patent foramen ovale, and balloon atrial septostomy.

[0032] In these and other embodiments, a method of performing a medical procedure on a patient is provided, the method including advancing a sheath to a desired location adjacent or proximate to a surgical site, moving a balloon visualization module from the sheath, inflating a balloon of the balloon visualization module to a visualization state and positioning a camera within the balloon visualization module at a desired location, positioning the balloon adjacent target tissue using imaging by the camera within the balloon visualization module, performing one or more steps of an interventional procedure using a tool delivered using a working channel and channel extension of a shaft, and performing one or more steps of the interventional procedure by directly viewing the surgical site, the tool, or a surgical field using output from the camera within the balloon visualization module.

[0033] In these and other embodiments, a method of performing a medical procedure on a patient is provided, including navigating an access sheath to a desired location using a balloon visualization module in an uninflated, housed state within the access sheath, advancing a shaft having the balloon visualization module at its distal end from its housed state within the access sheath, flushing the fluid lines and balloon of the balloon visualization module, pumping fluid into the balloon to initiate a transition from an uninflated state to an inflated state, increasing the amount of fluid to unfold or expand the balloon and elevate a housed camera module, continuing to pump fluid into the balloon until the balloon is fully inflated and the camera module is in position to view a surgical field, and maintaining inflation of the balloon to gently conform to tissue at a treatment site during the procedure.

[0034] In some embodiments, the method further includes, after completion of the procedure, deflating the balloon and retracting the balloon visualization module into the access sheath, thereby folding or bending the camera module into the outer diameter of the sheath. The method may further include withdrawing the sheath and the balloon visualization module. The fluid may be saline. In some embodiments, flushing the fluid lines and the balloon comprises continuously pumping fluid through the fluid lines and the balloon.

[0035] In some embodiments, continuing to pump fluid includes pumping the fluid until visual feedback confirms full inflation. In some embodiments, continuing to pump fluid includes pumping the fluid until a predetermined amount of the fluid is delivered to the balloon. In some embodiments, continuing to pump fluid includes providing one or more of constant balloon pressure, leak detection, and contact force sensing through active pressure control.

[0036] The medical procedure may include ablation, left atrial appendage closure, minimally invasive mitral valve surgery, minimally invasive aortic surgery, coronary artery surgery, minimally invasive surgery for intrapericardial tumors, pacemaker lead removal, endocardial biopsy, transcatheter mitral valve repair, transcatheter mitral valve replacement, tricuspid valve repair, right ventricular reshaping, tether implants, closure of an atrial septal defect or patent foramen ovale, and balloon atrial septostomy.

[0037] In these and other embodiments, a method for performing a medical procedure on a patient is provided, the method including: navigating an access sheath to a desired location using a balloon visualization module in an uninflated, housed state within the access sheath; advancing a shaft having the balloon visualization module at its distal end from its housed state within the access sheath; pumping fluid into the balloon to initiate a transition from the uninflated state to an inflated state; continuing to pump fluid into the balloon until the balloon is fully inflated; and positioning a camera module within the balloon such that a field of view of the camera module covers at least 90% of the distal surface of the balloon.

[0038] In these and other embodiments, a method of performing a medical procedure is provided that includes contacting a fluid-inflated balloon of a balloon visualization module with tissue adjacent a treatment site to displace blood within the treatment site, receiving image data from a camera module disposed within the balloon and the fluid, advancing a surgical tool through a working channel of the balloon visualization module that extends through the balloon, and visualizing the surgical tool exiting the working channel with the camera module.

[0039] In these and other embodiments, a balloon for use with a surgical access device is provided, the balloon comprising: an open proximal end, a generally tubular body, a proximal portion extending distally from the proximal end, an intermediate portion extending distally from the proximal portion to a mid-surface portion, the intermediate portion extending radially outward from the proximal portion along at least one of an upper surface or a lower surface of the intermediate portion, the mid-surface portion extending radially inward from a distal end of the intermediate portion and forming a generally closed, distally-facing surface with an opening, and a distal portion extending from the opening in the mid-surface portion and having a generally tubular shape and an open distal end.

[0040] In some embodiments, when assembled for use with the surgical access device, the distal portion is inverted to be positioned within the intermediate portion, with the open distal end positioned proximal to the intermediate surface portion, and a balloon channel formed within the intermediate portion. In some embodiments, when assembled for use with the surgical access device, the open distal end is positioned within the intermediate portion proximal to the intermediate surface portion and distal to the open proximal end. In some embodiments, the intermediate surface is the distal surface of the balloon when assembled for use with the surgical access device. In some embodiments, when assembled for use with the surgical access device, the open proximal end of the balloon is coupled to the distal end of an elongate body.

[0041] The distal portion may be coupled to the lumen such that the lumen extends through the balloon channel. The lumen may comprise a flexible lumen. The lumen may comprise a rigid lumen with a notch at its top. The lumen may comprise a rigid lumen. The lumen may comprise a lumen having a notch at an upper portion. In some embodiments, the notch extends along approximately 60-90% of the length of the distal portion of the balloon. The lumen may be made of an optically transparent material.

[0042] A camera module may be coupled to the balloon channel. In some embodiments, the camera module is coupled to the balloon channel such that when the balloon is inflated, the field of view of the camera module covers approximately 90% of the midsurface of the balloon. The camera module may be coupled to the balloon channel using a camera mount.

[0043] In some embodiments, the open distal end is coupled to the distal end of the working channel of the elongate body. The distal portion may have a first durometer and the intermediate portion and / or the mid-surface portion may have a second durometer. The first durometer may be different from the second durometer.

[0044] In some embodiments, the open distal end is coupled to the distal end of the working channel of the elongate body. The distal portion may have a first flexibility and the intermediate portion and / or the midsurface portion may have a second flexibility, and the first flexibility may be different from the second flexibility.

[0045] In some embodiments, when assembled for use with the surgical access device, the distal portion is coupled to a lumen. The lumen may comprise a flexible or rigid lumen. The lumen may have a cutout top.

[0046] In some embodiments, the distal portion has a length of about 16-18 mm. The proximal portion may have a length of about 4 to 6 mm. The diameter of the distal portion is about 3 to 4 mm. In some embodiments, the diameter of the proximal portion is about 3-5 mm.

[0047] The proximal portion may be coaxial or non-coaxial with the distal portion.

[0048] The balloon may be symmetric or asymmetric about the longitudinal axis of the distal portion. In some embodiments, the balloon has a larger volume above the distal end than below the distal portion.

[0049] The intermediate surface may be convex or concave.

[0050] The balloon may be made of an optically transparent material. In some embodiments, the balloon is made from at least one of polyurethane, silicone, Pebax®, nylon, and polyester / PET. [Brief explanation of the drawings]

[0051] [Figure 1] FIG. 1 is a perspective view of the distal end of a conventional instrument. [Figure 2]FIG. 1 is a perspective view of the distal end of a surgical access device with a balloon visualization module (BVM). [Figure 3A] 1 illustrates one embodiment of a surgical access device using a BVM in a procedure involving surgical access. [Figure 3B] 1 illustrates one embodiment of a surgical access device using a BVM in a procedure involving surgical access. [Figure 4A] FIG. 10 is a side view of the distal end of one embodiment of an access device with a BVM. [Figure 4B] 1 shows an example of a field of view from a camera module. [Figure 5A] FIG. 10 is a side cross-sectional view of the distal end of one embodiment of an access device with a BVM. [Figure 5B] 1 shows an example of a field of view from a camera module. [Figure 6A] 1A-1D are side cross-sectional and perspective views of the distal end of one embodiment of an access device comprising a BVM. [Figure 6B] 1A-1D are side cross-sectional and perspective views of the distal end of one embodiment of an access device comprising a BVM. [Figure 7A] 1A-1C each show the distal end of an embodiment of an access device comprising a BVM. [Figure 7B] 1A-1C each show the distal end of an embodiment of an access device comprising a BVM. [Figure 7C] 1A-1C each show the distal end of an embodiment of an access device comprising a BVM. [Figure 7D] 1A-1C each show the distal end of an embodiment of an access device comprising a BVM. [Figure 7E] 1A-1C each show the distal end of an embodiment of an access device comprising a BVM. [Figure 7F] 1A-1C each show the distal end of an embodiment of an access device comprising a BVM. [Figure 8A] 1 illustrates the deployment of one embodiment of a BVM. [Figure 8B] 1 illustrates the deployment of one embodiment of a BVM. [Figure 8C] 1 illustrates the deployment of one embodiment of a BVM. [Figure 8D] 1 illustrates the deployment of one embodiment of a BVM. [Figure 8E] 1 illustrates the deployment of one embodiment of a BVM. [Figure 8F] 1 illustrates the deployment of one embodiment of a BVM. [Figure 9A] 10A and 10B are diagrams illustrating an access device with a BVM in a stored state. [Figure 9B] 10A and 10B are diagrams illustrating an access device with a BVM in a stored state. [Figure 9C] 10A and 10B are diagrams illustrating an access device with a BVM in a stored state. [Figure 10] FIG. 1 is an isometric view of one embodiment of an access sheath and BVM. [Figure 11A] 1 illustrates a conventional pacemaker lead removal technique. [Figure 11B] 1 illustrates a conventional pacemaker lead removal technique. [Figure 11C] 1 illustrates a conventional pacemaker lead removal technique. [Figure 11D] 1 illustrates a conventional pacemaker lead removal technique. [Figure 11E] 1 illustrates a conventional pacemaker lead removal technique. [Figure 12] 1 illustrates an embodiment of an access device comprising a BVM. [Figure 13] FIG. 13 is a cross-sectional side view of the device in position to remove the pacemaker lead of FIG. 12. [Figure 14A] 1A and 1B each illustrate an embodiment of an access device including a BVM. [Figure 14B] 1A and 1B each illustrate an embodiment of an access device including a BVM. [Figure 14C] 1A and 1B each illustrate an embodiment of an access device including a BVM. [Figure 15A] 1 is a cross-sectional view of an embodiment of a multi-lumen shaft. [Figure 15B]1 is a cross-sectional view of an embodiment of a multi-lumen shaft. [Figure 16] FIG. 10 is a perspective view of the distal end of one embodiment of an extension channel. [Figure 17A] FIG. 1 is a side cross-sectional view of a balloon and a BVM with the balloon. [Figure 17B] FIG. 1 is a side cross-sectional view of a balloon and a BVM with the balloon. [Figure 18A] 1 illustrates various configurations of a camera module mount. [Figure 18B] 1 illustrates various configurations of a camera module mount. [Figure 19A] FIG. 1 is a side view of the BVM. [Figure 19B] A representative viewpoint from the camera module of the BVM is shown. [Figure 20A] 1A-1D are perspective views of a balloon at two steps in an assembly process according to one embodiment. [Figure 20B] 1A-1D are perspective views of a balloon at two steps in an assembly process according to one embodiment. [Figure 21A] 1A-1D are side views of various embodiments of balloons used in BVMs. [Figure 21B] 1A-1D are side views of various embodiments of balloons used in BVMs. [Figure 21C] 1A-1D are side views of various embodiments of balloons used in BVMs. [Figure 21D] 1A-1D are side views of various embodiments of balloons used in BVMs. [Figure 22A] 10A-10C each illustrate an embodiment of a method for connecting a balloon and a channel extension. [Figure 22B] 10A-10C each illustrate an embodiment of a method for connecting a balloon and a channel extension. [Figure 22C] 10A-10C each illustrate an embodiment of a method for connecting a balloon and a channel extension. [Figure 23A] 10A-10C each show an embodiment of a method for connecting the camera support to the distal leg of the balloon. [Figure 23B]10A-10C each show an embodiment of a method for connecting the camera support to the distal leg of the balloon. [Figure 23C] 10A-10C each show an embodiment of a method for connecting the camera support to the distal leg of the balloon. [Figure 23D] 10A-10C each show an embodiment of a method for connecting the camera support to the distal leg of the balloon. [Figure 24A] 10 illustrates an embodiment of a method for connecting a shaft to a balloon and a channel extension. [Figure 24B] 10 illustrates an embodiment of a method for connecting a shaft to a balloon and a channel extension. [Figure 24C] 10 illustrates an embodiment of a method for connecting a shaft to a balloon and a channel extension. [Figure 24D] 10 illustrates an embodiment of a method for connecting a shaft to a balloon and a channel extension. [Figure 25] 1 illustrates one embodiment of the proximal end of a BVM device. [Figure 26A] 1A-1C each illustrate an embodiment of a steerable BVM device. [Figure 26B] 1A-1C each illustrate an embodiment of a steerable BVM device. [Figure 27A] 1 illustrates an embodiment of a method for inflating and deflating a balloon. [Figure 27B] 1 illustrates an embodiment of a method for inflating and deflating a balloon. [Figure 28] 1 illustrates one embodiment of a channel extension. [Figure 29A] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29B] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29C] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29D] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29E]10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29F] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29G] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29H] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29I] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29J] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29K] 10A-10C illustrate channel extensions of various embodiments with various proximal and distal coupling mechanisms. [Figure 29L] 10A-10C are perspective and side views of one embodiment of a channel extension. [Figure 29M] 10A-10C are perspective and side views of one embodiment of a channel extension. [Figure 29N] 10A and 10B are perspective and side views of a channel extension. [Figure 29O] 10A and 10B are perspective and side views of a channel extension. [Figure 30A] 10A-10C each show an embodiment of a channel extension with multiple lumens. [Figure 30B] 10A-10C each show an embodiment of a channel extension with multiple lumens. [Figure 30C] 10A-10C each show an embodiment of a channel extension with multiple lumens. [Figure 30D] 10A-10C each show an embodiment of a channel extension with multiple lumens. [Figure 31] 10 illustrates several different channel extension embodiments and configurations with various cutout and proximal and distal coupling mechanism configurations. [Figure 32A] 1 illustrates one embodiment of a method for deploying a BVM from a stowed state. [Figure 32B] 1 illustrates one embodiment of a method for deploying a BVM from a stowed state. [Figure 32C] 1 illustrates one embodiment of a method for deploying a BVM from a stowed state. [Figure 33] 1 illustrates an embodiment of a BVM with multiple camera modules. [Figure 34] 1 illustrates an embodiment of an access device with a BVM. [Figure 35] 1 illustrates one embodiment of a method for using a BVM device. [Figure 36] 1 illustrates one embodiment of a method for using a BVM device. [Figure 37A] 10 illustrates an embodiment of a balloon with a distal window having an optical scale. [Figure 37B] 10 illustrates an embodiment of a balloon with a distal window having an optical scale. [Figure 37C] 10 illustrates an embodiment of a balloon with a distal window having an optical scale. [Figure 37D] 10 illustrates an embodiment of a balloon with a distal window having an optical scale. [Figure 38A] 37A and 37C show the field of view from the camera module shown in FIG. [Figure 38B] 37B and 37D show the field of view from the camera module shown in FIG. [Figure 39] An example of how the BVM can be used as a tissue manipulator is shown. [Figure 40A] 1 shows the field of view from the camera module during an ablation procedure. [Figure 40B] 1 shows a BVM device positioned toward a pulmonary vein. [Figure 41A] 1 shows the field of view from the camera module during pacemaker lead removal. [Figure 41B] 1 shows a BVM device visualizing a scarred pacemaker lead site. [Figure 42A]13 shows the view from the camera module of the BVM device during pacemaker lead removal with the pacemaker lead in the working channel. [Figure 42B] 1 shows a circular cutting element being fed through the working channel. [Figure 42C] FIG. 10 shows a pacemaker lead inserted into the working channel of a BVM device and acting as a guidewire. [Figure 43A] 1 shows the view from the camera module of the BVM device performing a biopsy procedure on the valve annulus. [Figure 43B] 1 shows a BVM device positioned towards target tissue. [Figure 44A] 1 illustrates various embodiments of a camera support or mount. [Figure 44B] 1 illustrates various embodiments of a camera support or mount. [Figure 44C] 1 illustrates various embodiments of a camera support or mount. [Figure 44D] 1 illustrates various embodiments of a camera support or mount. [Figure 45A] 1 illustrates various embodiments of a camera support or mount. [Figure 45B] 1 illustrates various embodiments of a camera support or mount. [Figure 45C] 1 illustrates various embodiments of a camera support or mount. DETAILED DESCRIPTION OF THE INVENTION

[0052] As described herein, embodiments of the surgical access device of the present invention equipped with a balloon-based visualization module (BVM) can be used to address a wide range of clinical challenges in various medical procedures.

[0053] 2 is a perspective view of the distal end of a surgical access device 200 including a BVM 202. The device 200 includes a shaft 204. A working channel 205 extends through the shaft 204. A balloon 206 is disposed at the distal or proximal end of the shaft 204. A camera and lighting system 208 is disposed within the balloon 206.

[0054] Inlet and outlet channels 210 and 212 are in fluid communication with the balloon 206. The inlet channel 210 can be used to inflate the balloon with a fluid (e.g., saline, water, etc.), and the outlet channel 212 can be used to evacuate air bubbles from the balloon during inflation.

[0055] The distal end of shaft 204 comprises a transparent portion 209. In some embodiments, transparent portion 209 comprises an extension 216 and a cutout 214 configured to expose at least a portion of the BVM upon inflation of the balloon.

[0056] As shown in FIG. 2, the balloon is shaped like a truncated portion of a sphere positioned above the working shaft. The sphere is truncated at the distal end of the balloon to create an optical window. The sphere is truncated at the bottom end of the balloon around the shaft and / or working channel. The bottom central portion of the balloon includes a recess 220. In some embodiments, the shape and size of the recess 220 can be configured to correspond to the size of the distal end of the working channel of the shaft. In some embodiments, other balloon shapes are used. Alternative balloon shapes can be selected to provide field of view adjustment with selected imaging / illumination components. In some aspects, the shape and dimensions of the balloon correspond not only to the external physical size and shape of the imaging component, but also to the optical properties related to the functionality of the imaging component.

[0057] The balloon may be constructed of silicone, although other materials may also be employed.

[0058] The thickness of the balloon can be about 0.20 mm to 0.25 mm (or about 0.15 mm to 0.30 mm, about 0.10 mm to 0.35 mm, about 0.05 mm to 0.1 mm, 0.075 mm to 0.1 mm, about 0.1 mm, etc.).

[0059] Advantageously, when the balloon 206 is in its deflated, retracted state, the BVM is positioned within the extension 216 at the distal end of the shaft 204. The BVM can be inserted and advanced to the surgical site while maintaining this position. In contrast to conventional systems, the components of the BVM are positioned within the cross section of the working channel, allowing for a significantly smaller outer diameter. When the balloon is inflated, the balloon and camera / illumination system move beyond the size of the outer diameter of the shaft 204. When the balloon is fully or nearly fully inflated, the camera 208 is positioned at the desired location, and the balloon provides the desired field of view.

[0060] In some embodiments, the base or contour 218 of the balloon, when inflated, forms a portion of the working channel in or around the notch. In some embodiments, the shape of the balloon's base is a portion of the working channel in the shaft. In some embodiments, the balloon's base comprises features that form the most distal portion of the working channel.

[0061] In some embodiments, extension 216 has a semi-tubular or partial tubular shape, forming a portion of a tubular shape. Other configurations can also be employed. For example, in some embodiments, extension 216 comprises a flexible rounded extension at the distal end of shaft 204 (see, e.g., devices 600, 700, 800, 900, etc.).

[0062] In some embodiments, the device has an outer diameter of about 3-10 mm, about 4-8 mm, about 5-7 mm, etc. It should be understood that, in various embodiments, the device shaft, working channel, and balloon visualization module are adapted and configured to perform one or more steps of a minimally invasive, single-port access, or robotically-assisted interventional or surgical procedure to address various medical procedure shortcomings or clinical problems. In some embodiments, the elongate body of the surgical access device can be adapted and configured to have flexibility, flexibility, or controllability to accommodate various shapes or curvatures along all or a portion of its length to assist in advantageous positioning and use of the balloon visualization module and associated medical procedures. For example, the surgical access device can be used with a sheath that has steerability (e.g., 60°-90° steerability in one direction). The handle or proximal end is adapted and configured to allow user or robotic control of such functions of the elongate body.

[0063] Embodiments of the surgical access device of the present invention incorporating a balloon visualization module have a proximal end with a handle or suitable connection or configuration, and the lighting, camera, and / or visualization components of the balloon visualization module provide enhanced visualization capabilities as part of an arthroscope, laparoscope, endoscope, robotic-assisted surgical instrument, or other surgical instrument. The surgical access device also has an elongate body with an internal lumen. The internal lumen of the elongate body is used for a working channel extending from the proximal end to the distal end of the elongate body. The proximal end communicates with the handle, and the distal end communicates with or connects to a BVM support structure. The lumen of the elongate body also provides inlet and outlet access to the balloon interior (i.e., for fluid inflation control, deflation, and bubble management, or other functions). Furthermore, the internal lumen of the elongate body is used for input, output, power, fiber optic, and other connections common to surgical vision systems, depending on the type of imaging desired based on the medical procedure being performed. These various additional connections are also located within the lumen of the elongate body. As described further below, the balloon visualization module is coupled to the distal end of the elongate body. A support structure is provided extending from the distal end of the elongate body. The balloon and visualization components are provided along and above the support structure in an uninflated / stowed state. When the balloon is deployed / inflated, it is positioned above the support structure, and a portion of the surface of the balloon and the support structure further extend the working channel. Additionally or alternatively, the balloon may be easily maneuverable to fit the surgical field and may have an outer shape, such as a rounded circle or cylinder, to accommodate imaging of complex shapes or to further aid in moving blood away from the surgical field. These shape and field of view design aspects may accommodate various medical procedures described herein. The elongate body may be configured for use with an access sheath. The access sheath may be steerable or otherwise controllable.

[0064] In particular, in certain embodiments, the balloon visualization module (BVM), due to its advantageous configuration, forms part of a hybrid working channel, providing a visualization chamber with a desired field of view associated with an imaging and illumination system or component, and the ability to transition from a stowed state to a deployed state. The hybrid working channel effectively combines a working channel within the shaft of the access device and a working channel extending from the distal end of the access device. The working channel extension combines a partial or semi-tubular base piece with a balloon base or contoured portion that forms the upper portion of the working channel. In some embodiments, the hybrid working channel may have the same inner diameter along its entire length. Alternatively, the inner diameters may be different, one smaller than the other.

[0065] A balloon visualization module (BVM) is attached to the surgical access tool shaft at its proximal end. The balloon used in the balloon visualization module is configured with a screen-like distal surface shape and size to mimic the desired field of view of the onboard camera / lighting components associated with the balloon visualization module. The balloon visualization module may have a bottom surface along a semi-tubular extension from the distal end of the device. The semi-tubular or partial tubular extension is aligned with the working channel lumen of the surgical access device and is considered an extension of the working channel lumen. While illustrated along the bottom, it should be understood that the BVM extension can have other relationships to the working channel, such as being aligned above, to the side, or at any intermediate peripheral position (e.g., angular positions on a clock face). Additionally or alternatively, the bottom surface of the inflated balloon may be used to form an inflatable upper wall of the working channel. In some embodiments, the balloon comprises a channel configured to surround the extension of the working channel. In some embodiments, in a stowed / deflated state, the balloon visualization module completely or partially blocks the working channel of the surgical access tool. In some embodiments, even in the stowed state, the bottom of the balloon is positioned upward, forming the upper side of the hybrid working channel.

[0066] As a result, in some embodiments, the working channel of the BVM surgical access device is a combination of a working channel within the elongate body lumen and a passageway formed by the balloon extension or semi-tubular extension, and may optionally include a portion or surface of the inflated / deployed balloon.

[0067] Additionally or alternatively, in some embodiments, the various components and parts of the surgical access devices described herein, such as the handle, elongate body, working channel, balloon, and visualization module (including the shape / image and illumination field of view of the distal balloon portion), are adapted and configured to provide the desired access and imaging capabilities in surgical, interventional, endoscopic, arthroscopic, or minimally invasive, single-port access, open, conventional, or robotic-assisted medical procedures.

[0068] 4A is a side view of the distal end of one embodiment of an access device 400 comprising a BVM 402. Device 400 comprises a shaft 404 having a working channel 405. An optically transparent window 407 is located at the distal end of balloon 406. In some embodiments, the entire balloon is optically transparent. In some embodiments, a distal portion of balloon 406 is optically transparent.

[0069] Camera module 408 is positioned within balloon 406. A connector, wire, or cable 411 extends from camera module 408 to the proximal end of the device and may be used to provide data and / or power to the camera module.

[0070] In some embodiments, the distal window 407 of the balloon has a diameter of about 10-15 mm, providing a field of view of about 10-15 mm diameter.

[0071] In some embodiments, the shaft diameter is approximately 5-6 mm, although other configurations are also possible (eg, 3-8 mm, 4-7 mm, etc.).

[0072] In some embodiments, the working channel has a diameter of about 3-5 mm (or about 3 mm, 4 mm, 5 mm, etc.).

[0073] In some embodiments, the distal window has a diameter about 2 times (or about 3 times, or about 2-3 times, etc.) the diameter of the shaft. In some embodiments, the distal window has a diameter about 3 to 5 times (or about 3 times, or about 4 times, or about 5 times, etc.) the diameter of the working channel.

[0074] 4B is a representative perspective view from camera module 408. The transparent distal portion of working channel 405 and the inner surface 411 of the balloon are visible in the field of view. A device extending through working channel 405 will also be within the field of view.

[0075] FIG. 5A illustrates one embodiment of an access device 500 with a BVM 502 disposed at the distal end.

[0076] In some embodiments, as shown in Figure 5A, the balloon 506 comprises a silicone balloon. The thickness of the balloon is about 0.25 mm.

[0077] 5A, the camera module 508 may have a diameter of approximately 1.6 mm. The length of the camera module 508 may be approximately 5 mm. In some embodiments, the camera module includes an integrated lighting system (e.g., LED lighting). The camera module may have a field of view of approximately 110°.

[0078] 5A, the camera module is positioned a distance 513 back from the distal window 507 of the balloon 506. In some embodiments, the distance 513 is about 8 mm (or about 7-9 mm, about 7 mm, about 9 mm, etc.).

[0079] In some embodiments, the long axis of the camera module is positioned a distance 515 above the long axis of the shaft 504 and / or working channel 505. In some embodiments, the distance 515 is about 3.5 mm (or about 3-4 mm, about 3 mm, about 4 mm, etc.).

[0080] As described herein, access devices comprising the BVMs described herein can be adapted and configured to provide working channels for use with a variety of instruments and / or implants, including, but not limited to, grasping forceps, snares, biopsy needles, RF ablation devices, tissue disruptors, ultrasound probes, and the like.

[0081] FIG. 5B shows the field of view from camera 508 in the simulated use environment.

[0082] 6A and 6B are cross-sectional and perspective views of the distal end of one embodiment of an access device 600 comprising a BVM 602. The device 600 comprises a shaft 604 and a balloon 606 coupled to the distal end of the shaft 604. A working channel 605 extends through the shaft 604. A camera module 608 is positioned within the balloon 606. A flexible channel extension 616 extends from the distal end of the shaft.

[0083] In some embodiments, the flexible channel extension 616 is made of silicone.

[0084] The balloon has an asymmetric bulb shape with the majority of its volume located above the shaft 604 and working channel 605. The balloon can increase in diameter from the proximal end to the distal end. The balloon has a curved distal end that serves as a distal window for the camera module 608. The distal window 620 can be sized and shaped to approximate the desired field of view of the camera / illumination / imaging module 608.

[0085] The proximal end of the balloon may be generally tubular with a generally circular cross-section to correspond to the distal end of the sheath 604 .

[0086] The balloon includes a channel 622 shaped to receive the distal end of the flexible channel extension 616. The balloon 606 may be coupled to the flexible channel extension 616 around the channel 622.

[0087] In this manner, a first portion of the distal end of the balloon is shaped to align with and provide access to the working channel 605 in the sheath 604, and a second portion of the distal end of the balloon is sized and shaped to accommodate the desired field of view of the camera / illumination / imaging module 608.

[0088] An inlet channel 610 and an outlet channel 612 extend along the shaft 604 and are in fluid communication with the balloon 606 .

[0089] In some embodiments, the camera module 608 is positioned on top of the flexible channel extension 616 .

[0090] In some embodiments, the balloon is made of silicone, although other materials (e.g., Pebax®, nylon, specially formulated blends such as polyester / PET, TPU / Pebax® and Pebax® / nylon, laminate structures, etc.) can also be used.

[0091] In some embodiments, the durometer of the material may be approximately 80-90A on the Shore A scale (e.g., Shore 85A). Other durometers (e.g., Shore 20-60A, 30-40A, 35-45A, 45-75A, 75-85A, 60-100A, 70-90A, etc.) may also be employed.

[0092] The thickness of the balloon can be about 0.20 to 0.25 mm (or about 0.15 to 0.30 mm, or about 0.10 to 0.35 mm, etc.).

[0093] In some embodiments, the balloon has a uniform thickness. In some embodiments, the balloon has a varying thickness.

[0094] 7A-7F respectively illustrate another embodiment of an access device 700 including a BVM 702. Figures 7A and 7B respectively illustrate an isometric view and a side cross-sectional view of another embodiment of device 700 including a BVM 702. Unless otherwise noted, device 700 includes similar features to device 600.

[0095] The device 700 includes a shaft 704 having a working channel 705 extending therethrough. A flexible extension 716 is located at the distal end of the shaft. The flexible extension 716 is connectable to the shaft.

[0096] In some embodiments, the flexible extension 716 is transparent. Non-transparent (e.g., stainless steel or nitinol) construction can also be employed.

[0097] The distal end of the flexible extension 716 may include a distal tip 728 that tapers to a rounded distal end. Other shapes may also be employed (e.g., as shown in Figures 6A and 6B).

[0098] The camera module 708 is located on a flexible extension 716 .

[0099] The balloon has an asymmetrical bulb shape with most of its volume disposed above a flexible extension 716. The balloon 706 can increase in diameter from the proximal end to the distal end. The balloon has a curved, rounded distal end that serves as a distal window for the camera module 608. The distal window 720 can be sized and shaped to approximate the desired field of view of the camera / illumination / imaging module 708.

[0100] The proximal end of the balloon may be generally tubular with a generally circular cross-section to correspond to the distal end of the sheath 704 .

[0101] The balloon includes a channel 722 shaped to receive the distal end of the flexible channel extension 716. The balloon 706 may be coupled to the flexible channel extension 716 around the periphery of the channel 722.

[0102] In this manner, a first portion of the distal end of the balloon is shaped to align with and provide access to the working channel 705 in the sheath 704, and a second portion of the distal end of the balloon is sized and shaped to accommodate the desired field of view of the camera / illumination / imaging module 708.

[0103] Inlet and outlet channels (not shown) may extend along shaft 704 and be in fluid communication with balloon 706 .

[0104] FIG. 7C is a cross-sectional view of the device taken along line AA in FIG. 7A. In this view, the shaft 704 and balloon 706 are visible. The camera module 708 is shown positioned on the flexible extension 716. As shown in FIG. 7C, the flexible extension may have a feature 734 (e.g., a ridge, a protrusion, etc.) configured to mate with a corresponding feature 732 (e.g., a groove, a recess, etc.). The corresponding mating feature may contribute to a stronger bond between the two components. The camera module 708 and the flexible extension 716 may be bonded to one another. Other configurations are also possible (e.g., glued, etc.). A band 726 may be used to bond the components together.

[0105] 7D-7F show side, top, and end views, respectively, of access device 700 with BVM 702. These views show device shaft 704 and flexible extension 716. Camera module 708 is disposed on the flexible extension. Camera module 708 connector 711 extends proximally from the camera module through shaft 704.

[0106] The plan view of Figure 7E shows that the balloon 706 is generally symmetrical along its width 736 and coaxial with the sheath 704. The side view of Figure 7D shows that the balloon 706 is not symmetrical or coaxial with the shaft 704 along its height 738. Instead, more of the balloon is located above the shaft 704 and working channel 705.

[0107] The flexible extension shown in FIGS. 7D-F includes ridges / ridges 740.

[0108] 8A-8E illustrate the deployment of one embodiment of a BVM similar to that shown in FIGS. 6A-7B. FIGS. 8A and 8B show isometric and side views, respectively, of a fully deployed BVM 802. The BVM 802 can be delivered through an access sheath. In the fully deployed configuration, the camera 808 is positioned at a desired location. The camera module 808 can be retained by a balloon 806 in a working channel extension 816.

[0109] 8C and 8D show isometric and side views, respectively, of a partially deployed or retrieved BVM 802. A retrieved BVM refers to a BVM being retracted into the access sheath. 8C and 8D show a working channel 805 being advanced from the access sheath 804. Retraction of the working channel 805 couples a balloon 806, and in some embodiments, a camera module 808, to the working channel 805, thereby retracting the balloon 806 and camera module 808 along with the working channel 805. For similar reasons, as the working channel 805 advances from the sheath 804, the balloon 806 and camera module 808 also advance from the sheath 804. Once the BVM 802 is advanced from the sheath 804, the balloon can be inflated and the camera can be aimed at a desired location.

[0110] 8E and 8F are isometric and side views of the stowed or retracted state of BVM 802. In the stowed and / or retracted state, portions of the BVM and working channel extension 805 are housed within sheath 804 for device insertion or removal.

[0111] 9A-9C show side, isometric, and cross-sectional views of the distal end of an access device 900 including a BVM 902 in a stowed configuration. A flexible extension 916 is shown positioned within a sheath 904. A portion 940 of the balloon 906, which would be the proximal portion of the deployed balloon, is shown extending from the sheath 904 and folded back. The balloon 906 is in an inverted position relative to its deployed position within the sheath 904. The balloon 906 is not coupled to the interior of the sheath 906. The balloon 906 is coupled to a portion 942 of the flexible extension 916 that is positioned proximal to the distal end 944 of the flexible extension. The flexibility of the extension 916 allows the portion of the extension to fold around the camera module 908, allowing the camera module 908 to fit within the dimensions of the sheath 904. FIG. 9C is a cross-sectional view taken along line BB in FIG. 9A. In this view, extension 916 is shown folded along its upper section, resulting in a deformation and reduction of working channel 906. This deformation of extension 916 allows the camera module to be accommodated within the sheath for insertion and removal. The flexibility of the extension allows it to return to a more tubular shape upon advancement from the sheath, allowing the camera module to be lifted into a desired position.

[0112] 10 is an isometric view of one embodiment of an access sheath 1000 comprising a BVM 1002. The access device comprises a region of controlled flexibility 1050 within the sheath.

[0113] 26A and 26B show one embodiment of a steering mechanism 2668 and control 2670 that can be used within a sheath. The sheath may include pull wires 2672 that can be secured to a distal tip 2671. The sheath includes a stiffer proximal section 2673 and a softer, steerable distal end 2674. A steering knob 2675 on the handle can pull on either of the pull wires 2672, causing the distal end 2674 to articulate.

[0114] As described herein, embodiments of the surgical access device of the present invention equipped with a balloon-based visualization module (BVM) can be used to address a wide range of clinical challenges in various medical procedures. FIG. 3A illustrates one embodiment of a surgical access device in which a BVM is used in a procedure involving surgical access. FIG. 3B illustrates one embodiment of a surgical access device using a BVM in a procedure involving catheter-based (e.g., transjugular) access. It should be understood that, in various embodiments, the device shaft, working channel, and balloon visualization module are adapted and configured to perform one or more steps of a minimally invasive, single-port access, or robotically assisted interventional or surgical procedure to address shortcomings or clinical challenges in various medical procedures. In some specific embodiments, the medical procedures may relate to minimally invasive mitral valve surgery, minimally invasive aortic valve surgery, minimally invasive coronary artery surgery, surgical tachyarrhythmia treatment, and left atrial appendage occlusion.

[0115] 14A and 14B are side cross-sectional and perspective views of the distal end of another embodiment of an access device 1400 including a BVM 1402. FIG. 14C is an exploded view of the distal end of the access device 1400. The device 1400 includes a shaft 1404 having a balloon 1406 coupled to the distal end of the sheath 1404. A working channel 1405 extends through the sheath 1404. A camera module 1408 is positioned within the balloon 1406. A channel extension 1416 extends from the distal end of the working channel 1405.

[0116] The shaft 1404 may comprise a multi-lumen shaft. The lumens may extend within the wall of the sheath or within a central lumen of the shaft. In some embodiments, some lumens are disposed within the wall of the shaft and other lumens are disposed within the central lumen of the sheath.

[0117] In some embodiments, the shaft is flexible.

[0118] The shaft may be 14F in some embodiments, but may also be other diameters (eg, 10-18F, etc.).

[0119] 14C, fluid channels 1410, 1412 extend along shaft 1404 and are in fluid communication with balloon 1406. The fluid channels can be used to inflate, deflate, and purge balloon 1406.

[0120] In some embodiments, the channel extension 1416 is made of an optically transparent material, hi some embodiments, the channel extension 1416 is made of polycarbonate or other thermoplastic.

[0121] The channel extension 1416 may be transparent in some embodiments.

[0122] As best seen in FIG. 14C, the channel extension 1416 includes a notch 1418 extending along at least a portion of the channel extension 1416 .

[0123] The cutout 1418 allows space for the camera module 1408 and a portion of the encased balloon 1406 to be positioned and stowed during delivery and retraction of the device 1400. As shown in Figure 14C, the cutout 1418 may include an upper portion (e.g., upper half, upper third, upper quarter, etc.) of the channel extension. Other configurations may also be employed.

[0124] In some embodiments, the cutout 1418 extends along approximately 60% to 90% of the length of the cutout 1418 .

[0125] In some embodiments, the notch 1418 begins at a location distal to the distal end of the shaft 1404 .

[0126] In some embodiments, the notch 1418 terminates near the distal end of the channel extension 1416 .

[0127] The balloon has an asymmetrical bulb shape with the majority of its volume located above the shaft 1404 and working channel 1405. The balloon 1406 can increase in diameter from a location at or near the proximal end to the distal end. Along the top surface or contour 1407 of the balloon, the balloon 1406 can increase in diameter at a greater rate than the bottom surface of the balloon. The balloon includes a curved distal end that serves as a distal window for the camera module 1408. The distal window 1420 can be sized and shaped to approximate the desired field of view of the camera / illumination / imaging module 1408.

[0128] In some embodiments, the balloon material is refractive index matched to the fluid (e.g., saline) used to fill the balloon to minimize unwanted reflections and distortions on the camera image.

[0129] The proximal end of the balloon is tubular with a generally circular cross-section and can correspond to the distal end of shaft 1404. In some embodiments, the length of the generally tubular proximal end is about 5 mm (or about 4-6 mm, 3-7 mm, 4.5-5.5 mm, etc.).

[0130] In some embodiments, the diameter of the generally tubular proximal end is about 3.6-4.6 mm (or about 3.8-4.4 mm, 4.1 mm, 3.5-4.7 mm, 3-5 mm, 2.5-5.5 mm, etc.).

[0131] The balloon includes a channel 1422 shaped to receive the distal end of the channel extension 1416. The balloon 1406 may be coupled to the channel extension 1416 around the channel 1422.

[0132] In this manner, a first portion of the distal end of the balloon is shaped to align with and provide access to the working channel 1405 in the shaft 1404, and a second portion of the distal end of the balloon is sized and shaped to accommodate the desired field of view for the camera / illumination / imaging module 608.

[0133] In some embodiments, the camera module 1408 is positioned above the balloon channel 1422. A connector 1411 extends proximally from the camera module. The connector 1411 can be configured to provide a data and / or electronic connection.

[0134] In some embodiments, the device 1400 includes a position tracking sensor 1421 (eg, an electromagnetic position tracking sensor) next to the camera module 1408 .

[0135] 14C , a camera mount 1413 can be used to attach the camera module 1408 to the balloon 1406. The camera mount 1413 includes an upper portion 1461 and a lower portion 1462. The lower portion 1462 can include a lumen or opening 1464 configured to be positioned over the balloon channel 1422 in the balloon. The upper portion 1461 can include an opening, slot, or lumen 1466 configured to receive the camera module 1408. In some embodiments, the upper portion 1461 can be coupled at its distal end to a distal portion of the lower portion 1462. The lower surface of the upper portion 1461 can include a shape configured to match the upper surface of the balloon channel 1422.

[0136] In some embodiments, the balloon comprises polyurethane (e.g., Percene 80AE thermoplastic polyurethane). Other materials (e.g., silicone, Pebax®, nylon, specially formulated blends such as polyester / PET, TPU / Pebax® and Pebax® / nylon, multi-layer constructions, etc.) can also be employed.

[0137] In some embodiments, the durometer of the material may be approximately 80-90A on the Shore A scale (e.g., Shore 85A). Other durometers (e.g., Shore 20-60A, 30-40A, 35-45A, 45-75A, 75-85A, 60-100A, 70-90A, etc.) may also be employed.

[0138] The thickness of the balloon can be less than about 0.1 mm (or about 0.05 to 0.01 mm, or 0.05 to 1.5 mm, etc.).

[0139] In some embodiments, the balloon has a uniform thickness. In some embodiments, the balloon thickness varies. For example, balloon channel 1422 may have a greater thickness (e.g., 0.1 mm, 0.2 mm, 0.15 mm, etc.) in some embodiments.

[0140] In some embodiments, the balloon is made of a non-compliant material, in which the balloon material does not stretch when pressurized.

[0141] In some embodiments, the balloon is made of an optically transparent material, although non-optically transparent materials can also be employed.

[0142] 15A is a cross-sectional view of one embodiment of a multi-lumen shaft 1500 (e.g., similar to multi-lumen shaft 1406). The shaft may be constructed of a flexible material. In some embodiments, the shaft is laminated. The outer portion of the shaft may comprise a jacket. The jacket may comprise a thermoplastic tubing.

[0143] The shaft comprises four lumens 1502, 1504, 1506, 1508 embedded in its wall. The lumens 1502, 1504 can be configured to receive fluid lines (e.g., fluid lines 1410, 1412). In some embodiments, the fluid lines are made of plastic (e.g., a high melting point plastic).

[0144] Lumen 1506 may be configured to receive a connector for a camera module (e.g., connector 1411). Lumen 1510, in some embodiments, may be configured to receive position tracking sensor wiring. While the lumen is shown as embedded within the shaft wall, it should be understood that in some embodiments, the lumen may extend along the interior of shaft 1406.

[0145] In some embodiments, lumens 1502, 1504, 1506 may have an inner diameter of about 0.4-0.6 mm (or about 0.3-0.7 mm, about 0.45-0.55 mm, about 0.5 mm, etc.).

[0146] In some embodiments, the working channel 1505 extending through the shaft has a diameter of about 8-9F (or about 7-10F, 6-11F, etc.).

[0147] In some embodiments, the outer diameter of the shaft is about 15F (or about 14-16F, about 13-17F, etc.).

[0148] A tube 1511 can extend through the central lumen, forming a working channel 1505. In some embodiments, the tube 1511 is made of a thermoplastic resin. Other materials can also be employed (e.g., metal). The tube 1511 can have a braided construction.

[0149] In some embodiments, additional lumens are included (eg, lumens for sensors, light output, heat transfer, etc.).

[0150] It should be understood that the lumens or tubes described herein may have a circular, oval, flat, or other shape through which fluids and other objects pass.

[0151] It should be understood that in some embodiments, one or more working channels (e.g., two, three, four, five, six, etc.) are contemplated. Figure 15B is a cross-sectional view of a shaft 1500 comprising a dual lumen working channel tube 1511 having two lumens 1520, 1522. The shaft 1500 comprises a wall 1524 separating the two lumens 1520, 1522. Fluid channels 1502, 1504 and a lumen 1506 for receiving a camera module connector are also shown.

[0152] A multi-lumen shaft can be constructed by inserting lumens or tubing for the working fluid channels and camera module connectors onto the exterior of the working channel tubing. The working channel tubing can be positioned on a mandrel. A jacket tubing can be positioned over all tubing / lumens. Heat shrink can be applied over the assembly. When heated, the jacket tubing melts around the inner tubing and lumens. After removal of the heat shrink, the individual components form an integrated multi-lumen shaft.

[0153] 16 is a perspective view of the distal end of one embodiment of extension channel 1616 (e.g., extension channel 1416) and shaft 1606 (e.g., shaft 1406). Shaft 1606 and working channel 1605 are visible in FIG. 16. Fluid channels 1610, 1612 and a camera module connector 1611 extend through shaft 1606. A camera module is shown connected to connector 1611. An extension 1616 extends from and is coupled to the distal end of channel 1605. In some embodiments, extension 1616 extends from the distal end of the shaft.

[0154] In some embodiments, the working channel 1605 extends through the distal end of the shaft before being coupled to the extension 1616 .

[0155] The channel extension 1616 has the advantage of providing axial strength to the balloon, preventing it from collapsing when pressed against the target tissue.

[0156] In some embodiments, the camera module 1608, in the stowed state, blocks a portion of the working channel 1605 and / or channel extension 1616. This prevents full access to the working channel until the balloon is sufficiently inflated to lift the camera module out of the way of the working channel. In some embodiments, when the BVM is in the stowed state, the working channel is sufficiently open to allow the passage of some instruments (such as a guidewire or dilator).

[0157] 28 illustrates one embodiment of a channel extension 2816. The channel extension may comprise a distal mating portion 2802, a ring 2804, a notch 2818, and a proximal mating portion 2806.

[0158] The distal mating portion 2802 and the proximal mating portion 2806 can be used to aid in connecting the channel extension to other portions of the device. The mating of the channel extension can be achieved, for example, by bonding, welding, or other joining methods. The mating portions can consist of grooves, threads, snap fits, etc.

[0159] In some embodiments, the channel extension is made of a transparent material. Non-transparent materials can also be employed.

[0160] The channel extension may be rigid or flexible.

[0161] In some embodiments, the channel extension is made of a thermoplastic material, although other materials may also be employed (e.g., metal or ceramic).

[0162] The channel extension may have a diameter of about 8F or 2.6 mm (or about 2.1-3.1 mm, 2-3 mm, 1.5-3 mm, etc.).

[0163] FIGS. 29A-29K illustrate various embodiments of the channel extension 2916 with various proximal 2906 and distal 2902 mating portions. The mating portions 2906, 2902 may be comprised of tabs or protrusions (FIGS. 29A, B, D, E, G, H, I), ridges (FIGS. 29C, 29J, 29K), apertures (FIGS. 29B, 29D, 29E, 29G, 29H, 29I), or any combination thereof. The ridges may be fully circular, as shown in FIG. 29C, or segmented, as shown in FIGS. 29J and 29K. A notch 2918 may extend along the body of the channel extension between the mating portions 2906, 2902. The embodiment shown in FIGS. 29A-29K is a top view of the elongated, generally rounded rectangular top portion of the notch 2918. FIG. 29F illustrates an embodiment in which the size of the cutout 2918 is maximized while minimizing the proximal and distal distal fit. The lower portion of the cutout 2918 may be solid, as shown in FIGS. 29A, 29B, 29C, 29G, 29H, 29I, 29J, and 29K. Additionally or alternatively, the lower portion of the cutout 2918 may include various patterns (e.g., repeating oval cutouts, an aperture grid, a lattice structure, etc.), as shown in FIGS. 29D-29F. The shape, size, and dimensions of the cutout 2918 are related to the size of the balloon and balloon visualization module in the stowed state. A larger balloon may result in a longer channel extension between the proximal and distal coupling mechanisms. A larger balloon visualization module, or a balloon visualization module with multiple modes or multiple cameras, may result in greater variation and modification of the length and shape or contour of the cutout 2918. Additionally, in other channel extension embodiments, the cutout bottom of the channel extension can accommodate changes in structural properties to alter either flexibility or stiffness when used with a balloon. Additionally or alternatively, modifications to the cutout bottom can be provided to increase the field of view (i.e., have more open space at the bottom). In other configurations, the channel extension is formed from an optically clear material selected to minimize interference with the camera's field of view or the optics of the balloon visualization module.

[0164] 29L and 29M show perspective and side views of one embodiment of a channel extension 2916. The channel extension 2916 has a proximal mating portion 2906 and a distal mating portion 2902. A cutout 2918 has a top and a bottom that form a side rail that extends from the proximal end to the distal end and terminates at the distal mating portion 2902. The use of a structure such as the cutout 2918 maximizes storage space for the balloon and balloon visualization module, while also maximizing the field of view by removing the bottom portion of the channel extension.

[0165] Figures 29N and 29O are perspective and side views of a channel extension 2916. The channel extension 2916 includes a proximal fitting 2906. The channel extension 2916 includes a single cutout 2918 forming a semi-tubular configuration. As in Figure 29L, the distal ring does not include a distal fitting. Alternatively, the balloon distal legs may be attached to the distal portion of the bottom surface of the channel extension (see, for example, Figures 20A-24D).

[0166] 30A-30D each show an embodiment of a channel extension 3016 with multiple lumens.

[0167] 30A and 30B are perspective and side cross-sectional views, respectively, of a channel extension 3016 comprising two lumens 3002, 3004. The channel extension 3016 comprises a single notch 3018 disposed within the top lumen 3002. The channel extension 3016 comprises a distal end ring 3006. A wall 3008 separates the two lumens 3002, 3004. The channel extension 3016 comprises a proximal mating portion 3010 comprising a ring of multiple openings.

[0168] 30C and 30D are perspective and side cross-sectional views of a channel extension 3016 comprising two lumens 3002, 3004 and two cutouts 3018 disposed in each lumen. The channel extension 3016 comprises a distal end ring 3006. A wall 3008 separates the two lumens 3002, 3004. The channel extension 3016 comprises a proximal mating portion 3010 comprising a ring of multiple openings. It should also be understood that more than two lumens (e.g., 3, 4, 5, 6, etc.) can be employed.

[0169] FIG. 31 illustrates various embodiments and various different possible channel extension numbers, notches, and proximal and distal coupling mechanism configurations. In one aspect, the channel extension can be considered to have a generally cylindrical overall shape. In some specific embodiments, the proximal end of the channel extension is coupled to the distal end of the elongate body. Additionally or alternatively, the proximal end may be used to provide a physical connection point for the balloon inflation line, balloon deflation line, camera power and imaging connections, and other control lines as needed, depending on the specific function of the balloon and balloon visualization module. The proximal end may be adapted and configured to couple to the proximal end of the balloon (see, e.g., FIGS. 14A, 14B, 14C, or 33). In other aspects, the proximal end is adapted and configured to couple to the distal end of the balloon. In this aspect, the inverted end of the distal end of the balloon is bonded, joined, or otherwise coupled to the proximal end of the channel extension. Thus, the proximal end and mating portion 3106 are provided for these and other purposes and can have a variety of configurations. The distal end of the channel extension is used to mate with the distal end of the balloon and provide additional structural and longitudinal support for the balloon. The upper portion of the cutout 3118 is used to provide space for the balloon and balloon visualization module. The lower portion of the cutout 3118 is used to adjust structural characteristics or to remove material that may obstruct or impede the view of the camera in the balloon visualization module. Each embodiment shown in FIG. 31 includes an elongated upper cutout that forms the proximal end and distal ring. The lower cutout can be full-length, as shown in FIGS. 31A1 / 2, 31B1 / 2, 31E1 / 2, 31F1 / 2, and 31G1 / 2, or partial-length, as shown in FIG. 31D1 / 2. The resulting channel extension has a generally cylindrical end, with the distal end terminating in a pair of side rails that differ in size based on the relative dimensions of the upper and lower cutouts. As an exaggerated example of this aspect, compare the width of the side rail in Figure 31G2 with the width of the side rail in Figure 31C2.

[0170] Further aspects of the various channel extension embodiments can be understood by reference to the front perspective views of Figures 31H1-31M1 and the rear perspective views of Figures 31H2-31M2. Like the embodiments of Figures 31A1-31G2, each illustrated channel extension embodiment has a long upper notch. The distal end mating portion is similarly arranged in a ring, and various sizes of side rails or side walls are shown. The lower notch may be provided along the entire length, as shown in Figure 31I1, or only along the lower distal portion or lower half, as shown in Figures 31H1, J1, K1, L1, and M1. Additionally, the proximal end of Figures 31H-31M2 includes functional features not found in the embodiments of Figures 31A1-31G2. The proximal end may include modifications for mating with portions of a balloon and may include mechanical connections for balloon inflation and deflation, as well as connections for a camera, power source, or image processing.

[0171] 17A and 17B are side cross-sectional views of balloon 1606 alone and balloon visualization module 1602 including balloon 1606. Unless otherwise noted, the balloon and balloon visualization module may be similar to those described above (e.g., balloon 1406 and BVM 1402).

[0172] The balloon has a tubular profile at the proximal end 1701, from which the upper surface 1407 extends radially outward from the longitudinal axis of the channel 1722. The upper surface 1407 may extend radially outward from the longitudinal axis 1723 of the channel 1722 at an angle of about 40-50° (or about 45°, about 30-60°, about 25-65°, about 20-70°, etc.).

[0173] The balloon's underside or profile 1725 may extend from the proximal portion at an angle of about 5-20° (or about 5-15°, 5-10°, 5-25°, 10-20°, 10-25°, 15-25°, etc.).

[0174] The distal portion of the balloon provides a contact visualization surface 1720 of the balloon 1706. The contact visualization surface 1720 may have a rounded shape.

[0175] 17B shows the field of view 1727 of the camera module 1708. As shown in FIG. 17B, when the camera module is in the deployed position, the field of view of the camera module 1708 includes a majority of the contact visualization surface. In some embodiments, the field of view of the camera module includes at least 95% of the contact visualization surface (or about 90%, or about 85%, or about 80%, or about 75%, or about 70%, etc.).

[0176] Balloon channel 1722 is positioned to surround the periphery of channel extension 1716. The asymmetrical structure allows the balloon to closely surround the effective volume of the device, minimizing blood displacement and flow disturbances (e.g., within the heart). This structure is described in more detail below (e.g., Figures 22A-22C).

[0177] In some embodiments, the balloon may be symmetrical (e.g., spherical, conical, cylindrical, etc.), allowing for specialized treatments and ease of manufacturing.

[0178] In some embodiments, the camera module may be positioned at a non-perpendicular angle to the working channel, in which case the contact visualization surface may be located on the side of the balloon with the angled camera arrangement.

[0179] As shown in FIG. 17A, in some embodiments, the balloon height 1702 in an inflated state may be about 12-14 mm (or about 13 mm, or about 11-15 mm, or about 12.75-13.23 mm, or about 10-13 mm, or about 11-13 mm, or about 11-14 mm, or about 12-15 mm, etc.).

[0180] In some embodiments, the diameter of the balloon channel 1722 may be about 3-3.8 mm (or about 3.3-3.5 mm, or about 3.4 mm, or about 3-4 mm, or about 2-5 mm, or about 2.5-4.5 mm, etc.).

[0181] In some embodiments, the length of the balloon channel 1722 is about 16-17.4 mm (or about 16.5-16.9 mm, or about 16.7 mm, or about 15-18.4 mm, or about 14-19.4 mm, or about 15.5-18.9 mm, etc.).

[0182] 18A and 18B show two configurations of camera module mount 1811. Camera module mount 1811 is shown in use with a device such as device 1400. In FIG. 18A, camera module mount 1811 is shown attached to channel extension 1816. In FIG. 18B, camera module mount 1811 is shown attached to balloon channel 1822.

[0183] The camera module mount is configured to hold the camera in place for visualization and allows the camera module to flex within the instrument channel during insertion and withdrawal.

[0184] The camera module mount can be configured to hold the camera horizontally or at an angle depending on the requirements of the procedure and the shape of the balloon.

[0185] In some embodiments, the camera module comprises a 400x400 pixel color camera module. The camera module may have a field of view of approximately 110° in air and approximately 80° in water. Other fields of view (e.g., 100-180°, 100-170°, 100-160°, 100-150°, etc.) may also be employed.

[0186] In some embodiments, the camera module comprises an integrated camera module and lighting (eg, LED) system.

[0187] 19A and 19B are side views of one embodiment of a BVM 1902. A camera module 1906 is positioned on the camera mount. As shown in FIG. 19, the camera module can be positioned at an angle relative to the long axis of the channel extension 1916. For example, the angle can be approximately 0-10° (or 1-20°, 5-10°, 5-15°, 5-20°, etc.).

[0188] In some embodiments, the camera module can be configured to select a distance from the contact visualization surface 1920 and an angle α with respect to the long axis 1923 of the channel extension 1916 such that the field of view 1927 of the camera module 1908 corresponds to or covers the periphery of the contact visualization surface 1920.

[0189] The distance between the camera module and the touch visualization surface may be approximately 8-13 mm in some embodiments.

[0190] The positioning of the camera module 1908 can be such that a portion of the distal end of the channel extension 1916 is visualized by the camera module. In some embodiments, about 6-7 mm (or about 7 mm, or about 5-9 mm, or about 6.5-7.5 mm, etc.) of the top 1929 of the distal end of the channel extension is included within the field of view 1927. In some embodiments, about 2-3 mm (or about 1-4 mm, 1.5-3.5 mm, 2.5 mm, etc.) of the bottom 1931 of the distal end of the channel extension 1916 is included within the field of view 1927.

[0191] Figure 19B shows the perspective from camera module 1908. As shown in Figure 19B, in some embodiments, channel extension 1916 is visible in lower portion 1947 of the field of view. Channel extension 1916 may comprise approximately one-third (or approximately 30-35%, 30-40%, 25-35%, 20-40%, 15-45%, etc.) of lower portion 1947 of the field of view of the camera module.

[0192] The shape and size of the window 1920 can be optimized depending on the goal of the procedure. For example, a procedure at the apex of the heart can use a smaller field of view and a smaller distal radius 1949, while a procedure at a valve may require a larger field of view and a larger radius 1949.

[0193] 20A and 20B show an embodiment of balloon 2002 during two steps of the manufacturing process. FIG. 20A shows manufactured balloon 2002. The shape of the balloon can be set by a blow mold tool. As manufactured, balloon 2002 comprises an optical window 2033, distal legs 2035, a balloon body 2037, and proximal legs 2039. Distal legs 2035 comprise a generally tubular shape with an open distal end 2041. Proximal legs 2039 comprise a generally tubular shape with an open proximal end 2043. Proximal legs 2039 can be shorter than the distal legs.

[0194] 20B shows the balloon 2002 in an assembled state, with the distal legs 2035 folded back to be closer to the optical window 2033.

[0195] The balloon can be in four states: non-overinflated, overinflated, partially inflated, and overinflated. Each balloon state can be achieved by filling the balloon with fluid (air, saline, or other fluids) using one or more fluid lines. The balloon can be purged by continuously flowing fluid through the balloon.

[0196] When the balloon is in an under-inflated, inflated, or over-inflated state, it displaces blood from the camera system's field of view. The BVM is deployed to the target area through the access sheath, and then the balloon is (under- / over-) inflated. In this state, contact optical visualization is achieved when the balloon's optical window is pressed against the surface tissue of the heart. The balloon pressure can be set to gently conform the distal window to the target tissue, reducing unnecessary pressure on the target tissue.

[0197] Balloon inflation and purging can be managed by a fluid pump or syringe operator.

[0198] The distal legs 2035 of the balloon 2002 are positioned around the channel extension and are joined to the proximal end of the distal end of the channel extension.

[0199] In embodiments in which the camera module is coupled to the balloon, the camera module may be bonded (or otherwise attached) to the distal legs 2035 after being folded back inside the balloon.

[0200] The proximal leg 2039 of the balloon can be bonded (or otherwise attached) to the outer portion of the shaft (e.g., the outer jacket), and the distal leg of the balloon can be bonded (or otherwise attached) to the working channel of the device, near the opening 2041.

[0201] 27A and 27B show an embodiment of a method for inflating and deflating a balloon. Before the balloon is inflated, the fluid channels 2710, 2712 and balloon 2706 are purged to remove air from within the channels and balloon. The balloon assumes its full shape in the inflated state. By maintaining constant pressure within the fluid channels and balloon body, stiffness can be maintained.

[0202] To perform purging, a syringe or fluid pump 2702 is connected to the fluid inlet 2704 on the handle 2707. A stopcock 2708 can be connected to the fluid outlet 2714. During purging, the stopcock 2708 is in the open position, and the syringe 2702 continuously pumps fluid from the fluid inlet 2704 to the balloon 2706 and out of the system via the fluid outlet 2714. During purging, the pressure in the balloon 2706 is not constant, so the balloon does not become inflated. In some embodiments, approximately 100 ml of fluid is flushed through the fluid channels and balloon during purging. Purging can be performed twice before inflating the balloon, although fewer or more purges can be performed. Once purging is complete, the stopcock 2708 is moved to the closed position.

[0203] After purging the balloon 2706, a syringe 2702 or pump filled with fluid (e.g., saline) is connected to the fluid inlet 2704. A pressure sensor can be connected to the fluid inlet 2704. A stopcock 2708 is closed at the fluid outlet 2714. Fluid from the syringe 2702 or pump is forced through the fluid inlet 2704 and into the balloon 2706. Pressure can be measured continuously. If the pressure sensor detects an increase in pressure, the injection of fluid can be stopped. At this point, the balloon is inflated.

[0204] The over-inflated state can be achieved by injecting more fluid into the balloon after it has reached its inflated state.

[0205] To deflate, the stopcock 2708 is closed, and then the syringe 2702 or pump is used to aspirate fluid until the pressure sensor detects negative pressure.

[0206] 21A-21D show side views of various balloon embodiments that can be used with the devices described herein. As shown in these embodiments, the balloons can have symmetric or asymmetric balloon bodies. The proximal and distal legs can be aligned or non-aligned with respect to one another. Additionally, the proximal and distal legs can be aligned or offset relative to the longitudinal axis of the balloon. Additionally, the optical window can be convex or concave in shape. Any combination of these features can also be used.

[0207] FIG. 21A shows an embodiment of a balloon having a balloon body 2137 that is symmetrical about a longitudinal axis, with an optical window 3133 having a convex surface, in which the centers of the proximal leg 2139 and the distal leg 2135 are aligned with each other.

[0208] 21B shows an embodiment of a balloon having a balloon body 2137 that is asymmetrical about its longitudinal axis (e.g., shaped like balloon 2002). The proximal leg 2135 and distal leg 2139 are centered relative to one another. The optical window 2133 comprises a convex surface.

[0209] 21C shows an embodiment of a balloon having a balloon body that is symmetrical about its longitudinal axis. The distal leg 2135 and proximal leg 2139 are not aligned with one another. The proximal leg 2139 is aligned with the longitudinal axis of the balloon. The distal leg is positioned off-axis relative to the longitudinal axis of the balloon. The optical window 2133 has a concave surface.

[0210] 21D shows an embodiment of a balloon having a balloon body 2137 that is asymmetrical relative to its longitudinal axis. The distal leg 2135 and proximal leg 2139 are eccentric (i.e., not aligned with one another). The distal leg 2135 is aligned with the longitudinal axis of the balloon. The proximal leg 2139 is positioned off-axis relative to the longitudinal axis of the balloon. The optical window 2133 comprises a convex surface.

[0211] 22A-22C illustrate an embodiment of a method for connecting the balloon 2202 and the channel extension 2216. In FIG. 22A, the channel extension 2216 is shown positioned over the mandrel 2242. The balloon 2206 is shown with the distal legs 2235 positioned over the channel extension 2216. The heat shrink 2240 is shown positioned over the distal legs 2235. The application of heat bonds the balloon 2202 and the channel extension.

[0212] In Figure 22B, the distal legs 2235 of the balloon are positioned over the channel extension 2216. A mandrel 2242 is shown extending into the channel extension 2216. An adhesive is applied between the distal legs 2235 and the channel extension 2216.

[0213] 22C shows the assembled balloon with the distal leg, i.e., channel extension 2216, coupled (e.g., laminated or bonded) to the balloon channel 2222. The proximal leg 2239 of the balloon is laminated or bonded to the outer diameter of the shaft 2204.

[0214] 23A-23C show embodiments of methods for connecting the camera support 2311 to the distal leg 2335 of the balloon 2302. These methods may be performed with or without a mandrel. FIG. 23A shows the channel extension 2316 positioned over the mandrel 2340. The distal leg 2335 is positioned above the channel extension 2316. As shown in FIG. 23B, an adhesive 2345 can be applied between the camera support 2311 and the distal leg 2335 to bond them together.

[0215] 23C shows camera support 2311 positioned over distal leg 2335 and channel extension 2316. Upon heating, camera support 2311 (e.g., constructed from plastic) is laminated to distal leg 2335 of balloon 2306.

[0216] 23D shows the assembled BVM 2302 with the distal legs of the balloon retracted proximally within the balloon to form a balloon channel 2322 with channel extension 2316. A camera mount 2311 is shown coupled to the balloon channel 2322. A camera module 2308 is positioned within the camera mount 2311.

[0217] 24A-24D show an embodiment of a method for connecting the shaft 2404 to the balloon 2406 and channel extension 2416. FIG.

[0218] 24A shows the balloon 2406 and distal leg 2435. The distal leg 2435 is positioned over the channel extension 2416. The channel extension is positioned over the mandrel. The shaft 2404 is positioned on the mandrel 2440 distal to the distal leg 2435 and the channel extension 2416. The working channel 2405 of the shaft 2404 extends beyond the end of the shaft 2404. The camera support 2411 is coupled to the distal leg 2435.

[0219] 24B shows channel extension 2416 connected to working channel 2405. Distal leg 2435 of balloon 2406 (or, in some embodiments, an outer thermoplastic layer) is positioned over the junction of working channel 2405 and channel extension 2416.

[0220] 24C shows heat shrink 2442 applied to the junction of working channel 2405 and channel extension 2416, and where distal leg 2435 extends. When heat is applied, the layers melt together, bonding the pieces together.

[0221] FIG. 24D shows working channel 2405 of shaft 2404 laminated with distal leg 2435 and channel extension 2416 of balloon 2406 (or outer thermoplastic layer).

[0222] It should be understood that in some embodiments, the parts may be joined by other methods (eg, adhesives).

[0223] 25 shows one embodiment of the proximal end of device 2500. A proximal entry point 2564 into the working channel is shown. Entry point 2564 may include a hemostatic seal. Device 2500 may include a fluid channel 2566 that can be used to flush and purge the working channel.

[0224] Figures 32A-32C illustrate one embodiment of a method for deploying a balloon visualization module (BVM) from a stowed state. Figure 32A shows the BVM 3200 in a deflated state. The camera module connector 3202 is in a relaxed state.

[0225] As shown in FIG. 32B, when the BVM 3200 is inserted distally into the sheath 3201, the balloon 3205 wraps more tightly around the channel extension 3206.

[0226] When the BVM 3200 is fully inserted into the sheath 3201, the camera module 3208 moves into the notch in the channel extension and is housed therein.

[0227] 33 illustrates an embodiment of a BVM 3300 that includes multiple cameras or imaging sensors 3304. The additional cameras or imaging sensors can operate outside the visible wavelength spectrum (e.g., ultraviolet or infrared) and can provide additional information about the structure being inspected (e.g., thermal images). Embodiments with multiple cameras have the advantages of an expanded field of view, increased resolution, 3D imaging, and / or thermal image capture.

[0228] 34 provides one embodiment of an access device 3400 including a BVM 3402 as described herein. The device 3400 includes a handle 3403. A sheath 3404 extends from the handle. The BVM 3402 and shaft extend through the sheath 3404. The handle 3403 includes a control 3475 for affecting steering of the distal end of the sheath.

[0229] It should be understood that the handle 3403 may include the features described with respect to the device 2500 of Figure 25 and the device of Figure 27B.

[0230] Figures 37A-37D show an embodiment of a balloon 3702 with a distal window 3704 equipped with an optical scale. Figures 37A and 37C show a perspective view of the BVM and a field of view from camera 3706 of a BVM with a balloon equipped with an optical scale including a dot grid, respectively. Figures 37B and 37D are perspective views of a BVM with a balloon having an optical scale including crosshairs, respectively. Other optical scales can also be used on the balloon's distal window.

[0231] Figure 38A shows the field of view from the camera module using the BVM shown in Figures 37A and 37C. Figure 38B shows the field of view from the camera module using the BVM as shown in Figures 37B and 37D. The scale allows for precise positioning relative to the target tissue and accurate measurement of the size of the tissue structure. The working channel 3802 (e.g., channel extension) is shown at the bottom of the field of view.

[0232] Figure 39 shows an example of how the BVM can be used as a tissue manipulator. The device 3900 is positioned near the tricuspid valve. As shown in Figure 39, the balloon 3902 gently stabilizes or supports the mobile (or unstable) structure and can be used to locate the appropriate location for a therapeutic or surgical instrument or implant. In Figure 39, the balloon 3902 is shown supporting a mobile or unstable tissue segment 3904 (e.g., a tendon, valve, etc.).

[0233] 44A-44D show further embodiments of a camera support or mount. The camera support can function as a position fixture for the camera. The position of the light source of the camera module may or may not be fixed to the camera support.

[0234] The camera support can be configured to accommodate one or more camera modules.

[0235] The camera support may be constructed of plastic (e.g., additive manufacturing, injection molding, etc.). Other materials may also be employed (e.g., metal, ceramic, silicone).

[0236] The camera support can be secured to the balloon channel, and in some embodiments has a structure that completely surrounds the balloon channel.

[0237] 44A shows one embodiment of a camera support 4402. The support includes a bottom surface 4404 configured to be bonded to a component of the device (e.g., a balloon channel). The surface 4404 may be contoured to better fit the component to be bonded.

[0238] The camera support further comprises a platform 4406. The camera module may be disposed on the platform 4406.

[0239] In some embodiments, the camera support comprises a slot 4408. A camera module 4410 can be configured to be placed in the slot 4408, as shown in FIG. 44B. The slot 4408 and / or the platform 4406 may be sized to accommodate the size of the camera module.

[0240] 44C and 44D show another embodiment of a camera support 4420. The support includes a bottom surface 4422 configured to be bonded to a component of the device (e.g., a balloon channel). The surface 4422 may be contoured to better fit the component to be bonded.

[0241] The camera support further comprises a platform 4424. The camera module may be disposed on the platform 4424.

[0242] In some embodiments, the camera support includes a slot 4426. A camera module 4428 can be configured to be positioned within the slot 4426, as shown in FIG. 44B. The slot 4426 differs from the slot 4408 in that it is open at the top to expose the top of the camera module 4428. The slot 4426 and / or the platform 4424 may be sized to accommodate the size of the camera module.

[0243] The camera support may be coupled to the balloon channel (see, e.g., FIGS. 23A-23C), after which the camera module can be placed into a slot in the camera support and secured to the support (e.g., with adhesive).

[0244] As shown in FIGS. 45A-45C, a camera support 4502 can be used to set the central axis angle of the camera view relative to the long axis 4504 of the working channel / channel extension 4506. FIG. 45A shows a camera support 4502 with a parallel platform 4508. Such a camera support positions the central axis angle parallel to the long axis of the working channel / channel extension. FIG. 45B shows a camera support 4502 with an angled platform 4510. The platform angle 4512 positions the camera view axis 4502 at an angle 4514 relative to the long axis 4504 of the working channel / channel extension. The platform angle 4512 can be set to substantially correspond to the angle 4514 of the camera view axis relative to the long axis of the working channel / channel extension.

[0245] 35 illustrates one embodiment of a method 3500 of using a BVM device. The method includes, in step 3502, advancing an access sheath to a position adjacent or proximal to a surgical site.

[0246] Step 3504 includes sheathing the BVM device by advancing a shaft with the BVM coupled to its distal end relative to the access sheath.

[0247] The method comprises a step 3506 of transitioning the BVM to a visualization state, which may include inflating a balloon to move the camera module to a desired position.

[0248] Step 3508 includes positioning a distal portion of the device (eg, BVM) adjacent to the surgical site using imaging by a camera module within the BVM.

[0249] The method includes a step 3510 of performing one or more steps of the interventional procedure using a tool delivered using the working channel and channel extension of the shaft.

[0250] Step 3512 includes performing one or more steps or portions of the interventional procedure while directly visualizing the surgical field, surgical instruments, or surgical site using output from a camera in the BVM.

[0251] The method comprises a step 3514 of transitioning the BVM out of the visible state.

[0252] Step 3516 includes retracting the BVM into a stowed position within the access sheath.

[0253] FIG. 36 illustrates one embodiment of a method for performing an interventional procedure using a BVM device.

[0254] The method includes navigating 3602 the access sheath to a desired location when the BVM is uninflated and housed within the access sheath.

[0255] Step 3604 includes advancing a shaft with a BVM at its distal end from its retracted position within a sheath.

[0256] The method includes flushing the fluid lines and balloon 3606. Flushing may include continuously supplying fluid to the fluid lines and balloon.

[0257] Step 3608 involves pumping fluid into the interior of the balloon to initiate the transition to an inflated state.

[0258] The method includes a step 3610 of increasing the amount of fluid to expand the balloon and lift the camera module from the stowed state.

[0259] Step 3612 includes continuously pumping fluid into the balloon so that the balloon reaches a fully inflated state until the camera module reaches a position where it can view the surgical field.

[0260] In some embodiments, visual feedback is used to determine when inflation is complete: inflation is determined to be complete when there is a clear view with no significant wrinkles visible in the camera's field of view.

[0261] In some embodiments, a fixed volume can be used to determine full inflation: the balloon can be set to inflate with a defined volume of fluid (e.g., saline).

[0262] In some embodiments, active pressure control can be used to determine when inflation is complete. The balloon pressure can be measured directly at the proximal end of the fluid line. Based on the pressure data and a syringe pump connected to the fluid inlet, a control loop can be established to provide one or more of the following functions: maintaining constant balloon pressure, detecting balloon leaks, and sensing contact force with tissue.

[0263] The method includes a step 3614 of maintaining the balloon inflated to gently conform to the tissue at the treatment site during the procedure.

[0264] Step 3616 includes, once the procedure is complete, deflating the balloon and retracting it into the access sheath, thereby collapsing or bending the camera module into the outer diameter of the sheath.

[0265] The sheath and BVM can then be withdrawn from the vessel.

[0266] Ablation (atrial fibrillation) Current state of the art Ablation is a surgical treatment option for atrial fibrillation (AF). AF is a common cardiac disorder associated with irregular heart rhythms and a subsequent increased risk of stroke and heart failure. The procedure requires visualization of the abnormal area and the use of surgical ablation devices. The basic principle of this treatment is to apply radiofrequency or cooling energy to the abnormal area to create scar tissue, preventing the area from conducting electrical signals to the heart and maintaining sinus rhythm. However, despite its widespread use, this treatment carries risks, including bleeding, infection, and damage to the heart valves.

[0267] Clinical problems to be solved The procedure can be performed using a catheter (through an intravascular catheter to perform radiofrequency or cryoballoon pulmonary vein isolation) or through minimally invasive video-assisted or fully thoracoscopic procedures. In video-assisted thoracoscopic surgery (VATS), a small camera and surgical instruments are inserted into the chest through a minimally invasive incision. Other treatments include a minimally invasive right minithoracotomy (RMT) using the Cox-Maze procedure (combining radiofrequency and cooling energy), or as an add-on to other cardiac procedures.

[0268] Thus, in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured to perform one or more steps of a minimally invasive, single port access, or robotic-assisted interventional or surgical procedure, addressing shortcomings or clinical issues associated with procedures for ablation (atrial fibrillation), or optionally, improving visualization through the application of BVM, and addressing challenges associated with providing various instruments and devices utilizing a hybrid working channel.

[0269] An example of a method for performing pulmonary vein ablation using a BVM is described below. The device is placed in the left atrium, for example, according to steps 3502-3508 of method 3500 described with reference to FIG. 35 or steps 3602-3614 of method 3600 described with reference to FIG. 36. The method further includes maintaining visualization of the pulmonary vein ostium (see FIG. 40B, which shows the BVM device positioned toward the pulmonary vein) and advancing an ablation electrode into the working channel. A series of spot ablations are performed while positioning the ablation electrode using the output of the BVM's camera module. The output of the BVM's camera module is also used to visually confirm the formation of a continuous coagulation zone around the vein ostium. The ablation electrode is then retracted from the working channel of the BVM shaft.

[0270] Thereafter, steps 3514 and 3516 of method 3500 described in connection with FIG. 35 or step 3616 of method 3600 described in connection with FIG. 36 may be performed to withdraw the sheath from the vessel.

[0271] 40A shows the field of view of the camera module during an ablation procedure. An ablation electrode 4002 is shown within the working channel 4004 (e.g., a channel extension). A pulmonary vein 4008 and previously ablated surface 4006 are visible within the field of view. A target site 4010 for the next spot ablation, forming a continuous ablation line around the vein ostium, is shown near the distal end of the channel 4004.

[0272] LAA occlusion Current state of the art The left atrial appendage (LAA) is a sac-like portion of the left atrial wall of the heart, and its anatomical shape is highly variable. External shapes include round, triangular, and teardrop-shaped, while internal structures include chicken-wing, cactus, windsock, and cauliflower shapes. In the case of atrial fibrillation (AF), the LAA contributes to thrombus formation and increases the risk of stroke, making treatment necessary. Currently, there are two methods for treating the LAA: left atrial appendage closure and left atrial appendage amputation (LAAE).

[0273] Clinical problems to be solved The anatomical morphology of the LAA is diverse, which complicates treatment, making it necessary to visualize the shape of the LAA before and during treatment.

[0274] In LAAO, a catheter-based device (with a lobe- or umbrella-shaped tip) is inserted intravascularly into the LAA to occlude blood flow. Preoperative imaging is typically performed before the procedure. The gold-standard imaging modality is transesophageal echocardiography (TOE), either 2D or 3D imaging. Cardiac computed tomography angiography (CCTA) is also used. 3D imaging provides a more accurate depiction of the LAA anatomy than 2D imaging, but suffers from poor temporal resolution. Furthermore, intraprocedural imaging modalities, such as fluoroscopy (2D imaging), do not provide sufficient anatomical detail or guidance to visualize the planned structural cardiac intervention.

[0275] LAA closure can be performed surgically, either as a concomitant procedure during open-heart surgery or as a standalone procedure as part of minimally invasive ablation procedures (mini-thoracotomy or thoracoscopic surgery). However, this procedure has a high failure rate and insufficient data to establish its efficacy.

[0276] It should therefore be appreciated that in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured to perform one or more steps of a minimally invasive, single-port access, or robotic-assisted interventional or surgical procedure to address traditional shortcomings or clinical problems associated with the treatment of left atrial appendage (LAA) / left atrial obstructions, and may additionally or optionally address challenges associated with the application of BVM for enhanced visualization and delivery of various instruments and devices utilizing a hybrid working channel.

[0277] Visualization During Minimally Invasive Mitral Valve Surgery Current state of the art Minimally invasive cardiac surgery (MICS) is becoming increasingly popular among cardiac surgeons due to its many advantages, including reduced postoperative pain, reduced risk of bleeding and wound infection, smaller incisions and faster recovery, cosmetic benefits (less scarring), and shorter hospital stays.

[0278] Minimally invasive mitral valve surgery (MIMVS) requires minimal surgical incisions through a right mini-thoracotomy to allow treatment of mitral valve disorders such as mitral regurgitation and stenosis. Mitral regurgitation occurs when the valve does not close properly, resulting in blood leaking between the heart chambers. Mitral stenosis, on the other hand, occurs when the mitral valve does not open sufficiently, leading to blood congestion, arrhythmias (atrial fibrillation), pulmonary hypertension, and ultimately right ventricular failure.

[0279] One of the treatment options for mitral stenosis or mitral regurgitation surgery is replacement with a bioprosthetic (porcine, bovine, or human heart tissue) or mechanical valve. Prior to surgery, the patient's heart must be mapped. This can be done with an electrocardiogram (ECG), chest X-ray, transesophageal echocardiography (TEE), or coronary angiography. During surgery, a cardiopulmonary bypass (CPB) machine is used by inserting cannulae into the arteries and veins. Before and after replacement, a transesophageal echocardiogram (TEE) is used, inserted through the esophagus.

[0280] Clinical problems to be solved The procedure is performed through a minimally invasive thoracotomy, and visualization is achieved using a thoracoscope.

[0281] Direct and adequate visualization during surgery is highly beneficial to physicians. Thus, in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured to perform one or more steps of a minimally invasive, single-port access, or robotic-assisted interventional or surgical procedure to address procedural challenges or clinical issues related to minimally invasive mitral valve surgery, and optionally, challenges associated with the application of BVM for enhanced visualization and the delivery of various instruments and devices using a hybrid working channel.

[0282] Visualization During Minimally Invasive Aortic Surgery Current state of the art Minimally invasive cardiac surgery (MICS) is becoming increasingly popular among cardiac surgeons due to its many advantages, including reduced pain, reduced bleeding and risk of wound infection, faster recovery due to smaller incisions, better cosmetic results, and shorter hospital stays.

[0283] Minimally Invasive Aortic Valve Surgery (MIAVS) involves minimal surgical incisions to treat aortic disease through aortic valve replacement or repair. In the case of aortic stenosis, the valve narrows and calcifies, preventing the left ventricle from functioning properly and causing left ventricular hypertrophy. In the case of aortic regurgitation, the valve does not close properly, allowing blood to flow backward into the left ventricle, resulting in left ventricular hypertrophy.

[0284] Before surgery, the patient's heart and aorta must be mapped. This mapping can be done using an electrocardiogram (ECG), computed tomography (CT), and transesophageal echocardiography (TEE), similar to mitral valve replacement. During surgery, cardiopulmonary bypass (CPB) is used and cannulae are inserted into the arteries and veins. Before and after valve replacement, a transesophageal echocardiogram (TEE) is used, inserted through the esophagus.

[0285] Clinical problems to be solved Currently, this procedure is performed through a right anterior thoracotomy (RAT) or minithoracotomy (MS), with visualization achieved using a thoracoscope.

[0286] Direct and adequate visualization during surgery is highly beneficial to physicians. Thus, in various embodiments, the surgical access devices, device shafts, working channels, and balloon visualization modules are adapted and configured to perform one or more steps of a minimally invasive, single-port access, or robotic-assisted interventional or surgical procedure to address challenges or clinical issues related to minimally invasive aortic surgery procedures, and optionally, challenges associated with the application of BVM for enhanced visualization and the delivery of various instruments and devices using hybrid working channels.

[0287] Visualization during coronary artery surgery Current state of the art In coronary artery disease, the walls of the coronary arteries (arteries that supply blood to the heart) become blocked by lipid deposits.

[0288] The main treatment for coronary artery disease is coronary artery bypass grafting (CABG), which can now be performed using minimally invasive surgery (MIDCAB). During the procedure, a bypass is created in the area of ​​the blood vessel behind the stenosis, using a graft. Clinically, coronary angiography is the primary diagnostic technique. A contrast agent is injected into the coronary arteries and used to identify existing blockages or stenosis due to plaque or calcification.

[0289] Clinical problems to be solved Direct and adequate visualization during surgery is highly beneficial to physicians. Thus, in various embodiments, the surgical access devices, device shafts, working channels, and balloon visualization modules are adapted and configured to perform one or more steps of a minimally invasive, single-port access, or robotic-assisted interventional or surgical procedure to address challenges or clinical issues related to minimally invasive coronary artery surgery procedures, and optionally, challenges associated with the application of BVM for enhanced visualization and the delivery of various instruments and devices using hybrid working channels.

[0290] Visualization during minimally invasive surgery for intrapericardial tumors Current state of the art An intrapericardial tumor (or teratoma) is an abnormal tissue growth that occurs within the heart. Intrapericardial tumors are rare cardiac tumors that are usually diagnosed in infants and newborns. These tumors are generally benign, but can be life-threatening.

[0291] Clinical problems to be solved In this case, open-heart surgery is necessary to remove the tumor. Two-dimensional echocardiography is considered the best diagnostic imaging method for tumor visualization, although magnetic resonance imaging (MRI) may also be used (MRI has the advantage of potentially better visualization of adjacent areas).

[0292] Direct and adequate visualization during surgery is highly beneficial to physicians. Thus, in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured to perform one or more steps of a minimally invasive, single-port access, or robotic-assisted interventional or surgical procedure, and may address shortcomings or clinical challenges associated with minimally invasive surgical procedures for intrapericardial tumors, as well as, or optionally, challenges associated with the application of BVM for improved visualization and the delivery of various instruments and devices using a hybrid working channel.

[0293] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured for use with transjugular access to transvenously perform one or more steps of a minimally invasive, single-port access, or robotic-assisted interventional or surgical procedure to address the shortcomings or clinical problems detailed herein. The surgical access device may include embodiments specific to medical procedures via the transjugular approach. Additionally or alternatively, improvements related to improved visualization through the application of a balloon visualization module (BVM) and delivery of instruments and devices utilizing a hybrid working channel may be implemented. By way of example and not limitation, examples of transjugular procedures include pacemaker lead removal, endomyocardial biopsy, transcatheter mitral valve replacement / repair, and transcatheter tricuspid valve replacement / repair.

[0294] Pacemaker lead removal Current Technology Implantation of pacemaker leads induces a fibrotic proliferation process, typically resulting in the formation of lead-vascular attachment sites along the vascular pathway and electrode-myocardial interfaces. Removal of a fixed or perforated lead can result in serious complications, including superior vena cava injury, cardiac avulsion, and even death. Diagnostic imaging is crucial for identifying potential vascular adhesions, cardiac perforations, and aberrant lead pathways and for tailoring the approach to each case's unique challenges.

[0295] 11A-11D illustrate conventional pacemaker lead removal techniques. These techniques include force removal, force removal using a locking stylet, use of a countertraction sheath, and removal by ablation using mechanical and laser cutter sheaths. However, each of these techniques carries its own challenges and potential risks.

[0296] Force extraction, such as the embodiment shown in Figure 11A, involves applying force to the end of the lead and applying consistent outward traction to facilitate lead removal. However, this method has the disadvantage of disintegrating or breaking the lead during the procedure. Additionally, scar tissue around the pacemaker lead may tear uncontrollably, posing a risk of complications.

[0297] Figure 11B shows a locking stylet traditionally used for pacemaker lead removal. Forced removal using a locking stylet involves inserting and deploying the locking stylet into the lead lumen. The stylet provides uniform traction along the lead axis, reducing the risk of lead fracture. However, this method can potentially cause uncontrolled tearing of scar tissue around the pacemaker lead, potentially leading to complications.

[0298] When a countertraction sheath is used for lead removal, as shown in Figures 11C and 11D, the sheath is placed around the pacemaker lead to serve to support the surrounding tissue before the electrode is withdrawn. However, this method can result in uncontrolled tearing of the tissue, although the extent of the tearing may be limited by the size of the sheath.

[0299] Removal by ablation using a mechanical cutter sheath (FIG. 11E) and a laser cutter sheath (FIG. 11F) involves adding a cutting element to the distal end of the countertraction sheath. This removal method carries the risk of perforating cardiac or vascular tissue because feedback regarding the cutting action of the device is very limited.

[0300] As discussed above, conventional pacemaker lead extraction techniques present many challenges, including robust lead engraftment, difficulty assessing scar tissue formation around the pacemaker electrode, lack of visual feedback during the procedure, and lack of feedback regarding the force applied directly to the tissue. Typically, the electrode separates from the scar tissue in a highly uncontrollable manner without visualization.

[0301] Clinical problems to be solved Intraprocedural imaging serves two purposes: to further explore any concerns suggested by preprocedural imaging, and to monitor the patient's condition during the procedure.

[0302] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured to perform one or more steps of a pacemaker lead removal procedure via a transjugular approach to address the shortcomings or clinical problems detailed herein. The surgical access device may include embodiments specific to medical procedures via a transjugular approach. Additionally or alternatively, enhanced visualization through the application of a balloon visualization module (BVM) and other related improvements to instruments or devices utilizing a hybrid working channel may be implemented, thereby providing an access platform and direct visualization for introducing instruments into the beating heart. In certain aspects, the surgical access device of the present invention enables near-field direct visualization of target cardiac tissues and instrument-tissue interactions. Additionally or alternatively, embodiments of the present invention are developed based on an improved understanding of cardiac anatomy and adhesions to provide guidance for the lead removal procedure and enable rapid detection and close monitoring of potential complications through the beneficial application of a balloon visualization module (BVM).

[0303] 12, another embodiment of an access device 1200 is shown in a deployed state and includes a balloon visualization module (BVM) 1202. Unless otherwise noted, device 1200 may have similar features to other devices described herein (e.g., devices 400, 500, 600, 700, 800, 900, etc.). In addition to BVM 1202, device 1200 includes cutting member 1203 (e.g., disposed within the instrument channel of the BVM).

[0304] Device 1200 includes a sheath 1204. A working channel 1205 extends through the sheath. A flexible extension 1216 is coupled at its distal end to sheath 1204 and extends working channel 1205.

[0305] The cutting member 1203 is located at or near the distal end of the flexible extension 1216. The cutting member 1203 can be positioned so that it is always or generally located within the field of view 1254 of the camera module 1208. In some embodiments, the cutting member comprises a mechanical cutter, an RF electrode, or a laser cutter.

[0306] The cutting member actuation portion 1256 may extend from the cutting member 1203 along the sheath toward the handle. It should be appreciated that the handle may include a control mechanism used to actuate the cutting member 1203.

[0307] The device 1200 can include a pressure sensor lumen 1252 configured to provide data regarding tissue contact force. Other pressure sensor configurations are possible. In some embodiments, the balloon pressure can be measured directly at the proximal end of the fluid line. Based on the pressure data and a pressure source (e.g., a syringe pump) connected to the balloon inlet, a control loop can be established to provide one or a combination of maintaining a constant balloon pressure, detecting balloon leaks, and sensing tissue contact force.

[0308] The balloon has an asymmetrical spherical shape with the majority of its volume disposed above the sheath 1204 and working channel 1205. The balloon can increase in diameter from the proximal end to the distal end. The balloon has a curved distal end that serves as a distal window for the camera module 1208. The distal window 1220 can be sized and shaped to accommodate the desired field of view of the camera / illumination / imaging module 1208.

[0309] The proximal end of the balloon has a generally tubular shape with a generally circular cross-sectional shape to accommodate the sheath 1204 at the distal end.

[0310] The balloon includes a channel 1222 shaped to accommodate the distal end of the flexible channel extension 1216. The balloon 1206 is coupled to the flexible channel extension 616 around the channel 1222.

[0311] In this manner, a first portion of the distal end of the balloon is shaped to align with and provide access to the working channel 1205 in the sheath 1204, and a second portion of the distal end of the balloon is sized and shaped to accommodate the desired field of view of the camera / illumination / imaging module 1208.

[0312] An inlet channel 1210 and an outlet channel 1212 extend along the shaft 1204 and are in fluid communication with the balloon 1206 .

[0313] In some embodiments, the camera module 1208 is located on top of the flexible channel extension 1216 .

[0314] In some embodiments, the balloon is made of silicone, although other materials (e.g., Pebax®, nylon, specially formulated blends such as polyester / PET, TPU / Pebax® and Pebax® / nylon, laminate structures, etc.) can also be used.

[0315] In some embodiments, the durometer of the material may be approximately 80-90A on the Shore A scale (e.g., Shore 85A). Other durometers (e.g., Shore 20-60A, 30-40A, 35-45A, 45-75A, 75-85A, 60-100A, 70-90A, etc.) may also be employed.

[0316] The thickness of the balloon can be about 0.20 to 0.25 mm (or about 0.15 to 0.30 mm, or about 0.10 to 0.35 mm, etc.).

[0317] In some embodiments, the balloon has a uniform thickness. In some embodiments, the balloon has a varying thickness.

[0318] 13 shows a side cross-sectional view of device 1200 deployed in a position for pacemaker lead extraction. The device can act as a countertraction sheath, clearing blood from the camera's field of view, while the balloon functions as a visualization tool. Additionally, the balloon can function as a manipulation tool to assist in the withdrawal of the pacemaker electrode while supporting the tissue surrounding the engraftment.

[0319] The cutting element 1203 provides controlled separation of the lead electrode from the scar tissue. The cutting element may comprise a mechanical cutter, an RF electrode, or a laser cutter. Other techniques may also be employed.

[0320] In some embodiments, the balloon may include a pressure sensor or pressure sensor lumen to provide data regarding tissue contact forces.

[0321] The operating principle may be similar or identical to conventional methods using a countertraction sheath with a cutting element. The device is positioned around the pacemaker lead and then advanced. The cutting element is then actuated to separate the lead electrode from the scar tissue under direct visualization with a known contact force.

[0322] An example of pacemaker lead removal using a BVM may be as follows: The device is set up in the right ventricle, for example, according to steps 3502-3508 of method 3500 associated with FIG. 35 or steps 3602-3614 of method 3600 associated with FIG. 36. The device is navigated to the target pacemaker lead using the output of the camera module. The camera module output is used to inspect for scar tissue formation around the pacemaker lead. If necessary, a tissue manipulation tool (e.g., forceps, blade, etc.) is inserted into the working channel of the device to separate the pacemaker lead from the scar tissue. After the pacemaker lead is removed, the tissue manipulation tool is withdrawn from the working channel. Next, steps 3514 and 3516 of method 3500 associated with FIG. 35 or step 3616 of method 3600 associated with FIG. 36 are performed to withdraw the sheath from the vasculature.

[0323] 41A shows a view from a camera module showing a pacemaker lead 4102 and scar tissue formation 4104 at the anchor portion of the pacemaker lead. A cutting member 4106 (e.g., a blade, biopsy forceps, etc.) is positioned within a working channel 4108 (e.g., a channel extension). The cutting member 4106 is used to separate the pacemaker lead from the scar tissue.

[0324] FIG. 41B shows BVM visualizing the scarred lead from the side.

[0325] The BVM device can be used as an examination and diagnostic tool to supplement traditional pacemaker lead extraction techniques. The procedure can also be performed using a cutting element delivered through the working channel. The cutting element can be either mechanical or radio frequency (RF) powered.

[0326] The procedure for removing a pacemaker lead using the over-the-wire technique is as follows: The BVM device is advanced using the pacemaker lead as a guidewire. The BVM is housed within the access sheath, and the camera module is folded into the working channel, leaving enough space for a pacemaker lead with an outer diameter of 1.5–2 mm to pass through. Once the device reaches a cavity large enough, the BVM is deployed (e.g., according to steps 3504–3508 of method 3500 associated with FIG. 35 or steps 3604–3612 of method 3600 associated with FIG. 36). The camera module output is used to inspect for scar tissue formation around the pacemaker lead. If necessary, a cutting device is inserted into the working channel and the pacemaker lead is separated from the scar tissue under visual control of the camera module. After the pacemaker lead is removed, the tissue manipulation instrument is withdrawn from the working channel. Next, steps 3514, 3516 of method 3500 associated with FIG. 35 or step 3616 of method 3600 associated with FIG. 36 are performed to remove the sheath from the vasculature.

[0327] Figure 42A shows a view from the camera module of a BVM device with a pacemaker lead 4202 in the working channel 4204. A scarred pacemaker lead anchor 4206 is shown. Figure 42B shows a circular cutting member 4208 being fed through the working channel 4204.

[0328] FIG. 42C shows a pacemaker lead inserted into the working channel of a BVM device and acting as a guidewire.

[0329] In this method, the BVM device can be used to supplement conventional traction techniques: as the electrode is withdrawn, the balloon gently presses against the surrounding tissue, allowing visual inspection of the tissue loading state.

[0330] The cutting member may be either mechanically or radio frequency (RF) driven.

[0331] Endocardial biopsy (myocarditis, heart transplant) Current state of the art Endomyocardial biopsy (EMB) is an invasive clinical procedure used to obtain myocardial tissue for histological analysis, which can be used to diagnose heart transplant rejection, cardiomyopathy, myocarditis, and drug toxicity.

[0332] Clinical problems to be solved In endomyocardial biopsy (EMB), transthoracic echocardiography (TTE) is used to control the flexible biopsy tube and avoid injury. However, endomyocardial biopsy is not a completely risk-free procedure and may result in complications such as cardiac tamponade.

[0333] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured to perform one or more steps of an endomyocardial biopsy (myocarditis, cardiac transplant) procedure via a transjugular approach, addressing the shortcomings or clinical problems detailed herein. The surgical access device may include embodiments specific to transjugular medical procedures. Additionally or alternatively, improved visualization through the application of a BVM and other improvements related to instruments or devices utilizing a hybrid working channel may be implemented, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0334] An exemplary method for performing a biopsy using a BVM is as follows: The device is set up at or near the surgical site, for example, according to steps 3502-3508 of method 3500 associated with FIG. 35 or steps 3602-3614 of method 3600 associated with FIG. 36. A biopsy forceps is inserted into the working channel and the biopsy is performed. After the biopsy is completed, the biopsy forceps is withdrawn from the working channel.

[0335] Steps 3514, 3516 of method 3500 described with reference to Figure 35 or step 3616 of method 3600 described with reference to Figure 36 may then be performed to withdraw the sheath from within the blood vessel.

[0336] 43A shows a view from the camera module of a BVM device performing a biopsy procedure on the annulus of a valve 4302. Visible within the field of view are the annulus 4302 and the valve leaflets 4304. A biopsy forceps 4306 is positioned within a working channel 4306 (e.g., a channel extension).

[0337] FIG. 43B shows the BVM device positioned toward the target tissue.

[0338] Mitral valve closure clip Current state of the art Treatment of dysfunctional mitral valves includes the following conditions: primary mitral regurgitation (MR), in which degenerative mitral valve disease causes anatomical changes to the valve and chordae tendineae, resulting in MR; and secondary MR, in which the mitral annulus is enlarged due to ischemic or non-ischemic left ventricular failure or the left atrium is dilated due to atrial fibrillation. Minimally invasive mitral valve clips are used in these cases. These tiny metal clips are delivered transcatheter to the mitral valve. This procedure is called transcatheter mitral valve repair (TMVr), although transcatheter mitral valve replacement (TMVR), in which a complete prosthetic valve is implanted, is also an option.

[0339] Clinical problems to be solved Transcatheter Mitral Valve Repair (TMVr) There are different treatment methods for transcatheter mitral valve repair, including transcatheter edge-to-edge repair (TEER-MitraClip, Pascal), direct / indirect mitral annuloplasty (Cardioband, Mitralign, Carillon), and chordae tendineae repair (NeoChord). These can be used for both primary and secondary mitral regurgitation (MR), but mitral annuloplasty is only indicated for secondary MR.

[0340] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured for use via a transjugular approach to perform one or more steps of a mitral valve plication clip procedure, and may address the shortcomings or clinical problems detailed herein. The surgical access device may include embodiments specific to medical procedures via a transjugular approach. Additionally or alternatively, improved visualization through the application of a BVM and other improvements related to instruments or devices may be implemented utilizing a hybrid working channel, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0341] Transcatheter Mitral Valve Replacement (TMVR) There are several different methods for transcatheter mitral valve replacement, including the transseptal approach (HighLife TMVR System, Sapien M3 System, EVOQUE TMVR System) and the transapical approach (Tendyne Mitral Valve System, Tiara TMVR System, Intreped TMVR System). Clinical experience with TMVR is related to three main conditions: valve-in-valve, valve-in-ring, and valve-in-native ring.

[0342] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of various embodiments are adapted and configured for use via a transjugular approach to perform one or more steps of a transcatheter mitral valve replacement (TMVR) procedure, and may address the shortcomings or clinical problems detailed herein. The surgical access device may include embodiments specific to medical procedures via the transjugular approach. Additionally or alternatively, improved visualization through the application of a BVM and other improvements related to instruments or devices may be implemented utilizing a hybrid working channel, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0343] Visualization during the MitraClip procedure Current state of the art One treatment option for mitral valve repair is the MitraClip, which is based on the traditional edge-to-edge technique and consists of two main components: a polyester-coated metal clip and a catheter. Although MitraClip is one of the most reliable treatments, rare complications can occur, including atrial septal defect, bleeding, pericardial effusion, infective endocarditis, clip detachment, clip embolization, and mitral stenosis.

[0344] Clinical problems to be solved The device is delivered to the left atrium through a catheter inserted into a vein in the leg, and visualization during treatment may be achieved using transesophageal echocardiography (TEE) and fluoroscopy.

[0345] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of various embodiments are adapted and configured for use via a transjugular approach and can be used to perform one or more visualization steps in a MitraClip procedure, addressing the shortcomings or clinical problems detailed herein. The surgical access device may include embodiments specific to medical procedures via a transjugular approach. Additionally or alternatively, improved visualization through the application of a BVM and other improvements related to instruments or devices utilizing a hybrid working channel may be implemented, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0346] Tricuspid valve closure clip Current state of the art Tricuspid regurgitation is a very common heart valve disease. The tricuspid valve is located between the right atrium and the right ventricle, and if it does not close properly, blood can leak backward from the right ventricle into the right atrium, increasing the risk of cardiovascular morbidity and mortality in the long term.

[0347] Clinical problems to be solved Tricuspid valve interventional devices include coaptation and leaflet devices (TriClip, Pascal, Mistral) and annuloplasty devices (ring annuloplasty, suture annuloplasty). Challenges exist regarding delivery and patient selection.

[0348] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured for use via a transjugular approach to perform one or more steps of a tricuspid valve plication clip procedure, and may address the shortcomings or clinical problems detailed herein. The surgical access device may also include embodiments specific to transjugular medical procedures. Additionally or alternatively, improved visualization through the application of a BVM and other improvements related to instruments or devices utilizing a hybrid working channel may be implemented, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0349] Right ventricular reshaping or tether implant Current state of the art Tether is a novel, minimally invasive, implantable mitral regurgitation treatment system developed by Argo Cardiovascular. It is a simple, easy-to-use mechanical medical device system that can be applied for right ventricular reshaping in right ventricular failure and / or severe tricuspid regurgitation. Details are described in U.S. Patent Application Publication No. US 2020 / 0268514, filed as Application No. 16 / 789,250, entitled "Mechanically Locking Adjustable Cardiac Catheter," the entire contents of which are incorporated herein by reference.

[0350] Clinical problems to be solved The Tether can be placed through a hybrid procedure using both a transcatheter approach and minimally invasive surgical access.

[0351] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured for use via a transjugular approach to perform one or more steps of a right ventricular reshaping or tether implant procedure, which may address the shortcomings or clinical problems detailed herein. Additionally, the access device may include embodiments specific to medical procedures via a transjugular approach. Additionally or alternatively, improved visualization through the application of a BVM and other improvements related to instruments or devices utilizing a hybrid working channel may be implemented, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0352] Atrial septal defect / patent foramen ovale closure Current state of the art Atrial septal defect (ASD) is the second most common type of congenital heart disease and is a congenital structural abnormality of the heart. An ASD is a hole in the wall (septum) separating the upper chambers (atria) of the heart, and the most common type is located in the fossa ovale. A patent foramen ovale (PFO) is a condition in which the foramen ovale remains open after birth, which can frequently cause reflux emboli and contribute to stroke.

[0353] Clinical problems to be solved Therapeutic options include transcatheter closure. While this is a safe procedure, it is not without risks, and serious complications such as erosion and device embolization can occur. Accurate characterization of the atrial septal defect (ASD) morphology is required, which requires the use of transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE).

[0354] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured for use via a transjugular approach to perform one or more steps of an atrial septal defect / patent foramen ovale closure procedure, and may address the shortcomings or clinical problems detailed herein. Additionally, the surgical access device may include embodiments specific to medical procedures via a transjugular approach. Additionally or alternatively, improved visualization through the application of a BVM and other improvements related to instruments or devices utilizing a hybrid working channel may be implemented, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0355] Balloon atrial septostomy Current state of the art Balloon atrial septostomy is a minimally invasive procedure that uses a balloon catheter to widen the foramen ovale (the hole between the left and right atria), allowing blood from both sides of the heart to mix in certain cases of congenital heart disease.

[0356] Clinical problems to be solved The balloon is passed through the foramen ovale in a deflated state into the left atrium, then inflated and pulled back into the right atrium, a procedure visualized by echocardiography and hemodynamic monitoring.

[0357] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured to perform some or all of the balloon atrial septostomy procedure sequence via a transvenous approach to address the shortcomings or clinical problems detailed herein. The surgical access device may also include embodiments specific to transjugular medical procedures. Additionally or alternatively, improved visualization through the application of a BVM and other related improvements to instruments or devices utilizing a hybrid working channel may be implemented, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0358] In yet another embodiment, the surgical access device, device shaft, working channel, and balloon visualization module of each embodiment are adapted and configured for use in performing one or more steps, or portions thereof, of any of the procedures described in the following publications: Additionally or alternatively, enhanced visualization through the application of BVM and other improvements related to instruments or devices utilizing hybrid working channels may be implemented, thereby providing a platform for providing access and direct visualization to guide instruments used in these procedures.

[0359] It should be understood that all combinations of the above concepts and the additional concepts described in more detail below (to the extent that these concepts are not mutually inconsistent) may be considered as part of the inventive subject matter disclosed herein, and may be utilized to achieve the advantages described herein.

[0360] The balloon of the balloon visualization module is positioned to surround the camera and light source. Advantageously, the balloon is conformable and can also serve as an atraumatic tissue-contacting surface. In some typical clinical procedures, surgical access device embodiments may be specifically adapted and configured for electrophysiological mapping and ablation procedures. In these embodiments, electrodes of a design typical of electrophysiological mapping electrodes are attached to the surface of the balloon. In one embodiment, a surgical access device configured in this manner allows for simultaneous mapping and ablation procedures. In this mode of use, electrodes on the balloon surface are used for mapping, while ablation electrodes introduced through the working channel of the surgical access device are used for ablation. As yet another aspect, the visual image obtained from the balloon visualization module can be enhanced with software mapping results. Additionally, projecting neural networks, neural junctions, and ablation targets onto the optical image provided by the balloon visualization module of the surgical access device, thereby enabling their visualization, can be highly beneficial for various electrophysiological applications. In yet another embodiment, the electrode pattern on the balloon surface has the added benefit of visually identifying the balloon surface. This feature advantageously allows for measurements of distances, diameters, sizes, etc. of cardiac structures and features located in front of the optical unit of the balloon visualization module.

[0361] The balloon of the balloon visualization module can be adapted and configured as a balloon tamponade device during biopsy procedures and other procedures that pose a risk of cardiac perforation and may result in pericardial effusion or cardiac tamponade. Advantageously, the balloon of the balloon visualization module can be used to occlude the perforation from within the heart and mitigate the consequences of the perforation until pericardiocentesis or surgical intervention is ready and performed. Furthermore, a puncture closure solution similar to various vascular closure devices can be introduced through the working channel of the surgical access device to occlude the perforation. Such a closure device or plug can be deployed from the endocardial side toward the pericardial cavity to achieve hemostasis. This use may completely stop bleeding from the perforation or may slow the rate of bleeding, allowing time for emergency surgery.

[0362] As these additional applications demonstrate, surgical access device balloons often serve multiple functions beyond clearing blood from in front of the optical unit. As a further aspect, surgical access device operators can adjust the pressure within the balloon in various ways, such as by increasing, decreasing, adjusting, depressurizing, or pressurizing it. Adjusting the pressure within the balloon can also adapt the balloon's shape. For example, lowering the pressure can cause the balloon to become more flexible and malleable, allowing it to more easily conform and mold to the intracardiac structures, improving blood clearance and visualization. Lowering the pressure within the balloon can also allow the surgical access device to more easily access smaller intracardiac spaces or narrower openings. In contrast, increasing the balloon pressure can be advantageous in mapping applications, allowing electrodes or other treatment-appropriate components mounted on the balloon to more reliably contact the endocardium or other target tissue. As a further aspect, the balloon's responsiveness to pressure changes can include configurations in which the overall balloon has one or more different or deformed shapes, which change in response to the pressure characteristics within the balloon. For example, a pressure-responsively shaped balloon may assume a first shape at a first pressure and a second, different shape at a different pressure. As yet another variation, balloon embodiments may include one or more shapes or contours that exhibit or function in response to a specific pattern of pressure modulation. For example, a balloon may have no distinctive features at one pressure, but at a different pressure, one or more features, contours, or surfaces may be activated and available at the surgical site in conjunction with other features of the surgical access device. In some embodiments, the balloon's properties (i.e., flexible, rigid, stiff), shape, features, contours, or surfaces may be reversible and controllable by the operator or function in response to input from the operator or surgical system. In one embodiment, the balloon pressure is controlled by a pump in communication with the balloon pressurization lumen of the surgical access device.The pump may be controlled by a manual operation, a floor pedal, or other controller commonly used to control fluid management systems. The pump is used to inflate, depressurize, or adjust the pressure of the balloon and may include safety features to prevent over-inflation of the balloon, prevent balloon rupture, and prevent unnecessary depressurization of the balloon below the baseline pressure required to maintain adequate optical visualization.

[0363] The process parameters and sequence of steps described and / or illustrated herein are presented by way of example only and may be varied in any way. For example, although steps illustrated and / or described herein may be shown in a particular order, they do not necessarily have to be performed in that order. Additionally, the various exemplary methods described and / or illustrated herein may omit one or more steps described or illustrated herein or may include additional steps in addition to those disclosed.

[0364] In this specification, when a feature or element is referred to as being "on" another feature or element, the feature or element may be directly on top of the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements. Also, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, the feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Although one embodiment has been described or illustrated, the described or illustrated features and elements may be applicable to other embodiments. Furthermore, those skilled in the art will understand that references to structures or features located "adjacent" to other features may have overlapping or underlying portions with the adjacent feature.

[0365] The terms used herein are for the purpose of describing particular embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. It should also be understood that the terms "comprises" and "comprising" as used herein specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The term "and / or," as used herein, includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0366] As shown in the figures, spatially relative terms, such as "bottom," "lower," "belower," "upper," "above," etc., may be used for ease of description to describe the relationship of one element or feature to another. It should be understood that spatially relative terms are intended to encompass different orientations of use or operation of a device in addition to the orientation depicted in the figures. For example, if a device in the figures were inverted, elements described as "below" or "below" other elements or features would then be oriented "above" or "above" the other elements or features. Thus, the exemplary term "bottom" can encompass both an orientation of above and below. The device may be in other orientations (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein should be interpreted accordingly. Similarly, unless otherwise noted, terms such as "upper," "lower," "vertical," "horizontal," etc. are used herein for descriptive purposes only.

[0367] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless otherwise indicated in the context. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element described below could be referred to as a second feature / element, and similarly, a second feature / element described below could be referred to as a first feature / element without departing from the teachings of the present invention.

[0368] In this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" mean that various components can be used together in methods and articles (e.g., compositions and apparatus (including devices and methods)). For example, the term "comprise" is understood to mean the inclusion of any of the listed elements or steps, but not the exclusion of any other elements or steps.

[0369] As a whole, any of the apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or alternatively "consisting essentially of" various components, steps, subcomponents, or substeps.

[0370] Throughout this specification and claims, including use in the examples, unless otherwise stated, all numbers may be construed as if preceded by the word "about" or "approximately," even if the term is not explicitly recited. The terms "about" or "approximately," when describing values ​​and / or locations, may be used to indicate that the described value and / or location is within a range of reasonably expected values ​​and / or locations. For example, a numerical value may have a value that is ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context dictates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Numerical ranges cited herein are intended to include all subranges within that numerical range. It is also understood that when a value is disclosed, the value "less than or equal to," "greater than or equal to," and possible ranges between values ​​are also disclosed, as understood by one of ordinary skill in the art, where appropriate. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numeric value) are also disclosed. It is also understood that throughout this application, data is provided in several different formats, and that this data represents endpoints and starting points, as well as ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than, greater than, less than, less than, equal to, equal to, and between 10 and 15 are disclosed. It is also understood that each unit between two specified units is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0371] Although various exemplary embodiments have been described, certain modifications can be made to each embodiment without departing from the scope of the invention, as described by the claims. For example, the order of execution of various described method steps may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of various device and system embodiments may be included in some embodiments and not in other embodiments. Therefore, the above description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention, as described in the claims.

[0372] The examples and illustrations contained herein are by way of example and illustrate specific embodiments in which the subject matter of the present disclosure may be practiced, but are not intended to be limiting. Structural and logical substitutions and changes may be made without departing from the scope of the present disclosure, such that other embodiments may be utilized and derived therefrom. Although such aspects of the present invention may be referred to individually or collectively as the "invention" for convenience, no attempt is made to automatically limit the scope of the claims herein to a single invention or inventive concept, even if multiple inventions or inventive concepts are in fact disclosed. Thus, while specific embodiments have been illustrated and described, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment illustrated. The present disclosure contemplates any adaptations or variations of each embodiment. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description.

Claims

1. an elongate body having a working channel; a balloon visualization module disposed at a distal end of the elongate body, the balloon visualization module comprising a balloon and a camera module disposed within the balloon; the camera module is housed within an outer diameter of the access sheath in a stowed state; and wherein the camera module, when deployed with the inflated balloon in use, moves radially outward relative to a longitudinal axis of the elongate body to a position substantially beyond an outer wall of the elongate body. Surgical access devices.

2. the balloon visualization module fits completely within the working channel when retracted; The surgical access device of claim 1 .

3. At least a portion of the distal surface of the balloon forms a contact visualization surface configured to contact a target tissue to enable visualization of the target tissue by the camera module. The surgical access device of claim 1 or 2.

4. When the camera module is in a deployed state, at least 90% of the distal surface of the balloon is within the field of view of the camera module. The surgical access device of claim 3 .

5. and when the camera module is in a deployed state, at least 95% of the distal surface of the balloon is within the field of view of the camera module. The surgical access device of claim 3 .

6. The distal surface of the balloon is rounded. The surgical access device of any one of claims 1 to 5.

7. The balloon is made of an optically transparent material. The surgical access device of any one of claims 1 to 6.

8. the camera module is spaced approximately 8-13 mm from the distal surface of the balloon; The surgical access device of any one of claims 1 to 7.

9. The elongate body includes a plurality of lumens. The surgical access device of any one of claims 1 to 8.

10. the elongate body comprising a fluid lumen; The surgical access device of any one of claims 1 to 9.

11. The diameter of the fluid lumen is about 0.4 to 0.6 mm. The surgical access device of claim 10.

12. the elongate body includes a position tracking sensor; The surgical access device of any one of claims 1 to 11.

13. the camera module includes an electronic connector extending proximally toward the proximal end of the elongate body; The surgical access device of any one of claims 1 to 12.

14. the camera module includes one or more lights; The surgical access device of any one of claims 1 to 13.

15. the camera module is positioned generally parallel to the longitudinal axis of the elongate body; The surgical access device of any one of claims 1 to 14.

16. the camera module is positioned at an angle relative to a longitudinal axis of the elongate body; The surgical access device of any one of claims 1 to 14.

17. the balloon visualization module comprises a channel extension coupled to a distal end of the working channel. The surgical access device of any one of claims 1 to 16.

18. a camera mount attached to the channel extension and configured to support the camera module. The surgical access device of claim 17.

19. the channel extension comprises a lumen having a cutout; The surgical access device of claim 17.

20. the balloon is configured to complete the lumen at least in part at the notch when inflated.

20. The surgical access device of claim 19.

21. the cutout portion occupies approximately 60-90% of the length of the channel extension.

21. The surgical access device of claim 19 or 20.

22. the channel extension comprises a flexible tube; The surgical access device of any one of claims 17 to 21.

23. the channel extension is made of an optically transparent material; The surgical access device of any one of claims 17 to 22.

24. the balloon includes a balloon channel configured to surround the channel extension. The surgical access device of any one of claims 17 to 23.

25. The diameter of the balloon channel is about 3 to 3.8 mm.

25. The surgical access device of claim 24.

26. The length of the balloon channel is about 16 to 17.4 mm.

26. The surgical access device of claim 24 or 25.

27. a camera mount attached to the balloon channel and configured to support the camera module. The surgical access device of any one of claims 24 to 26.

28. The balloon has a thickness of about 0.1 mm or less. The surgical access device of any one of claims 1 to 27.

29. the balloon has a durometer of about 80-90A on the Shore A scale; The surgical access device of any one of claims 1 to 28.

30. The elongate body has a diameter of about 12-16F. The surgical access device of any one of claims 1 to 29.

31. the balloon is asymmetric about the longitudinal axis of the channel extension. The surgical access device of any one of claims 17 to 30.

32. a majority of the volume of the balloon is disposed above the channel extension; 32. The surgical access device of claim 31.

33. More than 80% of the volume of the balloon is disposed above the channel extension.

32. The surgical access device of claim 31.

34. approximately 6-7 mm of the distal end of the channel extension is within the field of view of the camera module when the camera module is in the deployed position; The surgical access device of any one of claims 17 to 33.

35. approximately 2-3 mm of the bottom of the distal end of the channel extension falls within the field of view of the camera module when the camera module is in the deployed position; The surgical access device of any one of claims 17 to 34.

36. the channel extension includes approximately the bottom third of the field of view of the camera module. The surgical access device of any one of claims 17 to 35.

37. The working channel has a diameter of about 8-9F. The surgical access device of any one of claims 1 to 36.

38. the working channel extends beyond the distal end of the elongate body; The surgical access device of any one of claims 1 to 37.

39. The balloon is made of one or a combination of polyurethane, silicone, Pebax®, nylon, polyester / PET, The surgical access device of any one of claims 1 to 38.

40. a proximal end of the balloon coupled to a distal end of the elongate body; The surgical access device of any one of claims 1 to 39.

41. The balloon has a height of about 12-14 mm. The surgical access device of any one of claims 1 to 40.

42. The camera module has a field of view of approximately 110° in air. The surgical access device of any one of claims 1 to 41.

43. the camera module includes an integrated lighting system; The surgical access device of any one of claims 1 to 42.

44. The refractive index of the fluid within the balloon is substantially the same as the refractive index of the balloon. The surgical access device of any one of claims 1 to 43.

45. the balloon is responsive to modulated pressure applied to the interior of the balloon. A device according to any one of claims 1 to 44.

46. the balloon, in response to modulated pressure applied to the interior of the balloon, becomes more compliant, less compliant, stiffer, more rigid, or develops one or more of a complementary shape, surface, or portion supported by the balloon; 46. ​​The device of claim 45.

47. The surface of the balloon is provided with one or more electrodes, wiring, circuits, or components for mapping or ablation performed using the surgical access device. A device according to any one of claims 1 to 46.

48. an elongate body having a working channel; a balloon visualization module disposed at a distal end of the elongate body, the balloon comprising a camera module; the camera module is disposed within the balloon and spaced from a distal surface of the balloon; The camera module is configured to be at least partially disposed within a path of the working channel in a stowed state; and wherein, when deployed with the inflated balloon in use, the camera module moves radially outward relative to a longitudinal axis of the elongate body out of the path of the working channel such that at least 90% of the distal surface of the balloon is within the field of view of the camera module. Surgical access devices.

49. 100. A method of performing a medical procedure using a surgical access device according to any one of claims 1 to 48, comprising providing a handle, suitable connection, or configuration at a proximal end thereof, the method comprising: the lighting, camera, and / or visualization components of the balloon visualization module enhance visualization capabilities as part of an arthroscope, laparoscope, endoscope, robotic-assisted surgical instrument, or other surgical instrument during the medical procedure; method.

50. advancing the sheath to a desired location adjacent or proximal to the surgical site; moving a balloon visualization module from the sheath; transitioning the balloon visualization module to a visualization state; positioning a distal portion of the sheath adjacent a surgical site using imaging by a camera within the balloon visualization module; performing one or more steps of the interventional procedure using a tool delivered through the working channel and channel extension of the shaft; performing one or more steps of the interventional procedure by directly viewing the surgical site, the tool, or the surgical field using output from a camera in the balloon visualization module; transitioning the balloon visualization module from the visualization state; and returning the balloon visualization module to a retracted state within the sheath. How medical procedures are performed on patients.

51. moving the balloon visualization module from the sheath includes advancing a shaft coupled to the balloon visualization module relative to the sheath.

51. The method of claim 50.

52. transitioning the balloon visualization module to a visualization state includes inflating a balloon of the balloon visualization module with a fluid.

52. The method of claim 50 or 51.

53. transitioning the balloon visualization module to a visualization state includes inflating a balloon of the balloon visualization module with saline.

53. The method according to any one of claims 50 to 52.

54. purging the balloon and / or fluid lines of the balloon visualization module.

54. The method according to any one of claims 50 to 53.

55. the purging includes continuously pumping fluid through the fluid line and the balloon.

55. The method of claim 54.

56. transitioning the balloon visualization module to a visualization state includes inflating a balloon of the balloon visualization module with a fluid.

56. The method according to any one of claims 50 to 55.

57. inflating the balloon of the balloon visualization module with fluid until visual feedback confirms full inflation; 57. The method of claim 56.

58. Inflating the balloon of the balloon visualization module with fluid occurs until a predetermined amount of fluid is pumped into the balloon.

58. The method of claim 56 or 57.

59. Inflating the balloon of the balloon visualization module with a fluid includes providing one or more of constant balloon pressure, leak detection, and contact force sensing through active pressure control.

59. The method according to any one of claims 56 to 58.

60. Transitioning the balloon visualization module to a visualization state includes inflating a balloon of the balloon visualization module with a fluid and moving the camera to a desired position.

60. The method according to any one of claims 50 to 59.

61. and withdrawing the sheath and the balloon visualization module from the patient.

61. The method according to any one of claims 50 to 60.

62. the medical procedure comprises ablation; 62. The method of any one of claims 50 to 61.

63. the medical procedure includes left atrial appendage closure.

62. The method of any one of claims 50 to 61.

64. the medical procedure comprises minimally invasive mitral valve surgery; 62. The method of any one of claims 50 to 61.

65. the medical procedure comprises minimally invasive aortic surgery; 62. The method of any one of claims 50 to 61.

66. the medical procedure comprises coronary artery surgery; 62. The method of any one of claims 50 to 61.

67. the medical procedure includes minimally invasive surgery for intrapericardial tumors; 62. The method of any one of claims 50 to 61.

68. the medical procedure includes removal of a pacemaker lead.

62. The method of any one of claims 50 to 61.

69. the medical procedure comprises an endomyocardial biopsy; 62. The method of any one of claims 50 to 61.

70. the medical procedure comprises transcatheter mitral valve repair; 62. The method of any one of claims 50 to 61.

71. the medical procedure comprises transcatheter mitral valve replacement.

62. The method of any one of claims 50 to 61.

72. the medical procedure comprises tricuspid valve repair.

62. The method of any one of claims 50 to 61.

73. the medical procedure comprises remodeling of the right ventricle; 62. The method of any one of claims 50 to 61.

74. the medical procedure includes a tethered implant.

62. The method of any one of claims 50 to 61.

75. the medical procedure comprises closure of an atrial septal defect or a patent foramen ovale; 62. The method of any one of claims 50 to 61.

76. the medical procedure includes balloon atrial septostomy; 62. The method of any one of claims 50 to 61.

77. advancing the sheath to a desired location adjacent or proximal to the surgical site; moving a balloon visualization module from the sheath; inflating a balloon of the balloon visualization module to a visualization state and positioning a camera within the balloon visualization module at a desired position; positioning the balloon adjacent to a target tissue using imaging by a camera in the balloon visualization module; performing one or more steps of the interventional procedure using a tool delivered through the working channel and channel extension of the shaft; performing one or more steps of the interventional procedure by directly viewing the surgical site, the tool, or the surgical field using output from a camera in the balloon visualization module; How medical procedures are performed on patients.

78. navigating the access sheath to a desired location using an uninflated, contained balloon visualization module within the access sheath; advancing a shaft having the balloon visualization module at its distal end from a housed position within the access sheath; Flushing the fluid lines and balloons of the balloon visualization module; pumping fluid into the interior of the balloon to initiate a transition from an uninflated state to an inflated state; Increasing the amount of fluid to expand or unfold the balloon and lift the stowed camera module; continuing to pump fluid into the balloon until the balloon is fully inflated and the camera module is positioned to view the surgical field; and maintaining the balloon inflated during the procedure so that it gently conforms to the tissue at the treatment site. How medical procedures are performed on patients.

79. and after completion of the procedure, further comprising deflating the balloon and retracting the balloon visualization module into the access sheath, thereby folding or bending the camera module into the outer diameter of the sheath.

79. The method of claim 78.

80. and retracting the sheath and the balloon visualization module.

80. The method of claim 78 or 79.

81. The fluid is saline.

81. The method of any one of claims 78 to 80.

82. flushing the fluid lines and the balloon includes continuously pumping fluid through the fluid lines and the balloon.

82. The method of any one of claims 78 to 81.

83. Continuing to pump the fluid includes pumping the fluid until visual feedback confirms full inflation.

83. The method of any one of claims 78 to 82.

84. Continuing to pump the fluid includes pumping the fluid until a predetermined amount of the fluid is delivered to the balloon.

84. The method of any one of claims 78 to 83.

85. Continuing to pump the fluid includes providing one or more of constant balloon pressure, leak detection, and contact force sensing through active pressure control.

85. The method of any one of claims 78 to 84.

86. the medical procedure comprises ablation; 86. The method according to any one of claims 78 to 85.

87. the medical procedure includes left atrial appendage closure.

86. The method according to any one of claims 78 to 85.

88. the medical procedure comprises minimally invasive mitral valve surgery; 86. The method according to any one of claims 78 to 85.

89. the medical procedure comprises minimally invasive aortic surgery; 86. The method according to any one of claims 78 to 85.

90. the medical procedure comprises coronary artery surgery; 86. The method according to any one of claims 78 to 85.

91. the medical procedure includes minimally invasive surgery for intrapericardial tumors; 86. The method according to any one of claims 78 to 85.

92. the medical procedure includes removal of a pacemaker lead.

86. The method according to any one of claims 78 to 85.

93. the medical procedure comprises an endomyocardial biopsy; 86. The method according to any one of claims 78 to 85.

94. the medical procedure comprises transcatheter mitral valve repair; 86. The method according to any one of claims 78 to 85.

95. the medical procedure comprises transcatheter mitral valve replacement.

86. The method according to any one of claims 78 to 85.

96. the medical procedure comprises tricuspid valve repair.

86. The method according to any one of claims 78 to 85.

97. the medical procedure comprises remodeling of the right ventricle; 86. The method according to any one of claims 78 to 85.

98. the medical procedure includes a tethered implant.

86. The method according to any one of claims 78 to 85.

99. the medical procedure comprises closure of an atrial septal defect or a patent foramen ovale; 86. The method according to any one of claims 78 to 85.

100. the medical procedure includes balloon atrial septostomy; 86. The method according to any one of claims 78 to 85.

101. navigating the access sheath to a desired location using an uninflated, contained balloon visualization module within the access sheath; advancing a shaft having the balloon visualization module at its distal end from a housed position within the access sheath; pumping fluid into the interior of the balloon to initiate a transition from an uninflated state to an inflated state; continuing to pump fluid into the interior of the balloon until the balloon is fully inflated and positioning a camera module within the balloon such that the field of view of the camera module covers at least 90% of the distal surface of the balloon. How medical procedures are performed on patients.

102. contacting a fluid-inflated balloon of a balloon visualization module with tissue adjacent to the treatment site to displace blood within the treatment site; receiving image data from a camera module disposed within the balloon and the fluid; advancing a surgical tool through a working channel of the balloon visualization module extending through the balloon; and visualizing the surgical tool exiting the working channel with the camera module. How to perform a medical procedure.

103. an open proximal end; a proximal portion having a generally tubular body and extending distally from the proximal end; an intermediate portion extending distally from the proximal portion to an intermediate surface portion, the intermediate portion extending radially outward from the proximal portion along at least one of an upper surface or a lower surface of the intermediate portion; an intermediate surface portion extending radially inward from a distal end of the intermediate portion and defining a generally closed, distally facing surface with an opening; a distal portion extending from the opening in the mid-surface portion and having a generally tubular shape and an open distal end; A balloon for use with a surgical access device.

104. When assembled for use with the surgical access device, inverted so that the distal portion is disposed within the intermediate portion; a balloon channel formed within the intermediate portion with the open distal end disposed proximal to the intermediate surface portion; 104. The balloon of claim 103.

105. when assembled for use with the surgical access device, the open distal end is disposed within the intermediate section proximal to the intermediate surface section and distal to the open proximal end.

105. The balloon of claim 104.

106. the intermediate surface defines a distal surface of the balloon when assembled for use with the surgical access device.

106. A balloon according to claim 104 or 105.

107. When assembled for use with the surgical access device, the open proximal end of the balloon is coupled to the distal end of the elongate body. A balloon according to any one of claims 104 to 106.

108. the distal portion is coupled to the lumen such that the lumen extends through the balloon channel; A balloon according to any one of claims 104 to 107.

109. The lumen comprises a flexible lumen.

109. The balloon of claim 108.

110. The lumen comprises a rigid lumen having a notch at an upper portion.

109. The balloon of claim 108.

111. the notch extends along approximately 60-90% of the length of the distal portion of the balloon; 111. The balloon of claim 110.

112. The lumen is made of an optically transparent material. A balloon according to any one of claims 108 to 110.

113. A camera module is connected to the balloon channel. A balloon according to any one of claims 104 to 112.

114. the camera module is coupled to the balloon channel such that, when the balloon is inflated, the field of view of the camera module covers approximately 90% of the midsurface of the balloon. A balloon according to any one of claims 104 to 113.

115. the camera module is coupled to the balloon channel using a camera mount; 115. A balloon according to claim 113 or 114.

116. the open distal end is coupled to the distal end of the working channel of the elongate body; A balloon according to any one of claims 104 to 107.

117. the distal portion has a first durometer; the intermediate portion and / or the intermediate surface portion have a second durometer; A balloon according to any one of claims 103 to 116.

118. the first durometer is different from the second durometer; 118. The balloon of claim 117.

119. The balloon has a distal portion having a first flexibility and a middle portion and / or a mid-surface portion having a second flexibility. A balloon according to any one of claims 103 to 118.

120. the first durometer is different from the second durometer; 120. The balloon of claim 119.

121. When assembled for use with the surgical access device, the distal portion is coupled to a lumen. A balloon according to any one of claims 103 to 120.

122. The lumen comprises a flexible lumen.

122. The balloon of claim 121.

123. the lumen comprises a rigid lumen with a notched upper portion; 122. The balloon of claim 121.

124. the distal portion has a length of about 16-18 mm; A balloon according to any one of claims 103 to 123.

125. The proximal portion has a length of about 4 to 6 mm. A balloon according to any one of claims 103 to 124.

126. The diameter of the distal portion is about 3-4 mm. A balloon according to any one of claims 103 to 125.

127. The diameter of the proximal portion is about 3 to 5 mm. A balloon according to any one of claims 103 to 126.

128. the proximal portion is coaxial with the distal portion; A balloon according to any one of claims 103 to 127.

129. the proximal portion is not coaxial with the distal portion; A balloon according to any one of claims 103 to 127.

130. the balloon is not symmetrical about the longitudinal axis of the distal portion; A balloon according to any one of claims 103 to 129.

131. the balloon is symmetrical about the longitudinal axis of the distal portion; A balloon according to any one of claims 103 to 129.

132. the balloon having a larger volume above the distal end than below the distal portion; A balloon according to any one of claims 103 to 129.

133. The intermediate surface portion is convex. A balloon according to any one of claims 103 to 132.

134. The intermediate surface portion is concave. A balloon according to any one of claims 103 to 132.

135. The balloon is made of an optically transparent material. A balloon according to any one of claims 103 to 134.

136. the balloon is made of at least one of polyurethane, silicone, Pebax®, nylon, and polyester / PET; A balloon according to any one of claims 103 to 135.

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