Surgical access device with built-in balloon visualization module

Abstract

A surgical access device with a built-in balloon visualization module is described. The balloon and visualization module may form part of a hybrid working channel when deployed. When stowed, the visualization module and balloon are fully enclosed within the elongate body of the surgical access device. Embodiments of the surgical access device and balloon visualization system may be applied in a variety of medical procedures.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 376,049 filed on September 16, 2022, U.S. Provisional Patent Application No. 63 / 384,372 filed on November 18, 2022, and U.S. Provisional Patent Application No. 63 / 482,000 filed on January 27, 2023, each of which is incorporated herein by reference in its entirety.

[0003] Incorporation by Reference

[0004] 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. Technical Field

[0005] Various alternative surgical access device embodiments are directed to surgical devices having built-in imaging capabilities. Background Art

[0006] Some conventional surgical devices offer visualization capabilities. However, a common drawback of conventional designs is that visualization systems compete with Figure 1 The valuable space in the internal working channel of the equipment shown, Figure 1 A view of the distal end of a conventional instrument is shown. Thus, there is a negative tradeoff in providing a visualization system at the expense of a reduction or compromise in the size of the working channel. There is a need for an improved visualization system that allows the size of the working channel to be increased while maintaining the desired surgical imaging capabilities. Summary of the invention

[0007] In these and other embodiments, a surgical access device is provided. The device includes an elongated body having a working channel; and a balloon visualization module (BVM) located at a distal end of the elongated body, the balloon visualization module including a balloon, a camera module located within the balloon, wherein when in a stowed configuration, the camera module is configured to be contained within an outer diameter of an access sheath, and when deployed with an inflated balloon in use, the camera module moves radially outward relative to a longitudinal axis of the elongated body to a position substantially beyond an outer wall of the elongated body.

[0008] In some embodiments, the balloon visualization module is completely located within the working channel when retracted.

[0009] At least a portion of the distal surface of the balloon may form a contact visualization surface configured to contact a target tissue and allow visualization of the target tissue therethrough by the camera module.

[0010] In some embodiments, when the camera module is in the expanded configuration, at least 90% of the distal surface of the balloon is within the field of view of the camera module. In some embodiments, when the camera module is in the expanded configuration, at least 95% of the distal surface of the balloon is within the field of view of the camera module.

[0011] The distal surface of the balloon may be rounded.In some embodiments, the balloon comprises an optically transparent material.

[0012] The camera module may be spaced approximately 8-13 mm from the distal surface of the balloon.

[0013] In some embodiments, the elongated body includes a plurality of cavities. The elongated body may include a fluid cavity. In some embodiments, the diameter of the fluid cavity is approximately 0.4-0.6 mm. The elongated body may include a position tracking sensor.

[0014] In some embodiments, the camera module includes an electronic connector extending proximally toward the proximal end of the elongated body. The camera module may include more than one light source. In some embodiments, the camera module is positioned approximately parallel to the longitudinal axis of the elongated body. The camera module may be positioned approximately parallel to the longitudinal axis of the elongated body. In some embodiments, the camera module is positioned at an angle relative to the longitudinal axis of the elongated body. The device may include a camera mount configured to attach to the channel extension and support the camera module.

[0015] The balloon visualization module may include a channel extension portion coupled to the distal end of the working channel. In some embodiments, the channel extension portion includes a cavity with a cutout portion. The balloon may be configured to complete the cavity within at least a portion of the cutout portion when inflated. In some embodiments, the cutout portion includes approximately 60-90% of the length of the channel extension portion. The channel extension portion may include a flexible tube. In some embodiments, the channel extension portion includes an optically transparent material.

[0016] The balloon may include a balloon channel configured to surround the channel extension. In some embodiments, the diameter of the balloon channel is about 3-3.8 mm. The length of the balloon channel may be about 16-17.4 mm. In some embodiments, the device includes a camera mount configured to be attached to the balloon channel and support the camera module. The balloon may include a thickness less than or equal to about 0.1 mm. In some embodiments, the balloon includes a hardness of about Shore 80-90A.

[0017] The balloon may be asymmetric about the longitudinal access of the channel extension. In some embodiments, the greater volume of the balloon is located above the channel extension. In some embodiments, more than 80% of the volume of the balloon is located above the channel extension.

[0018] The elongated body may include a diameter of approximately 12-16F.

[0019] In some embodiments, when the camera module is in the deployed position, about 6-7 mm of the distal end of the channel extension is within the field of view of the camera module. 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 about 1 / 3 of the bottom of the field of view of the camera module.

[0020] In some embodiments, the working channel has a diameter of about 8-9F. The working channel can extend beyond the distal end of the elongated body. In some embodiments, the balloon comprises polyurethane, silicone, One or a combination of nylon, polyester / PET. The proximal end of the balloon can be connected to the distal end of the elongated body. In some embodiments, the height of the balloon is about 12-14 mm.

[0021] The camera module may include a field of view of approximately 110° in air. The camera module may include an integrated lighting system.

[0022] In some embodiments, the refractive index of the fluid within the balloon is substantially similar to the refractive index of the balloon.

[0023] The balloon can be responsive to a modulated pressure applied to the interior of the balloon. In some embodiments, when the balloon is responsive to a modulated pressure applied to the interior of the balloon, the balloon is more compliant, less compliant, firmer, rigid, or the balloon deploys one or more features, surfaces, or auxiliary shapes supported by the balloon.

[0024] The surface of the balloon may include one or more electrodes, wiring, circuits, or components for mapping or ablation applications using a surgical access device.

[0025] In these and other embodiments, a surgical access device is provided. The surgical access device includes an elongated body having a working channel; and a balloon visualization module located at a distal end of the elongated body, the balloon visualization module including a balloon, a camera module located in an interior volume of the balloon and spaced from a distal surface of the balloon, wherein when in a stowed configuration, the camera module is configured to be at least partially within the path of the working channel, and when deployed with an inflated balloon in use, the camera module moves radially outward relative to a longitudinal axis of the elongated body 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.

[0026] In these and other embodiments, a method of performing a medical procedure using a surgical access device as described above is provided. The device includes a proximal end having a handle or suitable connection or configuration, wherein the lighting, camera and / or visualization components of the balloon visualization module provide improved visualization capabilities as part of an arthroscopic, laparoscope, endoscope, robotic-assisted or other surgical instrument used when performing a medical procedure.

[0027] In these and other embodiments, a method of performing a medical procedure on a patient is provided. The method includes: advancing a sheath to a desired position adjacent to or proximate to a surgical site; moving a balloon visualization module out of 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 within 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 portion of a shaft; performing one or more steps of the interventional procedure under direct visualization of the surgical site, tool, or surgical field using output from the camera within the balloon visualization module; transitioning the balloon visualization module out of the visualization state; and returning the balloon visualization module to the stowed configuration within the sheath.

[0028] In some embodiments, the method includes moving the BVM out of the sheath, which includes advancing a shaft coupled to the BVM relative to the sheath. Converting the BVM to a visualization state may include inflating a balloon of the BVM with a fluid. Converting the BVM to a visualization state may include inflating a balloon of the balloon visualization module with saline.

[0029] In some embodiments, the method includes cleaning the fluid line and / or the balloon of the BVM. Cleaning may include continuously pumping fluid through the fluid line and the balloon.

[0030] In some embodiments, converting the BVM to a visualization state comprises inflating a balloon of the BVM with a fluid. Inflating the balloon may comprise inflating until visual feedback confirms full inflation. Inflating the balloon may comprise inflating until a predefined volume of fluid is pumped into the balloon. Inflating the balloon may comprise using active pressure control to provide one or more of a constant balloon pressure, leak detection, and contact force sensing.

[0031] Converting the BVM to a visualization state may include inflating a balloon of the BVM with a fluid, thereby moving the camera to a desired position.

[0032] In some embodiments, the method includes withdrawing the sheath and balloon visualization module from the patient.

[0033] 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, endomyocardial biopsy, transcatheter mitral valve repair, transcatheter mitral valve replacement, tricuspid valve repair, right ventricular remodeling, tether implantation, atrial septal defect or patent foramen ovale closure, or balloon atrial septostomy.

[0034] In these and other embodiments, a method of performing a medical procedure on a patient is provided. The method includes: advancing a sheath to a desired position adjacent to or proximate to a surgical site; moving a balloon visualization module out of the sheath; inflating a balloon of the balloon visualization module to a visualization state, thereby positioning a camera within the balloon visualization module to a desired position; positioning the balloon adjacent to the target tissue using imaging from 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 a channel extension portion of a shaft; and performing one or more steps of the interventional procedure under direct visualization of the surgical site, the tool, or a surgical field using output from the camera within the balloon visualization module.

[0035] In these and other embodiments, a method of performing a medical procedure on a patient is provided. The method includes: navigating an access sheath to a desired location with a balloon visualization module in an uninflated, stowed configuration within the access sheath; advancing a shaft from its stowed configuration within the access sheath, the shaft having a BVM at its distal end; flushing a fluid line and a balloon of the BVM; pumping fluid into the interior volume of the balloon to initiate a transition from an uninflated to an inflated state; increasing the volume of fluid to cause the balloon to deploy or open and raise a camera module from its stowed configuration; continuing to pump fluid into the interior volume of the balloon until it is fully expanded to an inflated state with the camera module in a position to view a surgical field; and maintaining the inflation of the balloon so that it gently conforms to tissue at the treatment site during the procedure.

[0036] In some embodiments, the method includes, upon completion of the procedure, deflation of the balloon and retraction of the BVM into the access sheath, causing the camera module to collapse or bend back into the outer diameter of the sheath. The method may include withdrawing the sheath and the BVM. The fluid may be saline. In some embodiments, flushing the fluid line and balloon includes continuously pumping fluid through the fluid line and balloon.

[0037] In some embodiments, continuously pumping fluid includes pumping fluid until visual feedback confirms full inflation. In some embodiments, continuously pumping fluid includes pumping fluid until a predefined volume of fluid is pumped into the balloon. In some embodiments, continuously pumping fluid includes using active pressure control to provide one or more of constant balloon pressure, leak detection, and contact force sensing.

[0038] Medical procedures 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, endomyocardial biopsy, transcatheter mitral valve repair, transcatheter mitral valve replacement, tricuspid valve repair, right ventricular remodeling, tether implantation, atrial septal defect or patent foramen ovale closure, or balloon atrial septostomy.

[0039] In these and other embodiments, a method of performing a medical procedure on a patient is provided. The method includes: navigating an access sheath to a desired location with a balloon visualization module located within the access sheath in an uninflated, stowed configuration; advancing a shaft from its stowed configuration within the access sheath, the shaft having a BVM at its distal end; pumping a fluid into the interior volume of the balloon to initiate a transition from an uninflated to an inflated state; and continuing to pump a fluid into the interior volume of the balloon until it is fully expanded to an inflated state, placing a camera module within the balloon in position such that its field of view covers at least 90% of the distal face of the balloon.

[0040] In these and other embodiments, a method of performing a medical procedure is provided, the method comprising: contacting tissue adjacent to a surgical site using a balloon of a balloon visualization module to displace blood within the surgical site, wherein the balloon is inflated with a fluid; receiving imaging data from a camera module located within the balloon and in the fluid; advancing a surgical tool through a working channel of the balloon visualization module, extending through the balloon; and visualizing the surgical tool using the camera module as it is withdrawn from the working channel.

[0041] In these and other embodiments, a balloon for use with a surgical access device is provided. The balloon includes an open proximal end; a proximal portion extending distally from the proximal end and including a generally tubular body; a mid-section extending from the proximal portion, the mid-section extending radially outward from the proximal portion along at least one of a top or bottom surface of the mid-section and extending distally from the proximal portion to a mid-face section; the mid-face section extending radially inwardly from the distal end of the mid-section to form a generally closed distal-facing surface including an aperture; and a distal portion extending from the aperture of the mid-face section, the distal portion including a generally tubular shape and an open distal end.

[0042] In some embodiments, when assembled for use with a surgical access device, the distal portion is inverted so that it is located within the middle portion, where the balloon channel is formed, and the open distal end is located proximal to the mid-face portion. In some embodiments, when assembled for use with a surgical access device, the open distal end is located within the middle portion, proximal to the mid-face portion, and distal to the open proximal end. In some embodiments, when assembled for use with a surgical access device, the mid-face portion is the distal surface of the balloon. In some embodiments, when assembled for use with a surgical access device, the open proximal end of the balloon is coupled to the distal end of the elongated body.

[0043] The distal portion may be coupled to the cavity so that the cavity extends through the balloon passage. The cavity may include a flexible cavity. The cavity may include a rigid cavity with a cutout at the top thereof. The cavity may include a rigid cavity. The cavity may include a cavity with a cutout at the top thereof. In some embodiments, the cutout extends along approximately 60-90% of the length of the distal portion of the balloon. The cavity may include an optically transparent material.

[0044] The camera module can be coupled to the balloon channel. In some embodiments, the camera module is coupled to the balloon channel so that when the balloon is inflated, the field of view of the camera module covers about 90% of the mid-face of the balloon. The camera module can be coupled to the balloon channel using a camera mount.

[0045] In some embodiments, the open distal end is coupled to the distal end of the working channel of the elongated body. The distal portion may include a first hardness, and the middle portion and / or mid-face portion include a second hardness. The first hardness may be different from the second hardness.

[0046] In some embodiments, the open distal end is coupled to the distal end of the working channel of the elongated body. The distal portion may include a first flexibility, while the middle portion and / or mid-face portion include a second flexibility. The first flexibility may be different from the second flexibility.

[0047] In some embodiments, when assembled for use with a surgical access device, the distal portion is coupled to a cavity. The cavity may include a flexible cavity or a rigid cavity. The cavity may include an incision top.

[0048] In some embodiments, the distal portion comprises a length of about 16-18 mm. The proximal portion may comprise a length of about 4-6 mm. In some embodiments, the proximal portion has a diameter of about 3-5 mm.

[0049] The proximal portion may or may not be coaxial with the distal portion.

[0050] The balloon may be symmetrical or asymmetrical about the longitudinal axis of the distal portion.In some embodiments, the larger volume of the balloon is located above the distal portion rather than below the distal portion.

[0051] The mid-face portion may be concave or convex.

[0052] The balloon may include an optically transparent material. In some embodiments, the balloon includes polyurethane, silicone, At least one of nylon and polyester / PET. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 A stereoscopic view of the distal end of a conventional instrument is shown.

[0054] Figure 2 A stereoscopic view of the distal end of a surgical access device with a balloon visualization module (BVM) is shown.

[0055] Figure 3A and Figure 3B An embodiment of a surgical access device having a BVM is shown for use in a procedure involving surgical access.

[0056] Figure 4A A side view of the distal end of an embodiment of an access device including a BVM is shown.

[0057] Figure 4B Representative views from the camera module are shown.

[0058] Figure 5A A side cross-sectional view of the distal end of an embodiment of an access device including a BVM is shown.

[0059] Figure 5B Representative views from the camera module are shown.

[0060] Fig. 6A and Figure 6B Side cross-sectional and perspective views of the distal end of an embodiment of an access device including a BVM are shown.

[0061] 7A to 7F Various views of the far end of an embodiment of an access device including a BVM are shown.

[0062] FIG. 8A to FIG. 8F An expansion of an embodiment of a BVM is shown.

[0063] 9A to 9C Various views of an access device including a BVM in a stowed configuration are shown.

[0064] Fig.10 An isometric view of an embodiment of an access sheath and BVM is shown.

[0065] FIG. 11A to FIG. 11E The conventional pacemaker lead removal technique is shown.

[0066] Fig.12 An embodiment of an access device including a BVM is shown.

[0067] Fig.13 Shows Fig.12 A cross-sectional side view of the device in position for removal of the pacemaker lead.

[0068] FIG. 14A to FIG. 14C Various views of an embodiment of an access device including a BVM are shown.

[0069] Fig.15A and Fig. 15B A cross-sectional view of an embodiment of a multi-lumen shaft is shown.

[0070] Fig.16 A perspective view of the distal end of an embodiment of an extension channel is shown.

[0071] Fig.17A and Fig. 17B A side cross-sectional view of the balloon and the BVM including the balloon is shown.

[0072] Fig.18A and Fig.18B Various configurations of camera module mounts are shown.

[0073] Fig.19A A side view of the BVM is shown.

[0074] Fig.19B A representative view of the camera module from the BVM is shown.

[0075] Fig. 20A and Fig. 20B Shown are perspective views of an embodiment of a balloon during two steps of the assembly process.

[0076] FIG. 21A to FIG. 21DSide views of various embodiments of balloons for use with a BVM are shown.

[0077] FIG. 22A to FIG. 22C Various views of an embodiment of a method of connecting a balloon to a channel extension are shown.

[0078] FIG. 23A to FIG. 23D Various views of an embodiment of a method of attaching a camera mount to a distal leg of a balloon are shown.

[0079] FIG. 24A to FIG. 24D An embodiment of a method of connecting a shaft to a balloon and a channel extension is shown.

[0080] Fig.25 An embodiment of the proximal end of a BVM device is shown.

[0081] Fig.26A and Fig.26B Various views of an embodiment of a steerable BVM device are shown.

[0082] Fig.27A and Fig.27B An embodiment of a method of balloon inflation and deflation is shown.

[0083] Fig.28 An embodiment of a channel extension is shown.

[0084] FIG. 29A to FIG. 29K Various embodiments of channel extensions are shown including various proximal and distal mating features.

[0085] Figure 29L and Fig.29M A perspective view and a side view of an embodiment of a channel extension are shown.

[0086] Fig.29N and Fig.29O A perspective view and a side view of the channel extension are shown.

[0087] FIG. 30A to FIG. 30D Various views of an embodiment of a channel extension including multiple cavities are shown.

[0088] 31A1-31M2 illustrate various embodiments and configurations of many different possible channel extension portions including various cut-out portions and proximal and distal mating feature configurations.

[0089] FIG. 32A to FIG. 32C An embodiment of a method of deploying a BVM from a collapsed configuration is shown.

[0090] Fig.33 An embodiment of a BVM including multiple camera modules is shown.

[0091] Fig.34 An embodiment of an access device with a BVM is shown.

[0092] Fig.35 An embodiment of a method of using a BVM device is shown.

[0093] Fig.36 An embodiment of a method of using a BVM device is shown.

[0094] FIG. 37A to FIG. 37D An embodiment of a balloon including a distal window with optical scaling is shown.

[0095] Fig.38A Shows Fig.37A and Fig.37C The camera module's field of view is shown.

[0096] Fig.38B Shows Fig.37B and Fig.37D The camera module's field of view is shown.

[0097] Fig.39 An exemplary method of using a BVM as a tissue manipulator is shown.

[0098] Fig.40A The field of view from the camera module during an ablation procedure is shown.

[0099] Fig.40B The BVM device is shown positioned toward the pulmonary veins.

[0100] Fig.41A The view from the camera module during pacemaker lead removal is shown.

[0101] Fig.41B A BVM device is shown visualizing scarred pacemaker lead sites.

[0102] Fig.42A Shown is the view from the camera module of the BVM device during pacemaker lead removal, with the pacemaker lead in the working channel.

[0103] Fig.42B A circular cutting element is shown being delivered through a working channel.

[0104] Fig.42C A view showing a pacemaker lead inserted into the working channel of a BVM device and used as a guidewire.

[0105] Fig.43A A view of the camera module of a BVM device is shown performing a biopsy procedure at the annulus of a valve.

[0106] Fig.43BThe BVM device is shown positioned toward the target tissue.

[0107] FIG. 44A to FIG. 44D Various embodiments of camera supports or mounts are shown.

[0108] FIG. 45A to FIG. 45C Various embodiments of camera supports or mounts are shown. DETAILED DESCRIPTION

[0109] As described herein, various alternative embodiments of the surgical access device of the present invention having a balloon-based visualization module (BVM) can be used to solve a wide range of clinical problems in many different medical procedures.

[0110] Reference Figure 2 , shows a perspective view of the distal end of a surgical access device 200 having a BVM 202. The device 200 includes a shaft 204. A working channel 205 extends through the shaft 204. Located at or near the distal end of the shaft 204 is a balloon 206. Located within the balloon 206 is a camera and lighting system 208.

[0111] Inflow channel 210 and outflow channel 212 are in fluid communication with balloon 206. Inflow channel 210 may be used to inflate the balloon with a fluid (e.g., saline, water, etc.). Outflow channel 212 may be used to vent air bubbles from the balloon during inflation.

[0112] The distal end of the shaft 204 includes a transparent portion 209. In some embodiments, the transparent portion 209 includes an extension portion 216 and a cutout portion 214, and the BVM is configured to at least partially extend from the cutout portion 214 when the balloon is inflated.

[0113] Figure 2 The display balloon includes a shape similar to a truncated portion of a sphere located above the working axis. The sphere is truncated at the distal end of the balloon to create an optical window. The sphere is truncated around the axis and / or working channel at the bottom end of the balloon. The bottom central portion of the balloon includes a recessed portion 220. In some embodiments, the shape and size of the recessed portion 220 can be configured to correspond to the size of the distal end of the working channel of the axis. In some embodiments, other balloon shapes are used. Alternative balloon shapes can be selected to provide different fields of view that are coordinated with the selected imaging / illumination assembly. Certain aspects of the balloon shape and size correspond to both the physical external dimensions and shape of the imaging assembly and the optical devices associated with the functionality of the imaging assembly.

[0114] The balloon may comprise silicone. Other materials are also contemplated.

[0115] The balloon may include a thickness of about 0.20-0.25 mm (or about 0.15-0.30 mm, about 0.10-0.35 mm, about 0.05-0.1 mm, 0.075-0.1 mm, about 0.1 mm, etc.).

[0116] Advantageously, the BVM is located within the extension 216 at the distal end of the shaft 204 when in the stowed configuration with the balloon 206 uninflated. The BVM can maintain this position when inserted and advanced to the surgical site. The BVM assembly is placed within the cross-section of the working channel, thereby enabling a significantly smaller outer diameter than conventional systems. When the balloon is inflated, the balloon and camera / illumination system move beyond the dimensions of the outer diameter of the shaft 204. When the balloon is fully or mostly inflated, the camera 208 is in the desired position and the balloon provides the desired field of view.

[0117] In some embodiments, when the balloon is inflated, the bottom or profile 218 of the balloon forms a portion of the working channel, located in or around the cutout portion. In some embodiments, the bottom profile of the balloon is a portion of the working channel of the shaft. In some embodiments, the bottom of the balloon includes features that form the distal-most portion of the working channel.

[0118] In some embodiments, the extension portion 216 is similar to a half-tube or partial tube shape, forming a portion of a tubular shape. Other configurations are also contemplated. For example, in some embodiments, the extension portion 216 includes a circular flexible extension of the distal end of the shaft 204 (e.g., as shown with respect to devices 600, 700, 800, 900, etc.).

[0119] In some embodiments, the device includes an outer diameter of about 3-10 mm, or about 4-8 mm, or about 5-7 mm, etc. It will be appreciated, therefore, that in various embodiments, the device shaft, working channel, and balloon visualization module are adjusted and configured to perform one or more steps in a minimally invasive, single-port access, robotic-assisted, interventional, or surgical procedure to address deficiencies or clinical problems associated with various medical procedures. In some embodiments, the elongated body of the surgical access device can be adjusted and configured to be flexible, bendable, or controllable into a range of various shapes or curvatures along all or part of its length to support the 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 configured to be steerable (e.g., 60-90° steerability in one direction). The handle or proximal end will be adjusted and configured to allow user or robotic control of such functionality of the elongated body.

[0120] Typically, embodiments of the surgical access device of the present invention with a built-in balloon visualization module include a proximal end having a handle or suitable connection or configuration, wherein the lighting, camera and / or visualization components of the balloon visualization module provide improved visualization capabilities as part of an arthroscopic, laparoscope, endoscope, robot-assisted or other surgical instrument. The surgical access device also has an elongated body with an internal cavity. The internal cavity of the elongated body is used as a working channel extending from the proximal end of the elongated body to the distal end. The proximal end is connected to the handle, and the distal end is connected or connected to the BVM support structure. The internal cavity of the elongated body also provides access to the inlet and outlet of the balloon internal volume (i.e., controlling the inflation with fluid and managing bubbles and deflation or other functions). In addition, the internal cavity of the elongated body is used for input, output, power supply, optical fiber and any other connection, which are common in surgical vision systems, depending on the type of imaging required according to the medical procedure performed. These various additional connections are also located in the cavity of the elongated body. As further described herein, the balloon visualization module is connected to the distal end of the elongated body. There is a support structure that extends from the distal end of the elongated body. The balloon and visualization assembly are placed against and along the support structure when deflated / folded. When the balloon is unfolded / inflated, the balloon is located above the support structure, and a portion of the balloon surface and the support structure further extend the working channel. Additionally or optionally, the balloon can be compliant and operable to conform to the surgical field of view, having a rounded, circular or cylindrical external overall shape or other external shape to accommodate imaging of complex geometries or further help move blood away from the surgical field of view. These shapes and field of view design aspects can correspond to the various medical procedures described herein. The elongated body can be configured for use with an access sheath. The access sheath can be steerable or otherwise controllable.

[0121] In particular, in certain embodiments, the balloon visualization module (BVM) is advantageously configured to provide a portion of a hybrid working channel, a visualization cavity associated with the field of view required by the imaging and illumination system or assembly, and the ability to transition from a stowed configuration to an expanded configuration. A hybrid working channel refers to a combination of a working channel within the shaft of the access device and a working channel extending from the distal end of the access device. The extension of the working channel is a combination of a portion of a partial or half-tube base member and a portion of the bottom surface or contour of the balloon forming the upper portion of the working channel. In some embodiments, the hybrid working channel has the same inner diameter along the entire length, or the inner diameters may be different, with one being smaller than the other.

[0122] The balloon visualization module (BVM) is attached to the surgical access tool shaft at the proximal end. The distal face of the balloon used in the balloon visualization module is shaped and sized similar to a screen to mimic the desired field of view of the built-in camera / lighting assembly associated with the balloon visualization module. The bottom surface of the balloon visualization module can be arranged along, embedded in, or along a half-tube extension from the distal end of the device. The half-tube or partial tube extension is aligned with the working channel cavity of the surgical access device and is considered to be an extension thereof. Although shown along the bottom, it is understood that the BVM extension can be in other relationships relative to the working channel, such as aligned at the top, side, or any intermediate peripheral position (e.g., similar to various angular positions on a clock face). Additionally or alternatively, the bottom surface of the inflated balloon can be used to form an expandable upper wall of the working channel. In some embodiments, the balloon includes a channel configured to surround the extension of the working channel. In some embodiments, in the retracted / deflated state, the balloon visualization module completely or partially blocks the working channel of the surgical access tool. In some embodiments, even in the retracted state, the bottom surface of the balloon is located above and forms the upper side of the hybrid working channel.

[0123] Therefore, in some embodiments, the working channel of the BVM surgical access device is composed of a working channel within the slender body cavity and a channel formed by an extended balloon or a half-tube extension, and optionally also includes certain portions or surfaces of the inflated / expanded balloon.

[0124] Additionally or alternatively, in some embodiments, the various components and parts of the surgical access device (e.g., the handle, elongated body, working channel, balloon, and visualization module, including the balloon distal shape / image and illumination field of view) are adapted and configured to provide the desired access and imaging capabilities for surgical, interventional, endoscopic, arthroscopic, minimally invasive, single port access, open, conventional or robotic-assisted medical procedures as described herein.

[0125] Reference now Figure 4A , shows a side view of the distal end of an embodiment of an access device 400 including a BVM 402. The device 400 includes a shaft 404 including a working channel 405 extending through the shaft 404. An optically transparent window 407 is located at the distal end of a balloon 406. In some embodiments, the entire balloon is optically transparent. In some embodiments, a distal portion of the balloon 406 is optically transparent.

[0126] The camera module 408 is located within the balloon 408. A connector, wire, or cable 411 may extend from the camera module 408 to the proximal end of the device and may be used to provide data and / or power to the camera module.

[0127] In some embodiments, the distal window 407 of the balloon comprises a diameter of approximately 10-15 mm and provides a field of view of approximately 10-15 mm in diameter.

[0128] In some embodiments, the diameter of the shaft is approximately 5-6 mm. Other configurations are also contemplated (e.g., 3-8 mm, 4-7 mm, etc.).

[0129] In some embodiments, the working channel has a diameter of about 3-5 mm (or about 3 mm, 4 mm, 5 mm, etc.).

[0130] In some embodiments, the distal window comprises a diameter that is about 2 times (or about 3 times, or about 2-3 times, etc.) the size of the shaft diameter. In some embodiments, the distal window comprises a diameter that is about 3-5 times (or about 3 times, or about 4 times, or about 5 times, etc.) the diameter of the working channel.

[0131] Go to Figure 4B , shows a representative view from camera module 408. The transparent distal portion of working channel 405 and the interior surface 411 of the balloon are visible in the field of view. Devices extending through working channel 405 will be in the field of view.

[0132] refer to Figure 5A , shows a view of an embodiment of an access device 500 having a BVM 502 located at a remote end thereof.

[0133] In some embodiments, Figure 5A As shown, balloon 506 comprises a silicone balloon. The thickness of the balloon is about 0.25 mm.

[0134] like Figure 5A As shown, the camera module 508 may include 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 include a viewing angle of approximately 110°.

[0135] In some embodiments, Figure 5A As shown, the camera module is disposed rearwardly from the distal window 507 of the balloon 506, separated by a distance 513. In some embodiments, the distance 513 is about 8 mm (or about 7-9 mm, about 7 mm, about 9 mm, etc.).

[0136] In some embodiments, the longitudinal axis of the camera module is located above the longitudinal axis of the shaft 504 and / or the working channel 505 by a distance 515. In some embodiments, the distance 515 is about 3.5 mm (or about 3-4 mm, about 3 mm, about 4 mm, etc.).

[0137] As described herein, the access devices with BVM described herein can be adapted and configured to provide a working channel for use with instruments and / or various implants. Instruments can include, but are not limited to, graspers, snares, biopsy needles, radiofrequency ablation devices, tissue morcellators, and ultrasound probes.

[0138] Figure 5B The field of view from camera 508 in a simulated usage environment is shown.

[0139] Go to Fig. 6A and Figure 6B , shows a cross-sectional view and a perspective view of the distal end of an embodiment of an access device 600 including a BVM 602. The device 600 includes a shaft 604 with 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 located within the balloon 606. A flexible channel extension 616 extends from the distal end of the shaft.

[0140] In some embodiments, the flexible channel extension 616 comprises silicone. In some embodiments.

[0141] The balloon includes an asymmetric bulb shape with most of its volume located above the shaft 604 and working channel 605. The balloon can increase in diameter from its proximal end to its distal end. The balloon includes a curved distal end providing a distal window for the camera module 608. The size and shape of the distal window 620 can be determined to approximate the desired field of view of the camera / illumination / imaging module 608.

[0142] The proximal end of the balloon can be generally tubular with a generally circular cross-section to correspond to the distal end of the sheath 604 .

[0143] The balloon is configured with a channel 622 shaped to receive the distal end of the flexible channel extension 616. The balloon 606 can be coupled to the flexible channel extension 616 around the channel 622.

[0144] As described above, a first portion of the distal end of the balloon is shaped to provide alignment and access to the working channel 605 within the sheath 604 , and a second portion of the distal end of the balloon is sized and shaped to correspond to the desired field of view of the camera / illumination / imaging module 608 .

[0145] An inlet channel 610 and an outlet channel 612 extend along the shaft 604 and are in fluid communication with the balloon 606 .

[0146] In some embodiments, the camera module 608 is located on top of the flexible channel extension 616 .

[0147] In some embodiments, the balloon comprises silicone. Other materials (e.g. Nylon, polyester / PET, such as TPU / and Special composite blends of polyamide / nylon, multilayer structures, etc.) are also considered.

[0148] In some embodiments, the hardness of the material can be about Shore 80-90A (e.g., Shore 85A). Other hardnesses (e.g., Shore 20-60A, 30-40A, 35-45A, 45-75A, 75-85A, 60-100A, 70-90A, etc.) are also contemplated.

[0149] The balloon may comprise a thickness of about 0.20-0.25 mm (or about 0.15-0.30 mm, or about 0.10-0.35 mm, etc.).

[0150] In some embodiments, the balloon comprises a uniform thickness. In some embodiments, the thickness of the balloon varies.

[0151] Reference now 7A to 7F , various views of another embodiment of an access device 700 having a BVM 702 are shown. Fig. 7A and Figure 7B An isometric view and a side cross-sectional view, respectively, are shown of another embodiment of a device 700 including a BVM 702. Device 700 includes similar features as device 600 unless otherwise noted.

[0152] Device 700 includes a shaft 704 through which a working channel 705 extends. At the distal end of the shaft is a flexible extension 716. Flexible extension 716 may be coupled to the shaft.

[0153] In some embodiments, the flexible extension 716 is transparent. Non-transparent configurations (eg, stainless steel or Nitinol) are also contemplated.

[0154] The distal end of the flexible extension 716 may include a distal tip 728 that tapers to a rounded distal point. Other shapes are also possible (e.g., Fig. 6A and Figure 6B shown). Distal tip.

[0155] The camera module 708 is located on the flexible extension 716 .

[0156] The balloon includes an asymmetric bulb shape with most of its volume located above the flexible extension 716. The balloon 706 can increase in diameter from its proximal end to its distal end. The balloon includes a rounded distal end with a curved profile that provides a distal window for the camera module 608. The size and shape of the distal window 720 can be determined to approximate the desired field of view of the camera / illumination / imaging module 708.

[0157] The proximal end of the balloon can be generally tubular with a generally circular cross-section to correspond to the distal end of the sheath 704 .

[0158] The balloon is configured with a channel 722 that is shaped to receive the distal end of the flexible channel extension 716. The balloon 706 can be coupled to the flexible channel extension 716 around the channel 722.

[0159] As described above, a first portion of the distal end of the balloon is shaped to provide alignment and access to the working channel 705 within the sheath 704 , and a second portion of the distal end of the balloon is sized and shaped to correspond to the desired field of view of the camera / illumination / imaging module 708 .

[0160] An inlet channel and an outlet channel (not shown) may extend along the shaft 704 and be in fluid communication with the balloon 706 .

[0161] Figure 7C Shown through Fig. 7A 704 and the balloon 706 are visible in this view. The camera module 708 is shown as being located on the flexible extension 716. Figure 7C As shown, the flexible extension portion can have features 734 (e.g., ridges, protrusions, etc.) configured to mate with corresponding features 732 (e.g., grooves, depressions, etc.). The corresponding mating features can help strengthen the bond between the two components. The camera module 708 and the flexible extension portion 716 can be bonded together. Other configurations are also possible (e.g., glued together). Band 726 can also be used to join the components together.

[0162] FIG. 7D to FIG. 7F A side view, a top view, and an end view of an access device 700 with a BVM 702 are shown, respectively. These views show the device shaft 704 and a flexible extension 716. A camera module 708 is located on the flexible extension. A connector 711 of the camera module 708 extends proximally from the camera module through the shaft 704.

[0163] Fig. 7E The top view of shows that the balloon 706 is roughly symmetrical along its width 736 and coaxial with the sheath 704. Fig.7D The side view of 730 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 the working channel 705.

[0164] FIG. 7D to FIG. 7F The flexible extension includes a protrusion / ridge 740 .

[0165] Now go to FIG. 8A to FIG. 8E , showing something like 6A to 7B An expansion of an embodiment of a BVM is shown. Fig. 8A and Figure 8BAn isometric view and a side view of a fully deployed BVM 802 are shown, respectively. The BVM 802 can be delivered through an access sheath. In the fully deployed configuration, the camera 808 is in a desired position. The camera module 808 can be held by the balloon 806 of the working channel extension 816.

[0166] Figure 8C and Fig.8D An isometric view and a side view are shown, respectively, of a partially deployed or retrieved BVM 802. A retrieved BVM refers to a BVM being pulled back into an access sheath. Figure 8C and Fig.8D Working channel 805 is shown advanced out of access sheath 804. Retraction of working channel 805 causes balloon 806 and camera module 808 to be pulled back with working channel 805 because balloon 806 (and, in some embodiments, camera module 808) are coupled to working channel 805. For the same reason, advancement of working channel 805 out of sheath 804 causes balloon 806 and camera module 808 to also be advanced out of sheath 804. Once BVM 802 is advanced out of sheath 804, the balloon can be inflated to orient the camera to a desired position.

[0167] Now go to Fig. 8E and Figure 8F , showing an isometric view and a side view of a stowed or retracted state of the BVM 802. In the stowed and / or retracted configuration, each portion of the BVM and the working channel extension 805 are stowed within the sheath 804 to facilitate insertion or removal of the device.

[0168] Reference now 9A to 9C , showing a side sectional view, an isometric view, and a sectional view, respectively, of the distal end of the access device 900 including the BVM 902 in a stowed configuration. The flexible extension 916 is shown as being located within the sheath 904. A portion 940 of the balloon 906, which becomes the proximal portion of the deployed balloon, is shown extending from the sheath 904 and folded over the sheath 904. The balloon 906 is in an inverted position relative to its deployed position within the sheath 904. The balloon 906 is not coupled to an interior portion of the sheath 906. The balloon 906 is coupled to a portion 942 of the flexible extension 916, which is located proximal to the distal end 944 of the flexible extension. The flexibility of the extension 916 allows the portion of the extension surrounding the camera module 908 to collapse to accommodate the camera module 908 within the dimensions of the sheath 904. Fig. 9C Shows along Fig.9ABB of FIG. 9 . In this view, the extension 916 is shown collapsed along the top, causing the working channel 906 to deform and shrink. This deformation of the extension 916 causes the camera module to be retracted within the sheath for insertion and removal. The flexibility of the extension allows it to return to its more tubular shape after being pushed out of the sheath, lifting the camera module to the desired position.

[0169] Now go to Fig.10 , shows an isometric view of an embodiment of an access sheath 1000 including a BVM 1002. The access device includes a region 1050 of controlled flexibility in the sheath.

[0170] Fig.26A and Fig.26B An embodiment of a steering mechanism 2668 and a control device 2670 that can be used in a sheath is shown. The sheath can include a pull wire 2672 that can be anchored at a distal tip 2671. The sheath includes a relatively stiff proximal portion 2673 and a relatively soft, steerable distal portion 2674. A steering knob 2675 on the handle can be used to pull either pull wire 2672, causing articulation of the distal portion 2674.

[0171] As described herein, various alternative embodiments of the surgical access device of the present invention having a balloon-based visualization module (BVM) can be used to solve a wide range of clinical problems in a variety of different medical procedures. Figure 3A An embodiment of a surgical access device having a BVM is shown for use in a procedure involving surgical access. Figure 3B An embodiment of a surgical access device with a BVM for use in a procedure involving catheter (e.g., transjugular) access is shown. Thus, it will be appreciated that in various embodiments, the device shaft, working channel, and balloon visualization module are adapted and configured for use in performing one or more steps in a minimally invasive, single-port access, robotic-assisted, interventional, or surgical procedure to address deficiencies or clinical problems associated with various medical procedures. In some specific embodiments, the medical procedure may involve minimally invasive mitral valve surgery, minimally invasive aortic valve surgery, minimally invasive coronary artery surgery, surgical tachyarrhythmia treatment, and left atrial appendage closure.

[0172] Reference now Fig.14A and Fig. 14B , showing a side cross-sectional view and a perspective view of the distal end of another embodiment of an access device 1400 having a BVM 1402. Fig. 14C An exploded view of the distal end of access device 1400 is shown. Device 1400 includes shaft 1404 with balloon 1406 coupled to the distal end of sheath 1404. Working channel 1405 extends through sheath 1404. Camera module 1408 is located within balloon 1406. Channel extension 1416 extends from the distal end of working channel 1405.

[0173] The shaft 1404 may include a multi-lumen shaft. The lumens may extend within the wall of the sheath or within the central lumen of the shaft. In some embodiments, some lumens are located within the wall of the shaft and some lumens are located within the central lumen of the sheath.

[0174] In some embodiments, the shaft is flexible.

[0175] In some embodiments, the shaft is 14 F. Other diameters (eg, 10-18 F, etc.) are also possible.

[0176] like Fig. 14C As best shown, fluid channels 1410, 1412 extend along shaft 1404 and are in fluid communication with balloon 1406. The fluid channels may be used for inflation, deflation, and cleaning of balloon 1406.

[0177] In some embodiments, channel extension portion 1416 comprises an optically transparent material. In some embodiments, channel extension portion 1416 comprises polycarbonate or other thermoplastic.

[0178] In some embodiments, channel extension portion 1416 may be transparent.

[0179] like Fig. 14C As best shown, channel extension 1416 includes a cutout portion 1418 that extends along at least a portion of channel extension 1416. Cutout portion 1418 provides a space through which camera module 1408 and a portion of collapsed balloon 1406 can be positioned and stored during delivery and retraction of device 1400.

[0180] like Fig. 14C As shown, the cutout portion 1418 can include the top portion of the channel extension (eg, upper half, upper third, upper quarter, etc.). Other configurations are also contemplated.

[0181] In some embodiments, the cut-out portion 1418 extends along approximately 60-90% of the length of the cut-out portion 1418 .

[0182] In some embodiments, the cut-out portion 1418 begins at a location distal to the distal end of the shaft 1404 .

[0183] In some embodiments, the cut-out portion 1418 ends at a location proximal to the distal end of the channel extension portion 1416 .

[0184] The balloon includes an asymmetric bulb shape with most of its volume located above the shaft 1404 and working channel 1405. The balloon 1406 can increase in diameter from its proximal end or a position close to the proximal end to the distal end of the balloon. Along the upper surface or contour 1407 of the balloon, the diameter of the balloon 1406 can increase faster than the bottom surface of the balloon. The balloon includes a curved distal end that provides a distal window for the camera module 1408. The size and shape of the distal window 1420 can be determined to approximate the desired field of view of the camera / illumination / imaging module 1408.

[0185] In some embodiments, the balloon material includes a refractive index that matches the fluid (eg, saline) used to fill the balloon to minimize unwanted reflections and distortion on the camera image.

[0186] The proximal end of the balloon can be generally tubular with a generally circular cross-section to correspond to the distal end of the 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.).

[0187] 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.).

[0188] The balloon is configured with a channel 1422 that is shaped to receive the distal end of the channel extension 1416. The balloon 1406 can be coupled to the channel extension 1416 around the channel 1422.

[0189] As described above, a first portion of the distal end of the balloon is shaped to provide alignment and access to the working channel 1405 within the shaft 1404 , and a second portion of the distal end of the balloon is sized and shaped to correspond to the desired field of view of the camera / illumination / imaging module 608 .

[0190] In some embodiments, camera module 1408 is located at the top of balloon channel 1422. Connector 1411 extends proximally from the camera module. Connector 1411 can be configured to provide data and / or electronic connections.

[0191] In some embodiments, device 1400 includes a position tracking sensor 1421 (eg, an electromagnetic position tracking sensor) located adjacent to camera module 1408 .

[0192] like Fig. 14CAs best shown, camera mount 1413 can be used to mount camera module 1408 to balloon 1406. Camera mount 1413 includes upper portion 1461 and lower portion 1462. Lower portion 1462 can include cavity or hole 1464 configured to be positioned over balloon channel 1422 within the balloon. Upper portion 1461 includes hole, slot or cavity 1466 configured to receive camera module 1408. In some embodiments, upper portion 1461 can be coupled at its distal end to a distal portion of lower portion 1462. A lower surface of upper portion 1461 can include a shape configured to conform to an upper surface of balloon channel 1422.

[0193] In some embodiments, the balloon comprises polyurethane (e.g., pellethane 80AE thermoplastic polyurethane). Other materials (e.g., silicone, Nylon, polyester / PET, such as TPU / and Special composite blends of polyamide / nylon, multilayer structures, etc.) are also considered.

[0194] In some embodiments, the hardness of the material can be about Shore 80-90A (e.g., Shore 85A). Other hardnesses (e.g., Shore 20-60A, 30-40A, 35-45A, 45-75A, 75-85A, 60-100A, 70-90A, etc.) are also contemplated.

[0195] The balloon may comprise a thickness of less than about 0.1 mm (or about 0.05-0.01 mm, or 0.05-1.5 mm, etc.).

[0196] In some embodiments, the balloon comprises a uniform thickness. In some embodiments, the thickness of the balloon varies. For example, in some embodiments, the balloon channel 1422 can comprise a greater thickness (e.g., 0.1 mm, 0.2 mm, 0.15 mm, etc.).

[0197] In some embodiments, the balloon comprises a non-compliant material. In such embodiments, the balloon material does not stretch when pressurized.

[0198] In some embodiments, the balloon comprises an optically transparent material. Non-optically transparent materials are also contemplated.

[0199] Now go to Fig.15A , shows a cross-sectional view of an embodiment of a multi-lumen shaft 1500 (e.g., similar to multi-lumen shaft 1406). The shaft can include a flexible material. In some embodiments, the shaft is laminated. The exterior of the shaft can include a sheath. The sheath can include a thermoplastic tube.

[0200] The shaft includes five cavities 1502, 1504, 1506, 1508 embedded in its wall. Cavities 1502, 1504 can be configured to receive fluid lines (eg, fluid lines 1410, 1412). In some embodiments, the fluid lines include plastic (eg, high melting point plastic).

[0201] Cavity 1506 can be configured to receive a connector (e.g., connector 1411) for a camera module. In some embodiments, cavity 1510 can be configured to receive wiring for a position tracking sensor. Although the cavities are shown as being embedded within the shaft wall, it is understood that in some embodiments, they can extend along the interior of shaft 1406.

[0202] In some embodiments, the cavities 1502, 1504, 1506 may include 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.).

[0203] In some embodiments, the working channel 1505 extending through the shaft comprises a diameter of about 8-9F (or about 7-10F, 6-11F, etc.).

[0204] In some embodiments, the outer diameter of the shaft is about 15F (or about 14-16F, about 13-17F, etc.).

[0205] Tube 1511 can extend through the central cavity to form working channel 1505. In some embodiments, tube 1511 comprises thermoplastic. Other materials are also contemplated (e.g., metal). Tube 1511 can include a braided structure.

[0206] In some embodiments, additional cavities are included (eg, for sensors, emitters, heat transfer, etc.).

[0207] It will be appreciated that the cavities or tubes described herein may include circular, oval, flat, or any other shape through which fluids and other items may travel.

[0208] It will be appreciated that in some embodiments, more than one working channel (eg, 2, 3, 4, 5, 6, etc.) is contemplated. Fig. 15B A cross-sectional view of a shaft 1500 is shown including a dual lumen working channel tube 1511 having two lumens 1520, 1522. The shaft 1500 includes a wall 1524 for separating the two lumens 1520, 1522. Also shown are fluid channels 1502, 1504 and a cavity 1506 for receiving a camera module connector.

[0209] A multi-lumen shaft can be constructed by inserting cavities or tubes for the working fluid channels and camera module connectors into the outer portion of the working channel tube. The working channel tube can be placed on the mandrel. A sheath tube can be placed over all the tubes / cavities. Heat shrink tubing can be applied to the assembly. When heated, the sheath tube melts around the inner tubes and cavities. When the heat shrink tubing is removed, the individual components form a unified multi-lumen shaft.

[0210] Reference now Fig.16 , showing a perspective view of the distal end of an embodiment of an extension channel 1616 (e.g., similar to extension channel 1416) and a shaft 1606 (e.g., similar to shaft 1406). Shaft 1606 and working channel 1605 are Fig.16 16. Fluid channels 1610, 1612 and camera module connector 1611 extend through shaft 1606. The camera module is shown connected to connector 1611. Extension 1616 extends from and couples to the distal end of channel 1605. In some embodiments, extension 1616 extends from the distal end of the shaft.

[0211] In some embodiments, working channel 1605 extends beyond the distal end of the shaft prior to coupling to extension portion 1616 .

[0212] The channel extension portion 1616 can advantageously provide axial strength to the balloon, enabling it to push against target tissue without collapsing the balloon.

[0213] In some embodiments, the camera module 1608 blocks a portion of the working channel 1605 and / or the channel extension 1616 when in the stowed configuration. Thus, the working channel is not fully accessible or cannot be fully accessible until the balloon is sufficiently inflated to lift the camera module out of the path of the working channel. In some embodiments, when the BVM is in the stowed configuration, the working channel is open enough to allow certain tools (e.g., guidewires, dilators) to pass through.

[0214] Reference now Fig.28 , shows an embodiment of a channel extension portion 2816. The channel extension portion may include a distal mating feature 2802, a ring 2804, a cutout portion 2818, and a proximal mating feature 2806.

[0215] The distal mating feature 2802 and the proximal mating feature 2806 can be used to help the channel extension portion to be connected to other parts of the device. The use of mating features to join the channel extension portion can be performed using, for example, bonding, welding or other joining methods. The mating features can include grooves, threads, snap fits, etc.

[0216] In some embodiments, the channel extension portion comprises a transparent material. Non-transparent materials are also contemplated.

[0217] The channel extension may be rigid or flexible.

[0218] In some embodiments, the channel extension portion comprises a thermoplastic. Other materials are also contemplated (eg, metal or ceramic).

[0219] The channel extension may include a diameter of about 8F or 2.6 mm (or about 2.1-3.1 mm, 2-3 mm, 1.5-3 mm, etc.).

[0220] FIG. 29A to FIG. 29K Various embodiments of channel extensions 2916 are shown including various proximal 2906 and distal 2902 mating features. The mating features 2906, 2902 may include lugs or protrusions ( Fig.29A , B, D, E, G, H, I), Ridge( Fig.29C , 29J , 29K), hole ( Fig.29B , 29D , 29E, 29G, 29H, 29I) or any combination thereof. The ridge may be fully circular (e.g. Fig.29C as shown) or segmented (as shown Fig.29J and Figure 29K A cutout feature 2918 may extend along the body of the channel extension between the mating features 2906, 2902. FIG. 29A to FIG. 29K The embodiment of FIG. 2 shows a top view of the upper portion of the elongated, generally rounded rectangular shape of the cutout feature 2918 . Fig.29F An embodiment is shown in which the proximal and distal mating features are minimized to maximize the size of the cutout feature 2918. The lower portion of the cutout portion 2918 can be solid (e.g. Fig.29A , 29B , 29C, 29G, 29H, 29I, 29J and 29K). Additionally or alternatively, the lower portion of the cutout portion 2918 may include various patterns (repeated elliptical cutouts, hole grids, lattice structures, etc.), such as FIG. 29D to FIG. 29FAs shown. The shape, size and dimensions of the cutout portion 2918 are related to the size of the balloon and the balloon visualization module in the stowed configuration. A larger balloon may result in an increase in the length of the channel extension portion between the proximal and distal mating features. A larger balloon visualization module or a multi-mode or multi-camera balloon visualization module may result in greater modifications and changes in the length and shape or profile of the cutout portion 2918. Other channel extension portion embodiments may modify the bottom area of ​​the channel extension portion cutout portion to change structural properties, such as adjusting flexibility or rigidity when used with a balloon. Additionally or alternatively, modifications to the bottom of the cutout portion may enhance the field of view (i.e., more open space at the bottom). In other configurations, the channel extension portion is made of an optically transparent material that is selected to minimize interference with the field of view of the optics of the camera or balloon visualization module.

[0221] Figure 29L and Fig.29M A perspective view and a side view of an embodiment of a channel extension 2916 are shown. Channel extension 2916 has a proximal mating feature 2906 and a distal mating feature 2902. A cutout portion 2918 has an upper portion and a lower portion forming a side rail extending from the proximal end to the distal end, terminating at the distal mating feature 2902. Using a cutout portion such as 2918 provides maximum space for storage of the balloon and balloon visualization module, and maximizes the field of view by removing the lower portion of the channel extension.

[0222] Fig.29N and Fig.29O A perspective view and a side view of a channel extension 2916 are shown. The channel extension 2916 includes a proximal mating feature 2906. The channel extension 2916 includes a single cutout portion 2918 that forms a half-tube configuration. Figure 29L In contrast, the distal legs of the balloon can be attached to the distal portion of the bottom surface of the channel extension portion (see, e.g. FIG. 20A to FIG. 24D ).

[0223] refer to FIG. 30A to FIG. 30D , various views of an embodiment of a channel extension portion 3016 including multiple cavities are provided.

[0224] Fig. 30A and Fig. 30B A perspective view and a side cross-sectional view are shown, respectively, of a channel extension 3016 including two cavities 3002, 3004. The channel extension 3016 includes a single cut-out portion 3018 located within the top cavity 3002. The channel extension 3016 includes a distal ring 3006. A wall 3008 separates the two cavities 3002, 3004. The channel extension 3016 includes a proximal mating feature 3010, which includes a circle of holes.

[0225] Fig. 30C and Fig.30D A perspective view and a side cross-sectional view of a channel extension 3016 are shown, respectively, including two cavities 3002, 3004 and two cutout portions 3018, one in each cavity. The channel extension 3016 includes a distal ring 3006. A wall 3008 separates the two cavities 3002, 3004. The channel extension 3016 includes a proximal mating feature 3010, which includes a circle of holes. It is understood that more than two cavities (e.g., 3, 4, 5, 6, etc.) are also contemplated.

[0226] Figure 31 shows various embodiments and configurations of many different possible channel extension cutout portions and proximal and distal mating feature configurations. In one general aspect, the channel extension can be considered to have an overall shape that is generally cylindrical. According to a specific embodiment, the proximal portion of the channel extension is used to connect to the distal portion of the elongated body. Additionally, or alternatively, the proximal portion is used to provide a physical connection point for balloon inflation lines, balloon deflation lines, camera power and imaging connections, and other control lines required depending on the specific capabilities of the balloon and balloon visualization module. The proximal portion can also be adjusted and configured to connect to the proximal end of the balloon (see, e.g., Fig.14A , 14B , 14C or 33). In other aspects, the proximal end is adjusted and configured to be connected to the distal end of the distal end of the balloon. In this regard, the flip end of the distal end of the balloon is connected, combined or otherwise engaged to the proximal end of the channel extension. Therefore, the proximal end and matching feature 3106 are provided for these and other purposes and can have a variety of different configurations. The distal end of the channel extension is also used to connect to the distal end of the balloon and provide additional structural and longitudinal support for the balloon. The upper portion of the cutout portion 3118 is used to provide space for the storage of the balloon and the balloon visualization module. The lower portion of the cutout portion 3118 is used to adjust the structural properties or also remove materials that may block or hinder the field of view of the camera in the balloon visualization module. The various embodiments shown in Figure 31 include an elongated upper cutout portion that produces a proximal portion and a distal ring portion. The lower cutout portion can then be full length (as shown in Figures 31A1 / 2, 31B1 / 2, 31E1 / 2, 31F1 / 2, 31G1 / 2) or partial length (as shown in Figure 31D1 / 2). The resulting channel extension has a generally cylindrical end with the distal end located at the end of a pair of side rails that have various sizes based on the relative sizes of the upper and lower cutouts. The extremes of this aspect can be understood by comparing the widths of the side rails in Figures 31G2 and 31C2.

[0227] About the front stereogram of Figure 31H1 to Figure 31M1 and the rear stereogram of Figure 31H2 to Figure 31M2, other aspects of various channel extension embodiments can be understood.Each channel extension embodiment shown has an elongated upper incision, as shown in the embodiment of Figure 31A1 to Figure 31G2.The distal matching feature is also similarly arranged as a ring, and side rails or walls of various sizes can be seen.The lower incision portion can be full length (as shown in Figure 31I1) or only in the distal portion or distal half of the lower part (as best shown in Figure 31H1, J1, K1, L1 and M1).In addition, the proximal portion of Figure 31H to Figure 31M2 includes functional features that do not exist in the embodiment of Figure 31A1 to Figure 31G2.The proximal portion can include an enhancement for connecting to the various parts of the balloon, or for providing a mechanical connection connected to balloon inflation, balloon deflation, and camera, power supply or imaging.

[0228] Go to Fig.17A and Fig. 17B , a side cross-sectional view of only balloon 1606 and balloon visualization module 1602 including balloon 1602 is shown. Unless otherwise noted, the balloon and balloon visualization module can be similar to those described above (eg, balloon 1406 and BVM 1402).

[0229] At its proximal end, 1701, the balloon comprises a tubular profile. From there, an upper surface 1407 extends radially outward from the longitudinal axis of the passage 1722. The upper surface 1407 may extend radially outward from the longitudinal axis 1723 of the passage 1722 at an angle of about 40-50° (or about 45°, about 30-60°, 25-65°, 20-70°, etc.).

[0230] The lower surface or profile 1725 of the balloon can 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.).

[0231] The distal portion of the balloon provides a contact visualization surface 1720 of the balloon 1706. The contact visualization surface 1720 may include a rounded contour.

[0232] Fig. 17B The field of view 1727 of the camera module 1708 is shown. Fig. 17B As shown, when the camera module is in the deployed position, the field of view of the camera module 1708 includes most of the contact visualization surface. In some embodiments, the field of view of the camera module includes at least 95% (or about 90%, or about 85%, or about 80%, or about 75%, or about 70%, etc.) of the contact visualization surface.

[0233] The balloon channel 1722 is wrapped around the channel extension 1716. This asymmetric structure allows the balloon to be tightly wrapped around the useful volume of the device to minimize blood displacement and flow disturbance (e.g., within the heart). This structure is described in further detail below (e.g., with respect to FIG. 22A to FIG. 22C ).

[0234] In some embodiments, the balloon can be symmetrical (e.g., spherical, conical, cylindrical, etc.). Such balloons can be used for specialized procedures. They can also provide ease of manufacturing.

[0235] In some embodiments, the camera module can be provided at an angle other than perpendicular to the working channel. In these embodiments, a contact visualization surface can be provided on the side of the airbag, corresponding to the angled camera placement position.

[0236] like Fig.17A As shown, in some embodiments, the height 1702 of the airbag in the inflated configuration can 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.).

[0237] In some embodiments, the diameter of the balloon channel 1722 can 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.).

[0238] 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.).

[0239] Reference now Fig.18A and Fig.18B , two configurations of camera module mount 1811 are shown. Camera module mount 1811 is shown for use with a device such as device 1400. Fig.18A , the camera module mount 1811 is shown mounted on the channel extension 1816. Fig.18B , the camera module mount 1811 is shown mounted on the airbag channel 1822.

[0240] The camera module mount is configured to hold the camera in the correct position for visualization while allowing the camera module to flex within the instrument channel during insertion and withdrawal.

[0241] The camera module mount can be configured to hold the camera horizontally or at an angle depending on surgical requirements and balloon shape.

[0242] In some embodiments, the camera module includes a 400x400 pixel color camera module. The camera module can include a field of view of approximately 110° in air and approximately 80° in water. Other field of view ranges (e.g., 100-180°, 100-170°, 100-160°, 100-150°, etc.) are also contemplated.

[0243] In some embodiments, the camera module includes an integrated camera module and lighting (eg, LED) system.

[0244] Reference now Fig.19A and Fig.19B , showing a side view of an embodiment of BVM 1902. Camera module 1906 is positioned on a camera mount. As shown in FIG. 19 , the camera module can be positioned so as to be angled relative to the longitudinal axis of channel extension 1916. For example, the angle can be about 0-10° (or 1-20°, 5-10°, 5-15°, 5-20°, etc.).

[0245] In some embodiments, the distance between the camera module and the contact visualization surface 1920 and the angle α relative to the longitudinal axis 1923 of the channel extension portion 1916 can be selected so that the field of view 1927 of the camera module 1908 corresponds to and / or covers the periphery of the contact visualization surface 1920.

[0246] In some embodiments, the distance between the camera module and the contact visualization surface can be approximately 8-13 mm.

[0247] Camera module 1908 may be positioned so that a portion of the distal end of channel extension 1916 is visible to the camera module. In some embodiments, about 6-7 mm (or about 7 mm, about 5-9 mm, about 6.5-7.5 mm, etc.) of a top 1929 of the distal end of channel extension is within 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 a bottom 1931 of the distal end of channel extension 1916 is within field of view 1927.

[0248] Fig.19B The view from camera module 1908 is shown. Fig.19BAs shown, in some embodiments, channel extension 1916 is visible at bottom 1947 of field of view. Channel extension 1916 may comprise approximately 1 / 3 (or approximately 30-35%, 30-40%, 25-35%, 20-40%, 15-45%, etc.) of bottom 1947 of the field of view of the camera module.

[0249] The shape and size of the window 1920 can be optimized based on the goals of the procedure. For example, for a procedure at the top of the heart, a smaller field of view and a tighter distal radius 1949 may be used than when performing a procedure at a valve, where a larger field of view and a larger radius 1949 may be required.

[0250] Reference now Fig. 20A and Fig. 20B , shows an embodiment of an airbag 2002 during two steps in the manufacturing process. Fig. 20A A manufactured balloon 2002 is shown. The shape of the balloon is set by a blow mold tool. As manufactured, the balloon 2002 includes an optical window 2033, a distal leg 2035, a balloon body 2037, and a proximal leg 2039. The distal leg 2035 includes a generally tubular shape with an open distal end 2041. The proximal leg 2039 includes a generally tubular shape with an open proximal end 2043. The proximal leg 2039 can be shorter than the distal leg.

[0251] Fig. 20B The assembled balloon 2002 is shown. The distal leg 2035 is folded back so that it is now adjacent to the optical window 2033.

[0252] The balloon can be in four states: deflated, inflated, under-inflated, and over-inflated. The different states of the balloon can be achieved by injecting fluid (air, saline, or other fluid) into the balloon using one or more fluid lines. Cleaning of the balloon can be accomplished by continuously flowing fluid through the balloon.

[0253] As the balloon is under-inflated, inflated, and over-inflated, it pushes blood away from the camera system's field of view. The BVM is deployed to the target area through an access sheath and the balloon is (under / over)inflated. In this state, contact optical visualization is achieved as the balloon's optical window is pushed against the cardiac surface tissue. The balloon pressure can be set so that the distal window gently conforms to the target tissue, reducing unnecessary pressure on the target anatomy.

[0254] Inflation and purging of the balloon can be managed by a fluid pump or syringe operator.

[0255] The distal legs 2035 of the balloon 2002 are positioned around the channel extension and are coupled proximal to the distal end of the channel extension.

[0256] In embodiments where the camera module is coupled to the airbag, the camera module may be coupled to (or otherwise attached to) the distal legs 2035 after they are folded back inside the airbag.

[0257] The proximal leg 2039 of the balloon can be coupled (or otherwise attached) to an outer portion of the shaft (eg, an outer sheath). The distal leg of the balloon is coupled (or otherwise attached) to the distal end of the working channel of the device at or near the hole 2041 .

[0258] Reference now Fig.27A and Fig.27B , shows an embodiment of a method for inflating and deflating an airbag. Before the airbag is inflated, the fluid channels 2710, 2712 and the airbag 2706 are purged to eliminate the residual air in the channels and the airbag. When the airbag is inflated, it assumes its full shape. The rigidity is maintained by maintaining a constant pressure in the fluid channels and the airbag body.

[0259] For cleaning, syringe or fluid pump 2702 is connected to fluid inlet 2704 at handle 2707. Stop valve 2708 can be connected to fluid outlet 2714 at handle 2707. During cleaning, stop valve 2708 is in open position, and fluid is continuously flushed into airbag 2706 by syringe 2702 through inlet 2704, and is flushed out from system through outlet 2714. During cleaning, airbag 2706 is not in its inflated configuration because its pressure is not constant. In certain embodiments, during cleaning, about 100 milliliters are flushed through fluid channel and airbag. Cleaning can be performed 2 times before airbag inflation. Also can consider to perform less or more examples. After cleaning is completed, stop valve 2708 moves to closed position.

[0260] After cleaning 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. The shutoff valve 2708 is in a closed state at the fluid outlet 2714. The fluid is pushed from the syringe 2702 or pump through the inlet 2704 into the balloon 2706. The pressure can be continuously measured. When the pressure sensor senses that the pressure begins to rise, the fluid injection can be stopped. At this point, the balloon is in its inflated state.

[0261] The over-inflated state may be achieved by pushing more fluid into the airbag after the airbag has reached the inflated state.

[0262] To deflate, place shutoff valve 2708 in the closed position. Draw fluid back into syringe 2702 or pump until the pressure sensor senses negative pressure.

[0263] FIG. 21A to FIG. 21DSide views of various balloon embodiments that can be used with the devices described herein are shown. As shown in these embodiments, the balloon can include a symmetrical or asymmetrical balloon body. The proximal leg and the distal leg can be centered or misaligned relative to each other. The proximal leg and the distal leg can be aligned or offset relative to the longitudinal axis of the balloon. The optical window can be convex or concave. Any combination of these features is contemplated.

[0264] Fig.21A An embodiment of a balloon is shown, comprising a symmetrical balloon body 2137, the balloon being symmetrical along its longitudinal axis, with the proximal and distal legs 2139, 2135 aligned with each other. The optical window 3133 comprises a convex surface.

[0265] Fig. 21B An embodiment of a balloon is shown having a balloon body 2137 that is asymmetric about its longitudinal axis (eg, similar to balloon 2002). The proximal and distal legs 2135, 2139 are aligned with each other. The optical window 2133 comprises a convex surface.

[0266] Fig. 21C An embodiment of a balloon having a balloon body that is symmetrical about its longitudinal axis is shown. The distal and proximal legs 2135, 2139 are not centered with respect to each other. The proximal leg 2139 is centered with respect to the longitudinal axis of the balloon. The distal leg is off-axis with respect to the longitudinal axis of the balloon. The optical window 2133 comprises a concave surface.

[0267] Fig.21D An embodiment of a balloon having a balloon body 2137 is shown that is asymmetric about its longitudinal axis. The distal and proximal legs 2135, 2139 are eccentric (i.e., not centered with respect to one another). The distal leg 2135 is centered with respect to the longitudinal axis of the balloon. The proximal leg 2139 is off-axis with respect to the longitudinal axis of the balloon. The optical window 2133 comprises a convex surface.

[0268] FIG. 22A to FIG. 22C An embodiment of a method of connecting the balloon 2202 to the channel extension 2216 is shown. Fig.22A , channel extension 2216 is shown positioned on mandrel 2242. Balloon 2206 is shown with its distal legs 2235 positioned on channel extension 2216. Heat shrink tubing 2240 is shown positioned on distal legs 2235. After heating, balloon 2202 and channel extension are bonded.

[0269] exist Fig. 22B , the distal legs 2235 of the balloon are positioned on the channel extension 2216. The mandrel 2242 is shown extending within the channel extension 2216. Glue is applied between the legs 2235 and the channel extension 2216.

[0270] Reference now Fig. 22C , shows the assembled balloon with the channel extension 2216 coupled (eg, laminated or bonded) to the distal leg (now the balloon channel 2222). The proximal leg 2239 of the balloon is laminated or bonded to the outer diameter of the shaft 2204.

[0271] Now go to FIG. 23A to FIG. 23C , shows embodiments of methods of connecting the camera mount 2311 to the distal legs 2335 of the balloon 2302. These methods can be performed with or without a mandrel. Fig.23A Channel extension 2316 is shown positioned on mandrel 2340. Distal legs 2335 are positioned on channel extension 2316. Glue 2345 may be applied between camera mount 2311 and distal legs 2335 to couple them together, as shown in FIG. Fig. 23B shown.

[0272] Fig.23C The camera support 2311 is shown positioned over the distal legs 2335 and the channel extension 2316. After heating, the camera support 2311 (which may include plastic, for example) is laminated to the distal legs 2335 of the balloon 2306.

[0273] Fig.23D The assembled BVM 2302 is shown with the distal legs of the balloon drawn together within the balloon to form a balloon channel 2322 including a 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.

[0274] Reference now FIG. 24A to FIG. 24D , an embodiment of a method of connecting the shaft 2404 to the balloon 2406 and the channel extension portion 2416 is shown.

[0275] Fig.24A Balloon 2406 and distal legs 2435 are shown. Distal legs 2435 are shown positioned on channel extension 2416. Channel extension is shown positioned on mandrel. Shaft 2404 is shown positioned distal to distal legs 2435 and channel extension 2416, on mandrel 2440. Working channel 2405 of shaft 2404 is shown extending beyond one end of shaft 2404. Camera mount 2411 is shown coupled to distal legs 2435.

[0276] Go to Fig. 24B , channel extension 2416 is shown mating with working channel 2405. Distal legs 2435 (or in some embodiments, outer thermoplastic layer) of balloon 2406 are shown positioned at the point where working channel 2405 and channel extension 2416 meet.

[0277] Fig.24C Heat shrink tubing 2442 is shown applied where working channel 2405 and channel extension 2416 meet and distal legs 2435 extend. Upon heating, the layers melt together and join the assembly.

[0278] Fig.24D The working channel 2405 of the shaft 2404 is shown laminated with the channel extension 2416 and the distal legs 2435 (or outer thermoplastic layer) of the balloon 4206.

[0279] It will be appreciated that in some embodiments, the components may be joined by other methods (eg, glue).

[0280] Go to Fig.25 , shows an embodiment of the proximal end of the device 2500. A proximal entry point 2564 of the working channel is shown. The entry point 2564 may include a hemostatic seal. The device 2500 may include a fluid channel 2566 for flushing and cleaning the working channel.

[0281] refer to FIG. 32A to FIG. 32C , showing an embodiment of a method of deploying a balloon visualization module (BVM) from a collapsed configuration. Fig.32A , shows the BVM 3200 in a deflated state. The camera module connector 3202 is loose.

[0282] When the BVM 3200 is inserted into the sheath 3201 from its distal end, as shown in FIG. Fig.32B As shown, the balloon 3205 begins to wrap more tightly around the channel extension portion 3206.

[0283] Once the BVM 3200 is fully inserted into the sheath 3201, the camera module 3208 moves and fits into the cutout portion of the channel extension.

[0284] Fig.33 An embodiment of a BVM 3300 is shown including multiple cameras or imaging sensors 3304. Additional cameras or imaging sensors may operate outside the visible wavelength spectrum (e.g., ultraviolet or infrared) to provide additional information about the inspected structure (e.g., thermal imaging). Multi-camera embodiments may advantageously provide enhanced field of view, enhanced resolution, 3D imaging, and / or thermal imaging.

[0285] Fig.34 An embodiment of an access device 3400 having a BVM 3402 as described herein is provided. The device 3400 includes a handle 3403. A sheath 3404 extends from the handle. The BVM 3402 and a shaft extend through the sheath 3404. The handle 3403 includes a controller 3475 for affecting the steering of the distal tip of the sheath.

[0286] It is understood that the handle 3403 may include similar Fig.25 Devices 2500 and Fig.27B The capabilities of the device are described.

[0287] Go to FIG. 37A to FIG. 37D , an embodiment of a balloon 3702 having a distal window 3704 including an optical scale is provided. Fig.37A and Fig.37C The field of view from camera 3706 and a stereoscopic view of the BVM including a balloon with an optical scale including a grid of dots are shown respectively. Fig.37B and Fig.37D The field of view and the stereogram of the BVM including the balloon with an optical scale including crosshairs are shown, respectively. Any other optical scale may also be used for the distal window of the balloon.

[0288] Fig.38A Shows the use of Fig.37A and Fig.37C The field of view of the BVM's camera module is shown. Fig.38B Shows the use of Fig.37B and Fig.37D The field of view of the camera module of the BVM is shown. The scale allows precise positioning on the target tissue and accurate measurement of the size of the tissue structure. The working channel 3802 (e.g., the channel extension) is shown at the bottom of the field of view.

[0289] Fig.39 An example of how a BVM can be used as a tissue manipulator is shown. Device 3900 is shown positioned near the tricuspid valve. Fig.39 As shown, balloon 3902 can be used to gently stabilize or support mobile (or floppy) structures while finding the proper location for a therapeutic or surgical tool or implant. Fig.39 In FIG. 3 , balloon 3902 is shown supporting a mobile or flabby tissue segment 3904 (eg, a tendon, a valve, etc.).

[0290] FIG. 44A to FIG. 44D A further embodiment of a camera support or mounting is shown. The camera support can serve as a position fixing device for the camera. The position of the light source of the camera module can be fixed to the camera support or not.

[0291] The camera mount can be configured to accommodate more than one camera module.

[0292] The camera mount may include plastic (e.g., additive manufacturing, injection molding, etc.). Other materials are also contemplated (e.g., metal, ceramic, silicone).

[0293] The camera support can be fixed on the balloon channel. In some embodiments, it completely surrounds the balloon channel.

[0294] Fig.44A An embodiment of a camera bracket 4402 is shown. The bracket includes a bottom surface 4404 that is configured to engage a device component (e.g., a balloon channel). Surface 4404 can be contoured to better fit the component to be engaged.

[0295] The camera support also includes a platform 4406. The camera module can be placed on the platform 4406.

[0296] In some embodiments, the camera support includes a slot 4408. The camera module 4410 can be configured to be positioned within the slot 4408, such as Fig.44B Groove 4408 and / or platform 4406 may be sized to correspond to the size of the camera module.

[0297] Fig.44C and Fig.44D Another embodiment of a camera bracket 4420 is shown. The bracket includes a bottom surface 4422 that is configured to engage a device component (e.g., a balloon channel). Surface 4422 can be contoured to better fit the component to be engaged.

[0298] The camera bracket also includes a platform 4424. The camera module can be placed on the platform 4424.

[0299] In some embodiments, the camera support includes a slot 4426. The camera module 4428 can be configured to be positioned within the slot 4426, such as Fig.44B Groove 4426 differs from groove 4408 in that it is open at the top, leaving the top of camera module 4428 exposed. Groove 4426 and / or platform 4424 may be sized to correspond to the size of the camera module.

[0300] The camera support can be coupled to the balloon channel (e.g., as described with respect to FIG. 23A to FIG. 23C The camera module may then be placed in the camera bracket slot and bonded to the bracket (e.g., using glue).

[0301] like FIG. 45A to FIG. 45C As shown, the camera bracket 4502 can be used to set the central axis angle of the camera field of view relative to the longitudinal axis 4504 of the working channel / channel extension portion 4506. Fig.45A A camera mount 4502 is shown with parallel platforms 4508. Such a camera mount would angle the central axis parallel to the longitudinal axis of the working channel / channel extension. Fig.45BA camera support 4502 is shown with an angled platform 4510. The angle 4512 of the platform causes the camera field of view axis 4502 to be at an angle 4514 relative to the longitudinal axis 4504 of the working channel / channel extension. The angle 4512 of the platform may generally correspond to the angle 4514 of the camera field of view axis relative to the longitudinal axis of the working channel / channel extension.

[0302] Reference now Fig.35 , describes an embodiment of a method 3500 for using a BVM device. The method includes step 3502 of advancing an access sheath to a position adjacent to or proximate to a surgical site.

[0303] Step 3504 includes removing the BVM device from the sheath by advancing the shaft with the BVM coupled at its distal end relative to the access sheath.

[0304] The method includes converting the BVM to a visualization state, step 3506. This step may include inflating the balloon to move the camera module to a desired position.

[0305] Step 3508 includes positioning a distal portion of the device (eg, the BVM) adjacent to the surgical site using imaging from a camera module within the BVM.

[0306] The method includes step 3510 of performing one or more steps of an interventional procedure using a tool delivered using the working channel and channel extension of the shaft.

[0307] Step 3512 includes performing one or more steps or portions of steps of the interventional procedure under direct visualization of the surgical site, tools, or surgical field using output from a camera in the BVM.

[0308] The method includes step 3514, transitioning the BVM out of a visualization state.

[0309] Step 3516 includes retracting the BVM to a stowed configuration within the access sheath.

[0310] Go to Fig.36 , an embodiment of a method for performing an interventional surgical procedure using a BVM device is shown.

[0311] The method includes step 3602 of navigating an access sheath to a desired location with the BVM uninflated and in a stowed configuration within the access sheath.

[0312] Step 3604 includes advancing the shaft including the BVM at its distal end from a stowed configuration within the sheath.

[0313] The method includes flushing the fluid line and balloon, step 3606. Flushing can include continuously providing fluid to the fluid line and balloon.

[0314] Step 3608 includes pumping fluid into the interior volume of the balloon, initiating the transition to the inflated state.

[0315] The method includes step 3610 of increasing the fluid volume to cause the balloon to expand / deploy and lift the camera module from a stowed configuration.

[0316] Step 3612 includes continuing to pump fluid into the balloon until it is fully expanded to an inflated state, with the camera module in position to view the surgical field.

[0317] In some embodiments, visual feedback is used to determine that inflation is complete. Inflation is complete once no major wrinkles are visible in the camera's field of view and the field of view is clear.

[0318] In some embodiments, a fixed volume may be used to determine full inflation.The balloon may be prescribed to be inflated with a certain volume of fluid (eg, saline).

[0319] In some embodiments, active pressure control can be used to determine full inflation. 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 inlet, a control loop can be constructed that can provide one or more of the following: constant balloon pressure, leak detection of the balloon, and contact force sensing with the tissue.

[0320] The method includes step 3614, which includes maintaining the inflation of the balloon during the procedure so that it gently conforms to tissue at the treatment site.

[0321] Step 3616 includes deflating the balloon and retracting it into the access sheath upon completion of the procedure, causing the camera module to collapse or flex into the outer diameter of the sheath.

[0322] The sheath and BVM can then be withdrawn from the vascular system.

[0323] Ablation (atrial fibrillation)

[0324] Current state of the art

[0325] Ablation can be a surgical treatment for atrial fibrillation (AF). Atrial fibrillation is a global heart problem that is accompanied by an irregular rhythm of the heart (arrhythmia) and subsequently increases the risk of stroke or heart failure. During treatment, visualization of the abnormal area, surgery and ablation equipment are necessary. The basis of the treatment is to create scar tissue in the abnormal part of the heart using radiofrequency or freezing technology, so that the area does not conduct the heart's electrical signals and thus maintain sinus rhythm. However, although this treatment is frequently used, it is not without risks (e.g., bleeding, infection, damage to the heart valves).

[0326] Clinical problems to be solved

[0327] Treatment can be done via catheter (through the blood vessels, using radiofrequency or cryoballoons for pulmonary vein isolation) or by minimally invasive video-assisted or fully thoracoscopic surgery. During video-assisted thoracoscopic surgery (VATS), a small camera and surgical instruments are inserted through small incisions in the chest. Other treatments are the Cox-Maze procedure (hybrid radiofrequency and cryotherapy) with a minimally invasive right thoracotomy (RMT) or as an add-on to cardiac surgery for other indications.

[0328] It will therefore be appreciated that in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured for use in performing one or more steps of a minimally invasive, single port access, robotic-assisted, interventional, or surgical procedure to address deficiencies or clinical issues associated with ablation (atrial fibrillation) procedures, and additionally or alternatively, those associated with the improved visualization provided by the application of a BVM and instruments or devices provided by utilizing a hybrid working channel.

[0329] The following is an example method for pulmonary vein ablation using a BVM. Fig.35 Steps 3502-3508 of method 3500 described or related Fig.36 The sequence described in steps 3602-3614 of method 3600 places the device in the left atrium. The method also includes maintaining visualization of the pulmonary vein entrance, such as Fig.40B Figure 2 (showing the BVM device positioned toward the pulmonary vein). The ablation electrode is advanced within the working channel of the device. A series of point ablations are performed while the ablation electrode is positioned using the output of the BVM's camera module. Visual verification using the output from the BVM's camera module confirms that a continuous zone of coagulation has been created around the vein entry. The ablation electrode is retracted from the working channel of the BVM shaft.

[0330] Then you can execute about Fig.35 Steps 3514, 3516 of method 3500 described herein or with respect to Fig.36 Step 3616 of method 3600 is described, and the sheath is retracted from the vascular system.

[0331] Fig.40A The field of view from the camera module during an ablation procedure is shown. The ablation electrode 4002 is shown within a working channel 4004 (e.g., a channel extension). The pulmonary vein 4008 and the previously ablated surface 4006 are visible in the field of view. The target site 4010 for the next point ablation is shown at the distal end of the channel 4004 to provide a continuous ablation line around the vein entrance.

[0332] Left atrial appendage occlusion

[0333] Current state of the art

[0334] The left atrial appendage (LAA) is a sac-like structure in the wall of the left atrium of the heart with a highly variable anatomy. It can be round, triangular, teardrop-shaped on the outside and chicken wing-shaped, cactus-shaped, windsock-shaped or cauliflower-shaped on the inside. In cases of atrial fibrillation (AF), the LAA can lead to thrombosis and increase the risk of stroke, so treatment is required. There are currently two methods, left atrial appendage occlusion (LAAO) and left atrial appendage exclusion (LAAE).

[0335] Clinical problems to be solved

[0336] Because the LAA has a diverse anatomy and is complex to treat, visualization of the morphology is necessary before or during treatment.

[0337] During LAAO, a catheter-based device, with a leaflet- or umbrella-shaped end, is inserted intravascularly into the LAA to stop blood flow. Preoperative imaging is often used before the procedure. 2D or 3D transesophageal echocardiography (TOE) is the gold standard, and other procedures are cardiac computed tomography angiography (CCTA). However, 3D procedures show more accurate pictures of the LAA anatomy than 2D, but the temporal resolution is much slower. Another type of imaging during treatment is fluoroscopic 2D imaging, but it does not provide enough anatomical detail or guidance to visualize planned structural heart interventions.

[0338] LAA closure can be performed surgically, either as an adjunct to thoracotomy or as a stand-alone procedure during minimally invasive (small incision thoracotomy or thoracoscopic) arrhythmia surgery. High failure rates exist, and no reliable outcome data are available.

[0339] It will therefore be appreciated that in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured for use in performing one or more steps of a minimally invasive, single port access, robotic-assisted, interventional, or surgical procedure to address procedural deficiencies or clinical issues associated with left atrial appendage (LAA) / left atrium occlusion, and additionally or alternatively, those associated with the improved visualization provided by the application of a BVM and instruments or devices provided by utilizing a hybrid working channel.

[0340] Visualization during minimally invasive mitral valve surgery

[0341] Current state of the art

[0342] Minimally invasive cardiac surgery (MICS) is becoming increasingly popular among cardiac surgeons because of the many advantages of this procedure. The advantages are less pain, lower risk of bleeding and wound infection, smaller incisions leading to faster recovery, better cosmetic results, and shorter hospital stays.

[0343] During minimally invasive mitral valve surgery (MIMVS), a minimally invasive surgical incision must be made through a right-sided thoracotomy to treat mitral valve disease such as mitral regurgitation or stenosis. Mitral regurgitation is when the valve does not close properly, causing blood to leak between the heart chambers. In contrast, with mitral stenosis, the mitral valve does not open adequately, leading to congestion, abnormal heart rhythms (atrial fibrillation), pulmonary hypertension, and ultimately right ventricular failure.

[0344] One treatment option for mitral stenosis or regurgitation surgery is to replace the valve with a bioprosthetic valve (porcine, bovine, or human heart tissue) or a mechanical valve. Before the procedure, the patient's heart must be mapped. This can be done with an electrocardiogram (ECG), chest x-ray, transesophageal echocardiogram (TEE), or coronary angiography. During the procedure, a heart-lung machine (CPB) is used by inserting cannulas into the arteries and veins. Before and after the replacement, a transesophageal echocardiogram (TEE) is used, which will be inserted through the esophagus.

[0345] Clinical problems to be solved

[0346] The surgery was performed via minimally invasive thoracoscopic surgery, using a thoracoscope for visualization.

[0347] During surgery, direct and appropriate visualization is very helpful to the physician. Therefore, it will be appreciated that in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured for performing one or more steps of a minimally invasive, single-port access, robotic-assisted, interventional, or surgical procedure to address deficiencies or clinical issues associated with minimally invasive mitral valve surgical procedures, and additionally or alternatively, those associated with the improved visualization provided by the application of a BVM and the instruments or devices provided by utilizing a hybrid working channel.

[0348] Visualization during minimally invasive aortic surgery

[0349] Current state of the art

[0350] Minimally invasive cardiac surgery (MICS) is becoming increasingly popular among cardiac surgeons because of the many advantages of this procedure. The advantages are less pain, lower risk of bleeding and wound infection, smaller incisions leading to faster recovery, better cosmetic results, and shorter hospital stays.

[0351] During minimally invasive aortic valve surgery (MIAVS), a minimally invasive surgical incision must be made to treat aortic disease through aortic valve replacement or aortic valve repair. In the case of aortic stenosis, the valve is narrowed and calcified, thereby not allowing the left ventricle to function properly, causing left ventricular hypertrophy; while in the case of aortic regurgitation, the valve does not close properly and blood flows back into the left ventricle, also causing left ventricular hypertrophy.

[0352] Before the procedure, the patient's heart and aorta must be mapped. This can be done with an electrocardiogram (ECG), computed tomography (CT), or a transesophageal echocardiogram (TEE), similar to a mitral valve replacement. During the procedure, a heart-lung machine (CPB) is used by inserting cannulas into the arteries and veins. Before and after the replacement, a transesophageal echocardiogram (TEE) is used, which will be inserted through the esophagus.

[0353] Clinical problems to be solved

[0354] Currently, surgery is performed via right anterior thoracotomy (RAT) or mini-thoracotomy (MS), using thoracoscopy for visualization.

[0355] During surgery, direct and appropriate visualization is very helpful to the physician. Therefore, it will be appreciated that in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured for performing one or more steps of a minimally invasive, single-port access, robotic-assisted, interventional, or surgical procedure to address procedurally related deficiencies or clinical issues of minimally invasive aortic surgery, and additionally or alternatively, those associated with the improved visualization provided by the application of a BVM and the instruments or devices provided by the hybrid working channel.

[0356] Visualization during coronary surgery

[0357] Current state of the art

[0358] During CAD, the walls of the coronary arteries (which carry blood to the heart) become clogged with fatty deposits.

[0359] The main treatment is coronary artery bypass grafting (CABG), which can now be performed with minimally invasive surgery (MIDCAB). During the procedure, the area of ​​the blood vessel behind the stenosis is bypassed, for which a graft is used. Coronary angiography is the main clinical modality. Contrast medium is injected into the coronary arteries to identify existing blockages or stenosis caused by plaque / calcification.

[0360] Clinical problems to be solved

[0361] During surgery, direct and appropriate visualization is very helpful to the physician. Therefore, it will be appreciated that in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured for performing one or more steps of a minimally invasive, single-port access, robotic-assisted, interventional, or surgical procedure to address procedurally related deficiencies or clinical issues of minimally invasive coronary surgery, and additionally or alternatively, those associated with the improved visualization provided by the application of a BVM and the instruments or devices provided by utilizing a hybrid working channel.

[0362] Visualization during minimally invasive intrapericardial tumor surgery

[0363] Current state of the art

[0364] An intrapericardial tumor (or teratoma) is an abnormal growth of tissue inside the heart. Intrapericardial tumors are rare heart tumors that are usually diagnosed in infants and newborns. Usually these tumors are benign, but they can also be life-threatening.

[0365] Clinical problems to be solved

[0366] In this case, resection of the tumor inevitably requires open-chest surgery. Two-dimensional echocardiography is considered the best diagnostic imaging method for tumor visibility, but magnetic resonance imaging (MRI) can also be used (it may have the advantage of better visualization of adjacent areas).

[0367] Direct and appropriate visualization is very helpful to the physician during surgery. Therefore, it can be appreciated that in various embodiments, the surgical access device, device shaft, working channel, and balloon visualization module are adapted and configured for performing one or more steps of a minimally invasive, single-port access, robotic-assisted, interventional, or surgical procedure to address procedurally related deficiencies or clinical issues of minimally invasive intrapericardial tumor surgery, and additionally or alternatively, those associated with the improved visualization provided by the application of the BVM and the instruments or devices provided by the hybrid working channel.

[0368] In further alternative embodiments, the surgical access devices, device shafts, working channels, and balloon visualization modules of the various embodiments are adapted and configured for performing one or more steps of a minimally invasive, single-port access, robotic-assisted, interventional, or surgical procedure via transjugular access to address the deficiencies or clinical problems described herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to the improved visualization provided by the application of a BVM and the improved instruments or devices provided by utilizing a hybrid working channel. For example, but not limited to, exemplary transjugular procedures may include: pacemaker lead removal, endomyocardial biopsy, transcatheter mitral valve replacement / repair, and transcatheter tricuspid valve replacement / repair.

[0369] Pacemaker lead removal

[0370] Current state of the art

[0371] Pacemaker lead implantation initiates a fibrous growth process that often results in lead-vessel adhesion sites along the vascular path and at the lead-myocardial interface. Removal of adherent or perforated leads may result in serious complications such as superior vena cava laceration, cardiac laceration, and even death. Imaging is critical in defining potential vascular adhesions, cardiac perforations, and any anomalous lead paths, as well as modifying protocols to address case-specific challenges.

[0372] refer to FIG. 11A to FIG. 11D , showing traditional techniques for pacemaker lead removal. These techniques include force removal, force removal using a locking guidewire, use of reverse traction on the sheath, and removal using mechanical and laser sheath removal. Each of these techniques presents challenges and potential risks.

[0373] During forceful removal, Fig.11A In an embodiment of this invention, a force is applied to the end of the lead to apply constant outward traction to facilitate lead removal. This method may disadvantageously cause the lead to disintegrate or break during the procedure. This method may also cause uncontrolled tearing of scar tissue around the pacemaker lead, leading to complications.

[0374] Fig. 11B A locking guidewire traditionally used for pacemaker lead removal is shown. Forced removal using a locking guidewire may include inserting and deploying a locking guidewire within the lumen of the lead. The guidewire provides uniform tension along the axis of the lead, which may reduce the chance of lead fracture. This approach may result in uncontrolled tearing of scar tissue around the pacemaker lead, which may lead to complications.

[0375] When using a reverse traction sheath for lead removal, e.g. Fig. 11C and Fig.11DAs shown, it can be placed around the pacemaker lead to support the surrounding tissue before pulling the electrode. Using this approach may result in uncontrolled tearing of the tissue, although the tearing may be limited by the size of the sheath.

[0376] Use machinery ( Fig.11E ) and laser sheath cutting (FIG. 11F) removal by excision may include adding a cutting element to the distal end of the reverse traction sheath. This removal method has the potential to puncture cardiac or venous tissue because there is very limited feedback on the cutting action of the device.

[0377] As previously mentioned, conventional pacemaker removal techniques offer many challenges, including the severity of ingrowth, the inability to inspect for scar tissue formation around the pacemaker electrode, the lack of visual feedback during the procedure, and the lack of feedback of the forces applied directly to the tissue during the procedure. Often, the electrode is separated from the scar tissue in a highly uncontrolled manner without any visualization.

[0378] Clinical problems to be solved

[0379] In-hand imaging serves two purposes: to further explore any questions raised by preoperative imaging and to monitor the patient during the procedure.

[0380] In further alternative embodiments, the surgical access devices, device shafts, working channels, and balloon visualization modules of various embodiments are adapted and configured for use in performing one or more steps of a pacemaker lead removal procedure via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access devices may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to the improved visualization provided by the application of a BVM and the improvements provided by instruments or devices utilizing a hybrid working channel to provide a platform for access and direct visualization to guide instruments into a beating heart. In certain aspects, the surgical access devices of the present invention may provide near-field direct visualization of target cardiac tissue and instrument / tissue interactions. Additionally or alternatively, embodiments may be developed based on a better understanding of cardiac anatomy and adhesions to guide lead removal procedures and to more quickly detect and closely monitor potential complications resulting from the beneficial use of embodiments of the BVM.

[0381] Reference now Fig.12 , another embodiment of an access device 1200 having a BVM 1202 is shown in a deployed configuration. Unless otherwise described, the device 1200 may include features similar to those described elsewhere herein (e.g., with respect to devices 400, 500, 600, 700, 800, 900, etc.). In addition to the BVM 1202, the device 1200 also includes a cutting element 1203 (e.g., located in an instrument channel of the BVM).

[0382] Device 1200 includes a sheath 1204. A working channel 1205 extends through the sheath. A flexible extension 1216 is coupled to the sheath 1204 at its distal end and extends the working channel 1205.

[0383] Cutting element 1203 is located at or near the distal end of flexible extension 1216. Cutting element 1203 can be positioned to always or generally be within field of view 1254 of camera module 1208. In some embodiments, cutting element comprises a mechanical cutter, a radio frequency electrode, a laser cutter.

[0384] The cutting element actuation member 1256 can extend proximally from the cutting element 1203 along the sheath to the handle. It will be appreciated that the handle can include a control mechanism for actuating the cutting element 1203.

[0385] The device 1200 may include a pressure sensing chamber 1252 configured to provide data about tissue contact force. Other pressure sensing configurations are also 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 inlet of the balloon, a control loop can be constructed that can provide one or a combination of the following functions: constant balloon pressure, leak detection of the balloon, and contact force sensing with the tissue.

[0386] The balloon includes an asymmetric bulb shape with most of its volume located above the sheath 1204 and working channel 1205. The diameter of the balloon can increase from its proximal end to its distal end. The balloon includes a curved distal end that provides a distal window for the camera module 1208. The size and shape of the distal window 1220 can be determined to approximate the desired field of view of the camera / illumination / imaging module 1208.

[0387] The proximal end of the balloon can be generally tubular with a roughly circular cross-section to correspond to the distal end of the sheath 1204 .

[0388] The balloon is configured with a channel 1222 shaped to receive the distal end of the flexible channel extension 1216. The balloon 1206 can be coupled to the flexible channel extension 616 around the channel 1222.

[0389] As described above, a first portion of the distal end of the balloon is shaped to provide alignment and access to the working channel 1205 within the sheath 1204 , and a second portion of the distal end of the balloon is sized and shaped to correspond to the desired field of view of the camera / illumination / imaging module 1208 .

[0390] An inlet channel 1210 and an outlet channel 1212 extend along the shaft 1204 and are in fluid communication with the balloon 1206 .

[0391] In some embodiments, the camera module 1208 is located on top of the flexible channel extension 1216 .

[0392] In some embodiments, the balloon comprises silicone. Other materials (e.g., Nylon, polyester / PET, such as TPU / and Special composite blends of polyamide / nylon, multilayer structures, etc.) are also considered.

[0393] In some embodiments, the hardness of the material can be about Shore 80-90A (e.g., Shore 85A). Other hardnesses (e.g., Shore 20-60A, 30-40A, 35-45A, 45-75A, 75-85A, 60-100A, 70-90A, etc.) are also contemplated.

[0394] The balloon may comprise a thickness of about 0.20-0.25 mm (or about 0.15-0.30 mm, or about 0.10-0.35 mm, etc.).

[0395] In some embodiments, the balloon comprises a uniform thickness. In some embodiments, the thickness of the balloon varies.

[0396] Fig.13 A cross-sectional side view of the device 1200 in its deployed configuration, in position for removal of a pacemaker lead, is shown. The device can act as a reverse traction sheath with the balloon as a visualization tool and configured to exclude blood from the camera's field of view. The balloon can also act as a manipulator to support tissue around the ingrowth area as the pacemaker lead is pulled.

[0397] The cutting element 1203 provides controlled separation of the lead electrode from the scar tissue. The cutting element may include a mechanical cutter, a radio frequency electrode, a laser cutter. Other techniques are also contemplated.

[0398] In some embodiments, the balloon includes a pressure sensor or pressure sensing chamber to provide tissue contact force data.

[0399] The principle of operation may be similar or identical to the conventional method using a reverse traction sheath with a cutting element. The device is placed around the pacemaker lead and then advanced. The lead electrode is then separated from the scar tissue by activating the cutting element under direct visualization and with a known contact force.

[0400] An example method of performing pacemaker lead removal using a BVM is as follows. The device is based on, for example, Fig.35 Steps 3502-3508 of method 3500 described or related Fig.36The method 3600 described in steps 3602-3614 is set in the right ventricle in the order described. The device can navigate to the target pacemaker lead using the output from the camera module. The scar tissue morphology around the pacemaker lead is inspected using the output from the camera module. Optionally, a tissue manipulation device (e.g., forceps, a blade, etc.) can be advanced within the working channel of the device to release the pacemaker lead from the scar tissue. Once the pacemaker lead is removed, the tissue manipulation device can be retracted from the working channel. The device can then perform a procedure related to Fig.35 Steps 3514, 3516 of method 3500 described herein or with respect to Fig.36 Step 3616 of method 3600 is described, and the sheath is retracted from the vascular system.

[0401] Fig.41A A view from a camera module is shown showing a pacemaker lead 4102 and scar tissue morphology 4104 at an anchoring portion of the pacemaker lead. A cutting element 4106 (e.g., a blade, biopsy forceps, etc.) is shown within a working channel 4108 (e.g., a channel extension). The cutting element 4106 can be used to release the pacemaker lead.

[0402] Fig.41B The BVM is shown visualizing the scar wire from the side.

[0403] The BVM device can be used as an inspection, diagnostic tool to assist with traditional pacemaker lead removal techniques. The procedure can be performed selectively with a cutting element delivered through the working channel. The cutting element can be mechanical or radiofrequency powered.

[0404] A method for removing a pacemaker lead over the guidewire is as follows. The target pacemaker lead can be inserted into the distal exit port of the working channel. The BVM device is advanced with the pacemaker lead as the guidewire. While the BVM is packaged in an access sheath and the camera module is bent into the working channel, there is still enough space to allow a 1.5-2 mm outer diameter pacemaker lead to pass through. Once the device has entered a cavity large enough, the BVM is deployed (e.g., according to the Fig.35 Steps 3504-3508 of method 3500 described or related Fig.36 The method 3600 of FIG. 10 is described in detail in steps 3604-3612 of the method 3600 described above). The scar tissue morphology around the pacemaker lead is examined using the output from the camera module. Optionally, a cutting device can be advanced within a working channel around the pacemaker lead to release the pacemaker lead from the scar tissue under visual control of the camera module. Once the pacemaker lead is removed, the tissue manipulation device can be retracted from the working channel. Fig.35 Steps 3514, 3516 of method 3500 described herein or with respect to Fig.36 Step 3616 of method 3600 is described, and the sheath is retracted from the vascular system.

[0405] Fig.42A The view from the camera module of the BVM device is shown with the pacemaker lead 4202 within the working channel 4204. The scar pacemaker lead anchor point 4206 is shown. Fig.42B A circular cutting element 4208 is shown being delivered through working channel 4204.

[0406] Fig.42C Shown is a view of a pacemaker lead inserted into the working channel of a BVM device and used as a guidewire.

[0407] This approach using the BVM device can assist with traditional pulling methods. As the electrode is pulled, the balloon gently blocks the surrounding tissue while tissue strain can be visually inspected.

[0408] The cutting element may be mechanical or actively RF powered.

[0409] Endomyocardial biopsy (myocarditis, heart transplantation)

[0410] Current state of the art

[0411] Endomyocardial biopsy (EMB) is an invasive clinical procedure used to sample myocardium for histological analysis, thus diagnosing rejection after heart transplantation, cardiomyopathy, myocarditis, drug toxicity, etc.

[0412] Clinical problems to be solved

[0413] During EMB, transthoracic echocardiography (TTE) is used because it is easier to control the flexible biopsy forceps and avoid possible injury. Endomyocardial biopsy is not completely without risks (such as cardiac tamponade).

[0414] In further alternative embodiments, the surgical access device, device shaft, working channel, and balloon visualization module of the various embodiments are adapted and configured to be used to perform one or more steps of an endomyocardial biopsy (myocarditis, heart transplant) procedure via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations of improvements related to instruments or devices, such as improved visualization through the application of a BVM and utilizing a hybrid working channel to provide a platform for access and direct visualization to guide instruments used in these procedures.

[0415] An example method for performing a biopsy using a BVM is as follows. The device is based on, for example, Fig.35 Steps 3502-3508 of method 3500 described or related Fig.36The sequence described in steps 3602-3614 of the described method 3600 is set at or near the surgical site. The biopsy forceps is advanced in the working channel and a biopsy is performed. The biopsy forceps is retracted from the working channel.

[0416] Then you can execute about Fig.35 Steps 3514, 3516 of method 3500 described herein or with respect to Fig.36 Step 3616 of method 3600 is described, and the sheath is retracted from the vascular system.

[0417] Fig.43A A view of the camera module of a BVM device is shown performing a biopsy procedure at the annulus of a valve 4302. The annulus 4302 and leaflets 4304 are visible within the field of view. A biopsy forceps 4306 is positioned within a working channel 4306 (eg, a channel extension).

[0418] Fig.43B The BVM device is shown positioned toward the target tissue.

[0419] Mitral valve clipping

[0420] Current state of the art

[0421] For the treatment of a dysfunctional mitral valve (primary mitral regurgitation MR): degenerative mitral valve disease resulting in anatomical changes to the valve and chordae tendineae, causing MR; secondary MR: ischemic or non-ischemic left ventricular failure with mitral annular enlargement, or left atrial dilation in atrial fibrillation): minimally invasive mitral valve clips are used. These are tiny metal clips that are delivered to the mitral valve via a transcatheter approach. This is called transcatheter mitral valve repair (TMVr), but there is also the option of delivering a completely prosthetic valve: transcatheter mitral valve replacement (TMVR).

[0422] Clinical problems to be solved

[0423] Transcatheter Mitral Valve Repair (TMVr)

[0424] There are different treatments, such as transcatheter edge-to-edge repair (TEER-MitraClip, Pascal), direct / indirect annuloplasty (Cardioband, Mitralign, Carillon), and chordal repair (NeoChord). They can be used for both primary and secondary MR, with the exception of annuloplasty, which is only used for secondary MR.

[0425] In further alternative embodiments, the surgical access device, device shaft, working channel, and balloon visualization module of the various embodiments are adapted and configured for use in performing one or more steps of a mitral valve clipping procedure via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to improved visualization through the application of a BVM and improvements to instruments or devices provided by utilizing a hybrid working channel, thereby providing a platform for access and direct visualization of instruments used in these procedures.

[0426] Transcatheter Mitral Valve Replacement (TMVR)

[0427] There are several different approaches, such as transseptal (HighLife TMVR System, Sapien M3 System, EVOQUE TMVR System) and transapical (Tendyne Mitral System, Tiara TMVR System, Intreped TMVR System). Clinical experience with TMVR involves the following three main scenarios: valve-in-valve, valve-in-annulus, and native valve-in-annulus.

[0428] In further alternative embodiments, the surgical access devices, device shafts, working channels, and balloon visualization modules of various embodiments are adapted and configured for use in performing one or more steps of a transcatheter mitral valve replacement (TMVR) procedure via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access devices may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to improved visualization through the application of a BVM and improvements to instruments or devices provided by utilizing a hybrid working channel, thereby providing a platform for access and direct visualization for guiding instruments in these procedures.

[0429] Visualization during the MitraClip procedure

[0430] Current state of the art

[0431] One of the treatment options for mitral valve repair is MitraClip, which is based on the traditional edge-to-edge approach. It has two main components: a metal clip coated with polyester fabric and a catheter. It is one of the most reliable treatments, but some complications may occasionally occur (atrial septal defect, bleeding, pericardial effusion, endocarditis, clip dislodgement, clip embolism, mitral stenosis).

[0432] Clinical problems to be solved

[0433] The device is delivered to the left atrium via a catheter inserted into a vein in the leg. Transesophageal echocardiography (TEE) and fluoroscopy can be used for visualization during treatment.

[0434] In further alternative embodiments, the surgical access device, device shaft, working channel, and balloon visualization module of various embodiments are adapted and configured for one or more steps of visualization during the MitraClip procedure performed via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to improved visualization through the application of a BVM and improvements to instruments or devices provided by a hybrid working channel, thereby providing a platform for access and direct visualization of instruments used in these procedures.

[0435] Tricuspid valve clipping

[0436] Current state of the art

[0437] Tricuspid regurgitation is a very common heart valve disease. The tricuspid valve is located between the right atrium and ventricle. If it does not close properly, blood can flow back from the right ventricle to the right atrium, increasing the risk of cardiovascular morbidity and mortality in the long term.

[0438] Clinical problems to be solved

[0439] The tricuspid valve intervention devices are: coaptation and leaflet devices (TriClip, Pascal, Mistral), annuloplasty devices (ring annuloplasty, suture annuloplasty). There are delivery and patient selection issues.

[0440] In further alternative embodiments, the surgical access device, device shaft, working channel, and balloon visualization module of the various embodiments are adapted and configured for use in performing one or more steps of a tricuspid valve clipping procedure via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to improvements in visualization through the application of a BVM and instruments or devices provided by a hybrid working channel, thereby providing a platform for access and direct visualization of instruments used in these procedures.

[0441] Right ventricular remodeling or tether implantation

[0442] Current state of the art

[0443] The Tether is a new minimally invasive implantable system for mitral regurgitation developed by Argo Cardiovascular. It is a simple to use mechanical medical device system. It can be applied to the right ventricle for remodeling of right ventricular failure and / or severe tricuspid regurgitation. For more details, please refer to published U.S. Patent Application Publication No. US2020 / 0268514, entitled "Mechanically Locked Adjustable Cardiac Catheter", Application No. 16 / 789,250, the entire contents of which are incorporated herein by reference.

[0444] Clinical problems to be solved

[0445] The tether can be placed via a hybrid procedure, using both transcatheter access and minimally invasive surgical access.

[0446] In further alternative embodiments, the surgical access device, device shaft, working channel, and balloon visualization module of various embodiments are adapted and configured for use in performing one or more steps of a right ventricular remodeling or tether implantation procedure via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to improvements in visualization through the application of a BVM and instruments or devices provided by a hybrid working channel, thereby providing a platform for access and direct visualization of instruments used in these procedures.

[0447] Atrial septal defect / patent foramen ovale closure

[0448] Current state of the art

[0449] Atrial Septal Defect (ASD) is the second most common congenital heart defect and is a type of birth defect of the heart. An ASD is a hole in the wall (atrial septum) that separates the upper chambers of the heart (the most common type of ASD is located in the fossa ovalis). PFO is patent foramen ovale and is a common cause of paradoxical embolism, which can lead to stroke.

[0450] Clinical problems to be solved

[0451] Treatment is transcatheter closure. This is a safe procedure but not without risk (serious complications such as erosion and device embolization can occur). The morphology of the ASD needs to be known by transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE).

[0452] In further alternative embodiments, the surgical access device, device shaft, working channel, and balloon visualization module in various embodiments are adjusted and configured to perform one or more steps of the atrial septal defect / patent foramen ovale closure procedure via transjugular access to address the deficiencies or clinical problems detailed herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to improvements in visualization through the application of a BVM and instruments or devices provided by a hybrid working channel, thereby providing a platform for access and direct visualization of instruments used in guiding these procedures.

[0453] Balloon atrial septostomy

[0454] Current state of the art

[0455] Balloon atrial septostomy is a minimally invasive procedure that uses a balloon catheter to enlarge the foramen ovale (the hole between the left and right atria). This allows blood from both sides of the heart to mix in certain cases of congenital heart anomalies.

[0456] Clinical problems to be solved

[0457] The uninflated balloon is delivered through the foramen ovale into the left atrium and then inflated and pulled back into the right atrium. The procedure is visualized by echocardiography and hemodynamic monitoring.

[0458] In further alternative embodiments, the surgical access device, device shaft, working channel, and balloon visualization module of the various embodiments are adapted and configured for performing one or more steps of a balloon atrial septostomy procedure via transjugular access to address the deficiencies or clinical issues detailed herein. The surgical access device may also include embodiments specific to transjugular access medical procedures. Additionally or alternatively, there may be other variations related to improvements in visualization through the application of a BVM and instruments or devices provided by a hybrid working channel, thereby providing a platform for access and direct visualization of instruments used in these procedures.

[0459] In further alternative embodiments, the surgical access devices, device shafts, working channels, and balloon visualization modules of the various embodiments are adapted and configured to perform one or more steps or portions of any of the procedures described in the publications listed below. Additionally or alternatively, there may be other variations with improved visualization through the application of BVM and instrument or device related improvements provided by the hybrid working channel, thereby providing a platform for access and direct visualization of instruments used in these procedures.

[0460] It should be appreciated that all combinations of all concepts discussed above, as well as additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent), are considered to be part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0461] The balloon of the balloon visualization module surrounds the camera and the light source. Advantageously, the balloon can also serve as a compliant, non-invasive tissue contact surface. In some exemplary clinical procedures, embodiments of the surgical access device can be specially adjusted and configured for electrophysiological mapping and ablation procedures. These embodiments attach to the surface of a balloon electrode of a typical design of an electrophysiological mapping electrode. In one embodiment, the surgical access device configured in this way will be able to be used for mapping and ablation procedures at the same time. In this use case, the electrodes on the balloon surface will be used for mapping, while the ablation electrodes introduced through the working channel of the surgical access device will be used for ablation. In another aspect, the visual image obtained from the balloon visualization module can be enhanced by software using the results of the mapping. In addition, the visualization of the neural network, connection points, and ablation targets achieved by projecting the neural network, connection points, and ablation targets onto the optical image provided by the balloon visualization module of the surgical access device will be very beneficial for various electrophysiological applications. In a further embodiment, the electrode pattern on the balloon surface also has the additional benefit of visually marking the balloon surface. Advantageously, this feature can be used to measure distances, diameters, sizes, etc. of cardiac structures and features located in front of the optical unit of the balloon visualization module.

[0462] The balloon of the balloon visualization module can also be adjusted and configured as a balloon tamponade device for use in biopsy procedures and other procedures where there is a risk of cardiac perforation, resulting in pericardial effusion and tamponade. Advantageously, the balloon of the balloon visualization module can be used to block the perforation from inside the heart until a pericardial puncture or surgical response can be organized and the surgery performed. In addition, puncture occlusion solutions, such as those similar to various vascular occlusion devices, can be introduced through the working channel of the surgical access device and used to block the perforation, deploying such occlusion devices or plugs from the endocardial surface of the heart into the pericardial space. Such use may be sufficient to completely stop bleeding through the perforation, or may reduce the rate of bleeding, thereby buying more time for emergency surgery.

[0463] As can be appreciated from these additional various uses, the balloon of the surgical access device generally plays a multifaceted role, not just to remove blood in front of the optical unit. In an additional aspect, the operator of the surgical access device can raise, lower, adjust, deflate, inflate, and perform other forms of adjustment of the pressure inside the balloon, or adjust the shape of the balloon by adjusting the pressure inside the balloon. For example, by reducing the pressure, the balloon becomes softer and more flexible, and can be shaped around the intracardiac structure, thereby providing better blood removal and better visualization. The lower pressure inside the balloon will enable the surgical access device to enter the intracardiac space with a smaller volume or a narrower opening. In contrast, a higher balloon pressure may be advantageous in mapping applications because it can ensure that the electrodes or other components suitable for the procedure carried by the balloon are better fitted to the endocardium or other target tissue. In further aspects, the adjustment of pressure and the balloon response may also include the aspect that the overall shape of the balloon has more than one different or modified shape, including a shape that responds to the pressure characteristics inside the balloon. For example, a pressure-responsive balloon has a first shape at a first pressure and a different second shape at a different pressure. In another different aspect, the balloon embodiment may have one or more features or profiles that appear or exist and function in response to a pressure regulation signal. For example, the balloon may have a first shape without obvious features, and at a second pressure, one or more features, profiles, or surfaces are activated and can be used in conjunction with other functions of the surgical access device for the surgical site. In some embodiments, the characteristics of the balloon (i.e., soft, firm, hard), balloon shape, features, profiles, or surfaces can be reversible and can be controlled by an operator or responsive to input from an operator or surgical system. In one embodiment, the balloon pressure is controlled by a pump connected to the balloon inflation chamber of the surgical access device. The pump can be controlled by a manual control, a foot pedal, or other controller commonly used to control a fluid management system. The pump can be used to inflate, deflate, or adjust the balloon pressure and has a safety feature to prohibit over-inflation of the balloon and prevent balloon rupture, or accidental deflation of the balloon at the baseline pressure required for proper optical visualization.

[0464] The process parameters and step sequences described and / or illustrated herein are provided as examples only and may be varied as desired. For example, although the steps illustrated and / or described herein may be shown or discussed in a particular order, the steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more steps described or illustrated herein, or include additional steps in addition to the disclosed steps.

[0465] When a feature or element is referred to as "on" another feature or element in this article, it can be directly on another feature or element, or there may be intermediate features and / or elements. On the contrary, when a feature or element is referred to as "directly on" another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown for one embodiment, the features and elements described or shown in this way may be applicable to other embodiments. It should also be understood by those skilled in the art that the reference to the structure or feature arranged "adjacent" another feature may have a portion overlapping or located below the adjacent feature.

[0466] The terms used herein are only used for the purpose of describing specific 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 also include plural forms, unless the context clearly indicates otherwise. It should also be understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of the 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. As used herein, the term "and / or" includes any and all combinations of more than one related listed items and may be abbreviated as " / ".

[0467] Spatially relative terms, such as "below", "below", "down", "above", "on", etc., can be used in this article to simplify the description to describe the relationship between one element or feature and another element or feature, as shown in the figure. It should be understood that spatially relative terms are intended to cover different directions of the device in use or operation, not just the direction shown in the figure. For example, if the device in the figure is inverted, the elements described as "below" or "below" other elements or features will be oriented to be "above" other elements or features. Therefore, the exemplary term "below" can cover both "above" and "below" directions. The device can be oriented in other ways (rotated 90 degrees or other directions), and the spatially relative descriptors used in this article should be interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", etc. are used for explanation purposes only in this article unless otherwise explicitly indicated.

[0468] 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 the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Thus, the first feature / element discussed below can be referred to as the second feature / element, and similarly, the second feature / element discussed below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0469] 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 for methods and articles (e.g., compositions and devices including apparatus and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0470] In general, any apparatus and method described herein should be understood to be inclusive, but all or a portion of the components and / or steps may also be exclusive and may be expressed as "consisting of" or "consisting essentially of" various components, steps, subcomponents or sub-steps.

[0471] As used herein in the specification and claims, including when used in the examples, unless otherwise expressly stated, all numbers can be understood as being preceded by the word "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" can be used to indicate that the value and / or position described is within the reasonable expected range of the value and / or position when describing a quantity and / or position. For example, a numerical value can have a value that is + / -0.1% of the value (or range of values), + / -1% of the value (or range of values), + / -2% of the value (or range of values), + / -5% of the value (or range of values), + / -10% of the value (or range of values), etc. Any numerical value given herein should also be understood to include "about" or "approximately" the value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range listed herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value", and possible ranges between values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., X is a numerical value) are also disclosed. It should also be understood that throughout the application, data are provided in a variety of different formats, and that these data represent endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and ranges between 10 and 15 are also considered disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0472] Although various illustrative embodiments are described above, any of a number of changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, the order in which the various described method steps are performed may generally be changed in alternative embodiments, and in other alternative embodiments, more than one method step may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments but not in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as described in the claims.

[0473] The examples and illustrations contained herein show, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As previously mentioned, other embodiments may be utilized and derived therefrom, so that structural and logical replacements and changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to herein individually or collectively as the term "invention", for convenience only, and if more than one invention or inventive concept is actually disclosed, it is not intended to actively limit the scope of the present application to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement intended to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all adjustments or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will become apparent to those skilled in the art after reading the above description.

Claims

1. A surgical access device comprising: an elongated body having a working channel; as well as A balloon visualization module is located at the distal end of the slender body, the balloon visualization module includes a balloon, and a camera module is located within the balloon, wherein when in a stowed configuration, the camera module is configured to be contained within the outer diameter of the access sheath, and when expanded with the inflated balloon in use, the camera module moves radially outward relative to the longitudinal axis of the slender body to a position substantially beyond the outer wall of the slender body.

2. The surgical access device of claim 1, wherein the balloon visualization module is completely located within the working channel when retracted.

3. A surgical access device as described in any one of claims 1 or 2, wherein at least a portion of the distal surface of the balloon forms a contact visualization surface, which is configured to contact the target tissue and allow the target tissue to be visualized therethrough through the camera module.

4. The surgical access device of claim 3, wherein 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 expanded configuration.

5. The surgical access device of claim 3, wherein 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 expanded configuration.

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

7. The surgical access device of any one of claims 1 to 6, wherein the balloon comprises an optically transparent material.

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

9. The surgical access device of any one of claims 1 to 8, wherein the elongated body comprises a plurality of cavities.

10. The surgical access device of any one of claims 1 to 9, wherein the elongated body comprises a fluid cavity.

11. The surgical access device of claim 10, wherein the diameter of the fluid cavity is approximately 0.4-0.6 mm.

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

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

14. The surgical access device of any one of claims 1 to 13, wherein the camera module comprises more than one light source.

15. The surgical access device of any one of claims 1 to 14, wherein the camera module is positioned generally parallel to a longitudinal axis of the elongated body.

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

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

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

19. The surgical access device of claim 17, wherein the channel extension portion includes a cavity with a cutout portion.

20. The surgical access device of claim 19, wherein the balloon, when inflated, is configured to complete the cavity within at least a portion of the incision portion.

21. The surgical access device of any one of claims 19 or 20, wherein the cutout portion comprises approximately 60-90% of the length of the channel extension portion.

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

23. The surgical access device of any one of claims 17 to 22, wherein the channel extension portion comprises an optically transparent material.

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

25. The surgical access device of claim 24, wherein the balloon channel has a diameter of approximately 3-3.8 mm.

26. The surgical access device of claim 24 or 25, wherein the balloon channel has a length of approximately 16-17.4 mm.

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

28. The surgical access device of any one of Claims 1-27, wherein the balloon comprises a thickness of less than or equal to approximately 0.1 millimeters.

29. The surgical access device of any one of claims 1 to 28, wherein the balloon comprises a durometer of approximately Shore 80-90A.

30. The surgical access device of any one of Claims 1 to 29, wherein the elongated body comprises a diameter of approximately 12-16F.

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

32. The surgical access device of claim 31 , wherein a larger volume of the balloon is located above the channel extension.

33. The surgical access device of claim 31 , wherein greater than 80% of the volume of the balloon is located above the channel extension portion.

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

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

36. The surgical access device of any one of claims 17 to 35, wherein the channel extension comprises approximately a bottom 1 / 3 of the field of view of the camera module.

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

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

39. The surgical access device of any one of claims 1 to 38, wherein the balloon comprises polyurethane, silicone, One or a combination of nylon, polyester / PET.

40. The surgical access device of any one of claims 1 to 39, wherein a proximal end of the balloon is coupled to a distal end of the elongated body.

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

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

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

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

45. The apparatus of any one of claims 1 to 44, wherein the balloon is responsive to a modulated pressure applied to an interior of the balloon.

46. ​​An apparatus as described in claim 45, wherein when the balloon responds to a modulated pressure applied to the interior of the balloon, the balloon is more compliant, less compliant, firmer, rigid, or the balloon deploys one or more features, surfaces or auxiliary shapes supported by the balloon.

47. The device of any one of claims 1 to 46, wherein the surface of the balloon comprises one or more electrodes, wiring, circuits or components for mapping or ablation applications using the surgical access device.

48. A surgical access device comprising: an elongated body having a working channel; A balloon visualization module is located at the distal end of the slender body, the balloon visualization module includes a balloon, and a camera module is located in the internal volume of the balloon and is separated from the distal surface of the balloon, wherein when in a retracted configuration, the camera module is configured to be at least partially within the path of the working channel, and when expanded with an inflated balloon in use, the camera module moves radially outward relative to the longitudinal axis of the slender body to outside the path of the working channel, so that at least 90% of the distal surface of the balloon is within the field of view of the camera module.

49. A method of performing a medical procedure using a surgical access device as described in any of claims 1 to 48, wherein the surgical access device includes a proximal end having a handle or suitable connection or configuration, wherein the lighting, camera and / or visualization components of a balloon visualization module provide improved visualization capabilities as part of an arthroscopic, laparoscope, endoscope, robotic-assisted or other surgical instrument used in performing the medical procedure.

50. A method of performing a medical procedure on a patient, comprising: Advancing the sheath to the desired location adjacent to or proximal to the surgical site; moving the balloon visualization module out of the sheath; Converting 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 within the balloon visualization module; performing one or more steps of an interventional procedure using a tool delivered using the working channel and the channel extension portion of the shaft; performing one or more steps of the interventional procedure under direct visualization of a surgical site, tool, or surgical field using output from a camera within the balloon visualization module; switching the balloon visualization module out of the visualization state; and Returning the balloon visualization module to a stowed configuration within the sheath.

51. The method of claim 50, wherein moving the BVM out of the sheath comprises advancing a shaft coupled to the BVM relative to the sheath.

52. The method of claim 50 or 51, wherein converting the BVM to a visualization state comprises inflating a balloon of the BVM with a fluid.

53. The method of any one of claims 50 to 52, wherein converting the BVM to a visualization state comprises inflating a balloon of the BVM with saline.

54. The method of any one of claims 50 to 53, further comprising cleaning the fluid line and / or the balloon of the BVM.

55. The method of claim 54, wherein purging comprises continuously pumping fluid through the fluid line and the balloon.

56. The method of any one of claims 50 to 55, wherein converting the BVM to a visualization state comprises inflating a balloon of the BVM with a fluid.

57. The method of claim 56, wherein inflating the balloon of the BVM with fluid is performed until visual feedback confirms full inflation.

58. The method of any one of claims 56 or 57, wherein inflating a balloon of the BVM with a fluid is performed until a predefined volume of fluid is pumped into the balloon.

59. The method of any one of claims 56 to 58, wherein inflating the balloon of the BVM with a fluid comprises using one or more of active pressure control to provide constant balloon pressure, leak detection, and contact force sensing.

60. The method of any one of claims 50 to 59, wherein converting the BVM to a visualization state comprises inflating a balloon of the BVM with a fluid to move the camera to a desired position.

61. The method of any one of claims 50 to 60, further comprising withdrawing the sheath and balloon visualization module from the patient.

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

63. The method of any one of claims 50 to 61, wherein the medical procedure comprises left atrial appendage occlusion.

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

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

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

67. The method of any one of claims 50 to 61, wherein the medical procedure comprises minimally invasive surgery of an intrapericardial tumor.

68. The method of any one of claims 50 to 61, wherein the medical procedure comprises pacemaker lead removal.

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

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

71. The method of any one of claims 50 to 61, wherein the medical procedure comprises transcatheter mitral valve replacement.

72. The method of any one of claims 50 to 61, wherein the medical procedure comprises tricuspid valve repair.

73. The method of any one of claims 50 to 61, wherein the medical procedure comprises right ventricular remodeling.

74. The method of any one of claims 50 to 61, wherein the medical procedure comprises tether implantation.

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

76. The method of any one of claims 50 to 61, wherein the medical procedure comprises a balloon atrial septostomy.

77. A method of performing a medical procedure on a patient, comprising: Advancing the sheath to the desired location adjacent to or proximal to the surgical site; moving the balloon visualization module out of the sheath; Inflate the balloon of the balloon visualization module to a visualization state, thereby positioning the camera in the balloon visualization module to a desired position; positioning the balloon adjacent to target tissue using imaging from a camera within the balloon visualization module; performing one or more steps of an interventional procedure using a tool delivered using the working channel and the channel extension portion of the shaft; as well as One or more steps of the interventional procedure are performed under direct visualization of the surgical site, tools, or surgical field using output from a camera in the balloon visualization module.

78. A method of performing a medical procedure on a patient, comprising: navigating an access sheath to a desired location with the balloon visualization module positioned within said access sheath in an uninflated, stowed configuration; an advancement shaft, the shaft having a BVM at a distal end thereof, moving out of its stowed configuration within the access sheath; flushing the fluid lines and the balloon of the BVM; pumping a fluid into the interior volume of the balloon to initiate a transition from an uninflated to an inflated state; increasing the volume of the fluid to expand or deploy the balloon and lift the camera module from its stowed configuration; Continue to pump fluid into the interior volume of the balloon until it is fully expanded to an inflated state, with the camera module in a position to observe the surgical field; and The balloon is maintained inflated so that it conforms gently to the tissue at the treatment site during the procedure.

79. The method of claim 78 further comprising, after completion of the procedure, deflation of the balloon and retraction of the BVM into the access sheath, causing the camera module to collapse or bend back into the outer diameter of the sheath.

80. The method of any one of claims 78 or 79, further comprising withdrawing the sheath and BVM.

81. The method of any one of claims 78 to 80, wherein the fluid is saline.

82. The method of any one of claims 78 to 81, wherein flushing the fluid line and balloon comprises continuously pumping fluid through the fluid line and balloon.

83. The method of any one of claims 78 to 82, wherein continuing to pump fluid comprises pumping fluid until visual feedback confirms full inflation.

84. The method of any one of claims 78 to 83, wherein continuously pumping fluid comprises pumping fluid until a predefined volume of fluid is pumped into the balloon.

85. The method of any one of claims 78 to 84, wherein continuously pumping fluid comprises using one or more of active pressure control to provide constant balloon pressure, leak detection, and contact force sensing.

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

87. The method of any one of claims 78 to 85, wherein the medical procedure comprises left atrial appendage occlusion.

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

89. The method of any one of claims 78 to 85, wherein the medical procedure comprises minimally invasive aortic surgery.

90. The method of any one of claims 78 to 85, wherein the medical procedure comprises coronary artery surgery.

91. The method of any one of claims 78 to 85, wherein the medical procedure comprises minimally invasive surgery of an intrapericardial tumor.

92. The method of any one of claims 78 to 85, wherein the medical procedure comprises pacemaker lead removal.

93. The method of any one of claims 78 to 85, wherein the medical procedure comprises an endomyocardial biopsy.

94. The method of any one of claims 78 to 85, wherein the medical procedure comprises transcatheter mitral valve repair.

95. The method of any one of claims 78 to 85, wherein the medical procedure comprises transcatheter mitral valve replacement.

96. The method of any one of claims 78 to 85, wherein the medical procedure comprises tricuspid valve repair.

97. The method of any one of claims 78 to 85, wherein the medical procedure comprises right ventricular remodeling.

98. The method of any one of claims 78 to 85, wherein the medical procedure comprises tether implantation.

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

100. The method of any one of claims 78 to 85, wherein the medical procedure comprises a balloon atrial septostomy.

101. A method of performing a medical procedure on a patient, comprising: navigating an access sheath to a desired location with the balloon visualization module positioned within said access sheath in an uninflated, stowed configuration; an advancement shaft, the shaft having a BVM at a distal end thereof, moving out of its stowed configuration within the access sheath; pumping a fluid into the interior volume of the balloon to initiate a transition from an uninflated to an inflated state; Fluid is continuously pumped into the interior volume of the balloon until it is fully expanded to an inflated state, and a camera module within the balloon is positioned so that its field of view covers at least 90% of the distal face of the balloon.

102. A method of performing a medical procedure, comprising: contacting tissue adjacent to the surgical site with a balloon of the balloon visualization module to displace blood within the surgical site, wherein the balloon is inflated with a fluid; receiving imaging data from a camera module located within the balloon and the fluid; advancing a surgical tool through a working channel of the balloon visualization module, extending through the balloon; as well as The camera module is used to visualize the surgical tool as it is withdrawn from the working channel.

103. A balloon for use with a surgical access device, the balloon comprising: Open proximal end; a proximal portion extending distally from the proximal end and comprising a generally tubular body; a middle portion extending from the proximal portion, the middle portion extending radially outwardly along at least one of a top or bottom surface of the middle portion and extending distally from the proximal portion to a mid-face portion; a mid-face portion extending radially inwardly from a distal end of the mid-section to form a substantially closed distal-facing surface including an aperture; as well as A distal portion extends from the aperture in the mid-face portion, the distal portion comprising a generally tubular shape and an open distal end.

104. The balloon of claim 103, wherein: When assembled for use with a surgical access device, the distal portion is inverted so that it is located within the mid-section, forming a balloon passage within the mid-section, with the open distal end located proximal to the mid-face portion.

105. The balloon of claim 104, wherein: When assembled for use with a surgical access device, the open distal end is located within the mid-portion, proximal to the mid-face portion and distal to the open proximal end.

106. The balloon of claim 104 or 105, wherein: The mid-face portion is the distal surface of the balloon when assembled for use with a surgical access device.

107. The balloon of any one of claims 104 to 106, wherein When assembled for use with a surgical access device, the open proximal end of the balloon is coupled to the distal end of the elongated body.

108. The balloon of any one of claims 104 to 107, wherein the distal portion is coupled to a cavity such that the cavity extends through the balloon channel.

109. The balloon of claim 108, wherein the cavity comprises a flexible cavity.

110. The balloon of claim 108, wherein the cavity comprises a rigid cavity with a cutout at a top thereof.

111. The balloon of claim 110, wherein the cut extends along approximately 60-90% of the length of the distal portion of the balloon.

112. The balloon of any one of claims 108 to 110, wherein the cavity comprises an optically transparent material.

113. The balloon of any one of claims 104 to 112, wherein a camera module is coupled to the balloon channel.

114. The balloon of any one of claims 104 to 113, wherein the camera module is coupled to the balloon channel such that when the balloon is inflated, a field of view of the camera module covers approximately 90% of a mid-face of the balloon.

115. The balloon of any one of claims 113 or 114, wherein the camera module is coupled to the balloon channel using a camera mount.

116. The balloon of any one of claims 104 to 107, wherein the open distal end is coupled to the distal end of the working channel of the elongated body.

117. The balloon of any one of claims 103 to 116, wherein the distal portion comprises a first hardness and the middle portion and / or mid-face portion comprises a second hardness.

118. The balloon of claim 117, wherein the first hardness is different from the second hardness.

119. The balloon of any one of claims 103 to 118, wherein the distal portion comprises a first flexibility and the middle portion and / or mid-face portion comprises a second flexibility.

120. The balloon of claim 119, wherein the first hardness is different from the second hardness.

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

122. The balloon of claim 121, wherein the cavity comprises a flexible cavity.

123. The balloon of claim 121, wherein the cavity comprises a rigid cavity with a cut-out top.

124. The balloon of any one of claims 103 to 123, wherein the distal portion comprises a length of approximately 16-18 mm.

125. The balloon of any one of claims 103 to 124, wherein the proximal portion comprises a length of approximately 4-6 mm.

126. The balloon of any one of claims 103 to 125, wherein the diameter of the distal portion is approximately 3-4 mm.

127. The balloon of any one of claims 103 to 126, wherein the proximal portion has a diameter of approximately 3-5 mm.

128. The balloon of any one of claims 103 to 127, wherein the proximal portion is coaxial with the distal portion.

129. The balloon of any one of claims 103 to 127, wherein the proximal portion is not coaxial with the distal portion.

130. The balloon of any one of claims 103 to 129, wherein the balloon is asymmetric about a longitudinal axis of the distal portion.

131. The balloon of any one of claims 103 to 129, wherein the balloon is symmetrical about a longitudinal axis of the distal portion.

132. The balloon of any one of claims 103 to 129, wherein the larger volume of the balloon is located above the distal portion rather than below the distal portion.

133. The balloon of any one of claims 103 to 132, wherein the midface is convex.

134. The balloon of any one of claims 103 to 132, wherein the mid-face portion is concave.

135. The balloon of any one of claims 103 to 134, wherein the balloon comprises an optically transparent material.

136. The balloon of any one of claims 103 to 135, wherein the balloon comprises polyurethane, silicone, At least one of nylon and polyester / PET.

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