Fully integrated single-use tissue visualization device

Abstract

The present invention discloses a fully integrated disposable tissue visualization device. The present invention relates to a fully integrated sterilizable single-use disposable tissue visualization device and methods of using the device. Preferred embodiments of the present invention facilitate visualization of internal tissue sites while causing minimal damage to surrounding tissue. Further preferred embodiments may allow for delivery of fluids and other treatments to internal tissue sites.

Description

[0001] This application is a divisional application of an invention patent application filed on August 11, 2016, with application number 201680052447.0, PCT international application number PCT / US2016 / 046630, and invention name “Fully integrated disposable tissue visualization device”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application No. 62 / 203,898, filed on August 11, 2015, entitled “FULLY INTEGRATED, DISPOSABLETISSUE VISUALIZATION DEVICE.” The contents of the foregoing application are incorporated herein by reference in their entirety as if fully set forth herein. The priority interest of the foregoing application is asserted on an appropriate legal basis, including, but not limited to, as shown under 35 U.S.C. §119(e). Technical Field

[0004] This application describes embodiments of apparatus, methods, and systems for tissue visualization. Background Art

[0005] Traditional surgical procedures (including treatment and diagnosis) for lesions located in the body can cause significant trauma to intervening tissues. These operations usually require long incisions, extensive muscle stripping, long-term retraction of tissues, denervation of tissues, and devascularization. Due to the destruction of tissues during the operation, such operations may require several hours of operating room time, followed by a few weeks of recovery time after the operation. In some cases, these invasive operations result in permanent scarring and pain, which may be worse than the pain that caused the surgical intervention.

[0006] The development of percutaneous procedures has made significant progress in reducing recovery time and postoperative pain because it requires minimal dissection of tissue, such as muscle tissue. For example, minimally invasive surgical techniques are ideal for spinal and neurosurgical applications due to the required access locations within the body and the risk of damaging important intervening tissue. Although the development of minimally invasive surgery is moving in the right direction, further development of minimally invasive surgical instruments and methods is still needed.

[0007] Treatment of internal tissue sites (e.g., treatment of orthopedic joints) often requires visualization of the target internal tissue. However, if magnetic resonance imaging (MRI) is required, proper visualization of the internal tissue site can be expensive and time consuming. In addition, other imaging modalities can potentially damage the tissue site, resulting in poor diagnosis and prolonged recovery time. Therefore, there is a need for improved devices and methods for visualizing internal tissue sites. Summary of the invention

[0008] Embodiments of the present invention relate to tissue visualization devices, methods, and systems. In some embodiments, the tissue visualization device includes a visualization sensor and an elongated body having a proximal end and a distal end. The distal end of the elongated body can be sized to pass through a minimally invasive body opening. In certain embodiments, the device also includes an integrated engagement mechanism that imparts manipulability to at least one of the visualization sensor and the distal end of the elongated body. Additional embodiments provide methods for modifying internal target tissue using a tissue modification device.

[0009] A preferred embodiment of the present invention is a fully integrated sterilizable disposable tissue visualization device. The device includes a handle and a rigid elongated body extending along a longitudinal axis between a proximal end fixed to the handle and a distal end having a sharp tip. An image sensor is provided in the handle, and an elongated optical element extends through the probe, the optical element having a proximal end in optical communication with the sensor and having a distal end.

[0010] A control device is disposed on the handle for axially moving the elongated body between a proximal position in which the sharp tip is proximal to the distal end of the optical element and a distal position in which the sharp tip is distal to the distal end of the optical element.

[0011] An electrical wire may be integrally connected to the handle, having a free end with a connector for releasable electrical connection to an external viewing device.

[0012] The entire assembly of the handle, stylet, and wire can be sterilized and packaged in a single sterile container. This enables the sterile container to be opened within the sterile field of a clinical setting, the wire inserted into a compatible external viewing device, and the procedure to be started on a patient without requiring any additional assembly steps.

[0013] The distal end of the elongated body may be provided with a lateral deflection. The deflection may be in a first direction relative to the longitudinal axis, and the line is attached to the handle in a second direction relative to the longitudinal axis, and the second direction is offset by about 180° from the first direction. This provides visual and / or tactile feedback of the distal lateral deflection direction. The proximal retraction of the elongated body causes the distal end of the optical element to lateral deflect at least about 1°, in some embodiments at least about 2° or 3° or 5° or more to enhance the field of view. In certain embodiments, rather than lateral deflection at the distal end of the elongated body, the entire elongated body may be physically bent, thereby providing a bend within the elongated body. Such a curve may have a curvature of about at least 0-5°, 5-10°, 10-20°, 20-40°, 40-60°, 60-90°, or greater than 90°.

[0014] The optical element may include at least one and typically multiple optical visualization fibers and a distal lens. The optical element may additionally include at least one and typically multiple illumination fibers. The optical visualization fibers, optical illumination fibers, and lenses may be contained within a tubular body such as a hypotube.

[0015] The optical element may have an outer diameter spaced radially inwardly from the inner surface of the elongated body to define an annular lumen extending the length of the elongated body. The lumen may communicate with an injection or aspiration port on the handle, for example for flushing a medium such as an irrigant or an active agent or for aspiration.

[0016] In one embodiment of the invention, the device comprises an elongated body comprising a 14-gauge needle (2.1 mm outer diameter) or an outer tubular body having a sharp distal end. An optical hypotube is axially movably positioned within the outer tubular body such that it can be moved from a distal position extending beyond the sharp end and a proximal position where the sharp end is exposed distally. In certain embodiments, the optical hypotube may include a distal lens, an image guide comprising multiple optical fibers, and additional illumination fibers all contained within the hypotube. The image guide may include any number of suitable elements, such as 10,000 elements (e.g., optical fibers), and the hypotube may be any suitable gauge, such as an 18-gauge hypotube. In some embodiments, the image guide may include approximately at least 1,000 elements, at least 3,000 elements, at least 8000 elements, at least 10,000 elements, at least 12,000 elements, at least 15,000 elements, at least 20,000 elements, at least 30,000 elements, or more than 30,000 elements. The elongated body may include an injection cavity, such as an annular space between the optical hypotube and the inner diameter of the outer tubular body. The lumen may be used to inject a therapeutic medium such as saline, a liquid containing a biological component such as stem cells, a synthetic lubricant, or other flowable medium. In some embodiments, the lumen may be used to deliver saline or other therapeutic agents, such as growth factors, antibacterial molecules, or anti-inflammatory molecules to a tissue site. In certain embodiments, and as described elsewhere in the specification, the optical hypotube may be non-concentrically positioned within the elongated body. For example, the central axis of the optical hypotube may be biased toward one side or the other of the elongated body. The tire optical hypotube may be aligned along the bottom of the elongated body to help blunt the sharp distal tip of the elongated body. Additionally, in certain embodiments and as described elsewhere in the specification, the distal end of the optical hypotube can be bent to provide an enhanced field of view. When the optical hypotube includes a bent / deflected distal side, the difference in axis between the optical hypotube and the elongated body will also advantageously allow for more vertical clearance of the optical hypotube.

[0017] In some embodiments, the visualization device described here or elsewhere in this specification can be used for various image-guided injections other than combined injections. For example, medications sometimes need to be injected into the pericardium surrounding the heart. Currently, such injections are done blindly or with the help of expensive visualization. As an alternative application, the visualization device can be used when pericardial effusion occurs, which occurs when too much fluid accumulates around the heart. The doctor can use a needle to enter the pericardial cavity and then drain the fluid from the pericardium through a process called pericardiocentesis. However, certain embodiments of the tissue visualization device can also be used to accomplish such a task by piercing the tire pericardium along with the tire elongated body and then draining the fluid. Currently, doctors use imaging devices such as echocardiography or fluoroscopy (X-rays) to guide this type of work.

[0018] The elongated body is carried by a proximal handpiece which may be connected to a monitor such as an iPad or other display via a wired or wireless connection. Output video and / or image data may be projected via a wired or wireless connection. The proximal handpiece includes a CCD or CMOS optical sensor for capturing still and / or video images. The imaging device of the present invention is capable of accurately locating the distal end of the elongated body under direct observation, such as within a joint capsule. The imaging device provides diagnostic functionality, allowing a clinician or other personnel to effectively diagnose injuries and / or conditions. In embodiments, the device may also allow for reliable delivery of therapeutic media into a joint in a physician's office under local anesthesia, thereby avoiding other diagnostic procedures that may be less accurate and / or require longer wait times.

[0019] In some embodiments, the tissue visualization device comprises:

[0020] A handpiece including a visualization sensor configured to collect images of an internal tissue site:

[0021] At least one lens:

[0022] an elongated body comprising a proximal end and a distal end, the elongated body comprising a lumen and an optical hypotube configured to deliver a fluid to a tissue site;

[0023] An algorithm stored in the handpiece, the algorithm configured to correct optical aberrations in an image of an internal tissue site:

[0024] A deflected distal end comprising a sharp tip.

[0025] In some embodiments, optical correction can be generated by comparing the captured image with a known defined pattern and generating an algorithm that corrects chromatic aberration and image distortion specific to each individual tissue visualization device. In some embodiments, the optical correction can be unique to an individual tissue visualization device. In a specific embodiment, additional information about the tissue visualization device, such as the X, Y position of the center of the lens, the size of the image circle, and the unique characteristics of the LED, can be stored to provide a consistent initial illumination level. The above features of the tissue visualization device and additional features described elsewhere in the specification can be determined during the manufacturing process and stored in a computer memory, such as an electrically erasable programmable read-only memory (EEPROM). In an embodiment, the entirety of the handpiece and the elongated body can be an integrated unit. In some embodiments, the handpiece also includes a retraction control device configured to retract the elongated body to expose the distal lens of the optical hypotube. In some embodiments, the handpiece may further include a Luer configured to guide a fluid to an internal tissue site via an inner cavity.

[0026] In certain embodiments, a method of optical correction includes:

[0027] focusing a tissue visualization device on a known defined pattern;

[0028] capturing an image of a known defined pattern;

[0029] comparing the image of the known defined pattern to a reference data set corresponding to the known defined pattern;

[0030] generating an algorithm based on a difference between the image of the known defined pattern and the known defined pattern, the algorithm configured to restore the image of the known defined pattern to parameters of the known defined pattern;

[0031] storing the optical correction in the tissue visualization device; and

[0032] Optical correction is used to correct the images collected by the tissue visualization device.

[0033] In some embodiments, the method may further include inserting a tissue visualization device into the tissue site and collecting images. In some embodiments, a system for visualizing a tissue site may include: a fully integrated tissue visualization device including a handpiece, an image sensor in the handpiece, and an integrated probe having an optical fiber and an injection lumen; a display configured to display images collected by the tissue visualization device; and a cable providing electrical communication between the display and the tissue visualization device.

[0034] In certain embodiments, a sterile, integrated, single-use tissue visualization device may include:

[0035] A handle including a visualization sensor;

[0036] a monitor configured to display an image;

[0037] an elongated body extending along a longitudinal axis between a proximal end secured to the handle and a distal end including a laterally deflectable sharpened tip;

[0038] an elongated optical element extending through the elongated body, the optical element having a proximal end and a distal end in optical communication with the visualization sensor;

[0039] a controller on the handle for axially moving the elongated body between a proximal position in which the sharpened tip is proximal to the distal end of the optical element and a distal position in which the sharpened tip is distal to the distal end of the optical element;

[0040] wherein said distal end of said elongated body is configured to penetrate tissue along said longitudinal axis; and

[0041] wherein the distal end of the elongated optical element includes a viewing axis that is laterally deflected from the longitudinal axis,

[0042] In an embodiment, the lateral displacement of the sharp tip is 50% of the outer diameter of the elongated body. The observation axis may be at an angle of 15 degrees to the longitudinal axis. The elongated optical element may further include a field of view including a front field of view along the longitudinal axis. In an embodiment, the visualization sensor communicates wirelessly with the monitor. The handle may include a clamshell shape. The distal end may be laterally deflected by an axially movable control line. The elongated body may include an inner cavity configured to deliver an anti-inflammatory agent to an internal tissue site. In an embodiment, the tissue visualization device may further include a rotation sensor configured to determine the rotational orientation of the visualization device. The rotation sensor may communicate with the monitor to rotate the image so that the patient reference direction will always appear at the top of the screen. In an embodiment, the elongated body may include an outer tubular body, wherein the outer tubular body is composed of a heat-sensitive material.

[0043] In certain embodiments, a method of manufacturing a tissue visualization device may include:

[0044] cutting the tubular reflective material at a desired angle to expose the angled surface;

[0045] milling the angled surface until the angled surface is configured to reflect the image;

[0046] inserting the tubular reflective material into a tubular body, the tubular body comprising a gap; and

[0047] The tubular reflective material is positioned so that the angled surfaces reflect light that passes through the gap.

[0048] In an embodiment, an integrated single-use tissue visualization device may include:

[0049] handle;

[0050] an elongated rigid tubular probe extending along a longitudinal axis between a proximal end secured to the handle and a distal end having a sharp tip;

[0051] Image sensor in the handle;

[0052] an elongated imaging fiber extending through the probe, the imaging fiber having a proximal end in optical communication with the sensor and a distal end;

[0053] a controller on the handle for axially moving the tubular probe between a proximal position in which the sharpened tip is proximal to the distal end of the optical element and a distal position in which the sharpened tip is distal to the distal end of the optical element;

[0054] a lens in optical communication with a distal end of the imaging fiber, and

[0055] a mask on the lens, the mask comprising an annular blocker for blocking visible light, surrounding the optically transparent window to increase the depth of field perceived by the image sensor,

[0056] In an embodiment, the distal end of the tubular probe is provided with a lateral deflection. The handle may further include an image capture controller on the handle. The deflection may be in a first direction relative to the longitudinal axis, and the wire may be attached to the handle in a second direction relative to the longitudinal axis, the second direction deviating from the first direction by approximately 180 degrees. Axial proximal movement of the tubular probe may cause the distal end of the optical element to lateral deflect at least about 1 degree. In certain embodiments, wherein the lens has an outer diameter of not more than about 0.75 mm and / or 1, not more than about 0.5 mm. In certain embodiments, the diameter of the window is in the range of about 50 microns to about 300 microns. The diameter of the window may be in the range of about 100 microns to about 200 microns.

[0057] In an embodiment, the lens may include a gradient refractive index optical lens having a flat distal surface. The tissue visualization device may further include a plurality of axially extending illumination fibers spaced circumferentially around the lens. In some embodiments, the mask includes a thin film coating. The mask may include a low reflectivity chrome coating of the visualization device as described in claim 1, which includes an annular lumen extending along the length of the tubular probe and positioned between the imaging fiber and the inner surface of the elongated probe. In certain embodiments, the lumen is connected to an injection or aspiration port on the handle. The mask may have a light transmission in the visible light range of no more than about 10%. The mask may further have a light transmission in the visible light range of no more than about 5%.

[0058] In certain embodiments, a distal tip assembly for an elongated viewing instrument includes:

[0059] an imaging fiber optic bundle having a fiber optic bundle distal end;

[0060] a lens optically coupled to the distal end of the optical fiber bundle, the lens having a lens distal end;

[0061] an unpowered board optically coupled to a distal end of the lens; and

[0062] A mask is located between the lens and the plate, the mask including an annular barrier for blocking visible light, surrounding an optically transparent window through the plate, for increasing the depth of field perceived by the viewing instrument.

[0063] In some embodiments, the mask is carried by a plate. The mask may include a coating applied to the plate. The lens may have an outer diameter of no more than about 0.75 mm or no more than about 0.5 mm. In some embodiments, the diameter of the window is in the range of about 50 microns to about 300 microns. The diameter of the window may be in the range of about 100 microns to about 200 microns. In some embodiments, the lens includes a gradient refractive index optical lens with a flat distal surface. The distal end of the assembly may further include a plurality of axially extending illumination fibers spaced circumferentially around the lens.

[0064] In certain embodiments, a tissue visualization apparatus comprises:

[0065] handle;

[0066] an elongated tubular probe extending along a longitudinal axis between a proximal end secured to the handle and a distal end having a sharp tip;

[0067] Image sensor in the handle;

[0068] an elongated imaging fiber extending through the probe, the imaging fiber having a proximal end in optical communication with the sensor and a distal end;

[0069] a lens in optical communication with a distal end of the imaging fiber, and

[0070] a mask in optical communication with the lens, the mask comprising an annular barrier for blocking visible light, surrounding the optically transparent window to increase the depth of field perceived by the image sensor;

[0071] wherein the mask is located in a plane spaced apart from the focus of the lens along the optical path,

[0072] The tissue visualization device may further include a non-powered optical transmission plate, and the mask is located between the lens and the plate. The mask may include a coating on the plate. The coating may include low transmittance and low reflectivity in the visible light range. In some embodiments, the diameter of the effective area of ​​the imaging fiber is at least twice the diameter of the window.

[0073] In an embodiment, a depth-of-field enhancement optical assembly for imaging the distal end of a probe may include:

[0074] a powered lens having a distal end and an optical path extending therethrough;

[0075] an unpowered plate in the optical path and adjacent the distal end of the lens; and

[0076] A mask is between the lens and the plate, the mask comprising an annular barrier for blocking visible light, the mask surrounding an optically transparent window aligned with the optical path.

[0077] In an embodiment, the lens may include a gradient index lens. The mask may include a low reflectivity coating on the plate. In some embodiments, the coating includes chrome. BRIEF DESCRIPTION OF THE DRAWINGS

[0078] Other features and advantages of the present invention will become apparent from the following detailed description of the present invention in conjunction with the accompanying drawings, in which:

[0079] Figure 1 One embodiment of a tissue visualization system is shown.

[0080] Figure 2A-2C Various embodiments of tissue visualization devices are shown.

[0081] Figure 3A-3C Shows Figure 2A A close-up cross-sectional side view of an embodiment of the distal end of a tissue visualization device is shown.

[0082] Figure 4 A cross-sectional top view of an embodiment of a tissue visualization and modification device is shown.

[0083] Figure 5 A cross-sectional view of an embodiment of a tubular portion of a tissue visualization and modification device is shown.

[0084] Figure 6A-6C An embodiment of the tissue visualization device is shown with the outer housing removed.

[0085] Figure 7 Shows Figure 6A-6C A cross-sectional side view of an embodiment of a lens housing is shown in FIG.

[0086] Figure 8A-B Examples of images with and without rotational image stabilization are shown.

[0087] Figure 9A-9D An embodiment of a tissue visualization device including a mirror is shown.

[0088] Figure 10A-10C An embodiment of a tissue visualization device is shown.

[0089] Fig.11 is a comparison of photos taken with and without the embodiment without powered board and mask.

[0090] Fig.12 is a close-up view of an embodiment of an unpowered plate with an optical mask.

[0091] Figure 13A-13C Embodiments of tissue visualization devices including curved optical hypotubes are depicted.

[0092] Figure 14A-14B are photographs and illustrations of embodiments of the distal tip of a tissue visualization device.

[0093] Fig.15 Embodiments of methods for visualizing internal tissue sites are described.

[0094] Fig.16 An embodiment of a visualization sensor at the distal end of a tissue visualization device is depicted.

[0095] Fig.17 Embodiments of tissue visualization devices are depicted. DETAILED DESCRIPTION

[0096] Embodiments disclosed in this section or elsewhere in this application relate to minimally invasive tissue visualization and access systems and devices. Methods of using the system in imaging applications, and kits for performing the method are also provided. Before describing the present invention in more detail, it should be understood that the present invention is not limited to the specific embodiments described, as those can certainly change. It should also be understood that the terms used herein are only for the purpose of describing specific embodiments and are not restrictive, as the scope of the present invention will be limited only by the appended claims. The numerical range provided, it should be understood that each intermediate value between the upper and lower limits of the range and any other specified value or intermediate value within the specified range are included in the present invention. The upper and lower limits of these smaller ranges can be independently included in the smaller range, and are also included in the present invention, subject to any special exclusionary restrictions within the specified range. The specified range includes one or two restrictions, and the range excluding any one or two of those included restrictions is also included in the present invention.

[0097] Certain ranges are given herein where numerical values ​​are preceded by the terms "about," "around," and "approximately." These terms are used herein to provide literal support for the exact number that precedes them, as well as a number that is close to or approximately the number that follows the term. In determining whether a number is close to or approximately a specifically recited number, a number that is close to or approximately an unrecorded number may be a number that, in the context in which it is presented, provides a substantial equivalence to the specifically recited number.

[0098] All publications and patents cited in this specification are incorporated herein by reference as if each individual publication or patent was specifically and individually indicated to be incorporated herein by reference and are incorporated herein by reference to disclose and describe the tire methods and / or materials to which the cited publication relates. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

[0099] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. Therefore, this statement is intended to serve as antecedent basis for use of terminology such as "solely," "only," etc., in connection with limitation of claim elements, or use of a "negative" limitation.

[0100] It will be apparent to those skilled in the art after reading this disclosure that each individual embodiment described and illustrated herein has discrete components and features that can be easily separated or combined with the features of any other several embodiments without departing from the scope or spirit of the invention. Any method described can be performed in the order of events described or in any other order that is logically possible.

[0101] As outlined above, aspects of the invention include minimally invasive imaging and visualization systems. In some embodiments, the imaging systems of the invention are minimally invasive such that they can be introduced through minimal incisions into a patient's internal target site, such as a spinal location near or within a disc or an orthopedic joint capsule.

[0102] In some embodiments, the imaging system of the present invention may include both an access device and an elongated body. The access device may be a tubular device having a proximal end and a distal end and an internal passage extending from the proximal end to the distal end. Similarly, the elongated body has a proximal end and a distal end and is sized to slidably move through the internal passage of the access device.

[0103] In certain embodiments, the access devices of the present invention are elongated elements having an internal channel configured to provide access to a user (e.g., a health care professional such as a surgeon) from an external location to a target tissue site in vivo through a minimally invasive incision, such as a location near or within the spine or a component thereof, such as near or within an intervertebral disc, etc. The access devices of the present invention can be a cannula, a component of a retractor tube system, etc. Since the access devices are elongated, their length is 1.5 times or more of their width, such as 2 times or more of their width, including 5 times or even 10 times or more of their width, such as 20 times longer than their width, 30 times or more of their width.

[0104] In certain embodiments, where the access device is configured to provide access through a minimally invasive incision, the longest cross-sectional outer dimension of the access device (e.g., the outer diameter of a tubular access device, including the wall thickness of the wall access device, which in some cases may be a port or cannula) may range from 5 mm to 50 mm, such as from 10 to 20 mm in some cases. With respect to the internal passage, the passage may be sized to provide a passage for an imaging device from an external site to an internal target tissue location. In certain embodiments, the longest cross-sectional dimension of the internal passage, such as the inner diameter of a tubular shaped access device, ranges from 5 to 30 mm, such as 5 to 25 mm, including 5 to 20 mm, such as 7 to 18 mm in length. Where desired, the access device has sufficient rigidity to maintain mechanical separation of tissues, such as muscle, and may be manufactured from any convenient material. Materials of interest from which the access device may be manufactured include, but are not limited to, metals, such as stainless steel and other medical grade metal materials, plastics, and the like.

[0105] The system of the present invention may further include an elongated body with a proximal end and a distal end, wherein the size of the elongated body is designed to allow it to slidably move through the internal passage of the entry device or directly through the tissue without using an additional entry device. Since this part of the system is elongated, the length it has is 1.5 times or longer of its width, for example, 2 times or longer of its width, including 5 times or even 10 times or longer of its width, for example, 20 times, 30 times, or longer than its width. When designed for knee surgery, the size of the elongated body is designed to enter the capsule of the knee joint. At least the distal end of the device has 10mm or less, for example, 8mm or less and includes a longest cross-sectional dimension of 7mm or less, wherein in certain embodiments, the longest cross-sectional dimension is from 5 to 10mm, for example, 6 to 9mm, and includes 6 to 8mm. The elongated body can be solid or include one or more lumens so that it can be regarded as a catheter. The term "catheter" is adopted in its conventional sense to refer to a hollow, flexible or semi-rigid tube configured to be inserted into the body. The catheter of the present invention may comprise a single lumen, or two or more lumens, such as three or more lumens, as desired.Depending on the particular embodiment, the elongate body may be flexible or rigid, and may be made of any convenient material.

[0106] As outlined above, some embodiments of the present invention include visualization sensors and lighting elements. In certain embodiments, these visualization sensors are positioned within a handle at the proximal end of the device. The system may include one or more visualization sensors at the proximal end of the tire of the device and one or more lighting elements located between the distal end and / or proximal end of the slender body. In certain embodiments, one or more visualization sensors such as those described elsewhere in this section or in the specification may be located in the distal end of the device, for example, within the distal end of the tire slender body. In some embodiments, one or more visualization sensors may be located at different locations within the slender body, such as approximately one-quarter, one-half, or three-quarters of the length of the slender body from the distal end. In certain embodiments, the visualization sensors may be miniaturized so that they do not substantially increase the outer diameter of the slender body.

[0107] Similarly, with respect to the lighting elements, embodiments of the system include those in which one or more lighting elements are located at the distal and / or proximal ends of the elongated body. Embodiments of the system also include those in which one lighting element is located at the distal and / or proximal ends of the elongated body and another lighting element is located at the distal and / or proximal ends of the entry device. In addition, embodiments of the system include those in which one or more lighting elements are located at the proximal end of the device, and light is propagated toward the distal end of the device via a waveguide such as an optical fiber bundle. The longest cross-sectional dimension of the elongated body is typically 20 mm or less, 10 mm or less, 6 mm or less, such as 5 mm or less, including 4 mm or less, and even 3 mm or less.

[0108] The elongate body preferably contains an image capture waveguide, an illumination waveguide, and an inner lumen for fluid irrigation or aspiration.

[0109] In some embodiments, the micro-visual sensor has a longest cross-sectional dimension (e.g., diagonal dimension) of 20 mm or less, 10 mm or less, 5 mm or less, or 3 mm or less, wherein in some cases the sensor may have a longest cross-sectional dimension ranging from 2 to 3 mm. In some embodiments, the micro-visual sensor has a cross-sectional area that is small enough for its intended use and still maintains a sufficiently high matrix resolution. In some embodiments, the micro-visual sensor may have a longest cross-sectional dimension of 0.5 mm. In some embodiments, the longest cross-sectional dimension is approximately 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, or greater than 0.5 mm. In some embodiments, the visual sensor may be between 1-2 mm, such as 1.3 mm, or between 0.5-1 mm, such as 0.75 mm. Examples of small visual sensors are produced by Fujikura and Medigus. Certain visualization sensors may have a cross-sectional area (i.e., xy dimensions, also referred to as package chip size) of 2 mm×2 mm or less (e.g., 1.8 mm×1.8 mm or less), and also have a matrix resolution of 400x400 or greater, such as 640x480 or greater. In some cases, the visualization sensor has a sensitivity of 500 mV / Lux-sec or greater, such as 700 mV / Lux-Sec or greater, including 1000 mV / Lux-Sec or greater, wherein in some cases, the sensitivity of the sensor is 2000 mV / Lux-Sec or greater, such as 3000 mV / Lux-Sec or greater. In a particular embodiment, the visualization sensors of interest are those that include a photosensitive component (e.g., a photosensitive element array) coupled to an integrated circuit, wherein the integrated circuit is configured to obtain and integrate signals from the photosensitive array and output analog data to a back-end processor. The visualization sensors of interest may be considered integrated circuit image sensors, and include complementary metal oxide semiconductor (CMOS) sensors and charge coupled device (CCD) sensors. In certain embodiments, the visualization sensor may further include a lens positioned relative to the photosensitive component to focus the image on the photosensitive component.

[0110] Visualization sensors of interest include, but are not limited to, products from QminVision Technologies Inc., Sony Corporation, Cypress Semiconductors. The visualization sensor may be integrated with the component of interest, such as the proximal handle or the elongated structure or both. In some embodiments, when the visualization sensor is integrated at the proximal end of the component, it cannot be removed from the remainder of the component without significantly interfering with the structure of the component. In this way, the integrated visualization sensor may not be easily removed from the rest of the assembly, such that the visualization sensor and the rest of the assembly form an interrelated whole. As described above, in some embodiments, the visualization sensor may be located at the distal end of the elongated body or at other locations along the elongated body.

[0111] Although any convenient visualization sensor may be used in the apparatus of the present invention, in some cases, the visualization sensor may be a CMOS sensor. For example, the CMOS sensor may be an Aptina CMOS sensor such as the Aptina MT9V124. Such a CMOS sensor may provide very small pixels with a small package size coupled with a low voltage differential signal (LVDS). Such a CMOS sensor allows the cable to the display to include fewer conductors, and thus the cable cost may be reduced compared to other options. Also of interest as a CMOS sensor is the OmniPixel series of CMOS sensors available from QminVision (Sunnyvale, Calif.), including the OmniPixel, QmmPixel2, OmniPixelS, OmniPixel3-HS, and OmniBSI series of CMOS sensors. These sensors may be front or back illuminated sensors. Aspects of these sensors are further described in one or more of the following U.S. Patents, the disclosures of which are incorporated herein by reference: U.S. Patent Nos. 7,388,242, 7368772, 7355228, 7345330, 7344910, 7268335, 7209601, 7196314, 7193198, 7161130, and 7,154,137.

[0112] In some embodiments, the elongated body may further include one or more injection lumens that extend at least the substantial length of the device, e.g., for performing a variety of different functions. In some embodiments where it is desired to flush (i.e., clean) the location of the target tissue at the distal end of the elongated body and remove excess fluid, the elongated body may include a flushing lumen and a suction lumen. During use, the flushing lumen is operably connected to a fluid source (e.g., a physiologically acceptable fluid, such as saline) at the proximal end of the device, wherein the fluid source is configured to introduce fluid into the lumen under positive pressure, e.g., within a pressure range of 0-500 mmHg, so that the fluid is transported along the flushing lumen and output from the distal end.

[0113] Although the size of the flushing lumen can vary, in some embodiments, the longest cross-sectional dimension of the flushing lumen is in the range of 1 to 3 mm. During use, the suction lumen is operably connected to a negative pressure source (e.g., a vacuum source) at the proximal end of the device, wherein the negative pressure source is configured to draw fluid from the tissue position at the distal end to the flushing lumen under positive pressure, such as in the pressure range of 50-600 mmHg, so that the fluid is removed from the tissue site and transmitted along the flushing lumen and transmitted from the proximal end, such as into a waste storage device. Although the size of the suction lumen can vary, in some embodiments, the longest cross-sectional dimension of the suction lumen is in the range of about 1 to 10 mm, about 1 to 4 mm, about 1 to 3 mm, or less than 1 mm. Alternatively, a single lumen can be provided, by which flushing and / or suction can be completed. In an embodiment, the product packaging can include a single port stopcock as a means of controlling fluid flow. In a specific embodiment, a stopcock or a suitable valve can be directly integrated into the device. In further embodiments, more than one port or stopcock may be used, such as two ports and two stopcocks, three ports and three stopcocks, etc. In some embodiments, a three-way stopcock may be provided so that the clinician can "switch" between injection and aspiration, or inject a first and a second fluid, without connecting and reconnecting tubing.

[0114] In some embodiments, the system of the present invention is used in conjunction with a controller configured to control the illumination of the illumination element and / or capture images from the visualization sensor (e.g., as a still image or video output). The controller can take a variety of different forms, including hardware, software, and combinations thereof. The controller can be physically positioned relative to the elongated body and / or the access device at any convenient location (e.g., at the proximal end of the system). In some embodiments, the controller can be different from the system component, i.e., the elongated body, so as to provide a different controller interface from the proximal handle, or the controller can be integrated with the proximal handle.

[0115] Figure 1An embodiment of a system 2 for visualization of an internal tissue site is shown. In some embodiments, the tissue visualization system 2 includes a tissue visualization device 4 , which will be described in more detail below, a controller 6 , and a cable 8 providing electrical communication between the controller 6 and the tissue visualization device 4 .

[0116] In some embodiments, the controller 6 may include a housing with a memory port, such as an SD card slot 10 and a camera button 12. The camera button 12 may activate the system to collect and store still or moving images, and the controller 6 may also include a power button 14, a mode switch button 16, and a brightness control 18. The controller 6 may also include a display such as a screen 19 for displaying still images and / or video.

[0117] Activating the mode switching button 10 can switch the system between different modes, such as a process mode for collecting and displaying video and / or still images in real time on a video screen 19, and a consultation mode, wherein a clinician can selectively display stored images and videos on the video screen 19 for analysis. For example, in the process mode, the system can display a video or image from a visualization sensor in real time. Real-time means that the screen 19 can display a video inside the tissue part, just as the clinician is checking. The video and / or image can be further automatically stored by the system for later playback. For another example, in the consultation mode, the screen 19 can conveniently display a specific image or video that the system has previously acquired, so that the clinician can analyze the collected images / data relatively easily, and discuss the images and data with the patient. In some embodiments, the clinician may be able to annotate the image via a touch screen or other suitable means.

[0118] In some embodiments, screen 19 may be any type of image plane suitable for visualizing an image, such as a screen on an iPad, a camera, a computer monitor, a mobile phone, or a display carried by a head-mounted support device, such as glasses or other heads-up display, etc. In some embodiments, the use of cables may be avoided by configuring the device and display to communicate wirelessly.

[0119] In some embodiments, it may be desirable to remove the cord and instead provide a wireless communication link between the probe and the monitor, and possibly also provide it to a location of centralized medical record storage and / or evaluation. Local projection, such as to a monitor within a medical suite, may be accomplished via a local area network, such as a "WiFi" network based on the IEEE 802.11 wireless local area network standard, the Bluetooth wireless personal area network standard, or the low power ANT wireless protocol. Transceiver chips and associated circuitry are well understood in the art and may be located within the handpiece housing of the visualization device 4, which will be discussed below.

[0120] As another alternative to traditional WiFi or IEEE 801.11-based local area networks, ZIGBEE networks based on the IEEE 802.15.4 standard for wireless personal area networks have been used to collect information from various medical devices for point-of-care medical device communications according to IEEE 11073 device specialization, including, for example, pulse oximeters, blood pressure monitors, pulse monitors, weight scales, and blood glucose meters. For example, compared to the current IEEE 802.15.1 BLUETOOTH wireless personal area network, the ZIGBEE network has the advantage of low power consumption requirements (e.g., enabling the ZIGBEE transceiver to be integrally coupled to the probe under battery power). However, the projection range between a single ZIGBEE transceiver is generally limited to no more than a few hundred feet. Therefore, this network is suitable for on-site communication with medical devices, but cannot be used for centralized monitoring locations located in remote locations. Thus, a hybrid system may be desirable in which one or more wireless personal area networks are configured to facilitate on-site communications between the detector and an associated monitor, and also between the detector and one or more wireless relay modules that are further configured to communicate with an off-site centralized monitoring system (e.g., via an Internet connection or a wireless wide area network (WWAN) such as a mobile phone data network, such as based on a Global System for Mobile Communications (GSM) or Code Division Multiple Access (CDMA) mobile network or related wireless data channels). Suitable relay modules and systems are described in patent applications entitled "Wireless Relay Module for Remote Monitoring Systems" (U.S. application serial number 13 / 006,769, filed on January 14, 2011) and "Medical Device Wireless Network Architectures" (U.S. application serial number 13 / 006,784, filed on January 14, 2011), respectively, which are hereby incorporated by reference into this patent application.

[0121] Thus, any probe disclosed herein may be provided with an interface circuit comprising a transceiver having one or more of a transmitter and / or a receiver for sending and receiving video images, still images, and potentially other signals, respectively, via an associated monitor in a medical kit to a wireless network (such as a low-rate wireless personal area network or "LR-WPAN", a ZIGBEE network or another low power personal area network, such as low power Bluetooth or other WiFi network, existing or subsequently developed).

[0122] Optionally, one or more relay modules are also provided within the patient facility. Each relay module includes a first transceiver for receiving signals from and sending signals to an interface circuit within a handheld probe or associated monitor, and also includes an output such as an Internet connection or a second transceiver for wirelessly sending signals to and receiving signals from an access point via a wireless wide area network ("WWAN"). Suitable WWANs for use with the present invention include, for example, those based on a Global System for Mobile Communications (GSM) or Code Division Multiple Access (CDMA) mobile network or associated with 2G, 3G, 3G Long Term Evolution, 4G, WiMAX mobile wireless standards of the International Telecommunication Union Radiocommunication Sector (ITU-R). To comply with any applicable patient data privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), communications are preferably performed securely over each of the facility-oriented wireless network and the WWAN using, for example, a Secure Sockets Layer (SSL) protocol or a Projected Layer Security (TLS) protocol.

[0123] Also provide for the kit of practicing subject method, wherein kit can comprise one or more above-mentioned devices, and / or the parts of subject system as above-mentioned.Like this, kit can comprise visual device and the cable for being connected to controller, and it is contained in sterile packaging.This kit can further comprise other components, such as controller, guide wire, lancet etc., and it can be used for practicing the method for this subject.Various parts can be packaged as required, such as together or separately packaged.Preferably, the parts in the package are sterilized in advance.The further details about the pre-sterilization of packaging can be found in the U.S. Patent 8,584,853 submitted on February 16, 2013, and it is incorporated into this specification sheet by reference at this.

[0124] In addition to the above-mentioned components, the subject kit can also include instructions for practicing the subject method using the components of the kit. The instructions for practicing the subject method can be recorded on a suitable recording medium. For example, the instructions can be printed on a substrate, such as paper or plastic, etc. Therefore, the instructions can be present in the kit as a packaging insert, in the label of the container of the kit or its components (that is, associated with packaging or sub-packaging), etc. In other embodiments, the instructions exist as an electronic storage data file present in a suitable computer-readable storage medium, such as a CD-ROM, a floppy disk, etc. In other embodiments, actual instructions do not exist in the kit, but mean that they can be obtained from a remote resource, such as, provided by the Internet. The example of this embodiment is that the kit includes a website address where the instructions can be viewed and / or can be downloaded from it. Like the instructions, this method of obtaining instructions is recorded on a suitable substrate.

[0125] Also of interest is programming configured for operating a visualization device according to the method of the present invention, wherein the programming is recorded on a physical computer-readable medium, for example, any medium that can be directly read and accessed by a computer. Such media include, but are not limited to: magnetic storage media, such as floppy disks, hard disk storage media, and magnetic tapes; optical storage media such as CD-ROMs; electrical storage media such as RAM and ROM; and hybrids of these categories, such as magnetic / optical storage media. A person skilled in the art can readily understand how to use any currently known computer-readable medium to create a storage medium having minimally invasive operation instructions according to the present invention.

[0126] In some embodiments, the programming of the device includes instructions for operating the device of the present invention, such that when executed by the programming, the executed instructions result in the execution of the imaging device: illuminating a target tissue site, such as an orthopedic joint or a portion thereof; and capturing one or more image frames of the illuminated target tissue site using a visualization sensor,

[0127] Visual sensors of interest are those that include a photosensitive component, such as an array of photosensors that convert light into electrons, coupled to an integrated circuit. The integrated circuit can be configured to obtain and integrate signals from the photosensitive array and output image data, which in turn can be transmitted to an external display configured to receive the data and display it to a user. The visual sensors of these embodiments can be viewed as integrated circuit image sensors,

[0128] The integrated circuit components of these sensors can include various different types of functions, including but not limited to: image signal processing, memory, and data projection circuits for projecting data from the visualization sensor to an external location, etc. The micro visualization sensor may also include a lens component consisting of one or more lenses positioned relative to the photosensitive component so as to focus the image on the photosensitive component. If necessary, the one or more lenses may be present in the housing. Specific types of micro visualization sensors of interest include complementary metal oxide semiconductor (CMOS) sensors and charge coupled device (CCD) sensors. The sensor may have any convenient configuration, including circular, square, rectangular, etc. The visualization sensor of interest may have a longest cross-sectional dimension that varies according to the specific embodiment, wherein in some cases, the longest cross-sectional dimension (e.g., diameter) is 10.0 mm or less, such as 6.0 mm or less, including 3.0 mm or less.

[0129] The visualization sensors of interest may be front or back illuminated sensors and have a sufficiently small size while maintaining sufficient functionality to be integrated at the proximal end of the elongated body within the handpiece of the device of the present invention. Various aspects of these sensors are further described in one or more of the following U.S. patents, the disclosures of which are incorporated herein by reference. U.S. Patent Serial Nos. 7,388,242, 7368772, 7355228, 7345330, 7344910, 7268335, 7209601, 7196314, 7193198, 7161130, and 7,154,137.

[0130] The distal end of the elongated body can be configured for frontal viewing and / or side viewing as desired. In other embodiments, the elongated body can be configured to provide image data from both the front and side, for example, with the main viewing axis extending from the distal end of the waveguide at an angle of greater than about 2°, or 5°, or 10°, or 15° relative to the longitudinal axis of the elongated body, as described in more detail below.

[0131] Depending on the specific device embodiment, the elongated body may or may not include one or more lumens extending at least partially along its length. When present, the diameter of the lumen can vary and can be used for a variety of purposes, such as flushing, suction, electrical isolation (such as conductive members, such as wires), as mechanical guidance, etc., which will be described in more detail below. When present, the longest cross-section that this lumen has is variable, and its scope can be 0.5-5.0mm, such as 1.0-4.5mm, including 1.0 to 4.0mm. As required, the lumen can have any convenient cross-sectional shape, including but not limited to circle, square, rectangle, triangle, semicircle, trapezoid and irregular shape, etc. These lumens can be provided for a variety of functions, including flushing and / or suction lumen, as described in more detail below.

[0132] In some embodiments, the device may include one or more lighting elements configured to illuminate the target tissue location so that the location can be visualized using a visualization sensor, for example, as described above. Various different types of light sources can be used as lighting elements, as long as their size allows them to be positioned at the distal end of the elongated body or carry light to the distal end of the elongated body. The light source can be integrated with a given component (e.g., an elongated body) so that they are configured relative to the component so that the light source element cannot be removed from the rest of the component without significantly damaging the structure of the component. In this way, the integrated lighting elements of these embodiments are not easily removed from the rest of the component, so that the lighting element and the rest of the component form an interrelated whole. The light source can be a light emitting diode configured to emit light of a desired wavelength range, or an optical transmission element such as an optical fiber configured to transmit light of a desired wavelength range from a position different from the distal end of the elongated body, such as a position at the proximal end of the elongated body in a handpiece to the distal end of the elongated body.

[0133] As with the visualization sensor, the light source may include a conductive element (eg, a wire) or an optical fiber or fiber optic bundle that extends the length of the elongated body to provide power and control of the light source from a location outside the body, eg, an extracorporeal control device.

[0134] Where desired, the light source may include a diffusing element to provide uniform illumination of the target tissue site. Any convenient diffusing element may be used, including but not limited to a translucent cover or layer (made of any convenient translucent material) through which the light from the light source passes and is thus diffused. In those embodiments of the present invention where the system includes two or more lighting elements, the lighting elements may emit light of the same wavelength, or they may be spectrally different light sources, where "spectrally different" refers to light sources emitting light at wavelengths that are substantially non-overlapping, such as white light and infrared light. In certain embodiments, an illumination configuration as described in U.S. Application Serial Nos. 12 / 269,770 and 12 / 269,772 (the disclosures of which are incorporated herein by reference) is present in the device.

[0135] In some embodiments, the device of the present invention may include a linear mechanical actuator for linearly translating a distal element of the device relative to a visualization element, such as a tubular needle surrounding the visualization element. By "linear translation" is meant movement along a substantially straight path. As used herein, the term "linear" also includes movement in a non-straight (i.e., curved) path.

[0136] In some embodiments, there is also an integrated engagement mechanism in the device that imparts steerability to the distal end of the elongated body and / or the distal end of the visualization element. "Steerability" refers to the ability to manipulate or direct the distal end of the visualization element, tissue modifier and / or elongated body as needed during the operation process, for example, by using a controller positioned at the proximal end of the device. In these embodiments, the device includes a steerability mechanism (or one or more elements located at the distal end of the elongated body) that makes the desired distal component manipulable as needed by the proximal controller. Thus, the term "steerability" as used herein refers to a mechanism that provides a user with steering functionality, such as the ability to change direction in a desired manner, such as by deflecting the primary observation axis to the left, right, upward or downward relative to the initial axis.

[0137] The steering function can be provided by a variety of different mechanisms. Examples of suitable mechanisms include, but are not limited to, one or more axially movable pull or push wires, tubes, plates, meshes, or combinations thereof made of suitable materials such as shape memory materials, piano wires, etc. For example, the active deflection mechanism includes providing a plurality of transverse slots, which are axially spaced apart along the first side of the outer tubular body 1126 in the distal segment 1108. The second side of the outer tubular body 1126 in the distal segment 1108 is opposite to the first side (i.e., 180°) and serves as an axially incompressible spine, while the first side can be axially compressed, resulting in a lateral deflection concave toward the first side. The axial compression (or elongation) of the first side relative to the second side to cause or eliminate bending can be achieved by an axially movable controller. The distal end of the control line can be fixed to the outer tubular body 1126 in the distal segment 1108, preferably fixed at the distal end of the distal segment 1108. The control line extends to the proximal deflection controller over the length of the entire outer tubular body 1126. Manipulating the controller to retract the control wire proximally will collapse the transverse slot, shortening the axial length of the first side relative to the second side, thereby deflecting the distal segment 1108 .

[0138] In some cases, the distal end of the elongated body is provided with a unique additional capability that allows it to be independently rotated about its longitudinal axis while a significant portion of the operating handle remains in a fixed position, as discussed in more detail below.

[0139] The engagement range of the distal main observation axis of the present invention can be changed, for example, at least about 5 °, 10 °, 25 ° or 35 ° or more from the main observation axis. The visualization element can be configured to rotate around its axis, so that the full angle range can be approached on either side of the axis of the probe, substantially doubling the effective viewing angle, as described in more detail below. The engagement mechanism of interest is further described in disclosed PCT application publication numbers WO 2009029639, WO 2008 / 094444, WO 2008 / 094439 and WO2008 / 094436, and its disclosure is hereby incorporated by reference. The specific engagement configuration of interest is further described below in conjunction with the accompanying drawings.

[0140] In certain embodiments, the device of the present invention may further include a flusher and an aspirator, which are configured to flush the internal target tissue site and / or components of the device, such as the lens of the visualization sensor. Thus, the elongated body may also include one or more lumens, which extend at least the substantial length of the device, for example, for performing a variety of different functions, as described above, in certain embodiments, it is desired to flush (e.g., clean) the target tissue site at the distal end of the elongated body (e.g., remove the excised tissue from the location, etc.), and the elongated body may include a flushing lumen and an aspiration lumen. Therefore, the tissue modification device may include a flushing lumen extending axially through the elongated body. During use, the flushing lumen may be operably connected to a fluid source (e.g., a physiologically acceptable fluid, such as saline) at the proximal end of the device, wherein the fluid source is configured to introduce a fluid into the lumen under positive pressure, for example, within a pressure range of 0 psi to 60 psi, so that the fluid is transported along the flushing lumen and output from the distal end. Although the size of the flushing lumen may vary, in certain embodiments, the longest cross-sectional dimension of the flushing lumen is 0.5 mm to 5 mm, for example 0.5 mm to 3 mm, including 0.5 mm to 1.5 mm

[0141] During use, the suction lumen can be operably connected to a negative pressure source (e.g., a vacuum source) at the proximal end of the device. Although the size of the suction lumen can vary, in some embodiments, the longest cross-sectional dimension of the suction lumen ranges from 1 mm to 7 mm, such as 1 mm to 6 mm, including 1 mm to 5 mm. In some embodiments, the aspirator includes a port having a cross-sectional area that is 33% or more, such as 50% or more, including 66% or more of the cross-sectional area of ​​the distal end of the elongated body.

[0142] In some cases, the negative pressure source is configured to draw fluid and / or tissue from a target tissue site at the distal end into a suction lumen under negative pressure, e.g., 300-600 mmHg, e.g., 550 mmHg, such that the fluid and / or tissue is removed from the tissue site and transported along the suction lumen and output from the proximal end, e.g., into a waste reservoir. In some embodiments, the flushing lumen and the suction lumen may be separate lumens, while in other embodiments, the flushing and suction functions may be accomplished in a single lumen.

[0143] In some embodiments, the device may include a control structure, such as a handle, operably connected to the proximal end of the elongated body. "Operably connected" means that one structure communicates with another structure (e.g., mechanically, electrically, optically connected, etc.). When present, the control structure (e.g., handle) is located at the proximal end of the device. The handle may have any convenient configuration, such as a handheld cane with one or more control buttons, a handheld gun with a trigger, etc., and examples of suitable handle configurations are provided further below.

[0144] In some embodiments, the distal end of the elongated body can rotate about its longitudinal axis while the majority of the operating handle remains in a fixed position. Thus, at least the distal end of the elongated body can rotate to a certain extent while the handle connected to the proximal end of the elongated body remains in a fixed position. The degree of rotation in a given device can vary and can range from 0 to 360°, such as 0 to 270°, including 0 to 180°.

[0145] As described herein in this section and elsewhere in the specification, in certain embodiments, the device can be disposable or reusable. Thus, the device of the present invention can be fully reusable (e.g., a multi-use device), or fully disposable (e.g., all components of the device are single-use). In some cases, the device can be fully reusable (e.g., where all components can be reused a limited number of times). Each component of the device can be individually disposable, have limited reusability, or be infinitely reusable, resulting in an overall device or system composed of components with different usability parameters.

[0146] As described herein and elsewhere in this specification, in certain embodiments, the devices of the present invention may be manufactured using any convenient material or combination thereof, including but not limited to: metallic materials, such as tungsten, stainless steel alloys, platinum or its alloys, titanium or its alloys, molybdenum or its alloys, and nickel or its alloys; polymer materials, such as polytetrafluoroethylene, polyimide, PEEK, etc.; ceramics, such as alumina (e.g., STEATITE TM Alumina, MAECOR TMAlumina), etc. In some embodiments, materials that provide both structural and lightweight piping properties may be used.

[0147] With respect to imaging the interior of a joint capsule, the method includes positioning the distal end of a visualization element of the present invention in an observation relationship with a target tissue. By observation relationship is meant positioning the distal end within 40 mm, such as within 10 mm, including within 5 mm of the target tissue site of interest. Positioning the distal end of the observation device relative to the desired target tissue can be achieved using any convenient method, including linear advancement from a percutaneous entry point directly to the target tissue. After positioning the distal end of the imaging device in an observation relationship with the target tissue, the target tissue is imaged using an illumination element and a visualization sensor to obtain image data. The image data obtained according to the method of the present invention is output to a user in the form of an image, for example using a monitor or other convenient medium as a display device. In some embodiments, the image is a still image, while in other embodiments, the image can be a video.

[0148] In embodiments, the internal target tissue sites can vary widely. Interested internal target tissue sites include, but are not limited to, orthopedic joints, cardiac locations, vascular locations, and central nervous system locations, etc. In some cases, the internal target tissue sites include spinal tissue. Orthopedic joints can include any type of joint of interest in the human body, such as a knee or shoulder. In some embodiments, the internal tissue sites can include sites of interest during general surgery, such as abdominal organs and / or surrounding tissue.

[0149] Further applications of the tissue visualization device described in this section or elsewhere in this specification include use in general surgery (laparoscopic or other minimally invasive surgery) as an auxiliary visualization device. In some cases, it may be necessary to remove the laparoscopic camera and the surgery is blind. However, the outer diameter of the device described in the present application is small enough that they can be used to eliminate interruptions once the laparoscopic camera is removed. In such an embodiment, the slender body is no longer rigid, but the main body is flexible, and the slender body can be installed in the slender flexible tubular body by deflecting the distal end using any of a variety of steering mechanisms, such as one or two or three or more pull wires. In some embodiments, the device may include a biased curved distal end (e.g., nitinol), which can be selectively bent or straightened by retracting an outer straight sleeve or an internal straightening line, etc.

[0150] In addition to general surgical procedures and other applications described in this section and elsewhere in this specification, embodiments of the visualization devices described herein can be used for ear, nose, and throat applications. For example, the devices described herein can be used for any diagnostic evaluation where visualization may be valuable. As another example, the devices described herein can also be used to guide or evaluate the treatment of chronic sinusitis, such as dilation of a sinus, such as a maxillary sinus,

[0151] In some embodiments, the apparatus and methods of the present invention can be used for various applications where it is desired to image and / or modify the internal target tissue of a subject while minimizing damage to surrounding tissue. The apparatus and methods of the present invention can be used in many applications, such as, but not limited to, surgical procedures, where various different types of tissue can be visualized and potentially treated, including, but not limited to, soft tissue, cartilage, bone, and ligaments, etc. Other methods for which the imaging apparatus can be used include those described in U.S. Published Application 2008 / 0255563.

[0152] In one embodiment, the distal end of the needle is precisely positioned within a joint capsule, such as the knee, using an imaging device. This allows for reliable injection of the therapeutic medium into the capsule. For this application, the outer diameter of the tubular body has a diameter of less than about 3 mm, preferably less than about 2.5 mm, and in one embodiment has a diameter of about 2.1 mm (14 gauge).

[0153] Figure 2A An embodiment of a tissue visualization device 1100 is shown, which includes an elongated body 1102 and a handpiece 1104. The elongated body can have a length of at least about 1.5 times its width, at least about 2 times its width, at least about 4 times its width, at least about 10 times its width or longer, at least about 20 times its width, at least about 30 times its width, at least about 50 times its width, or more than 50 times its width. The length of the elongated body can vary, and in some cases can be at least about 2 cm long, at least about 4 cm long, at least about 6 cm long, at least about 8 cm long, at least about 10 cm long, at least about 15 cm long, at least about 20 cm long, at least about 25 cm, at least 50 cm, or longer than 50 cm. The elongated body can have the same outer cross-sectional size (e.g., diameter) along the entire length. Alternatively, the cross-sectional diameter can vary along the length of the elongated body. In some embodiments, the outer diameter of the elongated body is about 0.1 to 10 mm, about 0.5 to 6 mm, about 1 to 4 mm, about 1.5 to 3 mm, about 2 to 2.5 mm, or about 2.1 mm. In some embodiments, the elongated body is a 14-gauge needle having an OD of about 2.1 mm and an ID of about 1.6 mm.

[0154] In certain embodiments, and as described elsewhere in the specification, the elongated body can have a proximal end 1106 and a distal end 1108. The term "proximal end" as used herein refers to the end of the elongated body that is closer to the user, (e.g., a physician operating the device during a tissue modification procedure), and the term "distal end" as used herein refers to the end of the elongated body that is closer to the internal target tissue of the subject during use. In some cases, the elongated body has a sufficiently rigid structure to allow the distal end to be pushed through tissue when sufficient force is applied to the proximal end of the elongated body. Thus, in these embodiments, the elongated body is not pliable or flexible, at least not to any significant extent. In certain embodiments, the distal end 1108 can further include, for example, Figure 2A The sharp tip shown in , thereby allowing the distal end to pierce tissue such as a joint capsule. In certain embodiments, the distal end can be pushed into the joint capsule from the outside of the body by penetrating the skin and underlying tissue.

[0155] like Figure 2A As shown, in an embodiment, the handpiece can have a rounded "clamshell" shape including a seam 1110 connecting a clamshell top 1112 and a clamshell bottom 1114. In some embodiments, the clamshell top 1112 and the bottom 1114 can be made in two pieces and then connected together at the seam 1110. The rounded clamshell shape provides a comfortable and ergonomic grip for the user when using the device. In certain embodiments and as will be described in more detail later, the handpiece can include an image capture controller, such as a button 1116 configured to capture a desired image. In further embodiments, the image capture controller can include a switch, a dial, or other suitable mechanism. The handpiece 104 can further include a retraction control 1118 that retracts or extends a portion of the elongated body 1102, such as a sharp needle. In combination with Figure 2B -C and subsequent figures describe the retraction controller in more detail.

[0156] In certain embodiments, the controller 1116 can selectively activate the acquisition of images and / or video. The controller 1116 can therefore be configured to selectively start video recording, stop video recording, and / or capture still images during video recording or when video recording is turned off. In some embodiments, the controller or another controller can turn on / off an ultraviolet light (UV) source, which is to be used with UV sensitive materials (e.g., gels). For example, a UV-sensitive liquid can be delivered to a target tissue, such as a knee, followed by application of the UV liquid to cure the liquid into a solid or semi-solid material, and the UV light can be generated by a standard LED, such as those described elsewhere in the specification. The UV light can be directed toward the target tissue via illumination fibers such as those described elsewhere in this specification, while still retaining some illumination fibers to illuminate the target tissue for imaging,

[0157] In embodiments, the handpiece can include a Luer connector 1120 configured to connect to any fluid source described in this section or elsewhere in this specification, such as sterile saline. The Luer connector 1120 can be in fluid communication with a lumen extending throughout the entire length of the elongated body, thereby allowing fluid or medication to be delivered to a tissue site.

[0158] The junction between the handpiece 1104 and the elongated body 1102 may include a hub 1122 that connects the handpiece 1104 to the elongated body 1102. In some embodiments, the hub may be removable, allowing the elongated body to be removed from the handpiece. In other embodiments, the elongated body is permanently attached to the handpiece via the hub to provide an integrated assembly,

[0159] The handpiece may also include a strain relief node 1124 configured to attach to the cable ( Figure 2A Strain relief nodes 1124 may be used to reduce strain on electrical wiring that is in electrical communication with the hand piece.

[0160] In some embodiments, the tissue visualization device 1100 is configured as an integrated assembly for single use. In certain embodiments, the tissue visualization device 1100 is pre-sterilized, so the combination of integration and pre-sterilization allows the tissue visualization device to be used immediately after being removed from the packaging. After use, it can be discarded. Therefore, the handpiece 1104, the elongated body 1102, and other components such as cables can all be an integrated unit. By an integrated unit, it is meant that the various parts described above can be connected together as a single component rather than being disassembled by the user. In some embodiments, the various parts of the integrated unit are inseparable and will not destroy one or more components. In some embodiments, a display as described in this section or elsewhere in the specification may also be incorporated and sterilized as part of a single integrated tissue visualization device.

[0161] Figure 2B Shows Figure 2A A cross-sectional side view of an embodiment of a tissue visualization device is depicted in FIG. Figure 2A As in FIG. 1 , the tissue visualization device includes multiple components such as an image capture trigger 1116 , a retraction control 1118 , a luer 1120 , an elongated body 1102 , a handpiece 1104 , and a hub 1122 .

[0162] In some embodiments, the distal end 1108 may include a deflection structure, wherein the distal end of the elongated body is deflected from the longitudinal axis of the elongated body 1102. The tip of the deflection is preferably sharpened to allow the tip to pass through the tissue site of interest. Figure 3A-B describes in more detail a deflectable tip embodiment of the distal end 1108. In an embodiment, the tip is capable of penetrating skin and other tissues to reach internal tissue sites.

[0163] Now available in Figure 3A As seen in FIG. 1 , the elongated body 1102 includes an outer tubular body 1126, which may be a hypodermic needle, such as a 14-gauge needle with a sharp tip. The visualization element is in the form of an inner optical hypotube 1128 extending concentrically through the outer tubular body 1126. The optical hypotube may be used to project an image of the tissue site to a visualization sensor 1132 ( Figure 2B ), such as those described in this section and elsewhere in this specification. The handpiece 1104 also includes a proximal lens housing 1130, which is described below in Figure 7 Described in more detail in .

[0164] In some embodiments, as described elsewhere, the distal end of the visualization element can include one or more visualization sensors 1350, such as any visualization sensor or imaging sensor described in this section or elsewhere in this specification. In some embodiments, one or more visualization sensors can be located on the inner diameter of the outer tubular body. In embodiments in which one or more visualization sensors are positioned on the inner diameter of the outer tubular body, the visualization sensors can be positioned in a manner that allows the sensor to have an angled field of view outside the end of the outer tubular body, such as at an optional position 1352. In some embodiments, the visualization sensor can be positioned on the inner diameter of the outer tubular body, opposite the sharp tip. The sensor can also be located at any suitable location on the interior of the outer tubular body to provide a field of view through the distal opening of the outer tubular body.

[0165] Reference Figure 2C and Figure 3A As described above, in some embodiments, the handpiece can include a retraction control 1118. The retraction control can be used to retract the optical hypotube relative to the Figure 3A The outer tubular body 1126 of the embodiment of the present invention thus allows the optical hypotube to extend beyond the front opening of the outer tubular body at the distal end 1108. Figure 3B. In some embodiments, the sharp distal end is used to pierce tissue to guide the elongated body into a target area. Once the elongated body has reached the target area, such as within a joint capsule, the retraction control 1118 can be used to retract the sharp tip at the distal end of the visualization element proximally. By retracting the sharp tip, the user can guide the now blunt distal end of the elongated body into the tissue site without the risk of piercing the tissue again. Retraction of the sharp tip may be particularly useful for certain tissue sites. For example, once the sharp distal end pierces the joint capsule of an orthopedic joint, there is a risk of penetrating the other end of the joint capsule. By retracting the sharp end, an image of the joint capsule can be captured and medication injected without worrying about further damaging the joint capsule.

[0166] In some embodiments, the edges and sides of the elongated body are blunted so as not to damage surrounding tissue when the elongated body is inserted. The blunting of the sharp edges of the axial ends and sides is critical because the integrated nature of the device results in sharp edges being exposed to internal anatomical structures. Similarly, the generally blunt cannula has a removable trocar that provides a passage through the tissue, which is then replaced with a separate camera hypotube.

[0167] In some embodiments, the passivation is achieved by the deflection geometry of the distal end biasing the optical hypotube against the inner diameter of the outer tubular body. In addition, the distal end of the outer tubular body may include a reverse grind to further protect the sharp edge when the sharp edge is directly against the OD of the optical hypotube. In some embodiments, the outer tubular body may include a pit on the outer tubular body or the optical hypotube, which biases the OD of the optical hypotube against the ID of the elongated body. In some embodiments, there may be one pit, two pits, three pits, four pits, or more than four pits. In some embodiments, the pits can be replaced or added with spring claws and / or other auxiliary components to bias and guide the optical hypotube. For example, the spring claws on the hypotube can contact the inner diameter of the outer tubular body. Such claws or features can keep the optical hypotube properly positioned to guide the optical hypotube to blunt the sharp tip. Such claws or features can be shaped to minimize disruption of fluid flow. In embodiments, the prongs or features may present a thin cross-section parallel to the direction of fluid flow, such as one, two, three, four or more "c" shaped features protruding from the outer diameter of the optical hypotube to provide an axially long cabin with a thin cross-section for the fluid.

[0168] Reference Figure 3BA reverse grind or reverse bevel feature can be seen. The outer tubular body 1126 can be provided with a bevel cut to produce a primary bevel surface 1416, which is common for hypodermic needle tips. However, this results in a sharp distal tip 1410 that is separated from the inner wall of the outer tubular body 1126 by the thickness of the wall. In this configuration, distal advancement of the probe through tissue can cause tissue to become trapped in the space between the distal tip 1410 and the outer wall of the optical hypotube 1128.

[0169] Therefore, refer to Figure 3B , the outer tubular body 1126 may be additionally provided with a reverse bevel or tapered surface 1418 which slopes radially inwardly in a distal direction, opposite to the direction of the main bevel 1416. This will cause the distal sharp tip 1410 to abut against the inner wall of the outer tubular body 1126, thereby eliminating or minimizing the risk of tissue damage caused by distal advancement of the sharp tip 1410. When the outer tubular body 1126 is in a position such as for blunting Figure 3B In the retracted orientation shown, the sliding contact point 1408 (discussed below) is located at the distal tip 1410. The combination of the lateral offset of the optical hypotube 1128 relative to the outer tubular body 1126 and the reverse bevel 1418 produces an atraumatic distal structure.

[0170] Figure 3A Describes something like Figure 2A -C. The elongated body 1102 may be located at a distal end 1108 of the embodiment described in Figure 3A The extended position shown allows the sharp tip 1410 of the distal end 1108 to pierce the tissue of interest, as described in this section or elsewhere in this specification. As described above, when in Figure 3B ), the elongated body is less likely to further damage the tissue site. In addition, the sharp distal tip 1410 of the elongated body 1108 may have a lateral deflection relative to the longitudinal axis of the elongated body 1102, thereby resulting in a deflected tip 1130. In other embodiments, the tip may be straight. When the direction of the handle is as shown Figure 2B As shown, and when the controller is at the top, the deflection may be in an upward direction. The angle of deflection from the elongated body axis may be at least about 1 degree, 3 degrees, 7 degrees, 12 degrees, 15 degrees or more.

[0171] The deflection tip 1130 allows for a mechanical means of changing the viewing direction of the optical hypotube (e.g., about 5-6 degrees). In some embodiments, the viewing direction can deviate from the central longitudinal axis 1112 of the optical hypotube by at least about 3 degrees, at least about 6 degrees, at least about 12 degrees, at least about 15 degrees, at least about 20 degrees, at least about 30 degrees, at least about 45 degrees, or greater than 45 degrees. A wide-angle field of view can be accomplished with a lens, or by rotating the optical fiber if the distal end is off-axis. The deflection tip can also provide better directional performance during insertion and limit "coring" associated with traditional needle geometries (minimizing the possibility that the skin core is dragged into the patient and may cause infection).

[0172] Continue to refer to Figure 3A As already discussed, the elongated body 1102 can be substantially linear throughout at least about 65% of the proximal and in some embodiments at least about 80% of the axial length, with a deflected distal segment 1108. Regardless of the deflection, the elongated body 1102 is characterized by a central longitudinal axis 1104 from which the distal segment 1108 is laterally offset.

[0173] In the illustrated embodiment, the degree of deflection of the distal segment 1108 positions the distal sharpened tip 1410 to be generally aligned with the central longitudinal axis 1404. Thus, in the illustrated embodiment, the lateral displacement 1406 produced by the deflection is approximately 50% of the outer diameter of the elongated body 1102. The lateral displacement 1406 is typically no greater than the outer diameter of the elongated body 1102, and in many embodiments is at least about 10%, and sometimes at least about 25%, of the OD of the elongated body 1102. In certain embodiments of the invention, the lateral displacement 1106 is in the range of about 40% to about 60%, and sometimes in the range of about 45% to 55% of the OD of the elongated body 1102.

[0174] The aforementioned tip configuration allows the elongated body 1102 to pass through tissue along a generally linear axis while laterally tilting the distal end of the optical hypotube. Since the optical hypotube 1128 is substantially linear and the elongated body 1102 is provided with a deflected distal segment, a sliding contact point 1408 is formed between the distal edge of the optical hypotube 1128 and the inner surface of the elongated body 1102. When the outer tubular body 1126 is retracted proximally relative to the optical hypotube 1128, the lateral tilting of the outer tubular body 1126 causes the optical hypotube 1128 to bend laterally. This result can alternatively be achieved by providing a predetermined lateral deflection within the distal segment of the optical hypotube in combination with an outer tubular body having a deflected or substantially linear distal segment 1408.

[0175] As already briefly discussed, the effect of the foregoing geometry is to enable a mechanical widening of the lateral field of view.Optical widening of the field of view may alternatively or additionally be achieved using various optical lens systems well known in the art.

[0176] Reference Figure 3B , the optical hypotube 1128 will be able to observe along a primary observation axis 1412. Depending on the distal optics of the optical hypotube, the primary observation axis 1412 will typically originate at an angle perpendicular to the surface of the distal optics and be located at the center of rotation of a generally substantially conical field of view 1414. The geometry of the field of view 1414 can be modified as desired, such as by optics or software to be elliptical, rectangular, or other shapes.

[0177] The lateral deflection of the primary viewing axis 1412 can be quantified by identifying, among other things, an angle θ between the central longitudinal axis 1404 of the elongated probe body 1102 and the primary viewing axis 1412. The angle θ can be at least about 1°, at least about 3°, at least about 7°, at least about 12°, at least 15°, or more, but typically does not exceed about 45°, and in certain embodiments, at least about 3°, and no greater than about 8° or 10°.

[0178] The field of view 1414 can be characterized by an angle α, which will depend primarily on the distal optics 1136. The angle α will typically be between about 45° and about 120°, such as between about 55° and 85°. In one embodiment, the angle α is about 70°.

[0179] As reference Figure 3B As understood, the field of view α enables the main viewing axis 1412 to be deflected laterally throughout the range to achieve lateral viewing, while still allowing the central longitudinal axis 1104 to intersect the target tissue at a point that remains within the field of view 1414. This enables visualization along the central longitudinal axis just in front of the tubular body while allowing increased lateral viewing over the deflection angle. Rotation of the elongated body 1102 about the central longitudinal axis 1404 thus enables sweeping of the optical field of view through the range of rotation, which effectively increases the total visualized target size. For example, in an embodiment with a 70° field of view and a 5° deflection, rotation about the central longitudinal axis 1404 during the entire rotation process enables sweeping of an effective field of view of 152°.

[0180] In some embodiments, the elongated body 1102 includes a lumen 1138 that can deliver fluids including, for example, anti-inflammatory agents, antibiotics, anesthetics, or other drugs known in the art into the capsule or to other tissue sites. Figure 3A As shown, the inner cavity 1138 can surround the annular space between the optical hypotube 1128 and the outer tubular body 1126.

[0181] In some embodiments, the distal end of the visualization element may include a distal lens 1136 configured to facilitate imaging of internal tissue sites. The distal lens or any other lens may have defects and imperfections during the manufacturing process that result in image distortions. These distortions may be unique to individual lenses, and in the case of the embodiments disclosed herein, they may be unique to individual tissue visualization devices. Therefore, in order to enhance image quality, such as Figure 2A The device 1100 shown may include automatic optical correction in the form of a unique algorithm. In some embodiments, the algorithm may be stored in a chip or other suitable device within the handpiece 1004.

[0182] In certain embodiments, automatic optical correction can be used to improve the image quality produced by the tissue visualization device. The Abbe number, also known as the V number or inverse dispersion coefficient of a transparent material, is a measure of the dispersion of a material related to the refractive index (the variation of the refractive index with wavelength), with a high V value indicating low dispersion (low chromatic aberration). Low chromatic aberration is desired to optimize image quality, but achieving low chromatic aberration typically increases manufacturing costs. In some embodiments, chromatic aberration in the tissue visualization device can be corrected via the above-mentioned software algorithm during clinical use to achieve manufacturing economy. For example, optical correction can allow the visualization performance of a device with a lower cost lens to be comparable to the performance of a visualization device with a higher cost and lower defect lens.

[0183] In an embodiment, to generate the algorithm at the point of manufacture, the distal optics are focused on a known defined pattern. The computer can then compare the captured image to the known pattern and create an algorithm that restores the captured image to the true defined pattern. The algorithm can then be stored in a chip in the handpiece 1104 as described above.

[0184] When the handpiece 1104 is connected to the display 6 at the clinical site, as previously described in conjunction with Figure 1 As described, the algorithm serves as the basis for display 6 to correct the captured image, thereby removing aberrations in the optical system. Each individual tissue visualization device will have unique aberrations, and therefore each handpiece will carry a unique algorithm to correct the system,

[0185] Back to Figure 3B , Figure 3B A closer view of an embodiment of the sharp distal end 1204 of the elongated body in the retracted position is further depicted. Figure 2C , a retraction control is used to retract the sharp deflecting tip 1204 to prevent further damage to surrounding tissue when observing internal tissue sites.

[0186] like Figure 3CAs shown, in some embodiments at the distal end of the elongated body 1700, the distal end of the optical hypotube 1702 can be flared 1706 to accommodate a larger diameter sensor 1708 positioned at the distal end of the optical hypotube 1702 than would ideally fit in a standard hypotube 1704. The flare can simply be a larger diameter cross section, a square cross section, or something that matches the interior thereof. The axial length of the flare will accommodate the length of the sensor plus the routing of the illumination fiber around the sensor, and will have a transition region back to the circular cross section of a normal hypotube. In some embodiments, this can be done with a non-circular cross section. A sharp tip may also require flaring, with or without a gap to provide a lumen between the "OD" of the optical hypotube and the "ID" of the elongated member. In some embodiments, the outer tubular body may be curved, such as described elsewhere in this section or in the specification disclosed herein, or the outer tubular body may be straight to accommodate the flared tip.

[0187] As described above with respect to the "flared" embodiment, to minimize the overall size of the product / needle, the inner diameter (ID) of the outer tubular body can be sized so that it is completely "filled" by the outer diameter (OD) of the flared distal end of the optical hypotube. In embodiments, the flared geometry limits the lumen and prevents fluid from passing through the end of the outer tubular body.

[0188] In an embodiment, to allow fluid flow, the axial length of the flared geometry can be designed to be shorter than the translation distance of the outer tubular body 1710. When the outer tubular body is in the forward or pointed position, the flare is contained within the inner diameter of the tubular body and fluid is restricted from passing through the lumen 1712. However, when the tubular body is in the retracted position (and blunted), the flared portion of the hypotube protrudes completely beyond the opening bevel of the tubular body, allowing the effective lumen of the device to be located between the normal cross-section of the hypotube and the inner diameter of the needle. In some embodiments, the outer tubular body can include an axial hole to allow fluid to flow out of the lumen from a different direction and position than the open end of the elongated body.

[0189] Figure 4 A cross-sectional top view of one embodiment of a tissue visualization device 1100 is depicted. The handpiece 1104 includes an illumination element 1134 and a visualization sensor support 1180, which will be described in more detail below. Similar to the illumination elements or devices described elsewhere in this specification, the illumination element 1134 can extend downward along the length of the elongated body and transmit light below the elongated body to the internal tissue site to allow visualization of the target tissue. In some embodiments, the illumination element 1134 includes one or more illumination optical fibers.

[0190] Figure 5 A cross-sectional view of an embodiment of a tissue visualization device is shown down the length of the elongated body 1200, similar to Figure 2A-4The elongated body shown in . In certain embodiments, the optical hypotube 1204 may include an image guide 1202, at least one illumination fiber or fiber bundle 1210, an injection lumen 1206, and an outer tubular body 1208. As will be appreciated by those skilled in the art, the term "illumination fiber" as used herein includes illumination fibers or fiber bundles. As described elsewhere in the specification, the illumination fibers or fiber bundles may be configured to project wavelengths of light suitable for illuminating target tissue for visualization. However, the illumination fibers may also be configured to project UV light to the tissue site in order to cure UV sensitive materials. For example, if there are a total of 14 illumination fibers or fiber bundles, 7 may be configured to deliver light suitable for visualization, while another 7 may be suitable for delivering UV light. However, any suitable combination may be used. For example, a majority of the illumination fibers may be UV, half may be illumination fibers, or less than half. In certain embodiments, the number of illumination fibers may be from 4 to 8 %. Figure 5 For example, there can be 1 optical fiber, at least 2 optical fibers, at least 5 optical fibers, at least 10 optical fibers, at least 14 optical fibers, at least 20 optical fibers, at least 25 optical fibers, at least 50 optical fibers, or more than 50 optical fibers. In some embodiments, the illumination fiber can be configured to output light of multiple wavelengths suitable for imaging an internal tissue site.

[0191] Through the illumination fibers 1210 [which can be at least 4, 8, 12 or more fibers or fiber bundles and can be arranged in a ring configuration around the image guide 1202, such as Figure 5 [shown but described in detail below] The wavelength of light delivered can be selected for various wavelength-specific applications. For example, wavelengths in the UV range can be used to allow visual differentiation of tissue types, such as to distinguish neural tissue from surrounding tissue and / or minimally vascularized neural tissue. Blood vessels appear to have a first color (e.g., red), while neural tissue may appear to have a second color (e.g., blue). The wavelength can also be optimized to distinguish neural tissue from muscle.

[0192] In another application, light such as UV light or visible light can be transmitted through the optical fiber 1210 to promote or initiate solidification (e.g., by polymerization or cross-linking) of an infusion solution, wherein the solution or gel is administered through the infusion lumen 1206 to form a solid or semi-solid substance in vivo. The substance can be a tissue expansion device, coating, or other structural element.

[0193] Another wavelength-specific application involves directing a preselected wavelength to a target impregnated with a drug or drug precursor. Upon delivery of the preselected wavelength to the target, the drug is released, or the precursor is converted to the drug and then releases the drug. The target can be an implanted substance or device, or an impregnated carrier medium, such as any one or a combination of liquids, gels, or beads.

[0194] UV light can include ultraviolet A, long wave or black light, abbreviated as "UVA" and having a wavelength of 400nm-315nm; near ultraviolet light, abbreviated as "NUV" and having a wavelength of 400nm-300nm; ultraviolet B or medium wave, abbreviated as "UVB" and having a wavelength of 315nm-280nm; mid ultraviolet light, abbreviated as "MUV" and having a wavelength of 300nm-200nm; ultraviolet C, short wave or germicide, abbreviated as "UVC" and having a wavelength of 280nm-280nm. nm-100nm; far ultraviolet light, abbreviated as "FUV" and having a wavelength of 200nm-122nm; vacuum ultraviolet light, abbreviated as "VUV" and having a wavelength of 200nm-400nm; low ultraviolet light, abbreviated as "LUV" and having a wavelength of 100nm-88nm; ultra ultraviolet light, abbreviated as "SUV" and having a wavelength of 150nm-10nm; and extreme ultraviolet light (abbreviated as "EUV") having a wavelength of 121nm-10nm. In some embodiments, the conduit may include an element that emits visible light. Visible light may include violet light with a wavelength of 380-450nm; blue light with a wavelength of 450-475nm; cyan light with a wavelength of 476-495nm; green light with a wavelength of 495-570nm; yellow light with a wavelength of 570-590nm; orange light with a wavelength of 590-620nm, and red light with a wavelength of 620-750nm. In some embodiments, the catheter includes an element that emits light having a wavelength between about 300 nm and 500 nm. Specifically, the catheter can include an element that emits light having a wavelength associated with blue light (e.g., light having a wavelength between about 450-475 nm). Wavelength selection information and features and other details related to infrared endoscopes can be found in U.S. Patent No. 6,178,346, U.S. Patent Application Publication No. 2005 / 0014995, and U.S. Patent Application Publication No. 2005 / 0020914, each of which is incorporated herein by reference in its entirety.

[0195] In some embodiments, the outer diameter of the optical hypotube can range from about 0.1 mm to 3 mm, about 0.5 mm to 2.5 mm, or about 1 mm to 2 mm. In some embodiments, the outer diameter of the optical hypotube is about 1.27 mm. In some embodiments, the inner diameter of the outer tubular body ranges from about 1 mm to 10 mm, about .2 mm to 8 mm, about 0.5 mm to 6 mm, about 1 mm to 5 mm, about 1.2 mm to 4 mm, or about 1.4 mm to 3 mm. In some embodiments, the inner diameter of the outer tubular body 1208 is about 1.6 mm.

[0196] In some embodiments, image guide 1202 allows viewing of images of tissue sites via visualization sensors in the hand piece. In certain embodiments, the image guide can be an optical fiber or other suitable medium to allow imaging of tissue sites via visualization sensors as described in this section or elsewhere in this specification. Depending on the desired performance, the fiber bundle can have at least about 6K, or at least about 10K, or at least about 15K, or at least about 30K or more fibers. In some embodiments, the image fiber can be a 6.6k fiber bundle or a 10k fiber bundle.

[0197] Fig. 6A -C shows an embodiment of an elongated body and internal components of a tissue visualization device 1300, similar to embodiments depicted elsewhere herein. In this particular figure, the housing of the phone is removed to better view the interior of the device. In certain embodiments, the tissue visualization device includes an elongated body 1302, an illumination element 1304, a light source housing 1306, a proximal lens housing 1310, a ferrule 1314, a nose piece 1312, and a distal lens 1316.

[0198] Figure 6B Shows Fig. 6A A top view of the tissue visualization device 1300 is shown. Figure 6C The components in these figures are similar to those shown in 6A, but in 6B, the visualization complex is identified as 1318. The visualization complex and surrounding components can be seen in Figure 7 See more details in .

[0199] Figure 7 Shows Figure 6C 13. In some embodiments, visualization complex 1318 can include visualization sensor 1320, such as those described in this section or elsewhere in this specification. In some embodiments, the visualization sensor can be a CMOS sensor as described in this section or elsewhere in this specification.

[0200] In some embodiments, the visualization complex can include a first lens 1322, an optical aperture 1324, and a second lens 1326. In some embodiments, the aperture can have a diameter of at least about 0.1 mm, at least about 0.2 mm, at least about 0.3 mm, at least about 0.5 mm, or greater than 0.5 mm. Preferably, the aperture can be about 0.222 mm. To support the lenses, the visualization complex can include a proximal lens housing as previously described, wherein the proximal lens housing can be used to secure lenses 1320 and 1326 in the appropriate position and orientation. The visualization complex can further include an image guide, similar to that previously described with respect to Figure 5 Describe the image guide.

[0201] like Figure 1 and Fig. 8A As shown, one result of the integrated visualization device of the present invention is that the visualization device 4 rotates about the central longitudinal axis 1404 to achieve an expanded field of view that will simultaneously cause the clinician to see on the display, for example Figure 1 Video screen 19 or Fig. 8A The image 1501 is rotated in a significantly inferior to superior orientation. It may therefore be desirable to compensate so that, for example, the superior patient reference direction always appears at the top of the screen 19, regardless of the rotational orientation of the visualization device 4, such as Figure 8B As shown in image 1503.

[0202] This may be accomplished by including one or more sensors or switches carried by the visualization device 4 that are capable of generating a signal indicative of the rotational orientation of the visualization sensor 1132. The signal may be transmitted via a wired or wireless protocol to the controller 6 for processing and correcting the rotational orientation of the image on the screen 19 or other display to stabilize the image.

[0203] Suitable sensors may include simple tilt or orientation sensors such as mercury switches or other systems capable of determining rotational orientation relative to an absolute reference direction such as up and down. Alternatively, the rotational orientation image correction system may include a 3-axis accelerometer with associated circuitry, such as a small accelerometer built using MEMS (micro-electromechanical systems) technology that determines acceleration using capacitance measurements, available from Freescale Semiconductor, Inc., of Austin, Tex, and other companies.

[0204] As an alternative or in addition to the accelerometer, the visualization device may carry a gyroscope, such as a three-axis gyroscope. The output of the gyroscope may be the rate of change of the roll, pitch, and yaw angles, and the rotation rate measurements provided by the gyroscope may be combined with the measurements made by the accelerometer to provide a complete six-degree-of-freedom description of the motion and position of the sensor 1132, although it may not be necessary to simply correct for rotational orientation. A control may be provided on the handpiece or controller 6 that allows the clinician to select what reference orientation (e.g., superior, inferior, true up or down, etc. of the patient or a true sensor view so that the image on the screen rotates with the sensor) they want to appear at the top of the screen regardless of the sensor orientation. In some embodiments, markers such as arrows or lines may be projected onto the image to further identify different orientations and / or directions.

[0205] In some embodiments, the optical hypotube may be sheathed in a heat shrink tubing. For example, the outer tubular body as described elsewhere in the specification may be constructed of a heat-sensitive material. Thus, in order to construct the elongated body described elsewhere in the specification, the optical hypotube and other components may be extended downward along the oversized outer tubular body, which is then shrunk to the diameter of the optical hypotube by means such as heat, ultraviolet light, and chemicals. In contrast, conventional endoscopes and some endoscopes described elsewhere in the specification place the optics in a rigid stainless steel tube. However, housing the optics within a stainless steel tube may require forcing many optical and illumination fibers to a very tight ID and then applying an adhesive such as epoxy. Such a process is difficult and expensive.

[0206] Fig.9A -D shows the Figure 1-7 An embodiment of a visualization device similar to the visualization device in. Fig.9A -D The visualization device comprises at least one reflector to change the viewing direction and the field of view of the visualization device. Fig.9A A reflective plug 1600 is depicted that can be inserted into the distal end of a tubular body, such as in conjunction with Figure 1-3B The plug may include a mirror 1602 that reflects an image at a particular angle 1604, for example, providing a viewing direction of 30 degrees from the axis of the plug. In some embodiments, the angle may be much smaller, for example between 0-15 degrees. In further embodiments, the angle may be in the range of 15-45 degrees. In some embodiments, the angle may be at least 45 degrees, at least 60 degrees, at least 75 degrees, or at least 90 degrees or more. Fig. 9B As shown, and in combination with Fig.9A As described, plug 1600 can be inserted into the end of tubular body 1606, similar to the tubular body described elsewhere in the specification. In embodiments, the plug can be incorporated into any visualization device described elsewhere in the specification. In some embodiments, the plug can be sharpened to allow the plug to pierce tissue.

[0207] Fig. 9C -D shows a gap 1608 Fig. 9B1602 and directed downwardly to the tubular body 1606, thereby projecting an image of the field of view obtained through the gap downwardly to the elongated body. Such an image can be projected along an optical hypotube and / or image guide such as described elsewhere in the specification. Other components such as lighting elements can be used to direct light along the mirror surface and illuminate surrounding tissue outwardly through the gap. In an embodiment, the gap can allow a field of view 1610 extending in front of and above the distal end of the tubular body. Depending on the angle and orientation of the mirror, the size of the field of view can be between about 45° and 120°, for example between about 55° and 85°. In one embodiment, the angle can be approximately 70°.

[0208] In an embodiment, Fig.9A -D visualization devices can be manufactured by various means. For example, a tubular reflective material such as depicted by reflective plug 1600 can be sliced ​​at a desired angle and ground / polished to produce a mirror surface 1602. Such a plug with a mirror surface can be fed through the open end of a tubular body with a cut gap 1608, such as Fig. 9B -D tubular body 1606 and welded to the tubular body. Once the mirror is properly positioned within the tubular body, the tubular body and reflective plug can be cut / milled simultaneously to form a sharp tip 1612, such as Fig.9D shown.

[0209] In some embodiments, the desired viewing angle direction can be achieved by positioning a prism at the distal end of the elongated body. Such a prism can provide a viewing angle direction, such as disclosed elsewhere in the specification, for example: providing a viewing angle direction of 30 degrees to the axis of the elongated body. In some embodiments, the angle can be much smaller, such as between 0-15 degrees. In further embodiments, the angle can be in the range of 15-45 degrees. In some embodiments, the angle can be at least 45 degrees, at least 60 degrees, at least 75 degrees, or at least 90 degrees or more.

[0210] In some embodiments, the elongated body can be a non-circular shape. For example, the overall shape of the elongated body can be oval or elliptical. In some embodiments, only the distal end of the elongated body is elliptical, and the rest of the elongated body is circular. The elliptical elongated body advantageously provides additional space for the deflected distal tip. In certain embodiments, the major axis of the ellipse is approximately 1.1 times the minor axis. In some embodiments, the major axis is at least 1.2 times, 1.3 times, 1.5 times, 1.75 times, 2 times, 3 times, 4 times, 5 times or more than 5 times the minor axis.

[0211] In certain embodiments, the distal tip of the elongated body may be constructed of an elastic material to allow the distal tip to flex distally. In addition, the deflection portion of the distal tip may be very short to allow the deflection portion to stay within the periphery of the elongated body.

[0212] In some embodiments, the distal end of the elongated body can be rotated relative to the optical hypotube. For example, the sharp distal point can be located below the optical hypotube, above the top of the optical hypotube, or above one side of the optical hypotube. In some embodiments, the optical hypotube can be used as a shield to prevent the sharp distal point from damaging surrounding tissue in any direction. In some embodiments, the optical hypotube can include a shield at the distal tip that protects surrounding tissue from the sharp distal tip of the elongated body. As the optical hypotube rotates, the shield can move from the sharp distal tip of the elongated body, allowing further penetration of the tissue.

[0213] Fig. 10A Shown with Figure 1 -9. Here, arrow "C" indicates the distal direction toward the tissue site. The distal end of the slender member 5 includes an optical fiber 3, similar to the optical hypotube and optical elements described elsewhere in the specification. The distal lens 2 can include any type of lens described herein or elsewhere in this specification, including a GRIN (gradient refractive index) lens. The lens can have a diameter of about 100-700 microns, about 200-600 microns, about 400-500 microns, or about 465 microns.

[0214] In certain embodiments, such as Fig. 10A As shown, the distal end of the tissue visualization device may include a circular transparent plate 12, such as a glass plate or other suitable transparent material. Fig. 10A In the illustrated embodiment, the plate is unpowered, but in some embodiments, the plate can be powered to have a magnification level of about 2x, 4x, 10x, 20x, 100x, or greater than 100x. The plate can be flat on both sides of the plate, rounded on both sides of the plate, or rounded on one side and flat on the other side. In some embodiments, the plate can have a diameter of about 100-700 microns, about 200-600 microns, about 400-500 microns, or about 465 microns. In some embodiments, adhesive 11 adheres the plate to the distal lens 2, and the distal lens 2 is adhered to the optical fiber 3 by another adhesive.

[0215] In an embodiment, and as Fig. 10AAs shown, the plate 12 can include a mask 13 surrounding a transparent window 14 on the proximal side of the plate. However, in some embodiments, the mask can be located on the distal side of the plate. By placing the mask on the proximal side of the panel, potentially toxic mask materials can be prevented from interacting with tissue. The mask can include any suitable material that limits the projection of light, such as a chrome coating. However, any suitable evaporated coating can be used, such as different metallic materials.

[0216] The window includes the area of ​​the plate not covered by the mask, thereby allowing light to pass through the window. Fig.12 As described in more detail, a mask may be applied in an annular region of the plate, thereby forming a circular window 14 .

[0217] In certain embodiments, the mask is used to limit the projection of light through the plate, for example, the mask can limit the collection of light reflected from all angles of the object being observed (e.g., a tissue site). As a result, the overlap of light rays on the image is very small, resulting in a clearer image over a wider depth of field. Although this may reduce the brightness of the image, the image is clearer. In certain embodiments, the material of the mask allows a transmittance of light passing through the material of up to about 0%, about 2%, about 4%, about 5%, or about 10%. In addition, the mask preferably absorbs light rather than reflects it to limit stray light from affecting the clarity of the image. In embodiments, the material of the mask can reflect light that strikes the surface up to about 0%, about 5%, about 10%, about 20%, about 25%, or about 30%. In certain embodiments, the reflectance of 400nm light can be 12%, 500nm is 20%, 600nm is 27%, and 700nm is 33%.

[0218] The circular plate can be sized to have the same diameter as the lens 2, however in embodiments the plate can be smaller than the lens 2, for example at least about 10%, 25%, 50%, 75% or 90% of the size of the lens. When the plate is smaller than the lens, light may leak through the plate into the lens, so in these cases an opaque adhesive or covering may be applied to the distal end of the lens to limit light from entering the lens. In some embodiments, the plate can be non-circular, such as rectangular or polygonal. As with the circular plate, the non-circular plate can be approximately 10%, 25%, 50%, 75% or 90% of the size of the lens. As with the smaller circular plate, the uncovered area of ​​the lens can be coated with an opaque adhesive to limit the projection of light.

[0219] In some embodiments, instead of using a transparent plate with a mask, the plate can be replaced by any suitable material including holes. For example, a metal plate with windows or an opaque polymer material can be used.

[0220] Typically in the field of imaging, when using GRIN lenses (such as those described in those sections of this document or elsewhere in this specification), an optical mask such as in the description above with respect to the plate will typically be placed between two GRIN lenses or at the focal point of the lens, however, here the mask is located between the unpowered plate and the powered lens. In addition, although the mask can be placed at the focal point of the lens, here the mask does not need to be at the focal point.

[0221] Fig. 10B Shown with Fig. 6A 0026] Figure 2 is a side view and a front view of an embodiment of a visualization device similar to the embodiment shown in FIG.

[0222] In other embodiments, the CMOS / CCD sensor may be located at the distal tip of the visualization device rather than a proximal location. For distally mounted sensors, the distally positioned LEDs may be used with or without short light pipes rather than relying on illumination fibers to project light from the proximal LEDs.

[0223] Fig. 10C A view along an elongated member of a visualization device is shown, e.g. Figure 5 The illumination fiber 10 is secured in epoxy surrounding the central optical element and / or image guide.

[0224] In some embodiments, the illumination fibers can also be gathered to one side of the tube, with the imaging lens and fibers on the opposite side (the pattern in the figure is to have them around the circumference, but it can also be asymmetric). The claims also discuss the ratio of window to fiber, but this ratio is more appropriate for the diameter of the lens,

[0225] Fig.11 A picture of the interior of a red pepper imaged with a visualization device including the plate described above and a visualization device without the plate was compared. As can be seen in the images, the addition of the plate greatly improves the clarity of the image.

[0226] Fig.12A plate 2000 is depicted, such as the plate described above in conjunction with FIG. 10 . Here, a mask 2002 is annular and surrounds a transparent window 2004 that allows light to pass through. Although the mask and window are depicted as annular here, in other embodiments, the mask and window can be in the form of a rectangle, triangle, octagon, or other suitable polygon. In certain embodiments, the mask can cover at least: about 25% of a single side of the plate, about 50%, about 60%, about 70%, about 80%, about 90%, or about 95% of the surface area of ​​one side of the plate. In some embodiments, as described above, the plate can have a diameter of about 0.5 mm or any of the above diameters, however, the window 2004 can have any suitable diameter corresponding to the above percentages, for example, the window can have a diameter between about 50-200 microns, 75-150 microns, or about 100-125 microns. For example, the diameter can be 90 microns, 130 microns, or 150 microns.

[0227] In some embodiments, the ratio between the diameter of the active area of ​​the imaging element / imaging fiber and the diameter of the window can be approximately at least: about 2x, about 3x, about 4x, about 5x, about 6x, about 8x, about 10x, or more than 10x. In some embodiments where the window is non-circular, the ratio of the area of ​​the window to the active area of ​​the imaging element or imaging fiber can be at least about 5x, about 10x, about 15x, or about 20x.

[0228] Fig.13A An embodiment of an inner optical hypotube 3002 is depicted, similar to that previously described in Figure 3A-6C Here, the optical hypotube is shown without the outer tubular body, however, in use, as Figure 3A-6C As shown, the optical hypotube will be contained within the outer tubular body. In embodiments, the optical hypotube may have a bend 3004 that biases the distal end 3006 of the optical hypotube against the outer tubular body when the optical hypotube is contained within the outer tubular body. In certain embodiments, the bend may be positioned about 50%, about 60%, about 70%, about 80%, or about 90% down the length of the optical hypotube from the handpiece. In certain embodiments, the bend may be a gradual bend, wherein other embodiments of the bend may be a sharp bend. In embodiments, there may be a single bend, two bends, three bends, four bends, five bends, or more than five bends. In certain embodiments, the bend may have a bend of at least about 1 degree, 5 degrees, 10 degrees, 15 degrees, 25 degrees, 35 degrees, 45 degrees, 50 degrees, 60 degrees, 75 degrees, or 90 degrees.

[0229] Fig. 13B It is similar to the previous Figure 3A-6C3008, juxtaposed with an embodiment of an outer tubular body 3006. Here, the bend 3004 is quite gradual, biasing the tip 3006 against the sharp distal end of the outer tubular body 3008. Fig. 13C Further depicting an embodiment of an optical hypotube 3002 and an outer tubular body 3008, however, here the needle hub assembly 3012 and electro-optical assembly 3010 are similar to those in the above combined embodiment. Figure 1-7 Described embodiments.

[0230] Fig.14A 31 is a close-up photograph of an embodiment of the distal end of the elongated body 3100 similar to that previously described, which includes the outer tubular body 3104 and the optical hypotube 3102. Here, the outer tubular body 3104 is retracted and blunted as will be further described below. As previously described, the elongated body has a reverse grind 3106 to bring the needle tip 3108 closer to the optical hypotube. Fig.13A As shown in Figure 3-C, the optical tubular body is bent so that it abuts the inner diameter of the outer tubular body 3104, closest to the point of sharpness 3108. As shown in the previous embodiment, when the outer tubular body is retracted, it abuts against the optical hypotube 3102. Fig. 14B A close-up view of an embodiment of the distal end of an outer tubular body 3104 similar to the previous embodiments is depicted. Here, a reverse grind on the outer tubular body raises the sharp tip upward, allowing it to be better blunted by the optical hypotube. In some embodiments, the reverse grind may raise the sharp tip upward by an angle 3110. In some embodiments, the angle may be approximately 5, 10, 15, 25, 30, 45, 60, 75, 90, or more than 90 degrees.

[0231] In some embodiments, the blunting contact between the optical hypotube 3102 and the outer tubular body 3104 can generate a tangential contact force. In some embodiments, a Huber-type bend in the outer tubular body can cause tangential contact with the optical hypotube and deflect the hypotube to provide a contact force that provides blunting because resistance to the force needs to be overcome before the optical hypotube no longer blunts the sharp tip. In some embodiments, for example, the outer tubular body can include a long bend in the needle to bias the optical hypotube toward the direction of the bend of the outer tubular body, and in some embodiments, the bend can have a bend of at least about 1 degree, 5 degrees, 10 degrees, 15 degrees, 25 degrees, 35 degrees, 45 degrees, 50 degrees, 60 degrees, 75 degrees, or 90 degrees.

[0232] In certain embodiments, a thin-walled component may be attached to the optical hypotube to bias the optical hypotube in a certain direction and / or orientation. The component may have a larger diameter than the distal portion of the optical hypotube and may optionally be attached to the outer surface of the optical hypotube, for example at a point / line at the lowest portion of the outer diameter. The component may be in the form of a tube along the outside of the optical hypotube, but in certain embodiments, portions of it may be removed to minimize impact on the lumen or fluid path. In certain embodiments, the thin-walled component may be located at a location near a flare in the optical hypotube. Thin-section "fingers" may be used to center the hypotube within the needle,

[0233] Fig.15 is a flow chart illustrating an embodiment of a method of treating a tissue site in a knee using the apparatus disclosed herein and throughout this specification. However, as will be appreciated by those skilled in the art, the method may be applicable to any type of joint and other tissue types. For example, the method may rely on tissue visualization devices and systems, such as Figure 1 of the previous figure. In the first step 3202, the patient can lie supine or sit with the joint slightly bent. In the second step 3204, a local antiseptic solution is used to prepare the entry site. The next analgesic is delivered to the joint 3206 and the joint is filled with at least 30cc of sterile fluid. In the fourth step 3208, the controller and viewing screen are turned on and the visualization device is connected to the controller and screen. In addition, the piston and syringe can be connected to the visualization device. Next, the visualization device is inserted into the lower or inner lower entrance based on the suspected pathology and guided to the tissue site 3210. The visualization device can be inserted directly into the lateral or medial compartment, avoiding the "notch" and fat pad. Once entering the joint capsule, the sharp tip or "needle" of the external tubular body is retracted by the retraction button 3212. Finally, the physician can use the visualization device to perform an examination 3214 by applying varus and valgus stretch on the tibia to allow medial and lateral expansion. In addition, extending the knee allows easier visualization of the posterior compartment. Additional sterile saline can be injected as needed at any time throughout the examination to clean the field of view.

[0234] In some embodiments, when the visualization device is navigated toward the tissue site, the optical hypotube can remain retracted into the outer tubular body, allowing a "tunnel" view of the tire tissue outside the outer tubular body. Soft tissue interacts with the optical hypotube and provides an offset from the distal end, allowing improved visualization in some cases. In some embodiments, additional fluid can be added to the joint (e.g., the knee) to improve visualization by clearing debris and creating optical element space. Before the visualization device is inserted, fluid can be added to the knee through a secondary needle to pre-adjust the knee for visualization. In some embodiments, fluid can be added to the knee through the visualization device while the outer tubular body is still in a forward position. Constant fluid can also be added through a syringe, such as a syringe pressed down by a doctor or through an extension tube plus an assistant. In some embodiments, short bursts of fluid (1-2ml) can be applied to clear the area immediately in front of the visualization device.

[0235] Fig.16 An embodiment of a visualization sensor 3202 positioned at the distal end of an elongated body 3300 within an optical hypotube 3306 and an outer tubular body or needle 3304 is depicted, similar to Figure 1-7 3302 is an elongated body present in the visualization device depicted in . Here, the sensor 3302 is rotated approximately 30 degrees from the longitudinal axis of the elongated body. However, in some embodiments, the visualization sensor can be rotated at least about 5 degrees, 10 degrees, 15 degrees, 20 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, or greater than 90 degrees. In certain embodiments, as previously described, the optical sea wave tube may also have a flared outer diameter at the distal tip, such as the portion disclosed herein or elsewhere in the specification, but may also be straight as shown. As with the embodiments previously described in the specification in conjunction with the previous figures, illumination can be provided by various means, such as via optical fibers and / or discrete LEDs located at the distal end of the elongated body. The optical fibers and / or LEDs may be oriented on the same axis as the visualization sensor, or on a different axis.

[0236] Fig.17 Describes something like Figure 1-7 As described herein previously in this specification, it is possible to redirect the image in a manner such as Figure 1The image of the tissue displayed on the screen 19 is to maintain the "up" position by communicating with the orientation sensor. In some embodiments, the screen can be manually re-oriented through the use of buttons. For example, on a square and / or circular screen, 4 buttons can be placed at the top, bottom, left and right sides of the screen. By pressing the buttons, the tire user can adjust the orientation of the screen so that the side of the screen where the button was pressed is now the top or "up" position of the screen. In this way, the user can ensure that the screen is always facing the desired direction. In some embodiments, such as Fig.17 As shown, such buttons 3402 can be positioned on handpiece 3400 so that the user can press a button to rotate the image 45 degrees, 90 degrees, 135 degrees, 180 degrees, 225 degrees, 270 degrees, or 315 degrees to orient the screen in a desired position. These buttons can be spaced 90 degrees apart and are located at the top, left side, right side, and bottom of the handpiece as shown. LEDs can be used to indicate valid buttons and the current "up" position. In some embodiments, there can be 1 button, 2 buttons, 3 buttons, 4 buttons, 6 buttons, 8 buttons, or more than 8 buttons to reposition the screen. In some embodiments, for example, with a circular image, the screen can be configured to rotate only 45 degrees per button press.

[0237] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example should be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification, unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any preceding embodiments. The protection extends to any novel feature or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or any novel method or process disclosed or any novel combination thereof.

[0238] Although certain embodiments have been described, these embodiments are presented only by way of example and are not intended to limit the scope of protection. In fact, the novel methods and systems described in this section or other parts of this specification may be embodied in various other forms. In addition, various omissions, substitutions and changes may be made to the form of the methods and systems described in this section or elsewhere in this specification. Those skilled in the art will recognize that, in some embodiments, the actual steps taken in the process shown and / or disclosed may be different from the steps shown in the accompanying drawings. Depending on the embodiment, some of the above steps may be removed and other steps may be added. In addition, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form other embodiments, all of which fall within the scope of the present disclosure.

[0239] Although the present disclosure includes certain embodiments, examples, and applications, it should be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and obvious modifications and equivalents thereof, including embodiments that do not provide all of the features and advantages set forth in this section or elsewhere in this specification. Therefore, the scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, and may be limited by the claims set forth in this section or elsewhere in this specification or subsequently.

Claims

1. A disposable visualization device (1100) suitable for single use, comprising: an elongated tubular body extending along a longitudinal axis between a proximal end and a distal end (3108) adapted to be secured to a handle; an optical hypotube (1128) extending through the elongated tubular body, the optical hypotube comprising a proximal end and a distal end (3006); and an image sensor located at the distal end of the optical hypotube; wherein the optical hypotube comprises a first section and a second section, the first section comprises a first bend, and the second section comprises a second bend (3004); and Wherein, the first bend and the second bend (3004) are configured to bias the distal end (3006) of the optical hypotube against the distal end of the slender tubular body.

2. The visualization device (1100) according to claim 1, wherein: The distal end of the elongated tubular body has a pointed tip.

3. The visualization device (1100) according to claim 1 or 2, wherein: The optical hypotube also includes a third segment including a third bend configured to bias the distal end of the optical hypotube against the distal end (3108) of the elongated tubular body.

4. The visualization device (1100) according to claim 1 or 2, wherein: The first bend is located at a position between 50 and 90% of the length of the optical hypotube in a direction away from the handle.

5. The visualization device (1100) according to claim 4, wherein: The first bend is located at 70% of the length of the optical hypotube in a direction away from the handle.

6. The visualization device (1100) according to claim 4, wherein: The first bend is located at 80% of the length of the optical hypotube in a direction away from the handle.

7. The visualization device (1100) according to claim 1 or 2, wherein: The first bend is located at 90% of the length of the optical hypotube in a direction away from the handle.

8. The visualization device (1100) according to claim 1 or 2, wherein: The first bend includes a bend degree of 1-35 degrees.

9. The visualization device (1100) according to claim 8, wherein: The first section includes a curvature of 5-10 degrees.

10. The visualization device (1100) according to claim 2, wherein: The biasing is configured to provide blunting of the tip, the blunting configured to prevent damage to a tissue site.

11. The visualization device (1100) according to claim 1 or 2, wherein: The optical hypotube also includes a linear segment located away from the first bend.

12. The visualization device (1100) according to claim 2 or 10, wherein: The tip includes a back grind.

13. The visualization device (1100) according to claim 1 or 2, wherein: The distal end of the optical hypotube is configured to provide illumination.

Images