Patent Application
20200383554
The present invention relates generally to apparatus for the illumination of endoscopic and borescopic fields, in minimally invasive surgical (MIS) procedures, general or diagnostic medical or industrial procedures using endoscopes or borescopes, respectively. More particularly, embodiments of the invention relate to use of a deployable light reflective balloon for use in association with a Light Emitting Photodiode or other solid state light sources in endoscopic and borescopic procedures, as a means of assisting in illumination.
Endoscopy is used in both diagnostic and surgical procedures. Currently, MIS procedures, as opposed to open surgical procedures, are routinely done in almost all hospitals. MIS techniques minimize trauma to the patient by eliminating the need to make large incisions. This both reduces the risk of infection and reduces the patient's hospital stay. Endoscopic procedures in MIS use different types of endoscopes as imaging means, giving the surgeon an inside-the-body view of the surgical site. Specialized endoscopes are named depending on where they are intended to look. Examples of specialized endoscopes include: cystoscopes (bladder), nephroscopes (kidney), bronchoscopes (bronchi), laryngoscopes (larynx+the voice box), otoscopes (ear), arthroscopes (joint), laparoscopes (abdomen), gastrointestinal endoscopes, and specialized stereo endoscopes used as laparoscopes or for endoscopic surgery.
Such endoscopes may be inserted, for example, through a tiny surgical incision to view joints or organs in the chest or abdominal cavity. More often, an endoscope is inserted into a natural body orifice such as the nose, mouth, anus, bladder, or vagina. There are three basic types of endoscopes: rigid, semi-rigid, and flexible. The rigid endoscope comes in a variety of diameters, lengths, and various angles of view, such as zero, 30 or 70 deg. endoscopes and used depending on the requirements of the procedure. Typical endoscopic procedures require a large amount of equipment. The main equipment used in conjunction with the visual part of the endoscopic surgery are the endoscope body, fiber optics illumination bundles, illumination light source, light source controller, imaging camera, camera control module, and video display unit.
It can be advantageous to reduce the number of incisions as well as the size of the incision as much as possible in an endoscopic surgery. Normally a separate port is necessary to be used with a large diameter endoscope that takes the entire opening of the port, cannula or catheter once access to inside the body is obtained. Space is also very limited at the proximal end of the port and tools and endoscopes with proximal camera, are bulky and heavy, often propped up and locked in position with secondary mechanism that may physically interfere with other devices used by the surgeon, especially if multiple ports are close to one another, or in Single Port Procedures.
Another common problem that occurs with endoscopic procedures is that, because the endoscope is inserted into the body, the cavity being imaged by the endoscope is small and difficult to view. One way to obtain better images is to insufflate the cavity with gas to increase the volume of the area being imaged. Insufflation can be problematic because of inadequate seals between the port opening and the endoscopic device used. In addition, the smallness of the space may cause too much contact with the endoscope, which may result in the endoscope becoming smeared with blood and liquids that obscure the view for the camera on the endoscope to capture images of the cavity. In which case the procedure has to be stopped, the endoscope taken out, wiped clean and put back into the port to resume the procedure.
The quality of images obtained by an endoscope is also partly dependent on the quality of illumination, and not just resolving power of the imaging lenses and sensor sampling frequency. Because of the limited space at the distal end of the endoscope, there is limited room to place a fiber optic or LED ring illuminator around the front aperture of imaging optics of the endoscope. In addition due to limitations in thermal heat management, limited and very low power solid state illumination sources can be placed at the distal tip of the endoscope where there is limited space for heat from the LED sources, for example, to be successfully kept away from human tissue. Consequently, heat emitted from the light sources may come in contact with human tissue during the procedure. Silicone dome lenses are commonly used on LED light sources to improve light extraction and efficacy of the light source. One disadvantage of such configurations, however, is that these dome-over-molds also increase the size of the LED light sources since there is limited or no space at the distal tip of an endoscope to also use illumination optics in conjunction with the solid state light sources which control the illumination profile over the object/tissue within the Field of View (FOV) of the imaging optics.
These and other limitations may be overcome by embodiments of the invention which relate to a deployable balloon illumination system that can be used in minimally invasive surgical procedures and/or diagnostic procedures in order to assist in illuminating the cavity. The deployable balloon illumination system not only provides illumination optics conditioning the illumination profile to best fit the imaging optics FOV, it also increases light extraction from the LEDs more efficiently so higher light efficacy can be achieved. Deployable balloon illumination system, with an inflatable balloon or balloons allows positioning of the solid state illumination light sources away from the very front surface of the endoscope where a ring illumination would need to be otherwise disposed, allowing the entire cross section of the endoscope distal tip to be used for larger imaging optics, thus enabling a higher numerical aperture imaging optics to be employed at the distal tip, which enables better light collection for imaging and provides higher resolution in the endoscope. Or the saved space where a ring illumination would need to be disposed otherwise, can serve as irrigation, suction or working catheter interior to the deployable balloon illuminator within the endoscope profile. The inflated balloon can also act not only as heat dissipation reservoir or heat sink with much larger heat dissipation surface for the solid state light sources, allowing higher power solid state light sources to be used and run at higher currents, but also acts as a soft and deformable safety buffer for any tissue that could come in contact with the distal tip of the endoscope, as well as keeping the imaging optics aperture away from any liquid or blood that could smear onto the imaging lenses which would otherwise require cleaning mid-procedure. Within the internal lumens of the body, the inflatable illumination balloon can also be used to keep away or plug the internal lumen in the body to allow effective local inflation of he body lumen with air, to visualize and operate on, or with selective inflation and deflation of multiple illumination balloons used as means for steering a flexible endoscope or catheter inside a internal lumen or body cavity under endoscopic procedure. According to some embodiments, the deployable balloon illumination system may be implemented in parts (multiple inflatable sections), have a reduced, or a very small and flat, shape when in a non-deployed state so as to be electively located inside a surgical port or cannula for articulation and deployment. In some of the embodiments, the deployable balloon illumination system includes a reflective and a transmissive portion, with specific optical characteristics to, reflect, transmit or with features to scatter light, so as to assist in effective illumination of the body cavity under observation.
In some embodiments, a selectively deployable balloon member for insertion into and illumination of a body cavity is described. The selectively inflatable deployable balloon member includes a flexible tubular body having a non-deployed configuration during insertion into the body cavity and a deployed configuration after insertion into the body cavity. A very thin portion of the flexible tubular body is configured to be selectively inflated after the insertion into the body cavity so as to be in the deployed configuration and having a reflective portion configured to reflect illuminated light received from at least one light source disposed on an interior surface of the flexible tubular body when in the deployed configuration. A transparent portion is built into the flexible tubular body over the light sources being or so as to come into intimate contact with the illumination sources located on the inner surface of the tubular body as the balloon is inflated. The transparent portion enables effective extraction of the light from the illumination sources allowing the illuminated light from the light source to pass therethrough the inflated balloon.
In some embodiments, the flexible tubular body may be configured to be filled with gel or fluid, such as saline, when in the deployed position. The gel or fluid may have a higher index of refraction than air so as to better extract light from the illumination light sources.
In some embodiments, the flexible tubular body may have a heart, apple, or bulb shape, or an asymmetric shape when in the deployed position, that is fully or partially deployed as needed.
In some embodiments, the thin flexible membrane of the flexible tubular body is deployed outwardly or inwardly (or in both directions) via a very small diameter air, liquid, or gel feed tube which inflates one or multiple balloon illumination systems, that is built in the wall or interior of the flexible tubular body, allowing deployment from the proximal end source of air, liquid or gel, or a separate reservoir built in the device
In some embodiments, the flexible tubular body has a toroid shape with a recess formed therein which permanently or selectively houses a camera of a medical scope, or where a traditional rigid glass lens endoscope with proximal end camera can be inserted in the flexible tubular body, which itself can have a rigid portion.
In some embodiments, the at least one light source may emit light in laterally from the interior to the flexible tubular body, the light being reflected from the reflective portion of the balloon, having passed through the air/liquid/gel material that was used to inflate the balloon, toward the transparent portion of the flexible tubular body, where scattering or lensing features such as Fresnel lens, could be used or molded within or on the reflective or transparent portions of the flexible tubular body to condition the illumination light further or assist in better light extraction.
In some embodiments, the light source may be a light emitting diode or VCSEL of various wavelengths that can be turned on and off selectively based on the imaging optics used.
Another embodiment of the invention corresponds to a device for insertion into and illumination of a body cavity. The device includes a plurality of selectively deployable balloon members having a non-deployed configuration during insertion into the body cavity and a deployed configuration after insertion into the body cavity, the selectively deployable balloon members being inflated after the insertion into the body cavity so as to be in the deployed configuration and having a reflective portion configured to reflect illuminated light received from at least one light source disposed on an interior of the selectively deployable balloon member when in the deployed configuration, and a transparent portion located at a distal end thereof which enables illuminated light from the at least one light source to pass therethrough.
Another embodiment of the invention includes an illumination device for insertion into a body cavity. The device includes an elongate hollow tube with an internal lumen between a distal opening at a distal end and a proximal opening at a proximal end, the elongate hollow tube including a rigid distal portion associated with the distal opening configured to be at least partially inserted into the body cavity, a selectively deployable balloon member operably coupled to the rigid distal portion and having an insertion position and a deployed position. The a selectively deployable balloon member is operably coupled to the rigid distal portion and has an insertion position and a deployed position. The selectively deployable balloon member has an interior portion configured to receive light from at least one electro-optic illumination element coupled to the selectively deployable balloon member, wherein the at least one electro-optic illumination element provides illumination at one or more electromagnetic wavelengths and is configured to be selectively turned on or off. The selectively deployable balloon member also has a reflective portion configured to reflect illuminated light, a transparent portion located at a distal end thereof which enables illuminated light to pass therethrough. The illumination device also includes an imaging element housing portion permanently or selectively plugged into and positioned in the rigid distal portion which is configured to house an imaging element when coupled thereto. The at least one electro-optic illumination element is disposed within an interior of the selectively deployable balloon member and is configured such that when the at least one electro-optic illumination element is turned on, light from the at least one electro-optic illumination element is reflected or scattered from the reflective or scattering portion of the selectively deployable balloon member and is transmitted through the transparent portion of the selectively deployable balloon member, which may possess light scattering and wavelength as well as directional mixing properties, towards the rigid distal portion where the imaging element is disposed to exit the balloon illumination system through a transparent or scattering front surface positioned around the imaging element in the deployed position.
In some embodiments, This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. The embodiments provided do not limit the disclosure but provide scenarios to aid understanding thereof. The Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
To further clarify the above and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Exemplary embodiments of the invention concern a deployable balloon illuminator which may be used as a component of or in association with an endoscope, surgical port, a catheter or surgical tool body, with or without access ports, on a flexible, partially flexible, articulating or rigid device body. Embodiments may employ or be used in association with monochromatic or polychromatic, in various visible or non-visible electromagnetic wave spectrum, solid state light sources such as high power Light Emitting Devices (LEDs), Laser Diodes. Surface Emitting Vertical Cavity Lasers (VSCELs) as a means of illumination in a diagnostic or surgical endoscopic procedures, or functional borescopic systems. In particular, these solid state light sources are incorporated near or at the distal end, or otherwise on the body of the endoscope, borescope, surgical or industrial tools, and the tip end of cannulas and other functional devices. They can also be incorporated in an illumination body that is inserted separately, or in conjunction with a lighted or dark scope, into the body. The illumination of an object inside a body, a body herein being defined as at least a portion of a human, animal or physical object not easily accessible, is performed to actively modify the body or a dye used inside the body, to detect the modified light, image the object, or manipulate a change in the object. The solid state illumination schemes of the present invention can replace, or can be used in addition to, the conventional fiber optic or solid state source illumination system and other diagnostic devices such as ultrasound imaging, or functional tools such as surgical tools used in endoscopy and borescopy.
The embodiments described herein utilize deployable balloon mechanisms, which as are described more fully herein, may have a variety of different shapes and be comprised of different materials so as to have different transparencies, elasticities, or any number of other suitable and advantageous optical or non-optical mechanical and or electrical properties. As is described herein, the deployable balloon mechanisms are configured to temporarily increase the volume of the endoscope body in its illumination system to allow effective illumination of the area to be imaged, protect the imaging components, and help keep solid state illuminators away from body organs, lumen walls, fluid, blood, or other parts and tools inside the examination body, dissipate the heat from high power solid state light sources and chip on tip imaging electronics, and to improve the ability for the camera to capture images of the cavity by allowing a larger diameter conventional or chip on tip imaging endoscope to be used without a ring illuminator fiber optic or solid state light sources around the imaging endoscope distal aperture.
As may be understood, the use of solid state light sources in association with or as a single component with a deploy able balloon and an imaging system inside a cavity in the body, replaces variety of instruments and parts otherwise needed for the same purposes, such as an external light source, fiber light guides, and a means of transmitting the light to the desired object. Further, the embodiments described herein may replace the need for a ring shaped illuminator at the very distal tip surface of the device and allow entire diameter of the imaging endoscope to be used for the imaging optics, image sensor, working channel for the endoscope or catheter for introduction of other tools, and means for articulation and navigation of the endoscope, tool or catheter. Consequently, the embodiments described herein provide a compact, effective, and easy to operate endoscopic vision system that can be made as a separate reusable endoscope, plugged into or inserted into the deployable balloon illumination body (such as chip on the tip endoscope or traditional rigid glass imaging endoscope), which can be made inexpensively and which is exchangeable for variety of illumination characteristics and types as well as in variety of illumination wavelengths required for a specific procedure, and which can be made disposable after each use.
Further, in some instances, the DBI tubular body 120, or the DBI 120 with the LED illumination sources included therein may be designed to be single-use or disposable.
In the embodiment shown in
As is further shown in
As is shown in
In some embodiments, the DBI 120 may have an internal window at least the same size as the in front of the illumination sources 300, that if filled with an appropriately designed refractive index material to improve light extraction from the illumination sources 300 into the DBI 120. The internal tubular body of the DBI 120 or endoscope tube 370 can be made transparent in front of the illumination sources 300 and reflective otherwise to trap light inside the DBI 120, as it reflects back and forth towards the exit transparent surface 110. The DBI's 120 internal tubular surface in front of the illumination sources 300 or endoscope tube 370, can be also made very thin and flexible, so when the DBI 120 is deployed, this flexible tubular portion inside also flexibly presses against the illumination sources 300 to make an intimate contact with the illumination sources, for better light extraction from the illumination sources 30), especially when the DBI 120 is filled with higher index matching material, such as water or gel, such as the light from sources 300 travels only in higher refractive index medium until its exit from transparent surface 110.
The camera 135 is also connected to a rigid or flexible PCB 380 which controls and powers the camera 135 and it should be understood that although not expressly described herein, the endoscope system 100 also includes the necessary wiring and electrical connections necessary to power and control both the camera 135 and the illumination sources together or separately. The camera electronic connections could provide analog or digital means of imaging data transmission, in any of the variety of protocols such as MIPI, LVDS, USB/UVS, or otherwise, where the camera clock signal can be used in common with the illumination source on/off signals or with one or more other camera imagers. It should be understood that a variety of configurations may be used to provide the wiring and electrical connections for powering and controlling the camera 135, illumination sources 300 one of which is through separate USB devices controlled through a USB HUB, and the ability to selectively inflate and deflate the deployable balloon portion 120 of the endoscope system 100 through mechanical or automated inlet valves positioned inside or outside the endoscope system 100.
Examples of endoscopes which include examples of additional mechanical and electrical elements, connections, and the illuminating sources which may be used in association and in addition with this invention are found in at least U.S. Pat. Nos. 8,480,566 and 9,033,870, which are both herein incorporated by reference in their entirety.
In one embodiment, a portion of the heat generated by the illumination sources 300 is transferred to the camera 135 so as to defog the lens and maintain the quality of the images captured by the camera 135. More specifically, the heat from the illumination sources 300 may provide the proper temperature setting to avoid any condensation on an optical window or lens of the camera 135 which may accumulate during operation. Additionally, any heat from the illumination sources 300 may be used to warm the distal end of the cold endoscope 100 when it is inserted into the warm and humid body cavity. In turn a separate low power infrared LED can also be used for the purpose of heating the endoscope tip.
The DBI 120 may be inflated after the endoscope system 100 has reached its desired position within a patient or it may be entirely, partially deployed, or sectionally deployed at any desired point. The DBI 120 may be inflated by any number of known materials, including a variety of gases or liquids generally used in the medical field, such as a saline solution. The deployable balloon 120 may be deployed through a number of means, such as via a tube or other connection which inflates the interior 315 of the DBI 120, using an internal reservoir or bladder, and/or an external syringe and valves mechanism commonly used in the medical filed in inflating catheter balloons, endrotracheal intubation tube cuffs, used proximally, or any separate or device embodied prefilled reservoir in place of the air or liquid filled syringe, once the endoscope system 100 has reached a desired position or an area of a patient which is desired to be imaged and which also may require additional illumination and/or clearance around the camera 135 so as to improve the image capturing process. Subsequently, in one embodiment, after the imaging process is complete, the DBI 120 or sections of it may be deflated so as to reduce the profile of the endoscope system 10), using the same means such as a deflating syringe and proximal valve opening mechanism, and better facilitate the removal of the endoscope 100 from a patient.
As may be understood by one of skill in the art, one benefit of inflating the DBI 120 during the imaging process is that the air, liquid, or other material disposed in the interior 315 of the DBI 120 assists in isolating the patient anatomy from any heat produced by the illumination sources 300. As such, inflating the DBI 120 during guidance inside a body lumen, partially, completely or in sections, could aid the advancement and placement of a flexible or articulating endoscope through a natural orifice, where the embodiments described herein provide a safe and reliable way to capture improved endoscopic images without increasing the risk of burn or other harm to the patient during the procedure. Furthermore the inflated balloon illuminator could be used to plug an internal lumen or section of the body, where the working and imaging area can be filled with air for clear viewing within the working distance in front of the DBI.
Although in the previous embodiments, the DBI 120 is described as a component in an integrated camera 135 as a component of an endoscope system 100, in other embodiments the DBI 120 provides an endoscope tube 370 (as shown in
In an alternate embodiment of the independent balloon illuminator shown in
As such, in this configuration, the deployable balloon illuminating surgical port or catheter 600 may be a separate product that may be used in association with other existing products so as to improve the operation and use of existing endoscope products 650 that could have their own illumination system or designed without an illumination system (dark scope). In the embodiment shown in
Similar to the configurations described with respect to
Furthermore, in this configuration, a plurality of illumination sources 710 are disposed in form of an array outside the sides of the port or catheter distal tip 720 where their electrical power connections as well the camera 810 electrical lines could run within a separate lumen in the body or wall of the port or catheter 720. As was previously described, the illumination sources 710 may include a variety of different types of illumination sources, including any desired combination of LEDs. VCSELs, or other light sources which may provide the desired type of illumination, of sequence of various illumination for the particular application and use of the endoscope. The 810 camera equipped port or catheter 720 could be used as an auxiliary camera with a broader FOV of the general surgical site, in conjunction with the main endoscope or a camera stylet, used separately inside the port or catheter 720, where the illumination sources 710 could provide illumination for both camera 810 as well as the separate dark or illuminated endoscope or camera equipped articulating stylet used inside the port or catheter 720.
Although the deployable balloon endoscope systems described above with respect to
As may be understood by one of skill in the art, one advantage of the embodiments described herein is that the systems described herein enable the placement of illumination light towards an object inside the body in diagnostic or surgical procedures, while providing an illuminated endoscope system which has little loss in conjunction with the transmission of light from the external source to the surgical site. Furthermore, the embodiments are able to provide a large array of light transmission sources which can also include different types of light transmission sources without enlarging the size of the distal end of the endoscope. This provides an endoscope which has a small cross-sectional profile, making it easier to travel through small passages in the human body. Once the endoscope has been placed at a location which a physician or other health care provider wishes to image, the embodiments herein also provide a safely and easily deployed balloon which enlarges the cavity to be imaged and also acts as a reflective illuminator which assists in lighting the cavity. As such, the deployable balloons described herein also assist in positioning the imaging system and transmitting light to the desired area of the cavity, allowing higher power solid state light sources to be used distally with well managed and safe heat dissipation mechanism through the DBI itself, where the light extraction efficacy as well as pointing and uniformity of the illumination light are improved by the DBI.
The embodiments described herein are able to be used in association with LEDs or other light sources which have equal efficiency in converting electrical power to useful light, can be operated in much lower input power, eliminating the need for sophisticated power and heat management. Power and control signals transmitting through appropriate wires and flex circuitry, can be easily routed along the rigid, flexible, partially flexible, or articulating tool or endoscope body to the illumination sources.
Although not expressly described herein, miniature, optical components such as lenses, miniature autofocus mechanisms, mirrors, beam splitters, polarizers, waveplates, etc. can also be used in conjunction with the light emitting sources, camera, or other optical components, as well as the DBI itself and optical features built in, molded within, or thin film coatings deposited on its surfaces, is used to further manipulate the illumination characteristics of the light or the ability to capture the reflected light by the imaging optics of a DBI incorporated endoscope or a separate endoscope. The DBI surface curvature, optional surface features, and filling material could be designed to act as a lens for example, to direct the light to larger or smaller areas of the scene, or focusing the beam to a small area on the object depending on the application.
Polarization and wavelength characteristics of the solid state laser or LED light output can also be used in special detection schemes, where depth perception or other biological imaging characteristics that depend on the polarization or wavelength of the light can be better perceived, similar to polarized microscopy or through IR tissue penetrated imaging to locate veins, etc. Miniature Deployable Balloon illuminators can be used on access devices such as speculum distal tips to look into nose, ear, oral cavity, vagina or other natural orifices. Deployable Balloon illuminators can also be used in catheters that enter and travel through orifices and lumens filled with urine or blood, where specialized cameras need specific illumination and excitation sources, with narrow band lasers or wide band LED sources, in infrared, spectral or speckle imaging.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application claims priority U.S. Provisional Application No. 62/858,909, filed on Jun. 7, 2019. The foregoing patent application is herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62858909 | Jun 2019 | US |
