Abstract
Implementations of the tissue illumination systems, devices, and methods disclosed herein take advantage of the translucent nature of tissue to reveal properties by light transmission, for example, tissue type, tissue transition locations, underlying structures, and the like, that are not easily distinguished by reflected light. Illuminating a back-side of a translucent tissue permits a user to distinguish between different types of tissue, tissue transition locations, and/or structures that are difficult or impossible to discern under overhead or front-side illumination. Implementations include a light source that is positionable behind a tissue or disposable within a body cavity or duct, for example, within a heart ventricle.
Claims
1. A method of visualizing translucent tissue structures, the method comprising, accessing a heart valve of a medical patient, positioning a portion of a body of an illumination device under an annulus of the heart valve on a ventricular side of the heart valve's leaflets, wherein the portion of the body positioned under the valve annulus includes a generally arc-shaped structure that carries a plurality of light emitters spaced apart along the arc of the structure, positioning the arc-shaped structure and the light emitters snugly around and under the valve annulus, causing light to be emitted from the light emitters and transmitted through tissue of the heart valve annulus, and viewing the light transmitted through the annulus from an atrial side of the annulus opposite the side of the annulus at which the arc-shaped structure is snugly positioned.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1A is a schematic of a light ball implementation of the illumination device, positioned within a cardiac chamber.
(2) FIG. 1B is a schematic of the light ball from FIG. 1A.
(3) FIG. 1C illustrates an implementation of a light ball with a shading mechanism.
(4) FIG. 1D illustrates another implementation of a light ball with a shading mechanism and a retrieval stick.
(5) FIG. 2A illustrates a light rope implementation of the illumination device.
(6) FIG. 2B illustrates another view of the light rope implementation of FIG. 2A.
(7) FIG. 2C illustrates another view of the light rope implementation of FIG. 2A.
(8) FIG. 2D demonstrates a location in which the implementation of FIG. 2A may be positioned during operation.
(9) FIG. 2E is a photograph of a cardiac valve when a light rope implementation is positioned and in operation. The valve leaflets are pulled taut in this image.
(10) FIG. 2F is another photograph of a cardiac valve when the light rope is positioned and in operation. The valve leaflets are pulled taut in this image.
(11) FIG. 2G is another photograph of a cardiac valve when the light rope is positioned and in operation. The valve leaflets are pulled taut in this image.
(12) FIG. 2H is a photograph of a cardiac valve when the light rope is positioned and in operation. The valve leaflets are not pulled taut in this image.
(13) FIG. 2I is a photograph demonstrating a light rope implementation positioned behind a cardiac valve annulus.
(14) FIG. 2J is another photograph demonstrating a light rope implementation positioned behind a cardiac valve annulus.
(15) FIG. 2K is another photograph demonstrating a light rope implementation positioned behind a cardiac valve annulus.
(16) FIG. 2L is another photograph demonstrating a light rope implementation positioned behind a cardiac valve annulus.
(17) FIG. 2M is another photograph demonstrating a light rope implementation positioned behind a cardiac valve annulus.
(18) FIG. 2N is a magnified inset of a portion of FIG. 2M.
(19) FIG. 3A illustrates a multiple-source light implementation of the illumination device.
(20) FIG. 3B illustrates another multiple-source light implementation of the illumination device.
(21) FIG. 4A illustrates an inflatable implementation of the illumination device, in its inflated state.
(22) FIG. 4B illustrates another inflatable implementation of the illumination device, in its inflated state and positioned within a cardiac chamber.
(23) FIG. 5A illustrates a light catheter implementation of the illumination device.
(24) FIG. 5B illustrates another view of the light catheter implementation of the illumination device.
(25) FIG. 5C is a photograph from the outside of a cardiac valve. The valve is illuminated from behind the tissue by the light catheter implementation of the illumination device.
(26) FIG. 5D is a photograph from the outside of a cardiac valve. The valve is illuminated from behind the tissue by the light catheter implementation of the illumination device.
(27) FIG. 5E is a photograph from the outside of a cardiac valve. The valve is illuminated from behind the tissue by the light catheter implementation of the illumination device.
(28) FIG. 5F is a photograph from the outside of a cardiac valve, for comparison to FIGS. 5C-5E. The valve is not illuminated from behind the tissue.
(29) FIG. 6 is an illustration of a C-light implementation of the illumination device.
(30) FIG. 7 is an illustration of a forceps light implementation of the illumination device.
(31) FIG. 8 is an illustration of an implementation of the illumination device similar to FIGS. 3A-3B and including tissue contact leads.
DETAILED DESCRIPTION
(32) Implementations of the systems, devices, and methods disclosed herein take advantage of the translucent nature of tissue to reveal properties by light transmission, for example, tissue type, tissue transition locations, underlying structures, and the like, that are not easily distinguished by reflected light. For example, viewing from a left atrium an annulus and or leaflets of a mitral valve illuminated by a source disposed in a left ventricle reveals additional structure that is difficult or impossible to discern under overhead or front-side illumination. The systems, devices, and methods are described in the context of back-side illumination of a mitral valve from a left ventricle, but are also applicable any suitable application involving surgery on or near translucent tissue, for example, other valves, blood vessels, organs with ducts or lumens, procedures in utero, and/or on infants. Some implementations are applicable to laparoscopic and/or arthroscopic procedures.
(33) Implementations of the devices include at least one light emitter that suitable for placement within a patient, for example, light emitters and/or sources that do not generate excessive heat, dangerous radiation, a dangerous risk of electrical shock, and the like. Examples of suitable light emitters include light sources, for example, light emitting diodes (LEDs), electroluminescent wire, and solid state lasers. Another example of a suitable light emitter is an optical fiber or waveguide optically coupled with a suitable light source.
(34) Some implementations of the light emitters require a power source to generate power for the light emitters. In some implementations, the power source and light emitter are integrated and positioned adjacent each other in or on the device or a portion thereof. In these implementations, the power source is intended and dimensioned for placement within the body of the patient. In other implementations, the power source is not intended or configured for placement within a patient.
(35) Implementations of any of the devices described herein comprise one or more chemiluminescent sources of any suitable type. Examples of suitable chemiluminescent sources generate light using a reaction between hydrogen peroxide and a bisphenol oxalate diester, for example, diphenyl oxalate, di(2,4,6-trichlorophenyl) oxalate, and the like. Some implementations further comprise one or more dyes, which modify the color of the emitted light. Chemiluminescent sources are self-contained, requiring no power source. As such, implementations of lighting devices using chemiluminescent sources are portable and reliable. Some implementations comprising a chemiluminescent source further comprise another type of light emitter or source.
(36) Some implementations comprise an optional control unit, which is operable to modify or control an output of the at least one light emitter. For example, controlling the viewed light may include controlling whether a particular emitter is on or off, or may include controlling the intensity, color, wavelength, duration, or shading of the light. For example, some tissue is more easily visualized or distinguished under certain wavelengths. Pulsation or short bursts of light are useful in some visualizations of the eye to prevent accommodation of the user's iris. Some implementations of the control unit include a wired connection to the at least one emitter, while other implementations use a wireless connection. Some implementations of the control unit, such as diffusers or shields, shade or partially block the emitted light. Some implementations of the control unit may include a dimmer to adjust the light intensity. In some implementations including a plurality of emitters, a property of at least a first emitter, for example, intensity and/or color, is adjustable relative to at least a second emitter.
(37) Left Ventricular Ball Light
(38) Some implementations of the illumination device are dimensioned for placement within the left ventricle with the output of the one or more light emitters directed outwards. For example, the light may be directed towards the annulus of the mitral valve. FIG. 1A schematically illustrates an implementation of a ball light positioned within a cardiac chamber. Ball light implementations may be a self-contained device comprising a power source and a source of light in the shape of a ball. Other implementations comprise an external power source, and optionally, a control unit. FIG. 1B illustrates an implementation of the illumination device with a body in the shape of a ball 101. In this example, the light emitters are one or more LEDs supported by and integrated into the body 101. In some implementations, the device is deployed at the beginning of the procedure and retrieved post repair or replacement. In other implementations, the device is deployed and/or retrieved at different times, for example, deployed for improved visualization at a certain step or set of steps in a procedure. Some implementations of the illumination device include a positioning mechanism 103. The positioning mechanism may comprise a permanent suture with a first end 105 attached to the device and a second end 107 external to the patient. The second end 107 may be a loop of a suture line. In some implementations, the positioning mechanism may comprise hook-and-loop fasteners, retrieval sticks, magnets, or any other system that would permit easy deployment and retrieval. In some implementations, the positioning mechanism comprises a flexible and/or malleable rod or other elongate member.
(39) As illustrated in FIGS. 1C-1D, some implementations may include a shading mechanism configured to partially block the emitted light. The implementation illustrated in FIG. 1C includes an optional, adjustable shield 109. The shield may block or redirect light, for example, away from a surgeon's eyes. In some implementations, a tint of the shield 109 is electronically controllable, either for the entire shield or independently for different portions or sections thereof. In some implementations, the shield in incorporated into the device 101 itself, for example, at or near a surface thereof. The implementation illustrated in FIG. 1D includes a diffuser 111 that permits sufficient light to shine through the tissue, but not so much as to overwhelm the user during a surgical procedure, as well as to even out the light intensity to provide a more accurate impression of relative tissue thickness, type, and/or color. In some implementations, an intensity of the one or more light sources is adjustable, either globally, or for individual light sources in the device. For example, an externally placed control unit may include a dimmer to adjust the light intensity.
(40) The implementation illustrated in FIG. 1D illustrates an alternative implementation of the positioning mechanism 103. The positioning mechanism 103 is a retrieval stick with an adhesive tip 113. In this implementation, the adhesive tip is designed to adhere to the body of the illumination device. For example, in FIG. 1D, the tip 113 is magnetic and adheres to a magnetic portion 115 on the body of the light ball implementation.
(41) Light Rope
(42) As illustrated in FIGS. 2A-2C, some implementations of the illumination device include a light rope with a flexible, elongate body 201 and an external power source. The body of the light rope supports at least one light emitter 202. The light emitters may include an array of LEDs, at least one electroluminescent (EL) wire, or another source of compact, localized light. In some implementations, the illumination portion comprises fiber optic light emitters optically coupled to an external light source. A positioning device 203 may be used to thread the body and light emitters through a mitral valve commissure, around chordae tendineae, and position them snugly around and under the valve annulus (in the location shown by the arrows in FIG. 2D).
(43) FIGS. 2E-2G are photographs of the light rope implementation positioned within a cardiac chamber with the cardiac valve leaflets pulled taut. In FIG. 2H, the light rope implementation is positioned within a cardiac chamber and the cardiac valve leaflets are not taut. FIGS. 2I-2L are photographs showing the light rope implementation placed below the annulus of the mitral valve. FIG. 2M-2N are photographs demonstrating that sub-annular illumination of the mitral valve by the light rope implementation permits visualizing the connection 204 between the leaflet and the valve annulus.
(44) Adjustable, Multiple-Source Light
(45) FIGS. 3A-3B illustrate implementations of an adjustable, multiple-source light. The adjustable, multiple-source light comprises a body 301 and a plurality of adjustable elongate limbs 317, each terminating in at least one light emitter 302. In the implementation depicted in FIG. 3A, the limbs 317 may include one or more adjustment features, and may be independently adjustable. For example, in some implementations, the adjustment feature may include a malleable material that enables bending and/or twisting, but retains sufficient rigidity to maintain the adjusted shape or configuration. In other implementations, the adjustment feature of at least one of the limbs 317 may include at least one telescoping mechanism, enabling at least one limb is to be telescopically adjustable. In some implementations, the user adjusts the limbs of the device to position the light emitters proximate to desired locations in a patient's anatomy, for example, around the annulus of the mitral valve. In some implementations, like the one illustrated in FIG. 3B, the light emitters 302 are positioned along the length of the limbs, or at branch points between the limbs. Suitable light emitters include LEDs and optical fiber. In some implementations, at least one of the limbs comprises electroluminescent wire.
(46) Balloon Light
(47) FIGS. 4A-4B illustrate a balloon light implementation of the illumination device. The implementation depicted in FIG. 4A includes an elongate, C-shaped body 401 similar to the light rope described above. The body is coupled to a balloon 419. This implementation is dimensioned for disposition in the ventricle along the mitral valve annulus. In the implementation illustrated by FIG. 4A, the light emitters are disposed on an outer surface of the balloon. In other implementations, the light emitters may be disposed within the balloon.
(48) Other implementations of a balloon light, such as the one illustrated in FIG. 4B, comprise a round balloon 419 dimensioned for disposition within the ventricle. Expanding the balloon inflates the ventricle, simulating a filled ventricle, thereby allowing the light emitters 402 to contact and illuminate surrounding tissue. The balloon light implementation of FIG. 4B also includes a positioning mechanism, 403.
(49) Light Catheter
(50) FIGS. 5A-5B schematically illustrates an implementation of a light catheter. Implementations of a light catheter comprise a device similar to a low-profile catheter. The body of the light catheter implementation comprises one or more pre-shaped, bendable, and/or steerable arms 501, on which light emitters 502 are disposed, for example at the distal, illuminating ends thereof. In use, the one or more arms are advanced through the valve and the light emitters positioned or steered into the desired position by the user. The light catheter implementations may include a positioning device 503. For example the implementation shown in FIGS. 5A-5B includes a positioning device in the form of a handle.
(51) FIGS. 5C-5F are photographs illustrating the use of a light catheter implementation to illuminate a mitral valve. FIGS. 5C-5E depict a mitral valve illuminated by a light catheter implementation from within the cardiac chamber. FIG. 5F shows the mitral valve without illumination from behind the tissue.
(52) C-Light
(53) FIG. 6 schematically illustrates an implementation of a pair of C-lights. C-light implementations may include an elongate array of light emitters 602 disposed on a crescent or C-shape frame or body 601 dimensioned for insertion into the ventricle beneath and extending along the underside of the mitral valve. Some implementations of the C-light include body pieces with ends 621 that are coupleable to other body pieces, thereby illuminating the entire periphery of the mitral valve. Implementations of the ends 621 comprise any suitable coupling means or combination thereof, for example, magnets, hook-and-loop fasteners, clips, latches, bayonet mounts, suture, and the like. In some implementations, the user positions a first C-light body piece within the left ventricle behind the anterior leaflet and associated chordae tendineae, positions a second C-light body piece behind the posterior leaflet and associated chordae tendineae, and couples the proximate ends thereof, securing the assembly beneath the mitral valve and illuminating the tissue thereof.
(54) Forceps Lights
(55) FIG. 7 illustrates an implementation of a forceps light. Surgeons use forceps in manipulating structures of the mitral valve and surrounding tissue during a repair and/or replacement procedures. For example, implementations of a forceps light comprise at least one light emitter 702 supported by the body 701 of a pair of forceps, which provides improved illumination of desired locations in the surgical field. The positioning mechanism includes the end 703 opposite the illuminating end. End 703 may be used to control the position of the light emitters. In some implementations, the positioning mechanism includes a flexible positioning member 723 that is permanently or removably coupled to a pair of forceps. The light emitter 702 may be disposed on the flexible positioning member 723. The member 723 is user adjustable to direct and/or modulate the illumination as desired. In some implementations, a power source 725 is also carried on the forceps.
(56) Tissue Contact Leads
(57) FIG. 8 illustrates an implementation of the illumination device comprising tissue contact leads 827. The lead(s) are disposed at strategic locations on the lighting device such that the one, a plurality, or all of the emitters are activated only when the lead is in contact with tissue. If the lead is not in contact with tissue, the emitter(s) 802 electrically coupled to the lead cannot be activated. The tissue contact leads ensure that the coupled emitter(s) will not be activated unless tissue is interposed between the emitter and the user. In some implementations, the effect of the tissue contact lead can be overridden. FIG. 8 depicts just one implementation including tissue contact leads. In practice, tissue contact leads 827 may be integrated into any of the aforementioned implementations of an illumination device.
(58) In view of the many possible implementations to which the disclosed principles may be applied, it should be recognized that the implementations described and illustrated herein are only examples and should not be taken as limiting the scope of the disclosure
