METHODS AND APPARATUS FOR CONTROLLING OPTICAL PROPERTIES OF LIGHT
A surgical instrument for illuminating a surgical field has an optical waveguide for transmitting light by total internal reflection. One or more control elements are disposed on the optical waveguide. The control elements extract light from the optical waveguide and control first and second optical properties of the extracted light. Another surgical instrument includes a first and second optical waveguide for transmitting light by total internal reflection. A coupling element is attached to both optical waveguides such that the optical waveguides are movable and pivotable relative to one another.
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The present application is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application No. 61/705,027 (Attorney Docket No. 40556-726.101) filed Sep. 24, 2012; the entire contents of which are incorporated herein by reference.
BACKGROUND OF THE INVENTIONIllumination of target areas to allow an operator to more clearly observe the target area can be challenging. External lighting provided by headlamps or wall mounted lights require constant adjustment and can still cast unwanted shadows in the target area. Additionally, these methods of illumination may not be capable of illuminating a target area that is deep and disposed far below a surface. Fiber optics may be coupled to tools to help illuminate the target area, but fiber optic systems can be inefficient at transmitting light, and the resulting light loss significantly reduces the amount of light delivered to the target area. Attempts to overcome inefficiency of light transmission may be made by providing powerful light sources, but this can result in excessive heat generation and in some cases this results in fires. In addition to challenges associated with providing adequate illumination of the work area, the illumination system must be able to access tight spaces without occupying significant volume that otherwise is needed for tools, an operator's hands, or otherwise visualizing the working area. The illumination devices and systems must also be able to cooperatively interact with the tools being used and conform to the space in which they are being used.
Therefore, there still is a need for improved lighting devices and systems that efficiently deliver light and provide quality light to illuminate a work area. Such lighting devices and systems preferably have low profiles so they can be easily positioned in the work area and conform to the area without occupying too much space. In preferred embodiments, the lighting devices and systems may be used in surgical applications to illuminate a surgical field, and they may be used cooperatively with other surgical instruments such as retractors that keep tissue away from the working area or suction wands that remove unwanted fluids and debris from the surgical field. At least some of these objectives will be met by the exemplary embodiments described herein.
SUMMARY OF THE INVENTIONThe present invention generally relates to instruments for illuminating an area, and preferably may relate to instruments for illuminating surgical fields.
In a first aspect of the present invention, a surgical instrument for illuminating a surgical field comprises an optical waveguide for transmitting light from a proximal end of the optical waveguide to a distal end of the optical waveguide by total internal reflection. The optical waveguide has a front surface and a rear surface. The surgical instrument also has one or more control elements disposed on the front surface and/or the rear surface that extract light from the optical waveguide and independently control two or more optical properties of the extracted light. The control elements may be surface features on the waveguide and thus may also be referred to in this specification as surface features. However, this is not intended to be limiting and thus the control elements need not be surface features.
The optical waveguide may be a non-fiber optic waveguide and may be formed from a single homogenous material. The one or more control elements may comprise a first surface feature disposed on the front surface and a second surface feature disposed on the rear surface. The two or more optical properties may comprise a first and second optical property. The first optical property may comprise a first direction or a first divergence angle, and the second optical property may comprise a second direction or a second divergence angle, and the first surface feature controls the extracted light in the first direction or the first divergence angle, and the second surface feature controls the extracted light in the second direction or the second divergence angle. The one or more control elements may comprise one or more front control elements disposed on the front surface and one or more rear control elements disposed on the rear surface. The front control elements may control the first optical property independently of the one or more rear control elements which control the second optical property. At least some of the one or more control elements may control both the first and the second optical property and they may be disposed on the front or rear or both surfaces. The first control element may be different than the second control element. The one or more control elements may comprise a prismatic pattern, a plurality of facets, or a lenticular lens.
The prismatic pattern may comprise a thickness, a riser and an exit face, and a groove having a depth that extends from a top of the riser to a bottom of the exit face. The groove depth may be less than ⅓ of the thickness of the optical waveguide. The groove depth may be constant along the prismatic pattern. The optical waveguide may comprise a plurality of grooves, and the plurality of grooves may fit an aspheric equation. The prismatic pattern may have a pitch of less than 1 mm, and the riser may have a riser angle of 0 degrees to 25 degrees. The exit face may have an exit face angle of 0 degrees to 25 degrees. The prismatic pattern may be orthogonal to the longitudinal axis of the optical waveguide.
The control elements may comprise a plurality of facets disposed on the front or rear surface. One or more control elements may comprise a lenticular lens that may be parallel to the longitudinal axis of the optical waveguide. The front surface of the optical waveguide may be substantially planar and the rear surface may comprise a concave or convex lenticular lens having a pitch and a radius. The pitch and radius may control lateral divergence of light extracted through the lens and relative to the longitudinal axis of the optical waveguide.
The optical waveguide may comprise a longitudinal axis and the first direction may be transverse to the longitudinal axis. The first optical property may comprise a first direction or a first divergence angle and the direction or first divergence angle may be transverse to the longitudinal axis. The first direction or first divergence angle may form an angle relative to the longitudinal axis. The second optical property may comprise a second direction or a second divergence angle and the second direction or second divergence angle may be transverse to the first direction. The second direction or second divergence angle may form a divergence angle relative to the longitudinal axis.
The one or more control elements may comprise a first group of surface features oriented parallel to the longitudinal axis of the optical waveguide for controlling light extraction in a direction transverse to the longitudinal axis, and a second group of surface features oriented transverse to the longitudinal axis for controlling light extraction in a direction that forms an angle relative to the longitudinal axis. The first group and the second group of surface features may be disposed on the same surface of the optical waveguide as one another. The one or more control elements may comprise surface features formed from a combination of features oriented in a first direction and a second direction opposite the first direction. The control elements may form one or more protuberances or pillows disposed on the front surface or the rear surface. The one or more protuberances control extracted light in the two directions or in the two divergence angles. The front or the rear surface of the optical waveguide may comprise a convex or a concave region for controlling divergence angle of the light extracted from the waveguide, and the other of the front or the rear surface may be substantially planar. The optical waveguide may comprise an angled distal tip for capturing remaining light that has not been extracted by the one or more surface features. The tip may be angled, flat, or have other configurations. Additionally, the tip may have surface features such as microfeatures including prisms, lenslets, facets, or other configurations for controlling the light exiting the distal tip of the optical waveguide. The one or more surface features may comprise surface features disposed on the front surface and surface features that are disposed on the rear surface. The surface features on the front may control the first optical property and the surface features on the rear may control the second optical property. A coating or cladding may be disposed over the front or rear surfaces. The coating or cladding may have an index of refraction that is lower than the index of refraction of the waveguide.
In another aspect of the present invention, a method for illuminating a surgical field comprises providing an optical waveguide having a front surface and a rear surface, inputting light into the optical waveguide, and transmitting the light through the optical waveguide by total internal reflection. The method also comprises extracting light from the optical waveguide via one or more control elements disposed on the front or rear surface of the optical waveguide, and controlling the extracted light from the optical waveguide controls at least two optical properties of the extracted light with the one or more surface features. The two optical properties may include two directions or two divergence angles so that the light illuminates the surgical field.
Inputting the light may comprise optically coupling the optical waveguide with a source of light. Optically coupling may comprise coupling the optical waveguide with a fiber optic. The one or more control elements may be disposed on only the front surface or only on the rear surface of the optical waveguide. Controlling the extracted light may comprise controlling horizontal and vertical divergence of the extracted light relative to the longitudinal axis of the optical waveguide.
In another aspect of the present invention, a surgical instrument for illuminating a surgical field comprises a first optical waveguide and a second optical waveguide. The waveguides are configured for transmitting light from a light source to the surgical field by total internal reflection, and the optical waveguides have a front surface facing the surgical field and a rear surface opposite thereto. The surgical instrument also comprises a coupling element attached to both the first optical waveguide and the second optical waveguide. The coupling element has a longitudinal axis, and the first and second optical waveguides are movable relative to one another and pivotable about the longitudinal axis.
The coupling element may allow positioning of the first optical waveguide relative to the second optical waveguide so that an angle or radius of curvature between the two optical waveguides is adjustable. The first optical waveguide or the second optical waveguide may comprise one or more control elements that are disposed on either the front surface or the rear surface, and the one or more control elements extract light from the optical waveguide and control a first optical property of the extracted light. The one or more control elements may also extract light from the optical waveguide and control a second optical property of the extracted light.
The surgical instrument may further comprise a retractor blade having an inner and outer surface, and that is coupled to the first optical waveguide or the second optical waveguide. The first and second optical waveguides may conform to the inner or the outer surface of the retractor blade or to any other substrate such as a malleable backing. The retractor blade may comprise a tubular cannula and the first or the second optical waveguide may comprise a planar and rectangular shaped waveguide. The first or the second optical waveguide may comprise a trapezoidal cross-section. Preferably, an air gap is disposed between the waveguides and the retractor blade or other substrate. The air gap helps prevent light loss and may be used in any of the embodiments described in this specification. Alternatively, a cladding or coating having an index of refraction lower than the waveguide may be disposed between the waveguides and the retractor blade or other substrate. The coating or cladding may also be used to help prevent light loss. In this embodiment, or any coating or cladding embodiments described in this specification, the index of refraction of the coating or cladding is preferably lower than the index of refraction of the waveguide. An exemplary range of the index of refraction is from about 1 to about 1.5.
The coupling element may comprise a hinge, a film, or a flexible joint. The front or the rear surface of the first or the second optical waveguide may be convex or concave. The surgical instrument may further comprise a substrate layer of material and the first and second optical waveguides may be attached to the substrate. The first and the second optical waveguides may be disposed in a layer of material. An air gap may be disposed between the substrate and the first or the second optical waveguide. Each of the first and the second optical waveguides may be independently coupled with a light source. A separate optical fiber may be coupled to each of the first and second optical waveguides. The surgical instrument may further comprise an optical coating or cladding disposed over the first or the second optical waveguide. The coating or cladding may have an index of refraction lower than that of the respective optical waveguide thereby enhancing total internal reflection therein. A film may be disposed over the first or the second optical waveguide. The film may have surface features for extracting and controlling the extracted light. The film may polarize the extracted light. The first optical waveguide may comprise control elements for extracting and controlling optical properties of the light, and the second optical waveguide may comprise control elements which extract and control optical properties of the light. The surgical instrument may further comprise a stabilizing element coupled to the optical waveguides and adapted to hold the optical waveguides in a desired shape. The first optical waveguide may be substantially planar and the second optical waveguide may be convex or concave. The first optical waveguide may have a size or shape different than the second optical waveguide. The surgical instrument may further comprise one or more optical fibers optically coupled with each optical waveguide for inputting light thereinto. The surgical instrument may also have a single integrally formed input stem optically coupled with each optical waveguide for inputting light thereinto.
In another aspect of the present invention, a method for illuminating a surgical field comprises providing a first optical waveguide having a front surface facing the surgical field, and a rear surface opposite thereto, and providing a second optical waveguide having a front surface facing the surgical field, and a rear surface opposite thereto. The first and second optical waveguides are coupled together with a coupling element. The method also includes the steps of actuating the first and second optical waveguides about the coupling element to adjust angle or radius of curvature between the optical waveguides, and illuminating the surgical field with light extracted from the optical waveguides.
The method may further comprise fixing the position of the first and second optical waveguides thereby fixing the angle or radius of curvature therebetween. The method may also comprise coupling the optical waveguide with a surgical retractor blade.
In still another aspect of the present invention, a flexible illuminated surgical instrument may comprise an optional malleable backing element having a proximal portion and a distal portion, a fiber optic bundle and a non-fiber optical waveguide. The backing element may be manipulated into a plurality of shapes, and the fiber optic bundle has a proximal region and a distal region. The fiber optic bundle is cylindrically shaped in the proximal region, and the fiber optical bundle is flat and planar in the distal region. The fiber optic bundle may be coupled to the malleable backing. The non-fiber optical waveguide is optically coupled with the fiber optic bundle and also is coupled with the malleable backing. As in other embodiments, an air gap may be disposed between the waveguide any the backing element, or claddings or coatings may be applied to the waveguide to prevent light loss.
The distal portion of the malleable backing element may comprise a hinged region such that the distal portion is more flexible than the proximal portion thereof. The hinged region may comprise a plurality of serrations disposed along the malleable backing element. The instrument may further comprise a strain relief disposed over the proximal region of the fiber optic bundle. The strain relief is adapted to reduce kinking thereof. The instrument may also comprise an optical connector optically coupled with the proximal region of the fiber optic bundle.
The instrument may further comprise a crimping element crimped around the fiber optic bundle thereby coupling the fiber optic bundle to the malleable backing element. A sleeve may be disposed over the distal region of the fiber optic bundle and also disposed over a proximal portion of the optical waveguide. The sleeve may couple the optical waveguide with the fiber optic bundle. The instrument may comprise a frame that is coupled to a distal portion of the malleable backing element. The optical waveguide may be disposed in the frame.
The malleable backing element may comprise a window disposed along the distal portion thereof. The window may be configured to receive a portion of the optical waveguide. A proximal portion of the optical waveguide may comprise a flanged region for engaging a portion of the malleable backing. Standoffs may be disposed between the malleable backing and the optical waveguide. The standoffs form an air gap therebetween for enhancing total internal reflection of light travelling through the optical waveguide. The optical waveguide may comprise surface features for extracting light therefrom and controlling direction of the extracted light. The optical waveguide may also comprise a coating or cladding for controlling optical properties of the waveguide. The index of refraction of the coating or cladding is preferably less than the index of refraction of the waveguide.
In yet another aspect of the present invention, a method for illuminating a work space comprises proving an optical waveguide coupled to a malleable backing element, forming the backing element into a desired shape, coupling the optical waveguide to a source of light, extracting light from the optical waveguide, and illuminating the work space. Forming the backing element may comprise bending the backing element.
In still another aspect of the present invention, a surgical illumination system for illuminating a surgical field comprises an optical waveguide for illuminating the surgical field with light and a plurality of optical fibers arranged into a fiber bundle. The optical waveguide comprises a light input end, and light is transmitted through the waveguide by total internal reflection. The fiber bundle is optically coupled to the light input end, and the plurality of fibers in the bundle preferably have a diameter of 750 μm, but may be other sizes. The plurality of optical fibers are arranged in the bundle such that adjacent fibers engage one another with an interstitial space disposed therebetween. The fibers may be a polymer or they may be glass.
The plurality of fibers may be arranged into a bundle having an outer perimeter that is hexagonally shaped. The plurality of fibers may consist of 19 fibers when having a diameter of 750 μm to form an approximately 3.5 mm diameter bundle. Every three adjacent fibers may form a triangle. The plurality of fibers may be arranged in three concentric layers of fibers, or they may be arranged into a plurality of linear rows of fibers. More fibers may be combined to form a larger size bundle.
An optical element may be disposed between the bundle and the light input end of the waveguide. The optical element may comprise a lens, optical coupling gel, a relay rod or hollow coated cones. The optical coupling element may comprise a body having a circular shape on one end, and a hexagonal shape on an opposite end. The bundle may be butt coupled to the light input end of the waveguide.
These and other aspects and advantages of the invention are evident in the description which follows and in the accompanying drawings.
INCORPORATION BY REFERENCEAll publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
Many illumination devices and systems provide little control of the light being outputted. For example, fiber optic cables typically only output light radially with a fixed angle from the distal fiber tip. Some optical waveguides deliver light more efficiently and can control light extraction and delivery more effectively such as the embodiment in
Providing a contoured optical waveguide with prismatic structures allow control of light extraction and direction in two directions. For example,
Contouring the waveguide may result in the formation of a single lenticular such as seen with the D-shaped waveguide in
Surface Feature Configurations
Any of the waveguides disclosed herein may have light extraction features which have geometries and/or dimensions similar to or the same as the following exemplary embodiments.
A. Prismatic Structures.
There are unlimited combinations of thickness, riser angles, and extraction angles for prismatic structures, and one size does not necessarily fit all. The correct extraction surface size may depend on a number of factors including the thickness of the waveguide, the extraction and riser surface angles, as well as allowable light losses due to scattering.
Groove depth (here the distance between the top of the riser and the bottom of the exit face) is preferably no more than ⅓ to ⅕ of the part thickness. If the grooves are too deep, more than ⅓ the total thickness of the part, then plastic flow may be restricted and it may be difficult to injection mold the part due to high internal stresses, warping and the part may be excessively brittle. For example, for a 1 mm thick part, groove depth is preferably no deeper than 0.33 mm. For a 2.5 mm waveguide, groove depth is preferably no deeper than 0.83 mm.
The groove depth may be any depth, but is preferably ⅓ to ⅕ the part thickness for at least the following reasons. Each groove has a peak and a valley, each with a radius. The radius of the peak and the radius of the valley are determined based on the tools used to fabricate the part or the tools used to cut the part or mold, and/or based on the filling characteristics of the radius during molding of the part. Thus at the base and the peak of the grooves, the surfaces are rounded. During fabrication of the part such as during injection molding, the polymer may have difficulty flowing into and completely filling the grooves if the radii are too small. A radius of curvature of about 5 or 6 microns or greater is reasonable for both the peak and valley radii. Because the peak and valley radii remain fixed regardless of the dimensions of the extraction features, for a very small groove, the peak and valley radii take up a larger portion of the groove and thus the groove may not fill properly. For example, assuming a 5 or 6 micron radii on the peaks and valleys and a 20 micron groove, 10 to 12 microns are consumed by the radii. However, for a larger groove, the percentage of the groove consumed by the radii will be negligible and therefore more of the groove will fill properly. For example, if the groove is 1 mm, then considerably less of the groove is consumed by the radii.
To determine minimum groove width, an acceptable percentage for scattering is selected and then the minimum acceptable groove width is calculated. Groove depth should be deep enough such that in preferred embodiments no more than 5% to 10% of the surface area is consumed by groove peak and valley radii. Less is actually preferred. In the example below, 5% acceptable scatter was used and a preferred groove width was estimated to be 0.064 mm as the groove width. Acceptable scatter preferably ranges from about 1% to about 5%, and may be quantified as the ratio of total riser radius and valley radius to the total groove width. The calculations below are based on 5% scatter, but may be repeated using any value of scatter and preferably any value between 1% and 5%.
The following example illustrates various calculations related to the dimensions of the prismatic structures. Consider a simple groove with a fixed riser angle of 15 degrees and an extraction angle of 90 degrees (vertical). Assume the groove has a valley radius at it base, a length of correctly formed groove, and at the tip, a peak radius, and the following:
-
- A=Riser angle
- Rv=Valley Radius=0.006 mm
- Rp=Peak Radius=0.006 mm
- W=Total groove width
- H=groove height
- L=allowable loss=5%
- T=Waveguide thickness=1 mm
Equations (1), (2) and (3) allow calculation of the minimum recommended length and height of each groove.
Therefore, in this example the groove depth should be less than 0.33 mm and greater than 0.064 mm. But, one of skill in the art will appreciate that these dimensions are not intended to be limiting and that they may change. They can change depending on the total thickness of the part, the quality of the tooling and molding, the acceptable losses to scattering, and the design of the riser and extraction faces.
The extraction features have a riser and an exit surface, as seen in
The riser may be measured relative to the rear surface of the waveguide or relative to a plane that is parallel to the rear surface. In preferred embodiments, the riser angle will range between −16 degrees and 72 degrees (based on the numerical aperture NA of 0.55NA input light source and index of refraction of the waveguide material of 1.53). More preferred embodiments have further optimized riser angle values of between 18 degrees and 24 degrees. At below 12 degrees, most light will be pushed towards the distal end and not much light is extracted along the length of the waveguide. At 72 degrees is the critical angle and all the light will be extracted out of the riser surface. Preferred embodiments have light extracted only out of the exit surface, not the riser surface.
These angles are based on the axis described in
-
- φr=Riser Angle
- φc=Critical Angle=a sin(n1/n2)
- φna=extreme half angle of source=a sin(NA)
- n1=Index of refraction of air=1.00029
- n2=Index of refraction of the material of the optical device, typically 1.33 to 2.0
- θ>φna
The exit surface from
The relationships for the exit face are shown in
-
- φe=Exit Face Angle
- φc=Critical Angle=a sin(n1/n2)
- φna=extreme half angle of source=a sin(NA)
- n1=Index of refraction of air=1.00029
- n2=Index of refraction of the material of the optical device, typically 1.33 to 2.0
- θ>φna
Therefore, preferred values (but not intended to be limiting) for extraction features may be:
For a 1 mm×7 mm×20 mm waveguide, groove depth=0.064 mm to 0.33 mm. For a 2.5 mm×8 mm×30 mm waveguide, groove depth=0.064 mm to 0.83 mm. Riser angle ranges from 5° to 45° and more preferably from 0 to 25 degrees. Extraction angle ranges from 0° to 25°. A flat riser and deep groove depth will create the largest groove width, or pitch. Groove width will be between 9.48 mm for an extreme case of a 2.5 mm thick waveguide with 0.83 mm groove depth and 5° riser. A steep riser and shallow groove depth will create the smallest groove width, or pitch. Groove width will be the other extreme, 0.064 mm for 45° riser, and 0.064 mm groove depth. Preferably, groove depth is constant along a waveguide but the groove width may vary. Other embodiments where groove depth is variable are also contemplated. Grooves may be aspheric such that the light is modified by the extraction structures gradually, in an analog manner. Waveguides also preferably have an angled distal tip that captures remaining light that has not been extracted by the surface features. Other preferred angles (but not intended to be limiting) for waveguides are summarized in the table below. Values are based on index of 1.53, NA 0.55.
Waveguides may have extraction features with negative exit face angles as seen in
Therefore, in summary, the prismatic light extraction features may include:
Height of extraction features (or groove depth)—the features preferably have constant heights and varying widths. The heights may be designed based on manufacturing capabilities and preferably range between 64 microns and ⅓ of the thickness of the part.
The distal end of the waveguide may provide further light shaping. It can be flat or angled with lenslets on the surface to better mix the light. Exemplary distal waveguide ends are disclosed in U.S. Pat. No. 8,088,066; the entire contents of which are incorporated herein by reference.
Dead zones are areas along the stem or the extraction portion where the light does not interact with the surface and thus there is no or substantially no total internal reflection. These dead zones are ideal places to glue mechanical features in order to attach the waveguide to retractor blades for example. Since no light exists in the dead zones, light will not leak from these locations when something is glued to the waveguide. Dead zones are also disclosed in further details in U.S. Pat. No. 8,088,066; the entire contents of which are incorporated herein by reference.
B. Lenticular Array or Structures.
The purpose of the lenticular array is to spread the light output pattern and control lateral divergence (also referred to as the horizontal direction relative to the longitudinal axis of the waveguide) without changing waveguide thickness.
The geometry below explains the function of the lenticular. Each lenticular is a portion of a cylinder. Assume that light strikes the lenticulars from directly forward even though light rays will strike the lenticulars from various angles within the numerical aperture NA of the source and the acceptance NA of the waveguide, whichever is less. However, an average ray would be one originating from directly forward. For a quick calculation it is easier to work with this one ray.
Equations (4) and (5) below are used to calculate various aspects of the lenticulars including pitch and the radius of curvature.
-
- A=Deflection angle=26.3 degrees
- Ar=Ai=Reflection and Incidence angles=A/2
- d=lenticular half width
- r=lenticular radius
- h=height of lenticular edge (used later)
A lenticular array with millions of lenticulars creates the best mixing of light. However, the realities of manufacturing are that there will be a small defect area between each lenticular. This defect area is primarily caused by the radius of the tool used to cut the part and this radius is fixed. Therefore, as in the prisms previously discuss or other light extraction features, the lenticular size is tied to the amount of scattering that is acceptable. A very low amount of scattering is assumed in this example. In the case of the extraction features, scattered light will probably fall somewhere on the target plane and may still be useful. In this case, some scattered light will probably exit out the back or rear surface of the waveguide.
-
- Rv=valley radius=0.006 mm
- L=allowable loss due to scattering=1%
- d=lenticular half width from above
This permits calculation of r. The minimum pitch of the lenticular is 0.6 mm. The radius of the lenticulars is dependent on the pitch. For this pitch, the radius of curvature is 0.68 mm. To calculate the maximum pitch and radius waveguide desired thickness is maintained at the peak of the lenticular. Therefore the lenticular edges will penetrate into the device. In preferred embodiments this does not extend into the part more than about ⅓ of the total thickness of the waveguide, for manufacturing reasons.
From the geometry of part:
If t=1 mm and A=26.3 degrees, then r=3.22 and d=7.26 mm. This is the maximum groove pitch. This number is quite large, so preferred embodiments work within the constraints of the minimum dimensions.
Typical values for the lenticulars may include:
Minimum recommended pitch=0.3 mm.
Radius of curvature=0.68 mm.
Maximum pitch=18.1 mm, this is larger than the waveguide width, so it is substantially a single curved surface.
Maximum radius of curvature=8.05 mm.
Other embodiments disclosed herein include a cross lenticular array or pillowed array. The same analysis used above applies to these embodiments as well, but it must be performed in both the vertical as well as horizontal directions. Additionally, lengthening of the pattern has proven to be more efficiently accomplished by modifying the angles of the extraction features. Waveguides in this disclosure also are preferably between 0.5 mm and 1 mm thick. While still possible, thinner than 0.5 mm becomes difficult to mold and hard to keep flat.
Shapeable Waveguide
The waveguides disclosed above have rectangular cross-sections. However this is not intended to be limiting. In other embodiments the cross-section may be trapezoidal such as seen in
The waveguides may have a thin elongate bead of flexible material coupling them together along the longitudinal seam separating adjacent waveguides as seen in
Light may be delivered to the shapeable waveguide in any number of ways. For example, in
Because the shapeable waveguides are actuated and manipulated, it is often desirable to provide a strain relief on the input stem or fiber optic input cable to prevent damage.
Any of the waveguide segments in the shapeable waveguides described herein may also have surface features to extract and control the direction of the extracted light.
Once the shapeable waveguide has been manipulated into a desired configuration it may be coupled with a stabilizing member 1708 to hold its position as seen in
Coupling with Light Source
Any of the waveguides described in this specification may be coupled to a remote light source such as an external xenon lamp. The waveguide may be coupled to a fiber optic cable that is also coupled to the light source. The fiber optic cable is often a bundle of fiber optics. Preferably, the fiber bundles couple light from a source that may emit with a higher numerical aperture (NA) factor than the bundle. Many of the sources produce the numerical with a higher NA since the light source manufacturer does not always know which cable is going to be used. A simple lens and/or lens reflecting surfaces may be attached around or in front of a light source (e.g. xenon light sources, the most widely used source nowadays, are a discharge electric bulb housed in the focal point of a parabolic or other shape mirror. Many xenon light boxes have a lens in front of the bulb to effectively couple to a fiber bundle). To optimize the amount of light coupled into a cable requires consideration of several factors. One of which is matching the NA of the light source to the cable. As mentioned earlier, this may be achieved by placing an optical component between the bulb and the cable that matches the NA. Another important factor is the design of the fiber bundle. Several variables to consider when designing a bundle include:
A) the packing ratio and arrangement of individual fibers in the bundle;
B) the core to cladding ratio in the fiber bundle; and
C) Fresnel loss and misalignment losses.
Packing Ratio
Many fibers are produced round. When assembled into a bundle, there is a dead space between the individual round elements, especially when there are disruptions in the bundle which yields poorly packed bundle and transmission. By taking the best case scenario, packing fibers in a triangular pattern as seen in
Now comparing this to fibers 2702 that are stacked in a square pattern as seen in
The dead area in triangular packing=difference between triangle area [(2r)2√3]/3 and the area of half a circle is (πr2)/2. Therefore the dead area=[√3−π/2]r2, which is reduced to 0.16125 r2 where r is the radius of the fibers. For square packing the dead area is estimated as the difference between the square area (2r2) and the area of the circle πr2. Thus the dead area for square packing is (4−π) r2=0.85841r2, much larger than for the triangular packing.
Cladding Area
Fibers are not able to guide light on its core (the body of the fiber) unless they have cladding (or a coat over the core) with a lower refractive index than the core itself. Although the cladding is often made from transparent material, the light is not guided and it is lost. Traditional illumination fibers used in medical applications are produced from glass, with a 55 μm diameter and a 50 μm core. Computing the area difference of two circles of mentioned diameters leads to a 17.4% loss from cladding area that each fiber has. This can be minimized by identifying a fiber that has the highest possible core to cladding ratio.
Fresnel Loss and Misalignment
Glass fibers have an approximate refractive index equal to 1.5. The discontinuity of refractive index when light goes from air to fiber or fiber to air is responsible for approximately 4% loss (called Fresnel loss) at each interface, totaling 8%. When one fiber is to be connected to another bundle, in addition to Fresnel losses, we also get losses from misalignment. That is if the fibers are misaligned in the longitudinal direction by as much as 0.5 mm, one can approximate the losses to be up to 10%.
By adding the losses stated above, based on the best case scenario for the total loss, would add up to (9.3%+17.4%+8%+10%)=44.7% of the total light. This is a best approximation of loss that a bundled fiber cable (made from 50 μm/55 μm core/cladding glass fibers). Therefore a glass bundle would not be able to transmit higher than 55.3% of the input light.
By changing the fibers from glass to plastic in exemplary embodiments, we can change the cladding area loss. A 750 μm plastic fiber (commercially available and flexible enough to bend to necessary curvatures) has a 735 μm core and 15 μm cladding. The change in cladding area reduces the loss from 17.4% to 3.96% loss by reducing unusable transmitting area on the fibers. Other fibers such as 1000 μm core, or 1500 μm, 2000 μm, 2500 μm or 3000 μm diameter are available and may be used to construct fiber bundles. Use of the 750 μm fibers is discussed below.
Calculating the total loss for 750 μm is straight forward, by changing the area ratio of core and cladding to total area and leaving other sources of loss unchanged, the total loss is estimated to be 9.3%+3.96%+8%+10%=31.3%. Thus transmission should be up to 68.7%. This is the biggest gain that can be achieved by switching from the glass 50 μm/55 μm fibers previously described to the plastic 750 μm/735 μm plastic fibers describe above. Performing the same calculation for a 250 μm plastic fiber with a core diameter of 240 μm and outer diameter of 250 μm, the lost area is estimated to be 7.8% vs 3.96% of the 750 μm fiber. Thus, the 750 μm plastic fiber provides desired efficiency and this also helps to keep the illumination system thermally cool.
Next, the effect of finite size bundles is examined along with designs that maximize transmission of light along a bundled cable. The first goal is to determine the best packing scheme. As mentioned earlier, since most fibers are round, there are various ways to stack the bundle. The goal is to minimize the interstitial space (IS). By minimizing the space, system efficiency increases since less light is lost between the fibers.
Presented below are several examples of stacking the fibers and calculating the interstitial space. The optimal arrangement places the fibers in a triangular pattern. Additionally, it would also be desirable to make an arrangement of fibers in a bundle as close to a circular shape as possible, therefore in
In
For the hexagonal arrangement in
The embodiments described above employ plastic large core fibers with desirable ratios of core to cladding. Preferably a large core is used with thin cladding. This helps the fibers transmit light efficiently from an external light source to the waveguide. Efficiency is desirable since it helps keep temperature of the system low. Glass fibers are less desirable since they are expensive and are thus cost prohibitive in a disposable cable while the plastic is efficient and much less expensive. However, glass fibers may be used in any of the embodiments such as an exemplary glass fiber having a diameter of about 250 μm.
In still other embodiments, the fiber bundle may be heated and compressed to decrease or eliminate the interstitial space, further increasing efficiency. For example, the hexagonally shaped fiber bundle may be heated and compressed to form a hexagonal bundle with little or no interstial space, and the individual fibers will be reshaped into approximately hexagonally shaped fibers.
Previous embodiments of fiber bundles were circular. In some circumstances it would be desirable to provide a fiber bundle that is flat.
A single row of fibers may also be attractive as a very flat ribbon cable. Including the advantage that if properly wrapped, it could be contoured to any shape, such as a ring or bent. But for wider lengths, such as a length of 14.25 mm, the ribbon cable may be too wide to be practical. Therefore the two row device in
An alternative embodiment of a flat ribbon cable 3200 is illustrated in
Any of the fiber bundles described herein may be coupled to another fiber, fiber bundle or waveguide by butt coupling the two together or there may be optics disposed in between the two to correct misalignment errors. Additionally, coupling gels, lenses, relay rods or hollow coated cones may also be used to join the two together. Also, in any embodiment, the fibers may be formed from a polymer such as any optical plastic, or they may be formed from glass. Any embodiment may have smaller size or different shaped fibers inserted into the interstitial space formed during packing of the round fibers. The smaller size fiber may be shaped to fit the interstitial space and thus may be triangular or diamond-like in shape.
Even coupling a round to hexagonal bundle may be achieved with the exemplary coupler 3300 illustrated in
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
Claims
1. A surgical instrument for illuminating a surgical field, said instrument comprising:
- an optical waveguide for transmitting light from a proximal end of the optical waveguide to a distal end of the optical waveguide by total internal reflection, wherein the optical waveguide has a front surface and a rear surface; and
- one or more control elements disposed on the front surface and/or the rear surface, wherein the one or more control elements extract light from the optical waveguide and independently control two or more optical properties of the extracted light.
2. The surgical instrument of claim 1, wherein the optical waveguide is a non-fiber optic waveguide.
3. The surgical instrument of claim 1, wherein the optical waveguide is formed from a single homogeneous material.
4. The surgical instrument of claim 1, wherein the one or more control features comprise a first surface feature disposed on the front surface and a second surface feature disposed on the rear surface.
5. The surgical instrument of claim 4, wherein the two or more optical properties comprise a first and second optical property, the first optical property comprises a first direction or a first divergence angle, and the second optical property comprises a second direction or a second divergence angle, and wherein the first surface feature controls the extracted light in the first direction or the first divergence angle, and wherein the second surface feature controls the extracted light in the second direction or the second divergence angle.
6. The surgical instrument of claim 1, wherein the one or more control elements comprise one or more front control elements disposed on the front surface and one or more rear control elements disposed on the rear surface, and wherein the front control elements control the first optical property independently of the one or more rear control elements which control the second optical property.
7. The surgical instrument of claim 1, wherein at least some of the one or more control elements control both the first and the second optical property.
8. The surgical instrument of claim 5, wherein the first surface feature is different than the second surface feature.
9. The surgical instrument of claim 1, wherein the one or more control elements comprise a prismatic pattern disposed on the front surface or the rear surface.
10. The surgical instrument of claim 9, wherein the optical waveguide has a thickness, and wherein the prismatic pattern comprises a riser and an exit face, and a groove having a depth extending from a top of the riser to a bottom of the exit face, the groove depth being less than ⅓ of the thickness of the optical waveguide.
11. The surgical instrument of claim 10, wherein the groove depth is constant along the prismatic pattern.
12. The surgical instrument of claim 10, wherein the optical waveguide comprises a plurality of the grooves, and wherein the plurality of grooves fit an aspheric equation.
13. The surgical instrument of claim 9, wherein the prismatic pattern has a pitch less than 1 mm.
14. The surgical instrument of claim 10, wherein the riser has a riser angle of 0 degrees to 25 degrees.
15. The surgical instrument of claim 10, wherein the exit face has an exit face angle of 0 degrees to 25 degrees.
16. The surgical instrument of claim 9, wherein the optical waveguide comprises a longitudinal axis and wherein the prismatic pattern is orthogonal to the longitudinal axis of the optical waveguide.
17. The surgical instrument of claim 1, wherein the one or more control elements comprise a plurality of facets disposed on the front surface or the rear surface.
18. The surgical instrument of claim 1, wherein the one or more control elements comprise a lenticular lens.
19. The surgical instrument of claim 1, wherein the optical waveguide comprises a longitudinal axis, and wherein the one or more control elements comprise a lenticular lens, and wherein the lenticular lens is parallel to the longitudinal axis.
20. The surgical instrument of claim 19, wherein the front surface of the optical waveguide is substantially planar and the rear surface comprises a concave lenticular lens.
21. The surgical instrument of claim 19, wherein the front surface of the optical waveguide is substantially planar and the rear surface comprises a convex lenticular lens.
22. The surgical instrument of claim 19, wherein the lenticular lens has a pitch and a radius, and wherein the pitch and radius control lateral divergence of light extracted therethrough relative to the longitudinal axis of the optical waveguide.
23. The surgical instrument of claim 5, wherein the optical waveguide comprises a longitudinal axis, and wherein the first optical property comprises a first direction or a first divergence angle and wherein the first direction or the first divergence angle is transverse to the longitudinal axis.
24. The surgical instrument of claim 23, wherein the first direction or first divergence angle forms an angle relative to the longitudinal axis.
25. The surgical instrument of claim 23, wherein the second optical property comprises a second direction or a second divergence angle, and wherein the second direction or the second divergence angle is transverse to the first direction.
26. The surgical instrument of claim 25, wherein the second direction or the second divergence angle forms a divergence angle relative to the longitudinal axis.
27. The surgical instrument of claim 5, wherein the optical waveguide comprises longitudinal axis, and wherein the one or more control elements comprise a first group of surface features oriented parallel to the longitudinal axis for controlling light extraction in a direction transverse to the longitudinal axis, and a second group of surface features oriented transverse to the longitudinal axis for controlling light extraction in a direction that forms an angle relative to the longitudinal axis.
28. The surgical instrument of claim 27, wherein the first group and the second group of surface features are disposed on the same surface of the optical waveguide as one another.
29. The surgical instrument of claim 5, wherein the one or more control elements comprise surface features formed from a combination of features oriented in a first direction and a second direction opposite the first direction, the surface features forming one or more protuberances disposed on the front surface or the rear surface, the one or more protuberances controlling extracted light in the two directions or in the two divergence angles.
30. The surgical instrument of claim 1, wherein one of the front or the rear surface of the optical waveguide comprises a convex or concave region for controlling divergence angle of the light extracted therefrom, and wherein the other of the front or rear surface of the optical waveguide is substantially planar.
31. The surgical instrument of claim 1, wherein the optical waveguide comprises an angled distal tip for capturing remaining light that has not been extracted by the one or more control elements.
32. The surgical instrument of claim 5, wherein the one or more control elements comprise surface features disposed on the front surface and surface features disposed on the rear surface, and wherein the surface features on the front control the first optical property and wherein the surface features on the rear control the second optical property.
33. The surgical instrument of claim 1, further comprising a coating or cladding disposed over the front or rear surfaces.
34. The surgical instrument of claim 33, wherein the coating or cladding comprises an index of refraction lower than the index of refraction of the waveguide.
35. A method for illuminating a surgical field, said method comprising:
- providing an optical waveguide having a front surface and a rear surface;
- inputting light into the optical waveguide;
- transmitting the light through the optical waveguide by total internal reflection;
- extracting light from the optical waveguide via one or more control elements disposed on the front or rear surface of the optical waveguide; and
- controlling at least two optical properties of the extracted light from the optical waveguide with the one or more control elements so that the light illuminates the surgical field.
36. The method of claim 35, wherein inputting light comprises optically coupling the optical waveguide with a source of light.
37. The method of claim 36, wherein optically coupling comprises coupling the optical waveguide with a fiber optic.
38. The method of claim 35, wherein the one or more control elements are disposed on only the front surface or only on the rear surface.
39. The method of claim 35, wherein controlling the extracted light comprises controlling horizontal and vertical divergence of the extracted light relative to a longitudinal axis of the optical waveguide.
40. A surgical instrument for illuminating a surgical field, said instrument comprising:
- a first optical waveguide for transmitting light from a light source to the surgical field by total internal reflection, wherein the optical waveguide has a front surface facing the surgical field, and a rear surface opposite thereto;
- a second optical waveguide for transmitting light from a light source to the surgical field by total internal reflection, wherein the second optical waveguide has a front surface facing the surgical field, and a rear surface opposite thereto; and
- a coupling element attached to both the first optical waveguide and the second optical waveguide, wherein the coupling element has a longitudinal axis, and wherein the first and second optical waveguides are movable relative to one another and pivotable about the longitudinal axis.
41. The surgical instrument of claim 40, wherein the coupling element allows positioning of the first optical waveguide relative to the second optical waveguide so that an angle or radius of curvature between the two optical waveguides is adjustable.
42. The surgical instrument of claim 40, wherein the first optical waveguide or the second optical waveguide comprises one or more control elements disposed on either the front surface or the rear surface, wherein the one or more control elements extract light from the optical waveguide and control a first optical property of the extracted light.
43. The surgical instrument of claim 42, wherein the one or more surface features extract light from the optical waveguide and control a second optical property of the extracted light.
44. The surgical instrument of claim 40, further comprising a retractor blade having an outer surface, the retractor blade coupled to the first optical waveguide or the second optical waveguide, and wherein the first and the second optical waveguides conform to the outer surface.
45. The surgical instrument of claim 44, further comprising an air gap disposed between the retractor blade and the first or second optical waveguide.
46. The surgical instrument of claim 44, wherein the retractor blade comprises a tubular cannula.
47. The surgical instrument of claim 40, wherein the first or the second optical waveguide comprises a planar and rectangular shaped waveguide.
48. The surgical instrument of claim 40, wherein the first or the second optical waveguide comprises a trapezoidal cross-section.
49. The surgical instrument of claim 40, wherein the coupling element comprises a hinge.
50. The surgical instrument of claim 40, wherein the coupling element comprises a film.
51. The surgical instrument of claim 40, wherein the coupling element comprises a flexible joint.
52. The surgical instrument of claim 40, wherein the front or rear surface of the first or the second optical waveguide is convex or concave.
53. The surgical instrument of claim 40, further comprising a substrate layer of material, and wherein the first and second optical waveguides are attached thereto.
54. The surgical instrument of claim 53, wherein an air gap is disposed between the substrate layer and the first or second optical waveguide.
55. The surgical instrument of claim 40, wherein the first and the second optical waveguides are disposed in a layer of material.
56. The surgical instrument of claim 40, wherein each of the first and the second optical waveguides are independently coupled with a light source.
57. The surgical instrument of claim 56, wherein each of the first and the second optical waveguides is coupled to a separate optical fiber.
58. The surgical instrument of claim 40, further comprising an optical coating or cladding disposed over the first or the second optical waveguide.
59. The surgical instrument of claim 58, wherein the coating or cladding has an index of refraction lower than that of the respective optical waveguide thereby enhancing total internal reflection therein.
60. The surgical instrument of claim 40, further comprising a film disposed over the first or the second optical waveguide.
61. The surgical instrument of claim 60, wherein the film comprises surface features for extracting and controlling light the extracted light.
62. The surgical instrument of claim 60, wherein the film polarizes light extracted from the first or the second optical waveguides.
63. The surgical instrument of claim 40, wherein the first optical waveguide comprises control elements which extract and control optical properties of the light, and wherein the second optical waveguide comprises control elements which extract and control optical properties of the light.
64. The surgical instrument of claim 40, further comprising a stabilizing element coupled to the optical waveguides and adapted to hold the optical waveguides in a desired shape.
65. The surgical instrument of claim 40, wherein the first optical waveguide is substantially planar and the second optical waveguide is convex or concave.
66. The surgical instrument of claim 40, wherein the first optical waveguide has a size or shape different than the second optical waveguide.
67. The surgical instrument of claim 40, further comprising one or more optical fibers optically coupled with each optical waveguide for inputting light thereinto.
68. The surgical instrument of claim 40, further comprising a single integrally formed input stem optically coupled with each optical waveguide for inputting light thereinto.
69. A method for illuminating a surgical field, said method comprising:
- providing a first optical waveguide having a front surface facing the surgical field, and a rear surface opposite thereto;
- providing a second optical waveguide having a front surface facing the surgical field, and a rear surface opposite thereto,
- wherein the first and second optical waveguides are coupled together with a coupling element;
- actuating the first and second optical waveguides about the coupling element to adjust angle or radius of curvature between the optical waveguides; and
- illuminating the surgical field with light extracted from the optical waveguides.
70. The method of claim 69, further comprising fixing the position of the first and second optical waveguides thereby fixing the angle or radius of curvature therebetween.
71. The method of claim 69, further comprising coupling the optical waveguide with a surgical retractor blade.
72. A flexible illuminated surgical instrument, said instrument comprising:
- a fiber optic bundle having a proximal region and a distal region, wherein the fiber optic bundle is cylindrically shaped in the proximal region, and wherein the fiber optical bundle is flat and planar in the distal region; and
- a non-fiber optical waveguide optically coupled with the fiber optic bundle.
73. The instrument of claim 72, further comprising a strain relief disposed over the proximal region of the fiber optic bundle, the strain relief adapted to reduce kinking thereof.
74. The instrument of claim 72, further comprising a malleable backing element having a proximal portion and a distal portion, wherein the backing element is coupled to the waveguide and may be manipulated into a plurality of shapes.
75. The instrument of claim 74, wherein a distal portion of the malleable backing element comprises a hinged region such that the distal portion is more flexible than a proximal portion thereof.
76. The instrument of claim 75, wherein the hinged region comprises a plurality of serrations disposed along the malleable backing element.
77. The instrument of claim 72, further comprising an optical connector optically coupled with the proximal region of the fiber optic bundle.
78. The instrument of claim 74, further comprising a crimping element crimped around the fiber optic bundle thereby coupling the fiber optic bundle to the malleable backing element.
79. The instrument of claim 72, further comprising a sleeve disposed over the distal region of the fiber optic bundle and also disposed over a proximal portion of the optical waveguide, the sleeve coupling the optical waveguide with the fiber optic bundle.
80. The instrument of claim 74, further comprising a frame coupled to a distal portion of the malleable backing element, and wherein the optical waveguide is disposed in the frame.
81. The instrument of claim 74, wherein the malleable backing element comprises a window disposed along the distal portion thereof, the window configured to receive a portion of the optical waveguide.
82. The instrument of claim 74, wherein a proximal portion of the optical waveguide comprises a flanged region for engaging a portion of the malleable backing.
83. The instrument of claim 74, further comprising standoffs disposed between the malleable backing and the optical waveguide, the standoffs forming an air gap therebetween for enhancing total internal reflection of light traveling through the optical waveguide.
84. The instrument of claim 72, wherein the optical waveguide comprises surface features for extracting light therefrom and controlling direction of the extracted light.
85. The instrument of claim 72, wherein the optical waveguide comprises a coating or cladding for controlling optical properties of the waveguide.
86. The instrument of claim 85, wherein the index of refraction of the coating or cladding is less than the index of refraction of the waveguide.
87. A method for illuminating a work space, said method comprising:
- providing an optical waveguide coupled to a malleable backing element;
- forming the backing element into a desired shape;
- coupling the optical waveguide to a source of light;
- extracting light from the optical waveguide; and
- illuminating the work space.
88. The method of claim 87, wherein forming the backing element comprises bending the backing element.
89. A surgical illumination system for illuminating a surgical field, said system comprising:
- an optical waveguide for illuminating the surgical field with light, wherein the optical waveguide comprises a light input end, and wherein the light is transmitted through the waveguide by total internal reflection; and
- a plurality of optical fibers formed into a fiber bundle, the bundle optically coupled to the light input end, and
- wherein the plurality of optical fibers are arranged in the bundle such that adjacent fibers engage one another with an interstitial space disposed therebetween.
90. The system of claim 89, wherein the plurality of fibers arranged into a bundle having an outer perimeter that is hexagonally shaped.
91. The system of claim 89, wherein at least some of the plurality of optical fibers are formed from a polymer.
92. The system of claim 89, wherein at least some of the plurality of optical fibers have a diameter of about 750 μm.
93. The system of claim 89, wherein the plurality of fibers consist of 19 fibers.
94. The system of claim 89, wherein every three adjacent fibers form a triangle.
95. The system of claim 89, wherein plurality of fibers are arranged in three concentric layers of fibers.
96. The system of claim 89, wherein the plurality of fibers are arranged into a plurality of linear rows of fibers.
97. The system of claim 89, wherein an optical element is disposed between the bundle and the light input end of the waveguide.
98. The system of claim 97, wherein the optical element comprises a lens, optical coupling gel, a relay rod or hollow coated cones.
99. The system of claim 97, wherein the optical element comprises a body having a circular shape on one end, and a hexagonal shape on an opposite end.
100. The system of claim 89, wherein the bundle is butt coupled to the light input end of the waveguide.
101. The system of claim 89, wherein at least one optical fiber is disposed in at least one of the interstitial spaces.
Type: Application
Filed: Sep 24, 2013
Publication Date: Aug 7, 2014
Applicant: Invuity, Inc. (San Francisco, CA)
Inventors: Alex Vayser (Mission Viejo, CA), Fernando Erismann (New York, NY), Douglas Rimer (Los Altos Hills, CA), Gaston Tudury (San Francisco, CA)
Application Number: 14/035,583
International Classification: A61B 19/00 (20060101); A61B 17/02 (20060101);