Patent Application
20090093761
There are pocket-transportable inexpensive medical optical assistive devices (e.g., $200-$400 cost) and one very exceedingly expensive floor-mounted ($25,000 cost) medical optical assistive device of this general sort in the prior art of guiding devices for the insertion of needles into veins, for example, to draw blood or to give an injection (“needle-sticking”). Needle-sticking is a particularly exacerbating problem with older people, whose veins are notoriously difficult to find and to position.
The inexpensive devices, of which the Veinlite EMS® viewable at www.veinlite.com, Sugar Land, Tex. is a typical representative example, all give relatively poor optical contrast of subsurface lumens for their stated purpose of needle-stick guidance or subsurface lumen inspection. Further, they do not protect the practitioner from blood (or bodily fluid) splashes and they require the practitioner to utilize one hand to hold the device while the other hand does the sticking. This juggling invites practitioner self-inflicted needle-sticks which cause considerable mental anguish for the practitioner when accidentally stuck as he/she frequently is obliged to receive preventative treatments against blood-borne diseases which the patient might (or might not) have.
The prior art devices also offer no features or capabilities to address pain or to deliver any type of patient-beneficial therapy or treatment, such as for the potential or perceived pain caused by carrying out a needle or puncture-related procedure such as a needle-stick or needle-biopsy. Our invention herein addresses all of these issues by providing one or more cooperative means of improved device optical contrast, a means of device skin or tissue/limb attachment, juxtaposition or presentation and a means of blood-splash protection for the practitioner, all preferably in a lab coat pocketable device. We also provide multiple means for pain reduction and several means of enhancing lumen dilation such as for making a needle-stick easier. We further extend our device's novel integrated therapy capabilities beyond just pain treatment by making it capable of delivering electrode-excitation based therapeutic treatments and magnetic treatments of a variety of types—not just pain reduction therapies. Finally, we also enable our device to provide some physical guidance or mounting for procedural implements such as blood-sampling and biopsy needles. Thus the device can guide the practitioner to tissue targets of interest as well as help him/her guide a procedural implement to if not also into the tissue. The implement guiding can be both visual in nature (seeing the needle and/or target-possibly including while inside the tissue) as well as physical (helping the practitioner align or hold a procedural implement).
The very expensive VeinViewer® device from Luminetx of Memphis, Tenn. viewable at www.luminetx.com is not the sort of device that a doctor or practitioner could ever carry around in his/her pocket even if he/she desired to do so. That device utilizes infrared subsurface tissue imaging and reprojection of the imaged infrared contrast as human-visible optical contrast upon the overlying superficial skin surface. At $25,000 per system, still only one patient can be treated at a time. From our own developmental efforts, we do not see this expensive unit providing proportionally better procedure assistance than the far more inexpensive prior art devices nor than our inexpensive inventive device. In essence, the inexpensive units are about a hundred times more cost efficient-particularly ours herein which provides superior optical contrast and is safer and easier to use and optionally offers a variety of pain-control and electrode-based or magnetic-based therapy capabilities never seen before in such an assistive/guidance device.
We provide an improved device that solves the optical-contrast problem, the blood splash problem, and allows for the practitioner to utilize both hands (as needed) to undertake his/her medical procedure or intervention without having to hold or manipulate the assistive device with one hand while doing so if he/she so desires. This will reduce or completely avoid self-inflicted practitioner needle-sticks, as the practitioner will not be juggling two separate apparatus (e.g., assistive device and syringe) at the same time.
We further provide a means to manipulate blood flow in the limb as an integral part of the device solution, if that is also desired. Also new is the delivery of pain-management and other electrotherapies or magnetic-based therapies from such an optically assistive/guidance device. Such pain may or may not be related to the intended action of needle sticking or tissue penetration. The pain-therapy or other deliverable therapy may be related to a preexisting problem in the patients body (e.g., varicose veins or a muscle injury for example) and the assistive device assists in delivering the therapy to that location. Thus some applications of the device will not involve needle-sticking or skin-puncturing and may not even involve pain. The preferred device is pocketable, can run on a rechargeable lithium-ion or nickel-metal hydride battery, or can run off of an external battery charger or power pack. The optional device capabilities in a product would likely include the electrotherapy and magnetic therapy features and lumen-dilation features.
We anticipate device use in both an examination-only mode and an examination plus procedure and/or therapy mode. One may also choose to deliver only a therapy. Therefore, the device can also be considered a combination device whose one or more capabilities may be utilized on a given patient.
Colors, in terms of wavelength ranges, overlap to a degree as does human color judgment:
By “yellow-orange” or “orange-yellow” we mean containing at least one wavelength from each of the above orange and yellow wavelength ranges.
By “orange-red” or “red-orange” we mean containing at least one wavelength from each of the above red and orange wavelength ranges.
By “white” we mean having mixed wavelength content generally across or distributed continuously or discretely across some or most of the white wavelength range stated above.
By “infrared” we mean at least one wavelength of the NIR, SWIR, MWIR, LWIR or VLWIR ranges unless the specific range, (e.g., NIR) is specified. This will typically be a wavelength longer than 0.7 microns.
Electrotherapies and Electrode-Based Therapies
Examples of TENS and other electrotherapy device sources include:
Many such electrotherapy units utilize carbon electrodes with a stickable gel; however, it is possible to utilize needle or acupuncture needles as electrodes as well. We include in our inventive scope the use of a procedural needle or other puncturing or cutting implement as a TENS electrode (or as an electrode for any other inventive electrical or electrotherapy therapy). Our device housing might also be or support (or comprise) a TENS or other electrotherapy electrode(s) such as on its skin-contacting surface.
Let us begin with
The particular example device 1 shown in
Referring now to
Most often, but not always, the second tissue region whereat optical contrast is viewed will be a separate region such as the slot 2/radius 5 region while the light causing the optical contrast will be injected at a first tissue region, separate from the second region. In the
Continuing with
The example light sources 7 are mounted in holes 8 that intersect the bottom (skin) surface of the device with elliptical apertures 7a. This shape is the natural result of a cylindrical hole 8 intersecting a plane at an angle to the hole axis.
It will be noted in
We earlier noted access and viewing enhancement taper angles theta 1 on the slot arms 3 and 4 and radius 5 and these are specifically depicted in
Note that each LED 7 in
Note that the light sources 7 arranged on the side arms 3 and 4 and radius 5 are depicted as generally having their central emission axes 7b approximately parallel to each other (at least on the arms 3, 4) given the straight-arm defined slot 2. This parallelism is not a requirement nor is the depicted straight inside slot-edges as mentioned. We have found that for a variety of shaped slots 2, such as for a generally rectangular/straight slot (shown) or circular, elliptical or parabolic slots or windows 2 (not shown), it is beneficial to have at least some of the light source 7 central beam alignment axes 7b be oriented approximately normal to the local slot edge (as shown for all of the light sources 7 in this example). Note that because the light sources 7 are closely packed and their central beam lines 7b may be parallel (as shown on the straight interior slot edges), because of their divergence cone angles 7c light from adjacent neighboring sources 7 overlaps and it overlaps coming from different directions (from differently situated light sources 7). Note also that light sources 7 mounted at the radiused end 5 of the slot 2 are each depicted arranged being approximately individually perpendicular to the local round slot edge, thereby causing the light sources alignment axes 7b to be at an angle to each other (not parallel like on the arms 3 and 4) in this radiused region. The present inventors have found that good optical contrast for a region such as slot 2 or radius 5 can be derived from one or both of a) close juxtaposition of generally edge-normal light sources 7 as on the straight interior slot edges), and/or b) close juxtaposition of nonparallel but locally radius-edge normal sources 7 as shown in the radius 5 region. This is not to say that straight edge non-perpendicular sources are unattractive; in fact, we have found them to be also useful.
We mentioned the use of a light dam or gasket such as item 6. We wish to again note that if the illumination sources 7 are sufficiently tilted upwards (towards being skin-normal (e.g., 45 to 90 degrees to skin) and have sufficiently narrow divergence angles that one may eliminate the light gasket 6 whose job is to prevent direct lighting of the skin surface. Such a device would be functional even off the skin surface with a gap between the device and the skin. The present inventors have also noted, particularly for light sources 7 approaching skin-normal light entry, that the entire device can be lifted off the skin surface somewhat and still function. In fact, we have noticed that by slightly lifting the device from the skin surface, we eliminate skin extrusion out of region 2. Such skin/tissue mounding or extrusion may cause shadowing of some or all of the extruded skin regions. By slightly lifting (or spacing) the device off the surface, we eliminate all such shadowing because the tissue is not extruded or mounded-up above the light beams by the device. Such “lifting” or standoff-presenting of the device can be accomplished by an underside spacer(s) (not shown) similar to that of item 6 but larger and more likely placed around the outboard edge of the device as opposed to the inboard edge where light gasket 6 is shown. Conveniently, this lifting spacer can be part of the device housing or can be a separate attached spacer(s).
Before discussing light sources, we wish to emphasize that the inventive device may take many physical shapes/forms beyond that shown in
The above cuff-band device with an elongated co-wrapping observable window region 2 also does a particularly nice job of illuminating veins. For light sources situated on the long edges of the wrapping observable window, their light is passed into tissue generally parallel to the veins that mostly run up and down the arm. Because of this parallel illumination, one avoids circumferential shadowing of the veins themselves. In a preferred cuff-like device, it would wrap and self clamp on the arm and its elongated window would also peripherally or circumferentially wrap around some of the arm and have radiused or rounded ends. Light sources could be employed at the long edges as well as at the radiused ends. Similar to
The present inventors' best design to date is a cuff-like design wherein the elongated cuff window portion containing the light array is relatively flat at the skinline whereas the remainder of the cuff is curved. We also found that we could populate that elongated relatively flat window only on its opposed long sides and did not need lights of the radiused ends. So this is a little like a large watch wherein the skin-contacting watch body is flat but the flexible band is curved and conforming. The lights in this array are directed in planes approximately parallel to the veins running up and down the legs and arms.
This is an appropriate point at which to discuss light source technology useable in the inventive device. To begin with, our elliptical (in this example) light apertures or windows 7a out of which light emanates into the skin or tissues 9a/9b may or may not contain a local bulb or LED light source. Indeed, in
In general, we anticipate several different kinds of light sources useable in the inventive device. These include the following:
The present inventors have utilized red, red-orange, orange, orange-yellow, amber and yellow as well as white light sources and infrared light sources to good effect. Wavelengths in the red-red/orange-orange range or white give the best performance in a variety of skin and tissue types. Thus, inventive devices may be arranged, for example, to have any of a) only one wavelength or source color (e.g., all red or orange or white sources) or b) two or more different wavelength or color source types (e.g., some red sources and some orange or white sources), c) one or more source or color types having a distributed-wavelength or multiwavelength output capability (e.g., white or red-red/orange-orange), or d) one or more source or color types such as from light source (2) above wherein the light source can be operated at two or more different wavelengths or colors separately or simultaneously in time.
Further, we note that the inventive device 1 may have differing numbers of light sources (as well as both discrete and distributed sources), depending on their individual brightness, emission divergence angle, packing density, size, mounting geometry, and power-consumption. As an example, using medium brightness small 3 mm diameter LEDs, we would expect to have many light sources, for example on the order of 24 to 60. Using super-bright 3 mm or bigger (e.g., 5 mm) LEDs, one can make do with more like 12 to 30 light sources for the
The types of light source technologies useable in the present invention cover basically any available light source technology. These certainly include, for example, LEDs (light emitting diodes), filament-incandescents, solid state laser chips (including vertical cavity versions), halogen bulbs, arc-lamps and all manner of discharge lamps, fluorescent-based sources, phosphorescent-based sources and OLEDs (organic light emitting diodes). Also included are very short pulsed lamps such as flashlamps.
The light sources may emit constant light (e.g., DC or AC powered) or pulsed (e.g., DC or AC powered) light and those of the same or different color or mounting position may be operated simultaneously or in a temporally interdigitated, interleaved or overlapped manner. The user will perceive time-averaged or fusion-rate colors and intensities from mixed-color and pulsed lights in the known manner, presuming the pulsing frequency is above the beginning of the known visual fusion threshold in the 10-30 cycles/second regime. The invention may also be used with pulsing or switching lights wherein switching or pulsing frequencies are below the perceived visual fusion rate such as at 1 to 10 cycles/second. This is actually beneficial when the practitioner wants to discretely see the difference in contrast between two different lighting wavelengths and/or two differently situated light sources. The eye is very good at detecting and interpreting such variably-illuminated features, particularly in regard to their location and true dimensions.
Of particular utility is the time sequencing of light sources that deliver light to optically-contrasting targets of interest typically from different angles or depths (and/or from different colors from the same or different light source locations). This serves to help the user judge the feature position and depth in/under the observed tissue regions in slot 2 and radius 5. Such time sequencing is best done at visual fusion rates of 15 to 30 frames per second or faster if visual blending is desirable—and at a lower frequency (e.g., 1 to 10 cycles/second) if discrete states of differential lighting are to be compared or seen. Differential lighting effects can also include, as opposed to on/off operations, intensity-varying or color varying operation of two or more light sources relative to each other or of one or more light sources.
We note that surface-mount LEDs and light sources can be much smaller than cylindrical type LEDs or light sources and therefore one can fit more of them in a smaller and/or thinner and/or deformable package. They can also more easily be arrayed, perhaps even having different beam angles and in N by M rows/columns. They can also be mounted to a flex circuit or PC board and provided to the device during manufacturing as a pretested subassembly. A shaped flex circuit (not shown) with surface mount LED chips provides an inexpensive and compact manufacturing approach.
The present inventors make a further note regarding light sources and how to employ them. We have mentioned that viewing tissue features at two or more simultaneous or sequential wavelengths can be useful. Another way to do this is to populate a viewing aperture or window region 2 with different color lights at different window 2 locations. Now, when the device is physically scanned upon the tissues, one not only translates/rotates the skin/tissue under the window but also can alternately pass the two or more different colors over feature(s) of interest. So this is essentially color-switching via repositioning. Of course, our previously mentioned methods of electrical switching among bulbs or among the different colors of a given bulb can also be employed, in a fixed device position or also across scanned positions.
Moving now to
Most applications of the device 1 will involve a procedure being performed or delivered while the device 1 is on, juxtaposed to or held near the skin/tissue. However, the pre-sent inventors anticipate some applications wherein no immediate (or any) procedure is performed at all or wherein a procedure is performed after a feature of interest is located and the device has been removed or moved aside. By “procedure” here we mean all types of procedures including invasive ones, noninvasive ones and therapies such as electrotherapy and magnetotherapy or magnetotherapies.
In
Further, we see the near sides of two straps 11 in
We explicitly note that desired device motions may be relative to the skin or tissue surface and/or relative to the skin/tissue-underlying tissue (e.g. deeper veins or tumors) and these may move somewhat independently (or not) depending on how tightly the device is attached or otherwise juxtaposed. Veins can move somewhat relative to their overlying skin/tissue or vice-versa. Thus, when we implement device/tissue motion, it may be motion of the device relative to adjacent skin or device/skin coupled motion relative to deeper underlying tissue or lumens. Such relative motion variations are apparent given the optical contrast such that the practitioner can manage them as by controlling slippage (if any is to be allowed) of the device to skin interface. This can be done as by controlling strap(s) tightness or device skin contacting-forces.
It will be appreciated that the strap(s) 11 may be permanently attached to the device 1 or temporarily attached. In both of these cases, they may be attached to device 1 before or after device 1 itself is juxtaposed to tissue. In an alternative approach, the straps may be pre-attached to the skin/limb/organ, the skin/limb/organ possibly favorably distorted, and then the device 1 is attached to the pre-attached strap(s) 11. In any case, the straps may themselves totally enwrap the limb/organ or they may partially enwrap the limb/organ in the cases wherein
a) the strap(s) are attached to the device sides as shown, or
b) the “straps” are actually pliable clamping or pinching arms (not shown) and do not need to be completely enwrapped and co-linked to perform a useful limb or tissue gripping and/or distortion function.
We note that depicted strap(s) 11 may be stretchable, unstretchable, tapelike, bandlike, chainlike, adhesive-like or suction-like. The device housing itself may also or instead employ such attachment or friction-controlling means such as adhesives or suction between it and a skin or tissue surface. They may also be semi-rigid or elastically bendable and be more like clamps or clasps (not shown) than flexible straps (shown). They may or may not pass all the way around the limb or organ of interest and interlock to each other as described. However, a common approach will be stretchable straps (shown) that bind or otherwise adhere to each other's ends to achieve an at least temporary device 1 mounting. The straps, particularly if they are more in the form of separate malleable or elastic arms (not shown), will possibly not interlock as, for example, on the limb far side such as for the second device example of our cuff device. The arms might even be an integral part of the device 1 housing, for example, and such arms might form an enwrapped enclosure by buckling or clasping to the device housing upon snapping-shut. We noted that the straps/clamps may be pre-applied to the skin/tissue before the device 1. In that case, when the device is applied to the pre-applied straps, it might be rigidly held or it might be loosely held such that device/skin or device/skin subsurface tissue scanning motion is still allowed. The present inventors specifically anticipate an embodiment wherein the device is loosely (and possibly also tightly) mountable to the limb, the loose condition being a scanning condition. By “loose” we mean movable with some effort without dismounting, relative to one or both of surface skin or tissue/lumens underlying skin. Depending on scanning and fixation requirements for the intended procedure, one may arrange for the straps to either be slippery (e.g., Teflon® fabric) or non-slippery upon the skin surface.
In
We depict in
Again, by “strap” we include all manner of locking clamps or members 11, which may have their own malleability, elastic or spring nature, limb-grasping or locking means, clips, buckles, snaps, self-adhering portions, or zippers. These therefore do not necessarily have to clasp or fasten to each other in order to achieve limb or organ fixation; in fact, there may be only one which wraps mostly around a limb or organ on a housing-hinge, for example.
The strap(s), especially in the case of their being adhesive or microscopically (e.g., Velcro®) interlocking limb or tissue adhering members, might be disposable. They (or it) may also be situated partially, mostly or entirely under the device in the device/tissue interface and might therefore include holes or transparent regions for the light sources or for the viewable contrast region(s). Such strap(s), adhesive or otherwise, may also support a TENS or other electrode or magnetic therapy means or drug means such as for pain-reduction or lumen-dilation described further below. We also include in the scope of the invention the device delivery of warmth or cooling to tissue of interest used for purposes such as pain-relief, accelerating or activating drug activity or uptake or for encouraging lumen and/or capillary bed dilation or constriction. Such dilating warmth may come, for example, from our assistive light sources, from separate light sources (e.g., infrared), from the waste heat of the device itself, from dedicated heaters or coolers in/on the device or from a pre-warmed or pre-cooled device as pre-warmed or pre-cooled in a pre-warming or pre-cooling device-tank, holder or thermal medium.
The present inventors anticipate variations upon the device wherein one or more arms or members 3 or 4 can be flexed, bent, or twisted into a desired formable or positionable shape or geometry such as to more suitably conform to or favorably align with or be juxtapositioned to a tissue or limb of interest. Such deformation may be in one-, two- or three-dimensions and might be elastic and/or plastic in nature. Such deformation(s) may itself provide limb or tissue fixation capability, thus possibly eliminating the need for separate (from arms 3, 4) fixation straps 11. Note that this would comprise a self-fixating device 1. An example of this is that wherein arms 3 and 4 are elastically wrappably deformable around a limb or organ portion or skin volume such that they self-clamp to the limb, organ or skin. Our mentioned cuff device could easily be made self-clamping by making it in the form of a mostly closed or totally closed or closable bracelet or armband. By “conform” we mean any one or more of: (i) having minimal lateral surface light-leakage, (ii) having a set of light sources creating useful contrast from a desired set of injecting positions/angles, (iii) providing a loose or snug device fixation action by conformably squeezing a tissue or limb, (iv) causing a desired state of skin/tissue distortion for optical-contrast and/or flowable lumen manipulation reasons, or (v) applying TENS or other electrotherapy electrodes, magnetic therapy fields, a drug-source, a vibratory source or a heat-source to tissue utilizing a device conforming behavior or force.
We note example bending arcs 3a and 4a depicting two arms 3 and 4 which might be bent (or simply rotated), at least temporarily, to allow for better device conformance and/or a more desirable slot shape 2/radius 5 second tissue portion observable-contrast region. Note that such bending, distortion or rotation may be in one or more planes (one plane shown) and may involve malleable, plastic, elastic, hinged, sliding or pivotable motions of housing parts or of light sources within. It could also involve substitution of parts as for a kit containing a variety of arm geometries.
The first tissue region is that where the light sources are doing their light injection under the arms 3 and 4 and adjacent the radius 5 slot region. In the depicted device of
Practitioners doing needle-sticks will frequently utilize tourniquets or other blood flow stoppage means to make subsurface lumens more visible and/or more stickable. Within the inventive scope is the use of our fixation strap(s) or attachment means 11 for that tourniquet purpose and/or for the general purpose of distorting the tissue to favorably affect a desired aspect of procedurally-useful optical contrast or stickability. Recall that such fixation may, in part or in total, be offered instead by deformable or pivotable members themselves such as arms 3 and 4 which could capture tissue or a limb between them.
We note in
Recall that we may promote beneficial lumen or vein dilation using the TENS, NMES, other electrotherapy or magnetic therapies and/or drugs as well or instead of using physical tissue distortion means such as the strap/device loading.
The device 1 is comprised mainly of a housing which has one or more appendages, arms, or slot/window (region 2) defining perimeters possibly deformable or movable, which can define an observable second skin portion(s) such as a region 2. Observable second tissue region 2 does not necessarily have to include a lateral opening (shown in
We include in our inventive scope the inclusion of any blocking or masking feature(s) which favorably psychologically prevent the patient (or practitioner) from directly viewing the procedural site for at least some period of time-if that is desired.
We also include the option wherein a disposable entity is a light-distributor, such as a disposable arm that distributes light and when mated to the housing is optically coupled to a light source(s). Only the light-distributing element might rest on or juxtaposed to tissue. The powering housing might be situated off of the limb.
Movable or deformable housing members or arms such as 3 and 4 may be elastically or plastically deformable or may even be hinged or mounted on sliders. They may be lockable in various states of distortion, position or shape by a dedicated locking means (not shown) or as by a condition of strap or hand/finger-loading of the device 1. Any internal electrical wiring that connects to the light sources may be in the form of any one or more of flexible circuitry, printed circuit boards or discrete wires or cabling (none shown for simplicity) for example. Fiber optic or light-transmitting conduits, reflectors, gratings, other optical elements or arrays thereof or diffusers may also be routed in the housing as for delivery or direction of light to or from one or more discrete or distributed apertures or light-emitting windows.
Generally speaking the device will be at least wet-wipeable as with a damp disinfectant or sterilizing wipe or towel. Other hardier models may be designed to be further immersable or perhaps even autoclavable or treatable by hydrogen-peroxide sterilizing procedures. Further, looking at the bottom (skin-contacting when used in device-contact mode) first tissue-portion surfaces of the device where the light sources emit their light, it will be desirable to have a smooth surface with the possible exception of any depicted light-dam or light-gasket 6. Such a smooth surface can be provided as by a smooth optically transparent window layer (not shown) overlying at least the light sources. In some designs, this window layer may serve the above-mentioned skeleton function wherein light sources mount into that skeleton or backbone layer first during manufacture. It is advantageous from the cleanliness and comfort points of view to have the bottom device surface be smooth or at least have no reentrant cracks or slits between mating parts.
We now temporarily go back to
Preferably, it is anticipated that with a few hours of overnight recharging, the device can be utilized for most of the clinician's workday without a battery change or help from an external power source/recharger. However, the device may also be operated as by changing out weak batteries or by plugging in a power source and/or recharger into a connector such as 13 (with or without the battery present). A battery-capable or self-powered device capability is preferred. Obviously, the total useful light emission time will scale with the total integrated light intensity and battery capacity.
We anticipate the possibility of any one or more of the following features being utilized in/on/with the device apparatus or as part of the device application and use method:
Returning to
Let us now discuss the observable contrast region slot 2/radius 5 again. The pre-sent inventors anticipate in many embodiments this observable second tissue portion being entirely open and unencumbered (as shown in
Some embodiments are anticipated wherein observable region 2/5 has some bridging material elements or members (not shown in Figures). The term “bridging” means spanning across some or all of a dimension of the observable region 2 either in contact with the tissue or above the tissue. Presuming these bridging elements are optically transparent, then they will not interfere with the act of finding or locating the skin or subsurface tissue features of interest in the second observable contrast region(s). Such bridging features could, for example, be preferably transparent members which link or lock arm 3 to arm 4 at chosen adjusted or lockable slot widths or shapes. They could act as optical filters as well along the lines of 10. Unless these slot-bridging members are themselves stickable, which they might be, then one would move device 1 or a portion thereof (relative to tissue or lumens) to allow such sticking of tissue which was previously under such a bridging feature. Such bridging features may also comprise or include light source regions such as distributed light sources or transparent diffusers that may even be stickable through the bridging material (which may also be disposable). Note that in that case at least some first tissue portion and second tissue portion are the same portion. In one preferred case, a transparent bridging member is a distributed light source having its powering injecting light source off to the side such that the entire bridging feature, member or plate is transparent or translucent and light-injecting. We include in the inventive scope a bridging feature being any one or more of: (i) part of a strap 11 or other device retainment or fixation member, (ii) being disposable, (iii) being stickable as for a thin or perforated polymer or fabric, (iv) being a source of light, such as it being a light distributor (including even being the only light distributor), (v) being adhesive or suctioned in nature to the skin and/or to the device, (vi) being an optically transparent sheet of polymeric or fabric material as utilized, the sheet or fabric being either rigid or conforming, (vii) supporting or controlling a motion or distortion of an arm such as 3 or 4 or providing locking features therefore, (viii) serving as any part of a strap 11 system or anchor therefore, (ix) serving as a TENS or NMES electrode, other electrically-therapeutic or treatment electrode, source of magnetic therapy, source of drug, source of heating or source of vibration, (x) serving as a means to guide an implement, steady an implement, hold an implement or mate with and/or stick-protect a practitioner's finger(s) for any purpose, xi) being in contact with tissue or being raised off the surface of the tissue, or xii) being a tissue marking or measuring means.
It is expected that the inventive device 1 may be utilized anywhere on the body such as on an arm, leg, hand, wrist, ankle, neck or breast. It may also be utilized on exposed organs such as during surgery to find subsurface features or inserted invasive implements of interest or importance. Thus it might be inserted in a wound or body cavity, natural or otherwise. It could also be integrated onto the business end of a scope such as a colonoscope, gastroscope, bronchoscope or laparoscope and utilized remotely or by a robot.
The present inventors have also noted that the optical contrast provided includes optical contrast of the procedural implement itself, such as a view of the needle within the tissue and/or above the tissue. We include in our inventive scope the assistive/guidance device being used to visualize a needle or procedural implement below the skin/tissue surface. The present inventors have noted that needles can be seen to some depth as by a combination of toplighted/sidelighted reflection and bottomside light blockage or backlighting. One might even utilize a syringe lumen or other inserted implement as a light pipe in order to provide needle-tip tracking light on the needle itself. An invasive implement or needle might be made maximally reflective at the devices illumination wavelength(s) to enhance its subsurface visibility.
The present inventors emphasize that inventive assistive/guiding device 1 may be used for invasive or noninvasive procedural support. The “procedure” may involve an optical device exam alone, an optical device exam in support of a noninvasive or invasive treatment, or even delivery of a therapy alone without necessarily utilizing the optical exam capability. Many users will combine an optical exam with a treatment and many of those will have the treatment be optically-guided or assisted.
The practitioner, upon identifying a feature of interest using the device, may need to puncture or otherwise compromise a tissue/skin integrity or may not have to, either immediately or at a later time or date. An example of not having to disturb the tissue (at least not at the time of device observation) might be the device-assisted inspection of varicose veins to judge their state of disease. The practitioner might then recommend a non-surgical or surgical intervention or drug intervention be carried out on a different day(s) with or without the help of the device.
The present inventors also anticipate other valuable device embodiments such as:
The rationale for using TENS or NMES technology for pain is based on the following: It is well known that intensely massaging a pain site tends to reduce the perception of pain. This is because in the spinal cord there is a “pain gate” that serves to filter nerve impulses, only permitting the majority of impulses from a certain class of fiber to travel through the spinal cord and to the brain. For example, if pressure impulses from A delta fibers outnumber painful impulses from C pain fibers, then only the pressure impulses will be received by the brain. In this way, by applying strong pressure to a very localized site, pain signals will not successfully be transmitted through the pain gate and hence the patient will perceive little or no pain.
TENS, NMES or any other electrode-based treatment electrode(s) may be applied to the skin as by mounting them under or adjacent the device and/or its fixation straps 11. They may be powered by their own supply or by electronics and/or power provided by the device 1 as through an electrode jack similar to the jack 13. The present inventors have found that continuous TENS electrical excitation seems to give somewhat more patient pain-relief than pulsed excitation. We have also found that it is important not to press too hard on the operating TENS electrodes as this can actually cause pain. Thus, we anticipate lightly loaded TENS-pain electrodes or self-adhering electrodes being preferred. In terms of TENS electrode(s) placement, what is important is that the site of the actual procedure implementation benefit from the associated electrical TENS current but that will frequently be possible having the electrodes located away from the actual procedural site—such as on the device sides or further around or along the limb.
We emphasize again that device-integrated therapy or treatment delivering electrodes may be utilized for purposes other that pain reduction, whether the pain is needle-stick associated or is from a preexisting condition such a varicose veins, a pulled muscle or a pinched nerve. Thus the device is a generic electrotherapy, electrotreatment and magnetic-therapy/treatment tool as well. A second such purpose is the mentioned lumen dilation. Inventors have demonstrated both TENS and NMES lumen dilation.
The overall size of the device may be, depending on patient size and bodily application to man or animal, from an inch or so up to ten inches or so in its maximum length, width or diametral dimension. Most useful devices will be in the 1.5 inch to 8 inch maximum dimension range. A device skin-abutting or juxtaposable surface(s) may be flat or curved, rigid or conforming. The present inventors have fabricated more than 15 good working devices generally like that in
The second skin portion optical-contrast viewing region(s) may or may not have an access opening (or depression) on its end or edge (as shown in our
Any portion of a second skin portion viewing hole or window 2 may be temporarily or permanently bridged by assistive bridging components (none shown in
Examples of above-mentioned and further window/hole bridging components include:
Given that many of these capabilities may optionally be used with or on the device, the present inventors expect that the device may be provided in kits containing one or more of these additional optional components, some of which may be disposable. Other of these features, disposable or not, might be purchasable as optional separate items. We also expect that the practitioner may want to purchase such consumable components in quantity-preferably in individually sterilized packages in sterile bundles thereof. Web-based purchasing would be convenient.
We expect that the device will frequently be arranged, as taught, to support pain-reduction as for reducing the actual and/or perceived pain and/or anxiety of a needle-stick or other procedure-related skin disruption. The above described TENS and NMES electrode(s) on the face of the device or elsewhere on the skin surfaces can reduce such pain. Whether located on the device face, adjacent the device, or elsewhere on the skin one would likely utilize two or more cooperating electrodes that treat tissues, at least the procedure-related tissue between them or electrically coupled to them. Magnetic exposure may also decrease perceived pain.
Note again that pain treatment using the device might also involve preexisting pain having no association with pain caused or anticipated by a device-assisted procedure.
We emphasize also that device related pain treatment, such as by electrotherapy of drug delivery, may be for procedure related pain or preexisting pain issues such as pain from an injured joint or skin-burn.
A pain-relieving gel or cream as supplied in the form of an associated drug or medicament-laden wipe or patch may instead or additionally serve such a purpose. Such a wipe or patch may be used on the target tissue one or more of: (i) before device placement or juxtaposition to tissue or skin, (ii) after device placement or fixation such as after a feature of interest has been found using the device, or (iii) after or during delivery or performance of the device-assisted procedure (e.g., needle-stick, biopsy-stick) before or after device removal. Similarly, the device itself could be provided with a disposable pad that serves one or more purposes such as adhesive-mounting of the device and/or delivery of a pain-reduction or optical tissue-transmissivity improvement cream or gel. The device itself may include a reservoir or even just a wettable surface for such a drug or medicament. Both TENS and/or NMES electrodes and the drug may one or both also encourage lumen and capillary bed dilation.
An optical-contrast agent, if employed, would most likely utilize an optically excitable dye or nanoparticles that may be systemically or locally delivered, and furthermore may even be biologically targeted to specific molecules or diseased cells. Such excited optical contrast might also be excited from the natural tissue and body fluids themselves without an agent as some bodily constituents are fluorescent. In this manner, the assistive device may view skin and subsurface disease states that may then optionally be treated independent of the device, the device assistance being the finding of such disease state if it is pre-sent.
The device may be provided TENS and/or NMES-capable (or capable of other electrotherapy modalities), meaning it already has built-in at least some of the necessary connector(s), signal generation circuitry and power-source to drive TENS, NMES (or other electrotherapy) electrode(s). Thus using TENS, NMES (or other electrotherapy) would simply be a matter of plugging the electrode connector(s) into the device and switching the TENS, NMES (or other electrotherapy) capability on. We include in the scope of our invention the delivery of TENS, NMES (or other electrotherapy) treatment before, during and/or after a guided procedure is carried out. The device vendor may also opt to include the TENS or NMES support only on units specifically purchased to also support TENS, NMES (or other electrotherapy). This may be as by its omission or deactivation as well. The present inventors note that once electrodes are provided, a variety of electrotherapies (see terminology section above) can be provided by simply driving the electrodes differently using different software or firmware.
Pain reducing drugs that may be utilized in support of the device or its application method include topical rubs, balms, oils, lotions, liquids, creams, ointments, patches, gels and sprays. Ones that inventors have worked with include:
Any one or more of these may be used in combination, topically, subcutaneously or systemically, as the practitioner determines is safe. Further, any one or more may be used in combination with TENS, NMES or other electrotherapy or pain-relief, vibratory pain-relief, heating pain-relief or any other kind of heat-therapy or electrotherapy as also judged safe by a practitioner.
A tissue optical transmissivity improvement means, if employed, may include a chemical that permeates the skin or tissue such as glycerol, glucose, trazograph, propylene glycol, sodium lactate, butylene glycol, vegetal compounds or liposomes. Such materials are historically known to improve optical skin transmissivity. Another related known optical transmissivity improvement means is skin surface-layer stripping to get rid of the opaque dead skin cells on the skin surface. Either or both of these could be provided for use with the device including as part of the device itself as for a device adhesive pad which also delivers a transmissivity-improver. Likewise, the device itself, or a protective cover therefore, may deliver to the skin such a transmissivity improvement medium. Skin abrasion may be implemented using adhesive tape or an abrasive implement that may or may not be device-integrated. Included in the scope of the present invention is a pain-reducing drug or and device-delivered medicament that is also a transmissivity improver as is a pain-reducing drug or electrode treatment which relieves skin pain due to skin surface stripping.
The inventive device may even drive the transmissivity improver into the tissue as by an onboard heater, vibrator or ultrasound source or by electrophoretic or iontophoretic mechanisms. Any vibrator means may also be used to drive abrasive dead skin-cell removal.
