Medical-procedure assistance device and method with improved optical contrast, and new practitioner-safety, device-fixation, electrode and magnetic treatment and lumen-dilation capabilities

• US 20090093761A1
• Filed: 10/05/2007
• Published: 04/09/2009
• Est. Priority Date: 10/05/2007
• Status: Abandoned Application

• Current Assignee: Bryan T. Oronsky, Carol A. Tosaya, George W. Keilman, Herbert L. Berman, John W Sliwa, Neil C. Oronsky
• Original Assignee: Bryan T. Oronsky, Carol A. Tosaya, George W. Keilman, Herbert L. Berman, John W Sliwa, Neil C. Oronsky
• Inventors: Sliwa, John W., Tosaya, Carol A, Keilman, George W., Oronsky, Bryan T., Oronsky, Neil C., Berman, Herbert L.
• Application Number:
  US11/973,052
• Publication Number:
  US 20090093761A1
• Time in Patent Office: Days
• US Class Current: 604/116
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

Many medical procedures, such as needle-sticking, could benefit from an assistive device that improves the optical contrast of externally targeted features and lumens of interest residing in and underneath the skin and/or exposed organ tissues. The inventive inexpensive device and method are useable on such externally targeted features and lumens while also protecting the practitioner and freeing up both of his/her hands, if necessary, to thereby eliminate practitioner self-sticking problems. The present device provides good optical contrast and also provides splash-protection against HIV, hepatitis and other blood-borne diseases. The inventive device method and apparatus may also include vibratory subcutaneous electrical nerve stimulation (TENS), drug-based or heating treatment capabilities for reducing pain, both perceived and real pain, associated with a device guided procedure. Finally, the pain reduction mechanisms have also been found useful for lumen dilation.

Claims

1. A medical-procedure assistance or guidance device capable of providing substantially non-invasively-produced or excited optical-contrast of one or more of cutaneous, subcutaneous, subsurface or internal tissues, body-fluids, lumens or features that may require locating or invasive intervention, including such as for needle-sticking or needle-biopsy sampling, the produced optical contrast improving a practitioner'"'"'s ability to one or more of locate, target or avoid said tissues, body-fluids, lumens or other features in support of an immediate or later procedure, treatment, therapy, diagnostic test or intervention requiring knowledge of said features(s) location(s) or properties, the assisted or guided procedure, treatment, therapy, diagnostic test or intervention which may or may not involve physical skin or surface-tissue penetration to or in avoidance of the located subcutaneous or tissue-subsurface feature(s), the device comprising:

an illumination or optical-excitation housing physically coupleable, adjacently-presentable or closely or contact-wise juxtaposable to a skin, tissue, limb or organ surface, the housing containing, including or supporting at least one or more discrete light sources and/or one or more distributed light sources, at least some of the light output of the at least one powered discrete and/or distributed source directable at least into one or more skin, tissue, limb or organ first-portion(s);

and

an optical contrast-improvement means,

the device providing improved optical contrast of at least some subsurface or surface skin, tissue, limb or organ features or lumens as viewed at, from, from within, through or out of a second skin, tissue, limb or organ portion(s) such that the practitioner may then or thereafter one or both of;

(i) utilize the feature location information for a patient-beneficial purpose, or (ii) utilize the feature location information to guide or assist a subcutaneous, tissue-subsurface, cutaneous or skin-targeted non-invasive or invasive medical procedure;

the first and second skin, tissue, limb or organ portions being, at least in part, different or the same portions; and

one or more second skin, tissue, limb or organ portions allowing at least one of direct or indirect viewing or recording of the device-produced or excited optical contrast.

2. The device of claim 1 wherein said at least one discrete single or multielement light source includes at least one of an LED source, semiconductor-chip source, OLED source, laser source, surface-emitting laser source, incandescent source, halogen source, fluorescing source, phosphorescent source, plasma source, flashlamp source, electrical discharge source, arc-source, filament source or optical-excitation or agent exciting light source, said powering being by an external and/or internal energy storage source.

3. The device of claim 1 wherein said at least one distributed light source includes or utilizes any of (i) an optically leaky or non-leaky solid or hollow optical waveguide, (ii) an array of discrete single element or multielement light sources, (iii) a glass, ceramic or polymeric-containing optical waveguide of one, two or three dimensions, (iv) an optical fiber or conduit of any type, including solid and hollow-reflective and refractive optical conduits, (v) an optical diffuser, lens, reflector, prism, mirror or grating, including microarrays thereof, (vi) a microlens or lens array or a fiber-optic coupled lens, (vii) any type of physically, mechanically or electro-optically scanned light source, (viii) any type of diffractive optics, reflective optics or gradient-index optics, (ix) any type of optical-excitation or agent-excitation light source, or (x) a bulk light-emitting material or film, including an OLED emitter, said powering being by an external and/or internal energy storage source.

4. The device of claim 1 wherein the device supports the operation of any of:

an electrotherapy device, including a TENS device, a tissue ingoing or outgoing electrophoresis or iontophoresis device, a biomedical or physiological sensor for any purpose, whether being implanted or not, a vibratory pain-reduction device, a tissue or feature marking or measuring component, a warming or cooling pain reduction device, a vibratory needle puncture-assistance device, a drug infusion device, a tissue optical transmissivity modification device or a device-guided or device-assisted implement,

wherein by supporting is meant any one or more of;

a) the device provides power therefore;

b) the device provides power connectivity or data connectivity therefore;

c) the device provides mechanical guiding, mounting or measuring surfaces or features therefore;

d) the device dispenses or stores a drug, medicament, medium or gel therefore;

or

e) the device provides guidance—

for or procedural assistance therefore.

5. The device of claim 1 wherein the optical contrast-improvement means includes at least one of:

a) an optical filter that selectively admits or rejects at least one wavelength of light from any of (i) light entering the skin, tissue, limb or organ for a purpose of optical contrast production or light excitation, or (ii) light falling on the skin, tissue, limb or organ as from ambient light which might interfere with a desired optical contrast, or (iii) returned, reflected, scattered, diffracted, refracted or excited light leaving the skin, tissue, limb or organ and passing to the practitioner'"'"'s eye along an optical path or to an indirect contrast imaging or recording means providing the practitioner with a visible-contrast image;

b) an optical polarizer that polarizes at least some skin, tissue, limb or organ ingoing or outgoing light of at least one wavelength somewhere on an optical path;

c) a skin, tissue, limb or organ stretching, deformation or deformation-retainment means;

d) a skin, tissue, limb or organ optical-transmissivity improvement means, including one or both of (i) a skin, tissue, limb or organ optical-property manipulation medium that is delivered to one or both of the skin, tissue, limb or organ surface or subsurface, (ii) a means to remove a dead, damaged or diseased surface skin, tissue, limb or organ layer or portion thereof;

e) an ambient light-excluding shield, shroud, cover or room-light on/off or dimmer control, at least some ambient light being intercepted or avoided;

f) delivery or application of an optically-excitable or optically viewable dye, particles(s), nanoparticle(s), surface-coating, bulk-dopant or agent to a surface, subcutaneous or subsurface skin, tissue, limb or organ portion, to an assisted or guided implement or to an implantable implant or sensor, said viewing of excited contrast being at least one of unassisted or assisted;

g) an antireflective film or coating employed anywhere on an actual or potential optical path;

or

h) a means to excite or induce optical contrast in any of a natural healthy or unhealthy skin, tissue, limb or organ tissue or body fluid, said excited or induced contrast being human visible or made human visible using a non-visible-to-visible conversion and redisplay or recording approach,

6. A kit containing at least one assistive or guiding device of claim 1 and any one or more of:

a) one or more disposable or non-disposable components used in support of the device or of a device assisted or guided procedure, including possibly splashguards, glove(s), eye-protection, optical filters, lenses, polarizers, antireflection components, ambient light-shrouds, disposable device wraps or membranes, drug patches or wipes, excitable contrast agents, tissue marking components or mediums, TENS or other electrotherapy electrodes, gels, components or materials, magnetic-field therapy components or materials, combination optical-filter/splashguards or needles;

b) a charger, external power supply, battery, power-pack, external powering means or any type of power or data cabling, connectors or jacks;

c) replacement, spare or different color or optical-parameter light sources;

d) an extra or different housing arm member, optionally including different length or shaped arms or arms with different color lights, the housing arm(s) optionally being movable or deformable;

e) a device patient-fixation means optionally including a selection thereof for different patient types and/or sizes and/or an adjustable fixation means;

f) an ultrasonic device utilized to validate or find flowing lumens, optionally including one through which a penetrating needle may be passed into tissue, said ultrasonic device possibly being mounted on a bridging member or element and possibly providing imaging or flow information;

g) a bridging element of any type, disposable or non-disposable;

h) a mating or guiding means used to mate with or guide a procedural implement, optionally including a syringe or biopsy needle, the means not necessarily also being or utilizing a bridging element;

i) a tissue marking or measuring entity, member or marking-medium, including tape or ink used to at least temporarily mark tissue locations, feature locations or device-locations of interest;

j) an adhesive member(s) used to fixate the device, an implement, a sensor, an electrode or a device fixation strap;

k) a tissue-distortion or rolling vein clamping or loading component;

l) an article of disposable or non-disposable device-supportive eyewear or headwear;

m) a selection of types or sizes of device fixation means, optionally including straps and malleable, elastic or viscoelastic limb-clamping or limb enwrapping members;

n) an imaging device or chip, optionally including an infrared or ultraviolet imaging device and optionally lenses or connectors therefore;

o) a room-light dimmer or switch, optionally having a wireless capability;

p) one or more amusing or entertaining light-show programs or audio recordings for amusing, distracting or entertaining patients, optionally stored on a memory media pluggable into the device or into a connected PC or PDA;

q) any accidental needle-stick prevention material, component or member regardless of whether it is mounted to the device or tissue or not or whether it is worn by the practitioner;

r) a display on which to observe optical contrast gathered by an imaging means, at least the displayed contrast being human-visible, whether or not said display is device mountable;

s) any type of supportive cables, connectors, jacks, optical fibers or umbilicals;

t) any type of holder for the device, optionally including a pocket-based holder, a waistband or belt-based holder, a desktop holder, a wall holder, any holder having an integrated recharger or a wrist-leash to prevent droppage;

u) any type of skin-surface abrasion media or member;

v) any type of skin or tissue optical-transmissivity improvement medium;

w) any cable or wireless item for network or PC connectivity, including for display or device powering.

x) any type of consumable or disposable drug, medicament, optical-transmissivity enhancing medium or electrode gel used in combination with the assistive or guiding device

y) instructions for use;

or

z) ordering information for consumables and/or device servicing information, preferably internet web based.

7. The device of claim 1 wherein said one or more discrete and/or distributed light sources is, includes or is optically-sourced or fed by any of (i) a surface-mount light source, (ii) a standard 3 mm or 5 mm diameter LED, (iii) any LED or laser industry-standardized-pinout or standardized-package light-emitting device (iv) a human-visible or human-non-visible light emitting light source, (v) an infrared or ultraviolet light source, including any emitting in any portion of any one or more of the NIR, SWIR, MWIR, LWIR, VLWIR or UV wavelength regimes, (vi) an arc, discharge, halogen, plasma or glowing filament-based source, (vii) any diode device, (viii) any laser or lasing device, including solid-state lasers, ion-lasers, dye-lasers, vertical-cavity lasers, excimer-lasers and gaseous lasers, (ix) a light source that excites an excitable agent or tissue/bodyfluid constituent to produce excited light, including those wherein said agent is delivered into the patient tissue or wherein said agent is part of a light-producing device light source, (x) any semiconductor chip based light source, or (xi) a light source known to provide desirable contrast by any mechanism including as by differential transmissivity, opacity, reflectivity or optical-excitation.

8. The device of claim 1 wherein any one or more of:

a) one or more discrete or distributed light sources is operated in a continuous or pulsed manner;

b) a discrete or distributed pulsed light source is operated below, at or above a visual-fusion rate;

c) two or more discrete or distributed light sources are operated in a sequential, interleaved or simultaneous manner;

d) one or more discrete or distributed light sources can be switched or tuned with respect to color;

e) one or more discrete or distributed light sources has a fixed or controlled beam entry angle into tissue or with respect to a lumen;

f) one or more discrete or distributed light sources has a fixed or controlled beam divergence angle;

g) tissue is beneficially deformed for any reason by the device or its fixation means;

h) tissue is deformed into or extruded into or by the device;

i) optical contrast of features is generated using any one or more of backlighting, sidelighting or toplighting of said features;

j) a guided or assisted implement can be seen inside tissue using produced or excited optical contrast;

k) a guided or assisted implement of (j) is treated or capable of emitting light to enhance its visibility;

l) a bridging element is useable with the device, whether permanently or temporarily attached to the device;

m) a light shroud or light-gasket is employed by the device;

n) at least one discrete or distributed light source is or are capable of emitting any one or more of a normally human-visible red, red-orange, orange, orange-yellow, yellow, amber or white color or wavelength(s);

o) at least one discrete or distributed light source is an infrared light source emitting in any of the following wavelength ranges;

or

NIR or Near Infrared approx 0.7-1.0 microns, SWIR or Short Wave Infrared approx 1.0-3.0 microns, MWIR (or MIR) or Mid Infrared approx 3.0-8.0 microns, LWIR (or LIR) or Long Wave Infrared approx 8.0-12.0 microns, VLWIR or Very Long Wave Infrared approx 12-30 microns;

p) at least one discrete or distributed light source is an ultraviolet or UV source or emits in the 255 nanometers to 420 nanometers wavelength range;

q) a feature of interest is optically contrasted by two or more light sources from different angles, optionally sequentially;

r) two or more discrete light sources form an array or two or more distributed light sources are employed, or

s) illumination or excitation light is delivered at an angle or angles to features of interest to minimize a shadowing phenomenon, including delivering illumination in planes generally parallel to elongated lumens.

9. A guiding or assistive device for guiding, assisting or implementing pain-free or reduced-pain patient skin, tissue, limb, organ or lumen-disrupting, penetrating or painful medical procedures therein or thereat, the device including:

a) an optical contrast producing means for producing surface-visible or surface-imageable optical contrast of patient features of interest in the skin or in a subsurface tissue, organ, lumen or body-fluid, the contrast producing means utilizing at least some skin or tissue injected or penetrating light deliverable by one or more discrete light sources and/or one or more distributed light sources; and

b) a real-pain or perceived-pain reduction means utilizing at least one TENS, other electrotherapy, magnetic-field based therapy or a drug, heating, cooling or vibratory pain-relief mechanism, the pain reduction mechanism being applied at one or more points in time to reduce some patient real or perceived pain related to a future, current or prior procedure, the procedure carried out with optical assistance or guidance from the assistive device,

the optical contrast being caused by at least one mechanism of optical attenuation, optical scattering, optical excitation, optical reflection, optical refraction, optical diffraction or by any of optical shadowing, optical backlighting, optical side-lighting or optical toplighting, an optical contrast agent or optically excitable agent optionally being employed.

10. The device of claim 9 wherein said at least one discrete single or multielement light source includes at least one of an LED source, semiconductor-chip source, OLED source, laser source, surface-emitting laser source, incandescent source, halogen source, fluorescing source, phosphorescent source, plasma source, flashlamp source, electrical discharge source, arc-source, filament source or optical-excitation or agent exciting light source.

11. The device of claim 9 wherein said at least one distributed light source includes or utilizes any of (i) an optically leaky or non-leaky solid or hollow optical waveguide, (ii) an array of discrete single element or multielement light sources, (iii) a glass, ceramic or polymeric-containing optical waveguide of one, two or three dimensions, (iv) an optical fiber or conduit of any type, including solid and hollow-reflective and refractive optical conduits, (v) an optical diffuser, lens, reflector, prism, mirror or grating, including microarrays thereof, (vi) a microlens or lens array or a fiber-optic coupled lens, (vii) any type of physically, mechanically or electro-optically scanned light source, (viii) any type of diffractive optics, reflective optics or gradient-index optics, (ix) any type of optical-excitation or agent-excitation light source, or (x) a bulk light-emitting material or film, including an OLED emitter.

12. The device of claim 9 wherein the device is attached or juxtaposed to a patient'"'"'s body, organ, skin, tissue or limb, said attachment optionally still allowing for some device scanning or motion relative to said body, tissue or organ, the attachment or juxtaposition utilizing any one or more of:

a) any type of retainment strap, cord, chain, clamp, belt, suction or adhesive;

b) any type of elastic, plastic, malleable or spring loaded clamping member or arm;

c) the at least partial enwrapping or surrounding of a patient limb or organ by the inherent surrounding shape of the device itself, including for a bracelet or cuff shaped device;

or

d) the device is held on the patient by the practitioner or the patient.

13. A method of executing a skin, tissue, organ, limb, body-fluid or lumen related, medically-related or health-related procedure with minimal or no pain, the procedure which might otherwise cause perceived or real pain for a patient or subject, the method utilizing both an optical-contrast provision assistive or guiding device and a device-integrated or device-supporting pain-reduction means comprising:

a) an optical contrast producing or exciting device for viewing or locating skin, tissue, limb, organ, body-fluid or lumen-related subsurface features of interest, said features(s) being the target of the intended procedure or being features to be avoided during said procedure, the device assisting or guiding the procedure, optical light being delivered or excited by at least one discrete light source and/or at least one distributed light source, the optical contrast being caused by at least one mechanism of optical attenuation, optical scattering, optical excitation, optical reflection, optical refraction, optical diffraction or by any of optical shadowing, optical backlighting, optical side-lighting or optical toplighting, an optical contrast agent or optically excitable agent optionally being employed; and

b) at least one of a heating, cooling, vibratory, acoustic, drug-based, TENS-based or other electrotherapy-based or magnetic-field application-based pain reduction means that can be applied in an appropriate timed and locational relationship to the actual site of the procedure and/or site of the procedural pain, wherein;

i) the pain reducing means is operated or applied at least one of before, during or after the execution of the procedure in support of a pain-limited or pain-free procedure wherein real or perceived pain relief is delivered;

ii) the assistive or guiding device is optionally fixated, loosely and/or snugly, to a limb, tissue, organ or skin of interest at least one point in time in support of one or more of feature-finding, tissue or lumen manipulation or procedure delivery; and

iii) the assistive or guiding device optionally provides operational support for, if not also actually copackages or physically supports, one or more of said pain-reduction means.

14. The method of claim 13 wherein said at least one discrete single or multielement light source includes at least one of an LED source, semiconductor-chip source, OLED source, laser source, surface-emitting laser source, incandescent source, halogen source, fluorescing source, phosphorescent source, plasma source, flashlamp source, electrical discharge source, arc-source, filament source or optical-excitation or agent exciting light source.

15. The method of claim 13 wherein said at least one distributed light source includes or utilizes any of (i) an optically leaky or non-leaky solid or hollow optical waveguide, (ii) an array of discrete single element or multielement light sources, (iii) a glass, ceramic or polymeric-containing optical waveguide of one, two or three dimensions, (iv) an optical fiber or conduit of any type, including solid and hollow-reflective and refractive optical conduits, (v) an optical diffuser, lens, reflector, prism, mirror or grating, including microarrays thereof, (vi) a microlens or lens array or a fiber-optic coupled lens, (vii) any type of physically, mechanically or electro-optically scanned light source, (viii) any type of diffractive optics, reflective optics or gradient-index optics, (ix) any type of optical-excitation or agent-excitation light source, or (x) a bulk light-emitting material or film, including an OLED emitter.

16. The method of claim 13 wherein the device is attached or juxtaposed to a patient'"'"'s body, organ, skin, tissue or limb, said attachment optionally still allowing for some device or device-portion scanning or motion relative to said body, tissue or organ, the attachment or juxtaposition utilizing any one or more of:

a) any type of retainment strap, cord, chain, clamp, belt, suction or adhesive;

b) any type of elastic, plastic, malleable or spring loaded clamping member or arm;

or

c) the at least partial enwrapping or surrounding of a patient limb or organ by the inherent surrounding shape of the device itself, including for a bracelet or cuff shaped device.

17. A method of favorably dilating a lumen in preparation or support of a medical procedure, including a needle-stick, comprising:

a) optically determining a skin or tissue region containing or overlying said lumen utilizing at least one discrete light source and/or at least one distributed light source mounted in or on a light-housing juxtaposable, presentable-to or mountable to a patients tissues, the light housing including at least one discrete and/or distributed light source, optical contrast being caused by at least one mechanism of optical attenuation, optical scattering, optical excitation, optical reflection, optical refraction, optical diffraction or by any of optical shadowing, optical backlighting, optical side-lighting or optical toplighting, an optical contrast agent or optically excitable agent optionally being employed; and

b) applying TENS or other electrotherapy excitation, vibratory or acoustic excitations to said lumen region sufficient to cause the desired dilation of the lumen for a useful period, the exciter(s) itself not necessarily being located directly over or adjacent said lumen but at least its excitations being coupled into said lumen region.

18. The device of claim 17 wherein said at least one discrete single or multielement light source includes at least one of an LED source, semiconductor-chip source, OLED source, laser source, surface-emitting laser source, incandescent source, halogen source, fluorescing source, phosphorescent source, plasma source, flashlamp source, electrical discharge source, arc-source, filament source or optical-excitation or agent exciting light source.

19. The device of claim 17 wherein said at least one distributed light source includes or utilizes any of (i) an optically leaky or non-leaky solid or hollow optical waveguide, (ii) an array of discrete single element or multielement light sources, (iii) a glass, ceramic or polymeric-containing optical waveguide of one, two or three dimensions, (iv) an optical fiber or conduit any type, including solid and hollow-reflective and refractive optical conduits, (v) an optical diffuser, lens, reflector, prism, mirror or grating, including microarrays thereof, (vi) a microlens or lens array or a fiber-optic coupled lens, (vii) any type of physically, mechanically or electro-optically scanned light source, (viii) any type of diffractive optics, reflective optics or gradient-index optics, (ix) any type of optical-excitation or agent-excitation light source, or (x) a bulk light-emitting material or film, including an OLED emitter.

20. The device of claim 17 wherein the device is attached or juxtaposed to a patient'"'"'s body, organ, skin, tissue or limb, said attachment optionally still allowing for some device or device-portion scanning or motion relative to said body, tissue or organ, the attachment or juxtaposition utilizing any one or more of:

a) any type of retainment strap, cord, chain, clamp, belt, suction or adhesive;

b any type of elastic, plastic, malleable or spring loaded clamping member or arm;

or

c) the at least partial enwrapping or surrounding of a patient limb or organ by the inherent surrounding shape of the device itself, including for a bracelet or cuff shaped device.

21. The device of claim 17 wherein said lumen-region dilation excitations are produced in or on the device or are patient or practitioner-applied utilizing any of power, logic circuitry, physical or wireless connectivity, mechanical guidance, electrodes, fixation or physical alignment provided by the device.

22. A cuff-like optical assistance or guidance device for application to medical procedures, exams, treatments, therapies or surgeries comprising:

a) a cuff-like entity that wraps around or surrounds at least a portion of a human limb or organ, said wrapping or surrounding being at least in part one or both of in contact with said limb or being proximal or gapped from or to said limb surface;

b) the cuff-like entity including one or more single element or multielement discrete light sources and/or one or more distributed light sources capable of injecting light into or upon a first skin or tissue portion; and

c) the cuff-like entity including or defining a second skin or tissue portion wherefrom or whereat optical contrast of tissue surface or subsurface features produced by said injected light may be observed in at least one of an unaided or aided manner by a practitioner,

wherein;

the optical contrast being caused by at least one mechanism of optical attenuation, optical scattering, optical excitation, optical reflection, optical refraction, optical diffraction or by any of optical shadowing, optical backlighting, optical side-lighting or optical toplighting, an optical contrast agent or optically excitable agent optionally being employed; and

the device allowing for any required access of a device-guided or assisted procedural implement to the patient'"'"'s tissues.

23. The device of claim 22 wherein said at least one discrete single or multielement light source includes at least one LED source, semiconductor-chip source, OLED source, laser source, surface-emitting laser source, incandescent source, halogen source, fluorescing source, phosphorescent source, plasma source, flashlamp source, electrical discharge source, arc-source, filament source or optical-excitation or agent exciting light source.

24. The device of claim 22 wherein said at least one distributed light source includes or utilizes any of (i) an optically leaky or non-leaky solid or hollow optical waveguide, (ii) an array of discrete single element or multielement light sources (iii) a glass, ceramic or polymeric-containing optical waveguide of one, two or three dimensions, (iv) an optical fiber or conduit any type, including solid and hollow-reflective and refractive optical conduits, (v) an optical diffuser, lens, reflector, prism, mirror or grating, including microarrays thereof, (vi) a microlens or lens array or a fiber-optic coupled lens, (vii) any type of physically, mechanically or electro-optically scanned light source, (viii) any type of diffractive optics, reflective optics or gradient-index optics, (ix) any type of optical-excitation or agent-excitation light source, or (x) a bulk light emitting material or film, including an OLED emitter.

25. The device of claim 22 wherein the device any one or more of:

a) can be attached or mounted to one or more of a patient'"'"'s body, limb, tissue or organ, b) utilizes for optical contrast improvement any of a filter, antireflection coating, polarizer. optical contrast agent, light shroud or ambient-light switching or modulation element, c) utilizes for safety any of a blood-splash protection feature, a disposable polymeric device membrane, or a shroud or shield, d) utilizes, records or presents an image or display of optically contrasted features, e) is fittable or shapeable to a particular patient, limb or organ using an exchangeable, adjustable, malleable, elastic, spring-loaded or size-settable feature or member, f) utilizes a disposable component, including a disposable optical filter that might double as a splash guard, g) has a practitioner self needle-stick protection feature, h) has a practitioner useable finger-rest or finger guidance feature, i) has a practitioner useable guiding or mechanical reference feature for supporting a guided or assisted implement, including a syringe or biopsy needle, j) dispenses or delivers a drug for any purpose, optionally including lumen dilation encouragement or pain-reduction, or k) treats real, anticipated or perceived pain with an acoustic, vibratory, electrotherapeutic, heating, cooling or magnetic component.