WO2007117656A2

WO2007117656A2 - Point of procedure lighting device

Info

Publication number: WO2007117656A2
Application number: PCT/US2007/008672
Authority: WO
Inventors: Joel J. Rodriguez
Original assignee: Embo-Optics, Llc
Priority date: 2006-04-07
Filing date: 2007-04-09
Publication date: 2007-10-18
Also published as: WO2007117656A3

Abstract

The present invention provides illuminated medical devices for illuminating a subject or a region of a subject that is experiencing a medical procedure. The illumination devices provide for rapid visual identification of disease states or disorders, and illuminates the regions proximal to them. The devices are particularly useful in field situations or emergency medical situations with low ambient light.

Description

POINT OF PROCEDURE LIGHTING DEVICE

FIELD OF THE INVENTION

[0001] The present invention relates to the field of medical equipment, and the illumination and control of the same.

SUMMARY OF THE INVENTION

[0002] In one aspect the invention provides an illumination apparatus including, a substrate and an illumination source; the substrate having channel or aperture capable of receiving and securing the illumination source. In one embodiment, the substrate further comprises a first and second pair of substantially parallel elongated and flattened sides, having annular edges. In another embodiment, the device includes geometric features that can be engaged by a user of the device, such as ridges that provide a holding region, where the ridges enhance the coefficient of friction between the user and the device. In yet another embodiment, the illumination source is chemiluminescent. In another embodiment, the illumination source provides light of a particular color. In still another embodiment, the invention includes a lens or a light transmissive element (e.g., a light pipe), wherein light from the illumination source is transmitted externally to at least one end of the device.

[0003] In another aspect, the invention provides a method of illuminating the area proximal to a medical procedure including the steps of: obtaining a device having an illuminating apparatus comprising a substrate and an illumination source; the substrate having a first channel capable of receiving and securing the illumination source; and activating the illumination source thereby locally illuminating the subject at the region proximal to the device, i.e.. approximately 100-1000 cm² area surrounding the medical device. In one embodiment, the illumination source provides sufficient illumination to assist a medical procedure, and is mounted to the body, i.e., the finger of an operator. In another embodiment, the medical procedure is examination of a body cavity, such as the oral cavity. In yet another embodiment, the medical procedure occurs in a low light environment. In still yet another embodiment, the illumination source is chemiluminescent. In even another embodiment, the invention provides a second illumination source that provides light of a particular color different from the first illumination source. In a currently preferred embodiment, the illuminated medical device is a chemically illuminated self-contained tongue depressor. In another currently preferred embodiment, the device mounts to the finger of an operator, or to other medical devices in use in a medical procedure.

[0004] In another aspect, the invention provides a kit for illuminating a medical procedure comprising, a medical apparatus further comprising a substrate and an illumination source; the substrate having a first channel capable of receiving and securing the illumination source, the kit further comprising suitable packaging material and instructions for using the apparatus to illuminate a medical procedure. In one embodiment, the illumination source is chemiluminescent. In another embodiment, the illumination source provides light of a particular color. In even yet another embodiment, the kit includes a second illumination source, wherein the second illumination source is a different color from the first illumination source. In still another embodiment, the contents are sterile. In another embodiment, the packaging material provides a hermetic seal that indicates the sterility of the device contained therein. In yet another embodiment, the packaging material is chemically compatible with ethylene oxide sterilization, and approved by the FDA or a regulatory authority for use as sterile packaging for medical devices.

[0005] In another aspect, the invention provides a method of making a kit for illuminating a medical procedure comprising, obtaining the medical line illuminating apparatus of described above; obtaining suitable packaging material and instructions for using the device, and incorporating the device into the packaging material.

[0006] These and other embodiments are set forth in greater detail below.

SUMMARY OF THE DRAWINGS

[0007] FIG. 1 is an illustration of a device of the present invention. The device shown comprises a substrate having two annular sides, the annular sides capable of slight deformation/expansion and able to engage a syringe barrel or a finger of an operator. The substrate further comprises an aperture, the aperture capable of engaging and containing a light source. [0008] FIG. 2a-c are other embodiments of a device of the present invention, in various viewing angles. The aperture does not extend through the substrate, so light is partially occluded.

[0009] FIG. 3a-c are yet other embodiments of a device of the present invention. The device as shown comprises a substrate having two sides, the sides capable of slight expansion and defining a first aperture that adapts to and engages the barrel of a syringe having an outside barrel diameter of 0.375 inches. Annular features secure the substrate to e.g. a syringe barrel.

[0010] FIG. 4a-c are even yet other embodiment of a device of the present invention. The device as shown comprises a substrate having two annular sides, the annular sides capable of slight expansion and defining a first aperture that adapts to and engages the barrel of a syringe having an outside barrel diameter of 0.250 inches. Annular features secure the substrate to e.g. a syringe barrel.

[0011] FIG. 5 is still another embodiment of the invention. The device shown comprises a substrate having two parallel sides, the sides capable of slight expansion and defining a first aperture that adapts to and engages a corresponding geometric section of an i.v. apparatus. The device is shown with a light source and attached to the i.v. device.

[0012] FIG. 6 is an illustration of a PIN-LITE™ brand device in use. The user has removed the product from its packaging, bent and shaken the light module to activate the chemilumenescent reaction, and inserted it into the aperture on the substrate. The PIN-LITE™ product is then affixed to a medical apparatus by clipping the substrate on to the medical apparatus (i.v. assembly). The light source emits an approximate 100 cm² lighted area forward of the substrate, for illumination of the hand veins of a person about to receive an i.v. line.

[0013] FIG. 7 is an illustration of a medical device having point of procedure lighting capability. The device shown comprises a substantially elongated substrate having two flattened sides with annular edges. The substrate further comprises an aperture, the aperture capable of engaging and containing a light source. The light source emits an approximate 100 cm² lighted area or greater for illumination of the medical procedure performed on a subject. This particular product is used as a tongue depressor. The flattened paddle region is pressed against the tongue of a subject by the operator, and the device provides localized illumination of the oral cavity and throat.

[0014] FIG. 8 is another embodiment of a point of procedure lighting device, having an integral light source.

DETAILED DESCRIPTION

10015] The present invention provides point of procedure illumination sources for illuminating a medical procedure. The medical device comprises a substrate and an illumination source. Where the light source is not integral to the device, the substrate has a channel capable of receiving and securing the illumination source. In a variation of the invention, the substrate includes an integral light source, i.e., an internal lumen that includes a first container having a first luminescent reagent and a second frangible container having a second chemiluminescent reagent. When the second frangible container is broken, the first and second chemiluminescent reagents mix and emit light. Kits are also provided, including suitable packaging material and instructions for using the apparatus to illuminate a medical procedure. An illuminated medical device illuminates everything within the field of the light source, for example, within 10 cm², 100 cm², 500 cm² or 1000 cm² or more of the source of light emission from the device. Preferably, the device includes a lens, to provide directed lighting of the procedure area. A diffusing lens increases the surface area that is illuminated. A focusing lens concentrates the light. A light "pipe" or conduit otherwise directs or restricts light emissions from the light source to one or more sides of the device, from where it is emitted outside the device. Light emissions can also be restricted temporally, i.e., by quick burning chemical lights having a short lifespan and a high luminosity. Alternatively, light sources may be masked or otherwise covered in parts to prevent light emissions in various directions. Color spectrum of the illumination source can be selected to more particularly distinguish anatomical features such as blood vessels (an illumination source with an amber/orange hue is used, which aids in the identification of subcutaneous blood vessels, because it visually renders vessels black while rendering other tissues substantially white (or light)). In low ambient light environments red, blue or green hues allow localized lighting without harsh contrast that would reduce the operator's night vision. Specialized light sources such as infrared spectrum emitters are particularly preferred for devices that are intended to be employed in military and combat situations. With such devices, an operator must use detection equipment such as night vision scopes, but the process of use of the invention adapted as an infrared emitter is essentially the same as devices emitting visible light. The light sources can also be adapted for the examination of physical evidence and crime scenes using illumination sources emitting light at wavelengths between 300 nm and 750 nm, to examine all types of physical evidence, e.g., for developing latent prints, for searching for blood stains, body fluids stains, narcotics, and semen and for use in specialized photography. These methods may require an operator use detection equipment, such as forensic examination goggles having orange, yellow or red lenses.

[0016] If the device is intended to be removable, the substrate is modified accordingly, e.g., spring clips are incorporated into the substrate instead of locking tabs, allowing attachment and detachment from a medical apparatus, or from clothing. Permanent embodiments include locking clips and/or adhesive strips disposed on the substrate.

[0017] The medical illumination system is preferably a self-illuminating device that provides patient illumination in low ambient light environments, common in many surgeries, hospital wards, and field environments. The substrate provides a structural frame that is adapted to receive and contain an illumination source. The substrate is molded to various shapes for particular medical purposes. For example, one embodiment provides an illuminated tongue depressor shown in FIG's 7 and 8. The substrate is elongated and substantially flattened on two opposing sides. The edges of the device are tapered and annular, and substantially smooth along the regions that are to be introduced into the oral cavity of a patient. In other embodiments, the tongue depressor has geometric features that assist in a user gripping the device, such as knobs, ridges, a depression or a taper in the substrate. In certain embodiments, the geometric features engage structures in the oral cavity, i.e.. ridges that contact the tongue provide added traction.

[0018] Preferred materials for the substrate include polypropylene, polyethylene, and other common plastic materials. The substrate can be transparent or semitransparent, or can be opaque provided it has one or more apertures or windows, through which the light can exit the substrate. Alternative embodiments having variously sized and shaped apertures are suitable for applications where it is desirable to direct or mask light emissions from the substrate to a particular illumination field. In various other embodiments, the substrate includes words or symbols or other identifying and distinguishing features, which can be inscribed upon or formed into the substrate. The self-illuminating device provides a source of localized illumination, wherein medical devices and/or controls in proximity to the device, i.e., within the luminescent field, are thereby illuminated. If the device presents imprinted data or formed features (as described above), such are preferably illuminated by the illumination source.

[0019J The illuminated medical line illumination system includes an illumination source. The illumination source can be, for example, an LED or bulb, using a button battery as a power source. Controls and power supplies would thus be provided, which can be remote, or integrated into the substrate, particularly for finger mount devices. Alternatively, an optical fiber can be introduced into the device. But preferably, the illumination source is a self contained unit. A small chemiluminescent device is a suitable self-contained illumination source, and provides a bright cool light for many hours. A Cyalume®-type chemical light stick exemplifies such a chemiluminescent device. Small button style lights approximating the size of a watch battery are also suitable.

[0020] The user activates the illumination source, e.g., bends the stick, prior to insertion of the illumination source into the substrate. In a medical device that contains an integral light source, the same procedure is applied, i.e., the user bends the device. In one embodiment, the illumination source does not display a long life after activation, but supplies very high lumens for a short period of time. In another embodiment, the illumination source has a lifespan of several hours after activation, for example, 1, 2, 3, 4, 5 hours or more, and supplies lower intensity light for a period of time. For example, a 2-inch diameter ultra-bright illumination source would be used as a local illuminator for neonates or elderly patients in hospital settings. In another embodiment, the ultra-bright illumination source is attached to, or incorporated into, a tongue depressor, thus permitting illumination of, e.g., the oral cavity.

[0021] Chemiluminescent devices that emit various color spectra are commonly available, such as those from OmniGIow, Inc. In certain embodiments, a single illumination source is employed, that provides two or more discrete regions of color, such as dual color chemical light sticks. Color lenses may also be incorporated into one or more regions of the substrate to provide additional multi-color effects.

[0022] The illumination and identification systems described are suitable for incorporation into a kit for surgical and medical uses. An illumination system kit includes any of the following: one or more illuminated medical devices, suitable packaging materials and instructions for use. Kit contents may be sterilized, in which case the packaging material can be hermetically sealed. Sterilization techniques for medical devices are well known in the art, for example, irradiation or ETO- Ethylene Oxide gas are both suitable for sterilizing the invention. In another embodiment, the kit packaging has a label/backer made of Tyvek® (DuPont), the only FDA approved material for use in sterile packaging employing an ETO-Ethylene Oxide gas sterilization technique.

EXAMPLE ONE: ILLUMINATED MEDICAL DEVICES FOR VENIPUNCTURE OR INJECTION

[0023] Various embodiments of point of procedure/point of infusion illumination devices are provided in FIG. 1 - FIG. 6. These various devices, shown in FIG. 1 - FIG. 5 are used to illuminate a local area, for example on or near the body of a human subject. These devices aid persons administering medical care in low ambient light environments, or provide forensic illumination of a crime scene. A finger mounted illumination system, referred to as FIREFLY™ (Embo-Optics, Beverly, MA) is shown in FIG 1. Devices that direct mount to medical equipment are referred to as PIN-LITE™ (Embo-Optics, Beverly, MA) and are shown in FIGs. 2-6. Both types of devices comprise a substrate and a light source. The light source is activated and inserted into the substrate, which in the case of the PIN-LITE™ is then attached to a medical device as shown in FIGs. 5-6. The PlN-LITE device provides localized illumination for a medical procedure, shown in FIG. 8. Alternatively, the FIREFLY™ product may be attached to a finger of the user. In various other embodiments, a universal clip is provided, which attaches the substrate to various types of medical devices - i.v. lines, syringes, catheters, etc., or body parts such as a finger, wrist, etc. The universal clip may also attach to an article of clothing such as a shirt sleeve, lapel, etc. The FIREFLY™ device shown in FIG. 1 comprises a substrate having two annular sides 102, the annular sides capable of slight deformation/expansion and able to engage a syringe barrel or a finger of an operator. The substrate further comprises an aperture 101, the aperture capable of engaging and containing a light source, not shown. FIG. 2a-c are of a PIN-LITE™ device of the present invention, in various viewing angles, face on (2a) side angle (2b) and side view (2c). The aperture 101 does not extend through the substrate, so light is partially occluded. FIG. 3a-c are yet other embodiments of a PIN-LITE™ device of the present invention. The device as shown comprises a substrate having two parallel sides 301, the sides capable of slight expansion and defining a first aperture 101 that adapts to and engages the barrel of a syringe having an outside barrel diameter of 0.375 inches. Annular features 302 located inside the parallel sides 301 engage a syringe (not shown) and secure the substrate to the barrel. FIG. 4a-c are even yet other embodiment of a PIN-LITE™ device of the present invention. The device as shown comprises a substrate having two parallel sides 402, the sides capable of slight expansion and defining a first aperture 101 that adapts to and engages the barrel of a syringe having an outside barrel diameter of 0.250 inches. Annular features 401 secure the substrate to e.g. a syringe barrel. FIG. 5 is still another embodiment of the invention. The PIN-LITE™ device shown comprises a substrate having two parallel sides, the sides capable of slight expansion and defining a first aperture that to adapts to and engages a corresponding geometric section of an i.v. apparatus. The device is shown with a light source and attached to the i.v. apparatus. FIG. 6 is an illustration of a PIN-LITE™ brand device in use. The user has removed the product from its packaging, bent and shaken the light module to activate the chemilumenescent reaction, and inserted it into the aperture on the substrate. The PIN-LITE™ product is then affixed to a medical apparatus by clipping the substrate on to the medical apparatus (i.v. assembly). The light source emits an approximate 100 cm² lighted area forward of the substrate, for illumination of the needle region and the target hand veins of a person about to receive an i.v. line. Following insertion of the i.v., the PIN- brand device may be left in place by the user, to identify the type of medication to be delivered through the i.v. line. Such uses of color coded medical lines are described in Applicant's copending patent applications publication numbers: WO2005058410 and WO2006065271.

EXAMPLE TWO: ILLUMINATED MEDICAL DEVICES FOR EXAMINATION OF BODY CAVITIES

[0024] Two variations of an illuminated medical device are provided in FIG. 7- FIG. 8. In both illustrations, the TONGUE-LITE™ device comprises a substrate, having an illumination source. In FlG. 7, the light source is removable from the device, and to use the device, the light source (701 ) is first activated then inserted into a channel (702) in the substrate (703). A cap (704) engages threads, grooves or other features (705) on the end of the substrate, and contains the light source in the device. Alternatively, the embodiment shown in FIG. 8 illustrates a substrate (801) that includes an integral light source (802), contained in an internal lumen (803). The light source includes a first container having a first luminescent reagent and a second frangible container having a second luminescent reagent. When the second frangible container is broken, the first and second luminescent reagents mix and emit light. The emitted light is focused through a light transmissive element (804) which is directed out one end of the device (805). In various other embodiments, geometric features such as ridges, knobs or depressions permit the user to obtain a more secure grip on the device. Preferably the geometric features are located on the substrate at a position distal to the location on the substrate from which the light source emits.

EQUIVALENTS

[0025] From the foregoing detailed description of the specific embodiments of the invention, it should be apparent that unique medical devices and medical kits have been described. Although particular embodiments have been disclosed herein in detail, this has been done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims which follow. In particular, it is contemplated by the inventor that various substitutions, alterations, and modifications may be made to the invention without departing from the spirit and scope of the invention as defined by the claims. For instance, the choice of color spectrum, or the illumination source used is believed to be matter of routine for a person of ordinary skill in the art with knowledge of the embodiments described herein.

[0026] All references referred to in this specification are hereby incorporated herein in their entirety.

Claims

ClaimsI claim:

1. An apparatus comprising, a substrate and an illumination source, the substrate having two substantially parallel sides that engage a medical device and reversibly secure it to the medical device, the substrate further comprising an aperture capable of receiving and securing the illumination source.

2. The apparatus of claim 1, wherein the illumination source is chemiluminescent.

3. The apparatus of claim 1, wherein the illumination source provides light of a particular color.

4. The apparatus of claim 1, further comprising a second illumination source, wherein the second illumination source is a different color from the first illumination source.

5. A method of illuminating the area proximal to a medical procedure comprising:

a. obtaining a medical illuminating apparatus comprising a substrate and an illumination source; the substrate having a channel capable of receiving and securing the illumination source the substrate further having two substantially parallel sides that engage a medical device and reversibly secure it to the medical device., and further comprising a light transmissible element; and

b. activating the illumination source, thereby illuminating a subject for approximately 100 cm² area surrounding the illumination source.

6. The method of claim 7, wherein the illumination source provides sufficient illumination to assist a medical procedure.

7. The method of claim 8, wherein the medical procedure is a venipuncture procedure.

8. The method of claim 8, wherein the medical procedure occurs in a low light environment.

9. The method of claim 8, wherein the illumination source is chemiluminescent.

10. The method of claim 8, wherein the apparatus provides a second illumination source that provides light of a particular color different from the first illumination source.

11. A kit for illuminating a medical procedure comprising the device of claim 1 , and further comprising suitable packaging and instructions for use.

12. The kit of claim 1 1 , wherein the contents are sterile.

13. The kit of claim 1 1, wherein the packaging material provides a hermetic seal that indicates the sterility of the device contained therein.

14. The kit of claim 1 1 , wherein the packaging material is compatible with ethylene oxide sterilization.

15. A method of making a kit for illuminating a medical procedure comprising, obtaining the medical apparatus of claim 1 ; obtaining suitable packaging material and instructions for using the device, and incorporating the device into the packaging material.

16. A illumination apparatus comprising, a substrate and an illumination source; the substrate having two substantially parallel sides that engage a finger of a user and reversibly secure it to the finger, the substrate further comprising an aperture capable of receiving and securing the illumination source.

17. The apparatus of claim 16, wherein the substrate further comprises geometric features that engage the medical line or device.

18. The apparatus of claim 17, wherein the engaged geometric features irreversibly lock the substrate in a closed position, thereby preventing removal of the substrate from the medical line or device.

19. The apparatus of claim 16, wherein the illumination source is chemiluminescent .

20. The apparatus of claim 16, wherein the illumination source provides light of a particular color.

21. The apparatus of claim 16, further comprising a second illumination source, wherein the second illumination source is a different color from the first illumination source.

22. A method of illuminating the area proximal to a medical procedure comprising."

a. obtaining a medical illuminating apparatus comprising a substrate and an illumination source; the substrate having a first channel capable of receiving and securing the illumination source, and further comprising a second channel capable of receiving and securing a medical device, clothing, or the body of an operator or a patient; and

b. activating the illumination source and affixing the medical line illumination apparatus to a medical line, thereby illuminating a portion of the medical line and approximately 100 cm² area surrounding the illumination source.

23. The method of claim 22, wherein the illumination source provides sufficient illumination to assist a medical procedure.

24. The method of claim 23, wherein the medical procedure is a venipuncture procedure.

25. The method of claim 23, wherein the medical procedure occurs in a low light environment.

26. The method of claim 23, wherein the illumination source is chemiluminescent.

27. The method of claim 23, wherein the apparatus provides a second illumination source that provides light of a particular color different from the first illumination source.

28. A kit for illuminating a medical procedure comprising, a medical illuminating apparatus further comprising a substrate and an illumination source; the substrate having a first channel capable of receiving and securing the illumination source, and further comprising a second channel capable of receiving and securing a medical device, clothing, or the body of an operator or a patient., the kit further comprising suitable packaging material and instructions for using the apparatus to illuminate a medical procedure.

29. The kit of claim 28, wherein the illumination source is chemiluminescent.

30. The kit of claim 28, wherein the illumination source provides light of a particular color.

31. The kit of claim 28, further comprising a second illumination source, wherein the second illumination source is a different color from the first illumination source.

32. The kit of claim 28, wherein the contents are sterile.

33. The kit of claim 32, wherein the packaging material provides a hermetic seal that indicates the sterility of the device contained therein.

34. The kit of claim 32, wherein the packaging material is compatible with ethylene oxide sterilization.

35. A method of making a kit for illuminating a medical procedure comprising, obtaining the medical line illuminating apparatus of claim 22; obtaining suitable packaging material and instructions for using the device, and incorporating the device into the packaging material.

36. A medical procedure illumination apparatus comprising, a substrate and an illumination source; the substrate having a distal end being substantially wide and flat and a proximal end having an aperture, the aperture capable of receiving the illumination source.