PHOTODISINFECTION DELIVERY DEVICES AND METHODS
The present invention presents devices, kits, systems and methods that can be used to deliver and activate a photosensitizing composition in a cavity. For example, a device of the present invention includes a member having a base portion, an insert portion adapted for insertion into the cavity, and a pocket adapted for communication with a waveguide which is connected to a light source for delivering light to the device, wherein the pocket includes a light dispersing section that is adapted for light communication with distal end of the waveguide and desired illumination pattern for photodisinfection of the cavity is provided by at least one of the elements selected from the group consisting of: surface finish of the light dispersing section, geometry of the light dispersing section, surface finish of the member, geometry of the member, and a combination thereof. The present invention can be used for humans, other animals, and inanimate objects.
1 . A device for photodisinfection of a cavity comprising: a member having a base portion, an insert portion adapted for insertion into the cavity, and a pocket adapted for communication with a waveguide which is connected to a light source for delivering light to the device, wherein the pocket includes a light dispersing section that is adapted for light communication with distal end of the waveguide and desired illumination pattern for photodisinfection of the cavity is provided by at least one of the elements selected from the group consisting of: surface finish of the light dispersing section, geometry of the light dispersing section, surface finish of the member, geometry of the member, and a combination thereof.
2 . The device of claim 1 wherein the member is constructed of a translucent material selected from the group consisting of plastic, epoxy, glass, and a combination thereof.
3 . The device of claim 1 wherein the member is constructed of polycarbonate.
4 . The device of claim 1 wherein the member is constructed of poly(methyl methacrylate).
5 . The device of claim 1 wherein the inserted portion does not contain any sharp corner or sharp edge that may cause damage to tissues within the cavity during insertion of the device into the cavity.
6 . The device of claim 1 wherein the surface finish of the member is selected from the group consisting of smoothness, roughness, ribs, pigments, microspheres, Fresnel elements, deflective elements, reflective elements, facets, embossed patterns, and a combination thereof.
7 . The device of claim 1 wherein the surface finish of the light dispersing section is selected from the group consisting of smoothness, roughness, ribs, pigments, microspheres, Fresnel elements, deflective elements, reflective elements, facets, embossed patterns, and a combination thereof.
8 . The device of claim 1 wherein the geometry of the light dispersing section is selected from the following: flat, concave conic, convex conic, hemisphere with an apex cone, and a combination thereof.
9 . The device of claim 1 wherein the cavity is selected from the group consisting of: ear cavity, nasal cavity, vagina, lung, throat, esophagus, stomach, intestine, rectum, gall bladder, bladder, open wound cavity, and a cavity of an inanimate object.
10 . The device of claim 1 wherein the inserted portion is adapted for insertion into the nasal cavity, radius of the base portion is larger than radius of the inserted portion, the surface finish of the member includes ribs wherein each of the ribs has a wedge angle of about 17 degree and a rib width ranges from about 0.48 mm to about 0.5 mm, the geometry of the light dispersing section is a hemisphere with an apex cone.
11 . The device of claim 1 wherein the inserted portion is adapted for insertion into the nasal cavity, radius of the base portion is larger than radius of the inserted portion, the surface finish of the member is smooth, the geometry of the light dispersing section is a concave cone with an about 60 degree half angle.
12 . The device of claim 1 further comprises a hermetic cap.
13 . The device of claim 1 wherein the member further comprises at least one tubular member configured for fluid delivery of a photosensitizing composition.
14 . The device of claim 13 further comprises an atomizing nozzle attached to opening port of the at least one tubular member for delivery of the photosensitizing composition onto treatment site within the cavity.
15 . The device of claim 14 wherein the opening port is sealed with a removable tip prior to use for photodisinfection of the cavity.
16 . The device of claim 13 wherein the at least one tubular member has multiple branches allowing multiple opening ports for delivery of the photosensitizing composition onto treatment site within the cavity.
17 . The device of claim 1 wherein the device further comprises a second member that has the same structural components as the member.
18 . The device of claim 17 wherein a light distribution manifold routes the light from the waveguide to the member and the second member.
19 . The device of claim 17 wherein the member and the second member each further comprises at least one tubular member configured for fluid delivery of a photosensitizing composition.
20 . The device of claim 19 wherein a light distribution manifold routes the light from the waveguide to the member and the second member and a fluid distribution manifold routes the photosensitizing composition to the member and the second member.
21 . The device of claim 1 wherein the device further comprises a retention feature.
22 . The device of claim 1 wherein the device is constructed of biocompatible material.
23 . A treatment system for photodisinfection of a cavity comprising:
(a) a device comprising a member having a base portion, an insert portion adapted for insertion into the cavity, and a pocket adapted for communication with a waveguide which is connected to a light source for delivering light to the device, wherein the pocket includes a light dispersing section that is adapted for light communication with distal end of the waveguide;
(b) the waveguide; and
(c) the light source; wherein desired illumination pattern for photodisinfection of the cavity is provided by at least one of the elements selected from the group consisting of: surface finish of the light dispersing section, geometry of the light dispersing section, surface finish of the member, geometry of the member, surface finish of distal end of the waveguide, geometry of the waveguide, and a combination thereof
24 . The treatment system of claim 23 wherein the waveguide is selected from the group consisting of a plastic fiber, a plastic clad glass fiber, a glass fiber, multiple plastic fibers, multiple plastic clad fibers, multiple glass fibers, and a combination thereof.
25 . The treatment system of claim 23 wherein the waveguide is attached to the device by attachment means selected from the group consisting of adhesive, mechanical deformation, physical gripping features, ferrule, friction, threads, “twist and lock” bayonets and a combination thereof.
26 . The treatment system of claim 23 wherein the distal end of the waveguide is enclosed in a ferrule and the waveguide is removably attached to the pocket via the ferrule.
27 . The treatment system of claim 23 wherein the distal end of the waveguide includes a surface finish that is rough.
28 . The treatment system of claim 23 wherein the distal end of the waveguide includes a surface finish that is smooth.
29 . The treatment system of claim 23 wherein the distal end of the waveguide has a geometry selected from the group consisting of flat, concave conic, convex conic, hemisphere with an apex cone, and a combination thereof.
30 . The treatment system of claim 23 wherein the waveguide is connected to the light source via a connector.
31 . The treatment system of claim 30 wherein the connector includes a light source adapter that connects to the light source and a waveguide adapter designed to be removably attached to the waveguide.
32 . The treatment system of claim 23 wherein the light source is selected from a group consisting of laser, light emitting diode, arc lamp, incandescent source, fluorescent source, gas discharge tube, thermal source, light amplifier, and a combination thereof.
33 . The treatment system of claim 23 wherein the light source can be adjusted to provide a condition selected the group consisting of wavelength, power output, size of illumination, and a combination thereof.
34 . The treatment system of claim 23 wherein the light source further includes a temperature monitoring device.
35 . The treatment system of claim 34 wherein the temperature monitoring device is selected from the group consisting of an IR device, a fiber optic device, a thermocouple, and a combination thereof.
36 . The treatment system of claim 23 wherein the waveguide is contained within a holder.
37 . The treatment system of claim 36 wherein the holder further comprises a communication port for light communication between the waveguide and the light source and a switch for controlling the light input to the device.
38 . The treatment system of claim 23 wherein the member further comprises at least one tubular member configured for fluid delivery of a photosensitizing composition.
39 . The treatment system of claim 38 wherein the waveguide is contained within a holder and the holder further comprises a communication port for light communication between the waveguide and the light source, a switch for controlling the light input to the device; and a fluid communication means for fluid communication with the at least one tubular member and adapted for fluid communication with a fluid source containing a photosensitizing composition.
40 . The treatment system of claim 23 wherein the device further comprises a second member that has the same structural components as the member.
41 . The treatment system of claim 23 further comprising a photosensitizing composition contained in a fluid source.
42 . A treatment kit comprising:
(a) a device comprising a member having a base portion, an insert portion adapted for insertion into the cavity, and a pocket adapted for communication with a waveguide which is connected to a light source for delivering light to the device, wherein the pocket includes a light dispersing section that is adapted for light communication with distal end of the waveguide and desired illumination pattern for photodisinfection of the cavity is provided by at least one of the elements selected from the group consisting of: surface finish of the light dispersing section, geometry of the light dispersing section, surface finish of the member, geometry of the member, and a combination thereof;
(b) a photosensitizing composition contained in a fluid source; and
(c) an application tip.
43 . The treatment kit of claim 42 wherein the device, the photosensitizing composition and the application tip are all biocompatible and placed into a sterile package.
44 . The treatment kit of claim 42 wherein the fluid source is a syringe.
45 . The treatment kit of claim 42 further comprises the waveguide.
46 . The treatment kit of claim 42 wherein the member further comprises at least one tubular member configured for fluid delivery of a photosensitizing composition and the application tip is the tubular member of the device.
47 . The treatment kit of claim 46 further comprising a second member having at least one tubular member configured for fluid delivery of the photosensitizing composition, a light distribution manifold for routing the light from the waveguide to each of the two members, the photosensitizing composition is contained in a fluid source, wherein the fluid source is in fluid communication with each of the at least one tubular member of the two members via a fluid distribution manifold.
48 . A method of photodisinfection of a cavity comprising:
(a) providing a device comprising: a member having a base portion, an insert portion adapted for insertion into the cavity, and a pocket adapted for communication with a waveguide which is connected to a light source for delivering light to the device, wherein the pocket includes a light dispersing section that is adapted for light communication with distal end of the waveguide and desired illumination pattern for photodisinfection of the cavity is provided by at least one of the elements selected from the group consisting of:
surface finish of the light dispersing section, geometry of the light dispersing section, surface finish of the member, geometry of the member, surface finish of distal end of the waveguide, geometry of the waveguide, and a combination thereof;
(b) applying a photosensitizing composition to treatment site within the cavity;
(c) inserting at least a portion of the insert portion into the cavity; and
(d) applying light delivered by the device from the light source and via the waveguide to the treatment site within the cavity at a wavelength absorbed by the photosensitizing composition so as to inhibit or eliminate microbes located at the treatment site.
49 . The method of claim 48 wherein the cavity is selected from the group consisting of: ear cavity, nasal cavity, vagina, lung, throat, esophagus, stomach, intestine, rectum, gall bladder, bladder, open wound cavity, and a cavity of an inanimate object.
50 . The method of claim 49 wherein the application of light step does not cause physiological damage to host tissue within the cavity.
51 . The method of claim 48 wherein the cavity is the nasal cavity, the treatment site is the anterior nares, the microbes are MRSA.
52 . The method of claim 51 wherein both nasal cavities of a patient are simultaneously treated by the photodisinfection method.
53 . The method of claim 48 wherein the microbes are selected from the group consisting of Staphylococcus aureus, MRSA, E. coli, E. fecalis, Pseudomonas aeruginosa, Aspergillus, Candida and a combination thereof.
54 . The method of claim 48 the light delivered by the device to the treatment site has multiple wavelengths.
55 . The method of claim 54 wherein the photosensitizing composition can absorb the multiple wavelengths so as to inhibit or eliminate the microbes located at the treatment site.
56 . The method of claim 48 wherein at least the step (b) to (d) are repeated as necessary to further eliminate the microbes at the treatment site.
57 . A device for nasal decolonization of microbes comprising at least one member comprising: a base portion, an insert portion adapted for insertion into a nasal cavity and has a surface finish comprising of ribs, a pocket adapted for communication with a waveguide and has a light dispersing section having a geometry of a hemisphere with an apex cone.
58 . The device of claim 57 wherein each of the ribs has a wedge angle ranging from about 13 degree to about 33 degree.
59 . The device of claim 57 wherein each of the ribs has a width ranging from about 0.25 mm to about 1.5 mm.
60 . The device of claim 57 wherein the hemisphere's radius is about 0.5 mm, the apex cone's height is about 0.175 mm, and the apex cone's base radius is about 0.3 mm.
61 . The device of claim 57 wherein the at least one member is constructed of poly(methyl methacrylate).
62 . The device of claim 57 wherein the at least one member further comprises at least one tubular member configured for fluid delivery of a photosensitizing composition.
63 . The device of claim 62 further comprises an atomizing nozzle attached to opening port of the at least one tubular member for delivery of the photosensitizing composition onto treatment site within the cavity.
64 . The device of claim 57 further comprising the waveguide and the light source.
65 . The device of claim 64 wherein the waveguide is an optical fiber and is attached to the pocket via a ferrule.
66 . The device of claim 57 wherein the light source is a laser.
67 . A method for nasal decolonization of microbes comprising:
(a) providing a device comprising: a member comprising: a base portion, an insert portion adapted for insertion into a nasal cavity and has a surface finish comprising of ribs, a pocket adapted for communication with a waveguide and has a light dispersing section having a geometry of a hemisphere with an apex cone;
(b) applying a photosensitizing composition to anterior nares;
(c) inserting at least a portion of the insert portion into the nasal cavity; and
(d) applying light delivered by the device from a light source via the waveguide to the anterior nares at a wavelength absorbed by the photosensitizing composition so as to inhibit or eliminate microbes located at the anterior nares but does not cause physiological damage to host tissue within the nasal cavity.
68 . The method of claim 67 wherein both nasal cavities of a patient are simultaneously treated by the photodisinfection method.
69 . The method of claim 67 wherein at least the step (b) to (d) are repeated as necessary to further eliminate the microbes at the anterior nares.