U.S. patent application number 12/559267 was filed with the patent office on 2010-01-21 for light diffusing tip.
This patent application is currently assigned to VISUALASE, INC.. Invention is credited to Matthew Fox, Marc Gelnett, Ashok Gowda, Roger McNichols.
Application Number | 20100016930 12/559267 |
Document ID | / |
Family ID | 36386383 |
Filed Date | 2010-01-21 |
United States Patent
Application |
20100016930 |
Kind Code |
A1 |
Gowda; Ashok ; et
al. |
January 21, 2010 |
LIGHT DIFFUSING TIP
Abstract
A light diffusing tip is provided. The light diffusing tip
comprises a housing and a monolithic light scattering medium
disposed within the housing. The monolithic light scattering medium
comprises a first scattering region at a first position, the
scattering region having a first scattering property and a second
scattering region at a second position, the second scattering
region having a second scattering property different from the first
scattering property, wherein the first scattering region and the
second scattering region are coextensive along a substantial
portion of a length of the housing. A light diffusing applicator
also is provided. The light diffusing applicator comprises at least
one optical waveguide, a first termination coupled to a first end
of the at least one optical waveguide, the first termination to
couple to a light source and a light diffusing tip coupled to a
second end of the at least one optical waveguide.
Inventors: |
Gowda; Ashok; (Houston,
TX) ; McNichols; Roger; (Pearland, TX) ;
Gelnett; Marc; (Houston, TX) ; Fox; Matthew;
(Bellaire, TX) |
Correspondence
Address: |
BIOTEX, INC.
8058 EL RIO STREET
HOUSTON
TX
77054
US
|
Assignee: |
VISUALASE, INC.
Houston
TX
|
Family ID: |
36386383 |
Appl. No.: |
12/559267 |
Filed: |
September 14, 2009 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12169602 |
Jul 8, 2008 |
7609927 |
|
|
12559267 |
|
|
|
|
11777856 |
Jul 13, 2007 |
7412141 |
|
|
12169602 |
|
|
|
|
10989894 |
Nov 16, 2004 |
7274847 |
|
|
11777856 |
|
|
|
|
Current U.S.
Class: |
607/88 ;
264/1.24 |
Current CPC
Class: |
A61N 5/0603 20130101;
A61N 5/062 20130101; G02B 6/241 20130101; G02B 6/262 20130101 |
Class at
Publication: |
607/88 ;
264/1.24 |
International
Class: |
A61N 5/06 20060101
A61N005/06; B29D 11/00 20060101 B29D011/00 |
Claims
1. A method of delivering energy to a tissue comprising:
positioning a light diffusing tip proximate to at least one desired
region of said tissue; and providing optical energy to said light
diffusing tip; and delivering said optical energy to said at least
one desired region; wherein said optical energy is variably
scattered along at least one axis of said light diffusing tip.
2. The method of claim 1, wherein said at least one desired region
is a tumor.
3. The method of claim 1, wherein the amount of said optical energy
delivered via said light diffusing tip is substantially uniform
along said at least one axis.
4. The method of claim 1, wherein the amount of said optical energy
delivered via said light diffusing tip substantially varies along
said at least one axis.
5. The method of claim 1, wherein said optical energy is variably
scattered along a long axis of said light diffusing tip.
6. A light diffusing tip comprising: a housing; and a monolithic
light scattering medium disposed within the housing and comprising:
a first scattering region comprising a first scattering material;
and a second scattering region comprising a second scattering
material; wherein said first scattering region at least partially
envelops said second scattering region.
7. The light diffusing tip of claim 6, wherein said first and
second scattering materials comprise scattering centers suspended
in a light transmissive medium.
8. The light diffusing tip of claim 7, wherein at least a portion
of said scattering centers comprise discrete gas bubbles.
9. The light diffusing tip of claim 6, wherein the concentration of
said scattering centers in said light transmissive medium varies
along at least one axis of said light diffusing tip.
10. The light diffusing tip of claim 6, wherein said first
scattering region contacts the entire outer surface of said second
scattering region.
11. The light diffusing tip of claim 6, wherein said second
scattering region comprises a portion of an optical fiber.
12. The light diffusing tip of claim 11, wherein said portion of an
optical fiber comprises the surface of said optical fiber.
13. A method of forming an applicator, the method comprising:
forming a first scattering region in a housing; and forming a
second scattering region in said housing at least partially
coextensively with said first scattering region.
14. The method of claim 13, wherein forming at least one of said
first and second scattering regions comprises injecting a liquid or
gel into said housing.
15. The method of claim 14, wherein said liquid or gel is injected
with a needle.
16. The method of claim 14 further comprising varying the rate of
injection of said liquid or gel into said housing.
17. The method of claim 14 further comprising solidifying at least
one of said first and second scattering regions.
18. The method of claim 17, wherein solidifying at least one of
said first and second scattering regions comprises curing.
19. The method of claim 13, wherein said forming a second
scattering region comprises at least partially displacing the
material of said first scattering region in said housing.
20. The method of claim 15, further comprising: positioning said
needle in proximity to said housing; and injecting said liquid or
gel into said housing; wherein the position of said needle in said
housing is varied during said injecting of liquid or gel into said
housing.
21. The method of claim 20, wherein the positioning of said needle
is varied based on observation of the injection of liquid or gel
into said housing.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] The present application is a divisional application of and
claims priority from U.S. patent application Ser. No. 10/989,894,
filed Nov. 16, 2004, entitled "LIGHT DIFFUSING TIP," naming
inventors Ashok Gowda, Roger McNichols, Marc Gelnett, and Mathew
Fox, which application is incorporated by reference herein in its
entirety.
FIELD OF THE DISCLOSURE
[0002] The present disclosure relates generally to fiber optic
light applicators and more particularly to light diffusion
devices.
BACKGROUND
[0003] Light diffusing tip applicators find application in a number
of clinical settings. Prevalent uses include the treatment of
cancerous tumors using either photodynamic therapy (PDT) or laser
interstitial thermal therapy (LITT). In PDT, light diffusing fiber
optics are used to uniformly irradiate an organ or tissue that has
been previously treated with a photo-sensitive light-activated
compound which has been allowed to accumulate in the tumor. In
LITT, laser energy is applied to tissues for treating solid
malignant tumors in various organs such as the liver, brain, ear
nose or throat (ENT), or abdominal tissues, as well as for treating
benign alterations such as prostate adenomas. Volumetric heating
within target tissues during LITT results in thermal tissue
necrosis and tumor death.
[0004] Light diffusing tip applicators used to carry light from a
source into a target tissue during such therapies can vary
significantly in terms of their size and shape, as well as the way
that they distribute light. A conventional bare fiber optic that
terminates in a cleaved or polished face perpendicular to the optic
axis is limited in most PDT and LITT procedures. To illustrate, for
LITT procedures the power density and resulting heat generation
using a bare fiber often exceed the thermal diffusion into the
tissue, and areas close to the applicator therefore char or
vaporize. These tissue phenomena are problematic for creating
controlled photothermal lesions. For example, chairing limits heat
deposition within deeper tissue volumes due to increased absorption
of light energy by the charred region. As charred tissue continues
to absorb incident light, its temperature continues to rise leading
to more carbonization around the applicator, and temperature rise
in deeper layers is strictly dependent on heat conduction away from
this carbonized volume. While it is possible to create large
thermal lesions in this manner, the morphology of the resulting
lesion is highly undesirable. Furthermore, the high temperatures
associated with the carbonized tissue often result in burning and
failure at the tip of the optical fiber with significant attendant
risk for patients and equipment. Therefore, many LITT procedures
employ an applicator with a light diffuser (or diffusing tip) at
the delivery end of the optical fiber. In such applications, the
scattering of light over a larger surface area provided by the
diffusing tip reduces the power density on the adjacent tissue and
creates a larger coagulation volume while minimizing char
formation.
[0005] Several techniques have been developed to obtain scattering
of light from an optical fiber. One conventional technique includes
selecting the ratio of the index of refraction between the core of
the optical fiber and the transparent cladding such that total
internal reflection is prevented, thereby allowing light to escape
and radiate outside of the fiber. It is difficult, however, to
achieve uniform output intensity using this method, and its use
therefore is not widespread. Other conventional techniques include
etching the outer surface of the core or clad using chemical or
mechanical means or embedding scattering particles around the outer
surface of the core or within the cladding. Such techniques
typically result in a decrease in the mechanical integrity of the
fiber and frequently are incapable of achieving a wide range of
light distributions.
[0006] Another conventional technique employs the use of a
transmissive medium such as an epoxy with embedded scattering
particles and a reflector at the tip. The reflector serves to both
improve homogeneity of the light exiting the fiber as well as
prevent significant forward light propagation. However, the use of
metallic or dielectric reflectors or plugs limits the utility of
such sensors because such reflectors may absorb light energy and
lead to fiber failure. Moreover, metal reflectors, in particular,
may not be compatible with new magnetic resonance imaging (MRI)
image-guided procedures. A further disadvantage is that such
reflectors may be difficult or expensive to produce. Finally, the
reflector and scattering medium, being of significantly different
materials with differing mechanical properties, may partially or
fully separate at their interface, leading to potential "hot
spots," undesirable light distributions, or degradation of diffuser
performance, all of which are likely to lead to a failure in the
applicator.
[0007] Another conventional technique employs a cylindrical
diffusing tip that includes an optically transparent core material
such as silicone with scattering particles dispersed therein which
abuts the core of the optical fiber. This diffusing tip is
manufactured such that the concentration of scattering particles
continuously increases from the proximal to distal ends of the
diffusing tip. The increase in the concentration of scattering
particles eliminates the need for a reflector because light is
increasingly scattered along the diffusing tip length while the
amount of light available decreases distally. However, this
conventional technique has a number of limitations. For one, the
gradient in the tip is extruded using a two-channel injector system
with a mixing chamber whose contents are combined and extruded
through a die. The contents are combined by varying the relative
feed rates of elastomer with two different concentrations of
scatterers to create a gradient in the scattering particles along
the axial length of the diffusing tip. This mixing process places
fundamental limitations on the range of gradients (e.g., the rate
of change of said gradients) which can be produced. Moreover, this
mixing process allows for the creation of gradients only in the
direction of the axis of the fiber. A radial gradient in scattering
particle concentration, for example, is unachievable by this
conventional process.
[0008] Further, the elastomer-based tip is first extruded as
described above, cut to length and then affixed to the end of the
terminus face of the delivery fiber. A plastic tube then is slid
over both the jacket of the optical fiber and the diffuser core.
Thus the diffuser core must be separately affixed to the optical
fiber core which results in a small bonding surface area. Further,
an outer tube larger than the fiber's outer jacket is required,
thereby increasing the overall diameter of the device beyond the
outer diameter of the fiber's outer jackets. Another disadvantage
related to affixing the tip in this manner is that there are no
bonding interfaces to any circumferential surfaces of the fiber.
The sole axial bond is vulnerable to defects such as air gaps,
especially when flexion occurs at the interface between the optical
fiber core and diffuser core that causes the two to separate. Air
or other gaps between the optical fiber core and diffuser core
change the intended light distribution and may result in unintended
"hot spots" which significantly increase the risk of fiber failure
during use. Gaps or defects in the interface between the diffusing
core and the plastic tube placed over the core may also lead to
"hot spots," degradation of diffuser uniformity, and a decrease in
power handling capability.
[0009] Accordingly, a light diffusing tip that overcomes the
limitations of conventional light diffusing tips would be
advantageous.
SUMMARY
Brief Description of the Drawings
[0010] The purpose and advantages of the present disclosure will be
apparent to those of ordinary skill in the art from the following
detailed description in conjunction with the appended drawings in
which like reference characters are used to indicate like elements,
and in which.
[0011] FIG. 1 is a schematic diagram illustrating an exemplary
light applicator in accordance with at least one embodiment of the
present disclosure.
[0012] FIGS. 2-7 and 9 are cross-section views illustTating various
exemplary light diffusing tips in accordance with various
embodiments of the present disclosure.
[0013] FIG. 8 is an isometric view illustrating an exemplary light
diffusing tip having reflective material overlaying a portion of
the tip in accordance with at least one embodiment of the present
disclosure.
[0014] FIGS. 10-13 are cross-section views illustrating an
exemplary method of manufacturing a light diffusing tip in
accordance with at least one embodiment of the present
disclosure.
[0015] FIG. 14 is a flow chart illustrating an exemplary method for
utilizing a light applicator in accordance with at least one
embodiment of the present disclosure.
DESCRIPTION OF THE DRAWINGS
[0016] FIGS. 1-14 illustrate various exemplary light diffusing
applicators and exemplary methods of their use and manufacture. The
devices and methods described herein may find advantageous
application in the treatment of solid cancerous tumors and other
defects in soft tissue. In at least one embodiment of the
disclosures made herein, a light diffusing applicator includes an
optical waveguide designed for connection to an energy source and
further includes an optical diffusing tip designed to cause
cylindrical or substantially cylindrical scattering of light
radiation around the axis of the optical waveguide.
[0017] The term light, as used herein, refers to electromagnetic
radiation within any of the infrared, visible, and ultraviolet
spectra. Consequently, the term light transmissive, as used herein,
is used in the context of the type of light implemented. Exemplary
sources of light may include, but are not limited to, lasers, light
emitting diodes, arc lamps, light bulbs, flash lamps, and the
like.
[0018] Referring now to FIG. 1, an exemplary light applicator 10 is
illustrated in accordance with at least one embodiment of the
present disclosure. The light applicator 10 includes a connector 11
coupled to a proximal end of a flexible optical waveguide 12 and a
light diffusing tip 13 optically and mechanically coupled to a
distal end of the optical waveguide 12. The connector 11 couples to
a light source (not shown) to receive light energy for transmission
to the diffusing tip 13 via the waveguide 12. An example of the
connector 11 includes the SMA905 fiber connector (available from
Amphenol-Fiber Optic Products of Lisle, Ill.) which is frequently
used for stable and reliable coupling to common lasers and other
light sources. The diffusing tip 13, in turn, scatters the light
energy over a substantial portion of the diffusing tip 13. As
disclosed in greater detail herein, in at least one embodiment, the
diffusing tip 13 comprises a light transmissive housing having a
monolithic scattering medium disposed within the housing, where the
monolithic scattering medium includes two or more distinct
scattering regions, each scattering region comprising a scattering
material having scattering properties different from the scattering
properties of the remaining scattering regions. Additionally, each
scattering region may be coextensive along a length of the tubing
with one or more adjacent scattering regions so that the diffusing
tip exhibits a gradient in its scattering coefficient both axially
and radially.
[0019] Referring now to FIG. 2, an exemplary implementation of a
light diffusing tip is illustrated in accordance with at least one
embodiment of the present disclosure. The illustrated diffusing tip
23 includes an optical waveguide 22 having one or more optical
fiber cores 24 surrounded by a cladding layer 25 and protective
jacketing 26. A portion of the distal end of the optical waveguide
22 may be stripped of its outer protective jacketing 26, thereby
exposing the cladding 25 over a length of the fiber. In the
illustrated example, the distal end of the optical waveguide 22 is
cleaved or polished flat, but other termination configurations,
such as termination in a point, ball or at an angle, may be
implemented as appropriate. The diffusing tip 23 further includes
an outer housing 28 to enclose scattering material and to provide a
surface for bonding the diffusing tip 23 to the optical waveguide
22. The outer housing 28 preferably is composed of any of a variety
of light transmissive materials, such as, for example, flexible
PTFE or "Teflon," polycarbonate, polyurethane, polyethylene,
polypropylene, silicon, nylon, PVC, PET, ABS, PES, PEEK, FEP, as
well as other flexible or rigid, radio-opaque or non radio-opaque
materials as appropriate.
[0020] Disposed within the housing 28 is scattering material
forming a monolithic scattering medium having two or more regions,
where each region comprises a scattering material having one or
more scattering properties that are distinct from the scattering
properties of the scattering materials of the other regions. In the
illustrated example of FIG. 2, the monolithic scattering medium
disposed within the housing 28 includes two scattering regions 30
and 31. The scattering region 30 includes a scattering material 32
having one or more scattering properties that are distinct from the
scattering material 33 comprising the scattering region 31. In at
least one embodiment, the scattering material 32 of the scattering
region 30 comprises scattering particles 34 suspended in a light
transmissive material 35 and the scattering material 33 comprises
scattering particles 36 suspended in a light transmissive material
37. Examples of materials suitable for the scattering particles 34
and 36 include, but are not limited to plastics, glasses, metals,
metal oxides, or other particles known in the art to scatter
optical radiation. An exemplary commercial product which may be
implemented as scattering particles 34 or 36 includes titanium
dioxide particles available from Sigma-Aldrich Co. of St. Louis,
Mo. Examples of materials suitable for the light transmissive
materials 35 and 37 include, but are not limited to, plastics (such
as described above with reference to the housing 28), epoxies, and
elastomers such as silicone or cyanoacrylates. An exemplary
commercial product which may be implemented as materials 35 or 37
includes Mastersil 151 two-part silicone epoxy available from
Master Bond, Inc., of Hackensack, N.J. As depicted by FIG. 2, the
scattering material 32 (or, alternatively, the scattering material
33) further may be used as an adhesive to bond the housing 28 to
the fiber core 24 and/or cladding 26.
[0021] As noted above, the scattering material 32 and the
scattering material 33, in one embodiment, have one or more
different scattering properties. Different scattering properties
between the scattering materials 32 and 33 may be implemented by,
for example, utilizing one type of scattering particle 34 (e.g.,
titanium dioxide) for scattering material 32 and a different type
of scattering particle 36 (e.g., gold particles) for scattering
material 33. As another example, the scattering particles 34 and 36
may be of different sizes and/or shapes so as to exhibit different
scattering properties. As a further example, the concentration of
the scattering particles 34 in the material 32 may be different
than the concentration of scattering particles 36 in the material
37 so that the scattering materials 32 and 33 exhibit different
scattering properties. It also should be noted that other
configurations like gas bubbles in the elastomer or an emulsified
liquid also may create scattering centers. Different scattering
properties also may be achieved using light transmissive materials
with different indexes of refraction. The scattering materials 32
and 33 also may be different from each other by a combination of
any of scattering particle type, scattering particle size,
scattering particle shape, scattering particle concentration or a
transmissive material's index of refraction. Typically, the
difference between the scattering properties of the two materials
32 and 33 is represented by a difference in their scattering
coefficients (i.e., a measure of the amount of light scattering
exhibited by a material).
[0022] In at least one embodiment, the scattering materials 32 and
33 are positioned within the housing 28 such that the scattering
regions 30 and 31 are coextensive for, at least a portion 40 of the
length of the housing 28. In the example illustrated in FIG. 2, the
scattering regions 30 and 31 are arranged such that the scattering
region 31 forms a substantially cone shaped portion that is at
least partially surrounded by material of the scattering region 30,
and thus the scattering regions 30 and 31 are coextensive along the
housing 28 for part or all of the cone shaped region. As discussed
in greater detail herein, the scattering regions 30 and 31 may be
formed so as to take on any of a variety of shapes in the
coextensive portion 40 of the housing 28 as appropriate.
[0023] As illustrated by cross-sections 42-44 at positions 45-47,
respectively, of diffusing tip 23, the geometric relationship
between the two scattering regions 30 and 31 varies. As the
distance from the termination of the fiber core 24 increases, the
cross-sectional area of the scattering material 32 decreases while
the cross-sectional area of the scattering material 33 increases.
At point 45, the scattering medium of the diffusing tip is made up
of the scattering material 32. At point 46, the amount of
scattering material 32 present decreases and the amount of
scattering material 33 increases. At point 47, the scattering
element of the diffusing tip 23 is almost entirely made up of the
scattering material 33. Thus, the proportion of the scattering
material 33 to the scattering material 32 (i.e., the proportion of
the scattering region 31 to the scattering region 30) of the
monolithic scattering medium generally increases from the proximal
end to the distal end of the diffusing tip 23. The distal end of
diffusing tip 23 may be made up entirely of scattering material
33.
[0024] The concentration and length of both the scattering region
30 and the scattering region 31 within the diffusing tip 23 may be
varied to achieve a desirable light distribution. For example,
longer diffusing tips may have lower concentration scattering
regions or shorter lengths of higher concentration scattering
regions. Similarly, shorter diffusing tips may contain a shorter
length of a low concentration scattering region and a longer length
of a higher concentration scattering region.
[0025] The concentration and length of each scattering region
preferably is selected to result in substantially uniform emission
of light along the length of the diffusing tip. The intensity of
light in a partially transmissive (i.e., scattering and/or
absorptive) medium typically exhibits a fall-off described by
Beer's Law, I=I.sub.oe.sup.-.mu.z, where I represents intensity at
z, Io represents initial intensity, .mu. represents attenuation
coefficient and z represents distance away from the source.
Accordingly, the characteristics of the scattering regions may be
chosen so as to make the light scattered along the length of the
diffusing tip approximately constant in view of Beer's Law. To
illustrate, scattering legions may be arranged so that the
effective scattering coefficient .mu.(z)=-log(1-z/L)/z, for
z.di-elect cons.e[0,L]. This may be achieved by, for example,
arranging the scattering regions such that the overlapping segments
have profiles substantially related by the preceding equation. As
another example, the scattering material 32 may have a lower
concentration of scattering particles 34 than the concentration of
scattering particles 36 of the scattering material 33 and,
therefore, the effective concentration of scattering particles
increases over the coextensive portion 40 even as the intensity of
the light energy decreases. However, in certain instances it may be
desirable to preferentially emit light over a given cross section
of the diffusing tip 23 which may be accomplished by concentrating
scattering material having higher scattering coefficients at
positions where more light is intended to exit the diffusing tip
23.
[0026] Referring now to FIGS. 3 and 4, alternate exemplary
implementations of a light diffusing tip are illustrated in
accordance with at least one embodiment of the present disclosure.
FIG. 3 illustrates a diffusing tip 71 comprising a monolithic
scattering medium disposed within the housing 28 and having two
scattering regions 50 and 51. In contrast with the diffusing tip 23
of FIG. 2, the scattering region 50 includes a scattering material
52 having a substantially conical portion directed away from the
termination of the fiber core 24 and the scattering region 51
includes a scattering material 53 having a region that at least
partially surrounds the conical region and is therefore coextensive
with the scattering material 52 over the portion 48 of the length
of the diffusing tip 71. In the illustrated embodiment, the
scattering material 52 has a lower scattering coefficient than the
scattering material 53. As the cross-sections 54-56 at positions
57-59, respectively, illustrate, the proportion of the scattering
material 52 to the scattering material 53 decreases, and the
effective scattering coefficient therefore increases, as the
distance from the termination of the fiber core 24 increases.
[0027] FIG. 4 illustrates another exemplary implementation of a
diffusing tip having a monolithic scattering medium with two or
more partially overlapping, distinct scattering regions. FIG. 4
illustrates an exemplary diffusing tip having distinct scattering
regions 60 and 61, wherein the scattering region 61 comprises a
substantially conical region surrounded by the scattering region 60
over portion 49. The scattering region 60 comprises a scattering
material 62 having a first scattering property and the scattering
region 61 comprises scattering material 63 having a second
scattering property different from the first scattering property.
Whereas the exemplary diffusing tips 23 and 71 of FIGS. 2 and 3 are
illustrated as having scattering regions that include conical
portions substantially coaxial with the axis of the housing 10, the
axis of the substantially conical portion of scattering region 60
is offset from the longitudinal axis of the housing 28, as
illustrated by cross-sections 64-66 at positions 67-69,
respectively. Such an implementation may be employed to
preferentially scatter light out of a given angular region of the
diffusing tip. During the manufacture the diffusing tip, the
scattering region 61 can be formed by allowing the scattering
materials 62 and 63 to cure in the horizontal position or in a
centrifuge, where the conical region 61 may settle due to gravity
or centrifugal force.
[0028] Referring now to FIGS. 5-7, exemplary diffusing tips having
various caps secured to their distal ends are illustrated in
accordance with at least one embodiment of the present disclosure.
FIG. 5 depicts a diffusing tip 73 having a pointed cap 74 that
facilitates insertion of the fiber into tissues for interstitial
applications. FIG. 6 depicts a diffusing tip 83 having a rounded
cap 84 that may be used in hollow organs or to minimize risk of
vessel punctures during interstitial applications. FIG. 7 depicts a
diffusing tip 93 having a blunt cap 94 that represents a third
scattering region having a scattering material with a high
scattering coefficient for further minimizing forward propagation
of light from the distal end of the diffusing tip 93. Blunt cap 94
may also be made of a biocompatible material to prevent contact of
scattering material with bodily tissue.
[0029] Referring now to FIGS. 8 and 9, exemplary treatments to the
housing of the diffusing tip are illustrated in accordance to at
least one embodiment of the present disclosure. FIG. 8 depicts an
exemplary diffusing tip 103 with a selective angular. emission
profile that is achieved using a reflective material 104 overlaying
a section of the surface of the housing 28 of the diffusing tip
103, where the reflective material 104 prevents light energy from
passing through that section. Suitable materials for the reflective
material 104 include, for example, deposited surfaces of gold,
silver, aluminum, chrome, nickel, or other reflective materials.
The reflective material 104 may be disposed either on the inner
surface or outer surface of the housing 28. FIG. 9 depicts an
exemplary diffusing tip 113 having a non-stick coating 114 disposed
on some or all of the outer surface of the housing 28. The
non-stick coating 114 may include, for example, any of a number of
light transmissive fluoropolymers with high temperature handling
capability and non-stick surface properties with respect to
thermally coagulated tissues. Materials for the housing 28 can then
be chosen based on the desired stiffness of the diffusing tip while
the non-stick coating 114 of fluoropolymer provides the ideal
surface properties. Alternatively, the non-stick coating 114 may be
used to provide increased stiffness or durability for the diffusing
tip 113.
[0030] Referring now to FIGS. 10-13, an exemplary method for
manufacturing a light diffusing tip is illustrated in accordance
with at least one embodiment of the present disclosure. Initially,
a scattering material having a lower scattering coefficient is
created, for example, by mixing a lower amount of scattering
particles in an elastomer material to create a scattering material
with a lower concentration of scattering particles. A scattering
material having a higher scattering coefficient also is created.
The scattering material having a higher scattering coefficient may
be created by, for example, mixing a higher amount of scattering
particles in an elastomer material to create a scattering material
having a higher concentration of scattering particles. To
illustrate, the scattering particle and elastomer mixtures may
include, for example, titanium dioxide particles mixed in silicone
epoxy. In order to minimize or eliminate air bubbles in the
scattering materials, a vacuum may be applied to the uncured
silicone/titanium dioxide mixture prior to use.,
[0031] In certain instances, the scattering particle concentration
range for the lower scattering coefficient material and the higher
scattering coefficient material varies depending on the length and
core diameter of the optical waveguide. For a typical 400 micron
core diameter optical waveguide, a diffusing tip of for example, 10
mm in length typically has a lower scattering coefficient material
with a concentration of TiO.sub.2 scattering particles preferably
between 100 mg/ml and 180 mg/ml and more preferably between 145 mg
/ml and 155 mg /ml. The higher scattering coefficient material
typically has a concentration of TiO.sub.2 scattering particles
preferably between 2500 mg/ml and 6500 mg /ml and more preferably
between 4400 mg /ml and 4650 mg /ml The scattering regions formed
from the scattering materials also may vary in length. To
illustrate, for the same 10 mm long diffusing tip, the length of
the scattering region resulting from the lower scattering
coefficient material preferably is between 1 mm and 100 mm, more
preferably between 5 mm and 10 mm and even more preferably is about
6 mm. For the same diffusing tip length, the length of the
scattering region formed from the higher scattering coefficient
material preferably is between 1 mm and 100 mm, more preferably is
between 2 mm and 5 mm and even more preferably is about 4 mm. The
shapes and lengths of each scattering region and the concentration
of each scattering material may be varied to achieve the desired
output profile for light emitted from the diffusing tip,
[0032] Referring to FIG. 10, lower scattering coefficient material
122 is transferred to a first injector barrel 124 (e.g., a 3 cc
barrel available from EFD, Inc. of East Providence, R.I.) supplied
with a blunt ended needle 125 (e.g., a 27 Ga needle available from
EFD, Inc.). A housing 126 is positioned over the distal end of an
optical waveguide 128 over a length where the protective jacket has
previously been removed from the optical waveguide 128. In at least
one embodiment, the housing 126 includes a tubular housing having
an outer diameter selected to substantially match the outer
diameter of the optical waveguide's protective jacket so that a
uniform surface profile is provided along the entire length of the
resulting light applicator. The wall thickness of the housing 126
may be selected to allow space for a bonding region 130 between the
inner wall of the housing 126 and the exposed cladding on the
optical waveguide 128.
[0033] Referring to FIG. 11, the needle 125 is introduced into the
distal end of the housing 126 and a plunger tip 131 within barrel
124 is actuated either manually or using a regulated dispenser (for
example, the EFD Ultra Dispenser available from IFD, Inc.) to
inject lower scattering coefficient material 122 into the lumen of
the housing 126. The lower scattering coefficient material 122 may
be injected until, for example, the distance 132 between the end of
the optical waveguide 128 and the blunt ended needle 125 and
approximately half the length 129 of housing 126 covering the
exposed end of the optical waveguide 128 are filled. At this point,
the needle 125 may be removed from the distal end of the housing
126 while continuing to inject.
[0034] Referring to FIG. 12, the higher scattering coefficient
material 134 is transferred to a second injector barrel 136
supplied with a second blunt ended needle 137. The needle 137 then
is positioned inside the distal end of the housing 126. Actuation
of plunger tip 138 infuses higher scattering coefficient material
134 into a portion of the lower scattering coefficient material 122
which results in the formation of a discrete substantially
cone-shaped portions of higher scattering coefficient material 134
within the lower scattering coefficient material 122 over a length
140 of the housing 126. During injection of higher scattering
coefficient material 134, lower scattering coefficient material 122
is forced toward the optical waveguide 128 and allowed to fill the
bonding region 130 between the housing 126 and the exposed cladding
of the optical waveguide 128. At this point the needle 137 is
removed from the housing 126 while continuing to inject.
Alternatively, the higher scattering coefficient material 134 may
be inserted via the proximal end of the housing 126 and the optical
waveguide 128 subsequently inserted before or during the curing of
the scattering material 134.
[0035] As illustrated by FIG. 13, the distal end of the resulting
diffusing tip 143 may be cut or otherwise trimmed to the
appropriate length, and the finished tip/fiber assembly may be
positioned vertically and the scattering materials 132 and 134
allowed to cure. Alternatively, the diffusing tip 143 may be placed
in a horizontal position or subjected to a centrifuge so as to
cause the scattering particles of the scattering materials 132 and
134 to settle in one or more desired locations. Thus, as FIGS.
10-13 illustrate, although injected as two separate preparations,
the scattering materials 132 and 134 may be formulated of the same
base material and thus cure into a monolithic scattering medium
with spatially varying (both longitudinally and radially)
scattering particle concentrations.
[0036] Although FIGS. 11-13 illustrate an exemplary method for
manufacturing a diffusing tip, other techniques may be implemented
without departing from the spirit or the scope of the present
invention. For example, the diffusing tip may be formed by
inserting one type of scattering material into the housing 126 and
allowing the scattering material to partially or fully cure. A
cavity is then formed in one end of the scattering material using,
for example, a drill bit or scraping tool. Alternatively, a mold
having the desired cavity shape may be inserted into one end of the
scattering material prior to curing and then removed after the
first scattering material has at least partially cured. Another
type of scattering material then is inserted into the housing 126
so that it occupies the cavity in formed the first scattering
material, The second scattering material then may be left to cure
and bond to the first scattering material so as to form the
scattering medium of the resulting diffusing tip.
[0037] While several specific geometric shapes and relationships
for the discrete scattering regions have been disclosed herein, any
suitable arrangement of scattering regions may be implemented using
the teachings provided herein without departing from the spirit or
scope of the present disclosure. For example, the shape of the a
scattering region is generally described herein as being conical in
shape and increasing linearly in size from proximal to distal ends,
but alternatively its shape could have a non-linear taper, such as
in accordance with Beer's Law, or other geometric shape and still
achieve a desired effect. As such, there are many suitable
modifications and variations in the shapes, sizes, lengths, and
positional arrangements of the discrete scattering regions that are
within the scope of the present disclosure
[0038] Referring now to FIG. 14, an exemplary method 140 of use of
a light applicator having a diffusing tip is illustrated in
accordance with at least one embodiment, Generally, the exemplary
method 140 initiates at step 142 wherein a light applicator having
a diffusing tip (e.g., the light applicator 10 of FIG. 1) is
obtained. The light applicator then may be affixed or otherwise
coupled to a light source via the connector 11 (FIG. 1). At step
144, the diffusing tip is placed on or in a patient and the light
diffusing tip is located proximate to the bodily tissue to be
treated. At step 146, the light source is activated and light
energy is transmitted to the diffusing tip 13 (FIG. 1) via the
connector 11 and the optical waveguide 12 (FIG. 1). Upon reaching
the diffusing tip 13, the light is scattered along and out of the
monolithic scattering medium in accordance with the scattering
properties of the two or more distinct scattering regions of the
monolithic scattering medium so as to irradiate the bodily tissue
proximal to the diffusing tip 13 As noted above, in one embodiment,
the two or more scattering regions have particular scattering
properties and overlap in such a way so as to provide a
substantially uniform light scattering along the length of the
diffusing tip. In other embodiments, the scattering regions may be
arranged so as to concentrate the light scattering in certain areas
or in certain directions. Specific implementations of the general
method 140 may include, for example LITT treatment of focal or
metastatic tumors in brain, prostate, kidney, liver, breast,
uterine, spinal, bone or other organs, as well as photodynamic
therapy in hollow organs.
[0039] The previous description is intended to convey a thorough
understanding of the present disclosure by providing a number of
specific embodiments and details involving light diffusion
techniques. It is understood, however, that the present disclosure
is not limited to these specific embodiments and details, which are
exemplary only. It is further understood that one possessing
ordinary skill in the art, in light of known systems and methods,
would appreciate the use of the disclosure for its intended
purposes and benefits in any number of alternative embodiments,
depending upon specific design and other needs.
* * * * *