NZ722168B2 - Device for use of photodynamic therapy - Google Patents
Device for use of photodynamic therapy Download PDFInfo
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- NZ722168B2 NZ722168B2 NZ722168A NZ72216815A NZ722168B2 NZ 722168 B2 NZ722168 B2 NZ 722168B2 NZ 722168 A NZ722168 A NZ 722168A NZ 72216815 A NZ72216815 A NZ 72216815A NZ 722168 B2 NZ722168 B2 NZ 722168B2
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- New Zealand
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- distal end
- outer shaft
- brain
- end cap
- wand
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Abstract
Photodynamic therapy (PDT) is a form of treatment that relies on exposing an area of tissue to a selective wavelength of activating radiation. PDT has been used effectively in oncology for the destruction of malignant cell masses in the body. However, use in the brain has been limited by the lack of proven devices familiar to neurosurgeons to deliver PDT for the treatment of brain tissue. There is a need for a new device for PDT that is useful and effective for other parts of the body in addition to the brain. The present invention provides a non-implantable surgical apparatus that uses a light source and a power supply for minimally invasive surgical treatment of a tissue region of a brain of a patient. The apparatus comprises a housing having a proximal and distal end, and the housing comprises a handle configured to be grasped and manipulated by a surgeon during a surgical procedure and to remain outside of the patient throughout the surgical procedure. The apparatus also comprises a wand extending from the distal end of the housing. The wand comprises an outer shaft having a proximal end and a distal end for positioning within the tissue region of the brain during the surgical procedure. The outer shaft defines a lumen extending between the proximal end and the distal end of the outer shaft. The wand also comprises an end cap having a closed distal end and being coupled to the distal end of the outer shaft. The end cap comprising one or more apertures disposed along a longitudinal surface of the end cap and parallel to a longitudinal axis of the end cap. The wand also comprises an inner fiber optic cable having a distal end and a proximal end adapted to be operatively connected to the light source. The fiber optic cable is configured to be received within the lumen and extend from the proximal end of the shaft to adjacent the distal end of the shaft. The wand also comprises a diffuser element disposed within the end cap and configured to receive light emitted at the distal end of the inner fiber optic cable, and a ball bearing having a reflective outer surface disposed at a distal end of the diffuser element and within the end cap, and configured to reflect light received from the diffuser element laterally and proximally through the one or more apertures. The wand also comprises a piezoelectric ceramic member disposed within the end cap and located distally from the ball bearing, the piezoelectric ceramic member being coupled to wire connectors that extend to the proximal end of the outer shaft where they are adapted to be operatively connected to the power supply. The piezoelectric ceramic member is adapted to deliver sound waves to the tissue region of the brain during the surgical procedure. The piezoelectric ceramic member has a cylindrical shape having a cylindrical axis co-axial with a longitudinal axis of the outer shaft lumen. The fiber optic cable is adapted to deliver light from the light source via the diffuser element and the ball bearing through the at least one aperture of the end cap to the tissue region of the brain in proximity to the distal end of the outer shaft during the surgical procedure. proven devices familiar to neurosurgeons to deliver PDT for the treatment of brain tissue. There is a need for a new device for PDT that is useful and effective for other parts of the body in addition to the brain. The present invention provides a non-implantable surgical apparatus that uses a light source and a power supply for minimally invasive surgical treatment of a tissue region of a brain of a patient. The apparatus comprises a housing having a proximal and distal end, and the housing comprises a handle configured to be grasped and manipulated by a surgeon during a surgical procedure and to remain outside of the patient throughout the surgical procedure. The apparatus also comprises a wand extending from the distal end of the housing. The wand comprises an outer shaft having a proximal end and a distal end for positioning within the tissue region of the brain during the surgical procedure. The outer shaft defines a lumen extending between the proximal end and the distal end of the outer shaft. The wand also comprises an end cap having a closed distal end and being coupled to the distal end of the outer shaft. The end cap comprising one or more apertures disposed along a longitudinal surface of the end cap and parallel to a longitudinal axis of the end cap. The wand also comprises an inner fiber optic cable having a distal end and a proximal end adapted to be operatively connected to the light source. The fiber optic cable is configured to be received within the lumen and extend from the proximal end of the shaft to adjacent the distal end of the shaft. The wand also comprises a diffuser element disposed within the end cap and configured to receive light emitted at the distal end of the inner fiber optic cable, and a ball bearing having a reflective outer surface disposed at a distal end of the diffuser element and within the end cap, and configured to reflect light received from the diffuser element laterally and proximally through the one or more apertures. The wand also comprises a piezoelectric ceramic member disposed within the end cap and located distally from the ball bearing, the piezoelectric ceramic member being coupled to wire connectors that extend to the proximal end of the outer shaft where they are adapted to be operatively connected to the power supply. The piezoelectric ceramic member is adapted to deliver sound waves to the tissue region of the brain during the surgical procedure. The piezoelectric ceramic member has a cylindrical shape having a cylindrical axis co-axial with a longitudinal axis of the outer shaft lumen. The fiber optic cable is adapted to deliver light from the light source via the diffuser element and the ball bearing through the at least one aperture of the end cap to the tissue region of the brain in proximity to the distal end of the outer shaft during the surgical procedure.
Description
DEVICE FOR USE OF PHOTODYNAMIC THERAPY
Background
A device and method is shown and described for use in irradiating or otherwise administering
light to a location within the body of a patient and, more particularly, a device and method for the use of
photodynamic therapy for the therapeutic treatment of tissue in the brain or other part of the body of the
patient, including tumors, such as malignant brain neoplasms.
There are a variety of medical procedures that require light or irradiated energy to be
administered to a patient within the body. Photodynamic therapy (PDT) is a form of treatment that relies
on exposing an area of tissue to a selected wavelength of activating radiation. PDT uses non-toxic,
photosensitive compounds that accumulate selectively in targeted tissue. The photosensitive compounds
become toxic when exposed to light at selected wavelengths. This leads to chemical destruction of any
tissues which have selectively taken up the photosensitizer and have been selectively exposed to light.
One application of PDT is in oncology for the destruction of malignant cell masses in the body.
PDT has been used effectively in the treatment of a variety of human tumors and precancerous
conditions, including basal and squamous cells, skin cancers, lung cancer, breast cancer, metastatic to
skin, brain tumors, and head and neck, stomach, and the female genital tract malignancies. PDT has also
been used to treat the cancers and precancerous conditions of the esophagus, such as Barrett's esophagus.
In the latter application, a photosensitizer, such as Photophrin, is first administered. A 630 nm light from
a KTP/dye laser, a diode laser, or an argon-pumped dye-laser is delivered using a PDT balloon having a
reflective inner surface. The PDT balloon includes an internal cylindrical diffuser and has several
windows for illuminating the treatment area.
Therapeutic use of PDT in the brain has been minimal. Therefore, evidence for the efficacy and
the safety of PDT for use in the brain is limited in quality and quantity. However, the introduction of
probes or similar devices into the brain is common in many surgical procedures. The probes used for
intracranial penetration are typically fabricated so that their introduction into the brain is as minimally
traumatic as possible. During typical implantation, a surgeon feeds the probe into the brain through an
aperture in the skull. Probes inserted into the brain typically include ports for drug delivery or paired
contacts positioned at specific points or regions in the brain. The contacts are electrical, chemical,
electrochemical, temperature or pressure contacts, which enable the observation and analysis of the brain
state or provide stimulation. In addition, neurosurgeons use photosensitizers when resecting infiltrative
tumors. The photosensitizers fluoresce when light of a certain wavelength is shined on the cells allowing
for rough identification of the tumor margins.
For the foregoing reasons, there is a need for a new device and method for the use of
photodynamic therapy (PDT) for the therapeutic treatment of tissue in the brain of a patient. The new
device and method should ideally include a probe or similar device familiar to neurosurgeons to deliver
PDT for the treatment of the brain tissue, including tumors such as malignant brain neoplasms. In one
aspect, the new device and method for PDT is useful and effective for other parts of the body in addition
to the brain.
Summary
The present invention provides a non-implantable surgical apparatus that uses a light source and
a power supply for minimally invasive surgical treatment of a tissue region of a brain of a patient, the
non-implantable surgical apparatus comprising: a housing having a proximal and distal end, the housing
comprising a handle configured to be grasped and manipulated by a surgeon during a surgical procedure
and to remain outside of the patient throughout the surgical procedure; and a wand extending from the
distal end of the housing, the wand comprising: an outer shaft having a proximal end and a distal end for
positioning within the tissue region of the brain during the surgical procedure, the outer shaft defining a
lumen extending between the proximal end and the distal end of the outer shaft; an end cap having a
closed distal end and being coupled to the distal end of the outer shaft, the end cap comprising one or
more apertures disposed along a longitudinal surface of the end cap and parallel to a longitudinal axis of
the end cap; an inner fiber optic cable having a distal end and a proximal end adapted to be operatively
connected to the light source, the fiber optic cable configured to be received within the lumen and extend
from the proximal end of the shaft to adjacent the distal end of the shaft; a diffuser element disposed
within the end cap and configured to receive light emitted at the distal end of the inner fiber optic cable; a
ball bearing having a reflective outer surface disposed at a distal end of the diffuser element and within
the end cap, and configured to reflect light received from the diffuser element laterally and proximally
through the one or more apertures; and a piezoelectric ceramic member disposed within the end cap and
located distally from the ball bearing, the piezoelectric ceramic member being coupled to wire connectors
that extend to the proximal end of the outer shaft where they are adapted to be operatively connected to
the power supply, wherein the piezoelectric ceramic member is adapted to deliver sound waves to the
tissue region of the brain during the surgical procedure, wherein the piezoelectric ceramic member has a
cylindrical shape having a cylindrical axis co-axial with a longitudinal axis of the outer shaft lumen, and
wherein the fiber optic cable is adapted to deliver light from the light source via the diffuser element and
the ball bearing through the at least one aperture of the end cap to the tissue region of the brain in
proximity to the distal end of the outer shaft during the surgical procedure.
An apparatus for use in photodynamic therapy is described, in one embodiment, for intracranial
treatment of a tissue region of a brain of a patient. The intracranial treatment apparatus comprises an
outer shaft having a proximal end and a distal end for positioning within the tissue region of the brain.
The outer shaft defines a lumen extending between the proximal end and the distal end of the outer shaft
and having at least one aperture adjacent the distal end of the outer shaft. An inner light-delivery element
has a distal end and a proximal end adapted to be operatively connected to a light source. The light–
delivery element is configured to be received within the lumen and extend from the proximal end of the
shaft to adjacent the distal end of the shaft. The light-delivery element is adapted to deliver light from
the light source through the at least one aperture of the outer shaft to the tissue region of the brain in
proximity to the distal end of the outer shaft.
In one aspect, the outer shaft has a plurality of ports radially or axially spaced along the outer
shaft. In this embodiment, the light-delivery element comprises a plurality of independently movable
fiber optic cables, each of the plurality of fiber optic cables extending from one of the ports and axially
movable within the lumen relative to the outer shaft between a first position where the distal end of the
fiber optic cable is adjacent the outer shaft, and a second position where the distal end of the fiber optic
cable extends into the tissue region of the brain in proximity to the outer shaft.
A method for intracranial treatment of a tissue region of a brain of a patient is also described.
The intracranial treatment method comprises the steps of providing a device including a light source for
selectively irradiating tissue. The irradiating device comprises an outer shaft having a proximal end and
a distal end for positioning within the tissue region of the brain. The outer shaft defines a lumen
extending between the proximal end and the distal end of the outer shaft and having at least one aperture
adjacent the distal end of the outer shaft. An inner light-delivery element has a distal end and a proximal
end configured to be operatively connected to the light source. The light–delivery element is configured
to be received within the lumen and extend from the proximal end of the outer shaft to adjacent the distal
end of the outer shaft. The distal end of the outer shaft is positioned within close proximity to a selected
site adjacent the tissue region in the brain. Light is delivered from the light source through the light-
delivery element and the at least one aperture of the outer shaft to the tissue region of the brain in
proximity to the distal end of the outer shaft sufficient to kill a portion of the tissue.
In a further aspect of the method, the outer shaft has a plurality of ports radially or axially spaced
along the outer shaft. The light-delivery element comprises a plurality of independently movable fiber
optic cables, each of the plurality of fiber optic cables extending from one of the ports and axially
movable within the lumen relative to the outer shaft between a first position where the distal end of the
fiber optic cable is adjacent the outer shaft, and a second position where the distal end of the fiber optic
cable extends into the tissue region of the brain in proximity to the outer shaft. The positioning step
comprises moving the plurality of fiber optic cables to the second position such that the distal end of each
of the plurality of fiber optic cables extends through the port of the outer shaft and into the tissue region
in proximity to the outer shaft when the plurality of fiber optic cables is advanced distally relative to the
lumen.
Brief Description Of The Drawings
For a more complete understanding of the present invention, reference should now be had to the
embodiments shown in the accompanying drawings and described below. In the drawings:
is a perspective view of an embodiment of a device for providing photodynamic therapy
to the brain of a patient.
is exploded perspective of the photodynamic therapy device as shown in
is a longitudinal cross-section view of the photodynamic therapy device as shown in
is a close-up view of an embodiment of tip of a wand for use with the photodynamic
therapy device as shown in
is an exploded perspective view of the tip of the wand as shown in
is a longitudinal cross-section view of the tip of the wand as shown in
is front perspective view of another embodiment of a device for providing photodynamic
therapy to the brain of a patient.
is a rear perspective view of the photodynamic therapy device as shown in
is an exploded perspective view of the photodynamic therapy device as shown in FIGs. 7
and 8.
is a longitudinal cross-section of the photodynamic therapy device as shown in FIGs. 7
and 8.
is a close-up perspective view of an embodiment of tip of a wand for use with the
photodynamic therapy device as shown in FIGs. 7 and 8 and showing with light delivering elements in a
first position.
is a close-up perspective view of the tip of the wand as shown in with light
delivering elements in a second position.
Description
Certain terminology is used herein for convenience only and is not to be taken as a limitation on
the invention. For example, words such as "upper," "lower," "left," "right," "horizontal," "vertical,"
"upward," and "downward" merely describe the configuration shown in the FIGs. Indeed, the
components may be oriented in any direction and the terminology, therefore, should be understood as
encompassing such variations unless specified otherwise.
As used herein, the term “light”, “light irradiation”, or “irradiation” refers to light of wavelengths
from about 300 nm to about 1200 nm. This includes UV, visible and infrared light. The PDT device can
be used with any wavelength of light. The choice of wavelength will be determined by the intended
application, namely being selected to match the activation wavelength of the photosensitive drug or the
wavelength used for irradiation when a photo-activated compound is not employed.
Referring now to the FIGs. 1-3, wherein like reference numerals designate corresponding or
similar elements throughout the several views, an embodiment of a device for selectively applying
photodynamic therapy to structures in the brain is shown in FIGs. 1-3 and generally designated at 20.
The PDT device 20 comprises a housing 22 that accommodates a light-generating apparatus, including a
light source 24 and a power source 26 to power the light source. A tubular wand 28 extends from a distal
end 23 of the housing 22. A embodiment of a method of photodynamic therapy comprises positioning
the wand 28 of the PDT device 20 adjacent to the target site so that the wand is brought into at least
partial contact, or close proximity, with a tissue structure within the patient's brain, such as tumor tissue.
Light is then delivered via the wand 28 for treating at least a portion of the tissue structure in situ. The
PDT device 20 is particularly useful for therapeutic treatment of benign or malignant tumors in the brain.
The housing 22 may be formed from a plastic material that is molded into a suitable shape for
handling by a surgeon. As shown in FIGs. 2 and 3, the housing 22 defines an inner cavity 30 for
receiving the light source 24 and the power supply 26 and associated electrical connections (not shown).
In this embodiment of the PDT device 20, a proximal handle 32 is integral to the housing 22. The handle
32 is sized to be grasped and manipulated by the surgeon during a surgical procedure. It is understood
that the housing 22 of the PDT device 20 may be various sizes and shapes, depending upon the context of
use. As best seen in the proximal end 25 of the housing 22 includes an actuating button 34 for
selectively powering the light source 24. An indicator light 36 shows when the light source 24 is
powered. The power source 26 provides a sufficient voltage to establish the requisite conditions for light
delivery to the tissue. In the embodiment shown, the power supply 26 is an onboard battery, for example,
a rechargeable 11.1 V lithium ion battery.
The tubular wand 28 comprises an outer shaft 38 defining a lumen extending from the proximal
end 39 of the shaft to the distal end 42 of the shaft 38. A fiber optic cable 40 is disposed within the
lumen and operates to transfer light from the light source 24 to distal end 29 of the wand. The light is
emitted from the distal end 29 of the wand 28 for exposing a tissue region in the brain of a patient. The
outer shaft 38 is a thin elongated tubular element with a smooth outer surface in order to minimize the
amount of brain tissue contacted and to minimize damage to contacted brain tissue. The outer shaft 38
will typically have a diameter of at least about 0.6 mm and frequently in the range from about mm 1 to
about 10 mm. In one embodiment, the diameter of the outer shaft 38 is preferably between and 1.5
millimeters, most preferably about 1.0 millimeter. The outer shaft 38 generally has a length dimension
which permits the shaft 38 to be introduced through a burr hole in the cranium or through a conventional
transoral or transphenoidal route. Thus, the outer shaft 38 will typically have a length of at least about 5
cm for open surgical procedures and at least about 10 cm, or more typically about 20 cm or longer for
endoscopic procedures.
The outer shaft 38 is preferably rigid for percutaneous, transluminal or direct delivery to the
brain in either open procedures or port access type procedures. The outer shaft 38 may be formed from
polyurethane, silicone, polyimede, or other biocompatible material. Alternatively, the shaft may
comprise a metal, which is selected from the group consisting of tungsten, stainless steel alloys, platinum
or its alloys, titanium or its alloys, molybdenum or its alloys, and nickel or its alloys. Alternatively, the
outer shaft 38 may be flexible, being combined with a generally rigid internal tube (not shown) for
mechanical support. Flexible shafts may also be combined with pull wires for guiding the outer shaft 38
to a target tissue site, shape memory actuators, and other known mechanisms for effecting selective
deflection of the outer shaft to facilitate positioning of a distal end 39 of the shaft 38. The outer shaft 38
may also include elements for providing a location marker for determining the precise position of the
wand 28 within the brain of a patient.
The fiber optic cable 40 may be a fiber optic bundle or liquid light guide. For convenience, these
elements hereinafter are referred to collectively as a fiber optic cable 40. The fiber optic cable 40 extends
from the proximal end 39 to the distal end 42 of the outer shaft 38. The proximal end of the fiber optic
cable 40 is operably connected to the light source 24 for delivering light to a tissue region adjacent the
distal end 42 of the shaft 38. The fiber optic cable 40 can be of any diameter so long as the fiber optic
cable can be inserted into the lumen of the outer shaft 38. The preferred diameter of the fiber optic cable
is from about 50 microns to about 1000 microns and preferably about 400 microns. The choice of the
diameter will depend on the brightness of the light source 24 and the optical power output required from
the tip of the fiber optic cable 40.
Referring to FIGs. 4-6, the distal end 29 of the wand 28 comprises a rigid elongated end cap 44
coupled to the distal end 42 of the outer shaft 38. The end cap 44 is generally cylindrical and extends
from the distal end 42 of the shaft 38 a distance of about 1 mm to about 20 mm. The end cap 44 tapers to
a point 45 at a closed distal end. The end cap houses a diffusion tip or diffuser 46 and a ball bearing 48.
As used herein, a diffuser or diffusion tip, is defined as an element that can be attached to the end of a
fiber optic cable, or a structure that can be formed at the end of the fiber optic cable, that provides a
means for diffusing (scattering) the light being transmitted through the fiber optic cable so that it radiates
outward from the fiber. In the embodiment shown in the FIGs., the diffuser 46 is a generally
hemispherical reflective shell that mounts to the distal end of the fiber optic cable 40 which is received
within the shell. Light transmitted and emitting from the fiber optic cable 40 is diffused by the diffuser
46 for providing an even radial distribution of the light. A diffuse source of radiation can expose a
greater area of tissue to activation energy. The outer surface of the ball bearing 48 is reflective to further
diffuse the transmitted light.
One or more apertures 50 are provided along the surface of the end cap 44. For example, the
embodiment shown in FIGs. 4-6 shows a pair of opposed axial apertures 50 circumferentially spaced on
the body of the end cap 44. During PDT, light is delivered to the surrounding brain tissue region through
the apertures 50. The end cap 44 may also contain a right angle prism to provide for re-direction of light
through the apertures 50. The fiber optic probe 40 is arranged to the right angle prism so that the light
exits from the apertures 50 in the end cap 44.
An optional piezoelectric ceramic member 52 may also be housed within the end cap 44. The
piezoelectric member 52 is coupled to wire connectors 54 that extend to the proximal end of outer shaft
38 where they are suitably connected to the power supply 26. A frequency level adjustment knob 56 on
the housing 22 enables adjustment of the intensity of the piezoelectric member 52 allowing for variable
intensity application of a desired frequency.
Referring now to the FIGs. 7-10, another embodiment of a device for selectively applying
photodynamic therapy to structures in the brain is shown and generally designated at 60. The PDT
device 60 comprises a housing 62 that accommodates a light source 64. The housing provides a suitable
interface for receiving an electrical connecting cable 66 from a power source (not shown) for providing
power to the light source 64. A tubular wand 66 extends from a distal end 63 of the housing 62 which
tapers to conform to a proximal end 67 of the wand 66. As shown in FIGs. 9 and 10, the housing 62
defines an inner cavity 70 that houses the light source 64 and associated electrical connections (not
shown). The housing 62 may be formed from a plastic material that is molded into a suitable shape for
handling by a surgeon. The housing 62 of the PDT device 60 is sized to be grasped and manipulated by
the surgeon during a surgical procedure.
The tubular wand 68 comprises an elongated outer shaft 72 defining a lumen extending from a
proximal end 73 of the shaft 72 to a distal end 74 of the shaft 72. A plurality of fiber optic cables 76 are
disposed within the lumen and operate to transfer light from the light source 64. The diameter of the
outer shaft is preferably in the range from about 0.08 mm to about 1.0 mm, and more preferably in the
range of from about 0.05 mm to about 0.4 mm. The outer shaft 72 extends about 1 cm to about 20 cm
from the distal end 63 of the housing 62. In this embodiment of the PDT device 60, the outer shaft 72
may assume a wide variety of configurations, with the primary purpose being to mechanically support a
plurality of light-delivering elements and permit the surgeon to manipulate the light delivery elements
from the proximal end of the housing 62. The shaft may be formed from the group including stainless
steel, copper-based alloys, titanium or its alloys, and nickel-based alloys.
Each of the fiber optic cables 76 has a proximal end and a distal end. The proximal portion of
outer shaft 72 includes a multi-fitment (not shown) which provides for interconnections between the
proximal ends of the fiber optic cables 76 and the light source 64 within the housing 62 adjacent to the
fitment. In one embodiment, the fiber optic cables 76 are independent from one another and deliver light
separately from the light source 64. Alternatively, the fiber optic cables 76 may be connected together at
their the proximal ends to form a single fiber that couples to the light source 64. It is understood that the
PDT device 60 is not limited to isolated fiber optic cables or even to a plurality of fiber optic cables. For
example, the plurality of fiber optic cables 76 may be connected to a single lead that extends through the
outer shaft 72 to the light source 64.
Referring to FIGs. 11-13, the outer shaft 72 defines a plurality of axially and circumferentially
spaced ports 78 adjacent the distal end 74 of the shaft 72. The posts 78 open into the lumen and are each
configured for passing one of the plurality of fiber optic cables 76 running axially through the lumen.
Each of the fiber optic cables 76 has a distal end which passes from the lumen via a corresponding port
78 into the tissue region beyond the surface of the outer shaft 72.
A light-emitting diode (LED) 80 is connected to the distal end of each of the fiber optic cables 76
external to the outer shaft 72. In this arrangement, the PDT device 60 comprises a distributed array of
LED’s 80 spaced axially and circumferentially around the distal end 74 of the outer shaft 72. LED’s 80
emit a diverging beam of light without the need for a diffuser. In addition, while the LED’s 80 are
depicted as short cylinders, the LED’s 80 can have any suitable shape, including spherical, twizzle shapes
for needle-like cutting, spring shapes or other twisted metal shapes, and the like.
The fiber optic cables 76 have a length greater than the shaft length and are configured for axial
movement relative to the shaft. It is understood that the assembly can include many fiber optic cables 76
of different lengths and having different arrangements of apertures or ports to selectively provide for
treatment of specific desired targeted tissue regions in the brain. Optic exit site and depth of penetration
can be determined preoperatively via 3-dimensional imaging planning software. The area of the tissue
treatment can vary widely, with particular areas and geometries being selected for specific applications.
This allows for optimal fiber optic penetration into, for example, a tumor, which also optimizes the
amount of light that is delivered to the tumor.
In use, the wand 28, 68 of the PDT device 20, 60 is introduced through a small opening, e.g., a
burr hole, or other percutaneous penetration in the patient's cranium, or through natural openings in the
patient's head, such as transoral or transphenoidal procedures. The wand is advanced intraluminally and
guided to a target site within the brain in a conventional manner, i.e., percutaneously, transluminally or
using other minimally invasive or traditional open surgery techniques. The chosen technique may be
performed in conjunction with an instrument guiding technology for guiding the PDT device 20, 60 to
the target site within the brain. Accordingly, the target site may be charted with a variety of imaging
techniques, such as computerized tomography (CT) scanning, magnetic resonance imaging (MRI),
ultrasound, angiography, radionucleotide imaging, electroencephalography (EEG) and the like. In
conjunction with one of these imaging procedures, typically CT or MRI, the user may also use
compatible stereotactic systems for guiding the instrument to the target site. In standard stereotactic
systems, a frame, e.g., a Leksell, Todd-Wells or Guiot frame, fixes the head of the patient to the image.
These frames, combined with radiological landmarks and a brain atlas, provide anatomical localization to
within +-1 mm. Alternatively, imaged guided frameless stereotactic systems that utilize modern imaging,
computer software and a locating device, may be employed. For use with these guidance and locating
techniques, the wand 28, 68 may have a location marker comprising material which contains a mobile
phase suitable for MRI imaging by commercial machines, and which is sufficiently X-Ray-opaque for
adequate imaging on CT or X-ray.
Once the distal end of the wand 28, 68 is positioned adjacent to, or in contact with, the affected
tissue at the target site, light is delivered via the fiber optic cables 40, 76. A photosensitive compound,
such as 5-ALA or Photophrin, is then delivered through the lumen of the shaft or through another
catheter to the tissue region. Light is then applied through the apertures 50 in the end cap 44 or from the
LED’s 80 directly at the desired site in the presence of the photosensitive compound to treat the tissue
structure. The light is sufficient for the therapeutic treatment of intracranial tumors while minimizing the
collateral damage to surrounding tissue or nerves within the brain of the patient. The power sources can
be utilized to illuminate fiber probes or the LED’s which emit light at wavelengths of either 405 nm
wavelength, for diagnostic purposes, or 635 nm, or therapeutic purposes. It is understood that the
delivered light may be at other wavelengths, including within or outside the range of 405 nm to 635 nm.
The application of light for appropriate time intervals affects or otherwise modifies the target tissue. The
light is sufficient to activate the photosensitive compound, which results in death of the tumor tissue.
The tissue volume over which the light is delivered may be precisely controlled.
When using the PDT device 60 comprising the plurality of LED’s 80, each corresponding fiber
optic cable 76 is preferably introduced to the brain through the wand 68 such that a particular LED 80
penetrates to a desired portion of the brain tissue. Such an arrangement allows for inserting the wand 68
through the intervening brain tissue, precisely locating the wand 68 relative to a specific tissue region and
then advancing the plurality of LED’s via the fiber optic cables 76 for positioning the LED’s at a
predetermined tissue region for treating the tissue region.
The device for selectively applying photodynamic therapy to structures in the brain has many
advantages, including providing a minimally invasive method for delivering light for PDT treatment of
tumors in the brain. Placement of means for light delivery at the distal end of the device to brings the
light source directly to the desired site providing light irradiation to a defined, targeted area of tissue.
The result is precise intracranial treatment within tissue in the brain of a patient. The device and method
provide the surgeon the ability to treat malignant brain tumors, even those that are in difficult to reach
locations, without a large open surgery. The device provides the potential to deliver light therapy, in a
diagnostic or therapeutic fashion, to brain tumors via a very small opening the skull, including for those
lesions deemed dangerous to operate on.
Although the device and method for PDT has been shown and described in considerable detail
with respect to only a few exemplary embodiments thereof, it should be understood by those skilled in
the art that we do not intend to limit the device and method to the embodiments since various
modifications, omissions and additions may be made to the disclosed embodiments without materially
departing from the novel teachings and advantages, particularly in light of the foregoing teachings. For
example, therapeutic use of PDT in the brain is described, but it is understood that PDT for any other part
of the body is contemplated. In addition, the choice of materials used in each of the components of the
devices described herein, and in particular the overall geometry of the devices, can be specifically
tailored to provide the desired properties for a given treatment indication. Accordingly, we intend to
cover all such modifications, omission, additions and equivalents as may be included within the spirit and
scope of the following claims. In the claims, means-plus-function clauses are intended to cover the
structures described herein as performing the recited function and not only structural equivalents but also
equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail
employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical
surface, in the environment of fastening wooden parts, a nail and a screw may be equivalent structures.
Claims (7)
1. A non-implantable surgical apparatus that uses a light source and a power supply for minimally invasive surgical treatment of a tissue region of a brain of a patient, the non-implantable surgical apparatus comprising: a housing having a proximal and distal end, the housing comprising a handle configured to be grasped and manipulated by a surgeon during a surgical procedure and to remain outside of the patient throughout the surgical procedure; and a wand extending from the distal end of the housing, the wand comprising: an outer shaft having a proximal end and a distal end for positioning within the tissue region of the brain during the surgical procedure, the outer shaft defining a lumen extending between the proximal end and the distal end of the outer shaft; an end cap having a closed distal end and being coupled to the distal end of the outer shaft, the end cap comprising one or more apertures disposed along a longitudinal surface of the end cap and parallel to a longitudinal axis of the end cap; an inner fiber optic cable having a distal end and a proximal end adapted to be operatively connected to the light source, the fiber optic cable configured to be received within the lumen and extend from the proximal end of the shaft to adjacent the distal end of the shaft; a diffuser element disposed within the end cap and configured to receive light emitted at the distal end of the inner fiber optic cable; a ball bearing having a reflective outer surface disposed at a distal end of the diffuser element and within the end cap, and configured to reflect light received from the diffuser element laterally and proximally through the one or more apertures; and a piezoelectric ceramic member disposed within the end cap and located distally from the ball bearing, the piezoelectric ceramic member being coupled to wire connectors that extend to the proximal end of the outer shaft where they are adapted to be operatively connected to the power supply, wherein the piezoelectric ceramic member is adapted to deliver sound waves to the tissue region of the brain during the surgical procedure, wherein the piezoelectric ceramic member has a cylindrical shape having a cylindrical axis co-axial with a longitudinal axis of the outer shaft lumen, and wherein the fiber optic cable is adapted to deliver light from the light source via the diffuser element and the ball bearing through the at least one aperture of the end cap to the tissue region of the brain in proximity to the distal end of the outer shaft during the surgical procedure.
2. The non-implantable surgical apparatus as recited in claim 1, wherein the outer shaft comprises a location marker adapted to be located by one of magnetic resonance imaging, computerized x-ray tomography, or combinations thereof.
3. The non-implantable surgical apparatus as recited in claim 1, wherein the housing includes an actuating button and a frequency level adjustment knob that enables adjustment of an intensity of the sound waves.
4. The non-implantable surgical apparatus as recited in claim 1, wherein the housing further includes an indicator light configured to show when the light source is powered.
5. The non-implantable surgical apparatus as recited in claim 1, wherein the end cap is tapered to a point at the closed distal end, and further comprises a cylindrical cavity co-extensive with the outer shaft lumen.
6. The non-implantable surgical apparatus as recited in claim 5, wherein the diffuser element, the ball bearing, and the piezoelectric ceramic member are disposed within the cylindrical cavity of the end cap.
7. The non-implantable surgical apparatus as recited in claim 1, wherein the one or more apertures comprises multiple apertures disposed circumferentially about a body of the end cap.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461923639P | 2014-01-04 | 2014-01-04 | |
US61/923,639 | 2014-01-04 | ||
PCT/US2015/010053 WO2015103484A1 (en) | 2014-01-04 | 2015-01-02 | Device and method for use of photodynamic therapy |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ722168A NZ722168A (en) | 2021-03-26 |
NZ722168B2 true NZ722168B2 (en) | 2021-06-29 |
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ID=
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