|
|
|
| United States Patent | 5437658 |
| Link to this page | http://www.wikipatents.com/5437658.html |
| Inventor(s) | Muller; David F. (Boston, MA);
Sacharoff; Alex C. (Framingham, MA) |
| Abstract | The invention is a system and method for modifying the corneal curvature by
irradiating the cornea to deliver thermal energy to the stroma. The system
includes multiple irradiation ports for introducing electromagnetic
radiation of a wavelength suitable for absorption in the stroma;
positioning means, such as a hemi-spherical dome with several tracks for
positioning the irradiation ports, respectively, at locations of a
preselected geometric pattern relative to the pretreated cornea, the
geometric pattern being selected to correspond to a desired modified shape
of the cornea; transmission means adapted to deliver controlled amounts of
the radiation from a radiation source to each of the irradiation ports;
and the irradiation ports, positioned at the locations of the geometric
pattern, constructed to introduce the radiation to treatment volumes of
the stroma in a cooperative manner to induce desired shrinkage of the
collagenous stromal tissue and cause change in the corneal curvature. Each
treatment volume, formed by a radiation pattern emanating from one
irradiation port or by intersection of radiation patterns emanating from
multiple irradiation ports, is created in a controllable manner to have a
desired volume and energy profile. The transmission means that includes
fiber optic waveguides are connected to distribution means for dispensing
controlled amounts of the radiation to each of the fiber optic waveguides.
The system also includes inspection means for observing and evaluating the
shrinkage of collagenous tissue. |
|
|
|
Title Information  |
|
|
|
|
|
Drawing from US Patent 5437658 |
|
|
Method and system for laser thermokeratoplasty of the cornea |
|
|
|
|
|
| Publication Date |
August 1, 1995 |
|
|
|
|
|
| Filing Date |
October 7, 1992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Title Information  |
|
|
References  |
|
|
| *references marked with an asterisk below are user-added references |
|
U.S. References |
|
|
| Add a new US reference: |
| | Reference | Relevancy | Comments | Reference | Relevancy | Comments | 5263950 L'Esperance, Jr. 606/6 Nov,1993 |      Your vote accepted [0 after 0 votes] | | 5263951 Spears 606/12 Nov,1993 |      Your vote accepted [0 after 0 votes] | | 5152759 Parel 606/5 Oct,1992 |      Your vote accepted [0 after 0 votes] | | 5133708 Smith 606/5 Jul,1992 |      Your vote accepted [0 after 0 votes] | | 5009660 Clapham 606/166 Apr,1991 |      Your vote accepted [0 after 0 votes] | | 4976709 Sand 606/5 Dec,1990 |      Your vote accepted [0 after 0 votes] | | 4917084 Sinofsky 606/7 Apr,1990 |      Your vote accepted [0 after 0 votes] | | 4880001 Weinberg 606/11 Nov,1989 |      Your vote accepted [0 after 0 votes] | | 4860743 Abela 606/7 Aug,1989 |      Your vote accepted [0 after 0 votes] | | 4732148 L'Esperance, Jr. 606/5 Mar,1988 |      Your vote accepted [0 after 0 votes] | | 4583539 Karlin 606/4 Apr,1986 |      Your vote accepted [0 after 0 votes] | | 5019074 Muller 606/5 Dec,1969 |      Your vote accepted [0 after 0 votes] | | |
|
|
|
|
U.S. References |
|
|
Foreign References |
|
|
|
|
|
|
Foreign References |
|
|
Other References |
|
|
|
|
|
|
Other References |
|
|
|
|
|
References  |
|
|
|
|
|
| Market Size |
|
Estimate the gross annual revenues of the relevant market
sector:
|
| | |
| |
|
|
| Market Share |
|
Estimate the percentage of the relevant market sector this invention will capture:
|
| | |
| |
|
|
| Reasonable Royalty |
|
What percentage of gross sales should the inventor or assignee be paid?
|
| | |
| |
|
|
|
Public's "Guesstimation" of Royalty Value
|
| Market Size | N/A | [No votes] | | x | Market Share | N/A | [No votes] | | x | Reasonable Royalty | N/A | [No votes] |
| | N/A | |
| |
|
|
|
|
|
|
|
|
|
|
|
|
Market Review  |
|
|
Technical Review  |
|
|
Claims  |
|
|
We claim:
1. A thermokeratoplasty system for modifying corneal curvature of a cornea
by localized thermal shrinkage of collagenous stromal tissue, said system
comprising:
means for inducing localized thermal shrinkage of the collagenous stromal
tissue using electromagnetic radiation of a wavelength suitable for
absorption in the stroma, said mean including a radiation-distributing
device that introduces the electromagnetic radiation to a multiplicity of
locations on the surface of the cornea according to a predetermined
pattern selected to correspond to a desired modification of said cornea,
and
a positioning structure that positions said radiation-distributing device
in close, fixed relationship to the cornea and introduces said radiation
via said locations to treatment volumes in the stroma below the surface of
the cornea to induce localized shrinkage of the collagenous stromal tissue
to cause change in the corneal curvature.
2. The system of claim 1 wherein said radiation-distributing device
delivers energy to each of said locations at an energy level substantially
below the energy necessary for shrinkage of said collagenous stromal
tissue and causes energy entering said locations to intersect to form said
treatment volumes in the stroma in which the energy level is sufficient to
induce shrinkage of the collagenous stromal tissue.
3. The system of claim 1 wherein said means includes a radiation source and
said radiation-distributing device further comprises a radiation
transmission system for receiving radiation from said source, the
radiation reaching the cornea being emitted from a set of irradiation
ports positioned corresponding to said locations.
4. A system for modifying curvature of a cornea by irradiating the cornea
with electromagnetic radiation of a wavelength suitable for absorption in
stromal tissue, said system comprising:
a radiation source, optically coupled to a transmission system, that emits
electromagnetic radiation of a wavelength suitable to induce localized
thermal shrinkage of the collagenous stromal tissue of the cornea,
said transmission system transmits controlled amounts of said radiation
from said source,
said transmission system having multiple irradiation ports for introduction
of the electromagnetic radiation to the stroma,
a positioning structure that positions said irradiation ports respectively
at preselected relationships to the cornea, said relationships being
selected to correspond to a desired modification of the cornea, and
said irradiation ports, positioned at said preselected relationships direct
the radiation to respective treatment volumes in the stroma in a
cooperative manner to induce localized shrinkage of the collagenous
stromal tissue to cause change in the corneal curvature.
5. The system of claim 4 or 3 wherein said positioning structure positions
said irradiation ports according to a selectable geometric pattern
relative to said cornea to create a specific distribution of treatment
volumes in each of which said desired shrinkage can occur.
6. The system of claim 5 wherein each of said treatment volumes is formed
by a radiation pattern emanating from one irradiation port.
7. The system of claim 5 wherein at least two of said ports are
cooperatively arranged to cause said desired shrinkage to occur in a
treatment volume formed by intersection of radiation patterns emanating
from aid irradiation ports, energy of a single radiation pattern being
substantially below the energy level necessary for shrinkage of said
collagenous stromal tissue, said intersection of radiation patterns
forming a treatment volume having sufficient energy to induce shrinkage of
said collagenous stromal tissue.
8. The system of claim 7 wherein an adjustable device is provided to vary
the spatial relationship of said ports to vary the conditions of
intersection of the emitted radiation forming said treatment volumes.
9. The system of claim 5, wherein said positioning structure enables
movement of said irradiation ports to selected different locations to
change said preselected geometric pattern.
10. The system of claim 5 wherein said positioning structure is attachable
to the surface of the cornea in a desired relationship to accurately
position said irradiation ports with respect to said cornea.
11. The system of claim 10 further comprising prophylactic means placed
between said surface of the cornea and said positioning structure.
12. The system of claim 11 wherein said prophylactic means comprise optical
interface matching means for coupling said radiation form said irradiation
ports to the cornea without substantial loss.
13. The system of claim 10 wherein said positioning structure includes an
eye fixation means for holding said positioning structure at a selected
location on said surface of the cornea while preventing movement of the
eye.
14. The system of claim 13 wherein said eye fixation means comprises a
thornton ring attached to said surface of the cornea by relatively small
protrusions.
15. The system of claim 5 wherein said irradiation port includes focusing
means for focusing said radiation within the stromal tissue.
16. The system of claim 15 wherein said focusing means and locations of
said ports define each said treatment volume and the energy profile of
delivered radiation to said treatment volume.
17. The system of claim 15 wherein said focusing means focus said radiation
to a desired depth within the stromal tissue.
18. The system of claim 15 wherein said focusing means comprise a focusing
lens.
19. The system of claim 15 wherein said focussing means comprise a
convergent fiberoptic wave guide.
20. The system of claim 15 wherein said focusing means comprises a
self-focusing fiber optic wave guide.
21. The system of claim 4 wherein said transmission system comprises a set
of fiber optic wave guides each corresponding to a respective irradiation
port, said irradiation ports being positioned according to a selectable
geometric pattern relative to said cornea to create a specific
distribution of treatment volumes, each said wave guide transmitting the
radiation from said source to its respective irradiation port.
22. The system of claim 21 wherein each said irradiation port is positioned
at a selected location according to said preselected geometric pattern
relative to the cornea and adapted to introduce a radiation pattern that
forms said treatment volume.
23. The system of claim 21 wherein said irradiation ports are positioned at
locations according to said preselected geometric pattern relative to the
cornea, said irradiation ports introducing radiation patterns that form
said treatment volume at their intersection, energy of a single radiation
pattern being substantially below the energy level necessary for shrinkage
of the collagenous stromal tissue, said treatment volume created by said
intersection of at least two of said radiation patterns having energy
sufficient to induce shrinkage of the collagenous stromal tissue.
24. The system of claim 22 further comprising a distribution system, said
distribution system distributing desired amounts of energy from said
radiation source in a predetermined sequence to each of said fiber optic
waveguides.
25. The system of claim 23 further comprising a distribution system, said
distribution system distributing simultaneously desired amounts of said
radiation from said radiation source to all of said fiber optic
waveguides.
26. The system of claim 22 further comprising a distribution system, said
distribution system distributing desired amounts of said radiation from
said source simultaneously to all of said fiber optic waveguides.
27. The system of claim 5 wherein said irradiation ports comprise optical
interface matching means for coupling the radiation to the cornea without
substantial radiation loss.
28. The system of claim 27 wherein said optical interface matching means
includes a fluid medium.
29. The system of claim 4 or 3 wherein said positioning structure
comprises:
a rigid hemi-spherically shaped member positionable upon the surface of
said cornea in a desired relationship to the shape of the cornea,
at least two tracks located in said rigid member at spaced apart positions,
each track retaining at least one said irradiation port within said rigid
member and enabling movement of said irradiation port to selected
different locations within said tracks, and
a holding member that holds said irradiation ports at said selected
different locations within said tracks, said holding member enabling said
ports to reside in locations according to said preselected geometric
pattern.
30. The system of claim 29 wherein said positioning structure further
comprises a ring shaped member having small protrusions constructed to be
affixed to said surface of the cornea, said ring shaped member being
connectable to said rigid hemi-spherically shaped member and being adapted
to maintain said irradiation ports at said selected different locations
within said tracks.
31. The system of claim 30 wherein said positioning structure further
comprises a membrane located between said surface of the cornea and said
ring shaped member, said membrane transmitting radiation to said cornea
from said irradiation ports.
32. A thermokeratoplasty system for modifying curvature of a cornea by
irradiating the cornea to deliver thermal energy to collagenous stromal
tissue, said system comprising:
a radiation source that emits electromagnetic radiation of a wavelength
suitable to induce localized thermal shrinkage of the collagenous stromal
tissue of the cornea,
a radiation-distributing device that introduces Controlled amounts of said
electromagnetic radiation from said source to a multiplicity of
irradiation ports located on locations on the surface of the cornea,
a rigid hemi-spherically shaped member positionable upon the surface of the
cornea in a desired relationship to the cornea,
at least two tracks located in said rigid member at spaced apart positions,
each track retaining at least one said irradiation port within said rigid
member and enabling movement of said irradiation port to a selected
location on a preselected geometric pattern, said preselected geometric
pattern being selected to correspond to a desired modified shape of said
cornea, a holding member that holds said irradiation ports at said
selected locations within said tracks according to said preselected
geometric pattern,
a ring shaped member having small protrusions affixable to the surface of
the cornea, said ring shaped member being connectable to said rigid
spherically shaped member to maintain said irradiation ports at said
locations, and
said irradiation ports, positioned at said selected locations, that
introduce said radiation to be absorbed in selected treatment volumes of
the stroma to induce shrinkage of the collagenous stromal tissue and cause
change in the corneal curvature to said desired modified shape.
33. The system of claim 32 wherein said ring shaped member is connectable
to said rigid hemi-spherically shaped member using a vacuum created
between said ring shaped member and said rigid hemi-spherically shaped
member.
34. The system of claim 33 wherein said ring shaped member is connectable
to said rigid hemi-spherically shaped member in a manner that enables
relative rotational movement of the two members.
35. The system of claim 4, 1 or 32 further comprising computer control
system that governs distribution of said radiation from said source to
each irradiation port in accordance with locations of irradiation ports
and said desired modification of the cornea.
36. The system of claim 32 wherein said treatment volumes introduced into
said stroma via said ports comprise a conical shape.
37. The system of claim 32 wherein said treatment volumes of the stroma are
formed by intersection of at least two radiation patterns emanating from
said irradiation ports.
38. The system of claim 4 or 32 wherein said wavelength is in the range of
about 1.4 .mu.m to 3.2 .mu.m.
39. The system of claim 32 further comprising a membrane located between
the corneal surface of the cornea and said irradiation ports, said
membrane transmits light to the cornea from said irradiation port.
40. The system of claim 4, 1 or 32 further comprises an inspection system
that observes and evaluates said shrinkage of the collagenous stromal
tissue while said radiation is introduced to the stroma.
41. The system of claim 4, 1 or 32 further comprises an inspection system
that observes and evaluates said shrinkage of the collagenous stromal
tissue after said radiation is introduced to the stroma.
42. The system of claim 40 wherein said inspection means comprise a
biomicroscope and a slit lamp.
43. A method of modifying the corneal curvature by irradiating the cornea
to deliver thermal energy to the stroma comprising:
(a) providing a radiation source for emitting electromagnetic radiation of
a wavelength suitable to induce localized shrinkage of the collagenous
stromal tissue of the cornea,
(b) providing a radiation-distributing device for receiving and distribute
said radiation to a set of irradiation ports corresponding to locations
for delivering radiation to the stroma,
(c) positioning said irradiation ports respectively according to a
preselected geometric pattern relative to said cornea, said pattern being
selected to correspond to a desired modification of the cornea,
(d) generating electromagnetic radiation of a wavelength suitable for
absorption in the stroma.
(e) transmitting controlled amounts of said radiation from said source to
at least one of said irradiation ports, and
(f) introducing to the cornea, at said irradiation ports, said radiation
for absorption in treatment volumes of the stroma in a cooperative manner
to induce desired thermal shrinkage of the collagenous stromal tissue and
to cause change in the corneal curvature.
44. The method of claim 43 wherein said irradiation ports are positioned
according to a preselected geometric pattern relative to the shape of the
cornea to create a specific distribution of treatment volumes.
45. The method of claim 44 wherein said step of introducing said radiation
is performed to form said treatment volume by a radiation pattern
emanating from one irradiation port.
46. The method of claim 44 wherein said step of introducing said radiation
is performed to form said treatment volume by intersection of radiation
patterns emanating from at least two irradiation ports, whereby the energy
of a single radiation pattern being substantially below the energy level
necessary for shrinkage of the collagenous stromal tissue, said
intersecting radiation patterns forming a treatment volume having
sufficient energy to induce shrinkage of the collagenous stromal tissue.
47. The method of claim 46 wherein said locations of said irradiation ports
are varied in a controllable manner to vary the conditions of intersection
of said radiation patterns.
48. The method of claim 44, 45 or 46 further comprising:
(a) moving said irradiation ports to different locations according to a
preselected geometric pattern,
(b) transmitting controlled amounts of said radiation from said source to
each of said irradiation ports, and
(c) introducing to the cornea, at said irradiation ports, treatment volumes
of said radiation for absorption in the stroma to induce shrinkage of the
collagenous stromal tissue and to cause change in the corneal curvature to
a desired modified shape.
49. The method of claim 48 wherein said step of moving said irradiation
ports is performed continually along a path while simultaneously
introducing said radiation to the stromal tissue in order to form said
treatment volumes, said path being chosen in correlation with said
preselected geometric pattern.
50. The method of claim 44 or 45 wherein said step of transmitting said
controlled amounts of radiation is performed sequentially to said multiple
irradiation ports.
51. The method of claim 46 wherein said step of transmitting said
controlled amounts of radiation is performed simultaneously to a set of
said irradiation ports constructed to introduced intersection radiation
patterns forming said treatment volumes.
52. The method of claim 44, 45 or 46 wherein said step of transmitting said
controlled amounts of radiation is performed simultaneously to all said
multiple irradiation ports.
53. The method of claim 44, 45 or 46 wherein said step of introducing to
the cornea said radiation comprises focussing said radiation to form said
treatment volume, said treatment volume extending to a depth of less than
about 450 .mu.m in the cornea.
54. The method of claim 44, 45 or 46 further comprising a step of
inspecting said treatment volumes in the stroma.
55. The method of claim 54 wherein said step of inspecting said treatment
volumes in the stroma is performed after causing said shrinkage of the
collagenous stromal tissue.
56. The method of claim 54 wherein said step of inspecting said treatment
volumes of the stroma is performed while introducing said radiation for
absorption in the stroma. |
|
|
|
|
Claims  |
|
|
Description  |
|
|
BACKGROUND OF THE INVENTION
The invention relates to controllable, reproducible, nonsurgical alteration
of the corneal curvature in the human eye.
Refractive errors of the eye such as hyperopia, myopia, and astigmatism are
widespread in the human population. The cornea which accounts for most of
the refractive power of the eye comprises transparent avascular tissue
that forms the anterior portion of the eye. It resides in the sclera at
the limbus. The transparency of the cornea is due to its uniform
structure, avascularity, and deturgescence, which is the state of relative
hydration of the corneal tissue. The average adult cornea is about 0.65 mm
thick at the periphery and about 0.50 mm thick in the center. From
anterior to posterior, the cornea has the following five distinct layers:
the epithelium, Bowman's membrane, the stroma, Descemet's membrane, and
the endothelium.
The present invention concerns hydrothermal shrinkage of collagen fibers
present in the stroma. The corneal stroma accounts for about 90% of the
corneal thickness; it is composed of intertwining lamellar fibers that are
about 1 .mu.m wide and run almost the full diameter of the cornea. The
lamellar fibers run parallel to the surface of the cornea and by virtue of
their size and periodicity are optically clear. Collagen is a protein
found in connective tissues of many organs of the human body including the
corneal stroma. The connective tissue of the corneal stroma possesses high
transparency of cross-oriented individual sheets, or lamellae of collagen,
with a high water content and small content of protein and
mucopolysaccharides. The intermolecular cross-links provide the collagen
fibers with unique physical properties of high tensile strength and
substantial elasticity. The extracellular matrix of the corneal connective
tissue consists of complex macromolecules, the biosynthesis of which
involves several specific reactions that are often under stringent
enzymatic control. The cross-linking of collagen fibers can be inhibited
by supplying energy to the matrix. The net generation of collagen
connective tissue is then dependent on the precise balance between the
synthesis and degradation of the above mentioned enzyme.
The hydrothermal shrinkage property of collagen fibers has been recognized
for many years. At increased temperatures, the collagen ultrastructural
stabilizing cross-links rupture resulting in immediate contraction of the
fibers to about 1/3 of their original linear dimension. At the same time
the caliber of individual fibers increases; however, the structural
integrity of the connective tissue is maintained. The shrinkage changes
the overall shape of the cornea and thus changes the refractive power of
the eye; this is utilized in thermokeratoplasty. This corneal recurving
procedure requires a predictable collagen shrinkage and thus predictable
change in the cornea shape. This should be achieved without damaging
either Bowman's membrane or Descemet's membrane. One disadvantage of the
above described thermal reshaping of the corneal profile could be rapid
replacement of contracted collagen fibers by new mature collagen fibers of
original length. This replacement is most pronounced in traumatic injuries
of the eye. However, if atraumatic collagen shrinkage is achieved, it is
believed that a protracted or permanent recurving of the cornea occurs.
In the past, various thermokeratoplastic techniques have been suggested.
Shrinkage of the collagen fibers was achieved by applying RF current,
inserting a hot microwire into the stroma, heating appropriate areas of
the stroma using laser energy, or placing a surface of a hot instrument
onto the eye surface. Many of these methods pose a high risk of damage to
the epithelium and Bowman's membrane on the anterior side of the cornea,
as well as Descemet's membrane and the endothelium on the posterior side
of the cornea. Thus, it is very important to precisely control the amount
of heat applied to the stroma. Sufficient heat must be delivered to cause
permanent fiber shrinkage. However, if too much heat is applied, then
permanent damage to Bowman's and Descemet layers can occur.
Different types of corrective procedures can be performed by selectively
heating the stroma and causing selective shrinkage of the stromal
collagen. Hyperopic corrections are achieved by causing shrinkage of the
collagen in a ring-shaped pattern about the optical axis of the eye. Large
hyperopic corrections are usually achieved by applying several
concentrically arranged ring patterns. Astigmatism can be treated by
applying accurate segments of the full treatment rings used for spherical
hyperopia with the arcs centered on the flat meridian of the cornea.
Myopic corrections can be achieved by central application of a focused
energy beam in order to flatten the corneal shape or by application of
radial patterns. In an eye which has several refractive errors a
combination of several patterns can be used. Thus, it is necessary to
select an appropriate geometric pattern corresponding to the shape of the
corneal curvature prior to the laser thermokeratoplasty and deliver heat
precisely to the selected locations.
Currently, laser thermokeratoplasty is performed by applying a handpiece to
the corneal surface in order to irradiate the cornea. To denote the
appropriate locations, a ring marker has been used to mark the cornea with
a dye. Then, the ophthalmologist positions the handpiece on the marked
site and irradiates the cornea. A series of focused exposures are made
sequentially on the marked sites. The introduced radiation is focused to a
depth of less than 450 .mu.m and is absorbed in the stroma. The plurality
of focused conical exposures creates reformation of the cornea. Even
though marking of the exposure sites using the dye gives some precision
and reproducibility to this corrective procedure, the result of the laser
thermokeratoplasty depends to a great extent on the skill of the
ophthalmologist performing the procedure. Furthermore, since desired
results of the laser thermokeratoplasty depend on appropriate energy
delivery to the number of predetermined sites on the eye surface, and on
the skills of the ophthalmologist, laser thermokeratoplasty, as currently
performed, requires a high degree of tactile skill.
In summary, there continues to be a need for a surgical device and
procedure which can deliver thermal energy to precisely defined locations
in the stroma, for an exactly controlled amount of time, performed in a
standardized manner, very quickly and without causing damage to the
cornea.
SUMMARY OF THE INVENTION
In general, the invention features a fiberoptic system for performing laser
thermokeratoplasty. The system delivers thermal energy by irradiating
precisely defined locations in the stroma to cause coagulation and
shrinkage of the collagen connective tissue of the stroma. The system
precisely controls the locations and the amount of energy delivered to the
stroma in order to prevent damage to the epithelium and Bowman's membrane
on the anterior side of the cornea, as well as Descemet's membrane and the
endothelium on the posterior side of the cornea. The system enables
reproducible performance of laser thermokeratoplasty.
According to one important aspect, the invention is a system method for
modifying the corneal curvature by irradiating the cornea to deliver
thermal energy to the stroma, the system comprising multiple irradiation
ports adapted to introduce to the stroma electromagnetic radiation of a
wavelength suitable for absorption in the stroma; positioning means
adapted to position the irradiation ports respectively at preselected
relationships to the pretreated cornea, the relationships being selected
to correspond to a desired modification of the cornea; transmission means
adapted to deliver controlled amounts of the radiation from a radiation
source to each of the irradiation ports; and the irradiation ports,
positioned at the preselected relationships, constructed to introduce the
radiation to controlled volumes of the stroma in a cooperative manner to
induce desired shrinkage of the collagenous stromal tissue to cause change
in the corneal curvature.
Preferred embodiments of this aspect of the invention may have one or more
of the following features.
The positioning means are adapted to position the irradiation ports on a
preselected geometric pattern relative to the pretreated shape of the
cornea to create a specific distribution of treatment volumes in each of
which the desired shrinkage can occur.
Each of the treatment volumes is formed by a radiation pattern emanating
from one irradiation port.
The desired shrinkage occurs in a volume formed by intersection of
radiation patterns emanating from at least two irradiation ports, energy
carried by a single radiation pattern being substantially below the energy
necessary for shrinkage of the collagenous stromal tissue, the
intersecting radiation patterns forming a treatment volume having
sufficient energy to induce shrinkage of the collagenous stromal tissue.
Each of the treatment volumes is formed by intersection of radiation
patterns emanating from at least two irradiation ports, energy carried by
a single radiation pattern being substantially below the energy necessary
for shrinkage of the collagenous stromal tissue, the intersecting
radiation patterns supplying sufficient energy to the treatment volume to
induce shrinkage of the collagenous stromal tissue.
Energy profile within the treatment volume may be varied in a controllable
manner by attuning the intersection of the treatment volumes.
The positioning means are further adapted to move the irradiation ports to
selected different locations on the geometric pattern.
The positioning means are further adapted to move the irradiation ports
continually along a path while simultaneously introducing the radiation to
the stroma in order to form the treatment volumes, the path being chosen
in correlation with the preselected geometric pattern.
Preferred embodiments of this aspect of the invention may also include one
or more of the following.
Positioning means that are constructed to be attached to the corneal
surface in a desired relationship to the pretreated corneal shape to
position the irradiation ports accurately with respect to the distribution
of treatment volumes of the stroma.
Prophylactic means placed between the corneal surface and the positioning
means.
The prophylactic means comprise optical interface matching means adapted to
couple the radiation from the irradiation ports to the cornea without
substantial loss.
The positioning means includes eye fixation means adapted to hold the
positioning means at a selected location on the corneal surface while
preventing movement of the globe of the eye.
The eye fixation means comprise a thornton ring attached to the corneal
surface by relatively small protrusions.
In preferred embodiments of this aspect of the invention, each irradiation
port may include focusing means adapted to modify the radiation pattern to
focus the absorbable radiation within the stroma of the eye.
The focusing means are further adapted to create in a controllable manner
the treatment volumes with variable energy profile.
The focusing means are further adapted to focus the radiation to a desired
depth.
The focusing means may comprise a lens system, a convergent fiber optic
wave guide or a self-focusing fiber optic wave guide.
Preferred embodiments of this aspect of the invention may have one or more
of the following features.
The transmission means comprise a set of fiber optic wave guides connected
respectively to the multiple irradiation ports and adapted to transmit the
radiation from a radiation source to the multiple irradiation ports.
Each irradiation port is positioned at a selected location on a preselected
geometric pattern relative to the pretreated shape of the cornea and
adapted to introduce a radiation pattern that forms the treatment volume.
The transmission means include distribution means adapted to distribute
desired amounts of energy in a predetermined sequence to each of the
irradiation ports from the radiation source.
A set of the irradiation ports that are geometrically ordered to each other
and each connected to the fiber optic waveguide, are positioned at the
same time at a selected location on the preselected geometric pattern
relative to the pretreated shape of the cornea, the set of geometrically
ordered irradiation ports being adapted to introduce radiation patterns
that form the treatment volume at their intersection, each of the
introduced radiation patterns having energy substantially below the energy
necessary for shrinkage of the collagenous stromal tissue, the treatment
volume having energy sufficient to induce shrinkage of the collagenous
stromal tissue.
The transmission means include distribution means adapted to distribute
simultaneously desired amounts of energy to one said set of irradiation
ports at a time.
The transmission means comprise distribution means adapted to distribute
desired amounts of energy simultaneously to all fiber optic waveguides
from the radiation source.
Preferred embodiments of this aspect of the invention may have one or more
of the following features.
The irradiation ports comprise optical interface matching means adapted to
couple the radiation to the cornea without substantial radiation loss. The
optical interface matching means includes a fluid medium.
Preferred embodiments of this aspect of the invention may include
positioning means that comprise a rigid hemi-spherically shaped member
adapted to be placed upon the corneal surface in a desired relationship to
the pretreated corneal shape; at least two tracks located in the rigid
member at spaced apart positions, each adapted to retain at least one the
irradiation port within the rigid member and adapted to enable movement of
the irradiation port to selected different locations; and a holding member
adapted to hold the irradiation ports at the locations within the tracks,
the holding member enabling the ports to reside in the geometric pattern.
The positioning means may further comprise a ring shaped member having
small protrusions constructed to be affixed to the corneal surface, the
ring shaped member being connectable to the rigid hemi-spherically shaped
member and being adapted to maintain the irradiation ports at the
locations while preventing movement of the globe of the eye.
The positioning means may further comprise a membrane located between the
corneal surface and the ring shaped member adapted to transmit light to
the cornea from the irradiation ports.
According to another important aspect, the invention is a system for
modifying the corneal curvature by irradiating the cornea to deliver
thermal energy to the stroma, the system comprising multiple irradiation
ports adapted to introduce to the stroma electromagnetic radiation of a
wavelength suitable for absorption in the stroma; a rigid hemi-spherically
shaped member adapted to be placed upon the corneal surface in a desired
relationship to the pretreated corneal shape; at least two tracks located
in the rigid member at spaced apart positions, each adapted to retain at
least one the irradiation port within the rigid member and adapted to
enable movement of the irradiation port to selected different locations on
a geometric pattern, the geometric pattern being selected to correspond to
a desired modified shape of the cornea; a holding member adapted to hold
the irradiation ports at the locations within the tracks, the holding
member enabling the ports to reside in the geometric pattern; a ring
shaped member having small protrusions constructed to be affixed to the
corneal surface, the ring shaped member being connectable to the rigid
spherically shaped member to maintain the irradiation ports at the
locations; a set of fiber optic wave guides connected respectively to the
multiple irradiation ports and adapted to transmit the radiation from a
radiation source to the multiple irradiation ports; distribution means
adapted to distribute controlled amounts of the radiation from a radiation
source to each of the respective fiber optic wave guides connected to the
irradiation ports; and the irradiation ports, positioned at the selected
locations, constructed to introduce the radiation to be absorbed in
selected treatment volumes of the stroma to induce shrinkage of the
collagenous stromal tissue and cause change in the corneal curvature to
the desired modified shape.
Preferred embodiments of this aspect of the invention may have one or more
of the following features.
The ring shaped member is adapted to be connected by substantial vacuum to
the rigid hemi-spherically shaped member.
The ring shaped member is connectable to the rigid hemi-spherically shaped
member in a manner that enables relative rotational movement of the two
members.
The system further includes computer control means adapted to govern
distribution of the radiation from the source to each irradiation port in
accordance with locations of the irradiation ports and the desired
modification of the cornea.
The treatment volumes have substantially conical shape.
The treatment volumes of the stroma are formed by intersection of at least
two radiation patterns emanating from the irradiation ports.
The wavelength of the radiation is in the range of about 1.4 .mu.m to 3.2
.mu.m.
The system further comprises a membrane located between the corneal surface
and the irradiation ports, the membrane adapted to transmit light to the
cornea from the irradiation port.
The system further comprises inspection means adapted to observe and
evaluate the shrinkage of the collagenous tissue while the radiation is
introduced to the stroma.
The system further comprises inspection means adapted to observe and
evaluate the shrinkage of the collagenous tissue after said radiation is
introduced to the stroma.
The inspection means comprise a biomicroscope ad a slit lamp.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an exploded persp | | |