U.S. patent application number 13/179685 was filed with the patent office on 2012-04-05 for method for removal of retained lens fragments using small diameter fragmatome.
Invention is credited to William J. Foster.
Application Number | 20120083793 13/179685 |
Document ID | / |
Family ID | 45890424 |
Filed Date | 2012-04-05 |
United States Patent
Application |
20120083793 |
Kind Code |
A1 |
Foster; William J. |
April 5, 2012 |
METHOD FOR REMOVAL OF RETAINED LENS FRAGMENTS USING SMALL DIAMETER
FRAGMATOME
Abstract
A medical instrument is disclosed, comprising a tubular member
with proximal and distal ends. The distal end of the tubular member
provides an elongated section having a substantially constant
outside diameter of no more than 23-gauge (about 0.57 mm). The
tubular member is in energy communication with an emulsification
energy source disposed to deliver emulsification energy at the
distal end of the tubular member. The tubular member may also be in
suction communication with a suction source disposed to deliver
suction at the distal end of the tubular member. The medical
instrument may be used in a method to remove lens fragments from
the eye, through incisions in the eye that are small enough not to
require suturing after the operation.
Inventors: |
Foster; William J.;
(Houston, TX) |
Family ID: |
45890424 |
Appl. No.: |
13/179685 |
Filed: |
July 11, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13106478 |
May 12, 2011 |
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13179685 |
|
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61389311 |
Oct 4, 2010 |
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Current U.S.
Class: |
606/107 |
Current CPC
Class: |
A61F 9/00745 20130101;
A61F 2009/00887 20130101; A61F 9/008 20130101; A61F 2009/0087
20130101 |
Class at
Publication: |
606/107 |
International
Class: |
A61F 9/00 20060101
A61F009/00 |
Claims
1. A method for removing at least one lens fragment from within an
eye, the method comprising the steps of: (a) making incisions in
the eye, each incision no larger than about 0.8 mm; (b) inserting a
fragmatome through a first one of the incisions, the fragmatome no
larger than 23-gauge; (c) using the fragmatome to emulsify the at
least one lens fragment into a plurality of emulsified fragments;
and (d) aspirating ones of the plurality of emulsified fragments
from the eye.
2. The method of claim 1, in which step (b) further includes the
substep of inserting a trochar into the first one of the incisions
prior to inserting the fragmatome therethrough, the trochar
suitable to port instrumentation of a diameter of at least
23-gauge.
3. The method of claim 1, in which step (d) includes the substeps
of (i) withdrawing the fragmatome and then inserting a vitrector
through the first one of the incisions, the vitrector no larger
than 23-gauge, and (ii) using the vitrector to aspirate ones of the
plurality of emulsified fragments from the eye.
4. The method of claim 1, in which step (d) includes the substeps
of (i) withdrawing the fragmatome and then inserting a suction tube
through the first one of the incisions, the suction tube no larger
than 23-gauge, and (ii) using the suction tube to aspirate ones of
the plurality of emulsified fragments from the eye.
5. The method of claim 1, in which step (b) further includes, prior
to inserting the fragmatome through the first one of the incisions,
the substeps of (i) inserting a vitrector through the first one of
the incisions, the vitrector no larger than 23-gauge, (ii) using
the vitrector to aspirate vitreous from around the at least one
lens fragment, and (iii) withdrawing the vitrector from the first
one of the incisions.
6. The method of claim 5, in which step (b) further includes, prior
to inserting the fragmatome through the trochar, the substeps of
(i) inserting a vitrector through the trochar, the vitrector no
larger than 23-gauge, (ii) using the vitrector to aspirate vitreous
from around the at least one lens fragment, and (iii) withdrawing
the vitrector from the trochar.
7. The method of claim 1, in which step (c) further includes the
substep of impaling the at least one lens fragment with the
fragmatome prior to using the fragmatome to emulsify the at least
one lens fragment.
8. A method for removing at least one lens tissue fragment from
within an eye, the method comprising the steps of: (a) making
first, second and third incisions in the eye, the incisions each no
larger than about 0.8 mm; (b) inserting an infusion cannula into
the first incision, the infusion cannula no larger than 23-gauge;
(c) inserting a light pipe into the second incision, the light pipe
no larger than 23-gauge; (d) inserting a vitrector into the third
incision, the vitrector no larger than 23-gauge; (e) using the
vitrector to aspirate vitreous immediately surrounding the at least
one lens tissue fragment situated within the eye; (f) withdrawing
the vitrector from the third incision and inserting a fragmatome
into the eye through the third incision, the fragmatome no larger
than 23-gauge; (g) using the fragmatome to emulsify the at least
one lens tissue fragment within the eye into a plurality of
emulsified fragments; (h) withdrawing the fragmatome from the third
incision and then inserting the vitrector through the third
incision; and (i) aspirating ones of the plurality of emulsified
fragments from the eye through the vitrector.
9. The method of claim 8, in which step (a) further includes the
substep of inserting a trochar into ones of the first, second and
third incisions prior to inserting instrumentation into the eye,
the trochars suitable to port 23-gauge instrumentation.
10. The method of claim 8, in which steps (h) and (i) are
substituted for the step of: (h) aspirating ones of the emulsified
fragments from the eye through the fragmatome.
11. The method of claim 8, in which steps (h) and (i) are
substituted for the steps of: (h) withdrawing the fragmatome from
the third incision and then inserting a suction tube through the
third incision; and (i) aspirating ones of the plurality of
emulsified fragments from the eye through the suction tube.
12. The method of claim 8, in which steps (d), (e) and (f) are
substituted for the single step of inserting a fragmatome into the
eye through the third incision, the fragmatome no larger than
23-gauge.
13. The method of claim 8, in which step (g) further includes the
substep of impaling the at least one lens fragment with the
fragmatome prior to using the fragmatome to emulsify the at least
one lens fragment.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of, and priority to,
U.S. provisional patent application No. 61/389,311 filed Oct. 4,
2010, the disclosure of which provisional application is
incorporated herein by reference.
[0002] This application is also a divisional application of U.S.
patent application Ser. No. 13/106,478 filed May 12, 2011.
BACKGROUND OF THE INVENTION
[0003] The present invention generally relates to eye surgery, and
more particularly relates to a method and an apparatus,
advantageously a small-diameter fragmatome, for removing retained
lens fragments in a minimally traumatic fashion.
[0004] During cataract surgery, the natural lens may be removed
from inside of the patient's eye. Conventional procedure for
removal of the natural lens typically involves making a large (2.9
mm, or larger) incision into the eye and a second, smaller
incision. Typically, two incisions are required to accommodate
conventional instrumentation into the eye. One incision allows a
tubular apparatus (a emulsification tip) into the eye to infuse
saline solution to maintain pressure inside the eye and to emulsify
and aspirate lens fragments. The second incision allows
conventional instrumentation into the eye for various purposes,
such as to assist in lens removal. The tubular apparatus emulsifies
the lens, typically with ultrasonic or laser energy provided at the
tip, causing the natural lens, once lifted toward the front of the
eye, to break apart. Application of energy from the tip of the
tubular apparatus causes the lens to break down into smaller
pieces, small enough to be removed by suction.
[0005] It is important to remove all lens fragments before ending
the operation. If lens fragments, and especially portions of the
center of the lens, also known as the nucleus or the nuclear lens,
shift into the back or posterior chamber of the eye, those lens
fragments may cause severe trauma (including inflammation and
blindness) if left unremoved. Occasionally lens fragments do get
left behind, requiring a further procedure for subsequent removal.
The conventional procedure is to remove the lens fragments using an
additional procedure, by making further incisions into the eye, and
removing the remaining lens fragments using a conventional
fragmatome. In this additional procedure, three incisions are
typically required to accommodate conventional instrumentation into
the eye. One incision allows tubular apparatus into the eye to
infuse saline solution to maintain vitreous pressure inside the
eye. The second incision allows conventional instrumentation into
the eye for various purposes, such as to provide light and/or
suction. The third incision allows a conventional fragmatome into
the eye. The fragmatome emulsifies the lens, typically with
ultrasonic or laser energy provided at the tip, causing the lens to
break down into smaller pieces, small enough to be removed by
suction. Relatively large incisions are suffered by the patient,
requiring suturing. Thus, the patient's trauma and healing time is
increased.
[0006] A drawback to conventional removal of lens fragments from
the back of the eye, as described above, is that conventional
fragmatomes are comparatively large in design. The tips are
typically 20-gauge (about 0.81 mm) in diameter or larger, requiring
the incision through which they enter the eye to be correspondingly
large. Popular conventional fragmatomes also combine, into one
instrument, a tip to provide emulsification energy and a tip to
aspirate fragments. This combination causes an even greater
potential for a need to introduce a large profile instrument into
the eye.
[0007] Such large incisions in the eye, as described above to
accommodate conventional instrumentation, typically require
suturing after the procedure is complete. This suturing, and the
healing of the sutured wounds, adds to the trauma suffered by the
patient in the operation. Post-operative healing time is also
increased.
[0008] Current thinking to address some of the above-described
drawbacks of conventional surgery to remove lens fragments from the
back of the eye appears to focus on miniaturizing the popular
combination fragmatome-aspirator, which by its nature has a larger
operational profile than either an individual fragmatome or suction
tube. Current thinking further appears to be stuck on the notion
that emulsification and fragmentation of the removed lens tissue
must be done at the same time as removal from the eye of the lens
fragments.
[0009] Recent professional commentary in the art has recognized a
long felt but unsolved need for apparatus and methods for removing
lens fragments using a small gauge fragmatome, advantageously
23-gauge (about 0.57 mm) or smaller in operative diameter. In his
article "Combined 20-gauge and 23-gauge pars plana vitrectomy for
the management of posteriorly dislocated lens: a case series"
(published in the 18 Jun., 2010 edition of the professional
magazine "Clinical Ophthalmology"), P. Kongsap teaches that small
gauge instrumentation (typically 23-gauge or smaller) may enter the
eye cavity though incisions small enough not to require suturing,
minimizing trauma to the patient and reducing recovery time.
However, when lens fragments are left in the posterior eye cavity,
removal of those fragments through those same small incisions is
made difficult by the unavailability of a small gauge (23-gauge or
less) fragmatome.
[0010] As can be seen, there is a need for a method and an
apparatus for removing lens fragments from the eye in a minimally
traumatic fashion, and in particular using a small gauge fragmatome
entering the eye through smaller incisions that will not require
suturing. An improved method using such a small gauge fragmatome
could also reduce patient trauma and post-operative healing
time.
SUMMARY OF THE INVENTION
[0011] The present invention addresses one or more of the
above-described drawbacks of the prior art. One aspect of this
invention includes a medical instrument comprising a tubular member
with proximal and distal ends. The distal end of the tubular member
provides an elongated section having a substantially constant
outside diameter of no more than 23-gauge (about 0.57 mm). The
medical device further comprises a handle connected to the proximal
end of the tubular member. The tubular member is in energy
communication with an emulsification energy source disposed to
deliver emulsification energy at the distal end of the tubular
member. In presently preferred embodiments, the emulsification
energy is selected from the group consisting of ultrasound energy
and laser energy, but the invention is not limited in this regard.
The tubular member may also be in suction communication with a
suction source disposed to deliver suction at the distal end of the
tubular member.
[0012] Another aspect of this invention includes a method for
removing at least one lens fragment from within an eye, the method
comprising the steps of: (a) making incisions in the eye, each
incision no larger than about 0.8 mm; (b) inserting a fragmatome
through a first one of the incisions, the fragmatome no larger than
23-gauge; (c) using the fragmatome to emulsify the at least one
lens fragment into a plurality of emulsified fragments; and (d)
aspirating ones of the plurality of emulsified fragments from the
eye.
[0013] In one variation on the method, step (b) further includes
the substep of inserting a trochar into the first one of the
incisions prior to inserting the fragmatome therethrough, the
trochar suitable to port instrumentation of a diameter of at least
23-gauge.
[0014] In another variation on the method, step (d) includes the
substeps of (i) withdrawing the fragmatome and then inserting a
vitrector through the first one of the incisions, the vitrector no
larger than 23-gauge, and (ii) using the vitrector to aspirate ones
of the plurality of emulsified fragments from the eye.
[0015] In another variation, step (d) includes the substeps of (i)
withdrawing the fragmatome and then inserting a suction tube
through the first one of the incisions, the suction tube no larger
than 23-gauge, and (ii) using the suction tube to aspirate ones of
the plurality of emulsified fragments from the eye.
[0016] In another variation, step (b) further includes, prior to
inserting the fragmatome through the first one of the incisions,
the substeps of (i) inserting a vitrector through the first one of
the incisions, the vitrector no larger than 23-gauge, (ii) using
the vitrector to aspirate vitreous from around the at least one
lens fragment, and (iii) withdrawing the vitrector from the first
one of the incisions.
[0017] In another variation, step (c) further includes the substep
of impaling the at least one lens fragment with the fragmatome
prior to using the fragmatome to emulsify the at least one lens
fragment.
[0018] It is therefore a technical advantage of the invention to
enter the eye with a fragmatome capable of being inserted through
incisions small enough not to require suturing after the operation.
An exemplary application of such a fragmatome is in a method for
removing lens tissue fragments from the vitreous cavity of the
eye.
[0019] A further technical advantage of the invention is that
trauma to the patient as a result of the operation is reduced, and
recovery time is improved.
[0020] The foregoing has outlined rather broadly the features and
technical advantages of the present invention in order that the
detailed description of the invention that follows may be better
understood. Additional features and advantages of the invention
will be described hereinafter which form the subject of the claims
of the invention. It should be appreciated by those skilled in the
art that the conception and the specific embodiment disclosed may
be readily utilized as a basis for modifying or designing other
structures for carrying out the same purposes of the present
invention. It should be also be realized by those skilled in the
art that such equivalent constructions do not depart from the
spirit and scope of the invention as set forth in the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] For a more complete understanding of the present invention,
and the advantages thereof, reference is now made to the following
descriptions taken in conjunction with the accompanying drawings,
in which:
[0022] FIG. 1 illustrates a fragmatome in accordance with one
aspect of the present invention;
[0023] FIG. 2A illustrates a first phase of a method in accordance
with a second aspect of the present invention;
[0024] FIG. 2B illustrates a second phase of a method in accordance
with a second aspect of the present invention; and
[0025] FIG. 2C illustrates a third phase of a method in accordance
with a second aspect of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0026] FIG. 1 is an outline illustration of a fragmatome 100 in
accordance with a first aspect of the present invention. Fragmatome
100 comprises a tubular member 110 with a substantially constant
outside diameter D. Tubular member 100 provides proximal end 112
and distal end 114. Fragmatome 100 may be constructed
conventionally. However, in accordance with the invention, D is no
more than 23-gauge (about 0.57 mm) in diameter. With further
reference to FIG. 1, handle 120 is attached to a proximal end 112.
Although not specifically illustrated, it will be understood that
fragmatome 100 is disposed to deliver emulsification energy at
distal end 114. Such emulsification energy may be, for example and
without limitation, ultrasonic energy or laser energy. The source
of emulsification energy may be conventional, and may be deployed
in handle 120 or elsewhere in emulsification energy communication
with distal end 114.
[0027] FIG. 1 shows tubular member 110 being of substantially
constant diameter D, but it will be appreciated that the invention
is not limited in this regard. In an embodiment not illustrated,
but consistent with the invention, an elongated length of tubular
member 110 at distal end 114 may have outside diameter D, while a
portion of the remaining length of tubular member 110 towards
proximal end 112 may have a different diameter.
[0028] It will be further appreciated that in some embodiments of
fragmatome 100 as illustrated on FIG. 1, distal end 114 may be
disposed to deliver suction. The suction source may be
conventional, and again may be deployed in handle 120 or elsewhere
in suction communication with distal end 114.
[0029] FIGS. 2A through 2C each illustrate, respectively, first,
second and third phases of a method in accordance with a second
aspect of the present invention. It will be appreciated that the
embodiment of the method as set forth in FIGS. 2A through 2C is one
exemplary application (and, at this time, a preferred application)
for the fragmatome disclosed herein, an embodiment of which was
described above with reference to FIG. 1. It will be further
appreciated that the fragmatome disclosed herein is suitable for
use in other methods, in addition to the method set forth with
reference to FIGS. 2A through 2C.
[0030] Turning to a first phase of the method in accordance with a
second aspect of the invention, and as illustrated in FIG. 2A,
fragmatome 100 from FIG. 1 (as described above) is in use in the
vitreous cavity of an eye 200. In FIG. 2A, two surgical incisions
205A and 205B have been made through the sclera into the vitreous
cavity. It will be understood that consistent with the invention,
incisions 205A and 205B are large enough to allow 23-gauge or
smaller instrumentation through into the vitreous cavity, but small
enough not to require suturing after the operation is complete. It
will be understood that nominally, according to current technology,
such an incision size is no larger than about 0.8 mm. Optionally,
and as illustrated on FIG. 2A, trochars 210A and 210B are deployed,
one each in incisions 205A and 205B, and through which 23-gauge or
smaller instrumentation may be ported.
[0031] It will be appreciated that, consistent with the invention
described with reference to FIGS. 2A through 2C, a third incision
is also made into the eye. This third incision has not been
illustrated on FIGS. 2A through 2C for the sake of clarity. This
third incision is, consistent with incisions 205A and 205B on FIG.
2A, also large enough to allow 23-gauge or smaller instrumentation
through into the vitreous cavity, but small enough not to require
suturing after the operation is complete (such an incision size
again, according to current technology, no larger than about 0.8
mm). It will be appreciated that a conventional infusion cannula is
inserted into the eye through the third incision and resides there
throughout the method described with reference to FIGS. 2A through
2C. The infusion cannula is operable to maintain vitreous pressure
in the eye during the method. Optionally, a trochar may also
deployed in the third incision prior to insertion of the infusion
cannula, the trochar suitable to port 23-gauge or smaller
instrumentation.
[0032] With further reference to FIG. 2A, a conventional 23-gauge
light pipe 220 is inserted through either one of trochars 210A or
210B (through trochar 210B as illustrated). Light pipe 220 is
operable to illuminate the vitreous cavity. Fragmatome 100 (as
described above with reference to FIG. 1) is inserted through the
other trochar (through trochar 210A as illustrated) and into the
vitreous cavity. As shown on FIG. 2A, fragmatome is disposed to
operate on lens tissue sample T found in the vitreous cavity. It
will be appreciated that lens tissue sample T may, without
limitation, have been lifted from the surface of the retina using
suction delivered through fragmatome 100, or through a separate
suction tube (not illustrated), or alternatively may have been
already floating in the vitreous cavity when encountered by
fragmatome 100. In another technique (not illustrated), lens tissue
sample T may have been impaled by a solid pin or by fragmatome 100
and withdrawn away from the retina while still impaled. It will be
further appreciated that as illustrated on FIG. 2A, lens tissue
sample T is too large to be withdrawn from the vitreous cavity
through 23-gauge instrumentation.
[0033] Turning now to FIG. 2B, a second phase of a method in
accordance with a second aspect of the present invention is
illustrated. It will be appreciated that in FIG. 2B, the items and
part numbers as illustrated and labeled on FIG. 2B are the same as
the corresponding items and part numbers on FIG. 2A, with the
exception of lens tissue sample T. In FIG. 2B, fragmatome 100 has
operated on lens tissue sample T (from FIG. 2A) to now present a
smaller lens tissue sample T.sub.S (as shown on FIG. 2B). More
specifically, in the passage from FIG. 2A to FIG. 2B, fragmatome
100 has delivered emulsification energy to lens tissue sample T
(from FIG. 2A) so that, as illustrated in FIG. 2B, lens tissue
sample T (from FIG. 2A) is broken down into a smaller lens tissue
T.sub.S and a plurality of lens tissue fragments T.sub.F. In the
technique described in the previous paragraph (not illustrated)
where lens tissue sample T is impaled by fragmatome 100, it will be
appreciated that delivery of emulsification energy to the
fragmatome will cause breakdown of lens tissue sample T into
smaller fragments while still impaled. It will also be understood
that lens fragments T.sub.F are created by fragmatome 100 to be
small enough to be able to be withdrawn from the vitreous cavity
through 23-gauge instrumentation.
[0034] Turning now to FIG. 2C, and continuing on to a third phase
of a method whose first and second phases are described above with
reference to FIGS. 2A and 2B, it will be appreciated that
fragmatome 100 (from FIGS. 1, 2A and 2B) has now been used to break
lens tissue sample T (from FIG. 2A) and T.sub.S (from FIG. 2B) all
the way down to a plurality of lens fragments T.sub.F. For the
avoidance of doubt, the items and part numbers as illustrated and
labeled on FIG. 2C are the same as the corresponding items and part
numbers on FIG. 2B, except that fragmatome 100 on FIG. 2B has been
withdrawn on FIG. 2C and replaced with vitrector 230. Vitrector 230
is of conventional manufacture and in FIG. 2C, consistent with
other instrumentation illustrated on FIGS. 2A through 2C, is no
larger than 23-gauge. In FIG. 2C, lens fragments T.sub.F are being
aspirated from the vitreous cavity through vitrector 230.
[0035] In a variation on the method described with reference to
FIGS. 2A through 2C (not illustrated), fragmatome 100 may be left
in place after emulsification of lens tissue sample T and T.sub.S
into lens fragments T.sub.F, and lens fragments T.sub.F may then be
aspirated from the vitreous cavity using suction capability within
fragmatome 100. In a further variation (not illustrated),
fragmatome 100 may be withdrawn after emulsification of lens tissue
sample T and T.sub.S into lens fragments T.sub.F, and replaced by
other conventional tubular suction instrumentation with which to
aspirate lens fragments T.sub.F from the vitreous cavity. In yet
another variation (not illustrated), vitrector 230 may be inserted
prior to insertion of fragmatome 100, for the purpose of aspirating
vitreous from around lens tissue sample T prior to emulsification
by fragmatome 100.
[0036] It should be understood, of course, that the foregoing
relates to exemplary embodiments of the invention and that
modifications may be made without departing from the spirit and
scope of the invention as set forth in the following claims.
* * * * *