Umted States Patent [19]
`Lee '
`
`[11] Patent Number:
`[45] Date of Patent:
`
`4,900,300
`Feb. 13, 1990
`
`[54] SURGICAL INSTRUMENT
`[76] Inventor‘: David A. Lee, 2868 Nicada Dr., #48,
`L°S Angeles’ Cahf' 90077
`[21] Appl' No‘: 315’190
`[22] Filed:
`Feb. 24, 1989
`
`Related US. Application Data
`Cw?nuati?“ of Ser- N°' 70325’ Jul‘ 6’ 1987’ aban'
`
`[63]
`
`doned.
`
`[51] Int. Cl.4 ................................. .. A61B 17/20
`[52] US. Cl. .................................... .. 604/22; 606/162;
`_
`606/166
`[58] Field of Search ........................... .. 604/22, 27, 28;
`128/304’ 305’ 321’ 757-758
`References Cited
`
`[56]
`
`U's' PATENT DOCUMENTS
`3,542,031 11/1970 Taylor ............................... .. 128/304
`4,011,869 3/1977 se‘l‘ir’ Jr
`ga/
`4’o43’322 8/1977 Robmson
`/
`4,220,155 9/1980 Kimberling et a1‘
`“““ " 128/305
`4,577,629 3/1986 Martinez .......... ..
`604/22
`4,655,743 4/1987 Hyde ................................... .. 604/22
`
`4,210,146 7/1980 Banko . . . . . . . . . . . . , . . .
`
`. . . . .. 128/305
`
`.
`
`.
`
`.
`
`.
`
`4,689,040 8/1987 Thompson ..... ................... .. 604/22
`FOREIGN PATENT DOCUMENTS
`2450597 11/1980 France .............................. .. 128/757
`Primary Examiner-C. Fred Rosenbaum
`Assistant Examiner-kathleeri A. Daley
`Attorney, Agent, or Firm——David Silverstein
`[57]
`ABSTRACI‘
`This invention relates to the design and application of a
`gomectomy instrument for the purpose of diagnosti
`cally and therapeutically removing tissue from the ante
`rior chamber angle of the eye and for retrieving this
`tissue for further examination. The surgical instrument
`of this invention comprises in combination; a hollow’
`tapered shaft having a cutting edge at one end as an
`integral part thereof; a retractable stylet contained
`within the hollow interior of the tapered shaft; and an
`irrigation port running along the outside of the tapered
`shaft_
`instrument is useful for excising tissue to
`relieve an obstruction blocking the out?ow of aqueous
`humor from the eye as well as for providing specimens
`0 t e excised tissue for histopathological examination.
`
`f h
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`.
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`.
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`.
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`24 Claims, 1 Drawing Sheet
`
`Petitioner - New World Medical
`Ex. 1006, p. 1 of 11
`
`

`

`U.S. Patent
`
`Feb. 13, 1990
`
`4,900,300
`
`20
`
`16
`
`24
`
`18 \
`
`26
`
`II
`
`14
`
`22
`
`FIG. I
`
`15
`
`14
`
`10
`
`3
`
`2 2
`
`16
`
`12
`
`FIG.2
`
`16
`
`40
`
`20
`
`18
`
`lj
`
`14
`
`12
`
`FIG.3
`20
`
`18
`
`4
`
`15
`
`20,
`16
`
`15
`
`11
`
`10
`
`(
`
`FIG.4
`
`10
`
`12
`
`38 36
`
`30
`
`32
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`1
`
`14
`
`40
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`34 10
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`I I
`
`24
`
`22
`
`FIG.5
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`5
`
`12
`
`50 "1-Ar-
`
`14
`
`FIG.6
`
`22
`
`10
`
`50)4
`
`FIG7
`
`
`50
`
`22
`
`22
`
`FIG.8
`
`10
`
`Petitioner - New World Medical
`Ex. 1006, p. 2 of 11
`
`

`

`1
`
`SURGICAL INSTRUMENT
`
`This is a continuation of co-pending application Ser.
`No. 07/070,325 ?led on July 6, 1987
`
`20
`
`30
`
`35
`
`4,900,300
`2
`and infection. In some cases it may also be impossible to
`locate a severed segment of tissue from the inner eye
`when using a second instrument to retrieve it. In addi
`tion, such a two-step procedure is certain to require
`more time than would a one-step procedure, a particu
`larly important factor if a plurality of tissue samples are
`desired.
`Those surgical instruments in the prior art which are
`capable of both cutting and removing tissue specimens
`in a single operation are, in general, either not adaptable
`for delicate glaucoma surgery, do not remove large
`enough tissue samples, or else result in damage to the
`structure of the- excised tissue. For example, the prior
`art includes a plethora of biopsy instruments which both
`cut and remove tissue. In testing for carcinomous tissue,
`however, only relatively small tissue samples are re
`quired, and the physical structure of the tissue is usually
`not important. Therefore, these instruments cannot be
`adapted for the excision of relatively large, undamaged
`segments of glaucoma scar tissue. Some of the more
`pertinent prior art patents in this ?eld are discussed
`below, and all of these patents are speci?cally incorpo
`rated herein by reference. .
`U.S. Pat. No. 3,996,935 (Banko II) is perhaps the most
`representative of the prior art in this ?eld, and of its
`limitations. Banko II discloses a multipurpose instru- ,
`ment designed for ophthalmic surgery including re
`moval of foreign matter, blood clots, lenses and other
`eye tissue. The instrument includes an internal probe
`having a distal end for engaging tissue or foreign matter
`to be removed from the interior of the eye. The internal
`probe comprises two coaxial shafts, each having a jaw
`or port at its terminal end, such that the inner shaft is
`slidable and rotatable with respect to the outer. In other
`embodiments of the Banko II device, the hollow inte
`rior of the inner coaxial shaft can be utilized as a ?uid
`irrigation channel or as a suction canal to facilitate tis
`sue removal.
`The Banko II patent, however, requires suction to
`engage and remove tissue. Banko’s “internal probe” or
`“inner jaw” has cutting edges to cut tissue against the
`sharp opening edges of the “outer jaw” at the end of the '
`outer hollow shaft resulting in a scissor-like cutting
`action which could damage the tissue. This instrument
`is designed to‘ cut tissue into small pieces for removal,
`not to extract a relatively large, undamaged and intact
`tissue segment. The shape of this instrument also makes
`it unsuitable for goniectomy surgery. This instrument is
`also relatively complex, requiring an external power
`source for applying suction and for continuously rotat
`ing the “internal probe.” Accordingly, this instrument is
`not suitable for conducting goniectomy surgery.
`U.S. Pat. No. 3,583,390 (Jascalevich) is an example of
`a typical biopsy instrument. This patent discloses a bi
`opsy device which has generally tapered, two-sided
`arrowhead-shaped cutting tool with a hole near the tip
`of the cutting edges. The shape of this biopsy instru
`ment makes it unworkable for goniectomy surgery be
`cause the opening that would be required to introduce
`the instrument into the eye would be too large. Also,
`the large exposed surface area of the blades could cause
`trauma or injury to adjacent intraocular tissue during
`the surgical procedure. With the instrument of this
`patent, the tissue specimen is cut and separated from
`adjacent tissue by two blades — the biopsy blade and
`the scalpel blade — operating in a scissor-like fashion.
`Use of the Jascalevich instrument in the eye would
`necessitate making three entry wounds, one for the
`
`BACKGROUND OF THE INVENTION AND
`DISCUSSION OF PRIOR ART
`Glaucoma is a major cause of irreversible blindness in
`the United States. Approximately one percent of the
`general population has this disease. Visual loss from
`glaucoma is usually due to elevated intraocular pressure
`which damages the optic nerve. The cause for the ele
`vated intraocular pressure is not entirely known, but, at
`least in many cases, appears to be due to an increase in
`the resistance to the out?ow of aqueous humor from the
`eye. Aqueous humor is a ?uid which circulates within
`the anterior portions of the eye and provides nourish
`ment to and removes waste products from various avas
`cular structures in the eye such as the cornea and the
`lens. Aqueous humor is continuously being formed
`within the ciliary body epithelium and is normally con
`tinuously drained out of the eye through the trabecular
`meshwork and Schlemm’s Canal into the venous sys
`tem. It is believed that the site of resistance to the out
`?ow of aqueous humor is in the juxtacanalicular portion
`of the trabecular meshwork.
`Treatment of glaucoma is, therefore, usually directed
`at lowering the intraocular pressure and thereby pre
`venting progressive optic nerve damage and visual ?eld
`loss. If medical therapy (topical eyedrops and oral tab
`lets) and laser therapy fail to adequately lower the intra
`ocular pressure, then glaucoma surgery is required.
`There are several different types of glaucoma surgery
`(?ltration, goniotomy, trabeculotomy, cyclodialysis,
`etc.), but all of them‘have a common purpose: that is, to
`bypass or eliminate any blockage and thereby restore
`the out?ow of aqueous humor from the eye.
`Goniotomy and trabeculotomy surgery involve incis
`ing the abnormal tissue which is overlying or inside the
`40
`trabecular meshwork in order to allow aqueous humor
`to ?ow freely into the normal out?ow system. These
`two procedures are most commonly used in treating
`childhood glaucomas, but also have limited success in
`adult-onset glaucomas. When these surgical procedures
`fail, the failure is usually due to scarring which blocks
`the incision in the trabecular meshwork. In an attempt
`to avoid this problem,» a technique was developed in
`which an intraocular diathermy probe is used to cauter
`ize the incision edges in an attempt to-reduce or elimi
`nate scarring. However, this technique has not been
`proven to be any more successful than the other surgi
`cal procedures.
`In identifying the reason for open-angle glaucoma
`and for failure of these surgical procedures and in deter
`mining the extent of the blockage and the preferred
`treatment, it would be useful to, extract relatively large
`intact samples of undamaged trabecular meshwork and
`scar tissue and, perhaps, the surrounding tissue for his
`topathologic examination. Unfortunately, existing in
`struments for performing this surgery do not simulta
`neously permit the cutting and removal of relatively
`large and undamaged tissue specimens. The use of sepa
`rate instruments as are known in the art for cutting and
`excision in a delicate operation like glaucoma surgery is
`65
`not a satisfactory alternative. Such a procedure may
`entail a plurality of surgical penetrations of the inner
`eye thereby increasing the dangers of trauma, injury,
`
`45
`
`Petitioner - New World Medical
`Ex. 1006, p. 3 of 11
`
`

`

`4
`FIG. 4 is a sectional bottom view of the forward end
`of the surgical instrument along the axis 4—4 in FIG. 3.
`FIG. Sis a schematic side view of an eyeball with the
`surgical instrument of this invention in place and ready
`to begin cutting and removing a tissue segment from the
`trabecular meshwork.
`FIG. 6 is a schematic side view of an alternative
`embodiment of the surgical instrument of this invention
`showing a slidable sleeve in the open position.
`FIG. 7 is a schematic side view of the alternative
`embodiment of the surgical instrument of this invention
`with the slidable sleeve in the closed position.
`FIG. 8 is a schematic bottom view of the forward end
`of the instrument as shown in FIG. 6.
`
`10
`
`4,900,300
`3
`biopsy device and two for the scalpel blade (one for
`each groove). Because the two blades must be sepa
`rately manipulated to excise a tissue specimen, unless a
`high degree of care and skill is exercised by the surgeon
`severe injury to the surrounding eye tissue could result.
`Upon withdrawing the biopsy instrument from the eye,
`the sharp comers of the arrowhead-like blade could
`catch on and injure eye tissue surrounding the entry
`incision. Accordingly, this instrument is also not suit
`able for goniectomy surgery.
`U.S. Pat. Nos. 3,844,272 (Banko I); 3,929,123 (Jam
`shidi); and 3,007,471 (McClure) disclose surgical instru
`ments which utilize tapered and pointed distal cutting
`tips in combination with coaxial members such that a
`'sheath can slidably expose or cover the cutting tip.
`McClure discloses the use of an internal stylet (refer
`ence numeral 40) inside the sliding coaxial members.
`Other patents which show surgical sampling instru
`ments having slidable, coaxial members, internal stylets
`or both include U.S. Pat. Nos. 4,308,875 (Young);
`2,850,007 (Lingley); 3,893,445 (Hofsess); and 4,282,884
`(Boebel).
`In addition, there are a number of recent patents
`which are speci?cally directed to instruments for oph
`thalmic surgery. These patents include U.S. Pat. Nos.
`4,590,935 (Ranalli); 4,577,629 (Martinez); 4,538,611
`(Kelman); 4,570,632 (Woods); 4,041,947 (Weiss); and
`4,320,761 (Haddad). These patents include discussion of
`such issues as the importance of irrigation during eye
`surgery and similar matters which have special rele
`vance for ophthalmic surgery. None of these various
`instruments is suitable, however, both as a surgical tool
`and as a device for excising relatively large, undamaged
`tissue segments.
`
`DETAILED DESCRIPTION AND PREFERRED
`EMBODIMENTS
`Referring to FIGS. 1 and 2, in the preferred embodi
`ment the surgical instrument of this invention comprises
`a more or less cylindrical hollow shaft 10 which is ta
`pered from a'larger diameter at the handle end 11 to a
`smaller diameter at the forward cutting edge end. The
`tapered shaft ranges from about 0.5 to 2 mm. in diame
`ter, being widest near the handle 11. The length of shaft
`10 is about 30 mm. and the overall length of the instru
`ment is about 120 mm. The diameter of the handle 11 is
`about 5 to 7 mm.
`Although in the preferred embodiment shaft 10 is
`generally cylindrical, the shaft may have a vertical
`cross-section shape which ranges from circular to oval‘
`to a square or trapezoidal shape with rounded corners.
`The taper of shaft 10 is relatively small of approxi
`mately 5 to 15 degrees and is intended to prevent or
`reduce the leakage of aqueous humor around the para
`centesis site. The taper is not an essential element of this
`invention, however; and, the use of shafts which are not
`tapered is within the scope of this invention.
`The forward end of shaft 10 comprises a parabolic,
`bowl-like cavity 12 having a sharpened rim which cre
`ates a single, more or less U-shaped cutting edge 14
`integral with the sides of shaft 10. The cutting edge is
`approximately 2.0 mm. in length and about 0.3 to 0.4
`mm. in width. The distal end 15 of cutting edge 14
`protrudes a distance of about 0.5 to 1.0 mm. for ease of
`tissue penetration and cutting. The cutting edge is softly
`rounded at its distal end and is generally parabolic in
`shape in order to avoid damage to the outer wall of
`Schlemm’s Canal.
`In the preferred embodiment, as better shown in FIG.
`3, the plane of the tip of cutting edge 14 will be at an
`acute angle of about 5 to 45 degrees with respect to the
`plane of shaft 10. The angle of cutting edge 14, how
`ever, may vary from as little as 0 degrees to greater than
`45 degrees depending on surgical requirements. As
`shown in FIGS. 2 and 4, in the preferred embodiment
`the bottom of cavity 12 also includes a hole or aperture
`16.
`The surgical instrument of this invention also in
`cludes a retractable rod or stylet 18 located inside shaft
`10. The forward end or tip 20 of stylet 18 is preferably
`made of a relatively soft, non-toxic material such as
`plastic, silicone or rubber to prevent injury or trauma to
`a tissue sample. The remainder of stylet 18, and all of
`shaft 10, can be made of any durable and corrosion
`resistant metal such as stainless steel. In another em
`bodiment, both shaft 10 and stylet 18 can be made from
`plastic, while cutting edge 14 is made from metal and
`attached to the end of shaft 10 by suitable means. There
`
`30
`
`OBJECTS OF THE INVENTION
`A principal object of this invention is to provide a
`surgical instrument for use in glaucoma surgery.
`A further object of this invention is to provide a
`surgical instrument suitable for both cutting and ex
`tracting relatively large, intact segments of internal eye
`tissue.
`Still a further object of this invention is to provide an
`instrument specially designed for goniectomy surgery
`comprising in combination a hollow, tapered shaft hav
`ing a cutting edge at one end as an integral part thereof;
`a retractable stylet contained within the hollow interior
`of the tapered shaft; and an irrigation port running
`along the outside of the tapered shaft.
`Speci?cally, it is an object of this invention to pro
`vide a surgical instrument for use in glaucoma surgery
`to excise a piece of tissue from the anterior chamber
`angle (trabecular meshwork and the inner wall of
`Schlemm’s Canal) to therapeutically relieve the ob
`struction of the out?ow of aqueous humor from the eye
`and to provide specimens of the abnormal tissues ex
`cised for histopathological examination.
`These and other objects and advantages of this inven
`tion will become apparent in the following description.
`
`35
`
`40
`
`45
`
`55
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a schematic side view of the surgical instru
`ment of this invention.
`FIG. 2 is a schematic bottom view of the surgical
`instrument of this invention.
`FIG. 3 is an enlarged, sectional side view of the for
`ward end of the surgical instrument of FIGS. 1 and 2
`along the axis 3-3 in FIG. 2.
`
`65
`
`Petitioner - New World Medical
`Ex. 1006, p. 4 of 11
`
`

`

`15
`
`25
`
`20
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`4,900,300
`5
`6
`(2) The patient’ head is rotated slightly away from the
`is also a lever 24 located on the handle 11 of the instru
`ment which can manually advance and retract the sty
`side of the surgery and the eye being operated on is
`slightly abducted. The eye’s position is fixed by
`let. There may also be a lubricated spring operated
`locking forceps which are being held by the surgi
`system 26 to facilitate sliding the stylet back and forth
`cal assistant.
`smoothly with minimal friction and force.
`(3) A surgical goniolens is placed over the cornea and
`The surgical instrument of this invention further in
`the air bubbles under the lens are removed with
`cludes an irrigation port 22 which runs along the out
`saline solution. The goniolens is positioned to leave
`side of shaft 10 on the same side of shaft 10 as' cutting
`2 to 3 mm. of limbal cornea exposed for the incision
`edge 14. The function of this irrigation port is to main
`and instrument entry. The anterior chamber angle
`tain ?uid levels in the anterior chamber of the eye dur
`is visualized through the goniolens under magni?
`ing a surgical procedure and to help protect the cornea
`cation with an operating microscope or a binocular
`and the lens from injury. The irrigation port is com
`head loupe.
`prised of ?exible irrigation tubing composed of plastic,
`(4) A paracentesis incision is made into the anterior
`silastic or similar material; and, such irrigation ports are
`chamber with a sharp knife through clear cornea
`readily commercially available.
`about 1 mm. anterior to the limbus. The length of
`The end of irrigation port 22 is about 3 to 5 mm. from
`the incision should be about 2 to 3 mm. and parallel
`the beginning of cutting edge 14. The diameter of the
`to the limbus.
`irrigation port is about 0.25 mm. or 30 gauge. The irri
`(5) The goniectomy instrument of this invention is
`gation port is connected to ?exible tubing (not shown)
`carefully introduced into the anterior chamber
`near the handle 11 of the instrument, which tubing is
`through the paracentesis site under constant irriga
`connected in turn to an irrigation bottle (not shown)
`tion. The cutting edge is passed across the center of
`containing sterile balanced salt solution which is sus
`the anterior chamber to a point in the anterior
`pended in the air by an adjustable intravenous stand.
`chamber angle 180 degrees from the entry site. The
`The rate of flow of the irrigation ?uid can be adjusted
`tapered shaft maintains a water tight seal and the
`by changing the height of the irrigating bottle, i.e. the
`irrigation maintains the anterior chamber ?uid
`higher the bottle, the faster the flow. The irrigation port
`level.
`has a secondary function of preventing cutting edge 14
`(6) The cutting edge 14 is used to excise the angle
`from getting caught at the paracentesis site when the
`tissue 40 for approximately one-third of the angle
`instrument is withdrawn from the eye at the end of the
`circumference. The excised tissue will be guided
`procedure. In some applications the instrument of this
`toward and through aperture 16 in‘cavity 12 (see
`invention may be used without the irrigation port or the
`FIG. 3) as cutting edge 14 is advanced. This will
`irrigation port 22 may be incorporated within the shaft
`help to hold the excised tissue in place during re
`10 of the instrument.
`moval. The paracentesis entry site is used as a piv
`FIG. 3 is an enlarged sectional side view of the cut
`otal point for the instrument as it swings across the
`ting edge end of the surgical instrument shown in FIGS.
`anterior chamber.
`1 and 2 along the axis 3-3 in FIG. 2. FIG. 3 shows
`(7) After the desired strip of angle tissue 40 is excised,
`stylet 18 with its soft tip 20 located inside shaft 10. FIG.
`the stylet 18 (not seen in FIG. 5) is advanced so
`3 also shows the angle of cutting edge 14 with respect to
`that stylet tip 20 holds tissue 40 ?rmly against the
`shaft 10, and the location of irrigationport 22 proximate
`interior of cavity 12 (see FIG. 3). Then the instru
`to the cutting edge. FIG. 3 further shows in dotted lines
`ment is carefully withdrawn from the anterior
`a segment of excised tissue 40 protrucing through aper
`chamber. The anterior chamber may then be deep
`ture 16 and held there in place by tip 20 of stylet 18
`ened with balanced salt solution, air, or a viscoelas
`when stylet 18 is advanced to its forward position, all as
`tic substance. The paracentesis wound may also be
`hereinafter described.
`closed with lO-O nylon suture if necessary.
`45
`FIG. 4 is a sectional bottom view of the cutting edge
`Alternatively, if desired, the instrument may be rein
`end of the surgical instrument along the axis 4-4 in
`serted into the eye through the existing incision or
`FIG. 3. FIG. 4 shows the generally parabolic shape of
`through a second incision to excise and collect addi
`cutting edge 14, including the softly rounded distal end
`tional tissue samples.
`15. FIG. 4 also clearly shows aperture 16 in the bottom
`A modi?ed version of the goniectomy instrument of
`of cavity 12. Tip 20 of stylet 18 is preferably of a para
`this‘ invention is illustrated in FIGS. 6, 7, and 8. In the
`bolic shape, as shown, in order to better ?t into distal
`modi?ed version of the instrument, stylet 18 and aper
`end 15 of cutting edge 14 when stylet 18 is advanced to ‘
`ture 16 have been eliminated, and slidable sleeve 50
`its forward position (dotted con?guration in FIG. 3).
`capable of enclosing the distal end 15 of shaft 10 has
`The application of the instrument of this invention to
`been added. As shown in FIG. 8, the forward end of
`goniectomy surgery will be described by reference to
`sleeve 50 is also of a generally parabolic shape in order
`FIG. 5. FIG. 5 is a schematic side view of an eyeball
`to achieve a good fit over distal end 15.
`showing the cornea 30, the iris 32, the anterior chamber
`With the modi?ed instrument as shown in FIGS. 6, 7
`34, the trabecular meshwork 36 which rings the iris, and
`and 8, the excised tissue specimen does not pass through
`Schwalbe’s line 38.
`aperture 16 to the other side of cavity 12. Instead, the
`The purpose of this instrument is to surgically re
`tissue specimen is now directed by the interior shape of
`move a tissue segment 40 from the anterior chamber
`cavity 12 into hollow shaft 10. Metal sleeve 50 around
`angle of the eye and to retrieve this tissue for further
`distal end 15 of the shaft helps to hold the specimen in
`examination after the surgical procedure. The surgical
`cavity 12. The metal sleeve is able to move along the
`technique is as follows:
`length of the shaft and is controlled by a lever (compa
`(1) The patient is placed in the supine position on the
`rable to lever 24 as shown in FIG. 1) located on the
`operating table. General or local anesthesia is
`handle of the instrument. After the tissue specimen 40 is
`given.
`cut and directed up the hollow shaft 10 of the instru
`
`50
`
`55
`
`65
`
`Petitioner - New World Medical
`Ex. 1006, p. 5 of 11
`
`

`

`10
`
`30
`
`35
`
`4,900,300
`7
`ment, sleeve 50 is advanced to the distal end 15 of the
`instrument to cover cutting edge 14 and to thereby
`contain the tissue specimen in cavity 12 and in the hol
`low shaft. After the instrument is removed from the
`eye, the sleeve can be retracted to expose the cutting tip
`so that the tissue specimen can be retrieved. The sleeve
`also serves a secondary purpose by covering the cutting
`edge to protect it from inadvertently damaging other
`structures within the eye and to protect the cutting edge
`from traumatic blunting.
`Many other variations and modi?cations of my basic
`design will be readily apparent to those skilled in the
`art. All such variations and modi?cations are within the
`spirit and the scope of this invention and, therefore, are
`intended to be encompassed by the following claims:
`Having described my invention, what I claim is:
`1. A surgical instrument designed for cutting and
`removing intact an elongated strip of internal tissue
`greater in length than the width of the instrument cut
`ting edge, said instrument comprising:
`(a) a hollow shaft with rounded sides having a cen
`tral, longitudinal axis, a handle at the rear end
`thereof and, at the forward end, a generally para
`bolic-shaped cavity which forms a bowl;
`(b) said bowl having closed sides, a closed forward
`wall, a closed bottom, and an open mouth such that
`the sides, forward wall and bottom form a continu
`ous inner wall integral with the adjacent sides of
`said hollow shaft except for an opening in said
`bowl which communicates with the interior of said
`hollow shaft; and,
`(0) further wherein said open mouth is de?ned by a
`generally U-shaped rim integral with the adjacent
`sides of said hollow shaft and said rim is sharpened
`so as to form a cutting blade having side cutting
`edges and a distal tip.
`2. The surgical instrument of claim 1 wherein said
`hollow shaft is tapered from a larger diameter at said
`handle end to a smaller diameter at said cutting edge
`end.
`3. The surgical instrument of claim 1 wherein the
`distal tip of said cutting blade is rounded.
`4. The surgical instrument of claim 1 further includ
`ing an irrigation port along the outside of said hollow
`shaft.
`5. The surgical instrument of claim 1 further includ
`ing tissue securing and removal for securing and remov
`ing intact and elongated strip of internal tissue.
`6. The surgical instrument of claim 5 wherein said
`tissue securing and removal means comprises a stylet
`slidably positioned inside said hollow shaft.
`7. The surgical instrument of claim 6 wherein said
`stylet has a soft blunt tip at the forward end thereof
`designed to engage without cutting a strip of tissue
`between said soft tip and the inner wall of said bowl.
`8. The surgical instrument of claim 6 further includ
`ing lever and spring means for moving said stylet inside
`said shaft.
`9. The surgical instrument of claim 6 further includ~
`ing an aperture located in the bottom of said bowl.
`10. The surgical instrument of claim 5 wherein said
`tissue securing and removal means comprises a sleeve
`slidably positioned along the outside of said hollow
`shaft.
`11. The surgical instrument of claim 10 further in
`cluding lever means for moving said sleeve.
`12. The surgical instrument of claim 1 wherein the
`mouth of said bowl is outwardly sloping with respect to
`
`8
`the adjacent sides of said hollow shaft at an acute angle
`to the central longitudinal axis of said shaft.
`13. A surgical instrument of comprising: a tubular
`member having a central, longitudinal axis and a for
`wardly extending leading end having an open month,
`said open mouth being outwardly sloping at an acute
`angle with respect to the central, longitudinal axis of
`said tubular member and having sharpened cutting
`edges; and, holding means slidably positioned within
`said tubular member, said holding means having a blunt
`front end for contacting and ?xing without cutting an
`excised tissue segment within said tubular member.
`14. The surgical instrument of claim 13 wherein said
`open mouth comprises a continuous cutting edge.
`15. The surgical instrument of claim 13 wherein said
`leading end has an aperture.
`16. The surgical instrument of claim 13 wherein said
`tubular member is forwardly tapered toward said lead
`ing end.
`17. The surgical instrument of claim 13 further in
`cluding an irrigation port attached to said tubular mem
`ber.
`18. In a surgical instrument designed for goniectomy
`surgery, the improvements which comprise: a hollow
`shaft having a handle at one end thereof and a parabolic
`cavity at the other end, said cavity having a sharpened
`rim which forms a U-shaped cutting edge integral with
`the sides of said shaft; a soft-tipped stylet slidably posi
`tioned inside said hollow shaft; and an irrigation port
`along the outside of said hollow shaft proximate to said
`cutting edge.
`‘
`19. A method for performing goniectomy surgery on
`an eye and for retrieving an elongated excised tissue
`segment comprising the following steps: p1 (a) intro
`ducing into the anterior chamber of the eye through an
`incision a surgical instrument comprising a hollow shaft
`with rounded sides and a parabolic cavity at the for
`ward end thereof, said cavity having sides and a bottom
`integral with the sides of said hollow shaft, and an open
`mouth having a sharpened rim which de?nes a gener
`ally U-shaped cutting edge, and an aperture in the bot
`tom of said cavity, and a blunt-tipped stylet slidably
`positioned inside said hollow said shaft;
`(b) excising an elongated tissue segment by drawing
`said cutting edge along the trabecular meshwork
`such that the end of the tissue segment is directed
`through said aperture in said cavity;
`(0) advancing said stylet such that the blunt tip en
`gages said tissue segment and holds it securely
`against the inside of including tissue securing and
`removal means for securing and removing intact an
`elongated strip of internal tissue.
`20. The method of claim 19 further comprising he
`step of irrigating the anterior chamber of the eye during
`the surgical procedure with a sterile balanced salt solu
`tion which is introduced into the eye through an irriga
`tion port along the outside of said hollow shaft.
`21. The method of claim 19 further comprising the
`step of irrigating the anterior chamber of the eye during
`the surgical procedure with a sterile balanced salt solu
`tion which is introduced into the eye through an irriga
`tion port located inside said hollow shaft.
`22. A method for performing goniectomy surgery on
`an eye and for retrieving an elongated excised tissue
`segment comprising the following steps:
`(a) introducing into the anterior chamber of the eye
`through an incision a surgical instrument compris
`ing: a hollow shaft with rounded sides having a
`
`45
`
`55
`
`60
`
`Petitioner - New World Medical
`Ex. 1006, p. 6 of 11
`
`

`

`4,900,300
`10
`9
`central‘, longitudinal axis, a handle at the rear end
`such that the end of the tissue segment is directed
`thereof and, at the forward end, a generally para-
`into the parabolic cavity and up the hollow shaft;
`bolic-shaped cavity which forms a bowl; said bowl
`(0) advancing said sleeve along the hollow shaft so as
`having closed sides, a closed forward wall, a closed
`to enclose the parabolic cavity and the tissue seg
`bottom, and an open mouth such that the sides, 5
`ment contained therein; and,
`forward wall and bottom form a continuous inner
`(d) removing said surgical instrument from the eye
`wall integral with the adjacent sides of said hollow
`together with said elongated tissue segment intact.
`shaft except for an opening in said bowl which
`23. The method of claim 22 further comprising the
`communicates with the interior of said hollow
`step of irrigating the anterior chamber of the eye during
`shaft; further wherein said open mouth is de?ned 10 the surgical procedure with a sterile balanced salt solu
`by a generally U-shaped rim integral with the adja-
`tion which is introduced into the eye through an irriga
`cent sides of said hollow shaft and said rim is sharp-
`tion port along the outside of said hollow shaft.
`ened so as to form a cutting blade having side cut-
`24. The method of claim 22 further comprising the
`ting edges and a distal tip; and further including a
`step of irrigating the anterior chamber of the eye during
`sleeve slidably positioned along the outside of said 15 the surgical procedure with a sterile balanced salt solu
`hollow shaft;
`tion which is introduced into the eye through an irriga
`(b) excising an elongated tissue segment by drawing
`tion port located inside said hollow shaft.
`said cutting edge along a trabecular meshwork
`*
`* * * *
`
`20
`
`25
`
`45
`
`50
`
`55
`
`65
`
`Petitioner - New World Medical
`Ex. 1006, p. 7 of 11
`
`

`

`at"
`
`I
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORR