BSC USP 8,142,413
`Exhibit 1011
`
`Page 1 of 24
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0127927 A1
`(43) Pub. Date:
`Jul. 1, 2004
`Adams
`
`US 20040127927A1
`
`(54) APPARATUS AND METHODS FOR
`STRAIGHTENING ANGLED TISSUE
`CUTTING INSTRUMENTS
`
`(76) Inventor: Kenneth Adams, Jacksonville, FL (US)
`
`Correspondence Address:
`Epstein, Edell, Shapiro, Finnan & Lytle, LLC
`Suite 400
`1901 Research Boulevard
`Rockville, MD 20850 (US)
`
`(21) Appl. No.:
`
`10/244,062
`
`(22) Filed:
`
`Sep. 16, 2002
`
`Publication Classi?cation
`
`(51) Int. Cl.7 ................................................... .. A61B 17/32
`(52) US. Cl. ............................................................ .. 606/170
`
`ABSTRACT
`(57)
`A straightening tool is disclosed for straightening angled
`tissue cutting instruments including an outer member having
`
`a proximal length portion and a pre-formed bend connecting
`the proximal length portion With a distal length portion
`extending from the bend at an angle to a distal end, and a
`?exible inner member movably disposed in the outer mem
`ber to cut anatomical tissue. The straightening tool com
`prises a handle and a positioning block extending from the
`handle coaxial With the straightening tool. The positioning
`block has a longitudinal bore for receiving the distal length
`portion therethrough to position the distal end Within a
`cavity of the positioning block and the bend Within a
`longitudinal slot of the positioning block With the proximal
`length portion extending externally through an opening of
`the slot. The bore con?nes the distal length portion against
`radial movement and serves as a fulcrum about Which the
`proximal length portion is manually pivotable into abutment
`With a ?oor of the slot extending from the bore at an angle
`in a direction opposite the slot opening. Upon release of the
`manual pivoting force, the proximal length portion springs
`back someWhat in the direction of the original bend to obtain
`a longitudinally straightened outer member. The straight
`ened outer member is used With the inner member to cut
`anatomical tissue as a straightened tissue cutting instrument.
`
`

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`Page 2 of 24
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`Patent Application Publication
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`Jul. 1, 2004 Sheet 1 0f 9
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`US 2004/0127927 A1
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`Patent Application Publication
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`Page 5 of 24
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`Patent Application Publication Jul. 1, 2004 Sheet 4 0f 9
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`Patent Application Publication Jul. 1, 2004 Sheet 6 0f 9
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`Patent Application Publication Jul. 1, 2004 Sheet 7 0f 9
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`Patent Application Publication Jul. 1, 2004 Sheet 9 0f 9
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`Page 11 of 24
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`US 2004/0127927 A1
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`Jul. 1, 2004
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`APPARATUS AND METHODS FOR
`STRAIGHTENING ANGLED TISSUE CUTTING
`INSTRUMENTS
`
`BACKGROUND OF THE INVENTION
`
`[0001] 1. Field of the Invention
`[0002] The present invention relates generally to angled
`tissue cutting instruments having pre-formed bends and,
`more particularly, to apparatus and methods for straighten
`ing the pre-formed bends of angled tissue cutting instru
`ments.
`
`[0003] 2. Brief Discussion of the Related Art
`[0004] Tissue cutting instruments comprising an elongate
`outer tubular member and an elongate inner member rotat
`ably disposed in the outer tubular member to cut anatomical
`tissue have become Well accepted for use in various surgical
`procedures. Typically, the inner member has a distal end
`With a cutting edge and the outer member has an opening
`through Which the cutting edge is exposed to access ana
`tomical tissue to be cut by the cutting edge When the inner
`member is rotated Within the outer member. The cutting
`edge may have various con?gurations in accordance With
`the type of tissue and/or the type of cutting action to be
`accomplished. In some instances, the distal end of the outer
`member has a cutting edge cooperable With the cutting edge
`of the inner member to cut the anatomical tissue as the inner
`member is rotated. The outer and inner members ordinarily
`have proximal ends adapted for coupling With a poWered
`surgical handpiece used to rotate the inner member relative
`to and Within the outer member. Many tissue cutting instru
`ments provide for aspiration of anatomical debris through
`the tissue cutting instrument and/or irrigation at the opera
`tive site via an irrigating or ?ushing ?uid supplied along the
`tissue cutting instrument.
`[0005] In tissue cutting instruments of the foregoing type,
`the outer members may be longitudinally or axially straight
`or may be longitudinally or axially bent, angled or curved
`depending on the surgical procedure being performed.
`Where the outer members are longitudinally or axially bent,
`angled or curved, the inner members are normally provided
`With a ?exible region adjacent the bend, angle or curve in the
`outer member Whereby the inner member assumes the
`longitudinally or axially bent, angled or curved con?gura
`tion of the outer member While still being rotatable Within
`the outer member. Angled tissue cutting instruments of the
`latter type are represented by US. Pat. No. 177,490 to
`Fones, US. Pat. No. 4,445,509 to Auth, US. Pat. No.
`4,466,429 to Loscher, US. Pat. No. 4,646,738 to Trott, US.
`Pat. No. 5,152,744 and US. Pat. No. 5,322,505 to Krause et
`al, US. Pat. No. 5,286,253, US. Pat. No. 5,411,514 and US.
`Pat. No. 5,601,506 to Fucci et al, US. Pat. No. 5,437,630 to
`Daniel et al, US. Pat. No. 5,529,580 to Kusumoki et al, US.
`Pat. No. 5,620,415 to Lucy et al, and US. Pat. No. 5,620,447
`to Smith et al. In most angled tissue cutting instruments, the
`bend, curve or angle is pre-formed in the outer member as
`part of the manufacturing or fabrication process and is
`essentially rigid or ?xed. HoWever, US. Pat. No. 5,601,586
`and US. Pat. No. 5,411,514 to Fucci et al are representative
`of variable angle tissue cutting instruments in Which a
`longitudinally straight outer member has a spiral relief cut
`forming a non-rigid bendable section along Which the outer
`member may be bent axially by a user, and the inner member
`
`is ?exible to folloW the bent con?guration of the outer
`member. The Fucci et al patents also disclose a bending tool
`permitting a user to bend the longitudinally straight outer
`member axially along the non-rigid bendable section to
`assume various predetermined angles.
`
`[0006] Angled tissue cutting instruments comprising
`essentially rigid outer members having pre-formed angles,
`bends or curves and rotatable inner members folloWing the
`pre-formed con?gurations of the outer members are illus
`trated by US. Pat. No. 5,922,003 to Anctil et al. Outer
`members that are pre-formed With a longitudinal or axial
`bend, angle or curve may advantageously be precision
`manufactured With the bend, angle or curve formed With
`exactitude to extend in a pre-selected direction at a speci?ed
`location and angle With a predetermined radius of curvature.
`Accordingly, the outer member can be manufactured With a
`pre-formed angle, bend or curve that is optimal for the
`surgical procedure being performed. As an example, the
`Anctil et al patent discloses an angled tissue cutting instru
`ment in Which the outer member has a pre-formed bend,
`curve or angle that is optimal for use of the instrument as an
`adenoid blade. In many surgical procedures facilitated by an
`angled tissue cutting instrument, it is preferable that the
`outer member be pre-formed With the most desirable or
`advantageous bend, curve or angle for the particular surgical
`procedure to ensure that the most optimal outer member
`con?guration is used for the particular surgical procedure.
`
`[0007] In some surgical procedures, it is desirable to
`utiliZe angled tissue cutting instruments to remove anatomi
`cal tissue and to thereafter utiliZe longitudinally or axially
`straight tissue cutting instruments for further removal of
`anatomical tissue. In a combined tonsillectomy and
`adenoidectomy procedure (T&A procedure), for instance, an
`adenoidectomy is performed prior to a tonsillectomy to
`remove all or part of an adenoid, using an angled tissue
`cutting instrument as represented by the adenoid blade
`disclosed in the Anctil et al patent and by the RADenoid®
`Blade of Medtronic Xomed Surgical Products, Inc. The
`tonsillectomy is thereafter performed, typically utiliZing the
`same angled tissue cutting instrument or another different
`tissue cutting instrument in Which the outer member is
`longitudinally or axially straight. Performing the tonsillec
`tomy using the angled tissue cutting instrument that Was
`used for the adenoidectomy, i.e. the adenoid blade, is dis
`advantageous since longitudinally or axially straight tissue
`cutting instruments provide better access to the tonsils.
`Using another different tissue cutting instrument having a
`longitudinally or axially straight outer member for the
`tonsillectomy is also disadvantageous for the increased cost
`associated With an additional instrument and/or the addi
`tional surgical time associated With preparing the additional
`instrument for use. The added steps involved in preparing an
`additional instrument for use during surgery may include
`removing the instrument from its package, assembling the
`inner member of the instrument Within the outer member,
`coupling the inner member and the outer member to the
`surgical handpiece, and/or removing the angled tissue cut
`ting instrument from the surgical handpiece so that the same
`handpiece can be coupled With the inner and outer members
`of the additional instrument. Furthermore, the need to inven
`tory and supply both angled and straight tissue cutting
`instruments for a surgical procedure imposes a difficult
`burden on hospitals and other surgical sites.
`
`

`

`Page 12 of 24
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`US 2004/0127927 A1
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`Jul. 1, 2004
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`[0008] In various sinus procedures, it is also common for
`surgeons to initially utiliZe an angled tissue cutting instru
`ment to remove anatomical tissue and to thereafter utiliZe a
`straight tissue cutting instrument to further remove anatomi
`cal tissue. The Rad® 40 Curved Blade and the Rad 60
`X-TREMETM Curved Blade of Medtronic Xomed Surgical
`Products are representative of angled tissue cutting instru
`ments Which alloW access into the frontal recess and max
`illary sinus and are popular for use in sinus surgery, par
`ticularly superior ethmoid and frontal recess surgery,
`removal of maxillary polyps, uncinectomy and antrostomy.
`During sinus surgery Where tissue removal is initially
`effected using an angled tissue cutting instrument, the sur
`geon Will sometimes sWitch to a longitudinally straight
`tissue cutting instrument Where needed to afford better
`access for further tissue removal. As discussed above, the
`need to sWitch betWeen tWo different instruments during a
`surgical procedure presents numerous draWbacks.
`
`[0009] Sometimes angled tissue cutting instruments hav
`ing blades With a particular distal end cutting con?guration
`are available to surgeons Without there being available
`straight tissue cutting instruments having the particular
`distal end cutting con?guration. There arises an unsatis?ed
`need Where a surgeon desires to use the particular distal end
`cutting con?guration of an available angled tissue cutting
`instrument but as a longitudinally straight tissue cutting
`instrument. Accordingly, an angled tissue cutting instrument
`may have to be used in a surgical procedure in Which use of
`a counterpart straight tissue cutting instrument Would be
`more preferable.
`
`[0010] It is seen from the above that a need exists for
`apparatus and methods to effect unbending or straightening
`of a pre-formed angle, bend or curve in an outer member of
`an angled tissue cutting instrument to obtain a longitudinally
`or axially straightened tissue cutting instrument therefrom.
`Apparatus and methods are needed Which are capable of
`accomplishing unbending or straightening of an angled
`tissue cutting instrument prior to or during a surgical pro
`cedure in a brief amount of time using a minimal number of
`simple procedural steps. In particular, apparatus and meth
`ods are needed for unbending or straightening an angled
`tissue cutting instrument for use as a longitudinally straight
`ened tissue cutting instrument during a surgical procedure to
`ensure that the instrument has both the optimal distal end
`cutting con?guration and the optimal longitudinal con?gu
`ration for the surgical procedure and/or to eliminate the need
`for surgeons to sWitch betWeen different instruments during
`the surgical procedure. There is also a need to reduce the
`number of different instruments made available for and/or
`used during a surgical procedure to reduce surgical costs and
`the burden on hospitals and other surgical sites associated
`With maintaining and supplying many different instruments.
`Especially in the areas of T&A procedures and sinus pro
`cedures, the need exists for alloWing a pre-formed angled
`tissue cutting instrument to be used in a surgical procedure
`to remove anatomical tissue and to be thereafter straightened
`or unbent for further use in the surgical procedure to remove
`anatomical tissue as a longitudinally straightened tissue
`cutting instrument. There is also a need to permit an avail
`able angled tissue cutting instrument having a particular
`distal end cutting con?guration desirable for use in a surgical
`procedure to be straightened or unbent prior to the surgical
`
`procedure to assume a straightened longitudinal con?gura
`tion that is more preferable for the surgical procedure than
`an angled con?guration.
`
`SUMMARY OF THE INVENTION
`
`[0011] Accordingly, it is a primary object of the present
`invention to overcome the aforementioned disadvantages of
`the prior art.
`
`[0012] Another object of the present invention is to
`straighten a pre-bent adenoid blade subsequent to perform
`ing an adenoidectomy With the adenoid blade and to there
`after perform a tonsillectomy With the straightened blade.
`
`[0013] A further object of the present invention is to
`eliminate the need for hospitals and other surgical sites to
`supply both angled and straight tissue cutting instruments
`for T&A, sinus, laryngeal and other surgical procedures.
`[0014] The present invention also has as an object to
`ensure the use of the most optimal distal end cutting con
`?gurations and/or longitudinal con?gurations for a blade
`used throughout a surgical procedure such as T&A, sinus,
`laryngeal and other surgical procedures.
`[0015] An additional object of the present invention is to
`straighten a pre-bent angled tissue cutting instrument used
`during a surgical procedure for subsequent use during the
`surgical procedure as a longitudinally straightened tissue
`cutting instrument.
`
`[0016] Still a further object of the present invention is to
`straighten an available angled tissue cutting instrument prior
`to a surgical procedure to obtain a straightened tissue cutting
`instrument that is more preferable for use in the surgical
`procedure than the angled instrument.
`
`[0017] It is also an object of the present invention to utiliZe
`one tissue cutting instrument in a surgical procedure nor
`mally requiring a plurality of different tissue cutting instru
`ments.
`
`[0018] The present invention has as another object to
`reduce the cost of surgery by reducing the number of
`different tissue cutting instruments required to perform a
`surgical procedure.
`[0019] Yet a further object of the present invention is to
`reduce the time needed to perform a surgical procedure by
`eliminating the need to sWitch betWeen different tissue
`cutting instruments during the surgical procedure.
`
`[0020] Moreover, it is an object of the present invention to
`provide a straightening tool of simpli?ed construction and
`operation for straightening a pre-bent angled tissue cutting
`instrument.
`
`[0021] The present invention also has as an object to
`straighten a pre-bent tissue cutting instrument in a short
`amount of time using a minimal number of procedural steps.
`
`[0022] Some of the advantages of the present invention are
`that the pre-bent outer member of the angled tissue cutting
`instrument is straightened Without kinking; the pre-bent
`outer member of the angled tissue cutting instrument is
`straightened While retaining its structural integrity; the
`proximal end of the outer member is not bent out of
`alignment With the poWered surgical handpiece; the inner
`member can remain disposed Within the outer member as the
`
`

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`Page 13 of 24
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`US 2004/0127927 A1
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`Jul. 1, 2004
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`outer member is straightened or can be removed from the
`outer member prior to the outer member being straightened;
`the outer and inner members can remain coupled to the
`poWered surgical handpiece as the outer member is straight
`ened With the inner member disposed therein; the outer
`member is straightened Without damage to the cutting edge
`and/or opening at its distal end; Where the outer member is
`straightened With the inner member disposed therein, the
`cutting edge of the inner member is not damaged; straight
`ening of the outer member may be accomplished by one
`person using a simple, tWo-step process; the same straight
`ening tool can be used to straighten various angled tissue
`cutting instruments having pre-formed bends of various
`angles and radii of curvature at various locations; the
`straightening tool can be designed to straighten angled tissue
`cutting instruments of different types and/or manufacturers;
`the straightening tool is capable of being steriliZed to
`medical standards to maintain the sterility of the angled
`tissue cutting instrument being straightened; the simpli?ed
`construction of the straightening tool promotes steriliZation;
`and the straightening tool may be reusable for repeated use
`or may be disposable for single patient use.
`
`[0023] These and other objects, advantages and bene?ts
`are realiZed With the present invention as generally charac
`teriZed in a straightening tool for straightening angled tissue
`cutting instruments including an elongate outer tubular
`member having a proximal length portion and a pre-formed
`bend connecting the proximal length portion to a distal
`length portion extending from the bend to a distal end and
`an elongate ?exible inner member movably disposed Within
`the outer member to cut anatomical tissue. The straightening
`tool comprises a handle and a positioning block extending
`from the handle. The handle and positioning block are
`coaxial With a central longitudinal axis of the straightening
`tool, and the positioning block has a longitudinal bore also
`coaxial With the central longitudinal axis for receiving the
`distal length portion of the outer member therethrough. The
`positioning block has a cavity for receiving the distal end of
`the outer member When the distal length portion extends
`through the bore. The cavity has a bottom Wall adjacent the
`bore and has an abutment Wall Which serves as a stop or
`abutment for the outer member inserted through the bore.
`The positioning block has a slot extending longitudinally
`from the bore to a forWard end Wall of the positioning block,
`and the slot has a ?oor extending doWnWardly from the bore
`at an angle, such as about 5 to 7 degrees. The slot has a top
`opening along a top of the positioning block and a forWard
`opening along the forWard end Wall, and the top opening and
`forWard opening of the slot are in communication With one
`another at the forWard end Wall. When the distal length
`portion is fully inserted in the bore, the bend is con?ned
`betWeen side Walls of the slot and the proximal length
`portion of the outer member extends upWardly and exter
`nally from the positioning block through the top opening of
`the slot. The bore serves as a fulcrum alloWing the proximal
`length portion to be manually pivoted Within the slot and
`into abutment With the ?oor of the slot. Upon release of the
`manual pivoting force on the proximal length portion, the
`proximal length portion is alloWed to spring back a small
`amount in the direction of the original pre-formed bend to
`obtain a longitudinally straightened outer member. The
`angle of the ?oor of the slot ensures that the longitudinally
`straightened outer member is completely longitudinally
`straight or is substantially completely longitudinally straight
`
`With only a slight positive bend in the direction of the
`original pre-formed bend. The straightened outer member
`and the inner member form a straightened tissue cutting
`instrument for cutting anatomical tissue.
`[0024] The present invention is also generally character
`iZed in a tissue cutting instrument system for use in surgery
`comprising an angled tissue cutting instrument and a
`straightening tool for straightening the angled tissue cutting
`instrument. The angled tissue cutting instrument comprises
`an elongate outer tubular member and an elongate inner
`member movably received Within the outer member. The
`outer member has a proximal length portion and a pre
`formed bend connecting the proximal length portion to a
`distal length portion extending from the bend to a distal end
`having an opening. The inner member is ?exible to conform
`to the con?guration of the outer member and has a cutting
`edge exposed by the opening to cut anatomical tissue When
`the inner member is moved Within the outer member. The
`straightening tool comprises a handle and a positioning
`block coaxial With a central longitudinal axis of the straight
`ening tool. The positioning block has an internal bore
`coaxial With the central longitudinal axis, the bore being
`disposed betWeen and communicating With a cavity of the
`positioning block and a slot of the positioning block. The
`cavity extends longitudinally, rearWardly from the bore to a
`rearWard internal Wall of the positioning block. The slot
`extends longitudinally, forWardly from the bore to a forWard
`slot opening along a forWard end Wall of the positioning
`block. The slot has a ?oor extending from the bore to the
`forWard opening at a doWnWard angle, such as 5 to 7
`degrees. The slot has opposing side Walls extending
`upWardly from the ?oor to a top slot opening along a top of
`the positioning block. The top slot opening and the forWard
`slot opening communicate With one another at the forWard
`end Wall. The outer member is insertable in the straightening
`tool With the distal length portion extending through the bore
`to position the distal end in abutment With the rearWard
`internal Wall of the positioning block and to position the
`bend With the slot With the proximal length portion extend
`ing externally from the top slot opening. The bore con?nes
`the distal length portion against movement in a direction
`radial to the central longitudinal axis to permit the proximal
`length portion to be pivoted Within the slot and into abut
`ment With the ?oor of the slot to effect straightening of the
`outer tubular member Whereby the straightened outer mem
`ber and the inner member form a longitudinally straightened
`angled tissue cutting instrument.
`[0025] The present invention is further characteriZed in a
`method of performing surgery comprising the steps of
`introducing a distal end of an angled tissue cutting instru
`ment at an operative site in a patient’s body, the angled tissue
`cutting instrument having an elongate outer tubular member
`With a proximal length portion and a pre-formed bend
`connecting the proximal length portion to a distal length
`portion extending from the bend to a distal end having an
`opening, and an elongate inner member disposed Within the
`outer member and having a cutting edge exposed by the
`opening; positioning the cutting edge adjacent anatomical
`tissue to be removed; moving the inner member Within the
`outer member to cut the anatomical tissue With the cutting
`edge; WithdraWing the angled tissue cutting instrument from
`the patient’s body; inserting the outer member through a
`longitudinal bore of a straightening tool until the distal end
`abuts an abutment Wall of the straightening tool With the
`
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`Page 14 of 24
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`US 2004/0127927 A1
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`Jul. 1, 2004
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`distal length portion disposed Within the bore in coaxial
`alignment With the straightening tool, the bend disposed in
`a slot of the straightening tool and the proximal length
`portion extending externally from an opening of the slot;
`applying manual pressure to the proximal length portion to
`pivot the proximal length portion Within the slot in a
`direction opposite the opening until the proximal length
`portion is in abutment With a ?oor of the slot extending from
`the bore at an angle in the direction opposite the opening;
`releasing the manual pressure on the proximal length portion
`so that the proximal length portion may spring back in the
`direction of the original bend to obtain a longitudinally
`straightened outer member; removing the straightened outer
`member from the straightening tool; introducing the distal
`end of the straightened outer member at an operative site in
`the patient’s body With the inner member received therein to
`form a longitudinally straightened tissue cutting instrument;
`positioning the cutting edge adjacent anatomical tissue to be
`removed; moving the inner member Within the straightened
`outer member to cut the anatomical tissue With the cutting
`edge; and WithdraWing the straightened tissue cutting instru
`ment from the patient’s body.
`[0026] The present invention is additionally characteriZed
`by a method of performing a combined tonsillectomy and
`adenoidectomy procedure comprising the steps of introduc
`ing a distal end of an angled tissue cutting instrument in the
`nasopharynx, the tissue cutting instrument having an elon
`gate outer tubular member With a proximal length portion
`and a pre-formed bend connecting the proximal length
`portion to a distal length portion extending from the bend to
`a distal end having an opening, and an elongate inner
`member disposed Within the outer member and having a
`cutting edge exposed by the opening; positioning the cutting
`edge adjacent an adenoid; moving the inner member Within
`the outer member to cut tissue of the adenoid With the
`cutting edge; WithdraWing the angled tissue cutting instru
`ment from the patient’s body; inserting the outer member in
`a longitudinal bore of a straightening tool such that the distal
`length portion is con?ned against radial movement With the
`bend disposed in a slot of the straightening tool and the
`proximal length portion extending externally from an open
`ing of the slot; applying manual pressure to the proximal
`length portion to pivot the proximal length portion Within
`the slot in a direction opposite the opening until the proximal
`length portion is in abutment With a ?oor of the slot
`extending from the bore at an angle in the direction opposite
`the opening; releasing the manual pressure on the proximal
`length portion so that the proximal length portion may
`spring back in the direction of the original pre-formed bend
`to obtain a longitudinally straightened outer member;
`removing the straightened outer member from the straight
`ening tool; introducing the distal end of the straightened
`outer member in the patient’s body With the inner member
`received therein to form a longitudinally straightened tissue
`cutting instrument; positioning the cutting edge adjacent a
`tonsil; moving the inner member Within the straightened
`outer member to cut tissue of the tonsil With the cutting
`edge; and WithdraWing the longitudinally straightened tissue
`cutting instrument from the patient’s body.
`[0027] Moreover, the present invention is generally char
`acteriZed in a method of performing sinus surgery compris
`ing the steps of introducing a distal end of an angled tissue
`cutting instrument in a sinus cavity in a patient’s body, the
`tissue cutting instrument having an elongate outer tubular
`
`member With a proximal length portion and a pre-formed
`bend connecting the proximal length portion to a distal
`length portion extending from the bend to a distal end having
`an opening, and an elongate inner member disposed Within
`the outer member and having a cutting edge exposed by the
`opening; positioning the cutting edge adjacent sinus tissue to
`be removed; moving the inner member Within the outer
`member to cut the sinus tissue With the cutting edge;
`WithdraWing the angled tissue cutting instrument from the
`patient’s body; inserting the outer member in a longitudinal
`bore of a straightening tool such that the distal length portion
`is con?ned against radial movement With the bend disposed
`in a slot of the straightening tool and the proximal length
`portion extending externally from an opening of the slot;
`applying manual pressure to the proximal length portion to
`pivot the proximal length portion Within the slot in a
`direction opposite the opening until the proximal length
`portion is in abutment With a ?oor of the slot extending
`doWnWardly from the bore at an angle in the direction
`opposite the opening; releasing the manual pressure on the
`proximal length portion so that the proximal length portion
`may spring back in the direction of the original pre-formed
`bend to obtain a longitudinally straightened outer member;
`removing the straightened outer member from the straight
`ening tool; introducing the distal end of the straightened
`outer member in the sinus cavity With the inner member
`received therein to form a longitudinally straightened tissue
`cutting instrument; positioning the cutting edge adjacent
`sinus tissue to be removed; moving the inner member Within
`the straightened outer member to cut the sinus tissue With the
`cutting edge; and WithdraWing the longitudinally straight
`ened tissue cutting instrument from the patient’s body.
`
`[0028] The present invention is also characteriZed in a
`method of performing surgery comprising the steps of
`selecting an angled tissue cutting instrument having an
`elongate outer tubular member manufactured or fabricated
`With a pre-formed bend connecting a proximal length por
`tion of the outer member to a distal length portion of the
`outer member extending from the bend to a distal end having
`an opening, and an elongate inner member disposed Within
`the outer member and having a cutting edge exposed by the
`opening; inserting the outer member through a longitudinal
`bore of a straightening tool until the distal end abuts an
`abutment Wall of the straightening tool With the distal length
`portion disposed Within the bore in coaxial alignment With
`the straightening tool, the bend disposed in a slot of the
`straightening tool and the proximal length portion extending
`externally from an opening of the slot; applying manual
`pressure to the proximal length portion to pivot the proximal
`length portion Within the slot in a direction opposite the
`opening until the proximal length portion is in abutment
`With a ?oor of the slot extending from the bore at an angle
`in the direction opposite the opening; releasing the manual
`pressure on the proximal length portion so that the proximal
`length portion may spring back in the direction of the
`original bend to obtain a longitudinally straightened outer
`member; removing the straightened outer member from the
`straightening tool; introducing the distal end of the straight
`ened outer member at an operative site in the patient’s body
`With the inner member received therein to form a longitu
`dinally straightened tissue cutting instrument; positioning
`the cutting edge adjacent anatomical tissue to be removed;
`moving the inner member Within the straightened outer
`
`

`

`Page 15 of 24
`
`US 2004/0127927 A1
`
`Jul. 1, 2004
`
`member to cut the anatomical tissue With the cutting edge;
`and WithdraWing the straightened tissue cutting instrument
`from the patient’s body.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0029] FIG. 1 is a side vieW of an angled tissue cutting
`instrument or blade.
`
`[0030] FIG. 2 is an exploded side vieW, partly in section,
`of the angled tissue cutting instrument.
`
`[0031] FIG