CA2126096C - Surgical cutting tool - Google Patents
Surgical cutting toolInfo
- Publication number
- CA2126096C CA2126096C CA002126096A CA2126096A CA2126096C CA 2126096 C CA2126096 C CA 2126096C CA 002126096 A CA002126096 A CA 002126096A CA 2126096 A CA2126096 A CA 2126096A CA 2126096 C CA2126096 C CA 2126096C
- Authority
- CA
- Canada
- Prior art keywords
- catheter tube
- distal end
- cutting tool
- guidewire
- hollow
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
- A61B2017/22041—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire outside the catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0183—Rapid exchange or monorail catheters
Abstract
An atherectomy catheter device (10) includes an improved guidewire system including a guidewire port member (16) secured to the distal tip portion (13) of the outer tubular member (12) of an atherectomy catheter of the coaxial type having large and small concentrically disposed elongated flexible tubular members (12, 15) with a rotating cutter member (18) fixed to the distal end of the inner tubular member (15). The guidewire (17) is spaced from the cutter head (18) yet controls the cutter disposition relative to the vessel lumen of interest. The inner and outer tubular members (12, 15) are constructed simultaneously to provide flushing liquid and to aspirate the cutting site.
Description
';'' 93/13716 PCI'/US92/10256 2 ~ 2 6 0 Q ~3 i~'s Surgic~l cutting tool.
Background o~ the Invention The pres~nl invention generally ~.e,l~ s to a relatively non-invasive plaque resolving devioe of the class adapted to be illse,led through the lumen of a blood ~'!$; vessel alnd manirulate{l ther~l ~rough to a clesil ed loca~ion to ply a cutting tool to excise ~ 1û deposits of athercsc'~rotic plaque from the internal suffaces of the vessel. More ',''','J' particularly, the present invention relates to a guidewire for use in conjunction with such ?~! a systern.
'~j Impairment of the circulation of blood occasione~l by intraarterial deposlts of ,,. .~
aU.ero~'erolic plaque is a major c~use of car.Jiovascular disease. Obstruction of 15 coronary arteries can lead to tissue death becP~use of oxygen deprivation to heart ~;. muscie. Coronary i~7f~.~tion (heart attack) is the result. Plaque-induced stenosis of . 1 other major artieries oan result in impairrnent of peripheral organ ~unc~ion. One long-, ~ used ~Jroce~Jre for overoo~ n~ such obstructions and l~lock~es involves a surgioal :'~ by-pass ope,~tiGn in which the obstructed ~,~eries are subtended by patient i~ 20 a~ .~l,ed blood vessels r~.. oved from other parts of the ,~~iiei.l'~ body. Sur~ically invasivs ~i~d~l~re~:tonly ha~ o been used with limited ~uccP,ss for clearing obstructed vessels.
~:~ The need has long existed for a less invasive and radical procedure to alleviate such ~ lo ~'t~ges and a~l~iev~ t, ~nsr.~yocar.lial revascu~ alion~ or the like, in a manner : 25 which causes no siy~ canl J~u-.&~e to the healthy ~n~l~t~ a~ lining of the surrounding ~: vessel. One device that ~t~r.,pt~ to tuiflll this n~ed is balloon angiopl~sty in which an inflatable balioon Is ~ se~l to th~ ~te~1otic region of the ~ ,t~d artery and i, If ld~J with a fluid to a pressure (normally ~bout 5 ~ Gspheres) to d~ ss the plaque a~ail ,:,l the , ~ .
arteriai wall ll-e,e~y op-ning up the arterial Yolume. ~ec~l~se ci~culation is grossly i.,.p~.e~l, hc~P/evcr, h~cD~ ion/cl~ n must occur in a matter of seconds to avoid illfa~ . In ~ ti~n, limited force is av~ilabie l~ecA~se of the fear of damage to the arteries c~ e~ by over~.ressL., i~c~iiOI . of the ballson. Also, the capture of plaque debris that may slough during the e).~,~r,siol) process is not as yet provided for by such .~ devices.
,, ~ther appruacl~es include the use of a laser to clear obstn3ctions in vessels asproposed~ for example, in U.S. P~ent 4,207,874 to Choy. In that devioe, la~.er energy : is conveyed by flexible fiberoptics in conjunction wlth avenial catheter and applied to ,, . ~, .
.i,,.
~,.
WO 93/13716 PCl/US92~10256 7,o6~S~ -2-;~ ~
~, the plaque obstruction in the occhJrled zone. In conjunction with this system various axial channels may be provided with appropriate fluid management manifolds in order to inject saline, sspirate debris with the saline and inject die for visu~ tign. Additional coherently aligned fibers may be provided tor actual viewing of the obstruction 5 intraluminally. In ~ tiGI~ to Choy, many other a,;~proaches utilizing v~ ialioOs on a !'; _ laser excisi.,g system hav~ also b~en proposed. Lasers, for example, have been utilized to resolve plaque by he~tins~ a catheter tip in a manner which causes the plaque ',''.. t', tissue to, in effect, be melted away by the heated tip of the call-eter resulting in permanent removal. The approach is illust,~ted by Her~hensol- in U.S. Patent ~,; 10 4,748,979. A variety of cutting devices have also been proposed in conjunction with ~'!. ' ' a c~tl.eter in which r~t~til lg cutt9rs actually address and excise the slenosis. Most ot ,~,. ~ , these devices, l~ov/~vcr, appear to be ine~f~ti.~e ~or rapid cutting of the stenosis without ~,~ aifect;ll~ or damaging the relatively soft ~Jj~ce"~ wall of the ~rterial vessel involved.
....
~- U.S. Patent 4,784,636 to Rydell is assigned to the same assiynee as the ,vresent ~ 15 invention and ill~lstrates such a device. An atherectorny catheter which includes a self-:;~ guiding catheter having an inflatable '- -"o o n d; sposed on the distal end portion thereof, the guide c&A;.eter being dimensiol.ed to rec~hre in its lumen an ~l~nydt~d drive tube having a r t~tior.al drive ...~cl~ m at its pr~)~i,nal end for ~t~tilly an angular cutting tip affixed to the distal end. In use, the guide od~l.~er with the drive tube and cutter 20 head r~t~ 1 is adv~-ceJ up to the occ~hlsion, th~ ' -" o ~n is i- ~l~te~ to lock the distal ;
1~ end in place and the cutter is rotated at high speed and adv~.-cecJ into the ocelusiQn, while bJood and any loose particular matter is aspirated. The balloon is then de~l-'ecl and adv~)ce.J ~urther into the lesion and the steps repei~lec~ until the occlusion is ~, r~fi~o~,~d.
. .
A more rece~tly issued patent to Rydell, cor,.,non ot assiynee with the above invention, is U.S. Patent 4,857,045, also directed to a seff~uiding dtl .e, ~ ctomy catheter system, utilizes a coaxial system of innor and outer flexible tubular Inenlbe.~ in which the inn~r tubular .. ~er ~ber is joumaled for r~ lion at the distal end of the outer tubular ,'~ member. A motor, located at the proximal end of the catheter assembly, dnves the inner tubular ,.,e~ber including a dom~shaped lotalional cutting head containing a ~,~ number of suL,~ tially round open ports for ad.i, ssi,.g blockage In,lle.ial upon . ,olclion. The motor is fixed to the inner tubular member just beyond the end portion of the o~er tubular me~ber. Aspi.alion is accomplished through the inner tubular .... .
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Background o~ the Invention The pres~nl invention generally ~.e,l~ s to a relatively non-invasive plaque resolving devioe of the class adapted to be illse,led through the lumen of a blood ~'!$; vessel alnd manirulate{l ther~l ~rough to a clesil ed loca~ion to ply a cutting tool to excise ~ 1û deposits of athercsc'~rotic plaque from the internal suffaces of the vessel. More ',''','J' particularly, the present invention relates to a guidewire for use in conjunction with such ?~! a systern.
'~j Impairment of the circulation of blood occasione~l by intraarterial deposlts of ,,. .~
aU.ero~'erolic plaque is a major c~use of car.Jiovascular disease. Obstruction of 15 coronary arteries can lead to tissue death becP~use of oxygen deprivation to heart ~;. muscie. Coronary i~7f~.~tion (heart attack) is the result. Plaque-induced stenosis of . 1 other major artieries oan result in impairrnent of peripheral organ ~unc~ion. One long-, ~ used ~Jroce~Jre for overoo~ n~ such obstructions and l~lock~es involves a surgioal :'~ by-pass ope,~tiGn in which the obstructed ~,~eries are subtended by patient i~ 20 a~ .~l,ed blood vessels r~.. oved from other parts of the ,~~iiei.l'~ body. Sur~ically invasivs ~i~d~l~re~:tonly ha~ o been used with limited ~uccP,ss for clearing obstructed vessels.
~:~ The need has long existed for a less invasive and radical procedure to alleviate such ~ lo ~'t~ges and a~l~iev~ t, ~nsr.~yocar.lial revascu~ alion~ or the like, in a manner : 25 which causes no siy~ canl J~u-.&~e to the healthy ~n~l~t~ a~ lining of the surrounding ~: vessel. One device that ~t~r.,pt~ to tuiflll this n~ed is balloon angiopl~sty in which an inflatable balioon Is ~ se~l to th~ ~te~1otic region of the ~ ,t~d artery and i, If ld~J with a fluid to a pressure (normally ~bout 5 ~ Gspheres) to d~ ss the plaque a~ail ,:,l the , ~ .
arteriai wall ll-e,e~y op-ning up the arterial Yolume. ~ec~l~se ci~culation is grossly i.,.p~.e~l, hc~P/evcr, h~cD~ ion/cl~ n must occur in a matter of seconds to avoid illfa~ . In ~ ti~n, limited force is av~ilabie l~ecA~se of the fear of damage to the arteries c~ e~ by over~.ressL., i~c~iiOI . of the ballson. Also, the capture of plaque debris that may slough during the e).~,~r,siol) process is not as yet provided for by such .~ devices.
,, ~ther appruacl~es include the use of a laser to clear obstn3ctions in vessels asproposed~ for example, in U.S. P~ent 4,207,874 to Choy. In that devioe, la~.er energy : is conveyed by flexible fiberoptics in conjunction wlth avenial catheter and applied to ,, . ~, .
.i,,.
~,.
WO 93/13716 PCl/US92~10256 7,o6~S~ -2-;~ ~
~, the plaque obstruction in the occhJrled zone. In conjunction with this system various axial channels may be provided with appropriate fluid management manifolds in order to inject saline, sspirate debris with the saline and inject die for visu~ tign. Additional coherently aligned fibers may be provided tor actual viewing of the obstruction 5 intraluminally. In ~ tiGI~ to Choy, many other a,;~proaches utilizing v~ ialioOs on a !'; _ laser excisi.,g system hav~ also b~en proposed. Lasers, for example, have been utilized to resolve plaque by he~tins~ a catheter tip in a manner which causes the plaque ',''.. t', tissue to, in effect, be melted away by the heated tip of the call-eter resulting in permanent removal. The approach is illust,~ted by Her~hensol- in U.S. Patent ~,; 10 4,748,979. A variety of cutting devices have also been proposed in conjunction with ~'!. ' ' a c~tl.eter in which r~t~til lg cutt9rs actually address and excise the slenosis. Most ot ,~,. ~ , these devices, l~ov/~vcr, appear to be ine~f~ti.~e ~or rapid cutting of the stenosis without ~,~ aifect;ll~ or damaging the relatively soft ~Jj~ce"~ wall of the ~rterial vessel involved.
....
~- U.S. Patent 4,784,636 to Rydell is assigned to the same assiynee as the ,vresent ~ 15 invention and ill~lstrates such a device. An atherectorny catheter which includes a self-:;~ guiding catheter having an inflatable '- -"o o n d; sposed on the distal end portion thereof, the guide c&A;.eter being dimensiol.ed to rec~hre in its lumen an ~l~nydt~d drive tube having a r t~tior.al drive ...~cl~ m at its pr~)~i,nal end for ~t~tilly an angular cutting tip affixed to the distal end. In use, the guide od~l.~er with the drive tube and cutter 20 head r~t~ 1 is adv~-ceJ up to the occ~hlsion, th~ ' -" o ~n is i- ~l~te~ to lock the distal ;
1~ end in place and the cutter is rotated at high speed and adv~.-cecJ into the ocelusiQn, while bJood and any loose particular matter is aspirated. The balloon is then de~l-'ecl and adv~)ce.J ~urther into the lesion and the steps repei~lec~ until the occlusion is ~, r~fi~o~,~d.
. .
A more rece~tly issued patent to Rydell, cor,.,non ot assiynee with the above invention, is U.S. Patent 4,857,045, also directed to a seff~uiding dtl .e, ~ ctomy catheter system, utilizes a coaxial system of innor and outer flexible tubular Inenlbe.~ in which the inn~r tubular .. ~er ~ber is joumaled for r~ lion at the distal end of the outer tubular ,'~ member. A motor, located at the proximal end of the catheter assembly, dnves the inner tubular ,.,e~ber including a dom~shaped lotalional cutting head containing a ~,~ number of suL,~ tially round open ports for ad.i, ssi,.g blockage In,lle.ial upon . ,olclion. The motor is fixed to the inner tubular member just beyond the end portion of the o~er tubular me~ber. Aspi.alion is accomplished through the inner tubular .... .
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, . :,: , ; member and a flushing fluid such as saline administered through the outer tubular .'?"' member. as required.
While the last-discussed system represents an improvement with regard to ~ centering and operating the atherectomy catheter within the vessel of interest, there i~ 5 remains a need to irnprove the efficacy of such devices with respect to complete ~i stenosis removal. There also exists a need to improve the ability of the operator to , . . .
.~. guide the catheter in navigating the vascular system particularly with regard to precise positioning of the cutter at the situs of the occlusion of interest. Positioning the cutter with respect to the blockage about the periphery of the vessel is di~ficult to achieve withoùt a controlling guidewire. Guidewires have been used with success in several i!~ types of over-the-wire catheter systems but heretofore they have not been used with ~', rotating atherectomy devices because of the need to coordinate the guidewire placernent to avoid the cutter head.
:,.
Of particular interest is the so-called MonorailTM catheter which has been used in connection with angioplasl~ balloon catheters with great success. In that system only a small distal segment of the balloon catheter actually passes o\/er the guidewire with the remaining portion of the guidewire then extending generally aiong the exterior wall extemal to the catheter in the ,~,oxi~nal direction. The short segment at the distal end provides the necess~ry control. The MonorailT~ catheter and its use is more particularly de~c"ib6d in the Bonzel U;S. Patent 4,762,129.
With respect to the present invention, there remains a need to provide more precise positioning of an athereclo~"3~ catheter within the vesse! ~f interest to assure ., ;i proper and cor"~le~ removal of the occlusion This is true not only for proYing of the eler along the Yessel but also for proper position of the cutter with respect to the 2~ n.aterial to be removed SummarY of the Invention The presen~ invention provides an atherectomy catheter device including an ; improved MonorailTh' type 9~ d ~i~ system c5~r~hl~ of operating in comt inalion with . ~ .
a high speed rotary cutting head. The system further has the ability to simultaneously - 30 infus~ flushing solution to cleanse and ~ le the treatment to remove the flushing so3ution and all the debris from the site during the alherectomy procedure.
-~i The system includes a guldewire port secured to the distal tip portion of the outer tubular member of an atherectorny catheter of the eoaxial type having large and . . .
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i~ small concentrically disposed elongated flexible tubular members. The rotating cutting ~. member is fixed to the distal end of the inner tubular member. The cutting member i, itself is a substantially hollow cylindrically symmetrical body having a symmetric distal, ~- preferably of an élliptical or ogive shape, nose portion containing à pluralib~ of openings ~ 5 extending alon~ and rearward from the nose. The openin~s are in communication with ,' I! the hollow interior and radially disposed about the tip. Each opening has an edge which ~:, operates to excise tissue upon rotation of the cutting tool and the excised tissue is ';~ generally direcled into the hollow interior of the cutting tool.
~rl The coaxial elongated flexible tubular members have suffi5ient clearance , '.~J~' ~; 10 between each other such that flushing liquid may be introduced into the lumen of the ., .:
"~ outer tubular member and passed out through one or more radial ports near the distal end of the outer tubular member. The inner tubular member is secured to a drive ,- .;
~i~, means at its proximal end which is configured to rotate the inner tubular member, and ~, with it the cutting tool, at relatively high speed while allowing the simultaneous infusion - 15 of a liquid through the outer tubular member and the aspiration of fluids through the ,~ lumen of the interior tubular member.
,~ The împroved MonorailTM guidewire system associated with the invention ~' includes an r-lon~led guidewire port fixed to the outside of and parallel to the outer tubular member of the coaxial atherectomy catheter. The distal end of the port is , 20 located adjacent the distai end of the outer tubular member. The port j6 of length and ~;~ inner dial"eler which can optimize the operation of the particular guidewire desired to be used with the system. A typical guidewire might have a nominal diameter in the range of 0.010-0.02~ inches (0.0254 - 0.0635 cm).
The ~u~ ;.e of the present invention can provide ~ssist~noe in navigating the coaxi~ U)eter through vascular system to reach the site of the ~lo ~';age of interest or installed thro~gh th~ 9~ ~e~!~;~ pon after the ~alh~iter is s~ ~s~nlially at the site in a well-. ., ~ known manner.
.
The mounting of the g~- de~ e port radially outward of the larger tubular member!,'~', allows and ~ids in securing the guidewire near but wi~hout interfering with ~he ~ ~ .
independent ~talional operation of the cutting tool. The guidewire is capable ofprecisely positioning and maneuvering the cutting head relative to the blockage material ~i.' to be excised. In this manner, the cutting head may be tumed about the guidewire as ....
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WO 93/13716 212 & 1~ Q ~ P~/US92/10256 ,,~," . ., ,.,;, ,....
a central axis to accurately poSitiGn the cutting tool throughout 360~ of the vessel's circular peri,vl ery to improve control of the cutting of the stenosis Briefly, in operation, upon insertion, the catheter is advanced withirl th~ patient's ~,x: .
, vascular systsm using the guidewire until the distal tip portion ll ereof is at the site of 5 the lesion to be ex~i~ecl The guidewire is used to maneuver ~nd positively place the cutter in the CiQS;. ~ loc~tiGn~ The site is 1' ~ Dded with a tlushing liquid and the cutter ~i is driven at hi~h speed and adv~ced into the lesion The flushing fluid and debris ~' su.,tiGI)ed from the lesion are aspirated through the hollow cutting tool jnto the lumen of the inner tubular member and are colle t3:1 in a suitable vessel at the proximal end ot the assembly Brief Desc i~tiGn of the D._ ~n~s ~3 Figure 1 is a view, partially in section, and with parts cut and broken away, illu~l ut;ng an a~l ele~tomy call ~ter employing the guidewire of the pr~senl invention;
Figure 2 is a greatly enlarged h~ ,.en~y view, with parts cut away, of one .,2,~
15 cutter head a an~~elent employing the guidewire system;
Flgure 3 is an end view of the cutter head and guidewire port of Figure 2 still further enlarged;
Figur~ 4 is a view illu:.lldtill~ the embodiment of the cutter head of Figure 2 in situ in a vessel; and Figure 5 is an end view of the embodiment of Figure 4 r , Detailed DeSCIilAiG-I of the Invention The prese ll i v~nlion i..1rolve~5 i .prov~d control for an ut~e~cto .~ ~dtl eter of the class in which a rotahble cutting tool is ~ os~.l at the distal end and in which i, _- means are p~ollid~d atthe ,~,r~ l end for driving the clmer at a high ~t~tio~al speed 25 The inver~tion ,~r~ iJes an i ..,~rweJ guidewire system of the M~nor~ type to control and rositivcly ,~osition the cutting tool within a vessel for exci~i ~y st~nosis throughout 360~ of the inner ,~ ril~h&ll~ of the vessel of i .le~l The system also allows the simultaneous intusion of a flushing liquid to cleanse the treatrnent site and aspiratîon of the flushing liquid and debris at the l,~l, ent site The invention will next be descri~e~ with particular r~fereoce to the drawing figures in which iike nu, ef~ls will be utilized to ~lesiy"~le like parts throughout the ' ~ same Figure 1 illusll~es a surgical device including the guidewire and infusion/aspira~ion system of the ~resent invention The atherectorny ~tht,ler system , ;r;
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~!' or device is indicated generally by îhe numeral 10 and includes a proximal housing 11 .; containing the control and drive systern, which may be of high impact plastic material.
~, The catheter itself is of the concentric or coa%ial type. The housing 11 is connected to an elongated outer flexible tubular member 12 extending between a distaJ end 13 and .. 5 a proximal end 14 coupled to the housing 11. The hollow lumen of the outer tubular member 12 carnes a coaxial elongated, flexible inner tubular member 15 which extends the full length of the outer tubular member 12. The outer tubular member 12, in the embodiment of Figure 1, also carries a hollow stationary monorail guidewire port 16 ' fixed to the outer surface of the outer tubular member 12 and which has a guidewire 17 threaded therethrough and which extends the full length of the system ~ut independent of the catheter other than in conjunction with the guidewire port.
~, As can better be seen in Figures 2 and 3, and will be described in greater detail ~ ,~
below, the distal end of the catheter carries a rotatable cutting head or cutting tool 18 which is fixed to and driv~n by the inner tube mernber 15 and is free to rotate about the . 15 outer tube member 12. The outer tube 12 is tapered or necked down to a distal end portion lg creatin9 a bearing surface which allows easy journaled rotation of the inner ~; tube 15 and cutter head 18 during the excising procedure.
::.
An infusion sy~tem is provided includin9 an indented annular area of re~uced ~ ' diameter near the distal end of the outer tubular member 12 which contains a series of ''' 20 radially ~isposed openings or holes 20 (Figure 2). Liquid introduced into the annular ~i space in the lumen of the member 12 surrounding the member 1~ as at 21 can be :,, .
,i ~ ejected through the holes 20 to flush the operating site. An annular spac r member 22 ~,~i is provided ~hich i5 bonded both to the distal tip of the inner tubular member 15 and the inn~r surface of the cuning tool 18 to fix the cutter head to the ~istal tip of the inner tubular member 15.
The guidewire 17 exiendç-through the central openin9 23 in the g~ ~e~ pOft ..'i' ~. 16 and exlends alon9 the length of but outside of the catheter itself. It is further held .~; at a d;slance from the cutting tool 18 so as not to interfere with the operation (rotation) i:~
of the cutting tool but is disposed to properly position and move the cutter head within ' ~. 30 the lumen of the vessel of interest as desired. The cuUer head 18 contairis a plurality of elongated oper.ings 24 ~lis~osed in radial symmetly about the center of the ~istal ~; nose as shown in Figure 3. The preferred ~uttin~ tool is initially cylindrical and tapers off in an elliptical fashion as lt approaches lhe distal end. The plurality of openings 24 .i,' ,.
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wo g3!~37l6 21 ~ 6 ~ 9 ~ PCI/U592/11)256 is usually an even number from two to six and the openings are placed close to the nose of the elliptical cutting tool 18 so that the possibility of contacting and accidently cutting the side wall of the vessel from which the plaque or other obstr~ction is to be ~cisecl is virtually eliminated.
A drive means is contained within the rigid tubular housing 11 loç-~ted at the ~Jroxi.oal end of the outer tubular member. The drive functiGns to rotate the inner tubular member within the lumen of the outer tubular member. The outer tubular ."e,..ber is joined to the tubular housing 11 as through end plug member 30 and is secured as by a con~pr~ssion fitting 31 which cr~t~s a liquid-tight seal. A rotary union shown generally at 32 is positiGoed within the housing 11 and includes a ataliOIl&.y ;~ tubular sleeve member 33 fixed to the housing 11 by pins or screws 34. A pair of O-ring seals 35 and 36 are dispos~l in annular grooves in the tubular sleeve 33 topreclude flushing liquid contained in the chamber 37 from ~assi,.~ beyond the rotary union.
The stationary sleeve 33 contains a IOtdtil l~ hollow .nar~ ld member 38 which rotatos within the bore of the r. .em~er 33 when driven by a motor such as that depicted generally at 39 having a drive shaft 40 and a coupling 41 col~ne~t~J in driving relation .
to the ~roxi...al end ot the hollow manifold ...efi~er 38. The hollow manifold r..t ~ er 38 hrther contains ~n annular recess 42 co, .ne~led to a central bore 43 which, in tum, is joined to the pr~xi."~l end ot the inner elon~,~ted flexible tubular r,~er ~ar 15 by a coupling n.en~l~er 44 The central inner bore 43, via the annular recess 42, is ~; ~ cGnne~ ~ed to a further tubular fflting 45 which passes through a bore in sleeve member 33 and the housing 11 to provide a suction out!et for the inner ~loo~ed flexible tubular er. l~er 15. Flushing saline or~other solution input is provided throu~h a turther access 25 tube 46 which eAlenJs through an n~klit;Qr.al bore in the housing 11 which communicates with the chamber 37.
In o~e.dt;on, the ~ -hg~teJ cd11.~ter asse..l~ly is a~ .ricSely intro~ ced into the vascular system as through the fe,..or~l artery, and, utilizing the guidewire 17 is advanced through the vascuiar system to the a,~ ro,~ri~e arterial or other location o~
30 i, .lel eat ~,laci.~ the cutter tip 18 adiacent to the atheroma or other lesion or blockage ..,aterial to t~e qxc ~ ecl from the vessel. The cutting tool is precisely positioned and then operated at high speed to excise the lesion.
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WO 93/13716 PCI/US92~10256 ! '~, ' :~
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The large repres~nt&lions of Figures 4 and 5 shown partly as schematics " illustrate a use of the device. In Figure 4, an artery wall is shown in section at 50 which :~ defines the hoilow lumen or in~erior of the artery 51. A stenotic lesion is illustrated at 52 adhering to the inner surface of the arterial wall 50 and severely narrowing the cross sectional area of the r~ss~-Je through the lumen 51. Figure 4 further illustratas the ,h,,~,, c~tter tip 18 adjacent the lesion in a poSitiGn to begin the excising operation. A
i ~ specially design~d guidewire 17 with a culved end porti~n is utilized in conjunction with the guidewire port 16 which can be used to ~ositi~, . the cutter head 18 with respect to the arterial wall 50 in a c~,lt,ollscl ,..~nner.
As bet~er illu~ lecJ in Figure 5, the guidewire 17 can be used to rot~te the cutter ~. head 18 about the periphery of the inner surface of the wall of the vessel of interest to 5 ~' control the peripheral QXCi~il Iy of the ~lanGlic lesion 52. Th~ guidewire is in a position to sense the pres~..ce or ~bsence of blc rk~ nl~teli~l and G,~erdles in a mann~r such '~ that it easily clears the 1O~Cltil ,~ cuttiny tool 18 which is ~ee to rotate independent of the 9U~ .e. The cutting tool 18 can then be ,~ is~ly maneuvered until the entire ,6,- st~oti¢ lesion 52 is r~r.~wad from the inner surface 54 of the arterial wall 50. It will ~;- ~rther be &~pr~ t~l îh~t the ~uidewire 17 can be utilized to more precisely aim the tip of cut!ing rnember 18 with respect to the ~lenosi~ so th~t ~xoisiQn can take place right up to the wall but withollt damaging the inner lining of the arterial wall at 54.
2Q During the time of Q?~C j~ jG~), O~ course, the are~ is continually flushed with saline, or the like, introfluce~l ~hrough îhe fftting 46 and flowing through the hJmen of the outer tubular ~l~ernber 12 and outward throu~h the radial ports 2û. This keeps the e~(cis~d debris in solution~ A suitable source of suction is simultaneously -~r; I e~ to the fitting 45whichopel~testhroughtheinnertubular~.,ember15go -sF:.dlethesitethroughthe cutting tool openings 24. The tlushing solution together with blood and/or ~xoised tissue and other deb~is pro~ ce~ dunng the removal ot a blockage is drawn into asuitable ~e_sp'e.cl~ (not shown).
The motor ~9 turns the inner hollow tubular member to rotalt~ the c~ter head or cutting tool at relatively high speed (up to 3000 rpm). The catheter is advanced and ~dj~sted laterally using IllGd~S pressure b_h~I~en the tool and the sten~io lesion and precisely aimed and cGntrolle:l by means of th~ guicle.~,:.e 17. Once the atheroma has been completely excised about the p~ e~ of the vessel, substantially full blood flow - through the vessel is restore~l. It will be appreeiaieJ it the position and attitude of the s i ,~,7, ~.., v ~ wo g3/137l6 2 1 2 6 0 9 ~ PCI'/US92/10256 ;.,i g "
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cutter head within the vessel can be continually adjusted during the excising procedure 31,, utilking the gu ~w:.e to b,-prove control and pr, ~ sion assuring a more complete ~ removal of the blockage.
,hL, The cutting head openings 24 are pr~fer .bly placed close to the nose so that 5 tissue loc~t~cl directly to the side of the tool including vessel walls or vessel wall linings ~' are not .I&n-a~e(~. This normally would result in a less than complete removal of the ,~,..
stenotic lesion from the vessel, although the vessel may be 5~ 5t~ ltially reopened The provision of the guidewire 17, hov/~wr, allows the ope,~tor to carefully manipulate ,- the cutting head of the c~l,~er during eltckicn, to acl. vo a more complete clearing 10 of the blockage This invention has been cJesc,iLecl herein in consicle,~ble detail in order to ~ .
coll.p!y with the patent sPtutes and to provide those skilled in the art with the ' information ne~ded to apply the novel principles and to construct and use such specialized components as are required However it is to be unde, ,tood that the 15 invention can be c~rried out by specffic~ly d;fl~r~nt equipment and devices and that various modHications, both as to ~quipment deta~ls and oper~ti. .~ proced-Jres, can be acco,..plished iwithout J~p~ti..~ from the scope of the inve.~tiG.) itseîf.
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, . :,: , ; member and a flushing fluid such as saline administered through the outer tubular .'?"' member. as required.
While the last-discussed system represents an improvement with regard to ~ centering and operating the atherectomy catheter within the vessel of interest, there i~ 5 remains a need to irnprove the efficacy of such devices with respect to complete ~i stenosis removal. There also exists a need to improve the ability of the operator to , . . .
.~. guide the catheter in navigating the vascular system particularly with regard to precise positioning of the cutter at the situs of the occlusion of interest. Positioning the cutter with respect to the blockage about the periphery of the vessel is di~ficult to achieve withoùt a controlling guidewire. Guidewires have been used with success in several i!~ types of over-the-wire catheter systems but heretofore they have not been used with ~', rotating atherectomy devices because of the need to coordinate the guidewire placernent to avoid the cutter head.
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Of particular interest is the so-called MonorailTM catheter which has been used in connection with angioplasl~ balloon catheters with great success. In that system only a small distal segment of the balloon catheter actually passes o\/er the guidewire with the remaining portion of the guidewire then extending generally aiong the exterior wall extemal to the catheter in the ,~,oxi~nal direction. The short segment at the distal end provides the necess~ry control. The MonorailT~ catheter and its use is more particularly de~c"ib6d in the Bonzel U;S. Patent 4,762,129.
With respect to the present invention, there remains a need to provide more precise positioning of an athereclo~"3~ catheter within the vesse! ~f interest to assure ., ;i proper and cor"~le~ removal of the occlusion This is true not only for proYing of the eler along the Yessel but also for proper position of the cutter with respect to the 2~ n.aterial to be removed SummarY of the Invention The presen~ invention provides an atherectomy catheter device including an ; improved MonorailTh' type 9~ d ~i~ system c5~r~hl~ of operating in comt inalion with . ~ .
a high speed rotary cutting head. The system further has the ability to simultaneously - 30 infus~ flushing solution to cleanse and ~ le the treatment to remove the flushing so3ution and all the debris from the site during the alherectomy procedure.
-~i The system includes a guldewire port secured to the distal tip portion of the outer tubular member of an atherectorny catheter of the eoaxial type having large and . . .
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i~ small concentrically disposed elongated flexible tubular members. The rotating cutting ~. member is fixed to the distal end of the inner tubular member. The cutting member i, itself is a substantially hollow cylindrically symmetrical body having a symmetric distal, ~- preferably of an élliptical or ogive shape, nose portion containing à pluralib~ of openings ~ 5 extending alon~ and rearward from the nose. The openin~s are in communication with ,' I! the hollow interior and radially disposed about the tip. Each opening has an edge which ~:, operates to excise tissue upon rotation of the cutting tool and the excised tissue is ';~ generally direcled into the hollow interior of the cutting tool.
~rl The coaxial elongated flexible tubular members have suffi5ient clearance , '.~J~' ~; 10 between each other such that flushing liquid may be introduced into the lumen of the ., .:
"~ outer tubular member and passed out through one or more radial ports near the distal end of the outer tubular member. The inner tubular member is secured to a drive ,- .;
~i~, means at its proximal end which is configured to rotate the inner tubular member, and ~, with it the cutting tool, at relatively high speed while allowing the simultaneous infusion - 15 of a liquid through the outer tubular member and the aspiration of fluids through the ,~ lumen of the interior tubular member.
,~ The împroved MonorailTM guidewire system associated with the invention ~' includes an r-lon~led guidewire port fixed to the outside of and parallel to the outer tubular member of the coaxial atherectomy catheter. The distal end of the port is , 20 located adjacent the distai end of the outer tubular member. The port j6 of length and ~;~ inner dial"eler which can optimize the operation of the particular guidewire desired to be used with the system. A typical guidewire might have a nominal diameter in the range of 0.010-0.02~ inches (0.0254 - 0.0635 cm).
The ~u~ ;.e of the present invention can provide ~ssist~noe in navigating the coaxi~ U)eter through vascular system to reach the site of the ~lo ~';age of interest or installed thro~gh th~ 9~ ~e~!~;~ pon after the ~alh~iter is s~ ~s~nlially at the site in a well-. ., ~ known manner.
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The mounting of the g~- de~ e port radially outward of the larger tubular member!,'~', allows and ~ids in securing the guidewire near but wi~hout interfering with ~he ~ ~ .
independent ~talional operation of the cutting tool. The guidewire is capable ofprecisely positioning and maneuvering the cutting head relative to the blockage material ~i.' to be excised. In this manner, the cutting head may be tumed about the guidewire as ....
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WO 93/13716 212 & 1~ Q ~ P~/US92/10256 ,,~," . ., ,.,;, ,....
a central axis to accurately poSitiGn the cutting tool throughout 360~ of the vessel's circular peri,vl ery to improve control of the cutting of the stenosis Briefly, in operation, upon insertion, the catheter is advanced withirl th~ patient's ~,x: .
, vascular systsm using the guidewire until the distal tip portion ll ereof is at the site of 5 the lesion to be ex~i~ecl The guidewire is used to maneuver ~nd positively place the cutter in the CiQS;. ~ loc~tiGn~ The site is 1' ~ Dded with a tlushing liquid and the cutter ~i is driven at hi~h speed and adv~ced into the lesion The flushing fluid and debris ~' su.,tiGI)ed from the lesion are aspirated through the hollow cutting tool jnto the lumen of the inner tubular member and are colle t3:1 in a suitable vessel at the proximal end ot the assembly Brief Desc i~tiGn of the D._ ~n~s ~3 Figure 1 is a view, partially in section, and with parts cut and broken away, illu~l ut;ng an a~l ele~tomy call ~ter employing the guidewire of the pr~senl invention;
Figure 2 is a greatly enlarged h~ ,.en~y view, with parts cut away, of one .,2,~
15 cutter head a an~~elent employing the guidewire system;
Flgure 3 is an end view of the cutter head and guidewire port of Figure 2 still further enlarged;
Figur~ 4 is a view illu:.lldtill~ the embodiment of the cutter head of Figure 2 in situ in a vessel; and Figure 5 is an end view of the embodiment of Figure 4 r , Detailed DeSCIilAiG-I of the Invention The prese ll i v~nlion i..1rolve~5 i .prov~d control for an ut~e~cto .~ ~dtl eter of the class in which a rotahble cutting tool is ~ os~.l at the distal end and in which i, _- means are p~ollid~d atthe ,~,r~ l end for driving the clmer at a high ~t~tio~al speed 25 The inver~tion ,~r~ iJes an i ..,~rweJ guidewire system of the M~nor~ type to control and rositivcly ,~osition the cutting tool within a vessel for exci~i ~y st~nosis throughout 360~ of the inner ,~ ril~h&ll~ of the vessel of i .le~l The system also allows the simultaneous intusion of a flushing liquid to cleanse the treatrnent site and aspiratîon of the flushing liquid and debris at the l,~l, ent site The invention will next be descri~e~ with particular r~fereoce to the drawing figures in which iike nu, ef~ls will be utilized to ~lesiy"~le like parts throughout the ' ~ same Figure 1 illusll~es a surgical device including the guidewire and infusion/aspira~ion system of the ~resent invention The atherectorny ~tht,ler system , ;r;
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~!' or device is indicated generally by îhe numeral 10 and includes a proximal housing 11 .; containing the control and drive systern, which may be of high impact plastic material.
~, The catheter itself is of the concentric or coa%ial type. The housing 11 is connected to an elongated outer flexible tubular member 12 extending between a distaJ end 13 and .. 5 a proximal end 14 coupled to the housing 11. The hollow lumen of the outer tubular member 12 carnes a coaxial elongated, flexible inner tubular member 15 which extends the full length of the outer tubular member 12. The outer tubular member 12, in the embodiment of Figure 1, also carries a hollow stationary monorail guidewire port 16 ' fixed to the outer surface of the outer tubular member 12 and which has a guidewire 17 threaded therethrough and which extends the full length of the system ~ut independent of the catheter other than in conjunction with the guidewire port.
~, As can better be seen in Figures 2 and 3, and will be described in greater detail ~ ,~
below, the distal end of the catheter carries a rotatable cutting head or cutting tool 18 which is fixed to and driv~n by the inner tube mernber 15 and is free to rotate about the . 15 outer tube member 12. The outer tube 12 is tapered or necked down to a distal end portion lg creatin9 a bearing surface which allows easy journaled rotation of the inner ~; tube 15 and cutter head 18 during the excising procedure.
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An infusion sy~tem is provided includin9 an indented annular area of re~uced ~ ' diameter near the distal end of the outer tubular member 12 which contains a series of ''' 20 radially ~isposed openings or holes 20 (Figure 2). Liquid introduced into the annular ~i space in the lumen of the member 12 surrounding the member 1~ as at 21 can be :,, .
,i ~ ejected through the holes 20 to flush the operating site. An annular spac r member 22 ~,~i is provided ~hich i5 bonded both to the distal tip of the inner tubular member 15 and the inn~r surface of the cuning tool 18 to fix the cutter head to the ~istal tip of the inner tubular member 15.
The guidewire 17 exiendç-through the central openin9 23 in the g~ ~e~ pOft ..'i' ~. 16 and exlends alon9 the length of but outside of the catheter itself. It is further held .~; at a d;slance from the cutting tool 18 so as not to interfere with the operation (rotation) i:~
of the cutting tool but is disposed to properly position and move the cutter head within ' ~. 30 the lumen of the vessel of interest as desired. The cuUer head 18 contairis a plurality of elongated oper.ings 24 ~lis~osed in radial symmetly about the center of the ~istal ~; nose as shown in Figure 3. The preferred ~uttin~ tool is initially cylindrical and tapers off in an elliptical fashion as lt approaches lhe distal end. The plurality of openings 24 .i,' ,.
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wo g3!~37l6 21 ~ 6 ~ 9 ~ PCI/U592/11)256 is usually an even number from two to six and the openings are placed close to the nose of the elliptical cutting tool 18 so that the possibility of contacting and accidently cutting the side wall of the vessel from which the plaque or other obstr~ction is to be ~cisecl is virtually eliminated.
A drive means is contained within the rigid tubular housing 11 loç-~ted at the ~Jroxi.oal end of the outer tubular member. The drive functiGns to rotate the inner tubular member within the lumen of the outer tubular member. The outer tubular ."e,..ber is joined to the tubular housing 11 as through end plug member 30 and is secured as by a con~pr~ssion fitting 31 which cr~t~s a liquid-tight seal. A rotary union shown generally at 32 is positiGoed within the housing 11 and includes a ataliOIl&.y ;~ tubular sleeve member 33 fixed to the housing 11 by pins or screws 34. A pair of O-ring seals 35 and 36 are dispos~l in annular grooves in the tubular sleeve 33 topreclude flushing liquid contained in the chamber 37 from ~assi,.~ beyond the rotary union.
The stationary sleeve 33 contains a IOtdtil l~ hollow .nar~ ld member 38 which rotatos within the bore of the r. .em~er 33 when driven by a motor such as that depicted generally at 39 having a drive shaft 40 and a coupling 41 col~ne~t~J in driving relation .
to the ~roxi...al end ot the hollow manifold ...efi~er 38. The hollow manifold r..t ~ er 38 hrther contains ~n annular recess 42 co, .ne~led to a central bore 43 which, in tum, is joined to the pr~xi."~l end ot the inner elon~,~ted flexible tubular r,~er ~ar 15 by a coupling n.en~l~er 44 The central inner bore 43, via the annular recess 42, is ~; ~ cGnne~ ~ed to a further tubular fflting 45 which passes through a bore in sleeve member 33 and the housing 11 to provide a suction out!et for the inner ~loo~ed flexible tubular er. l~er 15. Flushing saline or~other solution input is provided throu~h a turther access 25 tube 46 which eAlenJs through an n~klit;Qr.al bore in the housing 11 which communicates with the chamber 37.
In o~e.dt;on, the ~ -hg~teJ cd11.~ter asse..l~ly is a~ .ricSely intro~ ced into the vascular system as through the fe,..or~l artery, and, utilizing the guidewire 17 is advanced through the vascuiar system to the a,~ ro,~ri~e arterial or other location o~
30 i, .lel eat ~,laci.~ the cutter tip 18 adiacent to the atheroma or other lesion or blockage ..,aterial to t~e qxc ~ ecl from the vessel. The cutting tool is precisely positioned and then operated at high speed to excise the lesion.
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WO 93/13716 PCI/US92~10256 ! '~, ' :~
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The large repres~nt&lions of Figures 4 and 5 shown partly as schematics " illustrate a use of the device. In Figure 4, an artery wall is shown in section at 50 which :~ defines the hoilow lumen or in~erior of the artery 51. A stenotic lesion is illustrated at 52 adhering to the inner surface of the arterial wall 50 and severely narrowing the cross sectional area of the r~ss~-Je through the lumen 51. Figure 4 further illustratas the ,h,,~,, c~tter tip 18 adjacent the lesion in a poSitiGn to begin the excising operation. A
i ~ specially design~d guidewire 17 with a culved end porti~n is utilized in conjunction with the guidewire port 16 which can be used to ~ositi~, . the cutter head 18 with respect to the arterial wall 50 in a c~,lt,ollscl ,..~nner.
As bet~er illu~ lecJ in Figure 5, the guidewire 17 can be used to rot~te the cutter ~. head 18 about the periphery of the inner surface of the wall of the vessel of interest to 5 ~' control the peripheral QXCi~il Iy of the ~lanGlic lesion 52. Th~ guidewire is in a position to sense the pres~..ce or ~bsence of blc rk~ nl~teli~l and G,~erdles in a mann~r such '~ that it easily clears the 1O~Cltil ,~ cuttiny tool 18 which is ~ee to rotate independent of the 9U~ .e. The cutting tool 18 can then be ,~ is~ly maneuvered until the entire ,6,- st~oti¢ lesion 52 is r~r.~wad from the inner surface 54 of the arterial wall 50. It will ~;- ~rther be &~pr~ t~l îh~t the ~uidewire 17 can be utilized to more precisely aim the tip of cut!ing rnember 18 with respect to the ~lenosi~ so th~t ~xoisiQn can take place right up to the wall but withollt damaging the inner lining of the arterial wall at 54.
2Q During the time of Q?~C j~ jG~), O~ course, the are~ is continually flushed with saline, or the like, introfluce~l ~hrough îhe fftting 46 and flowing through the hJmen of the outer tubular ~l~ernber 12 and outward throu~h the radial ports 2û. This keeps the e~(cis~d debris in solution~ A suitable source of suction is simultaneously -~r; I e~ to the fitting 45whichopel~testhroughtheinnertubular~.,ember15go -sF:.dlethesitethroughthe cutting tool openings 24. The tlushing solution together with blood and/or ~xoised tissue and other deb~is pro~ ce~ dunng the removal ot a blockage is drawn into asuitable ~e_sp'e.cl~ (not shown).
The motor ~9 turns the inner hollow tubular member to rotalt~ the c~ter head or cutting tool at relatively high speed (up to 3000 rpm). The catheter is advanced and ~dj~sted laterally using IllGd~S pressure b_h~I~en the tool and the sten~io lesion and precisely aimed and cGntrolle:l by means of th~ guicle.~,:.e 17. Once the atheroma has been completely excised about the p~ e~ of the vessel, substantially full blood flow - through the vessel is restore~l. It will be appreeiaieJ it the position and attitude of the s i ,~,7, ~.., v ~ wo g3/137l6 2 1 2 6 0 9 ~ PCI'/US92/10256 ;.,i g "
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cutter head within the vessel can be continually adjusted during the excising procedure 31,, utilking the gu ~w:.e to b,-prove control and pr, ~ sion assuring a more complete ~ removal of the blockage.
,hL, The cutting head openings 24 are pr~fer .bly placed close to the nose so that 5 tissue loc~t~cl directly to the side of the tool including vessel walls or vessel wall linings ~' are not .I&n-a~e(~. This normally would result in a less than complete removal of the ,~,..
stenotic lesion from the vessel, although the vessel may be 5~ 5t~ ltially reopened The provision of the guidewire 17, hov/~wr, allows the ope,~tor to carefully manipulate ,- the cutting head of the c~l,~er during eltckicn, to acl. vo a more complete clearing 10 of the blockage This invention has been cJesc,iLecl herein in consicle,~ble detail in order to ~ .
coll.p!y with the patent sPtutes and to provide those skilled in the art with the ' information ne~ded to apply the novel principles and to construct and use such specialized components as are required However it is to be unde, ,tood that the 15 invention can be c~rried out by specffic~ly d;fl~r~nt equipment and devices and that various modHications, both as to ~quipment deta~ls and oper~ti. .~ proced-Jres, can be acco,..plished iwithout J~p~ti..~ from the scope of the inve.~tiG.) itseîf.
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Claims (11)
1. A surgical cutting tool (10) for excising undesirable deposits from the interior of a blood vessel of interest characterized by:
an outer elongate flexible hollow catheter tube member (12) having an outside diameter smaller than the lumen of the vessel of interest and capable of being advanced through the lumen of the vessel of interest and having a proximal end and a distal end, with at least one radial fluid passage opening (20) formed at or near the distal end thereof;
an inner elongated flexible hollow catheter tube member (15) coaxially disposed within the outer catheter tube member (12) and having a proximal end and a distal end wherein the outside diameter is journaled in the outer catheter tube member (12), the distal end of the inner tubular member (15) extending beyond the distal end of the outer catheter tube member (12);
a substantially hollow cylindrically symmetric cutter member (18) fixed to the distal end of the inner catheter tube member (15) and having a symmetric generally oval-shaped distal nose portion containing a plurality of radially disposed cutter openings (24) in communication with the hollow interior and disposed such that an edge thereof excises tissue upon rotation of the cutting member (18), the excised tissue being generally directed into the hollow interior of the cutter member (18), the hollow interior further being in communication with the hollow interior of the inner catheter tube member (12);
drive means (39) connected to the proximal end of the inner catheter tube member (15) for rotating the inner catheter tube member (15) thereby rotating the cutting member (18) to excise tissue deposits;
a guidewire port (16) in the form of a hollow, generally cylindrical tubular appendage fixed in parallel relation and spaced from the outer surface of the outer catheter tube member (12) approaching the distal end thereof but located proximal of cutter member (18); and a guidewire (17) for controlling the disposition of the cutter member (18) having its distal end extending through the hollow appendage of the guidewire port (17) in a manner which spaces the guidewire (17) from the cutter member (18).
an outer elongate flexible hollow catheter tube member (12) having an outside diameter smaller than the lumen of the vessel of interest and capable of being advanced through the lumen of the vessel of interest and having a proximal end and a distal end, with at least one radial fluid passage opening (20) formed at or near the distal end thereof;
an inner elongated flexible hollow catheter tube member (15) coaxially disposed within the outer catheter tube member (12) and having a proximal end and a distal end wherein the outside diameter is journaled in the outer catheter tube member (12), the distal end of the inner tubular member (15) extending beyond the distal end of the outer catheter tube member (12);
a substantially hollow cylindrically symmetric cutter member (18) fixed to the distal end of the inner catheter tube member (15) and having a symmetric generally oval-shaped distal nose portion containing a plurality of radially disposed cutter openings (24) in communication with the hollow interior and disposed such that an edge thereof excises tissue upon rotation of the cutting member (18), the excised tissue being generally directed into the hollow interior of the cutter member (18), the hollow interior further being in communication with the hollow interior of the inner catheter tube member (12);
drive means (39) connected to the proximal end of the inner catheter tube member (15) for rotating the inner catheter tube member (15) thereby rotating the cutting member (18) to excise tissue deposits;
a guidewire port (16) in the form of a hollow, generally cylindrical tubular appendage fixed in parallel relation and spaced from the outer surface of the outer catheter tube member (12) approaching the distal end thereof but located proximal of cutter member (18); and a guidewire (17) for controlling the disposition of the cutter member (18) having its distal end extending through the hollow appendage of the guidewire port (17) in a manner which spaces the guidewire (17) from the cutter member (18).
2. The apparatus of Claim 1 further comprising guidewire control means for operating the guidewire (17) independent of the operation of the cutting tool (10).
3. The apparatus of Claim 2 wherein the guidewire (17) is operable relative to the cutting tool (10) so as to control the disposition of the cutting tool (10) relative to its position and attitude throughout the circumference of the vessel of interest.
4. The apparatus of Claim 1 further comprising inlet means (46) for introducing a flushing liquid into the lumen of the outer catheter tube member (12) and infusing the liquid through the at least one radial fluid passage opening (20) near the distal end thereof and outlet means for aspirating liquids through the cutter openings (24) via the lumen of the inner tube member (15).
5. The apparatus of Claim 3 further comprising inlet means (46) for introducing a flushing liquid into the lumen of the outer catheter tube member 112) and infusing the liquid through the at least one radial fluid passage opening (20) near the distal end thereof and outlet means for aspirating liquids through the cutter openings (24) via the lumen of the inner tube member (15).
6. The apparatus of Claim 1 wherein She outer catheter tube member (12) has a plurality of symmetrically placed fluid passage holes (20) and the distal portion of the outer catheter tube member (12) has a necked-down segment of reduced diameter at the location of the at least one radial fluid passage (20) to prevent clogging thereof during passage of the outer catheter tube member (12) through the vascular system.
7. The apparatus of Claim 5 wherein the outer catheter tube member (12) has a plurality of symmetrically placed fluid passage holes (20) and the distal portion of the outer catheter tube member (12) has a necked-down segment of reduced diameter at the location of the at least one radial fluid passage (20) to prevent clogging thereof during passage with the outer catheter tube member (12) through the vascular system.
8. A surgical cutting tool (10) for excising undesirable deposits from the interior of a blood vessel of interest comprising:
an outer elongate flexible hollow catheter tube (12) having an outside diameter smaller than the lumen of the vessel of interest and capable of being advanced through the lumen of the vessel of interest, the outer catheter tube (12) having a proximal end and a distal end, the distal end portion having a necked-down segment of reduced diameter from that of the remaining length of the outer catheter tube (12) and at least one radial fluid passage opening (20) formed in the area of reduced diameter;
an elongated flexible hollow inner catheter tube (15) coaxially disposed within the outer catheter tube (12) and having a proximal end and a distal end, the outside diameter of the inner catheter tube (15) being journaled in the necked-down portion of the outer catheter tube (12), the distal end of the inner catheter tube (15) extending beyond the distal end of the outer catheter tube (12);
a generally hollow cylindrically symmetric cutting tool (18) having a symmetric generally oval-shaped distal nose portion fixed to the distal end of the inner catheter tube (15), the nose portion further comprising a plurality of radially disposed cutter openings (24) extending along and rearward from a point near the center thereof, the openings (24) being in communication with the hollow tool interior and disposed such that an edge thereof contacts and excises tissue upon rotation of the cutting tool (18) about its longitudinal axis, the excised tissue being generally directed into the hollow tool interior, the hollow tool interior further being connected to the interior of the inner catheter tube (15);
drive means (39) connected to the proximal end of the inner catheter tube (15) for rotating the inner catheter tube (15) thereby rotating the cutting tool (18) to excise deposits;
a guidewire port (16) in the form of a hollow, generally cylindrical tubular appendage fixed in parallel spaced relation to the outer surface of the outer catheter tube (12) near the distal end thereof but located proximal of cutter member (18); and a guidewire (17) for controlling the disposition of the cutting tool (18) having its distal end extending through the hollow appendage of the guidewire port (16) in a manner which spaces the guidewire (17) from the cutting tool (18).
an outer elongate flexible hollow catheter tube (12) having an outside diameter smaller than the lumen of the vessel of interest and capable of being advanced through the lumen of the vessel of interest, the outer catheter tube (12) having a proximal end and a distal end, the distal end portion having a necked-down segment of reduced diameter from that of the remaining length of the outer catheter tube (12) and at least one radial fluid passage opening (20) formed in the area of reduced diameter;
an elongated flexible hollow inner catheter tube (15) coaxially disposed within the outer catheter tube (12) and having a proximal end and a distal end, the outside diameter of the inner catheter tube (15) being journaled in the necked-down portion of the outer catheter tube (12), the distal end of the inner catheter tube (15) extending beyond the distal end of the outer catheter tube (12);
a generally hollow cylindrically symmetric cutting tool (18) having a symmetric generally oval-shaped distal nose portion fixed to the distal end of the inner catheter tube (15), the nose portion further comprising a plurality of radially disposed cutter openings (24) extending along and rearward from a point near the center thereof, the openings (24) being in communication with the hollow tool interior and disposed such that an edge thereof contacts and excises tissue upon rotation of the cutting tool (18) about its longitudinal axis, the excised tissue being generally directed into the hollow tool interior, the hollow tool interior further being connected to the interior of the inner catheter tube (15);
drive means (39) connected to the proximal end of the inner catheter tube (15) for rotating the inner catheter tube (15) thereby rotating the cutting tool (18) to excise deposits;
a guidewire port (16) in the form of a hollow, generally cylindrical tubular appendage fixed in parallel spaced relation to the outer surface of the outer catheter tube (12) near the distal end thereof but located proximal of cutter member (18); and a guidewire (17) for controlling the disposition of the cutting tool (18) having its distal end extending through the hollow appendage of the guidewire port (16) in a manner which spaces the guidewire (17) from the cutting tool (18).
9. The apparatus of Claim 8 further comprising control means for controllingthe guidewire (17) independent of the operation of the cutting tool (18), the guidewire (17) being operable relative to the cutting tool (18) so as to control the disposition of the cutting tool (18) both relative to its position and attitude longitudinally and circumferentially with respect to the vessel of interest.
10. The apparatus of Claim 8 further comprising:
inlet means (46) associated with the drive means (39) for introducing a flushing liquid between the inner and outer catheter tubes (12, 15), the flushing liquid exiting the lumen of the outer catheter tube (12) through the at least one radial fluid passing opening (20); and outlet means (24) associated with the drive means (39) for passing liquids and excised debris aspirated through the plurality of openings in the distal end portion of the cutting tool (18), via the lumen of the inner catheter tube (15) and out the proximal end of the inner catheter tube (15).
inlet means (46) associated with the drive means (39) for introducing a flushing liquid between the inner and outer catheter tubes (12, 15), the flushing liquid exiting the lumen of the outer catheter tube (12) through the at least one radial fluid passing opening (20); and outlet means (24) associated with the drive means (39) for passing liquids and excised debris aspirated through the plurality of openings in the distal end portion of the cutting tool (18), via the lumen of the inner catheter tube (15) and out the proximal end of the inner catheter tube (15).
11. The apparatus of Claim 9 further comprising:
inlet means (A6) associated with the drive means (39) for introducing a flushing liquid between the inner and outer catheter tubes (12, 15), the flushing liquid exiting the lumen of the outer catheter tube (12) through the at least one radial fluid passing opening (20); and outlet means (24) associated with the drive means (34) for passing liquids and excised debris aspirated through the plurality of openings in the distal end portion of the cutting tool (18), via the lumen of the inner catheter tube (15) and out the proximal end of the inner catheter tube (15).
inlet means (A6) associated with the drive means (39) for introducing a flushing liquid between the inner and outer catheter tubes (12, 15), the flushing liquid exiting the lumen of the outer catheter tube (12) through the at least one radial fluid passing opening (20); and outlet means (24) associated with the drive means (34) for passing liquids and excised debris aspirated through the plurality of openings in the distal end portion of the cutting tool (18), via the lumen of the inner catheter tube (15) and out the proximal end of the inner catheter tube (15).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US81985392A | 1992-01-13 | 1992-01-13 | |
| US819,853 | 1992-01-13 |
Publications (2)
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|---|---|
| CA2126096A1 CA2126096A1 (en) | 1993-07-22 |
| CA2126096C true CA2126096C (en) | 1998-04-28 |
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ID=25229260
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002126096A Expired - Fee Related CA2126096C (en) | 1992-01-13 | 1992-12-02 | Surgical cutting tool |
Country Status (11)
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|---|---|
| US (1) | US5358472A (en) |
| EP (1) | EP0621761B1 (en) |
| JP (1) | JP2549822B2 (en) |
| AT (1) | ATE150953T1 (en) |
| CA (1) | CA2126096C (en) |
| DE (2) | DE9290166U1 (en) |
| DK (1) | DK0621761T3 (en) |
| ES (1) | ES2099294T3 (en) |
| GR (1) | GR3023450T3 (en) |
| PT (1) | PT101173A (en) |
| WO (1) | WO1993013716A1 (en) |
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1992
- 1992-12-02 DE DE9290166U patent/DE9290166U1/en not_active Expired - Lifetime
- 1992-12-02 ES ES92925444T patent/ES2099294T3/en not_active Expired - Lifetime
- 1992-12-02 AT AT92925444T patent/ATE150953T1/en not_active IP Right Cessation
- 1992-12-02 JP JP5512424A patent/JP2549822B2/en not_active Expired - Fee Related
- 1992-12-02 DK DK92925444.9T patent/DK0621761T3/en active
- 1992-12-02 WO PCT/US1992/010256 patent/WO1993013716A1/en active IP Right Grant
- 1992-12-02 EP EP92925444A patent/EP0621761B1/en not_active Expired - Lifetime
- 1992-12-02 DE DE69218794T patent/DE69218794T2/en not_active Expired - Fee Related
- 1992-12-02 CA CA002126096A patent/CA2126096C/en not_active Expired - Fee Related
-
1993
- 1993-01-11 PT PT101173A patent/PT101173A/en not_active Application Discontinuation
- 1993-09-09 US US08/118,949 patent/US5358472A/en not_active Expired - Lifetime
-
1997
- 1997-05-16 GR GR970401099T patent/GR3023450T3/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| DE69218794T2 (en) | 1997-07-10 |
| WO1993013716A1 (en) | 1993-07-22 |
| PT101173A (en) | 1994-05-31 |
| CA2126096A1 (en) | 1993-07-22 |
| DK0621761T3 (en) | 1997-08-04 |
| ATE150953T1 (en) | 1997-04-15 |
| EP0621761B1 (en) | 1997-04-02 |
| DE69218794D1 (en) | 1997-05-07 |
| JPH06511176A (en) | 1994-12-15 |
| EP0621761A1 (en) | 1994-11-02 |
| JP2549822B2 (en) | 1996-10-30 |
| DE9290166U1 (en) | 1994-10-13 |
| US5358472A (en) | 1994-10-25 |
| GR3023450T3 (en) | 1997-08-29 |
| ES2099294T3 (en) | 1997-05-16 |
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