CA2125973C - Cutter for atherectomy catheter - Google Patents
Cutter for atherectomy catheterInfo
- Publication number
- CA2125973C CA2125973C CA002125973A CA2125973A CA2125973C CA 2125973 C CA2125973 C CA 2125973C CA 002125973 A CA002125973 A CA 002125973A CA 2125973 A CA2125973 A CA 2125973A CA 2125973 C CA2125973 C CA 2125973C
- Authority
- CA
- Canada
- Prior art keywords
- tubular member
- cutting tool
- guidewire
- distal end
- lumen
- 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
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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
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
An atherectomy catheter device (10) provided with an improved high speed rotatin g cutting head (17) is disclosed in which the cutting head has a generally ovalshaped nose portion which includes a plural ity of radially disposed excising openings (24) extending along and rearward from a point near the center of the nose. The openi ngs are elongated but do not extend beyond the elliptical portion of reduced diameter, and, therefore, do not damage the lining of the vessel involved.
Description
~v~)93/13717 f~ S~7~ Picr/~s92/l0257 t _ 1, ' 5 CUrrER FOR ATHERECTOMY CATHETER
Back~round of the Invention The present invention relates to a relatively non-invasive plaque resolvin~ device ot the class ~te~ to be inserted through the lumen ot a blood vessel and maniru~t~cl ther~lhrough to a desired location to ply a cutting tool to excise deposits - 10 of atherosclerotic plaque frorn the internal surfaces ot the vessel. More particularly, tha ~b pr~sent invention relates to an improved cutting tool ~or use in such a system.
I,nF,~ nent of the circulation of blood occ~ioned by intraarterial deposits of atheros~l~rotic plaque is a major cause of cardiovascular disease. Obstruction of :~ coronary artenies can lead to tissue death because of oxygen deprivation to heart 15 musde. Çoronary infarction (heart attack) is the resu~. Plaque-induced stenosis of other rnajor arteries can result in impairment of peripheral organ function. One iong-;- used procedure tor overoorning such obstructions and blockages involves a surgical by-pass operation in which the obstructed arteries are subtended by patient aL~ographed biood vessels removed trom other parts of the patient's body. Surgically 20 in~/asive end~rlerector~y has also been used with limited success ~or clearing .,, obstrwted vess~ls.
The ne~ has long existed for a less invasive iand radical procedure to alleviatesuch l~ ges and ac~ transmyocardial revascularization, or the like, in a n~annerwhich causes no significant damage to the healthy endothelial lining of the surro~Jnding 25 vessel. One device that,&ll~n~ts to ~lfill this need is ballo~n ang;oplasty in which an ~ ~ inflatable ~ "oon is ,~J~s~d to the stenotic region of the affected artery and inflated with '~ a ~luid to a pressure (normally about 5 a~mospheres) to depress the plaque against the ii arterial wall U.el~by op~ning up the arterial volume. P~ec~Jse circLIlation is grossly .- : impaired, how~ver, balloon i~lD~tiGI./deflation must ~ocur in ~ matter ot seconds to 30 avoid i"~ tion. In ~ditisn, limited ~orce is available bec~lse of the f~ar o~ dam~e to the ~ l~, ies caused by overpressurization o~ the balloon. fUso, the capture of plaque debri~ that may slou9h during the expansion process is not as yet provided ~or by such ?;'~ IlS?V~Ce5.
~' '~ Other ~pfo~ches inolude the use ot a laser to clear obstn~ctions in vessels as .~ 35 proposecl, for ~ rl~, in U.S. Patent ~,207,874 to Choy. In that device, laser energy is convey~d by flexible fiberoptics in conjunction with a vascular catheter and applied : ~ to the plaque obstnJction in the occluded zone In conjunction with this system various , ........ .
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Back~round of the Invention The present invention relates to a relatively non-invasive plaque resolvin~ device ot the class ~te~ to be inserted through the lumen ot a blood vessel and maniru~t~cl ther~lhrough to a desired location to ply a cutting tool to excise deposits - 10 of atherosclerotic plaque frorn the internal surfaces ot the vessel. More particularly, tha ~b pr~sent invention relates to an improved cutting tool ~or use in such a system.
I,nF,~ nent of the circulation of blood occ~ioned by intraarterial deposits of atheros~l~rotic plaque is a major cause of cardiovascular disease. Obstruction of :~ coronary artenies can lead to tissue death because of oxygen deprivation to heart 15 musde. Çoronary infarction (heart attack) is the resu~. Plaque-induced stenosis of other rnajor arteries can result in impairment of peripheral organ function. One iong-;- used procedure tor overoorning such obstructions and blockages involves a surgical by-pass operation in which the obstructed arteries are subtended by patient aL~ographed biood vessels removed trom other parts of the patient's body. Surgically 20 in~/asive end~rlerector~y has also been used with limited success ~or clearing .,, obstrwted vess~ls.
The ne~ has long existed for a less invasive iand radical procedure to alleviatesuch l~ ges and ac~ transmyocardial revascularization, or the like, in a n~annerwhich causes no significant damage to the healthy endothelial lining of the surro~Jnding 25 vessel. One device that,&ll~n~ts to ~lfill this need is ballo~n ang;oplasty in which an ~ ~ inflatable ~ "oon is ,~J~s~d to the stenotic region of the affected artery and inflated with '~ a ~luid to a pressure (normally about 5 a~mospheres) to depress the plaque against the ii arterial wall U.el~by op~ning up the arterial volume. P~ec~Jse circLIlation is grossly .- : impaired, how~ver, balloon i~lD~tiGI./deflation must ~ocur in ~ matter ot seconds to 30 avoid i"~ tion. In ~ditisn, limited ~orce is available bec~lse of the f~ar o~ dam~e to the ~ l~, ies caused by overpressurization o~ the balloon. fUso, the capture of plaque debri~ that may slou9h during the expansion process is not as yet provided ~or by such ?;'~ IlS?V~Ce5.
~' '~ Other ~pfo~ches inolude the use ot a laser to clear obstn~ctions in vessels as .~ 35 proposecl, for ~ rl~, in U.S. Patent ~,207,874 to Choy. In that device, laser energy is convey~d by flexible fiberoptics in conjunction with a vascular catheter and applied : ~ to the plaque obstnJction in the occluded zone In conjunction with this system various , ........ .
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~ ' WO ~3/13717 ,~ 7 ~ PCI/~S92/102~- ~
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axial channels may be provided with appropriate ~luid management manitolds in order ~ to inject saline, aspirate debris with the saline and inject die for visualization. Additional ;~ coherently aligned fibers may be provided ~or actual viewing of the~ obstruction intraluminally. In ~ddition to Choy, many other approaches utilizing variations on a laser excising system have {llso been proposecl. L~sers, tor example, have been .
.~ utilized to resolve plaque by heating a catheter tip in a manner which causes the plaque .5., .
. tissue to, in effectl be melted away by the heated tip of the catheter resulting in ; permanent removal. The approach is illustrated by Hershenson in U.S. Patent : 4,748,979.
f 10 A variety of cutting devices have also been proposed in conjunction with catheters in which rotb~ing cutters actually add~ess and excise the stenosis. Presently known devices, hov/~vor, have not been able to combine the required ability to achieve rapid cutting of the stenosis with the equally i,-,po,t~t ability to do so without a high degree of risk ot affecting or damaging the relatively soft adjacent wall of the artenal vessel involved.
One such device is dischsed in U.S. Patent 4,784,636 to Rydell which is assiynel to the same ~ssiy,~ee as the present invention. That invention provides an athere.,to--,y ~I.eter which inchlcles a guide catheter having an inflatable balloon ~is~sec! on the distal end portion thereof, the guide catheter being dimensioned to rec~iv0 in its illuminat~d 2' Q . ~gated drive tube having an angular cutting tip affixed to the j"
distal end thereof. A rt,tdtiooal drive .~echanism is coupled to the drive tube at its J proximal end for l~t~ting the cutting tip. rlc.v:sion is also mad~ in the drive l.~ect .sni~ m for introducing nuid through-the lumen of the guide catheter for i. If ld~ the b~ " c c n and for drawing a v~lcuum on ihe lumen of the drive tube for aspirating the b ed~el ~t site.
In use, ths guide cathet~r with the drive tube ~nd cutter he~d ~ t~d is ~dvanced up to the occlusicn and then, the balloon is inflated to lock the distal end in place. Next the cutter is rotated at high spe~d and ad~ced into the o~cl~ iQn, while btood and any loose particular matter is aspirated. The br"~D~;~ is then deflated and adv_nce~J
turther into the lesion and the steps r~peAle~ until th~ occlusion is re...ovod.
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A rnore recently issued patent to Rydell, also o~ coln,non assignee with the prior . ~ abov~r*ferenced patentl is U.S. Patent 4,857,045 which is directed to a self~uiding athere~tomy cdtl .~ter system utilizing coaxial inner and outer flexible tubular member~
in which the inner tubular member is joumaJed tor rotation at the distal end of the outer .' r ~,' WO93/137t7 2125973 PCT/~S~ o~-~3 . . .
tubular member. A motor, located at the proximaJ end oi the catheter assembly drives the inner tubular member including a cutter head fixed to the inner tubular member at B point just beyond the end portion of the outer tubular member. Aspiration is "; , . .
- acco.~plished through the inner tubular member and a flushing fluid such as saline 5 &II.I.nk.ler~J throtJgh the outer tubular mernber, as required.
That reference further ~isclo~es a dom~shaped rotationaJ cutting head containing a large number ot substantially round open ports ~or addressing b~ockage material upon rot&tion. When the cuttin~ head is rotated, the open ports directly z.J~ ss the plaque but are not precluded trom cutting into the arterial lining and wall 10 if extreme care is not taken with respect to the use of the device.
While the last-cliscussed system represents a~ improvement with regard to , A
cente,ing and o~er~tins~ the atherectomy catheter within a vessel o~ interest there ., remains a need to improve the safety of cutting devices of the class described with respect to reducing and preventing darnage to the vessel of interest inciuding its inner 16 lining which may be occ~sioned when removing a stenosis. There also exists a need to i,nprwo the ability of tho operator to guide the ~ll.etcr in navigalin~ the vascular . system to reach the situs of the occhl~ion of i"tere~t. GuideJii.r~s have been u~ed with ~i success in several types of cath~ters but hereto~ore have not been used with rotali"~l '''f'' ~ ati,~r~ t~,.,y duvices be~ se of the need to coordinate the gul~av::re placement to avoid the cutter head.
'- Summary of the Jnvent~on . q The ~res~nt invention provides an imprGv~d cutting h0ad ~.e.,.ber or cutting tool for use on ~n ~tl l~r~cto,ny ca~l ~eter device. The tool is securad to the distal tip portion of the inner tubular ~ nember of an atherecton~y call .eter o~ the cca~tial type ha~/ing large and sm~ll concei~tlically rlisposec~ elongated flexible tubular me~ er~ in one pr~f~:r,ed embodiment. The cutting member of the invention itself is a substanUally hollow I ~, ~; p~ ,h6r~11y sy."met~ l body ha~Jing a generally oval-shapsd distal nose portion containing a plurality o~ openings extending along and reanHard 1rom the nose. The ; ~ openings are in comm~ni ~-ion with the hol~ow interior and radially ~ F,o~o~l about the '; 30 tip. The edge ot each opening c~"t~cti,)g adjacerlt tissue vper~t~ to excise the tissue upon rot~lion o~ the cutting tool. The excised tissue is direc1ed through the opening into the hollow interior of the cutting tool.
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WO 93/13717 f ~ ~ ~ 9 7 3 PC~ S92/l02 ~
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. 4-W~h respect to the cutting tool shape, any symmetrical oval or olive shape which accG")plshes the desired diameter reduction in th~ vicinity of the cutting~'!' openings can be used. In this manner, ths tool may be in the form of a circular cylinder having a generally oval or ellip~ical sha~ed nose, or in the shape of a tully oval ,, 5 "~efi.~e., an ellipse represents b rt one ~cce~tP-'lle shape.
The concent,icalîy disposed, elongated flexible tubular members have a ,1~ res~e~ti~e inside and out~ide measurement allowing suffie;ent clearance between the two v~.er~l~y fluid may be p~S'QCJ through the lumen of the outer tubular member and OLlt through the end ot the lumen and/or one or more ports formed through the wall of 10 the outer tubular l~.e~nber near its distal end. The inner tubular member is secured to a drive means at is proximal end which is configured to rotate the inner tubular member relative to th~ outer tubular member. The system ~so allows the simu~aneous infusion , ot a liquid through the outer tubular member and the aspiration of fluids and debris through the lumen ot the interior tubular member. In this manner, site of the 15 lesion to be qxcised or other desired loc~tien can be flooded with a flushing liquid as ~; desired. When 1he Gper~ti- ~,a eutter is advancod into the lesion, the flushing fluid, and the debris se.,liGn~d from the lesion, ara directed into the hollow cutting head and are ;"
'd aspirated into the lumen of the inner tubular rnen~ber, which is connected wrth the hollow ir~brior of the cutter head, and are cclls t~d in 5 suitable vessel connected to 20 an outl~t at the ,c,ro~imal end ot the ~ssembly.
The system is further provided with a guide~nre to enable easier guiding of the catheter through the vascular system to the site ot the l~sion. In one embodiment the guidQ~nre extends throu~h the inner tubular ~ ,nber and drive shaft and is fixedb~yond the pro,.i...al end th~reof such that it is permitt~d to r~main stationary while the ~5 catheter is abb to mov~ treely atong it. in the alternative e~ GJi.~eot, a short , guid~Mre is mounted to and joumolled in a centr~l opening in the nose of ~he cutting . tool head in a In~ner whlch proviJes a clearance which sllows it to rotate with the ~n~".~cr ~d the end of the guidewire is free to do so or remain stationary if tesi:.~ce to rotation of the guidewire occurs. In either embodiment the guidewire is adapted to 30 e)nend through a central hole in the nose of the cutting tool in a manner which does ~'; not i~ .t~.~r~ wfth the operation of the f~teltin$~ aftter.
The openings in the rotating cutter member are located in the narrowed tront pGl~iGn of the oval-si,aped nose in a manner which preehJd~s contact between the :
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WO93/13717 212;~ ~ 73 pcr/~s92/1o2~
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culter openings and the sides or walls of ths vessel of interest during operation as . ~ norm~lly positioned. This minimizes the possibility of damage occurring to the lining ' ot th0 vessel or to th0 vessel wall during operation of the cutting tool The cutting tool is adapted to be driven at relatively high speed, so that the m~terial such as fatty tissue 5 a~ci5ed iS extremely finely divided prior to its being aspirated back through the lumen .i~ of ~he inn0r catheter. Speeds up to 30,000 rpm sre achieved.
. 13rief Descriction of the Drawin~s ~; Figure 1 is a viaw, partially in ~ction, broken, with parts cut away, illustrating an atherectomy catheter employing one embodiment of the present invention;
Figure 2 is a greatly enlarged fragmentary view, with parts cut away, showing one cutter head arrangam0nt;
... Figure 3 is an end view of the cutter head of Figure 2 still further enlarged;
Figure 4 is a view illustrating an altemativs embodiment of the cutter head of : Figure 2;
, i, Figure 5 is a partial sectional view of the embodiment of Figure 4; and ;; Figure 6 is a view similar to Figure S of another altemate embodiment.
Detailed Desc,i~iol~ of the Invention :
The present invention involves an atherectomy catheter in which a rotatable cutter is dispose~t at th~ distal end and in which means are provided at the proximal ~; 20 end for driving the cutt~r at ~ high rotational sp~ed while sim~ ously injecting a ~'t flushing li4uid ~nd aspir~ting the l. ~t~ rlt site. The invention hrther pro~ndes a outter he~d or cutter tool of improved safety eoordinated and oper~l~d wi~h ~ g~uidew~re system to aid and facilitate ~uiding the catheter through the tortuous path of the venal system to the tre l,..~nQ s~e. Th2 invention will b~ desc~ibecJ with particular r~ference 25 to th~ g figures in which like numerals will ba ~nilized to designate like par~s throu~hout tha 3aml31.
Figure 1 illl.st~t~s the surgical devic~ of the F.r~sent invention wi~h res~e~ to typical &~I.er~to.l~y c~ tar systern which is indicated gen~l~!y by the numeral 10.
..- The system includes a control and drive system located with~n a prC~hi~ housing 1 1, .~ 30 which may be of high impact plastic materi~. The c~theter i~se~ is o~ the coaxial bi-lumenal typa. The housing is connected to an elongaled outerflexible tubular ...ember ~; 12 extending betw~en a distal end 13 and a proximal end 14 coupl~rl to the housing - 11. The hollow lumen of the outer tubular member 12 carnes a concent~ically f' ,1';!
'~'' ~;"'' ~, ~, ,~ WO 93/13717 ~ 9 7 3 P~/~S92/102:~-.,.,;
!,'.' ','';' ' ''~"'' dispos~d, coaxial elongated, flexible inner tubular member 15 which exlends beyond . the full length of the outer tubular m~mber 12. The inner tubular member 15, in the embodiment of Figure 1, also is threaded over a non-rotating or stationary guidewire 16 which e~lends the full length of the inner tubular member 15 and protrudes S ther~hun~ and along which the catheter is free to travel.
As can better been seen in Figures 2 and 3, and will be described in grea~er , .
~; deWI below, the distal end of the catheter carries a hollow cutting head or cutting ~ool 17 which is fixed to the inner tubular member 15 and is tree to rotate about the ouler ~!' tubular member 12. The outer tubular member 12 is tapered down to a distal end portion 18 that creates a bear~'ing surface which allows ~asy joumaled rotation of the ~~ inner tube 15 and cutter head 17. An infusion system is provided including an indented ' annular area of reduced diarneter 19 near the distal end ot the outer tubular member 12 which ~ol)tai, .s a series of radially s~isposed openings or holes 20 (Figure 1). Uquid col)taine~J in the annular space in the lumen of the member 12 surrounding the member ~ 15 15 as ~t 21 ~n be ejected through the holes 20 to flush the opera~ing s~e. An annular ;~ spac~r l~Gn~ber 22 is provided which is bonded both to the distal tip of the inner tubular .er,.ber 15 and the inner surface ~f the cutler head 17 to fix the cutter head to the distal tip of the inner tubular m~mb~r 15.
The guidewire 16 is slidably threaded and extends through a central hole 23 in the distal tip ot the clJtter member 17, throughout the iength of the inner tubular ~ fi~e,nber 15 and housln~, and is sep~r~tely colltlc"e~l. The -atheter system is free to ;~ rnove alon9 the guidewir~, and it is ~esiylJed to remain ~t~tion~y as the cutter head member 17 is rotated. The cutter head 17 cont~ns ~ plural ty ot elongated openings 24 Jisrosed in radial syl"n.et. ~ out the center o~ the distal nos~ as shown in Flgure .~ 25 3. The cutter h~ad m~y typically be initiaJly cylindricai and t~per off in a symmetri~l oval sh~pe as it approaches the distal end. The plurality of openings 2~ is usu~ly an ven numb~r from two to six and the openings are placed close to the nose of the oval-t 51u~ cutter he~d 17 so thalt the possibility o~ inadvertently contacting and cutting the side wall of the vessel frorn which the plaque or other blockage is to be excis~ is 30 virtually slimina~ed.
;~ A dm~e means is contained within the n~id tubular housing 1~ looated at the ~. proximal end of the outer tubular member. The drive functions to rotate the inner .. tubular mernber within the lumen of the outer tubular member. The outer tubular .
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WO93/13717 ~ lq~ ~ 9 r! 3 Pcr/~s92/lo2 member is joined to the tubular housing 11 as through end plug member 30 and is secured as by a compression titting 31 which creates a liquid-tight seal. A rotary union ., shown generaily at 32 is positioned within the housing 11 and includes a stationary ,~ tubular sleeve member 33 fixed to the housing 11 by pins or screws 34. A pa~r of 0-ring seals 35 and 36 are disposed in annular grooves in thr~ tubular sleeve 33 to preclude flushin~ liquid contained in the chamber 37 ~rom passing beyond the rotary ur;ion.
Inside o~ the sta~ionary sleeve 33 is a rotating hollow mani~oJd member 38 whichrotates within the bor~ of the member 33 when driven by a motor such as that depicted genarally at 39 haYing a dnve sha~t 40 and a coupling 41 connec~ed in driving relation ~! to th~ proximai end of thc hollow mani~old member 38. The hollow manifold member '9 38 further contains an annuiar rec~ss 42 connected to a central bore 43 which, in t~-rn, i~ is joined to the proximai end ot the inner elongated flexibla tubular member 15 by a '~ coupling member 44. The central inner bore 43, via th0 annular recess 42, is ~ 15 conn~cted to a further tubular ~itting 45 which passes through a bore in sleeve rnernber ?'~ 33 arld the housing 11 to provide a suction outlet tor aspila(ing the inner elongated nexibl~ tubular member 15. By making the motor drive ~h~ft itself hollow, the staUonary guidewire can be ted through the entire system. Flushing saJine or other solution input k pro~lided through a further access tube 46 which e)ilends through an additional bore in the housing 1 1 which communicat~s with the chsr. ,ber 37.
'' In ~ e~tion, the elGrlgd~d eatheter assembly is a~l~rop~i~tely introduced into ,- the v~ system, as through the f~,l-or~l artery, and advaneed along th~ preYiously ert~ ;.e 16, navig~li"~ through the vascular syst~m to the appropriate arterial i,, or oth~r loc~,or~ o~ interest placing tlse cutter tip 17 adjacent to the atheroma or other . 25 lesion or blockaga .~at~liaJ to be ~ ecl from the vessel. The annular r~oessed ;~n~ter of the outer tubular ~ ber 12, at t 9, ~ids in pr~v~nting clogging of th~ pQ~S
20 dunng the insertion ot the ~tl,~ler through the arterial system. A flushing liquid such a saline is introduced through the fitting 46 into the chamber 37 of the housing ;; ~ 1 1 and ftows through the lumen of the outer tubular member 12 ou~side the outer wall 30 of the inner tubular member 15. The liquid then exits the radial ports 20 loca~ed radialiy .. about the side wall of th~ outer tubular member 12 near is distal end 13. Concurrently, :
a suitable source of suction or negative pressure is ~FI-~1 to thQ fi~ting ~5 in a well-known m~tter to operate in conjunction with the ~lushing solution to aspira~e the . . .
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, Wo 93/13717 ~ ; 9 ~ 3 PC~/~Sg2/102~
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flushing liquid along with blood and/or tissue or other debris which may be excised .. frorn th~ atheroma or artenal blockage is ~rawn through the openings 2~ in the cutter head 17 through the lumen of the inner tubular member into a suitable receptacl0 (not : shoum).
~;~ 5 The motor 39 is energized to rotate !he hollow manifold member of the rotary~
union wlthin its tubular sleeve and thereby drive the tube 15 to rotate the cutter head ~ 17 as desired. The catheter is advanced utilizing modest pressure between the cutter '. head 17 and lhe tissue lto be ~cis,ed so that the tissue is finely ~ivided by th~ rapidly sF.nr.in~ cutter head and wash~ by blood and flushing liquid through the centr,al i.' ~ 10 lumen of the tube 15 and into a collecting receptacle ~not shown). Once the atheroma has been completed penetrated, blood flow through the blood vessel is restored.
The position of the cutter head within the vessel can be adjusted ~with the l necess~y degree ~ precision during the procedure utilizing the guidewire to achieve Ib complete removal of the blockage. In this manner, the att~ude of the cutting head oan .~ 15 be co~t~ cl and mo~u'~tell with some lesway without the darger of inadvertent or ,ioteniionai damage to the vessel wall.
Figures 4 and 5 show an alle ate embodiment o~ the a~t,erec~omy oatheter of ~ thQ invention in which an al~e" .dtive guidewire 50 is ,orsvided in the nose of the cutter hea~ 17 anel which Ts fixed in a n~&nner which allows it to rotate wrth the cutler head . 2û in a loos~ly fitted or ioumaled arran~en~eu t in which it is free to be held or free to tum with the cutSer element 17 d~pending on the rQs;;.l~nce to tuming. This form ot guid~wirQ provides ~ certain amount o~ guidancs tor th~ ~t~later through the arterial '~ system of i.lter~ without th~ necsss~ty of haYing ths guidewir2 extend throughout th~
entire length of the iflner lumerl at 15. Thus, the ~u ~ir~ SO rnay b~ rivetted to the 25 opening 23 and the cutter ,--e",l~er 17 in a manner which allow very little wobble of the guidewir~ but which allows it to rotate fr~ely wiU~in the opening 23.
Figure 6 illustr~es yet sr.c~ther ~smbc~diment of the ~1h~3r~tc~ r ~lh~t~r of the invention in which th~ annular spacer rnernber 22 is not used and th~ cutter head or ;i alttin~ ltooi 117 is in the shap~ of a tull oval s~tion and co. Ine~led directly to the inn~r . 30 ~he~te~ 15. In a~ditiGn, openings 20 may be r~taced by annular space 120 or a co,l,Li.~a~ion of the hol~s 20 (shown in phantom~ ~nd annular spacer 120 us~d 10rthe ~ inh~sion of flushing iiquid.
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., ~125~73 WO 93/13717 PC'r/1~92/102~-. _ , .
The present invention has been described herein in considerable detail in order to comply with the patent statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such sp~8~ '7ed components as are required. However, it is to be understood that the ~ 5 invention can be carried out by specifieP"y dfflerent equipment and devices and that various modif,cations, both as to equipment details and operating procedures, can be accomplished without departing from the scope ot the invention itselt.
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.~ utilized to resolve plaque by heating a catheter tip in a manner which causes the plaque .5., .
. tissue to, in effectl be melted away by the heated tip of the catheter resulting in ; permanent removal. The approach is illustrated by Hershenson in U.S. Patent : 4,748,979.
f 10 A variety of cutting devices have also been proposed in conjunction with catheters in which rotb~ing cutters actually add~ess and excise the stenosis. Presently known devices, hov/~vor, have not been able to combine the required ability to achieve rapid cutting of the stenosis with the equally i,-,po,t~t ability to do so without a high degree of risk ot affecting or damaging the relatively soft adjacent wall of the artenal vessel involved.
One such device is dischsed in U.S. Patent 4,784,636 to Rydell which is assiynel to the same ~ssiy,~ee as the present invention. That invention provides an athere.,to--,y ~I.eter which inchlcles a guide catheter having an inflatable balloon ~is~sec! on the distal end portion thereof, the guide catheter being dimensioned to rec~iv0 in its illuminat~d 2' Q . ~gated drive tube having an angular cutting tip affixed to the j"
distal end thereof. A rt,tdtiooal drive .~echanism is coupled to the drive tube at its J proximal end for l~t~ting the cutting tip. rlc.v:sion is also mad~ in the drive l.~ect .sni~ m for introducing nuid through-the lumen of the guide catheter for i. If ld~ the b~ " c c n and for drawing a v~lcuum on ihe lumen of the drive tube for aspirating the b ed~el ~t site.
In use, ths guide cathet~r with the drive tube ~nd cutter he~d ~ t~d is ~dvanced up to the occlusicn and then, the balloon is inflated to lock the distal end in place. Next the cutter is rotated at high spe~d and ad~ced into the o~cl~ iQn, while btood and any loose particular matter is aspirated. The br"~D~;~ is then deflated and adv_nce~J
turther into the lesion and the steps r~peAle~ until th~ occlusion is re...ovod.
, .
A rnore recently issued patent to Rydell, also o~ coln,non assignee with the prior . ~ abov~r*ferenced patentl is U.S. Patent 4,857,045 which is directed to a self~uiding athere~tomy cdtl .~ter system utilizing coaxial inner and outer flexible tubular member~
in which the inner tubular member is joumaJed tor rotation at the distal end of the outer .' r ~,' WO93/137t7 2125973 PCT/~S~ o~-~3 . . .
tubular member. A motor, located at the proximaJ end oi the catheter assembly drives the inner tubular member including a cutter head fixed to the inner tubular member at B point just beyond the end portion of the outer tubular member. Aspiration is "; , . .
- acco.~plished through the inner tubular member and a flushing fluid such as saline 5 &II.I.nk.ler~J throtJgh the outer tubular mernber, as required.
That reference further ~isclo~es a dom~shaped rotationaJ cutting head containing a large number ot substantially round open ports ~or addressing b~ockage material upon rot&tion. When the cuttin~ head is rotated, the open ports directly z.J~ ss the plaque but are not precluded trom cutting into the arterial lining and wall 10 if extreme care is not taken with respect to the use of the device.
While the last-cliscussed system represents a~ improvement with regard to , A
cente,ing and o~er~tins~ the atherectomy catheter within a vessel o~ interest there ., remains a need to improve the safety of cutting devices of the class described with respect to reducing and preventing darnage to the vessel of interest inciuding its inner 16 lining which may be occ~sioned when removing a stenosis. There also exists a need to i,nprwo the ability of tho operator to guide the ~ll.etcr in navigalin~ the vascular . system to reach the situs of the occhl~ion of i"tere~t. GuideJii.r~s have been u~ed with ~i success in several types of cath~ters but hereto~ore have not been used with rotali"~l '''f'' ~ ati,~r~ t~,.,y duvices be~ se of the need to coordinate the gul~av::re placement to avoid the cutter head.
'- Summary of the Jnvent~on . q The ~res~nt invention provides an imprGv~d cutting h0ad ~.e.,.ber or cutting tool for use on ~n ~tl l~r~cto,ny ca~l ~eter device. The tool is securad to the distal tip portion of the inner tubular ~ nember of an atherecton~y call .eter o~ the cca~tial type ha~/ing large and sm~ll concei~tlically rlisposec~ elongated flexible tubular me~ er~ in one pr~f~:r,ed embodiment. The cutting member of the invention itself is a substanUally hollow I ~, ~; p~ ,h6r~11y sy."met~ l body ha~Jing a generally oval-shapsd distal nose portion containing a plurality o~ openings extending along and reanHard 1rom the nose. The ; ~ openings are in comm~ni ~-ion with the hol~ow interior and radially ~ F,o~o~l about the '; 30 tip. The edge ot each opening c~"t~cti,)g adjacerlt tissue vper~t~ to excise the tissue upon rot~lion o~ the cutting tool. The excised tissue is direc1ed through the opening into the hollow interior of the cutting tool.
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WO 93/13717 f ~ ~ ~ 9 7 3 PC~ S92/l02 ~
- ~ h~~
. 4-W~h respect to the cutting tool shape, any symmetrical oval or olive shape which accG")plshes the desired diameter reduction in th~ vicinity of the cutting~'!' openings can be used. In this manner, ths tool may be in the form of a circular cylinder having a generally oval or ellip~ical sha~ed nose, or in the shape of a tully oval ,, 5 "~efi.~e., an ellipse represents b rt one ~cce~tP-'lle shape.
The concent,icalîy disposed, elongated flexible tubular members have a ,1~ res~e~ti~e inside and out~ide measurement allowing suffie;ent clearance between the two v~.er~l~y fluid may be p~S'QCJ through the lumen of the outer tubular member and OLlt through the end ot the lumen and/or one or more ports formed through the wall of 10 the outer tubular l~.e~nber near its distal end. The inner tubular member is secured to a drive means at is proximal end which is configured to rotate the inner tubular member relative to th~ outer tubular member. The system ~so allows the simu~aneous infusion , ot a liquid through the outer tubular member and the aspiration of fluids and debris through the lumen ot the interior tubular member. In this manner, site of the 15 lesion to be qxcised or other desired loc~tien can be flooded with a flushing liquid as ~; desired. When 1he Gper~ti- ~,a eutter is advancod into the lesion, the flushing fluid, and the debris se.,liGn~d from the lesion, ara directed into the hollow cutting head and are ;"
'd aspirated into the lumen of the inner tubular rnen~ber, which is connected wrth the hollow ir~brior of the cutter head, and are cclls t~d in 5 suitable vessel connected to 20 an outl~t at the ,c,ro~imal end ot the ~ssembly.
The system is further provided with a guide~nre to enable easier guiding of the catheter through the vascular system to the site ot the l~sion. In one embodiment the guidQ~nre extends throu~h the inner tubular ~ ,nber and drive shaft and is fixedb~yond the pro,.i...al end th~reof such that it is permitt~d to r~main stationary while the ~5 catheter is abb to mov~ treely atong it. in the alternative e~ GJi.~eot, a short , guid~Mre is mounted to and joumolled in a centr~l opening in the nose of ~he cutting . tool head in a In~ner whlch proviJes a clearance which sllows it to rotate with the ~n~".~cr ~d the end of the guidewire is free to do so or remain stationary if tesi:.~ce to rotation of the guidewire occurs. In either embodiment the guidewire is adapted to 30 e)nend through a central hole in the nose of the cutting tool in a manner which does ~'; not i~ .t~.~r~ wfth the operation of the f~teltin$~ aftter.
The openings in the rotating cutter member are located in the narrowed tront pGl~iGn of the oval-si,aped nose in a manner which preehJd~s contact between the :
,:.
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WO93/13717 212;~ ~ 73 pcr/~s92/1o2~
i ~ - ~
,....... .
culter openings and the sides or walls of ths vessel of interest during operation as . ~ norm~lly positioned. This minimizes the possibility of damage occurring to the lining ' ot th0 vessel or to th0 vessel wall during operation of the cutting tool The cutting tool is adapted to be driven at relatively high speed, so that the m~terial such as fatty tissue 5 a~ci5ed iS extremely finely divided prior to its being aspirated back through the lumen .i~ of ~he inn0r catheter. Speeds up to 30,000 rpm sre achieved.
. 13rief Descriction of the Drawin~s ~; Figure 1 is a viaw, partially in ~ction, broken, with parts cut away, illustrating an atherectomy catheter employing one embodiment of the present invention;
Figure 2 is a greatly enlarged fragmentary view, with parts cut away, showing one cutter head arrangam0nt;
... Figure 3 is an end view of the cutter head of Figure 2 still further enlarged;
Figure 4 is a view illustrating an altemativs embodiment of the cutter head of : Figure 2;
, i, Figure 5 is a partial sectional view of the embodiment of Figure 4; and ;; Figure 6 is a view similar to Figure S of another altemate embodiment.
Detailed Desc,i~iol~ of the Invention :
The present invention involves an atherectomy catheter in which a rotatable cutter is dispose~t at th~ distal end and in which means are provided at the proximal ~; 20 end for driving the cutt~r at ~ high rotational sp~ed while sim~ ously injecting a ~'t flushing li4uid ~nd aspir~ting the l. ~t~ rlt site. The invention hrther pro~ndes a outter he~d or cutter tool of improved safety eoordinated and oper~l~d wi~h ~ g~uidew~re system to aid and facilitate ~uiding the catheter through the tortuous path of the venal system to the tre l,..~nQ s~e. Th2 invention will b~ desc~ibecJ with particular r~ference 25 to th~ g figures in which like numerals will ba ~nilized to designate like par~s throu~hout tha 3aml31.
Figure 1 illl.st~t~s the surgical devic~ of the F.r~sent invention wi~h res~e~ to typical &~I.er~to.l~y c~ tar systern which is indicated gen~l~!y by the numeral 10.
..- The system includes a control and drive system located with~n a prC~hi~ housing 1 1, .~ 30 which may be of high impact plastic materi~. The c~theter i~se~ is o~ the coaxial bi-lumenal typa. The housing is connected to an elongaled outerflexible tubular ...ember ~; 12 extending betw~en a distal end 13 and a proximal end 14 coupl~rl to the housing - 11. The hollow lumen of the outer tubular member 12 carnes a concent~ically f' ,1';!
'~'' ~;"'' ~, ~, ,~ WO 93/13717 ~ 9 7 3 P~/~S92/102:~-.,.,;
!,'.' ','';' ' ''~"'' dispos~d, coaxial elongated, flexible inner tubular member 15 which exlends beyond . the full length of the outer tubular m~mber 12. The inner tubular member 15, in the embodiment of Figure 1, also is threaded over a non-rotating or stationary guidewire 16 which e~lends the full length of the inner tubular member 15 and protrudes S ther~hun~ and along which the catheter is free to travel.
As can better been seen in Figures 2 and 3, and will be described in grea~er , .
~; deWI below, the distal end of the catheter carries a hollow cutting head or cutting ~ool 17 which is fixed to the inner tubular member 15 and is tree to rotate about the ouler ~!' tubular member 12. The outer tubular member 12 is tapered down to a distal end portion 18 that creates a bear~'ing surface which allows ~asy joumaled rotation of the ~~ inner tube 15 and cutter head 17. An infusion system is provided including an indented ' annular area of reduced diarneter 19 near the distal end ot the outer tubular member 12 which ~ol)tai, .s a series of radially s~isposed openings or holes 20 (Figure 1). Uquid col)taine~J in the annular space in the lumen of the member 12 surrounding the member ~ 15 15 as ~t 21 ~n be ejected through the holes 20 to flush the opera~ing s~e. An annular ;~ spac~r l~Gn~ber 22 is provided which is bonded both to the distal tip of the inner tubular .er,.ber 15 and the inner surface ~f the cutler head 17 to fix the cutter head to the distal tip of the inner tubular m~mb~r 15.
The guidewire 16 is slidably threaded and extends through a central hole 23 in the distal tip ot the clJtter member 17, throughout the iength of the inner tubular ~ fi~e,nber 15 and housln~, and is sep~r~tely colltlc"e~l. The -atheter system is free to ;~ rnove alon9 the guidewir~, and it is ~esiylJed to remain ~t~tion~y as the cutter head member 17 is rotated. The cutter head 17 cont~ns ~ plural ty ot elongated openings 24 Jisrosed in radial syl"n.et. ~ out the center o~ the distal nos~ as shown in Flgure .~ 25 3. The cutter h~ad m~y typically be initiaJly cylindricai and t~per off in a symmetri~l oval sh~pe as it approaches the distal end. The plurality of openings 2~ is usu~ly an ven numb~r from two to six and the openings are placed close to the nose of the oval-t 51u~ cutter he~d 17 so thalt the possibility o~ inadvertently contacting and cutting the side wall of the vessel frorn which the plaque or other blockage is to be excis~ is 30 virtually slimina~ed.
;~ A dm~e means is contained within the n~id tubular housing 1~ looated at the ~. proximal end of the outer tubular member. The drive functions to rotate the inner .. tubular mernber within the lumen of the outer tubular member. The outer tubular .
.:
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WO93/13717 ~ lq~ ~ 9 r! 3 Pcr/~s92/lo2 member is joined to the tubular housing 11 as through end plug member 30 and is secured as by a compression titting 31 which creates a liquid-tight seal. A rotary union ., shown generaily at 32 is positioned within the housing 11 and includes a stationary ,~ tubular sleeve member 33 fixed to the housing 11 by pins or screws 34. A pa~r of 0-ring seals 35 and 36 are disposed in annular grooves in thr~ tubular sleeve 33 to preclude flushin~ liquid contained in the chamber 37 ~rom passing beyond the rotary ur;ion.
Inside o~ the sta~ionary sleeve 33 is a rotating hollow mani~oJd member 38 whichrotates within the bor~ of the member 33 when driven by a motor such as that depicted genarally at 39 haYing a dnve sha~t 40 and a coupling 41 connec~ed in driving relation ~! to th~ proximai end of thc hollow mani~old member 38. The hollow manifold member '9 38 further contains an annuiar rec~ss 42 connected to a central bore 43 which, in t~-rn, i~ is joined to the proximai end ot the inner elongated flexibla tubular member 15 by a '~ coupling member 44. The central inner bore 43, via th0 annular recess 42, is ~ 15 conn~cted to a further tubular ~itting 45 which passes through a bore in sleeve rnernber ?'~ 33 arld the housing 11 to provide a suction outlet tor aspila(ing the inner elongated nexibl~ tubular member 15. By making the motor drive ~h~ft itself hollow, the staUonary guidewire can be ted through the entire system. Flushing saJine or other solution input k pro~lided through a further access tube 46 which e)ilends through an additional bore in the housing 1 1 which communicat~s with the chsr. ,ber 37.
'' In ~ e~tion, the elGrlgd~d eatheter assembly is a~l~rop~i~tely introduced into ,- the v~ system, as through the f~,l-or~l artery, and advaneed along th~ preYiously ert~ ;.e 16, navig~li"~ through the vascular syst~m to the appropriate arterial i,, or oth~r loc~,or~ o~ interest placing tlse cutter tip 17 adjacent to the atheroma or other . 25 lesion or blockaga .~at~liaJ to be ~ ecl from the vessel. The annular r~oessed ;~n~ter of the outer tubular ~ ber 12, at t 9, ~ids in pr~v~nting clogging of th~ pQ~S
20 dunng the insertion ot the ~tl,~ler through the arterial system. A flushing liquid such a saline is introduced through the fitting 46 into the chamber 37 of the housing ;; ~ 1 1 and ftows through the lumen of the outer tubular member 12 ou~side the outer wall 30 of the inner tubular member 15. The liquid then exits the radial ports 20 loca~ed radialiy .. about the side wall of th~ outer tubular member 12 near is distal end 13. Concurrently, :
a suitable source of suction or negative pressure is ~FI-~1 to thQ fi~ting ~5 in a well-known m~tter to operate in conjunction with the ~lushing solution to aspira~e the . . .
.
,, .
, Wo 93/13717 ~ ; 9 ~ 3 PC~/~Sg2/102~
," .j " -8- .
flushing liquid along with blood and/or tissue or other debris which may be excised .. frorn th~ atheroma or artenal blockage is ~rawn through the openings 2~ in the cutter head 17 through the lumen of the inner tubular member into a suitable receptacl0 (not : shoum).
~;~ 5 The motor 39 is energized to rotate !he hollow manifold member of the rotary~
union wlthin its tubular sleeve and thereby drive the tube 15 to rotate the cutter head ~ 17 as desired. The catheter is advanced utilizing modest pressure between the cutter '. head 17 and lhe tissue lto be ~cis,ed so that the tissue is finely ~ivided by th~ rapidly sF.nr.in~ cutter head and wash~ by blood and flushing liquid through the centr,al i.' ~ 10 lumen of the tube 15 and into a collecting receptacle ~not shown). Once the atheroma has been completed penetrated, blood flow through the blood vessel is restored.
The position of the cutter head within the vessel can be adjusted ~with the l necess~y degree ~ precision during the procedure utilizing the guidewire to achieve Ib complete removal of the blockage. In this manner, the att~ude of the cutting head oan .~ 15 be co~t~ cl and mo~u'~tell with some lesway without the darger of inadvertent or ,ioteniionai damage to the vessel wall.
Figures 4 and 5 show an alle ate embodiment o~ the a~t,erec~omy oatheter of ~ thQ invention in which an al~e" .dtive guidewire 50 is ,orsvided in the nose of the cutter hea~ 17 anel which Ts fixed in a n~&nner which allows it to rotate wrth the cutler head . 2û in a loos~ly fitted or ioumaled arran~en~eu t in which it is free to be held or free to tum with the cutSer element 17 d~pending on the rQs;;.l~nce to tuming. This form ot guid~wirQ provides ~ certain amount o~ guidancs tor th~ ~t~later through the arterial '~ system of i.lter~ without th~ necsss~ty of haYing ths guidewir2 extend throughout th~
entire length of the iflner lumerl at 15. Thus, the ~u ~ir~ SO rnay b~ rivetted to the 25 opening 23 and the cutter ,--e",l~er 17 in a manner which allow very little wobble of the guidewir~ but which allows it to rotate fr~ely wiU~in the opening 23.
Figure 6 illustr~es yet sr.c~ther ~smbc~diment of the ~1h~3r~tc~ r ~lh~t~r of the invention in which th~ annular spacer rnernber 22 is not used and th~ cutter head or ;i alttin~ ltooi 117 is in the shap~ of a tull oval s~tion and co. Ine~led directly to the inn~r . 30 ~he~te~ 15. In a~ditiGn, openings 20 may be r~taced by annular space 120 or a co,l,Li.~a~ion of the hol~s 20 (shown in phantom~ ~nd annular spacer 120 us~d 10rthe ~ inh~sion of flushing iiquid.
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., ~125~73 WO 93/13717 PC'r/1~92/102~-. _ , .
The present invention has been described herein in considerable detail in order to comply with the patent statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such sp~8~ '7ed components as are required. However, it is to be understood that the ~ 5 invention can be carried out by specifieP"y dfflerent equipment and devices and that various modif,cations, both as to equipment details and operating procedures, can be accomplished without departing from the scope ot the invention itselt.
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Claims (8)
1. A surgical cutting device (10) for excising abnormal tissue deposits from theinterior of a vascular passage or vessel of interest characterized by an outer hollow elongated flexible tubular member (12) having an outside diameter smaller than the lumen of the vessel of interest and capable of being advanced through that lumen, the outer tubular member (12) having a proximal end and a distal end; an inner hollow elongated flexible tubular member (15) coaxially disposed within the outer tubular member (12) and having a proximal end and a distal end with the outside of the inner tubular member (15) journalled for rotation inside the outer tubular member (12); drive means (39) connected to the proximal end of the inner tubular member (15) for rotating the inner tubular member (15); and a substantially hollow generally cylindrically symmetric cutting tool (17) having an oval-shaped distal nose portion fixed to the distal end of the inner tubular member (15), the nose portion further comprising a plurality of radially disposed cutting openings (24) extending along and rearward from a point near the distal nose thereof, the openings (24) being in communication with the hollow interior and disposed such that an edge thereof excises tissue contacted upon rotation of the cutting tool (17) about a longitudinal axis, the excised tissue being directed into the hollow interior of the tool, wherein the plurality of openings (24) are elongated and positioned within the distal oval portion of the nose of reduced diameter such that the cutting surfaces cannot engage tissue at right angles to the longitudinal axis of the cutting tool (17), the hollow interior of the cutting tool (17) further being incommunication with the interior of the inner tubular member (15).
2. The surgical device of Claim 1 further comprising a non-rotating guidewire means (16) disposed in the inner tubular member (15) and extending beyond both the proximal and distal ends thereof, the distal end of the guidewire means (16) protruding from a central opening provided in the nose of the cutting tool (17), the inner tube member (15) and the cutting tool (17) being free to rotate around the guidewire means (16), the guidewire means (16) extending through the drive means (39) on the proximal end to allow external control and operation of the guidewire means (16) independent of the operation of the remainder of the device.
3. The surgical device of Claim 1 further comprising a central opening (23) in the nose of the cutting tool (17), a guidewire (16) of fixed longitudinal disposition having a proximal end journal mounted in the central opening (23) in the cutting tool (17) and a distal end protruding from the central hole (23) in the cutting tool (17), said guidewire (16) having a longitudinal axis substantially parallel to the longitudinal axis of the cutting tool, the guidewire (16) being mounted in a manner such that it is free to rotate with the cutting tool (17) or is free to stop and allow the cutting tool (17) to rotate about the guidewire (16).
4. The surgical device of Claim 1 further comprising fluid inlet means (46) associated with the drive means (39) for introducing a flushing liquid into the lumen of the outer tubular member (12), and at least one fluid passing outlet opening (20) toward the distal end of the lumen of the outer tubular member (12) for the flushing liquid to exit the device.
5. The surgical device of Claim 4 further comprising at least one radial fluid passing opening (20) near the distal end of the outer tubular member (12).
6. The surgical device of Claim 1 further comprising fluid outlet means (45) associated with the drive means (39) for passing aspirated liquids and excised debris conducted from the excising openings (24) in the cutting tool (17) via the lumen of the inner tubular member (15) to the proximal end thereof.
7. The surgical cutting system of Claim 1 further comprising fluid inlet means (46) associated with the drive means (39) for introducing a flushing liquid between the walls of the inner and outer tubular members (12, 15), with the flushing liquid exiting the lumen of the outer tubular member (12) through at least one passage (20) toward or at the distal end thereof, and fluid outlet means (45) associated with the drive means (39) for passing aspirated liquids including flushing liquids and excised debris conducted from the excising openings (24) in the cutting tool (17) via the lumen of the inner tubular member (15) to the proximal end of the inner tubular member (15).
8. The surgical device of Claim 1 wherein the distal end of the outer tubular member (12) has an outside diameter which is necked down with respect to the diameter of the remaining portion of the outer tubular member (12), which has at least one radial opening (20) in the necked-down section for passing fluid outward therethrough.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US81978092A | 1992-01-13 | 1992-01-13 | |
| US819,780 | 1992-01-13 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2125973A1 CA2125973A1 (en) | 1993-07-22 |
| CA2125973C true CA2125973C (en) | 1998-04-28 |
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ID=25229042
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002125973A Expired - Fee Related CA2125973C (en) | 1992-01-13 | 1992-12-02 | Cutter for atherectomy catheter |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US5358485A (en) |
| EP (1) | EP0681458B1 (en) |
| JP (1) | JP2549823B2 (en) |
| AT (1) | ATE166780T1 (en) |
| CA (1) | CA2125973C (en) |
| DE (2) | DE9290167U1 (en) |
| DK (1) | DK0681458T3 (en) |
| ES (1) | ES2116355T3 (en) |
| PT (1) | PT101174A (en) |
| WO (1) | WO1993013717A1 (en) |
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-
1992
- 1992-12-02 DE DE9290167U patent/DE9290167U1/en not_active Expired - Lifetime
- 1992-12-02 EP EP92925445A patent/EP0681458B1/en not_active Expired - Lifetime
- 1992-12-02 CA CA002125973A patent/CA2125973C/en not_active Expired - Fee Related
- 1992-12-02 DE DE69225812T patent/DE69225812T2/en not_active Expired - Fee Related
- 1992-12-02 DK DK92925445T patent/DK0681458T3/en active
- 1992-12-02 AT AT92925445T patent/ATE166780T1/en active
- 1992-12-02 JP JP5512425A patent/JP2549823B2/en not_active Expired - Lifetime
- 1992-12-02 ES ES92925445T patent/ES2116355T3/en not_active Expired - Lifetime
- 1992-12-02 WO PCT/US1992/010257 patent/WO1993013717A1/en active IP Right Grant
-
1993
- 1993-01-11 PT PT101174A patent/PT101174A/en not_active Application Discontinuation
- 1993-08-16 US US08/109,003 patent/US5358485A/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JP2549823B2 (en) | 1996-10-30 |
| JPH06511177A (en) | 1994-12-15 |
| WO1993013717A1 (en) | 1993-07-22 |
| DE69225812T2 (en) | 1998-10-01 |
| PT101174A (en) | 1994-05-31 |
| CA2125973A1 (en) | 1993-07-22 |
| DK0681458T3 (en) | 1998-10-12 |
| EP0681458B1 (en) | 1998-06-03 |
| ES2116355T3 (en) | 1998-07-16 |
| US5358485A (en) | 1994-10-25 |
| EP0681458A1 (en) | 1995-11-15 |
| DE9290167U1 (en) | 1994-09-15 |
| ATE166780T1 (en) | 1998-06-15 |
| DE69225812D1 (en) | 1998-07-09 |
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| EEER | Examination request | ||
| MKLA | Lapsed |