CA2092992A1 - Atherectomy catheter having axially-disposed cutting edge - Google Patents
Atherectomy catheter having axially-disposed cutting edgeInfo
- Publication number
- CA2092992A1 CA2092992A1 CA002092992A CA2092992A CA2092992A1 CA 2092992 A1 CA2092992 A1 CA 2092992A1 CA 002092992 A CA002092992 A CA 002092992A CA 2092992 A CA2092992 A CA 2092992A CA 2092992 A1 CA2092992 A1 CA 2092992A1
- Authority
- CA
- Canada
- Prior art keywords
- catheter
- head
- distal end
- cutting head
- aperture
- 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.)
- Abandoned
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
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
Abstract
Atherectomy catheters are described having a cylindrical cutting head rotatably mounted at the distal end of a catheter body. The head has an axially elongated aperture and an open interior. A
severing means is disposed adjacent the elongated aperture such that atheromatous material invaginated by the head is severed and diverted into the interior of the head. A preferred embodiment has the elongated aperture helically-disposed about the central axis of the cylindrical head and a cutting means formed integrally along the periphery of the aperture. Another preferred embodiment has the cylindrical head provided with a tapered distal end that extends distally from a housing for the head and incorporates an extension of the elongated aperture.
severing means is disposed adjacent the elongated aperture such that atheromatous material invaginated by the head is severed and diverted into the interior of the head. A preferred embodiment has the elongated aperture helically-disposed about the central axis of the cylindrical head and a cutting means formed integrally along the periphery of the aperture. Another preferred embodiment has the cylindrical head provided with a tapered distal end that extends distally from a housing for the head and incorporates an extension of the elongated aperture.
Description
W~9~/07~00PCT/~'S91/08006 ;~
. . , ATHERECTOMY C~THETER ~VING
AXIAL~Y-DISPOSED C~TTING EDGE
CROSS-REFEREN OE TO RELATF.D APPLICATIONS
_The present application contains subjec~ matter related to co-pending application Seri,l No. ~05,~06, filed September 12, 1989, which is incorporated herein by reference.
BAC~GRO~ND OF TH~ INVENTION
1. Field of the In~ention The present invention relates generally to the construction and use of intravascular catheters. More particularly, the in~ention relates to atherec~omy ca~heters havlng means at their distal ends for severing - -stenotic material.
Human vascular systems commonly become constricted, or stenotic, due to the accumulation of atheromatous material on the inner walls of the vascular lumens. When blood vessels such as arteries or vein grafts are involved, this condition is known as arterio~clerosis, or atherosclerosis. Atherosclerosis occurs naturally as a part of the aging process, but may also be aggravated by such factors as diet, hypertension and heredity. The intravascular deposits, or atheromas, tend to restrict blood flow causing ischemia, and in acute cases can result in myocardial infarction. The material properties of the deposits vary widely, with some deposits being relati.vely so~t and others fibrous or calcified.
Many approaches for removin~ such deposits have been proposed. Generally, the approaches for removing atheromas have employed cutting, grinding or thermal ablation techniqu~s. Of particular interest to the present inventi~n are atherectomy de~ices and methods 35 ~ which employ a means for severing atheromatous material from the vessel wall.
.
, , . ~ , .. ,~, ;,. . , . ... , . . ,: :
~092/07500 PCT/VS91/OX~06 2 ~
In a t~Ipical atherectomy opera~ion, a catheter having a suitable diameter is introduced into a lumen of the pa~iPn~'s vascular system and positioned adjacent t~e ~arget ma~erial. ~ cutter blade provided at the distal end of the catheter is brought into contact with the target ma~erlal. The cathe~er may either ~e a front-end cutting type or a sidP-cutting type. Front-end cutting atherectomy catheters are particularly useful in penetrating non-crossable lesions as they can "drill"
through the lesion. Side-cutting atherectomy catheters are particularly useful in "debul~ing" a stenosed region and may employ an inflata~le balloon disposed opposite the cut~er blade tO assist the blade in removing succescive layers or s~enotic material.
Although atherectomy catheters hav~ en~oyed subs~antial success ln trealing vascular stenoses, some designs suffer from certain limitations. In particular, sev~ring or abrading of the occluding material can result in the release of atheromatous particles which may then embolize the vasculature. Such e~boli will lodge in the narrower regions of the vascular system and may siqnificantly restrict the blood flow in critical regions of the vascular system, such as the coronary arteries.
This may, in turn, endanger the patient's health.
Front-end cutting catheters are particularly prone to the release of large e~boli into the va~cular system. Some front-end cutting devices employ an exposed ~lade th~t severs or abradQs the stenotic material.
Usually provisions are made for aspirating the remoYed material, together with a substantial volume of blood, back throu~h the catheter so that it is not released in the vascular system. Seet for example, U.S. Patent Nos.
4,857,046, and 4,772,258. The use o~ aspiratio~ with a rapidly rotating blade, how~ver, cannot be re}ied on to capture all o~ the atheromatous material which is liberated during the atherectomy procedure.
w~92/~7soo ~CT/~'S91/08006 Side-cu~ting catheters generally reduce the propensity for release OI emboli lnto the vascular sys~em slnce a housin~ is useà to contain ~he olade and the housing ~s presse~ firmly agains~ the vessei wall having _ the atheromatous ma~erial. Most par~icles severed from the wall collect withln ~he housing; more so than with front-end cutting catheters. See, for exampie, U.S.
Patent No. 4,669,469 and EPO Publication No. 0 163 502.
For these reasons, it is desi.red to provide ~0 atherec~omy catheters that c~n remove stenotic material in a more con~rollea fashion with a minimum ris~ of releasing emboli into the vascular system. In particuiar, ~t is àeslred to invaginate atheromalous material within a subs~an~ially enclosed s~ruc~ure as ~he material is severed from the stenosed portion of the vascular lumen. ~ditionally, it is desired to provide a means for withdrawing the captured material from the enclosed structure. Also, it is desirable to provide methods for severing occluding material in such a manner as to ensure that it is retained within the means for containment until the catheter can be withdrawn from the patient. Finally, it would be desirable to provide atherectomy catheters which combine the ability of front-end cutters to penetrate lesions with the ability of side cutters to debulk stenosed regions.
2. escr ption of the Bac~qr und Art U.S. Patent Nos. 4,857,046; 4,772,258;
4,745,9l9: and 4,653,496, all describe front-end cutting ath~rectomy catheters and the disclosure of each is incorporated herein by reference. Several of these patents further disclose use of a helical cutting blade to sever material from the vascular lu~en. U.S. Patent Nos. 4,685,458; 4,669,469: 4,627,436; and EPO Publication - No. a 163 502 each describe a side cutting atherectomy catheter and the disclosure of each is incorporated herein by reference. These side-cutting devices may employ an inflatable balloon opposite an opening in the (~`
.
: ~
~o 92/07s00 , PCr/l,lS9l/08~)0~ :
~ . , i . ... .
housing tha~ contains the cutting blade. U.S. 2atent No.
4,020,847, describes a biopsy catheter having a slotted -~linder at its distal end, where the slot lncludes a cu~ting edge for severlng tissue as the cathe~er is - rotated.
SUMMARY OF THE INVENTION
According to the present invention, an atherectomy catheter comprises a catheter body having a cylindrical cutting head rotatably mounted at the distal '0 end of the catheter body. The cylindrical cu~tin~ head has an open lnterior and at least one axially elongated aperture. A means for rotating the cylindrical head is provided within the catheter body, and a means for severlng stenolic material and diver~ing said severed lS material into the interior of the head is disposed adjacent the elong~ted aperture. Thus, by rotat.inq the cuttinq head, the cathe~er can sever atheromatous material which lies to the side of the catheter body and capture the severed material within the interior o~ the head.
A preferred embodiment of the invention ~;
employs a cylindrical cutting head h~ving a tapered ;
~distal end. The axially elongated aperture and the severing means both ex~end to near the tapered distal end of the cylindrical cuttin~ head, and the head thus is capable of forward-cutting through lesions bloc~ing a vessel by axially advancing the catheter as th~ head ls rotated. Usually, the cut1:ing head may be axially advanced from the catheter body while the head is being rotated in oxder to facili~ate pene~ration of severe occlu~ions. Al~ernatively, the entire cathe~er body may be adv~nced axially forward within the blood vessel ~ lumen.
; In a further pre~erred embodi~ent of the inv~ntion, the elongated aperture and severing means are helically disposed about a central axis o~ the h~ad. The aperture~and cutting means may have a relatively ~ ` .
: : ' .
" : ,, , ", , ",, " ", "" "
wn 92/07S00 PcT/~ls91Jo~on6 "
"shallow" helical an~le so that the described helix subtends less t~an one complete turn about the oylindrical head, or may have a more steep anale so that ~he helix subten~s one or more turns aDOU~ ~he cyllndrical head.
30th s~eeD and shallow helica]. conrigurations will afford a more co~trolled removal of vascular atheromatous deposits than previously available devices ~ecause relatively thin "slices" will be removed from the vascular wall. HoweYer, cutting heads having relatively steep helical configuration will be generally more effective ~han sAallow configurations in removing plaque from t~e vascular lumen as steep configurations provide a more aggressiYe cutting angle than shallow ones.
lS Also, ~oth steep and shallow helical configura~lons will afford improved means ror re~oving severed atheroma slices as the severed material will be contained within the interior of the cutting heacl.
However, those embodiments employing relatively shallow configurations generally will be preferred with respect to withdrawing severed material since less open surface area is presented to the ou-tside of the head by shallow apertures and since the apertures with such shallow angle cutting heads can be "shielded'` by positioning the aper~ures adjacent the internal wall of housings. The selection of steep or shallow angle cutting catheters will depend on the particular application.
In a still further preferred embodiment of the invention, the severing means includes a cutting edge formed integrally along at least a part of the periph~ry of the elongated aperture, usually being ~ormed along the edqe o~ the aperture which ~rails as ~he head is rotated.
The elo~ga~ed aper~ure should allow substantial invagination of atheromatou~ ma~erial as the h~ad is rotated. Such invagination can be enhanced by provision of an inwardly-inclined leading edge to the aperture.
~ ' .
, ~
~: :
: .... , . , . . - - . - , - .
~092/07~00 PCT/US91/08006 6 - . ..-,, The cylindrical cutt ng head may be mounted free of a housing. Usually, howevar, the head will be mounted within a housing at the distal end of the catheter, with the housing having an axially elongated opening through which the cylindrical c~tting head ls exposed. The axially elonyated opening of the housing may be continued distally ~o expose the! tapered distal end o the cylindrical cutting head. With such a configuration, the tapered distal ~nd of the cu~tlng head may be initi~lly brought into contact with the stenotic material and used to "drill" through 50 that the housing can penetrate into even a severe occlu.sion. After the housing is located within the occlusion, the balloon can be used as described above to debulk the a~hercmatous material.
The present invention affords novel methods for removing atheromatous material from a patient's vascular system. The methods comprise the steps of introducing the distal end of t~e catheter into a vascular lumen adjacent the target material and rotating the cylindrical cutting head relative to the catheter body. The cutti~g head may be laterally displaced so that ~he atheromatous material is pushed into the aperture, severed by the severing means, and further captured within the intarior of the head. Alternatively, the cutting head and/or the .
entire catheter may be axially advanced within t~e lu~en of the vessel while the cutting head i~ ~eing rotat~d so that a forwardly disposed portion of the s~vering means can penetrate a stenosis and remove the atheromatous material which lies in front of the catheter. Usually, the atheromatous material will be removed by sequentially ad~ancing axially and then laterally displacing the cylindrical cutting head so ~hat extended and otherwise ~-i~passable regions of stenosis can be penetrated and debulked. Optionally, the entire catheter body is :
rotated while the cutting head is b~ing motor rotated and the inflation balloon is only moderately inflated in ~ .
:
~09Z/07;00 PCT/~'~91/Q8006 order to remove a~ ex~enàed arc or ~aterlal wlthin the blood vessel lumen. In ail cases, the severed materlal _an be removed -^_om ~he vascular svstem by ~l~harawina ~he catheter ~ith the ma~erlal re~ained withi~ s~e cylindrical cu~ting head.
The presen~ invention thereby arfords superior devices and me~hods ror removing atheroma~ous material from a patient's vascular system. The vascular deposits can be controllably invaginated, sev~red and captured as relatively thin slices having a predetermined range of thickness, ~hereby reducing the ris~ of releasing particles that can embolize the vascular system. Severed atheromas will be iargeiy re~ained within the cutt:Ln~
head until they can be wlthdrawn rrom the patien~, thereby affording a means for withdrawing the material ~hat does no~ require aspiration and the àesiq~ !
complexities that accompany use of an aspiration means.
Retention of severed atheromas will be particularly enhanced when a housing is employed with a side-cutting catheter so that the open aperture(s) of the cutting head will be adjacent either the internal wall of the housing or the vascular lumen during operation of the head. ;
Al~o, the present catheters enable more straightforward techniques for debulking stenose~ from nearly the entire region of a diseased vascular lumen by allowin~ the user to expand the scallop-shaped debulked region, normally produced by other ca~heters, using a "shaving" action until nearly all stenotic material is removed from the lumen.
BRIEF DESC~I~ION OF ~rn~ DRAWINGS
Fig. l is a side view of a side-cutting atherectomy catheter constructed in accordance with the ; principles of the present invention.
Fig. 2 is a broken-away view of the distal reglon of the catheter shown in Fig. l.
Fig. 3 is a perspective view of the cylindrical ~ cutting head of the catheter shown in Fig. l.
: ' ; .
.
W092/07~0 PCT/US91/0~006 .~ , , ~ . , ~, Fig. 4A is a cross-sectlonal vlew taken alon~
line 4A-~A of Fig. 1.
Fig. ~B is a cross-sectional view of an alternative embodiment of the cutting head of the present invention.
Fig. ~ is a perspective view of the distal region of a combined side and front-end cutting catheter constructed according to the principles of the present invention.
Fig. 6 is a perspective vlew of the cutting head of the catheler shown in Fig. 5.
Fig. 7 is a perspective view of an alternatlve embodiment for a side-cutting catheter constructed in ~ i accordance with the principles of the present invention.
Fig. 8 is a perspective view of the cutting head or the catheter shown in Fi~. 7.
Fig. 9 is a broken-away view of the distal end of the catheter shown .in Fi~. 7.
Fig. 10 is a vector diagram showing the ;
dependence of cutting edge velocity on the angle defined by the aperture pitch and the central axis of the cutting head.
DETAILED_DE5CRIPTION OF THE PREFER~ED_EMBODrMENTS
The 1ntravascular catheters of th~ present invention will have an elongated catheter body having distal and proximal ends. The cathet~rs will comprise a cylindrical cutting head for removing atheromatous material at the distal end of the catheter body. The cylindrical cutting head will be rotatably mounted at the distal end of the cath~ter body. Al50, the cylindrical head will have an open interior and at least one axially ~' elon~ated ap2rture. Means will be provided within the catheter hody for rotating the cylindrical head.
~ Additionally, means for severing atheromatous material will be disposed adjacent elongated ~perture~s) of the cylindrical head so as to divert severed material into the interior of the head.
'~ ' ,, , .:
W092/07~0~ PCT/~'S91/0800~
g R . . . . .: ~ .
In a preferred embodimen~, the cyllndrlcal head will have a tapered distal end. The tapered end may be formed in~egrally wlth the cylindrical body of ~he head or, alternatively, ~ay be formed separately as a "noseplece" attached to the distal end of the cylindrical head. The axially elon~ated aperture of the head may extend continuously into the tapered region of the head to afford front-end cutting capability. Alternatively, the tapered distal region of the head may include a separately formed aperture having an adjacPnt severing means like that provided on the cylindrical head.
Whenever a nosepiece is provided on the distal end of the head, the noseplece preferably will be detachable from the cylindrical body of the head to permit remov~l of severed material within the head. It is especi~lly desirable that the nosepiece be detachable when the nosepiece does not include a severing means, in order to allow cleaning of the interior of the head. Typically, the distal tip of the head will be provided with an orifice to permit passage of a guidewire therethrough.
The catheters of the present invention will usually be provided with a housinq ~or the cylindrical cutting head at the distal end of the cathater. Such a housing will have an axially elongated opening through ~;~
which target atheroma~ous material can co~tact the severing means of the rotatable head. Preferably, an in~latable balloon will be provided external the housing and generally opposite the axially elongated ~pening, with the balloon facilitating intimate contact of the rotatable head with the vascular lumen and atheromatous material.
Ath~romatous materials that can be removed by the present devic2s include all naturally-occurring occlusions found in vascular lumens, e.g., lipoprotein deposits, blood clots, atherosclerotic plaques, and the like. The materials may be hardened plaques or relatively soft athero~as, with the present invention '.
~'0 9t/07500 PCT/I,'S91/08~06 , :
par~icularly sulted for removing relatively soft deposlts .
A. Catheter Bodi~s Referring now to Fig. l, an atherectomy catheter 110 constructed in accordance with the principles of the present lnvention comprises a catheter body 112, a cylindrical housing 114 attached t~ the distal end of catheter body 112, and a connector manifold 116 attached to the proximal end nf the catheter body. A
cylindrical cu~ting head 11~ is dispo~ed within the interior of housing 114.
As illustrated, the catheter body 112 includes an annular lumen 120 which extends throuqh the entire length of the cathe~er body. Lumen 120 allows passage of torque cable 122 therethrough. Torque cable 122 is typically a braided cable or the like and is attached to the proximal end of rotatable cutting head 118. Methods for constructing suitable braided structures ~or torque cable 122 are described in U.S. Patent Nos. 4,425,919:
. . , ATHERECTOMY C~THETER ~VING
AXIAL~Y-DISPOSED C~TTING EDGE
CROSS-REFEREN OE TO RELATF.D APPLICATIONS
_The present application contains subjec~ matter related to co-pending application Seri,l No. ~05,~06, filed September 12, 1989, which is incorporated herein by reference.
BAC~GRO~ND OF TH~ INVENTION
1. Field of the In~ention The present invention relates generally to the construction and use of intravascular catheters. More particularly, the in~ention relates to atherec~omy ca~heters havlng means at their distal ends for severing - -stenotic material.
Human vascular systems commonly become constricted, or stenotic, due to the accumulation of atheromatous material on the inner walls of the vascular lumens. When blood vessels such as arteries or vein grafts are involved, this condition is known as arterio~clerosis, or atherosclerosis. Atherosclerosis occurs naturally as a part of the aging process, but may also be aggravated by such factors as diet, hypertension and heredity. The intravascular deposits, or atheromas, tend to restrict blood flow causing ischemia, and in acute cases can result in myocardial infarction. The material properties of the deposits vary widely, with some deposits being relati.vely so~t and others fibrous or calcified.
Many approaches for removin~ such deposits have been proposed. Generally, the approaches for removing atheromas have employed cutting, grinding or thermal ablation techniqu~s. Of particular interest to the present inventi~n are atherectomy de~ices and methods 35 ~ which employ a means for severing atheromatous material from the vessel wall.
.
, , . ~ , .. ,~, ;,. . , . ... , . . ,: :
~092/07500 PCT/VS91/OX~06 2 ~
In a t~Ipical atherectomy opera~ion, a catheter having a suitable diameter is introduced into a lumen of the pa~iPn~'s vascular system and positioned adjacent t~e ~arget ma~erial. ~ cutter blade provided at the distal end of the catheter is brought into contact with the target ma~erlal. The cathe~er may either ~e a front-end cutting type or a sidP-cutting type. Front-end cutting atherectomy catheters are particularly useful in penetrating non-crossable lesions as they can "drill"
through the lesion. Side-cutting atherectomy catheters are particularly useful in "debul~ing" a stenosed region and may employ an inflata~le balloon disposed opposite the cut~er blade tO assist the blade in removing succescive layers or s~enotic material.
Although atherectomy catheters hav~ en~oyed subs~antial success ln trealing vascular stenoses, some designs suffer from certain limitations. In particular, sev~ring or abrading of the occluding material can result in the release of atheromatous particles which may then embolize the vasculature. Such e~boli will lodge in the narrower regions of the vascular system and may siqnificantly restrict the blood flow in critical regions of the vascular system, such as the coronary arteries.
This may, in turn, endanger the patient's health.
Front-end cutting catheters are particularly prone to the release of large e~boli into the va~cular system. Some front-end cutting devices employ an exposed ~lade th~t severs or abradQs the stenotic material.
Usually provisions are made for aspirating the remoYed material, together with a substantial volume of blood, back throu~h the catheter so that it is not released in the vascular system. Seet for example, U.S. Patent Nos.
4,857,046, and 4,772,258. The use o~ aspiratio~ with a rapidly rotating blade, how~ver, cannot be re}ied on to capture all o~ the atheromatous material which is liberated during the atherectomy procedure.
w~92/~7soo ~CT/~'S91/08006 Side-cu~ting catheters generally reduce the propensity for release OI emboli lnto the vascular sys~em slnce a housin~ is useà to contain ~he olade and the housing ~s presse~ firmly agains~ the vessei wall having _ the atheromatous ma~erial. Most par~icles severed from the wall collect withln ~he housing; more so than with front-end cutting catheters. See, for exampie, U.S.
Patent No. 4,669,469 and EPO Publication No. 0 163 502.
For these reasons, it is desi.red to provide ~0 atherec~omy catheters that c~n remove stenotic material in a more con~rollea fashion with a minimum ris~ of releasing emboli into the vascular system. In particuiar, ~t is àeslred to invaginate atheromalous material within a subs~an~ially enclosed s~ruc~ure as ~he material is severed from the stenosed portion of the vascular lumen. ~ditionally, it is desired to provide a means for withdrawing the captured material from the enclosed structure. Also, it is desirable to provide methods for severing occluding material in such a manner as to ensure that it is retained within the means for containment until the catheter can be withdrawn from the patient. Finally, it would be desirable to provide atherectomy catheters which combine the ability of front-end cutters to penetrate lesions with the ability of side cutters to debulk stenosed regions.
2. escr ption of the Bac~qr und Art U.S. Patent Nos. 4,857,046; 4,772,258;
4,745,9l9: and 4,653,496, all describe front-end cutting ath~rectomy catheters and the disclosure of each is incorporated herein by reference. Several of these patents further disclose use of a helical cutting blade to sever material from the vascular lu~en. U.S. Patent Nos. 4,685,458; 4,669,469: 4,627,436; and EPO Publication - No. a 163 502 each describe a side cutting atherectomy catheter and the disclosure of each is incorporated herein by reference. These side-cutting devices may employ an inflatable balloon opposite an opening in the (~`
.
: ~
~o 92/07s00 , PCr/l,lS9l/08~)0~ :
~ . , i . ... .
housing tha~ contains the cutting blade. U.S. 2atent No.
4,020,847, describes a biopsy catheter having a slotted -~linder at its distal end, where the slot lncludes a cu~ting edge for severlng tissue as the cathe~er is - rotated.
SUMMARY OF THE INVENTION
According to the present invention, an atherectomy catheter comprises a catheter body having a cylindrical cutting head rotatably mounted at the distal '0 end of the catheter body. The cylindrical cu~tin~ head has an open lnterior and at least one axially elongated aperture. A means for rotating the cylindrical head is provided within the catheter body, and a means for severlng stenolic material and diver~ing said severed lS material into the interior of the head is disposed adjacent the elong~ted aperture. Thus, by rotat.inq the cuttinq head, the cathe~er can sever atheromatous material which lies to the side of the catheter body and capture the severed material within the interior o~ the head.
A preferred embodiment of the invention ~;
employs a cylindrical cutting head h~ving a tapered ;
~distal end. The axially elongated aperture and the severing means both ex~end to near the tapered distal end of the cylindrical cuttin~ head, and the head thus is capable of forward-cutting through lesions bloc~ing a vessel by axially advancing the catheter as th~ head ls rotated. Usually, the cut1:ing head may be axially advanced from the catheter body while the head is being rotated in oxder to facili~ate pene~ration of severe occlu~ions. Al~ernatively, the entire cathe~er body may be adv~nced axially forward within the blood vessel ~ lumen.
; In a further pre~erred embodi~ent of the inv~ntion, the elongated aperture and severing means are helically disposed about a central axis o~ the h~ad. The aperture~and cutting means may have a relatively ~ ` .
: : ' .
" : ,, , ", , ",, " ", "" "
wn 92/07S00 PcT/~ls91Jo~on6 "
"shallow" helical an~le so that the described helix subtends less t~an one complete turn about the oylindrical head, or may have a more steep anale so that ~he helix subten~s one or more turns aDOU~ ~he cyllndrical head.
30th s~eeD and shallow helica]. conrigurations will afford a more co~trolled removal of vascular atheromatous deposits than previously available devices ~ecause relatively thin "slices" will be removed from the vascular wall. HoweYer, cutting heads having relatively steep helical configuration will be generally more effective ~han sAallow configurations in removing plaque from t~e vascular lumen as steep configurations provide a more aggressiYe cutting angle than shallow ones.
lS Also, ~oth steep and shallow helical configura~lons will afford improved means ror re~oving severed atheroma slices as the severed material will be contained within the interior of the cutting heacl.
However, those embodiments employing relatively shallow configurations generally will be preferred with respect to withdrawing severed material since less open surface area is presented to the ou-tside of the head by shallow apertures and since the apertures with such shallow angle cutting heads can be "shielded'` by positioning the aper~ures adjacent the internal wall of housings. The selection of steep or shallow angle cutting catheters will depend on the particular application.
In a still further preferred embodiment of the invention, the severing means includes a cutting edge formed integrally along at least a part of the periph~ry of the elongated aperture, usually being ~ormed along the edqe o~ the aperture which ~rails as ~he head is rotated.
The elo~ga~ed aper~ure should allow substantial invagination of atheromatou~ ma~erial as the h~ad is rotated. Such invagination can be enhanced by provision of an inwardly-inclined leading edge to the aperture.
~ ' .
, ~
~: :
: .... , . , . . - - . - , - .
~092/07~00 PCT/US91/08006 6 - . ..-,, The cylindrical cutt ng head may be mounted free of a housing. Usually, howevar, the head will be mounted within a housing at the distal end of the catheter, with the housing having an axially elongated opening through which the cylindrical c~tting head ls exposed. The axially elonyated opening of the housing may be continued distally ~o expose the! tapered distal end o the cylindrical cutting head. With such a configuration, the tapered distal ~nd of the cu~tlng head may be initi~lly brought into contact with the stenotic material and used to "drill" through 50 that the housing can penetrate into even a severe occlu.sion. After the housing is located within the occlusion, the balloon can be used as described above to debulk the a~hercmatous material.
The present invention affords novel methods for removing atheromatous material from a patient's vascular system. The methods comprise the steps of introducing the distal end of t~e catheter into a vascular lumen adjacent the target material and rotating the cylindrical cutting head relative to the catheter body. The cutti~g head may be laterally displaced so that ~he atheromatous material is pushed into the aperture, severed by the severing means, and further captured within the intarior of the head. Alternatively, the cutting head and/or the .
entire catheter may be axially advanced within t~e lu~en of the vessel while the cutting head i~ ~eing rotat~d so that a forwardly disposed portion of the s~vering means can penetrate a stenosis and remove the atheromatous material which lies in front of the catheter. Usually, the atheromatous material will be removed by sequentially ad~ancing axially and then laterally displacing the cylindrical cutting head so ~hat extended and otherwise ~-i~passable regions of stenosis can be penetrated and debulked. Optionally, the entire catheter body is :
rotated while the cutting head is b~ing motor rotated and the inflation balloon is only moderately inflated in ~ .
:
~09Z/07;00 PCT/~'~91/Q8006 order to remove a~ ex~enàed arc or ~aterlal wlthin the blood vessel lumen. In ail cases, the severed materlal _an be removed -^_om ~he vascular svstem by ~l~harawina ~he catheter ~ith the ma~erlal re~ained withi~ s~e cylindrical cu~ting head.
The presen~ invention thereby arfords superior devices and me~hods ror removing atheroma~ous material from a patient's vascular system. The vascular deposits can be controllably invaginated, sev~red and captured as relatively thin slices having a predetermined range of thickness, ~hereby reducing the ris~ of releasing particles that can embolize the vascular system. Severed atheromas will be iargeiy re~ained within the cutt:Ln~
head until they can be wlthdrawn rrom the patien~, thereby affording a means for withdrawing the material ~hat does no~ require aspiration and the àesiq~ !
complexities that accompany use of an aspiration means.
Retention of severed atheromas will be particularly enhanced when a housing is employed with a side-cutting catheter so that the open aperture(s) of the cutting head will be adjacent either the internal wall of the housing or the vascular lumen during operation of the head. ;
Al~o, the present catheters enable more straightforward techniques for debulking stenose~ from nearly the entire region of a diseased vascular lumen by allowin~ the user to expand the scallop-shaped debulked region, normally produced by other ca~heters, using a "shaving" action until nearly all stenotic material is removed from the lumen.
BRIEF DESC~I~ION OF ~rn~ DRAWINGS
Fig. l is a side view of a side-cutting atherectomy catheter constructed in accordance with the ; principles of the present invention.
Fig. 2 is a broken-away view of the distal reglon of the catheter shown in Fig. l.
Fig. 3 is a perspective view of the cylindrical ~ cutting head of the catheter shown in Fig. l.
: ' ; .
.
W092/07~0 PCT/US91/0~006 .~ , , ~ . , ~, Fig. 4A is a cross-sectlonal vlew taken alon~
line 4A-~A of Fig. 1.
Fig. ~B is a cross-sectional view of an alternative embodiment of the cutting head of the present invention.
Fig. ~ is a perspective view of the distal region of a combined side and front-end cutting catheter constructed according to the principles of the present invention.
Fig. 6 is a perspective vlew of the cutting head of the catheler shown in Fig. 5.
Fig. 7 is a perspective view of an alternatlve embodiment for a side-cutting catheter constructed in ~ i accordance with the principles of the present invention.
Fig. 8 is a perspective view of the cutting head or the catheter shown in Fi~. 7.
Fig. 9 is a broken-away view of the distal end of the catheter shown .in Fi~. 7.
Fig. 10 is a vector diagram showing the ;
dependence of cutting edge velocity on the angle defined by the aperture pitch and the central axis of the cutting head.
DETAILED_DE5CRIPTION OF THE PREFER~ED_EMBODrMENTS
The 1ntravascular catheters of th~ present invention will have an elongated catheter body having distal and proximal ends. The cathet~rs will comprise a cylindrical cutting head for removing atheromatous material at the distal end of the catheter body. The cylindrical cutting head will be rotatably mounted at the distal end of the cath~ter body. Al50, the cylindrical head will have an open interior and at least one axially ~' elon~ated ap2rture. Means will be provided within the catheter hody for rotating the cylindrical head.
~ Additionally, means for severing atheromatous material will be disposed adjacent elongated ~perture~s) of the cylindrical head so as to divert severed material into the interior of the head.
'~ ' ,, , .:
W092/07~0~ PCT/~'S91/0800~
g R . . . . .: ~ .
In a preferred embodimen~, the cyllndrlcal head will have a tapered distal end. The tapered end may be formed in~egrally wlth the cylindrical body of ~he head or, alternatively, ~ay be formed separately as a "noseplece" attached to the distal end of the cylindrical head. The axially elon~ated aperture of the head may extend continuously into the tapered region of the head to afford front-end cutting capability. Alternatively, the tapered distal region of the head may include a separately formed aperture having an adjacPnt severing means like that provided on the cylindrical head.
Whenever a nosepiece is provided on the distal end of the head, the noseplece preferably will be detachable from the cylindrical body of the head to permit remov~l of severed material within the head. It is especi~lly desirable that the nosepiece be detachable when the nosepiece does not include a severing means, in order to allow cleaning of the interior of the head. Typically, the distal tip of the head will be provided with an orifice to permit passage of a guidewire therethrough.
The catheters of the present invention will usually be provided with a housinq ~or the cylindrical cutting head at the distal end of the cathater. Such a housing will have an axially elongated opening through ~;~
which target atheroma~ous material can co~tact the severing means of the rotatable head. Preferably, an in~latable balloon will be provided external the housing and generally opposite the axially elongated ~pening, with the balloon facilitating intimate contact of the rotatable head with the vascular lumen and atheromatous material.
Ath~romatous materials that can be removed by the present devic2s include all naturally-occurring occlusions found in vascular lumens, e.g., lipoprotein deposits, blood clots, atherosclerotic plaques, and the like. The materials may be hardened plaques or relatively soft athero~as, with the present invention '.
~'0 9t/07500 PCT/I,'S91/08~06 , :
par~icularly sulted for removing relatively soft deposlts .
A. Catheter Bodi~s Referring now to Fig. l, an atherectomy catheter 110 constructed in accordance with the principles of the present lnvention comprises a catheter body 112, a cylindrical housing 114 attached t~ the distal end of catheter body 112, and a connector manifold 116 attached to the proximal end nf the catheter body. A
cylindrical cu~ting head 11~ is dispo~ed within the interior of housing 114.
As illustrated, the catheter body 112 includes an annular lumen 120 which extends throuqh the entire length of the cathe~er body. Lumen 120 allows passage of torque cable 122 therethrough. Torque cable 122 is typically a braided cable or the like and is attached to the proximal end of rotatable cutting head 118. Methods for constructing suitable braided structures ~or torque cable 122 are described in U.S. Patent Nos. 4,425,919:
3,924,632; and 3,485,234, the disclosures of which are incorporated herein by reference. Torque cable 122 passes through manifold housing 124 and i5 secure~ at its distal end to drive spindle 126. Drive spindle 126 is adapted to bei connectaid to a motor drive unit of the type ;~
described in U.S. Patent No. 4,771,774, the disolosure of which is incorporated herein by reference.
The atherectomy catheter llO will usually be adapted to rotate cutting head 118 relative to catheter 110 to effectively cut atheromatous tissue with thie catheter 110 motionless w:Lthin th~ vessel.
Alternatively, cutting over an extended arc o~ the inner lu~en wall can be achieved by manually rotating the entire catheter body 12 while the cutting head 118 is being rotated at a relatively high rotational rate by the motor drive.
An in~latable balloon 130 is formed on thP
outside of housin~ 114 and dispos~d g~nerally opposite to .
~. ~ , " ...
::
W092/07500 PCT/~'S91/~8006 the location or an elongate aperture 132 formed in a side of housing 114. The interior of balloon 130 is in fluid communication wi~h inflation port 132 provided on manifold housing 124 to allow lnflation of the balloon.
_ A second port 134 is provided on housing 124 to allow perfusion of fluids through annular lumen 120 of catheter body 112.
Catheter body 1~2 will generally bP a flexible t~be having at least one lumen of the type generally e~ployed in vascular catheters. Suita~le materials and methods for forming such flexible catheter bo~y tubes are described in U.S. Patent No. 4,669,469, previously incorporated herein by reference. The catheter bodies will be comprise~ of a flexible material so as to minimize the rigldity of t~e catheter, especially when atheromatous material ls to be removed from the tortuous pa~hs of coronary arteries.
A tapered endpiece 136 is attached to the distal end of housing 114, which provides a means for sealing the distal end of housing 114 as well as means for tapering the distal end of housing 114 so that narrow passages in a vascular lumen can be more easily p~netrated. Endpiece 136 includes an orifice 138, which allows passage of a move ble guidewire t~erethrouyh.
The above-described catheter represents only one em~odiment of the present i~vention and may be modified in view of the remainin~ disclosure herein. For example, the dual-lobed balloon 130 could be substituted with a single-lobed balloon or with two single-lobed balloons. Additionally, endpiece 136 can have any shape consistent with ~ffective use of the catheter, e.g., conical, dome-shaped, and the like. Also, endpiece 136 may be dispensed with altogether and the housing 114 substituted with a housing having a continuous s~al ahout its distal end. Other modi~ications would be readily apparent to a skilled practitioner.
~ .
' W092/0~00 PCT/US9l/OB006 Referring now to Fig. 2., a side view of catheter llO is depicted with por~ions broken away to reveal the interlor of the catheter. Thus, catheter body 112 is attached at its distal end to houslng 114 havin~
open interior 140. Interior 140 contains cutting ~ead 118 which is attached at its proximal e~nd to torque cable 122 via shank 142. Torque cable 122 extends proximally throu~h annular lumen 120 provided in cathe~er body 112.
Opposite elongated aper~ure ].32 in housing 114 is balloon 130 which is connected at it:s proximal end to an inflation lumen 144. Inflation lumen 144 connects the interior of balloon 130 to an inflatio~l port. The inflation lumen may be provided integrally within the catheter body. Usually, however, the inflation lumen will be defined, as shown in Fig. 2, by an outer sheath 146 formed over catheter body 112. The fabrication of such coaxial inflation lumens is described in U.S. Patent No. 4,411,055, the disclosure of which is incorporated herein by reference.
B. Cylindrical Cuttinq Heads The instant atherectomy catheters will be ~
provided with a cutting head rotatably moun~ed at the ' -distal end of the catheters. The cutting head may be mounted free of any housing for containing the cutting head. Optionally, and pre~erably, however, the cutting head will be contained within a housing at the distal end of the catheter. When a housing is employed to support the cutting head, the head will be exposed ~o target atheromatous material through an axially elongated opening in the housing wall.
Referring to Figs. 2 and 3, the interior 140 of housing 114 contains cylindrical cutting head 11~. Head 118 includes an axially elongated aperture 148 helically disposed about the centra} axis of the head. The elongated aperture 148 allows invagination of atheromatous material into the interior 150 of cutting head 118. He}ical aperture 148 subtends less t~a~ o~e ,.
, .
. :, ~'092/07~00 PCT/~IS91/08006 half of a complete turn about the central axls of cylindrical head 11~. When the aperture 148 in head 118, as illustrated, subtends less than approximately one half turn about the head's surface, and the elongated aperture 132 in housing 114 also subtends less than approximately one half turn a~ou~ the housing surface, then head 118 can be positioned so as to shield aper-~ure 148 wholly within housing 114. Such positioni~g will help to avoid uninte~ded nicking and cutting of the vascular wall while the catheter is being introduced throuqh ~he vascular lumen and will prevent release of atheroma particles from the interior 150 of head 118 during withdrawal of the head from ~he vascular system.
Cutting head 118 further includes a cutting edge 152 formed along a portion of the periphery of aperture 148. Preferably, cutting ed~e 152 extends along ~-the distal side of aperture 148 so that a distal thrust is exerted on torque ca~le 122 as the head 118 is rotated in the direction of arrow 157. The distal thrust is absor~ed by endpiece 136 which is fixedly attached to housing 114. Cutting edge 152 severs atheromatous material 154 which pene~rates into the aperture 148, as illustrated in Fig. 4A. The severed at~eromatous material is simultaneously diverted by cut~ing edye 152 into the interior 150 of head 118. ~` .
In a typical application, cut~ing head 118 will be positioned adjacent such atheromatous material as illustrated by atheroma 154. Housing 114 will b~ made to press against the vascular lumen so as to contact atheroma 154 with cutting head 118 contained within housing 114. When aperture 148 is aligned with atheroma 154 the atheroma will tend to penetrate the aperture and thereby to ~e invaginated by head 118. Balloon 130 can : further assi~t in inva~inating atheroma 154 by pressing ; ~ 3~ against the opposite wall of the vascular lumen and thus further urging aperture 148 against the exposed vessel : . .
surf ace. Balloon 130 will also help to stabilize housing : ' .
~ , :
WO9~/07~00 PCT/US91/08~06 ,, 114 within the lumen as cutting head 118 ls manipulated by the interventlonist. As hPad 118 is rotated relative to the catheter, atheroma 154 will be compressed briefly aga1nst the intlma wall ~y edge 156. As cut~ing head 118 . .
further rotates in the direction of the arrow 157, atheromatous material sliding past edge 156 will be released ~rom compression and will penet:rate aperture 148. The atheroma~ous material, thus invaginated ~y .- .
cutting head 118, is readied for severance from the ~.
vessel wall by cutting edge 152. Cutting ed~e 152 will engage atheroma 154 a~ a point coincident with the periphery of aperture 148 and will seve:r and divert atheroma 154 lnto the interior 150 of head 118.
An alternative embodiment for a cylindrical cutting head is shown in ~ig. 4B. Par~s correspondin~ to those described for Fig. 4A are presented wi~h primed reference numerals. Thus, cutting head 118' includes a cutting edge 152' which severs and diverts atheroma 154' into the interior 150' of head 118'. Invagination of atheroma 154' within cut~ing head 118' throuqh aperture 148' is assisted by lip 156' which is radially inclined inward toward the interior 150' of head 118' along a ~ .
portion of the edge of aperture 1~8'. The angle of inclination of the edge is not critical and can be any value that generally aids in invaginating atheromatous material. Typica}ly, the angle of inclination of the lip from the tangent to the head at the juncture of the lip with the head will b~ in the range of 10--15~.
C. C~xbined S.ide and Front-end_Cuttin~ Head~ i , Referring now to Fig. 5, the distal region o~ a combined side and front-end cutting cat~eter 510 construGted in accordance with ~he principles of the present in~ention is depicted. Catheter 510 comprises a :-, cathet~r body 512 attached at its di~tal end to housing 514. Catheter body 512 has essentially the same ~ !
dimensions and is constructed from the same materials as the catheter bodi~c described above. Housing 514 is ;;
; ' '.".
,: '. .
~'092/07500 PCT/~'S91/08006 }5 _~ , ~, " ,. `,! I rl provided with axially elongated opening 516 ln its side and with distal opening 518 at its distal end. The openings permlt access to atheromatous material located either laterally or ahead of the distal end o~
catheter 510.
Cylindrical cutting head 520 is rotatably mounted within housing 514. Rotatable head 520 is attached at its proximal end to torque cable 522 which ext~nds proximally to a point external the patient' 5 body. Opposite the side opening 51~ in housing 514 is an infla~able balloon 524 which will assist upon inflation in pre~sing cutting head 520 against atheromatous material on the vascular lumen. Addi~ionally, head 520 has an orifice 526 which permits the passage of a movable quidewire therethrough. The torque cable 522 will include a lumen that permits such a guidewire to pass proximally through the catheter.
Catheter 510 will include a connector manifold (not illustrated) which is generally the same as connector manifold 116 in Fig. 1, except that a lever (not illustrated) for axially advancing the torque cable 522 will be provided. The construction and use of axial advance levers in catheters having torque cablss is well described in U.S. Patent Nos. 4,669,469 and 4,771,774, the disclosures of which ha~e previously been i~corporated herein by reference. The advance lever in catheter 510 can be used to advance the distal end of cutting head 518 from the forward end of housing 514 while the head i~ being rotated with a motor drive, as described above. In this way~ the tapered distal end of the cutting head 518 can penetrate even severe occlusions by "drilling" into narrow lumens which would otherwise be iD~assable.
As illustrated in Figs. 5 and 6, cylindrical head 52~ is tapered at its distal end with the tapered distal end ext~nding out from the distal end of housing 514. The tapered distal end of head 520 is formed :
~, .. . , - ~
w092/07500 ~ P~T/US91/08~6 .
con~inuously wlth the cylin~rical region of head 520 to '', give an lntegrated ro~atable cutting me,mber.
~lterna~iveiy, ,he dis~al 'apered end of the cu~ting head may be ~rcvlded as a separa~ely î~rmed member that is subseouen~ly a~tached, either permanently or detachably, ~o the cylin~rical region of the head.
Cylindrlcal head 520 has a helically disposed axially elongated aperture S2~ that extends from the '~
cylindrical region of head 5~0 to near the tap~red distal ' end of the ~ead. A cuttin~ edge 530 is formed integrally with the bodv of head 520 along the proximal ed~e oE
aperture 528. Also, cutting head 520 has an cpen interfor 532 to which severed a~heromas are diverted after belng severed from ~he lumen wall.
1~ Referring now to Fig. 7, another preferred embodimen~ or a combined side and front-end cutting catheter is depicted. Thus, atherectomy cathet~r 710 ,~
includes catheter body 712 attached at its distal end to housing 714, which has an axially elongated opening 716 in its sidP wall and distal end. Elongated opening 716 ; ' extends distally from a first point along the side of ~ , housing 714 to a second point on the opposite side of the housing ~hich is located dis~ally ~rom ~he first point.
Opening 716 is formed as an unbro~en open section of housing 714, i.e., ~he periphery of the opening forms a continuous and comple~e loop to for,m opening 716.
Cylindrical cutting head 718 is rotatably mounted within housing 7~4 and extends distally from ' ' , housing 714 through opening 716. The proximal end of head 718 is at~ached to torque cable 720 which extends through lumen 722 of catheter body 712. Inflatable ,' balloon 724 is provided opposite opening 716 in order to assist in urginy cutting head 718 in~o contact with target atheromas. Cutting head 718 has ori~ice 726 ~S provided f~r the passages of a guidewire.
Referring now ~o Fig. 8, a more complete cutting head 718 is shown. Head 718 will typically be '' w092/~7500 PCT/~'S91/08006 comprised of a strong, blologically compatible metal, e.g., s~ainless steel. The thickness of the metal sheet comprising head 71~ wlll usually be about 0.004 inches.
Cylindri~al head 718 further has a helically disposed aperture 728 about the central longitudlnal axis of head 718. As illustrated, the helical aperture 728 subtends more ~han one complete turn abou~ cutting head 716. The width of aperture 728 may vary substantially, depending upon the particular U52 contemplated for the catheter;
how~ver, a width of about 0.030 inc~s for the aperture will be typical.
A cuttlng edge 730 is provided along the proximal edge or aperture 728. cutting edge 730 severs atheromatous material and diver~s it to ~he interior 732 of head 718 until it can be conveniently withdrawn from the vascular lumen toge~her with the catheter. A tapered endpiece 734 is provided at the distal end of cutting head 718 in order to assist in penetrating lesions and in finding the desired course through the vascular system.
Referring now to Fig. 9, the interior o~ the catheter shown in Fig. 7 is shown. Thus, housing 714 is attached to the distal end of cathe~er body 71Z and has an axially elongated openin~ 716 throuqh which cutting head 718 extends distally. The cylindrical head 718 is mounted to the distal end of torque cable 720 as described for a previous embodiment. The torque cable extends proximally through lumen 722 provided in body 712. Inflatable balloon 724 is positioned opposite elongated opening 716 and is in~lated via an inflation lu~en as ~escribed ~or a previous embodiment. Orifice 726 in the distal end of head 718 allows passage of a guidewire, which extends proximally through a lumen provided in torque cable 720.
Axially elongated aperture 72~ in cutting head 718 subtends more t~an one complete turn about cylindrical head 7}8 and allows invagination of atheromatolls material by head 718 so t~at cutting ~dge :
.
' wn 92/07500 ~ PCT/~IS91/08006 .;~ .. ., .. , .~ .
730 can sever and diver~ such material to the ln~erior 732 of head 718. Tapered endpiece 734 including orifice 726 is àe~achably -it ~ia tabs 736 into the distal end or cutting head 718. ~ndDiece 734 is detachable r-om the distal end of head 718 so that the interior 732 or cutting head 718 can ~e exposed. Clean-ou~ spool 738 is slidably disposed within the interior of cylindrlcal cuttin~ he~d 718 and provides a means for withdrawing severed atheromatous material from the interior 732 and through the forward distal end of head 718. Alternative means for attaching the endpiece to the cutting head will be readily apparent to the skilled practitioner as will alternative deslgns for ~he spool located internal the cutting head.
A still further preferred embodiment of the present invention will have the detachable endpiece and ;
clean-out spool provided as a unitary component of the ~ `, cutting head, which will permit the spool to be withdrawn distal}y from the interior of the head toyether with the ' distal endpiece. Such a component may be discarded with any atheromas withdrawn with the component.
. Fur~her Considerations The axially elongated apertures of the cutting heads of the present invention may be disposed in a non~
helical fashion abou~ the cutting head. For example, ~he ~, elongated aperture may be disposed essentially collinearly with the central axis of the cylindrical ~;
cutting head.
Pre~erably, how~ver, the elongate apertures will be helically disposed about the cylindrical cutting head so that rotation o~ the head causes a first velocity co~ponent normal to and a second velo~ity co~ponent parallel to the edge of the helix to enhance the resultant cutting action. The direction which the cutting head is rotated will depend on the direc~ion of the helix (i.e., right-hand or leit hand) and on whether the distal si~e or proximal side o~ the aperture is .
:
... ~, , .. , , ~, . ..... ........ . . . . .
WO92/07jO0 PCTI~'S91/OB006 19 ;` ~ - .
sharpened t~ definP the cutting edge. For the embodimen~
of Figs. 1-3, the aperture 148 is a right-hand helix with the distal slde of the aperture being sharpened.
Rotation ln the direc~lon of arrow 157 (counter-clockwise when viewed distal to proxim~l) will cause the sharpened edge 152 to cut into atherom~ while the cutting head 118 experiences a distal thrust. The same result could be achi~ved with a left-hand helical aper~ure by rotating the cuttinq head in the opposite (clockwlse~
direction. So long as the dis~al side o~ the aperture carries the cutting edge, the cuttiny head will experience a distal thrust when rotated in the appropriate cutting direction. Such a distal thrust ls desirable since it is absorbed by the endpiece and allows cable 122 to operate as a torsional member without experiencing tenslon or compression during use of the cutting head 118.
For the embodiments of Fi~s. 5-9, the cutter torque cable 522, 720 will necessarily be under compression as the cutting head 5ZO, 718 is advanced forward through the atheromatous material or is used in the side-cutting mode. Thus, eff~ctlve cutting will be achieved by havi~g the cutting edge on the proximal side of the cutting aperture and rot~ting the cutting head in the direction dictated by the helical dirPotion, i.e., counter-clockwise when viewed distal to proximal for le~t-hand helices (~s illustrated in Figs. 5 and 6) and clockwise for right-hand h lices (as shown in Figs. 7-9).
In some applications, a plurality of helices about the rotatable head ~ay be preferred. Of course, the elongated aperture of the instant cutting heads may be disposed in a combined helical and non-helical fashion about the central axis of the head as well, if such a configuration is desir~d.
When a cukting edge is employed as the severing means of the present invention, such cutti~g edge may be formed as a smooth edge aLong the elongated aperture of ,:
;, ~
::
.
W092tO7;00 PCT/US91/OgO06 ~ ~ .
the cutting head. Alternatively, the cutting edge may be serrated, especlally when hardened plaques are expected ~o be encountered within the vascular lumen.
As depicted in Fig. lO, the efEecti~e c~tting velocity of the severing means adjacent a helical aper~ure will generally be less than the rotatlonal velocity of the cylindrical cutting head. Th~ls, when a helical aperture forms an angle ~ with the central axis of the cutting head, the velocity vector Vl normal to the lo aperture is displaced relative to the rotational velocity vector Vc by the same angle ~. The cutting veloclty Vl of the severing means, will therefore be less than Vc and as given by the eouation:
Vl = VC * COS ~- ~ .. ,`. ' Generally, cutting heads having a small value -for ~, i.e., shallow hellx heads, will be more effective at retaining severed or abraded material within the ~
cutting head than will steep helix cutting heads, which `
have relatively large values for ~. However, steep helix ; `
cutting heads will be more effective than the shallow helix cutting heads at slicing atheromatous material from `
the stenotic vessel lumen.
E. Housin~s The distal ends of the catheters illustrated above are fitted with a cylindrical housing for the cylindrical cutting head inside. The internal diameter of the cylindrical housing will be large enough to acco~modate the head within but small enough so that the housing fits around the head sufficiently closely to prevent undesired motions of the head, such as wobbling during rotation, as well as to prevent the release of atheroma particles from the cavity within the cutting head. Typically, the housing will have an outside diame~er close to that for the catheter body, i.e., 5 to 7 French for coronary arteries and 7 to 11 French 7', for perlpheral arteries.
W092/07500 PCT/~'S91/08006 ~`1 L' ' `
~ _ ,. . ........................ .
The cylinàrical housin~s of the presen~
inven~ion wlll be su~ficien~ly small to allow the ^atheter -~ "snake" through t~e tor~uous paths of the ~ascular system. However, the housings should also be large enough to allow as much atheromatous material as possible ~o De severed and cap~ured without the necessity of removing the catheter from the patient for cleaning purposes prior to relocating the housin~ to the same or a different cutting site in the vascular lumen. Typically, 0 in the configurations of Figs. 1, 2, and 5, the housing will have an axially elongated opening, or window, through which atheromatous ma~erial will contact the cu~ting Aead, ~hich is abou~ 10 mm in len~h.
~he nouslngs employed with the presen~
invention may be flexible housings of the type described in U.S. 2aten~ No. Y,781,186, ~he disclosure o~ which is incorpora~ed herein by reference. Flexible housings may a~so be provided by other designs, including laminate constructions having a plurality of overlapping slotted housings where the slots are formed in a offset pattern, i.e., the slots in one layer are covered by the material of another layer. The slotted layers can be formed from machined métals, such as stainless steel, which may be further thinned by chemical e~ching. Other suitable materials include thermosetting plastics and -thermoplastics, e.g., urethanes, polyvinyl chlorides, nylons, etc.
Flexible housings may also be machined to form a series of slots which penetrate the cylindrical wall of the housing from opposite sides of the elongate aperture.
The slots form independent segments in the housin~ and provide the desired flexibility without loss of circumferential stiffness. Optionally, the segmented housing may be coated in a plas~ic ma~erial to encloqe the interior without a substantial 10s5 of flexibility.
The flexible housing may also be fo~med as laminates of relatively thin, flexible layers which accommoda1:e . .
~' ,.: :,:
w092/07500 PCT/US91/0~006 2 ~-b~nding as the successive layers slide over one another.
Suitable construc~ions of the flexible housing are presenteà ln U.S. application Serial No. ~05,906, ~hich is incorpora~ed hereln by reference.
E. Method of Use As will be apparent from the above discussion, novel methods for removing atheromatous material from vascular lumens are provided by the present invention.
Thus, the distal end of a cathe~er is introdured int~ the lumen and positloned adjacent the target atheromatous material. The cylindrical cutting head mounted a~ the distal end of the catheter will ~e rotated so that material invaglna~ed by the cutting head will be severed and diverted into the interior of the head. The catheter will be withdrawn from the vascular lumen with the severed material remaining within the cylindrical head.
The catheter of the present invention may be utilized in a variety of operating modes, ~epending in part on the particular embodiment which is employed. The embodiment of Fig. 1 is intended primarily for side-cutting where the balloon 130 is inflated to laterally engage the cutting head 118 ag~inst atheromatous material while the housing 114 remains otherwise stationary within the blood vessel. The cutting head 118 is then rotated using a motor drive (while the catheter 110 remains substantially stationary) to sever and remove the atheromatous ma~erial. Alternatively, the entire catheter 110 can be manually rotated (while the balloon 7.
is inflated at a moderate pressure and the cutting head is rotated by the motor drive) in order to sever atheromatous material from an extended portion o~ the lumen arc.
The catheter 510 of Fig. 5 can be operated in a side cutting mode similar to tha~ of Fig. 1, or can be operated in a front-cu~ting mnde by rotating the cutting head 520 and moving the head axially forward within the b}ood vessel so that the tapered end o~ the cuttislg head :
: . . , . , .-.. , .... ,. , : , . - , ... . . :, .
w092/07500 PCT/~:S91~08~0 can penetrate the atheromatous material. Usually, the cutting head 520 will be extended axially forward from the housing 514 ~y advancing the toroue cable 522 in the distal direction, typically uslng an advance lever (not shown) of the type described in U.S. Patent No.
described in U.S. Patent No. 4,771,774, the disolosure of which is incorporated herein by reference.
The atherectomy catheter llO will usually be adapted to rotate cutting head 118 relative to catheter 110 to effectively cut atheromatous tissue with thie catheter 110 motionless w:Lthin th~ vessel.
Alternatively, cutting over an extended arc o~ the inner lu~en wall can be achieved by manually rotating the entire catheter body 12 while the cutting head 118 is being rotated at a relatively high rotational rate by the motor drive.
An in~latable balloon 130 is formed on thP
outside of housin~ 114 and dispos~d g~nerally opposite to .
~. ~ , " ...
::
W092/07500 PCT/~'S91/~8006 the location or an elongate aperture 132 formed in a side of housing 114. The interior of balloon 130 is in fluid communication wi~h inflation port 132 provided on manifold housing 124 to allow lnflation of the balloon.
_ A second port 134 is provided on housing 124 to allow perfusion of fluids through annular lumen 120 of catheter body 112.
Catheter body 1~2 will generally bP a flexible t~be having at least one lumen of the type generally e~ployed in vascular catheters. Suita~le materials and methods for forming such flexible catheter bo~y tubes are described in U.S. Patent No. 4,669,469, previously incorporated herein by reference. The catheter bodies will be comprise~ of a flexible material so as to minimize the rigldity of t~e catheter, especially when atheromatous material ls to be removed from the tortuous pa~hs of coronary arteries.
A tapered endpiece 136 is attached to the distal end of housing 114, which provides a means for sealing the distal end of housing 114 as well as means for tapering the distal end of housing 114 so that narrow passages in a vascular lumen can be more easily p~netrated. Endpiece 136 includes an orifice 138, which allows passage of a move ble guidewire t~erethrouyh.
The above-described catheter represents only one em~odiment of the present i~vention and may be modified in view of the remainin~ disclosure herein. For example, the dual-lobed balloon 130 could be substituted with a single-lobed balloon or with two single-lobed balloons. Additionally, endpiece 136 can have any shape consistent with ~ffective use of the catheter, e.g., conical, dome-shaped, and the like. Also, endpiece 136 may be dispensed with altogether and the housing 114 substituted with a housing having a continuous s~al ahout its distal end. Other modi~ications would be readily apparent to a skilled practitioner.
~ .
' W092/0~00 PCT/US9l/OB006 Referring now to Fig. 2., a side view of catheter llO is depicted with por~ions broken away to reveal the interlor of the catheter. Thus, catheter body 112 is attached at its distal end to houslng 114 havin~
open interior 140. Interior 140 contains cutting ~ead 118 which is attached at its proximal e~nd to torque cable 122 via shank 142. Torque cable 122 extends proximally throu~h annular lumen 120 provided in cathe~er body 112.
Opposite elongated aper~ure ].32 in housing 114 is balloon 130 which is connected at it:s proximal end to an inflation lumen 144. Inflation lumen 144 connects the interior of balloon 130 to an inflatio~l port. The inflation lumen may be provided integrally within the catheter body. Usually, however, the inflation lumen will be defined, as shown in Fig. 2, by an outer sheath 146 formed over catheter body 112. The fabrication of such coaxial inflation lumens is described in U.S. Patent No. 4,411,055, the disclosure of which is incorporated herein by reference.
B. Cylindrical Cuttinq Heads The instant atherectomy catheters will be ~
provided with a cutting head rotatably moun~ed at the ' -distal end of the catheters. The cutting head may be mounted free of any housing for containing the cutting head. Optionally, and pre~erably, however, the cutting head will be contained within a housing at the distal end of the catheter. When a housing is employed to support the cutting head, the head will be exposed ~o target atheromatous material through an axially elongated opening in the housing wall.
Referring to Figs. 2 and 3, the interior 140 of housing 114 contains cylindrical cutting head 11~. Head 118 includes an axially elongated aperture 148 helically disposed about the centra} axis of the head. The elongated aperture 148 allows invagination of atheromatous material into the interior 150 of cutting head 118. He}ical aperture 148 subtends less t~a~ o~e ,.
, .
. :, ~'092/07~00 PCT/~IS91/08006 half of a complete turn about the central axls of cylindrical head 11~. When the aperture 148 in head 118, as illustrated, subtends less than approximately one half turn about the head's surface, and the elongated aperture 132 in housing 114 also subtends less than approximately one half turn a~ou~ the housing surface, then head 118 can be positioned so as to shield aper-~ure 148 wholly within housing 114. Such positioni~g will help to avoid uninte~ded nicking and cutting of the vascular wall while the catheter is being introduced throuqh ~he vascular lumen and will prevent release of atheroma particles from the interior 150 of head 118 during withdrawal of the head from ~he vascular system.
Cutting head 118 further includes a cutting edge 152 formed along a portion of the periphery of aperture 148. Preferably, cutting ed~e 152 extends along ~-the distal side of aperture 148 so that a distal thrust is exerted on torque ca~le 122 as the head 118 is rotated in the direction of arrow 157. The distal thrust is absor~ed by endpiece 136 which is fixedly attached to housing 114. Cutting edge 152 severs atheromatous material 154 which pene~rates into the aperture 148, as illustrated in Fig. 4A. The severed at~eromatous material is simultaneously diverted by cut~ing edye 152 into the interior 150 of head 118. ~` .
In a typical application, cut~ing head 118 will be positioned adjacent such atheromatous material as illustrated by atheroma 154. Housing 114 will b~ made to press against the vascular lumen so as to contact atheroma 154 with cutting head 118 contained within housing 114. When aperture 148 is aligned with atheroma 154 the atheroma will tend to penetrate the aperture and thereby to ~e invaginated by head 118. Balloon 130 can : further assi~t in inva~inating atheroma 154 by pressing ; ~ 3~ against the opposite wall of the vascular lumen and thus further urging aperture 148 against the exposed vessel : . .
surf ace. Balloon 130 will also help to stabilize housing : ' .
~ , :
WO9~/07~00 PCT/US91/08~06 ,, 114 within the lumen as cutting head 118 ls manipulated by the interventlonist. As hPad 118 is rotated relative to the catheter, atheroma 154 will be compressed briefly aga1nst the intlma wall ~y edge 156. As cut~ing head 118 . .
further rotates in the direction of the arrow 157, atheromatous material sliding past edge 156 will be released ~rom compression and will penet:rate aperture 148. The atheroma~ous material, thus invaginated ~y .- .
cutting head 118, is readied for severance from the ~.
vessel wall by cutting edge 152. Cutting ed~e 152 will engage atheroma 154 a~ a point coincident with the periphery of aperture 148 and will seve:r and divert atheroma 154 lnto the interior 150 of head 118.
An alternative embodiment for a cylindrical cutting head is shown in ~ig. 4B. Par~s correspondin~ to those described for Fig. 4A are presented wi~h primed reference numerals. Thus, cutting head 118' includes a cutting edge 152' which severs and diverts atheroma 154' into the interior 150' of head 118'. Invagination of atheroma 154' within cut~ing head 118' throuqh aperture 148' is assisted by lip 156' which is radially inclined inward toward the interior 150' of head 118' along a ~ .
portion of the edge of aperture 1~8'. The angle of inclination of the edge is not critical and can be any value that generally aids in invaginating atheromatous material. Typica}ly, the angle of inclination of the lip from the tangent to the head at the juncture of the lip with the head will b~ in the range of 10--15~.
C. C~xbined S.ide and Front-end_Cuttin~ Head~ i , Referring now to Fig. 5, the distal region o~ a combined side and front-end cutting cat~eter 510 construGted in accordance with ~he principles of the present in~ention is depicted. Catheter 510 comprises a :-, cathet~r body 512 attached at its di~tal end to housing 514. Catheter body 512 has essentially the same ~ !
dimensions and is constructed from the same materials as the catheter bodi~c described above. Housing 514 is ;;
; ' '.".
,: '. .
~'092/07500 PCT/~'S91/08006 }5 _~ , ~, " ,. `,! I rl provided with axially elongated opening 516 ln its side and with distal opening 518 at its distal end. The openings permlt access to atheromatous material located either laterally or ahead of the distal end o~
catheter 510.
Cylindrical cutting head 520 is rotatably mounted within housing 514. Rotatable head 520 is attached at its proximal end to torque cable 522 which ext~nds proximally to a point external the patient' 5 body. Opposite the side opening 51~ in housing 514 is an infla~able balloon 524 which will assist upon inflation in pre~sing cutting head 520 against atheromatous material on the vascular lumen. Addi~ionally, head 520 has an orifice 526 which permits the passage of a movable quidewire therethrough. The torque cable 522 will include a lumen that permits such a guidewire to pass proximally through the catheter.
Catheter 510 will include a connector manifold (not illustrated) which is generally the same as connector manifold 116 in Fig. 1, except that a lever (not illustrated) for axially advancing the torque cable 522 will be provided. The construction and use of axial advance levers in catheters having torque cablss is well described in U.S. Patent Nos. 4,669,469 and 4,771,774, the disclosures of which ha~e previously been i~corporated herein by reference. The advance lever in catheter 510 can be used to advance the distal end of cutting head 518 from the forward end of housing 514 while the head i~ being rotated with a motor drive, as described above. In this way~ the tapered distal end of the cutting head 518 can penetrate even severe occlusions by "drilling" into narrow lumens which would otherwise be iD~assable.
As illustrated in Figs. 5 and 6, cylindrical head 52~ is tapered at its distal end with the tapered distal end ext~nding out from the distal end of housing 514. The tapered distal end of head 520 is formed :
~, .. . , - ~
w092/07500 ~ P~T/US91/08~6 .
con~inuously wlth the cylin~rical region of head 520 to '', give an lntegrated ro~atable cutting me,mber.
~lterna~iveiy, ,he dis~al 'apered end of the cu~ting head may be ~rcvlded as a separa~ely î~rmed member that is subseouen~ly a~tached, either permanently or detachably, ~o the cylin~rical region of the head.
Cylindrlcal head 520 has a helically disposed axially elongated aperture S2~ that extends from the '~
cylindrical region of head 5~0 to near the tap~red distal ' end of the ~ead. A cuttin~ edge 530 is formed integrally with the bodv of head 520 along the proximal ed~e oE
aperture 528. Also, cutting head 520 has an cpen interfor 532 to which severed a~heromas are diverted after belng severed from ~he lumen wall.
1~ Referring now to Fig. 7, another preferred embodimen~ or a combined side and front-end cutting catheter is depicted. Thus, atherectomy cathet~r 710 ,~
includes catheter body 712 attached at its distal end to housing 714, which has an axially elongated opening 716 in its sidP wall and distal end. Elongated opening 716 ; ' extends distally from a first point along the side of ~ , housing 714 to a second point on the opposite side of the housing ~hich is located dis~ally ~rom ~he first point.
Opening 716 is formed as an unbro~en open section of housing 714, i.e., ~he periphery of the opening forms a continuous and comple~e loop to for,m opening 716.
Cylindrical cutting head 718 is rotatably mounted within housing 7~4 and extends distally from ' ' , housing 714 through opening 716. The proximal end of head 718 is at~ached to torque cable 720 which extends through lumen 722 of catheter body 712. Inflatable ,' balloon 724 is provided opposite opening 716 in order to assist in urginy cutting head 718 in~o contact with target atheromas. Cutting head 718 has ori~ice 726 ~S provided f~r the passages of a guidewire.
Referring now ~o Fig. 8, a more complete cutting head 718 is shown. Head 718 will typically be '' w092/~7500 PCT/~'S91/08006 comprised of a strong, blologically compatible metal, e.g., s~ainless steel. The thickness of the metal sheet comprising head 71~ wlll usually be about 0.004 inches.
Cylindri~al head 718 further has a helically disposed aperture 728 about the central longitudlnal axis of head 718. As illustrated, the helical aperture 728 subtends more ~han one complete turn abou~ cutting head 716. The width of aperture 728 may vary substantially, depending upon the particular U52 contemplated for the catheter;
how~ver, a width of about 0.030 inc~s for the aperture will be typical.
A cuttlng edge 730 is provided along the proximal edge or aperture 728. cutting edge 730 severs atheromatous material and diver~s it to ~he interior 732 of head 718 until it can be conveniently withdrawn from the vascular lumen toge~her with the catheter. A tapered endpiece 734 is provided at the distal end of cutting head 718 in order to assist in penetrating lesions and in finding the desired course through the vascular system.
Referring now to Fig. 9, the interior o~ the catheter shown in Fig. 7 is shown. Thus, housing 714 is attached to the distal end of cathe~er body 71Z and has an axially elongated openin~ 716 throuqh which cutting head 718 extends distally. The cylindrical head 718 is mounted to the distal end of torque cable 720 as described for a previous embodiment. The torque cable extends proximally through lumen 722 provided in body 712. Inflatable balloon 724 is positioned opposite elongated opening 716 and is in~lated via an inflation lu~en as ~escribed ~or a previous embodiment. Orifice 726 in the distal end of head 718 allows passage of a guidewire, which extends proximally through a lumen provided in torque cable 720.
Axially elongated aperture 72~ in cutting head 718 subtends more t~an one complete turn about cylindrical head 7}8 and allows invagination of atheromatolls material by head 718 so t~at cutting ~dge :
.
' wn 92/07500 ~ PCT/~IS91/08006 .;~ .. ., .. , .~ .
730 can sever and diver~ such material to the ln~erior 732 of head 718. Tapered endpiece 734 including orifice 726 is àe~achably -it ~ia tabs 736 into the distal end or cutting head 718. ~ndDiece 734 is detachable r-om the distal end of head 718 so that the interior 732 or cutting head 718 can ~e exposed. Clean-ou~ spool 738 is slidably disposed within the interior of cylindrlcal cuttin~ he~d 718 and provides a means for withdrawing severed atheromatous material from the interior 732 and through the forward distal end of head 718. Alternative means for attaching the endpiece to the cutting head will be readily apparent to the skilled practitioner as will alternative deslgns for ~he spool located internal the cutting head.
A still further preferred embodiment of the present invention will have the detachable endpiece and ;
clean-out spool provided as a unitary component of the ~ `, cutting head, which will permit the spool to be withdrawn distal}y from the interior of the head toyether with the ' distal endpiece. Such a component may be discarded with any atheromas withdrawn with the component.
. Fur~her Considerations The axially elongated apertures of the cutting heads of the present invention may be disposed in a non~
helical fashion abou~ the cutting head. For example, ~he ~, elongated aperture may be disposed essentially collinearly with the central axis of the cylindrical ~;
cutting head.
Pre~erably, how~ver, the elongate apertures will be helically disposed about the cylindrical cutting head so that rotation o~ the head causes a first velocity co~ponent normal to and a second velo~ity co~ponent parallel to the edge of the helix to enhance the resultant cutting action. The direction which the cutting head is rotated will depend on the direc~ion of the helix (i.e., right-hand or leit hand) and on whether the distal si~e or proximal side o~ the aperture is .
:
... ~, , .. , , ~, . ..... ........ . . . . .
WO92/07jO0 PCTI~'S91/OB006 19 ;` ~ - .
sharpened t~ definP the cutting edge. For the embodimen~
of Figs. 1-3, the aperture 148 is a right-hand helix with the distal slde of the aperture being sharpened.
Rotation ln the direc~lon of arrow 157 (counter-clockwise when viewed distal to proxim~l) will cause the sharpened edge 152 to cut into atherom~ while the cutting head 118 experiences a distal thrust. The same result could be achi~ved with a left-hand helical aper~ure by rotating the cuttinq head in the opposite (clockwlse~
direction. So long as the dis~al side o~ the aperture carries the cutting edge, the cuttiny head will experience a distal thrust when rotated in the appropriate cutting direction. Such a distal thrust ls desirable since it is absorbed by the endpiece and allows cable 122 to operate as a torsional member without experiencing tenslon or compression during use of the cutting head 118.
For the embodiments of Fi~s. 5-9, the cutter torque cable 522, 720 will necessarily be under compression as the cutting head 5ZO, 718 is advanced forward through the atheromatous material or is used in the side-cutting mode. Thus, eff~ctlve cutting will be achieved by havi~g the cutting edge on the proximal side of the cutting aperture and rot~ting the cutting head in the direction dictated by the helical dirPotion, i.e., counter-clockwise when viewed distal to proximal for le~t-hand helices (~s illustrated in Figs. 5 and 6) and clockwise for right-hand h lices (as shown in Figs. 7-9).
In some applications, a plurality of helices about the rotatable head ~ay be preferred. Of course, the elongated aperture of the instant cutting heads may be disposed in a combined helical and non-helical fashion about the central axis of the head as well, if such a configuration is desir~d.
When a cukting edge is employed as the severing means of the present invention, such cutti~g edge may be formed as a smooth edge aLong the elongated aperture of ,:
;, ~
::
.
W092tO7;00 PCT/US91/OgO06 ~ ~ .
the cutting head. Alternatively, the cutting edge may be serrated, especlally when hardened plaques are expected ~o be encountered within the vascular lumen.
As depicted in Fig. lO, the efEecti~e c~tting velocity of the severing means adjacent a helical aper~ure will generally be less than the rotatlonal velocity of the cylindrical cutting head. Th~ls, when a helical aperture forms an angle ~ with the central axis of the cutting head, the velocity vector Vl normal to the lo aperture is displaced relative to the rotational velocity vector Vc by the same angle ~. The cutting veloclty Vl of the severing means, will therefore be less than Vc and as given by the eouation:
Vl = VC * COS ~- ~ .. ,`. ' Generally, cutting heads having a small value -for ~, i.e., shallow hellx heads, will be more effective at retaining severed or abraded material within the ~
cutting head than will steep helix cutting heads, which `
have relatively large values for ~. However, steep helix ; `
cutting heads will be more effective than the shallow helix cutting heads at slicing atheromatous material from `
the stenotic vessel lumen.
E. Housin~s The distal ends of the catheters illustrated above are fitted with a cylindrical housing for the cylindrical cutting head inside. The internal diameter of the cylindrical housing will be large enough to acco~modate the head within but small enough so that the housing fits around the head sufficiently closely to prevent undesired motions of the head, such as wobbling during rotation, as well as to prevent the release of atheroma particles from the cavity within the cutting head. Typically, the housing will have an outside diame~er close to that for the catheter body, i.e., 5 to 7 French for coronary arteries and 7 to 11 French 7', for perlpheral arteries.
W092/07500 PCT/~'S91/08006 ~`1 L' ' `
~ _ ,. . ........................ .
The cylinàrical housin~s of the presen~
inven~ion wlll be su~ficien~ly small to allow the ^atheter -~ "snake" through t~e tor~uous paths of the ~ascular system. However, the housings should also be large enough to allow as much atheromatous material as possible ~o De severed and cap~ured without the necessity of removing the catheter from the patient for cleaning purposes prior to relocating the housin~ to the same or a different cutting site in the vascular lumen. Typically, 0 in the configurations of Figs. 1, 2, and 5, the housing will have an axially elongated opening, or window, through which atheromatous ma~erial will contact the cu~ting Aead, ~hich is abou~ 10 mm in len~h.
~he nouslngs employed with the presen~
invention may be flexible housings of the type described in U.S. 2aten~ No. Y,781,186, ~he disclosure o~ which is incorpora~ed herein by reference. Flexible housings may a~so be provided by other designs, including laminate constructions having a plurality of overlapping slotted housings where the slots are formed in a offset pattern, i.e., the slots in one layer are covered by the material of another layer. The slotted layers can be formed from machined métals, such as stainless steel, which may be further thinned by chemical e~ching. Other suitable materials include thermosetting plastics and -thermoplastics, e.g., urethanes, polyvinyl chlorides, nylons, etc.
Flexible housings may also be machined to form a series of slots which penetrate the cylindrical wall of the housing from opposite sides of the elongate aperture.
The slots form independent segments in the housin~ and provide the desired flexibility without loss of circumferential stiffness. Optionally, the segmented housing may be coated in a plas~ic ma~erial to encloqe the interior without a substantial 10s5 of flexibility.
The flexible housing may also be fo~med as laminates of relatively thin, flexible layers which accommoda1:e . .
~' ,.: :,:
w092/07500 PCT/US91/0~006 2 ~-b~nding as the successive layers slide over one another.
Suitable construc~ions of the flexible housing are presenteà ln U.S. application Serial No. ~05,906, ~hich is incorpora~ed hereln by reference.
E. Method of Use As will be apparent from the above discussion, novel methods for removing atheromatous material from vascular lumens are provided by the present invention.
Thus, the distal end of a cathe~er is introdured int~ the lumen and positloned adjacent the target atheromatous material. The cylindrical cutting head mounted a~ the distal end of the catheter will ~e rotated so that material invaglna~ed by the cutting head will be severed and diverted into the interior of the head. The catheter will be withdrawn from the vascular lumen with the severed material remaining within the cylindrical head.
The catheter of the present invention may be utilized in a variety of operating modes, ~epending in part on the particular embodiment which is employed. The embodiment of Fig. 1 is intended primarily for side-cutting where the balloon 130 is inflated to laterally engage the cutting head 118 ag~inst atheromatous material while the housing 114 remains otherwise stationary within the blood vessel. The cutting head 118 is then rotated using a motor drive (while the catheter 110 remains substantially stationary) to sever and remove the atheromatous ma~erial. Alternatively, the entire catheter 110 can be manually rotated (while the balloon 7.
is inflated at a moderate pressure and the cutting head is rotated by the motor drive) in order to sever atheromatous material from an extended portion o~ the lumen arc.
The catheter 510 of Fig. 5 can be operated in a side cutting mode similar to tha~ of Fig. 1, or can be operated in a front-cu~ting mnde by rotating the cutting head 520 and moving the head axially forward within the b}ood vessel so that the tapered end o~ the cuttislg head :
: . . , . , .-.. , .... ,. , : , . - , ... . . :, .
w092/07500 PCT/~:S91~08~0 can penetrate the atheromatous material. Usually, the cutting head 520 will be extended axially forward from the housing 514 ~y advancing the toroue cable 522 in the distal direction, typically uslng an advance lever (not shown) of the type described in U.S. Patent No.
4,669,469, previDusly incorporated herein by reference, with the balloon 524 fully inflated to a,nchor the housing. Alternatively, the entire catheter 510 may be advanced through the ~lood vessel, with the ~alloon 524 deflated or lnflat~d with moderate pressure, in which .
case no advance lever is required (although it may be present). It would also be possible to manually rotate the entire catheter 510 while the cuttin~ hPad 520 is being motor rotated to effect severlng of the atheroma~ous material over an extended portion of the lumen arc.
Use of catheter 710 (Figs. 7-9) is similar to that of catheter 510, with two differences. First, the steep helical angle (~) of aperture 728 will be more effective in removing atheromatous material and is preferred when hardened stenotic material is bein~
removed. Second, the elongated opening 716 in housing 714 exposes a continuous length of the cutter head 718 from ~he distal tip rearward, while protecting the opposite side of the vessel from the cutting edge. Such .
a confi~uration is useful for direc~ional cut~ing when : :
advancing the catheter 710 while rotating the cutting head 718 and inflating balloon 72~ with a moderate pressure.
It will be appreciated, of course, that the cutting head 520 (Fig. 6) could be substituted ~or cutting head 718 in housing 714 of cathe~er 710. In this way, directional cut~ing, as just described, could be ~ :
a~hieved with a less steep he}ical angle. '`
The size, shape and thic~nesis of the atheroma particles s~evered from the vascular wall will depend on the type of atheroma encountered by ~he ~evice, but will ':"
~ . , 24 ~ i-also be lmpac~ed by the features and operating parameters of the atherectomy catheter of the present invention.
For example, the rotational velocity of the head, the ~idth of the aper~ure, the angle of inc:lination of the inwardly-inclined edge, the helical pitch of the aper~ure, and the like, each will affec:t the size, shape and thickness of particles severed from the lumen wall.
These parameters may be varied so as to obtain the desired particle size, shape and thickness for a particular application.
Also, whenever a housing is employed and the head has an axially elongated aperture disposed so that the aperture subtends less than one half of a turn around the cenlral axis of the culting head, the aperture may be rotationally positioned subs~antially opposite the elongated opening of the housing prior to introducing or withdrawing the head ~rom the vascular lumen. In this way, severed material internal to the head can be prevented from escaping the interior of the he~cl until the catheter can be withdrawn. Also, the interior of the ;
vascular lumen can thereby be shielded from the sharp cutting edges of the cylindrical head until the head is positioned adjacent target atheromas.
Although the f oregoing invention has been described in detail for purposes of clarity and understanding, it will be obvious that certain modifications may be practiced within the scope of the appended claims.
.. ~ . .
.. .: ::. : . . .: : : : . .
case no advance lever is required (although it may be present). It would also be possible to manually rotate the entire catheter 510 while the cuttin~ hPad 520 is being motor rotated to effect severlng of the atheroma~ous material over an extended portion of the lumen arc.
Use of catheter 710 (Figs. 7-9) is similar to that of catheter 510, with two differences. First, the steep helical angle (~) of aperture 728 will be more effective in removing atheromatous material and is preferred when hardened stenotic material is bein~
removed. Second, the elongated opening 716 in housing 714 exposes a continuous length of the cutter head 718 from ~he distal tip rearward, while protecting the opposite side of the vessel from the cutting edge. Such .
a confi~uration is useful for direc~ional cut~ing when : :
advancing the catheter 710 while rotating the cutting head 718 and inflating balloon 72~ with a moderate pressure.
It will be appreciated, of course, that the cutting head 520 (Fig. 6) could be substituted ~or cutting head 718 in housing 714 of cathe~er 710. In this way, directional cut~ing, as just described, could be ~ :
a~hieved with a less steep he}ical angle. '`
The size, shape and thic~nesis of the atheroma particles s~evered from the vascular wall will depend on the type of atheroma encountered by ~he ~evice, but will ':"
~ . , 24 ~ i-also be lmpac~ed by the features and operating parameters of the atherectomy catheter of the present invention.
For example, the rotational velocity of the head, the ~idth of the aper~ure, the angle of inc:lination of the inwardly-inclined edge, the helical pitch of the aper~ure, and the like, each will affec:t the size, shape and thickness of particles severed from the lumen wall.
These parameters may be varied so as to obtain the desired particle size, shape and thickness for a particular application.
Also, whenever a housing is employed and the head has an axially elongated aperture disposed so that the aperture subtends less than one half of a turn around the cenlral axis of the culting head, the aperture may be rotationally positioned subs~antially opposite the elongated opening of the housing prior to introducing or withdrawing the head ~rom the vascular lumen. In this way, severed material internal to the head can be prevented from escaping the interior of the he~cl until the catheter can be withdrawn. Also, the interior of the ;
vascular lumen can thereby be shielded from the sharp cutting edges of the cylindrical head until the head is positioned adjacent target atheromas.
Although the f oregoing invention has been described in detail for purposes of clarity and understanding, it will be obvious that certain modifications may be practiced within the scope of the appended claims.
.. ~ . .
.. .: ::. : . . .: : : : . .
Claims (27)
1. An atherectomy catheter comprising:
a catheter body having a proximal end and a distal end;
a cylindrical cutting head rotatably mounted at the distal end of the catheter body, said cylindrical head having an open interior and an axially elongated aperture;
means within the catheter body for rotating the cylindrical head; and means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated.
a catheter body having a proximal end and a distal end;
a cylindrical cutting head rotatably mounted at the distal end of the catheter body, said cylindrical head having an open interior and an axially elongated aperture;
means within the catheter body for rotating the cylindrical head; and means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated.
2. A catheter as in claim l, wherein the cylindrical cutting head is tapered at its distal end and wherein said tapered distal end extends out from the distal end of the catheter body.
3. A catheter as in claim 2, wherein the axially elongated aperture extends to near the tapered distal end of the head.
4. A catheter as in claim l, wherein the means for severing and diverting comprises a cutting edge which forms at least a portion of a trailing edge of the aperture as the cylindrical cutting head is rotated.
5. A catheter as in claim 4, wherein the means for severing and diverting further comprises a lip which is inclined radially inward along at least a position of a leading edge of the aperture.
6. A catheter as in claim 1, wherein the elongated aperture is helically-disposed about a central axis of the cylindrical cutting head.
7. A catheter as in claim 6, wherein the helical aperture subtends less than a complete turn about the cylindrical cutting head.
8. A catheter as in claim 6, wherein the helical aperture subtends at least one complete turn about the cylindrical cutting head.
9. An atherectomy catheter comprising:
a catheter body having a proximal end and a distal end;
a housing attached to the distal end of the catheter body, said housing having an axially elongated opening;
a cylindrical cutting head rotatably mounted in the housing, said head having an open interior and an axially elongated aperture;
means within the catheter body for rotating the cylindrical head; and means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated.
a catheter body having a proximal end and a distal end;
a housing attached to the distal end of the catheter body, said housing having an axially elongated opening;
a cylindrical cutting head rotatably mounted in the housing, said head having an open interior and an axially elongated aperture;
means within the catheter body for rotating the cylindrical head; and means disposed adjacent the elongated aperture of the cylindrical head for severing atheromatous material and diverting severed material into the interior of said head as the head is rotated.
10. A catheter as in claim 9, further comprising an inflatable balloon mounted externally on the housing and disposed generally opposite the elongated opening.
11. A catheter as in claim 9, wherein the cylindrical cutting head is tapered at its distal end and wherein said tapered distal end extends out from an opening in the distal end of the housing.
12. A catheter as in claim 11, wherein the axially elongated aperture extends to near the tapered distal end of the head.
13. A catheter as in claim 9, wherein the means for severing and diverting comprises a cutting edge which forms at least a portion of a trailing edge of the aperture as the cylindrical cutting head is rotated.
14. A catheter as in claim 13, wherein the means for severing and diverting further comprises a lip which is inclined radially inward along at least a portion of a leading edge of the aperture.
15. A catheter as in claim 9, wherein the elongated aperture is helically-disposed about a central axis of the head.
16. A catheter as in claim 15, wherein the helical aperture subtends less than a complete turn about the cylindrical cutting head.
17. A catheter as in claim 15, wherein the helical aperture subtends at least one complete turn about the cylindrical cutting head.
18. A catheter as in claim 9, further comprising means for withdrawing severed atheromatous material from the interior and through the forward distal end of the cylindrical cutting head.
19. A catheter as in claim 18, wherein the means for withdrawing severed atheromatous material comprises a spool which is slidably disposed within the interior of the cylindrical cutting head.
20. A method for removing atheromatous material from a vascular lumen comprising:
introducing the distal end of a catheter into the vascular lumen adjacent the atheromatous material;
rotating a cylindrical cutting head mounted at the distal end of the catheter, said head having an open interior, an axially elongated aperture, and means for severing adjacent the aperture, whereby atheromatous material is severed and diverted into the interior of the head; and withdrawing the distal end of the catheter from the vascular lumen while the severed material remains within the cylindrical cutting head.
introducing the distal end of a catheter into the vascular lumen adjacent the atheromatous material;
rotating a cylindrical cutting head mounted at the distal end of the catheter, said head having an open interior, an axially elongated aperture, and means for severing adjacent the aperture, whereby atheromatous material is severed and diverted into the interior of the head; and withdrawing the distal end of the catheter from the vascular lumen while the severed material remains within the cylindrical cutting head.
21. A method as in claim 20, wherein the cylindrical cutting head is rotated relative to the catheter.
22. A method as in claim 20, further comprising axially advancing the catheter within the lumen as the cylindrical cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.
23. A method as in claim 20, further comprising axially advancing the cylindrical cutting head relative to the catheter as the cutting head is being rotated, wherein the means for severing includes a forwardly disposed cutting edge and whereby atheromatous material in front of the catheter may be removed.
24. A method as in claim 20, further comprising displacing the cylindrical cutting head laterally as it is being rotated, whereby atheromatous material on the side of the catheter may be removed.
25. A method as in claim 20, wherein the entire catheter is rotated together with the rotating cylindrical cutting head.
26. A method as in claim 20, wherein the means for severing is shielded within a housing while the catheter is being introduced to or withdrawn from the vascular lumen.
27. A method as in claim 20, wherein the catheter is axially stationary with the vascular lumen and the means for severing includes a rearwardly disposed cutting edge, whereby the catheter experiences a distal thrust.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/604,036 US5242460A (en) | 1990-10-25 | 1990-10-25 | Atherectomy catheter having axially-disposed cutting edge |
| US604,036 | 1990-10-25 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2092992A1 true CA2092992A1 (en) | 1992-04-26 |
Family
ID=24417924
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002092992A Abandoned CA2092992A1 (en) | 1990-10-25 | 1991-10-24 | Atherectomy catheter having axially-disposed cutting edge |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US5242460A (en) |
| EP (1) | EP0554395A1 (en) |
| JP (1) | JPH06502562A (en) |
| CA (1) | CA2092992A1 (en) |
| WO (1) | WO1992007500A2 (en) |
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- 1990-10-25 US US07/604,036 patent/US5242460A/en not_active Expired - Lifetime
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- 1991-10-24 EP EP92900141A patent/EP0554395A1/en not_active Withdrawn
- 1991-10-24 WO PCT/US1991/008006 patent/WO1992007500A2/en not_active Application Discontinuation
- 1991-10-24 JP JP4500855A patent/JPH06502562A/en active Pending
- 1991-10-24 CA CA002092992A patent/CA2092992A1/en not_active Abandoned
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| Publication number | Publication date |
|---|---|
| JPH06502562A (en) | 1994-03-24 |
| WO1992007500A2 (en) | 1992-05-14 |
| EP0554395A4 (en) | 1994-04-13 |
| US5242460A (en) | 1993-09-07 |
| WO1992007500A3 (en) | 1992-06-11 |
| EP0554395A1 (en) | 1993-08-11 |
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