ICA angioplasty with cerebral protection

Information

  • Patent Grant
  • 6295989
  • Patent Number
    6,295,989
  • Date Filed
    Wednesday, February 4, 1998
    27 years ago
  • Date Issued
    Tuesday, October 2, 2001
    23 years ago
Abstract
A method of performing an operation including angioplasty of the internal carotid artery which includes blocking blood flow in the internal carotid artery, performing the angioplasty while the blood flow is blocked in the internal carotid artery, and reversing flow in the internal carotid artery after the angioplasty has been performed to wash material loosened during the angioplasty out of the internal carotid artery. Normal flow in the internal carotid artery is restored after the loosened material is washed out of the internal carotid artery.
Description




STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT




Not applicable




REFERENCE TO A “MICROFICHE APPENDIX”




Not applicable




BACKGROUND OF THE INVENTION




1. Field of the Invention




The present invention relates to internal carotid artery (ICA) angioplasty with cerebral protection. More particularly, the present invention relates to a system for conducting angioplasty while minimizing risk of strokes.




2. General Background of the Invention




When angioplasties are performed, sometimes plaque gets dislodged and travels into the brain, sometimes causing strokes.




The following references are hereby incorporated by reference:




Guide catheters these days are introduced generally through the body though a large sheath. There are now some guide catheters which are introduced with a small thin dilator that leads them over a wire into the body, and one ends up with a guide catheter in the body that was gotten in there loaded over the little dilator. These are then in a location not applicable to guide catheter use. For use in a branch vessel, they have to be led by a previously placed selective catheter and/or a guide wire.




U.S. Pat. Nos. 3,726,269; 4,033,331; 4,169,464; 4,573,966; 4,925,445; 4,935,017; 5,120,323; 5,163,906; 5,199,951; 5,203,776; 5,215,540; 5,219,355; 5,267,982; 5,290,229; 5,304,131; 5,342,306; 5,348,545; 5,368,566; 5,389,090; 5,458,574; 5,462,529; 5,480,380; 5,484,412; European Patent Specification Publication Nos. 0 339 799 B1 and 0 277 366 A1 and PCT International Application Publication No. WO 96/26758.




BRIEF SUMMARY OF THE INVENTION




The apparatus of the present invention solves the problems confronted in the art in a simple and straightforward manner. What is provided is a method of performing an operation including angioplasty of the internal carotid artery comprising the following steps: (a) blocking blood flow in the internal carotid artery; (b) performing the angioplasty while the blood flow is blocked in the internal carotid artery; (c) reversing flow in the internal carotid artery after the angioplasty has been performed to wash material loosened during the angioplasty out of the internal carotid artery; and (d) restoring normal flow in the internal carotid artery.




Also provided is a guide catheter system which can be inserted into a patient without a sheath, thus allowing the use of large guide catheters without a corresponding larger hole in the vessel wall.




The present system allows selective placement of a guide catheter in one step, eliminating the need for a sheath, selective diagnostic catheter, and exchange wire.




The entire process of guide catheter introduction is one process, thus much faster. The unit is placed over a standard guide wire through the skin into the vasculature. The lack of need for a separate sheath system saves this step from the introducer.




The eventual target vessel for the guide catheter is selected with a catheter/dilator specifically designed for that purpose (the inner “dilator”). This allows optimal design capabilities for the guide catheter due to the fact that it will not have to function as a selecting catheter at the same time.




The lack of need for a separate diagnostic catheter to pre-select the intended vessel saves the step of placing a diagnostic catheter into the intended location, placing an exchange wire, pulling the selective catheter, and then placing a guide catheter over this exchange wire.











BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS




For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:





FIG. 1

shows initial placement of the flow control guide catheter;





FIG. 2

shows the guide catheter balloon inflated;





FIG. 3

shows a soft tipped “wire with a balloon” being advanced through the lesion;





FIG. 4

shows the distal balloon inflated;





FIG. 5

shows the guide catheter balloon deflated;





FIG. 6

show both balloons inflated;





FIG. 7

shows the angioplasty being performed;





FIG. 8

shows a stent being delivered into the closed system;





FIG. 9

shows the stent being deployed;





FIG. 10

shows the stent in place;





FIG. 11

show the distal balloon deflated;





FIG. 12

show the distal balloon re-inflated;





FIG. 13

shows the proximal balloon deflated;





FIG. 14

shows the proximal balloon inflated;





FIG. 15

shows the distal balloon deflated;





FIG. 16

shows the guide catheter balloon deflated;





FIG. 17

is a schematic view of the vascular tree with the guide catheter system of the preferred embodiment of the apparatus of the present invention present therein;





FIG. 18

is a schematic view showing the dilator selecting the origin of a blood vessel;





FIG. 19

is a close-up view similar to

FIG. 18

;





FIG. 20

is a view similar to

FIG. 19

, and showing the guidewire advanced into a distal blood vessel;





FIG. 21

shows the dilator/guide catheter unit of the preferred embodiment of the apparatus of the present invention in a position in which the inner dilator has reached its intended location;





FIG. 22

shows the dilator/guide catheter unit of the preferred embodiment of the apparatus of the present invention where the guide catheter has been advanced over the inner dilator catheter to the intended location; and





FIG. 23

is a view similar to

FIG. 22

, after the inner dilator and guidewire have been removed from the guide catheter.











DETAILED DESCRIPTION OF THE INVENTION




In

FIG. 1

initial placement of the flow control guide catheter


111


has been made, but the balloon


118


has not been inflated; antegrade flow is still present in the common carotid artery


61


and internal and external carotid arteries


71


,


72


.




In

FIG. 2

, inflation of the guide catheter balloon


118


stops flow in the common carotid artery


61


and reverses flow in the internal carotid artery


71


. The high pressure intracranial vascular system will supply the low pressure sump of the external carotid artery


72


.




In

FIG. 3

, while flow reversal is occurring, a soft tipped “wire with a balloon”


80


is advanced safely through the lesion


40


; any material displaced during passage will flow in a retrograde course out the external carotid artery


72


.




In

FIG. 4

, the distal balloon


81


is inflated, stopping all flow in the internal carotid artery


71


.




In

FIG. 5

, the guide catheter balloon


118


is deflated, washing out the stagnant blood and debris in the region of the stenosis


40


.




In

FIG. 6

, both balloons


81


,


118


are inflated and the angioplasty catheter


90


is delivered safely to its intended location.




In

FIG. 7

, the angioplasty is performed while flow is arrested in the common carotid


61


and internal carotid


71


arteries.




In

FIG. 8

, after initial angioplasty, a stent


50


is delivered into the closed system, again with both the distal and proximal flow occluded.




In

FIG. 9

, the stent


50


is safely deployed under flow arrest.




In

FIG. 10

, the angioplasty catheter


90


is withdrawn, leaving the stent


50


in place with flow arrested in the carotid arteries


61


,


71


,


72


.




In

FIG. 11

, the distal balloon


81


is deflated, allowing reversal of flow again in the internal carotid artery


71


. This allows any retained material to be washed into the external carotid artery


72


again.




In

FIG. 12

, the distal balloon


81


is re-inflated, again stopping flow in the internal carotid artery


71


.




In

FIG. 13

, the proximal balloon


118


is deflated. This allows high pressure antegrade flow into the external carotid artery


72


and allows contrast injection through the inner lumen of the guide catheter


111


. Evaluation of the result of the angioplasty/stent is now possible. Any retained material is now forcefully washed out of the system into the external carotid artery


72


.




In

FIG. 14

, the proximal balloon


118


is again inflated.




In

FIG. 15

, the distal balloon


81


is deflated. While flow is again reversed in the internal carotid artery


71


, the distal wire/balloon


80


is safely withdrawn, again with no chance of dislodging any material into the intracranial flow.




In

FIG. 16

, once the inner wire/balloon


80


has been withdrawn, the guide catheter balloon


118


is deflated, allowing final contrast injection through the guide catheter lumen to evaluate the results.




This is also the technique of choice for internal carotid artery stenting due to its excellent cerebral protection.




1. Select the common carotid artery


61


using a selective diagnostic cerebral catheter; evaluate the path available to the angioplasty site.




2. Exchange the diagnostic catheter for a flow control guide catheter utilizing a safe “neuro” exchange wire. (Instead of the first two steps listed above, one could instead use the flow control guide catheter


111


of the present invention which is a modified version of the guide catheter disclosed in the attached provisional patent application entitled “Guide Catheter System”, which modified version is discussed below).




3. Inflate the balloon


118


on the flow control catheter


111


, occluding flow in the common carotid artery


61


and resulting in reversal of flow in the internal carotid artery


71


or cessation of flow (at the very least).




4. Load a micro-occlusion balloon catheter


80


containing a microwire through the selected angioplasty balloon catheter


90


. (This will necessitate the placement of a microballoon on a microcatheter after loading, or the use of a proprietary device, currently in development.) Carefully navigate the micro-occlusion balloon


81


past the stenosis


40


with the angioplasty balloon


91


remaining proximal within the guide catheter lumen. The occluded common carotid artery


61


thus protects this initial dangerous crossing.




5. Before inflating the distal balloon


81


, aspirate through the guide catheter


111


to remove any debris dislodged during the initial crossing of the plaque


40


; any remainder will flow in a retrograde direction into the external carotid artery


72


.




6. Inflate the distal micro-occlusion balloon


81


, stopping all flow in the internal carotid artery


71


.




7. Deflate the guide catheter occlusion balloon


118


; this now allows the previously stagnant blood in the common carotid artery


61


to wash out into the external carotid artery


72


and refreshes this territory. It also further washes out the potentially disturbed stenotic region, with debris again going into the external carotid artery


72


.




8. Reinflate the guide catheter occlusion balloon


118


, ceasing flow in the common carotid artery


61


.




9. Advance the angioplasty catheter


90


over the wire/micro-occlusion balloon


80


into place and perform the angioplasty (and stent placement, if applicable).




10. Deflate the angioplasty balloon


91


and withdraw this catheter


90


.




11. Slowly infuse contrast through the guide catheter


111


to visualize the angioplasty site.




12. Repeat if necessary (and place stent if necessary).




13. Open the external lumen of the guide catheter


111


to the air.




14. Deflate the distal occlusion balloon


81


and let backbleeding occur for a few seconds, both into the external carotid artery


72


and out the guide catheter


111


.




15. Close the external drainage of the guide catheter


111


; let the retrograde flow from the internal carotid artery


71


continue into the external carotid artery


72


. Perfuse with ReoPro, etc., as indicated.




16. Perform repeat angiogram to evaluate the status of the angioplasty site by injecting through the guide catheter lumen, slowly.




17. Remove all indwelling catheters/balloons except for the guide catheter


111


.




18. Deflate the guide catheter balloon


118


and perform final angioplasty site evaluation.




19. Perform final evaluation of intracranial cerebral vasculature.




The preferred guide catheter system for getting the balloon catheter


111


to its intended location is the guide catheter system shown in

FIGS. 17-23

, but modified to include a balloon


118


on the guide catheter


111


disclosed herein. Thus, one could use the system shown in

FIGS. 17-23

, replacing the catheter


11


shown in

FIGS. 17-23

with balloon catheter


111


, which is the same as catheter


11


except that catheter


111


also includes a balloon


118


and means for inflating and deflating balloon


118


.




PRODUCT:




The guide catheter design of the present invention incorporates design characteristics of a guide catheter with a method of introduction of the guide catheter into the vascular system and then into the target vessel all in one step.




PRODUCT DESCRIPTION:




TWO COMPONENTS:




1. A custom designed guide catheter


11


, with a non-tapering inner and outer lumen size but with varying stiffness in the shaft tapering from a very stiff proximal shaft


13


to a very soft, atraumatic tip


12


. Outer diameter of the guide will be non-tapering and can be from 5 fr. to 10 fr.




2. A custom made inner “dilator”


14


snugly hugging an 0.035 inch standard guidewire


21


and gradually expanding to fill the inner lumen of the guide catheter


11


. This inner dilator


14


will be substantially longer than the guide catheter


11


and have a preshaped curve


15


to allow selection of vessels similar to the function of a standard diagnostic catheter. This dilator


14


will be used to introduce the guide catheter


11


through the skin. The inner dilator catheter


14


will extend approximately 10-30 cm past the tip


12


of the guide catheter


11


and be used to select the intended target vessel


61


of the guide catheter


11


, just as a standard selecting diagnostic catheter would be used.




DESCRIPTION OF USE:




The inner dilator


14


will extend from 10-30 cm past the guide catheter tip


12


. This will be introduced over a standard guide wire


21


placed into the vascular tree


60


utilizing standard Seldinger technique. Once the wire


21


is in place, the dilator/guide catheter unit


10


will be slid over this wire


21


into place in the vascular tree


60


(FIG.


17


). The intrinsic curve


15


of the inner dilator


14


will then be used to select the origin of a blood vessel


61


(FIGS.


18


and


19


). A standard guidewire


21


will be placed through this into the distal blood vessel


61


(FIG.


20


). The dilator/guide catheter unit


10


will be slid over this guidewire


21


until the inner dilator


14


has reached its intended location


62


(FIG.


21


). The wire


21


and inner dilator


14


will be held in place and the guide catheter


11


advanced over this until it has reached its intended location


62


(FIG.


22


). The inner dilator


14


and wire


21


will be pulled, leaving the guide catheter


11


in its intended location


62


(FIG.


23


).




ADVANTAGES OVER STANDARD GUIDE CATHETER DESIGN:




1. The guide catheter can be introduced without the use of a large sheath, thus allowing the use of large guide catheters without a corresponding larger hole in the vessel wall.




2. The entire process of guide catheter introduction will be one process, thus much faster. The unit will be placed over a standard guide wire through the skin into the vasculature. The lack of need for a separate sheath system saves this step from the introducer.




3. The eventual target vessel for the guide catheter will be selected with a catheter/dilator specifically designed for that purpose (the inner “dilator”). This will allow optimal design capabilities for the guide catheter due to the fact that it will not have to function as a selecting catheter at the same time.




4. The lack of need for a separate diagnostic catheter to pre-select the intended vessel saves the step of placing a diagnostic catheter into the intended location, placing an exchange wire, pulling the selecting catheter, and then placing a guide catheter over this exchange wire.




Guide catheters these days are introduced generally through the body though a large sheath. And there are now some guide catheters which are introduced with a small thin dilator that leads them over a wire into the body, and one ends up with a guide catheter in the body that was gotten in there loaded over this little dilator. The present invention is a new system and technique for getting a guide catheter to the intended location which is described on the attached drawings (FIGS.


17


-


23


). The tip of the dilator has been extended a considerable distance past the guide catheter itself so that now the tip of this dilator acts not only as a small introducing agent to follow the wire to get the guide catheter into the body, but also has the purpose of being able to select the vessel. So once one gets it into the vascular tree, one can fish downstream, select the vessel that is intended for the final location of the guide catheter. Once one has selected the vessel, then one uses a guide wire through it, just like with a standard diagnostic catheter. One places a wire downstream into the intended vessel, fishes the entire dilator/guide catheter system downstream into this vessel, and then once the dilator gets downstream, one pushes the entire guide catheter off it until it gets to its intended location down to where one wants to leave it. At that point, one pulls the wire and dilator back, leaving the guide catheter in place. Therefore, in basically one giant procedure, one introduces all of the catheter system through the skin, into the body, and up the vessel, into the final location. The advantage of getting the catheter into the selected vessel into its final location in one step is that one does not have to do any exchanges or use various materials being put into and out of the body and steps along the way to get the guide catheter to the place where one intends it to be.




This system allows one to do away with the sheath. It allows one to do away with a normal selecting diagnostic catheter to select the vessel. It allows one to do away with an exchange wire, or putting the exchange wire up into the vessel and then pulling the diagnostic catheter out and then putting the guide catheter in over the exchange wire and finally getting into position that way. So instead of having these multiple steps in the procedure, one basically have this one continuous step to get the guide catheter into the final location.




Typical dimensions for a guide catheter


11


of the present invention are as follows: length: 40-130 cm (90-100 cm, for example); outer diameter: 1.5-5 mm, preferably 5-12 fr. (6 french, for example); inner diameter: 4 fr.-10 fr.




Typical dimensions for a dilator catheter


14


of the present invention are as follows: length: 50-175 cm (about 20 cm longer than the guide catheter, for example); outer diameter: (sized to match the inner diameter of the guide catheter); inner diameter: sized to fit over a guide wire (0.040 inches, for example).




The curve


15


is chosen such that it aids in selecting the origin of the intended blood vessel. The radius of curvature of the curve


15


can be as in the Cook diagnostic cerebral catheters.






10


Parts list






10


guide catheter system






11


guide catheter






12


soft, atraumatic tip of guide catheter


11


(made of, for example, nylon or polyethylene)






13


very stiff proximal shaft of guide catheter


11


(made of, for example, braided, multilayer construction)






14


inner dilator catheter (made of, for example, nylon or polyethylene)






15


pre-shaped curve of inner dilator catheter


14








21


guidewire (Terumo stiff-shaft angle-tip glide wire commercially available from Terumo in Japan and distributed by Boston Scientific)






22


curved tip of guidewire


21








40


stenosis






50


stent (made of stainless steel and could be, e.g., a stent commercially available from Palmaz)






60


vascular tree






61


selected vessel (common carotid artery)






62


intended location of tip


112


of catheter


111


(or tip


12


of catheter


11


)






71


internal carotid artery






72


external carotid artery






80


wire with balloon (e.g., a wire with balloon commercially available from Johnson & Johnson as part no. P104)






81


balloon of wire


80








90


angioplasty catheter (e.g., a Diamond™ brand angioplasty catheter commercially available from Boston Scientific having a balloon which is 6 mm in diameter by 20 mm long)






91


balloon of angioplasty catheter






110


guide catheter system






111


guide catheter (e.g., a catheter commercially available as FasGuide made by Target Therapeutic)






112


soft, atraumatic tip of guide catheter


111








113


very stiff proximal shaft of guide catheter


111






Enclosed is an appendix with more information about the present invention.




All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.




The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.



Claims
  • 1. A method of performing an operation including angioplasty of the internal carotid artery comprising the following steps:(a) blocking flow in the common carotid artery, thus causing retrograde blood flow in the internal carotid artery; (b) blocking flow in the internal carotid artery, distal of a stenosis; (c) performing angioplasty on the stenosis; (d) unblocking flow in the internal carotid artery, thus allowing retrograde blood flow in the internal carotid artery into the external carotid artery; and (e) unblocking flow in the common carotid artery.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority of my U.S. Provisional Patent Application Serial Nos. 60/038,040; 60/037,226; 60/037,225; and 60/038,039, all filed Feb. 6, 1997 and all incorporated herein by reference. This application also claims priority of my U.S. Provisional Patent Application also filed on Feb. 6, 1997 with the four above-mentioned provisional patent applications and entitled “ICA ANGIOPLASTY WITH CEREBRAL PROTECTION” and bearing attorney docket number V97004US (16064/4). That application is also incorporated herein by reference.

US Referenced Citations (24)
Number Name Date Kind
3726269 Webster, Jr. Apr 1973
4033331 Guss et al. Jul 1977
4169464 Obrez Oct 1979
4573966 Weikl et al. Mar 1986
4921478 Solano et al. May 1990
4925445 Sakamoto et al. May 1990
4935017 Sylvanowicz Jun 1990
5120323 Shockey et al. Jun 1992
5163906 Ahmadi Nov 1992
5199951 Spears Apr 1993
5203776 Durfee Apr 1993
5215540 Anderhub Jun 1993
5219355 Parodi et al. Jun 1993
5267982 Sylvanowicz Dec 1993
5290229 Paskar Mar 1994
5304131 Paskar Apr 1994
5342306 Don Michael Aug 1994
5348545 Shani et al. Sep 1994
5368566 Crocker Nov 1994
5389090 Fischell et al. Feb 1995
5458574 Machold et al. Oct 1995
5462529 Simpson et al. Oct 1995
5480380 Martin Jan 1996
5484412 Pierpont Jan 1996
Foreign Referenced Citations (3)
Number Date Country
0277366A1 Aug 1988 EP
0339799B1 Oct 1994 EP
WO9626758 Sep 1996 WO
Non-Patent Literature Citations (1)
Entry
Theron et al., Carotid Artery Stenosis: Treatment with Protected Balloon Angioplasty and Stent Replacement, Radiology, (Dec. 1996), 201(3), 627-36.
Provisional Applications (4)
Number Date Country
60/038040 Feb 1997 US
60/037225 Feb 1997 US
60/038039 Feb 1997 US
60/037226 Feb 1997 US