CA1289838C - Perfusion type balloon dilatation catheter and apparatus - Google Patents

Perfusion type balloon dilatation catheter and apparatus

Info

Publication number
CA1289838C
CA1289838C CA000555824A CA555824A CA1289838C CA 1289838 C CA1289838 C CA 1289838C CA 000555824 A CA000555824 A CA 000555824A CA 555824 A CA555824 A CA 555824A CA 1289838 C CA1289838 C CA 1289838C
Authority
CA
Canada
Prior art keywords
balloon
tubular member
proximal
catheter
extremity
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA000555824A
Other languages
French (fr)
Inventor
Michael J. Horzewski
Richard L. Mueller, Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Cardiovascular Systems Inc
Original Assignee
Advanced Cardiovascular Systems Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Advanced Cardiovascular Systems Inc filed Critical Advanced Cardiovascular Systems Inc
Application granted granted Critical
Publication of CA1289838C publication Critical patent/CA1289838C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1095—Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes

Abstract

ABSTRACT

PERFUSION TYPE BALLOON DILATATION CATHETER
AND APPARATUS

Perfusion-type balloon dilatation apparatus having a guiding catheter with proximal and distal extremities and with a flow passage extending therethrough. A balloon dilatation catheter is disposed in the guiding catheter.
The balloon dilatation catheter is comprised of a flexible elongate tubular member having proximal and distal extremities and having a first lumen extending therethrough.
First and second inflatable balloons are carried by the tubular member and having their interiors in communication with the first lumen in the tubular member. The first balloon is positioned within the guiding catheter. The second balloon is positioned adjacent the distal extremity of the tubular member. A second lumen is carried by the tubular member and extends through the first and second balloons and through the distal extremity of the tubular member. The second lumen has an opening proximal of the first balloon and opens into the interior of the guiding catheter. An adapter is carried by the proximal extremity of the guiding catheter and provides a liquid-tight seal between the guiding catheter and the dilatation catheter and also provides an inlet through which liquid can be introduced so that it can travel through the flow passage in the guiding catheter and into the second lumen carried by the dilatation catheter so that the liquid can flow through the second lumen beyond the second inflatable balloon.

Description

~Z~39~338 This invention relates to a perfusion-type balloon dilatation apparatus and more particularly, to one which has the capabilities to pump blood to the distal side of a stenosis.
Backqround of the Inven~ion In angioplasty procedures, it has been found that there has been a restenosis rate ranging from 15 to 30%. There is a belief that this restenosis rate can be lowered if longer inflation times are utilized for inflating the balloon which in 2 stenosis so that the stenosis will remain open and not restenose.
In order to accomplish such longer inflation times, there is a need to provide blood flow to the portions of the heart distal of the stenosis during the time that lonyer inflation times are taking place. There is a need for a catheter, apparatus and method which will make this possible.
Accordingly, the invention relates to a perfusion-type balloon dllatation apparatus comprising a guiding catheter having proximal and distal extremities and having a fluid flow passage extending therethrough, and a balloon dilatation catheter disposed in the gulding catheter. The balloon dilatation catheter comprises a flexible elongate tubular member having proximal and distal extremlties and having inflation means extending therethrough, first and second inflatable balloons carried by the tubular member and having their interlors in communication with the inflation means in the tubular .

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~2~3~838 memberO The first balloon is positioned within the guiding catheter and the second balloon is positioned adjacent the distal extremity of the tubular member. A
fluid flow lumen carried by the tubular member extends through the first and second balloons and through the distal extremity of the tubular member. The fluid flow lumen has an opening proximal of the first balloon and opening into the interior of the guiding catheter. An adapter is carried by the proximal extremity of the guiding catheter and provides a liquid-tight seal between the guiding catheter and the dilatation catheter and also provides an inlet through which liquid can be introduced, so that it can travel through the flow passage in the guiding catheter and the fluid flow lumen in the dilatation catheter, and so that the liquid can flow through the fluid flow lumen beyond the second inflatable balloon.
The invention also relates to a balloon dilatation cathetçr for use in a guiding catheter of the type having a flow passage extending therethrough, the balloon dilatation catheter comprising a flexible elongate tubular member having proximal and distal extremities, inflation means extending therethrough, first and second inflatable balloons the interiors of which are in fluid communication with the inflation means in the tubular member. The first balloon is positioned in a longitudinally spaced-apart position from the second balloon, so that it is adapted to be positioned within a guiding catheter when the balloon dilatation catheter is disposed in the guiding catheter. The first balloon has a size so that when it is inflated, it will occlude the flow passage in the guiding catheter. The second balloon is being disposed adjacent the distal extremity of the flexible tubular member. A fluid flow lumen is carried by the tubular member and extends through the .
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,'~ ~ ,' ' '' ' ' ' ' 12~39~ 8 first and second balloons and through the distal extremity of the tubular member. The fluid flow lumen has an opening proximal of the first balloon distal of the proximal extremity of the tubular member. An adapter is carried by the proximal extremity of the tubular member having an arm in fluid communication with the inflation means.
The invention is useful for perfusing blood beyvnd a stenosis in a vessel of a patient while accomplishing an angioplasty procedure. The method comprises the steps of introducing a guiding catheter into the vessel of the patient, placing a guide wire into a dilatation catheter having a balloon on a distal portion thereof and inserting the guide wire and dilatation catheter into the guiding catheter while advancing the guide wire ahead of the dilatation catheter positioning the balloon of the dilatation catheter in the ætenosis, occluding at least the distal extremity of the guiding catheter, providing a lumen in the dilatation catheter which extends from a position within the guiding catheter proximal of the portion which has been occluded through the distal extremity of the dilatation catheter and introducing blood into the lumen opening positioned with the guiding catheter and causing it to flow through the distal extremity of the dilatation catheter lnto the vessel of the patient beyond the stenosis and inflating the balloon to enlarge the opening in the stenosi~.
Additional features will appear in con~unction with the following descriptlon which is set forth in detail with the accompanying drawings.

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, 1~338,~8 FIGURE 1 is a ~ide elevational view of a perfusion type balloon dilatation catheter incorporating the present invention.
FIGURE 2 is a cross sectional view taken along the line
2-2 of Figure 1.
FIGURE 3 is a cross sectional view taken along the line
3-3 of Figure l.
FIGURE 4 is an enlarged cross sectional view of a portion of the catheter shown in Fig~re 1.
FIGURE 5 is a side elevational view of another embodiment of a balloon dilatation catheter incorporatlng the present invention.
FIGURE 6 is a cross section view taken along the line 6-6 of Figure 5.
FIGURE 7 is a cross sectional view taken along the line 7-7 of Figure 5.
FIGURE 8 is a partial slde elevational view of another embodiment of the catheter shown in Figure 5.
FIGURE 9 is a side elevational view partially in cross section of a balloon dilatation apparatus utllizing the balloon dilatation catheter shown in Figure 5.

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~L~8~838 Detailed Description In general the perfusion-type balloon dilatation catheter and apparatus consists of a guiding catheter and a balloon dilatation catheter. The auiding catheter has proximal and distal extremities and has a flow passage extending therethrough. The balloon dilatation catheter is disposed in the flow passage in -the guiding catheter and is comprised of a flexible elongate tubular element having proximal and distal extremities and having a first lumen extending therethrough. First and second inflatable balloons are carried by the tubular member and have their interiors in communication with a lumen in the tubular member. The first balloon is positioned within and near the proximal extremity of the guiding catheter. The second balloon is positioned adjacent the distal extremity of the tubular member. A second lumen is carried by the tubular member and extends through the second balloon and through the distal extremlty of the tubular member. The second lumen has an inl~t opening proximal of the first balloon which opens int-,o the interior of the guiding catheter. An adaptel is carried by the proximal extremity of the guiding cath~ter and has a liquicl-tight seal formed about the balloon dilata-tion catheter and is provided with an inlet port through whlch blood can be introduced into the flow passage in the guiding catheter and then into the inlet of the second lumen so that blood can flow through -the second ! lumen out the distal extremity of the tubular member.
More in particular,the perfusion-type balloon dilatation apparatus 11 and the method of the present invention consists of aguiding catheter 12 and a balloon dilatation catheter 13. The guiding catheter 12 as shown in Figure 9 is of a conventional construction and .
-:
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'' '' 1~8~38 is provided with an elongate flexible tubula, member 14 formed of a suitable material such as plastic and has proximal and distal extremities 16 and 17. The distal extremity 17 can be provided with any desired conventional bend.
The tubular member 14 is provided with a flow passage or lumen 18 which extends therethrough from the proximal to the distal extremities. By way of example, the tuhular member 14 can have an outside diameter of 1.95 mm - 2.9 mm (.078 to .116 inch) and an inside diameter of 1 mm - 1.25 mm (.040 to .078 inch.) The guiding catheter 12 is also provided with an adapter 21 which also is of a conventional type. It is provided with a hemostatic valve 22 through which the balloon dilatation catheter 13 can be introduced and a liquid-tight seal formed therein with respect to the same by tightening a knob 23. The adapter 21 is also provided with a side arm 24 which is provided with a Luer-type fitting 26 at its extremity which can be secured to another Luer fitting connected to another tubular member and/or a pump through which b:lood can be supplied as hereinafter described.
The balloon dilatation catheter 13 of the present invention consists of a flexible elongate tubular member 31 formed of a suitable polyolefin or polyolefin alloy to provide a shaft for the balloon dilatation catheter of varying stiffness with the stiffness being greatest at the proximal extremity 32 of the tubular member with decreasing stiffness in a direction toward the distal extremity 33 to provide maximum force or pushability in transmission in the straight sections of the tubular member 31 and lesser stiffness for in-creased flexibility and trackability in the distal portion to negotiate the aortic arch and lead into the coxonary vasculature. For maximum flexibility and trackability the extrjeme distal extremity can be made of very soft polyolefin. Different degrees of stiffness in the shaft can be readily obtained by forming portions of the tubular member from different composi-tions of a suitable polyolefin. For example, the proximal portion can be formed of a high density polyolefin compound, whereas the more flexible portions can be formed of a mixture of high density polyolefin and low density polyolefin with the tip being formed of a very low density polyolefin. The various portions can be heat bonded together.
A first lumen36 is provided in the tubular member 31 which extends from the proximal extremity of the tubular member 31 into a region at least near the distal extremity of the tubular member 31. As hereinafter described, the first lumen 36 can be identified as a balloon inflation/deflation lumen. First and second inflatable balloons 37 and 38 are carried by the tubular member 31. The first and second bal]oons 37 and 38 are formed in a suitable manner, as for e~ample, of soft polyolefin. The material for the balloons can be irradiated if desired so that the proximal and distal extremities of the balloon can be secured to the tubular member 31 by suitable means such as heat shrinking the same onto the tubular member or, alterna-tively, by utilizing an adhesive.
The second balloon 38 is positioned near the distal extremity of the tubular member 31 and serves as a conventional dilatation balloon for performing dilatation operations on a stenosis as hereinafter described. The first balloon 37 is provided for an entirely different purpose and is proximal of the distal or second balloon 38 and normally is positioned ,' : ' ~' ' 1~89~338 a suitable distance as, for example, approximately 20 centimeters from the distal or second balloon 38. The balloon 37 is disposed within and adjacent the proximal extremity of the guiding catheter 12 when the balloon dilatation catheter 13 is positioned in the guiding catheter and is being used to perform an enlargment of a stenosis.
As hereinafter described, the first balloon 37 is provided for forming a liquid-tight seal between the balloon dilatation catheter 13 and the inner wall of the guiding catheter 12. The distal or second balloon can have a suitable diameter as, for example, ranging from 1.5 to 4.0 centimeters. The proximal or first balloon 37'can have a diameter which is sufficient to close off the flow passage 18 in the guiding catheter 12. Thus if the guiding catheter has an ins,ide diame-ter 1-1.95 mm (.040 to .078 inch), the proxim~l or first balloon 37 should have a corresponding diameter but slightly larger.
Means is provided for establishing communication between the interior 41 of the first balloon 37 and thel~men 36 extending through the tubular menlber 31. As shown this is accomplished by providing at least one elongate slot 42 in the tubular member 31 which is in communication with the interior 41 of the first balloon 37. The interior 44 of the second balloon 3~ is in communication with the distal extremity of the first lumen 36 through an elongate slot 45. Although only a single lumen, namely the first lumen 36, has been provided for inflating and deflating both of the balloons 37 and 38, it should be appreciated that if desired, a separate balloon inflation lumen can be provided for each of the balloons. However, this is normally undesirable because this would require the --~Z~'83~

formation of an additional lumen and possibl~ make it necessary to increase the diameter of the tubular member 31.
A second lumen 46 is carried by the tu~ular member 31. The second lumen 46 can be formed into a separate sleeve carried by the tubular member 31 or alternative-ly, as shown, it can be formed in the tubular member 31 itself. Thus, the second lumen 46 as shown in Figure 4 has an inlet opening 47 which is just proximal of the first balloon 37 and extends through the portion of the tubular member 31 extending between the first and second balloons 37 and 38 through the second balloon 38 and through the distal extremity of the tubular member 31.
As shown in Figure 2, the first or balloon inflation/
deflation lumen 36 can have a suitable diameter such as an inside diameter of approximately 0.3 mm (.012 inch) for the tubular member 31 and an outside diameter of 0.5 mm (.020 inch). As shown in Figure 3, this first lumen 36 in that region can have an arcuate shape having suitable dimensions such as approximately 0.6 x 0.28 mm (.024 x .011 inch). The second lumen 46 can l1aV~ a diameter of approximately 1.03 x 0.73 mm (.0~1 x .029 inch) and as hereinafter explained serves as a guide wire/flow lumen. The outside diameter of the -tubular member 31 in the region of Figure 3 has an outside diameter of approximately 1.5 mm t.060 inch).
The distal extremity of the tubular member 31 is provided with a plurality of radially and longitudinally spaced openings 51 which are distal of the second balloon 38 and which are in communication with the ; second lumen 46. A radiopaque marker of a suitable material such as gold or platinum band or coi.l 52 is placed on the tubular member 31 equidistant ~etween the ends of the distal balloon 38. A similar radiopaque ' - , ~Z898~3 -8- ~6239-1370 marker 53 is provided on the melnber 31 just distal of the balloon 37 to indicate the position of the balloon 37.
An adapter 56 of a conventional type is secured to the proximal extremity of the tubular member 31 and is provided with a central ar~n 57 which is in communication wit'h the first lumen 36.
The adapter 56 is provided with a side arm 58 which is also in communication with the first lumen 36 and which can be utilized for introducing a liquid as, for example, a radiopaque contrast liquid for inflating and deflating the balloons 37 and 38.
Suitable means is provided for ven-ting the second or distal balloon 38 and as shown can consist of a vent tube 61 of a conventional type such as a flexible stainless steel tubular mem-ber which is inserted through the central~arm 57 t'hrough the first lumen 36 until it extends into tne balloon 38 near the distal extremity of the second or distal balloon 38. Thus it can be seen that when a liquid is introduced through -the arm 58 and throug'h the first lumen 36 to fill the balloons 37 and 38 that any air within t'he balloon 38 will be uryed out of the balloon through the vent tube 61 to the atmosphere. After the balloons 37 and 38 have been inflated in this manner and the air expelled therefrom, the radiographic contrast liquid can be removed to deflate the balloons 37 and 38 so that they can be introduced into the vessel of t'he patient.
It should be,appreciated that different means can be utilized for venting the distal balloon of the dual balloon cathe-ter than the use of the vent tube hereinbefore described. For example, self vent:ing means of the type described in copending application entitled "SELF VENDING BALLOON DILATION CATHETER AND
METHO~" Canadian Patent Application Serial No. 555,821 can be utilized.
~ The apparatus 11 also includes a guide wire 66 of a conventional type, as for example, an .018 Hi-Torque : : -' - .

~2~9838 Floppy (trademark) Guide Wire manufactured ar.d sold by Advanced Cardiovascular Systems, Inc. of Moui~tain Vie~, California. The guide wire 66 has roximal and distal extremities 67 and 68. In utilizing the guide wire, the proximal extremity of the same is inserted into the distal extremity of the balloon dilata-tion catheter 13 by introducing the same into the second lumen 46 and pushing it along the second lumen 46 until it exits through the inlet opening 47. After passing through the inlet opening, it is passed along the entire length of the tubular member 31 until the proximal extremity extends to or beyond the adapter 56.
The apparatus 11 also includes a removable slit sheath 71 formed of a suitable material such ~s high density polyolefin. The sheath 71 as shown in Figure 2 can have suitable dimensions, as for example, an outside diameter of 1.25 mm (.050 inch) and an inside diameter of 1 mm (.040 inch). It is provided with a slit 72 extend-ing longitudinally of the same. The sheath 71 can have any suitable length but it preferably should extend up to and in close proximity to the proxirnal extremity of the first balloon 37. Thus, by way oE cxample, with a balloon dilatation catheter having a length as, for example, 135 centimeters, the sheath would have a length of approximately 110 centimeters with the distance from the proximal extremity of the first balloon 37 and the distal extremity of the second balloon of approximately 20 centimeters. As shown the sheath 71 can be placed over the shaft of the balloon dilatation catheter 13.
In this position, it can be seen that it locates or positions the guide wire 66 adjacent the shaft of the balloon dilatation catheter formed by the tubular member 31. In addition, the sheath 71 supplements and aids in the pushability of the balloon dilatation cathe~er.

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1289B~8 Another embodiment of a balloon dilatation catheter incorporating the present invention is shown in Figure 5 and is one in which the guide wire is enc.losed along : its entire length rather than a portion of the same being placed in a split sheath as shown in I;~igure 1.
This balloon dilatation catheter 76 consists of a flexible elongate tubular member 77 formed of a suitable plastic such as a polyolefin and has varying stiffness to increase pushability of the catheter. This is accomplished in the manner hereinbefore described utilizing different mixtures of high density and low density polyolefins. The tubular member 77 is provided with proximal and distal extremitie~s 78 and 79.
The tubular member 77 is provided with a first lumen 81 ; 15 which extends from the proximal extremi Ly 0~ the tubular member to a region adjacent the distal extremity 79. This first lumen $1 can have a suitable diameter, such as approximately 0.3 mm (.012 inch) in the region of Figure 6 and a dimension of approximately 0.6 x 0.28 mm (.024 x .011 inch) in the regioll of Figure 7. First and second or proximal and distal inflatable balloons 82 and 83 of the type hereinbefore described are also carried by the tubular member 77 and are secured thereto in the manner hereinbefore described. The interior 84 of the first balloon 82 is placed in communication with the first lumen 81 by an elongate shot 86 extending between the first lumen 86 and the interior 84. The interior 87 of the second balloon 83 is also in communication with the distal extremity of the first lumen 81 through an elongate slot 88.
A second lumen 91 is carried by the tubular member 71 and extends from the proximal extremity to the distal extremity of the tubular member 71. This : ~ . - .
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12~9~338 second luman 91 should have a suitable size which is large enough to accommodate a guide wire and thus can have an inside diameter, as for example, approximately .021 inches in the region of Figure 6 and a size of approximately 1.03 x 0.73 mm (.041 x .029 inch) in the region of Figure 7. The tubular member 77 in the region of Figure 6 can have an outside diam~ter of approximately 1.1 mm (.044 inch) and in the region of Figure 7 have an outside diameter of approximately 1.5 mm (.060 inch). As can be seen, this second lumen 98 extends through the first and second balloons 82 and 83. An opening 92 is provided in the tubular member 77 just proximal of the proximal extremity of the first balloon 82 and is in communication with the second lumen 91. Alternatively, a plurality of such openings 92 can be provided in communication with the lumen 98 such as by providing a plurality of spaced apart notches extending over approximately five centimeters or greater as shown in Figure 8 just proximal of the balloon 82.
The distal extremity of the tubular member 77 is provided with a plurality of longitudinally and circumferentially spaced holes 93 distal of the distal or second balloon 83 which are in communication with the flow passage or second lumen 91 to permit blood perfusion as hereinafter described. A radiopaque marker 94 of the type hereinbefore described is provided on the tubular member 77 within the distal balloon 83. Also a radiopaque marker 95 is placed on the member 77 just distal of the balloon 82.
An adapter 96 is mounted on the proximal extremity of the tubular member 76 and is comprised of a central arm 97 which is in comrnunication with the second lumen 91. A guide wire 98 of conventional construction as, . .

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~;~89~8 for example, the .018 Hi-Torque Floppy guide wire manufactured and sold by Advanced Cardiovascular Systems, Inc. of Mountain View, California can be utilized.
This guide wire 98 can be inserted in a conve~ltional manner. It is provided with proximal and distal extremi-ties 99 and 101. Thus by way of example, the distal extremity 101 can be inserted through the central arm 97 and the guide wire threaded throuyh the second lumen 91 until the distal extremity 101 extends beyond the distal extremity of the tubular member 77. Alternatively, if desired, the proximal extremity 99 can be threaded through the distal extremity of the tubular member 77 and pushed rearwardly through the second lumen 91 until it extends out of the central arm 97 of the adapter 96 as shown in Figure 5.
The adapter 96 is also provided with sicle arms 102 and 103. Suitable means is provided for venting the distal or second balloon 83 and as shown consists of a vent tube 106 of a conventional type as, for exampl.e, a flexible stainless steel tube which is introduced throu~h the side arm 102 and extends through the first lumell 81 into the interior of the second balloon 83. The o-ther side arm 103 can be utilized for introducing radiopaque contrast liquid by use of a suitable device such as disclosed in U.S.
Patent No. 4,439, 185. As the radiopaque con(rast liquid is introduced into the side arm 103, the balloons 82 and 83 are inflated. Any air entrapped within the balloon 83 will be forced out to the atmosphere through thc vent tube 106.
After it has been observed that the balloon 83 has been filled with a radiopaque contrast liquid without any air bubbles therein, the balloon can be deflated b~ with-drawing the radiopaque liquid so that the balloon dilata-tion catheter is ready for use.
Operation and use of the apparatus 11 co~prising the , ' . ~ , -, ~21~983~

guiding catheter 12 and the balloon dilatation catheter 13 or alternatively, the balloon dilatation catheter 76 in performing the method of the present invention may now be briefly described as follows. Let it be assumed that it is desired to perform an angioplasty procedure in which it is believed that blood perfusion will be necessary because of the length of time that it is desired to inflate the dilatation balloon in the stenosis. The guiding catheter 12 is inserted into a vessel of the patient in a conven-tional manner by the use of a separate guide wire. Let itbe assumed that it is desired to utilize balloon dilata-tion catheter 76. The catheter 76 after it has been prepared is inserted through the adapter 21 of the guiding catheter 12 by opening of the ~nob 23 and then closing it down around the catheter to minimize the loss of blood.
The dilatation catheter is advanced in a conventional manner first by advancing the guide wire 98 and then ~advancing the catheter 76 over the guide wire 98 to the desired position. Let it be assumed that the guide wire 98 has been advanced into the stenosis and that the distal or second balloon 83 has been advanced into the stenosis and that it is now desired to inflate the same for a relatively lengthy period of tlme. Since this is the case, it is desirable to perfuse blood through the dilatation catheter. This can be readily accomplished by removing the guide wire and then taking blood from a suitable location as, for example, the femoral artery of the patient and pumping the same by use of a conventional pump and supplying the blood to the arm 24 of the guiding catheter 12. The arm 24 is in communication with the flow passage 18 oE the guiding catheter 12 and flows through this relatively large passage up to the point of the first balloon 82 which occludes the flow passage and prevents the flow of blood in the flow passage 18 beyond that point. The blood then must pass '~- . . . .

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through at least one of the opening 92 into -~he second lumen 91 and then through the openings 93 distal of the second balloon 83. Blood therefore flows through the dilatation catheter into a region beyond the stenosis so that there is a continued supply of blood to the heart : muscle during the period of inflation of the balloon.
Thus, relatively long balloon inflation periods can be utilized if desired without any possiblity o, damage to the heart muscle.
By utilizing such apparatus, it has been found that normal proximal coronary arterial flow of approximately 60 cubic centimeters per minute can be readily achieved at relatively low pressures with minimum turbulence and hemolysis. By way of example, pressures near 1.7 x 10 Pa can be utilized to achieve such flow rates utilizing the construction of the present invention. After the stenosis has been dilated for a sufficient period of time, the balloons 82 and 83 can be deflated and the balloon dilata-tion catheter 13 removed. Thereafter, the gui.ding catheter 12 can be removed.

~, It should be appreciated that the balloon dilatation catheter 13 can be also utili~ed in the guiding catheter 12 to perform the procedure hereinbefore described. Before introduction of the catheter 13 into -the guiding catheter 12, the removable slit sheath 71 is placed over the tubular mem-ber 31 proximal of the first balloon 37 so that the guide wire 66 is retained thereln. With this sheath 71 in place, the catheter 13 can be introduced into the guiding catheter 12 with the guide wire 68 preceding the distal extremity of the dilatation catheter 13. The sheath introducer 71, in addition to locating the guide wire 66 as hereinbefore described also facilitates the introduction of the catheter 13 into the guiding catheter 12 by increasing the - - -.
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stiffness of the shaft of the catheter 13.
After the catheter 13 has been positioncd in the desired location, the proximal extremity of the sheath 71 can be grasped and it can be slipped off of the catheter by peeling it away from the catheter through -the slit 72.
After the distal or second balloon 38 has been positioned in the lesion, the guide wire 66 can be removed so that the flow passage 46 is free for the passage of blood to be perfused. The operation of this balloon dilatation catheter 13 and the guiding catheter 12 thereafter is substantially identical to that hereinbèfore described for the balloon dilatation catheter 76. After the procedure for inflating the stenosis has been completed, ; ~ the balloon dilatation catheter 13 and the guiding catheter 12 can be removed in the manner hereinbefore described.
With the apparatus hereinbefore described it can be seen that the distal balloon can be utilized as a standard dilatation balloon while the proximal balloon remains within the guiding catheter and during inflation is used to seal the distal end of the guiding catheter which per-mits blood to be pumped into the proximal encl of the guid-ing catheter via the side arm 2~ of the rotating hemostatic valve 22. Blood pumped down the guiding cathcter uses the ; large inside diameter of the flow passage 18. This pro-vides low resistance to the flow of blood and thereby reduces pressures over the first 110 centimeters of the catheter system. Blood enters the dilatation catheter in a region adjacent the proximal extremity of the proximal ; balloon through an enlarged opening or multiple openings and continues through the relatively large guide wire/flow lumen or second lumen provided in the dilatation catheter.
Blood travels beyond the second balloon and perfuses through the plurality of openings provided in the distal extremity of the catheter.

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~L~89838 It should also be appreciated that in conjunction with the present invention, specific diameters and sizes have been given for the various components that di~ferent sizes and diameters can be utilized as desired to provide smaller and larger dilatation catheters.
Another alternative embodiment is to provide a large proximal balloon extending over substantiall~ the entire 110 centimeters of the dilatation catheter connecting the distal extremity of the same into the guide wlre/flow lumen and limiting the relatively short length proximal balloon. In utilizing such an embodiment, when blood is pumped into the catheter, it would be pumped in to fill the long 110 centimeter balloon which would expand and seal the dilatation catheter within the guiding catheter. This would still make it possible to take advantage of the large inside diameter of the guiding catheter -to provide a large flow passage for the flow of blood through substan-tially the entire length of the dilatation catheter.

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Claims (11)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. In a perfusion-type balloon dilatation apparatus, a guiding catheter having proximal and distal extremities and having a fluid flow passage extending therethrough, a balloon dilatation catheter disposed in the guiding catheter, the balloon dilatation catheter comprising a flexible elongate tubular member having proximal and distal extremities and having inflation means extending therethrough, first and second inflatable balloons carried by the tubular member and having their interiors in communication with the inflation means in the tubular member, the first balloon being positioned within the guiding catheter, the second balloon being positioned adjacent the distal extremity of the tubular member, a fluid flow lumen carried by the tubular member extending through the first and second balloons and through the distal extremity of the tubular member, the fluid flow lumen having an opening proximal of the first balloon and opening into the interior of the guiding catheter and an adapter carried by the proximal extremity of the guiding catheter and providing a liquid-tight seal between the guiding catheter and the dilatation catheter and also providing an inlet through which liquid can be introduced so that it can travel through the flow passage in the guiding catheter and the fluid flow lumen in the dilatation catheter so that the liquid can flow through the fluid flow lumen beyond the second inflatable balloon.
2. Apparatus as in claim 1 together with a guide wire extending through the fluid flow lumen having proximal and distal extremities, the distal extremity of the guide wire being adapted to extend beyond the distal extremity of the flexible elongate tubular member of the dilatation catheter, the proximal extremity of the guide wire being adapted to extend beyond the proximal extremity of the flexible elongate member of the dilatation catheter.
3. Apparatus as in claim 2 wherein the guide wire extends out of the opening for the fluid flow lumen proximal of the first balloon and extends rearwardly along the length of the flexible elongate tubular member of the dilatation catheter to a region beyond the proximal extremity of the dilatation catheter.
4. Apparatus as in claim 3 together with a slit sheath closing the flexible elongate tubular member in the region of the proximal extremity thereof and also enclosing at least a portion of the guide wire extending from the opening in the fluid flow lumen through the proximal extremity of the same.
5. Apparatus as in claim 2 wherein the fluid flow lumen extends to the proximal extremity of the flexible elongate tubular member and wherein the guide wire extends through the fluid flow lumen to the proximal extremity thereof.
6. Apparatus as in claim l wherein said first balloon is of relatively short length and is disposed near the distal extremity of the guiding catheter.
7. Apparatus as in claim 6 wherein the first balloon has a size sufficient so that when it is inflated it occludes the flow passage in the guiding catheter.
8. In a balloon dilatation catheter for use in a guiding catheter of the type having a flow passage extending therethrough, the balloon dilatation catheter comprising a flexible elongate tubular member having proximal and distal extremities, inflation means extending therethrough, first and second inflatable balloons the interiors of which are in fluid communication with the inflation means in the tubular member, the first balloon being positioned in a longitudinally spaced-apart position from the second balloon so that it is adapted to be positioned within a guiding catheter when the balloon dilatation catheter is disposed in the guiding catheter, the first balloon having a size so that when it is inflated, it will occlude the flow passage in the guiding catheter, the second balloon being disposed adjacent the distal extremity of the flexible tubular member, and a fluid flow lumen carried by the tubular member and extending through the first and second balloons and through the distal extremity of the tubular member, the fluid flow lumen having an opening proximal of the first balloon distal of the proximal extremity of the tubular member, and an adapter carried by the proximal extremity of the tubular member having an arm in fluid communication with the inflation means.
9. A catheter as in claim 8 wherein said fluid flow lumen extends the entire length of the flexible elongate tubular member.
10. A dilatation catheter comprising a flexible elongate tubular member having proximal and distal extremities, first and second longitudinally spaced apart inflatable balloons, inflation and deflation means in fluid communication with the interiors of the balloon, a fluid flow lumen within the tubular member extending through the first and second balloons and through the distal extremity of the tubular member, the fluid flow lumen having an opening proximal of the first balloon and a guide wire which extends through the fluid flow lumen out of said opening proximal of the first balloon and along the flexible elongate tubular member exteriorally thereof to a region which is beyond the proximal extremity of the flexible elongate tubular member.
11. Apparatus as in claim 10, together with a removable split sheath mounted on the proximal extremity of said elongate tubular member and enclosing the same and said guide wire.
CA000555824A 1987-01-06 1988-01-05 Perfusion type balloon dilatation catheter and apparatus Expired - Lifetime CA1289838C (en)

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US07/000,649 US4771777A (en) 1987-01-06 1987-01-06 Perfusion type balloon dilatation catheter, apparatus and method
US000,649 1987-01-06

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EP (1) EP0277367A1 (en)
JP (1) JPS63238877A (en)
AU (1) AU606116B2 (en)
CA (1) CA1289838C (en)

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EP0277367A1 (en) 1988-08-10
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AU1007088A (en) 1988-07-07
US4771777A (en) 1988-09-20

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