WO2001019445A1 - Balloon catheter to deliver a drug or to remove substances such as emboli or excess drug - Google Patents

Balloon catheter to deliver a drug or to remove substances such as emboli or excess drug Download PDF

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Publication number
WO2001019445A1
WO2001019445A1 PCT/US2000/024683 US0024683W WO0119445A1 WO 2001019445 A1 WO2001019445 A1 WO 2001019445A1 US 0024683 W US0024683 W US 0024683W WO 0119445 A1 WO0119445 A1 WO 0119445A1
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WO
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Patent type
Prior art keywords
balloon
catheter
tubular member
plurality
openings
Prior art date
Application number
PCT/US2000/024683
Other languages
French (fr)
Inventor
Daryush Mirzaee
Original Assignee
Advanced Cardiovascular Systems, Inc.
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Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1081Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1086Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/109Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters

Abstract

A balloon catheter includes an elongated tubular member and first and second balloons. The first balloon has proximal and distal ends and is coupled to the tubular member proximate a distal end. The second balloon, which can be an occlusive balloon, is coupled to the tubular member between the distal ends of the first balloon and the tubular member. The tubular member has a plurality of openings formed therein. The openings are located adjacent the proximal and distal ends of the first balloon and can remove a substance, such as emboli and debris, present in the vessel. Where the first balloon is a drug delivery balloon, the plurality of openings can also remove excess drug from the vessel to prevent regional and systemic toxicity.

Description

BALLON CATHETER TO DELIVER A DRUG OR TO REMOVE SUBSTANCES SUCH AS EMBOLI OR EXESS DRUG

FIELD OF THE INVENTION

The present invention relates to catheters. More particularly, the present invention relates to a balloon catheter with a retrieval system for removing emboli and excess drug.

BACKGROUND OF THE INVENTION

Balloon catheters have a wide variety of medical applications. Dilatation catheters employ inflatable balloons made of a non-compliant material for dilating vessels that have become occluded or blocked by plaque, thrombi or other deposits. Stent delivery catheters have a stent which is mounted about the outside of a balloon. When the balloon is inflated, it deploys the stent which positions itself within the vessel. Stent delivery catheters are particularly useful for dilating arterial stenoses. Drug delivery catheters use inflatable balloons to administer drugs, such as thrombolytic agents, to particular sections of blood vessels. A problem with balloon catheters is that they can dislodge emboli when they are placed in a vessel. These catheters are used in occluded or blocked vessels, and the inflation of a balloon or deployment of a stent can dislodge emboli into the bloodstream. A dislodged embolus can move downstream potentially causing serious harm, such as a stroke or distal occlusion of a downstream artery. One approach to this embolism problem utilizes a multi-catheter arrangement to contain and remove emboli. The arrangement, which includes three catheters, a main catheter with an occlusive balloon, an inner catheter with an occlusive balloon and an intermediate catheter, operates as follows. A guidewire is first inserted into the patient's vasculature to locate a stenosis. The main catheter is then advanced over the guidewire until its balloon is just proximal of the stenosis, and the balloon is deployed to occlude the vessel. Next, the inner catheter is inserted through a main lumen of the main catheter until its balloon is just distal of the stenosis, and the balloon is inflated to seal off the treatment site. The intermediate catheter is then advanced in the main lumen of the main catheter over the inner catheter to the stenosis. Following treatment of the stenosis, irrigation fluid is provided through a pathway between the inner and intermediate catheters, and aspiration is provided through a pathway between the intermediate and main catheters to remove any dislodged emboli. The multi-catheter is withdrawn by first removing the intermediate catheter. The occlusive balloons are then deflated, and the main and inner catheters removed.

A disadvantage of the multi-catheter arrangement described above is that the multiple catheters make it cumbersome to use. In addition, the numerous steps of inserting the guidewire and the various catheters is quite time-consuming. Another disadvantage is the large diameter of the main catheter, which must accommodate both the intermediate and inner catheters. Larger catheters are more likely to damage vessels, resulting in bleeding and further complications.

An additional problem exists for drug delivery catheters. It is often difficult to deliver a proper amount of medication to a treatment site, as some of the medication will travel downstream, away from the site, before the medication is fully absorbed. Isolating the treatment site prevents the medication from traveling downstream but can result in too much medication being delivered to the site. Drug run-off can cause regional and systemic toxicity if not retrieved.

Accordingly, there is a need for a medical device which is capable of removing emboli. There is also a need for a drug delivery catheter capable of delivering medication to a treatment site and retrieving any excess. The device should be able to remove emboli and/or excess drugs from the treatment site during actual treatment, as opposed to only after treatment is complete. The device should also be simple and easy to use.

SUMMARY

The disclosed catheter provides a balloon catheter with a plurality of openings located adjacent both ends of the balloon to retrieve emboli and/or excess medication.

In accordance with one embodiment of the invention, a balloon catheter includes an elongated tubular member and first and second balloons mounted on the tubular member. The first balloon, which has proximal and distal ends, is coupled proximate a distal end of the tubular member, and the second balloon is located distal of the first balloon. The second balloon is an occlusive balloon for occluding a vessel. The tubular member includes a plurality of openings formed therein and located adjacent the proximal and distal ends of the first balloon for receiving a substance present in the vessel. The substance can be emboli dislodged during placement of the catheter in the vessel. Where the first balloon is a drug delivery balloon, the plurality of openings can also remove excess drugs or medication not absorbed by the vessel.

In accordance with another embodiment of the invention, a balloon catheter includes a tubular member, a pair of occlusive balloons, and a third balloon. The occlusive balloons are coupled to the tubular member proximate a distal end and are spaced apart from each other by a predetermined distance. The third balloon is also mounted on the tubular member between the pair of occlusive balloons. The tubular member has a plurality of openings located adjacent the proximal and distal ends of the third balloon and a retrieval lumen extending from a proximal end of the tubular member to the plurality of openings for withdrawing a substance present in the vessel.

In accordance with another embodiment of the invention, a method of treating a treatment site in a vessel includes inserting a catheter, such as that described above, into the vessel and positioning the catheter such that a first balloon is situated at the treatment site. The method further includes inflating a second balloon to occlude the vessel, inflating the first balloon, and withdrawing a substance present in the vessel via the plurality of openings proximate the first balloon. If the catheter includes two occlusive balloons, both occlusive balloons may be inflated prior to inflation of the first balloon to isolate the treatment site.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention can be further understood by reference to the following description and attached drawings which illustrate the various embodiments.

Fig. 1 is a plan view of the balloon catheter in accordance with the present invention, illustrating a drug delivery balloon.

Fig. 2 is an enlarged view of the distal end of the catheter shown in Fig. 1. Fig. 3 is a cross-sectional view taken generally along the line 3-3 of Fig. 2. Fig. 4 is a partial sectional view of a blood vessel with the catheter of Fig. 1 positioned therein. Fig. 5 is a partial sectional view of a blood vessel with another embodiment of the catheter positioned therein and illustrating a stent delivery balloon.

Fig. 6 is an enlarged view of the distal end of another embodiment of a balloon catheter of the present invention. Fig. 7 is a cross-sectional view taken generally along the line 7-7 of Fig. 6.

Fig. 8 is an enlarged view of the distal end of the catheter of Fig. 1 including a retractable sheath.

DETAILED DESCRIPTION Referring to Figs. 1-4, components of a balloon catheter 10 in accordance with the present invention will be described. Catheter 10 includes a tubular member 12 having a proximal end 14 and a distal end 16. Catheter 10 further includes a pair of conventional occlusive balloons 18 and 20 for occluding a section of a vessel and an intermediate balloon 22, all three of which are illustrated in their expanded state. Balloons 18, 20 and 22 are mounted on tubular member 12 proximate distal end 16, with intermediate balloon 22 disposed between occlusive balloons 18 and 20.

In one embodiment of the invention, at proximal end 14 of tubular member 12 are a plurality of ports 24, 26 and 28. Main port 24 can be in communication with a main lumen 30 of tubular member (Fig. 3). Main lumen 30 extends from proximal end 14 of tubular member to an opening 32 formed in distal end 16. Opening 32 and main lumen 30 are adapted to receive a guidewire, not shown. Main port 24 can be connected to a vacuum source, as will be described in greater detail below. Port 26 can be connected via a secondary lumen 34 to occlusive balloons 18 and 20. Secondary lumen 34 extends from proximal end 14 of tubular member 12 to occlusive balloons 18 and 20. Port 26 can be used to inflate and deflate balloons 18 and 20. Alternatively, occlusive balloons 18 and 20 may be connected to separate inflation lumens and inflated independent of each other. Port 28 can be in fluid communication with intermediate balloon 22 via a secondary lumen 36 and inflates and deflates balloon 22.

Fig. 3 provides a cross-sectional view of tubular member 12 taken proximal of occlusive balloon 18. Lumens 30, 34 and 36 can taper or change diameters along their lengths. It will be recognized by one of ordinary skill in the art that catheter 10 is not limited by the size or cross-sectional shape of the lumens, by whether the lumens taper, or by the amount by which any of the lumens tapers. Furthermore, additional lumens may be provided. For example, a lumen separate from main lumen 30 can serve as the retrieval lumen, so that main lumen need not serve as both the guidewire and the retrieval lumen. The catheter illustrated in Figs. 1-4 is a drug delivery catheter for delivering medication or other fluids, such as a saline solution, to a treatment site. Intermediate balloon 22 includes a plurality of microscopic apertures 38, best illustrated in Fig. 2. Apertures 38 enable drugs, such as thrombolytic agents, supplied to balloon 22 via port 28 and lumen 36 to be administered to a treatment site in a vessel. Fig. 4 illustrates drug delivery catheter 10 positioned within a vessel 40. Drug delivery balloon 22 can be made of a compliant material, which will expand and conform to the shape of the vessel in which catheter 10 is located, or a non-compliant material. Drug delivery balloon 22 can be made of a non-compliant material, such as nylon or PET or a substantially non-compliant material, such as polyethylene. Alternatively, drug delivery balloon 22 can be made of a compliant material such as latex or polyurethane. When balloon 22 is fully inflated, apertures 38 abut the wall of vessel 40. Apertures 38 can be of micron or submicron size with a diameter ranging from approximately 0.2 μm to 10 μm. In one embodiment of the invention, apertures 38 are generally circular or elliptical in configuration, however, one of ordinary skill in the art will appreciate that apertures can be any other suitable configuration, such as rectangular. Apertures 38 can be aligned in rows or helically disposed about balloon 22. Drug delivery balloon can have between several hundred and several million apertures, ranging between approximately 0.20 μm to 10.0 μm in diameter. The exact number, size and arrangement of apertures 38 can be optimized for the particular application. In one embodiment, tubular member 12 also includes a plurality of openings 42 formed therein. Openings 42 can be located adjacent the proximal and distal ends 44 and 46, respectively, of intermediate balloon 22. Openings 42 enable excess drug dispensed by intermediate balloon 22 to be removed from the treatment site. In addition, openings 42 can also remove any emboli that may have been dislodged during placement of catheter 10 in the vessel. As discussed above, main lumen 30 extends from port 24 to openings 42. When a negative pressure source, not shown, is connected to port 24, port 24 can be used to withdraw excess medication and dislodged emboli from the treatment site.

While the embodiment of Figs. 1-4 depicts two openings 42 at each end of intermediate balloon 22, a single opening or more than two openings can also be provided. In one embodiment of the invention, openings 42 are elliptical in configuration with a length ranging between 0.1 mm and 2 mm and a width ranging between 0.1 and 1 mm. Although openings 42 illustrated in Figs. 1-4 are shown as elliptical, openings 42 may take on other suitable configurations, such as circular. One of ordinary skill in the art will appreciate that the number, size and shape of openings 42 at the proximal and distal ends of balloon 22 can be optimized in order to balance distal and proximal evacuation at the treatment site of vessel 40.

An embodiment of catheter 10 operates as follows. A guidewire, not shown, is inserted into the vasculature of a patient and directed to a treatment site in a vessel. Catheter 10 is advanced over the guidewire, with the guidewire passing through main lumen 30 of tubular member 12, until the proximal and distal occlusive balloons 18 and 20, respectively, are on opposite sides of the treatment site. The guidewire can then be removed from the patient's body.

Occlusive balloons 18 and 20 are inflated to isolate the treatment site. Occlusive balloons 18 and 20 can be made of a compliant material such as latex or polyurethane. While catheter 10 has two occlusive balloons 18 and 20 for isolating the treatment site, catheter 10 can be equipped with only a single occlusive balloon located distal of intermediate balloon 22. This distally located occlusive balloon can prevent emboli or excess medication from traveling downstream.

Once the treatment site is isolated, intermediate drug delivery balloon 22 is inflated. A drug supply, not shown, can be coupled to port 28. The drug supply provides the drug to balloon 22 via secondary lumen 36. As balloon 22 expands due to entry of the drug, the drug passes through apertures 38 of balloon 22 and into the vessel. So long as the drug supply continues to provide the drug to catheter 10, balloon 22 will dispense the drug into vessel. In one embodiment the drug may be dispensed through apertures 38 at a rate equal to the absorption rate of the vessel, so that no excess drug remains at treatment site. While balloon 22 dispenses the drug to the treatment site, main port 24 of catheter 10 can be connected to a negative pressure source, and a negative pressure can be applied. It should be noted that if main lumen 30 serves as both the retrieval lumen and the guidewire lumen, the guidewire may be retracted to at least proximal of the proximal evacuation openings 42 so as not to interfere with evacuation of the treatment site. Alternatively, the guidewire can be completely withdrawn from main lumen 30 prior to evacuation of the excess drug. Since main port 24 is in fluid communication with openings 42, the negative pressure at openings 42 can withdraw any excess drug located at the treatment site. Openings 42 can also retrieve emboli dislodged during placement of catheter 10 and located in the treatment site. By simultaneously administering the drug to and removing excess drug from the treatment site, catheter 10 can prevent regional or systemic toxicity of the treatment site. In addition, the catheter removes dislodged emboli from the vessel, which if not retrieved can travel downstream and occlude distal arteries.

Once drug delivery is complete, the drug supply can be disconnected from port 28. A negative pressure source may be connected to port 28 to deflate drug delivery balloon 22. While balloon 22 is deflating, main port 24 and lumen 30 can continue to remove emboli and excess drug from vessel 40, up until a short period of time, several seconds, after balloon 22 is fully deflated. Occlusive balloons 18 and 20 are deflated, and catheter 10 can be withdrawn from the patient's body.

Fig. 5 illustrates a catheter 10' in accordance with an embodiment of the present invention. Catheter 10' is a dilatation or stent delivery catheter used to dilate an occluded vessel. Catheter 10' is similar to drug delivery catheter 10, except for intermediate balloon 22'. Balloon 22' is a dilatation balloon or a stent delivery balloon and does not have any apertures formed therein. In one embodiment, dilatation balloon 22' is made of a non-compliant material, such as nylon and PET. The non-compliant material enables balloon 22' in its inflated state to dilate vessel 40.

Balloon 22' can also be a stent delivery balloon for implanting a stent 48 in vessel 40. Stent 48 can be any conventional metal stent or polymeric stent mounted around the outside of balloon 22' in its collapsed state. Balloon 22' can be inflated to implant stent 48 at the treatment site. When balloon 22' is deflated, stent 48 remains positioned in vessel 40. Inflating balloon 22' and positioning stent 48 at the treatment site can dislodge emboli from the wall of vessel 40. Openings 42, located adjacent the proximal and distal ends of balloon 22' of catheter 10', can be designed to receive emboli. A negative pressure applied to main port 24 can withdraw emboli from vessel 40 through openings 42, main lumen 30 and port 24.

Figs. 6 and 7 illustrate a catheter 10" in accordance with still another embodiment of the present invention. Catheter 10" is both a drug delivery and a stent delivery catheter. Intermediate balloon 22" has a plurality of apertures 38 formed therein for dispensing a drug to a treatment site in a vessel as well as a stent 48 mounted about the outside of balloon 22". A drug supply, not shown, provides a drug to inflate balloon 22". As balloon 22" expands, balloon 22" releases stent 48 while simultaneously administering the drug to the treatment site. During treatment, openings 42 in catheter 10" can remove emboli and excess drug from the treatment site.

Catheter 10" may further include at least one perfusion opening 50 formed in tubular member 12. Perfusion opening 50 is located proximal of occlusive balloon 18. Perfusion opening 50 can be in fluid communication with opening 32 at distal end 16 of tubular member 12. While balloon 22" delivers stent 48 and medication to the treatment site, blood can flow through perfusion opening 50, through main lumen 30" (Fig. 7) and out of opening 32 in distal end 18 of tubular member 12 to maintain blood flow along the vessel. Additional distal profusion openings, not shown, may be provided distal of distal occlusive balloon 20 for further blood flow from distal end 16 of catheter 10".

Fig. 7 is a cross-sectional view of tubular member 12 of catheter 10". Tubular member 12 has four lumens: a main lumen 30"; and three secondary lumens 34, 36 and 52. Main lumen 30" can provide the perfusion path for blood by connecting perfusion opening 50 with opening 32 in distal end 16 of tubular member 12. Main lumen 30" can also receive the guidewire during insertion of catheter 10" in the patient's body.

Secondary lumen 34 can provide access to occlusive balloons 18 and 20, while lumen 36 can provide access to intermediate balloon 22". The additional secondary lumen 52 can be coupled at one end to openings 42 and at the other end to an additional retrieval port, not shown. When connected to a negative pressure source, catheter 10" can draw emboli and excess medication into openings 42, through lumen 52 and out the retrieval port, thereby removing the emboli and excess medication from the patient's body.

In Fig. 8 drug delivery catheter 10 is illustrated with a sheath 54 over drug delivery balloon 22 and occlusive balloons 18 and 20. Sheath 54 ensures that deflated balloons 18, 20 and 22 maintain a low profile during insertion and removal of catheter 10 into the vessel. Sheath 54 can be slidably attached to tubular member 12 proximal to proximate occlusive balloon 18 and can be made of either a compliant or non-compliant material. The distal end of sheath 54 for drug delivery catheter 10 is not attached to tubular member 12. This enables that sheath 54 to be retracted, so that drug delivery balloon 20 can administer drugs to the treatment site. Once treatment is complete and balloons 18, 20 and 22 have been deflated, sheath 54 can be replaced over the deflated balloons to reduce the profile of catheter 10 for removal.

Sheath 54 can also be provided on a stent delivery catheter or a dilatation catheter. For a stent delivery catheter, sheath 54 can be retractable to enable deployment of the stent at the treatment site. For a dilatation catheter, sheath 54 need not be retractable and can be attached to tubular member 12 distal of distal occlusive balloon 22. In addition, the sheath for a dilatation catheter can be made of a compliant material so as to accommodate the inflation of the dilatation balloon.

While several aspects of the present invention have been described with regard to specific embodiments, those of ordinary skill in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention.

In one embodiment, the approximate dimensions of some of the components of catheter 10 can be as follows:

Figure imgf000011_0001

Those of ordinary skill in the art will appreciate that the various components described with respect to alternate embodiments may be rearranged or combined with each other without departing from the scope of the invention. For example, as noted above, stent 48 can be included on a drug delivery balloon 22'.

In another embodiment, one or more perfusion openings 50 can be provided on any one of the drug delivery catheter, dilatation catheter or stent delivery catheter to allow blood flow to continue during the treatment. In another embodiment, a single occlusive balloon 20 can be provided distal of the drug delivery, dilatation, or stent delivery balloon. As discussed above, the distal occlusive balloon can prevent drug run-off and dislodged emboli from traveling downstream to distal arteries.

In another embodiment, retrieval openings 42 can be located only between intermediate balloon 22 and distal occlusive balloon 20, rather than at both ends of intermediate balloon 22. Openings 42 could remove emboli and excess medication from the area between balloons 20 and 22 while balloon 22 is inflated. Removal of any emboli or excess medication located proximal of intermediate balloon 22 can take place during and immediately after deflation of balloon 22. Persons of ordinary skill in the art will appreciate that changes can be made to dimensions, sizing, relative dimensions, materials, spatial and angular relationships of and between components, and manufacturing processes and other commercial or industrial techniques, all without departing from the scope of the invention.

Claims

CLAIMSWhat is claimed is:
1. A balloon catheter comprising: an elongated tubular member having a proximal end and a distal end; a first balloon coupled to the tubular member proximate the distal end, the first balloon having a proximal end and a distal end; and a second balloon coupled to the tubular member, the second balloon being an occlusive balloon disposed between the distal ends of the first balloon and the tubular member, wherein the tubular member includes a plurality of openings formed therein for receiving a substance present in a vessel, the plurality of openings being located adjacent the proximal and distal ends of the first balloon.
2. The catheter of claim 1, wherein the tubular member has a retrieval lumen formed therein, the retrieval lumen extending from the proximal end to the plurality of openings to withdraw the substance present in the vessel.
3. The catheter of claim 1, wherein the tubular member has a delivery lumen formed therein and coupled to the first balloon, the first balloon being a fluid delivery balloon having a plurality of apertures formed therein for dispensing a fluid, and wherein the tubular member has a retrieval lumen formed therein, the retrieval lumen having a plurality of openings to remove excess fluid not absorbed by the vessel.
4. The catheter of claim 3, wherein the fluid delivery balloon dispenses a drug.
5. The catheter of claim 3 , wherein each of the plurality of apertures of the first balloon has a diameter ranging between approximately 0.2 μm and 10 μm.
6. The catheter of claim 1 , wherein the first balloon is a dilatation balloon comprising a non-compliant material.
7. The catheter of claim 1 , wherein the first balloon includes a stent.
8. The catheter of claim 1 , further comprising a third balloon mounted on the tubular member, the third balloon being an occlusive balloon disposed proximal of the first balloon.
9. The catheter of claim 1, further comprising a sheath extending over the first and second balloons, the sheath being attached to the elongated tubular member proximal of the first balloon.
10. A balloon catheter comprising: an elongated tubular member having a proximal end and a distal end; a pair of occlusive balloons coupled to the tubular member proximate the distal end, the pair of occlusive balloons being spaced apart by a distance; and a third balloon coupled to the tubular member and disposed between the pair of occlusive balloons, the third balloon having a proximal end and a distal end, wherein the tubular member has a plurality of openings and a retrieval lumen formed therein for withdrawing a substance present in a vessel, the plurality of openings being located adjacent the proximal and distal ends of the third balloon, the retrieval lumen extending from proximate the proximal end of the tubular member to the plurality of openings.
11. The catheter of claim 10, wherein the third balloon is a fluid delivery balloon having a plurality of apertures formed therein for dispensing a fluid, and wherein the plurality of openings and the retrieval lumen remove excess fluid not absorbed by the vessel.
12. The catheter of claim 11 , wherein the fluid delivery balloon dispenses a drug.
13. The catheter of claim 11 , wherein each of the plurality of apertures of the third balloon has a diameter ranging between approximately 0.2 μm and 10 μm.
14. The catheter of claim 10, wherein the third balloon is a dilatation balloon comprising a non-compliant material.
15. The catheter of claim 10, wherein the first balloon includes a stent.
16. A method of treating a treatment site in a vessel, the method comprising: inserting a catheter into the vessel, the catheter comprising a tubular member and first and second balloons coupled proximate a distal end of the tubular member, the second balloon being an occlusive balloon located distal of the first balloon, the tubular member having a plurality of openings proximate a proximal end and a distal end of the first balloon; positioning the catheter such that the first balloon is situated at the treatment site; inflating the second balloon to occlude the vessel; inflating the first balloon; and withdrawing a substance present in the vessel via the plurality of openings proximate the first balloon.
17. The method of claim 16, wherein the first balloon has a plurality of apertures formed therein, and further comprising dispensing a fluid from first balloon to the treatment site, wherein withdrawing the substance includes withdrawing excess fluid from the treatment site.
18. The method of claim 17, wherein dispensing the fluid includes dispensing a drug to the treatment site.
19. The method of claim 17, wherein the first balloon further includes a stent, and further comprising placing the stent at the treatment site
20. The method of claim 17, wherein withdrawing the substance further includes withdrawing emboli from the treatment site.
21. The method of claim 16, wherein the first balloon is a dilatation balloon comprising a non-compliant material.
22. The method of claim 16, wherein the first balloon includes a stent, and further comprising placing the stent at the treatment site.
23. The method of claim 16, wherein the catheter further comprises a third balloon mounted on the tubular member, the third balloon being an occlusive balloon disposed proximal of the first balloon, and further comprising inflating the third balloon to isolate the treatment site.
24. The method of claim 16, wherein withdrawal of the substance present in the vessel occurs simultaneous to inflation of the first balloon.
ww uι/ιy»» AMENDED CLAIMS
[received by International Bureau 8 February 2001 (08 02 01), original claims 16-24 cancelled, original claims 1 and 7 amended, remaining claims unchanged (3 pages)]
1 A balloon catheter composing. an elongated tubular member having a proximal end and a distal end, a first balloon coupled to the tubular member proximate the distal end, the first balloon having a proximal end and a distal end, wherein the first balloon includes a stent, and a second balloon coupled to the tubular member, the second balloon being an occlusive balloon disposed between the distal ends of the first balloon and the tubular member, wherein the tubular member includes a plurality of openings formed therein for receiving a substance present in a vessel, the plurality of openings being located adjacent the proximal and distal ends of the first balloon
2. The catheter of claim 1, wherein the tubular member has a retπeval lumen formed therein, the retπeval lumen extending from the proximal end to the plurality of openings to withdraw the substance present m the vessel
3. The catheter of claim 1, wherein the tubular member has a delivery lumen formed therein and coupled to the first balloon, the first balloon being a fluid delivery balloon having a plurality of apertures formed therein for dispensing a fluid, and wherein the tubular member has a retπeval lumen formed therein, the retπeval lumen having a plurality of openings to remove excess fluid not absorbed by the vessel
4. The catheter of claim 3, wherein the fluid delivery balloon dispenses a drug
5. The catheter of claim 3, wherein each of the plurality of apertures of the first balloon has a diameter ranging between approximately 0.2 μm and 10 μm
6 The catheter of claim 1, wherein the first balloon is a dilatation balloon composing a non-compliant mateπal
7 The catheter of claim 1, wherein the first balloon includes a plurality of apertures formed therein for dispensing a drug to a treatment site m a vessel, and a stent mounted outside the first balloon, the balloon being expandable on inflation with a medication, releasing the stent while simultaneously administeπng the medication
8 The catheter of claim 1 , further compπsing a third balloon mounted on the tubular member, the third balloon being an occlusive balloon disposed proximal of the first balloon
9 The catheter of claim 1, further compπsing a sheath extending over the first and second balloons, the sheath being attached to the elongated tubular member proximal of the first balloon
10 A balloon catheter compπsing an elongated tubular member having a proximal end and a distal end, a pair of occlusive balloons coupled to the tubular member proximate the distal end, the pair of occlusive balloons being spaced apart by a distance, and a third balloon coupled to the tubular member and disposed between the pair of occlusive balloons, the third balloon having a proximal end and a distal end, wherein the tubular member has a plurality of openings and a retrieval lumen formed therein for withdrawing a substance present in a vessel, the plurality of openings being located adjacent the proximal and distal ends of the third balloon, the retπeval lumen extending from proximate the proximal end of the tubular member to the plurality of openings
11 The catheter of claim 10, wherein the third balloon is a fluid delivery balloon having a plurality of apertures formed therein for dispensing a fluid, and wherein the plurality of openings and the retπeval lumen remove excess fluid not absorbed by the vessel
12. The catheter of claim 11 , wherein the fluid delivery balloon dispenses a drug.
13. The catheter of claim 11 , wherein each of the plurality of apertures of the third balloon has a diameter ranging between approximately 0.2 μm and 10 μm.
14. The catheter of claim 10, wherein the third balloon is a dilatation balloon comprising a non-compliant material.
15. The catheter of claim 10, wherein the first balloon includes a stent.
PCT/US2000/024683 1999-09-17 2000-09-08 Balloon catheter to deliver a drug or to remove substances such as emboli or excess drug WO2001019445A1 (en)

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WO2006133186A2 (en) * 2005-06-07 2006-12-14 The International Heart Institute Of Montana Foundation A system, including method and apparatus for percutaneous endovascular treatment of functional mitral valve insufficiency
WO2007136637A1 (en) * 2006-05-18 2007-11-29 Abbott Laboratories Dual balloon catheter and deployment of same
WO2012018899A1 (en) * 2010-08-03 2012-02-09 Bayer Pharma Aktiengesellschaft Balloon catheter with external delivery tube
US8603064B2 (en) 2008-09-22 2013-12-10 Covidien Lp Double balloon catheter and methods for homogeneous drug delivery using the same
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006133186A2 (en) * 2005-06-07 2006-12-14 The International Heart Institute Of Montana Foundation A system, including method and apparatus for percutaneous endovascular treatment of functional mitral valve insufficiency
WO2006133186A3 (en) * 2005-06-07 2007-02-08 Int Heart Inst Montana A system, including method and apparatus for percutaneous endovascular treatment of functional mitral valve insufficiency
US9101742B2 (en) 2005-10-28 2015-08-11 Baxter International Inc. Gastrointestinal applicator and method of using same
WO2007136637A1 (en) * 2006-05-18 2007-11-29 Abbott Laboratories Dual balloon catheter and deployment of same
US8603064B2 (en) 2008-09-22 2013-12-10 Covidien Lp Double balloon catheter and methods for homogeneous drug delivery using the same
WO2012018899A1 (en) * 2010-08-03 2012-02-09 Bayer Pharma Aktiengesellschaft Balloon catheter with external delivery tube
US9005163B2 (en) 2010-08-03 2015-04-14 Bayer Pharma Aktiengesellschaft Balloon catheter with external delivery tube
WO2016070032A1 (en) * 2014-10-30 2016-05-06 Neurotronic, Inc. Chemical ablation and method of treatment for various diseases

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