CA2136839A1 - Dual dilatation balloon and infusion balloon catheter - Google Patents

Dual dilatation balloon and infusion balloon catheter

Info

Publication number
CA2136839A1
CA2136839A1 CA002136839A CA2136839A CA2136839A1 CA 2136839 A1 CA2136839 A1 CA 2136839A1 CA 002136839 A CA002136839 A CA 002136839A CA 2136839 A CA2136839 A CA 2136839A CA 2136839 A1 CA2136839 A1 CA 2136839A1
Authority
CA
Canada
Prior art keywords
infusion
catheter
lumen
balloon
dilatation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002136839A
Other languages
French (fr)
Inventor
B. Daniel Burleigh
Leon R. Lyle
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.)
Mallinckrodt Inc
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2136839A1 publication Critical patent/CA2136839A1/en
Abandoned legal-status Critical Current

Links

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
    • 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0454Redundant cuffs
    • A61M16/0456Redundant cuffs one cuff within another
    • 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0475Tracheal tubes having openings in the tube
    • A61M16/0477Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0481Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids through the cuff wall
    • 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
    • A61M2025/1013Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
    • 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

Abstract

2136839 9325265 PCTABScor01 The present invention relates to a catheter which is capable of performing both an angioplasty procedure using a dilatation balloon (40) and application of therapeutic drugs using an infusion balloon (50). The catheter according to the present invention is advantageous because it eliminates the need for removal and reinsertion of separate catheters or repositioning of the same catheter to perform the dilatation and infusion procedures. The present invention also relates to a dual dilatation balloon and infusion balloon catheter, wherein the infusion balloon (50) is capable of infusing insoluble therapeutic agents to the treatment site. This is advantageous because the insoluble agents exhibit improved tissue residence profiles and more beneficial treatment characteristics.

Description

W093/25265 ~ ~ 3 ~ PCT/US93/05396 CATHETER

This is a continuation-in-part application of United States application, serial number 07/897,635 filed June 12, 1~92.

~ ..
,:
The pre~ent invention relates to a catheter which can be sequentially used to perform angioplasty and then the administration of therapeutic agents~ In particular, the present invention relates to a catheter having both dilatation and infusion balloons, wherein the infusion balloon has pores optimally sized to allow infusion of insoluble therapeutic agents.
.' P~rcutaneous transluminal angiopla~ty ~PTA) procedures ; 15 typically are performed using a guiding catheter which may be percutaneously introduced into the cardiovascular system of the patient through the brachial or femoral arteries and ad~anced therein until the tip thereof is properly positioned in the ostium of the a~fllcted artery. A
guidewire and a dilatation balloon catheter are then introduced through the guiding catheter, the guidewire being dispo~ed within an inner lumen of the balloon catheter. The guldewire and balloon are advanced until the dilatation balloon is properly located within the area of lesion to be treated. Once positione~, the dila~ation balloon is inflated to a prede~exmined size using a radiopaque li~uid, such as contras~t medium~ in order to radially compress the atherosclerotic plaque of ~he lesion against the inside of the artery wall and thereby dilate 30 ~ ~he ~lumen of the artery. The dilatation balloon is then deflated and the balloon catheter remo~ed so that blood flow may be resumed through the dllated artery.

' .

W093/~S265 PCT/US93/0539~ ~
~3~ '~33 ~nother means of treating stenosed arteries is through the administration of drugs such as anticoagulants, anti-proliferatives or gene transfection reagents. These drugs are commonly delivered to the stenosed artery through an infusion catheter which includes small holes formed through the catheter wall or through the wall of a balloon formed on ~-he catheter, so that the drug may he allowed to contact with the area of treatment over a prolonged time period.

It ~ay also be de~irable to infuse therapeutic agents which have been encapsulated into insoluble particles, such as, microspheres, liposomes, viruses, viral like particles, or other insoluble ar colloidal formulations which provide for more controlled release of the therapeutic agent. Such insoluble particles exhibit improved tissue residence lS profiles, and therefore, may pro~ide more favorable treatment xe~ults than primarily soluble agents.

Unfortunately, when balloon angioplasty is used to restore patency of the ar~ery, thromboiytic or proliferati~e events may operate to reocclude the artery 20 ~ following the balloon dilatation. Also, the use of drug therapy alone is not e~fective for treatment of all stenoses, and use of an dilatation b~lloon may be necessary. It is therefore, desirable to be able to provide for both balloon angioplasty and drug administration through the same catheter. Further, it is desirable to be able ~o infuse insoluble therapeutic agents to the treatment area through the same catheter which has been used for dilatation.

:
-. ~093/2~2~5 ~ 1 3 ~ ~ -, 9 PCT/US93/05396 ..

O~ cts Of The Invention It is one object of the present invention to pro~ide a dilatati~n catheter which can perorm both balloon :~
dilatation and therapeutic drug delivery.

, It is another object of the present invention to ~.
provide a dual dilatation balloon and inf.usion balloon catheter, wherein the infusion balloon i~ capable of in~using insoluble therapeutic agents to the treatment site.

; 10 SummarY O The Invention The objects of ~he present invention are accomplished by providing a catheter having a two concentrically formed balloons, the inner most balloon capable of performing : dilatation, and the outer balloon capable of delivering therapeutic drugs. The outer balloon comprises an infusion balloon having infusio~ poxes optimally sized to allow for infusion of soluble therapeutic agents to the treatment sit~. .

Fig. I is a plan view of a catheter according to a first embodiment of the present in~ention.

: Fig. ~ is a cross-sectional view of a catheter ~: according to the first ~mbodiment o the present in~ention, taken along line A-A of Fig. 1. ..

:~ 25 Fig. 3 is a plan view of a catheter according to a ` second embodiment o~ the present in~ention.
.

W0~3/~5265 PCT/U~3/05396 _ ~683~

Fig. 4 is a cross-sectional view of a catheter according to the present invention, taken along line B-s of Fig. 3.

Fig. 5 is a cross-sectional view of a catheter according to the present invention, taken along line C-C of Fig. 3.

Detailed Description Of The Invention Fig~ 1 is a plan view of a catheter according to a first embodiment of the present invent.ion. T~e catheter generally designated by reference numeral 10, ~ncludes a multi-lumen shaft 20, one lumen of which serves as a guidewire lumen, a second lumen of which serves as a : dilatation balloon inflation lumen, and a third lumen of which serves as a therapeutic druy infusion lumen. As best shown in Fig. 2, the various lumens of the shaft 20, according to this embodiment are formed in a concentric configuration.; In particular, a guidewire lumen 3S, :` ex~ends the entire length of the catheter 10, ending at the distal end 30. ~he guidewire lumen 35, is surrounded by a dilatation balloon inflation lumen 45, which extends form : a proximal end of the catheter 10, to a dilatation balloon : 40, formed near the distal end 30. The dilatation balloon j~
inflation lu~en 45, is surrounded by an infusion lumen 55, which extends from a proximal end of the catheter 10, to an infusion balloon 50, formed near the distal end 30.
, The infusion balloo~ 50, includes infusion pores 58, which allow~ or the infusion of therapeutic agents to a treatment site~ The infusion pores 58, normally have a diameter in the range of 15 to 75 microns, preferably about 25 to 50 microns. Infusion pores 58, having such a . ':
.

_ W093/25~6~ ~ 1 3 6 8 3 ~ PCT/US93/05396 .. ..

diameter allow for infusion of soluble therapeutic a~ents.
Infusion of large numbers or a high ~oncentration of insoluble particles having a particle size greater than 1 microns in diameter may cause problems of clogging or partial hlocking of the infusion pores 58, unless special measures are taken.

The pore size of infusion pores 58, may be increased so as to allow the administration of insoluble particle~.
~ Pore sizes up to 250 microns, preferable about 100 microns in di~meter may be successfully employed in the infusion of large numbexs or a high concentration of insoluble therapeutic ayent~ ha~ing a particle size up to 25 microns in diame~er. Howe~er, when relatively large pore sizes are utilized, optimal hydrosta~ic pressure may be compromised which could result in inadequate perfusion. This problem may be overcome and optimal conditions for hydrostatic pressure can be controlled by regulating the number of infusion pores 58.

Fig. 3 is a plan view of a ca~heter according to a ~0 second embodiment of the present invention. The catheter, generally de ignated by reference numeral 100, diEfers from the catheter shown in Fig. 1 only ~y the pro~ision of a main shaft 120, having lumens in a side-by-side configuration, attached to a balloon shaft 125, having lumens in a concentric configuration. The main shaft 120, and balloon shaft 125, are attached at joint portion 160.

~; As best;shown in Fig. 4, the main shaft 120, includes a guidewire lumen 135, a balloon dilatation inflation lumen 145, and an infu~ion lumen 155, each of which extend the entire length of the main shaft 120, from a proximal end of cathe~er 100, to the joint portion 160. The lumens 135, 145 and 155 are formed in a side-~y-side configuration.

W093/25265 PCT/~S93/05396 _~
~13~333 :

As best shown in Fig. 5, the balloon shaft 125, includes concentrically formed lumens. A guidewire lumen 135' extends the entire le~gth of the balloon shaft 125, :~
from the joint portion 160, to the distal end 130, of catheter lO0. The guidewire lumen 135', is surrounded by a dilatation balloon inflation lumen 145', which extends from the joint portion 160, to a dilatation balloon 140, formed near the distal end 130. The dilatation balloon inflation lumen 145', is surrounded by in infusion lumen 155' which extends ~rom the joint portion 160, to an infusion balloon 150, formed near the distal end 130.
':
. .
The infusion balloon 150, includes infusion pores 158, which allow for the infusion of therapeutic agents to a treatment site. The infusion pores 158, again have a diameter in the range of 15 to 75 microns, preferably about 25 to 50 microns, to al}ow for infusion of soluble therapeutic a~ents. As noted above, the diameter and number of infusion pores may be adjusted to allow for infusion of insoluble particles.-The main shaft 120, and balloon shaft 125, may be joined by any suitable method such that the corresponding lumens of the ~wo shafts are joined. In particular, guidewire lumens 135, and 135' are joined; dilatation balloon inflation lumens 145 and 145' are joined; and infusion lumens 155 and 155' are joined. In each instance, the joining ~hould provide a continuous lumen from the proximal end of the catheter 100, to the distal end 130, d~latation balloon 140, or infusion lumen 150, as appropriate.

The catheter according to the present in~ention is very advantageous in helping to prevent reocclusion or stenosis of arteries following a balloon angioplasty ': ' .

;~

7; ," "' W093/2526~ 3 ~ 8 3 9 PCT/US93/~5396 procedure. In particular, it is possible to perform an angioplasty procedure using the dilatation balloon of the catheter according to the present invention, followed by the infusion of therapeutic drugs through the infusion balloon, without re~uiring the removal and reinsertion of separate catheters. This is extremely advantageous in saving time and energy ln assuring exact placement and in avoiding excessive damage to the arterial structure o~ a patient. This construction is also advantageous in reducing Udead volumn" and conser~ing expensive drugs by reducing waste per dose.

In addition, the catheter according to the present invention is very advantageous because it allows both angioplasty and drug infusion to be carried out at their di~ferent optimal inflation pressures.

Also, the catheter according to the present invention is ~ery advantageous in allowing for the infusion of insoluble therapeutic agents. The relatively large infusion pores pro~ided through the infusion balloon of the ca~heter according to the prese~t invention allow such insoluble therapeutic agents to be deli~ered directly to the treatment site. This is ad~antageous because insoluble therapeutic agents exhibit improved tissue residence profiles and thus more favorable treatment characteristics.

Use of the catheter according to the present invention can greatly reduce the risk of restenosis of a dilated :~ artery by proYiding treatment thereof in a more expeditious : manner than possible with prior art catheters~

Further, use of the catheter acc~rding to the present invention can enable delivery of insoluble therapeutic agents directly to the treatment site, such insoluble WO 93/25265 PCr/US~3/05396 ~
~1~6~3J

agen~s providing more beneficial treatment results and characteristics.

The foregoirlg has been a description of certain preferred embodiments of the present invention, hut is not in'cended to limit the invention in any way. Rather, m~ny .modif icatioals, variations and changes in details may be made within the scope of the present invention.

Claims (9)

What is claimed is:
1. A catheter capable of performing both dilatation and infusion of therapeutic drugs, said catheter comprising;
a guidewire lumen;
a dilatation balloon inflation lumen coaxially surrounding said guidewire lumen at least along a distal end portion of said catheter, said inflation lumen including a dilatation balloon formed along a portion of its length; and an infusion lumen coaxially surrounding said inflation lumen at least along said distal end portion of said catheter, said infusion lumen including an infusion balloon formed along a portion of its length.
wherein said infusion balloon includes infusion pores having a size capable of infusing insoluble diagnostic agents.
2. A catheter according to claim 1, wherein said dilatation balloon inflation lumen surrounds said guidewire lumen, and said infusion lumen surrounds said dilatation balloon inflation lumen along substantially the entire length of said catheter.
3. A catheter according to claim 1, further comprising:
a main shaft in which said guidewire lumen, said dilatation balloon inflation lumen, and said infusion lumen, are formed in a side-by-side configuration; and a balloon shaft in which said guidewire lumen is surrounded by said dilatation balloon inflation lumen, and said dilatation balloon inflation lumen is surrounded by said infusion lumen;

wherein said main shaft and balloon shaft are joined at a joining portion, such that said guidewire lumen, said dilatation balloon inflation lumen, and said infusion lumen extend substantially the entire length of said catheter.
4. A catheter according to claim 1, wherein said infusion pores have a diameter which allow for infusion of soluble diagnostic agents.
5. A catheter according to claim 4, wherein said infusion pores have a diameter in the range of 15 to 75 microns.
6. A catheter according to claim 5, wherein said infusion pores have a diameter of about 25 to 50 microns.
7. A catheter according to claim 1, wherein said infusion pores have a diameter which allow for infusion of insoluble diagnostic agents having particle sizes up to about 25 microns in diameter.
8. A catheter according to claim 7, wherein said infusion pores have a diameter in the range of 35 to 250 microns.
9. A catheter according to claim 8, wherein said infusion pores have a diameter of about 100 microns.
CA002136839A 1992-06-12 1993-06-08 Dual dilatation balloon and infusion balloon catheter Abandoned CA2136839A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US89763592A 1992-06-12 1992-06-12
US07/897,635 1992-06-12
US2692993A 1993-03-05 1993-03-05
US08/026,929 1993-03-05

Publications (1)

Publication Number Publication Date
CA2136839A1 true CA2136839A1 (en) 1993-12-23

Family

ID=26701831

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002136839A Abandoned CA2136839A1 (en) 1992-06-12 1993-06-08 Dual dilatation balloon and infusion balloon catheter

Country Status (5)

Country Link
EP (1) EP0646031A1 (en)
JP (1) JPH07507704A (en)
AU (1) AU4408193A (en)
CA (1) CA2136839A1 (en)
WO (1) WO1993025265A1 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5368566A (en) * 1992-04-29 1994-11-29 Cardiovascular Dynamics, Inc. Delivery and temporary stent catheter having a reinforced perfusion lumen
JPH0751379A (en) * 1993-06-24 1995-02-28 Cardiovascular Dynamics Inc Injection catheter, intravascular site treating method, and production of catheter
US5344402A (en) * 1993-06-30 1994-09-06 Cardiovascular Dynamics, Inc. Low profile perfusion catheter
EP0959933A1 (en) * 1996-05-03 1999-12-01 Emed Corporation Combined coronary stent deployment and local delivery of an agent
US6099506A (en) 1997-09-26 2000-08-08 Macoviak; John A. Introducer and perfusion cannula
AU9510398A (en) * 1997-09-26 1999-04-12 Cardeon Corporation Main stage catheterization instrument
US7077836B2 (en) * 2000-07-21 2006-07-18 Vein Rx, Inc. Methods and apparatus for sclerosing the wall of a varicose vein
GB2426457A (en) * 2005-05-26 2006-11-29 Leonid Shturman Balloon angioplasty device with distal protection capability
US7789915B2 (en) 2005-08-31 2010-09-07 Vance Products Incorporated Stent for implantation
US9498356B2 (en) 2012-12-19 2016-11-22 Cook Medical Technologies, LLC Flexible stent and delivery system
US9763814B2 (en) 2014-10-24 2017-09-19 Cook Medical Technologies Llc Elongate medical device
CN109152650B (en) 2016-03-18 2021-10-26 普罗赛普特生物机器人公司 Minimally invasive methods and systems for hemostasis in a bleeding closed tissue volume

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4693243A (en) * 1983-01-14 1987-09-15 Buras Sharon Y Conduit system for directly administering topical anaesthesia to blocked laryngeal-tracheal areas
US4994033A (en) * 1989-05-25 1991-02-19 Schneider (Usa) Inc. Intravascular drug delivery dilatation catheter

Also Published As

Publication number Publication date
WO1993025265A1 (en) 1993-12-23
AU4408193A (en) 1994-01-04
JPH07507704A (en) 1995-08-31
EP0646031A1 (en) 1995-04-05

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Legal Events

Date Code Title Description
FZDE Discontinued
FZDE Discontinued

Effective date: 19951210