WO2001076674A1

WO2001076674A1 - Intra-aortic balloon catheter having an ultra-thin stretch blow molded balloon membrane

Info

Publication number: WO2001076674A1
Application number: PCT/US2000/009474
Authority: WO
Inventors: Olga Laksin
Original assignee: Datascope Investment Corp.
Priority date: 2000-04-07
Filing date: 2000-04-07
Publication date: 2001-10-18
Also published as: AU4221500A; EP1267981A1; CA2400481A1; ATE310558T1; EP1267981B1; AU2000242215B2; JP2004516857A; CA2400481C; DE60024323T2; DE60024323D1

Abstract

An intra-aortic balloon catheter (30) having an ultra-thin stretch blow molded balloon membrane (36). The balloon membrane (36). he balloon membrane is made from thermoplastic elastomeric and/or semicrystalline materials such as but not limited to polyurethane and polyetheramid.

Description

TITLE; INTRA-AORTIC BALLOON CATHETER HAVING AN

ULTRA-THIN STRETCH BLOW MOLDED BALLOON MEMBRANE

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to an improved intra-aortic balloon

catheter. More particularly, the invention relates to an

intra-aortic balloon catheter having an ultra-thin stretch

blow molded balloon membrane with improved abrasion

resistance, fatigue life, and aneurization resistance.

2. Description of the Prior Art

Intra-aortic balloon (IAB) catheters are used in patients

with left heart failure to augment the pumping action of the

heart. The catheters, approximately 1 meter long, have an

inflatable and deflatable balloon at the distal end. The

catheter is typically inserted into the femoral artery and

moved up the descending thoracic aorta until the distal tip of

the balloon is positioned just below or distal to the left

subclavian artery. The proximal end of the catheter remains

outside of the patient's body. A passageway for inflating and

deflating the balloon extends through the catheter and is

connected at its proximal end to an external pump. The patient's central aortic pressure is used to time the balloon

and the patient's ECG may be used to trigger balloon inflation

in synchronous counterpulsation to the patient's heart beat.

Intra-aortic balloon therapy increases coronary artery

perfusion, decreases the workload of the left ventricle, and

allows healing of the injured myocardium. Ideally, the

balloon should be inflating immediately after the aortic valve

closes and deflating just prior to the onset of systole. When

properly coordinated, the inflation of the balloon raises the

patient's diastolic pressure, increasing the oxygen supply to

the myocardium; and balloon deflation just prior to the onset

of systole lowers the patient's diastolic pressure, reducing

myocardial oxygen demand.

Intra-aortic balloon catheters may also have a central

passageway or lumen which can be used to measure aortic

pressure. In this dual lumen construction, the central lumen

may also be used to accommodate a guide wire to facilitate

placement of the catheter and to infuse fluids, or to do blood

sampling .

Typical dual lumen intra-aortic balloon catheters have an

outer, flexible, plastic tube, which serves as the inflating

and deflating gas passageway, and a central tube therethrough

formed of plastic tubing, stainless steel tubing, or wire coil embedded in plastic tubing. A polyurethane compound is used

to form the balloon.

All IAB catheters have two opposing design

considerations. On the one hand, it is desirable to make the

outer diameter of the entire catheter as small as possible: to

facilitate insertion of the catheter into the aorta,

maximizing blood flow past the inserted catheter, and to allow

for the use of a smaller sheath to further maximize distal

flow. On the other hand, however, it is desirable to make the

inner diameter of the outer tube as large as possible because

a large gas path area is required to accomplish the rapid

inflation and deflation of the balloon. As a result of these

opposing design considerations there is a need for a smaller

catheter with a larger gas path area.

One method of making the outer diameter of the wrapped

balloon portion of the catheter as small as possible is to

wrap the balloon in its deflated state as tightly as possible

around the inner tube. Wrapping the balloon tightly, however,

has posed a number of difficulties. First, it is difficult to

wrap the balloon tightly because of the friction between

contacting surfaces of the balloon. Second, contacting

surfaces of a tightly wrapped balloon may stick upon initial

inflation. Datascope Investment Corp.'s co-pending application no. 08/958,004, filed on October 27, 1997, herein incorporated

by reference in its entirety, discloses a lubricous coating

for the balloon membrane which solves the above mentioned

problems. The coating allows the balloon membrane to be

wrapped tightly more easily and prevents sticking of the

balloon membrane upon initial inflation.

A second method of making the outer diameter of the

wrapped balloon portion of the catheter as small as possible

is to decrease the size of the inner tube. Datascope

Investment Corp.'s co-pending application no. 08/958,004 also

discloses an intra-aortic balloon catheter with an inner tube

having a smaller diameter only in the portion enveloped by the

balloon membrane.

Although the above two methods have substantially reduced

the overall insertion size of the intra-aortic balloon

catheter the need still exists for greater size reduction.

Furthermore, the need also exists for a balloon membrane with

improved abrasion resistance, fatigue life, and aneurization

resistance. Currently, the method of manufacturing

polyurethane balloon membranes is solvent casting. This

casting method does not provide the formed membrane with ideal

physical and mechanical properties. A solvent caste membrane

with the basic mechanical properties necessary for balloon pumping, typically has a single wall thickness of 4 to 6 mils

(a mil is equal to one thousandth of an inch) which leads to a

relatively large wrapped diameter of the balloon membrane. A

thin solvent caste polyurethane membrane is capable of being

manufactured, however, such a membrane does not demonstrate

the required abrasion resistance and fatigue life. Therefore,

the need exists for an improved method of making a balloon

membrane which will allow for a balloon membrane having a

reduced thickness, and at the same, having improved mechanical

properties, including an improved abrasion resistance, fatigue

life, and aneurization resistance.

The present invention comprises an intra-aortic balloon

catheter having a stretch blow molded balloon membrane. The

balloon membrane is made from thermoplastic elastomeric and/or

semicrystalline materials such as but not limited to

polyurethane and polyetheramid. As discussed above, intra-

aortic balloon membranes are generally solvent cast.

The process of stretch blow molding catheter balloon

membranes is known in the art. However, intra-aortic balloons

have been traditionally made by solvent casting because intra-

aortic balloon membranes require special characteristics: they

must be substantially nondistensible and have high abrasion

resistance, fatigue life, and aneurization resistance. Stretch blow molding has been traditionally used for

angioplasty balloon membranes. These balloons are generally

made from PET, Nylon, or PEBAX materials. These materials

achieve their high strength at least partially because of the

crystallization formed in their microstructure during the

initial stretching step of the tube and as a result of quickly

cooling the tube to a temperature below the crystallization

temperature of the tube material. Crystallization of the

microstructure increases the strength of the balloon membrane,

however, as the inventors of the present invention have

discovered, it has a negative effect on the abrasion

resistance and fatigue life of the balloon membrane. Given

that angioplasty balloon/PTCA therapy is a short duration

therapy, crystallization is generally not a problem.

Actually, it is quite useful given that it enhances the

strength of the balloon material. Intra-aortic balloon

therapy, on the other hand, involves repetitive inflation and

deflation of the balloon membrane over a longer period of

time. Accordingly, it is known in the art that stretch blow

molded balloons are not appropriate for intra-aortic balloon

membranes, which require high^' strength as well as high

abrasion resistance and fatigue life.

The present invention overcomes the above described obstacle by relying on the increased strength of polyurethane

resulting from the high orientation and molecular interaction

of the polyurethane molecules along the longitudinal axis of

the tube. Said orientation results from stretching the tube

until substantially all stretchability is removed.

Polyurethane, and the other materials listed in the present

application, do not exhibit significant stress induced

crystallization upon stretching. Accordingly, the inventors

of the present invention have discovered a means to create a

balloon membrane strong enough to endure intra-aortic balloon

pumping therapy without creating crystallization

microstructure, which they have discovered, is detrimental to

the abrasion resistance and fatigue life of the balloon

membrane .

U.S. Patent No. 5370618 to Leonhardt discloses a

pulmonary artery balloon catheter comprising a catheter

terminating in a blow molded polyurethane balloon membrane.

Pulmonary artery catheters are generally used for blood

pressure measurements. Upon insertion and placement of the

catheter the balloon membrane is inflated, occluding the

housing blood vessel, so as to create a measurable pressure

differential on either side of the balloon membrane. In order

to achieve complete occlusion of the housing blood vessel the pulmonary artery catheter balloon membrane is elastic so as to

allow expansion of the membrane. This is in contrast to the

balloon membrane of the present invention which is stretch

blow molded and is specifically manufactured to substantially

eliminate distensibility in the final product.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the invention to produce

an ultra-thin intra-aortic balloon membrane with superior

abrasion resistance and fatigue life.

It is another object of the invention to produce a method

for manufacturing said ultra-thin intra-aortic balloon

membrane .

The invention is an intra-aortic balloon catheter having

an ultra-thin stretch blow molded balloon membrane. The

balloon membrane is made from thermoplastic elastomeric and/or

semicrystalline materials such as but not limited to

polyurethane and polyetheramid.

To the accomplishment of the above and related objects

the invention may be embodied in the form illustrated in the

accompanying drawings. Attention is called to the fact,

however, that the drawings are illustrative only. Variations are contemplated as being part of the invention, limited only by the scope of the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like elements are depicted by like

reference numerals. The drawings are briefly described as

follows .

FIG 1 is longitudinal cross section of a prior art intra-

aortic balloon catheter.

FIG 1A is a transverse cross section of the prior art

intra-aortic balloon catheter taken along line 1A-1A.

FIG 2 is a longitudinal cross sectional view of a distal

portion of the improved intra-aortic balloon catheter.

FIG 3 is a side view of a mold having a balloon shaped

cavity used to manufacture the balloon membrane.

FIG 4 is a top view of the first half of the mold

containing and securing a stretched tube used as a preform to

create the balloon membrane.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The general structure of an intra-aortic balloon catheter

is best described in relation to FIGS 1 and 1A which

illustrate a dual-lumen prior art intra-aortic balloon

catheter. The catheter 1 is constructed of a plastic outer

tube 2 forming a gas passageway lumen 3; and another plastic

central tube 4 disposed within outer tube 2 and creating a

central passageway or lumen 5 as may best be seen in FIG 1A.

A balloon 8 is disposed at the distal end of the catheter

1. The distal portion 7 of the central tube 4 extends beyond

the distal end 10 of outer tube 2. The distal end 8A of the

balloon 8 is attached to a tip 9 formed on the distal end 7 of

central tube 4. The proximal end 8B of the balloon 8 is

attached, by means of a lap joint, to the distal end 10 of the

outer tube 2. The distal portion 7 of the central tube 4

supports the balloon 8. Said distal portion 7 must have

sufficient strength to prevent inversion of the balloon 8 as

it inflates and deflates under aortic pressure, but at the

same time, be flexible enough to be safely inserted through an

introducer sheath, moved through the arterial tree, and

maintained in the thoracic aorta.

The balloon 8 is formed of a nonthrombogenic flexible material, such as polyurethane, and may have folds 11 formed

as a result of wrapping the balloon 8 about the central tube 4

to ease insertion of the catheter 1. The balloon 8 has a

single wall thickness of between 4 to 6 mils. Radio-opaque

bands 20 at the distal end of the catheter 1 aid in

positioning the balloon 8 in the descending aorta.

Inflation and deflation of the balloon 8 is accomplished

through the gas passageway lumen 3. The central passageway or

lumen 5 can accommodate a guide wire for placement or

repositioning of the catheter 1. When the guide wire is not

disposed in the central passageway or lumen 5, the central

passageway or lumen 5 may be used for measuring blood pressure

in the descending aorta. This pressure measurement may be

used to coordinate the inflation and deflation of the balloon

8 with the pumping of the heart, however, use of the patient's

ECG is preferred. Additionally, the central passageway or

lumen 5 may be used to infuse liquids into the descending

aorta, or to sample blood.

At the proximal end 12 of the catheter 1 a hub 13 is

formed on the proximal end 14 of the outer tube 2. The

central passageway or lumen 5 extends through the hub 13 and a

connector 16 is provided at the proximal end 15 (or exit) of

the central passageway or lumen 5. Measurement of aortic pressure and blood sampling may be done through the proximal

end 15 of the central passageway or lumen 5.

The proximal end 18 of the gas passageway or lumen 3

exits through a side arm 17 of the hub 13 on which is provided

a connector 19. The proximal end 18 of the gas passageway or

lumen 3 may be connected to an intra-aortic balloon pump.

The present invention comprises an intra-aortic balloon

catheter having an ultra-thin stretch blow molded balloon

membrane. FIG 2 illustrates a longitudinal cross sectional

view of a distal portion of an improved intra-aortic balloon

catheter 30 of the present invention comprising an outer tube

32, an inner tube 33, a tip 34, and an ultra-thin polyurethane

balloon membrane 36. The tip 34 is connected to a distal end

of the balloon membrane 36. A distal end of the outer tube 32

is seamlessly welded to a proximal end of the balloon membrane

36. The balloon membrane 36 has a single wall thickness of

between 1 to 2 mils.

The balloon membrane 36 may be made from a variety of

thermoplastic elastomeric and/or semicrystalline materials

including but not limited to polyurethane and polyetheramid

(known by its trade name as PEBAX, produced by ELF-Atochem of

Europe) .

Another feature of the invention involves the attachment of the outer tube 32 and the balloon membrane 36. The distal

end of the outer tube 32 is seamlessly welded to the proximal

end of the balloon membrane 36. The distal end of the outer

tube 32 has the same inner and outer diameters as the proximal

end of the balloon membrane 36, thus providing a smooth

transition between the two parts without a constriction of the

gas path. This is in contrast to the prior art catheter 1 of

FIG 2 in which the proximal end of the balloon 8 and the

distal end of the catheter 1 are attached by means of a lap

joint. The lap joint is generally compressed during the

manufacturing process in order to assure that the outer

diameter of the lap joint matches that of the outer tube 2.

Compression of the lap joint area leads to a restriction in

the gas flow path. The present invention avoids this

restriction through the use of a seamless weld.

FIG 3 illustrates a side view of a mold 38 with tube

clamps 44 on both sides for securing a tube 46 having ends 50

to the mold 38. The mold 38 has a first half 40 and a second

half 42 and is utilized in the manufacturing of the ultra-thin

balloon membrane 36 to assure the required profile of said

balloon membrane 36. The first half of the mold 40 and the

second half of the mold 42 together define a balloon shaped

cavity 48 illustrated in FIG 3 as a shadowed segmented line. The manufacturing process of the balloon membrane 36

comprises the following steps. First, a tube 46, as

illustrated in FIG 4, is stretched to the desired length of

the balloon membrane 36. In the preferred embodiment, and in

this example, the tube 46 is 8 inches long, has a wall

thickness of 0.02 inches, and is made from polyurethane;

however, the tube 46 may be of a different size and may made

from other thermoplastic elastomeric and/or semicrystalline

materials or other materials that do not display stress

induced crystallization or a combination of such materials.

FIG 4 illustrates a top plain view of the first half 40

of the mold 38 which is identical to a view of the mold 38

taken along lines 3A-3A. The ends 50 of the tube 46 are

secured by means of the clamps 44 (not shown in FIG 4 for

clarity) to opposite sides of the mold 38. The second half 42

of the mold 38, as illustrated in FIG 3, is attached to the

first half of the mold enclosing the stretched tube 46 in the

balloon shaped cavity 48.

Stretching the tube 46, approximately two times its

original length, prior to blowing orientates the polyurethane

molecules along the longitudinal axis of the tube and

substantially eliminates any further stretchability of the

balloon membrane 36, at internal pressures of two to four psi, by achieving a high molecular orientation and interaction.

Note that this orientation and molecular interaction is

achieved without significant crystallization; this is

important to assure improved abrasion resistance and fatigue

life. Significant crystallization is defined as any amount of

crystallization which negatively affects the abrasion

resistance and fatigue life of the balloon membrane.

Polyurethane and polyetheramid, and other thermoplastic

elastomeric and/or semicrystalline materials, do not exhibit

stress induced crystallization. This is in contrast to the

materials traditionally used for stretch blow molded

angioplasty balloon catheter membranes which on average have

approximately 30% crystallization.

The stretching step assures the substantial

nondistensibility of the final balloon membrane 36 under

balloon inflation pressures of approximately 2-4 psi. This is

in contrast to the pulmonary artery balloon catheter,

discussed above, whose polyurethane balloon membrane is

specifically designed to be distensible so as to allow the

membrane to expand, and thereby, occlude the blood vessel in

which blood pressure is being measured.

The next manufacturing step involves filling the tube 46

with a gas at approximately 150 psi, i.e. blowing the tube 46. The amount of pressure applied depends on the grade of

polyurethane: harder materials require higher pressure. In

all cases, however, the pressure must be sufficient to force

the tube 46 to take on the shape of the mold cavity 48. The

tube 46 is then heated above the tube melting temperature

while maintaining a pressure of 30-40 psi in the tube 46. The

final step involves quickly cooling the ballooned tube 46, to

a temperature above the crystallization temperature of the

tube 46, while maintaining a pressure of approximately 80 psi

in the tube 46.

It should be noted that the above detailed manufacturing

process is merely an illustrative example and will vary for

different sized tubes and for tubes made of different

materials. Manufacturing variables include tube material,

tube length, tube thickness, tube diameter, the required

pressure for blowing, the temperature for heating and cooling

of the tube, and the amount of pressure maintained in the tube

while heating and cooling the tube.

It should further be noted that balloon membrane of the

present invention may be used with any variation of intra-

aortic balloon catheters, including an intra-aortic balloon

catheter having a co-lumen catheter, i.e. the inner lumen

attached to or embedded in the catheter wall, or with any balloon catheter that requires a balloon membrane with

improved abrasion resistance and fatigue life.

Claims

CLAIMSWhat is claimed is:

1. An intra-aortic balloon catheter comprising an outer tube

with proximal and distal ends, and a stretch blow molded

balloon membrane with a proximal end connected to the distal

end of the outer tube, said balloon membrane having been

stretched without creating significant crystallization to

substantially eliminate stretchability under balloon inflation

pressures of approximately 2-4 psi.

2. The intra-aortic balloon catheter as claimed in claim 1

wherein the balloon membrane is at least partially composed of

a thermoplastic elastomeric material.

3. The intra-aortic balloon catheter as claimed in claim 1

wherein the balloon membrane is at least partially composed of

a semicrystalline material.

4. The intra-aortic balloon catheter as claimed in claim 1

wherein the balloon membrane is at least partially composed of

a thermoplastic elastomeric semicrystalline material.

5. The intra-aortic balloon catheter as claimed in claim 1

wherein the balloon membrane is at least partially composed of

polyurethane .

6. The intra-aortic balloon catheter as claimed in claim 1

wherein the balloon membrane is at least partially composed of

polyetheramid .

7. The intra-aortic balloon catheter as claimed in claim 2

wherein the balloon membrane is made from polyurethane.

8. A method for producing an ultra-thin balloon membrane for

an intra-aortic balloon catheter comprising the steps of:

a) stretching a tube made from a thermoplastic elastomeric

material without creating significant crystallization until

stretchability is substantially eliminated under balloon

inflation pressures of approximately 2-4 psi;

b) blowing the tube by increasing the pressure within the tube

until the tube has sufficiently ballooned;

c) heating the ballooned tube; and

d) cooling the ballooned tube to above the crystallization

temperature for the tube material .

9. The method as claimed in claim 8 wherein a pressure above

ambient is maintained in the tube while heating and cooling to

maintain the ballooned shape of the tube.

10. The method as claimed in claim 8 wherein the tube is at

least partially composed of a thermoplastic elastomeric

material .

11. The method as claimed in claim 8 wherein the tube is at

least partially composed of a semicrystalline material.

12. The method as claimed in claim 9 wherein the tube is at

least partially composed of a thermoplastic elastomeric

semicrystalline material.

13. The method as claimed in claim 9 wherein the tube is at

least partially composed of polyurethane.

14. The method as claimed in claim 9 wherein the balloon

membrane is at least partially composed of polyetheramid.

15. The method as claimed in claim 9 wherein tube is placed in

a mold having a cavity therein prior to blowing.

16. The method as claimed in claim 9 wherein a pressure above

ambient is maintained in the tube while heating and cooling to

maintain the ballooned shape of the tube.

17. The method as claimed in claim 13 wherein the tube is

stretched to approximately 2 times its original length.

18. The method as claimed in claim 1 wherein the intra-aortic

balloon catheter further comprises an inner tube at least

partially disposed within an outer surface of the outer tube,

a distal end of said inner tube being connected to a distal

end of the balloon membrane.

19. An intra-aortic balloon catheter comprising an outer tube

with proximal and distal ends, and a stretch blow molded

polyurethane balloon membrane with a proximal end connected to

the distal end of the outer tube, said balloon membrane having

been stretched without creating significant crystallization to

substantially eliminate stretchability under balloon inflation

pressures of approximately 2-4 psi.