Balloons for medical devices and fabrication thereof

Claim 2

A balloon for a medical device, the balloon comprising:

Claim 3

a length of biaxially orientable tubing made of a nylon material or of a polyamide material, said length of tubing having been formed into the balloon during a biaxial orienting procedure including inflating at least a section thereof with a pressurized fluid in order to at least double its outer diameter; said balloon has a non-distended working profile having a predetermined size to which the balloon inflates without significant stretching thereof, and said balloon has an expansion profile having a maximum inflated size to which the balloon stretches without bursting during dilatation, said maximum inflated size being greater than said predetermined size of the non-distended working profile; and said expansion profile of the balloon had been tailored whereby said balloon has a maximum inflated size selected from a range of maximum inflated sizes that are a function of balloon processing conditions.

Claim 4

a length of biaxially orientable tubing made of a nylon material or of a polyamide material, said length of tubing having been formed into the balloon during a biaxial orienting procedure including inflating at least a section thereof with a pressurized fluid in order to at least double its outer diameter; said balloon has a non-distended working profile having a predetermined size to which the balloon inflates without significant stretching thereof, and said balloon has an expansion profile having a maximum inflated size to which the balloon stretches without bursting during dilatation, said maximum inflated size being greater than said predetermined size of the non-distended working profile; and said expansion profile of the balloon had been tailored whereby said balloon has a maximum inflated size selected from a range of maximum inflated sizes that are a function of balloon processing conditions.

Claim 5

The balloon according to claim 1, wherein said balloon exhibits glass transition properties whereby the balloon is within its glass transition state at human body temperature.

Claim 6

The balloon according to claim 1, wherein said balloon has a calculated tensile strength of at least about 15,000 psi.

Claim 7

The balloon according to claim 1, wherein said range of expansion profile maximum inflated sizes is at least about 10 percentage points of radial expansion.

Claim 8

The balloon according to claim 1, wherein said maximum inflated size of the balloon is greater than 5 percent in excess of the predetermined size of the non-distended working profile.

Claim 9

The balloon according to claim 1, wherein said maximum inflated size of the balloon has a radius that exceeds said non-distended working size by between in excess of 5 percent and up to about 30 percent or above.

Claim 10

The balloon according to claim 1, wherein said nylon or polyamide biaxially oriented balloon has an intrinsic viscosity of between about 0.8 and about 1.5.

Claim 11

The balloon according to claim 1, wherein said balloon material is Nylon 12.

Claim 12

The balloon according to claim 1, wherein said biaxially oriented balloon had been made by a process including axially orienting the length of biaxially orientable tubing at approximately room temperature to provide drawn tubing and biaxially expanding the thus drawn tubing at an elevated temperature greater than room temperature, said biaxial orientation procedure having been followed by cooling the thus biaxially oriented section to at least about room temperature, axially stretching the thus cooled biaxially oriented section to provide a further drawn section, heating and inflating said further drawn section, and thermoforming said thus inflated further drawn section into the balloon.

Claim 13

The balloon according to claim 1, wherein said biaxially oriented balloon had been made by a process including stretching the length of biaxially orientable tubing and biaxially expanding the thus stretched tubing to thereby provide a balloon hoop expansion ratio of the mean diameter of said balloon to the mean diameter of said thermoformable tubing, and said selected maximum inflated size is a function of said hoop expansion ratio.

Claim 14

The balloon according to claim 10, wherein said process further includes heat setting said biaxially oriented balloon by raising said biaxially oriented balloon to a temperature in excess of the glass transition temperature of said nylon material or polyamide material and cooling same to a temperature below said glass transition temperature.

Claim 15

The balloon according to claim 11, wherein said glass transition temperature approximates human body temperature.

Claim 16

A dilatation catheter, comprising: a catheter body; a balloon member positioned along the length of said catheter body; said balloon member being constructed of a thermoformable nylon material or of a polyamide material tubing that had been biaxially oriented to provide a predetermined balloon diameter; said balloon member has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said catheter body, said balloon member further having a non-distended working diameter to which the balloon is inflated to its said predetermined balloon diameter without significant stretching thereof, and said balloon member also exhibits an expanded maximum inflated diameter to which the balloon member is stretched without bursting during dilatation, said maximum inflated diameter being in excess of said predetermined balloon diameter; and said tubing material of the balloon member has tailorability properties whereby said maximum inflated diameter had been selected to fall within a range of maximum inflated diameters that are a function of a hoop expansion ratio of the balloon member, said hoop expansion ratio being the approximate ratio of said predetermined balloon diameter to the diameter of said tubing prior to biaxial orientation.

Claim 17

A dilatation catheter, comprising: a catheter body; a balloon member positioned along the length of said catheter body; said balloon member being constructed of a thermoformable nylon material or of a polyamide material tubing that had been biaxially oriented to provide a predetermined balloon diameter; said balloon member has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said catheter body, said balloon member further having a non-distended working diameter to which the balloon is inflated to its said predetermined balloon diameter without significant stretching thereof, and said balloon member also exhibits an expanded maximum inflated diameter to which the balloon member is stretched without bursting during dilatation, said maximum inflated diameter being in excess of said predetermined balloon diameter; and said tubing material of the balloon member has tailorability properties whereby said maximum inflated diameter had been selected to fall within a range of maximum inflated diameters that are a function of a hoop expansion ratio of the balloon member, said hoop expansion ratio being the approximate ratio of said predetermined balloon diameter to the diameter of said tubing prior to biaxial orientation.

Claim 18

The dilatation catheter according to claim 13, wherein said maximum inflated diameter exceeds said predetermined balloon diameter by up to about 30 percent or more.

Claim 19

The dilatation catheter according to claim 13, wherein said maximum inflated diameter exceeds said predetermined balloon diameter by between in excess of 5 percent and about 40 percent or above.

Claim 20

The dilatation catheter according to claim 13, wherein said nylon or polyamide material is Nylon 12.

Claim 21

The dilatation catheter according to claim 13, wherein said balloon member material is Nylon 12 having an intrinsic viscosity of approximately 1.3.

Claim 22

A dilatation balloon, comprising: a length of thermoformable material tubing that had been biaxially oriented to a predetermined balloon diameter; said dilatation balloon has a collapsed profile at which the outer diameter of the dilatation balloon approximates the outer diameter of a component of a medical device, said dilatation balloon further having a non-distended, inflated working diameter at which the dilatation balloon is inflated to its said predetermined balloon diameter, and said dilatation balloon also exhibits a maximum stretched inflation diameter to which the dilatation balloon is expandable without bursting under needed dilatation conditions, said maximum stretched inflation diameter being in excess of said predetermined balloon diameter; and said tubing material of the dilatation balloon has tailorability properties whereby said maximum stretched inflation diameter had been selected during biaxial orientation to fall within a range of maximum stretched inflation diameter values, and said dilatation balloon maximum stretched inflation diameter had been selected from within said range of maximum stretched inflation diameter values.

Claim 23

A dilatation balloon, comprising: a length of thermoformable material tubing that had been biaxially oriented to a predetermined balloon diameter; said dilatation balloon has a collapsed profile at which the outer diameter of the dilatation balloon approximates the outer diameter of a component of a medical device, said dilatation balloon further having a non-distended, inflated working diameter at which the dilatation balloon is inflated to its said predetermined balloon diameter, and said dilatation balloon also exhibits a maximum stretched inflation diameter to which the dilatation balloon is expandable without bursting under needed dilatation conditions, said maximum stretched inflation diameter being in excess of said predetermined balloon diameter; and said tubing material of the dilatation balloon has tailorability properties whereby said maximum stretched inflation diameter had been selected during biaxial orientation to fall within a range of maximum stretched inflation diameter values, and said dilatation balloon maximum stretched inflation diameter had been selected from within said range of maximum stretched inflation diameter values.

Claim 24

The dilatation balloon according to claim 18, wherein said dilatation balloon has a calculated tensile strength of at least about 15,000 psi.

Claim 25

The dilatation balloon according to claim 18, wherein said maximum stretched inflation diameter exceeds said predetermined balloon diameter by up to about 30 percent or greater.

Claim 26

The dilatation balloon according to claim 18, wherein said maximum stretched inflation diameter exceeds said predetermined balloon diameter by between above 5 percent and about 40 percent or above.

Claim 27

The dilatation balloon according to claim 18, wherein said balloon had been subjected to at least two biaxial orientation procedures, and wherein said dilatation balloon is substantially free of expansion knurls.

Claim 28

A process for tailoring expansion properties of a balloon for a medical device, the process comprising: longitudinally stretching a length of biaxially orientable tubing having an initial diameter and made of material capable of being tailored by the steps hereof to provide drawn tubing; radially expanding the thus drawn tubing to a balloon member, said balloon member having a non-distended working diameter and having a hoop expansion ratio, which hoop expansion ratio is an approximate ratio of said non-distended working diameter to said initial diameter of the tubing; and said radially expanding step including selecting said hoop expansion ratio such that the balloon member exhibits a maximum inflated diameter to which the balloon stretches without bursting during dilatation, said maximum inflated diameter increasing in a manner which is indirectly proportional to said hoop expansion ratio.

Claim 29

A process for tailoring expansion properties of a balloon for a medical device, the process comprising: longitudinally stretching a length of biaxially orientable tubing having an initial diameter and made of material capable of being tailored by the steps hereof to provide drawn tubing; radially expanding the thus drawn tubing to a balloon member, said balloon member having a non-distended working diameter and having a hoop expansion ratio, which hoop expansion ratio is an approximate ratio of said non-distended working diameter to said initial diameter of the tubing; and said radially expanding step including selecting said hoop expansion ratio such that the balloon member exhibits a maximum inflated diameter to which the balloon stretches without bursting during dilatation, said maximum inflated diameter increasing in a manner which is indirectly proportional to said hoop expansion ratio.

Claim 30

A process according to claim 23, wherein said hoop expansion ratio is between about 3 and about 6.

Claim 31

The process according to claim 23, further including heat setting said balloon member by raising the temperature of the balloon member to a heat setting temperature above the glass transition temperature of the biaxially orientable tubing material, followed by cooling the balloon member to a temperature below the glass transition temperature, and said heat setting step tailors the balloon member whereby said maximum inflated diameter increases in a manner which is directly proportional to said heat setting temperature.

Claim 32

The process according to claim 25, wherein said heat setting temperature is between about 90°C. and about 180°C.

Claim 33

The process according to claim 25, wherein said glass transition temperature approximates human body temperature.

Claim 34

The process according to claim 25, wherein said temperature below the glass transition temperature approximates room temperature.