Apparatus and method for manufacturing balloons for medical devices

Claim 2

A molding apparatus for fabricating medical device balloons, comprising: a free-blow biaxial orientation molding chamber having an infeed opening and an outfeed opening; a blow molding chamber downstream of said free-blow biaxial orientation molding chamber, said downstream blow molding chamber having an infeed opening and an outfeed opening; means for thermally isolating said free-blow biaxial orientation molding chamber from other components of the apparatus including said downstream blow molding chamber; means for feeding a parison through the infeed opening and outfeed opening of the free-blow biaxial orientation molding chamber and through said infeed opening and outfeed opening of the downstream blow molding chamber; means for supplying pressurized fluid into said parison at a location upstream of said infeed opening of the free-blow biaxial orientation molding chamber; means for axially elongating said parison while a portion of the parison is within said free-blow biaxial orientation molding chamber and while another portion of the parison is within said downstream blow molding chamber; said free-blow biaxial orientation molding chamber having means for permitting biaxial orientation and radial enlargement of the portion of the parison therewithin upon passage thereinto of pressurized fluid from said supplying means; and said downstream blow molding chamber having means for permitting radial enlargement of the another portion of the parison therewithin upon passage thereinto of pressurized fluid from said supplying means.

Claim 3

The balloon molding apparatus according to claim 1, further including heat control means for raising the temperature of the portion of the parison within said free-blow biaxial orientation molding chamber during said biaxial orientation and radial enlargement of this portion of the parison in order to form a biaxially oriented portion of the parison.

Claim 4

The balloon molding apparatus according to claim 2, wherein said heat control means is also for lowering the temperature of said biaxially oriented parison portion such that said axially elongating means axially orients the parison when same is at approximately room temperature or less.

Claim 5

The balloon molding apparatus according to claim 1, wherein said parison is a nylon or a polyamide and said axially elongating means axially orients said parison having a temperature of approximately room temperature or below to at least in excess of twice the length of the parison prior to said axial orientation.

Claim 6

The balloon molding apparatus according to claim 1, further including heat control means for raising the temperature of the portion of the parison within said downstream blow molding chamber during said radial enlargement of this another portion of the parison and for subsequently cooling said portion of the parison.

Claim 7

The balloon molding apparatus according to claim 5, wherein said heat control means imparts a temperature between about 0 o C. and about 150 o C. or more to said downstream blow molding chamber.

Claim 8

The balloon molding apparatus according to claim 1, wherein said means for thermally isolating said chambers include chiller chambers substantially juxtaposed to the infeed and outfeed openings of said free-blow chamber and of said downstream blow molding chamber.

Claim 9

The balloon molding apparatus according to claim 1, wherein said axially elongating means includes upstream gripping means for preventing longitudinal movement of the parison and downstream gripping means for longitudinally translating the parison and for substantially preventing passage of the pressurized fluid thereby, said upstream gripping means being upstream of said free-blow chamber, and said downstream gripping means being downstream of said downstream blow molding chamber.

Claim 10

The balloon molding apparatus according to claim 8, further including intermediate gripping means for substantially preventing passage of the pressurized fluid within the parison between said free-blow chamber and said downstream blow molding chamber.

Claim 11

The balloon molding apparatus according to claim 1, further including means for controlling the amount of parison biaxial orientation that is effected by said free-blow molding chamber.

Claim 12

The balloon molding apparatus according to claim 10, wherein said controlling means includes a member that is activated upon being engaged at a preselected location by said parison while it is expanding within said free-blow molding chamber.

Claim 13

The balloon molding apparatus according to claim 11, wherein said member of the controlling means activates heat control means for lowering the temperature of the parison within the free-blow molding chamber from a free-blow temperature of about 75 o C. or above to about room temperature.

Claim 14

A process for fabricating medical device balloons, the process comprising: feeding an elongated parison through a molding apparatus including a free-blow biaxial orientation chamber and a downstream blow molding chamber; axially stretching to longitudinally orient the parison within the free-blow chamber to provide an axially oriented parison length; biaxially orienting the axially oriented parison length by infusing pressurized fluid thereinto to provide a biaxially oriented parison length; axially stretching the biaxially oriented parison length until its diameter is decreased; and blow molding the biaxially oriented and axially stretched parison length by infusing pressurized fluid thereinto while same is within the downstream blow molding chamber to provide a molded parison useful as a medical device balloon.

Claim 15

A process for fabricating medical device balloons, the process comprising: feeding an elongated parison through a molding apparatus including a free-blow biaxial orientation chamber and a downstream blow molding chamber; axially stretching to longitudinally orient the parison within the free-blow chamber to provide an axially oriented parison length; biaxially orienting the axially oriented parison length by infusing pressurized fluid thereinto to provide a biaxially oriented parison length; axially stretching the biaxially oriented parison length until its diameter is decreased; and blow molding the biaxially oriented and axially stretched parison length by infusing pressurized fluid thereinto while same is within the downstream blow molding chamber to provide a molded parison useful as a medical device balloon.

Claim 16

The balloon fabricating process according to claim 13, wherein said axially stretching steps are carried out at approximately room temperature.

Claim 17

The balloon fabricating process to claim 13, wherein said biaxially orienting step is carried out at an elevated temperature of between about 80 o C. and about 150 o C. or above.

Claim 18

The balloon fabricating process according to claim 13, wherein said blow molding step is carried out at an elevated temperature of between about 80 o C. and about 150 o C. or above.

Claim 19

The balloon fabricating process according to claim 14, wherein said biaxially orienting step and said blow molding step are carried out at a temperature of between about 80 o C. and about 150 o C. or above.

Claim 20

The balloon fabricating process according to claim 13, wherein said feeding step feeds a parison tube of a nylon or of a polyamide, and wherein said step of axially stretching the fed parison is carried out at approximately room temperature and elongates the parison to as least twice the length of the parison prior to the axially stretching step.

Claim 21

The balloon fabricating process according to claim 15, further including thermally isolating the free-blow biaxially orienting chamber so that the elevated temperature of the biaxially orienting step is substantially confined to the portion of the parison to be biaxially oriented.

Claim 22

The balloon fabricating process according to claim 16, further including thermally isolating the blow molding chamber so that the elevated temperature of the blow molding step is substantially confined to the portion of the parison to be blow molded.

Claim 23

The balloon fabricating process according to claim 13, further including controlling the extent of biaxial orientation achieved by said biaxially orienting step by carrying out the biaxial orientation at an elevated temperature and then reducing the temperature within the free-blow chamber to about room temperature or lower as soon as a desired extent of biaxial orientation is achieved.

Claim 24

A process for fabricating medical device balloons, the process comprising: feeding an elongated parison through a molding apparatus including a free-blow biaxial orientation chamber and a downstream blow molding chamber; longitudinally stretching to axially orient the parison within the free-blow chamber to provide an axially oriented parison length; biaxially orienting the axially oriented parison length by infusing pressurized fluid thereinto to provide a biaxially oriented parison length; axially stretching the biaxially oriented parison length; blow molding the biaxially oriented and axially stretched parison length, said blow molding step including raising the temperature of the biaxially oriented and axially stretched parison within the downstream blow molding chamber and infusing the pressurized fluid into a portion of the elongated parison that is upstream of the free-blow chamber whereby the pressurized fluid flows through the parison within the free-blow chamber and then into the biaxially oriented and axially stretched parison within the downstream blow molding chamber; closing off the parison between the free-blow chamber and the blow molding chamber to prevent passage of pressurized fluid therebetween, and biaxially orienting the longitudinally oriented parison at an elevated temperature within the free-blow chamber to form another biaxially oriented parison length; and axially stretching said another biaxially oriented parison length, followed by blow molding same within the blow molding chamber at an elevated temperature to provide a molded parison useful as an angioplasty balloon.

Claim 25

A process for fabricating medical device balloons, the process comprising: feeding an elongated parison through a molding apparatus including a free-blow biaxial orientation chamber and a downstream blow molding chamber; longitudinally stretching to axially orient the parison within the free-blow chamber to provide an axially oriented parison length; biaxially orienting the axially oriented parison length by infusing pressurized fluid thereinto to provide a biaxially oriented parison length; axially stretching the biaxially oriented parison length; blow molding the biaxially oriented and axially stretched parison length, said blow molding step including raising the temperature of the biaxially oriented and axially stretched parison within the downstream blow molding chamber and infusing the pressurized fluid into a portion of the elongated parison that is upstream of the free-blow chamber whereby the pressurized fluid flows through the parison within the free-blow chamber and then into the biaxially oriented and axially stretched parison within the downstream blow molding chamber; closing off the parison between the free-blow chamber and the blow molding chamber to prevent passage of pressurized fluid therebetween, and biaxially orienting the longitudinally oriented parison at an elevated temperature within the free-blow chamber to form another biaxially oriented parison length; and axially stretching said another biaxially oriented parison length, followed by blow molding same within the blow molding chamber at an elevated temperature to provide a molded parison useful as an angioplasty balloon.

Claim 26

The process according to claim 22, wherein said temperature of the blow molding steps is higher than said temperature of the biaxially orienting steps, and wherein pressure of the pressurized fluid of the blow molding steps is lower than the pressure of the pressurized fluid of the biaxially orienting steps.