Patent EP0439202A2 successfully refreshed from Google Patents.
EP0439202A2
Expired / Lapsed
EP
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Apparatus and method for manufacturing balloons for medical devices
Assignee: Cordis Corp
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Filing: 1990-02-02
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Granted: —
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Expires: 2010-02-02
Abstract
Abstract Apparatus and methods for forming dilatation balloons and catheters including same are provided. The balloons are fabricated of a biaxially orientable material such as a nylon or a polyamide material, and they have an inflated, non-distended working profile as well as a stretched inflated profile which is achieved by applying pressure through a dilatation catheter or the like that is in excess of that needed to achieve the inflated, non-distended profile and which is adequate to effect dilatation or the like up to a maximum pre-bursting pressure application. The maximum pre-bursting size of the balloon can be tailored depending upon the needs of the particular balloon within a wide range of possible maximum pre-bursting sizes. The apparatus and methods facilitate fabrication of the balloons which are subjected to longitudinal elongation or axial orientation and biaxial or radial orientation.
Inventors
- 👤 Stefan Jackowski
- 👤 Leonard Pinchuk
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 20:35
CPC Classifications
B; B29; B29C; B29C49/00; B29C49/08; B29C49/16; A; A61; A61M; A61M25/00; A61M25/10; A61M25/1027; A61M25/1029; A61M25/1034; B29C49/10; B29C49/14; B29C49/42; B29C49/64; B29C49/6409; B29C49/6436; B29C49/6445; A61B; A61B17/00; A61B2017/00743; A61B2017/00778; A61B2017/00783; B29C49/46; B29C2049/4602; B29C2049/465; B29C2049/4655; B29C2949/00; B29C2949/07; B29C2949/0715; B29C2949/079; B29C2949/08; B29C33/00; B29C33/02; B29C33/04; B29C49/02; B29C49/06; B29K; B29K2105/00; B29K2105/25; B29K2105/253; B29K2105/258
Claims Analysis
Total Claims: 23
Claim 1
Independent Claim
238 words
A molding apparatus for fabricating medical device balloons, comprising: a free-blow molding chamber in which mechanically streching of a parison in two directions can be achieved, having an infeed opening and an outfeed opening; a blow molding chamber downstream of said free-blow molding chamber, said downstream blow molding chamber having an infeed opening and an outfeed opening; means for thermally isolating said free-blow molding chamber from other components of the apparatus including said downstream blow molding chamber; means for feeding said parison through the infeed opening and outfeed opening of said free-blow molding chamber and through said infeed opening and outfeed opening of said downstream blow molding chamber; means for axially elongating said parison, thereby streching said parison in a first direction, while a portion of said parison is within said free-blow molding chamber and while another portion of said parison is within said downstream blow molding chamber; means for supplying pressurized fluid into said parison at a location upstream of said infeed opening of said free-blow molding chamber; said free-blow molding chamber having means for permitting stretching of a defined portion of said parison in a second direction by radially enlarging the portion of said 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 said parison therewithin upon passage thereinto of pressurized fluid from said supplying means.
Claim 2
Dependent Claim
49 words
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 molding chamber during said radial enlargement of this portion of the parison in order to form a radially expanded portion of the parison.
Claim 3
Dependent Claim
44 words
The balloon molding apparatus according to claim 2, wherein said heat control means is also for lowering the temperature of said radially expanded parison portion such that said axially elongating means axially orients the parison when same is at approximately room temperature or less.
Claim 4
Dependent Claim
57 words
The balloon molding apparatus according to any one of claims 1 - 3, wherein said parison is a nylon or a polyamide and said axially elongating means axially elongates 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 elongation.
Claim 5
Dependent Claim
54 words
The balloon molding apparatus according to any one of claims 1 - 4, 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 6
Dependent Claim
32 words
The balloon molding apparatus according to claim 5, wherein said heat control means imparts a temperature between about 0° C and about 150° C or more to said downstream blow molding chamber.
Claim 7
Dependent Claim
43 words
The balloon molding apparatus according to any one of claims 1 - 6, 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 8
Dependent Claim
71 words
The balloon molding apparatus according to any one of claims 1 - 7, 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 9
Dependent Claim
34 words
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 10
Dependent Claim
32 words
The balloon molding apparatus according to any one of claims 1 - 9, further including means for controlling the amount of parison radial expansion that is effected by said free-blow molding chamber.
Claim 11
Dependent Claim
37 words
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 12
Dependent Claim
45 words
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° C or above to about room temperature.
Claim 13
Dependent Claim
127 words
A process for fabricating medical device balloons, the process comprising: feeding an elongated parison through a molding apparatus including a free-blow molding chamber in which mechanically streching of said parison in two directions can be achieved, and a downstream blow molding chamber; axially stretching to longitudinally elongate the parison within said free-blow chamber to provide an axially elongated parison length; radially expanding said axially elongated parison length by infusing pressurized fluid thereinto to provide a radially expanded parison length; axially stretching said radially expanded parison length until its diameter is decreased; and blow molding said radially expanded 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 14
Dependent Claim
20 words
The balloon fabricating process according to claim 13, wherein said axially stretching steps are carried out at approximately room temperature.
Claim 15
Dependent Claim
33 words
The balloon fabricating process according to claims 13 or 14, wherein said radially expanding step is carried out at an elevated temperature of between about 80° C and about 150° C or above.
Claim 16
Dependent Claim
36 words
The balloon fabricating process according to any one of claims 13 - 15, wherein said blow molding step is carried out at an elevated temperature of between about 80° C and about 150° C or above.
Claim 17
Dependent Claim
40 words
The balloon fabricating process according to any one of claims 13 - 16, wherein said radially expending step and said blow molding step are carried out at a temperature of between about 80° C and about 150° C or above.
Claim 18
Dependent Claim
64 words
The balloon fabricating process according to any one of claims 13 - 17, 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 at least twice the length of the parison prior to the axially stretching step.
Claim 19
Dependent Claim
43 words
The balloon fabricating process according to any one of claims 13 - 18, further including thermally isolating the free-blow chamber so that the elevated temperature of the radially expanding step is substantially confined to the portion of the parison to be radially expanded.
Claim 20
Dependent Claim
39 words
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 21
Dependent Claim
63 words
The balloon fabricating process according to any one of claims 13 - 20, further including controlling the extent of radial expansion achieved by said radially expanding step by carrying out the radial expansion 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 radial expansion is achieved.
Claim 22
Dependent Claim
159 words
The balloon fabricating process according to any one of claims 13 - 21, wherein said blow molding step includes raising the temperature of the radially expanded 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 radially expanded 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 radially expanding the longitudinally elongated parison at an elevated temperature within the free-blow chamber to form another radially expanded parison length; and axially stretching said another radially expanded parison length, followed by blow molding same within the blow molding chamber at an elevated temperature to provide a molded parison useful as a medical device balloon.
Claim 23
Dependent Claim
51 words
The process according to claim 22, wherein said temperature of the blow molding steps is higher than said temperature of the radially expanding steps, and wherein the pressure of the pressurized fluid of the blow molding steps is lower than the pressure of the pressurized fluid of the radially expanding steps.
References Cited (Backward Citations)
No citation records indexed.
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