Balloon catheter and process for the manufacture thereof
First Claim
1. A self-supporting catheter device for passage into a body cavity through a natural or surgical opening in the body, said device comprising:
- a one-piece stem section having primary and secondary ends, being formed from one continuous flexible member comprising;
concentric inner and outer tube portions having respective first and second ends, said inner tube portion having an interior passage and having an external diameter that is smaller than the internal diameter of said outer tube portion, thereby providing an annular passage between said inner tube portion and said outer tube portion and permitting the relative movement thereof,wherein said respective tube portions are each of a length permitting passage of said device into a body cavity, andan inflatable end wall portion closing the space formed between said respective first ends of said inner tube portion and said outer tube portion, and covering said annular passage at said primary end, said inflatable end wall portion permitting axial movement of said inner tube portion relative to said outer tube portion,whereby axial movement of said inner tube portion relative to said outer tube portion in the direction of said secondary stem end draws said inflatable end wall portion to within said outer tube portion, and movement of said inner tube portion relative to said outer tube portion in the direction of said primary stem end pushes said inflatable end wall portion outside of said outer tube portion, and whereby said inflatable end wall portion can be inflated to a larger dimension, within the body cavity, by supply of a fluid to said annular passage, while maintaining access to the body via said primary passage.
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Accused Products
Abstract
The present invention relates to catheters and like devices for passage into a body cavity.
In the invention the device has a stem portion comprising at least a first tube disposed within a second tube, the tubes being joined at one pair of ends by a flexible member covering the opening of the passage formed between the inner tube and the outer tube. The flexible member is arranged such that the tubes are movable relative to each other and by movement of the inner tube away from or towards the one end of the outer tube the flexible member respectively either can be drawn within the adjacent one end of the outer tube to be enclosed within the outer tube or pushed outside the adjacent one end of the outer tube to expose a balloon. The balloon can be inflated within the body cavity using a fluid under pressure supplied to the balloon from outside the body through said passage.
This is a continuation of application Ser. No. 918,506, filed Oct. 14, 1986, now abandoned, which is a continuation of Ser. No. 617,998, filed May 31, 1984, now abandoned.
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Citations
25 Claims
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1. A self-supporting catheter device for passage into a body cavity through a natural or surgical opening in the body, said device comprising:
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a one-piece stem section having primary and secondary ends, being formed from one continuous flexible member comprising; concentric inner and outer tube portions having respective first and second ends, said inner tube portion having an interior passage and having an external diameter that is smaller than the internal diameter of said outer tube portion, thereby providing an annular passage between said inner tube portion and said outer tube portion and permitting the relative movement thereof, wherein said respective tube portions are each of a length permitting passage of said device into a body cavity, and an inflatable end wall portion closing the space formed between said respective first ends of said inner tube portion and said outer tube portion, and covering said annular passage at said primary end, said inflatable end wall portion permitting axial movement of said inner tube portion relative to said outer tube portion, whereby axial movement of said inner tube portion relative to said outer tube portion in the direction of said secondary stem end draws said inflatable end wall portion to within said outer tube portion, and movement of said inner tube portion relative to said outer tube portion in the direction of said primary stem end pushes said inflatable end wall portion outside of said outer tube portion, and whereby said inflatable end wall portion can be inflated to a larger dimension, within the body cavity, by supply of a fluid to said annular passage, while maintaining access to the body via said primary passage. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method for forming a device adapted for passage into a body cavity through a natural or surgical opening in the body, the device having a primary end and a secondary end, which process comprises the steps of:
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(i) setting an annular die to a first diameter and extruding an elastomeric material through said annular die to form a first tube portion of a first diameter having a first end; (ii) vacuum-forming or blow-moulding the first end of said first tube portion adjacent the annular die to form an inflatable end wall portion; (iii) setting the die to a second diameter; (iv) extruding the elastomeric material through the annular die to form a second tube portion of a second diameter having a first end and a second end, said first end being joined to said inflatable end wall portion; and (v) thereafter inserting the smaller diameter tube portion into the larger diameter tube portion or the larger diameter tube portion over the smaller diameter tube portion to form an annular passage therebetween, and so that the respective second ends of said respective tube portions are substantially equidistant in length from said inflatable end wall portion, wherein said tube portions are extruded to a length permitting passage of said device into a body cavity. - View Dependent Claims (15, 16, 24, 25)
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17. A method for forming a device adapted for passage into a body cavity through a natural or surgical opening in the body, the device having a primary end and a secondary end, which process comprises the steps of:
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(a) ejecting molten elastomeric material from an annular die for extruding concentric inner and outer tube portions, said tube portions each having a first end; (b) moulding, e.g. blow-moulding or injection-moulding an inflatable end wall portion between the tube portions first ends from the molten material; and (c) extruding the remainder of the two concentric tube portions to a length permitting passage of said device into a body cavity. - View Dependent Claims (18, 19, 20)
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21. A method for forming a device adapted for passage into a body cavity through a natural or surgical opening in the body, said device having a primary end and a secondary end, which process comprises the steps of:
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providing a performed tube portion of elastomeric material having a first and second end and a first diameter; disposing said preformed tube portion in an essentially concentric relationship with an annular die for extruding a die-formed tube portion of elastomeric material having a second diameter and a first and second end; ejecting at least sufficient molten elastomeric material from the annular die to form an inflatable end wall portion; moulding, e.g. blow-moulding or injection-moulding, an inflatable end wall portion between the end of said elastomeric material in the annular die and the first end of said preformed tube portion; and extruding a die-formed tube portion while passing said preformed tube portion in the same direction as the extrusion, and at the rate of the extrusion, wherein said preformed tube portion is of such a length, and said die-formed tube is extruded to a length, permitting passage of said device into a body cavity. - View Dependent Claims (22, 23)
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Specification