A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

The invention provides a heat-shrinkable polyester film which has sufficient heat shrinkage properties in the main shrinkage direction that is the longitudinal direction without containing a monomer component that can form an amorphous component in a large amount, and which has a low heat shrinkage and a low shrinkage stress in the width direction orthogonal to the main shrinkage direction. The film has a heat shrinkage of 15-50% in a main shrinkage direction of the film and 0-12% in a direction orthogonal to the main shrinkage direction of the film, when treated for 10 seconds in hot water of 90 C., and a maximum shrinkage stress of 2-10 MPa in the main shrinkage direction of the film when measured under hot air of 90 C. The film contains 7-30 mol % of a constituent unit derived from diethylene glycol in 100 mol % of the whole polyester resin component.

To produce a flexible pipe body, a length of tensile armour element (300) of pre-preg composite material is fed towards a fluid-retaining layer (602). The tensile armour element (300) passes through a guide (604) an a pre-heater (606). The tensile armour element (300) is then applied to the fluid-retaining layer (602), being wrapped around the fluid-etaining layer (602) by virtue of the rotation of the layer (602), the linear translation of the layer (602), and the fixed position of the tensile armour element feed (601). The element (300) is fed to the fluid-retaining layer under a constant, predetermined controlled tension. Positioning head (608) helps to position the element (300) on the fluid-retaining layer (602). As tensile armour element is wound onto the pipe body, the pipe body continues to move in a, linear direction and the pipe body moves through an oven (610).

A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

Apparatus and methods are provided for creating tubular devices, e.g., as components for catheters, sheaths, and or other devices sized for introduction into a patient. In one embodiment, a method is provided for making a tubular device using a sheet of material including a coated first surface. The sheet is rolled around a mandrel until longitudinal edges of the sheet are disposed near or adjacent one another, e.g., without attaching the longitudinal edges together. A tubular braid is positioned over the sheet-wrapped mandrel, one or more tubular segments are positioned over the tubular braid, and heat shrink tubing is positioned over the tubular segments. The resulting assembly is heated to cause the tubular segments to at least partially reflow and/or otherwise laminate the tubular segments to the tubular braid and sheet. The heat shrink tubing and mandrel are then removed to create the tubular device.

The present invention is directed to a method of preparing an actuator capable of being repeatedly and reversibly shifted between two freestanding shapes (A, B) under stress-free conditions upon varying a temperature between a temperature T.sub.low and a temperature T.sub.sep. The method comprising the steps: (a) providing an actuator consisting of or comprising a covalently or physically cross-linked polymer network, the polymer comprising a first phase having a thermodynamic phase transition extending in a temperature range from T.sub.trans,onset to T.sub.trans,offset, and an elastic phase having a glass transition temperature T.sub.g, with T.sub.g<T.sub.trans,onset, the polymer having an initial shape; (b) deforming the polymer to a deformation shape at a temperature T.sub.prog by applying a stress, where the deformation is adapted to align chain segments of the polymer; (c) setting the polymer to a temperature T.sub.low with T.sub.lowT.sub.trans,onset under maintaining the stress as to provide a solidified state of the polymer domains associated with the first phase; (d) heating the polymer to a predetermined separation temperature T.sub.sep, with T.sub.trans,onset<T.sub.sep<T.sub.trans,offset, under stress-free conditions as to melt first polymeric domains (AD) of the first phase having a transition temperature in the range between T.sub.trans,onset and T.sub.sep and to maintain second domains (SD) of the first phase having a transition temperature in the range between T.sub.sep and T.sub.trans,offset in the solidified state, thus implementing shape A, where shape A geometrically lies between the initial shape provided in step (a) and the deformation shape applied in step (b) and shape B is the shape at T.sub.low and lies geometrically between shape A and the shape of deformation of step (b).

Apparatus and methods are provided for making one or more tubular components of medical catheters or other tubular bodies using a strip of polymer material including a length, a width, and a first surface including a lubricious or other coating or surface modification. The strip is directed adjacent an elongate mandrel, such as beading, such that the length of the strip extends along the mandrel and the coating is disposed towards the mandrel. The strip is rolled at least partially around the mandrel such that the coating or surface modification is disposed inwardly towards the mandrel, and one or more strip-constrainment members are wrapped around the rolled strip. The directing, rolling, and wrapping steps may be substantially continuous to create one or more strip-mandrel-constrainment member subassemblies.

A method of manufacturing a fluid impermeable rigid composite pipe (10) or hollow tube comprising the steps of:a. providing a supporting mandrel (15) that is shaped to define a bore of the pipe (10); b. laying onto the outer circumferential surface of the mandrel (10) one or more first tapes (11) made of a thermoplastic material thereby to create a first region (11) that is predominantly thermoplastic material adjacent the bore of the pipe (10); c. providing a plurality of tows (14) that comprise co-mingled reinforcing fibres and thermoplastic filaments; d. weaving a plurality of the tows (14) to form one or more circular braids (13) and laying down the one or more of the circular braids (13) on to the first layer (11): to form a second region (12); e. applying to the outer surface of the second region (12) a heat-shrinkable layer (13); f. heating the product of steps (b) to (e) on the mandrel (15) to a first temperature at which the thermoplastic materials of the one or more tapes 11 and the tows 14 melt and the heat-shrinkable layer 13 shrinks radially inwards to consolidate the melted thermoplastic material to form a thermoplastic matrix in which the reinforcing fibres are embedded and a fluid impermeable thermoplastic rich region (11) is formed at the bore of the pipe (10); and, g. allowing the pipe (10) to cool to form a self supporting pipe (10).

An imaging window of an imaging catheter includes a first imaging window section and a second imaging window section. The first imaging window section has a finite length and is formed from a first material having a flexural modulus. The second imaging window section has a finite length and is formed from a second material having a flexural modulus. The flexural modulus of the first material is different than the flexural modulus of the second material.

Apparatus and methods are provided for making one or more tubular components of medical catheters or other tubular bodies using a strip of polymer material including a length, a width, and a first surface including a lubricious or other coating or surface modification. The strip is directed adjacent an elongate mandrel, such as beading, such that the length of the strip extends along the mandrel and the coating is disposed towards the mandrel. The strip is rolled at least partially around the mandrel such that the coating or surface modification is disposed inwardly towards the mandrel, and one or more strip-constrainment members are wrapped around the rolled strip. The directing, rolling, and wrapping steps may be substantially continuous to create one or more strip-mandrel-constrainment member subassemblies.