Abstract: A medical device with an expandable element and expandable tubular sleeve surrounding at least a portion of the expandable element which influences the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided.

Abstract: A medical device with an expandable element and expandable tubular sleeve surrounding at least a portion of the expandable element which influences the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided.

Abstract: The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

Abstract: The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

Abstract: In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

Abstract: In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

Abstract: A method of inflating a catheter balloon may include providing a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Abstract: A method of inflating a catheter balloon may include providing a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Abstract: The present disclosure is directed toward devices, systems and methods that reduce stress being exerted directly onto balloon seals.

Abstract: Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.

Abstract: In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

Abstract: Novel catheter constructions comprising thin covering or wrapping materials such as polymer films. A catheter provided with a guidewire catheter lumen having a thin covering that is easily punctured by a guidewire at virtually any desired point along the catheter length. The thin covering may be integral with the catheter shaft, or may be a separate component that covers only the portion of the catheter shaft immediately adjacent the outer portion of the guidewire lumen, or may be a thin tubular construct that surrounds the entire catheter shaft. Moreover, polymer film can be used in combination with one or more elements to produce novel catheter constructions.

Abstract: Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.

Abstract: A medical device with an expandable element and expandable tubular sleeve surrounding at least a portion of the expandable element which influences the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided.

Abstract: A medical device with an expandable element and slidable constraint of at least two portions surrounding the expandable element which slides away from the middle region and toward the distal and proximal ends of the expandable element upon expansion of the expandable element to influence the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided.

Abstract: A medical device with an expandable element and expandable tubular sleeve surrounding at least a portion of the expandable element which influences the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided.

Abstract: The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

Abstract: The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and a retractable outer sheath with a selectively permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during retraction of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: A method of inflating a catheter balloon may include providing a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.