Catheter curvature braces and methods of using same
Inventors
Assignees
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Publication Number
US-11065421-B2
Publication Date
2021-07-20
Expiration Date
Abstract
A catheter curvature brace, catheter assembly and method for managing fluid in a patient, the brace being attachable to a distal portion of a shaft of a catheter and having an elongated frame with a distal end and a proximal end. The frame is formed with at least one curve in a relaxed curved configuration. At least two coupling elements are connected to the frame, each coupling element configured to engage an outer surface of the catheter. At least the frame is formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the relaxed curved configuration after the force is removed, thereby bending the catheter to substantially conform to the relaxed curved configuration.
Core Innovation
An implantable catheter curvature brace includes an elongated frame with a distal end and a proximal end, formed with at least a first pre-defined curve in a first pre-defined relaxed curved configuration. The brace further includes at least two coupling elements connected to the frame, each coupling element configured to engage an outer surface of a catheter.
The frame is formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the first pre-defined relaxed curved configuration after the force is removed. This enables a distal catheter portion to be straightened for insertion and then to return to a relaxed curved configuration that conforms to a target ventricular geometry.
Disclosed variations include different brace curvature configurations, different fixed angles, a complex multi-curve configuration, and coupling elements implemented as ring-shaped coupling elements, C-shaped coupling elements, and open-ring shape coupling elements. Other embodiments include coupling elements formed as continuations of the frame, with the curvature brace used as part of a catheter assembly having distal fluid management openings located within a brain ventricle.
Claims Coverage
The document contains two independent claims. The first claim covers a catheter curvature brace with an elastic biocompatible curved frame and coupling elements, while the seventh claim covers a method of managing fluid using the brace to shape a distal catheter portion and implant it into a targeted location.
Elastic biocompatible elongated curved frame with pre-defined relaxed curved configuration
An elongated frame having a distal end and a proximal end, the frame being formed with at least a first pre-defined curve in a first pre-defined relaxed curved configuration; and at least the frame being formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the first pre-defined relaxed curved configuration after the force is removed.
Coupling elements engaging outer catheter surface connected to the frame
At least two coupling elements connected to the frame, each coupling element configured to engage an outer surface of a catheter.
Catheter assembly shaping of a distal portion to conform to desired pre-defined relaxed curved configuration
Selecting a catheter with an elongated shaft defining at least one lumen and a plurality of fluid management openings along a distal portion of the shaft in fluid communication with the lumen; selecting a catheter curvature brace attachable to the distal portion of the shaft with an elongated frame having at least one pre-defined curve in a desired pre-defined relaxed curved configuration, at least two coupling elements connected to the frame engaging an outer surface of the catheter, and at least the frame being formed of an elastic biocompatible material capable of being straightened by a force and then returning to the desired pre-defined relaxed curved configuration after the force is removed; attaching the catheter curvature brace to the distal portion of the catheter to form a catheter assembly and bend the distal portion to substantially conform to the desired pre-defined relaxed curved configuration.
Stylet-applied straightening during insertion and relaxed configuration upon stylet removal
Placing a stylet within the catheter lumen to apply the force to straighten the catheter assembly; inserting the catheter assembly within the patient to implant the distal portion in a targeted location; and removing the stylet to allow the distal portion to substantially conform to the desired pre-defined relaxed curved configuration.
Across the independent claims, the main inventive aspects are an elastic, biocompatible elongated frame with a pre-defined relaxed curved configuration that straightens under force and returns after force removal, coupling elements connected to the frame and configured to engage the catheter outer surface, and use of a catheter curvature brace in a fluid-management method with stylet-applied straightening for implantation and return to a relaxed configuration.
Stated Advantages
Enables the distal catheter portion to conform to a target ventricular geometry after returning to the pre-defined relaxed curved configuration.
Reduces tissue exposure and potential obstruction of fluid management openings.
Documented Applications
Managing fluid within a patient by implanting a catheter with distal fluid management openings into a targeted location, including the distal portion implanted within a brain ventricle as described in the document.
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