Insertion tools for medical device
Inventors
Jelle, Bruce M. • Slager, Joram • McGonigle, Joseph S. • Murphy, Rick • Bach, Andrew G. • Woodwick Sides, Teryl L. • Angamuthu, Ambereen • Lundquist, Sean • Opperman, Gary • Lockwood, Nathan A.
Assignees
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Publication Number
US-11576774-B2
Publication Date
2023-02-14
Expiration Date
Abstract
The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body. In embodiments the insertion tools have an elongate hollow body (50) that is able to protect a portion of a medical device, such as a balloon of a balloon catheter, during an insertion procedure. In one embodiment the insertion tool has an elongate hollow body (131), a tapered distal end (135), and a locking mechanism (133) at the proximal end which can secure a portion of a balloon catheter. An opening at the distal end can allow passage of the balloon in a folded uninflated state.
Core Innovation
The invention relates to an insertion tool for facilitating entry of a balloon catheter into a body of a subject. The tool includes a tubular member with a distal end and a proximal end, where the distal end has an opening defining inner and outer diameters sized to allow passage of a balloon portion through the tubular member and the proximal end has an opening defining inner and outer diameters.
The outer surface between the proximal and distal ends is sized to fit within a portion of a hemostatic valve. The tubular member has an overall length between the proximal and distal ends that is greater than the length between the proximal and distal openings of the hemostatic valve, and a flange arranged about the outer diameter of the proximal end comprises a circular rim with a flat proximal-facing surface and a flat distal-facing surface that abuts a proximal face of the hemostatic valve.
A continuous tapered configuration is provided by setting the inner diameter of the distal end smaller than the inner diameter of the proximal end, thereby forming a continuous taper from the proximal end to the distal end of the tubular member. The disclosed approach addresses reliable entry of a balloon catheter while interacting with a hemostatic valve, and also includes system-level arrangements for facilitating entry of a medical device using the insertion tool and the hemostatic valve structure.
Claims Coverage
The document includes two independent claims that cover an insertion tool configured to fit within a hemostatic valve and pass a balloon portion via a continuous tapered tubular member, and a system that uses the insertion tool with a hemostatic valve to facilitate entry of a medical device. Across the independent claims, the core inventive structure is a tubular member with a proximal flange rim that abuts a valve face, combined with an inner-diameter relationship that creates a continuous tapered configuration from proximal to distal through the tool and valve openings.
Continuous tapered tubular member with proximal fit in hemostatic valve
A tubular member comprising outer and inner surfaces, having a distal end with an opening defining inner and outer diameters sized to allow passage of a balloon portion through the tubular member, and a proximal end with an opening defining inner and outer diameters such that between the proximal and distal ends the outer surface is sized to fit within a portion of a hemostatic valve.
Flange circular rim with flat surfaces abutting valve proximal face
A flange arranged about the outer diameter of the proximal end, wherein the flange is in a form of a circular rim comprising a flat proximal-facing surface and a flat distal-facing surface, wherein the flat distal-facing surface of the circular rim is able to abut the proximal face of the hemostatic valve.
Tool length greater than hemostatic valve opening-to-opening length
A length between the proximal and distal ends of the tubular member that is greater than a length between the proximal and distal openings of the hemostatic valve.
Inner diameter distal smaller than inner diameter proximal for continuous taper
The inner diameter of the distal end is smaller than the inner diameter of the proximal end, thereby providing a continuous tapered configuration from the proximal end to the distal end of the tubular member.
System including medical device and hemostatic valve with insertion tool fitting within valve
A system comprising a medical device inserted into the body, a hemostatic valve comprising a proximal end with a proximal face and a proximal opening and a distal end with a distal opening, and an insertion tool comprising a tubular member sized so that between the proximal and distal ends the outer surface fits within a portion of the hemostatic valve and the distal inner diameter is sized to allow passage of a distal portion of the medical device.
Circular rim flange able to abut valve proximal face in system context
The insertion tool in the system includes a flange arranged about the outer diameter of the proximal end, wherein the flange is in a form of a circular rim with a flat proximal-facing surface and a flat distal-facing surface, and the flat distal-facing surface is able to abut the proximal face of the hemostatic valve.
System tool length greater than hemostatic valve proximal-to-distal opening length
The insertion tool in the system has a length between the proximal and distal ends that is greater than a length between the proximal and distal of a hemostatic valve.
System continuous tapered configuration from proximal to distal ends of tubular member
The insertion tool in the system has an inner diameter of the distal end smaller than the inner diameter of the proximal end, thereby providing a continuous tapered configuration from the proximal end to the distal end of the tubular member.
Overall, the independent claims focus on configuring an insertion tool tubular member to fit within a hemostatic valve portion and to create a continuous tapered inner diameter for passage of a balloon portion or distal portion, with a proximal circular-rim flange whose flat distal-facing surface abuts the valve proximal face, and with the tubular-member length set greater than the valve length between its openings. The system claim extends this structure to a system including the medical device and the hemostatic valve.
Stated Advantages
Facilitating entry of a balloon catheter into a body of a subject.
Facilitating entry of a medical device into a body using a hemostatic valve and an insertion tool.
Providing a continuous tapered configuration from the proximal end to the distal end of the tubular member for passage of the balloon portion or distal portion.
Allowing the flange circular rim to abut the proximal face of the hemostatic valve during insertion.
Documented Applications
Facilitating entry of a balloon catheter into a body of a subject.
Facilitating entry of a medical device into a body of a subject using a hemostatic valve and the insertion tool.
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