Vascular anchoring introducer sheath
Inventors
Gittard, Shaun Davis • Hardy, Gregory James • Sigmon, JR., John C. • Newkirk, Jeremy T. • Havel, William J. • Fearnot, Neal E. • Rogers, Toby • Ratnayaka, Kanishka • Lederman, Robert L.
Assignees
National Institutes of Health NIH • Muffin Inc
Publication Number
US-11071535-B2
Publication Date
2021-07-27
Expiration Date
2037-10-25
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
Among other things, there is disclosed structure and methods for maintaining access to a location in the body while reducing or eliminating the potential for pulling an access device (e.g. a catheter) back through an opening. An introducer sheath includes a distal indented portion and a balloon, so that once placed in a desired location through tissue, the balloon can be inflated to anchor the sheath against retraction. In particular embodiments, structure and methods for accessing the pericardial cavity via the right atrial appendage are shown.
Core Innovation
The invention disclosed is an introducer sheath designed for safe anchoring with respect to tissue, particularly for insertion through the right atrial appendage into the pericardial cavity. The sheath includes an inner lubricious layer defining an internal lumen, an outer heat-settable layer, and a coil core fixed between them. Of particular note is the linear distal portion of the sheath that includes an indented portion around its entire circumference housing a balloon. The balloon can be inflated to extend coaxially past the outer diameter of the linear distal portion, with a proximal-facing surface angled between 60 to 90 degrees relative to the longitudinal axis, serving to anchor the sheath against retraction through tissue.
The problem being addressed involves the difficulty of maintaining stable access to sensitive locations within the body, such as cardiac tissue, without causing additional trauma or risk due to inadvertent pullback of devices like introducer sheaths or catheters. For example, when passing through the interatrial septum or right atrial appendage to access the left atrium or pericardium, unintentional retraction necessitates re-puncturing, risking tissue damage or severe complications like pericardial tamponade. Existing devices generally lack suitable anchoring features that avoid expansion or damage to the tissue, especially in sensitive areas like the heart.
This disclosure provides a device and method that resolves these issues by incorporating an inflatable balloon anchored within an indentation of a linear distal portion of a sheath. This enables safe anchoring beyond the vascular or cardiac wall without enlarging or damaging the tissue passage. The sheath design includes an inner lubricious PTFE layer, an outer heat-settable PEBAX layer, and a coil core supporting flexibility and maneuverability. Method embodiments describe inserting the sheath via the inferior vena cava to the right atrial appendage, puncturing through it into the pericardial cavity, and inflating the balloon to maintain position, enabling safe delivery of treatment devices while preventing unintended pullback.
Claims Coverage
The patent includes one independent apparatus claim and one independent method claim, each detailing distinctive structural and procedural features for vascular access and anchoring.
Introducer sheath with layered construction and distal indented balloon
An introducer sheath comprising an inner lubricious layer with an internal lumen, an outer heat-settable layer surrounding it, and a coil core fixed between these layers. The coil core extends only through proximal and medial curved portions, not the linear distal portion, which includes an indented portion around its circumference. A balloon resides within this indented portion, deflated flush with the outer diameter, and inflates coaxially beyond it, featuring a proximal-facing surface angled 60 to 90 degrees relative to the longitudinal axis for anchoring.
Method of accessing the pericardial cavity via the right atrial appendage
A method including inserting the described introducer sheath into the inferior vena cava, moving it to the right atrium adjacent to the right atrial appendage, passing it through the appendage into the pericardial cavity, inflating the balloon within the cavity without enlarging the tissue hole, and engaging the balloon with the tissue facing the pericardial cavity to prevent retraction.
These independent claims cover the inventive structural features of the introducer sheath enabling secure, atraumatic anchoring via an inflatable balloon in a distal indented region, and the procedural method for safely accessing and maintaining sheath position within the pericardial cavity through the right atrial appendage.
Stated Advantages
Reduces or eliminates the risk of inadvertent pullback of an introducer catheter or sheath through cardiac or vascular tissue, preventing additional trauma or life-threatening complications.
The balloon anchors the sheath securely without expanding or damaging the access hole or surrounding sensitive cardiac tissue.
The sheath's multi-layer construction with a lubricious inner layer, heat-set outer layer, and coil core provides sufficient flexibility and torque transmission while maintaining integrity and atraumatic passage.
A linear distal portion without coil core enhances flexibility and provides an even surface for uniform balloon expansion and better tissue fit, minimizing leakage and trauma.
Imaging markers at the balloon indentation assist in confirming correct positioning before balloon inflation to ensure safe deployment.
Documented Applications
Accessing the pericardial cavity via the right atrial appendage for diagnostic or treatment procedures.
Enabling delivery of treatment devices into the pericardial cavity, including placement of a belt in the atrioventricular groove to treat tricuspid valve regurgitation.
Interested in licensing this patent?