Cardiac tissue penetrating devices, methods, and systems for treatment of congestive heart failure and other conditions
Inventors
Van Bladel, Kevin • Moshe, Meir • Annest, Lon
Assignees
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Publication Number
US-10314498-B2
Publication Date
2019-06-11
Expiration Date
Abstract
According to one embodiment, a tissue penetrating device includes an elongate shaft having a proximal end, a distal end, and a lumen extending there between. A first needle is disposed within the lumen of the elongate shaft and is extendable therefrom between a first configuration and a second configuration. In the first configuration, the first needle is disposed within the elongate shaft's lumen and is substantially aligned with an axis of the lumen. In the second configuration, the first needle extends distally of the elongate shaft's distal end and bends away from the lumen's axis. A second needle is disposed within a lumen of the first needle and is extendable therefrom when the first needle is positioned in the first configuration and when the first needle is positioned in the second configuration. The second needle may be extended from the first needle to penetrate tissue of a patient.
Core Innovation
The invention provides a minimally invasive tissue penetrating device with an elongate shaft having a proximal end positionable outside a patient and a distal end positionable within the patient, with a lumen extending between the ends. A first needle is disposed within the lumen and is extendable distally between a first orientation and a second orientation, where in the first orientation the first needle is substantially aligned with an axis of the elongate shaft lumen, and in the second orientation the first needle extends distally and bends away from the lumen axis. A flexible shape-memory material with a preconfigured bend or curve enables the first needle to change from the first orientation to the second orientation as the first needle extends distally.
A second needle is disposed within the first needle's lumen and is extendable distally from a distal tip of the first needle when the first needle is positioned in either orientation so as to penetrate tissue. The second needle is retractable within the lumen of the first needle subsequent to penetration such that the second needle is fully disposed within the first needle's lumen, while maintaining coaxial alignment: when the second needle is extended distally, a distal end of the second needle is coaxially aligned with the distal tip of the first needle. The second needle has an open distal end with a lumen such that a guidewire is insertable through the lumen and through the open distal end of the second needle.
For congestive heart failure treatment, the invention further provides a method of penetrating cardiac tissue that positions a distal end of an elongate shaft adjacent an external wall of a patient's heart with a proximal end outside the body. A needle is advanced through the external wall, with the needle disposed centrally within a lumen of a sleeve, and then the sleeve is advanced distally over the needle through the external wall so that the needle is retracted and fully disposed within the sleeve lumen. The sleeve comprises flexible shape-memory material with a preconfigured bend or curve such that the sleeve curves away from an axis of the elongate shaft lumen as the sleeve advances distally of the distal end and distally of the external wall, and when fully advanced it has a straight axially aligned section extending from the elongate shaft distal end and a curved section extending between the straight section and the distal tip of the sleeve.
The method then positions the sleeve and needle adjacent a septal wall with the needle fully disposed within the sleeve lumen, and advances the needle distally of the distal tip of the sleeve and through the septal wall, with coaxial alignment such that when the needle is advanced distally of the distal tip of the sleeve, a distal end of the needle is coaxially aligned with the distal tip of the sleeve. Additional features described include progressing along coupled paths using a guidewire and a snare and positioning anchors with an elongate tension member and applying tension to urge wall engagement, as well as sensing pressure using a distal end of the needle or sleeve.
Claims Coverage
The provided independent claims are clm-00001, clm-00012, and clm-00018. Across these claims, the central inventive content includes a coaxially aligned two-needle arrangement with orientation-dependent bending of a flexible shape-memory first needle, and in the cardiac CHF treatment method a sleeve that is curved by shape-memory material to enable penetration from an external wall to a septal wall with specified alignment relationships.
Orientation-dependent bending first needle with flexible shape-memory curve
A first needle disposed within the elongate shaft lumen that extends distally between a first orientation and a second orientation, where in the first orientation it is substantially aligned with an axis of the lumen and in the second orientation it bends away from the axis, the first needle made of flexible shape-memory material having a preconfigured bend or curve such that it bends or curves from the first orientation to the second orientation as it extends distally.
Coaxially aligned second needle extension and full retraction within first needle
A second needle disposed within the first needle lumen, extendable distally from a distal tip of the first needle to penetrate tissue and retractable within the lumen of the first needle subsequent to penetration so that the second needle is fully disposed within the first needle lumen, wherein when the second needle is extended distally of the distal tip, a distal end of the second needle is coaxially aligned with the distal tip.
Guidewire insertable through the second needle lumen
The second needle comprises a proximal end and an open distal end with a lumen extending between the proximal end and the open distal end such that a guidewire is insertable through the lumen and through the open distal end of the second needle.
Method advancement with coaxial alignment during penetration and retraction
A method comprising advancing the first needle distally so it bends away from an axis of the elongate shaft lumen as it extends, advancing the second needle distally of a distal tip of the first needle to penetrate tissue, and advancing the first needle over the second needle and through the tissue so that the second needle is retracted and fully disposed within the first needle lumen, wherein when the second needle is extended distally of the distal tip a distal end of the second needle is coaxially aligned with the distal tip.
Shape-memory first needle geometry with straight and curved sections
The method where in the second orientation the first needle has a straight section that extends from the elongate shaft distal end and that is axially aligned with the elongate shaft and a curved section that extends between the straight section and the distal end of the first needle.
CHF cardiac tissue penetration using curved flexible shape-memory sleeve
A method of penetrating cardiac tissue for treatment of congestive heart failure positioning a distal end of an elongate shaft adjacent an external wall while a proximal end is outside, advancing a needle through the external wall with the needle disposed centrally within a sleeve lumen, advancing the sleeve distally over the needle through the external wall so the needle is retracted and fully disposed within the sleeve lumen, and advancing the sleeve to adjacent a septal wall such that the sleeve curves away from an axis as it advances distally of the distal end and distally of the external wall, the sleeve comprising flexible shape-memory material having a preconfigured bend or curve.
Sleeve straight axially aligned section and curved section with alignment at septal penetration
Where the sleeve is advanced to position the sleeve and needle adjacent a septal wall with the needle fully disposed within the sleeve lumen and then the needle is advanced distally of the distal tip of the sleeve through the septal wall, wherein when the needle is advanced distally of the distal tip the distal end of the needle is coaxially aligned with the distal tip of the sleeve, and when the sleeve is fully advanced distally of the elongate shaft distal end the sleeve has a straight section axially aligned with the elongate shaft lumen and a curved section between the straight section and the distal tip.
The independent claims cover a two-stage tissue penetration device in which a first flexible shape-memory needle changes from a substantially axis-aligned orientation to an orientation that bends away from the lumen axis, while a second needle penetrates and then fully retracts within the first needle lumen with coaxial alignment at extension. For congestive heart failure, the claims also cover a sleeve-based penetration method in which a flexible shape-memory sleeve curves away from the shaft lumen axis when advanced through an external wall to adjacent a septal wall, enabling coaxially aligned needle penetration through the septal wall with defined straight and curved sleeve sections.
Stated Advantages
Documented Applications
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