US 11,890,190 B2Granted

Location indication system for implant-delivery tool

AssigneeEdwards Lifesciences Innovation (Israel) Ltd.

InventorsTal Sheps, Tal Hammer, Tal Reich, Ehud Aviv, Amir Gross, Yaron Herman, Alexei Koifman, Yuval Zipory

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Abstract

A catheter, advanced toward an anatomical site, has a proximal end and a steerable distal end. An anchor is advanced through the catheter. An anchor driver drives the anchor out of the catheter's distal end, anchoring the anchor at the site. A first constraining member engages tissue, and inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a first axis between the anchor driver's distal end and a site at which the first constraining member engages the tissue. A second constraining member inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a second axis. Other embodiments are also described.

Claims31

Dependent claims

A system, comprising:

an implant, comprising a tissue anchor comprising:
a coupling head, and
a distal helical tissue-engaging element,
a multi-component tubular system:
comprising:
a catheter, and
a channel, slidable within the catheter, the tissue anchor being slidable through the channel,
transluminally advanceable into a heart of a subject, and
configured to deliver the implant inside the heart;
an anchor driver having a distal end that is reversibly couplable to the coupling head of the tissue anchor in a manner that configures the anchor driver to:
drive the tissue anchor through the multi-component tubular system and out of a distal end of the multi-component tubular system, and
anchor the distal helical tissue-engaging element to tissue of the heart;
a first electrode configured to contact the subject;
a second electrode configured to be positioned inside the heart of the subject;
and
a control unit electrically coupled to the first electrode and the second electrode, the control unit comprising a display and circuitry configured, while the first electrode is in contact with the subject and the second electrode is inside the heart of the subject, to:
receive an electrical signal from the first electrode and the second electrode, and
based on the electrical signal, provide, via the display, information indicative of a position of the second electrode inside the heart;
wherein the channel is electrically coupled to the control unit such that the channel provides the second electrode.

16 more elements

A system, comprising:

a multi-component tubular system transluminally advanceable into a heart of a subject;
a first electrode configured to contact skin of the subject;
an implant, usable to change a shape of an annulus of a valve of the heart, and comprising:
a contraction wire, and
a tissue anchor comprising a coupling head and an electrically-conductive helical tissue-engaging element, wherein the tissue anchor is configured to act as a second electrode;
an anchor driver having a distal end that is reversibly couplable to the tissue anchor and configured to advance the tissue anchor through the multi-component tubular system and out of a distal end of the multi-component tubular system, and to anchor the distal helical tissue-engaging element to tissue inside the heart;
a first radiopaque marker, movable with respect to the tissue anchor and the anchor driver;
a second radiopaque marker, movable with the tissue anchor, the anchor driver, the implant, and the first radiopaque marker;
and
a control unit electrically coupled to the first electrode and the tissue anchor, the control unit comprising circuitry configured, while the first electrode is in contact with the subject and the tissue anchor is located inside the heart of the subject, to receive an electrical signal from the first electrode and the tissue anchor, and provide information indicative of a location of the tissue anchor inside the heart based on the electrical signal.

7 more elements

A system, comprising:

an implant, comprising a tissue anchor comprising:
a coupling head, and
a distal helical tissue-engaging element,
a multi-component tubular system:
comprising:
a catheter, and
a channel, slidable within the catheter, the tissue anchor being slidable through the channel,
transluminally advanceable into a heart of a subject, and
configured to deliver the implant inside the heart;
an anchor driver having a distal end that is reversibly couplable to the coupling head of the tissue anchor;
an electric motor configured to drive the anchor driver to:
drive the tissue anchor through the multi-component tubular system and out of a distal end of the multi-component tubular system, and
anchor the distal helical tissue-engaging element to tissue of the heart;
a first electrode configured to contact the subject;
a second electrode configured to be positioned inside the heart of the subject;
and
a control unit electrically coupled to the first electrode and the second electrode, the control unit comprising a display and circuitry configured, while the first electrode is in contact with the subject and the second electrode is inside the heart of the subject, to:
receive an electrical signal from the first electrode and the second electrode, and
based on the electrical signal:
provide, via the display, information indicative of a position of the second electrode inside the heart, and
via the electric motor, drive the anchor driver.

18 more elements

A system, comprising:

a multi-component tubular system transluminally advanceable into a heart of a subject;
a first electrode configured to contact skin of the subject;
an implant configured to treat a native atrioventricular valve of a patient by changing a shape of an annulus of a valve of the heart, and comprising:
a sleeve having a lumen and at least a proximal end, the proximal end being shaped so as to define an opening,
a closure element coupled to the sleeve in a vicinity of at least one end, the closure element comprising a flap having (1) an open state and (2) a closed state in which the lumen is in reduced fluid communication with outside of the sleeve compared to when the flap is in the open state, and configured to be biased toward assuming the closed state,
a contraction wire, and
a tissue anchor comprising a coupling head and an electrically-conductive helical tissue-engaging element, wherein the tissue anchor is configured to act as a second electrode;
an anchor driver having a distal end that is reversibly couplable to the tissue anchor and configured to advance the tissue anchor through the multi-component tubular system and out of a distal end of the multi-component tubular system, and to anchor the distal helical tissue-engaging element to tissue inside the heart;
and
a control unit electrically coupled to the first electrode and the tissue anchor, the control unit comprising circuitry configured, while the first electrode is in contact with the subject and the tissue anchor is located inside the heart of the subject, to receive an electrical signal from the first electrode and the tissue anchor, and provide information indicative of a location of the tissue anchor inside the heart based on the electrical signal.

7 more elements

A system, comprising:

an implant, comprising a tissue anchor comprising:
a coupling head, and
a distal helical tissue-engaging element,
a multi-component tubular system:
comprising:
a catheter, and
a channel, slidable within the catheter, the tissue anchor being slidable through the channel,
transluminally advanceable into a heart of a subject, and
configured to deliver the implant inside the heart;
an anchor driver having a distal end that is reversibly couplable to the coupling head of the tissue anchor in a manner that configures the anchor driver to:
drive the tissue anchor through the multi-component tubular system and out of a distal end of the multi-component tubular system, and
anchor the distal helical tissue-engaging element to tissue of the heart;
a first electrode configured to contact the subject;
a second electrode configured to be positioned inside the heart of the subject;
and
a control unit electrically coupled to the first electrode and the second electrode, the control unit comprising a display and circuitry configured, while the first electrode is in contact with the subject and the second electrode is inside the heart of the subject, to:
receive an electrical signal from the first electrode and the second electrode, and
based on the electrical signal, provide, via the display, information indicative of a position of the second electrode inside the heart;
wherein the control unit is further configured to provide feedback responsively to the position of the second electrode inside the heart, the feedback being selected from the group consisting of:
audio feedback and tactile feedback.

17 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/859,991Filed 27 Apr 2020 · continuation
Priority: 23 Oct 2012
Published: US 2020/0253730 A113 Aug 2020
Granted: 6 Feb 2024
Term ends: Not estimatedThe source records don’t support an estimate.

Classification33 codes

A61B 34/20
Computer-aided surgery; Manipulators or robots specially adapted for use in surgery: surgical navigation systems; Devices for tracking or guiding…
A61F 2/2436
Devices for manipulating or deploying heart valves during implantation: deployment by retracting a sheath
A61B 17/068
Surgical instruments, devices or methods: surgical staplers , e.g. containing multiple staples or clamps
A61F 2/2427
Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the…:…

Family

Application61/717,303Us provisional application · filed 23 Oct 2012
Application61/745,848Us provisional application · filed 26 Dec 2012
Application61/820,979Us provisional application · filed 8 May 2013
PCT/IL2013/050860Parent of this division · filed 23 Oct 2013
Application15/955,421Parent of this continuation · filed 17 Apr 2018
US 9,949,828 B2Parent of this division · filed 24 Apr 2018
US 2020/0253730 A1Pre-grant publication · published 13 Aug 2020
US 10,893,939 B2Parent of this continuation
Application14/437,373Parent of this division
Application15/955,421Parent of this division
US 2015/0272734 A1Published application
US 2018/0228608 A1Published application
US 11,890,190 B2This patent

From the US filing history. Foreign family members aren’t listed.