Apparatus for anchoring a ventricular assist system in a blood vessel, operating method, production method for producing an apparatus and ventricular assist system

Patent metadata

Field	Value
Publication number	US-12403296-B2
Application number	US-201917057420-A
Country	US
Kind code	B2
Filing date	May 30, 2019
Priority date	May 30, 2018
Publication date	Sep 2, 2025
Grant date	Sep 2, 2025

Abstract

The invention relates to an apparatus ( 100 ) for anchoring a ventricular assist system in a blood vessel, the apparatus ( 100 ) being able to assume an insertion state for insertion of the ventricular assist system into the blood vessel, and the apparatus ( 100 ) being able to assume an anchoring state in order to anchor the ventricular assist system in the blood vessel. The apparatus ( 100 ) has at least one fixing means ( 105 ) for fixing the apparatus ( 100 ) to the ventricular assist system ( 205 ), a crown ( 110 ) and a connection means ( 115 ). The crown ( 110 ) is formed from at least one unfolding element ( 120 ). The unfolding element ( 120 ) is designed to unfold during the transfer from the insertion state into the anchoring state in order to enlarge the diameter of the crown ( 110 ) so as to anchor the apparatus ( 100 ) in the blood vessel. The connection means ( 115 ) is designed to connect the crown ( 110 ) to the fixing means ( 105 ).

First claim

The invention claimed is:

1. An apparatus for anchoring a cardiac support system in a blood vessel, the apparatus comprising:
a fixing component configured to fix to the cardiac support system;
a ring-shaped crown, wherein a diameter of the ring-shaped crown is configured to increase during a transition of the apparatus from an insertion state into an anchoring state so as to anchor the cardiac support system in the blood vessel, wherein the apparatus is configured to assume the insertion state for inserting the cardiac support system into the blood vessel and to assume the anchoring state for anchoring the cardiac support system in the blood vessel;
a sleeve being movably displaceable relative to the crown during the transition from the insertion state into the anchoring state so as to allow the crown to unfold; and
a connection component configured to connect the crown to the fixing component, the connection component comprising a plurality of flexure struts configured to unfold in response to displacement of the sleeve, wherein each flexure strut of the plurality of flexure struts comprises a first end coupled to the fixing component,
wherein the ring-shaped crown comprises a plurality of unfolding elements configured to unfold during the transition of the apparatus from the insertion state into the anchoring state so as to increase the diameter of the crown,
wherein each unfolding element comprises two unfolding rods connected to one another at their ends,
wherein the plurality of unfolding elements connect to one another along a circular path, wherein a central section of each unfolding rod of each unfolding element is connected at a connection point to a central section of an adjacent unfolding rod of an adjacent unfolding element,
wherein each unfolding rod is disposed closer to each adjacent unfolding rod in the insertion state than in the anchoring state, wherein each of the plurality of flexure struts comprises a second end connected to the connection point of two unfolding rods of adjacent unfolding elements or to a connection at the ends of two unfolding rods of one of the unfolding elements at an end of the crown opposite the fixing component, and
wherein the sleeve is configured to enclose the crown in the insertion state and is configured to release the crown so as to initiate the transition from the insertion state into the anchoring state.

2. The apparatus according to claim 1 , wherein the unfolding elements are made of a shape memory material.

3. The apparatus according to claim 1 , further comprising an arching device comprising at least one foot, wherein the arching device is configured to unfold during the transition from the insertion state into the anchoring state so as to position the at least one foot in the blood vessel, and wherein the arching device is connected to the crown or the arching device comprises an arch fixing device for fixing the arching device to the cardiac support system.

4. The apparatus according to claim 3 , wherein the at least one foot comprises three feet, wherein each of the three feet are configured to be positioned in a cusp of a heart valve.

5. The apparatus according to claim 1 , wherein the apparatus is cylindrical in the insertion state.

6. The apparatus according to claim 1 , wherein the crown and the fixing component extend along a longitudinal axis, and wherein each of the plurality of unfolding elements is configured to be positioned in an inclined position relative to the longitudinal axis of the apparatus in the anchoring state.

7. The apparatus according to claim 1 , wherein the fixing component is configured to fix the apparatus to the cardiac support system in a form-locking and/or force-locking manner.

8. A method for producing an apparatus for anchoring a cardiac support system in a blood vessel, the method comprising:
providing a semi-finished product made of a shape memory material;
forming a fixing component, a ring-shaped crown and a connection component from the semi-finished product; and
heat treating the fixing component, the crown and the connection component in order to emboss a shape of the anchoring state;
wherein the fixing component is configured to fix to the cardiac support system,
wherein a diameter of the ring-shaped crown is configured to increase during a transition of the apparatus from an insertion state into an anchoring state so as to anchor the cardiac support system in the blood vessel, wherein the apparatus is configured to assume the insertion state for inserting the cardiac support system into the blood vessel and to assume the anchoring state for anchoring the cardiac support system in the blood vessel,
wherein the apparatus further comprises a sleeve being movably displaceable relative to the crown during the transition from the insertion state into the anchoring state so as to allow the crown to unfold,
wherein the connection component is configured to connect the crown to the fixing component, the connection component comprising a plurality of flexure struts configured to unfold in response to displacement of the sleeve, wherein each flexure strut of the plurality of flexure struts comprises a first end coupled to the fixing component,
wherein the ring-shaped crown comprises a plurality of unfolding elements configured to unfold during the transition of the apparatus from the insertion state into the anchoring state so as to increase the diameter of the crown,
wherein each unfolding element comprises two unfolding rods connected to one another at their ends,
wherein the plurality of unfolding elements connect to one another along a circular path, wherein a central section of each unfolding rod of each unfolding element is connected at a connection point to a central section of an adjacent unfolding rod of an adjacent unfolding element,
wherein each unfolding rod is disposed closer to each adjacent unfolding rod in the insertion state than in the anchoring state, wherein each of the plurality of flexure struts comprises a second end connected to the connection point of two unfolding rods of adjacent unfolding elements or to a connection at the ends of two unfolding rods of one of the unfolding elements at an end of the crown opposite the fixing component, and
wherein the sleeve is configured to enclose the crown in the insertion state and is configured to release the crown so as to initiate the transition from the insertion state into the anchoring state.

9. The method according to claim 8 , wherein the apparatus further comprises an arching device comprising at least one foot, wherein the arching device is configured to unfold during the transition from the insertion state into the anchoring state so as to position the at least one foot in the blood vessel, and wherein the arching device is connected to the crown or the arching device comprises an arch fixing device for fixing the arching device to the cardiac support system.

10. The method according to claim 8 , wherein the fixing component is configured to fix the apparatus to the cardiac support system in a form-locking and/or force-locking manner.

Assignees

• Kardion Gmbh

Inventors

• Baumbach Hardy
• Schuelke Armin
• Schellenberg Inga
• Minzenmay David

Classifications

• A61M60/183

  drawing blood from both ventricles, e.g. bi-ventricular assist devices [BiVAD] · CPC title

• A61M60/216 Primary

  including a rotating member acting on the blood, e.g. impeller · CPC title

• A61M60/178

  drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices · CPC title

• A61M2205/0266

  Shape memory materials · CPC title

• A61M60/861

  Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body · CPC title