US-20260123934-A1 - OCCLUDER STABILIZING MEMBERS

US20260123934A1US 20260123934 A1US20260123934 A1US 20260123934A1US-20260123934-A1

Abstract

A medical device including stabilizing members and a delivery system including the same are described herein. The medical device includes a device body and the stabilizing members coupled thereto. Each stabilizing member has a backing portion coupled to the device body and an engagement portion extending from an outward face of the backing portion. The engagement portion is configured to extend radially outward from the device body. The medical device also includes one or more features configured to control at least one of tissue penetration depth of the at least one engagement portion, extension of the stabilizing member from the device body, and tissue engagement of the at least one engagement portion. The delivery system includes the medical device and a delivery sheath configured to retain and recapture the medical device during deployment to a target site.

Inventors

Kristen Morin
Trevor Springer
Andrey Samaray
Linda Cornelius
Tracee Eidenschink
Yiru WANG
Christian Elmquist
Sam S. Leutbounshu
Gary Erzberger

Assignees

ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.

Dates

Publication Date: 20260507
Application Date: 20251230

Claims (20)

1 . An occluder for occluding a left atrial appendage (“LAA”), the occluder comprising: a proximal disc and a distal lobe connected to the proximal disc, the proximal disc and the distal lobe being formed of a braided mesh fabric, the braided mesh fabric being formed from a plurality of strands braided together, the plurality of strands being formed of a shape memory material; and a stabilizing member including a proximal U-shaped backing portion, a first leg and a second leg each having a base coupled to the proximal U-shaped backing portion and extending distally from the proximal U-shaped backing portion, a first hooked end at a distal end of the first leg and a second hooked end at a distal end of the second leg, the first and second hooked ends having free ends pointing proximally toward the proximal U-shaped backing portion; wherein a first loop extends radially inwardly from the first leg between the base of the first leg and the distal end of the first leg, the first loop forming a first eyelet, and a second loop extends radially inwardly from the second leg between the base of the second leg and the distal end of the second leg, the second loop forming a second eyelet; wherein the stabilizing member is coupled to the distal lobe so that (i) the backing portion is positioned external to the braided mesh fabric of the distal lobe, (ii) the first hooked end and the second hooked end are positioned external to the braided mesh fabric of the distal lobe, and (iii) an entirety of the first eyelet is positioned interior to the braided mesh fabric of the distal lobe and an entirety of the second eyelet is positioned interior to the braided mesh fabric of the distal lobe, the first eyelet being sewn to the braided mesh fabric of the distal lobe by at least one first stitch, the second eyelet being sewn to the braided mesh fabric of the distal lobe by at least one second stitch.
2 . The occluder of claim 1 , wherein the stabilizing member includes a plurality of stabilizing members.
3 . The occluder of claim 2 , wherein the plurality of stabilizing members are coupled to the distal lobe so that a first group of the plurality of stabilizing members is arranged in a first row, and a second group of the plurality of stabilizing members is arranged in a second row, the second row being axially offset from the first row.
4 . The occluder of claim 3 , wherein the plurality of stabilizing members are coupled to the distal lobe so that a third group of the plurality of stabilizing members is arranged in a third row, the third row being axially offset from both the first row and the second row.
5 . The occluder of claim 2 , wherein the plurality of stabilizing members are each formed from a laser cut sheet of material.
6 . The occluder of claim 5 , wherein the material is nitinol.
7 . The occluder of claim 5 , wherein, for each of the plurality of stabilizing members, the first hooked end terminates in a first tip, and the second hooked end terminates in a second tip, the first tip being rounded, and the second tip being rounded.
8 . The occluder of claim 7 , wherein the rounded first tip and the rounded second tip are formed by electropolishing.
9 . The occluder of claim 2 , wherein, for each of the plurality of stabilizing members, the first hooked end forms a first recess angle with respect to the distal end of the first leg so that the first hooked end does not extend linearly from the distal end of the first leg, and the second hooked end forms a second recess angle with respect to the distal end of the second leg so that the second hooked end does not extend linearly from the distal end of the second leg.
10 . The occluder of claim 9 , wherein, for each of the plurality of stabilizing members, the first hooked end extends radially inwardly adjacent a first transition point between the distal end of the first leg and a proximal end of the first hooked end, and the second hooked end extends radially inwardly adjacent a second transition point between the distal end of the second leg and a proximal end of the second hooked end.
11 . The occluder of claim 2 , wherein, for each of the plurality of stabilizing members, the proximal U-shaped backing portion defines a first transition point where a first side of the proximal U-shaped backing portion meets a proximal end of the first leg, and a second transition point where a second side of the proximal U-shaped backing portion meets a proximal end of the second leg.
12 . The occluder of claim 11 , wherein, for each of the plurality of stabilizing members, the proximal U-shaped backing portion extends radially outwardly relative to the first leg and the second leg between the first transition point and the second transition point.
13 . A medical device system comprising: the occluder of claim 1 ; and a delivery sheath configured to retain and recapture the occluder during deployment of the occluder to the LAA.
14 . The medical device system of claim 13 , wherein the stabilizing member includes a plurality of stabilizing members.
15 . The medical device system of claim 14 , wherein, for each of the plurality of stabilizing members, the first hooked end forms a first recess angle with respect to the distal end of the first leg so that the first hooked end does not extend linearly from the distal end of the first leg, and the second hooked end forms a second recess angle with respect to the distal end of the second leg so that the second hooked end does not extend linearly from the distal end of the second leg.
16 . The medical device system of claim 15 , wherein, for each of the plurality of stabilizing members, the first hooked end extends radially inwardly adjacent a first transition point between the distal end of the first leg and a proximal end of the first hooked end, and the second hooked end extends radially inwardly adjacent a second transition point between the distal end of the second leg and a proximal end of the second hooked end.
17 . The medical device system of claim 16 , wherein, for each of the plurality of stabilizing members, the first recess angle of the first hooked end and the second recess angle of the second hooked end reduce force required to recapture the occluder back into the delivery sheath.
18 . The medical device system of claim 14 , wherein the plurality of stabilizing members are each formed from a laser cut sheet of material.
19 . The medical device system of claim 18 , wherein, for each of the plurality of stabilizing members, the first hooked end terminates in a first tip, and the second hooked end terminates in a second tip, the first tip being rounded, and the second tip being rounded.
20 . The medical device system of claim 19 , wherein the first rounded tip and the second rounded tip of each of the plurality of stabilizing members are configured to allow the occluder to be recaptured back into the delivery sheath without the first tip or the second tip damaging the delivery sheath.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 17/684,183, filed Mar. 1, 2022, which claims the benefit of priority to U.S. Prov. Pat. App. No. 63/156,093 filed Mar. 3, 2021, the disclosures of which are hereby incorporated by reference herein in their entireties. BACKGROUND OF THE DISCLOSURE A. Field of Disclosure The present disclosure relates generally to medical devices that are used in the human body. In particular, the present disclosure is directed to stabilizing members incorporated into medical devices that are delivered to a target site within the human body. More specifically, the present disclosure is directed to stabilizing members that may reduce damage to cardiac tissue and for which tissue penetration depth can be controlled. B. Background A wide variety of medical devices are used to treat any target site, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, or the like, located anywhere in the body. Some conventional medical devices include conventional wires 12 (FIG. 1), which extend outward from a body of the medical device. The presence of stabilizing members (formed from wire or other materials described herein) as an alternative to conventional wires 12 may decrease the risk of the medical device migrating from its deployed location over time. Once medical devices with conventional wires 12 are deployed, the length of the conventional wires 12 may provide adequate engagement of surrounding tissue and prevent the device from becoming dislodged. In some instances however, the curve of the wire (absent any additional depth control feature or component) may provide less than desired control over penetration depth into the tissue. Specifically, the conventional wires 12 may penetrate the tissue too deeply in some cases and cause problematic issues such as cardiac tissue damage and pericardial effusion. For example, left atrial appendage (LAA) closure devices have gained traction in the treatment of patients with atrial fibrillation. Some conventional wire designs include two wire legs connected in a U shape, each with a hook at the distal aspect (FIG. 2 and FIG. 3). The conventional wire is attached to the braid with a suture stitch on each leg. In some conventional designs, conventional wires 12 may be relatively long and if their penetration depth into the tissue is not adequately controlled, the wire legs may be able to slide through the stitch and overextend outward from a lobe of the device body, such as if the lobe of the device body is compressed axially (FIG. 2). Inadequate control over tissue penetration depth can potentially cause perforation of the LAA, which may cause pericardial effusion or tamponade. SUMMARY OF THE DISCLOSURE In one embodiment, the present disclosure is directed to a medical device for treating a target site. The medical device includes a device body including at least one disc formed from a shape memory material, and a plurality of stabilizing members coupled to the device body. Each stabilizing member includes a backing portion coupled to the device body, an engagement portion extending from an outward face of the backing portion, and one or more features configured to control at least one of tissue penetration depth of the at least one engagement portion, extension of the stabilizing member from the device body, and tissue engagement of the at least one engagement portion. The engagement portion extends radially outward from the device body. In another embodiment, the present disclosure is directed to a delivery system including a medical device and a delivery sheath. The medical device includes a device body including at least one disc formed from a shape memory material, and a plurality of stabilizing members coupled to the device body. Each stabilizing member includes a backing portion coupled to the device body, and an engagement portion extending from an outward face of the backing portion. The engagement portion extends radially outward from the device body. The medical device also includes one or more features configured to control at least one of tissue penetration depth of the at least one engagement portion, extension of the stabilizing member from the device body, and tissue engagement of the at least one engagement portion. The delivery sheath is configured to retain and recapture the medical device during deployment of the medical device to a target site. In yet another embodiment, the present disclosure is directed to a method of attaching a stabilizing member to a medical device. The method comprises injection molding the stabilizing member directly to a device body of the medical device such that an engagement portion of the stabilizing member extends radially outward from the device body. The foregoing and other aspects, features, details, utilities and advantages of the present disclosure will be apparent from reading the following d