US-12622688-B2 - Methods and device for closure of a tissue defect

US12622688B2US 12622688 B2US12622688 B2US 12622688B2US-12622688-B2

Abstract

A coiled needle and deployment methods of the same are disclosed herein. The coiled needle includes a coiled body with one or more complete turns and at least one sharp end. The coiled needle may be used to close a patent foramen ovale (PFO) by advancing the coiled needle to a location adjacent to the PFO, positioning a first end of the coiled needle against tissue adjacent to the PFO, puncturing the tissue with the first end of the coiled needle, and rotating the coiled needle to advance the coiled needle through tissue of both a septum primum and a septum secundum defining the PFO. PFO closure systems and suture delivery systems including such coiled needles are further described.

Inventors

Theodore Dale
Tracee Eidenschink
Linda Cornelius
Caytlin Gale

Assignees

ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.

Dates

Publication Date: 20260512
Application Date: 20240827

Claims (16)

1 . A method of closing a patent foramen ovale (PFO), the method comprising: advancing a coiled needle to a location adjacent to the PFO; positioning a first end of the coiled needle against tissue adjacent to the PFO; puncturing the tissue with the first end of the coiled needle; and rotating the coiled needle to advance the coiled needle through tissue of both a septum primum and a septum secundum defining the PFO, wherein advancing the coiled needle to the location adjacent to the PFO comprises (i) retaining the coiled needle in a delivery configuration in a lumen of a delivery catheter, a pitch of the coiled needle in the delivery configuration being greater than a pitch of the coiled needle in a deployed configuration, (ii) positioning a distal end of the delivery catheter at the location, and (iii) advancing the coiled needle distally out of the distal end of the delivery catheter.
2 . The method of claim 1 , wherein a PFO tunnel is defined between the septum primum and the septum secundum, and wherein rotating the coiled needle to advance the coiled needle through the tissue comprises: rotating the coiled needle to advance the coiled needle through the tissue of the septum secundum and the septum primum through the PFO tunnel in an X direction that intersects the septum secundum and the septum primum.
3 . The method of claim 1 , wherein a PFO tunnel is defined between the septum primum and the septum secundum, and wherein rotating the coiled needle to advance the coiled needle through the tissue comprises: rotating the coiled needle to advance the coiled needle alternatingly through the tissue of the septum secundum and the septum primum, across the PFO tunnel in a Y direction.
4 . The method of claim 1 , wherein a PFO tunnel is defined between the septum primum and the septum secundum, and wherein rotating the coiled needle to advance the coiled needle through the tissue comprises: rotating the coiled needle to advance the coiled needle alternatingly through the tissue of the septum secundum and the septum primum, along the PFO tunnel in a Z direction.
5 . The method of claim 1 , wherein a suture is coupled to a second end of the coiled needle, the method further comprising: advancing the coiled needle beyond the tissue of the septum primum and septum secundum, said advancing drawing the suture through the tissue behind the coiled needle; decoupling the suture from the coiled needle; and withdrawing the coiled needle, leaving the suture in place in the tissue.
6 . The method of claim 1 , further comprising coupling a delivery cable to a second end of the coiled needle, wherein advancing the coiled needle distally out of the distal end of the delivery catheter comprises advancing the delivery cable distally through the delivery catheter.
7 . The method of claim 1 , wherein the coiled needle includes a hollow coiled body defining a lumen therethrough, the method further comprising: positioning a core within the coiled needle, advancing the core distally out of the distal end of the delivery catheter, and withdrawing the core from the coiled needle, leaving the coiled needle in place in the tissue at the location.
8 . A patent foramen ovale (PFO) closure system comprising: a closure device comprising a body extending between a first end and a second end, the body having a coiled shape comprising more than one complete turn, wherein at least one of the first end or the second end is a sharp point configured to puncture tissue at a target site within anatomy of a patient; and a delivery device configured to deliver the closure device to the PFO, wherein the closure device has a delivery configuration in which the closure device is retained in a lumen of the delivery device, and a deployed configuration in which the closure device is not retained in the lumen of the delivery device, a pitch of the closure device in the delivery configuration being greater than a pitch of the closure device in the deployed configuration.
9 . The PFO closure system of claim 8 , wherein the closure device body comprises more than three complete turns.
10 . The PFO closure system of claim 8 , wherein each turn of the closure device body is concentric with each other turn of the body.
11 . The PFO closure system of claim 8 , wherein the closure device body is flattened such that a respective plane of each turn of the body only partially overlaps a plane of an adjacent turn.
12 . The PFO closure system of claim 8 , wherein the first end of the closure device is the sharp point, the PFO closure system further comprising a suture material coupled to the second end to the closure device.
13 . A suture delivery system comprising: a coiled tube comprising a hollow coiled body defining a lumen therethrough, a first end, and a second end, the first end comprising a sharp point configured to puncture tissue at a target site within anatomy of a patient; and a delivery catheter configured to advance the coiled tube to the target site, wherein the coiled tube has a delivery configuration in which the coiled tube is retained in a lumen of the delivery catheter, and a deployed configuration in which the coiled tube is not retained in the lumen of the delivery catheter, a pitch of the coiled tube in the delivery configuration being greater than a pitch of the coiled tube in the deployed configuration.
14 . The suture delivery system of claim 13 , further comprising a suture material within the lumen of the coiled tube.
15 . The suture delivery system of claim 14 , the suture material comprising an anchoring component at a distal end thereof.
16 . The suture delivery system of claim 13 , wherein the coiled tube is formed from a polymeric material.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63/583,493, filed on Sep. 18, 2023, the entire contents of which are hereby incorporated by reference herein. BACKGROUND OF THE DISCLOSURE A. Field of Disclosure The present disclosure relates generally to medical devices that are used in the human body and methods of operating the same. In particular, the present disclosure is directed to a medical device for closure of a tissue defect, such as an atrial tissue defect, and methods of operating and deploying the same. B. Background An occluding device (or “occluder”) is a medical device used to treat tissue at a target site within the human body, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, a lumen, or the like. For example, an occluder may be used for treating atrial septal defects (ASDs). Atrial septal defects are common congenital heart defects that allow blood to flow between the left and right atria of the heart, decreasing cardiac output. Although ASDs come in many forms, one example type of ASD is conventionally referred to as a patent foramen ovale, or PFO. In PFOs, a tunnel within the atrial tissue is formed, such as during fetal development, between the left and right atria. PFOs may vary in severity from generally benign to those warranting surgical intervention, such as via implantation of an occluding device, which may be implanted in the heart to repair the PFO. In addition to PFO interventions, other percutaneous procedures are becoming more prevalent in surgical practice as well, including those for treating a variety of atrial septal defects, including as described above, but not limited to, PFOs. Conventional devices for closing ASDs include, for example, occlusive devices formed from a braided mesh material. However, future surgical access to left and/or right atria of the heart may be limited or otherwise made more difficult by the implantation of these braided occluding devices. In addition, implantation of some known occluders and other ASD treatment devices may also, in some cases, result in erosion of surrounding tissue and/or other disruption to the conduction system of the heart. Accordingly, it would be desirable to close an ASD, such as a PFO, with an alternate closure device or system. SUMMARY OF THE DISCLOSURE The present disclosure is directed to a method of closing a patent foramen ovale (PFO), the method including: (i) advancing a coiled needle to a location adjacent to the PFO, (ii) positioning a first end of the coiled needle against tissue adjacent to the PFO, (iii) puncturing the tissue with the first end of the coiled needle, and (iv) rotating the coiled needle to advance the coiled needle through tissue of both a septum primum and a septum secundum defining the PFO. The present disclosure is also directed to a PFO closure system including a closure device including a body extending between a first end and a second end, the body having a coiled shape including more than one complete turn. At least one of the first end or the second end is a sharp point configured to puncture tissue at a target site within anatomy of a patient. The PFO closure system also includes a delivery device for delivering the closure device to the PFO. Additionally, a suture delivery system as described herein includes a coiled tube having a hollow coiled body defining a lumen therethrough, a first end, and a second end, the first end including a sharp point configured to puncture tissue at a target site within anatomy of a patient. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a simplified diagram of a patent foramen ovale (PFO). FIG. 2 is a schematic view of an exemplary embodiment of a delivery system for deploying a medical device. FIGS. 3A and 3B depict a side view and a top view, respectively, of a first embodiment of a medical device, and FIGS. 3C-3E depict alternative embodiments of the medical device. FIG. 4 depicts the medical device shown in FIGS. 3A and 3B deployed through a simulated PFO. FIG. 5 depicts a perspective view of a second embodiment of a medical device. FIG. 6 depicts the medical device shown in FIG. 5 deployed across a simulated PFO. FIG. 7 illustrates a plurality of medical devices in accordance with the present disclosure, one medical device being deployed across a PFO in a first position and another medical device being deployed across an atrial septal aneurysm adjacent the PFO. FIG. 8 depicts the medical device deployed across the PFO shown in FIG. 7, the medical device being deployed across the PFO in a second position. FIGS. 9A and 9B schematically depict two side views of a medical device deployed along a PFO tunnel. FIG. 10 depicts a medical device in accordance with the present disclosure including a coiled needle and a suture coupled thereto. FIG. 11 illustrates a method of closing a PFO using the medical device shown in FIG. 10. FIG.