US-12616478-B2 - Magnetic compression anastomosis devices with multipiece internal vertebrae support structures

US12616478B2US 12616478 B2US12616478 B2US 12616478B2US-12616478-B2

Abstract

A magnetic compression anastomosis device comprises a first multipiece internal vertebrae support structure including a first set of magnets attached to an outward-facing side of the first multipiece internal vertebrae support structure; and a second multipiece internal vertebrae support structure including a second set of magnets attached to an outward-facing side of the second multipiece internal vertebrae support structure, wherein the first and second multipiece internal vertebrae support structures are attached together in a sandwich configuration with an inward-facing side of the first multipiece internal vertebrae support structure facing an inward-facing side of the second multipiece internal vertebrae support structure and the magnets on the outward-facing sides of the magnetic compression anastomosis device.

Inventors

Dane T. Seddon

Assignees

G.I. WINDOWS, INC.

Dates

Publication Date: 20260505
Application Date: 20230803

Claims (20)

1 . A magnetic compression anastomosis device comprising: a first multipiece internal vertebrae support structure including a first set of magnets attached to an outward-facing side of the first multipiece internal vertebrae support structure; and a second multipiece internal vertebrae support structure including a second set of magnets attached to an outward-facing side of the second multipiece internal vertebrae support structure, wherein the first and second multipiece internal vertebrae support structures are mechanically attached together in a sandwich configuration with an inward-facing side of the first multipiece internal vertebrae support structure facing an inward-facing side of the second multipiece internal vertebrae support structure and the first and second sets of magnets on the outward-facing sides of the magnetic compression anastomosis device.
2 . The device of claim 1 , wherein the first and second multipiece internal vertebrae support structures are mechanically attached together by welding.
3 . The device of claim 1 , wherein the first and second multipiece internal vertebrae support structures are mechanically attached together by bonding.
4 . The device of claim 1 , wherein the first and second multipiece internal vertebrae support structures are mechanically attached together by swaging.
5 . The device of claim 1 , wherein the first and second multipiece internal vertebrae support structures are mechanically attached together by stamping.
6 . The device of claim 1 , wherein each magnet has a north pole and a south pole, and wherein all of the north poles face outward such that both sides of the magnetic compression anastomosis device have all north-polarity magnets.
7 . The device of claim 1 , wherein each magnet has a north pole and a south pole, and wherein all of the south poles face outward such that both sides of the magnetic compression anastomosis device have all south-polarity magnets.
8 . The device of claim 1 , with the magnets are attached to the first and second multipiece internal vertebrae support structures using an adhesive.
9 . The device of claim 1 , with the magnets are attached to the first and second multipiece internal vertebrae support structures using mechanical fasteners.
10 . The device of claim 1 , with the magnets are attached to the first and second multipiece internal vertebrae support structures using clamps.
11 . The device of claim 1 , with the magnets are attached to the first and second multipiece internal vertebrae support structures using interlocking elements.
12 . The device of claim 1 , further comprising: at least one flex element biasing the first and second multipiece internal vertebrae support structures toward an assembled configuration.
13 . The device of claim 12 , wherein the assembled configuration is a circle.
14 . The device of claim 13 , wherein the assembled configuration is a polygon.
15 . The device of claim 1 , wherein each of the first and second multipiece internal vertebrae support structures includes a plurality of interconnected internal vertebra pieces having a male end opposite a female end, with ends of opposing genders configured for interlocking and joining pieces together.
16 . The device of claim 15 , wherein interconnected individual internal vertebra pieces are connected by a bolt.
17 . The device of claim 15 , wherein interconnected individual internal vertebra pieces are connected by a rivet.
18 . The device of claim 15 , wherein interconnected individual internal vertebra pieces are connected by a fastener.
19 . The device of claim 15 , wherein the connection between interconnected individual internal vertebra pieces is configured to allow rotation along an axis while also restricting tortional motion.
20 . The device of claim 1 , wherein the first and second multipiece internal vertebrae support structures are formed of metal alloy, polymer, and/or composite.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S) This patent application claims the benefit of U.S. Provisional Patent Application No. 63/400,904 entitled SUPPORT FOR MAGNETIC SEGMENTS OF A MAGNETIC ANASTOMOSIS DEVICE filed Aug. 25, 2022, which is hereby incorporated herein by reference in its entirety. FIELD OF INVENTION The invention relates to deployable magnetic compression devices, and, more particularly, to systems, devices, and methods for the delivery, deployment, and positioning of magnetic compression devices at a desired site so as to improve the accuracy of anastomoses creation between tissues, organs, or the like. BACKGROUND Bypasses of the gastroenterological (GI), cardiovascular, or urological systems are typically formed by cutting holes in tissues at two locations and joining the holes with sutures or staples. A bypass is typically placed to route fluids (e.g., blood, nutrients) between healthier portions of the system, while bypassing diseases or malfunctioning tissues. The procedure is typically invasive, and subjects a patient to risks such as bleeding, infection, pain, and adverse reaction to anesthesia. Additionally, a bypass created with sutures or staples can be complicated by post-operative leaks and adhesions. Leaks may result in infection or sepsis, while adhesions can result in complications such as bowel strangulation and obstruction. While traditional bypass procedures can be completed with an endoscope, laparoscope, or robot, it can be time consuming to join the holes cut into the tissues. Furthermore, such procedures require specialized expertise and equipment that is not available at many surgical facilities. As an alternative to sutures or staples, surgeons can use mechanical couplings or magnets to create a compressive anastomosis between tissues. For example, compressive couplings or paired magnets can be delivered to tissues to be joined. Because of the strong compression, the tissue trapped between the couplings or magnets is cut off from its blood supply. Under these conditions, the tissue becomes necrotic and degenerates, and at the same time, new tissue grows around points of compression, e.g., on the edges of the coupling. With time, the coupling can be removed, leaving a healed anastomosis between the tissues. Nonetheless, the difficulty of placing the magnets or couplings limits the locations that compressive anastomosis can be used. In most cases, the magnets or couplings have to be delivered as two separate assemblies, requiring either an open surgical field or a bulky delivery device. For example, existing magnetic compression devices are limited to structures small enough to be deployed with a delivery conduit e.g., an endoscopic instrument channel or laparoscopic port. When these smaller structures are used, the formed anastomosis is small and suffers from short-term patency. Furthermore, placement of the magnets or couplings can be imprecise, which can lead to anastomosis formation in locations that is undesirable or inaccurate. Thus, there still remains a clinical need for reliable devices and minimally-invasive procedures that facilitate compression anastomosis formation between tissues in the human body. SUMMARY During the deployment of a self-forming magnetic array, control of the individual magnetic pieces is critical. Limiting the degrees of freedom to a specific set of parameters provides durability as well as improved geometric shape control. When connecting two separate magnets it is also important that the geometric shapes align to produce a compression region with high enough pressure to shut down fluidic exchange to the tissue in the inner periphery of the geometric shape created by the self-forming array. An embodiment of the present invention utilizes independent magnets connected by a multipiece vertebrae design. Prior innovations utilize a single formed piece of alloy to create the support. The present invention utilizes individual flex segments which connect to flexing armatures, a vertebrae casing, and either a “roller” or an integrated “rolling node” to limit degrees of freedom during formation and increase durability. During coupling of two magnetic arrays, the ability to sense the mating array is more easily done with a single magnetic pole face. An embodiment of the invention provides for an internal skeleton that forces the same pole faces together. More particularly, in accordance with one embodiment of the invention, a magnetic compression anastomosis device comprises a first multipiece internal vertebrae support structure including a first set of magnets attached to an outward-facing side of the first multipiece internal vertebrae support structure; and a second multipiece internal vertebrae support structure including a second set of magnets attached to an outward-facing side of the second multipiece internal vertebrae support structure, wherein the first and second multipiece internal vertebrae support structures are attached together in