US-12616477-B2 - Pressure profile magnetic compression anastomosis devices

Abstract

Compression anastomosis devices having a plurality of distinct pressure profile zones on the surface of the device. The anastomosis devices may be comprised of a plurality of magnetic connecting members arranged in an annular geometry, e.g., a polygon or circle. The anastomosis device may also be a continuous, non-segmented magnet, or other compression anastomosis device. The compression anastomosis device is deployed into a body lumen, e.g., endoscopically and/or laparoscopically, at a target site. A second compression anastomosis device is placed at an adjacent target site in an adjacent lumen. The compression anastomosis devices are brought together and mate, e.g., magnetically, creating an anastomosis.

Inventors

• Peter F. Sugar
• Dane T. Seddon

Assignees

• G.I. WINDOWS, INC.

Dates

Publication Date

20260505

Application Date

20240807

Claims (20)

1. 1 . A magnetic compression anastomosis device comprising: a plurality of magnetic connecting members configured to assemble into a magnetic compression anastomosis device having a tissue-engaging face composed of face portions of the plurality of magnetic connecting members, the tissue-engaging face including a plurality of distinct pressure profile zones selected from the group consisting of a cutting zone, a fast release zone, a tissue fusion zone, a relief zone, and a securing zone, wherein each distinct pressure profile zone is configured to generate pressure within a predetermined pressure range, and wherein the pressure ranges of the plurality of distinct pressure profile zones are configured to decrease radially outward from an inner diameter to an outer diameter of the magnetic compression anastomosis device.
2. 2 . A device according to claim 1 , wherein the magnetic connecting members are configured to form an annular magnetic compression anastomosis device.
3. 3 . A device according to claim 1 , wherein the magnetic connecting members are configured to self-assemble into the magnetic compression anastomosis device.
4. 4 . A device according to claim 1 , wherein each of the magnetic connecting members includes a plurality of distinct pressure profile zones that collectively form the composite tissue-engaging face when the plurality of magnetic connecting members assemble into the magnetic compression anastomosis device.
5. 5 . A device according to claim 1 , wherein: the relief zone is capable of generating pressure between around 0 psi to around 25 psi on body tissues; the tissue fusion zone is capable of generating between around 25 psi to around 250 psi on body tissues; the fast release zone is capable of generating between around 250 psi to around 40,000 psi on body tissues; and the cutting zone is capable of generating between around 40,000 psi to around 75,000 psi on body tissues.
6. 6 . A device according to claim 1 , wherein at least one of: the securing zone has a knurled or cross-hatched geometric profile; or the cutting zone comprises an angled cutting pressure profile.
7. 7 . A device according to claim 1 , wherein a geometric profile of at least one of the distinct pressure profile zones is non-uniform and non-linear.
8. 8 . A device according to claim 1 , wherein the plurality of distinct pressure profile zones includes at least three distinct pressure profile zones.
9. 9 . A device according to claim 2 , wherein the annular magnetic compression anastomosis device comprises a polygon or circle geometry.
10. 10 . A system comprising: a first magnetic compression anastomosis device according to claim 1 ; and a second device configured to magnetically engage with the first magnetic compression anastomosis device.
11. 11 . A system according to claim 10 , wherein the magnetic connecting members are configured to form an annular magnetic compression anastomosis device.
12. 12 . A system according to claim 10 , wherein the magnetic connecting members are configured to self-assemble into the magnetic compression anastomosis device.
13. 13 . A system according to claim 10 , wherein each of the magnetic connecting members includes a plurality of distinct pressure profile zones that collectively form the composite tissue-engaging face when the plurality of magnetic connecting members assemble into the magnetic compression anastomosis device.
14. 14 . A system according to claim 10 , wherein: the relief zone is capable of generating pressure between around 0 psi to around 25 psi on body tissues; the tissue fusion zone is capable of generating between around 25 psi to around 250 psi on body tissues; the fast release zone is capable of generating between around 250 psi to around 40,000 psi on body tissues; and the cutting zone is capable of generating between around 40,000 psi to around 75,000 psi on body tissues.
15. 15 . A system according to claim 10 , wherein at least one of: the securing zone has a knurled or cross-hatched geometric profile; or the cutting zone comprises an angled cutting pressure profile.
16. 16 . A system according to claim 10 , wherein a geometric profile of at least one of the distinct pressure profile zones is non-uniform and non-linear.
17. 17 . A system according to claim 10 , wherein the plurality of distinct pressure profile zones includes at least three distinct pressure profile zones.
18. 18 . A system according to claim 11 , wherein the annular magnetic compression anastomosis device comprises a polygon or circle geometry.
19. 19 . A system according to claim 10 , wherein the first and second devices have the same pressure profile configurations.
20. 20 . A system according to claim 10 , wherein the first and second devices have different but complementary pressure profile configurations.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S) This patent application is a continuation-in-part of U.S. patent application Ser. No. 18/241,529 entitled PRESSURE PROFILE MAGNETIC COMPRESSION ANASTOMOSIS DEVICES filed Sep. 1, 2023, which claims the benefit of U.S. Provisional Patent Application No. 63/403,181 entitled MAGNETIC ANASTOMOSIS DEVICES WITH VARYING MAGNETIC FORCE AT A DISTANCE filed Sep. 1, 2022, each of 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. Tissues of different thicknesses require different pressures to puncture the tissues and/or bring magnetic anastomosis devices close enough together to mate. Sharp pressure profiles may cause abrupt transitions between healthy and necrotic tissues, which can cause poor sealing of the anastomosis. 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 in as few steps as possible. SUMMARY In accordance with one embodiment, a magnetic compression anastomosis device comprises at least one magnetic member that forms an annular shape including a tissue-engaging surface comprising a plurality of distinct pressure profile zones selected from the group consisting of a cutting zone, a fast release zone, a tissue fusion zone, a relief zone, and a securing zone. In various alternative embodiments, the relief zone is capable of generating pressure between around 0 psi to around 25 psi on body tissues; the tissue fusion zone is capable of generating between around 25 psi to around 250 psi on body tissues; the fast release zone is capable of generating between around 250 psi to around 40,000 psi on body tissues; and the cutting zone is capable of generating between around 40,000 psi to around 75,000 psi on body tissues. The plurality of distinct pressure profile zones may include an inner cutting zone; a fast response zone adjacent to the inner cutting zone; a tissue fusion zone adjacent to the fast response zone; and a relief zone adjacent to the tissue fusion zone. The securing zone may include a knurled or cross-hatched geometric profile. A geometric profile of at least one of the distinct pressure profile zones may be non-uniform and non-linear. The