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EP-4736813-A1 - MANUFACTURING METHOD FOR A MEDICAL IMPLANTABLE DEVICE AND A MEDICAL IMPLANTABLE DEVICE AND BASE BODY FOR SUCH IMPLANTABLE DEVICE

EP4736813A1EP 4736813 A1EP4736813 A1EP 4736813A1EP-4736813-A1

Abstract

A method for forming a braided tubular base body for a medical implantable device is disclosed. The method comprises providing a braiding head having form elements, and a plurality of bobbins. The method comprises providing a plurality of first-stage wires and forming a plurality of first-stage apices. The method comprises providing a plurality of second-stage wires and forming a plurality of second-stage apices. Each second-stage apex is located between two adjacent first-stage apices. The method further comprises braiding such a tubular base body for a medical implant , as well as medical implants made from such braided tubular base body and corresponding manufacturing methods for medical implants based on such a braided tubular base body .

Inventors

  • SOYUTEMIZ, Secil
  • ISILKI, Cansel
  • Karaman, Ugur
  • Çavusolu, Olcay

Assignees

  • OCCLUTECH GmbH

Dates

Publication Date
20260506
Application Date
20231229

Claims (15)

  1. A method of forming a medical implantable device having a channel, the method comprising: - providing a braided tubular base body (300) formed of interwoven wires; - inserting the braided tubular base body (300) into a mold structure (208); - inserting a peg (210) through the braided tubular base body (300) while the braided tubular base body (300) is positioned in the mold structure (208), such that the peg (210) passes through interspaces between the wires of the braided tubular base body (300); and - heat setting the braided tubular base body (300) in the mold structure (208) with the peg (210) inserted, thereby forming a medical implantable device (400) having a channel (410) defined by the peg (210).
  2. The method of claim 1, wherein the peg (210) is inserted after formation of the braided tubular base body (300).
  3. The method of claim 1 or 2, wherein the peg (210) is inserted while the braided tubular base body (300) is positioned in the mold structure (208).
  4. The method of any one of claims 1 to 3, wherein the peg (210) defines a final geometry of the channel (410) during the heat-setting step.
  5. The method of any one of claims 1 to 4, wherein the peg (210) is advanced between the wires so as to locally displace the wires.
  6. The method of any one of claims 1 to 5, wherein the peg (210) comprises a tapered or conical tip.
  7. The method of any one of claims 1 to 6, wherein the channel (410) is formed centrally through the braided tubular base body (300).
  8. The method of any one of claims 1 to 7, wherein the peg (210) remains inserted throughout the heat-setting step.
  9. The method of any one of claims 1 to 8, wherein the heat setting permanently deforms the braided tubular base body (300) such that the channel (410) remains after removal of the peg (210).
  10. The method of any one of claims 1 to 9, wherein the mold structure (208) constrains an outer shape of the braided tubular base body (300) while the channel (410) is formed.
  11. A medical implantable device (400), preferably made by the method of any of claims 1-10, comprising: a braided tubular body (300) formed of interwoven wires; and a channel (410) extending through the braided tubular body (300), wherein the channel (410) is formed by a local displacement of a subset of the wires of the braided tubular body (300) relative to surrounding wires, such that the channel (410) extends through interspaces between the displaced wires, wherein the local displacement is confined to a region of the channel (410) and the braided tubular body (300) remains otherwise continuous and braided, and wherein the braided tubular body (300) is heat-set after the local displacement so that the channel (410) is permanently maintained in the braided tubular body (300).
  12. The medical implantable device of claim 11, wherein wires of the braided tubular body (300) adjacent the channel (410) remain continuous and interconnected as part of the braid across the channel (410).
  13. The medical implantable device of claim 11 or 12, wherein the channel (410) has a cross-sectional shape corresponding to a shape of a peg (210) used to locally displace the wires during formation of the channel (410).
  14. The medical implantable device of any one of claims 11 to 13, wherein the braided tubular body (300) adjacent the channel (410) is locally deformed around the channel (410), while portions of the braided tubular body (300) remote from the channel (410) remain substantially undeformed.
  15. The implantable medical device (400) of any of claims 11 to 14, wherein said base body comprising an end at which is located: a plurality of first-stage wires, and a plurality of second-stage wires, a plurality of groups of first-stage apices, and a plurality of second-stage apices.

Description

TECHNICAL FIELD The present disclosure relates to the manufacturing of medical implants, in particular involving braiding of wires or strands and methods thereof, as well as base bodies manufactured of such braiding for forming medical implants including in particular shunting devices such as septal shunting devices, wherein such implants are of a braided mesh of strands. Even more particular, the present disclosure relates to methods for forming a braided tubular base body for a medical implantable device. The disclosure relates to methods involving braiding head having form elements, and a plurality of bobbins in a braiding process. The disclosure further relates to methods for braiding a tubular base body for a medical implant from such a braided tubular base body, as well as medical implants made from such braided tubular base body and corresponding manufacturing methods. BACKGROUND Various braided medical devices are used for treating various conditions in a patient. In certain circumstances it may be necessary to use such devices for occlusion of a patient's lumen, vessel, chamber, channel, hole, or cavity. Braided devices may also be used for shunting. When delivering or implanting such devices into the patient's body it is critical that the braided device is sufficiently flexible for safe delivery by a delivery device such as a catheter to a target site in the patient. The ease of operation by which the medical device can be delivered is crucial from several aspects such as requirements to comply with time limits for a quick treatment or overall safe positioning or maneuvering of the device at the target site. The braided medical devices often comprise one or more wires or strands used to braid a base body that is then used to form the medical device, often by heat-setting. The ends of the wires or strands are commonly fixed together to avoid unraveling of the braid, e.g. in fixtures, bundles or securing means which often are protruding from the medical device. Some braiding machines can be configured and set up to braid base bodies that may have open and/or closed ends. Different braiding techniques and set ups have been used to braid sturdy and flexible base bodies for medical devices. For example, in US 6,468,303 B1, or WO 99/12478A1 medical devices are disclosed made from tubular braiding and have securing means, such as a clamp, at each respective opposite end of the device. The securing means, however, in particular in the left heart, may increase a risk for blood clotting or other complications, since e.g. the distal clamp protrude from the device. This which may in particular be an issue in the left heart leading to high risk of undesired complications like stroke caused by blood clots, or punctures of cardiac tissue during deployment of the device. In international patent application publication WO 2005/020822 A1 an occlusion device is disclosed and in international patent application publication WO 2016/038115 A1 a shunt device is disclosed, wherein both disclose devices that are made from braided base bodies. These latter medical devices have one securing means, such as a clamp at only the proximal end. In another example In US 9,877,72 6B2 an occlusion device is disclosed having one clamp at one end, and a braided opening at the other end that is tied together with a suture thread to restrain the opening into forming a closed smooth surface. The device is an occlusion device for shutting off a blood flow through a hole in an atrial septum. Even there is a tiny opening disclosed at the distal end, the disclosure is about closing the opening by tightening the suture thread in a manual process, as the device has the purpose to close off blood flow. The wires at the opening would flare or even unravel without the suture holding together wire loops at the distal end of the occlusion device. The construction and cost of manufacture of the perimeter of the opening disclosed in US 9,877,72 6B2 can thus be improved. In international patent publication WO 2012/110355 A1, a medical device is disclosed having an expandable braided mesh consisting of wires which cross over one another and which form loops on at least one long end of the braided mesh. The medical device is a tubular stent. The construction of the perimeter of the braid can be improved, at least with regard to structural integrity and stability thereof. In patent application publication US 2007/112380 A1, a self-expanding occlusion device for occluding an atrial auricula in the heart of a patient is discloses, which includes a braiding of thin wires or threads given a suitable profile form by means of a molding and heat treatment procedure. The medical device has a distal central opening at which wire return from perimeter loops at a disc element. The purpose is to keep the channel as small as possible as the device is an occlusion device. No wire apices are arranged at the opening or the perimeter of the opening at all. The constructi