JP-7857494-B2 - Implantable medical device including a migration-preventing structure for forming an anastomosis site

Inventors

• ステープルトン、フィオン
• ファブロー、ジョン トーマス
• リンチ、ライアン デズモンド
• バーク、サンドラ
• ウォルシュ、マイケル
• パワー、フランシス
• フルーリー、ショーン ピー．

Assignees

• ボストン サイエンティフィック サイムド，インコーポレイテッド

Dates

Publication Date

20260512

Application Date

20230801

Priority Date

20220802

Claims (13)

1. It is an implantable medical device, A long body having a proximal end and a distal end, the long body defining a lumen extending therein; A proximal retaining member along the proximal end of the elongated main body; A distal holding member along the distal end of the elongated main body; A saddle region defined between the proximal holding member and the distal holding member; and at least one anti-movement structure extending outward from the outer surface of the elongated body, At least the saddle region has walls coated with a material that prevents the passage of fluid, The aforementioned at least one anti-movement structure is not coated in order to promote endoproliferation of surrounding tissue. An implantable medical device in which the at least one anti-movement structure is in a semi-closed or closed form relative to the elongated main body .
2. The implantable medical device according to claim 1 , wherein the at least one anti-movement structure includes at least one holding portion extending laterally with respect to the axis of a moving force affecting the implantable medical device.
3. The implantable medical device according to claim 2 , wherein the lumen of the elongated main body extends through the saddle region, and the retaining portion extends laterally with respect to the longitudinal axis of the saddle region.
4. The implantable medical device according to claim 3 , wherein the at least one movement prevention structure extends laterally from at least one of the proximal holding member or the distal holding member and extends toward the saddle region.
5. The proximal holding member and the distal holding member extend radially outward from the saddle region. The implantable medical device according to claim 1, wherein the at least one movement prevention structure extends laterally from at least one of the proximal holding member or the distal holding member and extends toward the saddle region.
6. The implantable medical device according to claim 5, wherein the saddle region is configured to extend between a proximal tissue wall and a distal tissue wall, the proximal retaining member is configured to fix the implantable medical device to the proximal tissue wall, the distal retaining member is configured to fix the implantable medical device to the distal tissue wall, and the at least one anti-movement structure is configured to be embedded in either the proximal tissue wall or the distal tissue wall.
7. The implantable medical device according to claim 6, wherein the at least one anti-movement structure includes at least one anti-movement structure extending from the proximal holding member toward the saddle region and at least one anti-movement structure extending from the distal holding member toward the saddle region .
8. The implantable medical device is transitionable between a long delivery configuration and a shortened deployment configuration. The proximal retaining member and the distal retaining member are defined when the implantable medical device transitions to the deployed configuration and a portion of the elongated main body extends radially outward. The implantable medical device according to claim 1, wherein in the deployed configuration, the length of the saddle region and the configuration of the proximal retaining member and the distal retaining member are selected so as to pull together the tissue extending across the elongated body and the at least one anti-movement structure is fixed to the tissue.
9. The implantable medical device according to claim 1, wherein at least one of the proximal retaining member or the distal retaining member is formed from woven filaments, and the at least one anti-movement structure is formed from one extension of the woven filaments.
10. The implantable medical device according to claim 1, wherein the at least one movement-preventing structure is formed separately from and coupled to at least one of the proximal retaining member or the distal retaining member.
11. It is an implantable medical device, A long body having a proximal end and a distal end, the long body defining a lumen extending therein; and including at least one anti-movement structure extending outward from the outer surface of the long body, The aforementioned elongated body is formed from a plurality of filaments that form the walls of the elongated body with gaps between them. At least a portion of the wall of the elongated body is coated to prevent fluid from passing through and to resist tissue infiltration. The aforementioned at least one anti-movement structure is not coated to promote endografting of surrounding tissue, An implantable medical device in which the at least one anti-movement structure is in a semi-closed or closed form relative to the elongated main body .
12. The implantable medical device according to claim 11 , wherein the at least one anti-movement structure includes at least one holding portion extending laterally with respect to an axis in the direction in which a moving force affecting the implantable medical device is applied.
13. The implantable medical device further includes a proximal retaining member extending radially outward along the proximal end of the elongated body, a distal retaining member extending radially outward along the distal end of the elongated body, and a saddle region defined between the proximal retaining member and the distal retaining member. The implantable medical device according to claim 11 , wherein the at least one movement prevention structure extends toward the saddle region from at least one of the proximal holding member or the distal holding member.

Description

This disclosure generally relates to the field of implantable medical devices. In particular, this disclosure relates to medical devices, systems, and methods extending across anatomical structures, such as those for establishing connections and/or fluid communication between anatomical structures. More specifically, this disclosure relates to devices, systems, and methods for establishing connections and/or fluid communication between anatomical structures, and to structures that prevent movement. Various devices, such as stents, are known for extending between anatomical structures for various purposes. For example, various stents are known for establishing connections between anatomical structures. Some of these connections are made simply to place tissues next to each other, while others establish fluid communication between anatomical structures such as organs, body cavities, lumens, and passages. In some cases, it is desirable to create a semi-permanent or permanent anastomosis that allows fluid flow or drainage from one anatomical structure to another. For example, in various gastrointestinal (GI) surgeries (e.g., gastric bypass surgery), lumen apposing stents may be used to form anastomoses in the digestive system, such as gastrojejunal anastomosis between the stomach and the jejunum. Gastrojejunal anastomosis makes it easier for food particles, liquids, and oatmeal to flow from the stomach to the lower digestive tract, bypassing the pylorus and duodenum (e.g., the first approximately 1.5 m of the small intestine where most food, fats, and nutrients are digested). Such procedures are considered less invasive than conventional Roux-en-Y bypass surgery and may be reversible. It is important to understand that the anastomotic device should remain firmly in place until removal is desired or medically instructed. Generally, in various stent surgeries and applications extending between anatomical structures, such as when forming an anastomosis, it may be desirable to leave the stent in place for extended periods (e.g., days, weeks, months, or even 6 to 12 months or more). Therefore, there is a continuous need for devices, systems, and methods with more robust anti-migration structures related to this. This summary is provided to introduce a selection of concepts in a simplified form, which will be further elaborated upon in the detailed description below. This summary is not intended to necessarily identify the primary or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that each of the various aspects and features of this disclosure, whether or not described in this summary, may be advantageously used separately or, in other cases, in combination with other aspects and features of this disclosure. The inclusion or exclusion of elements, components, etc., in this summary is not intended to limit the scope of the claimed subject matter. According to various principles of this disclosure, an implantable medical device comprises an elongated body having a proximal and distal end, the elongated body defining a lumen extending therein; a proximal retaining member along the proximal end of the elongated body; a distal retaining member along the distal end of the elongated body; a saddle region defined between the proximal and distal retaining members; and at least one anti-movement structure extending outward from the outer surface of the elongated body. In some embodiments, at least the saddle region has a coated wall formed of a material that prevents the passage of fluid, and the at least one anti-movement structure is uncoated to promote the growth of surrounding tissue. In some embodiments, the at least one anti-movement structure is in a semi-closed or closed form relative to the elongated body. In some embodiments, the at least one anti-movement structure includes at least one retaining portion extending laterally with respect to the axis of the moving force affecting the implanted medical device. In some embodiments, the lumen of the elongated body extends through the saddle region, and the retaining portion extends laterally with respect to the longitudinal axis of the saddle region. In some embodiments, the at least one anti-movement structure extends laterally from at least one of the proximal retaining member or the distal retaining member and extends toward the saddle region. In some embodiments, the proximal and distal retaining members extend radially outward from the saddle region, and the at least one anti-movement structure extends laterally from at least one of the proximal or distal retaining members and extends toward the saddle region. In some embodiments, the saddle region is configured to extend between the proximal and distal tissue walls, the proximal retaining member is configured to fix the implantable medical device to the proximal tissue wall, the distal