EP-4740992-A2 - FLOW CONTROL VALVE

Abstract

The present invention relates to a medical device, comprising an elongate tubular body comprising a proximal portion, a distal portion, and a length therebetween, the elongate tubular body defining a lumen along the length, the elongate tubular body having an unexpanded configuration, and an expanded configuration wherein the proximal portion expands into a proximal retention member and the distal portion expands into a distal retention member leaving a length of a saddle region extending therebetween, and a flexible member disposed around the saddle region and along at least a portion of the length of the saddle region, wherein the flexible member is configured to constrict at least a portion of the length of the saddle region, and wherein the flexible member is configured to move from a first non-expanded configuration, in which the at least a portion of the length of the saddle region is constricted, to a second expanded configuration.

Inventors

• WALSH, MICHAEL
• CURRAN, DARREN
• VAN DER KOOIJ, Otto
• TUCK, Daniel
• PALOMAR-MORENO, Javier
• GRAY, JEFF
• FOLAN, MARTYN
• MOONEY, Emma J.
• HANNON, Enda

Assignees

• Boston Scientific Scimed, Inc.

Dates

Publication Date

20260513

Application Date

20190322

Claims (15)

1. A medical device, comprising: an elongate tubular body comprising a proximal portion, a distal portion, and a length therebetween, the elongate tubular body defining a lumen along the length; the elongate tubular body having an unexpanded configuration, and an expanded configuration wherein the proximal portion expands into a proximal retention member and the distal portion expands into a distal retention member leaving a length of a saddle region extending therebetween; and a flexible member disposed around the saddle region and along at least a portion of the length of the saddle region; wherein the flexible member is configured to constrict at least a portion of the length of the saddle region; and wherein the flexible member (140a; 140b) is configured to move from a first non-expanded configuration, in which the at least a portion of the length of the saddle region is constricted, to a second expanded configuration.
2. The medical device of claim 1, wherein the flexible member is removably disposed around the saddle region.
3. The medical device of any of claims 1-2, wherein the flexible member is permanently disposed around the saddle region.
4. The medical device of any of claims 1-3, wherein the flexible member is a collar or a sheath.
5. The medical device of any of claims 1-6, wherein the flexible member defines a lumen, and wherein the flexible member is configured to move from the first non-expanded configuration to the second expanded configuration in response to a threshold level of force.
6. The medical device of any of claims 1-5, wherein an inner dimension of the flexible member in the first non-expanded configuration is less than an inner dimension of the flexible member in the second expanded configuration.
7. The medical device of any of claims 1-6, wherein the lumen of the constricted at least a portion of the length of the saddle region is completely closed when the flexible member is in the first non-expanded configuration.
8. The medical device of any of claims 1-6, wherein the lumen of the constricted at least a portion of the length of the saddle region is partially closed when the flexible member is in the first non-expanded configuration.
9. The medical device (100; 200; 300) of any of claims 1-8, wherein the saddle region defines a flow or access passage when the flexible member (140a; 140b) has the second expanded configuration.
10. The medical device of any of claims 1-9, wherein a surface of the proximal retention member is configured to contact an inner surface of a tissue wall of a first body lumen, and a surface of the distal retention member is configured to contact an inner surface of a tissue wall of a second body lumen.
11. The medical device of any of claims 1-10, wherein the flexible member and the constricted portion of the length of the saddle region are configured to move from a first diameter configuration to an expanded second diameter configuration in response to a threshold level of force.
12. The medical device (100; 200; 300) of claim 11, wherein the constricted at least a portion of the length of the saddle region is configured to expand in response to a threshold level of force.
13. The medical device (100; 200; 300) of any of claims 1-12, wherein the constricted at least a portion of the length of the saddle region is configured to move from a first diameter configuration to an expanded second diameter configuration when the flexible member expands from the first diameter to the second diameter.
14. The medical device (100; 200; 300) of any of claims 1-12, wherein the flexible member (140a; 140b) facilitates controlled periodic or intermittent flow or access through the saddle region.
15. The medical device (100; 200; 300) of any of claims 1-13, wherein the flexible member (140a; 140b) comprises two flexible members (140a) spaced apart from each other and disposed around the saddle region (130) to define a reservoir within the saddle region between the two flexible members (140a).

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority under 35 U.S.C. §119 to United States Provisional Patent Application Serial No. 62/650,068, filed on March 29, 2018, which is incorporated by reference in its entirety for all purposes. FIELD The present disclosure relates generally to the field of medical devices and establishing fluid communication between body lumens. In particular, the present disclosure relates to devices and methods for establishing a controlled flow or access passage between body lumens. BACKGROUND The desire to establish access between two body lumens to create fluid communication from one to the other is present under various circumstances and conditions. A variety of medical devices (e.g., anastomotic devices, drainage stents, etc.) are able to establish open flow or access passages between body lumens. For example, an anastomotic or drainage device which facilitates transgastric or transduodenal drainage of a symptomatic pancreatic pseudocyst adherent to the gastric or bowel wall may remain implanted for up to 60 days. The open access path provided by the device may allow the continued flow of fluid and/or debris from the pancreatic pseudocyst into the stomach or duodenum. Resolution of the pancreatic pseudocyst may be further enhanced by the flow of acidic stomach fluids into the pseudocyst, which neutralize the alkalinity and increase the viscosity of the fluid and/or debris. While continual uni-directional flow or bi-directional flow through the medical device may be advantageous in certain circumstances, various medical conditions require controlled periodic or intermittent drainage and/or access to a body lumen or organ. A variety of advantageous medical outcomes may be realized by the devices and/or methods of the present disclosure which allow, for example, infusion and/or drainage of body lumens or organs in a controlled manner for a period of time. SUMMARY In one aspect, the present disclosure relates to a medical device comprising an elongate tubular body, which may include a proximal portion, a distal portion and a length therebetween. The elongate tubular body may define a lumen along the length. The elongate tubular body may have an unexpanded configuration, and an expanded configuration wherein the proximal portion may expand into a proximal retention member, and the distal portion may expand into a distal retention member leaving a length of a saddle region (e.g., a cylindrical saddle region) extending therebetween. A flexible member may be disposed around the saddle region and along at least a portion of the length of the saddle region. The flexible member may be configured to constrict at least a portion of the length of the saddle region. The flexible member may be removably disposed around the saddle region. The flexible member may be permanently disposed around the saddle region. The flexible member may include a sheath disposed around the saddle region and along a portion of all or a substantial portion of the length of the saddle region. The flexible member may include a collar disposed around the saddle and along a portion of the length of the saddle region. The medical device may include two (or more) flexible collars spaced apart from each other and disposed around the saddle region. A portion of the length of the saddle region between the two flexible collars may define a reservoir. The flexible member may define a lumen. The flexible member may be configured to move from a first non-expanded configuration to a second expanded configuration. An inner dimension of the lumen of the flexible member in the first non-expanded configuration may be less than an inner dimension of the lumen of the flexible member in the second expanded configuration. The lumen of the constricted portion of the length of the saddle region may be completely closed when the flexible member is in the first non-expanded configuration. The lumen of the constricted portion of the length of the saddle region may be partially closed when the flexible member is in the first non-expanded configuration. A therapeutic agent may be disposed within the reservoir. The therapeutic agent may flow from the reservoir through the proximal retention member. The therapeutic agent may flow from the reservoir through the distal retention member. A surface of the proximal retention member may be configured to contact an inner surface of a tissue wall of a first body lumen, and a surface of the distal retention member may be configured to contact an inner surface of a tissue wall of a second body lumen. In addition, or alternatively, a surface of the proximal retention member may be configured to contact an inner surface of a tissue wall of a first body lumen, and a surface of the distal retention member may be configured to contact an outer surface of the tissue wall of the first body lumen. The distal retention member, proximal retention member and/or saddle region m