Device for intermittently obstructing a gastric opening

• US 10,166,133 B2
• Filed: 11/18/2016
• Issued: 01/01/2019
• Est. Priority Date: 09/07/2007
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: BAROnova, Inc.
• Inventors: Burnett, Daniel R., Narciso, Hugh, Paspa, Paul, Wiser, David, Meade, Stephen L. L.
• Primary Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US15/356,188
• Publication Number:
  US 20170065446A1
• Time in Patent Office: 774 Days
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The present invention relates to a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal member connected to a distal member by a tether. The proximal member includes an apron member surrounding a first occluding member, which is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the device of the present invention is arranged transluminally, with the distal member disposed in the duodenum and the proximal member disposed against the pyloric valve, intermittently occluding the pyloric valve and preventing or delaying the flow of gastric contents through the pyloric valve. In certain embodiments, a reservoir may be included for releasing a substance of interest, for example for releasing insulin from a reservoir disposed in the distal member. Sensors, actuators, and data transmission devices may also be included.

Claims

1. An obstructing member for intermittently obstructing a pyloric valve, comprising:

a coiling occluding member having a low-profile configuration wherein the coiling occluding member forms a helical structure extending longitudinally and wherein the coiling occluding member is configurable into a deployment configuration having a plurality of turns which nest one adjacent to the other forming a wound structure in the deployment configuration;

a locking mechanism in communication with the coiling occluding member when the coiling occluding member is in the deployment configuration, wherein the locking mechanism is configured to secure the coiling occluding member in the deployment configuration; and

a covering member which at least partially surrounds the coiling occluding member in its deployment configuration.

2. The member of claim 1 wherein the wound structure assumes a bulbous shape.

3. The member of claim 1 wherein the coiling occluding member is biased to compress or contract from the low-profile configuration to the deployment configuration.

4. The member of claim 1 wherein the coiling occluding member comprises a shape memory material.

5. The member of claim 1 wherein the locking mechanism comprises at least one connecting member within the plurality of turns, wherein the at least one connecting member is configured to interact with the locking mechanism to maintain the coiling occluding member in the deployment configuration.

6. The member of claim 5, wherein the at least one connecting member comprises a string.

7. The member of claim 1 wherein the covering member comprises a tapered portion.

8. The member of claim 1 wherein the coiling occluding member is removably attachable from the covering member.

9. The member of claim 1 further comprising a tether extending distally at a distance sufficient to extend through the pyloric valve.

10. The member of claim 9 further comprising a distal member coupled to a distal end of the tether.

11. An obstructing member for intermittently obstructing a pyloric valve, comprising:

a coiling occluding member having a low-profile configuration wherein the coiling occluding member forms a helical structure extending longitudinally and wherein the coiling occluding member is configurable into a deployment configuration having a plurality of turns which nest one adjacent to the other forming a wound structure in the deployment configuration;

a locking mechanism in communication with the coiling occluding member when the coiling occluding member is in the deployment configuration, wherein the locking mechanism is configured to secure the coiling occluding member in the deployment configuration, and wherein the locking mechanism is enclosed within the plurality of turns; and

a covering member which partially surrounds the coiling member in its deployment configuration.

12. The member of claim 11 wherein the coiling occluding member is biased to compress or contract from the low-profile configuration to the deployment configuration.

13. The member of claim 11 wherein the coiling occluding member comprises a shape memory material.

14. The member of claim 11 wherein the covering member comprises a tapered portion.

15. The member of claim 11 further comprising a tether extending distally at a distance sufficient to extend through the pyloric valve.

16. The member of claim 11, wherein the locking mechanism comprises at least one connecting member within the plurality of turns, wherein the at least one connecting member is configured to interact with the locking mechanism to maintain the coiling occluding member in the deployment configuration.

17. The member of claim 16, wherein the at least one connecting member comprises a string.

18. An obstructing member for intermittently obstructing a pyloric valve, comprising:

a coiling occluding member having a low-profile configuration wherein the coiling occluding member forms a helical structure extending longitudinally and wherein the coiling occluding member is configurable into a deployment configuration having a plurality of turns which nest one adjacent to the other forming a wound structure in the deployment configuration; and

a locking mechanism in communication with the coiling occluding member when the coiling occluding member is in the deployment configuration, wherein the locking mechanism is configured to secure the coiling occluding member in the deployment configuration, wherein the coiling occluding member is removably attachable from a covering member.