Controlling a size of a pyloris

• US 10,646,226 B2
• Filed: 12/08/2017
• Issued: 05/12/2020
• Est. Priority Date: 11/20/2013
• Status: Active Grant

• Current Assignee: Christy Cummins, James E. Coleman
• Original Assignee: Christy Cummins, James E. Coleman
• Inventors: Coleman, James E., Cummins, Christy
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US15/835,663
• Publication Number:
  US 20180098770A1
• Time in Patent Office: 886 Days
• Field of Search: 600 37, 623 1413
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 2017/00389 Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions

Abstract

Systems and methods are provided for reversibly controlling a size and/or restricting the movement of a body orifice, such as a pyloric opening, using an implantable device configured to allow a distance between opposed ends thereof to be adjusted. A device is provided having attachment members and a connector portion extending therebetween and configured such that a size of the pyloric opening is decreased upon the implantation of the device. The connector can be adjustable to allow a size of the pyloric opening to be adjusted after it has been restricted. The connector can include two or more bridge portions having different lengths such that cutting a first bridge portion can increase the distance between the attachment members so as to increase the size of the pyloric opening. To revert to a natural size of the body orifice, the entire connector can be cut or otherwise broken and/or removed.

Claims

1. A method of controlling a size of a body orifice, comprising:

implanting a first deployable implant into tissue at a first location on a first side of an orifice, the first deployable implant being coupled to a first end of a connector, the connector having at least first and second bridge portions;

implanting a second deployable implant that is coupled to a second end of the connector into tissue at a second location on a second side of the orifice, the connector configured to directly narrow the body orifice from a native unrestricted state to a restricted state, the first bridge portion extends between the first implant and the second implant to maintain the first and second locations at a first distance apart; and

cutting the first bridge portion to allow the second bridge portion to maintain the first and second locations at a second distance apart that is greater than the first distance.

2. The method of claim 1, further comprising, after cutting the first bridge portion, cutting the second bridge portion such that a third bridge portion of the connector maintains the first and second locations at a third distance apart that is greater than the second distance.

3. The method of claim 2, further comprising, after cutting the second bridge portion, cutting the third bridge portion to allow the connector to cease narrowing the orifice to thereby allow the orifice to return to the unrestricted state.

4. The method of claim 1, wherein implanting the first implant comprises deploying proximal and distal deployable wings of the first implant to engage tissue therebetween, and implanting the second implant comprises deploying proximal and distal deployable wings of the second implant to engage tissue therebetween.

5. The method of claim 1, wherein the connector is mated to the first and second implants via respective first and second attachment members.

6. The method of claim 1, further comprising, prior to implanting, delivering the first deployable implant to the orifice with the connector coupled to the first deployable implant and mounted on a delivery shaft coupled to the first deployable implant.

7. The method of claim 1, further comprising implanting a third deployable implant into tissue at a third location on the orifice to allow a first bridge portion of a second connector extending between the second implant and the third implant to maintain a third distance between the second and third locations.

8. The method of claim 1, wherein cutting the first bridge portion comprises cutting the first bridge portion at a site along a length thereof to form free ends at opposed sides of the site to allow the first and second implants to move from the first distance apart to the second distance apart.

9. The method of claim 1, wherein the first bridge portion has a first length and the second bridge portion has a second length that is greater than the first length.