Devices and methods for providing passage between heart chambers
US-2021121179-A1 · Apr 29, 2021 · US
US12364616B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12364616-B2 |
| Application number | US-202217747344-A |
| Country | US |
| Kind code | B2 |
| Filing date | May 18, 2022 |
| Priority date | May 19, 2021 |
| Publication date | Jul 22, 2025 |
| Grant date | Jul 22, 2025 |
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Official abstract text for this publication.
An implantable device having an adjustable passage therethrough. The passage may be adjustable to occlude or otherwise to regulate access or flow of materials therethrough. An elongated element may be inserted into the passage when in a closed configuration to selectively open the passage. For instance, the implantable device may be a tubular device with a twisted region closing the passage therethrough, and the elongated device may be configured to engage such twisted region and to be rotated to untwist the closed region. An additional tubular device with a passage therethrough may be inserted into the passage of the implantable device to hold open the passage for a selected period of time.
Opening claim text (preview).
What is claimed is: 1. A system for controlling a size of a passage through an implantable device while implanted within a patient's body, said system comprising: an adjustable tubular device having a first end and a second end and shiftable from a collapsed configuration for delivery to an expanded deployed configuration with a twisted adjustable passage formed therethrough between the first end and the second end; and an elongated element extendable into the adjustable passage formed through said adjustable tubular device in the expanded deployed configuration and including engagement features configured to engage the adjustable passage, wherein said elongated element is rotatable within the adjustable passage with said engagement features engaged with the adjustable passage to untwist the twisted adjustable passage to increase the size of the adjustable passage to allow increased flow of material through the adjustable passage upon removal of said elongated element from the adjustable passage. 2. The system of claim 1 , wherein the first end and the second end of the adjustable tubular device comprise an intermediate region therebetween, at least said intermediate region being twisted into closed configuration to close the adjustable passage therethrough. 3. The system of claim 2 , wherein said elongated element is a passage-opening device configured to untwist said twisted intermediate region of said adjustable tubular device. 4. The system of claim 1 , wherein said engagement features are radially-extending features configured to engage with features of the adjustable passage formed through said adjustable tubular device. 5. The system of claim 4 , wherein said engagement features include a plurality of projections extending radially outwardly from a distal end of said elongated element. 6. The system of claim 3 , wherein said passage-opening device is a catheter. 7. The system of claim 1 , wherein said elongated element comprises engagement features configured to engage with features of the adjustable passage of said adjustable tubular device to increase the size of the adjustable passage. 8. The system of claim 1 , wherein said adjustable tubular device is guided over said elongated element to a deployment site across an anatomical structure. 9. The system of claim 1 , further comprising a lumen-controlling plug configured to fit within the adjustable passage of said adjustable tubular device to hold the adjustable passage in an open configuration. 10. A system for adjusting the size of a passage through an implantable device, said system comprising: an adjustable tubular device having an adjustable passage defined therethrough between a first end and a second end of said adjustable tubular device and having an inner diameter and movable between a substantially closed configuration and an open configuration with an increased inner diameter allowing flow of materials therethrough; an elongated element having engagement features configured to engage the adjustable passage formed through said adjustable tubular device, wherein said elongated element is rotatable within the adjustable passage with said engagement features engaged with the adjustable passage to increase the inner diameter of and open the adjustable passage of said adjustable tubular device; and a first lumen-controlling plug configured to fit within the passage of said adjustable tubular device opened by said elongated element to hold the adjustable passage in a first open configuration. 11. The system of claim 10 , further comprising a second lumen-controlling plug configured to fit within the adjustable passage of said adjustable tubular device to hold the adjustable passage in a second open configuration with an inner diameter sized different from the first open configuration. 12. The system of claim 11 , wherein said second lumen-controlling plug is positionable within said first lumen-controlling plug. 13. The system of claim 10 , wherein said first lumen-controlling plug is configured to mate with said adjustable tubular device to reduce shifting of said first lumen-controlling plug within the adjustable passage through said adjustable tubular device. 14. The system of claim 13 , wherein: said adjustable tubular device has a first retention member along a first end thereof and a second retention member along a second end thereof; and said first lumen-controlling plug has a first retention member configured to engage with said first retention member of said adjustable tubular device, and a second retention member configured to engage with said second retention member of said adjustable tubular device to resist shifting of said first lumen-controlling plug with respect to said adjustable tubular device. 15. The system of claim 10 , wherein the elongated element is configured to open the adjustable passage of said adjustable tubular device to facilitate insertion of said first lumen-controlling plug therein. 16. The system of claim 15 , wherein said first lumen-controlling plug is guided over said elongated element and into said adjustable tubular device. 17. A method of adjusting an implantable adjustable tubular device with a twisted adjustable passage defined therethrough between a first end and a second end of the implantable adjustable tubular device, said method comprising: inserting an elongated element into the twisted adjustable passage defined in the adjustable tubular device to engage engagement features of the elongated element with the twistable adjustable passage; rotating the elongated element with the engagement features engaged with the twisted adjustable passage between the first end and the second end of the implantable adjustable tubular device to untwist and open the adjustable passage; and inserting a lumen-controlling plug into the adjustable passage to hold open the adjustable passage. 18. The method of claim 17 , wherein inserting the lumen-controlling plug comprises guiding the lumen-controlling plug over the elongated element. 19. The method of claim 17 , further comprising rotating the elongated element, with the engagement features engaged with the twisted adjustable passage between the first end and the second end of the implantable adjustable tubular device, to adjust the diameter of the twisted adjustable passage to adjust the rate of flow of materials through the passage. 20. The method of claim 17 , further comprising engaging a feature of the lumen-controlling plug with a feature of the adjustable tubular device to inhibit shifting of the lumen-controlling plug within the adjustable passage of the adjustable tubular device.
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