1. An implantable splinting device for supporting a defect in a passageway of a human or other animal subject comprising:
one or more bellow support structures together defining a structural component that substantially conforms to at least a portion of the passageway, wherein the one or more bellow support structures comprise a biocompatible polymeric material;
a longitudinal opening formed within the one or more bellow support structures to facilitate placement of the implantable splinting device over the passageway; and
a plurality of apertures defined in at least a portion of the one or more bellow support structures capable of receiving a suture for attaching the implantable splinting device to at least a portion of the passageway.
2. The implantable splinting device of claim 1, wherein the implantable splinting device is designed for placement around and substantially conforms to at least a portion of the passageway selected from the group consisting of: a trachea, a bronchi, an esophagus, and a blood vessel.
3. The implantable splinting device of claim 1, wherein the defect in the passageway is selected from the group consisting of: tracheomalacia, tracheoesophageal fistula, tracheoinnominate fistula, congenital stenosis, acquired stricture, cancer (obstruction from tumors), idiopathic tracheomalacia, trachealairway reconstruction surgery, bronchomalacia, weakened veins and a coronary bypass.
4. The implantable splinting device of claim 1, wherein the structural component has an inner diameter and an outer diameter, wherein the inner diameter ranges from greater than or equal to about 4 mm to less than or equal to about 30 mm and the outer diameter ranges from greater than or equal to about 5 mm to less than or equal to about 34 mm, and wherein the implantable splinting device has a length ranging from greater than or equal to about 10 mm to less than or equal to about 60 mm.
5. The implantable splinting device of claim 1, wherein the biocompatible polymeric material comprises a biodegradable polymer having a degradation time of from about 10 months to about 24 months.
6. The implantable splinting device of claim 5, wherein the biodegradable polymer is polycaprolactone.
7. The implantable splinting device of claim 1, wherein the structural component is capable of restricting displacement to less than 10% under a direct compression load of about 50N, while permitting outward radial displacement of at least 100% of an initial diameter of the structural component under non-stress conditions under a radial pressure of about 50N.
8. The implantable splinting device of claim 1, wherein the implantable splinting device further comprises a bioactive agent, wherein the bioactive agent is selected from the group consisting of: a cell adhesion factor, an isolated tissue material, a growth factor, a peptide, a cytokine, a hormone, a pharmaceutical active, and combinations thereof.
9. The implantable splinting device of claim 8, wherein the implantable splinting device comprises acellularized dermis, an acellularized tissue matrix, a composite of acellularized dermis matrix and designed polymer, or a composite of acellularized tissue matrix and designed polymer.
10. The implantable splinting device of claim 1, wherein a wave period of the one or more bellow support structures is greater than or equal to about 1.5 mm to less than or equal to about 6 mm.
11. The implantable splinting device of claim 1, wherein each bellow of the one or more bellow support structures comprises a protruding region and a recessed region.
12. The implantable splinting device of claim 11, wherein a first length of the protruding region is greater than or equal to about 1 mm to less than or equal to about 4 mm and a second length of the recessed region is greater than or equal to about 0.5 mm to less than or equal to about 2 mm.
13. The implantable splinting device of claim 1, wherein a width of the longitudinal opening ranges from greater than or equal to about 4 mm to less than or equal to about 15 mm.
14. The implantable splinting device of claim 1, wherein the plurality of apertures respectively has a diameter ranging from about 0.5 mm to about 3 mm.
15. The implantable splinting device of claim 1, wherein the implantable splinting device comprises a first structural component and a second structural component.
16. The implantable splinting device of claim 15, wherein the first structural component is a tracheal U-shaped structure and the second structural component is an esophageal U-shaped structure.
17. The implantable splinting device of claim 16, wherein the first structural component and the second structural component are joined together via a hinge to define the structural component.
18. A method of making an implantable splinting device for application to a passageway defect in a human or other animal subject comprising:
laser sintering or three-dimensional (3D) printing a biocompatible polymeric material to form a structural component comprising one or more bellow support structures that substantially conforms to a portion of a passageway having the passageway defect specific to the human or other animal subject, wherein the structural component comprises a longitudinal opening formed within the one or more bellow support structures to facilitate placement over the passageway; and
integrating a plurality of pores within the structural component capable of receiving a suture for attaching the implantable splinting device to at least a portion of the passageway.
19. The method of claim 18, further comprising designing a structural component for the implantable splinting device from a set of medical image data of the passageway defect specific to the human or other animal subject prior to the laser sintering or three-dimensional (3D) printing.
20. The method of claim 18, wherein the implantable splinting device is configured for placement around at least a portion of the passageway of the subject selected from the group consisting of: a trachea, a bronchi, an esophagus and a blood vessel.
21. The method of claim 18, wherein the biocompatible polymeric material is polycaprolactone and has a degradation time of from about 10 months to about 24 months.
22. A method of making an implantable splinting device for application to a defect in a passageway of a human or other animal subject comprising:
forming a biocompatible polymeric material into a U-shaped structural component comprising a plurality of apertures and a plurality of bellows, wherein the U-shaped structural component substantially conforms to at least a portion of the passageway selected from the group consisting of a trachea, a bronchi, an esophagus and a blood vessel.
23. The method of claim 22, wherein the biocompatible polymeric material is polycaprolactone and has a degradation time of from about 10 months to about 24 months.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A visual restoration aiding device for restoring vision of a patient, the device comprising:
an electrode array having a plurality of electrodes placed on or under a retina of an eye of the patient for applying an electrical stimulation pulse signal to cells constituting the retina;
a photographing unit which photographs an object to be recognized by the patient;
a converting unit which converts photographic data transmitted from the photographing unit to data for electrical stimulation pulse signals; and
a control unit which outputs an electrical stimulation pulse signal through each electrode based on the data for electrical stimulation pulse signals so that the control unit produces pulse output through one of a first electrode and a second electrode during a halt time of pulse output through the other electrode, the first and second electrodes being arranged within a distance such that electrical stimulation pulse signals outputted therethrough at substantially the same time are likely to interfere with each other.
2. The visual restoration aiding device according to claim 1, wherein the electrical stimulation pulse signal includes a two-phase pulse waveform signal.
3. The visual restoration aiding device according to claim 2, wherein the electrical stimulation pulse signal includes a bipolar pulse waveform signal, and
the control unit produces the pulse output through one of the first and second electrodes during the halt time of the pulse output through the other electrode between a negative pulse and a positive pulse.
4. The visual restoration aiding device according to claim 2, wherein the electrical stimulation pulse signal includes a bipolar pulse waveform signal, and
the control unit produces the pulse output through one of the first and second electrodes during the halt time of the pulse output through the other electrode between a bipolar pulse waveform signal and a next bipolar pulse waveform signal.
5. The visual restoration aiding device according to claim 2, wherein the electrical stimulation pulse signal includes a bipolar pulse waveform signal including a negative pulse and a positive pulse different in strength, and
the control unit produces the pulse output so that a high strength pulse through one of the first and second electrodes does not coincide with a high strength pulse through the other electrode.
6. A visual restoration aiding device for restoring vision of a patient, the device comprising:
a plurality of electrodes placed on or under a retina of an eye of the patient; and
a control unit which outputs an electrical stimulation pulse signal through each electrode so that the control unit produces pulse output through one of a first electrode and a second electrode during a halt time of pulse output through the other electrode, the first and second electrodes being arranged within a distance such that electrical stimulation pulse signals outputted therethrough at substantially the same time are likely to interfere with each other.