IMPLANTABLE DEVICES CAPABLE OF SELECTIVE DEGRADATION
20170196673 ยท 2017-07-13
Inventors
Cpc classification
A61F2250/0001
HUMAN NECESSITIES
A61B2017/00411
HUMAN NECESSITIES
A61B17/221
HUMAN NECESSITIES
A61F2210/0009
HUMAN NECESSITIES
A61F2/0105
HUMAN NECESSITIES
A61B17/1215
HUMAN NECESSITIES
A61F2/82
HUMAN NECESSITIES
A61F2002/9511
HUMAN NECESSITIES
A61B17/0057
HUMAN NECESSITIES
A61B2017/00039
HUMAN NECESSITIES
A61B2017/00606
HUMAN NECESSITIES
A61B2017/00575
HUMAN NECESSITIES
A61F2250/0043
HUMAN NECESSITIES
International classification
A61B17/12
HUMAN NECESSITIES
Abstract
Implantable medical devices that contain at least one region that is selectively degradable by electrolytic corrosion are provided. The electrolytic corrosion of the medical device is initiated by the formation of an electrolytic cell that can be activated wirelessly at a designated point in time. The medical device incorporates at least one section or region that is designed to be predisposed to structural failure. The medical device contains a cathode region, a sacrificial anode region, which will undergo degradation, and an antenna region. Electrolytic degradation of a sacrificial anode region may cause a de-anchoring of the medical device or a reconfiguration of the medical device from a first configuration to a second configuration. Alternatively, electrolytic degradation may precipitate the absorption of the medical device. In another embodiment, electrolytic protection may be employed to preserve an implanted device until such a time that its corrosion and subsequent absorption is desired.
Claims
1. An implantable device having a cathode region, a sacrificial anode region, and an antenna region, said implantable device comprising: a first configuration, and a second configuration wherein electrolytic degradation of said sacrificial anode region transforms said implantable device from said first configuration to said second configuration, and wherein said electrolytic degradation is initiated by the formation of an electrolytic cell, said electrolytic cell being formed when said antenna region remotely receives electrical energy from an external transmitter device.
2. The implantable device of claim 1, wherein said first configuration is an anchored configuration wherein said implantable device is anchored to a lumen wall, and wherein said second configuration is a non-anchored configuration in which said implantable device may be removed.
3. The implantable device of claim 1, wherein said first configuration is a first diameter of said implantable device, wherein said second configuration is a second diameter of said implantable device, and wherein said first diameter is less than said second diameter.
4. The implantable device of claim 3, wherein said second diameter anchors said implantable device in a lumen.
5. The implantable device of claim 1, further comprising at least one predetermined failure region susceptible to said electrolytic degradation.
6. The implantable device of claim 1, wherein said electrolytic degradation precipitates absorption of said implantable device.
7. An implantable device having a cathode region, a sacrificial anode region, and a piezoelectric receiver region, said implantable device comprising: a first configuration, and a second configuration wherein electrolytic degradation of said sacrificial anode region transforms said implantable device from said first configuration to said configuration, and wherein said electrolytic degradation is initiated by the formation of a electrolytic cell, said electrolytic cell being formed when said piezoelectric receiver region receives acoustic energy from an external transmitter device and converts the acoustic energy to electrical energy.
8. The implantable device of claim 7, wherein said first configuration is an anchored configuration wherein said implantable device is anchored to a lumen wall, and wherein said second configuration is a non-anchored configuration in which said implantable device may be removed.
9. The implantable device of claim 7, wherein said first configuration is a first diameter of said implantable device, and wherein said second configuration is a second diameter of said implantable device, wherein said first diameter is less than said second diameter.
10. The implantable device of claim 9, wherein said second diameter anchors said implantable device in a lumen.
11. The implantable device of claim 7, further comprising at least one predetermined failure region susceptible to said electrolytic degradation.
12. The implantable device of claim 7, wherein said electrolytic degradation precipitates absorption of said implantable device.
13. A method for remotely reconfiguring an implantable device comprising a sacrificial anode region, a cathode region, and an antenna region, said method comprising: receiving electrical energy from an external transmitter device to form a electrolytic cell and cause electrolytic degradation of said sacrificial anode region, wherein said electrolytic degradation transforms said implantable device from a first configuration to a second configuration.
14. The method of claim 13, wherein said first configuration is an anchored configuration wherein said implantable device is anchored to a lumen wall, and wherein said second configuration is a non-anchored configuration in which said implantable device may be removed.
15. The method of claim 13, wherein said implantable device is a stent comprising at least one region of variable diameter, and wherein said first configuration is a first diameter of said at least one region of variable diameter and said second configuration is a second diameter of said at least one region of variable diameter.
16. The method of claim 13, wherein said first configuration is a first diameter of said implantable device, and wherein said second configuration is a second diameter of said implantable device, and wherein said first diameter is less than said second diameter and said second diameter anchors said implantable device in a lumen.
17. The method of claim 13, wherein said first configuration is an anchored configuration wherein said implantable device is anchored to a lumen wall, and wherein said second configuration is a non-anchored configuration in which said implantable device may be removed.
18. The method of claim 13, further comprising at least one predetermined failure region susceptible to said electrolytic degradation.
19. An implantable device comprising: a cathode region and a sacrificial anode region between which an electrolytic cell is formed when an antenna region remotely receives energy from an external transmitter device, wherein electrolytic degradation of said sacrificial anode region occurs upon the formation of said electrolytic cell and transforms said implantable device from a first configuration to a second configuration.
20. The implantable device of claim 19, wherein said first configuration is an anchored configuration wherein said implantable device is anchored to a lumen wall, wherein said second configuration is a non-anchored configuration in which said implantable device may be removed.
21. The implantable device of claim 19, wherein said implantable device is a stent comprising at least one region of variable diameter, wherein said first configuration is a first diameter of said at least one region of variable diameter and said second configuration is a second diameter of said at least one region of variable diameter.
22. The implantable device of claim 19, wherein said implantable device has a first configuration as a vascular filter, wherein said first configuration of said implantable device positions emboli blocking elements in a blood stream and said second configuration removes said emboli blocking elements from the bloodstream.
23. The implantable device of claim 19, further comprising a rectification circuit adjacent to said antenna region to convert said electrical energy to direct current voltage.
24. The implantable device of claim 19, wherein said failure of said sacrificial anode region precipitates absorption of said implantable device.
25. The implantable device of claim 19, wherein said failure of said sacrificial anode region de-anchors said implantable device.
26. The implantable device of claim 19, wherein said sacrificial anode region comprises a narrowed region of a structural member of said device.
27. The implantable device of claim 19, wherein said sacrificial anode region comprises an electrically uninsulated subsection of a structural member of said device.
28. An implantable device comprising a cathode region, an anode region, and an antenna region, said implantable device comprising: a first configuration, and a second configuration wherein degradation of said cathode region transforms said implantable device from said first configuration to said second configuration, wherein said degradation of said cathode region is prohibited by the formation of an electrolytic cell causing active impressed current cathodic protection.
29. The implantable device of claim 28, wherein said first configuration is an anchored configuration wherein said implantable device is anchored to a lumen wall, and wherein said second configuration is a non-anchored configuration in which said implantable device may be removed.
30. The implantable device of claim 28, wherein said first configuration is a first diameter of said implantable device, and wherein said second configuration is a second diameter of said implantable device, wherein said first diameter is less than said second diameter.
31. The implantable device of claim 29, wherein said second diameter anchors said implantable device in a lumen.
32. A method of selectively degrading at least one predetermined portion of a conductive implantable device, said method comprising: remotely generating a voltage in said implantable device by coupling said implantable device to an electromagnetic field; converting said induced voltage to direct current voltage and forming an electrolytic cell; wherein structural failure of said implantable device at said at least one predetermined portion occurs upon the formation of the electrolytic cell, and wherein said structural failure transfigures said implantable device from a first configuration to a second configuration.
33. An implantable device comprising: a frame comprising an electrically conductive, corrosion resistant core and an electrochemically degradable outer surface, wherein energy transmitted to said frame degrades said outer surface and compromises the structural integrity of said frame.
34. The implantable device of claim 33, wherein said frame has at least one thinned region with a diameter smaller than a diameter of said frame.
35. An implantable device having a cathode region, a sacrificial anode region, and an antenna region, said implantable device comprising: a first configuration, and a second configuration wherein electrolytic degradation of said sacrificial anode region transforms said implantable device from said first configuration to said second configuration, and wherein electrical energy received by said antenna region from a remote transmitter is stored in said device, and wherein when said stored energy reaches a predetermined threshold, said stored energy is released to form an electrolytic cell which initiates said electrolytic degradation.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.
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DETAILED DESCRIPTION
[0029] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.
[0030] The present invention is directed to implantable medical devices that contain at least one region that is selectively degradable by electrolytic corrosion. The electrolytic corrosion is initiated by the formation of an electrolytic cell that can be activated wirelessly at a designated point in time. Additionally, the medical device can incorporate one or more section(s) or region(s) therein that are designed to be predisposed to structural failure. The medical device may contain a cathode region, an anode region that will undergo degradation, and an antenna region. Electrolytic degradation of the anode region may cause, for example, a de-anchoring of the medical device, a reconfiguration of the medical device from a first configuration to a second configuration, or it may precipitate the absorption of the medical device. Alternatively, electrolytic protection may be employed to preserve an implanted device until such a time that its corrosion and subsequent absorption is desired. It is to be appreciated that the terms electrolytic protection, cathodic protection, and impressed current cathodic protection as used herein refer to the application of a voltage potential to a structure in order to inhibit corrosion of the structure.
[0031] In one embodiment, selective electrolytic corrosion by the formation of an electrolytic cell may be used to adjust the medical device from a first configuration to a second configuration. As one example, electrolytic degradation may be used to adjust the diameter of an implanted medical device, such as, for example, an adjustable diameter stent. The stent may be any conventional tubular or radially expandable stent having a generally flexible frame and an opening extending therethrough. The frame of the stent may be formed of one or more elongate member (e.g., a wire) that has been helically wrapped into a tubular form. Additionally, the stent may be covered or partially covered with a cover material. It is to be appreciated that cover materials may be chosen and configured so as to confine and trap any degradation products produced during the degradation process. Stents described herein may be used in a wide variety of different anatomies, implant sites (e.g., body lumens, organs, cavities, and the like) and types of implementations.
[0032] Turning to
[0033] In the embodiment depicted in
[0034] When the stent 10 is energized, corrosion occurs over the uninsulated and/or exposed anode surfaces. Therefore, it is desirable to expose only the sections or regions in which degradation and mechanical failure are intended to occur. Limiting the area of the exposed anode region also serves to accelerate the degradation of the targeted, sacrificial region. In this manner energy wirelessly provided to the antenna (i.e., constraining member 12) from an external source creates an electrolytic cell and induces electrochemical corrosion at the exposed, sacrificial anode region 14. The antenna is activated remotely, and does need not to be in direct physical contact with the energy source.
[0035] Energy is provided until the sacrificial region 14 has corroded to an extent that the sacrificial region 14 breaks and releases the stent 10 from its constrained configuration to an expanded configuration. The degradation and subsequent release of the constraining member 12 permits the stent 10 to expand to its full (or substantially full) diameter (D) (e.g., second configuration) without the use of any invasive techniques. The fully expanded configuration of the stent 10 may anchor the medical device in a lumen. Alternatively, the expansion of the stent may cause anchors (not illustrated) affixed to the stent to engage with the lumen wall to anchor the stent therein. The expansion of the stent may be initiated in order to increase blood flow or to compensate for stenosis in the stent or lumen.
[0036] In another embodiment depicted in
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[0038] In some embodiments, the frame 20 of a stent may act as the receiving antenna.
[0039] In another exemplary embodiment, the sacrificial anode region may act as a link that holds a scissor or accordion structure in a retracted or extended position. Turning to
[0040] In a further exemplary embodiment, the formation of an electrolytic cell may be used to de-anchor a medical device from a lumen.
[0041] The degradation of the narrowed or uninsulated sacrificial anode region 36 of the anchor wings 32 causes the anchor wings 32 to fail in that once the narrow region 36 is electrochemically degraded and breaks, the anchor wings 32 are no longer able to apply the anchoring spring force necessary to hold the medical device 30 in the lumen 34. As a result, the medical device 30 is de-anchored from the lumen 34. Such a de-anchoring of the medical device 30 permits the medical device 30 to be non-invasively removed, such as via passage through the digestive tract. It is to be appreciated that regions susceptible to electrolytic degradation may also be created by electrically insulating a positively charged section(s) of the circuit with the exception of the regions, which are intended to degrade. A combination of narrowing and selective insulation may be used to predispose section(s) of the anchor wings 32 to electrochemical degradation.
[0042] In yet another embodiment, electrolytic degradation may be used to transform a medical device having one purpose into a second medical device having a second purpose. As one non-limiting example, an embolic filter may be electrochemically degraded and transformed into a stent-graft in situ.
[0043] In another embodiment, a medical device may be rendered conformable through the electrochemical degradation of a portion of the medical device. One non-limiting embodiment is depicted generally in
[0044] The conductive, corrosion-resistant core facilitates an extensive electrolytic degradation of the outer surface as it will continue to maintain electrical conductivity of the device via the electrically conductive (corrosion-resistant) core, even after a section or sections of the outer surface have been completely eroded. In such an embodiment, the core may be thin, flexible, and able to maintain an electrical connection between sections of the device, but is not able to contribute significantly to the device's strength or stiffness. The outer material, in contrast, maintains the strength and stiffness of the device until the material is degraded.
[0045] Still referring to
[0046] A second, non-limiting example of rendering a medical device conformable is depicted generally in
[0047] The occluder 70 may be covered in whole or in part with a biocompatible material, such as, for example, expanded polytetrafluoroethylene (ePTFE). The occluder 70 may be implanted in a body, and, after a period of time, the occluder 70 may become ingrown and/or covered with tissue. After a sufficient ingrowth of tissue, the frame 74 of the occluder 70 is no longer needed, as the ingrown tissue will hold the occluder 70 and covering material in place. At any time, particularly after tissue ingrowth into the occluder 70, energy may be transmitted to the occluder frame 74 from a remote energy source to erode the thinned areas 72 and compromise the occluder frame 74. Compromising the frame 74 reduces the chance of long-term abrasion during the cardiac cycle. As shown in
[0048] In a further embodiment, a medical device may be formed of an electrochemically degrading material such that the entirety of the medical device is degraded or substantially degraded when an electrolytic cell is formed. For instance, the elements forming the medical device may be tapered and/or otherwise designed so that the degradation of the medical device proceeds in a predictable and orderly manner such that a complete dissolution of the medical device or a nearly complete dissolution of the medical device occurs. Any portion of the medical device that is not completely dissolved may be passed through the digestive tract. As described above, a corrosion-resistant component may be embedded or otherwise incorporated in the medical device to maintain electrical connection between disparate elements of the degrading structure until complete or sufficient dissolution of the target sections has been accomplished.
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[0050] In yet another embodiment, a voltage may be maintained on a medical device in order to prevent its degradation until a time when the medical device is no longer needed. Once the medical device has served its purpose, the voltage potential is removed and the medical device begins degrading. In at least one embodiment, the medical device dissolves completely.
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[0052] It is to be noted that although the inventions described above are with reference to specific medical devices (e.g., stent devices, occluders, and embolic filters), it is to be appreciated that any medical device that contains a cathode, an anode region, is capable of receiving a wireless transmission from an external transmitter device, and contains at least one region that may be subjected to electrolytic degradation may be used and is considered to be within the purview of the invention. The devices described herein are exemplary in nature and are not meant to be limiting.
[0053] The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.