Patent Application
20230293783
Radiofrequency (RF)-induced heating of implantable medical device components, such as the electrodes of active implantable medical devices (AIMDs) and screw tips of external fixation medical devices, is the limiting factor for a safe MRI scan. In fact, many implantable medical devices are prohibited from MRI scans or scanned under restricted conditions due to such RF-induced heating. Furthermore, the re-engineering or re-design of implantable medical device components for RF-induced heating reduction are not feasible due to mechanical requirements. Numerous embodiments of the present disclosure aim to address these limitations.
Embodiments of the present disclosure pertain to implantable medical devices that are operational for mitigating radiofrequency (RF)-induced heating. The implantable medical devices of the present disclosure generally include a ferrite material that is associated with at least one component of the implantable medical device and operational to reduce the RF-induced heating of the implantable medical device.
Additional embodiments of the present disclosure pertain to methods of mitigating radiofrequency (RF)-induced heating of an implantable medical device by applying a ferrite material to at least one component of the implantable medical device. Thereafter, the ferrite material reduces the RF-induced heating of the medical device. In some embodiments, the methods of the present disclosure also include a step of implanting the implantable medical device into a subject, such as a human being.
It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory, and are not restrictive of the subject matter, as claimed. In this application, the use of the singular includes the plural, the word “a” or “an” means “at least one”, and the use of “or” means “and/or”, unless specifically stated otherwise. Furthermore, the use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. Also, terms such as “element” or “component” encompass both elements or components comprising one unit and elements or components that include more than one unit unless specifically stated otherwise.
The section headings used herein are for organizational purposes and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in this application, including, but not limited to, patents, patent applications, articles, books, and treatises, are hereby expressly incorporated herein by reference in their entirety for any purpose. In the event that one or more of the incorporated literature and similar materials defines a term in a manner that contradicts the definition of that term in this application, this application controls.
Magnetic resonance imaging (MRI) has been a standard medical diagnostic tool over recent decades owing to its high-resolution imaging quality for soft tissue. Compared with X-ray or computed tomography (CT) imaging, MRI does not have ionizing radiation and long-term health risks. In fact, MRI is considered as one of the safest imaging methods in hospitals. However, patients with implantable medical devices are usually restricted from MRI because of the potential safety concerns, especially the radiofrequency (RF) induced heating generated during MRI scans.
During magnetic resonance imaging (MRI), the radiofrequency (RF)-induced heating of implantable medical devices is one of the major concerns for patient safety. For instance, in active implantable medical devices (AIMDs), the concentrated energy dissipating in the lead-tip region can lead to high local temperature rise and cause tissue damage. To mitigate RF-induced heating of AIMDs, diverse approaches have been proposed in the literature. These methods can be divided into two classes.
The approaches in the first class have focused on reducing the strength of the incident electric (E)-fields in the device region by a) changing the construction of the transmit RF coil, b) selecting appropriate implantation trajectories of AIMDs in patients, c) using absorbing radio frequency shields, and d) applying RF-shimming techniques. The approaches in the second class have relied on modifications of the AIMDs to achieve heating reduction. These approaches have included a) increasing the RF resistance of the lead body with appropriate winding techniques, b) introducing band-stop filters or coaxial chokes on the lead body near the lead-tip, c) adding an external wire to the AIMD lead, d) introducing high-dielectric materials in the lead design to dissipate the induced energy along the lead body into the surrounding tissues, e) enlarging the electrode to reduce the energy density, f) adding lumped elements to change the termination impedance, and g) introducing a resistive-tapered strip line at the lead-tip.
The aforementioned approaches have made significant progress toward AIMD safety. However, most studies have only considered a limited number of in-vitro cases without evaluating the heating associated with clinically relevant in-vivo scenarios. Furthermore, the re-engineering or re-design of AIMD leads for RF-induced heating reduction may not always be feasible due to mechanical requirements.
External fixation medical devices are another type of implantable medical devices that can cause a severe heating concern during MRI scans. External fixation medical devices are surgical devices that may be used to stabilize fractured bones. A typical external fixation medical device generally includes three parts: 1) fixators (e.g., metallic pins or wires) to be screwed into the fractured bones, 2) a base area (e.g., rods or bars made of carbon fiber or metallic materials) to anchor (e.g., bridge) the fixators, and 3) securing mechanisms (e.g., metallic clamps) to connect the fixators to the base area (e.g., rods). Compared with other passive implants, the base area (e.g., rods) and securing mechanisms (e.g., clamps) are outside the human body and thus are much closer to the RF coils.
It has been observed that external fixation medical devices often experience a higher heating effect than that of fully implanted passive devices. For instance, it has been shown that external fixation devices can cause a high local peak specific absorption rate over 1 gram (SARig) of around 800 W/kg and lead to a temperature rise of more than 50° C. in specific settings.
To mitigate the RF-induced heating of the external fixation medical devices, studies have proposed the use of insulating materials to block the transmission of the RF energy to the fixator tips. Such studies have shown that, through the application of proper insulating materials, the RF-induced heating could be reduced by 67% at 1.5 T. Other studies improved this method by changing the insulating material to absorbing materials. Such materials could further absorb part of the RF-induced energy received by the device frame, thereby reducing the heating effect in the human body.
Although previous studies achieved good results in mitigating the RF heating of external fixation medical devices, there are remaining limitations associated with these works. First, the studies only investigated the effects of the relative permittivity on the RF heating and did not consider the effects of other parameters such as the thickness of the insulating material. Second, the methods used in the studies were demonstrated at 1.5 T MRI. As high field MRI is widely used in clinical settings, there arises a need to investigate the effectiveness of the insulating and absorbing materials in reducing RF heating of the external fixation devices at 3 T MRI.
As such, a need exists to develop more effective methods of mitigating RF-induced heating of implantable medical devices, such as AIMDs and external fixation medical devices. A need also exists to utilize more effective materials to mitigate RF-induced heating in such implantable medical devices. Numerous embodiments of the present disclosure aim to address the aforementioned needs.
In some embodiments, the present disclosure pertains to medical devices that are operational for mitigating radio frequency (RF)-induced heating. The medical devices of the present disclosure generally include a ferrite material that is associated with at least one component of the medical device. In some embodiments, the ferrite material is operational to reduce the RF-induced heating of the medical device.
In some embodiments, the medical devices of the present disclosure include implantable medical devices. Implantable medical devices generally refer to medical devices that can be completely or partially introduced into a tissue (e.g., cardiac tissue), organ (e.g., heart) or cavity (e.g., oral cavity) of a subject on a temporary or permanent basis. In some embodiments, implantable medical devices include, without limitation, external fixation medical devices, active implantable medical devices (AIMDs), cochlear implants, prosthetics, stents, hip implants, insulin injection patches, artificial joints, breast implants, intraocular lenses, intrauterine contraceptive devices, dental implants, or combinations thereof.
In some embodiments, the medical devices of the present disclosure include AIMDs. AIMDs generally refer to implantable medical devices that rely on artificially generated electrical energy or a power source for operation. In some embodiments, the AIMDs include, without limitation, cardiac implantable electrical devices (CIEDs), defibrillators, pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, CRT pacers (CRT-P), CRT defibrillators (CRTD), neuromodulation systems, deep brain stimulation systems, spinal cord stimulation systems, or combinations thereof.
In some embodiments, the implantable medical devices of the present disclosure include external fixation medical devices. External fixation medical devices generally refer to implantable medical devices that are operational to stabilize a compromised area of a body, such as a fractured bone or a strained muscle. In some embodiments, external fixation medical devices include fixators that are fully or partially implantable into a fractured area of a body, such as a fractured bone.
The medical devices of the present disclosure may include various types of ferrite materials. In some embodiments, ferrite materials include iron oxide (Fe2O3) combined with one or more additional metallic elements. In some embodiments, the one or more metallic elements include, without limitation, iron (Fe), strontium (Sr), barium (Ba), manganese (Mn), nickel (Ni), zinc (Zn), cobalt (Co), and combinations thereof. In some embodiments, the ferrite materials include, without limitation, strontium (Sr)-containing ferrites, barium (Ba)-containing ferrites, manganese (Mn)-containing ferrites, nickel (Ni)-containing ferrites, zinc (Zn)-containing ferrites, cobalt (Co)-containing ferrites, Ni, Zn-containing ferrites, Mn, Zn-containing ferrites, magnetite (Fe3O4), ZnFe2O4, BaFe12O19 (BaO:6Fe2O3), BaO·2(FeO)·8(Fe2O3), SrFe12O19 (SrO:6Fe2O3), MnZnFe2O4, NiZnFe2O4, CoFe2O4 (CoO·Fe2O3), Ba2ZnFe18O23, and combinations thereof. In some embodiments, the ferrite materials are operational for leading to a relative permeability that is larger than 1.
The ferrite materials of the present disclosure can be in various forms. For instance, in some embodiments, the ferrite materials of the present disclosure represent an exogenous component of a medical device. In some embodiments, the ferrite materials of the present disclosure are protruded out of at least one component of a medical device. In some embodiments, the ferrite materials of the present disclosure are in the form of one or more rings. In some embodiments, the ferrite materials of the present disclosure are in the form of one or more beads. In some embodiments, the ferrite materials of the present disclosure are in the form of one or more ferrite magnetic rings. In some embodiments, the ferrite magnetic rings include a magnetic core and an outer surface. In some embodiments, the outer surface includes a plastic outer surface.
In some embodiments, the ferrite materials of the present disclosure are in the form of composites. In some embodiments, the ferrite materials of the present disclosure are in the form of blocks.
In some embodiments, the ferrite materials of the present. disclosure are in the form of a coating. In some embodiments, the ferrite materials of the present disclosure are in the form of coating layers of different thicknesses.
In some embodiments, the ferrite materials have thicknesses that range from about 0.1 mm to about 10 mm. In some embodiments, the ferrite materials have thicknesses that range from about 0.1 mm to about 0.7 mm. In some embodiments, the ferrite materials have thicknesses that range from about 0.1 mm to about 0.5 mm.
Ferrite materials may be associated with various medical device components in various manners. For instance, in some embodiments, ferrite materials may be associated with an outer surface of a medical device component. In some embodiments, the medical device component includes at least one component that is partially or completely implantable into a subject. In some embodiments, the medical device component includes an electrode of an implantable medical device that is partially or completely implantable into the subject.
In some embodiments, the medical device component of an implantable medical device includes a lead body of an implantable medical device. In some embodiments, the lead body includes a lead body of an AIMD, such as a pacemaker. In some embodiments, the lead body includes a proximal end, a middle area, and a distal end. In some embodiments, the lead body is in the form of an elongated and insulated structure that includes one or more metallic inner conductors and contacting electrodes at the distal end.
The ferrite materials of the present disclosure may be associated with any locations or lengths of a lead body. For instance, in some embodiments, the ferrite material is inside the lead body. In some embodiments, the ferrite material is outside the lead body. In some embodiments, the ferrite material is at the proximal end of the lead body. In some embodiments, the ferrite material is inside the middle of the lead body. In some embodiments, the ferrite material is inside the distal end of the lead body. In some embodiments, the ferrite material may be associated 5 cm from the distal end of the lead body. In some embodiments, the ferrite material may be associated 10 cm from the distal end of the lead body.
In some embodiments, the ferrite materials of the present disclosure are associated with a fixator of an external fixation medical device. In some embodiments, the fixator is in the form of a wire. In some embodiments, the fixator is in the form of a pin. In some embodiments, the fixator includes a proximal end operational for attaching to a base area of the external fixation medical device, and a distal end operational for insertion into a subject's bone. In some embodiments, the ferrite material is associated with the proximal end of the fixator. In some embodiments, the ferrite material is associated with the distal end of the fixator.
In some embodiments, the ferrite material may be associated near the proximal end of the fixator. In some embodiments, the ferrite material may be associated 5 cm from the proximal end of the fixator. In some embodiments, the ferrite material may be associated 10 cm from the proximal end of the fixator.
In some embodiments, the ferrite materials of the present disclosure are associated with a base area of an external fixation medical device. In some embodiments, the base area is operational for anchoring a fixator. In some embodiments, the base area is in the form of a bar.
An example of a medical device of the present disclosure is illustrated in
Another example of a medical device of the present disclosure is illustrated in
In some embodiments, the present disclosure pertains to methods of mitigating radiofrequency (RF)-induced heating of a medical device. In some embodiments illustrated in
As set forth in more detail herein, the methods of the present disclosure can have numerous embodiments. In particular, various ferrite materials may be applied to various components of various medical devices to result in the reduction of the RF-induced heating of the medical devices in various environments. Moreover, the medical devices may be implanted into various subjects for various purposes.
The methods of the present disclosure may be utilized to apply ferrite materials to components of various medical devices. Suitable medical devices were described supra. For instance, in some embodiments, the medical devices include implantable medical devices. In some embodiments, the medical devices include external fixation medical devices. In some embodiments, the medical devices include an active implantable medical device (AIMD).
Ferrite materials may be applied to various medical device components. Suitable medical device components were also described supra. For instance, in some embodiments, the medical device component includes an implantable medical device component that is partially or completely implantable into a subject. In some embodiments, the medical device component includes an electrode of an implantable medical device that is partially or completely implantable into the subject. In some embodiments, the medical device component includes a lead body of an AIMD. In some embodiments, the medical device component includes a fixator of an external fixation medical device.
The methods of present disclosure may apply ferrite materials to medical device components in various manners. For instance, in some embodiments, the applying occurs by spraying the ferrite materials onto the medical device components. In some embodiments, the applying occurs by inserting the ferrite materials onto the medical device components. In some embodiments, the applying occurs by placing the ferrite materials on the medical device components. In some embodiments, the applying occurs by embedding the ferrite materials onto the medical device components.
The application of ferrite materials to medical device components may result in the reduction of RF-induced heating in various manners. For instance, in some embodiments, the applied ferrite material reduces RF-induced heating by blocking or minimizing the induced current from RF waves.
The application of ferrite materials to medical device components may result in the reduction of RF-induced heating in various environments. For instance, in some embodiments, the environment is an environment under magnetic resonance (MR), such as an MRI scanner. In some embodiments, the applied ferrite material mitigates RF-induced heating from a magnetic resonance (MR) RF coil. In some embodiments, the environment is an electromagnetic environment.
In some embodiments, the methods of the present disclosure also include a step of implanting the medical devices of the present disclosure into a subject. In some embodiments, the subject is a human being. In some embodiments, the implantation occurs surgically.
The methods and medical devices of the present disclosure provide numerous advantages and applications. For instance, in some embodiments, the methods and medical devices of the present disclosure can reduce RF-induced heating without requiring a redesign of medical devices (e.g., AIMD systems). Additionally, the methods and medical devices of the present disclosure can be utilized to reduce RF-induced heating of medical devices under various scenarios, such as under MRI scans. Furthermore, the methods and medical devices of the present disclosure may be applied to various implantable medical devices, such as pacemakers, implantable defibrillators, and external fixation medical devices.
Reference will now be made to more specific embodiments of the present disclosure and experimental results that provide support for such embodiments. However, Applicant notes that the disclosure below is for illustrative purposes only and is not intended to limit the scope of the claimed subject matter in any way.
This Example demonstrates the use of ferrite beads to reduce RF-induced heating in active implantable medical devices (AIMDs). Two different leads bodies, with and without the ferrite materials, were used in this Example. The device configurations are shown in
The different AIMD devices shown in
The results establish that the magnitude of the transfer functions of the AIMD models all decreased significantly when ferrite materials were applied along their leads bodies. In particular,
In summary, the results in this Example demonstrate that ferrite materials can be utilized to reduce RF-induced heating of medical devices, such as AIMDs, by reducing the RF-induced current on the device.
This Example demonstrates the use of ferrite beads to reduce RF-induced heating of additional active implantable medical devices (AIMDs). Three different leads bodies, with and without the ferrite materials, were used in this Example. The device configurations are shown in
The different AIMD devices shown in
The results further confirm that the magnitude of the transfer functions of the AIMD models all decreased significantly when ferrite materials were applied along their leads bodies, and consequently, the RF-induced heating at the device tip can be reduced significantly.
As indicated in
This Example demonstrates the use of ferrite beads to reduce RF-induced heating of external fixation medical devices. During experiments, the ASTM phantom with a commercially available external fixation device was tested as an example. Images of the external fixation medical devices tests in this Example are shown in
The different external fixation systems were placed under MR RF coil at 1.5 T. Optical-fiber thermal probes were used to measure the temperature rises near the pin tips. To hold the external fixation at the correct position, a plastic holder was used. For the temperature measurements, Applicant built the ASTM phantom with the following dimensions: 420 mm×180 mm×650 mm. The ASTM phantom was filled with GEL made of sodium chloride (NaCl, 1.32 g/L) and polyacrylic acid (10 g/L) dissolved in water. The phantom was filled with GEL to a depth of 90 mm. Based on the simulated results, the optical-fiber thermal probes were placed at the tips of the device pins. The total exposure time of the tested device in the RF field is 2 minutes at 1.5 T.
The results are summarized in Table 4. As summarized in Table 4, when external fixation devices are used, the RF-induced heating is reduced to background heating.
Without further elaboration, it is believed that one skilled in the art can, using the description herein, utilize the present disclosure to its fullest extent. The embodiments described herein are to be construed as illustrative and not as constraining the remainder of the disclosure in any way whatsoever. While the embodiments have been shown and described, many variations and modifications thereof can be made by one skilled in the art without departing from the spirit and teachings of the invention. Accordingly, the scope of protection is not limited by the description set out above, but is only limited by the claims, including all equivalents of the subject matter of the claims. The disclosures of all patents, patent applications and publications cited herein are hereby incorporated herein by reference, to the extent that they provide procedural or other details consistent with and supplementary to those set forth herein.
The present application claims the benefit of U.S. Provisional Patent Application No. 63/317,417, filed on Mar. 7, 2022 and U.S. Provisional Patent Application No. 63/317,882, filed on Mar. 8, 2022. The entirety of each of the aforementioned applications is incorporated herein by reference.
This invention was made with government support under Grant No. 1922389, awarded by the National Science Foundation. The government has certain rights in the invention.
| Number | Date | Country | |
|---|---|---|---|
| 63317417 | Mar 2022 | US | |
| 63317882 | Mar 2022 | US |
