Transponders and sensors for implantable medical devices and methods of use thereof

Abstract

Disclosed herein are implantable transponders that do not include ferromagnetic parts for use in medical implants. Such a transponder may help prevent interference of the transponder with medical imaging technology. Such transponders may optionally have a smaller size and may facilitate collection and transmission of data and information about implanted medical devices. Methods of using such transponders, readers for detecting such transponders, and methods for using such readers are also described.

Description

[0001] (Division of No. 201780014434.9)

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This disclosure claims priority to U.S. Provisional Patent Application No. 62 / 313,218, filed March 25, 2016, and U.S. Provisional Patent Application No. 62 / 293,052, filed February 9, 2016, each of which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure generally relates to transponder and sensor systems for use with implantable medical devices, implants incorporating such systems, and methods of use thereof. Background Art

[0005] Implantable medical devices may be implanted in patients for a variety of reasons, including, for example, to improve a patient's clinical condition, to replace a patient's natural tissue, or for cosmetic reasons. In many cases, implantable medical devices are implanted in patients with serious, complex, or chronic medical conditions. For example, breast implants may be used in post-mastectomy reconstructive surgery, e.g., following a cancer diagnosis, surgical removal of breast tissue, radiation therapy, and / or chemotherapy.

[0006] There are situations in which, after implantation, implantable medical devices and the tissue in which they are implanted may need to be inspected, monitored, identified, or further altered by invasive or non-invasive means. For example, after implantation of a medical device, follow-up visits may be required to monitor healing, check for clinical improvement, and / or screen for the development or recurrence of other medical conditions in the vicinity of the medical device (e.g., the recurrence of cancerous tissue in a patient in remission). As another example, it may be advantageous to be able to identify characteristics of an implanted device, such as the model, size, shape, batch number, or other characteristics of the device, without having to perform an invasive procedure to visually inspect the device. As yet another example, some implantable medical devices may need to be adjusted after implantation. For example, a tissue expander, such as one that may be used for a patient undergoing breast augmentation or reconstructive surgery, may be designed to gradually expand over time.

[0007] Various technologies have been developed to improve the safety and efficacy of breast implants and other implantable medical devices, in part to address some of the above-mentioned problems. These technologies include the use and integration of transponders such as radio frequency identification (RFID) transponders in implantable medical devices. Such transponders can be used, for example, to transmit information from the patient's body, such as information about the location of the device in the patient's body or the location of a portion of the device in the patient's body. As another example, such transponders can be used to transmit information about the implanted device itself, for example, by encoding a serial number on a chip in each transponder. Information about the implanted device can be used, for example, to determine whether the device will be subject to any recall, determine the materials in the device, and plan other surgeries. Information about the implanted medical device may also be useful before implantation, such as for tracking the device from manufacturing, to storage, sale, transportation, delivery to a medical center, and implantation in a patient. Microtransponders, such as transponders less than three centimeters in length and less than one centimeter in width, can provide additional advantages: they are small enough to be included in implantable medical devices without substantially affecting the size, shape, feel, or function of those devices.

[0008] However, the safety of implantable medical devices and their compatibility with ongoing patient care are also issues. Transponders implanted in medical devices may interfere with the use of certain diagnostic, imaging, or other medical technologies on patients with implants containing such transponders. For example, after a medical device is implanted, a patient may need to be monitored, examined, and / or screened, and the device may need to be compatible with various scanning, imaging, and diagnostic technologies, such as magnetic resonance imaging (MRI), radiography, ultrasound, and tomography. Transponders known in the art may include, for example, ferromagnetic parts that interfere with, for example, an MRI performed on a patient with such a transponder in their body. Such interference may include, for example, the generation of artifacts (e.g., small imaging gaps) in the imaging results of the patient being photographed. In such cases, the presence of artifacts in the imaging results may be associated with an increased risk of missing a diagnosis of the patient's condition. For example, a medical professional may miss the diagnosis of a recurring cancer due to artifacts obscuring the portion of the MRI showing cancer cells in the patient's body. As another example, a rupture of the implant (normally visible on an MRI result) may be obscured by artifacts caused by the transponder in the result. Therefore, MRI may not be the recommended imaging technique for such patients, or MRI may need to be combined with another imaging technique, such as ultrasound, which may result in additional time and expense for both the patient and the medical professional. As another example, after an implant containing smaller-sized transponders has been implanted in a patient, it may be difficult for an external reader to read those transponders. Alternatively, a medical professional may prefer not to use an implant that includes a transponder that would produce undesirable artifacts in the imaging results and / or may be difficult to read. Summary of the Invention

[0009] The present disclosure includes implantable transponders that include several features that may provide enhanced safety, compatibility with medical imaging techniques and other procedures, and a reduction in the need for invasive procedures. While portions of the present disclosure relate to breast implants and tissue expanders, the devices and methods disclosed herein may be used with other implantable medical devices, such as other implants used in cosmetic and / or reconstructive procedures (e.g., gastric implants, gluteal implants, calf implants, testicular implants, penile implants), pacemaker components (e.g., pacemaker caps) and other electrical stimulator implants, drug delivery ports, catheters, orthopedic implants, vascular and non-vascular stents, and other devices.

[0010] The present disclosure includes, for example, a transponder comprising an electromagnetic coil and a core comprising a non-ferromagnetic material, wherein the length of the transponder is between approximately 5 mm and approximately 30 mm, and the width of the transponder is between approximately 2 mm and approximately 5 mm. The transponder may also include a capsule encapsulating the electromagnetic coil and the core. The transponder may also include an integrated circuit chip coupled to the coil. The diameter of the coil may be greater than the width of the transponder. The core may include a core width and a core length, wherein the core length is greater than the core width, and wherein the coil is wound around the core such that the core length defines an inner diameter of the coil. The transponder may define a longitudinal axis along its length, and the electromagnetic coil may include a wire wound in the direction of the longitudinal axis. The transponder may also include: an integrated circuit chip coupled to each of two ends of the coil; a glass capsule encapsulating the electromagnetic coil, the integrated circuit chip, and an internal space between the glass capsule, the electromagnetic coil, and the integrated circuit chip; and an adhesive material filling at least 30% of the internal space.

[0011] The present disclosure also includes, for example, a transponder comprising a coil of wire, wherein the length of the transponder is between about 5 mm and 30 mm; the width of the transponder is between about 2 mm and about 5 mm and is less than the length of the transponder; the transponder does not contain ferromagnetic material; and the wire is wound around the length of the transponder. The transponder may also include an integrated circuit chip coupled to the coil. The transponder may also include a vessel encapsulating the coil and the integrated circuit chip coupled to the coil. The diameter of the coil may be less than the length of the transponder and greater than the width of the transponder. The transponder may be configured to send and / or receive information within a range of about 1 inch to about 5 feet. The wire may be enameled copper wire. The transponder may be wound around a core comprising biocompatible polyetheretherketone (PEEK). The transponder may be cylindrical.

[0012] The present disclosure also includes, for example, a transponder comprising an electromagnetic coil, a RFID chip, and a vessel enclosing the electromagnetic coil and the RFID chip, wherein the length of the vessel is between about 5 mm and about 30 mm, the diameter of the vessel perpendicular to the length is between about 2 mm and about 5 mm, and the transponder does not contain ferromagnetic material. The transponder may define a longitudinal axis along its length, and the electromagnetic coil may include a wire wound in the direction of the longitudinal axis. The electromagnetic coil may be wound around a core comprising biocompatible polyetheretherketone (PEEK). The core includes two notched ends, and the electromagnetic coil may include a wire wound around the core so that a turn of the wire is placed in each of the two notched ends. The longest diameter of the electromagnetic coil may be longer than the height of the coil.

[0013] The present disclosure also includes, for example, an integrated port assembly comprising: a chamber configured to receive a fluid; a wire coil, the coil sharing a central axis with the chamber; and a port dome covering an opening into the chamber. The wire coil may be an electromagnetic coil. The wire coil may have two ends, each of which is coupled to an integrated circuit chip. The port dome may seal the chamber of the integrated port assembly. The port dome may also be self-sealing. The integrated port assembly may also include walls defining sides of the chamber, the walls including at least one fluid outlet port. The integrated port assembly as described in claim may also include a wire coil chamber that houses the wire coil.

[0014] The present disclosure also includes, for example, an integrated port assembly comprising: a chamber configured to receive a fluid, the chamber having a fluid inlet aperture and a plurality of fluid outlet apertures; a wire coil surrounding the chamber; and a patch covering the fluid inlet aperture of the chamber. The chamber may further include an anti-puncture surface opposite the fluid inlet aperture. The fluid inlet aperture may define a plane, and each of the plurality of fluid outlet apertures may define a plane perpendicular to the plane defined by the fluid inlet aperture. The wire coil may have two ends, each of which is coupled to an integrated circuit chip, and wherein the outer diameter of the wire coil is between approximately 10 mm and approximately 50 mm. The integrated port assembly may further include at least four fluid outlet apertures. The integrated port assembly may further include a coil chamber housing the wire coil, wherein the coil chamber is fluid-impermeable. The integrated port assembly may be configured for use with a breast tissue expander. The patch of the integrated port assembly may be configured to attach to the exterior of a breast tissue expander. The patch may also be self-sealing.

[0015] The present invention also includes, for example, an integrated port assembly comprising: a housing defining a fluid injection chamber configured to receive fluid via a fluid inlet aperture; a wire coil within the coil chamber, the coil chamber being isolated from the fluid injection chamber, the coil having a central axis aligned with the center of the fluid injection chamber; and a port dome covering the fluid inlet aperture of the fluid injection chamber. The fluid injection chamber may include a plurality of fluid outlet apertures. The integrated port assembly may further include an integrated circuit chip positioned within the coil chamber, wherein both ends of the wire coil are coupled to the integrated circuit chip. The inner diameter of the coil may be between approximately 15 mm and approximately 35 mm.

[0016] The present disclosure also includes a method for broadcasting a transponder-specific signal, the method comprising: broadcasting a radio frequency signal across a scanning frequency within the range of a transponder; evaluating the signal strength of each of the return signals received from the transponder; determining the frequency of the broadcast radio frequency signal corresponding to the received return signal with the maximum signal strength; and broadcasting the radio frequency signal at the determined frequency. The method may also include receiving the return signal with multiple signal strengths at multiple antennas. The method may also include: receiving multiple return signals with multiple signal strengths; amplifying the received return signals having a signal strength below a threshold; and converting the amplified signals into digital values. The step of evaluating the signal strength of the received return signals may include converting the received return signals into digital values. The scanning frequency may include a frequency in the range of about 120 kHz to about 140 kHz. The range of the transponder may be about 5 feet.

[0017] The present disclosure also includes a system for broadcasting a transponder-specific signal, the system comprising a microcontroller and at least one antenna, the microcontroller being programmed with instructions for performing the steps of a method, the method comprising: broadcasting a radio frequency signal across a scanning frequency within the range of a transponder; evaluating the signal strength of each of the received return signals from the transponder; determining the frequency of the broadcast radio frequency signal corresponding to the received return signal with the greatest signal strength; and broadcasting the radio frequency signal at the determined frequency. The at least one antenna may include at least two antennas, and the method may further include receiving a plurality of return signals having a plurality of signal strengths at the at least two antennas. The system may further include a logarithmic amplifier and an analog-to-digital converter, and the method may further include: receiving a plurality of return signals having a plurality of signal strengths at the plurality of antennas; amplifying the received return signals having a signal strength below a threshold using the logarithmic amplifier; and converting the received and amplified signals using the analog-to-digital converter. The step of evaluating the strength of the received return signals may include converting the received return signals into digital values. The scanning frequency may include a frequency in the range of approximately 120 kHz to approximately 140 kHz. The range of the transponder may be approximately 5 feet. The system may also include a clock generator and a signal driver for performing the step of broadcasting a radio frequency signal across the scanned frequency. The step of evaluating the strength of the received return signal from the transponder may include instructing at least one analog-to-digital converter to convert the received return signal into a digital value and comparing the digital values ​​to each other.

[0018] The present disclosure also includes, for example, a method for broadcasting a transponder-specific signal, the method comprising: broadcasting a radio frequency signal across a scanning frequency within the range of a transponder using a signal driver and an antenna; receiving a return signal from the transponder using the antenna; amplifying a return signal from the transponder below a threshold using a logarithmic amplifier; converting the received return signal and the amplified signal into a digital value using an analog-to-digital converter; evaluating the digital value using a microcontroller to determine the strongest return signal; determining the frequency of the broadcast radio frequency signal corresponding to the strongest received return signal from the transponder; broadcasting the radio frequency signal at the determined frequency using the signal driver and antenna. The method may also include receiving a return signal below the threshold from the transponder at a pickup antenna. The step of broadcasting the radio frequency signal across the scanning frequency within the range of the transponder may also include determining the timing of the scanning frequency using a clock generator. The method may also include displaying the determined frequency on an LED display. The scanning frequency may include a frequency in the range of about 120 kHz to about 140 kHz. The range of the transponder may be less than five feet. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments and, together with the description, serve to explain the principles of the present disclosure. Any feature of an embodiment or example (e.g., device, method, etc.) described herein may be combined with any other embodiment or example and is encompassed in the present disclosure.

[0020] Figure 1A and Figure 1B An exemplary transponder according to some aspects of the present disclosure is shown.

[0021] Figure 2A and Figure 2B Another exemplary transponder according to some aspects of the present disclosure is shown.

[0022] Figures 3A to 3C An exemplary valve assembly according to some aspects of the present disclosure is shown.

[0023] Figure 4 Another view illustrating an example valve assembly according to aspects of the present disclosure.

[0024] Figures 5A to 5C An exemplary integrated port valve assembly according to aspects of the present disclosure is shown.

[0025] Figure 6 Another example integrated port valve assembly according to aspects of the present disclosure is shown.

[0026] Figure 7A and Figure 7B Showing some aspects of the present disclosure Figure 6 Additional views of an exemplary integrated port valve assembly are shown.

[0027] Figure 8 A schematic diagram illustrating a platform reader according to aspects of the present disclosure.

[0028] Figure 9 The steps of an exemplary method of broadcasting a signal according to other aspects of the present disclosure are shown in block diagram form.

[0029] Figures 10A to 10C Steps in an exemplary method of injecting a fluid into an implant are shown, according to aspects of the present disclosure.

[0030] Figure 11 Shown are exemplary implant shells according to aspects of the present disclosure. DETAILED DESCRIPTION

[0031] The following describes various aspects of the present disclosure in more detail. The terms and definitions used and illustrated herein are intended to represent the meaning within the present disclosure. In the event of a conflict with a term and / or definition incorporated by reference, the terms and definitions provided herein shall prevail.

[0032] Unless the context indicates otherwise, the singular forms "a," "an," and "the" include plural references. The terms "approximately" and "about" refer to being nearly the same as the referenced number or value. As used herein, the terms "approximately" and "about" should generally be understood to encompass ±5% of the specified amount or value.

[0033] The present disclosure generally relates to medical implants, features of medical implants, transponders and sensors for use with such implants, and methods of using such transponders, sensors, and implants. Various aspects of the present disclosure may be used with and / or included in the following applications: U.S. Provisional Application No. 62 / 313,218, filed on March 25, 2016, entitled “Sensors for Implantable Medical Devices and Methods of Use Thereof”; U.S. Provisional Application No. 62 / 293,052, filed on February 9, 2016, entitled “Identification System Including Transponder With Non-Magnetic Core”; U.S. Provisional Application No. 62 / 318,402, filed on April 5, 2016, entitled “Medical Imaging Systems, Devices, and Methods”; U.S. Provisional Application No. 62 / 323,160, filed on April 15, 2016, entitled “Minimally-Invasive Apparatus for the Implantation of Medical Devices and Methods of Use Thereof”; U.S. Provisional Application No. 62 / 336,160, filed on April 15, 2016, entitled “Implant Surface Technologies and Elements of U.S. Provisional Application No. 62 / 334,667, filed under the title "Formulation"; U.S. Application Publication No. 2015 / 0282926; U.S. Application Publication No. 2014 / 0081398; and / or U.S. Application Publication No. 2014 / 0078013.

[0034] Various aspects of the present disclosure can be used to collect and / or analyze data related to a patient, including, for example, physiological data and information about medical devices that can be implanted in a patient. The devices, systems, and methods disclosed herein can also be used to locate and / or change a medical device that can be implanted in a patient, including, for example, adjusting the size, shape, and / or position of a medical device that can be implanted in a patient. Such implantable medical devices may include, but are not limited to, breast implants, gluteal muscle implants, tissue expanders, and other medical devices in the field of cosmetic or reconstructive surgery, as well as other types of medical devices that are configured for temporary or permanent implantation in a patient. The devices, systems, and methods disclosed herein can also be used to overcome challenges presented in the prior art, such as artifacts produced by implanted transponders in patient imaging results, and difficulty reading transponders with weak signals.

[0035] As discussed herein, transponders such as microtransponders that are designed to avoid forming imaging artifacts (referred to herein as "low-artifact transponders") can be incorporated into implantable medical devices to monitor the status of the medical device over time and / or obtain certain types of patient data based on, among other things, the location of the transponder when implanted in the patient.

[0036] As also discussed herein, a valve assembly with a locator coil, such as an integrated port assembly designed for an implant that requires periodic addition of fluid (e.g., a tissue expander), can be incorporated into an implantable medical device to facilitate non-invasive positioning of the valve assembly after the medical device has been implanted in a patient.

[0037] Also disclosed herein are readers configured to read multiple types of transponders and locator coils, and methods of finding and broadcasting optimal signals for reading such transponders and / or locator coils.

[0038] Also disclosed are various data analysis techniques, systems, and methods for use in conjunction with the transponders, coils, and readers disclosed herein.

[0039] transponder

[0040] The present disclosure includes low-artifact transponders / chips that may include materials and / or design configurations for minimizing interference observed from magnetic resonance imaging (MRI), fluoroscopic (X-ray) imaging, and / or ultrasound imaging. As previously mentioned, MRI, X-ray, and ultrasound tests are frequently used in mammography and related tissue analysis to diagnose early signs of breast cancer and to evaluate other unrelated cardiopulmonary diseases. The transponders herein may be incorporated into breast implants and tissue expanders to reduce the amount of interference with diagnostic imaging.

[0041] Such transponders may be smaller in size to avoid affecting the size and shape of the implant in which they are located. Such transponders may also include materials as substitutes for ferromagnetic materials, which may cause imaging artifacts in the case of magnetic resonance imaging. For example, the transponders herein may include non-ferromagnetic materials such as polyetheretherketone (PEEK), other plastics, ceramics, or silicon dioxide (e.g., glass). Such transponders may also include configurations such as antenna coils that are designed to compensate for the lower antenna signal strength associated with small antenna coils without a ferromagnetic core.

[0042] Figure 1A and Figure 1B A top view of an exemplary transponder 100 that may embody one or more aspects of the present disclosure is depicted in schematic form. Figure 1A ) and side view ( Figure 1B ). Transponder 100 may include component 101, which may include antenna 102 and chip 110. Antenna 102 may include antenna core 104 and antenna coil 106. Antenna 102 may be connected to chip 110 via antenna coil end 108, which may be attached to bonding pads 112 of chip 110. Vessel 114 may enclose component 101 and may surround interior space 116 of component 101.

[0043] The transponder 100 can be configured to, for example, allow for continuous, intermittent / periodic, and / or on-demand (e.g., prompted by a user) collection and / or transmission of data. The transponder 100 can have any of a variety of shapes and sizes suitable for inclusion in an implant. For example, the transponder 100 can have a size and shape suitable for inclusion in a breast implant (such as a silicone-filled breast implant suitable for implantation in a patient during breast augmentation or reconstructive surgery). For example, in some embodiments, the transponder 100 can have a size and shape suitable for inclusion in an implant without substantially changing the size, shape, or weight of the implant. In some embodiments, the size and shape of the transponder 100 can be configured to be included in a breast implant. In some embodiments, the overall size and shape of the transponder 100 can be minimized to potentially reduce any impact of the transponder on the size, shape, appearance, feel, or implantation process of the implant to which the transponder 100 is mounted. Minimizing the overall size and shape of the transponder 100 can also help prevent the transponder from interfering with patient diagnostics, imaging procedures, and / or other medical procedures. Transponder 100 may also have an overall size and shape dictated in part by its components, as described in more detail below. For example, transponder 100 may have a long dimension or length determined in part by the size and shape of assembly 101 , particularly the size and shape of antenna 102 .

[0044] In some embodiments, the long dimension or length of the transponder 100 can be between about 5 mm and about 30 mm, such as between about 5 mm and about 10 mm, between about 8 mm and about 13 mm, between about 10 mm and about 20 mm, between about 10 mm and about 15 mm, between about 12 mm and about 18 mm, between about 15 mm and about 20 mm, between about 15 mm and about 25 mm, between about 18 mm and about 26 mm, or between about 20 mm and about 30 mm. In some embodiments, the long dimension of the transponder 100 can be about 8 mm, about 10 mm, about 13 mm, about 15 mm, about 18 mm, about 20 mm, about 23 mm, or about 25 mm.

[0045] In some embodiments, the width w or short dimension of the transponder 100, which is perpendicular to the length (e.g., Figure 1A The width or short dimension of the transponder 100 (as viewed from a top view of the transponder 100 in FIG. 1 ) can be between about 1 mm and about 20 mm. For example, in some embodiments, the width of the transponder 100 can be between about 2 mm and about 8 mm, between about 2 mm and about 5 mm, between about 2 mm and about 3 mm, between about 3 mm and about 6 mm, between about 5 mm and about 10 mm, between about 7 mm and about 12 mm, or between about 10 mm and about 15 mm. In some embodiments, the width or short dimension of the transponder 100 can be about 1 mm, about 2 mm, about 3 mm, about 5 mm, or about 6 mm.

[0046] In some embodiments, the thickness of the transponder 100, or the short dimension perpendicular to both the width w and length of the transponder 100, can be between about 1 mm and about 20 mm. For example, in some embodiments, the thickness of the transponder 100 can be approximately the same as the width w of the transponder 100. For example, in other embodiments, the thickness of the transponder 100 can be greater or less than the thickness of the width w of the transponder 100.

[0047] In some embodiments, the shape of the transponder 100 can be generally elongated. For example, in some embodiments, the length of the transponder 100 can be more than twice its width. The length of the transponder 100 can be about 13 mm and a width of about 2 mm, or a length of about 13 mm and a width of about 2.8 mm. In other embodiments, the length of the transponder 100 can be about 13 mm and a width of about 2.2 mm. In other embodiments, the length of the transponder 100 can be about 18 mm and a width of about 3 mm. The elongated shape can, for example, allow the transponder 100 to be easily inserted into a medical implant using, for example, a syringe into which the transponder 100 can be fitted. The elongated shape can also, for example, be suitable for accommodating a component 101 that is also elongated in shape, particularly the antenna 102.

[0048] For example, in some embodiments, the shape of transponder 100 can be generally cylindrical. In such embodiments, the width of transponder 100 can be, for example, the diameter of a cylinder. In other embodiments, the shape of transponder 100 can be set as a rectangular prism or any other shape. In some embodiments, transponder 100 can generally have almost no corners or have rounded corners, so as to, for example, reduce the risk of transponder 100 damaging an implant to which transponder 100 is mounted. In other embodiments, transponder 100 can be generally flat square, oval, or any other shape suitable for accommodating components of transponder 100 and for placing transponder 100 within a medical device.

[0049] The assembly 101 of the transponder 100 may include an antenna 102 and a chip 110, for example, connected via an antenna coil terminal 108. Both the antenna 102 and the chip 110 of the assembly 101 are described further below.

[0050] Antenna 102 may include, for example, an antenna core 104 and an antenna coil 106. In some embodiments, antenna coil 106 may be wound around antenna core 104. Antenna coil 106 may be made of a conductive, non-ferromagnetic material. In some embodiments, antenna coil 106 may be made of a material capable of withstanding high temperatures (e.g., temperatures ranging up to approximately 250 degrees Celsius) for up to approximately 10,000 hours. In some embodiments, antenna coil 106 may be made of a metal wire such as copper or aluminum. In some embodiments, antenna coil 106 may be made of enameled wire (e.g., a wire coated with a polymer). Suitable polymers may include, for example, polyvinyl formal (Formvar), polyurethane, polyamide, polyester, polyester-polyimide, polyamide-polyimide (or amide-imide), and polyimide. In some embodiments, antenna coil 106 may be made of enameled copper wire (such as, for example, Elektrisola enameled copper wire). In some embodiments, the antenna coil 106 can be made of a wire having a diameter ranging from about 0.010 mm to about 0.500 mm. For example, the antenna coil 106 can be made of a wire having a diameter of about 0.030 mm.

[0051] In some embodiments, the antenna coil 106 can include tens to thousands of turns (i.e., loops) of wire. For example, in some embodiments, the antenna coil 106 can include between about 30 and 1500 turns of wire, such as between about 30 and about 100 turns, between about 100 and about 200 turns, between about 100 and about 400 turns, between about 100 and about 600 turns, between about 200 and about 500 turns, between about 300 and about 700 turns, between about 400 and about 600 turns, between about 500 and about 800 turns, between about 600 and about 900 turns, between about 800 and about 1000 turns, between about 800 and about 1200 turns, between about 1000 and about 1500 turns, and between about 1100 and about 1500 turns.

[0052] like Figures 1A to 2B As shown, the antenna coil 106 can be wound in a longitudinal direction along the transponder axis AA so that it has a longitudinal turn diameter t. The turn diameter t can be greater than the coil's height h and / or the coil's width x. Advantageously, in some cases, this can allow the antenna coil 106 to generate a stronger signal when induced than an antenna coil that is wound so that its longitudinal turn diameter is less than its height h and / or width x (e.g., wound in a direction transverse to the axis AA). In some embodiments, the turn diameter t of the antenna coil 106 can range from about 5 mm to about 20 mm, such as, for example, from about 5 mm to about 15 mm, from about 5 mm to about 12 mm, from about 5 mm to about 10 mm, from about 5 mm to about 7 mm, from about 6 mm to about 8 mm, from about 7 mm to about 10 mm, from about 9 mm to about 13 mm, from about 10 mm to about 15 mm, from about 12 mm to about 17 mm, from about 15 mm to about 19 mm, or from about 16 mm to about 20 mm. In some implementations, the diameter of the antenna coil 106 may be approximately 6 mm, 7 mm, 8 mm, 10 mm, 11 mm, 12 mm, or 13 mm.

[0053] In some embodiments, the antenna coil 106 can have a height or thickness h that can be less than the turn diameter t of the antenna coil 106. The height (or thickness) h can generally be commensurate with the total thickness of the number of individual turns forming the antenna coil 106. The height h can range, for example, from about 0.2 mm to about 5 mm, such as, for example, from about 0.2 mm to about 0.5 mm, from about 0.2 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1.5 mm, from about 0.7 mm to about 1.2 mm, from about 0.7 mm to about 1.8 mm, from about 0.9 mm to about 1.4 mm, from about 0.9 mm to about 2 mm, from about 1 mm to about 1.5 mm, from about 1 mm to about 2.4 mm, from about 1.2 mm to about 1.8 mm. In some embodiments, the height h of the antenna coil 106 can be approximately 1.5 mm, 1.7 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, or 2.3 mm.

[0054] In some embodiments, the antenna coil 106 can have an elongated shape, for example, such that a turn diameter t of the antenna coil 106 can be longer than, for example, a height h of the antenna coil 106. However, in other embodiments, the antenna coil 106 can have other shapes, such as, for example, circular, square, etc.

[0055] The antenna core 104 around which the antenna coil 106 may be wound may be made of a biocompatible, non-conductive, non-ferromagnetic material. In other words, the material of the antenna core 104 is neither attracted nor repelled by an externally applied magnetic field. For example, the antenna core 104 may be made of PEEK, ceramic, silicon dioxide (glass), and / or other types of biocompatible plastics. In some embodiments, the antenna coil 104 may be made of a material that can withstand high temperatures (e.g., temperatures ranging up to about 250 degrees Celsius). The antenna core 104 may also be shaped to facilitate the formation of the antenna coil 106 around it. For example, as Figures 1A to 2BAs shown, antenna core 104 may have a notched end 104e into which the turns of antenna coil 106 may be wound. In alternative embodiments, antenna core 104 may not have a notched end. Antenna core 104 may have dimensions configured to support a coil of a desired size and shape. For example, antenna core 104 may have a length around which antenna coil 106 may be wound, ranging from about 4 mm to about 20 mm, such as about 4 mm to about 15 mm, about 4 mm to about 10 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 10 mm, about 9 mm to about 13 mm, about 10 mm to about 15 mm, about 12 mm to about 17 mm, about 15 mm to about 19 mm, or about 16 mm to about 20 mm. In some embodiments, antenna core 104 may have a length of about 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

[0056] In some embodiments, the antenna core 104 can have a width perpendicular to the length of the antenna core 104 (parallel to the width x of the antenna coil 106), and a thickness perpendicular to both the length and width of the antenna core 104 (parallel to the height h of the antenna coil 106). The width and thickness of the antenna core 104 can each range from about 0.5 mm to about 20 mm, such as, for example, about 0.5 mm to about 15 mm, about 0.5 mm to about 10 mm, about 0.5 mm to about 5 mm, or about 0.5 mm to about 3 mm. In some embodiments, each of the width and thickness of the antenna core 104 can be approximately about 0.5 mm, 1 mm, 2 mm, or 3 mm.

[0057] In an alternative embodiment, the antenna 102 may include only the antenna coil 106 without the antenna core 104 , such that the antenna coil 106 is not wrapped around a solid object (eg, it is an air coil surrounding air).

[0058] Chip 110 can be, for example, an integrated circuit (IC) chip. For example, in some embodiments of the present disclosure, chip 110 can be an application-specific integrated circuit (ASIC) chip with or without built-in capacitors. In some embodiments, chip 110 can be integrated with, for example, a printed circuit board (PCB). In some embodiments, chip 110 can be an RFID chip. Chip 110 can be configured to sense, receive, and send a wide variety of data. For example, in some embodiments, chip 110 can be an ASIC designed to sense environmental conditions. For example, chip 110 can be a pressure ASIC. In other embodiments, chip 110 can be combined with one or more gauges (such as physical strain gauges, pressure gauges, or thermometers) configured to sense environmental conditions. In some embodiments, chip 110 can be an ASIC or other type of chip, the chip being programmed with identification data such as a serial number so that when powered, chip 110 returns such identification data. Further examples of sensors and information that can be paired or associated with chip 110 are described herein.

[0059] Although one chip 110 is depicted, in other embodiments, two or more chips may be used in assembly 101. In such cases, the two or more chips may each share a single function, or may each carry different functions, for example, each may carry different identification information or may be paired with a different sensor.

[0060] Chip 110 may include bond pads 112 that may be used to connect chip 110 to antenna coil end 108. Bond pads 112 may, for example, be embedded in an etched surface of chip 110 so that they do not protrude from the surface of chip 110. Bond pads 112 may, for example, be made of a non-magnetic metal such as, for example, gold.

[0061] The antenna coil end 108 may be connected to the bond pad 112 via, for example, heat compression, laser welding, soldering, or crimping. Alternatively, the antenna coil end 108 may be connected to the bond pad 112 by other methods known in the art, such as using a conductive adhesive.

[0062] The vessel 114 can enclose the assembly 101 and the interior space 116 surrounding the assembly 101. The vessel 114 can be made of a biocompatible material such as glass (e.g., silicate glass, such as soda-lime silicate glass) or a biocompatible plastic, for example. The vessel 114 can be the outermost portion of the transponder 100 and can therefore have a size and shape corresponding to the desired size and shape of the transponder 100. Exemplary sizes and shapes of the transponder 100 have been previously disclosed herein. The vessel 114 can, for example, include two pieces that can be assembled around the assembly 101.

[0063] The interior space 116 may be a vacuum, or may contain air, a liquid, a solid, or a gel material. In some embodiments, the interior space 116 may be filled in whole or in part with a liquid, a solid, or a gel material. For example, in some embodiments, the interior space 116 may be filled with a liquid, a solid, or a gel material configured to provide impact resistance to the transponder 100. In some embodiments, the interior space 116 may be filled in whole or in part with an adhesive, such as glue. In such embodiments, the glue may be a biocompatible adhesive, such as an epoxy or an acrylate adhesive. In some embodiments, the glue may be a photocurable acrylate adhesive. In some embodiments, the glue may be an impact-resistant glue. In some embodiments, the glue may be a glue that can be exposed to temperatures up to 250 degrees Celsius and, after cooling to room temperature, may have similar or identical temperature, viscosity, and other properties to those it possesses in the art prior to exposure to temperatures up to 250 degrees Celsius.

[0064] In some embodiments, half of the interior space 116 may be filled with a liquid, solid, or gel material such as the adhesive described above. In other embodiments, at least 30% of the interior space 116 may be filled. In other embodiments, between approximately 30% and 50% of the interior space 116 may be filled. In other embodiments, more than 60% of the interior space 116 may be filled. In other embodiments, between approximately 50% and 100% of the interior space 116 may be filled, such as approximately 55%, approximately 65%, approximately 75%, approximately 85%, approximately 90%, approximately 95%, or approximately 100% of the interior space 116. In further embodiments, between approximately 80% and 100% of the interior space 116 may be filled. In other embodiments, approximately 90% or more of the interior space 116 may be filled. In further embodiments, approximately 95% or more of the interior space 116 may be filled.

[0065] Various configurations of transponders according to the present disclosure may be based on the exemplary transponder 100. For example, the chip 110 may have various configurations and specifications depending on the availability of chips in the art. The configuration of a transponder according to the present disclosure may vary based on, for example, the type of chip used.

[0066] Figure 2A and Figure 2B An example of an alternative embodiment of the transponder 100 is depicted in FIG.

[0067] Figure 2A and Figure 2B A top view of another configuration of a transponder 200 according to the present disclosure is depicted in schematic form ( Figure 2A ) and side view ( Figure 2B). In transponder 200, assembly 118 may include antenna 102, chip 110, capacitor 120 external to chip 110, and base 122 to which chip 112 and capacitor 120 may be attached. Antenna coil end 108 of antenna coil 106 may extend through base 122 or may be attached to electrical conductors extending through base 122 to positive and negative leads of capacitor 120 to complete an electrical circuit with capacitor 120. Wires 123 may connect capacitor 120 to bond pads 112 of chip 110. Vessel 124 may enclose assembly 118 and interior space 116 surrounding assembly 118.

[0068] The capacitor 120 may be separated from the chip 110 and included in the transponder 200. In the transponder 200, the chip 110 may or may not include a built-in capacitor. Figure 2A and Figure 2B As shown, the assembly 118 of the transponder 200 may include a base 122 to which the capacitor 120 and the chip 110 may be mounted and to which the antenna coil end 108 of the antenna 102 may be attached. The base 122 may provide, for example, stability and structure to the assembly 118 and may also serve as a medium through which the capacitor 120 may be connected to the antenna coil end 108 of the antenna 102 and the chip 110 as shown.

[0069] The base 122 can be made of any non-ferromagnetic biocompatible material, such as any material suitable for use in forming the antenna core 104 (e.g., PEEK or other biocompatible plastics). Additionally, in some embodiments, the base 122 can include conductive elements to which the antenna 102, capacitor 120, and / or chip 110 can be connected. For example, in some embodiments, the base 122 can include conductive tracks or pads configured as supporting connections between the antenna coil end 108, the capacitor 120, and the chip 110. In some embodiments, part or all of the base 122 can be a circuit board, such as a printed circuit board.

[0070] like Figure 2A and Figure 2B As shown schematically, antenna coil end 108 can be attached to base 122 by, for example, heat compression, welding, soldering, crimping, or other known types of attachment. Similarly, capacitor 120 can be connected to base 122 by, for example, heat compression, welding, soldering, etc. Connectors can extend through base 122 from one attached antenna coil end 108 to the positive lead of capacitor 120, and from the other attached antenna coil end 108 to the negative lead of capacitor 120. Capacitor 120 can also be connected to chip 110, which can also be attached to base 122, by, for example, wires 123 attached to bond pads 112 by, for example, heat compression, welding, soldering, crimping, or other types of attachment known in the art.

[0071] In other embodiments, the assembly 118 of the transponder 200 may not include the base 122. In such embodiments, the antenna coil end 108 may be directly connected to the capacitor 120 by, for example, thermocompression, welding, soldering, crimping, etc., and the capacitor 120 may be connected to the chip 110 in a similar manner. As with the transponder 100, the antenna 102 in the transponder 200 may or may not include the antenna core 104.

[0072] exist Figure 2A and Figure 2B In the embodiment shown, vessel 124 can be similar in construction to vessel 114. In some embodiments, depending on the size and shape of capacitor 120, vessel 124 may need to be larger than vessel 114 in order to accommodate capacitor 120. Similarly, interior space 124 of transponder 200 can be larger than interior space 116 of transponder 100. Interior space 124 can be a vacuum or can be filled with a variety of substances, as already disclosed with respect to interior space 116.

[0073] In some embodiments of transponders according to the present disclosure (e.g., transponders 100, 200), the transponder may not be enclosed in a vessel (e.g., having an interior space). Instead, in some embodiments, the transponder (e.g., transponder 100, 200) may only include components such as assemblies 101, 118.

[0074] In some embodiments of transponders according to the present disclosure, the chip of the transponder (e.g., chip 110) may not have built-in capacitors. In such embodiments, a capacitor external to chip 110 (e.g., capacitor 120) may be used as a primary energy storage device, for example, to power a chip such as chip 110. In other embodiments, such as embodiments in which the chip (e.g., chip 110) does not have built-in capacitors, the added capacitor (e.g., capacitor 120) may provide additional power to the chip, allowing the chip to be powered for a longer period of time or to supply a greater amount of power than would be possible with only built-in capacitors, such as those internal to chip 110. The added capacitor 120 in transponder 200 may, for example, allow transponder 200 to store a greater amount of electrical energy than would be possible with a transponder without capacitor 120.

[0075] According to the present disclosure, a transponder (such as Figures 1A to 2BThe transponders 100, 200 shown may be configured, for example, to transmit data via low-wavelength RF coupled communication. For example, data may be communicated via RF low-wave transmission having a frequency range of about 100 kHz to about 400 kHz, such as about 200 kHz to about 300 kHz, about 100 kHz to about 200 kHz, about 120 kHz to about 150 kHz, about 125 kHz to about 145 kHz, or about 130 kHz to about 135 kHz. In some aspects, the communication frequency of component 101 may be about 134.2 kHz.

[0076] Transponders according to the present disclosure (such as transponders 100, 200) can be suitable for temporary or permanent implantation with an implantable medical device. For example, one or more transponders according to the present disclosure can be partially or completely encapsulated in a biocompatible material and integrated into a medical device. Exemplary biocompatible materials include silicone and other polymers and polymer coatings suitable for temporary or permanent medical implantation. In some aspects of the present disclosure, the transponder can be placed between two portions of silicone that form a biocompatible envelope around the transponder.

[0077] Transponders according to the present disclosure, such as transponders 100 and 200, can be incorporated into the interior space of a medical device or attached to an interior or exterior surface of a medical device. In some aspects, the medical device can be a breast implant or tissue expander, and one or more transponders can be suspended within the breast implant or tissue expander. In other aspects, one or more transponders can be attached to the interior or exterior surface of the housing or exterior wall of the breast implant or tissue expander, or can be incorporated into the housing or exterior wall of the breast implant or tissue expander, for example, between layers comprising the housing or exterior wall of the breast implant or tissue expander. In at least one example, one or more transponders can be permanently attached or encapsulated in a silicone plastic case and integrated into the tissue expander or medical implant by dielectrically sealing or bonding the one or more encapsulated transponders to the housing of the tissue expander or medical implant. In some examples, one or more transponders encapsulated in silicone can be placed within the interior volume of the tissue expander or medical implant, for example, such that the one or more transponders are free-floating within the interior volume or suspended in the material filling the interior volume of the tissue expander or medical implant.

[0078] According to some aspects of the present disclosure, a medical device may include multiple transponders (e.g., transponders 100, 200), for example, 2, 3, 4, 5, or 6 or more transponders. Each transponder may be separated from one or more other sensors by a predetermined spatial interval. Such a combination of transponders in a medical device can be used to determine orientation information, such as a change in the orientation of the medical device, a displacement of the medical device, a change in the amount of material between the transponders, and / or a change in the physical or chemical properties of the material between the transponders. Such changes can be determined, for example, by measuring the impedance between two or more transponders.

[0079] Furthermore, for example, two or more medical devices implanted in a patient may include transponders capable of communicating and / or providing information about each other. For example, in a patient with two breast implants, each implant may include one or more transponders that communicate with one or more transponders in the other implant. Additionally or alternatively, the one or more transponders in each implant may be configured to provide data about common anatomical features of the patient and / or a common reference point in one of the implants.

[0080] Transponder 100,200 can be, for example, active, passive, or both active and passive.With regard to permanent implants or medical devices for relatively long-term implantation, passive transponders can avoid the problem of possible corrosion properties of certain materials (e.g., different materials) used in the design of power battery recharging, cycle life and / or active sensor batteries. Transponder can be actively and / or passively transmitted, received, stored and / or analyzed data. For example, data can be transmitted from transponder to an external reader (outside the implant) configured to receive and / or analyze or otherwise process data via radio frequency. This paper further discloses an exemplary embodiment of such reader. Such reader can be implanted in the patient, or can be outside the patient and attached or not attached to the patient. According to some aspects of the present disclosure, data can be transferred between transponder (e.g., transponder 100,200) and reader within a distance of about 10 feet separating the transponder from the reader, said distance being about 7 feet, about 5 feet, about 3 feet or about 1 foot. For example, in some aspects of the present disclosure, a transponder (e.g., transponder 100, 200) may be configured to transmit and / or receive information within a range of about 1 inch to about 5 feet, about 2 inches to about 3 feet, about 3 inches to about 1 foot, about 2 inches to about 9 inches, about 4 inches to about 8 inches, or about 4 inches to about 6 inches.

[0081] A transponder (e.g., transponder 100, 200) can be configured to detect and / or measure various stimulus factors or parameters. For example, a transponder according to the present disclosure can be configured to detect and / or measure one or more of acoustic data, temperature, pressure, light, oxygen, pH, motion (e.g., accelerometer), circumferential rotation (e.g., gyroscope sensor), or any other physiological parameter using sensors known in the art coupled to a chip of the transponder (e.g., chip 110 of transponder 100, 200). For example, an exemplary pH sensor may include a measuring electrode, a reference electrode, and a temperature sensor. The sensor may include a preamplifier and / or an analyzer or transmitter to facilitate display of the data. In some aspects, the sensor may be configured to determine the position and orientation of an implanted medical device, for example, to evaluate any inappropriate changes in position or orientation after initial implantation.

[0082] A sensor can be calibrated with an appropriate reference or standard to provide accurate measurements, or absolute or relative changes in values. For example, a temperature sensor can be calibrated based on one or more reference temperatures, and a pressure sensor can be calibrated to indicate changes in pressure.

[0083] In some instances, an implantable medical device may include a transponder and / or sensor package comprising a transponder in combination with one or more other transponders, sensors, and / or additional electronic components. The one or more transponders, one or more sensors, and multiple electronic components may be coupled together or otherwise communicate with each other. For example, an exemplary transponder and / or sensor package may include one or more transponders coupled to one or more sensors for measuring pressure, temperature, acoustic data, pH, oxygen, light, rotational motion, or circulation, or a combination thereof. The transponder and / or sensor package may include a single integrated circuit coupled together via a PCB or fully integrated into an ASIC.

[0084] The transponders of the present disclosure (e.g., transponders 100, 200) can be read / write, for example, where data can be written into each transponder by a user or otherwise associated with each transponder so as to be read by a suitable device such as an external reader. Such data may include a unique device identifier for the transponder, transponder and / or sensor package and / or medical device. The information provided by the unique device identifier may include, for example, one or more serial numbers, one or more manufacturer names, one or more manufacturing dates, one or more batch numbers and / or dimensions of the medical device and / or one or more sensors. For example, one or more transponders associated with a breast implant (e.g., transponders 100, 200) may include information about the dimensions of the implant (e.g., size and / or volume), manufacturer, manufacturing date and / or batch number. Additionally or alternatively, one or more transponders associated with a breast implant (e.g., transponders 100, 200) may include information about one or more transponders and / or one or more sensors paired with the one or more transponders, such as the type of data collected / measured, the manufacturer of the implant, the date of manufacture and / or one or more serial numbers of the implant and / or implant packaging, the type, dosage and / or composition of auxiliary coatings or materials used with the implant, and the like.

[0085] Integrating an acoustic sensor with a transponder (e.g., transponder 100, 200) into an implantable medical device can enhance auscultation, for example, allowing monitoring and / or inspection of the circulatory system (e.g., via heart sounds related to cardiac output or structural defects / disorder), the respiratory system related to lung function (e.g., via breathing sounds), and / or the gastrointestinal system related to obstruction and ulcers (e.g., via bowel sounds). Acoustic sensors may include levers and MEMS (micro-electromechanical systems) devices. In addition to other types of acoustic sensors, examples of acoustic sensors that can be used herein include, but are not limited to, accelerometers (e.g., measuring vibration noise), thermal sensors (e.g., measuring thermomechanical noise), and piezo-capacitive sensors. The acoustic sensor can be operated manually when powered (e.g., when the transponder paired with the sensor is coupled to a reader). A capacitor (e.g., capacitor 120 in transponder 200 or a built-in capacitor in chip 110) and / or a battery may allow a transponder (e.g., transponders 100, 200) to acquire information and store information and transmit data when interrogated or coupled to another electronic device.

[0086] In addition, transponders according to the present disclosure can be configured to enhance acoustic data. The enhanced acoustic sound may include an algorithm that is trained with known sounds to provide a reference for the amount or degree of change and / or to eliminate non-significant noise (e.g., a signal that may be an artifact of the measurement technique) that may interfere with generating a "clean" signal that provides meaningful information about the patient. Such an algorithm can be loaded onto a chip (e.g., chip 110) of a transponder (e.g., transponder 100, 200).

[0087] As described above, transponders such as transponders 100 and 200 can be configured to communicate with an external reader to process the data, for example, by filtering noise from the raw data. For example, the transponder can be used in conjunction with an algorithm that organizes and analyzes filtered data, for example, raw data acquired from a sensor in a minimal transmission (threshold) format based on pre-programmed parameters (e.g., data obtained from a reference table). Such algorithms can be designed to combine relevant integrated data that is specific to providing appropriate signals indicating mechanical or clinical problems, which can then be processed by the reader. The reader is described in more detail elsewhere in this disclosure. The reader can include a graphical display such as an LED display and can have parameters established in the reader's firmware to present data output on the display and / or provide notification signals. For example, the notification signal can be a recommendation displayed on the reader for the patient to contact his / her caregiver or clinician to follow up on a specific action item. For example, the reader can recommend that a specific aspect of the implanted medical device be reviewed or modified (e.g., adding more saline solution to a tissue expander via a syringe, etc.).

[0088] Other uses, systems, and combinations of transponders, sensors, and readers are disclosed elsewhere herein.

[0089] Integrated port assembly and locator coil

[0090] The present disclosure also includes low-artifact transponders that can be used to locate specific parts or features of implanted medical devices. For example, some implanted medical devices may require modification or adjustment after implantation. As an example, a tissue expander can be used during breast reconstruction or augmentation surgery to gradually expand breast tissue over time so that the tissue can accommodate a more permanent implant. Tissue expanders according to the present disclosure can also be used for procedures other than breast augmentation and reconstruction.

[0091] The tissue expander can be inflated manually and / or electronically, for example, with a syringe or other suitable device to introduce and withdraw a fluid (e.g., a liquid or gaseous fluid) or gel into and out of the tissue expander. The tissue expander can be inflated with a saline solution that can be supplied in a sterile bag, such as a sterile bag from Lab Products, Inc. product. In some aspects, inflation can be performed wirelessly, for example, by communicating with an internal sleeve or air cylinder of compressed air.

[0092] According to some aspects of the present disclosure, a tissue expander can include one or more pressure sensors and / or one or more strain gauges that can be coupled with, for example, a transponder (e.g., transponders 100, 200). Such sensors can allow for continuous and / or intermittent measurement of pressure in order to optimize, regulate, and / or wirelessly control expansion and contraction of such tissue expanders. A transponder / sensor package for a tissue expander (including, for example, sensors for measuring pressure, temperature, acoustic data, pH, oxygen, light, or combinations thereof) can be contained in a silicone molded housing. In at least one example, a tissue expander can include at least one of a pressure sensor or a strain gauge coupled to or embedded in an outer wall (shell) of the tissue expander. In some aspects, a tissue expander can include a sensor / transponder package (including, for example, sensors for measuring pressure, temperature, acoustic data, pH, oxygen, light, or combinations thereof) that can have a fixed position relative to the tissue expander. Such a sensor / transponder package can be paired with a reader, which is described in greater detail elsewhere in the present disclosure.

[0093] A tissue expander can include a port through which fluid can be injected into the tissue expander after the tissue expander has been implanted in a patient. The port can be located within an aperture in the shell of the tissue expander, the aperture sized to fit the port. Thus, the port can be implanted with the tissue expander and can not be immediately detectable from the outside of the patient. Advantageously, a transponder and / or coil according to the present disclosure can be combined with, for example, a tissue expander port and valve assembly in order to facilitate detection of the port and valve assembly. By mounting a transponder and / or antenna coil within a tissue expander port or valve assembly, a physician can be able to non-invasively identify the proper location of the port in order to inject a saline solution into a patient in which the tissue expander is implanted. As with transponders 100, 200, such a transponder, antenna coil, and / or valve assembly can be made of a material that replaces ferromagnetic materials that can cause imaging artifacts under magnetic resonance imaging. For example, a transponder, coil, and / or associated valve assembly disclosed herein can comprise a non-ferromagnetic material, such as polyether ether ketone (PEEK) or other plastic.

[0094] Figures 3A to 3C An exemplary valve assembly 300 according to the present disclosure is shown, which includes a housing 302, a coil 304, and a chip 306 attached to the coil 304. Figure 3A A three-dimensional view of the valve assembly 300 is depicted, Figure 3B A side view of the valve assembly 300 is depicted, and Figure 3CA top view of the valve assembly 300 is depicted. The housing 302 may have a circular well portion 308 in which the coil 304 and the chip 306 are housed. The well portion 308 may have a lip 309 with a wall 309A that protrudes inwardly on the well portion 308. The housing 302 may also include an inner chamber 307 centered within the well portion 308 and surrounded by a wall 311. A circumferential inner lug 323 may protrude into the inner chamber 307. Figure 3B As shown, a portion of the inner chamber 307 can extend to a greater depth than the well portion 308, such that the housing 302 has a central portion 312 that protrudes from the remainder of the housing 302 into a medical implant (e.g., a tissue expander). The central portion 312 can have a reinforced tip 315 at its distal-most end. One or more fluid holes 314 can extend from the inner chamber 310 through the central portion 312. The housing 302 can also have a circumferential outer ledge 317 surrounding the wall 311. The outer ledge 317 can include one or more notches 319.

[0095] The valve assembly 300 can be configured to be mounted within the housing of a tissue expander. The valve assembly 300 can be made of a biocompatible, non-magnetic, non-ferromagnetic material, such as molded PEEK. The valve assembly 300 can have sufficient rigidity to prevent puncture by a cannula, such as a syringe cannula used to inject fluid into the tissue expander in which the valve assembly 300 is mounted. The valve assembly 300 can be sized and shaped to allow the coil 304 to fit within the circumference of the valve assembly 300.

[0096] The coil 304 can be a wound radio frequency (RF) antenna coil made of, for example, a metal wire, such as copper or aluminum wire. In some embodiments, the coil 304 can be made of, for example, an enameled wire coated in a polymer. Suitable polymers can include, for example, polyvinyl formal (Formvar), polyurethane, polyamide, polyester, polyester-polyimide, polyamide-polyimide (or amide-imide), and polyimide. In some embodiments, the coil 304 can be made of an enameled copper wire, such as Elektrisola enameled copper wire.

[0097] The coil 304 can be sized and shaped to encircle a core or center portion through which a cannula can be passed into the central chamber 307 of the valve assembly 300. The coil 304 can also be sized and shaped to be detected by, for example, a reader configured to detect the center of the wound coil. In this way, the coil 304 can serve as a "targeting element" for a reader, for example, for searching for a valve assembly (e.g., valve assembly 300). In some embodiments, the coil 304 can have a regular hollow cylindrical shape, and its outer diameter can range from, for example, about 10 mm to about 50 mm, such as, for example, about 10 mm to about 40 mm, about 15 mm to about 25 mm, about 20 mm to about 35 mm, or about 22 mm to about 27 mm. For example, in some embodiments, the outer diameter of the coil 304 can be about 24 mm, about 24.6 mm, about 25 mm, about 25.3 mm, about 26 mm, or about 26.2 mm.

[0098] In some embodiments, the inner diameter of the coil 304 can range from about 10 mm to about 50 mm, such as, for example, about 10 mm to about 40 mm, about 10 mm to about 35 mm, about 15 mm to about 35 mm, about 15 mm to about 30 mm, about 15 mm to about 25 mm, or about 18 mm to about 22 mm. For example, in some embodiments, the inner diameter of the coil 304 can be about 18 mm, about 19 mm, about 19.5 mm, about 20 mm, about 20.1 mm, about 20.3 mm, about 20.4 mm, about 20.5 mm, about 20.6 mm, about 20.7 mm, about 21 mm, or about 22 mm.

[0099] In some embodiments, the height of the coil 304 can range from about 1 mm to about 20 mm, such as about 1 mm to about 15 mm, about 1 mm to about 13 mm, about 1 mm to about 10 mm, about 1 mm to about 8 mm, about 1 mm to about 5 mm, or about 1 mm to about 4 mm. For example, in some embodiments, the height of the coil 304 can be about 1 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.5 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.2 mm, about 3.4 mm, about 3.6 mm, about 3.8 mm, about 3.9 mm, or about 4.0 mm.

[0100] The coil 304 can be formed from any number of turns sufficient to be sensed by an external reader (e.g., reader 800, further described herein). For example, in some embodiments, the coil 304 can be formed from about 10 to about 2000 turns. For example, in some embodiments, the coil 304 can be formed from, for example, about 100 to about 1500 turns, about 500 to about 1100 turns, or about 800 to about 1000 turns. For example, in some embodiments, the coil 304 can be formed from, for example, about 500, about 700, about 800, about 1000, about 1100, or about 1200 turns.

[0101] Chip 306 can be an RF chip known in the art, such as, for example, a chip described elsewhere herein (e.g., chip 110). Generally, the disclosure herein with respect to chip 110 also applies to chip 306. For example, in some embodiments, chip 306 can be an ASIC. Chip 306 may or may not include a capacitor. In some embodiments, chip 306 can be an ASIC programmed with identification data, such as a serial number, such that when powered, chip 110 will return such identification data. In some embodiments, chip 306 can be a sensor, or can be paired with a sensor, as described elsewhere herein with respect to chip 110. In alternative embodiments of valve assembly 300, chip 306 may not be present. In such cases, coil 304 can serve primarily as a targeting element to assist in positioning valve assembly 300.

[0102] The housing 302 of the valve assembly 300 can be sized and shaped to accommodate the coil 304 and the chip 306 within the well 308 and the inner chamber 307. The well 308 of the valve assembly 300 can have a generally circular shape to accommodate the coil 304 and, for example, the chip 306 connected to the coil 304. Figures 3A to 3C 304 and chip 306 can be enclosed and sealed from the rest of the valve assembly 300 by, for example, a biocompatible material, such as the biocompatible material of which the body of the housing 302 is made (e.g., PEEK) or another biocompatible material (e.g., silicone).

[0103] A lip 309 that may protrude on the well portion 308 may be configured to interlock with, for example, a dome that may cover the valve assembly 300. Such a dome may be, for example, an integrated port dome 310, which may be used in, for example, Figure 4 In alternative embodiments, lip 309 may protrude in a different direction (e.g., outward and away from well 308), or may include interrupted protrusions for attachment to, for example, a dome that may cover valve assembly 300 in a different manner.

[0104] Inner chamber 307 is radially inside coil 304 and well 308. In some embodiments, inner chamber 307 can be cylindrical, bowl-shaped, or both. In some embodiments, inner chamber 307 can have a depth that is deeper than, for example, well portion 308, such that some or all of the inner chamber can extend into central portion 312, which can protrude below the rest of housing 312 (e.g., well portion 308), as shown, for example, in FIG. 3B. Inner chamber 307 can be configured to receive, for example, fluid from, for example, a cannula, syringe, or other fluid injection device. Fluid aperture 314 can extend from inner chamber 307 through housing 302 and out of central portion 312, such that fluid can pass from inner chamber 307 through fluid aperture 314 and into, for example, a medical implant in which valve assembly 300 is installed. In some embodiments, fluid aperture 314 can include a valve, for example, a one-way valve (e.g., duckbill valve), configured to allow fluid to pass outward from inner chamber 307 into, for example, a medical implant, and not back into inner chamber 307. The bottom surface of inner chamber 307 can be reinforced by inner tip 315 in order to prevent penetration by, for example, a cannula, syringe, or other injection device. Figure 3B and Figure 4

[0105] Figure 4 A side view of integrated port assembly 400 is depicted, which can include valve assembly 300 (presented in cross-section) and integrated port dome 310. Integrated port dome 310 can include a step 316, which can be configured to fit against the edge of an aperture in a wall of an implant in which integrated port assembly 400 can be installed, such that patch portion 314 is on the implant wall. Integrated port dome 310 can also have a flange 312, which can be configured to interlock with lip 309 of valve assembly 300, thereby connecting valve assembly 300 to integrated port dome 310. Patch portion 314 is wider than flange 312 and valve assembly 300.

[0106] ​The integrated port dome 310 can be made of a biocompatible material suitable for interacting with patient tissue and with the surface of an implant in which the integrated port assembly 400 can be installed. Some or all of the integrated port dome 310 can be made of a material that can be penetrated by, for example, a cannula, a syringe, or other injection device, such that the injection device can penetrate the integrated port dome 310 and inject fluid into the internal chamber 307 of the valve assembly 300. In some embodiments, the integrated port dome can be made of a self-sealing material such that when an injection device penetrates the integrated port dome 310 and the injection device is subsequently removed, the integrated port dome will seal the penetration site and prevent fluid from escaping from the valve assembly 300. In some embodiments, the integrated port dome 310 can be made of a silicone material. For example, in some embodiments, the integrated port dome 310 can be made of a vulcanizable silicone material.

[0107] The size and shape of the integrated port dome 310 can be set to, for example, securely interlock with the valve assembly 300. As depicted in, for example, Figure 5B and Figure 5C , the size and configuration of the flange 312 of the integrated port dome 310 can be further set to cover any openings in the well recess portion 308 of the valve assembly 300 when interlocked with the lip 309 of the valve assembly 300, thereby sealing the coil 304 (and the chip 306) within the well recess 308 and preventing the coil 304 and the chip 306 from being exposed to fluid.

[0108] Figure 5A , Figure 5B and Figure 5C depicts an integrated port assembly 400 installed in an example implant housing 500. The implant housing 500 can be, for example, a housing of a tissue expander, as shown in Figure 5A In some embodiments, the implant housing can be made of silicone; however, an implant housing of any biocompatible material can be used along with the integrated port assembly 400. The integrated port assembly 400 can be installed in an aperture 502 of the implant housing 500. The valve assembly 300 of the integrated port assembly can be located inside the implant housing 500. The integrated port dome 310 can be attached to the valve assembly 300, and the patch portion 314 can be located outside the implant housing 500. In Figure 5A , the patch portion 314 of the integrated port dome 310 is depicted by dashed lines, showing how the integrated patch portion 314 can overlap some surface areas of the implant housing 500. Other portions of the integrated port dome 310 are not shown in order to depict the valve assembly 300. In some embodiments, the patch portion 314 and the implant housing 500 can be attached to each other, for example, by vulcanization, adhesion, or other methods.

[0109] Figure 5BA cross-sectional view of the integrated port assembly 400 is depicted installed in the implant housing 500. Figure 5B As shown, the edge of the aperture 502 of the implant housing 500 can be angled in a manner complementary to the angle of the step 316 of the integrated port dome 310 so as to fit snugly against the step 316. In this manner, and in combination with the overlap and attachment of the patch portion 314 to the implant housing 500, the integrated port assembly 400 can be sealed and secured within the aperture 502 of the implant housing 500.

[0110] Figure 5C Describing and Figure 5B A cross-sectional view of the same integrated port assembly 400 installed in an implant housing 500. Figure 5C Also depicted is how an exemplary cannula 504 penetrates the integrated port dome 310 to reach the inner chamber 307. The cannula 504 can be configured to deliver fluid into the inner chamber 307 and subsequently to the interior of the implant shell 500. As previously described, the integrated port dome 310 can be made of a self-sealing material, such as a silicone material, such that when the cannula 504 is withdrawn, the integrated port dome 310 seals the fluid within the inner chamber 307 and the implant shell 500.

[0111] Figure 6 Another exemplary integrated port assembly 600 is depicted, which may include a valve assembly 610 and an integrated port dome 620. The valve assembly 610 may include a main chamber 612 surrounded by a wall 615 having a lip 619. The lip 619 has an inner edge 619E. The main chamber 612 may have a top opening defined by the edge 619E, which is configured to face the integrated port dome 620 and may accommodate a stopper 621 of the integrated port dome 620. The wall 615 of the main chamber 612 may have one or more fluid holes 618 that may exit the valve assembly 610 from the main chamber 612. The coil 616 may be located in a coil housing 614 separated from the main chamber 612 by a needle stop surface 617, such that the coil 616 is centered below the main chamber 612. The integrated port dome 620 can have a patch 622 that can have a width wider than the plug 621 and the valve assembly 610 and can be integral with the plug 621. A flange 626 between the patch 622 and the plug 621 can be configured to receive and interlock with the lip 619 of the valve assembly 610. The integrated port dome 620 can also have a step 624 that is configured to interface with a wall of the implant in which the integrated port assembly 600 can be mounted.

[0112] Generally speaking, aspects of the integrated port assembly 600 can be similar to aspects of the integrated port assembly 400. For example, in some embodiments, the valve assembly 610 can be made of any material from which the valve assembly 300 can be made, such as a biocompatible, non-ferromagnetic material such as PEEK. Furthermore, the main chamber 612 of the valve assembly 610 can have a function similar to the inner chamber 307 of the valve assembly 300, in that the main chamber 612 can be sized, shaped, and configured to receive fluid from, for example, a cannula, a syringe, or other fluid deposition device. The inner surface 617 of the main chamber 612 can be configured to prevent or resist puncture by, for example, a cannula depositing fluid within the main chamber 612. For example, the inner surface 617 can be made of a material having a density, hardness, or thickness configured to prevent or resist puncture by a fluid deposition device. In some embodiments, the main chamber 612, including the inner surface 617, can be made of biocompatible PEEK.

[0113] Coil 616 is similar to coil 304 in terms of size, shape, configuration, material, and construction, which was previously described above with respect to Figures 3A to 5C Disclosed. Coil 616 can be housed in coil housing 614. In some embodiments, coil housing 614 can be sealed closed so that fluid cannot enter or leave coil housing 614. In some embodiments, as shown, coil housing can be cylindrical and can be coaxial with main chamber 612 so that coil 616 is also coaxial with main chamber 612. In this way, the position of coil 616 can be used to locate the center or approximate center of main chamber 612. Coil housing 614 is depicted as having a circumference smaller than, for example, main chamber 612. However, in some embodiments, coil housing 614 can have a circumference as large as or almost as large as main chamber 612.

[0114] Although not shown, coil 616 may be coupled to a chip similar to chip 306 connected to coil 304. Such a chip may have any of the features and capabilities of the chips otherwise disclosed herein.

[0115] The integrated port dome 620 can be similar in shape, structure, and materials of construction to the integrated port dome 310 of the integrated port assembly 400. For example, the plug 621 of the integrated port dome 620 can be sized and shaped to snugly interlock with, for example, the lip 619 of the main chamber 612. Like the integrated port dome 310, the integrated port barrel 620 can be made of a biocompatible material (e.g., silicone) that has self-sealing capabilities.

[0116] Figure 7A and Figure 7B A three-dimensional view of the integrated port assembly 600 is shown. In particular, Figure 7AThe integrated port assembly is depicted installed within an opening 702 in an implant housing 700. As with the integrated port assembly 400 and implant housing 500, the edge of the opening 702 in the implant housing 700 can be angled in a manner complementary to the angle of the step 624 of the integrated port dome 620 so as to fit snugly into the step 624. Figure 7A and Figure 7B In both, the location of the coil 616 is indicated by dashed lines within the coil housing 614. The integrated port dome 620 can be attached to the outer surface of the implant housing 700 to form a seal therebetween.

[0117] The integrated port assemblies disclosed herein, such as integrated port assemblies 400, 600, may be used as, for example, refill ports in implants such as tissue expanders that need to be filled and / or refilled. Figures 10A to 10C Further description.

[0118] Implants (e.g., tissue expanders) having an integrated port assembly (e.g., integrated port assembly 400, 600) may further include one or more electronic components for controlling changes to the implant, such as, for example, inflation or deflation of the tissue expander via the integrated port assembly (e.g., integrated port assembly 400, 600). In some aspects, tissue expanders having an integrated port assembly such as those disclosed herein may also include a means for remote filling / inflation via the integrated port assembly.

[0119] In some aspects of the present disclosure, inflation and deflation may be performed automatically according to one or more algorithms or predetermined parameters, and / or may be controlled by user input, such as instructions provided via a user interface of a tablet computer or other electronic device that wirelessly communicates with the sensor package. In at least one example, inflation / deflation may be controlled according to parameters set in the reader and indicated in an LED display output. The reader according to the present disclosure is described in more detail below.

[0120] Platform Reader

[0121] The present disclosure also includes readers for use with the transponders, sensors, and integrated port assemblies disclosed herein. In general, the transponders and integrated port assemblies disclosed herein are compatible with a variety of commercially available RF readers. In addition, readers compatible with various types of transponders and coils are disclosed herein, which are capable of sending and / or receiving signals at varying degrees of strength and at varying frequencies. A platform reader is disclosed herein that, in order to detect a given transponder or coil, can scan frequency broadcast signals, receive signals at varying degrees of strength, and adjust the broadcast signal to correspond to the strongest received signal in order to best pick up a return signal from a given transponder or coil.

[0122] Figure 8 A block diagram of components of an exemplary platform reader 800 according to the present disclosure is shown. The platform reader 800 includes a microcontroller 802 that may have one or more USB connections 804 and a display 806. The platform reader 800 may also include one or more power supplies 808 connected to the microcontroller 802. The microcontroller 802 may control a clock generator 810, which in turn may control a driver / amplifier 812. The driver / amplifier 812 may be connected to an antenna 814. The antenna 814 may be connected to a transformer 816, which in turn may be connected to an analog front end 818. An analog-to-digital converter (ADC) 820 may be connected to the analog front end 818 and the microcontroller 802.

[0123] The antenna 814 may also be connected to a logarithmic amplifier 824. The pick-up antenna 822 may also be connected to the logarithmic amplifier 824.

[0124] The microcontroller 802 can be, for example, a small computer on an integrated circuit that can receive data from a variety of components and can also instruct the various components to perform their functions. For example, the microcontroller 802 can include one or more computer processing units (CPUs), as well as memory and programmable input / output peripherals. The microcontroller 802 can receive input and instructions, for example, via a digital connection, which can be, for example, a USB connection 804. In alternative embodiments, the USB connection 804 can be another type of connection, such as an eSATA connection, a FireWire connection, an Ethernet connection, or a wireless connection. The connection 804 can connect the microcontroller 802 to an input / output device, such as a computer, that can program the microcontroller 802.

[0125] The microcontroller 802 may also have a display 806, which may be, for example, an LED display. The display 806 may be configured to display calculations, inputs, outputs, and instructions sent and received by the microcontroller 802. In some embodiments, the display 806 may be configured to display instructions or inputs received via, for example, the connection 804. In alternative embodiments, the display 806 may simply be a series of display lights. In other alternative embodiments, the display 806 may be a non-LED display, such as an LCD display or other display.

[0126] The platform reader 800 may also include one or more power supplies 808. The power supplies 808 may include any type of power supply compatible with the elements of the platform reader 800, including, for example, an AC power supply, a DC power supply, a battery power supply, etc. Figure 8 , the power supply 808 is shown as being connected to the microcontroller 802. However, in other embodiments, the power supply may additionally or alternatively be connected to any other component of the platform reader 800.

[0127] Microcontroller 802 may be connected to a clock generator 810, which in turn may be connected to a driver / amplifier 812. Clock generator 810 may be a circuit that provides a timing signal having a precise frequency and / or wavelength, through which microcontroller 802 may instruct driver / amplifier 812 to output a wave of broadcast signals at a desired rate or interval. Driver / amplifier 812 may include, for example, a driver that generates an RF signal and an electronic amplifier that generates a low-power RF signal and amplifies it to a higher-power signal. Driver / amplifier 812 may include, for example, any type of RF driver / amplifier known in the art, such as a solid-state or vacuum tube amplifier.

[0128] The driver / amplifier 812 can be connected to an antenna 814. The antenna 814 can be, for example, an RF antenna. In one aspect, the antenna 814 can be connected to a transformer 816, which in turn is connected to an analog front end 818 and an ADC 820. The transformer 816, the analog front end 818, and the ADC 820 can be configured to receive and process signals (e.g., a carrier signal and a modulated signal) from the antenna 814 and convert them into digital values ​​for return to the microcontroller 802. In particular, the transformer 816 can be configured to transform the received high-voltage signal from the antenna 818 and convert it to a voltage that can be processed by other components of the reader 800 (e.g., the analog front end 818, the ADC 820, and / or the microcontroller 802) without damaging the other components. The analog front end 818 can be configured to filter out portions of the received and transformed signal from the transformer 816. For example, the analog front end 818 may be configured to process the received signal such that a carrier signal having the same wavelength and / or frequency as the signal broadcast by the antenna 814 is removed, thereby leaving only the modulated signal (e.g., a signal modulated by a transponder receiving and returning a signal from the antenna 814). The ADC 820 may be configured to convert the filtered modulated signal into a digital value.

[0129] The antenna 814 may also be connected to a logarithmic amplifier 824, which may also be connected to an optional pickup antenna 822. The pickup antenna 822 may serve as an additional antenna configured to assist in picking up weak signals. Weak signals received by the antenna 814 or the pickup antenna 822 may be amplified by the logarithmic amplifier 824 and passed to the ADC 826. The logarithmic amplifier 824 may be an amplifier configured to receive weak signals and amplify them on a logarithmic scale so that they can be processed by the ADC 826 and the microcontroller 802. The ADC 826 may be configured to convert the signals received from the logarithmic amplifier 824 and provide them to the microcontroller 802, which may be configured to evaluate the strength of the signals received from the ADC 826. In this manner, the platform reader 800 may be able to evaluate and process signals across a wide range of signal strengths.

[0130] In some embodiments of the reader 800, the microcontroller 802 may be connected directly to the driver / amplifier 812, for example. In such embodiments, the microcontroller 802 may be configured to provide the signal frequency and wavelength directly to the driver / amplifier 802, without the clock generator 810 generating the signal.

[0131] The elements of the reader 800 may be permanently or removably connected to each other. For example, the antenna 814 and / or the pickup antenna 822 may be removably connected to other elements of the reader 800.

[0132] Figure 9The steps of a method 900 for broadcasting a signal with a frequency optimized for a given transponder are depicted in block diagram form. The method 900 can be performed using, for example, a platform reader 800. According to step 900, a clock generator can be used to continuously provide a frequency sweep range to a signal driver / amplifier. According to step 904, a signal driver / amplifier can be used to continuously broadcast a signal with a provided frequency sweep range via a main antenna. According to step 906, the return signal of the transponder within the range of the main antenna can be continuously monitored via the main antenna. According to step 908, it can be determined whether any return signal is weak or does not exist. If not (i.e., if the return signal is strong), then according to step 910, a transformer can be used to continuously convert the return signal into a voltage difference. If so, then according to step 912, a pickup antenna can be used to continuously monitor weaker signals, and according to step 914, a logarithmic amplifier can be used to amplify the signals received by the pickup antenna and convert them into a voltage difference. At step 916, the voltage difference (converted in step 910 or step 914) can be continuously converted into a digital value using an analog-to-digital converter and the digital value can be transmitted to the microcontroller. At step 918, the microcontroller can be used to determine the highest received digital signal. At step 920, the microcontroller can be used to determine the frequency of the broadcast signal corresponding to the highest received digital signal. At step 922, the microcontroller can be used to instruct a clock generator to provide the determined frequency to the signal driver / amplifier. At step 924, the signal driver / amplifier broadcasts the signal having the determined frequency.

[0133] According to method 900, a clock generator can be used to continuously provide a frequency sweep range to a signal driver / amplifier. For example, with respect to platform reader 800, microcontroller 802 can provide instructions to clock generator 810 to provide a frequency sweep range to signal driver / amplifier 812. The frequency range can be, for example, about 80 kHz to about 400 kHz. For example, in some embodiments, the frequency range can be, for example, about 80 kHz to about 300 kHz, about 100 kHz to about 250 kHz, about 100 kHz to about 200 kHz, about 110 kHz to about 150 kHz, about 110 kHz to about 140 kHz, or about 120 kHz to about 150 kHz. In some embodiments, the frequency sweep frequencies can include commonly used or standardized frequencies, such as, for example, about 125 kHz and / or 134.2 kHz. In some embodiments, the frequency sweep range can span 3 or 4 kHz above and below a commonly used or standardized frequency, such as, for example, a range of about 121 kHz to about 129 kHz or about 130.2 kHz to about 138.2 kHz. In some embodiments, the speed at which the frequency sweep is provided may depend, for example, on the size of the frequency sweep and / or the number of sweep repetitions. For example, in some embodiments, a frequency sweep may be provided in less than one second. In other embodiments, a frequency sweep may be provided in one or more seconds.

[0134] According to step 904, a signal driver / amplifier (e.g., driver / amplifier 812) may be used to continuously broadcast a signal having the provided frequency sweep range via a primary antenna (e.g., antenna 814). The signal driver / amplifier may be instructed to begin continuously broadcasting the signal by a controller (e.g., microcontroller 802).

[0135] According to step 906, the return signal from the transponder within the range of the main antenna can be continuously monitored via the main antenna (e.g., antenna 814). The presence and / or strength of the return signal from the RF transponder (e.g., transponder 100, 200) within the range of the antenna can depend on, for example, the frequency broadcast by, for example, the driver amplifier 812 in step 904. The transponder can be configured to return the strongest signal at a specific frequency (such as, for example, 125kHz). Therefore, when the signal driver / amplifier approaches the frequency in its scanning broadcast, the return signal from the transponder can increase and peak at the frequency.

[0136] According to step 908, it can be determined whether any return signal is weak or absent. After transformer 816, analog front end 818, and ADC 820 have processed any received signals, such a determination can be made, for example, by low signal strength or absence of a signal received by microcontroller 802. If not (i.e., if the return signal is strong), then according to step 910, a transformer can be used to continuously convert the return signal into a voltage difference. If so, then according to step 912, a pickup antenna (e.g., pickup antenna 822) can be used in addition to the main antenna (e.g., antenna 814) to monitor for weaker signals, and according to step 914, a logarithmic amplifier (e.g., logarithmic amplifier 824) can be used to amplify weak signals received by the pickup antenna or the main antenna and convert them into a voltage difference that can be converted by an ADC (e.g., ADC 820 or ADC 826).

[0137] In an alternative embodiment, a pick-off antenna (e.g., pick-off antenna 822) may be used in addition to the main antenna to monitor for weaker signals, and a logarithmic amplifier (e.g., logarithmic amplifier 824) may be used to amplify weaker signals received by the pick-off antenna or the main antenna without first determining whether any return signal is weak or absent.

[0138] The voltage difference (converted in step 910 or step 914) can be continuously converted into a digital value using an analog-to-digital converter and transmitted to the microcontroller, according to step 916. For example, the voltage difference transformed by transformer 816 can be continuously converted using ADC 820, and the voltage difference amplified by logarithmic amplifier 824 can be continuously converted using ADC 826. According to step 918, a microcontroller (e.g., microcontroller 802) can be used to determine the highest received digital signal (e.g., from the combined digital signal pool received from both ADC 820 and ADC 826).

[0139] The microcontroller may be used to determine the frequency of the broadcast signal corresponding to the highest received digital signal, according to step 920. The highest received digital signal may correspond to the best broadcast signal for receiving the clearest return signal from a transponder near one or more antennas (e.g., antenna 814 and pickup antenna 822).

[0140] According to step 922 , a microcontroller may be used to instruct a clock generator to provide the determined frequency to a signal driver / amplifier, which may then be instructed to broadcast a signal having the determined frequency according to step 924 .

[0141] Thus, the method disclosed above provides a way to adjust the signal frequency to suit a particular transponder. Advantageously, this can allow a reader such as the platform reader 800 to broadcast a custom signal to a transponder that may not be configured to respond to an exact standard signal (including, for example, standard RFID signals of 125kHz and 134kHz). Because slight differences in, for example, coil shape, coil size, and number of coil turns can cause a transponder, particularly a relatively small transponder, to have an optimal frequency that is slightly different from the standard frequency, and because relatively small transponders without a ferromagnetic core (e.g., transponders 100, 200) may already have limited range and signal strength, determining the optimal frequency for the transponder and then reading the transponder at that frequency can produce an improved return signal that is stronger than with a standard signal.

[0142] A reader such as the platform reader 800 may be used to send information to and receive information from the transponders disclosed herein, such as the transponders 100, 200 and the integrated port assemblies 400, 600. Although the present disclosure describes the platform reader 800 in the context of a transponder for use in an implant, such as a breast implant, it should be understood that the platform reader 800 and methods of using the platform reader 800, such as the method 900, may also be used in other contexts.

[0143] Figures 10A to 10C Depicted is the use of reader 1000 to inject fluid into a tissue expander 1002 having an integrated port assembly 1004 equipped with an antenna coil 1006 (shown by dashed lines). As shown in each figure, a patient may have had tissue expander 1002 surgically implanted in, adjacent to, or in place of breast tissue 1001. For example, reader 1000 may be platform reader 800 or share features therewith. Integrated port assembly 1004 may be, for example, integrated port assembly 400 or integrated port assembly 600 or share features therewith. The center of integrated port assembly 1004 can be identified by an electronic reader that looks for an "open window" or center of a wound antenna coil in each integrated port assembly; for example, as a "targeting element," as described further below.

[0144] like Figure 10AAs shown, a reader 1000 configured to locate an antenna coil 1006 can be used to determine the position of the antenna coil 1006 and, therefore, the position of the integrated port assembly 1004 beneath the patient's tissue 1001. The reader 1000 may, for example, have an antenna configured to sense and detect the magnetic field of a nearby electromagnetic coil. The reader 1000 may, for example, output a number on the display 1000 indicating the distance between a point on the reader 1000 and the center of the core of the antenna coil 1006, and the output number may be continuously updated as the reader 1000 is moved over the patient's tissue 1001. Once the reader 1000 displays a number below a given threshold, or otherwise indicates that the reader 1000 has located the core of the antenna coil 1006, the physician can prepare to inject a fluid at the designated point in the patient's tissue 1001.

[0145] In some embodiments, once the integrated port assembly 1004 has been positioned, markings can be made on the skin of the patient's tissue 1001 for proper alignment of the fluid injection device with the integrated port assembly 1004. In some aspects, the reader 1000 can be equipped with a needle guide 1200 to facilitate alignment with the integrated port assembly 1004. In some aspects of the present disclosure, the needle guide can include a cannula that can be sterile and / or disposable, allowing the reader to be used on multiple patients.

[0146] like Figure 10B As shown, a fluid injection device 1008 can be used to inject fluid into the tissue expander 1002, thereby expanding the tissue expander 1002 and the integrated port assembly 1004 in the patient tissue 1001. The fluid injection device 1008 can be, for example, a syringe, such as a manual syringe, an automated syringe, a pipette, or other fluid deposition device. Finally, as Figure 10C As shown, once fluid has been injected using the fluid injection device 1008, and once the fluid injection device 1008 has been withdrawn, the tissue expander 1002 may have a larger volume.

[0147] Data analysis and other transponder uses

[0148] Various combinations and uses of the transponders, sensors, and readers disclosed herein can achieve different results. Some of these combinations and uses are expanded upon below.

[0149] Data Analysis

[0150] The present disclosure also includes algorithms that take into account the characteristics of the physiological environment from which data is collected. The algorithms can be used to evaluate and / or analyze data to provide translational results or outputs. For example, the algorithms can incorporate specific characteristics and nuances of the materials used in the construction of the medical device. Such characteristics can include, for example, the chemical composition and / or surface characteristics of the medical device (or other physical characteristics, such as the dissolution of a drug or agent from the surface or the degradation rate of a biodegradable material). For example, the specific chemical composition of the silicone used in a breast implant or tissue expander and / or the surface properties of the medical device may affect their interaction with the patient's surrounding tissue. The selection of appropriate materials can be based at least in part on biocompatibility, the ability to reduce or modulate an appropriate immune response, and / or the ability to be partially or completely inert. Sensors and microelectronics can be encapsulated in an inert coating of a suitable type using an impermeable material such as glass. Additionally or alternatively, the algorithms can include consideration of the depth and position of the medical device during implantation (e.g., characteristics of the surrounding tissue) and / or potential interference from other active (powered) devices such as other implants.

[0151] As another example, an algorithm may consider one or more physiological parameters such as pH, temperature, oxygen saturation, and other parameters that may be helpful in screening, diagnosing, and / or predicting a disease, disorder, or other health condition (including, for example, tissue inflammation or infection). These algorithms may be designed to filter data collected from one or more sensors to optimize the "signal-to-noise ratio" and include formulas that determine the significance of the combined analytical data; for example, pressure, pH, and / or temperature when evaluating infection or tissue inflammation. Other combinations of data may indicate foreign (e.g., cancerous) tissue. The algorithms herein may, for example, predict structural changes by revealing a weakening in a portion of a medical device before a failure occurs. For example, the algorithm may identify a weakening of a breast implant shell before it ruptures and / or sense a rupture or tear in the shell based on, for example, a change in pressure.

[0152] In some aspects, the algorithm can take into account personalized patient data. For example, the algorithm can analyze various data collectively, i.e., data collected from one or more sensors integrated into a medical device implanted in a patient, as well as data specific to the individual patient. For example, sensors collecting pH, pressure, and temperature may provide clinically more meaningful data in certain respects if the algorithm incorporates other physiological data, such as blood parameters, genomics, tissue elasticity, and / or other health parameters.

[0153] Data analysis according to the present disclosure may include anti-collision techniques for low-frequency systems, for example, with the ability to read data from multiple sensors simultaneously. Transponders including RF antennas typically have the ability to transmit and receive data. Communication of data may include specific ASIC programming that may depend on the frequency of the RF signal. Thus, each transponder can selectively communicate with one or more other sensors that are in close proximity, which may include transponders implanted elsewhere in the patient's body.

[0154] Medical device information

[0155] Device rupture / malfunction: pH change

[0156] According to some aspects of the present disclosure, the transponders disclosed herein, when used in conjunction with various types of sensors, can provide information about the status of an implanted medical device. For example, a pH sensor can be used to detect a breach in interstitial fluid, such as blood and / or proteins, that may have infiltrated a malfunctioning medical implant. Such pH sensors can be positioned at various locations around the surface of the medical device. For example, one or more pH sensors can be coupled to the surface of, or embedded within, a breast implant or tissue expander. Multiple sensors coupled to the transponder can communicate with each other via a frequency link (e.g., ad hoc or hardwired). In the event of a breach in the medical device, a change in pH can be detected by one or more sensors. For example, in the case of a breast implant, a change in pH can be caused by a breach in the outer shell wall, or a breach in a portion of the shell, resulting in permeable access to surrounding tissue. Some medical devices according to the present disclosure may include a conduit that allows external interstitial fluid to passively flow (e.g., by convection or conduction) to a sensor located deeper within the medical device, allowing bodily fluids, such as blood, to diffuse into the medical device due to the breach and be detected by the sensor.

[0157] Device Failure: Other Detection Methods

[0158] According to some aspects of the present disclosure, an implantable medical device may include a meshed nanoscale detection system that uses fluid chemistry, chemicals, electronics, or mechanical substrates to detect breaches (e.g., housing breaches) in the implantable medical device. Additionally or alternatively, the medical device may include an external and / or internal system for breach detection that uses infrared (IR) or low-wavelength light (or low-wavelength electron fields) to inspect a chip enhancer within the medical device. This type of system can help detect interruptions in a continuum, such as interruptions in wavelength or electromagnetic fields due to interference caused by mechanical breaks in the medical device. For example, in this type of system, the chip enhancer can use a full-duplex coupling system to find the highest (strongest) resonant frequency (highest Q) for a particular antenna and adjust to read data at that level. The search for the highest Q can be performed using a range of specialized crystals and a kernel placed in the firmware of a reader (e.g., reader 800).

[0159] As an example, an implantable medical device may include an intact conductive barrier as a housing component of the implantable medical device, such that a breach in the housing of the implantable medical device including the conductive barrier can cause a change in the resistance of the conductive barrier. The implantable medical device may also include a transponder (e.g., transponder 100, 200) located within the space enclosed by the conductive barrier (e.g., within the implant). Such a transponder can be, for example, an RF transponder, as previously disclosed herein. In some embodiments, such a transponder can be configured to receive power via induction performed by, for example, an external reader, as previously described herein. In other embodiments, such a transponder can be provided with an independent power source, such as a battery. A breach in the conductive barrier can cause a change in the ability of an external reader (e.g., reader 800) to send transmissions to and / or receive transmissions from the transponder within the space enclosed by the conductive barrier. Therefore, the presence and changes in the conductive barrier can help determine whether a portion of the implantable medical device (e.g., the housing) is intact, or has been breached or otherwise damaged.

[0160] Figure 11 An example of a portion of an implant housing that may include a conductive barrier layer is depicted. An implant having a multi-layer housing 1100 can be modified to include a conductive layer 1106 located between an inner layer 1104 of the housing 1100 and an outer layer 1102 of the housing 1100. The conductive layer 1106 can be configured to resist, block, reduce, interfere with, or prevent the transmission of signals (such as RF signals) through the housing 1100 of the implantable medical device as long as the conductive layer remains intact.

[0161] The inner layer 1104 and outer layer 1106 of the housing 1100 can be made of any suitable biocompatible material. In some embodiments, the inner layer 1104 and outer layer 1106 can be made of a non-conductive material. For example, one or more of the inner layer 1104 and outer layer 1106 can be made of silicone or a plastic such as PEEK.

[0162] Conductive layer 1106 can be made of any biocompatible material that blocks, reduces, interferes with, or prevents RF signal transmission through the layer. For example, in some embodiments, conductive layer 1106 can be a carbon layer. Conductive layer 1106 can be, for example, a solid layer, or can be a layer having a regular or irregular grid pattern (e.g., similar to a cage or mesh). In embodiments where conductive layer 1106 has a grid pattern, any gaps in the grid pattern can be sufficiently small to prevent signals from being received by or transmitted from a transponder enclosed by conductive layer 1106. In some embodiments, conductive layer 1106 can be or can resemble a Faraday cage or enclosure.

[0163] In some embodiments, the conductive layer 1106 can be, for example, between the inner layer 1104 and the outer layer 1102 of the implant housing 1100. In other embodiments, the conductive layer 1106 can be, for example, the innermost layer of the implant housing 1100. In further examples, the conductive layer 1106 can be, for example, the outermost layer of the implant housing 1100. In some embodiments, the implant housing 1100 can have multiple inner layers 1104, multiple outer layers 1102, and / or multiple conductive layers 1106.

[0164] The integrity of the conductive layer 1106 (and thus a component of the implantable medical device, such as a housing component) can be tested, for example, by an external reader such as reader 800, which can be configured to send transmissions to or receive transmissions from a transponder (e.g., transponder 100, 200) encapsulated by the conductive layer 1106. As previously described herein, a reader (e.g., reader 800) can be configured to determine and broadcast a signal at a frequency specifically calibrated for the transponder. If the conductive layer 1106 is intact (e.g., if it is not cracked, damaged, or has a manufacturing defect), the reader may receive no signal or a weak or low signal from the transponder encapsulated by the conductive layer 1106. If the conductive layer 1106 is incomplete, the reader may receive a stronger signal from the transponder encapsulated within the conductive layer 1106 because the barrier function of the conductive layer 1106 is interrupted. Thus, the conductive layer 1106 can help determine whether the implantable medical device is defective.

[0165] In some examples, the conductive layer 1106 can have a color so that defects, flaws, or tears can be visually inspected. In some embodiments, the color can make the conductive layer 1106 opaque or translucent. For example, the conductive layer 1106 can be black, or can be blue, green, pink, red, white, or any other color.

[0166] In other examples, the reader can provide power to an ASIC to detect changes in the barrier using an electromagnetic sensor. Similar techniques can be used with conductive nano-components or nano-materials. For example, a conductive nano-material can be sprayed within a single monolayer of the housing (e.g., to provide a thread similar to a substrate), which, if broken or damaged, can cause a change in resistance. In yet another example, a small, low-energy light source can be placed within the medical device, and when powered, light can illuminate and reflect from the material coating the inner layer of the housing. However, if there is a crack or breakage, the light may not be reflected, thereby providing a change that the reader detects and calculates based on the parameters of the initial calibration.

[0167] Advantageously, such conductive layers and reflective coatings can be used to determine whether an implantable medical device has been ripped, broken, or has a manufacturing defect before and after implantation. In particular, such layers can help to non-invasively determine whether an implantable medical device (e.g., a breast implant) is defective or has become defective. In some embodiments, a reader as disclosed herein (e.g., reader 800) can be used by, for example, a doctor, nurse, patient, or another individual associated with the implantable medical device or patient, together with an implant having a layer such as the above-described layer, to determine whether the implantable medical device is defective or has become defective. Thus, advantageously, such layers can also help to allow non-invasive inspection / analysis of, for example, the structural integrity of an implantable medical device by a variety of individuals.

[0168] Device location / orientation

[0169] In addition to information about malfunctions of a medical device, the transponders disclosed herein (e.g., transponders 100, 200) can be used to determine whether a medical device maintains its proper implant position and orientation. For example, after implantation, a medical device may migrate from its proper position over time. Sensors coupled to transponders according to the present disclosure can measure and project data indicating circumferential rotation, vibration, torsion, or misalignment (e.g., movement) of an implanted medical device. Such sensors can capture the number of cycles to which an articular surface may be exposed (i.e., the frequency of changes in pressure gradients in a knee or hip implant, a heart valve annulus, or a shunt or vascular graft). The sensor may include an element such as a gyroscope (a type of accelerometer) that can measure changes in angular measurement and / or angular velocity. Other suitable sensors include fiber optic rotation sensors, which may include an active light source and a reader. An inertial measurement unit (IMU) can be used to combine information from two or more sensors (e.g., a gyroscope, a 3D accelerometer, a magnetometer, and / or a GPS unit) to determine information such as device orientation and velocity vector. In some aspects, a combination of sensors can be used to determine comprehensive status information on the medical device.

[0170] In some aspects, one or more sensors coupled to a transponder of the present disclosure can measure changes in the orientation of a radiopaque marker relative to one or more anatomical features or landmarks. For example, a patient can undergo periodic X-rays to assess position and orientation information. In such cases, a sensor configured for dosimetry measurements can be used.

[0171] Data transmission

[0172] Data about the implantable medical device can be transmitted and received continuously, periodically, on demand (in response to user queries), or when certain values ​​or parameters are detected. In some examples, the transponder may include a dual-processor ASIC approach, where a particular ASIC may be used for medical management of the transponder (e.g., to determine when the sensor is actively "reading" or "sleeping"), while another ASIC may be used for power management (e.g., to regulate how much energy is supplied to the system). The power management ASIC may include algorithms for maintaining an appropriate charge level (e.g., to avoid complete discharge).

[0173] The method and / or frequency of data transmission may depend on the relevance of the data to the patient or a given medical context. For example, for more serious conditions or events (such as device rupture), a transponder coupled to one or more specific sensors configured to detect rupture may also be configured to push data to an external device, such as a mobile device or other electronic device. This type of data transmission may be incorporated into the algorithm and used as part of an active system. In addition, for example, data indicating tissue inflammation or improper rotation / placement of a medical device may be sent on demand by periodically (e.g., weekly, biweekly, or monthly) sending a wireless signal from an external device. For example, the on-demand transmission of data may be initiated when a patient is alerted by an uploaded app on a mobile device. A transponder configured for constant or nearly constant data transmission may include a power supply or recharging element sufficient to maintain power over an extended period of time.

[0174] Lab on a Chip

[0175] The transponders disclosed herein and the sensor combinations disclosed herein can be configured as chip labs, such as subsets of microelectromechanical systems (MEMS) that can be used to capture and identify and / or quantify biomarkers such as proteomics using microfluidics. Such microanalysis systems can use surface plasmon resonance (SPR) and related systems and techniques to detect a wide variety of biomolecular interactions that might otherwise have low spectral signals or heat of reaction. These systems can provide data analysis to optimize therapeutic devices and treatment modalities related to the binding affinity of antibodies that can affect the dosage (dosimetry) of chemotherapy or radiotherapy, drug / cell membrane absorption rate, and / or tissue sensitivity levels. Such chip lab sensor and transponder combinations can include a suitable power supply. These types of sensor and transponder combinations can be used as evaluation tools, for example, to determine whether a particular patient would respond better to an auxiliary matrix, such as hyaluronic acid or deacetylated chitosan.

[0176] Data Output

[0177] The present disclosure also includes means for optimizing the data output of the reader, including decoding the range and complexity of specific algorithms. The data can be encoded in accordance with HIPPA regulations for patient confidentiality. The data can be accessed by mobile devices such as smartphones or tablets, for example, via password or fingerprint protection.

[0178] The transponder disclosed herein can communicate on a specific radio frequency, for example, to optimize the inductive recharging of an active sensor. For example, an RF antenna can be used as a receiver for recharging an embedded battery using inductive energy. Such a frequency range can be utilized so that the sensor does not interfere with other communication frequencies or cause heating of the sensor's components or coatings or heating of surrounding patient tissue. Exemplary ranges include, for example, about 80kHz to about 400kHz, such as, about 80kHz to about 350kHz, about 80kHz to about 320kHz, about 100kHz to about 300kHz, about 100kHz to about 250kHz, about 100kHz to about 200kHz, about 100kHz to about 180kHz, about 100kHz to about 150kHz, about 100kHz to about 140kHz, about 110kHz to about 140kHz, about 120kHz to about 140kHz, or about 125kHz to about 135kHz. Reference may be made to ISO standard 11784 / 85.

[0179] The transponders disclosed herein may include one or more ASICs that provide storage and appropriate power management utilizing a self-sufficient threshold so that the system does not experience a complete discharge that could cause an outage. Self-sufficient systems are typically configured to regulate themselves and prevent complete discharge. For example, once the power level reaches a given threshold, the ASIC herein may put the power supply into hibernation, thereby allowing recharging rather than a completely "dead" battery.

[0180] Security

[0181] Transponders, readers, implants, and port assemblies disclosed herein can be incorporated into security systems for, for example, cloud data access. Such security systems can provide push opportunities (alarms) to user devices such as readers disclosed herein or other secure personal devices (such as tablet computers, computers, smart phones, mobile devices, etc.). Such security systems can thus provide tracking of transponders, implants, and implant parts from manufacturers to surgeons; and possibly tracking from surgeons to patients. Devices for receiving and transmitting information between medical devices, computers / mobile devices, and cloud / internet servers may include, but are not limited to, RF readers with WIFI connections and Bluetooth connections to electronic devices connected to the Internet. According to some aspects, manufacturers, doctors, and / or patients can interact with such security systems through the app on an RF reader and / or mobile electronic device.

[0182] Although the drawings and disclosure herein depict several exemplary configurations of transponders, sensors, assemblies, readers, implants, and several exemplary methods of use thereof, it will be understood by those of ordinary skill in the art that many other configurations and method variations are possible and may be suitable for a given implant, patient, procedure, or application based on the implant size, shape, orientation within the patient's body, and intended location. The examples of devices, systems, and methods herein are intended to be exemplary and not comprehensive; it will be understood by those of ordinary skill in the art that some variations of the devices, systems, and methods disclosed herein are also encompassed by the present disclosure.

Claims

1. A transponder comprising: electromagnetic coil; as well as a core comprising a non-ferromagnetic material, wherein the transponder defines a longitudinal axis along its length, and the electromagnetic coil comprises tens to thousands of turns of wire wound in the direction of the longitudinal axis, wherein the transponder has a length between about 5 mm and about 30 mm, and The transponder has a width between about 2 mm and about 5 mm, wherein the transponder is implantable; wherein the electromagnetic coil is made of a conductive non-ferromagnetic material and has a turn diameter that is greater than its height and / or its width, and the height of the electromagnetic coil is equivalent to the total thickness of the number of individual turns forming the electromagnetic coil; wherein the transponder does not contain ferromagnetic material; wherein the electromagnetic coil comprises a coiled wire having two ends, and further comprising: an integrated circuit chip coupled to each of the two ends of the coiled wire; a glass container enclosing the electromagnetic coil, the integrated circuit chip, and an internal space between the glass container, the electromagnetic coil, and the integrated circuit chip; and An adhesive material fills at least 30% of the interior space.

2. The transponder of claim 1, wherein the integrated circuit chip is an application specific integrated circuit chip.

3. The transponder of claim 1, wherein a turn diameter of the coil is larger than a short dimension of the transponder.

4. The transponder of claim 1 , wherein the core comprises a core width and a core length, wherein the core length is greater than the core width, and wherein the coil is wound around the core such that the core length defines an inner diameter of the coil.

5. The transponder of claim 1, wherein the electromagnetic coil comprises 30 to 1500 turns of wire. The transponder defines a longitudinal axis along its length, and the electromagnetic coil comprises wire wound in the direction of the longitudinal axis.

6. The transponder of claim 6, wherein the adhesive material fills 50% to 100% of the interior space.

7. The transponder according to claim 1, wherein the conductive wire is an enameled copper wire or an enameled aluminum wire.

8. The transponder of claim 1, wherein the core comprises polyetheretherketone, ceramic, quartz glass and / or another type of biocompatible plastic.

9. The transponder of claim 1, wherein the transponder is cylindrical.

10. The transponder of claim 1, wherein the transponder is configured to transmit and / or receive information within a range of 1 inch (2.54 cm) to 5 feet (152.4 cm).

11. The transponder of claim 1, wherein the transponder is configured to transmit data via RF low wave transmission at a frequency of 100 kHz to 400 kHz.

12. The transponder of claim 1, wherein the core includes a notched end (104e), the turns of the electromagnetic coil being located in the notched end.

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