The present disclosure claims priority from U.S. provisional patent application No. 62/313,218, filed 2016, 3, 25, and U.S. provisional patent application No. 62/293,052, filed 2016, 2, 9, each of which is incorporated herein by reference in its entirety.
Detailed Description
Aspects of the disclosure are described in more detail below. The terms and definitions used and set forth herein are intended to have meanings within the present disclosure. To the extent that there is a conflict with a term and/or definition incorporated by reference, the term and definition provided herein shall control.
The singular forms "a", "an" and "the" include plural references unless the context indicates otherwise. The terms "approximate" and "about" mean that the referenced number or value is nearly the same. As used herein, the terms "approximate" and "about" are generally understood to encompass a specified amount or value of ± 5%.
The present disclosure relates generally 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 entitled "Sensors for implantable Medical Devices and Methods of Use therof," filed on 25/3/2016; U.S. provisional application No. 62/293,052 entitled "Identification System incorporating Transpondwith Non-Magnetic Core", filed on 9/2/2016; U.S. provisional application No. 62/318,402, entitled "Medical Imaging Systems, Devices, and Methods," filed 4/5/2016; U.S. provisional application No. 62/323,160 entitled "minimum-active Apparatus for the transplantation of medical Devices and Methods of Use therof", filed on 15.4.2016; U.S. provisional application No. 62/334,667 entitled "Implant Surface Technologies and Elements of Formation" filed on 11/5/2016; U.S. application publication nos. 2015/0282926; U.S. application publication No. 2014/0081398; and/or U.S. application publication No. 2014/0078013.
Aspects of the present disclosure may be used to collect and/or analyze data related to a patient, including, for example, physiological data and information about a medical device implantable within the patient. The devices, systems, and methods disclosed herein may also be used to position and/or modify a medical device implantable in a patient, including, for example, adjusting the size, shape, and/or position of the medical device implantable in the patient. Such implantable medical devices may include, but are not limited to, breast implants, gluteal implants, tissue expanders, and other medical devices in the field of cosmetic or reconstructive surgery, as well as other types of medical devices configured for temporary or permanent implantation within a patient. The devices, systems, and methods disclosed herein may also be used to overcome challenges presented in the prior art, such as artifacts created in patient imaging results like implanted transponders, and difficulty in reading transponders with weak signals.
As discussed herein, transponders such as microreponders (referred to herein as "low artifact transponders") designed to avoid the formation of imaging artifacts may be incorporated into implantable medical devices to monitor the status of the medical device over time and/or to obtain certain types of patient data based on, inter alia, the location of the transponder when implanted in a patient.
As also discussed herein, a valve assembly having a locator coil, such as an integrated port assembly designed for implants requiring periodic addition of fluid (e.g., tissue expanders), may 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.
Also disclosed herein are readers configured to read multiple types of reading transponder and locator coils, and methods of finding and broadcasting the best signal for reading such transponder and/or locator coils.
Various data analysis techniques, systems, and methods are also disclosed for use in conjunction with the transponders, coils, and readers disclosed herein.
Transponder
The present disclosure includes a low artifact transponder/chip that may include materials and/or design configurations for minimizing interference observable from Magnetic Resonance Imaging (MRI), fluoroscopy (X-ray) imaging, and/or ultrasound imaging. As previously mentioned, MRI, X-ray and ultrasound tests are frequently used for mammography and related tissue analysis in order to diagnose early signs of breast cancer and to evaluate other unrelated cardiopulmonary diseases. The transponders herein can be incorporated into breast implants and tissue expanders to reduce the amount of interference with diagnostic imaging.
Such transponders may be small in size in order to avoid affecting the size and shape of the implant in which they are located. Such transponders may also include materials as an alternative to ferromagnetic materials, which may lead to imaging artifacts in the case of magnetic resonance imaging. For example, the transponders herein may comprise non-ferromagnetic materials such as Polyetheretherketone (PEEK), other plastics, ceramics, or silica (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 ferromagnetic cores.
Fig. 1A and 1B depict, in schematic form, a top view (fig. 1A) and a side view (fig. 1B) of an exemplary transponder 100 that may embody one or more aspects of the present disclosure. The transponder 100 may include a component 101, which component 101 may include an antenna 102 and a chip 110. The antenna 102 may include an antenna core 104 and an antenna coil 106. The antenna 102 may be connected to the chip 110 via an antenna coil end 108, the antenna coil end 108 may be attached to a bond pad 112 of the chip 110. The vessel 114 may enclose the assembly 101 and an interior space 116 that may surround the assembly 101.
The transponder 100 may be configured to, for example, allow for the collection and/or transmission of data continuously, intermittently/periodically, and/or on-demand (e.g., prompted by a user). The transponder 100 may have any of a variety of shapes and sizes suitable for inclusion in an implant. For example, the transponder 100 may have a size and shape suitable for inclusion in a breast implant (such as a silicone-filled breast implant suitable for implantation into a patient during breast augmentation or reconstruction procedures). For example, in some embodiments, the transponder 100 may have a size and shape suitable for inclusion in an implant without substantially altering the size, shape, or weight of the implant. In some embodiments, the transponder 100 may be sized and shaped for inclusion in a breast implant. In some embodiments, the overall size and shape of the transponder 100 may be minimized in order to potentially reduce any impact of the transponder on the size, shape, appearance, feel, or implantation process of the implant in which the transponder 100 is installed. Minimizing the overall size and shape of the transponder 100 may also help to avoid the transponder interfering with patient diagnosis, imaging procedures, and/or other medical procedures. The 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 component 101, and in particular the size and shape of antenna 102.
In some embodiments, the long dimension or length of the transponder 100 may be between about 5mm and about 30mm, such as between about 5mm and about 10mm, between about 8mm and about 13mm, between about 10mm and about 20mm, between about 10mm and about 15mm, between about 12mm and about 18mm, between about 15mm and about 20mm, between about 15mm and about 25mm, between about 18mm and about 26mm, or between about 20mm and about 30 mm. In some embodiments, the long dimension of the transponder 100 may be about 8mm, about 10mm, about 13mm, about 15mm, about 18mm, about 20mm, about 23mm, or about 25 mm.
In some embodiments, the width w or short dimension perpendicular to the length (as seen in the top view of the transponder 100 in fig. 1A) of the transponder 100 may be between about 1mm and about 20 mm. For example, in some embodiments, the width of the transponder 100 may be between about 2mm and about 8mm, between about 2mm and about 5mm, between about 2mm and about 3mm, between about 3mm and about 6mm, between about 5mm and about 10mm, between about 7mm and about 12mm, or between about 10mm and about 15 mm. In some embodiments, the width or short dimension of the transponder 100 may be about 1mm, about 2mm, about 3mm, about 5mm, or about 6 mm.
In some embodiments, the thickness of the transponder 100 or a short dimension perpendicular to both the width w and the length of the transponder 100 may be between about 1mm and about 20 mm. For example, in some embodiments, the thickness of the transponder 100 may be approximately the same as the width w of the transponder 100. For example, in other embodiments, the thickness of the transponder 100 may be greater than or less than the thickness of the width w of the transponder 100.
In some embodiments, the shape of the transponder 100 may be generally elongated. For example, in some embodiments, the length of the transponder 100 may be more than twice its width. The transponder 100 may be about 13mm in length and about 2mm in width, or about 13mm in length and about 2.8mm in width. In other embodiments, transponder 100 may be about 13mm in length and about 2.2mm in width. In other embodiments, transponder 100 may be about 18mm in length and about 3mm in width. The elongate shape may, for example, allow for easy insertion of the transponder 100 into a medical implant using, for example, a syringe into which the transponder 100 may fit. The elongated shape may also be adapted, for example, to accommodate a component 101, in particular an antenna 102, which is also elongated in shape.
For example, in some embodiments, the shape of the transponder 100 may be substantially cylindrical. In such embodiments, the width of the transponder 100 may be, for example, the diameter of a cylinder. In other embodiments, the shape of the transponder 100 may be configured as a rectangular prism or any other shape. In some embodiments, the transponder 100 may generally have few corners or have rounded corners, for example, to reduce the risk of the transponder 100 damaging an implant in which the transponder 100 is installed. In other embodiments, the transponder 100 may be a generally flat square, oval, or any other shape suitable for receiving components of the transponder 100 and for placing the transponder 100 within a medical device.
The component 101 of the transponder 100 may comprise an antenna 102 and a chip 110 connected, for example, via an antenna coil terminal 108. Both the antenna 102 and the chip 110 of the assembly 101 are described further below.
The antenna 102 may include, for example, an antenna core 104 and an antenna coil 106. In some embodiments, the antenna coil 106 may be wound around the antenna core 104. The antenna coil 106 may be made of an electrically conductive non-ferromagnetic material. In some embodiments, the antenna coil 106 may be made of a material capable of withstanding high temperatures (e.g., temperatures ranging up to about 250 degrees celsius) for up to about 10,000 hours. In some embodiments, the antenna coil 106 may be made of a metal wire such as a copper wire or an aluminum wire. In some embodiments, the antenna coil 106 may be made of enameled wire (e.g., polymer coated wire). Suitable polymers may include, for example, polyvinyl formal (Formvar), polyurethane, polyamide, polyester-polyimide, polyamide-polyimide (or amide-imide), and polyimide. In some embodiments, the 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 may be made of wire having a diameter ranging from about 0.010mm to about 0.500 mm. For example, the antenna coil 106 may be made of wire having a diameter of about 0.030 mm.
In some embodiments, the antenna coil 106 may include tens to thousands of turns (i.e., loops) of wire. For example, in some embodiments, the antenna coil 106 may include between about 30 to 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.
3 as 3 shown 3 in 3 fig. 3 1A 3- 32 3B 3, 3 the 3 antenna 3 coil 3 106 3 may 3 be 3 wound 3 in 3a 3 longitudinal 3 direction 3 along 3 the 3 transponder 3 axis 3a 3- 3a 3 such 3 that 3 it 3 has 3a 3 longitudinal 3 turn 3 diameter 3 t 3. 3 The turn diameter t may be larger than the height h of the coil and/or the width x of the coil. 3 advantageously 3, 3 in 3 some 3 cases 3, 3 this 3 may 3 allow 3 antenna 3 coil 3 106 3, 3 when 3 induced 3, 3 to 3 produce 3a 3 stronger 3 signal 3 than 3 an 3 antenna 3 coil 3 wound 3 such 3 that 3 its 3 longitudinal 3 turn 3 diameter 3 is 3 less 3 than 3 its 3 height 3 h 3 and 3 / 3 or 3 width 3 x 3 ( 3 e.g. 3, 3 wound 3 in 3a 3 direction 3 transverse 3 to 3 axis 3a 3- 3a 3) 3. 3 In some embodiments, the turn diameter t of the antenna coil 106 may range from about 5mm to about 20mm, such as, for example, from about 5mm to about 15mm, from about 5mm to about 12mm, from about 5mm to about 10mm, from about 5mm to about 7mm, from about 6mm to about 8mm, from about 7mm to about 10mm, from about 9mm to about 13mm, from about 10mm to about 15mm, from about 12mm to about 17mm, from about 15mm to about 19mm, or from about 16mm to about 20 mm. In some embodiments, the diameter of the antenna coil 106 may be approximately 6mm, 7mm, 8mm, 10mm, 11mm, 12mm, or 13 mm.
In some implementations, the antenna coil 106 may have a height or thickness h that may be less than the turn diameter t of the antenna coil 106. The height (or thickness) h may be generally commensurate with the total thickness of the number of individual turns forming the antenna coil 106. The height h may range, for example, from about 0.2mm to about 5mm, such as, for example, from 0.2mm to about 0.5mm, from about 0.2mm to about 1mm, from about 0.5mm to about 1.5mm, from about 0.7mm to about 1.2mm, from about 0.7mm to about 1.8mm, from about 0.9mm to about 1.4mm, from about 0.9mm to about 2mm, from about 1mm to about 1.5mm, from about 1mm to about 2.4mm, from about 1.2mm to about 1.8mm, from about 1.4mm to about 1.9mm, from about 1.5mm to about 2.0mm, from about 1.8mm to about 2.2mm, from about 2mm to about 2.4mm, from about 2.2mm to about 2.5mm, from about 2.4mm to about 2.8mm, from about 2.5mm, from about 3.6mm to about 3.4mm, from about 3mm, from about 3.4mm to about 2.8mm, from about 3mm, from about 3.8mm, or about 3 mm. In some embodiments, the height h of the antenna coil 106 may be approximately, for example, 1.5mm, 1.7mm, 1.9mm, 2mm, 2.1mm, 2.2mm, or 2.3 mm.
In some implementations, the antenna coil 106 may have an elongated shape, for example, such that a turn diameter t of the antenna coil 106 may be longer than, for example, a height h of the antenna coil 106. However, in other embodiments, the antenna coil 106 may have other shapes, such as, for example, circular, square, and the like.
The antenna coil 106 may be made of a biocompatible non-conductive non-ferromagnetic material around the wound antenna core 104. 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, silica (glass), and/or other types of biocompatible plastics. In some embodiments, the antenna coil 104 may be made of a material capable of withstanding high temperatures (e.g., temperatures ranging up to about 250 degrees celsius). The antenna core 104 may also be shaped to facilitate shaping of the antenna coil 106 therearound. For example, as shown in fig. 1A-2B, the antenna core 104 may have a notched end 104e in which turns of the wound antenna coil 106 may be seated. In alternative implementations, the antenna core 104 may not have a notched end. The antenna core 104 may have dimensions configured to support a coil having a desired size and shape. For example, the antenna core 104 may have a length around which the antenna coil 106 may be wound, the length ranging from about 4mm to about 20mm, such as, for example, from about 4mm to about 15mm, from about 4mm to about 10mm, from about 5mm to about 7mm, from about 6mm to about 8mm, from about 7mm to about 10mm, from about 9mm to about 13mm, from about 10mm to about 15mm, from about 12mm to about 17mm, from about 15mm to about 19mm, or from about 16mm to about 20 mm. In some embodiments, the length of the antenna core 104 may be about 4mm, 5mm, 6mm, 7mm, 8mm, 10mm, 11mm, 12mm, 13mm, or 14 mm.
In some embodiments, the antenna core 104 may 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 the 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 may each range from about 0.5mm to about 20mm, such as, for example, from about 0.5mm to about 15mm, from about 0.5mm to about 10mm, from about 0.5mm to about 5mm, or from about 0.5mm to about 3 mm. In some embodiments, each of the width and thickness of the antenna core 104 may be approximately about 0.5mm, 1mm, 2mm, or 3 mm.
In an alternative embodiment, antenna 102 may include only antenna coil 106 without antenna core 104, such that antenna coil 106 is not wound around a solid object (e.g., it is an air coil surrounding air).
Chip 110 may be, for example, an Integrated Circuit (IC) chip. For example, in some embodiments of the present disclosure, chip 110 may be an Application Specific Integrated Circuit (ASIC) chip with or without built-in capacitors. In some implementations, the chip 110 may have, for example, a Printed Circuit Board (PCB) integration. In some embodiments, chip 110 may be an RFID chip. Chip 110 may be configured to sense, receive, and transmit a wide variety of data. For example, in some embodiments, chip 110 may be an ASIC designed to sense environmental conditions. For example, the chip 110 may be a pressure ASIC. In other embodiments, the chip 110 may 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 may be an ASIC or other type of chip that is 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 may be paired with or associated with chip 110 are described further herein.
Although one chip 110 is depicted, in other embodiments, two or more chips may also be used in the assembly 101. In such cases, two or more chips may each share a single function, or may each carry a different function, e.g., each may carry different identification information or may be paired with different sensors.
The chip 110 may include bond pads 112 that may be used to connect the chip 110 with the antenna coil end 108. The bond pads 112 may, for example, be embedded in the etched surface of the chip 110 such that they do not protrude from the surface of the chip 110. The bond pads 112 may be made of, for example, a non-magnetic metal such as gold.
The antenna coil end 108 may be connected to the bond pad 112 via, for example, thermal 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.
The vessel 114 may enclose the assembly 101 and an interior space 116 surrounding the assembly 101. The vessel 114 may be made of a biocompatible material, such as, for example, glass (e.g., silicate glass, such as soda-lime silicate glass) or a biocompatible plastic. The capsule 114 may be the outermost portion of the transponder 100 and thus may 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 may, for example, comprise two pieces that may be assembled around the assembly 101.
The interior space 116 may be a vacuum or may contain air, liquid, solid, or gel material. In some embodiments, the interior space 116 may be filled, in whole or in part, with a liquid, solid, or gel material. For example, in some embodiments, the interior space 116 may be filled with a liquid, solid, or 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, for example, glue. In such embodiments, the glue may be a biocompatible adhesive, such as an epoxy or acrylate adhesive. In some embodiments, the glue may be a photo-initiated curing acrylate adhesive. In some embodiments, the glue may be an impact resistant glue. In some embodiments, the glue may be one that may be exposed to temperatures up to 250 degrees celsius and that may have similar or identical temperatures, viscosities, and other characteristics after cooling to room temperature as it had before temperatures up to 250 degrees celsius in the art.
In some embodiments, half of the interior space 116 may be filled with a liquid, a solid, or a gel material such as the adhesives described above. In other embodiments, at least 30% of the interior space 116 may be filled. In other embodiments, between about 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 about 50% and 100% of the interior space 116 may be filled, such as about 55%, about 65%, about 75%, about 85%, about 90%, about 95%, or about 100% of the interior space 116. In further embodiments, between about 80% and 100% of the interior space 116 may be filled. In other embodiments, about 90% or more of the interior space 116 may be filled. In other embodiments, about 95% or more of the interior space 116 may be filled.
Various configurations of transponders according to the present disclosure may be based on the exemplary transponder 100. For example, chip 110 may have a variety of configurations and specifications depending on the availability of chips in the field. The configuration of a transponder according to the present disclosure may vary, based on, for example, the type of chip used.
One example of an alternative implementation of transponder 100 is depicted in fig. 2A and 2B.
Fig. 2A and 2B depict, in schematic form, a top view (fig. 2A) and a side view (fig. 2B) as another configuration of a transponder 200 according to the present disclosure. In transponder 200, component 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. The antenna coil end 108 of the antenna coil 106 may extend through the base 122, or may be attached to an electrical conductor that extends through the base 122, leading to the positive and negative leads of the capacitor 120 to form an electrical circuit with the capacitor 120. Wires 123 may connect capacitor 120 to bond pads 112 of chip 110. The vessel 124 may enclose the assembly 118 and the interior space 116 surrounding the assembly 118.
The capacitor 120 may be included in the transponder 200 separately from the chip 110. In transponder 200, chip 110 may or may not include a built-in capacitor. As shown in fig. 2A and 2B, component 118 of transponder 200 may include a base 122, capacitor 120 and chip 110 may be mounted to base 122 and antenna coil end 108 of antenna 102 may be attached to base 122. The pedestal 122 may provide, for example, stability and structure to the component 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.
The base 122 may be made of any non-ferromagnetic biocompatible material, such as, for example, any material suitable for use in forming the antenna core 104 (e.g., PEEK or other biocompatible plastic). Additionally, in some implementations, the base 122 may include conductive elements through which the antenna 102, the capacitor 120, and/or the chip 110 may be connected. For example, in some embodiments, the base 122 may include conductive tracks or pads configured as support connections between the antenna coil end 108, the capacitor 120, and the chip 110. In some embodiments, part or all of the base 122 may be a circuit board such as, for example, a printed circuit board.
As schematically shown in fig. 2A and 2B, the antenna coil end 108 may be attached to the base 122 by, for example, thermal compression, welding, soldering, crimping, or other known types of attachment. Similarly, capacitor 120 can be connected to base 122 by, for example, thermal compression, welding, soldering, or the like. A connector may extend through the base 122 from one attached antenna coil end 108 to the positive lead of the capacitor 120 and from the other attached antenna coil end 108 to the negative lead of the capacitor 120. Capacitor 120 may also be connected to chip 110 of submount 122, which may also be attached, by wires 123 attached to bond pads 112, for example, via thermal compression, welding, soldering, crimping, or other attachment types known in the art.
In other embodiments, the component 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, thermal compression, welding, soldering, crimping, etc., and the capacitor 120 may be connected to the chip 110 in a similar manner. As with transponder 100, antenna 102 in transponder 200 may or may not include antenna core 104.
In the embodiment shown in fig. 2A and 2B, vessel 124 may be similar in construction to vessel 114. In some embodiments, depending on the size and shape of the capacitor 120, the vessel 124 may need to be larger than the vessel 114 in order to accommodate the capacitor 120. Similarly, the interior space 124 of the transponder 200 may be larger than the interior space 116 of the transponder 100. The interior space 124 may be a vacuum or may be filled with various substances as already disclosed with respect to the interior space 116.
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., have an interior space). Conversely, in some embodiments, a transponder (e.g., transponder 100, 200) may include only components such as components 101, 118.
In some embodiments of transponders according to the present disclosure, the chip of the transponder (e.g., chip 110) may not have a built-in capacitor. In such embodiments, a capacitor external to chip 110 (e.g., capacitor 120) may be used as a primary electrical energy store, for example, to power a chip such as chip 110. In other embodiments, such as embodiments where a chip (e.g., chip 110) does not have a built-in capacitor, the added capacitor (e.g., capacitor 120) may provide additional power to the chip, such that the chip may be powered for a longer period of time, or a greater amount of power may be supplied than if only a built-in capacitor was present, for example, inside chip 110. The addition of capacitor 120 in transponder 200 may, for example, allow transponder 200 to store a greater amount of electrical energy than a transponder without capacitor 120.
Transponders according to the present disclosure (such as transponders 100, 200 like those shown in fig. 1A-2B) may, for example, be configured to transmit data via low wavelength RF coupling communication. For example, the data may be communicated via RF low wave transmission having a frequency in the range of about 100kHz to about 400kHz, such as, for example, about 200kHz to about 300kHz, about 100kHz to about 200kHz, about 120kHz to about 150kHz, about 125kHz to about 145kHz, or about 130kHz to about 135 kHz. In some aspects, the communication frequency of the component 101 may be about 134.2 kHz.
Transponders according to the present disclosure (such as transponders 100, 200) may be adapted for temporary or permanent implantation with an implantable medical device. For example, one or more transponders according to the present disclosure may be partially or fully encapsulated in a biocompatible material and integrated into a medical device. Exemplary biocompatible materials include silicone and other polymers and polymeric coatings suitable for temporary or permanent medical implantation. In some aspects of the present disclosure, the transponder may be placed between two portions of silicone that form a biocompatible envelope around the transponder.
Transponders according to the present disclosure (such as transponders 100, 200) may 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 may be a breast implant or tissue expander, and the one or more transponders may be suspended within the breast implant or tissue expander. In other aspects, the one or more transponders may be attached to an inner or outer surface of a shell or outer wall of a breast implant or tissue expander, or may be incorporated into a shell or wall of a breast implant or tissue expander, such as between layers comprising the shell or wall of the breast implant or tissue expander. In at least one example, the one or more transponders can be permanently attached or encapsulated in a silicone plastic cassette and integrated into the tissue expander or medical implant by dielectrically sealing or bonding the one or more encapsulated transponders to a housing of the tissue expander or medical implant. In some examples, one or more transponders encapsulated in silicone may be placed in the internal volume of the tissue expander or medical implant, e.g., such that the one or more transponders are free floating in the internal volume or suspended in a material filling the internal volume of the tissue expander or medical implant.
According to some aspects of the present disclosure, the medical device may include a plurality of transponders (e.g., transponders 100, 200), e.g., 2, 3, 4, 5, or 6 or more transponders. Each transponder may be spaced apart from the other one or more sensors at a predetermined spatial interval. Such combinations of transponders in the medical device may be used to determine orientation information, such as changes in orientation of the medical device, displacement of the medical device, changes in the amount of material between transponders, and/or changes in the physical or chemical properties of material between transponders. Such a change may be determined, for example, by measuring the impedance between two or more transponders.
Further, for example, two or more medical devices implanted within a patient may include transponders having the ability to communicate and/or provide information related to each other. For example, for 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 of each implant may be configured to provide data regarding a common anatomical feature of the patient and/or a common reference point of one of the implants.
The transponders 100, 200 may be, for example, active, passive, or both active and passive. With permanent implants or medical devices for relatively long-term implantation, passive transponders may avoid issues of recharging the power battery, cycle life, and/or possible corrosive properties of certain materials (e.g., different materials) used in the design of the active sensor battery. The data may be actively and/or passively transmitted, received, stored, and/or analyzed by the transponder. For example, data may be transmitted via radio frequency from the transponder to an external reader (external to the implant) configured to receive and/or analyze or otherwise process the data. Exemplary embodiments of such readers are further disclosed herein. Such readers may be implanted within the patient, or may be external to the patient and attached or unattached to the patient. According to some aspects of the present disclosure, data may be transferred between a transponder (e.g., transponder 100, 200) and a reader within a distance of about 10 feet separating the transponder and the reader, the 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 in 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.
The transponder (e.g., transponder 100, 200) may be configured to detect and/or measure various stimuli or parameters. For example, a transponder according to the present disclosure may be configured to detect and/or measure one or more of acoustic data, temperature, pressure, light, oxygen, pH, motion (e.g., accelerometer), ring rotation (e.g., gyroscope sensor), or any other physiological parameter using sensors known in the art coupled to the chip of the transponder (e.g., chip 110 of transponder 100, 200). For example, an exemplary pH sensor may include a measurement 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 the implanted medical device, for example, in order to evaluate any undesirable change in position or orientation after initial implantation.
The sensor may be calibrated with an appropriate reference or standard to provide an accurate measurement, or an absolute or relative change in value. For example, a temperature sensor may be calibrated based on one or more reference temperatures, and a pressure sensor may be calibrated to indicate changes in pressure.
In some examples, an implantable medical device may include a transponder and/or a sensor package that includes the transponder in combination with one or more other transponders, sensors, and/or additional electronic components. One or more transponders, one or more sensors, and a plurality of electronic components may be coupled together or otherwise in communication 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 cycling, or a combination thereof. The transponder and/or sensor package may comprise a single integrated circuit coupled together via a PCB or fully integrated into an ASIC.
The transponders of the present disclosure (e.g., transponders 100, 200) may be read/written, e.g., where data may be written into or otherwise associated with each transponder by a user for reading by a suitable device, such as an external reader. Such data may include unique device identifiers for transponders, and/or sensor packages, and/or medical devices. 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 lot numbers, and/or the size of the medical device and/or one or more sensors. For example, one or more transponders (e.g., transponders 100, 200) associated with the breast implant may include information regarding the size (e.g., size and/or volume) of the implant, the manufacturer, the date of manufacture, and/or the lot number. Additionally or alternatively, one or more transponders (e.g., transponders 100, 200) associated with the breast implant 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 collected/measured data, 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 the ancillary coatings or materials used with the implant, and the like.
Integrating an acoustic sensor with a transponder (e.g., transponder 100, 200) into an implantable medical device may enhance auscultation, e.g., allowing monitoring and/or examination of the circulatory system (e.g., via heart sounds related to cardiac output or structural defects/disorders), the respiratory system related to lung function (e.g., via respiratory sounds), and/or the gastrointestinal system related to obstructions and ulcers (e.g., via bowel sounds). The acoustic sensor may include a lever and a MEMS (micro electro mechanical system) device. Examples of acoustic sensors that may be used herein include, but are not limited to, accelerometers (e.g., measuring vibration noise), thermal sensors (e.g., measuring thermo-mechanical noise), and piezoelectric capacitance sensors, among other types of acoustic sensors. The acoustic sensor may be operated manually when powered (e.g., when a transponder paired with the sensor is coupled with a reader). The capacitor (e.g., capacitor 120 in transponder 200, or a built-in capacitor in chip 110) and/or battery may allow the transponder (e.g., transponder 100, 200) to obtain and store information and transmit data when interrogated or coupled to another electronic device.
Furthermore, a transponder according to the present disclosure may be configured to enhance acoustic data. Enhancing the acoustic sounds may include algorithms that are trained with known sounds to provide a reference as to the amount or degree of change, and/or to eliminate non-significant noise (e.g., signals that may be artifacts of the measurement technique) that may interfere with producing a "clean" signal that provides meaningful information about the patient. Such algorithms may be loaded onto a chip (e.g., chip 110) of a transponder (e.g., transponders 100, 200).
As described above, transponders such as transponders 100, 200 may be configured to communicate with external readers to process data, for example, by filtering noise from raw data. For example, the transponder may be used in conjunction with an algorithm that collates and analyzes the filtered data, e.g., obtains raw data from the sensor in a minimum transmission (threshold) format based on preprogrammed parameters (e.g., data obtained from a reference table). Such algorithms may be designed to combine relevant integrated data that is specific to providing an appropriate signal indicative of a mechanical or clinical problem, which can then be processed by the reader. Readers are described in more detail elsewhere in this disclosure. The reader may include a graphical display, such as an LED display, and may have parameters established in the firmware of the reader to present a data output on the display and/or to provide a notification signal. For example, the notification signal may be a recommendation that the patient, as displayed on the reader, contact his/her caregiver or clinician to follow up with a particular action item. For example, the reader may suggest checking or modifying a particular aspect of the implanted medical device (e.g., adding more saline solution to the tissue expander via a syringe, etc.).
Other uses, systems, and combinations of transponders, sensors, and readers are also disclosed elsewhere herein.
Integrated port assembly and locator coil
The present disclosure also includes low artifact transponders that can be used to locate particular parts or features of an implanted medical device. For example, some implanted medical devices may require modification or adjustment after implantation. As an example, tissue expanders can be used during breast reconstruction or breast augmentation procedures to gradually expand breast tissue over time so that the tissue can accommodate more permanent implants. Tissue expanders in accordance with the present disclosure may also be used for procedures other than breast augmentation and reconstruction.
The tissue expander can be inflated, for example, manually and/or electronically with a syringe or other suitable device, to introduce and withdraw a fluid (e.g., a liquid or gaseous fluid) or gel into the tissue expander. The tissue expander may be inflated with saline solution that may be supplied in a sterile bag, such as Lab Products, IncAnd (5) producing the product. In some aspects, inflation may be performed wirelessly, for example, by communicating with an internal sleeve or cylinder of compressed air.
According to some aspects of the present disclosure, a tissue expander may include one or more pressure sensors and/or one or more strain gauges that may be coupled with, for example, a transponder (e.g., transponders 100, 200). Such sensors may allow for continuous and/or intermittent measurement of pressure in order to optimize, adjust, and/or wirelessly control the expansion and contraction of such tissue expanders. Transponder/sensor packages for tissue expanders (including, for example, sensors for measuring pressure, temperature, acoustic data, pH, oxygen, light, or combinations thereof) may be contained in a silicone molded housing. In at least one example, the tissue expander can comprise 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, the 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 sensor/transponder packages may be paired with a reader, which is described in more detail elsewhere in this disclosure.
The tissue expander can include a port through which fluid can be injected into the tissue expander after the tissue expander has been implanted in the patient. The port can be located within an aperture in a housing of the tissue expander, the aperture sized to mate with the port. Thus, the port may be implanted with a tissue expander and may not be immediately detectable from outside the patient. Advantageously, transponders and/or coils according to the present disclosure can be combined with, for example, tissue expander ports and valve assemblies to facilitate detection of the ports and valve assemblies. By mounting the transponder and/or antenna coil within the tissue expander port or valve assembly, the physician may be able to non-invasively identify the appropriate location of the port for injecting saline solution into a patient in which the tissue expander is implanted. As with the transponders 100, 200, such transponders, antenna coils, and/or valve assemblies may be made of materials that replace ferromagnetic materials that may cause imaging artifacts under magnetic resonance imaging. For example, the transponder, coil, and/or associated valve assembly disclosed herein may comprise a non-ferromagnetic material, such as Polyetheretherketone (PEEK) or other plastic articles.
Fig. 3A-3C illustrate an example valve assembly 300 according to the present disclosure that includes a housing 302, a coil 304, and a chip 306 attached to the coil 304. Fig. 3A depicts a three-dimensional view of the valve assembly 300, fig. 3B depicts a side view of the valve assembly 300, and fig. 3C depicts a top view of the valve assembly 300. 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 can have an inwardly projecting lip 309 of the wall 309A 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. The circumferential inner ledge 323 may protrude into the inner chamber 307. As shown in fig. 3B, a portion of the inner chamber 307 may extend to a deeper depth than the well portion 308 such that the shell 302 has a central portion 312 that protrudes from the remainder of the shell 302 into the medical implant (e.g., tissue expander). The central portion 312 may have a reinforcing tip 315 at the distal-most end of its protruding portion. One or more fluid apertures 314 may pass from the inner chamber 310 through the central portion 312. The housing 302 may also have a circumferential outer ledge 317 around the wall 311. The outer ear 317 may include one or more notches 319.
Valve assembly 300 can be configured for mounting in a housing of a tissue expander. Valve assembly 300 may be made of a biocompatible non-magnetic non-ferromagnetic material such as, for example, molded PEEK. The valve assembly 300 may have a hardness sufficient to prevent penetration by a cannula, such as a cannula of a syringe used to inject fluid into a tissue dilator in which the valve assembly 300 is installed. The valve assembly 300 may be sized and shaped to allow the coil 304 to fit within the circumference of the valve assembly 300.
The coil 304 may be a coiled Radio Frequency (RF) antenna coil made of, for example, metal wire such as, for example, copper or aluminum wire. In some embodiments, the coil 304 may be made of enameled wire, such as wire coated in a polymer. Suitable polymers may include, for example, polyvinyl formal (Formvar), polyurethane, polyamide, polyester-polyimide, polyamide-polyimide (or amide-imide), and polyimide. In some embodiments, the coil 304 may be made of enameled copper wire, such as, for example, Elektrisola enameled copper wire.
The coil 304 may be sized and shaped to encircle a core or central portion through which a cannula may pass into the central chamber 307 of the valve assembly 300. The coil 304 may also be sized and shaped to be detected by, for example, a reader configured to detect the center of the wound coil. In this manner, coil 304 may 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 may have a regular hollow cylindrical shape, and its outer diameter may range, for example, from about 10mm to about 50mm, such as, for example, from about 10mm to about 40mm, from about 15mm to about 25mm, from about 20mm to about 35mm, or from about 22mm to about 27 mm. For example, in some embodiments, the outer diameter of the coil 304 may be about 24mm, about 24.6mm, about 25mm, about 25.3mm, about 26mm, or about 26.2 mm.
In some embodiments, the inner diameter of the coil 304 may range, for example, from about 10mm to about 50mm, such as, for example, from about 10mm to about 40mm, from about 10mm to about 35mm, from about 15mm to about 30mm, from about 15mm to about 25mm, or from about 18mm to about 22 mm. For example, in some embodiments, the inner diameter of the coil 304 may be about 18mm, about 19mm, about 19.5mm, about 20mm, about 20.1mm, about 20.3mm, about 20.4mm, about 20.5mm, about 20.6mm, about 20.7mm, about 21mm, or about 22 mm.
In some embodiments, the height of the coil 304 may range from about 1mm to about 20mm, such as from about 1mm to about 15mm, from about 1mm to about 13mm, from about 1mm to about 10mm, from about 1mm to about 8mm, from about 1mm to about 5mm, or from about 1mm to about 4 mm. For example, in some embodiments, the height of the coil 304 may be about 1mm, about 2mm, about 2.1mm, about 2.2mm, about 2.5mm, about 2.7mm, about 2.8mm, about 2.9mm, about 3mm, about 3.2mm, about 3.4mm, about 3.6mm, about 3.8mm, about 3.9mm, or about 4.0 mm.
The coil 304 may be formed of any number of turns sufficient to be induced by an external reader (e.g., reader 800 described further herein). For example, in some embodiments, the coil 304 may be formed from about 10 to about 2000 turns. For example, in some embodiments, the coil 304 may 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 may be formed of, for example, about 500, about 700, about 800, about 1000, about 1100, or about 1200 turns.
Chip 306 may be an RF chip known in the art, such as a chip (e.g., chip 110) that has been described elsewhere herein. In general, the disclosure herein with respect to chip 110 is also applicable to chip 306. For example, in some embodiments, chip 306 may be an ASIC. Chip 306 may or may not include a capacitor. In some embodiments, chip 306 may be an ASIC programmed with identification data, such as a serial number, so that when powered, chip 110 will return such identification data. In some embodiments, chip 306 may be a sensor, or may be paired with a sensor, as described elsewhere herein with respect to chip 110. In an alternative embodiment of valve assembly 300, chip 306 may not be present. In such cases, coil 304 may be used primarily as a targeting element to help position valve assembly 300.
The housing 302 of the valve assembly 300 may be sized and shaped to receive the coil 304 and the chip 306 in the well portion 308 and the internal chamber 307. The well portion 308 of the valve assembly 300 may have a generally circular shape so as to accommodate the coil 304 and, for example, the chip 306 connected to the coil 304. The well portion 308 of the valve assembly 300 is depicted as open in fig. 3A-3C; however, in some embodiments, the circular well portion 308 containing the coil 304 and chip 306 may be closed off, and sealed from the rest of the valve assembly 300, by, for example, a biocompatible material, such as the biocompatible material from which the body of the housing 302 is made (e.g., PEEK) or another biocompatible material (e.g., silicone).
A lip 309, which may protrude above the well portion 308, may be configured to interlock with a dome, which may cover the valve assembly 300, for example. Such a dome may be, for example, an integrated port dome 310, as shown, for example, in fig. 4, and described further herein. In alternative embodiments, the lip 309 may project in a different direction (e.g., outwardly and away from the well portion 308), or may include intermittent projections to attach to a dome that may cover the valve assembly 300 in a different manner, for example.
The inner chamber 307 is radially inward of the coil 304 and the well 308. In some embodiments, the inner chamber 307 may be cylindrical, bowl-shaped, or both. In some embodiments, the inner chamber 307 may have a depth that is deeper than, for example, the well portion 308, such that some or all of the inner chamber may extend into the central portion 312, and the central portion 312 may protrude below the remainder of the housing 312 (e.g., the well portion 308), as shown, for example, in fig. 3B and 4. The inner chamber 307 may be configured to receive, for example, fluid from, for example, a cannula, syringe, or other fluid injection device. A fluid aperture 314 may extend from the inner chamber 307 through the housing 302 and out of the central portion 312 such that fluid may pass from the inner chamber 307 through the fluid aperture 314 and into, for example, a medical implant in which the valve assembly 300 is installed. In some embodiments, the fluid aperture 314 may comprise a valve, e.g., a one-way valve (e.g., a duckbill valve), configured to allow fluid from the inner chamber 307 out into, for example, a medical implant, and not back into the inner chamber 307. The bottom surface of the inner chamber 307 may be reinforced by an inner tip 315 to prevent penetration by, for example, a cannula, syringe, or other injection device.
Fig. 4 depicts a side view of an integrated port assembly 400, which may include a valve assembly 300 (in cross-section) and an integrated port dome 310. Integrated port dome 310 may include a step 316, which step 316 may be configured to fit against the edge of an aperture in the wall of an implant in which integrated port assembly 400 may be mounted, such that patch portion 314 is located on the implant wall. The integrated port dome 310 may also have a flange 312, which flange 312 may be configured to interlock with the lip 309 of the valve assembly 300, thereby connecting the valve assembly 300 to the integrated port dome 310. Patch portion 314 is wider than flange 312 and valve assembly 300.
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 integrated port assembly 400 can be installed. Some or all of the integrated port dome 310 may be made of a material that is penetrable by, for example, a cannula, syringe, or other injection device such that the injection device may penetrate the integrated port dome 310 and inject fluid into the interior chamber 307 of the valve assembly 300. In some embodiments, the integrated port dome may be made of a self-sealing material such that when an injection device is penetrated through 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 may be made of a silicone material. For example, in some embodiments, the integrated port dome 310 may be made of a vulcanizable silicone material.
The integrated port dome 310 may be sized and shaped to securely interlock with the valve assembly 300, for example. As depicted in, for example, fig. 5B and 5C, described further below, the flange 312 of the integrated port dome 310 may be further sized and configured to cover any openings in the well 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 308 and preventing the coil 304 and the chip 306 from being exposed to fluids.
Fig. 5A, 5B, and 5C depict integrated port assembly 400 installed in an exemplary implant housing 500. Implant shell 500 can be, for example, a shell of a tissue expander, as shown in fig. 5A. In some embodiments, the implant housing may be made of silicone; however, any biocompatible material implant housing may be used in conjunction with integrated port assembly 400. The integrated port assembly 400 may be mounted in the aperture 502 of the implant housing 500. The valve assembly 300 of the integrated port assembly may be located inside the implant housing 500. The integrated port dome 310 may be attached to the valve assembly 300 and the patch portion 314 may be located outside the implant housing 500. In fig. 5A, the patch portion 314 of the integrated port dome 310 is depicted by dashed lines, showing how the integrated patch portion 314 may overlap some surface area 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, patch portion 314 and implant housing 500 can be attached to one another, for example, by vulcanization, adhesive, or other methods.
Fig. 5B depicts a cross-sectional view of integrated port assembly 400 installed in implant housing 500. As shown in fig. 5B, the edges of the aperture 502 of the implant housing 500 may be angled in a complementary manner to the angle of the step piece 316 of the integrated port dome 310 so as to fit snugly against the step piece 316. In this manner, and in conjunction with the overlapping and attachment of patch portion 314 to implant housing 500, integrated port assembly 400 may be sealed and secured within aperture 502 of implant housing 500.
Fig. 5C depicts the same cross-sectional view of integrated port assembly 400 installed in implant housing 500 as fig. 5B. Fig. 5C also depicts how the 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 then into the interior of the implant shell 500. As previously described, the integrated port dome 310 may 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 fluid within the lumen 307 and the implant shell 500.
Fig. 6 depicts another example integrated port assembly 600 that may include a valve assembly 610 and an integrated port dome 620. Valve assembly 610 may include a main chamber 612 surrounded by a wall 615 having a lip 619. Lip 619 has an inner edge 619E. The main chamber 612 may have a top opening defined by a rim 619E, the rim 619E being configured to face the integrated port dome 620 and may receive the plug 621 of the integrated port dome 620. The wall 615 of the primary chamber 612 may have one or more fluid apertures 618 that may exit the valve assembly 610 from the primary chamber 612. The coil 616 may be located in a coil housing 614, which coil housing 614 is 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 may have a patch 622, which patch 622 may have a width wider than the plug 621 and the valve assembly 610 and may be integral with the plug 621. The flange 626 between the patch 622 and the plug 621 may be configured to receive and interlock with the lip 619 of the valve assembly 610. The integrated port dome 620 may also have a step 624 configured to interface with a wall of an implant in which the integrated port assembly 600 may be mounted.
In general, aspects of integrated port assembly 600 may be similar to aspects of integrated port assembly 400. For example, in some embodiments, valve assembly 610 may be made of any material from which valve assembly 300 may be made, such as a biocompatible non-ferromagnetic material (such as PEEK). Further, main chamber 612 of valve assembly 610 may have a similar function as inner chamber 307 of valve assembly 300 in that main chamber 612 may be sized, shaped, and configured to receive fluid from, for example, a cannula, syringe, or other fluid deposition device. The inner surface 617 of the main chamber 612 may be configured to prevent or resist puncture, for example, by a cannula that deposits fluid within the main chamber 612. For example, the inner surface 617 may be made of a material having a density, hardness, or thickness configured to prevent or resist puncture by the fluid deposition device. In some embodiments, the main chamber 612, including the inner surface 617, may be made of biocompatible PEEK.
The coil 616 is similar to the coil 304 in terms of size, shape, configuration, material, and construction, which was previously disclosed above with respect to fig. 3A-5C. The coil 616 may be housed in a coil housing 614. In some embodiments, the coil housing 614 may be sealed closed such that fluid cannot enter or exit the coil housing 614. In some embodiments, as shown, the coil housing may be cylindrical and may be coaxial with the main chamber 612, such that the coil 616 is also coaxial with the main chamber 612. In this way, the position of the coil 616 may be used to locate the center or approximate center of the main chamber 612. The coil housing 614 is depicted as having a smaller circumference than, for example, the primary chamber 612. However, in some embodiments, the coil housing 614 may have a circumference that is as large or nearly as large as the primary chamber 612.
Although not shown, coil 616 may be coupled to a chip similar to chip 306 connected to coil 304. Such chips may have any of the features and capabilities of the chips otherwise disclosed herein.
Integrated port dome 620 may be similar in shape, structure, and material of construction to integrated port dome 310 of integrated port assembly 400. For example, the plug 621 of the integrated port dome 620 may be sized and shaped to snugly interlock with, for example, the lip 619 of the primary chamber 612. Like the integrated port dome 310, the integrated port cylinder 620 may be made of a biocompatible material (e.g., silicone) having self-sealing capabilities.
Fig. 7A and 7B illustrate three-dimensional views of the integrated port assembly 600. In particular, fig. 7A depicts the integrated port assembly installed within an opening 702 in an implant housing 700. As with the integrated port assembly 400 and implant housing 500, the edges of the opening 702 in the implant housing 700 may be angled in a complementary manner to the angle of the step 624 of the integrated port dome 620 so as to snugly fit the step 624. As shown in both fig. 7A and 7B, the position of the coil 616 is indicated by dashed lines within the coil housing 614. The integrated port dome 620 may be attached to an outer surface of the implant shell 700 so as to form a seal between the integrated port dome and the implant shell 700.
The integrated port assemblies disclosed herein (such as integrated port assemblies 400, 600) may be used as refill ports in implants (such as tissue expanders), for example, that need to be filled and/or refilled. This is further described herein with respect to fig. 10A-10C.
An implant (e.g., a tissue expander) having an integrated port assembly (e.g., integrated port assembly 400, 600) can additionally 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 with integrated port assemblies such as those disclosed herein may also include means for remote filling/inflation via the integrated port assembly.
In some aspects of the 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 in wireless communication with the sensor package. In at least one example, inflation/deflation may be controlled according to parameters set in the reader and shown in the LED display output. Readers according to the present disclosure are described in more detail below
Platform reader
The present disclosure also includes a reader for use with the transponder, sensor and integrated port assembly disclosed herein. In general, the transponder and integrated port assemblies disclosed herein are compatible with a variety of commercially available RF readers. Additionally, disclosed herein are readers that are compatible with multiple types of transponders and coils, and that are capable of transmitting and/or receiving signals at different degrees of intensity and at different frequencies. A platform reader is disclosed that, in order to detect a given transponder or coil, can scan a frequency broadcast signal, thereby receiving signals at different 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 the given transponder or coil.
Fig. 8 illustrates a block diagram of components of an example platform reader 800 according to this disclosure. 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 clock generator 810 may in turn control a driver/amplifier 812. Driver/amplifier 812 may be connected to antenna 814. The antenna 814 may be connected to a transformer 816, which transformer 816 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.
The antenna 814 may also be connected to a logarithmic amplifier 824. The pick-up antenna 822 may also be connected to a logarithmic amplifier 824.
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, microcontroller 802 may include one or more Computer Processing Units (CPUs), as well as memory and programmable input/output peripherals. Microcontroller 802 may receive inputs and instructions, for example, via a digital connection, which may be, for example, USB connection 804. In alternative embodiments, the USB connection 804 may be another type of connection, such as an eSATA connection, a firewire connection, an ethernet connection, or a wireless connection. Connection 804 may connect microcontroller 802 to, for example, an input/output device, such as a computer, capable of programming microcontroller 802.
The microcontroller 802 may also have a display 806, which display 806 may be, for example, an LED display. Display 806 may be configured to display calculations, inputs, outputs, and instructions sent and received by microcontroller 802. In some embodiments, the display 806 may be configured to display instructions or input received via, for example, the connection 804. In an alternative embodiment, 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.
The platform reader 800 may also include one or more power supplies 808. The power supply 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, and the like. In fig. 8, a power supply 808 is shown 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.
The microcontroller 802 may be connected to a clock generator 810, which clock generator 810 may in turn be connected to a driver/amplifier 812. Clock generator 810 may be a circuit that can provide a timing signal having a precise frequency and/or wavelength through which microcontroller 802 can instruct driver/amplifier 812 to output a wave broadcast signal at a desired speed or interval. Driver/amplifier 812 may include, for example, a driver that generates an RF signal, and an electronic amplifier that may generate a low power RF signal and amplify the signal to a higher power signal. Driver/amplifier 812 may comprise, for example, any type of RF driver/amplifier known in the art, such as a solid state or vacuum tube amplifier.
Driver/amplifier 812 may be connected to antenna 814. The antenna 814 may be, for example, an RF antenna. In one aspect, the antenna 814 may be connected to a transformer 816, which transformer 816 in turn is connected to an analog front end 818 and an ADC 820. Together, the transformer 816, analog front end 818, and ADC820 may be configured to receive and process signals (e.g., carrier signals and modulation signals) from the antenna 814 and convert them to digital values for return to the microcontroller 802. In particular, the transformer 816 may be configured to transform the received high voltage signal from the antenna 818 and into a voltage that may be processed by other elements of the reader 800 (e.g., the analog front end 818, the ADC820, and/or the microcontroller 802) without damaging the other elements. Analog front end 818 may be configured to filter out portions of the received and transformed signal from transformer 816. For example, analog front end 818 may be configured to process the received signal such that carrier signals having the same wavelength and/or frequency as the signal broadcast by antenna 814 are removed, leaving only a modulated signal (e.g., a signal modulated by a transponder that receives and returns a signal from antenna 814). The ADC820 may be configured to convert the filtered modulated signal to a digital value.
The antenna 814 may also be connected to a logarithmic amplifier 824, which logarithmic amplifier 824 may also be connected to an optional pick-up antenna 822. The pick-up antenna 822 may serve as an additional antenna configured to help pick up weak signals. Weak signals received by the antenna 814 or the pick-up antenna 822 may be amplified by the log amplifier 824 and passed to the ADC 826. The logarithmic amplifier 824 may be an amplifier configured to receive weak signals and amplify them in a logarithmic scale so that they may be processed by the ADC 826 and the microcontroller 802. The ADC 826 may be configured to convert signals received from the logarithmic amplifier 824 and provide them to the microcontroller 802, which the microcontroller 802 may be configured to evaluate the strength of the signals received from the ADC 826. In this way, the platform reader 800 may be able to evaluate and process signals that span a wide signal strength.
In some embodiments of the reader 800, the microcontroller 802 may be directly connected to the driver/amplifier 812, for example. In such embodiments, microcontroller 802 may be configured to provide the signal frequency and wavelength directly to driver/amplifier 802 without the signal being generated by clock generator 810.
The elements of the reader 800 may be permanently or removably connected to each other. For example, antenna 814 and/or pickup antenna 822 may be removably connected to other elements of reader 800.
Fig. 9 depicts in block diagram form the steps of a method 900 for broadcasting a signal having a frequency optimized for a given transponder. The method 900 may be performed using, for example, the platform reader 800. According to step 900, a clock generator may be used to continuously provide a frequency sweep range to a signal driver/amplifier. A signal driver/amplifier may be used to continuously broadcast a signal having a frequency sweep range provided via the main antenna, per step 904. According to step 906, return signals from transponders within range of the primary antenna may be continuously monitored via the primary antenna. From step 908, it may be determined whether any return signals are weak or absent. If not (i.e., if the return signal is strong), then a transformer may be used to continuously transform the return signal into a voltage difference, per step 910. If so, then the weaker signals may be continuously monitored using the pick-up antenna, per step 912, and the signals received by the pick-up antenna may be amplified and converted to a voltage difference using a logarithmic amplifier, per step 914. According to step 916, the voltage difference (converted in step 910 or step 914) may be continuously converted to a digital value using an analog-to-digital converter and the digital value transmitted to the microcontroller. According to step 918, a microcontroller may be used to determine the highest received digital signal. According to step 920, a microcontroller may be used to determine the frequency of the broadcast signal corresponding to the highest received digital signal. According to step 922, the microcontroller may be used to instruct the clock generator to provide the determined frequency to the signal driver/amplifier. The signal driver/amplifier broadcasts a signal having a determined frequency, per step 924.
According to the method 900, a clock generator may be used to continuously provide a frequency sweep range to a signal driver/amplifier. For example, with respect to platform reader 800, microcontroller 802 may provide instructions to clock generator 810 to provide a frequency sweep range to signal driver/amplifier 812. The frequency may range, for example, from about 80kHz to about 400 kHz. For example, in some embodiments, the frequency may range from, for example, about 80kHz to about 300kHz, about 100kHz to about 250kHz, about 100kHz to about 200kHz, about 110kHz to about 150kHz, about 110kHz to about 140kHz, or about 120kHz to about 150 kHz. In some embodiments, the frequency sweep frequency may include a common or standardized frequency, such as, for example, about 125kHz and/or 134.2 kHz. In some embodiments, the frequency sweep range may span 3 or 4kHz above and below the usual or standardized frequencies, such as, for example, in the range of about 121kHz to about 129kHz or about 130.2kHz to about 138.2 kHz. In some implementations, the speed at which the frequency sweep range is provided may depend on, for example, the size of the frequency range and/or the number of sweep repetitions. For example, in some implementations, a frequency sweep range of less than one second, for example, may be provided. For example, in other embodiments, a frequency sweep range of, for example, one or more seconds may be provided.
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 main antenna (e.g., antenna 814). The signal driver/amplifier may be instructed to begin broadcasting signals continuously by a controller (e.g., microcontroller 802).
According to step 906, return signals from transponders within range of the primary antenna may be continuously monitored via the primary antenna (e.g., antenna 814). The presence and/or strength of a return signal from an RF transponder (e.g., transponder 100, 200) within range of the antenna may depend on, for example, the frequency broadcast by, for example, driver amplifier 812 in step 904. The transponder may be configured to return the strongest signal at a particular frequency, such as, for example, 125 kHz. Thus, as the signal driver/amplifier approaches the frequency in its sweep broadcast, the return signal from the transponder may increase and peak at the frequency.
From step 908, it may be determined whether any return signals are weak or absent. Such a determination may be made, for example, by a low signal strength or no signal received by the microcontroller 802, after the transformer 816, analog front end 818, and ADC820 have processed any received signals. If not (i.e., if the return signal is strong), then the return signal may be continuously transformed into a voltage difference using a transformer, per step 910. If so, then according to step 912, a pickup antenna (e.g., pickup antenna 822) may 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) may be used to amplify the weak signals received by the pickup antenna or main antenna and convert them to a voltage difference that may be converted by an ADC (e.g., ADC820 or ADC 826).
In an alternative embodiment, a pickup antenna (e.g., pickup antenna 822) may be used in addition to the main antenna to monitor for weaker signals, and a log amplifier (e.g., log amplifier 824) may be used to amplify weaker signals received by the pickup antenna or the main antenna without first determining whether any return signals are weak or absent.
According to step 916, the voltage difference (converted in step 910 or step 914) may be continuously converted to a digital value using an analog-to-digital converter and transmitted to the microcontroller. For example, the voltage difference converted by the transformer 816 may be continuously converted using the ADC820, and the voltage difference amplified by the logarithmic amplifier 824 may be continuously converted using the ADC 826. According to step 918, a microcontroller (e.g., microcontroller 802) may be used to determine the highest received digital signal (e.g., from a library of combined digital signals received from both ADC820 and ADC 826).
According to step 920, the frequency of the broadcast signal corresponding to the highest received digital signal may be determined using a microcontroller. The highest received digital signal may correspond to the best broadcast signal to receive the clearest return signal from transponders near one or more antennas (e.g., antenna 814 and pickup antenna 822).
The microcontroller may be used to instruct the clock generator to provide the determined frequency to the signal driver/amplifier, per step 922, after which the signal driver/amplifier may be instructed to broadcast a signal having the determined frequency, per step 924.
Thus, the above disclosed method provides a way to adjust the frequency of the signal to suit a particular transponder. Advantageously, this may allow a reader, such as platform reader 800, to broadcast a customized signal to transponders that may not be configured to respond to accurate standard signals (including, for example, standard RFID signals of 125kHz and 134 kHz). Because slight differences in, for example, coil shape, coil size, and number of coil turns may result in transponders, particularly relatively small transponders, having an optimum frequency that is slightly different from the standard frequency, and because relatively small transponders (e.g., transponders 100, 200) without a ferromagnetic core may already have a limited range and signal strength, determining the optimum frequency for the transponder, and then reading the transponder at that frequency may produce an improved return signal that is stronger than in the case of the standard signal.
A reader such as platform reader 800 may be used to send information to and receive information from transponders disclosed herein, such as transponders 100, 200 and integrated port assemblies 400, 600. While 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.
Fig. 10A-10C depict the use of reader 1000 to inject fluid into a tissue dilator 1002, the tissue dilator 1002 having an integrated port assembly 1004 equipped with an antenna coil 1006 (shown by dashed lines). As shown in each figure, the patient may have surgically implanted a tissue expander 1002 in breast tissue 1001, adjacent to breast tissue 1001, or in place of breast tissue 1001. For example, reader 1000 may be or share features with platform reader 800. Integrated port component 1004 may be or share features with, for example, integrated port component 400 or integrated port component 600. The center of the integrated port assembly 1004 may be identified by an electronic reader that looks for a "fenestration" or center of the wound antenna coil in each integrated port assembly; for example, as a "targeting element," as described further below.
As shown in fig. 10A, a reader 1000 configured to position an antenna coil 1006 may be used in order to determine the position of the antenna coil 1006, and thus the position of the integrated port assembly 1004 beneath the patient tissue 1001. Reader 1000 may, for example, have an antenna configured to sense and detect a magnetic field in a nearby electromagnetic coil. The reader 1000 may output a number, for example, 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 moves over the patient tissue 1001. Once the reader 1000 displays a number below a given threshold, or otherwise indicates that the reader 1000 has positioned the core of the antenna coil 1006, the physician may prepare to inject fluid at a specified point in the patient tissue 1001.
In some embodiments, once integrated port assembly 1004 has been positioned, a mark may be formed on the skin of patient tissue 1001 for proper alignment of the fluid injection device with integrated port assembly 1004. In some aspects, the reader 1000 may 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 may include a cannula that may be sterile and/or disposable such that the reader may be used for multiple patients.
As shown in fig. 10B, a fluid injection device 1008 can be used to inject fluid into the tissue dilator 1002, thus dilating through the tissue dilator 1002 and the integrated port assembly 1004 in the patient's tissue 1001. The fluid injection device 1008 may be, for example, a syringe, such as a manual syringe, an automated syringe, a pipette, or other fluid deposition device. Finally, as shown in fig. 10C, once the fluid injection device 1008 has been used to inject fluid, and once the fluid injection device 1008 has been withdrawn, the tissue dilator 1002 may have a larger volume.
Data analysis and other transponder uses
Various combinations and uses of the transponders, sensors, and readers disclosed herein can achieve different results. Some of these combinations and uses are extended below.
Data analysis
The present disclosure also includes algorithms that take into account characteristics of the physiological environment from which data is collected. The algorithms may be used to evaluate and/or analyze data to provide translation results or outputs. For example, the algorithms may include specific features and nuances of materials used in the construction of the medical device. Such features may include, for example, the chemical composition and/or surface characteristics (or other physical characteristics, such as the rate of degradation of a drug or agent dissolved from a surface or a biodegradable material) of the medical device. For example, the specific chemical composition of the silicone used in breast implants or tissue expanders and/or the surface properties of the medical devices may affect their interaction with the surrounding tissue of the patient. Selection of an appropriate material may 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. The sensors and microelectronics can be encapsulated as a suitable type of inert coating using an impermeable material such as glass. Additionally or alternatively, the algorithm may include consideration of the depth and location of the medical device at the time of implantation (e.g., characteristics of surrounding tissue) and/or potential interference from other active (powered) devices such as other implants.
As another example, the algorithm may consider one or more physiological parameters, such as, for example, pH, temperature, oxygen saturation, and other parameters, which 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 the data collected from one or more sensors in order to optimize the "signal-to-noise ratio" and include formulas that determine the meaning of the combined analytical data; for example, pressure, pH and/or temperature when assessing infection or tissue inflammation. Other combinations of data may be indicative of foreign (e.g., cancerous) tissue. The algorithms herein may predict structural changes, for example, by revealing a weakness in a portion of a medical device prior to failure. For example, the algorithm may identify the weakening of the shell of the breast implant before it ruptures and/or sense a rupture or tear in the shell based on, for example, a change in pressure.
In some aspects, the algorithm may take into account personalized patient data. For example, the algorithm may analyze various data collectively, both data collected from one or more sensors integrated into a medical device implanted within a patient and data specific to the individual patient. For example, if the algorithm encompasses other physiological data (such as, for example, blood parameters, genomics, tissue elasticity, and/or other health parameters), sensors that collect pH, pressure, and temperature may provide clinical data that is more meaningful in some respects.
Data analysis according to the present disclosure may include anti-collision techniques for low frequency systems, e.g., with the ability to read data from multiple sensors simultaneously. Transponders that include RF antennas typically have the ability to transmit and receive data. The communication of data may include specific ASIC programming that may depend on the frequency of the RF signal. Thus, each transponder may selectively communicate with one or more other sensors in sufficient proximity, which may include transponders implanted elsewhere in the patient.
Medical device information
Device breach/failure: change in pH
According to some aspects of the present disclosure, the transponders disclosed herein may provide information about the status of an implanted medical device when used in conjunction with various types of sensors. For example, a pH sensor may be used to detect the rupture of interstitial fluid, such as blood and/or proteins that may infiltrate a malfunctioning medical implant. Such pH sensors may be positioned at various locations around the surface of the medical device. For example, one or more pH sensors may be coupled to the surface of or embedded in a breast implant or tissue expander. Multiple sensors coupled with a transponder may communicate with each other via a frequency link (e.g., ad hoc or hard wired). In the event of a breach in the medical device, a change in pH may be detected by one or more sensors. For example, for a breast implant, the change in pH may be due to a breach of the wall of the outer shell, or a breach of a portion of the shell, resulting in a permeable entry into the surrounding tissue. Some medical devices according to the present disclosure may include a catheter that allows external interstitial fluid to passively flow (e.g., convect or conduct) to a sensor located deeper inside the medical device so that bodily fluids, such as blood, may diffuse into the medical device due to the breach and be detected by the sensor.
Device failure: other detection methods
According to some aspects of the present disclosure, an implantable medical device may include a mesh nanoscale detection system that uses fluidic chemical, electronic, or mechanical substrates to detect breaches (e.g., housing breaches) in the implantable medical device. Additionally or alternatively, the medical device may include external and/or internal systems that use Infrared (IR) or low wave light (or low wave electronic fields) to check for breach detection of the chip enhancer within the medical device. This type of system may help detect interruptions in the continuum, such as interruptions in the wavelength or electromagnetic field due to interference caused by mechanical breaks in the medical device. For example, in this type of system, the chip booster may use a full-duplex coupling system to find the highest (strongest) resonant frequency (highest Q) of a particular antenna and adjust to read the level of data. The search for the highest Q may be performed using a range of specialized crystals and kernels (kernel) placed in the firmware of the reader (e.g., reader 800).
As an example, the implantable medical device may include the complete conductive barrier as one housing component of the implantable medical device, such that breach of the housing of the implantable medical device including the conductive barrier may 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 may be, for example, an RF transponder, as disclosed herein before. In some embodiments, such transponders may be configured to receive power via induction, e.g., by an external reader, as previously described herein. In other embodiments, such a transponder may be provided with an independent power source, such as a battery. A breach in the conductive barrier may result in a change in the ability of an external reader (e.g., reader 800) to send and/or receive transmissions to and/or from transponders within the space enclosed by the conductive barrier. Thus, the presence and change of the conductive barrier may help determine whether a portion of the implantable medical device (e.g., housing) is intact, or has been breached or otherwise damaged.
Fig. 11 depicts an example of a portion of an implant shell that may include a conductive barrier layer. An implant with a multi-layered shell 1100 can be modified to include a conductive layer 1106 located between an inner layer 1104 of the shell 1100 and an outer layer 1102 of the shell 1100. As long as the conductive layer remains intact, 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.
The inner layer 1104 and the outer layer 1106 of the shell 1100 may be made of any suitable biocompatible material. In some embodiments, the inner layer 1104 and the outer layer 1106 can be made of a non-conductive material. For example, one or more of the inner layer 1104 and the outer layer 1106 can be made of silicone or plastic such as PEEK.
The conductive layer 1106 may be made of any biocompatible material that blocks, reduces, interferes with, or prevents the transmission of RF signals through the layer. For example, in some embodiments, the conductive layer 1106 may be a carbon layer. The conductive layer 1106 may be, for example, a solid layer, or may be a layer having a regular or irregular grid pattern (e.g., like a cage or mesh). In embodiments where the conductive layer 1106 has a mesh pattern, any gaps in the mesh pattern may be small enough to prevent signals from being received by or transmitted out of a transponder encapsulated by the conductive layer 1106. In some embodiments, the conductive layer 1106 may be or may be similar to a faraday cage or enclosure.
In some embodiments, the conductive layer 1106 can be, for example, between the inner layer 1104 and the outer layer 1102 of the implant shell 1100. In other embodiments, the conductive layer 1106 can be, for example, the innermost layer of the implant shell 1100. In further embodiments, the conductive layer 1106 may be, for example, the outermost layer of the implant shell 1100. In some embodiments, the implant shell 1100 may have multiple inner layers 1104, multiple outer layers 1102, and/or multiple conductive layers 1106.
The integrity of the conductive layer 1106 (and thus a component of the implantable medical device, such as a housing component) may be tested, for example, by an external reader, such as the reader 800, which may be configured to transmit transmissions to or receive transmissions from a transponder (e.g., the transponder 100, 200) enclosed by the conductive layer 1106. As has been previously described herein, a reader (e.g., reader 800) may be configured to determine and broadcast signals at frequencies specifically calibrated for transponders. If the conductive layer 1106 is intact (e.g., if it is not breached, damaged, or has a manufacturing defect), the reader may receive no signal or a weak or low signal from a transponder encapsulated by the conductive layer 1106. If the conductive layer 1106 is incomplete, the reader may receive a stronger signal from a transponder enclosed within the conductive layer 1106 because the blocking function of the conductive layer 1106 is interrupted. Thus, the conductive layer 1106 may help determine whether the implantable medical device is defective.
In some examples, the conductive layer 1106 can have a color such that defects, flaws, or breaches can be visually inspected. In some embodiments, the color may make the conductive layer 1106 opaque or translucent. For example, the conductive layer 1106 may be black, or may be blue, green, pink, red, white, or any other color.
In other examples, the reader may provide power to the ASIC to detect a change in the barrier using the electromagnetic sensor. Similar techniques may be used with conductive nano-features or nano-materials. For example, conductive nanomaterials (e.g., wires providing a similar substrate) may be sprayed within a single monolayer of the shell, which if broken or destroyed may cause a change in resistance. In yet another example, a small low energy light source may be placed within the medical device and, when powered, the light may illuminate and reflect from the material coating the inner layer of the housing. But if breached or broken, the light may not be reflected, thereby providing a change that is detected by the reader and calculated from the initially calibrated parameters.
Advantageously, such conductive and reflective coatings can be used to determine whether an implantable medical device has been breached, broken, or has manufacturing defects before and after implantation. In particular, such layers may help to non-invasively determine whether an implantable medical device (e.g., a breast implant) is or has become defective. In some embodiments, a reader (e.g., reader 800) as disclosed herein may be used by, for example, a doctor, nurse, patient, or another individual associated with an implantable medical device or patient, along with an implant having layers such as those described above, to determine whether an implantable medical device is defective or has become defective. Thus, advantageously, such layers may also help to allow for non-invasive inspection/analysis of, for example, the structural integrity of an implantable medical device by a variety of individuals.
Device position/orientation
In addition to information regarding failure of the medical device, the transponder disclosed herein (e.g., transponders 100, 200) can be used to determine whether the medical device maintains its proper implant position and orientation. For example, after implantation, the medical device may migrate from its proper position over time. Sensors coupled with transponders according to the present disclosure may measure and project data indicative of circular rotation, vibration, torsion, or misalignment (e.g., movement) of an implanted medical device. Such sensors may capture the number of cycles that the joint surface may be exposed to (i.e., the frequency of changes in pressure gradient in a knee or hip implant, heart valve annulus, or shunt or vascular graft). The sensor may comprise an element such as a gyroscope (an accelerometer) which may measure changes in goniometry and/or angular velocity. Other suitable sensors include fiber optic rotation sensors, which may include an active light source and a reader. Information from, for example, two or more sensors (e.g., gyroscopes, 3D accelerometers, magnetometers, and/or GPS units, may be combined using an Inertial Measurement Unit (IMU) to determine information such as device orientation and velocity vectors.
In some aspects, one or more sensors coupled with a transponder of the present disclosure may measure changes in orientation of the radiopaque marker relative to one or more anatomical features or landmarks. For example, the patient may undergo periodic X-rays to evaluate position and orientation information. In such cases, sensors configured for dosimetry measurements may be used.
Data transmission
Data regarding the implantable medical device may be transmitted and received continuously, periodically, on demand (in response to a user query), or upon detection of certain values or parameters. 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 provided to the system). The power management ASIC may include an algorithm for maintaining an appropriate charge level (e.g., avoiding a full discharge).
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 severe conditions or events (such as a device rupture), a transponder coupled with one or more particular sensors configured to detect the 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 can be incorporated into an algorithm and used as part of an active system. Further, data indicative of tissue inflammation or improper rotation/placement of the medical device may be transmitted on demand, for example, by periodically (e.g., on a weekly, bi-weekly, or monthly basis) transmitting a wireless signal from an external device. For example, when a patient is reminded from an uploaded app on the mobile device, an on-demand transfer of data may be initiated. A transponder configured for constant or nearly constant data transmission may include a power source or recharging element sufficient to maintain power for an extended period of time.
Lab-on-a-chip
The transponders disclosed herein in combination with the sensors disclosed herein can be configured as a lab-on-a-chip, e.g., a subset of micro-electromechanical systems (MEMS) that can employ microfluidics to capture and identify and/or quantify biomarkers, e.g., proteomics. Such micro-analysis systems may use Surface Plasmon Resonance (SPR) and related systems and techniques to detect a wide variety of biomolecular interactions that may otherwise have low spectral signals or heats of reaction. These systems can provide data analysis to optimize treatment devices and treatment modalities with respect to binding affinity of antibodies, drug/cell membrane uptake rate, and/or tissue sensitivity levels that can affect the dose (dosimetry) of chemotherapy or radiotherapy. Such lab-on-a-chip sensor and transponder combinations may include a suitable power source. These types of sensor and transponder combinations can be used as evaluation tools, for example, to determine whether a particular patient will respond better to a co-substrate, such as hyaluronic acid or chitosan.
Data output
The present disclosure also includes means for optimizing the data output of the reader, including the scope and complexity of decoding a particular algorithm. The data may be encoded according to HIPPA regulations for patient confidentiality. The data may be accessed by a mobile device, such as a smartphone or tablet computer, for example, via password or fingerprint protection rights.
The transponders disclosed herein may communicate at a particular radio frequency, for example, to optimize inductive recharging of the active sensor. For example, the RF antenna may be used as a receiver for inductive energy for recharging an embedded battery. Such frequency ranges may be utilized so that the sensor does not interfere with other communication frequencies or cause heating of components or coatings of the sensor 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 l00kHz 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 135 kHz. Reference may be made to ISO Standard 11784/85.
The transponder disclosed herein may include one or more ASICs that provide storage and appropriate power management that utilizes a self-sufficient threshold so that the system does not develop a full discharge that could result in explantation. Self-contained systems are typically configured to condition themselves and prevent complete discharge. For example, once the power level reaches a given threshold, the ASIC herein may place the power supply in sleep, thus allowing the battery to be recharged rather than becoming a completely "dead" battery.
Safety feature
The transponder, reader, implant, and port assemblies disclosed herein may be incorporated into a security system for, for example, cloud data access. Such a security system may provide push opportunities (alerts) to user devices such as readers like those disclosed herein or other secure personal devices such as tablet computers, smartphones, mobile devices, etc. Such a security system may thus provide for tracking of transponders, implants and implant parts from the manufacturer to the surgeon; and possibly tracking from surgeon to patient. The means for receiving and transmitting information between the medical device, the computer/mobile device and the cloud/internet server may include, but is not limited to, RF readers having WIFI and bluetooth connections with electronic devices connected to the internet. According to some aspects, a manufacturer, physician, and/or patient may interact with such a security system through an RF reader and/or an app on a mobile electronic device.
While the figures and disclosure herein depict several exemplary configurations of transponders, sensors, assemblies, readers, implants, and several exemplary methods of use thereof, one of ordinary skill in the art will appreciate that many other configurations and method variations are possible and may be suitable for a given implant, patient, procedure, or application based on implant size, shape, orientation within the patient, and intended location. The examples of apparatus, systems, and methods herein are intended to be illustrative and not comprehensive; one of ordinary skill in the art will appreciate that some variations of the devices, systems, and methods disclosed herein are also encompassed by the present disclosure.