WO2006135857A2

WO2006135857A2 - Method and apparatus for monitoring implants

Info

Publication number: WO2006135857A2
Application number: PCT/US2006/022761
Authority: WO
Inventors: Shane C. Mangrum; Daniel R. Burnett; Noel L. Johnson
Original assignee: Novalert, Inc.
Priority date: 2005-06-10
Filing date: 2006-06-12
Publication date: 2006-12-21
Also published as: EP1895894A2; BRPI0613214A2; AU2006257892A1; WO2006135857A3; CA2611746A1; EP1895894A4

Abstract

The present invention involves a device and method that communicate, to a patient and/or healthcare professionals, the failure, rupture, or breakage of a barrier within an implant. The device consists of an implantable sensor and an alerting mechanism. The device may include an internal power source and may employ software to allow for external programming and/or interrogation of the device. The device may also be recharged and/or powered through an external source.

Description

METHOD AND APPARATUS FOR MONITORING IMPLANTS

BACKGROUND

[0001] The present invention relates to the field of medical devices. In particular, the present invention relates to monitoring for the integrity of implants (such as breast implants) implanted in tissues or organs.

[0002] The primary parts of most breast implants are a shell (also known as an envelope or lumen), a filler, and a patch to cover a manufacturing hole. Breast implants may vary in shell surface (e.g., smooth or textured), shape (e.g., round or other shape), profile (i.e., how far it projects), volume, area, and shell thickness. With respect to the shell design, while most breast implants are single lumen (i.e., one shell), some breast implants are double lumen (i.e., one shell inside another shell). With respect to the filler, some breast implants are manufactured with a fixed volume of filler, some are filled during the implantation operation, and some allow for adjustments of the filler volume after the operation.

[0003] It should be noted that tissue expanders, which are silicone shells filled with saline, are regulated by FDA in a different way than breast implants. This is because tissue expanders are intended for general tissue expansion for a maximum of six months, after which, they are to be removed. Because of this, the design specifications (e.g., thinner shell) and preclinical testing recommendations are different for tissue expanders than for breast implants.

[0004] There are three types of silicone gel-filled breast implants: (1) a single lumen implant that is prefilled by the manufacturer with a fixed volume of silicone gel; (2) a double lumen implant with both an inner lumen prefilled by the manufacturer with a fixed volume of silicone gel and an outer lumen that is filled during the implantation with a fixed volume of saline through a valve; and (3) a double lumen implant with both an outer lumen prefilled by the manufacturer with a fixed volume of silicone gel and an inner lumen that is filled during the operation with saline through a valve that allows for adjustments of the saline volume after the operation. The filler may be, e.g., silicone gel that has the general composition of silicone oil, cured polymeric (large) silicones, small amounts of uncured large and smaller silicones and minute amounts (i.e., parts per million) of metals, including a metal catalyst (e.g., platinum). This third type of breast implant is not to be confused with a tissue expander; The former being a permanent implant (i.e., not intended to be removed) that allows for limited tissue expansion, but is regulated by FDA as a breast implant.

[0005] In 2001, the FDA published results in a study on the health effects of ruptured silicone gel breast implants. The FDA conducted this study because of concerns about the frequency and results of failure, rupture, breakage (hereinafter collectively "failure"). Failure is a concern because: (1) failure of silicone gel-filled implants may allow silicone to migrate through the tissues; (2) the relationship of free silicone to development or progression of disease is unknown; and (3) implant failure constitutes a device failure in that the implant is no longer performing as intended.

[0006] The study demonstrated that women with MRI diagnosed breast implant failure were no more likely than women with intact implants to report that they had either persistent symptoms or doctor-diagnosed illnesses that were listed. In addition, women with MRI- diagnosed extracapsular silicone gel (i.e., silicone that had migrated outside the fibrous scar around the implant) were 2.8 times more likely to report that they had the soft tissue syndrome, fibromyalgia. This association remained statistically significant after taking into account other factors including whether women thought their implants were ruptured, implant age, and implant manufacturer. Fibromyalgia is a syndrome characterized by widespread pain, fatigue, and sleep disturbance. Moreover, women with MRI-diagnosed extracapsular silicone gel were 2.7 times more likely to report that they had "other connective tissue disease," a category that included a diverse group of illnesses such as dermatomyositis, polymositis, and mixed connective tissue disease. This association did not remain statistically significant after taking into account other factors including whether women thought their implants were ruptured, implant age, and implant manufacturer.

[0007] Federal health advisers recently recommended that silicone-gel breast implants be allowed to return to the U.S. market after a thirteen year ban on most uses of the implants, but only under strict conditions that will limit access. The FDA can choose whether to adopt or reject this recommendation. The FDA's advisers said that Mentor Corporation, a manufacturer of silicone-gel breast implants, had performed more convincing research that indicated that only 1.4% of the implants break in the first three years after implantation. Mentor also showed some evidence that the implants may last as long as ten years. The FDA, however, stressed that sales should resume only if a manufacturer meets certain strict conditions, including: (1) that prospective patients sign consent forms that acknowledge implant risks, including that the implant ultimately may break and/or require removal and/or replacement; (2) that silicone implants are sold only to board-certified plastic surgeons who complete special training to insert implants in a way that minimizes the likelihood of breakage; (3) that data about patients receiving implants be maintained in a registry to track patients' long-term health; and (4) that formal studies be conducted to ascertain more definitively how often implants fail within ten years.

[0008] As implant failures typically do not cause immediate symptoms, it is recommended that implant patients receive, at minimum, an MRI scan five years post implant and then every two years thereafter. Patients should consider having broken implants removed to minimize risk of silicone oozing into the breast, or beyond. Currently, there are no available methods or systems for the monitoring of leakage of silicone from implants, including breast implants. MRI can be a useful tool for the detection of leakage, but there are no signals, or symptoms that indicate evaluation or monitoring should occur.

[0009] Numerous other implantable devices are currently used in medical practice. One such implantable device that is currently under consideration by the FDA for use in the U.S. is the BioEnterics® Intragastric Balloon (BIB®) System, a non-surgical, non-pharmaceutical alternative for the treatment of obesity. The BIB® System is designed to induce temporary weight loss in obese patients by partially filling the stomach to help them achieve a feeling of fullness.

[0010] Endoscopically placed within the stomach and inflated with saline, the BIB® System balloon partially fills the stomach to induce a feeling of satiety to support patients in reducing food intake and adopting new dietary habits. Although the balloon can be deflated and removed endoscopically, it may improperly deflate during the course of therapy. This improper deflation may lead to migration of the implant into the intestine with possible small bowel obstruction and subsequent surgery and even death. [0011] Over time, bodily fluids are capable of passing into virtually any implant, i.e., past virtually any barrier. Even non-inflatable implants are susceptible to loss of integrity following implantation. Given enough time, even titanium shells permit passage of bodily fluids. In fact, recalls for pacemakers, ICDS and other implants commonly occur due to invasion of the implant by bodily fluids and subsequent malfunction; malfunction of implants in this category are frequently life-threatening.

[0012] U.S. Patent No. 6,755,861 describes a method of breast reconstruction that uses a breast prosthesis having a plurality of chambers or compartments distributed through a body member or shell in the form of a breast. The chambers are disposed along the superior, lateral, and inferior surfaces, as well as in the interior, of the body member. The chambers are differentially pressurized or filled, in order to control the shape of the prosthesis upon implantation thereof. Valves are provided for regulating the flow of fluid into and from the chambers. The prosthesis and the fill levels of the respective chambers may be selected by computer. This implant provides for a plurality of one-way valves, each disposed between two adjacent chambers for enabling a transfer of fluid from one of the adjacent chambers to another of the adjacent chambers.

[0013] U.S. Patent No. 5,496,367 describes a breast implant that includes an elastomeric envelope adapted to contain a fluid material and baffles inside the envelope. The baffles are provided to reduce or dampen wave or ripple action and motion of the fluid material contained by the envelope when implanted in a breast.

[0014] U.S. Patent No. 4,795,463 describes a prosthesis for implantation into human soft tissue. This implant is constructed of a suitable implantable envelope and contents (e.g., silicone gel, saline, or a combination of silicone gel and saline) to form a breast shape when implanted. The envelope is labeled with a marker that absorbs electromagnetic energy to an extent different from that of the envelope, its contents, and the human soft tissue in the breast cavity into which the prosthesis is implanted. This marker makes possible the use of roentgenographic imaging to determine whether the envelope has ruptured or whether the envelope is folded persistently in a particular location, thereby increasing the probability that the envelope may rupture along such a fold line. Also disclosed are: (a) a method for using roentgenography to determine whether the contents (e.g., silicone gel) have escaped from the envelope of the prosthesis by labeling the envelope with radioopaque materials; and (b) a method for determining whether fold-fault failure of the envelope of the implanted prosthesis is likely to occur.

[0015] U.S. Patent Publication 2005/0033331 (published 02/10/2005) describes a gastric balloon implantation device that may incorporate a visible dye or marker to enable detection of device rupture.

[0016] U.S. Patent Publication 2005/0267595 (published 12/01/2005) describes a gastric balloon implantation device which includes as a leak monitoring system, a sensor that comprises a fine lattice or continuous film of detection material embedded in the wall or in between layers of the wall covering the entire device.

[0017] U.S. Patent Publication 2006/0111777 (published 05/25/2006) describes a various implantation devices including breast implants which include as a leak monitoring system a sensor that comprises a fine lattice or continuous film of detection material embedded in the wall or in between layers of the wall covering the entire device.

SUMMARY

[0018] Provided are devices for monitoring the integrity of implants, such as breast implants. These devices function to alert the user or a healthcare provider that the integrity of the implant is failing. The devices are useful for measuring leakage into and out of the implant as well as other parameters such as changes in pressure.

[0019] One embodiment of the present invention addresses a device for monitoring a failure in an external shell of an implant, following implantation in a user. This device includes, among other possible things: a sensor configured to detect a failure in the external shell of the implant; and a signaling element located in a lumen of the implant, wherein the signaling element is configured to be triggered by the sensor to alert the user or a healthcare provider of the failure.

[0020] Another embodiment of the present invention addresses a device for monitoring a failure in an external shell of a breast implant following implantation in a user. This device includes, among other possible things: a sensor configured to detect a failure in the external shell of the breast implant; and a signaling element located in a lumen of the breast implant, wherein the signaling element is configured to be triggered by the sensor to alert the user or a healthcare provider of the failure.

[0021] Yet another embodiment of the present invention addresses a device for monitoring a failure in an external shell of a breast implant following implantation in a user. This device includes, among other possible things: a sensor configured to detect a failure in the external shell of the breast implant; and a signaling element located in a lumen of the breast implant, wherein the sensor is a conductive material present on the inside surface of the external shell and configured to be triggered by the sensor to alert the user or a healthcare provider of the failure.

[0022] A further embodiment of the present invention addresses a method of monitoring for a failure in an implant. This method includes, among other possible steps: (a) providing a device for monitoring a failure in an external shell of an implant, following implantation in a user, the device comprising: (i) a sensor configured to detect a failure in the external shell of the implant, wherein the sensor is a conductive material present on the inside surface of the external shell ; and (ii) a signaling element located in a lumen of the implant; (b) monitoring, using the sensor, physical conditions present within the lumen; (c) determining, using the sensor, that a failure of the implant has occurred based on changes in the physical conditions monitored by the sensor; (d) triggering the signaling element; and (e) alerting, using the signaling element, the user or a healthcare provider of the failure.

[0023] In any of the foregoing embodiments, the sensor may be configured to detect a change in conductivity.

[0024] Another embodiment for the sensor includes a thin electrical contact liner coated on the skin of an implant wherein the conductive layer has a larger surface area or volume that the lumen. This sensor may be triggered by any failure in the integrity of the skin (or outer layer) of the implant, detected through changes in conductivity or other properties associated with the liner. The signal may be triggered by a breakage, stretching, or displacement of any of these wires.

[0025] Yet another embodiment of the present invention addresses an apparatus that includes, among other possible things: a sensor configured to detect a failure in an external shell of an implant following implantation in a user; a signaling element configured to be triggered by the sensor to alert the user or a healthcare provider of the failure; and a power source. At least one of the sensors, the signaling element, and the power source is configured to be provided in a patch for the implant.

[0026] A further embodiment of the present invention addresses a method of monitoring for a failure in an implant. This method includes, among other possible steps: (a) providing a device for monitoring a failure in an external shell of an implant, following implantation in a user, the device comprising: (i) a sensor configured to detect a failure in the external shell of the implant; and (ii) a signaling element located in a lumen of the implant; (b) monitoring, using the sensor, physical conditions present within the lumen; (c) determining, using the sensor, that a failure of the implant has occurred based on changes in the physical conditions monitored by the sensor; (d) triggering the signaling element; and (e) alerting, using the signaling element, the user or a healthcare provider of the failure.

[0027] In any of the foregoing embodiments, the device may include a power source for the device which is contained within the device.

[0028] In any of the foregoing embodiments, the power source may be rechargeable transcutaneously.

[0029] In any of the foregoing embodiments, the device may include a energy source that is external to the device. Further, the device may be configured to receive power transmitted transcutaneously by the external power source.

[0030] In any of the foregoing embodiments, the sensor may be configured to detect the influx of bodily fluids and/or compounds.

[0031] In any of the foregoing embodiments, the sensor may be configured to detect salinity, hydration, pH, electrolyte concentration, or other properties of the bodily fluids and/or compounds entering the lumen.

[0032] In any of the foregoing embodiments, the sensor may be configured to detect changes to the environment inside the lumen.

[0033] In any of the foregoing embodiments, the sensor may be configured to detect changes in pressure, impedance, conductance or other physical property within the lumen. [0034] In any of the foregoing embodiments, the sensor may be incorporated into the external shell or may not incorporated into the external shell.

[0035] In any of the foregoing embodiments, the sensor may be a mesh incorporated throughout shell.

[0036] In any of the foregoing embodiments, the sensor may be configured to detect alterations in the external shell based on electrical, chemical or physical changes to the mesh.

[0037] In any of the foregoing embodiments, the sensor may be located external to the shell.

[0038] In any of the foregoing embodiments, the sensor may be configured to detect an outflow of materials encased in the implant.

[0039] In any of the foregoing embodiments, the sensor may be configured to detect changes in salinity, pH, hydration, chemical markers or other compounds.

[0040] In any of the foregoing embodiments, the power source may be a battery or capacitor. ' Further, the battery or capacitor may be configured to be inductively recharged.

[0041] In any of the foregoing embodiments, the device may incorporate a second signaling element to alert the user that recharging is required. Further, the second signaling element may be a vibratory, acoustic, visual, tactile, electromagnetic field or other stimulus.

[0042] In any of the foregoing embodiments, the signaling element may be configured to alert the user and/or healthcare provider upon triggering of the sensor.

[0043] In any of the foregoing embodiments, the signaling element may be a vibratory, acoustic, visual, tactile, or other stimulus.

[0044] In any of the foregoing embodiments, the signaling element may be electromagnetic, radiofrequency or ultrasound.

[0045] In any of the foregoing embodiments, the device may incorporate a receiver and/or transmitter for external communication.

[0046] In any of the foregoing embodiments, the device may utilize ultrasound, radiofrequency or electromagnetic fields for communication.

[0047] In any of the foregoing embodiments, the transmitter may externally transmit data relating to the implant. [0048] In any of the foregoing embodiments, the receiver may receive external information. Further, the received information may allow for programming, resetting or other manipulation of the device.

[0049] In any of the foregoing embodiments, the implant may be inflatable. Further, the device may be used to monitor the inflatable implant.

[0050] In any of the foregoing embodiments, the failure may be a rupture or deflation of the implant. Further, the user and/or healthcare provider may be alerted to failure of the implant.

[0051] In any of the foregoing embodiments, the external shell may be rigid.

[0052] In any of the foregoing embodiments, circuitry within the implant may allow for external powering of the sensor and/or the signaling element via an external power source/signal transmitter.

[0053] In any of the foregoing embodiments, ground contacts for the circuitry of the breast implant may be located external to the shell.

[0054] In any of the foregoing embodiments, the external power source may be supplied by an external device placed within the living space of the user.

[0055] In any of the foregoing embodiments, the external power source may be located outside the user.

[0056] In any of the foregoing embodiments, the external power source maybe located within or near a bed, couch, chair or seat of the user.

[0057] In any of the foregoing embodiments, the external power source may be located within accessories, clothing, personal items, house, car or workspace of the user.

[0058] In any of the foregoing embodiments, the power source may be battery and/or capacitor powered. Further, the power source may be portable. In addition, the battery and/or capacitor powering the power source may be rechargeable.

[0059] In any of the foregoing embodiments, the power source may be powered by a standard wall outlet.

[0060] In any of the foregoing embodiments, the external powering may be continuous when the implant is within a predetermined range of the external power source. [0061] In any of the foregoing embodiments, the signaling may be continuous when the implant is within a predetermined range of an external signal transmitter.

[0062] In any of the foregoing embodiments, the external powering and/or signaling maybe intermittent with at least weekly, at least monthly or at least yearly interaction with the implant.

[0063] In any of the foregoing embodiments, the sensor, the power source, the signaling element, and related circuitry may be provided in the lumen. Further, the sensor, the power source, the signaling element, and related circuitry may be provided in a signal compartment within the lumen.

[0064] In any of the foregoing embodiments, all of the sensor, the signaling element, and the power source may be configured to be provided in a patch for the implant.

[0065] In any of the foregoing embodiments, the implant may be a breast implant. Moreover, the patch may be configured to be housed within an inflation port of the breast implant.

[0066] In any of the foregoing embodiments, the implant may be a breast implant and the breast implant is radiolucent.

[0067] In any of the foregoing method embodiments, the step of monitoring, using the sensor, physical conditions present within the lumen may include monitoring one or more of a salinity, hydration, pH, electrolyte concentration, and other properties of bodily fluids and/or compounds entering the lumen.

[0068] In any of the foregoing method embodiments, the step of alerting, using the signaling element, the user or a healthcare provider of the failure may include producing one or more of a vibratory, acoustic, visual, tactile, and electromagnetic field.

[0069] In any of the foregoing method embodiments, the method may also include the step of recharging the device periodically. Further, the recharging of the device may be performed in conjunction with an external power source.

[0070] In any of the foregoing method embodiments, the method may also include the step of alerting the user and/or healthcare provider that the device needs to be recharged. [0071] In any of the foregoing method embodiments, the method may also include the step of resetting periodically baseline levels for the physically conditions.

[0072] In any of the foregoing method embodiments, monitoring may be conducted before implantation of the device. In one such embodiment, monitoring is conducted during manufacturing of the device. In another embodiment, monitoring is conducted just prior to surgical implantation.

[0073] In any of the foregoing method embodiments, monitoring may be conducted after implantation of the device. In one such embodiment, monitoring is conducted just after implantation during the initial surgery.

[0074] As used herein, the term "shell" refers to the exterior portion of an implant device which functions to separate the interior contents from body tissue and fluids. In a preferred embodiment, the shell has a thicknesses of .002-.2 inches and a durometer value of 20A-90A for hardness.

[0075] As used herein, the term "lumen" refers to a cavity that is present inside of the shell of an implant.

[0076] As used herein, the term "patch" refers to a plug for an inflation opening of an implant, which plug generally defines a discrete region of increased durometer and/or thickness through which the implant may be inflated or filled. The inflation patch is typically formed from a much stronger silicone than the rest of the shell and is added, usually by vulcanization, to the remainder of the implant shell after the shell has been fully manufactured.

[0077] These and other features, aspects, and advantages of the present invention will become more apparent from the following description, appended claims, and accompanying exemplary embodiments shown in the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0078] Figure 1 is a perspective view of an embodiment of an implant monitoring device for a fluid- or gas-filled implant according to the present invention;

[0079] Figure 2 is a perspective view of another embodiment of an implant monitoring device according to the present invention; [0080] Figure 3 is a perspective view of another embodiment of an implant monitoring device according to the present invention;

[0081] Figure 4 is a perspective view of another embodiment of an implant monitoring device according to the present invention;

[0082] Figure 5 is a perspective view of another embodiment of an implant monitoring device according to the present invention;

[0083] Figures 6 A and 6B are perspective views of a breast implant function of the implant monitoring device shown in Figure 4;

[0084] Figures 7A-7C are perspective views of another embodiment of an implant monitoring device according to the present invention in which the implant is powered and/or interrogated externally; and

[0085] Figure 8A is a perspective and enlarged view of another embodiment of an implant monitoring device according to the present invention whereas Figures 8B and 8C are perspective views of a function of the implant monitoring device shown in Figure 8 A in both an intact state and a failure state, respectively, of an implant.

DETAILED DESCRIPTION

[0086] Presently preferred embodiments of the invention are illustrated in the drawings. An effort has been made to use the same, or like, reference numbers throughout the drawings to refer to the same or like parts.

[0087] The proposed implant monitoring device of this application serves as a solution to the issue of monitoring for leakage from, or leakage into, implants (such as the BIB®, breast implants, pacemakers, implantable cardioverter defibrillators, and other related devices). The device described herein has the ability to sense and communicate the occurrence of loss of integrity in the shell of virtually any implant.

[0088] The innovation of the present invention involves a device and method that communicate, to the patient and healthcare professionals, the failure of a barrier within an implantable device. The implant monitoring device consists of an implantable sensor and a means of external communication. The sensor may be made of a conductive material that may be either metallic or organic. For example, the sensor in some embodiments may be formed of gold.

[0089] The device may include an internal power source and may employ software to allow for programmability and/or interrogation of the device. The device may also be recharged and/or powered through an external source. Circuitry associated with the sensor, the signaling element, external powering, and/or external interrogation may be composed of resistors and capacitors. Moreover, in certain embodiments (such as that later described with reference to Figures 8A-8C) the circuitry may be formed of resistors and capacitors that are printed onto a patch of the implant. The wireless communication to external devices may be done using RFID circuitry that may be printed on the patch.

[0090] In one embodiment, the sensor component of the device is able to detect changes in wall pressure, fluid pressure, pH, salinity, hydration, electrical fields, etc. This device may also detect disruption of the encasing membrane, the presence of specific markers found in surrounding body tissues, or other potential markers that are indicative of failure. This ability to detect changes in the integrity of an implant facilitates continuous monitoring of the implant, thereby enhancing the safety and integrity associated with the implant.

[0091] An embodiment for the sensor includes a thin electrical contact liner embedded in the skin of an implant. This sensor may be triggered by any failure in the integrity of the skin (or outer layer) of the implant, detected through changes in conductivity or other properties associated with the liner. An alternative embodiment for the sensor mechanism may involve thin filament wires (or fibers of any type) placed in a meshwork throughout the shell of an implant. The signal may be triggered by a breakage, stretching, or displacement of any of these wires.

[0092] Another embodiment of the sensor includes a sensor/switch that is triggered once certain conditions are met, thus preserving the power within the implantable power source for signal generation. For example, two leads may be positioned within a space that contains a desiccated hydrophilic polymer, which may be coated by an aqueous barrier that dissolves in the presence of bodily fluids (e.g., ions, proteins, glucose, etc.). Once introduced to bodily fluids, the aqueous barrier may rapidly degrade, thereby exposing the hydrophilic polymer to water. The water may cause the hydrophilic polymer to expand, thereby connecting the two electrodes and completing a circuit that causes the activation of the alert mechanism. [0093] While not required for all applications, the aqueous barrier may be more necessary for any application in which the implant may be penetrated by water vapor. In particular, silicone-encased implants may be exposed to large amounts of water vapor (but not ions) within the implant. Thus, once the silicone shell ruptures and the aqueous barrier (i.e., enteric coatings or other coatings sensitive to bodily fluids) is rapidly compromised, the hydrophilic polymer may rapidly swell and close the circuit to generate the rupture alert. In the absence of such an aqueous barrier, at least in this instance, there may be a large number of false positives, due to water vapor causing expansion of the hydrophilic polymer. In contrast, in instances in which the shell of the implant is relatively impermeable to water and other vapors, the aqueous barrier coating may be unnecessary, thereby allowing for the use of a hydrophilic polymer (or other bodily fluid sensor). This is but one embodiment of the present invention; other embodiments exist in which the switch may be triggered by changes in salinity, pressure, pH, hydration, or other components found external to the implant.

[0094] Once the sensor conditions have been met, the alert mechanism for the device delivers a device failure signal to the patient and/or healthcare professionals. The alert mechanism may be capable of communicating the occurrence of integrity failure for an implant via a plurality of different patient-centered stimuli, including visual stimulus (e.g., activation of a light visible through the skin), palpatory stimulus (e.g., vibration) or auditory stimulus (e.g., emitting a beeping sound). The vibratory alert signal, for example, could be either constant or intermittent in nature and would be intended to be forceful enough not to be mistaken for other body sensations. This alert may be programmed to be sensed solely by the patient (for privacy concerns) and not to interfere with sleep, but, at the same time, not to be easily ignored. The triggering of this alert mechanism would signal to the patient and/or a healthcare professional that the device needs to be inspected. The device may alternatively communicate the existence of a failure to an external device via radio-frequency or electromagnetic fields. In those instances in which the power source is internal and is rechargeable, these signaling mechanisms may also be triggered to inform the patient or the healthcare provider that the device requires recharging.

[0095] In some embodiments of the present invention, the communication element of the device may provide for exchange of information with an external device. For example, the device may contain internal programming capabilities that allow for monitoring of changes in the implant that might indicate a failure of the device while at the same time adjusting a baseline for monitoring these changes. This feature maybe used as a safeguard to ensure that the patient is not subjected to unnecessary surgeries prompted by false positives in instances in which the device could have been safely reprogrammed externally.

[0096] An example of how this integrity monitoring device may work in a silicone gel-filled breast implant may be as follows, hi the event that the outer silicone envelope of a silicone gel-filled breast implant fails, bodily fluids will enter the implant. The ability of bodily fluids to enter the implant may be enhanced by the addition of various coatings (e.g., parylene, heparin hydromer, etc.) or channels on the inside of, or within, the implant shell. Thus, upon failure of the shell, bodily fluids will come in contact with the sensor (e.g., one or more hydration monitors inside the shell of the implant). The aqueous barrier (e.g., a pH-sensitive Eudragit) covering the hydration sensors will rapidly degrade in the presence of the bodily fluids, thereby exposing the hydrophilic polymer to water. The polymer will swell, thereby forcing two electrodes into contact and completing a circuit that triggers the alert signal (e.g., a small eccentric motor could draw power from a life-time battery and cause a vibration in the affected breast or alert the healthcare provider remotely).

[0097] Alternatively, the power source and signal may be outside of the patient's body, thereby allowing interrogation of the breast implant once it comes within range of the power/signal transmitter. Thus, by having a simple receiver/transmitter in the breast implant (e.g., an RFID chip within the implant or printed on the silicone shell of the implant itself), the present invention will: (a) have a minimal impact on the design of the breast implant; (b) be unlikely to be able to be palpated upon examination; and (c) function for the life of the implant (even with implants that last decades). In this embodiment, the patient will simply have to ensure that she comes in contact with the power/signal transmitter, which could be placed in the patient's home (e.g., at her bedside for daily or more frequent checks) or in a physician's office (for less frequent checks). The power/signal transmitter could then contact the physician or healthcare provider automatically and/or alert the patient. In the event that the patient is alerted, the previously trained and educated patient would then contact a healthcare professional to have her device interrogated (i.e., to have an MRI or other appropriate investigation initiated) and/or to have surgery to remove the implant. As a result, a patient would know relatively immediately about failure of a device and would not have to wait, in some cases up to five years or more, to have a regularly scheduled MRI. The embodiments of this device may be externally-powered, may incorporate a battery that could be rechargeable in nature, or may incorporate a battery that has a life-time functional expectancy (i.e., having a very-low-current-draw sensor or a zero-current-draw switch activated device).

[0098] The device of this application has the capability of being used with any implantable technology. Although breast implants are specifically mentioned as examples in this application, the nature of this device makes it applicable to all forms of implants, hi particular, the use of this technology within implantable gastric balloons is readily appreciated. In such gastric embodiments, as with the breast implant embodiments, one scenario involves the use of an external power/signal generator that communicates with a receiver/transmitter (e.g., an RFID chip) associated with the shell of the gastric implant. The receiver/transmitter (e.g. an RFID chip) may be located within the shell, printed on the outside of the shell, attached to the inside wall of the shell, or located in the lumen of the shell but not attached to the shell wall. Thus, modifications and alterations to the design and function of the gastric balloon can be minimized with the use of an external power/signal generator. These options also are applicable to breast or other types of implants.

[0099] In this embodiment, as well, the gastric balloon may be inflated with a solution that is non-conductive (or at a minimum is less conductive than normal saline) but osmotically active. Thus, upon ingress of bodily fluids into the failing implant, as in the case of the breast implant, the conductivity across the electrodes within the implant (or printed on the inside of the shell of the implant) will be altered; this information will be transmitted externally via the RFID mechanism coupled to the electrodes. This mechanism has been validated by the inventors in a protocol that found that the capacitance of a solution of deionized water is on the order of picofarads across electrodes spaced five millimeters apart, while normal saline capacitance across this gap is on the order of 10 to 100 nanofarads (a 1000-fold difference). The relationship is nearly linear such that even a small amount of saline or gastric fluid is capable of registering a significant difference in capacitance or conductivity, which maybe transmitted via the coupled RFID electronics. Thus, by filling the implant with psyllium fiber (or another osmotically active, FDA-cleared substance that is either more or less conductive than normal saline or gastric secretions), the conductivity, capacitance, resistance, etc. across the electrodes within the implant may be checked intermittently (or continuously). Further, if a change in any of these parameters is found, the device maybe rapidly replaced prior to dangerous passage into the intestine.

[0100] The present invention may also be used in the gastric space or other space using any of the embodiments previously discussed with respect to the breast implant technology. However, in any technology in which the implanted device is inflated at the time of the procedure, the present invention contemplates a significant advance in the use of a fluid with a conductivity, resistance, or capacitance which deviates from that of normal saline or bodily secretions in order to use the electrodes to measure the change in electrical parameters in the detection of implant failure. Unfortunately, devices that are currently inflated inside the body (e.g., gastric balloons, breast implants, etc.) are typically filled with saline, which removes the benefit of simple detection of changes in electrical parameters found with the ingress of saline into a more or less electrically active fluid medium. Furthermore, the filling fluid may also be significantly different with respect to the chemical, optical, physical, pH, and/or electrical properties of normal saline and/or the fluid surrounding implant such that these parameters may be sensed within the implant as well. Changes to any one of these, or other, parameters within the implant may indicate failure of the external implant barrier.

[0101] The present invention may also use scaffolding and/or other support structures in combination with the aforementioned failure sensing technologies. Some such scaffolding and support structures are disclosed in U.S. Patent Publication 2005/0033331 (published 02/10/2005) (U.S. Patent Application No. 10/833,950, which is entitled "Pyloric Valve Obstructing Devices and Methods" and which was filed on April 27, 2004). The support structures disclosed in U.S. U.S. Patent Publication 2005/0033331, which is hereby incorporated by reference in its entirety, may ensure that the device does not deflate and cause problems (e.g., intestinal obstruction in the case of the gastric balloon) in the event of a catastrophic failure and/or rapid leak. An embodiment of such a support structure may additionally allow for rapid collapse of the device with standard endoscopic tools, thereby providing a significant advance over the current removal procedures with the gastric balloon. By using a scaffold, which may be easily engaged and collapsed by endoscopic snares, forceps or scissors, the device may be extracted without the need for cumbersome and unwieldy puncturing, which is typically necessary with current gastric balloon removal. [0102] The competitive advantages of this integrity monitoring system for long-term implants include: (1) continuous (or intermittent but frequent) monitoring of implant integrity; (2) an implant failure signaling mechanism for both the patient and healthcare professional; and (3) the ability to have a sensor communicate, with an external device, information about the state of an implanted device.

[0103] Figure 1 is an illustration of an implant integrity monitoring device 100 for a fluid- or gas-filled implant 103. As can be seen in this embodiment, a sensor 101, a signaling or alerting element 102, and other electronics (not labeled) are incorporated into an internal element 1 that is housed within an open space or cavity defined by an exterior shell 4 of the implant 103. As a result, the sensor 101 of this embodiment is not provided as a continuous film or as a mesh on the shell 4.

[0104] The shell 4 may include an optional injection/inflation patch 5 for implants designed to be placed within the body and then filled. The patch 5, which is designed to plug an inflation opening, generally defines a discrete region of increased durometer and/or thickness through which the implant 103 may be inflated or filled.

[0105] As shown, the device 100 may also include an optional communicating/inductive charging ring 2 and a connecting tether 3 that connects the charging ring 2 to the internal element 1. The internal element 1 senses and communicates externally if there has been a failure of the shell 4. The sensor 101 may detect changes in salinity, pH, pressure, presence of certain compounds, or any other change in the internal milieu once the external shell 4 has been compromised. The signaling element 102 within the internal element 1 may vibrate, communicate to an external device (not shown), make an audible noise, or emit a light to indicate that a check is required to ensure integrity of the shell 4. The signaling element 102 may also alert the user that recharging of her device 100 is required in those embodiments in which the device 100 is internally powered. In both the internally and externally powered embodiments, the device 100 may communicate externally and be programmable/resettable such that if it is triggered without a failure of the shell 4, it can simply be reset to continue monitoring.

[0106] Although the device 100 is shown monitoring an implant 103 having a spherical shell 4 (as would be the case for many breast implants and gastric balloons), this is but one embodiment of the device 100 and other embodiments contemplate non-spherical shapes. Moreover, the device 100 may be adapted to monitor implants in any area of the body and may be made of any material.

[0107] The sensor 101 within the internal element 1 may be one or more of a variety of sensors including sensors for detecting changes in: salinity, pH, hydration, chemical markers (or other compounds), pressure, impedance, conductance, or other physical properties within the monitored device. Moreover, the sensor 101 itself may use electric, spectrophotomoteric, chemical or physical measurement technologies.

[0108] Alternatively, the device 100 may use a passive sensor that will not require active measurements of the internal milieu, but instead will remain dormant until the appropriate conditions are met (i.e., until a failure of the implant 103 occurs). Two examples of this are pH- and/or ion-sensitive polymers. The polymers may swell, degrade, or alter their physical properties in some manner that allows electrodes to come in contact with each other, thereby signaling a failure of the implant 103. An embodiment of this design may involve the use of a pH-sensitive compound (e.g., a pharmaceutical enteric coating) that is placed between the electrodes of the alerting element 102 and remains there until aqueous fluid enters the implant 103. At this point, the polymer degrades and the electrodes come into contact. When the electrodes contact each other, the user is alerted to a failure. Two examples of a material that could be used for this application are Eudragit (Rohm and Haas) and Opadry AMB (Colorcon). These are but two examples and this is but one embodiment of the many possible embodiments of the envisioned sensor 101. The only requirement is that the sensor 101 be resistant to compounds normally found within the monitored device (e.g., water vapor), but be triggered upon influx of abnormal materials (e.g., ions or proteins).

[0109] The alerting element 102 within the internal element 1 maybe one or more of a variety of possible signal generating devices including physical stimuli generators and/or energy or electromagnetic communicators. Among the possible physical stimuli are: auditory (e.g., a sound), visual (e.g., a light under the skin) and tactile (e.g., a vibration). Further, it is noted that vibration, which may be essentially soundless, may satisfy both privacy concerns and the desire to communicate robustly. In the case of vibration, a small eccentric motor, piezoelectric element or very low-range acoustic element may be used to generate the intended vibration. Any source of vibration or energy-delivery could be used, though, with the only requirement being that the patient be sufficiently alerted. [0110] The alert may be activated during certain time periods, over intervals, or with a unique signal to indicate device conditions. For example, in the case of a rechargeable device, if the device requires recharging, the alert may be of a certain nature so as to indicate that the battery is low, as opposed to a signal for implant failure. Moreover, once alerted, the healthcare provider may, in one embodiment, be able to interrogate the device 100 and even reprogram the sensitivity threshold in the instance of a sensor 101 with a slow baseline drift.

[0111] In the case of a device without an internal battery, the alerting element 102 and/or sensor 101 may be powered externally via inductive, RF or EMF energy generation to provide for intermittent, non-continuous interrogation of the device 100. The interrogating device (not shown) may be an office-based device for routine checks or a home-use device designed to interrogate the device 100 automatically and to report (to the user or healthcare provider) that the implant 103 has failed. Placement of the interrogating device in an area in which the patient can interact with it on a daily basis will allow for regular, but intermittent, interrogation of the device 100 with subsequent rapid reporting. This reporting could, again, be a local activity signaling the user, or could be directly transmitted to the healthcare provider to allow for immediate action.

[0112] Figure 2 is an illustration of another embodiment of an implant integrity monitoring device 200. As can be seen in this embodiment, in contrast to the design of Figure 1, the sensor 101 is not part of the internal element 1 and is instead incorporated into a mesh 6 of the implant 103. The mesh 6 may be incorporated into the shell 4, may be just inside the shell 4, or may be just outside of the shell 4. The signaling element 102, circuitry and all electronics other than the optional communicating/inductive charging ring 2 and the connecting/recharging tether 3 are still incorporated into an internal element 1. However, the tether 3 may be used to transfer information between the sensor 101 within the mesh 6 and the internal element 1 (which can actually be located anywhere within the shell and does not need to be centrally located). In this embodiment, alterations to the external shell 4 can be detected by changes in volume, impedance, conductivity, magnetic field, etc. which may arise as a result of a break in the sensing mesh 6.

[0113] Figure 3 illustrates another embodiment of an implant integrity monitoring device 300 in which sensors 7 are interspersed throughout a shell 4 of the implant 103. The internal element 1 may contain a power source 104, an external communication component 105, and/or a signaling or alerting element 102. Moreover, the internal element 1 may communicate with the sensors 7 in the external shell 4 via a communicating/recharging tether 3. Alternatively, and this goes for all embodiments, the internal element 1 maybe affixed to the internal surface of the shell 4 of the implant 103 at one or more points requiring little, or even no, tether. The sensors 7 inside of, or within, the shell 4 may detect influx of external components from tissue (e.g., breast tissue) surrounding the implant 103. For example, the sensors 7 may be hydration sensors or salinity sensors. Alternatively, the sensors may be pH, conductivity, impedance, light, or chemically-based. There may also be multiple sensors 7 in regions of high-risk (e.g., the inflation patch and/or manufacturing seam(s)). Once again, this is but one embodiment of the present invention and it maybe adapted to monitor implants in any area of the body and may be made of any material.

[0114] Figure 4 illustrates another embodiment of an implant integrity monitoring device 400 according to the present invention. Although sensing element 101, communicating element 105, and alerting element 102 may be separately provided throughout the implant 103, they may, as shown, be incorporated into one internal element 1. This internal element 1 communicates with the optional communicating/recharging ring 2 via a recharging tether 8 that has additional properties. In this embodiment, the tether 8, also channels fluid from the inside of the shell 4 to the sensing element 101 within the internal element 1. Further, the inside of the shell 4 may also be coated with a coating material 9 designed to bring the sensed substance to the sensing element 101 within the internal element 1. The coating material 9 may be, e.g., parylene or heparin hydromer and may be designed to carry the ionic bodily fluid to the sensor element 101 at which the ion- or pH-sensitive sensor element 101 maybe triggered, thereby alerting the patient and/or healthcare provider of an implant failure. This design will be particularly useful for indications in which the filling of the implant 103 is relatively impervious to the substance being sensed. A good example is the silicone gel breast implant, which, when filled with silicone gel 10, discourages influx of any aqueous material. The internal coating material 9, though, allows the aqueous fluids to track around the gel 10 to the tether 8 from which the fluids may be carried to the sensor element 101 within the internal element 1.

[0115] The coating material 9 may consist of any one or more of a variety materials, including, as previously mentioned, parylene and/or heparin hydromer. These compounds may coat tracks within the silicone shell 4 (assuming the breast implant case) or may coat the entire inside of the shell 4. This will help to generate a potential space between the gel 10 and the shell 4 (in the case of parylene) and/or to attract aqueous fluid due to hydrophilicity (in the case of hydrophilic polymers such as the heparin hydromer coating). Whether drawing the fluid around to the sensor element 101 or creating a plane for the fluid to track within, either mechanism could be used if the desired rate of fluid ingress is not found to occur of its own volition in an unmodified implant 103.

[0116] Figure 5 illustrates another embodiment of an implant integrity monitoring device 500. In this embodiment, the device 500 is incorporated into an internal element 1 that is provided adjacent an external shell of an electronic device 11. As shown, the device 500 is minimized to allow for incorporation into a small space from which the device may monitor the electronic device 11, which could be, e.g., a pacemaker, an implantable pump, implantable glucose sensor, an implantable cardioverter defibrillator, an implantable left ventricular assist device, or any other implantable device with electrical components.

[0117] Figures 6A and 6B illustrate the action of an implant 103 (e.g., a breast implant) and the implant integrity monitoring device 400 from Figure 4. The implant 103 is shown with a failure (e.g., a rupture) 12 in its shell 4. The failure 12 allows fluid 13 to track around the inside of the shell 4 along the optional coating material 9 to the sensor element 101 within the internal element 1 via the optional tether 8. Once the fluid 13 has made it way from the site of the rupture 12 to the inside of the implant 103 and reaches the internal element 1, the sensor element 101 (which may be, e.g., a pH or salinity sensor) is triggered due to its exposure to the constituents within bodily fluid 13. Once the sensor element 101 is triggered, the signaling or alerting element 102 (which maybe, e.g., an eccentric motor) may, as shown at label 14 in Figure 6B, vibrate rapidly. This is but one of several alerting mechanisms with auditory signals, visual signals, and radio communication being three other possibilities. These are exemplary illustrations, though, and should not be interpreted to be the only possible embodiments.

[0118] Figures 7A-7C illustrate perspective views of the function of an implant integrity monitoring device 700 for breast implants in which the implant 103 is powered and/or interrogated externally. In this embodiment, a power and/or signal emitter/receiver 16 emits a radiofrequency or electromagnetic waves 17 to power and/or communicate with the implant 103. In turn, the internal element 1 of the device 700 emits a signal 18, 19 in response to the power and/or signal emitter/receiver 16. This signal 18, 19 may then be interpreted by the power and/or signal emitter/receiver 16, thereby alerting the user and/or healthcare provider of changes in the monitored implant such as a failure 13. In the case of a failure 13 of the external shell 4, bodily fluid 15 will track to the internal element 1.

[0119] In response to the bodily fluid 15, the internal element 1 will emit a signal to the power and/or signal emitter/receiver 16 to inform the user and/or healthcare provider that the implant 103 has been compromised. A breach will be evident based on the change in the signal from a normal signal response 18 (Figures 7A and 7B) to that of a compromised implant signal response 19 (Figure 7C). In response to the signal from the power and/or signal emitter/receiver 16, the responsive signal 18, 19 may be generated by an active mechanism such as, e.g., an active RFID tag or other EMF, ultrasound or radiofrequency emitter, or may be generated by a passive mechanism such as, e.g., a passive RPID tag.

[0120] The power and/or signal emitter/receiver 16 may be designed to interact intermittently with the internal element 1 or may monitor the internal element 1 on a continuous basis. In some embodiments, the power and/or signal emitter/receiver 16 may be placed within the home of the implant patient in an area that she will frequent at least once per day. For example, the power and/or signal emitter/receiver 16 may be placed in, or near, a bed, chair, car, office, table or any other object or region that the implant patient will frequent on a daily basis. Moreover, the power and/or signal emitter/receiver 16 may be powered by battery, capacitor, or wall outlet and may be fixed in place or easily portable. From there, the power and/or signal emitter/receiver 16 will interact with the implant integrity monitoring device 700 and receive the signal 18, 19 from the device 700 to determine if the implant 103 has been compromised, as shown in Figure 7C.

[0121] In the event that the implant 103 is inflated within the body (e.g., for breast implants or and/or gastric balloons) the implant 103 may, as shown, be filled with the optional filling fluid 20 of known conductivity, capacitance, resistance and/or other electrical properties that vary significantly from normal saline and/or the bodily fluid 15 surrounding the implant 103. Thus, by using the internal element 1 to measure the electrical properties of the filling fluid 20 and to detect variations in these properties upon mixing of the filling fluid 20 with bodily fluids 15, a failure 13 in the external shell 4 maybe sensed and communicated. [0122] As previously shown and discussed, in inflatable fluid- or gel-filled implants, there is typically an inflation patch 5 somewhere on the implant. This inflation patch 5 is typically formed from a much stronger silicone and is added, usually by vulcanization, to the remainder of the implant shell 4 after the shell 4 has been fully manufactured. A simpler, alternative embodiment to such a structure involves modifications only to this inflation patch 5 and no modifications to the silicone shell 4. However, tracking of bodily fluids through silicone gels filling such a structure is limited whereas tracking of bodily fluid and ions through hydrogels filling such a structure occurs readily. As a result, a solution for a implant with a non-conductive filling (e.g., silicone gel) would likely require modification to the entire shell 4. This process, however, is laborious and provides a future risk of failure (e.g., from perforation or rupture) due to the added elements in the shell 4 that either encourage tracking of the fluid or conduct signals from the failure to the communication patch at the back of the implant.

[0123] An alternative option for any device filled with saline or another conductive fluid that is much more reliable with much less added risk of rupture, is to incorporate the entire implant integrity monitoring device within the patch 5 of the implant. This is possible due to the nature of the conductive filler (e.g., saline or other material), in that the sensor requires only: (a) a contact point on the inside of the shell 4, which can be on the patch 5 or free- floating with a connection to the patch 5; and (b) an external contact point, which can simply be a small electrically conductive region on the outside of the implant. In such embodiments, the only modification to the implant would be required at the patch 5 (and possibly within the filler). Moreover, no modification would be need to be made to the shell 4 at which any modification may increase the risk of failure. An embodiment of such a patch will hereafter be described with reference to Figures 8A-8C.

[0124] Figure 8A is a perspective and enlarged view of the injection patch 5 of a fluid- or gel-filled implant 103. The implant 103 is filled with a conductive material in which the sensing and communicating components (e.g., an RFID chip) of the implant integrity monitoring device 800 are incorporated within the injection patch 5 as a chip 804, i.e., the shell is unmodified. In the enlarged portion of Figure 8 A, an external electrical contact point 802 can be seen incorporated into the standard injection patch 5. This external electrical contact point 802 is in electrical communication with the electrical sensing and communicating chip 804 via electrical connections 806 spanning and across the patch 5. [0125] As can be seen in Figure 8B, in the presence of an intact shell 4, the electrical impulse released into the conductive filling media 810 inside of the implant 103 by the sensing and communicating chip 804 is exposed to an open circuit due to the insulating properties of the intact shell 4. As a result, none of the electrical impulse is transmitted to the external electrical contact point 802.

[0126] In contrast, as can be seen in Figure 8C, in the presence of a shell 4 that has a failure, the electrical impulse released into the conductive filling media 810 inside of the implant 103 by the sensing and communicating chip 804 is in electrical communication with the conductive bodily fluids 812 outside of the implant. As a result, the electric impulse is transmitted to the external electrical contact point 802. As the external electrical contact point 802 is in electrical communication with the sensing and communicating chip 804 (via an electrical connection 806 spanning the patch 5), the now closed circuit allows the sensing and communicating chip 804 to receive the impulse from the external electrical contact point 802 and, therefore, to report a failure.

[0127] The patch only modification found in Figures 8A-C may be used with the silicone gel embodiment by modifying the silicone gel to render it conductive (through the addition of metals, organometals, or other charge-carrying molecules to the silicone gel). Alternatively, the circumference of the silicone gel mass (at the gel-shell interface) may be made conductive while the central gel may be the standard, non-conductive gel. This may be accomplished through a two step gel insertion process whereby the outer rim of conductive gel is placed and cured (or partly cured) prior to instillation and curing of the remainder of the non- conductive silicone gel. This approach will minimize the conductive silicone gel required and will provide a superior solution compare to conductive layers or meshes within the shell in that the silicone gel emanating from the tear will not coat and insulate the conductive layer if it is the conductive layer itself. In addition to the standard dip-molding of the shell and injection of the silicone gel, the layered and/or conductive silicone gel approach could also be manufactured using single or multiple shot molding processes. In this embodiment, the device may or may not be radiolucent.

[0128] While the embodiment shown in Figures 8A-8C is shown as being used with a silicone device with a shell 4 and conductive filling media 810, the implant integrity monitoring device 800 could also be used with any implant 103 that has a non-conductive shell 4. For example, in the instance of a pacemaker or implantable cardioverter defibrillator, the device 800 could be used in the titanium shell of the implant near the most likely point of fluid ingress. The device 800 may then be interrogated routinely to determine if the shell has been compromised via the detection of the ingress of conductive bodily fluids. Further, while the embodiment shown in Figures 8A-8C has been described as being fully incorporated into the patch of the implant, some element of the device 800 may be included within the implant or within the external milieu (e.g., in the manner of the tethers of embodiments shown in Figures 1-4), so long as an external communication exists across the implant shell 4. Finally, whereas the embodiment shown in Figures 8A-8C is described as monitoring an internal conductivity of the fluid 810 within implant 103, other embodiments of the present invention envision simultaneously monitoring both the fluid 810 within the implant 103 and the fluid 812 outside of the implant 103 to determine the presence or absence of a complete conducting pathway across the shell 4 of the implant 103.

[0129] The present invention has been envisioned as being highly useful for any inflatable implant, including breast implants, percutaneous gastrostomy tubes, Foley catheters, penile implants, gastric balloons, etc. Further, due to the relative ease of measuring electrical properties and relative ease of translation to an RFID-based technology, the internal element 1 could be reduced significantly in size or even simply encompass an RFID and electrical property sensing element that are printed on the inside of the implant to be monitored, hi this way, changes in electrical properties can be quickly and easily measured and reported in a very low-profile manner within the implant. This feature may also apply to other characteristics of the filling fluid including chemical, optical, physical, pH, electrical properties, etc.

[0130] Lastly, while RFID has been mentioned as a communicating mechanism, a variety of other mechanisms may be employed including auditory, acoustic, vibrational or other stimuli to alert the patient that the implant has been compromised. Also, while RFID has also been mentioned as a method of powering the device, the device may also be powered by alternative mechanisms, including a self-winding mechanism (as found in watches), an internal rechargeable battery, or a long-lasting capacitor/internal battery. These alternative charging and alerting mechanisms all provide for an additional safeguard in that the patient may be notified nearly instantaneously of a rupture and not require the additional step of exposure to an RPID transmitting/receiving apparatus.

[0131] All patents and publications mentioned in the specification are indicative of the levels of those of ordinary skill in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

[0132] The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Thus, for example, in each instance herein any of the terms "comprising," "consisting essentially of and "consisting of may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

[0133] Other embodiments are set forth within the following claims.

Claims

WHAT IS CLAIMED IS:

1. A device for monitoring a failure in an external shell of an implant, following implantation in a user, said device comprising: a sensor configured to detect a failure in the external shell of the implant; and a signaling element located in a lumen of the implant, wherein the signaling element is configured to be triggered by the sensor to alert the user or a healthcare provider of said failure.

2. The device of claim 1 wherein the device includes a power source for the device which is contained within the device.

3. The device of claim 2 wherein the power source is rechargeable transcutaneously.

4. The device of claim 1 wherein the device includes a power source that is external to the device, and wherein the device is configured to receive power transmitted transcutaneously by the external power source.

5. The device of claim 1 wherein the sensor is configured to detect the influx of bodily fluids and/or compounds.

6. The device of claim 5 wherein the sensor is configured to detect salinity, hydration, pH, electrolyte concentration, or other properties of the bodily fluids and/or compounds entering the lumen.

7. The device of claim 1 wherein the sensor is configured to detect changes to the environment inside the lumen.

8. The device of claim 4 wherein the sensor is configured to detect changes in pressure, impedance, conductance or other physical property within the lumen.

9. The device of claim 1 wherein said sensor is incorporated into said external shell.

10. The device of claim 1 wherein said sensor is not incorporated into said external shell.

11. The device of claim 9 wherein said sensor is a mesh incorporated throughout shell.

12. The device of claim 11 wherein said sensor is configured to detect alterations in the external shell based on electrical, chemical or physical changes to said mesh.

13. The device of claim 1 wherein said sensor is located external to said shell.

14. The device of claim 13 wherein said sensor is configured to detect an outflow of materials encased in the implant.

15. The device of claim 13 wherein said sensor is configured to detect changes in salinity, pH, hydration, chemical markers or other compounds.

16. The device of claim 2 wherein said power source is a battery or capacitor.

17. The device of claim 16 wherein said battery or capacitor is configured to be inductively recharged.

18. The device of claim 17 wherein the device incorporates a second signaling element to alert the user that recharging is required.

19. The device of claim 18 wherein said second signaling element is a vibratory, acoustic, visual, tactile, electromagnetic field or other stimulus.

20. The device of claim 1 wherein said signaling element is configured to alert the user and/or healthcare provider upon triggering of the sensor.

21. The device of claim 20 wherein said signaling element is a vibratory, acoustic, visual, tactile, or other stimulus.

22. The device of claim 20 wherein the signaling element is electromagnetic, radiofrequency or ultrasound.

23. The device of claim 1 wherein the device incorporates a receiver and/or transmitter for external communication.

24. The device of claim 23 wherein the device utilizes ultrasound, radiofrequency or electromagnetic fields for communication.

25. The device of claim 23 wherein said transmitter externally transmits data relating to the implant.

26. The device of claim 23 wherein said receiver receives external information.

27. The device of claim 26 wherein said received information allows for programming, resetting or other manipulation of the device.

28. The device of claim 1 wherein the implant is inflatable, and wherein the device is used to monitor the inflatable implant.

29. The device of claim 1 wherein the failure is a rupture or deflation of said implant, and wherein the user and/or healthcare provider is alerted to failure of said implant.

30. The device of claim 1 wherein the external shell is rigid.

31. The device of claim 4 wherein circuitry within the implant allows for external powering of said sensor and/or said signaling element via an external power source/signal transmitter.

32. The device of claim 4 wherein said external power source is supplied by an external device placed within the living space of the user.

33. The device of claim 4 wherein said external power source is located outside the user.

34. The device of claim 33 wherein said external power source is located within or near a bed, couch, chair or seat of the user.

35. The device of claim 33 wherein said external power source is located within accessories, clothing, personal items, house, car or workspace of said user.

36. The device of claim 4 wherein the power source is battery and/or capacitor powered, and wherein the power source is portable.

37. The device of claim 36 wherein the battery and/or capacitor powering the power source is rechargeable.

38. The device of claim 32 wherein the power source is powered by a standard wall outlet.

39. The device of claim 32 wherein said external powering is continuous when the implant is within a predetermined range of the external power source.

40. The device of claim 31 wherein said signaling is continuous when the implant is within a predetermined range of an external signal transmitter.

41. The device of claim 31 wherein said external powering and/or signaling is intermittent with at least weekly, at least monthly or at least yearly interaction with the implant.

42. The device of claim 2 wherein the sensor, the power source, the signaling element, and related circuitry are provided in the lumen.

43. The device of claim 42 wherein the sensor, the power source, the signaling element, and related circuitry are provided in a signal compartment within the lumen.

44. A device for monitoring a failure in an external shell of a breast implant following implantation in a user, said device comprising: a sensor configured to detect a failure in the external shell of the breast implant; and a signaling element located in a lumen of the breast implant, wherein the signaling element is configured to be triggered by the sensor to alert the user or a healthcare provider of said failure.

45. The device of claim 44 wherein the device includes a power source for the device which is contained within the device.

46. The device of claim 45 wherein the power source is rechargeable transcutaneously.

47. The device of claim 44 wherein the device includes a power source that is external to the device, and wherein the device is configured to receive power transmitted transcutaneously by the external power source.

48. The device of claim 44 wherein the sensor is configured to detect the influx of bodily fluids and/or compounds.

49. The device of claim 48 wherein the sensor is configured to detect salinity, hydration, pH, electrolyte concentration, or other properties of the bodily fluids and/or compounds entering the lumen.

50. The device of claim 44 wherein the sensor is configured to detect changes to the environment inside the lumen.

51. The device of claim 50 wherein the sensor is configured to detect changes in pressure, impedance, conductance or other physical property within the lumen.

52. The device of claim 44 wherein said sensor is incorporated into said external shell.

53. The device of claim 44 wherein said sensor is not incorporated into said external shell.

54. The device of claim 52 wherein said sensor is a mesh incorporated throughout shell.

55. The device of claim 54 wherein said sensor is configured to detect alterations in the external shell based on electrical, chemical or physical changes to said mesh.

56. The device of claim 44 wherein said sensor is located external to said shell.

57. The device of claim 56 wherein said sensor is configured to detect an outflow of materials encased in the implant.

58. The device of claim 56 wherein said sensor is configured to detect changes in salinity, pH, hydration, chemical markers or other compounds.

59. The device of claim 45 wherein said power source is a battery or capacitor.

60. The device of claim 59 wherein said battery or capacitor is configured to be inductively recharged.

61. The device of claim 60 wherein the device incorporates a second signaling element to alert the user that recharging is required.

62. The device of claim 61 wherein said second signaling element is a vibratory, acoustic, visual, tactile, electromagnetic field or other stimulus.

63. The device of claim 44 wherein said signaling element is configured to alert the user and/or healthcare provider upon triggering of the sensor.

64. The device of claim 63 wherein said signaling element is a vibratory, acoustic, visual, tactile, or other stimulus.

65. The device of claim 63 wherein the signaling element is electromagnetic, radiofrequency or ultrasound.

66. The device of claim 44 wherein the device incorporates a receiver and/or transmitter for external communication.

67. The device of claim 66 wherein the device utilizes ultrasound, radiofrequency or electromagnetic fields for communication.

68. The device of claim 66 wherein said transmitter externally transmits data relating to the implant.

69. The device of claim 66 wherein said receiver receives external information.

70. The device of claim 69 wherein said received information allows for programming, resetting or other manipulation of the device.

71. The device of claim 44 wherein the implant is inflatable, and wherein the device is used to monitor the inflatable implant.

72. The device of claim 44 wherein the failure is a rupture or deflation of said implant, and wherein the user and/or healthcare provider is alerted to failure of said implant.

73. The device of claim 47 wherein circuitry within the implant allows for external powering of said sensor and/or said signaling element via an external power source/signal transmitter.

74. The device of claim 47 wherein said external power source is supplied by an external device placed within the living space of the user.

75. The device of claim 47 wherein said external power source is located outside the user.

76. The device of claim 75 wherein said external power source is located within or near a bed, couch, chair or seat of the user.

77. The device of claim 75 wherein said external power source is located within accessories, clothing, personal items, house, car or workspace of said user.

78. The device of claim 47 wherein the power source is battery and/or capacitor powered, and wherein the power source is portable.

79. The device of claim 78 wherein the battery and/or capacitor powering the power source is rechargeable.

80. The device of claim 74 wherein the power source is powered by a standard wall outlet.

81. The device of claim 74 wherein said external powering is continuous when the implant is within a predetermined range of the external power source.

82. The device of claim 73 wherein said signaling is continuous when the implant is within a predetermined range of an external signal transmitter.

83. The device of claim 73 wherein said external powering and/or signaling is intermittent with at least weekly, at least monthly or at least yearly interaction with the implant.

84. The device of claim 45 wherein the sensor, the power source, the signaling element, and related circuitry are provided in the lumen.

85. The device of claim 45 wherein the sensor, the power source, the signaling element, and related circuitry are provided in a signal compartment within the lumen.

86. The device of claim 44 wherein the breast implant is radiolucent.

87. The device of claim 44 wherein the signaling element is located to one side of the lumen so that when implanted into the breast, the signaling element is positioned further from the surface of the breast to lessen detection of the signaling element by external body palpation.

88. An apparatus comprising: a sensor configured to detect a failure in an external shell of an implant, following implantation in a user; a signaling element configured to be triggered by the sensor to alert the user or a healthcare provider of said failure; and a power source, wherein at least one of the sensor, the signaling element, and the power source is configured to be provided in a patch for the implant.

89. The apparatus according to claim 88 wherein all of the sensor, the signaling element, and the power source are configured to be provided in a patch for the implant.

90. The apparatus according to claim 88 wherein the implant is a breast implant.

91. The apparatus according to claim 90 wherein the patch is configured to be housed within an inflation port of the breast implant.

92. A method of monitoring for a failure in an implant, the method comprising the steps of: providing a device for monitoring a failure in an external shell of an implant, following implantation in a user, said device comprising: a sensor configured to detect a failure in the external shell of the implant; and a signaling element located in a lumen of the implant; monitoring, using the sensor, physical conditions present within the lumen; determining, using the sensor, that a failure of the implant has occurred based on changes in the physical conditions monitored by the sensor; triggering the signaling element; and alerting, using the signaling element, the user or a healthcare provider of said failure.

93. The method according to claim 92 wherein the step of monitoring, using the sensor, physical conditions present within the lumen comprises monitoring one or more of a salinity, hydration, pH, electrolyte concentration, and other properties of bodily fluids and/or compounds entering the lumen.

94. The method according to claim 92 wherein the step of alerting, using the signaling element, the user or a healthcare provider of said failure comprises producing one or more of a vibratory, acoustic, visual, tactile, and electromagnetic field.

95. The method according to claim 92 further comprising the step of: recharging the device periodically.

96. The method according to claim 95 wherein the recharging of the device is performed in conjunction with an external power source.

97. The method according to claim 96 further comprising the step of: alerting the user and/or healthcare provider that the device needs to be recharged.

98. The method according to claim 92 further comprising the step of: resetting periodically baseline levels for the physically conditions.

99. The method according to claim 92 wherein monitoring is conducted before implantation of the device.

100. The method according to claim 99 wherein monitoring is conducted during manufacturing of the device.

101. The method according to claim 92 wherein monitoring is conducted after implantation.

102. The method according to claim 101 wherein monitoring is conducted after implantation during the initial surgery.