|Publication number||US20090088618 A1|
|Application number||US 11/865,464|
|Publication date||Apr 2, 2009|
|Filing date||Oct 1, 2007|
|Priority date||Oct 1, 2007|
|Also published as||US8869390, US20120153981, US20150033552, WO2009045409A1|
|Publication number||11865464, 865464, US 2009/0088618 A1, US 2009/088618 A1, US 20090088618 A1, US 20090088618A1, US 2009088618 A1, US 2009088618A1, US-A1-20090088618, US-A1-2009088618, US2009/0088618A1, US2009/088618A1, US20090088618 A1, US20090088618A1, US2009088618 A1, US2009088618A1|
|Inventors||Michael R. Arneson, William R. Bandy, Roger A. Davenport, Kevin J. Powell, Michael C. Sloan|
|Original Assignee||Arneson Michael R, Bandy William R, Davenport Roger A, Powell Kevin J, Sloan Michael C|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (24), Classifications (24), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
1. Field of the Invention
The present invention relates to medical diagnostics, and in particular, to swallowable medical diagnostic devices.
2. Background Art
The population of the United States is aging. The first wave of the 78 million “Baby Boomers” is beginning to turn 60 years old. There has been an explosion in diabetes cases, estimated at 194 million cases worldwide today, and predicted to reach 350 million cases by year 2025. Obesity currently affects two thirds of the U.S. population. There is a rising incidence of cardiac problems for women (the number one cause of death for women). Hepatitis C will soon reach epidemic levels, infecting nearly 5 million people, more than the number of people infected with AIDS in the U.S. Thus, simple and easy diagnostic and treatment techniques are needed, especially because many of the diseases that afflict the population are chronic, requiring repeat testing and treatment over time.
Such diagnostic and treatment techniques may be realized by using a swallowable sensor device that is ingested by a patient. The swallowable sensor device could be used to sense a condition and/or deliver medical treatment as it travels through the patient's gastrointestinal tract.
However, conventional swallowable sensor devices have several drawbacks. One drawback of conventional swallowable sensor devices is that they are quite large. In fact, conventional swallowable sensor devices are so large that a portion of the patient population cannot even swallow these devices. Even if a patient could swallow a conventional swallowable sensor device, its large size could cause it to become lodged in the patient's gastrointestinal tract, which would require surgery to remove.
Another problem with conventional swallowable sensor devices is that they use a radio frequency (RF) signal platform to communicate with external entities. The extent to which RF signals cause harm to human tissue is not fully understood. The potential for harm only increases as the source of the RF signals comes closer to human tissue. As a result, many patients are apprehensive about ingesting conventional swallowable sensor devices.
Given the foregoing, what is needed is an improved swallowable sensor device, and a method for manufacturing such a swallowable sensor device.
The accompanying drawings, which are incorporated herein and form part of the specification, illustrate the present invention and, together with the description, further serve to explain the principles of the invention and to enable a person skilled in the relevant art(s) to make and use the invention.
The features and advantages of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout. In the drawings, like reference numbers generally indicate identical, functionally similar, and/or structurally similar elements. The drawing in which an element first appears is indicated by the leftmost digit(s) in the corresponding reference number.
Described herein are methods and systems for manufacturing a swallowable sensor device, and applications thereof. In the specification, references to “one embodiment,” “an embodiment,” “an example embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.
A swallowable sensor device manufactured in accordance with an embodiment of the present invention is relatively small compared to conventional swallowable sensor devices. In addition, a swallowable sensor device manufactured in accordance with an embodiment of the present invention uses acoustic frequencies, rather than RF frequencies, to communicate with an external entity (such as a computer or hand-held device). As a result, the swallowable sensor device may be ingested by a patient for diagnostic or treatment purposes. To diagnose the patient, the swallowable sensor device may collect data and/or samples as it travels through the gastrointestinal tract of the patient. To treat the patient, the swallowable sensor device may deliver medication or other types of treatment at specific locations within the patient's body. Similarly, the swallowable sensor device may deliver material to augment a particular sensor device or an external diagnostic procedure, such as a dye, marker, or radioactive isotope.
The diagnostic and treatment functionalities are performed by diagnostic/treatment components of the swallowable sensor device. The diagnostic/treatment components are exposed to the external environment of the swallowable sensor device. For example, sensors of the swallowable sensor device are exposed to fluids and acids within the patient's gastrointestinal tract in order to collect data regarding the patient's internal body chemistry. Similarly, treatment delivery components are exposed to the external environment of the swallowable sensor device in order to deliver certain types of treatment to the patient.
Circuitry contained within the swallowable sensor device controls the implementation of the diagnostic and/or treatment functionalities. Although the diagnostic/treatment components are coupled to the circuitry, the circuitry and other internal components (such as a power supply, a communication module, and other such components) are not exposed to the external environment. Exposing the circuitry and other internal components to the external environment would likely cause the swallowable sensor device to malfunction, and/or could also be harmful to the patient.
To expose the diagnostic/treatment components, while protecting the internal components, an embodiment of the present invention uses a molding technique to manufacture a swallowable sensor device. In this embodiment, the internal components of the swallowable sensor device—such as a printed circuit (PC) board, a battery, and a transducer—are mechanically and electrically coupled to each other. The internal components are inserted into a molding cavity. The cavity may be pre-filled with a potting material or the potting material may be injected into the cavity after the internal components have been inserted therein. The cavity is then sealed, allowing the potting material to harden. The hardened potting material forms an exterior housing that protects the internal components of the swallowable sensor device from the external environment.
In an embodiment, the potting material comprises a UV curable epoxy. In this embodiment, the chemical composition of the potting material results in an acoustically transmissive substance (transmissive at a desired acoustic frequency) with an impedance between that of a transducer and the human body. Furthermore, curing the UV epoxy in an oxygen rich environment results in a layering of the cure, which in turn results in a layering of the impedance from the potting material abutting the transducer and the external layer of the swallowable sensor device. Ideally, the swallowable sensor device includes an infinite number of layers from the acoustic impedance of the transducer to the acoustic impedance of the human body, resulting in the highest possible acoustic performance (i.e., the most energy transmitted outward from the acoustic source). Accordingly, embodiments of the present invention include a relatively large number of layers of acoustic impedance between the transducer and the human body. The aforementioned layered impedance construction yields a highly efficient swallowable sensor device in acoustic performance.
Importantly, the PC board includes a plurality of projections that extend radially outward causing them to abut against the cavity wall. Because the projections abut against the cavity wall, the potting material is prevented from covering the distal ends of the projections. As a result, when the potting material hardens to form the exterior housing, the projections will be exposed to the then external environment. However, the projections will be mechanically and/or electrically coupled to the internal components of the swallowable sensor device.
Each projection may comprise an electrode or a hollow tubing. The electrodes are coupled to sensors that collect data corresponding to the internal body chemistry of a patient. Because the housing does not cover the electrodes, the sensors will be exposed to the external environment of the swallowable sensor device, but electrically coupled to internal components. Thus, the sensors can properly function to receive stimuli from the external environment, which can then be communicated to internal circuitry contained within the swallowable sensor device.
Additionally, each sensor may be covered with a digestible, protective material.
As the swallowable sensor device travels through a human's gastrointestinal tract, the protective material covering each sensor is digested. By covering the sensors with different thicknesses of protective material, the sensors can be exposed to the external environments at different times as the swallowable sensor device travels through a human's gastrointestinal tract. Thus, the swallowable sensor device can be configured for timed release of each sensor based on the thickness of the digestible, protective material covering each sensor.
Similar to each electrode, a first end of the hollow tubing is exposed to the external environment and a second end is coupled to a container that is sealed within the housing of the swallowable sensor device. Thus, the hollow tubing can properly function to deliver materials and treatment to and/or collect samples from the external environment of the swallowable sensor device.
The methods and systems of the present invention for manufacturing a swallowable sensor device are described in greater detail below. To better understand these methods and systems, however, it is first helpful to describe an example environment in which such a swallowable sensor device may be implemented and an example swallowable sensor device.
While passing through human 102, swallowable sensor device 104 transmits information in a communication signal 106 to be received outside human 102. As shown in
In an embodiment, computing device 108 can interact with swallowable sensor device 104 by transmitting a communication signal 110. Such interaction may be used to control functions of swallowable sensor device 104 and/or to image at a desired resolution an internal portion of a patient, as described for example in U.S. Provisional Patent Application No. 60/924,928 Arneson et al., entitled “Imaging and Locating Systems and Methods for a Swallowable Sensor Device” and filed Jun. 5, 2007, and U.S. patent application Ser. No. 11/851,179 to Arneson et al., entitled “Imaging and Locating Systems and Methods for a Swallowable Sensor Device” and filed Sep. 6, 2007. The entirety of each of the foregoing applications is incorporated by reference herein.
In embodiments, human 102 may be provided with one or more swallowable sensor devices 104 that human 102 may swallow at designated times and/or periodically to perform an analysis of one or more health-related conditions of human 102.
Computing device 108 may be configured to communicate with remote entity 190 using wired and/or wireless links, in a direct fashion or through network 170. For example, computing device 108 transmits a communication signal 160 to network 170, which transmits a communication signal 180 to remote entity 190. Network 170 may be any type of network or combination of networks, such as a telephone network (e.g., a land line and/or cellular network), a personal area network (PAN), a local area network (LAN), and/or a wide area network (WAN) such as the Internet.
Remote entity 190 may be one or more of a variety of entities, including a human and/or computer-based entity. For example, remote entity 190 may include a doctor who receives information collected by swallowable sensor device 104 (and optionally processed by computer device 108) in communication signal 180.
Remote entity 190 may send a return communication to computing device 108 via network 170. For example, a return communication signal 182 is transmitted by remote entity 190 to network 170, which transmits a return communication signal 162 to computing device 108. In this manner, remote entity 190 (e.g., doctor and/or computer system) can provide feedback to computing device 108 in communication signal 182 regarding the analysis of human 102 performed by swallowable sensor device 104. Return communication signal 182 may include any type of data/information format for providing the feedback, including an email, a text message, a text file, a document formatted for commercially available word processing software, a proprietary document/data format, auditory alarms, alerts and messages, etc. In addition, computing device 108 may send instructions to swallowable sensor device 104 in communication signal 110 based on the feedback provided from remote entity 190 via network 170.
Swallowable sensor device 104 may optionally communicate with computing device 108 via an intermediate sensor link module 112. Sensor link module 112 may receive communication signal 106 from swallowable sensor device 104. Sensor link module 112 transmits a communication signal (not shown) to computing device 108 on a wired or wireless connection, to provide the information sensed by swallowable sensor device 104 to computing device 108. For example, sensor link module 112 may be used when swallowable sensor device 104 communicates using an acoustic communications signal having a power level too low to reliably be received by computing device 108.
In another embodiment, sensor link module 112 may provide a communication interface between swallowable sensor device 104 and network 170, such that a separate computing device 108 is not required. In such an embodiment, sensor link module 112 may perform some or all functions of computing device 108 described above, and thus sensor link module 112 may be referred to as a computing device. For example sensor link module 112 may receive communication signal 106 from and transmit communication signal 110 to swallowable sensor device 104.
Multiple sensor link modules 112 may provide a capability of accurately locating swallowable sensor device 104 as it travels through human 102. Example locating systems and methods are described in the aforementioned U.S. Provisional Patent Application No. 60/924,928 to Arneson et al., entitled “Imaging and Locating Systems and Methods for a Swallowable Sensor Device” and filed Jun. 5, 2007, and U.S. patent application Ser. No. 11/851,179 to Arneson et al., entitled “Imaging and Locating Systems and Methods for a Swallowable Sensor Device” and filed Sep. 6, 2007. The entirety of each of the foregoing applications is incorporated by reference herein.
As shown in
Housing 208 may be the size of a vitamin or other type of pill that is swallowable by humans. For example, housing 208 may be approximately 1 mm to 10 mm in diameter and approximately 4 mm to 25 mm in length, and preferably approximately 5 mm in diameter and approximately 14 mm in length. Housing 208 may be any suitable shape, including oval, elliptical, capsule shaped, or spherical. The small size of housing 208 allows swallowable sensor device 104 to be easily ingested by an average human 102. The small size overcomes difficulties present with conventional swallowable sensor devices, which are often so large that only a small percentage of the population can actually swallow them safely. Further, the small size of housing 208 allows swallowable sensor device 104 to pass completely through the digestive system of a human 102 without becoming trapped due to size incompatibilities or blockage (growths) along the way.
Housing 208 may be made from a variety of non-digestible or slow rate of digestion materials. Such materials may include, but are not limited to, the following materials: a plastic material (such as a resin, a resinoid, a polymer or polymer matrix, a cellulose derivative); a casein material; a protein; a metal (including a combination of metals/alloy); a glass material; a ceramic; a composite material; an enteric coating; and/or other material/combination of materials. In an embodiment, housing 208 may be comprised of a material that aids in the sensing of biological, chemical, or other attributes of body material that touches or comes in close proximity to the housing 208, such as could be called an integrated housing and sensor material. Furthermore, in an embodiment, housing 208 comprises primarily a non-digestible material with orifices or indentations which are filled with a layer of digestible material of variable thickness covering a sensor material that is in turn deposited on top of an electrically conductive pathway to internal components.
Swallowable sensor device 104 also includes treatment/diagnostic components 202, such as a treatment delivery component 202 a, a sample receiver component 202 b, and a sensor 202 c. Treatment/diagnostic components 202 are coupled to PC boards 220 a-c, but are not contained within materials comprising housing 208. In other words, treatment/diagnostic components 202 are exposed to the external environment of swallowable sensor device 104 in order to deliver treatment and/or collect data as swallowable sensor device travels through the gastrointestinal tract of human 102. Treatment delivery component 202 a is configured to deliver treatment (such as medication, radiation therapy, or another form of treatment or therapy) to human 102. Sample receiver component 202 b is configured to receive one or more samples (such as digestive fluid, stomach acid, tissue, or some other sample) from human 102. Sensor 202 c is used to sense (e.g., measure, detect, etc.) a received stimulus 210. Swallowable sensor device 104 can include any number of sensors 202 c, each of which may all sense the same condition or may sense a different condition than another sensor 202 c. In an embodiment, a molding technique is used to seal the internal components within housing 208, while exposing treatment/sensor components to the external environment—as described in more detail below.
In an embodiment, the treatment/sensor components may be covered by a digestible, protective material. By applying different thicknesses of protective material, the treatment/sensor components can be released at different times corresponding to the amount of time it takes to digest the protective material, as described in more detail below.
A first end 232 and a second end 234 of post 230 are also exposed to the external environment of swallowable sensor device 104. A voltage and/or signal may be applied across first end 232 and second end 234, after swallowable sensor device 104 is fabricated, to test whether swallowable sensor device 104 is functioning properly, as described in more detail below.
Communications module 204 receives the output from treatment/diagnostic components 202 and generates communication signal 106 to include data based on the output. Communication signal 106 is transmitted from swallowable sensor device 104. Communications module 204 may also receive communication signal 110 transmitted from external computing device 108.
In an embodiment, communication signal 106 comprises an acoustic signal. In this embodiment, communications module 204 includes one or more transducers (such as transducer 240) that are configured to convert electrical energy to mechanical energy, and vice versa. For example, the one or more transducers convert the electrical energy received from treatment/diagnostic components 202 into the mechanical energy of acoustic communication signal 106, and convert the mechanical energy of acoustic communication signal 110 into electrical energy sent to communications module 204, control logic 214, or treatment/diagnostic components 202. Example methods and systems for transmitting data from swallowable sensor device 104 are described, for example, in the aforementioned U.S. Provisional Patent Application No. 60/941,184 to Arneson et al., entitled “System and Method for Acoustic Data Transmission Involving a Swallowable Low Power Sensor Device” and filed May 31, 2007; U.S. patent application Ser. No. 11/851,214 to Arneson et al., entitled “System and Method for Acoustic Data Transmission Involving a Swallowable Low Power Sensor Device” and filed Sep. 6, 2007; U.S. patent application Ser. No. 11/851,236 to Arneson et al., entitled “System and Method for Acoustic Data Transmission” and filed Sep. 6, 2007; and U.S. patent application Ser. No. 11/896,946 to Arneson et al., entitled Methods and Systems for Acoustic Data Transmission and filed Sep. 6, 2007. The entirety of each of the foregoing applications is incorporated by reference herein.
Swallowable sensor device 104 also includes control logic 214, which may be used to gate or control swallowable sensor device 104. Control logic 214 may be included on one or more PC boards 220. Control logic 214 may operate in a sub-threshold voltage (Vt) manner (e.g., to save power), or may operate in normal bias modes. In an embodiment, swallowable sensor device 104 is an autonomous device with one way communication (transmission capability), so that control logic 214 may be extremely simple, and thus would not consume much power even when operating in normal bias modes. In another embodiment, swallowable sensor device 104 may communicate in both directions—i.e., it may be configured to transmit information to and receive instructions from computing device 108 and/or sensor link module 112. Control logic 214 may thus have additional complexity in order to, for example, decode and implement received instructions.
Swallowable sensor device 104 also includes power source 206. Power source 206 provides power (e.g., via electrical energy) to operate the components of swallowable sensor device 104 that require power, such as communications module 204 and/or sensor 202. Power source 206 may include, for example and without limitation, battery 260 of
In an embodiment, swallowable sensor device 104 is configured for low power operation, including extreme low power (XLP) operation. To achieve XLP operation, swallowable sensor device 104 can use one or both of a very small battery and energy harvesting to operate swallowable sensor device 104. In an embodiment, circuits of swallowable sensor device 104 are implemented on one or more integrated circuits (ICs), in a technology such as CMOS, or other technology. The IC(s) and any other internal components of swallowable sensor device 104 are mounted to one or more PC boards 220 of
In a CMOS embodiment, MOSFET circuits may be configured to operate in a deep sub-threshold voltage (sub-Vt) mode, which lowers their switching time to acoustic switching frequencies, and lowers their power consumption by orders of magnitude. In such a mode the MOSFET devices operate as analog devices. Such operation was demonstrated in the mid-1980's by Carver Meade with regard to eye and ear chips. Such a mode of operation eliminates the need for digitizing the sensor data, which can be very power intensive, and which further reduces the power consumption by a large factor.
After being swallowed by human 102, swallowable sensor device 104 eventually passes from human 102, such as when human 102 has a bowel movement to excrete waste. In an embodiment, swallowable sensor device 104 is disposable.
It may be useful to have positive confirmation if and when sensor device 104 has been excreted. In some humans 102, sensor device 104 may not pass through the digestive tract within an average life time of sensor device 104. In an embodiment, a power source 206 (
In another embodiment, swallowable sensor device 104 may be recovered (and recycled) for reuse. Depending upon the ability or control of the patient, swallowable sensor device 104 may alternatively be inserted into a lower gastrointestinal tract of human 102 as a suppository device. In a further embodiment, sensor device 104 may also be placed within a female reproductive tract. In this further embodiment, sensor device 104 is configured to sense body temperature, hormonal levels, cancer markers, and a variety of STDs. This embodiment is a potential aid to conception and/or reproductive disease and cancer diagnoses.
Depending on the configuration of sensor 202, while passing through human 102, swallowable sensor device 104 can sense conditions and/or features of any part of the gastrointestinal tract or contents thereof, and any of the materials/fluids contained within and/or secreted by the organs in the gastrointestinal tract or organs indirectly associated with the gastrointestinal tract. Swallowable sensor device 104 can deliver treatment to patient 102. Swallowable sensor device 104 can also receive conditions or signals from even more remote body organs such as acoustic pickup of heartbeat and/or breathing and more indirect conditions such as temperature. In an embodiment, an imager device is contained within swallowable sensor device 104 to allow visual observation of the gastrointestinal tract of human 102.
Having presented a description of an example environment and swallowable sensor device, a method for manufacturing such a swallowable sensor device is now described.
In a step 320, a cavity is filled with a potting material, and in a step 330, the mechanically coupled components are inserted in the cavity. In an embodiment, step 320 occurs before step 330. In another embodiment, step 320 occurs after step 330. In other words, the cavity may be pre-filled with the potting material. Alternatively, the mechanically coupled components can be inserted into the cavity, and then the potting material can be injected therein. The potting material may include, but is not limited to, the following materials: a plastic material (such as a resin, a resinoid, a polymer, a cellulose derivative); a casein material; a protein; a glass material; a ceramic; a composite material; and/or other materials or combinations of materials.
In a step 340, the cavity is sealed with a cap. The cap contains the potting material, forming the entire outside shape. The cavity may be passive to UV, allowing UV curing potting materials to harden quickly. The cavity may also simply contain the potting material while it hardens without external influence. The internal components include a PC board having a plurality of projections. As set forth above and described in more detail below, the projections abut against a wall of the cavity, thereby preventing the potting material from covering a distal end of each projection. As a result, the distal ends are exposed to an external environment of the swallowable sensor device upon the completion of the hardening of the potting materials.
B. Example Mechanical and Electrical Couplings
The mechanical and electrical coupling of the internal components is now described with reference to
Post 230 includes a plurality of grooves 432 encircling its exterior. Post 230 may also include traces 434 that are disposed on the exterior. The interior of post 230 includes an insulator layer 440 and a central conductor 232. In one embodiment, central insulator layer 440 may comprise a transducer that is configured to convert electrical energy to mechanical energy. Additionally or alternatively, an annularly-shaped transducer may be coupled to post 230 by inserting post 230 into the inner opening of the annularly-shaped transducer 240, as illustrated for example in
PC board 220 is mechanically coupled to post 230 by inserting post 230 in opening 438. In an embodiment, post 230 and opening 438 are keyed such as not to be able to assemble in an incorrect configuration. As post 230 is inserted into opening 438 of PC board 220, inner knobs 424 are urged into one of the grooves 432 providing a mechanical coupling and mechanical spacing as appropriate. In another embodiment, grooves 432 are not required as mechanical spacing can be attained from spacing materials deposited onto PC board 220, transducer 240 and the like. Additionally, traces 434 come into electrical contact with inner knobs 424 providing an electrical coupling between PC board 220 and post 230. Other internal components, such as a battery and transducer, are mechanically and electrically coupled to post 230 in a similar manner.
The assembly of stack 600 illustrated in
The assembly of stack 600 illustrated in
C. An Example Molding Technique
Given the stack of mechanically and electrically coupled internal components (as illustrated in
Moldings 810 and cavities 812 may contain small indentations for sensors (not shown in
A plurality of stacks of mechanically coupled internal components 830 is inserted into molds 810. For example, a mechanically coupled stack of internal components 832 is inserted in cavity 812. In an embodiment, each cavity of molding 810 is pre-filled with potting material 820 before inserting the internal components 830 therein. In another embodiment (not shown), the internal components 830 are inserted in molds 810, and then potting material 820 is injected therein.
In either embodiment, molds 810 are sealed with caps 840, after the internal components 830 and potting material 820 have been inserted in molds 810. For example, cap 842 seals cavity 812 after stack 832 and potting material 820 is inserted in cavity 812. As a result, potting material 820 hardens within the sealed cavities forming an exterior housing of each stack of internal components, thereby forming the swallowable sensor devices.
Importantly, however, projections included on one or more of the PC boards (such as projections 422 of PC board 220 (
In another embodiment, indentations are included in side wall 934. When these indentations are aligned with projection 922, distal end 924 is exposed (not encased in potting material) but also leaves an indentation in the hardened potting material (such as indentations 1410, 1420, and/or 1430 illustrated in
In addition to projection 922, a first and second end of central post 930 abuts against a base and cap of sealed cavity 812, as illustrated in
As discussed above with reference to
D. Example Projections
As mentioned above, the projections of one or more PC boards will be exposed to the external environment of the manufactured swallowable sensor device. The projections may comprise an electrode or a hollow tubing. The electrodes may be coupled to a sensor and used to sense a condition of patient 102. The hollow tubing may be configured to deliver treatment, diagnostic aid (dye or radioactive materials), and/or to receive a sample as it travels through patient 102.
First hollow tubing 1032 is configured to deliver treatment, such as medicine, as the swallowable sensor device travels through patient 102. A first end of first hollow tubing 1032 will be exposed to an external environment of a manufactured swallowable sensor device. In an embodiment, a second end of first hollow tubing 1032 is coupled to a container 1040. In this embodiment, container 1040 includes a medicine (or some other substance) that is to be delivered to patient 102. Circuitry on PC board 1020 is configured to cause the medicine stored in container 1040 to pass through first hollow tubing and into the external environment of the swallowable sensor device.
In an embodiment, the medicine is pressure sealed in container 1040. In this embodiment, a relatively low pressure in container 1040 keeps medicine within container 1040. At a specified time, a micro-pump 1042 increases the pressure in container 1040, thereby causing the medicine in container 1040 to pass through first hollow tubing 1032 and into the external environment. Micro-pump 1042 is controlled by circuitry contained on PC board 1020 or other circuitry contained in the swallowable sensor device.
In another embodiment, the medicine in container 1040 is prevented from passing through first hollow tubing 1032 by a blocking member (such as a gate, a membrane, a screen, or some other element). At a specified time, the blocking member is removed, thereby allowing the medicine to pass through first hollow tubing 1032 into the external environment of the swallowable sensor device. An exemplary material for blocking is a microencapsulated structure which breaks down at a certain ultrasonic frequency—such as a frequency that is equal to a frequency generated by a transducer adjacent to tubing 1032 being blocked.
A second hollow tubing 1036 is configured to receive a sample, such as a gastrointestinal fluid, as the swallowable sensor device travels through patient 102. A first end of second hollow tubing 1036 will be exposed to an external environment of a manufactured swallowable sensor device. In an embodiment, a second end of second hollow tubing 1036 is coupled to container 1040. In this embodiment, container 1040 is configured to receive the sample from the gastrointestinal tract of patient 102. Circuitry on PC board 1020 is configured to cause the sample to pass through second hollow tubing and into container 1040. For example, micro-pump 1042 may decrease the pressure in container 1040, for example by pumping out sterile water, thereby forcing the desired sample through second hollow tubing 1036 and into container 1040 through the vacuum created in the container 1040.
An embodiment of micro-pump 1042 is further depicted in
Tube 1620 (e.g., the chamber of micro-pump 1042) expands and contracts upon a charge deposited by electrical wiring 1630. A common material for tube 160 (as used, for example, in some ink jet printers) is a piezoelectric material, such as PZT. An example configuration is depicted in
When electrical charges on conductors 1630 are altered, the volume 1650 of the inside of the tube 1620 will also alter. A pumping action is a resultant of the expansion and contraction of the volume 1650 in combination with the valves 1610 that allow expansion of fluid to flow from the right, and contraction by allowing fluid to flow to the left. The frequency and voltage of the electrical charge alterations will control the rate of the fluid flow, and can be categorized by timing, frequency, current and the like to a certain volume of liquid pumped through the assembly 1600.
Electrode 1034 is configured to be coupled to a sensor that senses a condition of patient 102.
E. Example Sensor Implementations
An example application for using swallowable sensor device 104 in combination with biological sensor materials is described below. As previously mentioned,
In an embodiment, a sensor material 1440 (
F. Timed Release Sensor Material
An embodiment of the present invention enables timed release of sensor material 1440 based on a thickness of a protective layer, as described in more detail below.
The enzymatic sensor material 1440 does not function long while exposed to a harsh environment (such as the stomach acid, and in general, the digestive system itself). Accordingly, a protective layer 1450 can be used to protect sensor material 1440. Importantly, the thickness of protective layer 1450 can be manufactured to enable sensor material 1440 to be exposed at specific times and/or locations as swallowable sensor device 104 travels through the digestive system of human 102.
To provide this feature, an embodiment of sensor device 104 includes a plurality of sensors 202, each having sensor material 1440 and a layer of protecting material 1450A, B, C, wherein the layers of protecting material 1450 have differing thickness or density to expose sensor material 1440 of each sensor 202 at different times as sensor device 104 travels through human 102. Protecting material 1450 may comprise known types of digestible materials, such as known timed release medicines available over-the-counter, as would be apparent to a person skilled in the relevant art(s). For example, a thickness of material 1450A may expose sensor material 1440 to a stomach environment after 30 minutes, while a thickness of material 1450B may expose sensor material 1440 to a small intestine environment after 1 hour. Given a sensor material functional life span of 30 minutes, and a desired operational time for sensor device 104 of approximately 24 hours, for example, then embodiments of the present invention include 48 (or more) different thicknesses for protective layer 1450.
An embodiment of this present invention creates sensor device 104 from a cavity 812 that has a tapered portion of the length of the cavity, as illustrated for example in
In an alternate embodiment, sensor material 1440 can be applied at a uniform thickness, such as with a uniform spray technique, into a site 1410, 1420, and 1430 of different thickness and volume, as illustrated for example in
F. Example Testing Methods
Ingestible, pill-formed and packaged electronic products are a new concept. Although packaging and production of electronics is well-known and packaging and production of medicine is well-known, a process that combines both provides some interesting issues. Final testing of production pieces of electronics and resultant packaging can be done in a delicate environment, preserved with electrostatic bags and other protective packaging. Medicines also have a delicate environment for biological sensitivity, but not for electrical sensitivity. Thus, a process for a combination of packaging and testing of ingestible electronic devices is a new requirement, and an object of this present invention.
Assembly 1700 is then introduced into a mold, with heat and some form of pressure common with the molding of plastic packaging. The mold causes wells 1765 to be formed in assembly 1700, as depicted in
Assembly 1850 illustrates the capability to both biologically contain an ingestible electronic device while facilitating direct electrical connection for a variety of testing, programming, and energy transfer (for example, battery charging) functions while not requiring all of the test platforms and environments within and between to be sterilized and/or germ free. Furthermore, as depicted in
In an alternate embodiment, test points 1895 can be electronically connected through conductive pathways 1720 and 1730, with optional additional electronic components and/or power supplies deposited upon package material 1710. In this embodiment, the removal of electronic device 1890 from assembly 1850 is detectable or determinable. Upon removal, electronic device 1890 can be configured to autonomously prepare for subsequent ingestion within an animal or human, for example by turning one or more features and functions.
G. Layered Structure
In an embodiment, swallowable sensor device 104 has a layered structure to provide efficient transfer of sound energy into the surrounding medium (e.g., liquid, solid, human tissue or viscoelastic materials). Each layer or composite layers has a particular acoustic impedance. The material closest to the sensor has an acoustic impedance that is a large percentage of the sensor. As the material or material layers transition to the outside of swallowable sensor device 104, the fractional percentage of the material's acoustic impedance drops to match the surrounding medium. The change in material properties can be accomplished by multiple layers of materials (
In an embodiment, the anisotropic layer 2003, illustrated in
According to an example embodiment, a swallowable sensor device may execute computer-readable instructions to perform its functions. Furthermore, a sensor link module for communicating with the swallowable sensor device may execute computer-readable instructions to communicate with the swallowable sensor device. Still further, a computing device may execute computer-readable instructions to control and communicate with the swallowable sensor device and/or the sensor link module, and/or to process data obtained by the swallowable sensor device and/or sensor link module, as described above. Still further, a test kit and medical diagnostic network system may each execute computer-readable instructions to perform its functions.
In one embodiment, one or more computer systems are capable of carrying out the functionality described herein. An example of a computer system 1300 is shown in
The computer system 1300 includes one or more processors, such as processor 1304. The processor 1304 is connected to a communication infrastructure 1306 (e.g., a communications bus, cross-over bar, or network). Various software embodiments are described in terms of this exemplary computer system. After reading this description, it will become apparent to a person skilled in the relevant art(s) how to implement the invention using other computer systems and/or architectures.
Computer system 1300 can include a display interface 1302 that forwards graphics, text, and other data from the communication infrastructure 1306 (or from a frame buffer not shown) for display on the display unit 1330.
Computer system 1300 also includes a main memory 1308, preferably random access memory (RAM), and may also include a secondary memory 1310. The secondary memory 1310 may include, for example, a hard disk drive 1312 and/or a removable storage drive 1314, representing a floppy disk drive, a magnetic tape drive, an optical disk drive, etc. The removable storage drive 1314 reads from and/or writes to a removable storage unit 1318 in a well known manner. Removable storage unit 1318 represents a floppy disk, magnetic tape, optical disk, etc. which is read by and written to by removable storage drive 1314. As will be appreciated, the removable storage unit 1318 includes a computer usable storage medium having stored therein computer software and/or data.
In alternative embodiments, secondary memory 1310 may include other similar devices for allowing computer programs or other instructions to be loaded into computer system 1300. Such devices may include, for example, a removable storage unit 1322 and an interface 1320. Examples of such may include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as an erasable programmable read only memory (EPROM), or programmable read only memory (PROM)) and associated socket, and other removable storage units 1322 and interfaces 1320, which allow software and data to be transferred from the removable storage unit 1322 to computer system 1300.
Computer system 1300 may also include a communications interface 1324. Communications interface 1324 allows software and data to be transferred between computer system 1300 and external devices. Examples of communications interface 1324 may include a modem, a network interface (such as an Ethernet card), a communications port, a Personal Computer Memory Card International Association (PCMCIA) slot and card, etc. Software and data transferred via communications interface 1324 are in the form of signals 1328 which may be electronic, electromagnetic, optical or other signals capable of being received by communications interface 1324. These signals 1328 are provided to communications interface 1324 via a communications path (e.g., channel) 1326. This channel 1326 carries signals 1328 and may be implemented using wire or cable, fiber optics, a telephone line, a cellular link, a radio frequency (RF) link and other communications channels.
In this document, the terms “computer program medium” and “computer usable medium” are used to generally refer to media such as removable storage drive 1314 and a hard disk installed in hard disk drive 1312. These computer program products provide software to computer system 1300. The invention is directed to such computer program products.
Computer programs (also referred to as computer control logic) are stored in main memory 1308 and/or secondary memory 1310. Computer programs may also be received via communications interface 1324. Such computer programs, when executed, enable the computer system 1300 to perform the features of the present invention, as discussed herein. In particular, the computer programs, when executed, enable the processor 1304 to perform the features of the present invention. Accordingly, such computer programs represent controllers of the computer system 1300.
In an embodiment where the invention is implemented using software, the software may be stored in a computer program product and loaded into computer system 1300 using removable storage drive 1314, hard drive 1312 or communications interface 1324. The control logic (software), when executed by the processor 1304, causes the processor 1304 to perform the functions of the invention as described herein.
In another embodiment, the invention is implemented primarily in hardware using, for example, hardware components such as application specific integrated circuits (ASICs). Implementation of the hardware state machine so as to perform the functions described herein will be apparent to persons skilled in the relevant art(s).
In yet another embodiment, the invention is implemented using a combination of both hardware and software.
Methods and systems for manufacturing a swallowable sensor device have been presented. Example embodiments described above relate to a human subject. This is for illustrative purposes, and not limitation. Embodiments of the present invention are applicable to other types of animals, including livestock (cattle, sheep, pigs, chickens, turkeys, ostriches, etc.), pets (e.g., dogs, cats, horses, etc.), and other animals of interest such as race horses or other performance/sport animals. Such applicability to these types of animals, and other types, will be apparent to persons skilled in the relevant art(s) from the teachings herein, and is within the scope and spirit of embodiments of the present invention.
Furthermore, example embodiments described above relate to passing a swallowable sensor device through a gastrointestinal tract, for illustrative purposes. However, embodiments of the present invention are applicable to farther bodily systems other than the gastrointestinal tract, including the circulatory system, the urinary tract, and other bodily systems and additionally other means of entry or implant into a body cavity of an animal or human. Such applicability to other types of bodily systems will be apparent to persons skilled in the relevant art(s) from the teachings herein, and is within the scope and spirit of embodiments of the present invention.
In addition, it should be understood that spatial descriptions (e.g., “above,” “below,” “up,” “left,” “right,” “down,” “top,” “bottom,” “vertical,” “horizontal,” etc.) used herein are for purposes of illustration only, and that practical implementations of the structures described herein can be spatially arranged in any orientation or manner.
Moreover, it is to be appreciated that the Detailed Description section, and not the Abstract section, is intended to be used to interpret the claims. The Abstract section may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, is not intended to limit the present invention and the appended claims in any way.
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7978064||Jul 12, 2011||Proteus Biomedical, Inc.||Communication system with partial power source|
|US8617058 *||Jul 9, 2009||Dec 31, 2013||Innurvation, Inc.||Displaying image data from a scanner capsule|
|US8674825||Mar 13, 2009||Mar 18, 2014||Proteus Digital Health, Inc.||Pharma-informatics system|
|US8718193||Nov 19, 2007||May 6, 2014||Proteus Digital Health, Inc.||Active signal processing personal health signal receivers|
|US8721540 *||Nov 18, 2010||May 13, 2014||Proteus Digital Health, Inc.||Ingestible circuitry|
|US8730031||Jul 11, 2011||May 20, 2014||Proteus Digital Health, Inc.||Communication system using an implantable device|
|US8802183||Jul 11, 2011||Aug 12, 2014||Proteus Digital Health, Inc.||Communication system with enhanced partial power source and method of manufacturing same|
|US8816847||Jun 3, 2011||Aug 26, 2014||Proteus Digital Health, Inc.||Communication system with partial power source|
|US8836513||Jul 11, 2011||Sep 16, 2014||Proteus Digital Health, Inc.||Communication system incorporated in an ingestible product|
|US8868453||Nov 4, 2010||Oct 21, 2014||Proteus Digital Health, Inc.||System for supply chain management|
|US8869390 *||Feb 29, 2012||Oct 28, 2014||Innurvation, Inc.||System and method for manufacturing a swallowable sensor device|
|US8912908||Jul 11, 2011||Dec 16, 2014||Proteus Digital Health, Inc.||Communication system with remote activation|
|US8945005||Oct 25, 2007||Feb 3, 2015||Proteus Digital Health, Inc.||Controlled activation ingestible identifier|
|US8956287||May 2, 2007||Feb 17, 2015||Proteus Digital Health, Inc.||Patient customized therapeutic regimens|
|US9014779||Jan 28, 2011||Apr 21, 2015||Proteus Digital Health, Inc.||Data gathering system|
|US9060708||Jul 25, 2014||Jun 23, 2015||Proteus Digital Health, Inc.||Multi-mode communication ingestible event markers and systems, and methods of using the same|
|US9078580||Nov 6, 2013||Jul 14, 2015||Innurvation, Inc.||Displaying image data from a scanner capsule|
|US9083589||Mar 6, 2014||Jul 14, 2015||Proteus Digital Health, Inc.||Active signal processing personal health signal receivers|
|US9107806||Nov 18, 2011||Aug 18, 2015||Proteus Digital Health, Inc.||Ingestible device with pharmaceutical product|
|US20110004059 *||Jan 6, 2011||Innurvation, Inc.||Displaying Image Data From A Scanner Capsule|
|US20110065983 *||Nov 18, 2010||Mar 17, 2011||Hooman Hafezi||Ingestible Circuitry|
|US20120153981 *||Feb 29, 2012||Jun 21, 2012||Innurvation, Inc.||System and Method for Manufacturing a Swallowable Sensor Device|
|US20130261410 *||Mar 28, 2012||Oct 3, 2013||Larger Reality Technologies LLC||System and Method for Body and In-Vivo Device, Motion and Orientation Sensing and Analysis|
|US20140375428 *||Sep 4, 2014||Dec 25, 2014||Fitbit, Inc.||Near Field Communication System, and Method of Operating Same|
|U.S. Classification||600/373, 29/829, 340/870.01, 206/305|
|International Classification||H05K3/00, B65D85/38, G08C19/16, A61B5/04|
|Cooperative Classification||A61B1/0011, H05K3/36, A61B5/073, Y10T29/49126, Y10T29/5313, Y10T29/53022, Y10T29/49146, Y10T29/49117, Y10T29/4913, Y10T29/49004, Y10T29/49002, Y10T29/49124, A61B5/07, H05K1/144, A61B1/041|
|Jan 24, 2008||AS||Assignment|
Owner name: INNURVATION, INC., MARYLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ARNESON, MICHAEL R.;BANDY, WILLIAM R.;DAVENPORT, ROGER A.;AND OTHERS;REEL/FRAME:020407/0870
Effective date: 20071206