In vivo imaging device and method of manufacture thereof

Field of invention The present invention generally relates to in-vivo imaging devices, and in particular to in-vivo imaging devices having a spherical, oval, elliptical or similar shape.

Background of the invention Devices and methods for in vivo imaging of passages or cavities in the body are known in the art. Such devices may include, among other things, various endoscopic imaging systems and devices for performing imaging in various internal body cavities. Some of these devices use wireless connections to transmit image data.

Several factors have limited the extent to which the size of the imaging device can be reduced. The first factor may be the size of the circuit connected to the imaging sensor portion of the imaging device. The second factor can be the cumulative width of some of the components of the imaging device. Another factor that reduces the size of the imager or limits the use of space can be the size of the antenna for transmitting (and / or receiving) data such as image data.

The size of the imaging device available for small openings in the lumen of many bodies can be limited. The reduced size of the imaging device allows greater access to the body's lumen at narrower or restricted access points. Further, other components can be included by reducing the space occupied by the components of the imaging apparatus.

When an in-vivo imager images a relatively large lumen, it may be desirable for the imager to provide a stable image stream of one wall of the lumen. When some imaging devices move across the surface of such a cavity, they roll, for example, to produce a swaying motion or a discontinuous image. Some imaging devices cannot provide a relatively stable view of such a lumen and cannot easily turn to a portion of such a lumen that should be imaged.

<p> Outline of the invention In one embodiment of the invention, the in vivo imaging device can have an elliptical, spherical or substantially spherical shape. In another embodiment, the imaging device may include a support supporting the image sensor, a lighting source, an antenna on the first surface of the support, and a transmitter and battery support on the second surface of the support. The antenna may be combined with or attached to other elements of the in-vivo imaging device to reduce the amount of space it occupies.</p><p> The invention will be described by way of example with reference to the accompanying drawings in which similar components are designated with similar reference numbers.</p><p> It is understood that the elements shown in the drawings are not necessarily drawn to the same scale for the sake of clarity and brevity. For example, some dimensions of an element may be exaggerated relative to other elements for clarity. In addition, reference numbers may be repeated between drawings to indicate corresponding or similar elements, as deemed appropriate.</p>

Detailed description of the invention In the following detailed description, a number of specific details will be given to fully understand the invention. However, those skilled in the art will appreciate that the invention can be realized without these specific details. In some cases, well-known methods, procedures, components and circuits are not described in detail to avoid obscuring the invention.

An embodiment of the apparatus and system of the present invention may, of course, image other suitable parts of the body, but for example, particularly the stomach or other large lumen (eg, the large intestine). It may include an imaging device suitable for this purpose, for example, which may be a capsule. For such applications, for example, high resolution may not be required, but for example, a wide field of view may need to be imaged. In some embodiments, the entire organ may be imaged, for example, to diagnose the presence of a suspected lesion. This may be the case if the details of the lesion are less important than its presence. The imaging apparatus according to some examples can be used for other suitable purposes other than the diagnosis of lesions. Of course, high resolution imaging devices can be used in the embodiments of the present invention, but the embodiments of the present invention can also be used in other applications. Examples of the present invention make it possible to reduce, for example, the size and / or components of an in vivo imaging device.

Various embodiments of the present invention, incorporated herein by reference, are assigned to the same assignee as the present invention, published September 13, 2001, "Devices and Systems for In vivo Imaging (In vivo Imaging Devices and Systems). A Device And System For In Vivo Imaging), the same invention as in some examples of International Application Publication No. WO 01/65995, and / or hereby incorporated by reference in its entirety. It can be incorporated into or used with an imaging device similar to the embodiment described in US Pat. No. 5,604,531 to Iddan et al., Which has been assigned to the assignee. In other embodiments, the embodiments of the invention can be incorporated into or used with other imaging capsules or devices having other structures.

FIG. 1A is a schematic view of an in-vivo imaging device according to an embodiment of the present invention. FIG. 1B is a perspective view of an in- vivo imaging device according to an embodiment of the present invention . With reference to FIGS. 1A and 1B, in an exemplary embodiment, the device 40 is swallowable capable of capturing images and other data, for example, from the lumen of the body, typically the GI (gastrointestinal) tract. It may be a device. Other body cavities can also be examined by means other than swallowing, such as insertion with suitable tools such as endoscopes, catheters, implants, and the like. According to one embodiment, the generally transparent dome 52 provides a generally transparent cover for the optics, provides a sealed barrier to body fluids, and may perform other functions (retention of the optics). Such). The outer shell or container 53 may provide a container for the components. In one embodiment, the outer shell or container 53 provides the overall shape for a device, such as substantially spherical. Alternatively, other components may provide the shape. The upper portion 70 may be separated from the lower portion 72 by, for example, a support 80. In alternative embodiments, such separation may not be performed. As used herein, the terms above and below are relative terms and are interchangeable depending on the context. These parts do not have to divide the device evenly. The outer shell or container may be uniform or may have multiple components. For example, a portion of the outer shell may be a transparent optical window or dome, or the outer shell may be made of multiple components.

Typically, the outer shape of the device 40 (formed from the dome 52 and the outer shell 53 in the illustrated embodiment, but may be formed from other components) is oval, spherical or substantially spherical. It may be. As used herein, "spherical or substantially spherical" can be defined as a geometry having a diameter r and a longitudinal axis L, where r L 1.5 r. L = 1. At 5r, the shape can be oval and can also be considered an ellipse. In one embodiment, r can be about 11.4 mm, however, other dimensions may be used. It should be noted that when the device 40 can be rotated about an axis, the various cross sections of the device 40 can be different. For example, device 40 may be a somewhat irregular sphere or oval. The shape of the device 40 may differ when viewed from different angles.

Typically, the device 40 may include at least one sensor (and other sensors such as a temperature sensor, pH sensor, pressure sensor, etc.) such as an image sensor 46 for capturing an image. Even if you use a set of illumination sources 41 (the set can contain one item), for example a set of LEDs such as white LEDs (other suitable elements are also available) to illuminate the area to be viewed. Good.

The optical system may be, for example, one or more lenses or composite lens assemblies 50, one or more suitable optical filters (not shown), or other suitable optical elements (not shown). A plurality of optical elements may be included, and the reflected light can be focused on the image sensor 46 to assist in processing other light. The lens 50 may be attached to the optical resolution element 170. Separator 170 optically partially separates sections of the device from each other, for example, by preventing light from the illumination source from reaching the imaging system directly against reflections from the object being imaged. Or it can help to separate overall. Other systems or methods for positioning the lens may be used. In one embodiment, the field of view may be 80 to 90 degrees and may use a 140 degree field of view or another suitable field of view, such as a field of view in the 80 to 140 degree range. The focal length can typically be between 0 mm and 40 mm, but other suitable distances may be used.

The device 40 may have components similar to, for example, the components of the examples described in US Pat. Nos. 5,604,531 and / or WO 01/65995 described above. However, the device 40 may be any type of in vivo sensor device and may have other components and configurations. For example, the device 40 or the components of the device 40 may be included in the endoscope.

The device 40 may typically include a transmitter 54 for transmitting images and other (eg, non-image) information to the receiver, eg, a compression module for compressing data (not shown). ) And other components may be included. The transmitter 54 may typically be an ultra-low power radio frequency (RF) transmitter with high bandwidth inputs that can be provided in chip-scale packaging. The transmitter 54 may include circuits and functionality for controlling device 40. The transmitter 54 is, for example, an ASIC, a "computer on a chip". It may be on a chip) , a microcontroller, or other component. The transmitter 54 is, in one embodiment, a general purpose integrated device that may include, for example, transmitter and / or receiver capabilities, a controller, a driver for a luminaire, and various analog and / or digital elements. May be good.

Components such as the image sensor 46, the illumination source 41, the optical resolution element 170, and the transmitter 54 may be mounted on the support 80, which may be, for example, a printed circuit board (PCB) or a plastic board or sheet. You may. The support 80 may be in a different configuration or substrate, may be made of other materials, and the components need not be attached to another support.

In one embodiment, the image sensor 46, the illumination source 41 and the transmitter 54 and / or other components may be attached to the support 80 to minimize the amount of space occupied by such components. Good. FIG. 2A shows the top surface of the support of the imaging device according to the embodiment of the present invention. It is a figure. FIG. 2B is a bottom view of a support for an imaging device according to an embodiment of the present invention. As used herein, top and bottom are relative terms and may be interchangeable depending on the context.

7A and 7B are alternative diagrams of support 80 according to an embodiment of the present invention. Referring to FIGS. 7A and 7B, the support 80 includes an image sensor 46, one or more illumination sources 41, an antenna 48, an optical resolution element 170 (shown in FIGS. 1A and 1B), etc. on one surface. Other components may be attached. The example shown in FIG. 7A shows eight illumination sources. Other suitable numbers of illumination sources may be used. On another side, the support 80 is fitted with a transmitter 54, a battery support 60 for holding a power source 45 (which could be a battery in one embodiment), and other components. In another embodiment, the battery support may be a component that provides battery contact to power one or more components within device 40. Other sets of components may be included on various sides of the support or board.

With reference to FIG. 1A again, the image sensor 46, one or more illumination sources 41, and the antenna 48 (through which the transmitter 54 can transmit) are located on the top or top of the support, the transmitter 54. May be located on the bottom side or bottom of the support 80. The various components may be electrically communicated, for example, through wires or electrical contacts (not shown) on the support 80 that can intersect from one side of the support 80 to the other by holes or passages.

The various components of the device 40, as well as other components, may be positioned on the support 80 in different ways. For example, the transmitter 54 and the illumination source 41 may be located on the same side. The one or more illumination sources 41 may be arranged in different ways. In alternative embodiments, the various components of device 40 need not be mounted or configured on a support or circuit board as illustrated herein.

In one embodiment of the invention, the sections of the imaging device may be optically separated from each other. One or more optical separation elements 170 are used to optically separate sections of the device, for example, to prevent light scattering from the illumination source 41 from reaching the image sensor 46, and to combine the image sensor section 180 into one. It may be separated from one or more lighting sections 190.

In general, the illumination section includes an area that includes at least the illumination element, and the imaging section includes an area that includes at least one or more imaging devices. However, the illumination section may include other additional components and areas, and the imaging section may include other additional components and areas. Further, each of the illumination section and the imaging section may be divided into two or more discontinuous sections, and may have a configuration different from that shown in the illustration. The illumination portion may include a suitable illumination source such as an LED or a white LED, and other illumination sources may be used.

In some embodiments, the antenna 48 may be configured to occupy minimal space within the device 40. For example, the antenna 48 may be combined with another element, such as a support, embedded therein, substantially therein, or mounted therein so as not to occupy a large amount of space. Antenna 48 may be enclosed or contained within components such as supports, isolation or isolation elements.

In one embodiment, the antenna 48 is positioned or mounted within the surface of the optical resolution element 170. In the embodiment shown in FIG. 1A, the antenna 48 is, for example, placed between two sections of the separating element 170 or molded within the separating element 170. Alternatively, by being embedded, it may be wound around in the separating element 170, or it may be embedded within or substantially inside it (part of it may extend outward). FIG. 3A shows an optical resolution element 170 and an antenna 48 according to an embodiment. FIG. 3B is a cutaway view showing the optical resolution element 170 and the antenna 48 according to the embodiment. FIG. 3C shows the antenna 48 according to one embodiment. Referring to FIG. 3A, the optical resolution element 170 may be conical in one embodiment, and the antenna 48 may be wound around the outside of the optical resolution element 170. With reference to FIG. 3b, the antenna 48 may be wound around the inside of the separating element 170. The antenna 48 need not be positioned within or above the optical element 170, and the separating element 170 need not be included. The optical resolution element 170 may have other suitable shapes (eg, FIG. 5). In alternative embodiments, other suitable number of optical resolution elements with different shapes may be used. An optical resolution element is, for example, an extension of a component of a device such as a light source or image sensor, a piece integrated with or extending from a dome or lens, a translucent or translucent member. It may be in any suitable form.

In another embodiment, the antenna 48 may be attached to the support 80. For example, the antenna 48 may be mounted flat over the surface of the support 80 (Figure 2A). In Figure 2A, the antenna 48 is located around the support 80. Alternatively, the antenna 48 may be arranged on the support 80 in a different manner or pattern. For example, the antenna 48 may be embedded within the support 80 or substantially embedded within the support 80.

The transmitter 54 may be connected to the antenna 48, for example, by a wire or connection (not shown) on the support 80, or through the support 80 (in this case, for example, the antenna 48 and the transmitter 54 are on the opposite side of the support 80). Can be in). In alternative embodiments, the antenna does not have to be configured to occupy a small amount of space.

With reference to FIG. 1A again, the device typically includes a power source 45, such as one or more batteries. For example, the power source 45 may include a silver oxide battery, a lithium battery, or another electrochemical cell having a high energy density. Other suitable power sources may be used. Introducing power from an external source may be used.

In one embodiment, the location vs. geometric center of the center of gravity (cg) of the device 40 is due to the stability of the optical axis of the device 40 when the device 40 enters a cavity larger than its own size. Can be important to One or more weights or ballasts 74 may be included in a portion of device 40, such as the bottom of lower portion 72 (bottom and top are relative terms and are interchangeable in context). The weight 74 may be included in other parts of the device 40. The weight or ballast may take the form of other functional components of the device, for example the battery may be positioned to alter the weight or mass balance of the device. Counterweights or other elements that can reduce specific gravity may be included, for example, gas may be included in a portion of the device to change the distribution of specific gravity or weight. The weight 74 may be arranged to hold substantially one orientation while the device 40 traverses the GI tube, or to return to that orientation when moved from that orientation. The center of gravity may typically be opposite to the direction of the field of view. In other embodiments, the weight may be included in a portion of the device 40, eg, to balance an existing weight, and, for example, to center the center of gravity in the geometric center of the device. In one embodiment of the invention, the device 40 may be configured not to hold a particular orientation.

Other components and sets of components may be used. For example, the power source may be an external power source that transmits power to the device, or a controller other than the transmitter 54 may be used.

In one embodiment, the image sensor 46 may be a complementary metal oxide semiconductor (CMOS) image sensor. CMOS image sensors are typically ultra-low power image sensors and may be provided in chip-scale packaging (CSP). One suitable CMOS camera can be, for example, a "camera on a chip" CMOS image sensor. Other types of CMOS image sensors may be used. In another embodiment, other suitable image sensors such as CCD image sensors, or other suitable image sensors may be used. Typically, the image sensor may have a square shape (eg, a 256x256 CMOS array). Elements of other dimensions, eg 512x512, may be used. For example, other shapes such as rectangles, or other suitable shapes may be used.

The in-vivo imaging device 40 may transmit the image or other information to the receiver system, and the image and other information may be displayed on the display system. In one embodiment, a receiving and displaying system as described in WO 01/65995 and / or US Pat. No. 5,604,531 examples described above may be used. In alternative embodiments, other receiving or displaying systems with other configurations may be used.

FIG. 4 shows an element of an imaging system according to an embodiment of the present invention. With reference to FIG. 4, the receiver 12 is preferably located at one or more locations outside the patient's body and is an antenna or array of antennas 15, images and other for receiving images and other data from device 40. It is preferred to include a receiver storage unit 16 for storing data, a data processor 14, a data processor storage unit 19, and an image monitor 18 for displaying images transmitted by device 40 and recorded by receiver 12 in particular. Typically, the receiver 12 and receiver storage unit 16 are small and portable and can be worn on the patient's body during image recording. Typically, the data processor 14, the data processor storage unit 19 and the monitor 18 may be part of a personal computer or workstation, which is the processor 13, memory (eg, storage 19 or other memory). , Disk drive (not shown), I / O device (not shown), and other standard components, but alternative configurations are possible.

In alternative embodiments, the data reception and storage components may have different configurations. It should be emphasized that other embodiments may include wired devices rather than wireless devices. In such cases, certain elements shown in FIGS. 1A and 4, such as transmitter 54, antenna 48, antenna array 15 and receiver 12, may be omitted.

Typically, the device 40 may be swallowable by the patient, eg, across the patient's GI tract, however, other body cavities or cavities may be imaged or examined. The device need not be swallowable. Typically, the device 40 may transmit information (eg, image information) in separate parts. Each part typically corresponds to, for example, an image or frame. Other suitable transmission methods are also possible. For example, device 40 may capture an image or other information once every half second, capture such an image, and then transmit, for example, that information to a receiving antenna. Other capture speeds are also possible. Typically, the image data recorded and transmitted can be digital color image data, but in alternative embodiments, other image formats (eg, black and white image data) may be used. In one embodiment, each frame of image data may contain 256 rows, each of which is 256 pixels, and each pixel contains data for color and brightness by known methods. For example, in each pixel, the color is represented by a mosaic of four subpixels, and each subpixel corresponds to a primary color such as red, green, or blue (one primary color can be represented twice). The overall pixel brightness can be recorded, for example, by a brightness value of 1 byte (ie 0-255). Other data formats may be used and other image formats may be used.

FIG. 5A is a side view of the optical resolution element according to an embodiment of the present invention. FIG. 5B is a top view of the optical resolution element according to an embodiment of the present invention. With reference to FIGS. 5A and 5B, the optical resolution element 170 may be a relatively flat ring or cone of one of plastics, polymers, or other suitable materials. For example, ABS (acrylic nitrile butadiene styrene) may be used. The separating element 170 may have other shapes, for example, the conical shape shown in FIG. 3, or may be made of other suitable materials (including two or more materials), and may have a plurality of shapes. It may be composed of one piece. The antenna (FIG. 1A) may be included in or on the separating element 170. For example, the antenna may be molded within the material of the separating element 170, or it may be mounted on the surface of the separating element 170 (eg, inner surface 171 or outer surface 172).

In FIG. 1A, the separating element 170 is shown, for example, as a single ring shown in cross section, but may have other suitable shapes. The optical resolution element 170 may be, for example, an opaque or transparent barrier, a shading device, an optical filter, a series of separate barriers, or other suitable structures.

The separating element 170 may be attached to the device 40 by, for example, gluing, acoustic welding, friction fitting, may be held by other assembled components, or by other methods. The separating element 170 may be part of an extending portion of another element, such as a supporting surface such as a support 80. The separating element 170 may, for example, separate the illumination section 190 and the imaging section 180, which in FIG. 1A may generally be, for example, within the illumination section 190. In the illustrated embodiment, the imaging section 180 may be round and the lighting section 190 may be ring-shaped or substantially ring-shaped.

Examples of the device can typically be autonomous and typically self-contained. For example, the device may be a capsule or other unit, with substantially all components contained within a container or shell, and the device may be, for example, a wire or cable to receive power or transmit information. Does not need. The device may communicate with an external reception and display system to provide data display, control or other functions. For example, power may be provided by an internal battery or a wireless receiving system. Other embodiments may have other configurations and capabilities. For example, the components may be distributed across multiple locations or units. Control information may be received from an external source.

In one embodiment, the imaging device may be spherical or substantially spherical (including an oval as used herein). Such a shape allows the device to slide or roll on a typically moist surface of a body cavity such as the stomach. In addition, the spherical device can slide or roll on the ridges formed on the lumen wall (gastrointestinal wall) of the GI (gastrointestinal) tract and does not stick within or on these ridges. In such cases, the movement of the image sensor in the device can be relatively smooth and continuous. This can be in contrast to other shaped (eg, oblong) devices that can produce swaying motions and discontinuous images in the same situation, for example when rolling over a surface.

Any ballast or weight can usually point a portion, such as the image sensor 46, upwards. In such an embodiment, the captured image may include a field of view directed outward from that wall rather than that of a wall where the device could be if it is on the surface of the lumen. In a relatively large lumen (eg, stomach or large intestine), when the patient is directed in some way to act on the ballast or weight, the wall opposite to the wall on which the device can be imaged is imaged. Walls close to the device that can block the field of view are not imaged. Such an embodiment can provide a relatively stable field of view of the lumen and is preferably imaged. Can be easily pointed at the part of.

FIG. 6 shows a device 40 in a patient's stomach 200 according to an embodiment of the invention. Referring to FIG. 6, if a weight or ballast 74 may be included in the device 40, the device 40 may be oriented such that the image sensor 46 (FIG. 1A) is generally directed upwards. Thus, assuming the stomach 200 is oriented such that the top 200 is above the bottom 200 , the image sensor 46 can capture the image in the direction indicated by a, for example, indicated by b. The orientation generally does not capture the image.

In an embodiment in which the device images one wall of the lumen from a "distant wall", the illumination source typically outputs sufficient light to allow the distant wall to be properly illuminated. Various methods may be used to change the amount of light output by the lighting unit in response to detection of the amount of light required by the imaging device or the amount of light received thereby. Examples of devices and methods for altering the light output from the imaging device are hereby incorporated by reference in their entirety and transferred to the same assignee as this invention, internationally filed on July 26, 2002. Explained in Application No. PCT / IL02 / 00622. The antennas described herein in the various embodiments need not be used, for example, in devices that are substantially spherical or have a certain shape. For example, such an antenna may be used in an oblong device. Similarly, a circuit board or set of circuit boards as described herein in various embodiments need not be used in devices that are substantially spherical or have a certain shape. For example, such a configuration may be used in an oblong device. Further, the imaging apparatus according to an embodiment of the present invention having a spherical or substantially spherical shape need not include an antenna as described herein, or a circuit board or internal configuration as described herein.

According to an embodiment of the present invention, there is provided a method of manufacturing a substantially spherical in-vivo imaging apparatus. According to one embodiment, the method may include attaching the image sensor and transmitter to one support and sealing the support in a substantially spherical housing. According to some embodiments, the image sensor and transmitter may be mounted on two sides of the support, typically opposite sides. The support and / or housing according to the embodiments of the present invention may be, for example, as described above.

FIG. 8 shows a set of steps in a method for manufacturing an imaging apparatus according to an embodiment of the present invention. Referring to FIG. 8, in step 100, the image sensor and transmitter are mounted on one support. In alternative embodiments, additional components may be attached to the support and the composition of the various components may vary. For example, the antenna may be mounted on a different side or side of the support than the transmitter. In yet another embodiment, the configuration of other components is realized, for example, the image sensor and transmitter do not have to be mounted on the same support.

At step 110, the support may be enclosed or sealed in a substantially spherical housing. Other components may be included, for example ballasts or other weights may be included within the housing.

Other steps or a series of steps may be used.

Having described the invention with respect to a limited number of examples, it will be appreciated that many modifications, modifications and other applications are possible within the scope and spirit of the invention.

<figref num="1A">It is the schematic of the in-vivo imaging apparatus according to one Example of this invention.</figref><figref num="1B">It is a perspective view of the in-vivo imaging apparatus according to one Example of this invention.</figref><figref num="2A">It is a top view of the support of the imaging apparatus according to a certain embodiment of this invention.</figref><figref num="2B">It is a bottom view of the support of the imaging apparatus according to an embodiment of this invention.</figref><figref num="3A">It is a figure of the optical resolution element and the antenna by one Example of this invention.</figref><figref num="3B">It is a figure of the optical resolution element and the antenna by one Example of this invention.</figref><figref num="3C">It is a figure of the optical resolution element and the antenna by one Example of this invention.</figref><figref num="4">It is a figure of the element of the imaging system according to one Example of this invention.</figref><figref num="5A">It is a side view of the optical resolution element according to one Example of this invention.</figref><figref num="5B">It is a top view of the optical resolution element according to one Example of this invention.</figref><figref num="6">It is a figure of the device in the stomach of a patient according to one embodiment of the present invention.</figref><figref num="7A">It is a top view of the support of the imaging apparatus according to a certain embodiment of this invention.</figref><figref num="7B">It is a bottom view of the support of the imaging apparatus according to an embodiment of this invention.</figref><figref num="8">FIG. 5 is a set of steps of a method for manufacturing an imaging apparatus according to an embodiment of the present invention.</figref>