1. Field of the Invention
The present invention relates to a video endoscopy device, e.g. those for depicting the interior walls of the cardiovascular system or those suitable for being used within the cardiovascular system.
2. Description of Prior Art
Even though for a few years, calls have been made for an extremely miniaturized, high-resolution endoscopy-suitable and, in particular, “blood-penetrating” camera on the part of the medical world with high priority, significant technological development steps are required for implementation, these steps still being utopian up until recently. So far, all over the world no one has yet succeeded in developing a diagnostic device which may image, through the blood, the vascular walls of the cardiovascular system with sufficiently high resolution. Since Bozzini developed the first endoscope in 1806, optical technology has made much progress and has been specialized for various applications for inspecting manifold body orifices and organs. Classical fiber endoscopy is being replaced increasingly by modern video endoscopy, since the latter guarantees considerably improved image resolution and quality. However, when used within blood vessels, both technologies have failed due to the scattering of light at the hemoglobin molecules, similar to the fact that visibility in fog is severely restricted depending on the density and size of drops. The medium of blood actually exhibits an optically opaque behavior due to the Mie scattering at the erythrocytes and/or due to the high level of absorption of the water molecules. Blood becomes sufficiently transparent for radiation within near infrared (NIR) in the range from 1.5 to 1.8 μm, as well as in the range from 2.1 to 2.3 μm, so that the use of a miniaturized NIR camera provides insights into the vascular system which has so far been detectable only with weak outlines.
With the conventional realization for representing the cardiovascular system, essentially four different methods are currently employed.
With the ultrasonic methods, both the movement of the heart may be observed and the artery and vein systems may be represented by means of a method of the Doppler technique, which is referred to as the duplex method. However, since this method actually serves for flow metering, the image resolution cannot meet the demands made by a cardiosurgeon.
In computer tomography, the activity distribution of various body layers is detected in a two-dimensional manner using emission computer tomography (ECT) following an injection of a radiopharmaceutical agent. Indeed, the concentration of TC or I within the vasculature system allows a representation of the arteries and veins, but pronounced instances of inhomogeneity and dissymmetry lead to major artifacts (misrepresentations), such as due to lung or mamma absorption in heart examinations. Due to the artifacts, the image quality of this imaging method is not adequate for heart surgery. In addition, the above-mentioned method also fails in terms of representing moving pictures.
In magnet resonance tomography, (electrocardiogram-triggered) phase contrast angiography allows a rough representation of the vascular system, but not in real time, and is part of clinical routine.
At the moment, the technology of modified balloon catheters is still being discussed and tested, however without any prospects of a sweeping success: with this method, a balloon catheter is introduced into the cardiovascular system and is pushed, by the doctor performing treatment, through the veins and on to the location of examination before the balloon catheter is blown up there by means of Ringer's solution. The transparent envelope of the balloon presses directly against the vascular wall in the process, so that an optical system integrated into the balloon can image the structure of the wall. The disadvantages of this method are complete vascular obstruction, on the one hand, and the high pressure load on the vessels, on the other hand.
From the technical point of view, classical fiber endoscopy is optimized with regard to narrow diameters in that quartz fibers having diameters of 2.8 μm are employed as light-conducting fibers. Even though very small pixels can be realized in this manner, the method exhibits several disadvantages due to the high light losses within the visible range and due to the small numerical aperture. Even though the examination location is highly illuminated, this method will only provide images of low brightness, especially as the transmission within the infrared region deteriorates as compared to the visible region.
U.S. Pat. No. 6,178,346 describes and infrared fiber endoscopy method which is registered under the trademark of Transblood Vision in the US. Due to Mie scattering at the enthrocytes and/or due to the high level of absorption of the water molecules, blood is actually opaque. The method proposed in U.S. Pat. No. 6,178,346, however, circumvents the problems by specifically selecting the infrared wavelength. In the method, radiation generated by a laser diode is coupled into a light-conducting fiber of the endoscope by means of a beam splitter, the location of examination being illuminated as a result. The light reflected from the examination location is in turn passed on to an external camera sensor via the proximal end of the catheter via the beam splitter. An advantage of the approach suggested there is the considerable level of attenuation of the optical signal containing the image-providing information, and thus the limitation of the achievable brightness of the object.
It is the object of the invention to provide a video endoscope device which enables improved image quality, such as for pre-, intra-, and post-operative observations at and/or within organs and vessels in an actual, i.e. blood-filled, environment.
The present invention provides a video endoscopy device including:
a sensor device; and
a catheter for outputting radiation at a distal end of the catheter, and for receiving reflected radiation at the distal end, and imaging same onto the sensor device,
the sensor device being arranged, within the catheter, in the vicinity of the distal end of the catheter, and is configured to convert the radiation reflected into an electric signal, and the catheter being configured to route the electric signal to a proximal end of the catheter.
An inventive video endoscopy device includes an (image) sensor device and a catheter for routing radiation to a distal end of the catheter and for outputting same at the distal end of the catheter, and for receiving reflected radiation at the distal end and imaging same onto the sensor device. The sensor device is arranged, within the catheter, near the distal end of the catheter, and is configured to convert the reflected radiation into an electric signal. The catheter is configured to route the electric signal to a proximal end of the catheter.
The core idea on which the invention is based is to illuminate an object to be examined by means of radiation transmitted, for example, by a light-conducting fiber, while the backscatter radiation is detected by a sensor arranged within the catheter tip so as to convert the image of the object into an electric signal which may be supplied to an external image processing device via, for example, a cable or line connection. In this manner, image transmission by means of optical-fiber cables may be dispensed with, and as a consequence, the negative impacts on the image quality due to the optical attenuation of the signal, in particular on the way back from the catheter tip to the external unit, may be avoided.
These and other objects and features of the present invention will become clear from the following description taken in conjunction with the accompanying drawing, in which:
The movable part 20 forms a movable catheter arrangement. In particular, it comprises a catheter 40 which contains optics 42 for illuminating an object 44 to be examined, such as the vascular wall of a blood vessel, an optical system 46 for imaging the illuminated object 44 onto a photodetector array, also arranged within catheter 40, as a sensor 48, a pre-processing circuit and/or sensor electronics 50 and, optionally, further sensor elements 52. Sensor electronics 50 preferably consist of a sensor drive, a readout circuit, and an image pre-processing unit.
The static part 30 essentially forms the external apparatus of video endoscopy device 10. It comprises a radiation source 60, an image and signal processing means 62, a display unit and/or a monitor 64 and a memory 66.
Catheter 40 may be coupled, at a proximal end 67 of same, to the external apparatus 30, such as via a releasable or permanent plug connection. The interface between catheter 40 and external apparatus 30 is indicted at 68 in
A radiation router 70, such as a plurality of monomode fibers, as will be explained later on, by way of example, with reference to
An electrical connection system 78 is located between sensor 48 and electronics 50 and serves to electrically connect them and/or to pass on the pixel measurement values to subsequent circuit 50. An electrical conductor 80, such as one or a plurality of cables, extends between circuit 50 and proximal end 67 of catheter 40 so as to pass on pre-processed image data obtained by circuit 50 from the pixel measurement values to image processing 62 via interface 68 in the coupled state of catheter 40. The data is thus handed over to a hardware, here image processing 62, which is external to catheter 40, via a defined interface. A further electrical conductor 82, such as one or a plurality of cables, is arranged between the optional further sensor elements 52 and image and/or signal processing 62, and/or extends therebetween, so as to pass on measurement data of sensor elements 52 to processing means 62.
As will become more obvious later on with reference to
Within the external apparatus 30, image processing 62 is connected to interface 68 for coupling proximal end 67 of catheter 40 so as to obtain, in the coupled state of catheter 40, the pre-processed data via cable 80 from pre-processing means 50, and to obtain the sensor measurement data from the optional sensors 52 via cable 82. An output of processing means 62 is connected to the input of monitor 64 so as to be able to display the image of object 44, which has been obtained within photodetector array 48, to the user of device 10 as well as to be able to display, as the case may be, current measurements results of the additional sensors 52. In addition, the output of processing means 62 is connected to memory 66 so as to be able to archive the data obtained from pre-processing means 50 and sensor elements 52, such as, for example, for subsequent evaluation of the data.
Infrared diode 60 is also connected—this time, however, in an optical manner—to interface 68 so as to be able to couple light into radiation router 70 of catheter 40 via interface 68 as soon as same is coupled to apparatus 30.
Having given the above description of the architecture of device 10, its mode of operation will be briefly described below.
In order to illuminate the examination location 44, radiation is generated externally to light source 60, which, by way of example, shall be an infrared diode below. This irradiation is then transported though catheter 40 via light conductor 70 or, in the case of the embodiment of
It is possible for the physician to obtain, via further sensor elements 52, further information about the examination location 44, such as blood flow performed by a flow meter, temperature measurement performed by a temperature sensor, or the like. These measurement values may then be used for further diagnostics and control. It shall be noted that it is possible for the physician to perform, as the case may be, adjustments to pre-processing means 70 or photodetector array 48, such as an alteration of the resolution with simultaneous corresponding alteration of the image repetition rate or the like, via an input device not shown in
Having described an embodiment of the present invention in rather general terms above with reference to
The catheter tip 100 of
Lenses 108a and 108b are arranged at distal end 69 as a termination of the catheter in a manner such that they are axially symmetrical to longitudinal axis 106, lenses 108a and 108b forming the optical system 46 of the catheter. They are attached to the inside of sheath 102 via annular fixtures 110. It is through these fixtures 110 that monomode fibers 104 extend to be able to output their light at distal end 69. As the case may be, elements for beam expansion are provided within the fixtures 110 per monomode fiber 104. Alternatively, the terminal ends of monomode fibers 104 form optics 42 of
The catheter tip of
With reference to
Using flip-chip bonding as an example of a method of structural design and coupling technology, the photodiode array 112 thus formed is disposed onto a semiconductor chip, such as a CMOS chip 114, which has the pre-processing means 50 integrated therein. Photodiode array 112 and chip 114 are connected to each other such that the main side of the semiconductor substrate within which the photodiode array 112 is formed faces the semiconductor chip 114 with that main side within which the photodiode array 112 is formed, i.e. with the side facing away from the main side 204, or with that main side which is facing away from the distal end. Semiconductor chip 114, in turn, is connected to photodiode array 112 such that it faces same with that main side of the chip within which the circuit which forms the drive, readout, and pre-processing electronics 50 is integrated.
A specific configuration of a video endoscope in accordance with all of the previous embodiments of FIGS. 1 to 3, i.e. of a video endoscope exhibiting the structure of
A cardiovascular video endoscope formed in such a manner considerably simplifies planning, implementation and subsequent monitoring of medical interventions within the vascular system of humans. Defects of the cardiovascular system may herewith be evaluated directly within a blood-filled environment. Due to the reduced intervention time, this results in a treatment which is overall more gentle on patients. Once the method has become well-established, the cost for treatment may be drastically reduced. In comparison with prior diagnostic systems, an endoscope formed in such a manner provides a clearly higher image resolution. Using the methods of modern image processing, such as pattern recognition which is performed, for example, within processing means 62 or within a different processor unit which has access to memory 66, any information desired on the part of the physician may be immediately derived from the data obtained by means of the catheter.
As has already been described above, sensor elements 52 are not absolutely necessary. Examples of such sensory elements which extend the distal end of the endoscope within the catheter tip in accordance with the user's requirements include a flow sensor, a temperature sensor, chemical sensors or the like.
Compared to the method of U.S. Pat. No. 6,178,346 which was mentioned in the introduction to the description, a video endoscope in accordance with the present invention comprises in-situ mounting of the camera device and/or the image sensor. From that point of view, image transmission by means of optical-fiber cables may also be dispensed with. Since such cables exhibit a lower aperture and, in addition, attenuate the optical signal, the image quality is comparatively poor with the conventional method. The above-described embodiments, by contrast, promise to achieve a considerably improved image quality.
An endoscopy device in accordance with the previous embodiments which is to be suitable for cardiovascular examination should operate at a wavelength of 2.1 μm, unlike conventional video endoscopes which exploit the visible wavelength range of 400-700 nm. Both our own theoretical calculations and experimental investigation confirm that blood is sufficiently transparent at this wavelength. The choice of wavelength is the result of a compromise: at low wavelengths, scattering of light at the particles is too high, at higher wavelengths, the absorption is too high due to the high proportion of water. The visibility range that can be achieved amounts to about 12 mm in blood at this wavelength. What is also feasible is a video endoscope which operates at a wavelength of 1.7 μm. In this case, the achievable visibility range would amount to 8 mm. Other wavelength ranges, such as from 1.5 μm to 1.8 μm, or from 2.1 μm to 2.3 μm, may also be sufficient, however.
Put differently again, the overall architecture, proposed above with reference to
In addition, it is possible to directly integrate light sources, such as photodiodes, into the distal end of the catheter head, rather than using an externally arranged light source. These could then, in the embodiment of
As has been described with reference to
Since the external diameter is limited by the vessels—the larger arteries and/or veins have diameters of between 6 and 14 mm—the structure of the catheter of the above embodiments should be sufficiently miniaturized in the implementation. The minimum photodiode pitch is predefined by the diffraction-limited resolution, at 7 μm, so that a video endoscope having a diameter of 1.5 mm theoretically could offer a resolution of 20,000 picture elements (pixels).
The optics, or the optical system, should enable a visual range of at least 25 degrees. The optical system should autofocus within an image-width range from 5 to 12 mm. The lens diameter should not exceed 3 mm. The image rate of the image sensor should be at least 15 images per second.
A catheter head in accordance with the embodiments of
It shall be noted that even though, in accordance with the above-described embodiments, a pre-processing means 50 has always already been arranged within the catheter head, it would also be possible to perform this pre-processing only within the framework of image processing within image processing means 62. Performing the pre-processing already within the catheter head, such as dynamics adjustment, channel adjustment, filtering out or source encoding, however, may possibly reduce the demands made on the routing of the pixel information and/or pixel measurement values to the external apparatus 30, such as reduce the number of cables required, or the like, or increase the transmission rate with the cabling unchanged.
As has already been mentioned above, arranging further sensors is not essential to the present invention. Conversely, as has also already been mentioned above, further devices, such as ones for navigating the endoscope within the blood vessels, may be provided within the catheter. To this end, one or more actuators which may—as the situation may be—be of mechanical nature, may be provided, which is why a mechanical Bowden control, which extends from the proximal end to the catheter so as to be able to control this actuator, may also be provided within the catheter.
In addition, it shall be pointed out that it is by way of example only that the previous embodiments referred to the representation of the cardiovascular system, i.e. to a cardiovascular endoscope for representing the interior walls of the cardiovascular system by means of a minimally invasive imaging system. Inventive video endoscopes, however, may also be employed in other places in medical diagnosis.
The preceding embodiments could be employed as an angioscope and could support, as a diagnostic tool, the heart and vascular surgeon in heart surgery to be performed with minimum invasiveness, such as in reconstructing and/or replacing mitral or tricuspidal valves, in obstructing an interventricular septal defect or in implanting coronary bypasses. In addition, various defects of the vascular system, e.g. lesions, aneurisms, scleroses and stenoses, can be made visible and evaluated pre-operatively. As far as intra-operative employment is concerned, the removal of these effects, e.g. by implanting a stent or by HF, or high frequency, ablation or cryoablation, may be accompanied with an angioscope. These interventions can be very readily evaluated post-operatively. A further large area of application of the embodiments described above is the exact evaluation of thromboses, embolisms and infarcts, which nowadays represents a challenge in a society with increasingly older patients. The improvement in the examination increases the safety in ensuing therapy.
Thus, above embodiments form a diagnostic tool and enable a diagnostic method associated therewith by means of which observations at and/or in organs and vessels may be performed pre-, intra-, and post-operatively in an actual, i.e. blood-filled, environment. The physician is able to look into the cardiovascular system through the catheter, the distal end of which he/she adducts to the examination location via the blood vessels, and through the extra-corporal image processing unit within the monitor. These video endoscopy devices support the surgeon performing treatment in navigating and performing difficult operations, for example on the heart. The above configurations enable novel diagnostic methods which, in turn, allow simple morphological-functional imaging of the cardiovascular system with variable application possibilities, and which accompany the physician both pre-, intra-, as well as post-operatively. Unlike the standard imaging methods used for representing the cardiovascular system, this imaging method provides a higher resolution without ionizing radiation.
While this invention has been described in terms of several preferred embodiments, there are alterations, permutations, and equivalents which fall within the scope of this invention. It should also be noted that there are many alternative ways of implementing the methods and compositions of the present invention. It is therefore intended that the following appended claims be interpreted as including all such alterations, permutations, and equivalents as fall within the true spirit and scope of the present invention.
This application is a continuation of copending International Application No. PCT/EP2004/008058, filed Jul. 19, 2004, which designated the United States, and was not published in English and is incorporated herein by reference in its entirety.
Number | Date | Country | |
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Parent | PCT/EP04/08058 | Jul 2004 | US |
Child | 11625218 | Jan 2007 | US |