Endoscopy is a minimally invasive medical procedure using an endoscope. The endoscope allows a physician to visually examine internal organs of the patient through a small incision in the patient. The device also provides suction, water dispensing, and surgical functions. During endoscopic operations it is possible to perforate an internal lining or organ of the patient. Perforations can be caused by several factors during a procedure, one of which is “looping.” Looping occurs when the rate at which the endoscope's flexible shaft advances is greater than the speed at which the tip of the endoscope advanced into the patient. When this occurs the flexible shaft can loop upon itself. The loop can exert pressure on the wall of a patient's lumen that is sufficient to cause a perforation. Looping is the leading cause of perforations during a colonoscopy.
The present disclosure describes a device and method for measuring the pressure a medical device, such as an endoscope, applies to an internal organ or lumen of a patient. The device includes an optical fiber that is helically wound around the flexible shaft of the medical device. The shaft also includes a number of small ridges, which deform the optical fiber when a pressure is applied to the device. As light propagating down the optical fiber encounters a microbend a portion of the light will scatter and be lost to the environment. The light attenuation can be measured and used to calculate the radius of the microbend and subsequently the pressure that caused the microbend. This system can then be used to warn physicians before a perforation occurs.
According to aspect of the disclosure, a pressure sensor for a medical device includes an elongated shaft having a first end, a second end, and a plurality of frets spaced a set distance apart along a substantial portion the elongated shaft. The device also includes a first optical fiber having an inlet and an outlet and running along a substantial length of the elongated shaft. A first light source is configured to project light into the inlet of the first optical fiber, and a first sensor is positioned to detect light emitted from the outlet of the first optical fiber.
In some implementations, the first light source and the first sensor are positioned near the first end of the elongated shaft and connected by the first optical fiber. In other implementations, the first optical fibers run non-tangentially over the frets. In yet other implementations, the device further includes a processor configured to calculate a pressure exerted on the elongated shaft.
In some implementations, the first optical fiber is helically wound around the elongated shaft, and the pitch of the first helically wound optical fibers is four times the set distance between adjacent frets.
In yet other implementations, the first light source is configured to project light of a first wavelength and second wavelength. The first wavelength and second wavelength are selected to attenuate at different rates when the first optical fiber is bent a set amount. In some implementations, the first optical fiber is multi-modal.
In other implementations, a second optical fiber is helically wrapped along the elongated shaft substantially parallel to the first optical fiber, and the second optical fiber is connected to a second sensor and a second light source emitting a second wavelength of light. In some implementations, the elongated shaft is part of a catheter, an endoscope, or a colonoscope.
According to another aspect of the disclosure, a method for measuring a pressure along a medical device includes wrapping a first optical fiber along an elongated shaft of the medical device, wherein a plurality of frets are spaced a set distance apart along substantial portion of the elongated shaft. The method also includes projecting, by a light source, a first wavelength of light into the first optical fiber, wherein the first wavelength of light has a first intensity. Responsive to projecting the light, the method includes detecting, by a sensor, a second intensity of the first wavelength of light when the first wavelength of light exits the optical fiber. The method also includes determining, by a processor, a pressure along the elongated shaft of the medical device by comparing the first intensity to the second intensity.
In some implementations, the method also includes projecting, by the light source, a second wavelength of light into the first optical fiber, wherein the second wavelength of light has a third intensity; and detecting, by the sensor, a fourth intensity of the second wavelength of light when the second wavelength of light exits the optical fiber. Furthermore, in some implementations, the method includes determining, by the processor, a distribution of the pressure along the elongated shaft of the medical device by comparing a first difference between the first intensity and second intensity to a second difference between the third intensity and fourth intensity.
In some implementations, the first wavelength and second wavelength are selected to attenuate at different rates when the first optical fiber is bent a set amount. In other implementations, the method includes wrapping a second optical fiber along the elongated shaft of the medical device; projecting, by a second light source, a second wavelength of light into the second optical fiber, wherein the second wavelength of light has a third intensity; and detecting, by a second sensor, a fourth intensity when the second wavelength of light exits the second optical fiber.
In yet other implementations, the method includes determining, by the processor, a distribution of the pressure along the elongated shaft of the medical device by comparing a first difference between the first intensity and second intensity to a second difference between the third intensity and fourth intensity.
In some implementations, the method includes warning a user if the pressure exceeds a set threshold. In other implementations, the method further includes helically wrapping the first optical fiber around the length of the elongated shaft and non-tangentially over the frets. In some of these implementations, the pitch of the helically wound optical fiber is four times the set distance between adjacent frets.
The skilled artisan will understand that the figures, described herein, are for illustration purposes only. It is to be understood that in some instances various aspects of the described implementations may be shown exaggerated or enlarged to facilitate an understanding of the described implementations. In the drawings, like reference characters generally refer to like features, functionally similar and/or structurally similar elements throughout the various drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the teachings. The drawings are not intended to limit the scope of the present teachings in any way. The system and method may be better understood from the following illustrative description with reference to the following drawings in which:
The following description in conjunction with the above-reference drawings sets forth a variety of implementations for exemplary purposes, which are in no way intended to limit the scope of the described methods or systems. Those having skill in the relevant art can modify the described methods and systems in various ways without departing from the broadest scope of the described methods and systems. Thus, the scope of the methods and systems described herein should not be limited by any of the exemplary implementations and should be defined in accordance with the accompanying claims and their equivalents.
In a brief overview, the device 100 may include a flexible or inflexible elongated shaft 103. A number of frets 104 may be spaced along the length of the shaft. A optical fiber 105, having an inlet portion 106 and an outlet portion 107 may be wrapped around the length of the shaft. The inlet portion 106 of the optical fiber is connected to a light source 109, and the outlet portion 107 of the optical fiber is connected to a power meter 108. A processor 110 may control the device 100 and provide output to a display 112. Finally, the components of the device 100 receive power from a power source 111.
Still referring to device 100 of
The device 100 may include a plurality of frets 104 along the length of the shaft, discussed in greater detail in relation to
The device 100 also includes an optical fiber 105. In some implementations, such as the example illustrated in device 100, the optical fiber 105 is wound from a proximal end of the shaft 103 to the distant end of the shaft 103 and then back to the proximal end of the shaft 103. In other implementations the light source 109 and power meter 108 are placed at opposite ends of the shaft 103, such that the optical fiber 105 only travels from a first end of the shaft 103 to a second end of the shaft 103. In some implementations, the optical fiber 105 is wound such that the outlet portion 107 of the optical fiber does not wrap over the inlet portion 106 of the optical fiber.
In some implementations, the optical fiber 105 is helically wound around the shaft 103. In other implementations, the optical fiber 105 is strung linearly from the proximal end to the distal end of the shaft. For example, the optical fiber may substantially parallel to the length of the shaft 103. In some of these implementations, the flexibility of the optical fiber 105 may be configured to match the tensile properties of the shaft 103 as to not induce artifact into the measurement. In some implementations, the device 100 may include a means to add or remove slack from the optical fiber, such as a spring. Consider the example where two optical fibers run parallel to the shaft 103 and 180 degrees apart from one another. Further consider the shaft 103 is bent such that a first optical fiber 105 runs along the inner diameter of the curved shaft and a second optical fiber 105 runs along the outer diameter of the curved shaft 103. In this example, slack develops in the first optical fiber 105 and a strain develops in the second optical fiber 105. A spring or recoil mechanism would allow the first and second optical fibers to adjust to the flexing shaft 103 without inducing inaccurate pressure readings. In other implementations, the helically wound optical fiber reduces light loss caused by flexing of the shaft 103, by allowing the shaft 103 to flex without inducing pressure on optical fiber 105.
In device 100, the wrapped optical fiber 105 crosses over a plurality of frets 104. When pressure is applied to the device 100, the optical fiber 105 may deform around the fret 104. This small deformation, or microbend, allows a portion of light to escape the optical fiber 105. As discussed below in relation to
In some implementations, the optical fiber 105 is a single-mode optical fiber. Additionally, the optical fiber 105 may be a multi-mode optical fiber. The device 100 may include more than one optical fiber 105. For example, the device may include a second optical fiber wound in tandem with the first optical fiber. In some of these implementations the first and second optical fibers carry light of different wavelengths. In yet other implementations, a plurality of light rays of multiple frequencies may be projected into a single optical fiber. In some implementations, the optical fiber 105 is a fused quartz or glass fiber and in other implementations the optical fiber 105 is a plastic fiber. Discussed further in relation to
Still referring to device 100 of
The device 100 also includes a power meter 108 connected to the output portion 107 of the optical fiber 105. The power meter 108 measures the light intensity exiting the optical fiber 105 from the outlet portion 107 and provides the processor 110 with the measurement. In some implementations, the power meter 108 has a resolution of 0.1 dB or 0.01 dB and an accuracy of 5%. In other implementations, the intensity of the light exiting the fiber optic 105 at the outlet portion 107 may be measured with a photoresitor, photodiode, or similar optoelectronic device.
As mentioned above, the device 100 also includes a processor 100. In some implementations the device 100 includes more than one processor 110. The processor 110 controls the components of device 100. For example, the processor 110 may control the intensity of light the light source 109 projects into the optical fiber 105. The processor 110 may also receive the readings from the power meters 108 of device 100. The processor 110 may calculate the pressure exerted along the shaft 103 of the device 100. As discussed later, in some implementations, the processor 110 may also calculate the distribution of the pressure. For example, the processor 110 may collect intensity readings from two power meters 108 or one power meter 108 measuring two separate wavelengths to calculate the pressure per unit area. In doing so, the device 100 may determine if an applied pressure is spread along the entire length of the shaft 103 or focalized to a small portion of the shaft 103. The processor may compare the total pressure and/or the pressure per unit area to a set threshold to determine if the pressure being applied by the medical device to the patient is dangerous. The processor 110 may be a microprocessor unit, such as: those manufactured by Intel Corporation of Santa Clara, Calif.; those manufactured by Motorola Corporation of Schaumburg, Ill.; those manufactured by Atmel of San Jose Calif., or any other single- or multi-core processor, or any other processor capable of operating as described herein and performing the calculations described in reference to
In some implementations, the processor 110 outputs the pressure readings to a display 112. The display may be a screen that provides real-time pressure readings to a user. In other implementations, the display indicates relative pressure measurements. For example, the display may be an indicator light on the handle of the endoscope that is green when the pressure is within safe tolerances, yellow as the pressure approaches the predetermined threshold, and red when the detected pressure exceeds the predetermined threshold. In other implementations, the device may provide a user with audio and/or tactile feedback.
The device 100 is powered by a power source 111. In some implementations, the device 100 is powered by battery power. In other implementations, the device 100 is powered by a medical grade AC power supply.
As discussed briefly above in relation to
As described above, and illustrated by device 100,
In some implementations of the above configurations, the fret spacing 203 and the optical fiber spacing 204 are adjustable. For example, the device 100 may be configured such that a surgeon may rearrange the frets 104 and optical fiber 105 to provide greater pressure distribution resolution. Additionally, in some implementations, more than one optical fiber 105 is wound around the shaft 103 of the device 100. For example, a second optical fiber may be wound in tandem with the first optical fiber or a first optical fiber 105 may be wound from the proximal end to the distal end and then a second fiber optic 105 may be wound from the distal to the proximal end. In some implementations, these multiple optical fibers 105 have separate light sources and in some implementations they share a single light source.
Referring now to
As set forth above, and referring to
A first wavelength is projected into a first optical fiber (step 302). As described above, in some implementations, the light source may be a light lamp, a laser, or a LED. In some implementations, the wavelength of the first wavelength is 1550 nm. In some implementations, a second wavelength of light is projected into the optical fiber (step 303). In some implementations, the second wave of light is projected into a second optical fiber. The wavelength of the second wavelength may be 1310 nm.
The method 300 continues with the detection of the intensity of the first wavelength as it exits the optical fiber (step 304) and the detection of the intensity of the second wavelength of light as it exits the optical fiber (step 305). As described above, a portion of light may be lost to the environment at each microbend of the optical fiber. Accordingly, if a pressure causes the optical fiber to bend around a fret, the intensity of the light exiting the optical fiber will be less the optical fiber entering the optical fiber.
Responsive to detecting the intensities of the first and second wavelength of light exiting the optical fiber, the device determines the pressure asserted along the device (step 306). In some implementations, the pressure along the device is determined by using only the detected intensity of the first wavelength of light exciting the optical fiber. In these implementations, a known initial power (Pi) of the first wavelength of light is projected into the optical fiber. The power meter determines the exiting power of the first wavelength of light (Pf). In some implementations, a portion of Pi will be lost when the optical fiber bends around a fret. This light attenuation (ΔP=Pi−Pf) can be used to calculate the bend radius of the optical fiber, which in turn can be used to determine the pressure applied to the optical fiber. In one embodiment, the processor first calculates the an amplitude loss coefficient (2α) using the equation:
After calculating 2α, the bend radius (R) can be calculated with:
In Equation 2, K is the field decay rate in the fiber core, βg is the propagation constant, γ is the field decay in the fiber cladding, ev is a constant that depends on the propagation mode in the fiber, and V is the propagation factor.
Next, modeling the optical fiber as a beam with fixed ends experiencing a uniformly distributed load (w), the load can be calculated with:
In equation 3, E is the modulus of elasticity, I is the moment of inertia, and l is the width of the fret. R is the calculated bend radius from Equation 2. In some implementations, these calculations are continually calculated by the processor or calculated at a given interval. In other implementations, the above equations are used to generate a lookup table that the processor uses to associate a given light loss with an applied pressure. In yet other implementations, when graphed on a log scale, the relationship between light loss and applied pressure is modeled with a linear equation that allows for a direct, approximate calculation of the applied pressure.
Again referring to method 300, the method continues by calculating a pressure distribution along the medical device. In some implementations, the light loss when the optical fiber bends over multiple frets is additive. For example, it may be difficult to delineate 10 kPa applied to two frets from 20 kPa applied to one fret. As described above, in some implementations, a second wavelength of light is projected into the optical fiber. The second wavelength of light may be used as a reference wavelength. The second wavelength of light may be projected down the same optical fiber as the first wavelength of light or it may be projected down a second optical fiber. The reference wavelength of light may be near the first wavelength of light. In some implementations, the second wavelength of light is selected such that it reacts differently to applied pressures and microbends. For example, 1550 nm may be chosen as the first wavelength and 1310 may be chosen as the second wavelength. In some implementations, the second wavelength of light is chosen such that it is less sensitive to microbends. For example, the first wavelength of light may experience attenuation starting at 10 kPa, while the second wavelength may experience attenuation starting at 20 kPa. By taking the ratio of the detected power of the first wavelength of light to the detected power of the second wavelength of light, the processor can distinguish high pressures that are distributed over a large area and are therefore not dangerous from high pressures distributed over a small area that are dangerous. For example and referring to
This application claims priority from Provisional U.S. Patent Application 61/567,065, filed Dec. 5, 2011, incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2012/067933 | 12/5/2012 | WO | 00 |
Number | Date | Country | |
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61567065 | Dec 2011 | US |