Patent Application
20170189231
The present disclosure is directed to ophthalmic surgical devices, systems, and methods. More particularly, but not by way of limitation, the present disclosure is directed to devices, systems, and methods of measuring aspiration and/or irrigation fluid pressure.
Fluid pressure within an eye of a patient, often referred to as “intraocular pressure,” should be maintained at a relatively constant value during an ophthalmic surgical procedure to avoid adverse physiological effects. Ophthalmic surgical procedures frequently remove body tissue from the eye, as well as fluid and other anatomy, in a process referred to as aspiration. To counteract the decrease in fluid pressure resulting from aspiration, the surgical probe or another surgical device can deliver fluid into the eye in a process referred to as irrigation.
A fluidics module of a surgical console and a fluidics cassette that interfaces with the fluidics module can be utilized to maintain intraocular pressure through aspiration and irrigation. The fluidics cassette generally includes tubing involved in guiding aspiration fluid away from the eye and irrigation fluid towards the eye. The fluid pressures of the aspiration fluid and the irrigation fluid must be monitored in order to maintain appropriate intraocular pressure.
Some conventional systems determine fluid pressures based on a position of a portion of the fluidics cassette in the surgical console. In the systems, movement of the fluidics module or fluidics cassette can impact the pressure readings, introducing measurement inaccuracies. While manufacturers strive to minimize unwanted movement, the fluidics module and fluidics cassette are susceptible to such movement during the surgical procedure. For example, the geometry and force of a mechanism clamping the fluidics cassette and the fluidics module, the operation of rollers and valves of the fluidics module, and/or the pulling of tubing can result in unwanted movement. As a result of such movement, accurately determining the aspiration and irrigation fluid pressures can be difficult.
According to one aspect, the present disclosure describes an ophthalmic surgical system including at least one light source. The at least one light source is configured to output light towards a fluidics cassette in a manner that a first portion of the light reflects from a deflectable diaphragm of the fluidics cassette, and in a manner that a second portion of the light reflects from a reference portion of the fluidics cassette. The diaphragm is configured to deflect relative to the reference portion in response to a pressure associated with a fluid within the fluidics cassette. The system also includes at least one sensor configured to receive the first portion of the light reflected from the diaphragm and the second portion of the light reflected from the reference portion. The system further includes a computing device in communication with the at least one sensor. The computing device is configured to determine the pressure associated with the fluid within the fluidics cassette based on the received first and second portions of the light.
Another aspect of the present disclosure is directed to an ophthalmic surgical system including at least one light source. The at least one light source is configured to output light towards a fluidics cassette in a manner that a first portion of the light reflects from a first region of diaphragm of the fluidics cassette, and in a manner that a second portion of the light reflects from a component of the fluidics cassette spaced from the first region of the diaphragm. The diaphragm is configured to be deflected in response to a pressure associated with a fluid within the fluidics cassette. The system also includes at least one sensor configured to receive the first portion of the light reflected from the first region of the diaphragm and the second portion of the light reflected from the mount for the diaphragm. The system further includes a computing device in communication with the at least one sensor. The computing device is configured to determine the pressure associated with the fluid within the fluidics cassette based on the received first and second portions of the light.
A third aspect of the disclosure is directed to a method of determining a pressure within an ophthalmic surgical system. The method includes controlling, using a computing device, at least one light source to output light towards a fluidics cassette such that a first portion of the light reflects from a region of a diaphragm of the fluidics cassette and such that a second portion of the light reflects from a component of the fluidics cassette spaced from the region of the diaphragm. The diaphragm is configured to be deflected in response to a pressure associated with a fluid within the fluidics cassette. The method also includes receiving at the computing device, from at least one sensor, a first signal representative of the first portion of the light reflected from the region of the diaphragm and a second signal representative of the second portion of the light reflected from the component of the fluidics cassette remote from the region of the diaphragm. The method further includes determining, using the computing device, the pressure associated with the fluid within the fluidics cassette based on the received first and second signals.
The various aspects of the disclosure may include one or more of the following features. The system may further include a beam splitter configured to direct the first portion of the light towards the diaphragm of the fluidics cassette and the second portion of the light towards the reference portion. The at least one sensor can include a first sensor configured to receive the first portion of the light reflected from the diaphragm; and a second sensor configured to receive the second portion of the light reflected from the reference portion. The at least one light source may include a first light source configured to output the first portion of the light; and a second light source configured to output the second portion of the light. The at least one sensor can include a first sensor configured to receive the first portion of the light reflected from the diaphragm; and a second sensor configured to receive the second portion of the light reflected from the reference portion. The at least one light source may be configured to output light towards a fluidics cassette such that a third portion of the light reflects from a second diaphragm of the fluidics cassette and a fourth portion of the light reflects from a second reference portion of the fluidics cassette. The further diaphragm is configured to be deflected in response to a pressure associated with a second fluid within the fluidics cassette. The at least one sensor is configured to receive the third portion of the light reflected from the second diaphragm and the fourth portion of the light reflected from the second reference portion. The computing device is configured to determine the pressure associated with the further fluid within the fluidics cassette based on the received third and fourth portions of the light. The pressure associated with the fluid within the fluidics cassette may be representative of an irrigation pressure. The pressure associated with the second fluid within the fluidics cassette can be representative of an aspiration pressure.
The at least one light source can include a laser source or a laser diode. The system can further include a surgical console housing the at least one light source, the at least one sensor, and the computing device. The system may further include the fluidics cassette. The computing device can be configured to determine the pressure associated with the fluid within the fluidics cassette by: determining a first distance between the at least one sensor and the diaphragm based on the received first portion of the light reflected from the diaphragm; and determining a second distance between the at least one sensor and the reference portion based on the received second portion of the light reflected from the reference portion. The computing device may be configured to determine the pressure associated with the fluid within the fluidics cassette by: calculating a displacement of the diaphragm by subtracting the second distance from the first distance. The computing device can configured to determine the pressure associated with the fluid within the fluidics cassette by: correlating the displacement of the diaphragm to the pressure associated with the fluid within the fluidics cassette.
The component of the fluidics cassette spaced from the first region of the diaphragm can include at least one of: a second region of the diaphragm; and a mount for the diaphragm. The first region of the diaphragm may include a central region of the diaphragm. The second region of the diaphragm may include a peripheral region of the diaphragm.
The various aspects of the disclosure may also include one or more of the following features. Determining the pressure associated with the fluid within the fluidics cassette can include determining a first distance between the at least one sensor and the region of the diaphragm based on the received first signal; and determining a second distance between the at least one sensor and the component of the fluidics cassette spaced from the region of the diaphragm based on the received second signal. Determining the pressure associated with the fluid within the fluidics cassette may include: calculating a displacement of the diaphragm by subtracting the second distance from the first distance. Determining the pressure associated with the fluid within the fluidics cassette can include: correlating the displacement of the diaphragm to the pressure associated with the fluid within the fluidics cassette.
It is to be understood that both the foregoing general description and the following drawings and detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following.
The accompanying drawings illustrate embodiments of the systems, devices, and methods disclosed herein and together with the description, serve to explain the principles of the present disclosure.
These figures will be better understood by reference to the following Detailed Description.
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the implementations illustrated in the drawings and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with reference to one or more implementations may be combined with the features, components, and/or steps described with reference to other implementations of the present disclosure. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.
The present disclosure relates generally to devices, systems, and methods for determining the irrigation pressure and the aspiration pressure within a fluidics cassette. In the implementations described herein, the irrigation pressure and the aspiration pressure may be indicative of intraocular pressure within a patient's eye. In some implementations, the fluidics cassette may include an irrigation diaphragm and an aspiration diaphragm. These diaphragms may be respectively configured to deflect in response to the pressure (e.g., fluid pressure and/or vacuum pressure) associated with irrigation fluid and aspiration fluid within the cassette. By measuring the deflection with a fluidics module of a surgical console, a user/controller may determine the pressure. In some implementations, the fluidics module includes an optical pressure sensor that measures the deflection of the irrigation diaphragm and the aspiration diaphragm. In some implementations, the optical pressure sensor may include one or more laser sources that output light that is reflected by the irrigation diaphragm and/or the aspiration diaphragm. The reflected light can be received at one or more sensors, and a computing device can determine the deflection based on the reflected light received at the sensor. The distance can vary as the diaphragms are displaced.
In some implementations as a point of reference, the optical pressure sensor may also measure the distance to a relatively more stationary part of the cassette, such as a mount for the diaphragm. In that regard, the diaphragm is configured to deflect relative to the reference location in response to pressure within the cassette. For example, measuring the distance to the mount can account for any unwanted movement of the fluidics module and/or the cassette. By subtracting the distance to the mount from the distance to the diaphragm, the displacement of the diaphragm resulting from pressure within the cassette can be determined. The computing device can determine the pressure associated with irrigation fluid and/or aspiration fluid based on the displacement of the diaphragm.
The devices, systems, and methods of the present disclosure provide numerous advantages over conventional systems. In particular, the pressure associated with the irrigation fluid and/or aspiration fluid may be more accurately determined by using the reference measurement location on the fluidics cassette. Displacement of the diaphragm resulting from pressure can be separated from unwanted movement of the fluidics cassette and/or the fluidics module. Accordingly, the geometry and force of the mechanism clamping the fluidics cassette and the fluidics module, the operation of rollers and valves of the fluidics module, the pulling of tubing, and/or other sources of unwanted movement can be accounted for. The devices, systems, and methods disclosed herein may also permit easier manufacturing than prior systems. For example, in order to prevent unwanted movement, cassettes were rigidly coupled to the fluidics module of the surgical console, with high clamp tension and force, in some systems. The disclosure herein allows for the clamp tension and force to be reduced because the pressure measurement accounts for any movement of the cassette and/or the fluidics module.
Additionally, calibration of the fluidics cassette can be more efficiently completed based on the present disclosure. In particular, zero cassette calibration is typically performed just before the surgical procedure when the cassette is inserted into the fluidics module of the surgical console. According to the present disclosure, this calibration step can be removed from the surgical setup workflow, which allows for a more efficient set up for the user, such as the surgeon or other medical profession. Zero cassette calibration is used to determine the diaphragm position when there is no pressure in the fluidics cassette. The zero cassette calibration may be completed during cassette manufacturing. The calibration data may be stored on a memory device associated with the cassette, such as a barcode that is read when the cassette is inserted into the fluidics module of the console. The calibration will not change when the cassette is inserted into the fluidics module, and the known zero cassette calibration data obtained during manufacturing can be advantageously utilized.
One or more surgical devices, including the handpiece 150, can be communicatively coupled to the console 110. For example, the handpiece 150 may be in fluid and/or electrical communication with the console 110. One or more conduits 151, such as tubing configured to carry aspiration fluid and/or irrigation fluid, can extend between the console 110 and the handpiece 150. A distal portion of handpiece 150 may be inserted into the eye to treat an optical condition. In various embodiments, the handpiece 150 can be a cutting probe, a vitrectomy probe, a phacoemulsification probe, a laser probe, an ablation probe, a vacuum probe, a flushing probe, scissors, forceps, an infusion device, an irrigation device, an aspiration device, other suitable surgical device, and/or combinations thereof. For example, in a cataract procedure, a phacoemulsification probe can be used to reshape the lens of the patient's eye.
Embodiments of the fluidics module 200 of the surgical console 110 are illustrated in
Returning to
Referring to
Referring again to
Referring to
The computing device 160 can be any suitable computer having a processor and a memory forming a processing circuit. The processor may execute computer instructions, such as those stored on the memory, to control various components of the system 100 described herein. The memory, which is typically a semiconductor memory such as RAM, FRAM, or flash memory, interfaces with the processor. As such, the processor(s) may write to and read from the memory, and perform other common functions associated with managing semiconductor memory. Processing circuit(s) of the computing device 160 may be integrated circuits with power, input, and output pins capable of performing logic functions. In various implementations, the processor is a targeted device controller, a microprocessor configured to control one or components of the surgical system 100 and/or a combination thereof. The computing device 160 can be a part of the console 110, the fluidics module 200, and/or the optical pressure sensor 250.
The computing device 160 can generate and transmit control signals to the light source 252, the motors 210 of the fluidics module 200 that control irrigation and aspiration using the cassette 300, and/or other powered components of the surgical system 100. The computing device 160 can also receive signals representative of the light received at the sensor 254. The computing device 160 can process the signals received from the sensor 254 to determine distances between the optical pressure sensor 250 and components, such as the body 302, diaphragms 310, 320, and/or mounts 350, of the cassette 300. Based on the measured distances, the computing device 160 can further determine the vacuum pressure and/or fluid pressure associated with the irrigation fluid and/or aspiration fluid within the cassette 300. Exemplary methods of determining distance and pressure using an optical pressure sensor are described in U.S. application Ser. No. 10/879,789, filed Jun. 29, 2004, the entirety of which is hereby incorporated by reference. For example, the computing device 160 mathematically correlates a distance value (e.g., the displacement of the diaphragms 310, 320) to a pressure value. In some embodiments, the memory of the computing device 160 can store a look up table listing distance values and corresponding pressure values. The computing device 160 identifies the corresponding pressure value in the look up table once the distance value is determined.
During use, the nature of moveable parts introduces some level of variability in distances between the parts. For example, various components of the fluidics module 200 (e.g., the motors 210, the valve controls 220, the attachment members 230, the rollers 260) and the cassette 300 (e.g., the pump 330, the valves 340, the tubes 360) can introduce movement of the cassette 300 relative to the fluidics module 200. Movement the fluidics module 200 and/or the cassette 300 changes the distance between the optical pressure sensor 250 and the diaphragms 310, 320. Accordingly, the accuracy of the pressure determination can be adversely impacted by unaccounted movement of the fluidics module 200 and the cassette 300. To minimize this potential for inaccurate pressure measurement, the present disclosure describes measuring the distance between the optical pressure sensor 250 and a reference location on the cassette 300, as well as the distance between the optical pressure sensor 250 and the diaphragms 310, 320. The reference location, such as the mounts 350, experiences the same movement as the cassette 300 and/or the fluidics module 200. Therefore, even as the whole cassette 300 moves relative to the fluidics module 200, the distance between the diaphragms 310, 320 and the reference location on the cassette 300 is unaffected. By subtracting the two distances to find the difference, the displacement of the diaphragms 310, 320 due solely to pressure within the cassette 300 can be isolated. The computing device 160 can more accurately determine the pressure associated with the irrigation fluid and/or the aspiration fluid within the cassette based on the displacement of the diaphragms.
As illustrated in
Beams 258, 259 interact with different components of the fluidics cassette 300. For example, the diaphragm 310 reflects at least a portion of the beam 258. The sensor 254 can be positioned to receive the reflected portion of the beam 258. The sensor 254 generates and transmits a signal representative of the reflected portion of the beam 258 to the computing device 160. Based on the received signal from the sensor 254, the computing device determines a distance 292 between the sensor 254 and the diaphragm 310.
The mount 350 reflects at least a portion of the beam 259. The sensor 254 can be positioned to receive the reflected portion of the beam 259. The sensor 254 generates and transmits a signal representative of the reflected portion of the beam 259 to the computing device 160. Based on the received signal from the sensor 254, the computing device determines a distance 294 between the sensor 254 and the mount 350.
The computing device 160 can process the received signals from the sensor 254 to isolate the displacement of the diaphragm 310 due to pressure associated with the irrigation fluid 304 within the body 302 of the cassette 300. In that regard, the mount 350 can serve as a reference location. For example, the computing device 160 can subtract the distance 294 from the distance 292 to yield a distance 296. Displacement of the diaphragm 310 changes the distance 296. By subtracting the distance 294, the computing device 160 minimizes any influence of unintended movement of fluidics module 200 and/or the cassette 300. In some implementations, the computing device 160 is arranged to determine the pressure associated with the irrigation fluid 304 within the cassette 300 using the look up table with the calculated distance 296. While the discussion of
In various embodiments, the system 100 can include a single light source and a single sensor, a single light source and multiple sensors, multiple light sources and a single sensor, multiple light sources and multiple sensors. In that regard, it is understood that the computing device 160 can determine the pressure associated with both the irrigation path 205 and the aspiration path 207. For example, the irrigation pressure and/or the aspiration pressure can be monitored in an ad hoc or on demand manner, at regular or irregular intervals, simultaneously and/or at times offset from one another. The optical pressure sensor 250 can include one or more light sources and one or more sensors to measure irrigation pressure based on deflection of the irrigation diaphragm 310. For example, the one or more sensors associated with the irrigation path 205 can respectively receive first and second reflected portions of light from the irrigation diaphragm 310 (e.g., the central portion 312 and/or the peripheral portion 314) and the reference portion of the fluidics cassette 300 (e.g., the mount 350 and/or the peripheral portion 314). The optical pressure sensor 250 can additionally include one or more light sources and one or more sensors to measure aspiration pressure based on deflection of the aspiration diaphragm 320. For example, the one or more sensors associated with the aspiration path 207 can respectively receive third and fourth reflected portions of light from the aspiration diaphragm 320 (e.g., the central portion 312 and/or the peripheral portion 314) and a reference portion of the fluidics cassette 300 (e.g., the mount 350 and/or the peripheral portion 314). The computing device 160 can be in communication with the light source(s) and sensor(s) associated with both the irrigation path 205 and the aspiration path 207. In some embodiments, the same light source(s) and the same sensor(s) are used to determine pressures associated with both the irrigation path 205 and the aspiration path 207.
The method 600 can be implemented during an ophthalmic surgical procedure, such as a cataract procedure, for example, or other suitable procedures. The surgeon may perform the surgical procedure using the components of the system 100. For example, the surgeon may perform surgical maneuvers using the handpiece 150 within the patient eye 160. The components of the system 100 can together facilitate irrigation and aspiration within the eye 160. The steps the method 600 can be implemented to monitor a pressure associated with irrigation fluid and/or aspiration fluid within the system 100.
At step 610, the method 600 includes irrigating a surgical site, such as the eye 160, by flowing fluid through the fluidics cassette 300. At step 620, the method 600 includes aspirating from the surgical site by flowing fluid through the fluidics cassette 300. The computing device 160 and/or a user, such as the surgeon or other medical professional, can coordinate delivery of irrigation fluid to the surgical site in step 610 and the removal of aspiration fluid from the surgical site in step 620 to maintain desired intraocular pressure during the surgical procedure. The step 610 can include the computing device 160 transmitting control signals to the irrigation bag 111, motors 200, and/or other powered components of the fluidics module 200 and/or the system 100 to facilitate delivery of irrigation fluid to the eye 160 using the fluidics cassette 300. Similarly, the step 620 can include the computing device 160 transmitting control signals to the motors 200 and/or other powered components of the fluidics module 200 and/or the system 100 to facilitate delivery of irrigation fluid to the eye 160 using the fluidics cassette 300.
At step 630, the method 600 includes controlling, using the computing device 160, at least one light source (e.g., the light source(s) 252, 253) to output light towards the fluidics cassette 300. The first portion of the light (e.g., beam 258) reflects from the central region 312 of the diaphragm 310, 320 of the fluidics cassette 300. A second portion of the light (e.g., the beam 259) is reflected from a component of the fluidics cassette 300 (e.g., the peripheral region 314, the mount 350) spaced from the central region 312 of the diaphragm 310, 320. In embodiments in which the beam 259 reflects from the mount 350, the beam 258 can be directed to any portion of the diaphragm 310, 320 (e.g., the central portion 312, the peripheral portion 314, etc.) The diaphragm 310, 320 is configured to deflect in response to a pressure associated with irrigation fluid and/or aspiration fluid within the fluidics cassette 300.
At step 640, the method 600 includes at least one sensor (e.g., the sensor(s) 254, 255) receiving reflected light from a first region (e.g., the central region 312 and/or the peripheral region 314) of the diaphragms 310, 320. Step 640 also includes the at least one sensor receiving reflected light from the reference component of the cassette 300 and/or the component of the cassette 300 spaced from the first region of the diaphragm (e.g., the peripheral region 314 and/or the mount 350). The at least one sensor is configured to generate respective electrical signals representative of the reflected light and transmit the signals to the computing device 160.
At step 650, the method 600 includes receiving first and second signals at the computing device 160, from the at least one sensor (e.g., the sensor(s) 254, 255). The first signal can be representative of the first portion of the light reflected from the central region 312 of the diaphragm 310, 320. The second signal can be representative of the second portion of the light reflected from the peripheral region 314 or the mount 350.
At step 660, the method 600 includes determining, using the computing device 160, the pressure (e.g., the fluid pressure and/or the vacuum pressure) associated with the irrigation fluid and/or aspiration fluid within the fluidics cassette 300 based on the received first and second signals. Determining the pressure of the irrigation fluid and/or aspiration fluid can include determining a first distance between the at least one sensor and the central region 312 of the diaphragm 310, 320 based on the received first signal. The method 600 can also include determining a second distance between the at least one sensor, and the peripheral region 314 or the mount 350, based on the received second signal. The method 600 can further include calculating a displacement of the diaphragm 310, 320 by subtracting the second distance from the first distance. The method 600 can also include correlating the displacement of the diaphragm 310, 320 to the pressure associated with the fluid within the fluidics cassette 300.
Once the pressure associated with the irrigation fluid and/or aspiration fluid is determined, the pressure can be increased, decreased, and/or kept the same in order to maintain proper intraocular pressure. For example, in response to the determined pressure(s), the computing device 160 can transmit control signals to the motors 210, the valve controls 220, the rollers 260, the pump 330, the valves 340, and/or other powered components of the system 100, to adjust the pressure associated with the irrigation fluid and/or aspiration fluid to maintain proper intraocular pressure. The user, such as the surgeon and/or other medical professional, can also monitor the measured pressure based on data displayed on the monitor 140. The user can adjust the aspiration and/or irrigation pressure as necessary.
Persons of ordinary skill in the art will appreciate that the implementations encompassed by the present disclosure are not limited to the particular exemplary implementations described above. In that regard, although illustrative implementations have been shown and described, a wide range of modification, change, combination, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.
| Number | Date | Country | |
|---|---|---|---|
| 62272946 | Dec 2015 | US |
