Tip Detection Apparatus and Method for Medical Device
20170224888 · 2017-08-10
Inventors
- Lauren M. Hickey (Torrance, CA, US)
- Kyle E. Lynn (Los Angeles, CA, US)
- Johan W. Steenstra Toussaint (Redondo Beach, CA, US)
- Frederick C. Lee (Tustin, CA, US)
- James W. Staggs (Laguna Niguel, CA)
Cpc classification
A61M1/774
HUMAN NECESSITIES
A61F9/00736
HUMAN NECESSITIES
A61M2205/14
HUMAN NECESSITIES
A61M1/73
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
An apparatus and method of detecting an interchangeable tip of a handpiece of an ocular surgical system is disclosed. The interchangeable tip of the system includes an irrigation port that receives fluid flowing from an irrigation source and an aspiration port that removes or aspirates fluid and/or materials from the surgical field, in particular a patient's eye, through use of an aspiration source or pump. The method comprises attaching the interchangeable tip to the handpiece, introducing fluid flow into the system and determining the fluid flow rate of fluid flow in the system, determining the pressure of fluid flowing into the interchangeable tip, determining the pressure of fluid flowing out of the interchangeable tip and comparing the flow rate and pressure information to known flow rate and pressure readings of known types of interchangeable tips to determine the type of interchangeable tip being used.
Claims
1. An ocular surgical apparatus comprising: a handpiece configured to receive an interchangeable tip; an irrigation line to transport fluid to the interchangeable tip, the irrigation line being connected to an irrigation source; an aspiration line to transport fluid away from the interchangeable tip, the aspiration line connected to an aspiration source; a sensor system capable of determining the pressure of fluid flowing in the aspiration line; and a controller capable of determining the flow rate of fluid flowing through the apparatus, and further capable of receiving information from the sensor system regarding the pressure of fluid flowing in the aspiration line; and wherein the controller is further capable of comparing the flow rate of the fluid flowing through the apparatus to known flow rate information of standard tips, and capable of comparing the pressure information received from the sensor system to known pressure information of standard tips, and further capable of determining the type of interchangeable tip attached to the handpiece, and wherein the controller can adjust one or more settings of the apparatus based on the type of interchangeable tip without user input.
2. The surgical apparatus of claim 1, wherein the interchangeable tip includes an irrigation port to receive fluid from the irrigation line.
3. The surgical apparatus of claim 2, wherein the interchangeable tip includes an aspiration port to remove fluid or materials via the aspiration line.
4. The surgical apparatus of claim 1, wherein the sensor system if further capable of determining the pressure of fluid flowing in the irrigation line.
5. The surgical apparatus of claim 4, wherein the controller is further capable of receiving information from the sensor system regarding the pressure of fluid flowing in the irrigation line.
5. The surgical apparatus of claim 1, wherein the sensor system includes a first sensor along the aspiration line.
6. The surgical apparatus of claim 4, wherein the interchangeable tip includes an aspiration port to receive fluid from an eye through the aspiration line, and the first sensor is positioned adjacent the aspiration port.
7. The surgical apparatus of claim 6, wherein the first sensor determines the pressure of fluid flowing in the aspiration line and the flow rate of fluid flowing through the aspiration line.
8. The surgical apparatus of claim 5, wherein the sensor system includes a second sensor along the irrigation line.
9. The surgical apparatus of claim 8, wherein the interchangeable tip includes an irrigation port to receive fluid from the irrigation line, and the second sensor is positioned adjacent the irrigation port.
10. The surgical apparatus of claim 9, wherein the second sensor determines the pressure of fluid flowing in the irrigation line and the flow rate of fluid flowing through the irrigation line.
11. The surgical apparatus of claim 1, wherein the aspiration source is a venturi pump or a peristaltic pump.
12. The surgical apparatus of claim 1, wherein the aspiration source is a combination venturi pump and peristaltic pump.
13. The surgical apparatus of claim 1, further including a pressure supply that maintains a predetermined amount of pressure in the irrigation source.
14. A method of detecting an interchangeable tip of a handpiece of an ocular surgical system, the method comprising: attaching the interchangeable tip to the handpiece; introducing fluid flow into the system and determining the fluid flow rate of fluid flow in the system; determining the pressure of fluid flowing into the interchangeable tip; determining the pressure of fluid flowing out of the interchangeable tip to an aspiration source; comparing the flow rate and pressure information to known flow rate and pressure readings of known types of interchangeable tips to determine the type of interchangeable tip being used; determining a set of surgical settings or system performance metrics for the system based on the interchangeable tip detected; and applying the surgical settings or metrics to the system automatically in order to have desired system performance during the surgical operation.
15. The method of claim 14, wherein the fluid flow is introduced into the system via an irrigation line connected to an irrigation source.
16. The method of claim 15, wherein the irrigation source is a drip bag.
17. The method of claim 16, wherein the method further comprises maintaining a predetermined amount of pressure in the irrigation source.
18. The method of claim 14, wherein the method further comprises using a venturi pump or a peristaltic pump to aspirate the fluid flowing out of the interchangeable tip.
19. The method of claim 18, wherein the fluid flowing out of the interchangeable tip carries ocular lens material.
20. The method of claim 14, wherein the method further comprises providing the set of surgical settings or system performance metrics to a user on a display.
21. The method of claim 20, wherein the method further comprises permitting a user to adjust or cancel the surgical settings or system performance metrics.
22. The method of claim 15, wherein the method further comprises providing a name or identification number of the interchangeable tip detected to a user on a display.
23. The method of claim 22, wherein the screen permits the user to interactively modify or cancel applying the surgical settings or metrics to the system once the name or identification number of the interchangeable tip is provided.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The organization and manner of the structure and function of the disclosure, together with the further objects and advantages thereof, may be understood by reference to the following description taken in connection with the accompanying drawings, and in which:
[0015]
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
DETAILED DESCRIPTION
[0022] The following description and the drawings illustrate specific embodiments sufficiently to enable those skilled in the art to practice the described system and method. Other embodiments may incorporate structural, logical, process and other changes. Examples merely typify possible variations. Individual components and functions are generally optional unless explicitly required, and the sequence of operations may vary. Portions and features of some embodiments may be included in or substituted for those of others.
[0023] A system and method for detecting interchangeable tips of a handpiece of a surgical system utilizing vacuum-based aspiration sub-system, which can be applied to any system, medical or non-medical, are disclosed herein. In illustrative embodiments, the system and method include means for automatically detecting the type of interchangeable tip connected to the handpiece and automatically calibrating or adjusting performance or settings of the system based on the characteristics of the tip attached to the handpiece
[0024] Embodiments of a subsystem and method will be discussed herein with a particular emphasis on a medical or hospital environment where a surgeon or health care practitioner performs. For example, an embodiment is a phacoemulsification surgical system that comprises an integrated high-speed control module for a vitrectomy handpiece that can accept a variety of interchangeable tips. The system further comprises sensors to detect the pressure of fluid flowing through the system, and in particular the pressure of fluid before and after the fluid flows through an interchangeable tip attached to the handpiece, and a processor that determines the size or type of the interchangeable tip based on known or predetermined pressure differentials known for various tips. The system further comprises a processor that can control, adjust or set various characteristics of the system to control a high-speed pneumatic vitrectomy handpiece.
[0025]
[0026] As illustrated in
[0027] During the surgical procedure, it may be necessary to remove or aspirate fluid and other material from the eye. Accordingly, fluid may be aspirated from the eye via the handpiece 20 to flow through an aspiration line 42 to the aspiration source 40. The aspiration source 40 may be any type of aspiration source 40 that creates a constant fluid flow such that vacuum pressure may be determined in the fluid flow. In illustrative embodiments, the aspiration source 40 may be configured to be a flow-based pump 44 (such as a peristaltic or scroll pump) that are well known in the art. The aspiration source 40 may create an aspiration system to pump a uniform or predetermined amount of fluid and/or material out of the eye via the aspiration line 42. Other embodiments of a uniform aspiration source are well known in the art.
[0028] The handpiece 20 includes a first end 22 and a second end 23 that includes means for attaching an interchangeable tip 24. The tip 24 includes an irrigation port 26 and an aspiration port 28. The irrigation port 26 is fluidly coupled to the irrigation line 32 to receive fluid flow from the irrigation source 30, and the aspiration port 28 is fluidly coupled to the aspiration line 42 to receive fluid and/or material flow from the eye. The handpiece 20 and the tip 24 may further emit ultrasonic energy into the patient's eye, for instance, to emulsify or break apart the crystalline lens within the patient's eye. Such emulsification may be accomplished by any known methods in the industry, such as, for example, a vibrating unit (not shown) that is configured to ultrasonically vibrate and/or cut the lens, as is known in the art. Other forms of emulsification, such as a laser, are well known in the art. Concomitantly with the emulsification, fluid from the irrigation source 30 is irrigated into the eye via the irrigation line 32 and the irrigation port 26. During and after such emulsification, the irrigation fluid and emulsified crystalline lens material are aspirated form the eye by the aspiration source 40 via the aspiration port 28 and the aspiration line 42. Other medical techniques for removing crystalline lenses also typically include irrigating the eye and aspirating lens parts and other liquids. Additionally, other procedures may include irrigating the eye and aspirating the irrigating fluid within concomitant destruction, alternation or removal of the lens.
[0029] As illustrated in
[0030] As illustrated in
[0031] As shown in
[0032] As shown in
[0033] As shown in
[0034] In illustrative embodiments, various types of tips may be used to perform various surgical procedures throughout a single surgical operation. The tips 24 may be coupled to the handpiece 20 through any known means, including coupling a threaded portion 18 of the tip 24, as illustrated in
[0035] As illustrated in
[0036] At a point after fluid flows through tip X.sub.1, as illustrated in block 208, the sensor system 52 determines an output pressure P.sub.2, as illustrated in block 210. The input and output pressures P.sub.1 and P.sub.2 are sent to the control module 60 where they are analyzed by the control module 60 to identify the specific type of tip, X.sub.1, being used on the handpiece 20, as illustrated in block 212. The control module 60 can then adjust various system settings, criteria or control characteristics of the system 100 in order to enhance or optimize the surgical procedure with tip X.sub.1, as illustrated in block 214. At this point, the surgeon or user will use tip X.sub.1 to perform various surgical action(s). Once finished, the surgeon may either choose remove the tip X.sub.1 from the handheld device 20 if the surgical procedure is complete, as illustrated in block 216, or remove tip X.sub.1 and attach a different tip, tip X.sub.2, to the handheld device for additional surgical operations, as illustrated in block 218. If the surgeon attaches a new tip X.sub.2 to the handheld device 20, another prime or tune cycle will be instituted in the system 100, and fluid can again be introduced into the system via the irrigation source 30 at a flow rate R.sub.2 (which may be the same or different from R.sub.1) to cause the system to be completely filed with fluid. Blocks 204-214 may then be repeated for operation with tip X.sub.2 in order to enhance or optimize the surgical procedure with tip X.sub.2. This process may be repeated as many times as necessary to calibrate or set the system 100 when and if a new or different tip is introduced to system 100.
[0037]
[0038] In illustrative embodiments, the sensor system 52 may be configured in a variety of ways or located in various locations. For example, the sensor system 52 may include at least a first sensor or strain gauge 54 and a second sensor or strain gauge 56, as illustrated in
[0039] The irrigation source 30 is configured to deliver irrigation fluid in a steady, uniform flow rate R. In illustrative embodiments, the pressure supply 50 may be connected to the lower end of the irrigation source 30 such that pressurization of the irrigation source 30 is accomplished by a gas being delivered through pressure supply line 58, as illustrated in
[0040] In an embodiment of the present invention, the pressurized gas 36 may be limited to a low pressure or low maximum available pressure, and may be constant so as to provide a stable and non-dynamic pressure to the irrigation source 30. In illustrative embodiments, the pressure supply 50 may include a pressurization device such as a compressor. As known in the art, the pressure supply 50 may be electronically controlled and monitored by the control module 60. The control module 60 may further measure and provide variables of the pressure supply 50 to a user or surgeon, and thereafter provide means for controlling the pressure supply 50.
[0041] In an alternative embodiment, instead of pressure supply 50, the amount of fluid supplied from irrigation source 30 may be controlled by gravity and an adjustable IV pole. The control module 60 may monitor the fluid flow from irrigation source 30 and adjust the IV pole to achieve a desired flow rate.
[0042] Similarly, the aspiration source 40 is configured to aspirate or remove fluid and other materials from the eye in a steady, uniform flow rate R. Various means for steady, uniform aspiration are well known in the art. In illustrative embodiments, the aspiration source 40 may be a venturi pump, a peristaltic pump, or a combined venturi and peristaltic pump. In illustrative embodiments, and as shown in
[0043] In illustrative embodiments, the control module 60 is configured to monitor and control various components of the system 100. For instance, the control module 60 may monitor, control, and provide power to the pressure supply 50, the aspiration source 40, and/or the handpiece 20. The control module 60 may be in a variety of forms as known in the art. In illustrative embodiments, the control module 60 may include a microprocessor computer 62, a keyboard 64 (which may be virtual displayed on a screen), and a display or screen 66, as illustrated in
[0044] The screen 66 may display various measurements, criteria or settings of the system 100—such as the type of procedure, the phase of the procedure F and duration of the phase D, flow rate R, the input and output pressures P, and the tip 24 the system has been calibrated for, as illustrated n
[0045] The tip calibration process illustrated in
[0046] Those of skill in the art will recognize that any step of a method described in connection with an embodiment may be interchanged with another step without departing from the scope of the invention. Those of skill in the art would further appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present invention.
[0047] The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed using a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
[0048] Any options available for a particular medical device system may be employed with the present invention. For example, with a phacoemulsification system the available settings may include, but are not limited to, irrigation, aspiration, vacuum level, flow rate, pump type (flow based and/or vacuum based), pump speed, ultrasonic power (type and duration, e.g. burst, pulse, duty cycle, etc.), irrigation source height adjustment, linear control of settings, proportional control of settings, panel control of settings, and type (or “shape”) of response.
[0049] The interface provides feedback to the user should the pre-selected or automatic settings or criteria need adjustment to ensure all the desired settings of the system. The interface can then permit the user to change or modify those settings accordingly.
[0050] Other mechanisms for setting and/or programming a particular setting may be employed with the present invention, including, but not limited to, clicking on an icon on a display screen using a mouse or touch screen, depressing a button/switch on a foot pedal, voice activated commands and/or combinations thereof.
[0051] The term “phacoemulsification” refers to a method of lens and cataract extraction from an eye. The procedure includes an ultrasonically vibrated needle which is inserted through a very small incision in the cornea in order to provide energy for emulsifying or breaking up of the lens and cataract which then can be aspirated and removed through the incision.
[0052] The term “vitrectomy surgery” refers to a method employed during cataract surgery when the posterior capsular bag has been broken and in the treatment of retinal detachments resulting from tears or holes in the retina. In cataract surgery, the same incision used for the phacoemulsification handpiece is used for inserting the vitrector to remove the vitreous gel. Vitrectomy surgery typically involves removal of vitreous gel and may utilize three small incisions in the pars plana of the patient's eye. These incisions allow the surgeon to pass three separate instruments into the patient's eye to affect the ocular procedure. The surgical instruments typically include a vitreous cutting device, an illumination source, and an infusion/aspiration port(s), but these devices may be combined into one single tool as well.
[0053] The term “screen,” “display,” or “display screen” as used herein shall mean a graphical user interface (GUI), a screen, a monitor, touch screen, or any other device known in the art for displaying a visual picture or representation.
[0054] The previous description is provided to enable any person skilled in the art to make or use the disclosed embodiments. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present disclosure is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.