WO2008014368A2

WO2008014368A2 - Patient support structure for ophthalmic procedures and associated methods

Info

Publication number: WO2008014368A2
Application number: PCT/US2007/074400
Authority: WO
Inventors: George Richard Downes, Iii; Patrick Mcneill; Roland Toennies
Original assignee: Alcon Refractivehorizons, Inc.
Priority date: 2006-07-28
Filing date: 2007-07-26
Publication date: 2008-01-31
Also published as: WO2008014368A3

Abstract

A system (10) is provided that includes a patient support structure (200) for performing laser ophthalmic surgery thereon. The patient support structure includes a movable platform having a headrest area (205) and a patient identification device integrated into the platform. The identification device (13) is adapted to receive a signal from a patient-borne device '(201) and is operable to communicate with a processor (14) for automatically confirming patient identity. A temperature and a humidity sensor are positioned adjacent the headrest area. A heatable cushion (40) is provided for heating at least a portion of the patient positionable on the platform. A calibration stage (29) is also provided for calibrating a patient head position, wherein the calibration means is integral to the structure and positioned adjacent the headrest area. The platform can be moved from a first position for entry/exit and/or for flap cutting and a second position for performing a corneal ablation.

Description

PATIENT SUPPORT STRUCTURE FOR OPHTHALMIC PROCEDURES

AND ASSOCIATED METHODS

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to provisional application 60/834,124, filed July

28, 2006, entitled "Patient Support Structure for Ophthalmic Procedures and Associated Methods."

FIELD OF INVENTION The present invention generally relates to patient support structures, and, in particular, to such structures and methods for performing ophthalmic procedures, most particularly, to such structures and methods for performing laser-assisted ophthalmic procedures.

BACKGROUND

Laser ophthalmic surgery is known to be performed with a patient positioned on a support structure such as a substantially horizontal bed. Identification of the patient is performed visually and/or verbally. Temperature and humidity sensors are typically associated with the laser system, as is an effluent removal system, which includes tubing and a nozzle that are integral to the laser system and are deployed from the optical head.

A common complaint of patients is being cold, which is currently addressed by providing blankets or elevating the room temperature, although this is less common since surgical suites are usually kept at lower temperatures.

Systems known in the art perform calibration with a separate calibration stage that is manually loaded by site personnel, and is often bulky and mis-handled.

Some systems for performing ophthalmic surgery employ two different instruments, such as in laser surgery, wherein a first laser is used for cutting a corneal flap and a second laser is used for performing corneal ablation. In such surgeries the patient bed is typically moved manually from one location to another, and often some adjustment is required to attain an optimal position relative to at least one of the lasers. Even if an optimal position is determined, servicing of the laser or other movement of the system can alter the optimal position.

Therefore, improvements in the patient support structures of currently used ophthalmic laser systems would be desirable.

SUMMARY OF THE INVENTION

The embodiments of the present invention address at least the above deficiencies in the prior art. Embodiments of this invention comprise a patient support structure for performing laser ophthalmic surgery thereon. The patient support structure comprises a platform having a headrest area and a patient identification device integrated into the platform. The identification device is adapted to receive a signal from a patient-borne device and is operable to communicate with a processor for automatically confirming patient identity.

A temperature and a humidity sensor are positioned adjacent the headrest area. Means are provided for heating at least a portion of the patient positionable on the platform. Means are also provided for calibrating a patient head position, wherein the calibration means is integral to the structure and positioned adjacent the headrest area.

One embodiment of a method in accordance with this invention for conducting a laser ophthalmic procedure comprises the steps of automatically identifying a patient by means of a patient-borne device and automatically retrieving patient surgical data from a database based upon the identifying step. The patient is positioned on a patient support structure, so that the patient's head is positioned on a headrest that is affixed to the patient support structure.

At least a portion of the patient support structure is heated. A position of an eye of the patient that is scheduled for a procedure is detected, and the patient support structure is automatically positioned so that the patient's eye is in a desired position for performing a laser ophthalmic procedure. The procedure on the eye is commenced.

A local temperature and a humidity adjacent the patient eye is detected during the procedure, and surgical debris from the patient eye is removed using an effluent removal device that is affixed to the patient support structure.

The features that characterize the invention, both as to organization and method of operation, together with further objects and advantages thereof, will be better understood from the following description used in conjunction with the accompanying drawing. It is to be expressly understood that the drawing is for the purpose of illustration and description and is not intended as a definition of the limits of the invention. These and other objects attained, and advantages offered, by the present invention will become more fully apparent as the description that now follows is read in conjunction with the accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is an exemplary system schematic for a patient support structure; FIG. 2 is an exemplary high-level flowchart for a method of performing a laser ophthalmic procedure on an eye; FIG. 3 is an exemplary lower-level flowchart wherein method steps are segregated into columns indicating human and system involvement and actions; FIG. 4 is a front/side perspective view of an exemplary patient bed; FIG. 5 is a front/side perspective view of the bed of FIG. 4 occupied by a patient; FIG. 6 is a side perspective view of the head region of the bed of FIG. 4; FIG. 7 is a side perspective view of the head region of the bed of FIG. 4 occupied by a patient and with the effluent removal device deployed;

FIG. 8 is a side perspective view of the head region of the bed of FIG. 4 with the calibration stage partially deployed;

FIG. 9 is a side perspective view of the head region of the bed of FIG. 4 with the calibration stage fully deployed;

FIGS. 1OA and 1OB are top plan views of the system in the first (FIG. 10A) and second (FIG. 10B) positions; and

FIG. 11 is a flowchart of steps for performing laser surgery using two lasers, wherein the bed can be moved into position beneath each of the two lasers;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A description of the preferred embodiments of the present invention will now be presented with reference to FIGS. 1-11.

A schematic for an exemplary system 10 for performing ophthalmic surgery is shown in FIG. 1, an exemplary method 100 for using same, in FIGS. 2 and 3, and an exemplary patient bed 200, in FIG. 4. It is to be understood that the word "bed" is used herein as an embodiment, and that other patient support structures are intended to be subsumed into this invention, such as chairs and the like.

The system 10 (FIG. 1) is encompassed in and adjacent a patient bed 200 (FIGS. 4-9), and includes hardware and software elements for carrying out the method 100

(FIGS. 2 and 3). When the patient 90 arrives (block 101), typically the patient bed 200 will be in a first, "exit," position (block 102), and a heating element in the bed 200 will have been turned on to prepare the bed 200 for the patient 90. The heating element 19, which may be enclosed in a cushion 40, for example, preferably will only activate if the laser system 17 is also activated, thereby saving power.

The patient 90, who is wearing an RFID tag 201, approaches an RFID antenna 11 (block 103), which is in signal communication with electronics 12 for reading and transmitting data read from the RFID tag 201 to an interface board 13 (block 104), which in turn is in signal communication with a processor 14. Software 15 resident on the processor 14 matches the received data with patient data from a database 16 and retrieves the patient data (block 105), including data on the procedure to be performed. The pertinent data are displayed to the user 91 (e.g., surgeon; block 106) on the laser system 17 display. Patient data are confirmed (block 107), or the data are input manually (block 108), and progress is permitted (block 109). A slit lamp (not shown) can also be affixed to the bed 200 to permit examination of the patient eye 95 at any time preparatory to or during the procedure.

When the patient 90 gets onto the bed 200 (block 110), a pressure switch 18 is activated (block 111) that turns off the heating element 19 (block 112) in the cushion 40 beneath the patient 90. The heating element 19 is turned off so that the bed 200 does not become too warm with the additional body mass and heat of the patient 90. The user 91 also activates a knee rest button 20 (block 113), which elevates a knee rest 203 adjacent the patient's knees 93 (block 114). In addition, the user 91 can activate head rest buttons 21 (block 115), which signals the head rest 205 (block 116) to move at the laser system

17 level (block 117), signals the head rest control at the bed 200 (block 118), and moves the head rest 205 (block 119) to position the patient's head 94.

When the user 91 presses a specified laser system button (block 120), a signal is sent to the bed 200 (block 121), and to the laser system 17 (block 122), and a command is sent by the laser system 17 to move the bed 200 into a second, surgical position (block 123), this command received by the bed 200 (block 124), causing the bed 200 to move (block 125) by means of a bed motor 22. There is also a feature available to command (block 126) and to disable the bed 200 (block 127).

The bed 200 can also be enabled when the user 91 presses an "enable bed" button (block 128), sending a signal to the bed 200 (block 129), which in turn signals the laser system 17 (block 130) to enable the bed 200 (block 131).

The user 91, when it is desired to begin the procedure, presses a button 23 to indicate which eye 95 is to be treated ("OS/OD"; block 132), which signal is again routed to the bed 200 level (block 133) and thence to the laser system 17 level (block 134) to activate autopositioning. A command to move the bed 200 is issued (block 135), initiating a bed-level signal (block 136) and subsequent movement of the bed 200 (block 137). The eye positioning is displayed to the user 91 (block 138), and confirmed (block 139), which again can be accomplished manually if necessary (block 140), and progress is allowed (block 141).

Once laser treatment begins (block 142), an effluent pump 24 is activated (block 143) that is in fluid communication with tubing 25, at the distal end of which is a nozzle 26. The nozzle 26 is affixed to the bed 200 and is movable relative thereto with the use of, for example, a motorized arm 206 to approach the patient's eye 95 (FIGS. 6 and 7). During treatment, temperature 27 and humidity 28 sensors that are positioned on the bed 200 adjacent the surgical site send data to the bed interface board 13 and thence to the processor 14 (block 144). When the treatment is complete (block 145), the effluent pump 24 is turned off (block 146). An additional feature of the system 10 is the calibration stage 29, which is integral to the bed 200 in an exemplary embodiment, and can be stowed out of the way of the surgical site during the procedure. This stage 29 is under processor 14 control via the bed interface board 13, and is shown moving from the stowed position in FIG. 4, through an intermediate position in FIG. 8, to a fully deployed position in FIG. 9. The calibration element 41 on the calibration stage 29 is intended in its deployed position to reside at a position at which the eye 95 will reside for the procedure.

When it is time for the patient 90 to exit, the user 91 presses an exit button (block 147), which passes through the bed 200 controls (block 148) to the laser system 17 (block 149), which issues a command to move the bed 200 (block 150) to the bed control (block 151), causing the bed 200 to move (block 152). Once the bed 200 has moved to the exit position (block 153) and the patient is off the bed 200 (block 154), the pressure switch 18 is released (block 155), and the heating element 19 is turned on, if desired, in preparation for the next patient (block 156).

Yet another feature of the system 10 is a nitrogen generator and delivery system 207 that can be positioned, for example, at the foot of the bed 200, although this is not intended as a limitation. The nitrogen can be delivered via tubing to the surgical site for protecting the optics and purging the laser beam path. In some systems 10' the "first" bed position can also be useful for performing another procedure. For example, in the case of laser ablation (FIGS. 10A- 11), a femtosecond laser 50 can be used to perform the cutting of a flap prior to performing the ablation with an excimer laser 51. Thus it would be useful to include a feature of permitting the bed 200' to be moved to an optimal position for performing the flap cutting (FIG. 10A) and thence to the second position for laser ablation (FIG. 10B). This position can also comprise the "exit" position, or can comprise a third position.

In use, a method 160 of performing laser ablation (FIG. 11) can comprise, following step 119 described above, positioning the bed in the cutting position (step 161), for example, with the use of a joystick or other control. The system 10' stores this position as an optimal cutting position (step 162), which can be reset as needed. The flap is cut using the femtosecond laser 50 (step 163) and folded over.

The user then directs the system 10' to move the bed 200' to the surgical position as above for step 120, and carries on with the surgical procedure as above using the excimer laser 51.

It can be seen by one of skill in the art that the system and method disclosed herein significantly improve the operation of a laser ophthalmic system by a plurality of means, including, but not limited to, by increasing patient comfort and safety, by improving the quality of collected data, and by reducing clutter at the surgical site.

In the foregoing description, certain terms have been used for brevity, clarity, and understanding, but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such words are used for description purposes herein and are intended to be broadly construed. Moreover, the embodiments of the apparatus illustrated and described herein are by way of example, and the scope of the invention is not limited to the exact details of construction.

Having now described the invention, the construction, the operation and use of preferred embodiments thereof, and the advantageous new and useful results obtained thereby, the new and useful constructions, and reasonable mechanical equivalents thereof obvious to those skilled in the art, are set forth in the appended claims.

Claims

CLAIMS What is claimed is:

1. A patient support structure for performing laser ophthalmic surgery thereon comprising: a platform having a headrest area; a patient identification device integrated into the platform, the identification device adapted to receive a signal from a patient-borne device and operable to communicate with a processor for automatically confirming patient identity; a temperature and humidity sensor positioned adjacent the headrest area; means for heating at least a portion of the patient positionable on the platform; and means for calibrating a patient head position integral to the structure and positioned adjacent the headrest area.

2. The patient support structure recited in Claim 1 , further comprising means for removing surgical effluent positioned adjacent the headrest area.

3. The patient support structure recited in Claim 2, wherein the effluent removing means comprises a nozzle having an inlet, the nozzle affixable in fluid communication with a suction means.

4. The patient support structure recited in Claim 3, wherein the nozzle is affixable to a motorized arm for effecting a positioning of the nozzle in a desired location adjacent a surgical site on the patient.

5. The patient support structure recited in Claim 1, wherein the patient identification device comprises a radio frequency identification device.

6. The patient support structure recited in Claim 1, wherein the heating means comprises a heatable cushion positionable beneath a patient.

7. The patient support structure recited in Claim 6, wherein the heating means further comprises a pressure-sensitive switch for deactivating the heatable cushion upon the patient being positioned on the patient support structure and for activating the heatable cushion upon the patient exiting the patient support structure.

8. The patient support structure recited in Claim 1, wherein the calibrating means is movable from the headrest area to a stowed position during surgery.

9. The patient support structure recited in Claim 1 , further comprising a nitrogen gas delivery system positioned adjacent the patient support structure and having an outlet adjacent a beam path of a laser being used for the procedure.

10. The patient support structure recited in Claim 1, further comprising means for moving the platform between a first position and a second position adapted for directing an ablating laser beam onto a patient eye.

11. The patient support structure recited in Claim 10, wherein the first position comprises a position for permitting patient entry and exit.

12. The patient support structure recited in Claim 10, wherein the first position comprises a flap-cutting position adapted for directing a flap-cutting laser beam onto a patient eye.

13. The patient support structure recited in Claim 12, further comprising means for adjusting the platform into the flap-cutting position, and for storing the flap- cutting position for subsequent recall.

14. A method for conducting a laser ophthalmic procedure comprising the steps of: automatically identifying a patient by means of a patient-borne device; automatically retrieving patient surgical data from a database based upon the identifying step; positioning the patient on a patient support structure, a head of the patient positioned on a headrest affixed to the patient support structure; heating at least a portion of the patient support structure; detecting a position of an eye of the patient scheduled for a procedure; automatically positioning the patient support structure so that the patient eye is in a desired position for performing a laser ophthalmic procedure; beginning the procedure on the eye based upon the retrieved patient surgical data; detecting a local temperature and a humidity adjacent the patient eye; and removing surgical debris from the patient eye using an effluent removal device affixed to the patient support structure.

15. The method recited in Claim 14, wherein the heating step is effected prior to the patient being positioned on the patient support structure and is halted automatically upon the patient being positioned on the patient support structure.

16. The method recited in Claim 14, further comprising the step of re- effecting the heating step upon completion of the procedure and upon the patient exiting the patient support structure.

17. The method recited in Claim 16, wherein the halting step if effected automatically upon the patient exiting the patient support structure.

18. The method recited in Claim 14, wherein the effluent removal device comprises a nozzle having an inlet, the nozzle affixable in fluid communication with a suction means.

19. The method recited in Claim 14, wherein the surgical debris removing step comprises positioning the nozzle in a desired position adjacent the patient eye using a motorized arm.

20. The method recited in Claim 14, wherein the patient identifying step comprises detecting a presence of a radio frequency identification device borne by the patient.

21. The method recited in Claim 14, wherein the heating step comprises heating a cushion positionable beneath the patient.

22. The method recited in Claim 14, wherein the step of automatically positioning the patient support structure comprises calibrating a position of the headrest using a calibration stage.

23. The method recited in Claim 22, further comprising the step, prior to beginning the procedure on the eye, of moving the calibration stage away from the surgical field.

24. The method recited in Claim 14, further comprising the step, following the patient positioning step, of elevating a knee rest on the patient support structure, the knee rest positioned to coincide with knees of the patient.

25. The method recited in Claim 14, further comprising the step, prior to the eye position detecting step, of determining upon which eye the procedure is to be performed, and wherein the eye position detecting step comprises detecting the position of the determined eye.

26. The method recited in Claim 14, further comprising the step of delivering nitrogen gas from a delivery system positioned adjacent the patient support structure to a beam path of a laser being used for the procedure.

27. The method recited in Claim 14, further comprising the step of moving the platform between a first position and a second position adapted for directing an ablating laser beam onto a patient eye.

28. The method recited in Claim 27, wherein the first position comprises a position for permitting patient entry and exit.

29. The method recited in Claim 14, wherein the first position comprises a flap-cutting position adapted for directing a flap-cutting laser beam onto a patient eye.