PERSONALIZED TOURNIQUET CUFF ASSEMBLY

Abstract

A personalized tourniquet cuff assembly comprises a sterile tourniquet cuff, a machine-readable instrument symbol, machine-readable personalization data and a sterile connector. The instrument symbol identifies a predetermined first type of tourniquet instrument from a plurality of types of tourniquet instruments, and is adapted for contactless reading by an optical tourniquet interface of the first type of tourniquet instrument. The personalization data represents a value of a personalization parameter for safe operation of the tourniquet cuff with the first type of tourniquet instrument and is adapted for contactless reading by the optical tourniquet interface. The connector is adapted for releasably connecting the tourniquet cuff to the first type of tourniquet instrument. The instrument symbol and the personalization data are carried at a location enabling contactless reading thereof only if the assembly is positioned within a predetermined range of distances and range of orientations relative to the optical tourniquet interface.

Claims

1. A personalized tourniquet cuff assembly, comprising: a sterile tourniquet cuff having a sterile connector adapted for releasably connecting the sterile tourniquet cuff to a plurality of types of tourniquet instruments, wherein the sterile tourniquet cuff is operable to stop arterial blood flow into a portion of a patient's limb distal to the sterile tourniquet cuff during a time period suitably long to perform a. surgical procedure; a contactlessly-readable instrument symbol identifying a predetermined first type of tourniquet instrument from the plurality of types of tourniquet instruments and configured upon reading by an optical tourniquet interface to automatically specify the sterile tourniquet cuff for operation with the first type of tourniquet instrument; and contactlessly-readable personalization data representing a value of a personalization parameter for safe operation of the sterile tourniquet cuff with the first type of tourniquet instrument and configured upon reading the optical tourniquet interface to further automatically specify operability of the sterile tourniquet cuff; wherein the sterile tourniquet cuff is operable with the personalization parameter of the contactlessly-readable personalization data if the sterile tourniquet cuff is connected to the first type of tourniquet instrument as identified by the contactlessly-readable instrument symbol, wherein the sterile tourniquet cuff is operable without the personalization parameter of the contactlessly-readable personalization data if the sterile tourniquet cuff is connected to other than the first type of tourniquet instrument, and wherein the instrument symbol and the personalization data. are carried at a location enabling the contactless reading of the instrument symbol and the personalization data only if the personalized tourniquet cuff assembly is positioned by a user within a predetermined range of distances and within a predetermined range of orientations relative to the optical tourniquet interface.

2. (canceled)

3. The tourniquet cuff assembly of claim 1, further comprising a sterile barrier to Which the sterile tourniquet cuff is removably coupled, and wherein the contactlessly-readable instrument symbol and the contactlessly-readable personalization data are positioned on the sterile barrier adjacent the sterile tourniquet cuff.

4. (canceled)

5. The tourniquet cuff assembly of claim 1, further comprising an instrument of the first type, wherein the instrument has the optical interface for contactlessly reading the contactlessly-readable instrument symbol and contactlessly-readable personalization data, a pressure controller and a safe transfer key, and wherein the safe transfer key is actuatable to transfer at least one value of a personalization parameter from the personalization data to the pressure controller only if the pressure controller is inoperable.

6. The tourniquet cuff assembly of claim 1, further comprising an instrument of the first type, wherein the instrument has the optical interface for contactlessly reading the contactlessly-readable instrument symbol and contactlessly-readable personalization data and a pressure controller connectible to the sterile tourniquet cuff, and wherein the pressure controller is responsive to at least one value of a personalization parameter from the personalization data in automatically controlling a pressure in the sterile tourniquet cuff.

7. A method of personalizing a tourniquet cuff assembly for use in a surgical tourniquet procedure, comprising: providing a sterile tourniquet cuff operable in a sterile surgical field, a contactlessly-readable instrument symbol, contactlessly-readable personalization data and a sterile connector; positioning the contactlessly-readable instrument symbol and contactlessly-readable personalization data for contactless reading by an optical interface of a tourniquet instrument; prior to connecting the sterile connector, reading the contactlessly-readable instrument symbol and personalization data, the contactlessly-readable instrument symbol indicating a predetermined type of tourniquet instrument; if a type of the tourniquet instrument matches the predetermined type of tourniquet instrument, enabling a personalization parameter read from the contactlessly-readable personalization data for use by the tourniquet instrument; if the type of the tourniquet instrument does not match the predetermined type of tourniquet instrument, then a predetermined stored value or a user-entered value is designated for use by the tourniquet instrument and the personalization parameter read from the contactlessly-readable personalization data is not used by the tourniquet instrument; and connecting the sterile connector to connect the sterile tourniquet cuff to the tourniquet instrument.

8. (canceled)

9. (canceled)

10. The method of claim 7, wherein positioning the contactlessly-readable instrument symbol and contactlessly-readable personalization data for contactless reading comprises positioning the contactlessly-readable instrument symbol and contactlessly-readable personalization data within a predetermined range of the tourniquet instrument, and wherein the predetermined range is set to reduce false readings.

11. The method of claim 7, wherein the contactlessly-readable instrument symbol and contactlessly-readable personalization data are positioned relative to each other for concurrent contactless reading.

12. The tourniquet cuff assembly of claim 1, wherein the contactlessly-readable instrument symbol and personalization data are configured to be read prior to connecting the sterile connector.

13. The tourniquet cuff assembly of claim 1, wherein the contactlessly-readable instrument symbol and personalization data are configured to be read before the cuff is connected to any of the plurality of types of tourniquet instruments, thereby preserving a sterile field.

14. The method of claim 7, wherein the reading of the contactlessly-readable instrument symbol and personalization data does not compromise the sterility of the sterile tourniquet cuff or the tourniquet instrument.

15. The method of claim 7, further comprising applying the sterile tourniquet cuff to a portion of a patient's limb in the sterile surgical field to be operable for stopping arterial blood flow into the patient's limb distal to the sterile tourniquet cuff during a time period suitably long for performing a surgical procedure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 is a block diagram of one implementation of a tourniquet system having an optical interface for safe personalization.

[0025] FIG. 2A is a schematic plan view showing a sterile tourniquet cuff assembly having a machine-readable instrument symbol, machine-readable personalization data and a sterile pediatric cuff.

[0026] FIG. 2B is a pictorial representation of the sterile tourniquet cuff assembly from FIG. 2A being used with an instrument.

[0027] FIG. 3A is a drawing of a representative remote device having a machine-readable remote device symbol and a machine-readable data.

[0028] FIG. 3B is a pictorial representation of the remote device from FIG. 3A being used with the instrument.

[0029] FIG. 4 is a pictorial representation of a remote device displaying a clinical summary of a surgery for future analysis as received from the instrument

DETAILED DESCRIPTION

[0030] Described below are implementations of a tourniquet system that can acquire personalization parameters for safe tourniquet personalization, such as only if the personalization parameters are intended for the tourniquet instrument. Such a system can include an optical tourniquet interface that can contactlessly read a machine-readable instrument symbol that identifies one type of tourniquet instrument from a plurality of types of tourniquet instruments, and a machine-readable personalization data representing one or more values of personalization parameters on a tourniquet cuff package or a remote device. Such a system may present in a form perceptible to a user the value(s) of the personalization parameter(s) if the machine-readable instrument symbol matches stored authentication data. Such a system may include a safe transfer key or other control element, operable by the user to manually accept and transfer the value(s) of the personalization parameter(s) to the pressure controller. Such a system may also include a reject key or other control element, operable by the user to reject and prevent the transfer of the value(s) of the personalization parameter(s) to a pressure controller. Such a system may automatically initiate actions, such as inflation or deflation, immediately or shortly after the manual or automatic transfer of the value(s) of the personalization parameter(s) to the pressure controller

[0031] FIG. 1 depicts a block diagram of the tourniquet system of one representative implementation. Cuff 2 having inflatable bladder is shown encircling a limb 4 of patient. Cuff 2 may be supplied to a user as a single-use sterile cuff, packaged in a sterile tourniquet cuff assembly (see FIG. 2A), or it may be a reusable cuff. A pneumatic passageway between instrument 100 and cuff 2 is provided by cuff port 6, male locking connector 8, female locking connector 10 and flexible tubing 12. Cuff port 6 is fitted with a male locking connector 8 that mates to form a releasable pneumatic connection with female locking connector 10. Instrument 100 comprises of pressure controller 110, optical tourniquet interface 120, safe transfer key 130, reject key 132, clinical summary key 134, and speaker 140.

[0032] Pressure controller 110 includes a pneumatic pump and valve assembly and is operable for automatically controlling pressure in the connected inflatable bladder of cuff 2 near a reference pressure during a pressure control time period suitably long for a surgical procedure. Pressure controller 110 is adapted to automatically measure Limb Occlusion Pressure (LOP) of limb 4 with cuff 2.

[0033] Pressure controller 110 is also adapted to respond to values of personalization parameters transferred from optical tourniquet interface 120 to improve the safety and effectiveness of the pressure regulation, automatic LOP measurement, and other tourniquet settings. Personalization parameters include: whether cuff 2 is a dual-purpose cuff suitable for automatic LOP measurement or not; whether cuff 2 is adapted for use in a surgical procedure involving intravenous regional anesthesia or not; whether cuff 2 is single-use or reusable; the size and shape of the limb for which cuff 2 is intended to be applied to; pressure and time settings; whether LOP measurement is required; LOP safety margin values; maximum reference pressure; and other.

[0034] Pressure controller 110 records cuff 2's pressure, time, and alarm history during a surgical procedure as a plurality of pressures and alarm events of cuff 2 for a plurality of times during the pressure control time period. Upon completion of the surgical procedure, i.e., at the end of the pressure control time period, and upon activation of clinical summary key 134, optical tourniquet interface 120 communicates with pressure controller 110 to display the pressure, time, and alarm history of cuff 2 on display 122. To enable a user to capture this information remotely for later analysis, optical tourniquet interface 120 may also encode and display the information in a machine-readable form that can be optically read by a remote device, as described below. Optical tourniquet interface 120 may also encode and display values of personalization parameters in a machine-readable form.

[0035] Optical tourniquet interface includes display 122, and optical scanner 124. Display 122 may include a touchscreen to allow a user to interface with optical tourniquet interface 120. Optical tourniquet interface 120 communicates with pressure controller 110 to allow a user to control the operation of instrument 100.

[0036] Display 122 displays information to the user including reference pressure, current pressure, elapsed time, and alarm messages. Optical scanner 124 is adapted to contactlessly acquire values of personalization parameters for safe personalization, only if the personalization parameters are intended for instrument 100, as described below. if the personalization parameters are not intended for instrument 100, pressure controller 110 may use a predetermined stored value of the personalization parameter. In addition, optical tourniquet interface 120 may notify to the user through display 122 and/or speaker 140.

[0037] Once values of personalization parameters are acquired, instrument 100 allows the user to activate safe transfer key 130 to selectively transfer the values of the personalization parameters to pressure controller 110. Instrument 100 further allows the user to activate reject key 132 to reject transfer of the values of personalization parameters to pressure controller 110.

[0038] Safe transfer key 130, reject key 132, and clinical summary key 134 may be mechanical buttons on instrument 100 or they may be incorporated as touchable keys on a touchscreen of display 122.

[0039] FIGS. 2A and 2B depict an example of the preferred embodiment in use.

[0040] FIG. 2A shows a sterile tourniquet cuff assembly 200 having machine-readable instrument symbol 202, machine-readable personalization data 204, and sterile single-use pediatric cuff 206 having an inflatable bladder adapted for connection to instrument 100. Cuff 206 includes sterile cuff port 208 and sterile male locking connector 210. Sterile male locking connector 210 is adapted for releasably connecting cuff 206 to instrument 100. Sterile tourniquet cuff assembly 200 includes a sterile barrier 212 to ensure the sterility of cuff 206 before use.

[0041] Machine-readable instrument symbol 202 and machine-readable personalization data 204 may be texts, images, barcodes or other marks identifiable and readable by optical scanner 124. Machine-readable instrument symbol 202 and machine-readable personalization data 204 may be encoded together in a single marking instead of two separate markings. Different techniques of encoding will be apparent to those skilled in the art. Machine-readable instrument symbol 202 and machine-readable personalization data 204 may be located on a tourniquet cuff assembly, as shown in FIG. 2A, and/or on a cuff itself, for instance, as part of a label on a reusable cuff.

[0042] Machine-readable personalization data 204 represents at least one value of a personalization parameter that is used to optimally configure instrument 100 to increase patient safety by personalizing the tourniquet settings for an individual patient, surgical procedure, or surgeon. In this example, personalization parameters include information indicating cuff 206 is a single-use, cylindrical pediatric cuff with a cuff width of 2.25. Furthermore, cuff 206 is a dual-purpose cuff and thus automatic LOP measurement using a dual-purpose cuff is enabled. Since the detected cuff is a pediatric cuff, the LOP safety margin is 50 mmHg.

[0043] Since different tourniquet instruments may use different methods of determining LOP, and regulate pressure, due to hardware and/or software differences, personalization parameters may be suitable for optimally configuring one type of tourniquet instrument but unsuitable or hazardous for another type of tourniquet instrument. For an example, personalization parameters intended for a single-port tourniquet instrument would not be suitable for a dual-port tourniquet instrument. Machine-readable instrument symbol 202 identifies the type of tourniquet instrument that is suitable for using the values of personalization parameters represented by machine-readable personalization data 204 from a plurality of tourniquet instruments.

[0044] FIG. 2B shows instrument 100 with display 122 and optical scanner 124. When a user positions sterile tourniquet cuff assembly 200 within the field of view of optical scanner 124, optical scanner contactlessly reads machine-readable instrument symbol 202 and machine-readable personalization data 204. The field of view of optical scanner 124 is optimized to encompass a predetermined range of distances and a predetermined range of orientations relative to optical scanner 124 to prevent inadvertent hazardous reading of a second tourniquet cuff assembly outside the predetermined ranges.

[0045] Optical tourniquet interface 120 authenticates machine-readable instrument symbol 202 by matching it to stored authentication data. Once machine-readable instrument symbol 202 is authenticated, optical tourniquet interface 120 displays the values of the personalization parameters through display 122. The user may review the values of the personalization parameters and if they are considered safe and appropriate for the surgical procedure, the user can then selectively transfer the presented values of the personalization parameters to pressure controller 110 through safe transfer key 130. The user may also reject the transfer of the presented values of the personalization parameters to pressure controller 110 through reject key 132.

[0046] If machine-readable instrument symbol 202 does not match stored authentication data, pressure controller 110 may use predetermined stored values of personalization parameters, or prompt the user to manually enter values of personalization parameters. In addition, optical tourniquet interface 120 may indicate to the user that an unknown machine-readable instrument symbol has been read through display 122 and/or speaker 140.

[0047] To ensure tourniquet settings are not altered inadvertently in certain situations which may be hazardous, such as changing the reference pressure while cuff 206 is pressurized, safe transfer key 130 only allows the transfer of the values of the personalization parameters to pressure controller 110 when pressure controller 110 is inoperable. Optical tourniquet interface 120 may also prevent optical scanner 124 from scanning machine-readable instrument symbol 202 and machine-readable personalization data 204 when pressure controller 110 is operable.

[0048] Once the values of the personalization parameters are transferred to pressure controller 110, instrument 100 may immediately utilize the values of the personalization parameters and initiate certain actions, such as inflation or a measurement of LOP. Alternatively, instrument 100 may wait for additional user inputs before initiating new actions.

[0049] FIGS. 3A and 3B depict another example of the preferred embodiment in use.

[0050] FIG. 3A shows remote device 300 having a touchscreen for a user to generate a safety protocol. Safety protocol includes personalization parameters that can be used to optimally configure instrument 100 to increase patient safety by personalizing the tourniquet settings to the patient, the surgical procedure, or the surgeon. FIG. 3A shows remote device 300 allowing the user to define the following personalization parameters: the name of the protocol; the maximum reference pressure limit; the alarm time limit; whether LOP measurement is required; whether LOP safety margin is for an adult or a pediatric patient; and the deflation sequence. In the preferred embodiment, remote device 300 is a smart-phone.

[0051] FIG. 3B shows instrument 100 with display 122 and optical scanner 124. After the generation of a safety protocol from FIG. 3A, remote device 300 shows machine-readable remote device symbol 302 corresponding to remote device 300, and machine-readable data 304 associated with remote device 300 that is indicative of at least one remote value of a personalization parameter of the developed safety protocol.

[0052] When a user positions remote device 300 within the field of view of optical scanner 124, optical scanner contactlessly reads machine-readable remote device symbol 302 and machine-readable data 304. The field of view of optical scanner 124 is optimized to encompass a predetermined range of distances and a predetermined range of orientations relative to optical scanner 124 to prevent inadvertent hazardous reading of a second remote device outside the predetermined ranges.

[0053] Optical tourniquet interface 120 authenticates machine-readable remote device symbol 302 by matching it to stored authentication data. Once machine-readable remote device symbol 302 is authenticated, optical tourniquet interface 120 displays the values of the personalization parameters through display 122. The user may review the values of the personalization parameters and if they are considered safe and appropriate for the surgical procedure, the user can then selectively transfer the presented values of the personalization parameters to pressure controller 110 through safe transfer key 130. The user may also reject the transfer of the presented values of the personalization parameters to pressure controller 110 through reject key 132. In this example, personalization parameters include information associated with a safety protocol named pediatric protocol such as the maximum reference pressure limit (400 mmHg), alarm time limit (60 min), whether LOP is required or not (yes), to use pediatric LOP safety margin, and to use a stepped-decrease deflation sequence, which may be used to facilitate the detection and closure of bleeding vessels.

[0054] FIG. 4 depicts another example of the preferred embodiment in use.

[0055] FIG. 4 shows instrument 100 after a user activated clinical summary key 134. Clinical summary key 134 may be activated by the user after a pressure control time period, such as one suitably long for a surgical procedure. Display 122 displays a graphical representation of plurality of pressure levels and alarm events corresponding to a plurality of times during the pressure control time period. Instrument 100 also displays machine-readable clinical data 402 that is indicative of the graphical representation. Machine-readable clinical data 402 may also be indicative of previously transferred values of personalization parameters. Remote personalization device 400 is shown with remote scanner 404 capable of reading machine-readable clinical data 402, and displaying the information contained in machine-readable clinical data 402 on remote display 406. In the preferred embodiment, remote device 400 is a smart phone.

[0056] The embodiments illustrated are not intended to be exhaustive or to limit the invention to the precise form disclosed. They are chosen and described in order to explain the principles of the invention and its application and practical use, and thereby enable others skilled in the art to utilize the invention.

[0057] In view of the many possible embodiments to which the disclosed principles may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting in scope. Rather, the scope of protection is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.