Device for assisting a medical procedure

Abstract

One example discloses a medical device comprising a controller configured to be coupled to a set of optical sensors, wherein the controller is configured to: detect a set of structures imaged by the set of optical sensors within a predefined boundary; classify each of the set of structures as sterile or non-sterile; detect physical contact between a first structure of the structures classified as sterile and a second structure of the structures classified as non-sterile; and reclassify the first structure as non-sterile.

Description

Technical Field

[0001] This specification relates to systems, methods, devices, apparatuses, articles of manufacture, and instructions for use in assisting medical procedures. Background Technology

[0002] Critical care environments (such as hospitals, operating centers, medical clinics, and nursing homes) require well-defined procedures to differentiate materials, objects, structures, equipment, and personnel that meet various care standards (such as whether something is sterile or non-sterile).

[0003] For example, many materials, objects, structures, and equipment in an operating room (e.g., a hospital operating room) should be sterile to prevent infection of patients during medical procedures such as surgery. To achieve these purposes, items need to be sterilized. However, some surfaces are difficult to sterilize (e.g., X-ray machines) but are still located near other surfaces that must be sterile within the operating room.

[0004] Sterilization equipment that comes into contact with non-sterile surfaces or objects becomes non-sterile after contact. When these non-sterile objects come into contact with a patient, they may infect the patient. Furthermore, objects, surgical instruments, or other materials may remain inside the patient unnoticed. Summary of the Invention

[0005] According to an example embodiment, a medical device includes a controller configured to be coupled to a set of optical sensors, wherein the controller is configured to: detect a set of structures imaged by the set of optical sensors within a predefined boundary; classify each of the set of structures as sterile or non-sterile; detect physical contact between a first structure classified as sterile and a second structure classified as non-sterile; and reclassify the first structure as non-sterile.

[0006] In another example embodiment, the set of optical sensors includes a set of cameras.

[0007] In another example embodiment, the group of cameras is configured to view the entire predefined boundary together.

[0008] In another example embodiment, the controller is configured to detect new structures entering the predefined boundary.

[0009] In another example embodiment, the controller is configured to detect at least one of the structures that leave the predefined boundary.

[0010] In another example embodiment, at least one of the structures is: a patient, a doctor, a nurse, a practicing physician, or a robotic device.

[0011] In another example embodiment, at least one of the structures is: an object, a surface, a surgical instrument, an instrument tray, a set of disposable materials, or a medical device.

[0012] In another example embodiment, the controller is configured to generate an indication that at least one of the set of structures has changed from a sterile classification to a non-sterile classification.

[0013] In another example embodiment, the indication is at least one of the following: an alarm, the addition of at least one of the structures in the set to a list on an optical display, a change in the illumination of at least one of the structures in the set, or haptic feedback.

[0014] In another example embodiment, an optical indicator coupled to the controller is also included.

[0015] In another example embodiment, the controller is configured to cause the optical indicator to use a first illumination to illuminate a first subset of the set of structures classified as sterile.

[0016] In another example embodiment, the controller is configured to cause the optical indicator to use a second illumination to illuminate a second subset of the set of structures that are classified as non-sterile.

[0017] In another example embodiment, the optical indicator is a laser indicator.

[0018] In another example embodiment, the controller is configured to illuminate the structure with an optical indicator in response to a query from a user for locating a structure within the set of structures.

[0019] In another example embodiment, the predefined boundary is a first predefined boundary, and the set of structures is a first set of structures; the controller is configured to detect a second set of structures imaged by the set of optical sensors within a second predefined boundary; and the second predefined boundary is within the first predetermined boundary.

[0020] In another example embodiment, the first predefined boundary is the operating room; and the second predefined boundary is the patient.

[0021] In another example embodiment, the controller is configured to detect a subset of the structure from within the first predefined boundary entering or leaving the second predefined boundary.

[0022] In another example embodiment, a display is also included; wherein the controller is configured to present on the display at least one of the following: a list of the second group of structures currently within the second predefined boundary; a list of the first group of structures or the second group of structures classified as sterile; a list of the first group of structures or the second group of structures classified as non-sterile; or a list of the first group of structures or the second group of structures classified as missing.

[0023] In another example embodiment, the second set of structures is permanently implanted into the patient during a medical procedure.

[0024] According to an example embodiment, a method for assisting medical procedures includes: detecting a set of structures within a predefined boundary using a set of optical sensors; classifying each structure in the set of structures as sterile or non-sterile; detecting physical contact between a first structure and a second structure in the set of structures using the set of optical sensors; and reclassifying the first structure as non-sterile if the second structure was previously classified as non-sterile.

[0025] The foregoing discussion is not intended to present every exemplary embodiment or implementation within the scope of the present or future claims. The accompanying drawings and detailed description also illustrate various exemplary embodiments.

[0026] A more complete understanding of the various exemplary embodiments can be achieved by considering the following detailed description in conjunction with the accompanying drawings. Attached Figure Description

[0027] Figure 1 This is the first example of a medical device used to assist in medical procedures.

[0028] Figure 2 This is a second example of a medical device used to assist in medical procedures.

[0029] Figure 3 This refers to the detection and classification of examples of sterile and non-sterile structures (e.g., objects) during medical procedures.

[0030] Figure 4 This section describes example systems and instructions used to activate medical devices.

[0031] While this disclosure allows for various modifications and alternatives, its details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that other embodiments besides the specific embodiments described may also exist. All modifications, equivalents, and alternative embodiments falling within the spirit and scope of the appended claims are also covered. Detailed Implementation

[0032] The present discussion pertains to various exemplary embodiments of medical devices, equipment, systems, and methods for visually tracking all materials, objects, structures, equipment, and personnel in an operating room and dynamically (i.e., in real time) classifying these items as sterile or non-sterile in order to provide maximum care for patients undergoing medical procedures.

[0033] Figure 1 This represents a first example 100 of a medical device for assisting medical procedures. In the first example 100, the medical device includes a controller 102, an optical sensor 104, an optical indicator 106, a display 108, and a user interface 110. The controller 102 includes a memory 111, an initialization module 112, a detector module 114, and a classifier module 116.

[0034] The first example 100 also shows an operating room (e.g., an operating room) defined by a first boundary 118, and a patient defined by a second boundary 120 within the operating room and thus within the first boundary 118.

[0035] Various structures (e.g., objects) 122 distributed along both the first boundary 118 and the second boundary 120 are also shown. These structures (e.g., objects) 122 represent different materials, objects, structures, equipment, and personnel within the operating room, including surfaces on walls, floors, instrument trays, surgical instruments, disposable materials, etc. The terms “object” and “structure” are used interchangeably throughout the specification as short terms to refer to at least the items listed above.

[0036] A set of optical sensors 104 are coupled to controller 102 and configured to substantially (if not entirely) survey the entire first boundary 118 (e.g., an operating room). In many example embodiments, the optical sensors 104 may be video or still cameras, but in other example embodiments they may be any type of imaging device.

[0037] The optical sensor 104 is configured to operate in real time to capture images of all structures / objects 122 within the first boundary 118 (e.g., an operating room) and the second boundary 120 (e.g., a patient).

[0038] The optical sensor 104 is also configured to capture any physical contact (i.e., touch, collision, etc.) between any first structure (e.g., doctor) 122 and any second structure (e.g., surgical instrument) 122.

[0039] Detector module 114 is coupled to receive imaging data from optical sensor 104. Detector module 114 is trained to actually identify (e.g., mark, match, etc.) all structures / objects 122 in both the first boundary 118 and the second boundary 120 (i.e., within the operating room and the patient) based on the received imaging data.

[0040] The detector module 114 also assigns a set of spatial coordinates to each structure / object 122. The real-time changes of these spatial coordinates of the various structures / objects 122 will enable the classifier module 116 (described below) to determine when any structure / object 122 is in physical contact with each other.

[0041] In various example embodiments, machine learning and / or artificial neural networks are used to train the detector module 114 to accomplish the tasks described above.

[0042] An initialization module 112 is coupled between the user interface 110 and the classifier module 116. Together, the initialization module 112 and the user interface 110 enable healthcare professionals, doctors, and / or other automated systems to specifically list and label various structures / objects 122. In some example embodiments, the user interface 110 may include voice recognition features to enable healthcare professionals to operate medical devices more effectively.

[0043] Which structure / object 122 appears on which "lists" and has which "labels" depends entirely on the medical procedure to be performed. For example, one "list" could be "structures / objects 122 used to perform the first step in the medical procedure," while another "list" could be "disposable structures / objects 122 to be discarded after the medical procedure is completed." Importantly, the initialization module 112 and the user interface 110 enable medical personnel to label which structures / objects 122 are "sterile" and which are "non-sterile."

[0044] The initialization module 112 and user interface 110 can also be used to help locate and aim the optical sensor 104 and optical indicator 106 to ensure coverage of important areas within the first boundary 118 and the second boundary 120 (i.e., within the operating room and the patient's room).

[0045] The initialization module 112 and the user interface 110 can also be used to specify which “lists” and “labels” should be displayed to medical personnel on the display 108 during a medical procedure.

[0046] The classifier module 116 is configured to integrate inputs from the detector module 114, the initialization module 112, and the user interface 110, and in response, control the optical indicator 106 and the display 108 (or additionally, as shown in the image). Figure 2 The alarm discussed in the document).

[0047] For example, classifier module 116 is configured to track all structures / objects 122 within the first boundary 118 and the second boundary 120 (i.e., within the operating room and the patient) and update the label of each structure / object 122 (e.g., sterile or non-sterile) and which lists they appear on.

[0048] In various example embodiments, machine learning and / or artificial neural networks are used to train the classifier module 116 to accomplish the tasks described above.

[0049] In various example embodiments, classifier module 116: tracks all objects placed into or removed from the patient's body (i.e., second boundary 120); maintains a list of new structures / objects 122 entering the operating room (i.e., first boundary 118); maintains a list of structures / objects 122 to be permanently implanted into the patient's body (i.e., second boundary 120) during surgery (e.g., identified by medical personnel using user interface 110 during initialization) to remain in place after surgery; updates the list when various structures / objects 122 previously marked as "sterile" become "non-sterile"; and maintains a list of consumable structures / objects 122 to be discarded (e.g., gauze pads). Additionally, the system should retain a list of objects it has lost tracking from. In various example embodiments, objects on this list can be shown with the latest coordinates and images to help staff locate them.

[0050] The classifier module 116 is also configured to determine when one or more structures / objects 122 are in physical contact with each other and thus update their “list” and “labels” (e.g., “sterile” structure / object 122 is in contact with “non-sterile” structure / object 122 and therefore needs to be reclassified as “non-sterile”).

[0051] In some example embodiments, various physical contacts may include: sterile to sterile; sterile to non-sterile; and non-sterile to non-sterile.

[0052] The classifier module 116 can be programmed to have a predetermined threshold based on imaging data from the optical sensor 104 that is defined as “physical contact.” In some example embodiments, this predetermined threshold can be based on a statistical model that provides a gap greater than zero between two structures / objects 122, but is determined as “physical contact” for medical purposes in order to provide maximum care to the patient and prevent infection.

[0053] The classifier module 116 can also list certain sterile objects that have come into contact with non-sterile patients but can still be reused on the patient under the assumption that the patient cannot infect themselves. Such a list can mark the structure / object 122 as quasi-sterile.

[0054] The optical indicator 106 is controlled by one or more modules within the controller 102 and is configured to illuminate (e.g., point to, highlight, etc.) one or more structures / objects 122 within the operating room and / or the patient (i.e., the first boundary 118 or the second boundary 120).

[0055] If medical personnel cannot locate a structure / object 122, the optical indicator 106 can be particularly useful. In this case, the medical personnel can query the memory of the controller 102 for the location of the missing object via the user interface 110. The controller 102 will then cause the optical indicator 106 to illuminate the structure / object 122 and / or cause the display 108 to show a set of physical spatial coordinates, possibly indicating the location of the structure / object 122 on a map of a first boundary 118 (e.g., the operating room) or a second boundary 120 (e.g., the patient).

[0056] In some example embodiments, the optical indicator 106 is a low-power laser indicator with a diffuse visible beam. In other example embodiments, the optical indicator 106 may be a conventional digital video projector, which can display arbitrary graphic overlays on any surface within one of the boundaries. Additionally, the optical indicator 106 may be physically coupled to the optical sensor 104 to achieve a smaller form factor and simpler installation in the operating room.

[0057] Display 108 is configured to allow medical personnel to visually view various “lists” and “labels” generated by classifier module 116. In various example embodiments, display 108 may be a tablet computer, a webpage, augmented reality (AR) glasses, a projector, or a regular computer monitor.

[0058] Figure 2 A second example 200 is shown, representing a medical device for assisting medical procedures. In this second example 200, a medical device controller 202, a set of optical sensors 204, a projection system 206, a display 208, a user interface 210, and an audio / visual alarm 212 are included. The controller 202 includes an object tracking module 214 and a set of object detection and classification modules 216.

[0059] The object tracking module 214 and the object detection and classification module 216 are used in conjunction with Figure 1 The initialization module 112, detector module 114 and classifier module 116 discussed in the article operate in a similar manner.

[0060] The new feature here is an audio / visual alarm 212. The audio / visual alarm 212 provides medical personnel with a more substantial indication of certain events (e.g., a transition from "sterile" to "non-sterile" contact) than just the display on monitor 208.

[0061] In one example embodiment, an audio / visual alarm 212 sounds if the surgeon has had physical contact with a non-sterile object.

[0062] However, more proactively, in another example embodiment, if the surgeon is about to make physical contact with a non-sterile object, an audio / visual alarm 212 sounds, allowing the surgeon to stop moving and thus preventing actual physical contact with the non-sterile object.

[0063] Figure 3 Example 300 illustrates the detection and classification of sterile and non-sterile structures (e.g., objects) during a medical procedure. Example 300 shows one or more users 302 (e.g., doctors, nurses, assistants, etc.) and a medical device 304. The medical device 304 is configured to interact with... Figure 1 and Figure 2 The operation is similar to the method discussed in the article.

[0064] At a first time 306, user 302 labels a group of objects detected by medical device 304 as sterile or non-sterile, generating an initial state 308 of a group of sterile or non-sterile objects in the operating room. In other example embodiments, medical device 304 proposes tags based on previous tags used for similar objects. This information is retrieved from storage. User 302 then verifies the tags and corrects them if necessary.

[0065] At a second time 310, the medical device 304 tracks and updates sterile and non-sterile objects during the operation to generate a set of current states 312 for sterile or non-sterile objects.

[0066] At the third time 314, the medical device 304 tracks and notifies the physician upon contact with a non-sterile object.

[0067] At the fourth time 316, the medical device 304 generates a list of sterile or non-sterile objects in the patient's body.

[0068] At time 318, the medical device 304 requests the physician to confirm that the object identified at time 316 should remain in the patient's body.

[0069] At the sixth time 320, the medical device 304 generates a report or exports data to include it in the external report generation process to help meet hospital regulatory requirements.

[0070] Figure 4 Example 400 system and instructions for enabling a medical device are shown. System 400 illustrates input / output data 402 interfaced with computing device 404. Computing device 404 includes processor device 406, storage device 408, and machine-readable storage medium 410. Instructions 412 to 418 within machine-readable storage medium 410 control how processor 406 interprets and transforms input data 402 using data within storage device 408. In an alternative example embodiment, the machine-readable storage medium is a computer-readable storage medium.

[0071] In one example, the instructions stored in the machine-readable storage medium 410 include: 412 detecting a set of structures within a predefined boundary; 414 classifying each structure in the set of structures as sterile or non-sterile; 416 detecting physical contact between a first structure and a second structure in the set of structures; and 418 reclassifying the first structure as non-sterile if the second structure was previously classified as non-sterile.

[0072] Figure 4 The instructions / steps described herein can be executed in any order unless explicitly limited to a particular order. In some example embodiments, the instruction set described above is implemented as functional and software instructions. In other embodiments, the instructions can be implemented using logic gates, application-specific chips, firmware, and other hardware forms. In various example embodiments, the instructions can be embodied as a set of executable instructions in a non-transitory computer-readable or computer-usable medium, implemented on a computer or machine programmed with and controlled by the executable instructions.

[0073] It is readily understood that the components of the embodiments generally described herein and illustrated in the accompanying drawings can be arranged and designed in a wide variety of different configurations. Therefore, the detailed descriptions of the various embodiments illustrated in the figures are not intended to limit the scope of this disclosure, but merely to illustrate various embodiments. Although various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless specifically stated otherwise.

[0074] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The described embodiments should be considered illustrative rather than restrictive in all respects. Therefore, the scope of the invention is indicated by the appended claims rather than by the detailed description herein. All modifications falling within the equivalent meaning and scope of the claims should be included within their scope.

[0075] References to features, advantages, or similar language throughout this specification do not imply that all features and advantages achievable with this invention should be included in or in any single embodiment of the invention. Rather, language relating to features and advantages should be understood to mean that a particular feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the invention. Therefore, discussions of features, advantages, and similar language throughout this specification may (but are not necessarily) refer to the same embodiment.

[0076] Furthermore, the features, advantages, and characteristics described in this invention can be combined in any suitable manner in one or more embodiments. Those skilled in the art will recognize that, in view of the description herein, this invention can be practiced without one or more specific features or advantages of a particular embodiment. In other instances, additional features and advantages that may not be present in all embodiments of the invention may be recognized in certain embodiments.

[0077] Throughout this specification, references to "an embodiment," "an embodiment," or similar language mean that a particular feature, structure, or characteristic described in connection with the indicated embodiment is included in at least one embodiment of the invention. Therefore, the phrases "in one embodiment," "in an embodiment," and similar language throughout this specification may (but not necessarily) all refer to the same embodiment.

[0078] As used herein, “predefined” is equivalent to “predetermined” and indicates a value or setting that is adjusted for a specific application / implementation / example of the described and / or claimed subject matter.

Claims

1. A medical device, characterized in that, The medical device includes: A controller, configured to be coupled to a set of optical sensors, The controller is configured to: Detect a set of structures imaged by the set of optical sensors within a predefined boundary; Each of the aforementioned set of structures is classified as either sterile or non-sterile; Detecting the physical contact between a first structure classified as sterile and a second structure classified as non-sterile in the structure; and The first structure is reclassified as non-sterile.

2. The apparatus according to claim 1, characterized in that: The set of optical sensors includes a set of cameras.

3. The apparatus according to claim 2, characterized in that: The group of cameras is configured to view the entire predefined boundary together.

4. The apparatus according to claim 1, characterized in that: The controller is configured to detect new structures entering the predefined boundary.

5. The apparatus according to claim 1, characterized in that: The controller is configured to detect at least one of the structures that leave the predefined boundary.

6. The apparatus according to claim 1, characterized in that: At least one of the structures is: a patient, a doctor, a nurse, a practicing physician, or a robotic device, or at least one of the structures is: an object, a surface, a surgical instrument, an instrument tray, a set of disposable materials, or a medical device.

7. The apparatus according to claim 1, characterized in that: The controller is configured to generate an indication that at least one of the structures in the set has been changed from a sterile classification to a non-sterile classification.

8. The apparatus according to claim 1, characterized in that: It also includes an optical indicator coupled to the controller.

9. The apparatus according to claim 1, characterized in that: The predefined boundary is a first predefined boundary, and the set of structures is a first set of structures; The controller is configured to detect a second set of structures imaged by the set of optical sensors within a second predefined boundary; and The second predefined boundary is within the first predetermined boundary.

10. A method for assisting medical procedures, characterized in that, The method includes: Use a set of optical sensors to detect a set of structures within a predefined boundary; Each of the aforementioned set of structures is classified as either sterile or non-sterile; The physical contact between the first structure and the second structure in the structure is detected using the set of optical sensors; and If the second structure was previously classified as non-sterile, the first structure is reclassified as non-sterile.

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