Systems and methods for drape volume control

Abstract

According to one embodiment of the present disclosure, a system for controlling the volume of a drape is provided, the system comprising: a drape (102) operable to substantially cover an articulating member (104) and having a pressure source opening (121) defining a path for fluid to flow into or out of a volume substantially enclosed by the drape and at least one tool opening (117) enabling a tool (106) to be supported outside the volume substantially enclosed by the drape through the articulating member; at least one sensor (114) operable to monitor a characteristic of the system; and a controller (112) causing the volume substantially enclosed by the drape to increase to a maximum volume, decrease to a minimum volume, or remain at a working volume, and wherein the drape gradually conforms to the articulating member as the volume substantially enclosed by the drape decreases.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application 63 / 031,197, filed May 28, 2020, entitled “System and Method for Drape Volume Control,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This technology relates in general to drapes, and more specifically, to controlling a volume that is substantially enclosed by a drape. Background Technology

[0004] Surgical drapes are used during surgical procedures to maintain sterility by preventing contact between non-sterile and sterile surfaces. A surgical drape may enclose one or more non-sterile devices and / or tools to create a barrier between the device / tool ​​and the patient. Surgical drapes can be oversized to accommodate devices of various shapes and sizes, as well as device movement. Summary of the Invention

[0005] According to at least one embodiment of the present disclosure, a system for controlling the volume of a cover includes: a cover configured to at least partially cover a hinge member; and a controller configured to cause the volume enclosed by the cover to change with movement of the hinge member, wherein the cover gradually conforms to the hinge member as the volume enclosed by the cover decreases.

[0006] In any aspect of this document, the controller may be configured to change the volume enclosed by the tarpaulin based at least in part on input from at least one sensor configured to monitor at least one of the following: pressure within the volume enclosed by the tarpaulin; or fluid flowing through one or more openings in the tarpaulin.

[0007] In any aspect of this document, the at least one sensor may be positioned inside or outside the volume enclosed by the cover.

[0008] In any aspect of this document, the controller may be configured to increase the volume enclosed by the cover prior to a planned movement of the hinged member.

[0009] In any aspect of this document, the controller may be configured to reduce the volume enclosed by the cover after a planned movement of the hinge member.

[0010] In any aspect of this document, the controller may be configured to cause a pressure source to purge fluid from the enclosed volume via a pressure source opening.

[0011] Any aspect of this document also includes a pressure source configured for fluid communication with the volume enclosed by the cover.

[0012] Any aspect of this document also includes at least one sensor configured to monitor pressure within the volume enclosed by the tarpaulin, and wherein the controller is configured to detect a collision between the tarpaulin and an external object based on input from the at least one sensor.

[0013] In any aspect of this document, the controller may be configured to change the volume enclosed by the tarpaulin by varying the working pressure within the volume enclosed by the tarpaulin between a first pressure greater than ambient pressure and a second pressure less than ambient pressure.

[0014] In any aspect of this document, the controller may be configured to change the volume enclosed by the tarpaulin by varying the working pressure within the volume enclosed by the tarpaulin between a first pressure less than ambient pressure and a second pressure different from the first pressure and also less than ambient pressure.

[0015] In any aspect of this document, the controller may be configured to change the volume enclosed by the tarpaulin by altering the working pressure within the volume enclosed by the tarpaulin.

[0016] In any aspect of this document, the cover may include at least one tool opening that allows a tool to be supported outside the volume enclosed by the cover via a hinged member.

[0017] According to at least one embodiment of the present disclosure, a system for controlling a volume substantially enclosed by a cover includes: a pressure source operable to selectively increase, maintain, or decrease the volume by selectively applying positive or negative pressure to the volume between the cover and the hinge member; at least one sensor operable to monitor characteristics of the system; and a controller that controls the pressure source at least in part based on data from the sensor, wherein the cover gradually conforms to the hinge member as the volume substantially enclosed by the cover decreases.

[0018] In any aspect of this document, the characteristic may be at least one of the following: pressure within a volume substantially enclosed by the cover; or fluid flowing through an opening in the cover.

[0019] In any aspect of this article, the characteristic may be the movement of a hinged member.

[0020] In any aspect of this article, the characteristic may be one or more leaks in the cover cloth.

[0021] In any aspect of this document, the controller may also control the pressure source based at least in part on information corresponding to the movement of the articulated member.

[0022] In any aspect of this document, whereby at least a portion of the hinged member may be repositionable when the cover is adapted to the hinged member.

[0023] In any aspect of this article, the controller can cause the pressure source to create a vacuum between the cover and the hinge member by allowing fluid to exit the substantially enclosed volume through an opening in the pressure source.

[0024] In any aspect of this article, a vacuum is maintained between the cover and the hinged member to prevent one or more leaks in the cover.

[0025] In any aspect of this article, the controller can detect impacts on the cover based on data received from at least one sensor.

[0026] According to at least one embodiment of the present disclosure, a method for controlling the volume of a drape includes receiving a surgical plan including information on one or more planned movements of an articulated member at least partially enclosed by the drape; determining, based on the surgical plan, a sequence for increasing and decreasing the volume of the drape-enclosed member and surrounding at least a portion of the articulated member; and generating instructions based on the sequence, the instructions being configured to cause a controller to control a pressure source to increase and decrease the volume according to the sequence.

[0027] Any aspect of this document, wherein the sequence may include: increasing the volume substantially enclosed by the cover prior to the planned movement of the articulated member.

[0028] In any aspect of this document, the hinged member may include a first movable segment and a second movable segment.

[0029] In any aspect of this document, the cover may include a first portion surrounding a first volume and a second portion surrounding a second volume, the first volume at least partially surrounding a first movable segment and the second volume at least partially surrounding a second segment.

[0030] In any aspect of this document, the surgical plan may include information about one or more planned movements of each of the first and second movable segments.

[0031] In any aspect of this document, wherein these instructions may be configured to cause the controller to control the pressure source based on the surgical plan to increase the first volume by following the movement of the first movable segment of the articulated member, while decreasing or maintaining the second volume by following the stationary state of the second movable segment of the articulated member.

[0032] Any aspect combined with any one or more other aspects.

[0033] Any one or more of the features disclosed in this document.

[0034] This document generally discloses any one or more of the features.

[0035] Any one or more of the features generally disclosed herein combined with any one or more other features generally disclosed herein.

[0036] Any aspect / feature / implementation can be combined with any one or more other aspects / features / implementations.

[0037] Use any one or more of the aspects or features disclosed herein.

[0038] It should be understood that any feature described herein may be combined with any other feature described herein to claim protection, regardless of whether the feature is derived from the same described implementation.

[0039] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the specification, drawings, and claims.

[0040] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that possess both connective and disjoint qualities in operation. For example, the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” mean only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to an element such as X, Y, and Z, or such as X1-X… n Y1-Y m and Z1-Z o When referring to a single class of elements, the phrase means a single element selected from X, Y, and Z; a combination of elements selected from the same class (e.g., X1 and X2); or elements selected from two or more classes (e.g., Y1 and Z). o () combination.

[0041] The term "a / an" refers to one or more of the entities mentioned. Thus, the terms "a / an," "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" are used interchangeably.

[0042] The foregoing is a simplified overview of this disclosure to provide an understanding of some aspects thereof. This summary is neither a broad nor an exhaustive overview of this disclosure and its various aspects, embodiments, and configurations. It is not intended to identify key or essential elements of this disclosure, nor to depict its scope, but rather to present selected concepts in a simplified form as an introduction to the more detailed description presented below. It should be understood that other aspects, embodiments, and configurations of this disclosure may utilize one or more of the features set forth above or described in detail below, individually or in combination.

[0043] Many additional features and advantages of the invention will become apparent to those skilled in the art upon consideration of the embodiments described below. Attached Figure Description

[0044] The accompanying drawings are incorporated in and form part of this specification to illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings simply illustrate preferred and alternative examples of how to carry out and use this disclosure, and should not be construed as limiting this disclosure to only the examples shown and described. Additional features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated by the figures referenced below.

[0045] Figure 1 A block diagram of a system according to at least one embodiment of this disclosure;

[0046] Figure 2 It is a block diagram of another system according to at least one embodiment of this disclosure;

[0047] Figure 3 It is a block diagram of another system according to at least one embodiment of this disclosure;

[0048] Figure 4 This is a block diagram of yet another system according to at least one embodiment of the present disclosure; and

[0049] Figure 5 This is a flowchart of a method according to at least one embodiment of the present disclosure. Detailed Implementation

[0050] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example or embodiment, certain actions or events of any of the processes or methods described herein may be performed in different sequences, and / or may be added, combined, or omitted entirely (e.g., depending on different embodiments of this disclosure, performing the disclosed technology may not require all the described actions or events). Furthermore, for clarity, although some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the technology of this disclosure can be performed by a combination of units or modules associated with, for example, computing devices and / or medical devices.

[0051] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which correspond to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and is accessible by a computer).

[0052] Instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple A11, A12, A12X, A12Z, or A13 Bionic processors; or any other general-purpose microprocessor), application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the term "processor" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technique can be fully implemented in one or more circuit or logic elements.

[0053] Before explaining any embodiment of this disclosure in detail, it should be understood that this disclosure is not limited in its application to the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. This disclosure can have other embodiments and can be practiced or carried out in various ways. Similarly, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “comprising,” “including,” or “having,” and variations thereof, is intended to cover items listed thereafter and their equivalents, as well as additional items. Furthermore, this disclosure may use examples to illustrate one or more aspects thereof. Unless expressly stated otherwise, the use or listing of one or more examples (which may be indicated by “for example,” “by means of an example,” “e.g.,” “such as,” or similar language) is not intended to, and does not limit, the scope of this disclosure.

[0054] In some applications, surgical drapes are custom-made to fit a device or other object to be covered, preventing excess material from pooling and preventing interference during surgical procedures. However, a shape-fitting drape may not be suitable for or able to accommodate the movement of the device or other object. In some applications, surgical drapes may be formed from biocompatible materials. However, the production and purchase of biocompatible drapes are expensive. In other applications, an oversized drape can be manually tightened when the device is stationary; however, excess material may pool or clump near the patient, potentially causing unintentional contact. This is particularly problematic if the drape is made of a non-biocompatible material and comes into contact with open tissue.

[0055] Embodiments of this disclosure advantageously provide a drape that is adaptable to and conforms to the movement of the device, thereby preventing excessive material buildup near the patient. By reducing the need to manually re-drape the device during movement, embodiments of this disclosure advantageously reduce overall surgical time (and cost). Embodiments of this disclosure may also advantageously provide monitoring for potential problems with the drape or other components, such as leakage in the drape or impact on the device.

[0056] First turn Figure 1 This diagram illustrates a block diagram of a system 100 according to at least one embodiment of the present disclosure. System 100 can be used in a sterile environment to prevent patient contamination by non-sterile operating equipment. System 100 can be used to control a volume 101 substantially enclosed by a drape 102. System 100 may include a drape 102, a hinge member 104 (which may include one or more members 104A connected via one or more connectors 104B), a pressure source 110, at least one sensor 114, a navigation system 116, and / or a computing device 118. In some embodiments of the present disclosure, the system (such as...) Figure 1System 100 may not include one or more of the components shown, but may include... Figure 1 Other components not shown, and / or may include those related to Figure 1 The system 100 shown may include one or more components that are similar but not identical. For example, the system 100 may not include at least one sensor 114, a navigation system 116, and / or a computing device 118.

[0057] The articulation member 104 may be, for example, a surgical robot (or any component thereof), a robotic arm, or an articulated arm. The articulation member 104 may extend from a base 103, which may be stationary or movable. One or more tools 106 may be disposed at an end of the articulation member 104, but one or more tools 106 may be disposed on any portion of the articulation member 104. The articulation member 104 is operable to: autonomously and / or based on input from a surgeon or operator, perform one or more planned movements and / or multiple movements. In some embodiments, the articulation member 104 and the base 103 may form a robot 134. The robot 134 may be any surgical robot or surgical robot system. The robot 134 may be, or include, for example, Mazor X. TM The Stealth Edition robotic guidance system. Some implementations use non-articulated components that can move during surgical procedures.

[0058] The drape 102 substantially surrounds the hinge member 104 such that at least 75% of the length of the hinge member (measured along the hinge member and from near, but excluding, the tool 106 towards the base 103) is covered by the drape 102. In some embodiments, the drape 102 sufficiently surrounds the hinge member 104 to provide a barrier at least between the hinge member and the patient, thereby preventing contamination of the patient or surgical site by the non-sterile hinge member 104. In some examples, the entire hinge member 104 is surrounded by the drape 102, and in other examples, the drape 102 surrounds the entire hinge member 104 and at least some of the base 103. In still other examples, a first portion of the hinge member 104 may be surrounded by the drape 102, and a second portion of the hinge member 104 may not be surrounded by the drape 102. In some examples, part or all of the drape 102 may be shaped to match the proportions of the hinge member 104. In other embodiments, the cover 102 may be formed, for example, spherical, rectangular, or elliptical, to accommodate the various shapes of the hinge members 104. In yet another embodiment, the cover 102 may also be segmented and include multiple sections that can be individually inflated or deflated, such as... Figure 3 As shown.

[0059] In some embodiments, the diaphragm 102 is disposable, but in other embodiments, the diaphragm 102 may be reusable. In some embodiments, the diaphragm 102 is also non-biocompatible (e.g., nylon), but in other embodiments, the diaphragm 102 may be biocompatible. In another embodiment, the diaphragm 102 may comprise a combination of biocompatible and non-biocompatible materials. For example, a portion of the diaphragm 102 near the patient may be biocompatible, and the remainder of the diaphragm 102 may be non-biocompatible.

[0060] The cover 102 may include at least one opening. This at least one opening may be or include a pressure source opening 121 and / or at least one tool opening 117. In some embodiments, the cover 102 may include multiple pressure source openings 121 and / or multiple tool openings 117. In some embodiments, the cover 102 is segmented (e.g., Figure 3 As shown, one or more sections of the cover 102 may include a pressure source opening 121 and / or at least one tool opening 117. The pressure source opening 121 may define a path for fluid to flow into or out of the volume 101 substantially enclosed by the cover 102. In some embodiments, the cover 102 does not include a pressure source opening or a tool opening. For example, in some embodiments, an imaging device disposed at the end of the hinge member 104 is operable from behind the cover 102 and can therefore be enclosed by the cover 102, so that the cover 102 does not need to include a tool opening. In other embodiments, the pressure source may be disposed within the cover 102 (e.g., on the hinge member 104, the robot 134, or any component within the cover 102), so that the cover 102 does not need to include a pressure source opening.

[0061] As will be described in more detail below, as the volume 101 substantially enclosed by the cover 102 decreases, the cover 102 gradually conforms to the hinge member 104. As the volume 101 substantially enclosed by the cover 102 increases, the shape of the volume 101 is gradually defined by the structure of the cover 102.

[0062] At least one tool opening 117 allows the tool 106 to be supported outside the volume 101 substantially enclosed by the cover 102 via the hinge member 104. In other words, at least a portion or all of the tool 106 can extend from inside the cover 102 to outside the cover 102 through at least one tool opening 117. At least one tool opening 117 can seal a portion of the tool 106 (or the support of the tool 106) by means of: for example, rubber seals, tape, fabric hooks and loops (e.g., (e.g., rubber bands, elastic bands, adhesives, silicone, or sealant). Similarly, the pressure source opening 121 can be sealed to the hose 108 (or another device for positioning the pressure source 110 in fluid communication with the volume 101) by: for example, rubber seals, tape, fabric hooks and loops (e.g., (e.g., rubber bands, elastic bands, adhesives, silicone, or sealant).

[0063] Pressure source 110 may be operable to selectively increase, maintain, and / or decrease the volume 101 substantially enclosed by cover 102 by selectively applying positive or negative pressure. In other words, pressure source 110 may allow fluid to continuously or intermittently enter or exit cover 102. The fluid may be a gas (e.g., oxygen, air, carbon dioxide, helium-oxygen mixture) or a liquid. Pressure source 110 may be, for example, a compressor or pump. As described above, in some embodiments, cover 102 is segmented (in... Figure 3 As can be seen in the image, the pressure source 110 can be operable to selectively increase, maintain, and / or decrease one or more of a plurality of volumes, each volume being surrounded by one of a plurality of sections. Alternatively, in some embodiments, the plurality of volumes can be selectively increased, maintained, and / or decreased by a single or dedicated pressure source 110.

[0064] In some embodiments, system 100 includes a hose 108 configured to position a pressure source 110 in fluid communication with a volume 101 substantially enclosed by a cover 102. The hose 108 may be coupled to a pressure source opening 121 and the pressure source 110. In other embodiments, the end of the hose 108 may be located within or outside the volume 101 (e.g., at or near the pressure source opening 121). However, in other embodiments, the pressure source 110 is directly coupled to the pressure source opening 121 (e.g., via a hose interface). In other words, in some embodiments, the hose 108 is not required. In still other embodiments, the pressure source 110 may be located near or attached to a hinge member 104. For example, the pressure source 110 may be located within the volume 101, and the hose 108 may be used to position the inlet and / or outlet of the pressure source 110 in fluid communication with the pressure opening and thus with the surrounding environment of the volume 101.

[0065] In the illustrated embodiment, system 100 includes a controller 112, but in some embodiments, system 100 may not include a controller 112. The controller 112 may be an electronic controller, a mechanical controller, or an electromechanical controller. The controller 112 may include or may be any processor described herein. The controller 112 may include a memory storing instructions for performing any function or method described herein performed by the controller 112. In some embodiments, the controller 112 may be configured to simply translate signals received from computing device 118 (e.g., via communication interface 122) into commands for operating pressure source 110, sensor 114, navigation system 116, and / or robot 134. In other embodiments, the controller 112 may be configured to process and / or translate signals received from pressure source 110, sensor 114, navigation system 116, and / or robot 134. Furthermore, the controller 112 may receive signals from one or more sources (e.g., pressure source 110, sensor 114, navigation system 116, computing device 118, and / or robot 134) and may output signals to one or more sources.

[0066] The controller 112 is operable to control the pressure source 110, and thus cause the volume 101 substantially enclosed by the cover 102 to increase or decrease between a maximum volume and a minimum volume (and / or any intermediate volume), and / or maintain a constant size and / or pressure, and / or remain within a range of size and / or pressure, and / or maintain a working volume. The working volume can be the maximum volume, the minimum volume, or a volume between the maximum and minimum volumes. Figure 1 As shown, the minimum volume corresponds to the cover 102 conforming to the hinge member 104, and as Figure 2 As shown, the maximum volume corresponds to the cover 102 spaced apart from the hinge member 104 or a portion thereof, whether to reduce the risk of the cover 102 becoming stuck in the joint 104B, or between member 104A and joint 104B, or in other locations, during movement of the hinge member 104. It should be understood that when the volume 101 is at its minimum volume, the hinge member 104 can be moved to a certain extent. In other words, when the cover 102 conforms to the hinge member 104, at least a portion of the hinge member 104 is repositionable.

[0067] In an embodiment where the cover 102 is segmented, the controller 112 can cause the pressure source 110 to increase or decrease the fluid flowing into one or more sections of the cover 102, thereby independently increasing or decreasing the corresponding volume 101 of each section. For example, in Figure 3In the illustrated embodiment, the hinge member 104 includes a first movable segment 105A and a second movable segment 105B, and the cover 102 includes a corresponding first portion 102A configured to at least partially enclose the first movable segment 105A; and a second portion 102B configured to at least partially enclose the second segment 105B. Surgical planning may include information regarding one or more planned movements of the first movable segment 105A and the second movable segment 105B. Furthermore, when the second movable segment 105B of the hinge member 104 does not move or moves insufficiently to require an increase in the corresponding volume 101B, the controller 112 may cause the pressure source 110 to increase the volume 101A enclosed by the first portion 102A of the cover 105A to accommodate movement of the first movable segment 105A, while simultaneously reducing or maintaining the volume 101B enclosed by the second portion 102B of the cover 105A. Based on the surgical plan, and / or based on the sensed movement of the first movable segment 105A and / or the second movable segment 105B, and / or based on input received from the surgeon or operator, the controller 112 can increase or decrease the volume 101 of the pressure source 110, either the first portion 102A or that segment portion. It should be understood that the hinge member 104 may include more than two movable segments, and the cover 102 may include more than two portions. Furthermore, as previously stated, it should be understood that each portion of the cover 102 may include a pressure source opening and / or a tool opening, but each portion of the cover 102 may not include a pressure source opening and / or may not include a tool opening.

[0068] In some embodiments, controller 112 controls pressure source 110 to increase, maintain, or decrease the fluid flowing into or out of volume 101, or to increase, maintain, or decrease the internal pressure of volume 101. Controller 112 may receive input from a surgeon or operator of system 100, or may receive signals from computing device 118 corresponding to commands to operate pressure source 110 in a particular manner (e.g., increase, decrease, or maintain the size of volume 101). Alternatively, controller 112 may operate pressure source 110 autonomously, whether based on detected or planned movement of articulated member 104 or information from sensor 114 or computing device 118, or based on a surgical plan as described in more detail below, or otherwise. Controller 112 may also operate pressure source 110 based on the distance between: on the one hand, articulated member 104; and on the other hand, the patient and / or the patient's tissue or anatomical features. For example, when the hinge member 104 is very close to the patient's open tissue, the controller 112 can reduce (or hold in a reduced position) the volume 101 to avoid contact between the drape 102 and the patient's open tissue. In the case where the drape 102 is segmented as described above, the controller 112 can reduce (or hold in a reduced position) only the volume 101 corresponding to this portion of the hinge member 104 near the patient's open tissue, without changing the volume 101 corresponding to other portions of the hinge member 104.

[0069] By allowing fluid to exit the substantially enclosed volume 101 through pressure source opening 121, controller 112 can cause pressure source 110 to create a vacuum between drape 102 and hinge member 104. Maintaining a vacuum or atmospheric pressure advantageously reduces the risk of contamination (e.g., infection) to the patient if drape 102 leaks, as potentially contaminated air will be continuously purged from or contained within volume 101 and thus kept away from the patient. Controller 112 can also cause pressure source 110 to create any range of pressures (e.g., high pressure, low pressure, atmospheric pressure, etc.) within volume 101. Controller 112 can also cause pressure source 110 to continuously purge air to maintain pressure within drape 102; however, in other embodiments, controller 112 can reset the pressure (e.g., atmospheric pressure, vacuum, etc.) at periodic intervals. In some implementations, controller 112 may cause pressure source 110 to operate continuously (e.g., when switching between minimum and maximum volume, or vice versa), while in other implementations, controller 112 may cause pressure source 110 to operate intermittently (e.g., when maintaining the current volume).

[0070] Based at least in part on the movement of the hinge member 104, the controller 112 can also increase or decrease the volume 101 substantially enclosed by the cover 102. For example, when one of the at least one of the sensors 114 senses movement from the hinge member 104, the controller 112 can increase the volume 101 (e.g., increase the fluid flow from the pressure source 110 into the volume 101), and when the sensor 114 no longer detects movement from the hinge member 104, the controller can decrease the volume 101 (e.g., decrease the fluid flow and create a negative pressure by the pressure source 110). In some embodiments, the same computing device 118 or the controller 112 operates or causes the operation of the pressure source 110 and the hinge member 104 such that the operation of the hinge member 104 can be followed, rather than providing an appropriate command to the pressure source 110 to increase or decrease the volume 101 upon detection of the operation of the hinge member 104. In other examples, the controller 112 can increase or decrease the volume 101 based on one or more pre-planned movements. When the hinge member 104 is stationary, the controller 112 can also reduce or maintain the volume 101 substantially enclosed by the cover 102 to a minimum volume (or another volume). The controller 112 can also detect impacts on the hinge member 104 and / or the cover 102 based on data received from at least one sensor 114, as will be described in more detail below.

[0071] System 100 may include at least one sensor 114, but in some embodiments, system 100 may not include any sensor 114. At least one sensor 114 is operable to measure or monitor a characteristic of system 100. This characteristic may include, but is not limited to, one or more of the following: leakage (e.g., permeation of the cover 102), impact (e.g., impact on the cover 102, tool 106, and / or hinge member 104), pressure (e.g., pressure of volume 101), pressure variation (e.g., pressure variation due to leakage, failure of pressure source 110, or other reasons), or movement (e.g., movement of hinge member 104), etc. In some embodiments, this characteristic is the pressure within volume 101 substantially enclosed by cover 102.

[0072] Sensor 114 can be any type of sensor used to measure the characteristics of this document. Sensor 114 may include one or more of the following or any combination thereof: electrical components, mechanical components, electromechanical components, magnetic components, or electromagnetic components, etc. Sensor 114 may include, but is not limited to, one or more of the following: pressure transducer, flow meter, strain gauge, capacitor, or accelerometer. In some embodiments, sensor 114 may include a memory for storing sensor data. In other examples, sensor 114 may output signals (e.g., sensor data) to one or more sources (e.g., pressure source 110, controller 112, navigation system 116, computing device 118, and / or robot 134).

[0073] In some examples, when the pressure changes, at least one sensor 114 can trigger a controller 112 (e.g., by sending a signal directly to the controller 112 or via a computing device 118) to increase or decrease the fluid flowing into or out of volume 101. In other examples, at least one sensor 114 can trigger the controller 112 to selectively operate the pressure source 110 to achieve a predetermined pressure within volume 101. In still other examples, at least one sensor 114 can trigger an alarm or notification to the surgeon or operator: the pressure has suddenly increased, which may indicate that the drape 102 has collided with another object; or the pressure has decreased or is decreasing, which may indicate a leak or some other malfunction in the drape 102. In embodiments where the fluid flows through the pressure source opening 121 and / or hose 108, at least one sensor 114 can trigger an alarm or notification if the fluid flow changes. For example, a change in fluid flow may indicate a problem with the pressure source 110 and / or the drape 102.

[0074] In some embodiments, at least one sensor 114 may be located within the volume 101 substantially enclosed by the cover 102, or in other embodiments, it may be located at the pressure source opening 121. In yet another embodiment, at least one sensor 114 may also be located at the pressure source 110. At least one sensor 114 may be located at or on any component of the system 100 or the environment (e.g., on a cover, articulation member, tool, robot, hose, pressure source, navigation system, and / or any part of any other component at a surgical site). The location of at least one sensor 114 may be determined based on the characteristics that at least one sensor 114 will measure or monitor. For example, if at least one sensor 114 will measure the internal pressure of the volume 101, then at least one sensor 114 may be placed on the articulation member 104 or on the inner surface of the cover 102. On the other hand, if at least one sensor 114 will measure the fluid flowing through the pressure source opening 121, then at least one sensor 114 may be placed adjacent to or within the pressure source opening 121, or within the hose 108. Furthermore, at least one sensor 114 may include multiple sensors, and each sensor may be positioned at the same location as any other sensor or at a different location.

[0075] At least one sensor 114 may be operable to sense pressure changes in volume 101, fluid flow rate changes at pressure source 110, or fluid flow rate changes at pressure source opening 121, etc. As previously described, data regarding the measured or monitored characteristic may be directly useful (e.g., the measured pressure may be compared to a target pressure to determine whether pressure source 110 needs to be operated and the extent of such operation) and / or indirectly useful (e.g., a sudden increase in pressure may indicate a collision between the cover 102 surrounding the hinge member 104 and another object, or a continuously decreasing pressure (when the desired pressure is positive) or continuously increasing pressure (when the desired pressure is negative) may indicate leakage in the cover 102 or at other locations in the pressurization system). When at least one sensor 114 detects a change in characteristic, at least one sensor 114 may send data to controller 112. Furthermore, in some embodiments, at least one sensor 114 may send data to computing device 118 for display on user interface 126. Figure 4The change in this characteristic is displayed on (as shown) or otherwise notified to the surgeon or operator. In other embodiments, at least one sensor 114 may alert the surgeon or operator to the change in this characteristic via an alarm, such as, but not limited to, an audible or indicator light display. By monitoring and alerting the surgeon or operator to one or more changes in system 100, at least one sensor 114 may advantageously provide a safety function, thereby alerting the surgeon or operator to potential problems with pressure source 110, cover 102, articulated member 104, or any other component or aspect of system 100.

[0076] In some embodiments, system 100 may include navigation system 116, but in other embodiments, system 100 may not include navigation system 116. During operation, navigation system 116 can provide navigation for surgeons and / or surgical robots. Navigation system 116 can be any navigation system now known or developed in the future, including, for example, Medtronic StealthStation. TM S8 Surgical Navigation System. In various embodiments, navigation system 116 can be used to track the position of articulated member 104 (or more specifically, a navigation tracker attached to articulated member 104). Navigation system 116 may include cameras or other sensors for tracking one or more reference markers, navigation trackers, or other objects within the operating room. Navigation system 116 may include a display for displaying one or more images from an external source (e.g., computing device 118, camera, or other source), or a video stream from the camera or other sensors of navigation system 116. In some embodiments, navigation system 116 may provide position, movement, and / or other information to controller 112 and / or computing device 118 for controlling pressure source 110 and / or any other aspect of system 100. In some embodiments, system 100 can operate without the use of navigation system 116.

[0077] Go to Figure 4 The diagram illustrates a system 100 having a computing device 118. According to embodiments of this disclosure, the computing device 118 may include a processor 120, a memory 124, a communication interface 122, and a user interface 126. (Refer to the above text) Figure 1 and Figure 2 Described Figure 4 Other components of the system 100 shown (e.g., pressure source 110, controller 112, sensor 114, navigation system 116, and / or robot 134). In some embodiments of this disclosure, the system (such as, Figure 4 System 100 may not include one or more of the components shown, but may include... Figure 4 Other components not shown, and / or may include those related to Figure 4The system 100 shown may contain one or more components that are similar but not identical. Furthermore, in some embodiments, a computing device (such as computing device 118) may have more or fewer components than computing device 118.

[0078] The processor 120 of the computing device 118 may be any processor described herein or any similar processor. The processor 120 may be configured to execute instructions stored in the memory 124, which may enable the processor 120 to perform one or more computational steps using or based on data received from the user interface 126, at least one sensor 114, robot 134, controller 112 and / or navigation system 116.

[0079] Memory 124 may be or include RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible non-transitory memory used to store computer-readable data and / or instructions. Memory 124 may store information or data that can be used to perform any step of the methods 500 described herein. Memory 124 may store, for example, one or more volume sequencing algorithms 128, one or more volume sequencing instructions 130, and / or one or more surgical plans 132. In some embodiments, such instructions 130 and / or algorithms 128 may be organized into one or more applications, modules, software packages, layers, or engines. Algorithms 128 and / or instructions 130 may cause processor 120 to manipulate data stored in memory 124 and / or received from navigation system 116.

[0080] The computing device 118 may also include a communication interface 122. The communication interface 122 can be used to receive sensor data or other information from external sources (such as pressure source 110, controller 112, at least one sensor 114, robot 134, and / or navigation system 116), and / or to transmit instructions, data, or other information to external systems or devices (e.g., pressure source 110, controller 112, at least one sensor 114, robot 134, and / or navigation system 116). The communication interface 122 may include one or more wired interfaces (e.g., USB port, Ethernet port, FireWire port) and / or one or more wireless interfaces (e.g., configured to transmit information via one or more wireless communication protocols (such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, etc.)). In some embodiments, the communication interface 122 can be used to enable the computing device 118 to communicate with one or more other processors 120 or computing devices 118, whether to reduce the time required to complete computationally intensive tasks or for any other reason.

[0081] The computing device 118 may also include one or more user interfaces 126. The user interface 126 may be or include a keyboard, mouse, trackball, display screen, television, touchscreen, joystick, switch, button, and / or any other means for receiving information from and / or providing information to the user. The user interface 126 may be used, for example, to receive user selections or other user input regarding surgical planning; to receive user input relevant to determining the order in which the volume 101 substantially enclosed by the cover 102 is selectively increased and decreased; to receive user input regarding the generation of instructions based on the order; and / or to display instructions for causing the controller 112 to control the pressure source 110. In some embodiments, the user interface 126 may be used to allow a surgeon or other user to modify the displayed first instruction, second instruction, or other information. In some embodiments, user inputs such as those described above may be optional or unnecessary for the operation of the systems, apparatus, and methods described herein.

[0082] Although the user interface 126 is shown as part of the computing device 118, in some embodiments, the computing device 118 may utilize the user interface 126, which is housed separately from one or more other components of the computing device 118. In some embodiments, the user interface 126 may be located close to one or more other components of the computing device 118, but in other embodiments, the user interface 126 may be located away from one or more other components of the computing device 118.

[0083] Now go to Figure 5 According to embodiments of this disclosure, the method 500 for controlling the volume 101 of the cover 102 can be performed wholly or partially on the computing device 118. Method 500 can use, for example, the methods described above. Figures 1 to 3 The system 100 is used to execute this.

[0084] Method 500 includes receiving a surgical plan 132 (step 502). The surgical plan 132 may be received via a user interface 126 and / or communication interface 122 of a computing device 118 and may be stored in a memory 124. The surgical plan 132 may include information regarding one or more planned movements of the articulated member 104, which is substantially enclosed by a drape 102 during the surgical procedure. This information may also include a timeline or schedule of the one or more planned movements. The one or more planned movements may include one or more of the following: timestamps, movement type (e.g., translational and / or rotational movement), movement duration, and / or location information (e.g., coordinates).

[0085] In some embodiments, method 500 may include determining information regarding one or more movements of the articulated member 104 during a surgical procedure outlined or otherwise described in surgical plan 132. In such embodiments, the surgical plan may not include any such information received by computing device 118, but processor 120 executing instructions stored in memory 124 may generate such information based on surgical plan 132.

[0086] Method 500 also includes determining, based on information regarding one or more planned or desired movements of the hinge member 104, a sequence for selectively increasing, maintaining, and / or decreasing the volume 101 substantially enclosed by the cover 102 (step 504). As described above, the cover 102 may at least partially surround the hinge member 104. One or more volume sequencing algorithms 128 may be configured to determine the sequence for selectively increasing, maintaining, and decreasing the volume 101. In some embodiments, the sequence may be determined based on a timeline or schedule of one or more planned movements. In other embodiments, the sequence may be determined based on one or more of the following: timestamps, the type of each movement (e.g., translational and / or rotational movements), the duration of each movement, and / or location information (e.g., coordinates).

[0087] Furthermore, this sequence may include increasing the volume 101 substantially enclosed by the cover 102 before the planned movement of the articulated member 104 exceeds a predetermined threshold. In other words, determining this sequence may include: for each movement, calculating the positional change of the articulated member 104; identifying whether the change exceeds or meets a predetermined threshold (which may be stored, for example, in memory 124, and / or may be proprietary to the articulated member 104, robot 134, cover 102, or any other component of system 100); and determining that the volume 101 will be increased when the change exceeds or meets the threshold, or that the volume 101 will be maintained or reduced to a minimum volume if the change is below the threshold. Thus, movements of the articulated member 104 below the predetermined threshold can be performed without increasing the volume 101. When the volume 101 increases due to the positional change of the articulated member 104 exceeding or meeting the threshold, the volume 101 can be reduced to a minimum volume (or reduced to an intermediate volume) after the articulated member 104 has completed the corresponding movement.

[0088] Method 500 further includes generating instructions based on the sequence (step 506). The generated instructions may be volume sequence instructions 130. Volume sequence instructions 130 may be configured to selectively increase, maintain, and decrease volume 101 based on the determined sequence. These instructions may be configured, for example, to cause controller 112 to control pressure source 110 to selectively increase and decrease volume 101 according to the sequence.

[0089] However, in some embodiments, based on instructions stored in its memory rather than on a surgical plan, the controller 112 can control the pressure source 110 to automatically increase and decrease the volume 101. For example, the controller 112 can be configured to automatically begin increasing the volume 101 when the articulated member 104 begins to move, and automatically begin decreasing the volume 101 when the articulated member 104 stops. The controller 112 can also be configured to automatically maintain a predetermined pressure within the volume when the articulated member is not moving.

[0090] These instructions may include one or more instructions that, prior to each movement of the articulated member 104 and / or before executing one of one or more planned volume increases or decreases, cause an alarm or other indication to be issued to the surgeon (e.g., via user interface 126). In some embodiments, such an alarm may suspend the execution of surgical plan 132 for surgeon or other operator approval. In other embodiments, the alarm may simply notify the surgeon of the planned movement and / or the planned volume increase or decrease, and automatically execute the planned movement. The alarm and / or notification may be displayed on user interface 126 and / or may include audible and / or visual displays.

[0091] As should be understood based on the foregoing disclosure, this disclosure covers companies with fewer than [number missing] [units missing]. Figure 5 The method for all steps identified in the code (and the corresponding description of method 500), and including all steps except... Figure 5 The method for additional steps beyond those steps identified in the diagram (and the corresponding description of method 500).

[0092] The methods and systems described herein provide a drape for protecting patients from non-sterile objects during surgical procedures. By selectively increasing or decreasing the volume enclosed by the drape using a pump, compressor, or other pressure source, the drape can be inflated to accommodate the movement of the movable device it encloses, and the drape can also be shaped to fit the movable device. These methods and systems advantageously allow for the movement of the device without re-draping, eliminate the risk of the drape getting stuck in the articulated arm or any of its components, and prevent excess material from pooling near the patient. These methods and systems also provide monitoring of the system and / or any of its individual components (e.g., the drape, articulated member, and / or pressure source) to alert the surgeon or operator to potential interference with the system.

[0093] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. In the foregoing specific embodiments, for the purpose of simplifying this disclosure, various features of this disclosure are grouped together in one or more aspects, embodiments, and / or configurations. Features of aspects, embodiments, and / or configurations of this disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those discussed above. The approach of this disclosure should not be construed as reflecting an intention that the claims require more features than expressly recited in each claim. Rather, as reflected in the following claims, aspects of the invention lie in fewer than all the features of a single foregoing aspect, embodiment, and / or configuration. Therefore, the following claims are hereby incorporated into this specific embodiment, wherein each claim exists independently as a separate preferred embodiment of this disclosure.

[0094] Furthermore, although the description already includes descriptions of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, other variations, combinations, and modifications are also within the scope of this disclosure upon understanding it, for example, as may be within the skill and knowledge of one skilled in the art. It is desired to obtain the right to include alternative aspects, embodiments, and / or configurations to the permissible extent, including claimed alternatives, replacements, and / or equivalent structures, functions, scopes, or steps, regardless of whether such alternatives, replacements, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended for use with any patentable subject matter.

Claims

1. A system for controlling the volume of a cover cloth, the system comprising: A cover cloth, the cover cloth being configured to at least partially cover the hinged member; and A controller, configured to cause a pressure source to change the volume enclosed by the cover by following the movement of the hinge member, thereby altering the working pressure within the volume enclosed by the cover. As the volume enclosed by the cover decreases, the cover gradually conforms to the hinge member. The controller is configured to increase the volume enclosed by the cover before the planned movement of the hinge member and decrease the volume enclosed by the cover after the planned movement of the hinge member.

2. The system of claim 1, wherein the controller is configured to change the volume enclosed by the tarpaulin based at least in part on input from at least one sensor, the at least one sensor being configured to monitor at least one of the following: pressure within the volume enclosed by the tarpaulin; or fluid flowing through one or more openings in the tarpaulin.

3. The system of claim 2, wherein the at least one sensor is located inside or outside the volume enclosed by the cover.

4. The system of claim 1, wherein the controller is configured to cause a pressure source to purge fluid from the enclosed volume via a pressure source opening.

5. The system according to claim 1, wherein, The pressure source is configured to communicate with the volume of fluid enclosed by the cover.

6. The system of claim 1, wherein the controller is configured to change the volume enclosed by the tarpaulin by varying the working pressure within the volume enclosed by the tarpaulin between a first pressure greater than the ambient pressure and a second pressure less than the ambient pressure.

7. The system of claim 1, wherein the controller is configured to change the volume enclosed by the tarpaulin by varying the working pressure within the volume enclosed by the tarpaulin between a first pressure less than the ambient pressure and a second pressure different from the first pressure and also less than the ambient pressure.

8. The system of claim 1, wherein the cover includes at least one tool opening that allows a tool to be supported outside the volume enclosed by the cover via the hinge member.

9. The system according to claim 1, wherein, The controller is further configured to change the volume enclosed by the cover, thereby inflating the cover to accommodate movement of the movable hinged member enclosed by the cover.

10. A system for controlling the volume of a cover cloth, the system comprising: A cover cloth, the cover cloth being configured to at least partially cover the hinged member; and A controller configured to cause the volume enclosed by the cover to change in response to the movement of the hinge member. As the volume enclosed by the cover decreases, the cover gradually conforms to the hinge member. The system also includes at least one sensor configured to monitor pressure within the volume enclosed by the tarpaulin, and wherein the controller is configured to detect collisions between the tarpaulin and external objects based on inputs from the at least one sensor.

11. The system according to claim 10, wherein, The controller is further configured to change the volume enclosed by the cover, thereby inflating the cover to accommodate movement of the movable hinged member enclosed by the cover.

12. A system for controlling a volume substantially enclosed by a tarpaulin, the system comprising: A pressure source operable to selectively increase, maintain, or decrease the volume by selectively applying positive or negative pressure to the volume between the cover and the hinge member; At least one sensor, said at least one sensor being operable to monitor characteristics of the system; and A controller, which controls the pressure source at least in part based on data from the sensor, is configured to change the volume enclosed by the cover cloth by altering the working pressure within the volume enclosed by the hinge member, thereby increasing the volume enclosed by the cover cloth before the planned movement of the hinge member and decreasing the volume enclosed by the cover cloth after the planned movement of the hinge member. As the volume substantially enclosed by the cover decreases, the cover gradually conforms to the hinge member.

13. The system according to claim 12, wherein, The controller is further configured to change the volume enclosed by the cover, thereby inflating the cover to accommodate the movement of the movable hinged member enclosed by the cover.

14. The system of claim 13, wherein the characteristic includes fluid flowing through an opening in the cover.

15. The system of claim 14, wherein the controller further controls the pressure source based at least in part on information corresponding to the movement of the articulated member.

16. The system of claim 13, wherein at least a portion of the hinge member is repositionable when the cover conforms to the hinge member.

17. The system of claim 13, wherein the controller creates a vacuum between the cover and the hinge member by causing fluid to exit the volume enclosed by the cover through a pressure source opening.

18. The system of claim 17, wherein the vacuum between the cover and the hinge member is continuously maintained to prevent one or more leaks in the cover.

19. The system of claim 13, wherein the characteristic is the movement of the hinge member.

20. The system of claim 13, wherein the characteristic is leakage at one or more points in the cover.

21. The system of claim 13, wherein the controller detects the impact on the cover based on data received from the at least one sensor.

22. A method for controlling the volume of a cover cloth, the method comprising: Receive a surgical plan, the surgical plan including information on one or more planned movements of an articulated member, the articulated member being at least partially covered by a drape; Based on the surgical plan, determine the order of increasing and decreasing the volume of the cover covering and surrounding at least a portion of the hinge member; as well as Based on the sequence of instructions, the instructions are configured to cause the controller to control the pressure source to increase and decrease the volume according to the sequence by changing the working pressure within the volume enclosed by the cover. The instruction is further configured to increase the volume enclosed by the cover before the planned movement of the hinge member, and to decrease the volume enclosed by the cover after the planned movement of the hinge member.

23. The method according to claim 22, wherein, The instruction is further configured to change the volume enclosed by the cover, thereby inflating the cover to accommodate the movement of the movable hinged member enclosed by the cover.

24. The method of claim 22, wherein the articulated member comprises a first movable segment and a second movable segment, wherein the cover comprises a first portion surrounding a first volume and a second portion surrounding a second volume, the first volume at least partially surrounding the first movable segment and the second volume at least partially surrounding the second movable segment, and further wherein the surgical plan comprises information regarding one or more planned movements of each of the first movable segment and the second movable segment.

25. The method of claim 24, wherein the instructions are configured to cause the controller to control the pressure source based on the surgical plan to increase the first volume by following movement of the first movable segment of the articulated member, while decreasing or maintaining the second volume by following the stationary state of the second movable segment of the articulated member.

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