Surgical drape installation aid
By designing an auxiliary tool for installing surgical drapes, and utilizing features such as side walls, rotatable sealing interfaces, and clamps, the problem of aseptic covering in computer-assisted surgery using electromechanical surgical manipulators was solved, achieving convenient sterility and alignment, and improving operational efficiency and safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2017-05-25
- Publication Date
- 2026-03-17
AI Technical Summary
In computer-assisted remote-controlled robotic surgery, it is difficult to cover the patient-side support system with parts of the electromechanical surgical manipulator without compromising sterility and integrity, especially due to the risk of contamination from servo motors and electrical connections that cannot be sterilized using conventional methods.
A surgical drape installation aid has been designed, including sidewalls and a rotatable sealing interface element for receiving and managing surgical drapes. The rotatable seal and clamps ensure the sterility and alignment of the drapes, and sterile covering is achieved by holding the device in place via a sterile adapter.
This tool facilitates the installation and positioning of sterile drapes, ensuring that sterility is not compromised, simplifying the application process, reducing the need for manual alignment, and improving operational efficiency and safety.
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Figure CN115252149B_ABST
Abstract
Description
[0001] This application is a divisional application of Chinese patent application 2017800482769 (PCT / US2017 / 034453) entitled “Surgical drape installation aid”, filed on May 25, 2017.
[0002] Related applications
[0003] This patent application claims priority and benefit to U.S. Provisional Patent Application 62 / 362,190, filed July 14, 2016, entitled “Surgical Drape Installation Aid,” which is incorporated herein by reference in its entirety. Technical Field
[0004] The present invention generally relates to sterile drapes / covers for computer-assisted surgical systems, and more specifically, to devices for installing sterile drapes. Background Technology
[0005] In computer-assisted, remotely controlled robotic surgery, the surgeon typically operates a master controller to control the movement of surgical instruments at the surgical site from a location potentially remote from the patient (e.g., across the operating room, in a different room, or in a completely different building). The master controller typically includes one or more input devices coupled to the surgical instruments using servo motors for articulating the instruments at the surgical site. Servo motors are typically part of a mechatronic device or surgical manipulator (“driven device”) that supports and controls surgical instruments that have been directly introduced into an open surgical site or introduced through a cannula into a body cavity (such as the patient’s abdominal cavity). During the procedure, the surgical manipulator provides mechanical articulation and control of various surgical instruments (such as tissue grippers, needle actuators, electrosurgical cauterization probes, etc.), each performing various functions for the surgeon, such as holding or driving a needle, grasping a blood vessel, or dissecting, cauterizing, or coagulating tissue.
[0006] Remotely controlled computer-assisted surgery reduces the size and number of incisions required in surgical procedures, thus improving patient recovery rates, while also helping to reduce patient trauma and discomfort. However, computer-assisted surgery also faces many new challenges.
[0007] One challenge is positioning a portion of an electromechanical surgical manipulator adjacent to the surgical site. Surgical manipulators can become contaminated during surgery and are typically discarded or sterilized between uses. From a cost perspective, sterilization of the equipment would be preferable. However, servo motors, sensors, encoders, and electrical connections necessary for robotically controlling motors are often not sterilizable using conventional methods (e.g., steam, heat and pressure, or chemicals) because system components could be damaged or destroyed during sterilization.
[0008] Sterile drapes have previously been used to cover surgical manipulators. The drapes have taken various forms. In each case, the surgical manipulator, along with the support linkages, is covered with a drape before the start of the surgical procedure. Unfortunately, the patient-side support system used in computer-assisted surgery is a large item, and its size makes it difficult to cover the necessary portions of the patient-side support system without compromising the sterility and integrity of the drape. Summary of the Invention
[0009] In one aspect, the surgical drape installation aid includes a body comprising sidewalls and a plurality of rotatable sealing interface elements. The sidewalls have a first end and a second end. The first end of the sidewall defines a first open end of the body, while the second end of the sidewall defines a second open end of the body. Each of the plurality of rotatable sealing interface elements extends from the second end of the sidewall. The sidewalls define an internal volume of the body.
[0010] The surgical drape installation aid also includes a bag with an open end. The open end of the bag is securely attached to a first surface (e.g., an inner side surface) of the sidewall between a first end and a second end of the sidewall. The bag is configured to extend from the first end of the sidewall.
[0011] In one aspect, the surgical drape installation aid also includes a plurality of surgical drape management features. Each of the plurality of surgical drape management features is configured to hold a portion of the surgical drape against a second surface (e.g., an outer side surface) of a sidewall. The first surface and the second surface of the sidewall are distinct surfaces. The plurality of surgical drape management features include clamps that can be attached to the sidewall. However, the surgical drape installation aid still includes a sterile adapter holding device.
[0012] A system includes a surgical drape and a surgical drape installation aid. The surgical drape includes a first portion and a second portion. The surgical drape installation aid includes a body having sidewalls. The sidewalls have a first end, a second end, an inner side surface, and an outer side surface. The outer side surface extends between the first end and the second end. The inner side surface extends between the first end and the second end. The first end of the sidewall defines a first open end of the body, while the second end of the sidewall defines a second open end of the body. The inner side surface of the sidewall defines an internal volume of the body.
[0013] The second part of the surgical drape is positioned within the internal volume of the main body. At least a portion of the first part of the surgical drape is mounted on the outer side surface of the main body.
[0014] In one aspect of the system, the surgical drape also includes an optional rotatable seal comprising a stationary seal portion and a rotatable seal portion. The rotatable seal portion is configured to rotate relative to the stationary seal portion. A first portion of the surgical drape is attached to the stationary seal portion, and a second portion of the surgical drape is attached to the rotatable seal portion. The surgical drape installation aid also includes a plurality of rotatable sealing interface elements. Each of the plurality of rotatable sealing interface elements extends from a second end of a sidewall. The rotatable sealing interface elements engage with the rotatable seal.
[0015] In another aspect of the system, the surgical drape installation aid includes an optional bag with an open end. The open end of the bag is securely attached to the inner side surface of the sidewall between a first end and a second end of the sidewall. The bag is configured to extend from the first end of the sidewall.
[0016] In another aspect of the system, the surgical drape installation aid includes a plurality of surgical drape management features. Each of the plurality of surgical drape management features is configured to retain a portion of a first part of the surgical drape against an outer side surface of a sidewall. In one aspect, the plurality of surgical drape management features includes a clamp attachable to the sidewall. The surgical drape installation aid in the system also includes a sterile adapter holding device.
[0017] A method includes placing a second portion of a surgical drape within an internal volume of a body. The body includes sidewalls. Each sidewall has a first end, a second end, an inner side surface, and an outer side surface. The outer side surface extends between the first and second ends. The inner side surface extends between the first and second ends. The first end of the sidewall defines a first open end of the body, while the second end of the sidewall defines a second open end of the body. The inner side surface of the sidewall defines an internal volume of the body. The method also includes attaching a first portion of the surgical drape to the outer side surface of the body.
[0018] In one aspect, a first and second portion of the surgical drape are attached to an optional rotatable seal. Installing the second portion then involves mounting the rotatable seal onto a plurality of rotatable sealing interface elements, each of which extends from a second end of the sidewall. Attached Figure Description
[0019] Figure 1 This is an illustration of a computer-aided surgical system having a surgical drape installation kit that includes a sterile surgical drape and a surgical drape installation aid.
[0020] Figure 2 This is an example representation of a surgical drape.
[0021] Figure 3 This shows one aspect of the surgical drape installation aid.
[0022] Figure 4 An example of a cover management feature is shown.
[0023] Figure 5 A sterile adapter holding device is shown.
[0024] Figure 6 It includes Figure 3 The illustration shows a surgical drape installation kit, which is an auxiliary tool for installing surgical drapes. Figure 2 The surgical drape is installed in the surgical drape installation aid.
[0025] Figure 7 This is a diagram of a tool for attaching a rotatable seal to a surgical drape.
[0026] Figure 8 This is an illustration of the surgical drape installation pack when it is lifted.
[0027] Figure 9A and Figure 9B The surgical drape mounting kit is shown being installed on the patient-side support system.
[0028] Figure 10 This is a more detailed illustration of the boot cover for a surgical drape.
[0029] In the accompanying drawings, the first digit of the odd-numbered reference numeral for an element is the number of the drawing in which that element first appears. Detailed Implementation
[0030] On the one hand, surgical drape installation kit 170 ( Figure 1The device includes a surgical drape installation aid 150, wherein a surgical drape 160 is packaged within the surgical drape installation aid 150. At least a portion of the surgical drape 160 is sterile.
[0031] The surgical drape installation kit 170 facilitates the positioning of the surgical drape 160 onto the computer-assisted surgical system 100 without contaminating the sterility of the sterile portions of the surgical drape 160 or compromising the integrity of the surgical drape 160. In one aspect, the surgical drape 160 includes a manipulator assembly shield and a sterile adapter packaged within the surgical drape installation aid 150.
[0032] The surgical drape installation package 170 (sometimes referred to as package 170) facilitates easy grasping of the large and bulky surgical drape 160 and allows for intuitive installation of package 170 onto the computer-assisted surgical system 100, enabling the draping process to be performed. Because the surgical drape 160 is sterilized after being positioned in the surgical drape installation aid 150, the use of the surgical drape installation aid 150 does not compromise sterility and instead helps ensure that the sterile portions of the surgical drape 160 do not come into contact with non-sterile surfaces or objects when initially attached to the computer-assisted surgical system 100 (sometimes referred to as the surgical system 100).
[0033] Furthermore, the features of the surgical drape installation aid 150 ensure that when the package 170 is mounted on the computer-assisted surgical system 100, the features of the surgical drape 160 are correctly aligned with the corresponding features of the patient-side support system 100. Automatic alignment of the features means that manual alignment is not required, and thus speeds up the draping process compared to draping processes that require manual alignment of these features.
[0034] The surgical drape 160 includes a first portion and a second portion. The surgical drape installation aid 150 includes a body having sidewalls. The sidewalls have a first end, a second end, an inner side surface, and an outer side surface. The outer side surface extends between the first end and the second end. The inner side surface also extends between the first end and the second end. The first end of the sidewall defines a first open end of the body, while the second end of the sidewall defines a second open end of the body. The inner side surface of the sidewall defines an internal volume of the body.
[0035] The second portion of the surgical drape 160 is positioned within the internal volume of the main body of the surgical drape installation aid 150. At least a portion of the first portion of the surgical drape 160 is mounted on the outer side surface of the main body.
[0036] In one aspect, the surgical drape 160 also includes an optional rotatable seal having a stationary seal portion and a rotatable seal portion. The rotatable seal portion is configured to rotate relative to the stationary seal portion. A first portion of the surgical drape is attached to the stationary seal portion, and a second portion of the surgical drape is attached to the rotatable seal portion. In this respect, the surgical drape installation aid 150 includes an optional plurality of rotatable sealing interface elements. Each of the plurality of rotatable sealing interface elements extends from a second end of a sidewall. The rotatable sealing interface elements engage with the rotatable seal and ensure that all portions of the rotatable seal are aligned to mate with corresponding portions on the patient-side support system 110.
[0037] On the other hand, the surgical drape installation aid 150 includes an optional bag with an open end. The open end of the bag is securely attached to the inner side surface of the sidewall between a first end and a second end of the sidewall. The bag is configured to extend from the first end of the sidewall.
[0038] The surgical drape installation aid 150 includes a plurality of surgical drape management features. Each of the plurality of surgical drape management features is configured to hold a portion of a first part of the surgical drape 160 against an outer side surface of a sidewall. In one aspect, the plurality of surgical drape management features include a clamp that can be attached to a sidewall.
[0039] A method includes placing a second portion of a surgical drape 160 within an internal volume of a body of a surgical drape installation aid 150. The body includes sidewalls. Each sidewall has a first end, a second end, an inner side surface, and an outer side surface. The outer side surface extends between the first and second ends. The inner side surface extends between the first and second ends. The first end of the sidewall defines a first open end of the body, while the second end of the sidewall defines a second open end of the body. The inner side surface of the sidewall defines an internal volume of the body. The method also includes attaching a first portion of the surgical drape 160 to the outer side surface of the body.
[0040] In one aspect, a first and second portion of the surgical drape 160 are attached to an optional rotatable seal. Installing the second portion then involves mounting the rotatable seal onto an optional plurality of rotatable sealing interface elements, each of which extends from a second end of the sidewall.
[0041] In this respect, the surgical system 100 includes an endoscopic imaging system 192, a surgeon's console 194 (master device), and a patient-side support system 110 (slave device), all interconnected via a wired (electrical or optical) or wireless connection 196. One or more electronic data processors may be located separately in these main components to provide system functionality. An example is disclosed in U.S. Patent No. 9,060,678, which is incorporated herein by reference.
[0042] Imaging system 192 performs image processing functions on, for example, endoscopic imaging data of captured surgical sites and / or preoperative or real-time image data from other imaging systems located outside the patient. Imaging system 192 outputs the processed image data (e.g., an image of the surgical site along with associated controls and patient information) to the surgeon at surgeon console 194. In some aspects, the processed image data is output to optional external monitors visible to other operating room staff or to one or more locations remote from the operating room (e.g., for surgeons at another location to monitor video; live feed video for training; etc.).
[0043] The surgeon's console 194 includes multiple degrees of freedom (“DOF”) mechanical input devices (“master devices”) that allow the surgeon to manipulate instruments, access guides (one or more), and imaging system devices (collectively, “slave devices”). In some aspects, these input devices can provide the surgeon with tactile feedback from instruments and components of surgical equipment. The console 194 also includes a stereoscopic video output display positioned such that the image on the display is generally focused at a distance corresponding to the surgeon’s hand working behind / below the display. These aspects are discussed more fully in U.S. Patent No. 6,671,581, which is incorporated herein by reference.
[0044] Control during instrument insertion can be achieved, for example, by the surgeon using one or two of the instruments presented in the image on the main device; the surgeon uses the main device to move the instruments in the image left and right and pull the instruments toward the surgeon. The movement of the main device commands the imaging system and associated surgical instrument components to turn toward a fixed center point on the output display and advance into the patient.
[0045] On one hand, the camera controls are designed to give the impression that the master device is fixed to the image so that the image moves in the same direction as the master device handle. This design ensures that the master device is in the correct position to control the instrument when the surgeon leaves camera control, and therefore avoids the need to connect (disconnect), move, and disconnect (engage) the master device back to its position before initiating or resuming instrument control.
[0046] The patient-side support system 110 has a base 101 support arm assembly, which includes a passive, uncontrolled assembly arm assembly 120 and an actively controlled manipulator arm assembly 130. The actively controlled manipulator arm assembly 130 is referred to as the entry guide manipulator 130.
[0047] In one example, the assembly includes two passive rotary assembly joints 103 and 105. Rotating assembly joints 103 and 105 allow manual positioning of coupled assembly links 104 and 106 if the joint brakes for assembly joints 103 and 105 are released. Alternatively, some of these assembly joints can be actively controlled, and more or fewer assembly joints can be used in various configurations. Assembly joints 103 and 105, as well as assembly links 104 and 106, allow a person to position the access guide manipulator 130 at various locations and orientations in Cartesian x, y, z space. A prism assembly joint (not shown) between link 104 of arm assembly 120 and base 101 is available for vertical adjustment 112.
[0048] The remote motion center 146 is the location where the yaw, pitch, and roll axes intersect (i.e., the location where the kinetic chain remains effectively stationary as the connector moves through its range of motion). Some of these actively controlled connectors are manipulators associated with the DOF (Domain of Function) controlling individual instruments, and others are associated with the DOF controlling individual components of these manipulators. The active connectors and linkages are movable via motors or other actuators and receive motion control signals associated with movement of the main device arm at the surgeon's console 194.
[0049] like Figure 1 As shown, a manipulator assembly deflector 111 is coupled between an end of the mounting link 106 and a second end (e.g., proximal end) of the first manipulator link 113. The deflector 111 allows the first manipulator link 113 to move relative to the link 106 in a movement that can be arbitrarily defined as a “deflection” about the manipulator assembly deflection axis 123. As shown, the axis of rotation of the deflector 111 is aligned with a remote motion center 146, which is typically the location where the instrument enters the patient (e.g., at the umbilicus for abdominal surgery).
[0050] In one embodiment, the mounting link 106 is rotatable in a horizontal plane or an x, y plane, and the deflector joint 111 is configured to allow the first manipulator link 113 in the access guide manipulator 130 to rotate about a deflection axis 123. The mounting link 106, the deflector joint 111, and the first manipulator link 113 provide a constant vertical deflection axis 123 for the access guide manipulator 130, as indicated by a vertical line passing through the deflector joint 111 to the remote center of motion 146.
[0051] The distal end of the first actuator link 113 is coupled to the proximal end of the second actuator link 115 via a first active control rotary joint 114. The distal end of the second actuator link 115 is coupled to the proximal end of the third actuator link 117 via a second active control rotary joint 116. The distal end of the third actuator link 117 is coupled to the distal portion of the fourth actuator link 119 via a third active control rotary joint 118.
[0052] In one embodiment, links 115, 117, and 119 are coupled together to act as a coupled motion mechanism. Coupled motion mechanisms are well known (e.g., such mechanisms are called parallel motion linkages when the input and output links move parallel to each other). For example, if rotary joint 114 rotates actively, joints 116 and 118 also rotate actively, causing link 119 to move with a constant relationship to link 115. Thus, it can be seen that the axes of rotation of joints 114, 116, and 118 are parallel. When these axes are perpendicular to the axis of rotation 123 of joint 111, links 115, 117, and 119 move relative to link 113 with a motion that can be arbitrarily defined as “pitch” about the pitch axis of the actuator assembly. In this respect, the actuator pitch axis extends into the remote motion center 146. Figure 1 The page and its extension Figure 1 The page. Movement about the pitch axis of the manipulator assembly is indicated by arrow 121. Since links 115, 117, and 119 move as a single component in this embodiment, the first manipulator link 113 can be considered as the active proximal manipulator link, and the second to fourth manipulator links 115, 117, and 119 can be collectively considered as the active distal manipulator links.
[0053] The access guide manipulator assembly platform 132 (sometimes referred to as platform 132) is coupled to the distal end of the fourth manipulator link 119. The access guide manipulator assembly 133 is rotatably mounted on platform 132. The access guide manipulator assembly 133 includes an instrument manipulator positioning system.
[0054] The entry guide manipulator assembly 133 causes a plurality of surgical instrument manipulator assemblies 140 to rotate as a group about axis 125. Specifically, the entry guide manipulator assembly 133 rotates relative to platform 132 as a single unit with a motion that can be arbitrarily defined as “rolling” about the entry guide manipulator assembly rolling axis 125.
[0055] Each of the plurality of surgical instrument manipulator assemblies 140 is coupled to the access guide manipulator assembly 133 via a different insertion assembly 136-1. In one aspect, each insertion assembly 136-1 is a telescopic assembly that moves the corresponding instrument manipulator assembly away from and toward the access guide manipulator assembly 133. Figure 1 In the middle, each of the inserted components is in the retracted position.
[0056] Each of the plurality of instrument manipulator assemblies 140 includes a plurality of motors that drive a plurality of outputs in the output interface of the instrument manipulator assembly. See U.S. Patent Application Publication No. US2016-0184037A1 (filed February 11, 2016) for an example of a surgical instrument manipulator assembly and a surgical instrument capable of being coupled to the surgical instrument manipulator assembly, which is incorporated herein by reference.
[0057] On one hand, a membrane interface, as part of a sterile surgical drape, may be placed between the instrument mounting interface of the instrument manipulator assembly and the input interface of the corresponding surgical instrument's transmission unit. See, for example, U.S. Patent Application Publication No. 2011 / 0277776 A1 for an example of a membrane interface and a sterile surgical drape. On the other hand, a sterile adapter, as part of a sterile surgical drape, may be placed between the instrument mounting interface of the instrument manipulator assembly and the input interface of the corresponding surgical instrument's transmission unit. See, for example, U.S. Patent Application Publication No. 2011 / 0277775 A1 for an example of a sterile adapter and a sterile surgical drape. The surgical drape 160 is configured to at least cover the entry guide manipulator 130. When the surgical drape 160 is fully deployed over the entry guide manipulator 130, the surgical drape 160 shields the non-sterile portion of the entry guide manipulator 130 from the sterile area and also shields the entry guide manipulator 130 from materials (e.g., bodily fluids) from the surgical procedure.
[0058] In one embodiment, the surgical drape 160 includes a first portion 261 configured as a shielding platform 132, links 113, 115, 117, and 119, and an associated connector. Figure 2 The first part 261 includes an external sterile surface and an internal surface. The internal surface is configured to be positioned adjacent to the platform 132, connecting rods 113, 115, 117 and 119, and associated connectors. The first part 261 is attached to the stationary portion of a rotatable seal 265, such as the rolling cap portion of a rotatable labyrinth seal.
[0059] The second part 262 of the surgical drape 160 includes a plurality of drape sleeves 262-1 to 262-4 (drape sleeves 262-3 and 262-4 are in...) Figure 2 (Not visible in the middle), wherein each cover sleeve includes a protective shield and a sterile adapter at the distal end—only the protective shields 263-1, 263-2 and the sterile adapters 264-1, 264-2 are visible in the middle. Figure 2As can be seen, each sterile adapter includes a mechanical interface configured to mate between the instrument mounting interface of the corresponding surgical instrument manipulator assembly and the input interface of the corresponding surgical instrument transmission unit.
[0060] The rotating portion of the rotatable seal 265 (such as the base comb portion of a rotatable labyrinth seal) is coupled to the proximal opening of each of a plurality of drape sleeves 262-1 to 262-4 to allow all drape sleeves to rotate together as a group relative to a first portion 261 more proximal to the surgical drape 160. See U.S. Patent Application Publication No. 2011 / 0277775 A1 for examples of suitable surgical drapes and rotatable seals.
[0061] On one hand, the first portion 261 of the surgical drape 160 and the plurality of drape sleeves are made of polyethylene material (such as ethylene methacrylate (commonly referred to as "EMA")). On the other hand, each of the plurality of protective covers is made of low-density polyethylene (LDPE).
[0062] As explained more fully below, the second portion 262 of the surgical drape 160 is placed within the internal space of the surgical drape installation aid 150. A rotatable seal 265 is mounted on the surgical drape installation aid 150. Then, the first portion 261 of the surgical drape 160 is accordion-folded and attached to the outer surface of the surgical drape installation aid 150. This arrangement of the surgical drape 160 within the surgical drape installation aid 150 allows a person to easily grasp the surgical drape installation aid 150 using the attached surgical drape 160.
[0063] The person uses the packaged surgical drape 160 to grasp the surgical drape installation aid 150, and makes the package surround the access guide manipulator assembly 133 and multiple surgical instrument manipulator assemblies 140 (see...). Figure 1 The package is moved by the dashed line (which indicates a possible range of motion) and the alignment feature on the stationary portion of the rotatable seal 265 is used to position the package such that the corresponding latch socket in each engagement platform 132 of the latch on the stationary portion of the rotatable seal 265 is located.
[0064] When the surgical drape installation kit 170 is installed on the system 100, the second portion of the surgical drape may rest below the bottom edge of the body of the surgical drape installation aid 150. However, the bag is attached to the interior of the body of the surgical drape installation aid 150 to prevent the second portion from contacting any non-sterile objects and to limit downward movement, so that the surgical drape installation kit can still be easily installed on the system 100.
[0065] Figure 3 This is an oblique view of the surgical drape installation aid 350. The surgical drape installation aid 350 is an example of the surgical drape installation aid 150.
[0066] The surgical drape installation aid 350 includes a body 351 (sometimes referred to as a collar). The body 351 includes sidewalls 351S and a plurality of rotatable sealing interface elements 380. If the surgical drape does not include a rotatable seal, the plurality of rotatable sealing interface elements 380 may not be necessary and are therefore considered optional.
[0067] The sidewall 351S has a first end 351E1 and a second end 351E2. The second end 351E2 is different from and removed from the first end 351E1. The first end 351E1 defines a first open end of the body 351, while the second end 351E2 defines a second open end of the body 351. The sidewall 351S has an inner sidewall surface 351SI and an outer sidewall surface 351SO (also referred to as "outer surface 351SO") defining the internal volume of the body 351. Each of a plurality of rotatable sealing interface elements 380 extends from the second end 351E2 of the sidewall 351S in a direction away from both the first end 351E1 and the second end 351E2.
[0068] On one hand, the body 351 is made of strips of high-density polyethylene (HDPE). The HDPE strips are formed into an open cylindrical shape, and then lap joints are made and ultrasonically welded to form... Figure 3 The main body 351 is shown in the figure. The use of the cylindrical main body is illustrative only and is not intended to be limiting. The shape of the main body of the surgical drape installation aid 350 is chosen to support the surgical drape and facilitate the attachment of the surgical drape to the surgical system.
[0069] The use of HDPE is also illustrative and not intended to be restrictive. Any material can be used to make the body 351, which is lightweight and rigid enough to support the surgical drape and rigid enough to allow manipulation of the resulting drape mounting package 170 during the mounting of the surgical drape mounting package 170 onto the surgical system without deformation that could cause the surgical drape to come into unintentional contact with non-sterile objects.
[0070] In this embodiment, the plurality of rotatable sealing interface elements 380 (sometimes referred to as a plurality of 380) includes four rotatable sealing interface elements 381, 382, 383, and 384. Each of the plurality of rotatable sealing interface elements 380 is sometimes referred to as a tab or a castellation.
[0071] In one respect, the number of rotatable sealing interface elements in the plurality of 380s is determined by the number of attachment elements (e.g., latches) of the rotatable seal 265 for attaching the rotatable seal 265 to the platform 132. In this respect, the stationary portion of the rotatable seal 265 includes four latches, and therefore the body 351 includes four rotatable sealing interface elements 381, 382, 383, and 384. This number of rotatable sealing interface elements is merely illustrative and not intended to be limiting. In other respects, the number of rotatable sealing interface elements in the plurality of 380s can be less than or greater than the number of attachment elements of the rotatable seal 265.
[0072] Multiple rotatable sealing interface elements 380 will install the surgical drape package 670. Figure 6 The surgical drape installation aid 350 is held in place until the first portion 261 of the drape 160 unfolds, for example, around the links 113, 115, 117, and 119 and the associated joint. On one hand, the surgical drape installation aid 350 is held in place by friction between two portions of a plurality of rotatable sealing interface elements 380 and rotatable seal 265. Alternatively, the surgical drape installation aid 350 can be held in place by means of features that lock to one or more elements of the sterile surgical drape. Figure 6 In the diagram, the proximal and distal directions are indicated by arrow 690.
[0073] Therefore, as long as there is sufficient friction between the multiple rotatable sealing interface elements 380 and the rotatable seal 265, the attachment portion of the cover installation aid 350 and the packaged cover 160 will not detach from the rotatable seal 265 until a person applying the cover system 100 pulls the cover installation aid 350 out of the rotatable seal 265, the number of rotatable sealing interface elements among the multiple rotatable sealing interface elements 380 can be varied. Typically, the cover installation aid 350 is removed after the first portion 261 of the cover 160 is unfolded, and the user is ready to unfold the second portion 262 of the cover 160. However, the cover installation aid 350 can also be removed before or perhaps during the unfolding of the first portion 261 of the cover 160.
[0074] The surgical drape installation aid 350 also includes multiple drape management features (e.g., drape management features 386, 387, and 388). In this example, drape management features 386, 387, and 388 are clamps attached to the sidewall 351S around an edge including a first end 351E1. Therefore, in this example, drape management features 386, 387, and 388 can also be referred to as clamps 386, 387, and 388. In this example, the body 351 of the surgical drape installation aid 350 includes multiple drape management alignment elements, such as through openings 351A, 351B, and 351C in the sidewall 351S (in... Figure 3 (Not visible in the middle). When the lip 387C on the drape management feature 387 is placed in the opening 351B (the opening 351B includes a portion of the drape management alignment element), the drape management feature 387 is correctly mounted on the surgical drape installation aid 350.
[0075] In this example, the cover management feature 387 is implemented as a clamp 387. Figure 4 Clamp 387 represents each of a plurality of cover management features. Clamp 387 includes a frame 401 in the shape of an inverted U. Frame 401 extends vertically away from the base 402 of clamp 387. Lip 387C extends from one side of a leg (a horizontal leg in this example) of frame 401, which is mostly removed from the base 402. Lip 387C is shaped to fit into opening 351B.
[0076] Two tabs 387A and 387B also extend vertically away from the base 402. Tabs 387A and 387B are separated from the vertical legs of the frame 401 by a distance approximately equal to the thickness of the sidewall 351S. This distance is large enough that the sidewall 351S can be positioned between the vertical legs of the frame 401 and the tabs 387A and 387B, and thus includes the edge of the first end 351E1 of the sidewall 351S contacting the base 401, but small enough that friction between the inner surface 351SI of the sidewall 351S and the vertical legs of the frame 401, and friction between the outer surface 351SO of the sidewall 351S and the tabs 387A and 387B, helps maintain the clamp 387 attached to the sidewall 351S. A spring clip 387D also extends vertically from the base 402. In one respect, the clamp 387 is made of polycarbonate, but other materials can be used, provided that the clamp 387 functions as described herein.
[0077] Although in this example multiple cover management features are mounted on the body 351 of the cover management aid 350, this is merely illustrative and not intended to be limiting. On the other hand, the multiple cover management features are formed as part of the body 351. In yet another aspect, the multiple cover management features are welded or heat-fused to the body 351 and thus become part of the body 351. Alternatively, the multiple cover management features can be tape or features molded into the cover management aid 350.
[0078] In this respect, the surgical drape installation aid 350 also includes a bag 352 having an open end attached to the inner surface 351SI of the sidewall 351S. For example, the open end of the bag 352 is attached to the inner surface 351SI using double-sided tape 389. The length of the bag 352 extending below the edge including the first end 351E1 of the sidewall 351S is selected such that the surgical drape installation package 170 can be installed on the access guide manipulator assembly platform 132, and no part of the bag 352 contacts the floor so that multiple protective covers do not need to be installed on multiple surgical instrument manipulator assemblies when installing the package 170, and no part of the bag 352 swings and does not contact the access guide manipulator linkage. In one respect, the bag is a polyethylene bag, but there are no special requirements for the material of the bag 352.
[0079] To mount the surgical drape in a surgical drape mounting aid 350 (sometimes referred to as aid 350), aid 350 is placed on a flat surface, with the bag 352 folded within the sidewall 351S. In this example, each of the plurality of sterile adapters 264-1 to 264-4 of the surgical drape 160 (sterile adapters 264-3 and 264-4 are not visible) is mounted on a sterile adapter holding device 501. In this example, the sterile adapter holding device 501 has a cross-shaped design with four legs equidistantly spaced. The legs of the holding device 501 are fitted into the corresponding sterile adapters. For clarity, the protective cover and plurality of drape sleeves of the surgical drape 160 attached to the sterile adapters are not shown. Additionally, Figure 5 The diagram shows an intermediate state in which only two of the four sterile adapters are mounted on the sterile adapter holding device 501.
[0080] After all sterile adapters are installed on the sterile adapter holding device 501, multiple sterile adapters, multiple protective covers 263-1 to 263-4, and multiple drape sleeves 262-1 to 262-4 are placed within the internal volume of the main body 351 inside the bag 352. Specifically, the second portion 162 of the surgical drape 160 is placed within the internal volume of the main body 351 inside the bag 352. Figure 6 ).
[0081] Then, the rotatable seal 265 is mounted on a plurality of rotatable sealing interface elements 380. Figure 7 An example of an interface between one of the rotatable seal elements 265 and one of the plurality of rotatable sealing interface elements 380 is shown in more detail. Figure 7 In the middle, the rotatable sealing interface element 384 is used to represent Figure 3 Each of the plurality of 380 rotatable sealing interface elements shown herein. In this example, the rotatable seal 265 is a labyrinth seal, as described above. The labyrinth seal includes a rolling cap portion 265-1 and a base comb portion 265-2. The base comb portion 265-2 is within the rolling cap portion 265-1 and is rotatable relative to the rolling cap portion 265-1.
[0082] exist Figure 6 In the example, the base comb portion 265-2 is a ribbed disc 665, the ribs forming a plurality of wedge-shaped "frames" with perforations, each of the frames being sized for an external instrument manipulator. The proximal end of each of the plurality of cover sleeves is coupled to a different frame of the base comb portion 265-2.
[0083] When the labyrinth seal is installed on the body 351, the latch 684 of the base comb portion 265-2 aligns with the rotatable sealing interface element 384 of the surgical drape installation aid 350, and the labyrinth seal is installed on the edge of the second end 351E2, including the sidewall 351S. The rotatable sealing interface element 384 protrudes between the latch 684 of the rolling cover portion 265-1 and the outer circumferential edge 665S of the disc 665. The outer circumferential edge 665S includes a notch 674 that locks the base comb portion 265-2 in place and thus prevents the base comb portion 265-2 from rotating until after the surgical drape installation aid 350 is removed.
[0084] The base comb portion 265-2 includes a plurality of pins 686 extending in the proximal direction from the proximal end of the disc 665. Each of the plurality of pins 686 must be installed in a mating socket in the distal side of the access guide manipulator assembly 133 so that the base comb portion 265-2 rotates when the access guide manipulator assembly 133 rotates the plurality of surgical instrument manipulator assemblies. Figure 3 , Figure 7 and Figure 8 The locking mechanism shown in the figure, which holds the base comb portion 256-2 in the correct orientation relative to the plurality of latches 681 to 684, ensures that each of the plurality of pins 686 is aligned with the corresponding socket when the rotatable seal 265 is installed using the surgical drape installation package 170.
[0085] Therefore, initially, multiple sleeves and protective covers are placed inside the body 351, and the base comb-shaped portion 265-2 and the rolling cover portion 265-1 are mounted on the body 351. Then, the first cover portion 261 is accordion-folded and the accordion-folded first cover portion 261 is held in the proper position around the outer surface 351SO by multiple cover management features. Figure 6 A surgical drape 160 is shown, which is mounted in a surgical drape installation aid 350 to form a surgical drape installation kit 670, which is an example of a surgical drape installation kit 170.
[0086] To assist the user in orienting the surgical drape installation kit 670 for installation on the patient-side support system 910 of the surgical system ( Figure 9A On the surgical drape mounting package 670, several orientation features are included. In one aspect, the disc of the rolling cover portion 265-1 has a cutout portion 666 shaped to assemble with respect to a portion of a fourth link 919 of the access guide manipulator 930 (also referred to as the "manipulator arm assembly 930"). The cutout portion 666 indicates to the user which portion of the surgical drape mounting package 670 should be oriented toward the link 919, and thus provides general orientation alignment guidance. More refined orientation alignment guidance is provided by a plurality of orientation marks 691 to 694. Each of the plurality of orientation marks 691 to 694 aligns with a corresponding latch among the plurality of latches 681 to 684. In one aspect, one or more orientation marks are used, for example, less than one orientation mark per latch.
[0087] On one hand, orientation marks 691 to 694 are colored pieces in cutouts in the disc of the rolling cover portion 265-1. Alternatively, the disc of the rolling cover portion 265-1 can be marked on its outer circumferential surface in other ways to indicate the position of the latch or multiple latches, such as holes, notches in the edge surface, notches in the edge surface, colored dots, etc. Multiple orientation marks 691 to 694 allow the user to align the package 670 with the access guide manipulator assembly platform 932 such that each of the multiple latches is aligned with a corresponding socket in the access guide manipulator assembly platform 932. Correct alignment of the rotatable seal portion with the features of the patient-side support system when installing the package 670 speeds up the application process because it is not necessary to align the rotatable seal portion with the patient-side support system 910 ( Figure 9A Manually align the corresponding parts.
[0088] Element 660 is a circumferential polyester strip attached to the outer surface of the first drape portion 261. When the surgical drape mounting package 670 is attached to the link 919, element 660 prevents the first drape portion 261 from unfolding. Element 660 is removed after the surgical drape mounting package 670 is attached to the patient-side support system 990, allowing the first drape portion 261 to be pulled over the link of the patient-side support system 990.
[0089] The surgical drape installation bag 670 can be picked up in one of two ways. In the first way, when the bag 670 is positioned for installation, the user grasps the bag 670 and keeps the pouch 352 folded. See also Figure 1 In the second method, the user grasps the side of the bag 670, and as the bag 670 is lifted, the pouch 352 transitions from a folded state to an expanded state. See also Figure 8 When bag 670 is lifted, the multiple protective covers 263-1 to 263-4 remain in bag 352 and are therefore no longer located in the internal volume of body 351.
[0090] exist Figure 9A In the middle, the patient-side support system 910 and Figure 1 The patient-side support system 110 is similar. Specifically, the actively controlled manipulator arm assembly 130 is equivalent to the actively controlled manipulator arm assembly 930, such that links 113, 115, 117, 119, the access guide manipulator assembly 133, and the multiple surgical instrument manipulator assemblies 140 are equivalent to links 913, 915, 917, 919, the access guide manipulator assembly 933, and the multiple surgical instrument manipulator assemblies 940, respectively. Therefore, for Figure 9A The corresponding components in the text, and the relationship between these components and... Figure 1 Related descriptions are not repeated here, but are incorporated into this article by reference.
[0091] Figure 9A Show package 670 ( Figure 8 Move into position for mounting on platform 932 at one end of link 919. Figure 9B Package 670 is shown mounted on platform 932. In particular, each of the plurality of latches of the rotatable seal 265 is engaged in a corresponding latch socket in platform 932.
[0092] The first portion 261 of the drape 160 unfolds from the package 670 and operates at least around links 919, 917, 915, and 913, and is then attached to link 913. Due to the physical dimensions of the patient-side support system 910, this process is difficult for one person to perform. Therefore, the aseptic person unfolding the first portion 261 of the drape 160 is assisted by a second person who does not require aseptic technique. Figure 6 and Figure 8 As shown, the interior of the first portion 261 of the drape 160 includes at least one assistant handle 695. A non-sterile person grasps the assistant handle 695 and facilitates operation on the side of the drape opposite the sterile person around the linkage. Because the assistant handle 695 is inside the surgical drape, the non-sterile person grasping and manipulating the drape does not affect the sterile outer portion of the surgical drape. In one aspect, the first portion 261 of the drape 160 includes multiple assistant handles.
[0093] After the first portion 261 of the surgical drape 160 is unfolded, the surgical drape installation aid 350 is pulled from the rotatable seal 265, and each of the plurality of sleeves 261-1 to 261-4 extends to its maximum length. Since the sterile adapters 264-1 to 264-4 are coupled together via the sterile adapter holding device 501, when the surgical drape installation aid 350 is removed, the sleeves, their protective covers, and the sterile adapters are prevented from swinging and coming into contact with non-sterile surfaces.
[0094] Figure 10 This is an illustration of a representative protective shield 263 among multiple protective shields and a corresponding sterile adapter 264 among multiple sterile adapters. In one aspect, the protective shield 263 is made of low-density polyethylene (LDPE) and is shaped to fit around an instrument manipulator. The protective shield 263 is attached to the sterile adapter 264 between portions of the sterile adapter 264. The sterile adapter 264 is configured to mate with a surgical instrument manipulator assembly. The band 1010 at the proximal end of the protective shield 263 is double-sided adhesive tape for attaching a drape sleeve to the protective shield 263.
[0095] As used in this article, "first," "second," "third," etc., are adjectives used to distinguish different parts or components. Therefore, "first," "second," and "third" are not intended to imply any order of parts or components or any total number of parts or components.
[0096] The above description and accompanying drawings illustrating aspects and embodiments of the invention should not be construed as limiting—the claims define the invention protected. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and claims. In some instances, well-known circuits, structures, and techniques have not been shown or described in detail to avoid obscuring the invention.
[0097] Furthermore, the terminology described herein is not intended to limit the invention. For example, spatially relative terms (such as "below," "under," "lower," "above," "upper," "proximal," "farthest," etc.) may be used to describe the relationship of one element or feature to another element or feature as shown in the figures. In addition to the positions and orientations shown in the figures, these spatially relative terms are intended to encompass different positions (i.e., locations) and orientations (i.e., rotational placement) of the device in use or operation. For example, if the device in the figures is flipped, an element described as "below" or "below other elements or features" would then be "above" or "above other elements or features." Thus, the exemplary term "below" can encompass both above and below positions and orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations) and the spatially relative descriptive terms used herein are interpreted accordingly. Similarly, descriptions of movement along and around various axes include individual device positions and orientations.
[0098] The singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context otherwise indicates. The terms “comprises,” “comprising,” “include,” etc., specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups. Components described as coupled may be electrically or mechanically coupled directly, or they may be indirectly coupled via one or more intermediate components.
[0099] All examples and illustrative references are non-limiting and should not be used to limit the claims to the specific embodiments and examples described herein and their equivalents. Any headings are for formatting purposes only and should not be used to limit the subject matter in any way, as text under one heading may be cross-referenced or applied to text under one or more headings. Finally, in view of this disclosure, particular features described with respect to one aspect or embodiment may be applied to other disclosed aspects or embodiments of the invention, even if not specifically shown in the drawings or described in the text.
[0100] The embodiments described above illustrate, but are not intended to limit, this disclosure. It should also be understood that many modifications and variations are possible based on the principles of this disclosure. For example, in many aspects, the device described herein is used as a single-port device; that is, all components necessary to perform the surgical procedure are introduced into the body via a single inlet. However, in some aspects, multiple devices and ports may be used.
Claims
1. A surgical drape installation aid, comprising: a body comprising a sidewall, wherein the sidewall comprises a first end defining a first opening and a second end defining a second opening; and a pocket attached to the body so as to be extendable from the second end of the body in a direction away from the body, wherein the sidewall and the pocket bound an interior volume; wherein the sidewall comprises an inner surface facing the interior volume and an outer surface opposite the inner surface, and wherein the body is configured to receive a surgical drape installed thereon such that: a first portion of the surgical drape is positioned on the outer surface of the sidewall; and a second portion of the surgical drape is positioned in the interior volume.
2. The surgical drape installation aid of claim 1, wherein the second portion of the surgical drape comprises one or more instrument sterile adapters, and wherein the pocket is configured to receive the one or more instrument sterile adapters in a state where the surgical drape is installed to the body.
3. The surgical drape installation aid of claim 2, wherein the surgical drape comprises a rotatable seal rotatably coupling the first portion to the second portion; and wherein the body is configured to receive the rotatable seal attached to the first end of the sidewall in a state where the surgical drape is installed to the body.
4. The surgical drape installation aid of claim 2, wherein the one or more instrument sterile adapters comprise a plurality of instrument sterile adapters.
5. The surgical drape installation aid of claim 4, wherein the surgical drape comprises a rotatable seal rotatably coupling the first portion to the second portion; wherein the second portion of the surgical drape comprises a plurality of sleeves extending from the rotatable seal, the plurality of instrument sterile adapters being respectively coupled to the plurality of sleeves; wherein the body is configured to receive the rotatable seal attached to the sidewall in a state where the surgical drape is installed to the body; and wherein the pocket is configured to hold the plurality of sleeves and the plurality of instrument sterile adapters in a position that is no more than a predetermined distance from the second end of the sidewall in the state where the surgical drape is installed to the body.
6. The surgical drape installation aid of claim 4, wherein the surgical drape installation aid further comprises a sterile adapter holding device comprising a plurality of legs, each of the plurality of legs being configured to receive a respective one of the plurality of instrument sterile adapters installed thereon.
7. The surgical drape installation aid of claim 1, wherein the surgical drape installation aid further comprises a plurality of surgical drape management features configured to hold a portion of the first portion of the surgical drape on the outer surface of the sidewall.
8. The surgical drape installation aid tool of claim 1, wherein the pocket is attached to the inner surface of the sidewall.
9. The surgical drape installation aid tool of claim 1, wherein the pocket is removably attached to the body.
10. The surgical drape installation aid tool of claim 1, wherein the body has a cylindrical shape.
11. The surgical drape installation aid tool of claim 1, wherein in a state where the pocket extends from the second end, the pocket has a length that enables the body to be installed to a manipulator assembly without the pocket contacting a floor on which the manipulator assembly rests.
12. A surgical drape system, comprising: the surgical drape installation aid tool of claim 1; and a surgical drape installed to the surgical drape installation aid tool, wherein the surgical drape includes a first portion positioned on the outer surface of the sidewall of the body and a second portion positioned in the interior volume.
13. The surgical drape system of claim 12, wherein the second portion of the surgical drape includes one or more instrument sterile adapters received within the pocket.
14. The surgical drape system of claim 13, wherein the surgical drape includes a rotatable seal rotatably coupling the first portion to the second portion; and wherein the rotatable seal is attached to the first end of the sidewall.
15. The surgical drape system of claim 13, wherein the one or more instrument sterile adapters include a plurality of instrument sterile adapters.
16. The surgical drape system of claim 15, wherein the surgical drape includes a rotatable seal rotatably coupling the first portion to the second portion; wherein the rotatable seal is attached to the sidewall of the body; wherein the second portion of the surgical drape includes a plurality of sleeves extending from the rotatable seal, the plurality of instrument sterile adapters being respectively coupled to the plurality of sleeves; and wherein the pocket holds the plurality of sleeves and the plurality of instrument sterile adapters in a position such that they are not located beyond a predetermined distance from the second end of the sidewall.
17. The surgical drape system of claim 15, further comprising: a sterile adapter holding device including a plurality of legs, each of the plurality of legs having a respective one of the plurality of instrument sterile adapters mounted thereon.
18. The surgical drape system of claim 12, wherein the surgical drape installation aid tool further includes a plurality of surgical drape management features that hold a portion of the first portion of the surgical drape on the outer surface of the sidewall.
19. The surgical drape system of claim 12, wherein the pocket is attached to the inner surface of the sidewall.
20. The surgical drape system of claim 12, wherein the body has a cylindrical shape.
21. The surgical drape system of claim 12, wherein the surgical drape includes a handle attached to an interior side of the first portion.
22. The surgical drape system of claim 12, wherein the pocket is removably attached to the body.
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