Pressure test port contained within a body of a surgical instrument

Abstract

The name of the invention is a pressure test port contained within a body of a surgical instrument. A surgical device includes a housing, a test port holder, a pressure test chamber, and an image capture assembly. The housing includes a pressure test port. The test port holder includes a test port holder housing, a probe seal, and a liquid barrier. In one aspect, the test port holder further includes a hydrophobic membrane mounted within the test port holder housing. The pressure test chamber includes a manifold and a center tube. A first end of the center tube is affixed to the image capture assembly to form a pressure seal, and a second end of the center tube is coupled to the test port holder such that the pressure test port is in communication with an interior volume of the center tube through the test port holder.

Description

[0001] This application is a divisional application of the original application which has an application date of May 8, 2017, application number 201780042179.9, and the title "A PRESSURE TEST PORT CONTAINED WITHIN A BODY OF SURGICAL INSTRUMENT."

[0002] Related Applications

[0003] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 362,188, filed July 14, 2016, and entitled "A PRESSURE TEST PORT CONTAINED WITHIN A BODY OF SURGICAL INSTRUMENT," the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0004] The present disclosure relates generally to endoscopes, and more particularly to features that facilitate testing and assembly of endoscopes. BACKGROUND

[0005] One or more endoscopes are commonly used in computer-assisted surgeries. The endoscope typically has a flexible or rigid shaft that extends into a patient. At the end of the endoscope within the patient is one or more ports that provide illumination of the surgical site and one or more ports that are used to capture one or more images of the surgical site. Cables and fiber optic cables typically extend through the shaft of the endoscope.

[0006] Because at least a portion of the endoscope is introduced into the patient during a surgical procedure, the endoscope must be cleaned and sterilized before each surgical procedure and after each surgical procedure. Typically, the endoscope is cleaned and sterilized by scrubbing the endoscope and then placing the endoscope in a bath and subjecting the endoscope to ultrasonic waves. The endoscope is sterilized by an autoclave process. In the autoclave process, the endoscope is subjected to a vacuum and to high pressure high temperature steam. Thus, the cleaning and sterilization process immerses the endoscope in a liquid and subjects the endoscope to various pressures and temperatures. In addition, the endoscope is also subjected to various pressures and temperatures when the endoscope is shipped through the air.

[0007] Finally, to ensure that the endoscope is not damaged, the endoscope is pressure tested before each use. See, for example, "Are You Properly Leak Testing Your Flexible Endoscope?", Fibertech Medical U.S.A., page 2 (2006).

[0008] Problems associated with cleaning, disinfecting, and pressure testing are well known and various approaches have been taken to address these problems. For example, U.S. Patent No. 5,868,667 discloses a device that allows equalization of pressure between the interior space of an endoscope and the environment outside the endoscope. The device is reported to be a vent cap that equalizes pressure while reducing any flow of liquid, water vapor, and hydrogen peroxide into the interior space of the endoscope. The vent cap is designed to receive a port that is connected to the interior space of the endoscope.

[0009] However, while some manufacturers manufacture endoscopes to include ports that can accommodate vent caps, the use of vent caps requires different caps depending on the procedure being used according to U.S. Patent Application Publication No. US2014 / 0100425A1. U.S. Patent Application Publication No. US2014 / 0100425A1 describes yet another example of a pressure compensating cap that can be placed over a port of an endoscope. SUMMARY

[0010] According to an embodiment, a surgical device includes a housing, a pressure test chamber, and a test port retainer. The housing includes a pressure test port. The test port retainer is mounted within the housing. The test port retainer couples the pressure test port to the pressure test chamber. The test port retainer includes a test port retainer housing, a probe seal, and a liquid barrier. The probe seal and the liquid barrier are mounted within the test port retainer housing.

[0011] In one aspect, the test port retainer further includes a hydrophobic membrane mounted within the test port retainer housing. In this aspect, the liquid barrier is mounted between the probe seal and the hydrophobic membrane. In one aspect, the hydrophobic membrane includes a polyvinylidene fluoride membrane and the liquid barrier includes an X-slit valve.

[0012] The pressure test chamber includes a manifold. The test port retainer is mounted between the pressure test port and the manifold such that the pressure test port is in communication with the manifold through the test port retainer.

[0013] According to an embodiment, the surgical device further includes an image capture assembly. The pressure test chamber includes a central tube having a first end, a second end, and a central lumen. The central lumen extends between the first end and the second end. The first end of the central tube is affixed to the image capture assembly to form a pressure tight seal. The second end of the central tube is coupled to the test port retainer such that the pressure test port is in communication with the central lumen of the central tube through the test port retainer. More specifically, the second end of the central tube is affixed to the manifold such that the pressure test port is in communication with the central lumen of the central tube through the manifold.

[0014] According to an embodiment, the surgical device further includes a pressure sealed cable. The pressure sealed cable is connected to the image capture assembly and extends through the central lumen into the manifold. The manifold includes a pressure seal. The pressure sealed cable extends through the pressure seal and out of the manifold.

[0015] The pressure sealed cable further includes one or more conductors, a first insulating jacket surrounding the one or more conductors, a first shield surrounding the first insulating jacket, a second insulating jacket surrounding the first shield, and a first pressure seal formed around and inside the first shield. In one aspect, the pressure sealed cable further includes a second shield surrounding the second insulating jacket, a third insulating jacket surrounding the second shield, and a second pressure seal formed around and inside the second shield and extending between the second insulating jacket and the third insulating jacket. The pressure sealed cable has a first end and a second end. In one aspect, the first pressure seal is adjacent to one of the first end and the second end and the second pressure seal is adjacent to the other of the first end and the second end.

[0016] According to an embodiment, the endoscope includes an image capture subassembly and a central tube bundle subassembly. The image capture subassembly (second subassembly) includes a cable and an image capture unit subassembly (first subassembly). The cable and the image capture unit subassembly include a cable and an image capture unit. The cable is connected to the image capture unit and extends proximally from the image capture assembly. The central tube bundle subassembly (third subassembly) includes a central tube. The central tube has a distal end. The cable enters the distal end of the central tube forming the central tube bundle subassembly and the cable extends from a proximal end of the central tube. The distal end of the central tube is connected to the image capture subassembly. The central tube bundle subassembly further includes a light tube coupled to the image capture subassembly and extending through the central tube. In one aspect, the cable is a pressure sealed cable.

[0017] In one aspect, the central tube is a single continuous tube with a single lumen. The single continuous tube has an outer surface and an inner surface. The inner surface bounds the single lumen. In yet another aspect, a friction reducing coating coats both the inner surface and the outer surface of the single continuous tube.

[0018] According to an embodiment, the endoscope further includes a base instrument subassembly (fourth subassembly). The base instrument subassembly includes a base, a shaft, and an optional articulation assembly. The shaft is coupled between the base and the articulation assembly. The central tube extends through the articulation assembly and the shaft. The articulation assembly is connected to the image capture assembly.

[0019] In one aspect, the articulation assembly includes a first disk, a second disk, an actuation cable having a distal end, and a fitting. The first disk and the second disk form part of an articulating joint when mated. The distal end of the actuation cable passes through the second disk, and then the fitting is attached to the distal end of the actuation cable. The fitting is contained in a cavity formed by mating the first disk and the second disk.

[0020] According to an embodiment, the base instrument subassembly further includes a manifold and a manifold pressure seal. The pressure seal cable and the light tube pass through the manifold pressure seal, and the manifold pressure seal is installed within the manifold. The base instrument subassembly further includes a test port holder installed on the manifold.

[0021] In another aspect, the endoscope includes a pressure seal cable connected to an image capture unit to form a first subassembly. The endoscope further includes a housing having a distal end and a proximal end. The image capture unit is installed into the housing from the distal end of the housing, with the pressure seal cable extending proximally through the proximal end of the housing. A light tube has a distal end of the light tube installed in the housing, with the light tube extending proximally through the proximal end of the housing. A cap is affixed to the distal end of the housing. The housing, the cap, the light tube, and the first subassembly are a second subassembly.

[0022] According to an embodiment, the endoscope further includes a flange and a center tube having a distal end. The distal end of the center tube is installed on the flange and the flange is affixed to the housing. The center tube, the flange, and the second subassembly are a center tube subassembly.

[0023] In yet another aspect, according to an embodiment, the endoscope includes a center tube subassembly and a base instrument subassembly. The center tube subassembly includes an image capture assembly, a light tube having a distal end installed in the image capture assembly, a pressure seal cable having a distal end connected to the image capture assembly, and a center tube having a distal end and a lumen. The distal end of the center tube is connected to the image capture unit. The light tube and the pressure seal cable pass through the lumen of the center tube. The base instrument subassembly includes a base, a shaft, and an articulation assembly. The shaft is coupled between the base and the articulation assembly. The center tube extends through the articulation assembly and the shaft. The articulation assembly is connected to the image capture assembly.

[0024] In one aspect, the center tube of the endoscope is a single continuous tube. The single continuous tube has an outer surface and an inner surface. The inner surface bounds a single lumen. A friction-reducing coating coats both the outer surface and the inner surface of the single continuous tube. The pressure seal cable has an outer surface, with the friction-reducing coating on the outer surface of the pressure seal cable.

[0025] In yet another aspect, an endoscope includes an image capture assembly and an articulation assembly connected to the image capture assembly. The articulation assembly includes a first disk, a second disk, an actuation cable having a distal end, and a fitting. The distal end of the actuation cable passes through the second disk and then the fitting is attached to the distal end of the actuation cable. The fitting is contained in a cavity formed by mating the first disk and the second disk. The mating of the first disk and the second disk forms part of an articulation joint. The first disk is connected to the image capture assembly.

[0026] According to an embodiment, a method of manufacturing an endoscope includes assembling a first sub-assembly including a pressure sealed cable connected to an image capture unit. An electrical conductivity test is performed on the first sub-assembly and then a second sub-assembly is assembled including the first sub-assembly, a housing, a light pipe, and a cap. The housing has a distal end and a proximal end. The image capture unit is installed in the housing from the distal end of the housing as the second sub-assembly is assembled with the pressure sealed cable extending proximally through the proximal end of the housing. The distal end of the light pipe is installed in the housing with the light pipe extending proximally through the proximal end of the housing. Finally, the cap is affixed to the distal end of the housing.

[0027] After the second sub-assembly is assembled, a seal verification test is performed on the second sub-assembly. Once the seal verification test is successfully completed, a center tube assembly is assembled. The center tube assembly includes the second sub-assembly, a center tube, and a flange. Assembling the center tube includes installing the center tube onto the flange, threading the pressure sealed cable and the light pipe through the flange and the center tube, and affixing the flange to the housing.

[0028] The center tube of the center tube assembly is threaded through the shaft of the base instrument sub-assembly and then the pressure sealed cable and the light pipe are passed through a pressure seal. The pressure seal is installed in a manifold and the center tube is affixed to the manifold. Finally, a pressure test is performed using a port in the manifold.

[0029] Thus, in one aspect, an endoscope includes a first sub-assembly, a second sub-assembly, a third sub-assembly, and a fourth sub-assembly that are assembled and tested in sequence in manufacturing the endoscope. The first sub-assembly includes a pressure sealed cable connected to an image capture unit. The second sub-assembly includes the first sub-assembly, a housing, a light pipe, and a cap. The third sub-assembly includes the second sub-assembly, a center tube, and a flange. The fourth sub-assembly includes the third sub-assembly, a base, a shaft, and optionally an articulation assembly. BRIEF DESCRIPTION OF DRAWINGS

[0030] Figure 1 is a schematic side view showing aspects of a surgical system including a surgical device having a pressure test port, a test port retainer, and a pressure test chamber.

[0031] Figures 2A to 2D is a schematic side view showing aspects of a surgical system including a surgical device having a pressure test port, a test port retainer, and a pressure test chamber.Figure 1 Alternatives to surgical devices.

[0032] Figure 3 It is suitable for Figure 1 and Figures 2A to 2D A more detailed schematic diagram of the test port holder and pressure test chamber used in any of the surgical devices.

[0033] Figure 4A and Figure 4B These are end views and sectional views of one aspect of the pressure-sealed cable.

[0034] Figure 5 It is suitable for Figure 1 , Figures 2A to 2D and Figure 3 A diagram of the light tube used in the surgical apparatus.

[0035] Figure 6 It is suitable for Figure 1 , Figures 2A to 2D and Figure 3 A cross-sectional view of the manifold and test port holder used in the surgical apparatus.

[0036] Figure 7A This is a diagram of the central canal bundle assembly of an endoscope.

[0037] Figure 7B yes Figure 7A A diagram of the base instrument sub-assembly of an endoscope.

[0038] Figure 7C It is installed in Figure 7B In the base instrument sub-assembly Figure 7A The diagram shows the central tube assembly and the instruments and endoscopic imaging system connected as a combination.

[0039] Figure 8 This is a flowchart of the process of assembling and testing sub-components in the assembly and testing of an endoscope.

[0040] Figures 9A to 9C Shown in Figure 8 The sub-component used in the process.

[0041] Figure 10A and Figure 10B This demonstrates how to modify the disk of the articulated assembly to eliminate possible fluid flow paths.

[0042] In the accompanying drawings, for single-digit drawing numbers, the first digit in the element's reference numeral indicates the drawing number in which that element first appears. For double-digit drawing numbers, the first two digits in the element's reference numeral indicate the drawing number in which that element first appears. Detailed Implementation

[0043] According to an embodiment, a novel structure and method eliminates the drawbacks of the prior art associated with the ports of an endoscope, where the ports of the endoscope require some type of cap to seal the port. Even though a vented cap can provide pressure compensation and prevent liquid from entering the interior space of the endoscope, the use of a vented cap still requires the user to remember to use and properly install the vented cap. If the user forgets to install the vented cap or installs the vented cap incorrectly, the endoscope can be damaged during endoscope sterilization due to liquid intrusion into the interior space of the endoscope. As more fully described below, this problem is eliminated with a test port 138 coupled to a test port holder inside the endoscope 135-1. The endoscope 135-1 is an imaging instrument and can therefore be referred to as the instrument 135-1.

[0044] Furthermore, vented caps that include filters made of materials that pass gas under pressure but prevent liquid from passing can have false positives during pressure testing. If the filter is covered or wet with liquid during pressure testing, the gas is prevented from passing through the filter, and thus the pressure tester sees a positive pressure. However, this positive pressure is not the result of the interior space of the endoscope being properly sealed, but rather the result of the membrane being unable to pass gas due to moisture on or covering the filter. Furthermore, as more fully described below, not only is the reliance on vented caps eliminated, but the test port holder coupled to the test port 138 ensures that no moisture or liquid blocks the flow of gas into the interior space of the endoscope 135-1 during pressure testing of the endoscope 135-1.

[0045] Figure 1 is a schematic side view showing aspects of a computer-assisted teleoperated surgical system 100 that includes an endoscope imaging system 192, a surgeon’s console 194 (master device), and a patient-side support system 110 (slave device) interconnected by wired (electrical or optical) or wireless connections 196. One or more electronic data processors can be located in different places among these main components to provide system functionality. An example is disclosed in U.S. Patent No. US 9,060,678 B2, which is incorporated herein by reference.

[0046] The patient-side support system 110 includes an access guide manipulator 130. At least one surgical device assembly is coupled to the access guide manipulator. Each surgical device assembly includes an instrument, which in turn includes a surgical instrument or an image capture assembly. For example, in Figure 1In particular embodiments, a surgical device assembly includes an instrument 135-1 having a shaft 137-1 and an image capture assembly that extends through the access guide 115 during a surgical procedure. The instrument 135-1 is sometimes referred to as an endoscope, or alternatively as an imaging system device or camera instrument. The instrument 135-1 includes a novel test port holder that connects a test port 138 to a manifold in a pressure test chamber (described more fully below) within the instrument 135-1. Generally, the access guide 115 includes a plurality of lumens.

[0047] The imaging system 192 performs image processing functions on, for example, captured endoscopic imaging data of a surgical site and / or preoperative or real-time image data from other imaging systems outside the patient. The imaging system 192 outputs the processed image data (e.g., images of the surgical site along with related control and patient information) to the surgeon at the surgeon’s console 194. In some aspects, the processed image data is output to an optional external monitor visible to other operating room personnel or to one or more locations remote from the operating room (e.g., a surgeon at another location can monitor the video; live feed video can be used for training, etc.).

[0048] The surgeon’s console 194 includes a plurality of degree-of-freedom (“DOF”) mechanical input devices (“master devices”) that allow the surgeon to manipulate the instruments, access guides(s), and imaging system devices, collectively referred to as slave devices. In some aspects, these input devices can provide haptic feedback to the surgeon from the surgical device assembly components. The console 194 also includes a stereoscopic video output display that is positioned so that the images on the display are generally focused at a distance corresponding to the surgeon’s hands working behind / below the display screen. These aspects are discussed more fully in U.S. Patent No. 6,671,581, which is incorporated by reference herein.

[0049] Control during insertion of the instruments can be accomplished, for example, by the surgeon moving the instruments and / or image capture assemblies presented in the images with one or both of the master devices; the surgeon uses the master devices to move the instruments left and right in the images and to pull the instruments toward the surgeon. Motion of the master devices commands the imaging system and related surgical device assembly to turn toward a fixed center point on the output display and to advance inside the patient.

[0050] In one aspect, the camera control is designed to give the impression that the active device is fixed to the image so that the image moves in the same direction as the active device handle is moved. This design allows the active device to be in the correct position to control the instrument when the surgeon exits the camera control and thus this design avoids the need to uncouple, move and decouple the active device back to position before starting or resuming instrument control.

[0051] In certain aspects, the active device orientation can be made proportional to the insertion speed to avoid using a large active device workspace. Alternatively, the surgeon can uncouple and decouple the active device to use a ratcheting action for insertion. In some aspects, insertion can be controlled manually (e.g., by a hand-operated wheel) and then automatically (e.g., a servo-motor driven roller) when the distal end of the surgical device assembly is near the surgical site. Preoperative or real-time image data (e.g., MRI, X-ray) of the patient's anatomy and the available space of the insertion trajectory can be used to assist insertion.

[0052] The patient-side support system 110 includes a floor-mounted base 101 or, alternatively, a ceiling-mounted base (not shown). The base 101 can be movable or fixed (e.g., fixed to the floor, ceiling, wall, or other equipment such as an operating table).

[0053] The base 101 supports an arm assembly that 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 an entry guide manipulator 130.

[0054] A cannula 116 is detachably coupled to the cannula mount. In this description, a cannula is generally used to prevent an instrument or entry guide from rubbing against a patient's tissue. Cannulas can be used for both incisions and natural orifices. For cases where an instrument or entry guide does not frequently translate or rotate relative to its insertion (longitudinal) axis, a cannula can not be used. For cases where insufflation is required, a cannula can include a seal to prevent excessive insufflation gas from leaking past the instrument or entry guide. Examples of cannula assemblies that support insufflation and procedures that require insufflation gas at the surgical site can be found in U.S. Patent Application No. 12 / 705,439 (filed February 1, 2010; published as "Entry Guide for Multiple Instruments in a Single Port System"), the entire disclosure of which is incorporated herein by reference for all purposes. For thoracic surgical procedures that do not require insufflation, the cannula seal can be omitted, and the cannula itself can be omitted if the instrument or entry guide insertion axis moves minimally. In some configurations of instruments, a rigid entry guide can serve as a cannula for a cannula inserted relative to the entry guide. The cannula and entry guide can be, for example, steel or extruded plastic. Plastic, which is less expensive than steel, can be suitable for single use.

[0055] As the patient is placed in various positions on the movable table, various passive assembly joints / links and active joints / links allow the instrument manipulator to be positioned, moving the instrument with a greater range of motion. In some examples, the cannula mount can be coupled to a first manipulator link.

[0056] Certain assembly and active joints and links in the manipulator arm can be omitted to reduce the size and shape of the surgical system, or joints and links can be added to increase degrees of freedom. It should be understood that the manipulator arm can include various combinations of links, passive joints, and active joints (which can provide redundant degrees of freedom) to achieve the necessary range of poses for surgery. Furthermore, various instruments, individually or including entry guides, multiple instruments, and / or multiple entry guides, and instruments coupled to the instrument manipulator (e.g., an active actuator assembly) via various configurations (e.g., on a proximal or distal face of an instrument transfer device or instrument manipulator) are applicable in aspects of the present disclosure.

[0057] Each of the multiple surgical apparatus assemblies 180 includes an instrument manipulator assembly and an instrument including one of a surgical instrument and an image capture assembly. In Figure 1In the figure, two of the plurality of surgical device assemblies 180 are visible, and while one of the two visible surgical device assemblies has a surgical instrument and the other has an image capture assembly, each of the two visible surgical device assemblies includes an instrument manipulator assembly. In one aspect, each of the instrument manipulator assemblies 140-1 and 140-2 is computer-assisted, and thus each assembly is sometimes referred to as a computer-assisted instrument manipulator assembly. Each of the instrument manipulator assemblies 140-1 and 140-2 is coupled to the access guide manipulator assembly 133 by a different insertion assembly, e.g., the instrument manipulator assembly 140-1 is coupled to the access guide manipulator assembly 133 by the insertion assembly 136-1.

[0058] In one aspect, the insertion assembly 136-1 is a telescoping assembly that moves the respective surgical device assembly away from and toward the access guide manipulator assembly 133. In Figure 1 In the figure, the insertion assembly 136-1 is in a fully retracted position.

[0059] Each of the instrument manipulator assemblies 140-1, 140-2 includes a plurality of motors that drive a plurality of outputs in an output interface of the instrument manipulator assembly 140-1, 140-2. Each of the instruments 135-1, 135-2 includes a body that houses a transmission unit. The transmission unit includes an input interface that includes a plurality of inputs. Each of the instruments 135-1, 135-2 also includes a shaft 137-1, 137-2, which is sometimes referred to as a main tube that extends in a distal direction from the body. An end effector is coupled to a distal end of the shaft of one instrument assembly, and an image capture assembly (e.g., a camera) is included in the distal end of a different instrument assembly. See U.S. Patent Application Publication No. 2016 / 0184037 for one example of an instrument manipulator assembly and a surgical instrument, which is incorporated by reference.

[0060] Each of the instruments 135-1, 135-2 is coupled to an instrument mounting interface of the respective instrument manipulator assembly 140-1, 140-2, such that the plurality of inputs in the input interface of the transmission unit in the instrument 135-1, 135-2 is driven by the plurality of outputs in the instrument mounting interface of the instrument manipulator assembly 140-1, 140-2. See U.S. Patent Application Publication No. 2016 / 0184037.

[0061] In one aspect, one or more of the instrument manipulator assemblies can be configured to support and actuate a particular type of instrument, such as the instrument 135-1. As Figure 1As shown in FIG. 1, shafts of a plurality of surgical device assemblies 180 extend distally from a body of the instrument. The shafts extend through a common cannula 116 placed at an access port into a patient (e.g., through a body wall or at a natural orifice). In one aspect, an access guide 115 is positioned within the cannula 116, and each instrument shaft extends through a passage in the access guide 115 to provide additional support for the instrument shafts.

[0062] Surgical procedures that can be performed using the surgical system 100 can be performed on different areas of the body. For example, one surgical procedure can be performed through a patient's mouth. Another surgical procedure can be performed between a patient's ribs. Still other surgical procedures can be performed through other orifices of the patient or through incisions in the patient. Each different access into the patient can require an access guide having a different shape and / or different size. Thus, the appropriate access guide 115 is selected for a particular surgical procedure.

[0063] Figures 2A to 2D Different aspects of the endoscope 135-1 are shown in FIGS. 1-4. Figures 2A to 2D In FIG. 1, only aspects of the endoscope 135-1 that are needed to understand aspects of the present application are shown. Some of these aspects are shown in dashed lines to indicate that the aspect is included within the endoscope.

[0064] The endoscope 235A( Figure 2A ) includes a housing 241A from which a hollow shaft 237A extends. In this aspect, serially connected to a distal end of the shaft 237A are a parallel kinematic mechanism 270A and a wrist assembly 280A, which are examples of articulated assemblies. An image capture assembly 242A is connected to the parallel kinematic mechanism 270A by the wrist assembly 280A.

[0065] The test port retainer 250A connects the pressure test port 238A in the housing 241A to a pressure test chamber. The pressure test chamber includes the test port retainer 250A, a manifold 260A, and a center tube 265A.

[0066] The test port retainer 250A connects the pressure test port 238A to the manifold 260A. When the endoscope 235A is not being pressure tested, the test port retainer 250A allows any pressurized gas in the pressure test chamber to be vented. Thus, there is no possibility of pressure buildup inside the endoscope 235A during a heat press process in which the endoscope 235A is heated to around 140°C or during transport of the endoscope 235A. When the endoscope 235A is being cleaned manually or in an ultrasonic bath, the test port retainer 250A prevents any liquid or any moisture from passing through the test port retainer 250A into the interior of the pressure test chamber.

[0067] Manifold 260A is connected between test port holder 250A and center tube 265A. A first end of center tube 265A is connected to image capture assembly 242A by a pressure tight seal, while a second end of center tube 265A is connected to manifold 260A by another pressure tight seal. In this context, a pressure tight seal refers to a seal sufficient to maintain the minimum pressure required during a pressure test.

[0068] Thus, in one aspect, center tube 265A is a single continuous tube having a single lumen or passageway, while in another aspect, it is a molded single continuous silicone tube having a single lumen. Center tube 256A has an outer surface and an inner surface. The inner surface bounds the single lumen. As shown, when center tube 265 passes through parallel motion mechanism 270A and wrist assembly 280A, the longitudinal axis of center tube 265 coincides with the longitudinal axis of shaft 237A, the longitudinal axis of parallel motion mechanism 270A, and the longitudinal axis of wrist assembly 280A. Figure 2A

[0069] Generally, image capture assembly 242A includes one or more video cameras and one or more illumination ports. Pressure sealed cable 261A (sometimes referred to as cable 261A) is connected to the one or more video cameras and extends through the center lumen of center tube 265A and through a first opening in manifold 260A into the interior volume of manifold 260A and out of manifold 260A. Specifically, pressure sealed cable 261A has a distal end that is connected to image capture assembly 242A. Pressure sealed cable 261A passes through the single lumen in center tube 365A, through manifold 260A and out of manifold 260A, and the proximal end of pressure sealed cable 261A is connected to repeater board 268A.

[0070] In one aspect, pressure sealed cable 261A is a shielded cable having one or more conductors. Each of the one or more conductors is connected to a connector that is, in turn, connected to the one or more video cameras. The one or more conductors are potted in the connector. The one or more shields of cable 261 are also pressure sealed. In this context, pressure sealed refers to a seal formed within and around the shield sufficient to maintain the minimum pressure required during a pressure test. Thus, a pressure sealed cable is a cable that does not have a passageway between the insulating jacket that would prevent the endoscope from being maintained at the minimum pressure required during a pressure test or a passageway within a portion of the cable, such as a shield, that would allow gas flow.

[0071] ​In this regard, light emitting diodes on the relay board 268A are used to indicate whether the lasers are on or off. Accordingly, the endoscope 235A includes at least one light pipe 262A having a first end connected to an illumination port in the image capture assembly 242A and a second end canned in a metal ferrule connected to the connector 269A. The two ends of the light pipe 262A are mounted such that the connections are pressure sealed. The light pipe 262A also extends through the central lumen of the central tube 265A.

[0072] The use of the light pipe 262A is merely illustrative and is not intended to be limiting. If an illuminator is included in the image capture assembly 242A, the light pipe 262A will not be used.

[0073] The cable 261 A and the light pipe 262A enter the manifold 260A through a first opening and exit through a second opening. In one aspect, pressure seals are used around the cable 261 A and the light pipe 262A in the first and second openings. In another aspect, the manifold 260A is configured to use a single pressure seal.

[0074] The relay board 268A is connected to the connector 269A. The instrument to endoscope imaging system cable is connected to the connector 269A to couple the endoscope 235A to an endoscope imaging system, such as the endoscope imaging system 192.

[0075] The test port holder 250A includes a body, a probe seal 251 A, a liquid barrier 252A, and a hydrophobic membrane 253A. Each of the probe seal 251 A, the liquid barrier 252A, and the hydrophobic membrane 253A are mounted within the body of the test port holder 250A with the probe seal 251 A closest to the pressure test port 238A and the hydrophobic membrane 253A farthest from the pressure test port 238A, i.e., the liquid barrier 252A is mounted between the probe seal 251 A and the hydrophobic membrane 253A.

[0076] The probe seal 251 A has an opening in the center that is designed to form a seal around the tip of a pressure test probe. In one aspect, the liquid barrier 252A is an x-slit valve. If there is a pressure differential across the x-slit valve, the x-slit valve opens until the pressure is equalized. When cleaning the endoscope 235A, the water pressure on the x-slit valve is not enough to cause the x-slit valve to open, so the x-slit valve prevents liquid from entering the pressure test chamber that includes the central lumen of the central tube and the manifold.

[0077] In one aspect, the hydrophobic membrane 253A is a polyvinylidene fluoride (PVDF) membrane having a 0.22-0.45 micron pore size. PVDF is solvent resistant and is a highly non-reactive and pure thermoplastic fluoropolymer polymerized from vinylidene fluoride. PVDF melts around 177°C, which is above the temperatures encountered during the heat press process. The hydrophobic membrane 253A protects the pressure test chamber from the ultrasonic fluid and prevents any pressure build-up within the pressure test chamber during the heat press process.

[0078] Furthermore, the liquid barrier 252A keeps moisture and liquid away from the hydrophobic membrane 253A so that the membrane 253A functions properly during pressure testing. In prior art systems, if the hydrophobic membrane is wet, the hydrophobic membrane can cause false positive pressure readings because the moisture prevents the gas used in the pressure test from passing through the hydrophobic membrane. The test port holder 250A eliminates the possibility of such false positive pressure readings by preventing moisture and / or liquid from reaching the surface of the hydrophobic membrane 253A.

[0079] To ensure that there is no leak from the environment outside of the endoscope 235A to the pressure test chamber, the pressure test probe is inserted into the test port 238A and the pressure test chamber is pressurized to a predetermined pressure. If the pressure test chamber maintains the pressure greater than a predetermined minimum pressure for a predetermined time interval, then there is no fluid (liquid or gas) passageway for communication between the environment outside of the endoscope and the interior of the pressure test chamber, which is important in surgical procedures. Thus, the pressure test chamber is not contaminated during the surgical procedure in which the endoscope 235A is used for insufflation pressure.

[0080] In another aspect, the endoscope 235B Figure 2B ) includes a housing 241B from which a shaft 237B extends. In this aspect, an image capture assembly 242B is connected to the distal end of the shaft 237A.

[0081] The test port holder 250B connects the pressure test port 238B in the housing 241B to a pressure test chamber. The pressure test chamber includes the test port holder 250B, a manifold 260B, and a center tube 265B. The manifold 260B is connected between the test port holder 250B and the center tube 265B.

[0082] The structure and configuration of the relay board 268B, the connector 269B, the test port holder 250B (including the probe seal 251B, the liquid barrier 252B, and the hydrophobic membrane 253B), the manifold 260B, and the center tube 265B (including the pressure-sealed cable 261B and the light tube 262B) are the same as the relay board 268A, the connector 269A, the test port holder 250A (including the probe seal 251A, the liquid barrier 252A, and the hydrophobic membrane 253A), the manifold 260A, and the center tube 265A (including the cable 261A and the light tube 262A), respectively. Accordingly, the description of the test port holder 250A (including the probe seal 251A, the liquid barrier 252A, and the hydrophobic membrane 253A), the manifold 260A, and the center tube 265A (including the cable 261A and the light tube 262A) is not repeated here.

[0083] In another aspect, the endoscope 235C Figure 2C ) includes a housing 241C into which the shaft 237C extends. In this aspect, serially connected to the distal end of the shaft 237C are a parallel kinematic mechanism 270C and a wrist assembly 280C. The image capture assembly 242C is connected to the parallel kinematic mechanism 270C through the wrist assembly 280C.

[0084] The test port holder 250C connects the pressure test port 238C in the housing 241C to a pressure test chamber. The pressure test chamber includes the test port holder 250C, a manifold 260C, and a center tube 265C. The manifold 260C is connected between the test port holder 250C and the center tube 265C.

[0085] The structure and configuration of the relay board 268C, the connector 269C, the parallel kinematic mechanism 270C, the wrist assembly 280C, the manifold 260C, and the center tube 265C (including the pressure-sealed cable 261C and the light tube 262C), and the image capture assembly 242C are the same as the relay board 268A, the connector 269A, the parallel kinematic mechanism 270A, the wrist assembly 280A, the manifold 260A, and the center tube 265A (including the pressure-sealed cable 261A and the light tube 262A), and the image capture assembly 242A, respectively. Accordingly, the description of the parallel kinematic mechanism 270A, the wrist assembly 280A, the manifold 260A, and the center tube 265A (including the cable 261A and the light tube 262A), and the image capture assembly 242A is not repeated here.

[0086] The test port holder 250C includes a body, a probe seal 251C, and a liquid barrier 252C. The probe seal 251C and the liquid barrier 252C are mounted within the body of the test port holder 250C, with the probe seal 251C being closest to the pressure test port 238C and the liquid barrier 252C being farthest from the pressure test port 238C.

[0087] In another aspect, the endoscope 235D Figure 2D includes a housing 241D from which a shaft 237D extends. In this aspect, an image capture assembly 242D is connected to a distal end of the shaft 237D.

[0088] The test port holder 250D connects the pressure test port 238D in the housing 241D to a pressure test chamber. The pressure test chamber includes the test port holder 250D, a manifold 260D, and a center tube 265D. The manifold 260D is connected between the test port holder 250D and the center tube 265B.

[0089] The structure and construction of the repeater board 268D, the connector 269D, the test port holder 250D (including the probe seal 251D and the liquid barrier 252D), the manifold 260D and the center tube 265D (including the electrical cable 261D and the optical tube 262D), and the image capture assembly 242D are the same as the repeater board 268C, the connector 269C, the test port holder 250C (including the probe seal 251C and the liquid barrier 252C), the manifold 260C and the center tube 265C (including the electrical cable 261C and the optical tube 262C), and the image capture assembly 242C, respectively. Accordingly, the description of the test port holder 250C (including the probe seal 251C and the liquid barrier 252C), the manifold 260C and the center tube 265C (including the electrical cable 261C and the optical tube 262C), and the image capture assembly 242C is not repeated here.

[0090] Figure 3 is a more detailed illustration of a test port holder 350 and a pressure test chamber 370, which are suitable for use with any of the endoscopes 235A-235D. A pressure test port 338 in a housing of the endoscope is a first opening of the test port holder 350. The test port holder 350 includes a probe seal 351 and a liquid barrier 352, and optionally a hydrophobic membrane 353. In this aspect, the pressure test chamber 370 includes a manifold 360 and a center tube 365.

[0091] The test port retainer 350 includes a first opening into the interior volume of the test port retainer 350, which is the pressure test port 338. A second opening into the interior volume of the test port retainer 350 communicates with the second opening 360-2 in the manifold 360, i.e., at least a portion of the second opening of the test port retainer 350 coincides with the second opening 360-2 of the manifold 360.

[0092] The probe seal 351 is mounted in the interior volume of the test port retainer 350 closest to the pressure test port 338 (as measured along the longitudinal axis 355 of the test port retainer 350 from the center of the probe seal 351 to the center of the pressure test port 338) and farthest from the second opening 360-2 in the manifold 360. The optional hydrophobic membrane 353 is mounted in the interior volume of the test port retainer 350 closest to the second opening 360-2 in the manifold 360 (as measured along the longitudinal axis 355 of the test port retainer 350 from the center of the hydrophobic membrane 353 to the center of the second opening 360-2 in the manifold 360) and farthest from the pressure test port 338.

[0093] When the optional hydrophobic membrane 353 is included in the test port retainer 350, the liquid barrier 352 is mounted in the interior volume of the test port retainer 350 between the probe seal 351 and the optional hydrophobic membrane 353. In this regard, the center of each of the probe seal 351 and the liquid barrier 352 and the hydrophobic membrane 353 intersects the longitudinal axis 355 of the test port retainer 350. When the optional hydrophobic membrane 353 is not included in the test port retainer 350, the liquid barrier 352 is mounted in the interior volume of the test port retainer 350 closest to the second opening 360-2 in the manifold 360 (as measured along the longitudinal axis 355 of the test port retainer 350 from the center of the liquid barrier 352 to the center of the second opening 360-2 in the manifold 360) and farthest from the pressure test port 338.

[0094] Similar to the probe seals described above, the probe seal 351 has an opening in its center that is shaped to form a pressure seal around the tip of a pressure test probe when the tip of the pressure test probe is inserted through the probe seal 351. In one aspect, the shape of the opening is selected to be the same as the cross-sectional shape of the outer surface of the tip of a pressure test probe inserted into the test port 338.

[0095] Similar to the liquid barriers described above, in one aspect, the liquid barrier 352 is an x-shaped slit valve. Further, as described above for the hydrophobic membrane, in one aspect, the hydrophobic membrane 353 is a PVDF membrane.

[0096] In this regard, the manifold 360 includes three openings 360-1, 360-2, and 360-3. The first opening 360-1 is located in the flange and is in communication with the central tube lumen of the central tube 365. A heat shrink tube is fitted over the second end of the central tube 365 and the second end of the central tube 365 is pressed onto the flange. Next, the heat shrink tube is moved over the second end of the central tube and the flange and shrunk. The combination of the press fit of the central tube with the manifold flange and the force provided by the heat shrink is sufficient to provide a pressure tight seal. The first end of the central tube 356 is pressed against the flange that is welded to the camera module 342 (sometimes referred to as the image capture assembly 342).

[0097] A pressure sealed cable 361, sometimes referred to as cable 361, and two light tubes 362A and 362B extend in a proximal direction from the proximal end of the image capture assembly 342. The two light tubes 362A and 262B merge into one light tube 362 that passes through the central tube lumen of the central tube 365 through the first opening 360-1 into the interior volume of the manifold 360. The use of two light tubes is merely illustrative, i.e., optional, and is not intended to be limiting. In other aspects, a single light tube can be used or no light tube can be used.

[0098] The cable 361 and the light tube 362 exit the interior volume of the manifold 360 through the third opening 360-3. A pressure seal 366 surrounds the cable 361 and the light tube 362 in the third opening 360-3. In one aspect, the pressure seal 366 is made of a two-part, platinum catalyzed, heat cured silicone elastomer. Dow Corning Corporation (Dow Corning®) sells a two-part, platinum catalyzed, heat cured silicone elastomer suitable for making the pressure seal 366 under the trademark QP1-20 Liquid Silicone Rubber.

[0099] Figure 4A and Figure 4B are an end view and a cross-sectional view, respectively, of one aspect of the pressure sealed cable 361. Arrow 490 defines a first and a second direction. In one aspect, the first direction is a distal direction and the second direction is a proximal direction.

[0100] ​In this aspect, the cable 361 is a double shielded cable. Each of the plurality of conductors 410 of the cable 361 is surrounded by its own insulating jacket 401. A first braided shield 411 surrounds the plurality of conductors 410. A second insulating jacket 402 surrounds the first braided shield 411. A second braided shield 412 surrounds the second insulating jacket 402, and a third insulating jacket 403 surrounds the second braided shield 412. In one aspect, the third insulating jacket 403 does not extend the entire length of the cable 361. In one aspect, the third insulating jacket 403 is a silicone insulating jacket. The ends of the third insulating jacket 402 are removed from the ends of the cable 361 to facilitate connecting the cable 361 to the connectors 426, 425. In the cable 361, the insulating jackets are electrically insulating jackets.

[0101] Prior to connecting the connectors 425 and 426 to the two ends of the cable 361, a strip of the third insulating jacket 403 is removed near the first end of the cable 361 to expose an outer circumferential surface of the second braided shield 412. (In the Figure 4B aspect, the first end of the cable 361 is proximate to the connector 425, which is an image capture unit connector.) A heat shrink tube is attached to the third insulating jacket 403 proximate to the edge of the exposed braided shield. Silicone is injected into the heat shrink tube around the exposed outer circumferential surface of the second braided shield 412, and then the heat shrink tube is shrunk to replace the strip of the third insulating jacket 403 that was removed. The shrinking of the heat shrink tube forces the silicone into any openings in the second braided shield 412 to form a first pressure seal 421 in and around the second braided shield 412.

[0102] After the pressure seal 421 is formed, the connector 425 is attached to the second end of the cable 361. The first end of each of the plurality of conductors 410 is crimped in the connector 425.

[0103] To form a pressure seal in the first woven shield 411 and around the plurality of conductors 410, the second woven shield 412 is pushed back from the second end of the cable 361 that is connected to the connector 426. One of the second insulating jackets 402 is removed to expose the outer circumference of the first woven shield 411. A heat shrink tube is attached to the second insulating jacket 402 adjacent to the edge of the exposed first woven shield 411. Silicone is injected into the heat shrink tube around the exposed outer circumference of the first woven shield 441 and around the plurality of conductors 410. Next, the heat shrink tube is shrunk to replace the removed one of the second insulating jackets 402. The shrinking of the heat shrink tube forces the silicone into any openings in the first woven shield 411 and around openings between the plurality of conductors 410, and the silicone is injected around and between the plurality of conductors 410. The plurality of conductors 410 can include a plurality of wires. This forms a second pressure seal 422 within and around the first woven shield 411 and around the plurality of conductors 410. After the pressure seal 422 is formed, the second woven shield 412 is returned to its proper position, and the connector 426 is attached to the second end of the cable 361. Each of the plurality of conductors 410 is crimped in the connector 426.

[0104] In another aspect, the seals 421 and 422 are made during the process of manufacturing the cable. Further, in one aspect, the outer surfaces of all of the insulating jackets are coated with a friction-reducing coating during the cable manufacturing.

[0105] Figure 5 is an example of a light pipe 362 suitable for use in a surgical device of Figure 1 , Figures 2A to 2D and Figure 3 . The light pipe 362 includes a fiber optic bundle 501, a protective sheath 502, and a ferrule 503. A first end, or distal end, of the fiber optic bundle 501 is split into two smaller fiber optic bundles 501-1 and 501-2. A second end of the fiber optic bundle 501 is crimped in the ferrule 503.

[0106] The protective sheath 502 has a first end 502-1 and a second end 502-2 that are both open in Figure 5 , and a third end 502-3 that is sealed from the outer circumferential surface of the ferrule 503. When the fiber optic bundle 501 is connected to the image capture assembly 342, the first end 502-1 and the second end 502-2 of the protective sheath 502 are sealed within the image capture assembly 342 so that there is no fluid flow path between the outer surface of the fiber optic bundle 501 and the inner surface of the protective sheath 502, which is important during a surgical procedure.

[0107] Figure 6is a cross-sectional view of one aspect of a manifold 660 and a test port holder 650. The manifold 660 is one example of the manifold 360 and the manifolds 260A-260D. The test port holder 650 is one example of the test port holders 250A-250D and the test port holder 350.

[0108] The test port holder 650 connects the pressure test port 638 to the manifold 660. The test port holder 650 includes a body 654, a seal holder 655, and an end cap 656. A probe seal 651, a liquid barrier 652, and a hydrophobic membrane 653 are mounted within the test port holder 650, with the probe seal 651 closest to the pressure test port 638 and the hydrophobic membrane 653 farthest from the pressure test port 638. The hydrophobic membrane 653 is optional.

[0109] The body 654 includes an inner wall 654-3 with an opening 654-4 directly adjacent to an opening 660-2 of the manifold 660, such that there is a bidirectional fluid communication path between the test port holder 650 and the manifold 660. Within the body 654, an O-ring 657 pushes against an outer circumferential portion of a first surface of the hydrophobic membrane 653 to seat an outer circumferential portion of a second surface of the hydrophobic membrane 653 on a step 654-5 extending from the wall 654-3 to an interior volume of the body 654.

[0110] The second end 655-2 of the seal holder 655 includes an opening 655-3. The tapered surface of the seal holder 655 holds the O-ring 657 on the outer circumferential portion of the first surface of the hydrophobic membrane 653. The first end 655-1 of the seal holder 655 is between the first end 654-1 of the body 654 and the second end of the end cap 656 to form an outer surface of the test port holder 650. The first end 655-1 forms a groove with the second end of the end cap 656. The probe seal 651 and the liquid barrier 652 are mounted in the groove.

[0111] In this aspect, the probe seal 651 has a circular opening in the center and is designed to form a seal around the tip of a pressure test probe. In one aspect, the liquid barrier 652 is an x-shaped slit valve. In one aspect, the hydrophobic membrane 653 is a polyvinylidene fluoride (PVDF) membrane as described above.

[0112] The probe seal 651 is one example of the probe seals 251A to 251D and the probe seal 351. The liquid barrier 652 is one example of the liquid barriers 252A to 252D and the liquid barrier 352. The hydrophobic membrane 653 is one example of the hydrophobic membranes 253A to 253B and the hydrophobic membrane 353.

[0113] The end cap 656, the seal retainer 655, and the main body 654 are welded together to form the entire main body for the test port retainer 650.

[0114] The manifold 660 includes three openings 660-1, 660-2, and 660-3. In one aspect, the manifold 660 is made of a polymer formed by injection molding polyphenylsulfone (PPSU). Polyphenylsulfone has heat and chemical resistance. Polyphenylsulfone provides a tensile strength of up to 55 MPa (8000 psi). Thus, PPSU can withstand continuous exposure to moisture and high temperatures and absorb impacts without breaking or fracturing. One example of a polyphenylsulfone suitable for forming the manifold 660 is R5500 resin by Solvay Advanced Polymers L.L.C. R5500 resin is a registered trademark of Solvay Advanced Polymers L.L.C.

[0115] Because the inner diameter of the center tube is sized such that the center tube can be force fit over the flange to form a pressure tight seal, the first opening 660-1 in the flange 661 of the manifold 660 is in communication with the center tube lumen of the center tube. A pressure seal 666 is installed near the third opening 660-3. Cables and optical tubes (not shown) pass through the pressure seal 666 and then through the third opening 660-3. The pressure seal 666 is made of a two-part, platinum-catalyzed, heat-cured silicone elastomer. One two-part, platinum-catalyzed, heat-cured silicone elastomer suitable for making the pressure seal 666 is sold by Dow Corning Corporation under the trademark QP1-20 Liquid Silicone Rubber.

[0116] As explained more fully below, in assembly, the optical tubes 362 and the pressure sealed cables 361 pass through the pressure seal 666 and then the assembly is installed in the manifold 660. Next, the test port retainer 650 is installed on the end of the manifold 660 that includes the pressure seal 666. In this regard, the interface between the test port retainer 650 and the manifold 660 is stepped. The test port retainer 650 is secured to the end of the manifold that includes the pressure seal 666 such that the manifold 660 exerts a radially inward force that compresses the pressure seal 666 around the optical tubes 362 and the pressure sealed cables 361 to form a pressure tight seal. As used herein, a pressure tight seal is a seal that allows the pressure chamber within the endoscope to maintain a predetermined minimum pressure required to pass a pressure test.

[0117] The following discussion applies to each of the endoscopes 135-1, 235A, 235B, 235C, and 235D. In particular, with respect to Figures 7A to 7C , Figure 8 and Figures 9A to 9C ​descriptions of elements having the same name as elements in endoscopes 135-1, 235A, 235B, 235C, and 235D apply to elements in endoscopes 135-1, 235A, 235B, 235C, and 235D having that name. Similarly, descriptions of elements in endoscopes 135-1, 235A, 235B, 235C, and 235D having the same name as elements in Figures 7A to 7C , Figure 8 and Figures 9A to 9C apply to elements in endoscopes 135-1, 235A, 235B, 235C, and 235D having that name. Accordingly, correspondence between elements in the various figures is not explicitly called out in the following description to avoid detracting from aspects of the present disclosure. Figures 7A to 7C , Figure 8 and Figures 9A to 9C . Thus, correspondence between elements in the various figures is not explicitly called out in the following description to avoid detracting from aspects of the present disclosure.

[0118] Generally, prior art endoscopes used in computer-assisted teleoperational systems include a single continuous electrical and illumination bundle. The electrical and illumination components in the bundle are separate. The bundle extends from an endoscope imaging system to a housing of the endoscope, through the housing of the endoscope, and along a shaft of the endoscope to a distal end of the shaft. The electrical and illumination components pass through the shaft along different paths to the distal end of the shaft. The endoscope is assembled in a proximal-to-distal direction.

[0119] In contrast, rather than a single continuous electrical and illumination bundle from an endoscope imaging system distally away from the endoscope through the endoscope, the endoscope is divided into multiple testable subassemblies that are integrated together when assembling the endoscope. Figures 7A to 7C An example of three subassemblies 701, 702, 703 is shown.

[0120] One subassembly is a center bundle subassembly 701 Figure 7A ), sometimes referred to as center bundle 701, and referred to as the third subassembly. Center bundle 701 includes center tube 765, image capture subassembly 742 (sometimes referred to as the second subassembly), pressure-sealed cable 361, and light tube 362. In one aspect, center tube 765 is a single continuous tube having a single center tube lumen. In another aspect, center tube 765 is a molded single continuous silicone tube having a single center tube lumen. The single continuous tube eliminates potential leak paths. Image capture subassembly 742 is equivalent to the image capture assembly described above.

[0121] The center tube 765 is connected to the image capture subassembly 742 such that a pressure-tight seal is formed between the center tube 765 and the image capture subassembly 742. The pressure-sealed cable 361 is electrically connected to the image capture unit within the image capture subassembly 742. The ends 501-1 and 501-2 of the fiber optic bundle 501 terminate in the image capture subassembly 742 to output light through the distal end of the image capture subassembly 742. The pressure-sealed cable 361 and the light tube 362 are passed through the center tube lumen of the center tube 762.

[0122] As explained more fully below, in one aspect, the cable 361 and the image capture unit are assembled as a subassembly. The image capture unit of the subassembly is inserted into a housing with the cable 361 extending through the proximal end of the housing in a proximal direction. The distal end of the light tube 362 is mounted in the housing with the light tube 362 also extending through the proximal end of the housing in a proximal direction. A cap is attached to the distal end of the housing and the subassembly is subjected to a seal verification test. The cable 361 and the light tube 362 are then passed through the lumen of the center tube 765 and the center tube is attached to the housing to form the center tube bundle subassembly 701. The center tube bundle subassembly 701 can be tested to determine whether the one or more cameras in the image capture unit are functioning properly and whether the light tube is providing proper illumination.

[0123] Another subassembly is the base instrument subassembly 702 Figure 7B , which is sometimes referred to as the fourth subassembly. In this aspect, the base instrument subassembly 702 includes a base, a shaft, a parallel kinematic mechanism 770, and a wrist joint assembly 780. The parallel kinematic mechanism 770 and the wrist joint assembly 780 are each examples of an articulating assembly. Other articulating assemblies can be used in the base instrument subassembly 702, or alternatively, the base instrument subassembly 702 can not contain articulating assemblies (see Figure 2B and Figure 2D ) or can contain only one articulating assembly, such as the wrist joint assembly 780.

[0124] The base instrument subassembly 702 includes a repeater board, a manifold such as the manifold 660, and a test port holder such as the test port holder 350, as well as a cable subassembly connector 705. The base instrument subassembly 702 is connected to the proximal end of the shaft 757. The repeater board includes lasers on indicators (e.g., one or more light emitting diodes), voltage regulators, a first connector configured to connect to the proximal end of the pressure-sealed cable 361, and a second connector configured to electrically connect to the instrument- endoscope imaging system cable subassembly 703. The repeater board is electrically connected to the image capture unit in the image capture subassembly 742 Figure 7C) receive power and control signals and provide the power and control signals to the image capture subassembly 742. The repeater board receives video signals from the image capture subassembly 742 and provides these video signals to the instrument- endoscope imaging system cable subassembly 703.

[0125] The distal end of the shaft 757 is connected to the proximal end of the parallel motion mechanism 770. The distal end of the parallel motion mechanism 770 is connected to the proximal end of the wrist assembly 780.

[0126] A wrist assembly suitable for use as the wrist assembly 780 is described, for example, in U.S. Patent Application No. US 2003 / 0036748 Al (filed June 28, 2002, which published “Surgical Tool Having Positively Positionable Tendon-Activated Multi-Disk Wrist Joint”), which is incorporated herein by reference. A parallel motion mechanism suitable for use as the parallel motion mechanism 770 is described, for example, in U.S. Patent No. US 7,942,868 B2 (filed June 13, 2007, which published “Surgical Instrument With Parallel Motion Mechanism”), which is also incorporated herein by reference. The parallel motion mechanism 770 and the wrist assembly 780 are constructed in the same manner as the prior art and the cables are tensioned in the same manner as the prior art, except in one aspect, the distal-most disk of the wrist assembly 780, as described below with respect to Figure 10B .

[0127] In one aspect, the range of motion of the parallel motion mechanism 770 and the wrist assembly 780 are tested. In addition, the cable friction through the shaft 737 and the friction within the parallel motion mechanism 770 and the wrist assembly 780 are also tested.

[0128] After testing the subassemblies 701 and 702, the center tube bundle 701 is transferred from the distal end of the shaft 737 to the proximal end of the shaft 737. The pressure sealed cable 361 and the light tube 362 are transferred through the manifold 660 and the pressure sealed cable 361 is connected to the repeater board. The distal end of the center tube 765 is attached to the manifold 660 and the image capture subassembly 742 is attached to the wrist assembly 780. After combining the subassemblies 701 and 702, the electrical, illumination, and camera tests can be repeated to ensure that nothing was damaged during the assembly process.

[0129] To complete the assembly for testing, another subassembly, the instrument- endoscope imaging system cable subassembly 703 Figure 7C ) is connected to the base instrument subassembly 702. The instrument-endoscope imaging system cable subassembly 703 can now be used to repeat the tests to determine if the system is working properly.

[0130] Figure 8 is a process flow diagram for assembling and testing a subassembly of an endoscope during assembly of the endoscope. In the cable-camera connection (CABLE-CAMERA CONNECT) process 801, each of the plurality of conductors 410 in the distal end of the pressure sealed cable 361 is connected to a corresponding conductor in the image capture unit 943 Figure 9A ). In this regard, the connector 425 on the distal end of the pressure sealed cable 361 is connected to a connector on the image capture unit 943. In this example, the image capture unit 943 is a stereo image capture unit and thus includes two stereo cameras 944, 945. The use of stereo cameras is optional, as the assembly and testing process is the same if only a single camera is used. For a single camera, there can be a different number of conductors in the plurality of conductors 410 in the pressure sealed cable 361.

[0131] A ground wire is woven into the outer woven shield 412 of the pressure sealed cable 361 and then the outer woven shield 412 is electrically connected to the body of the image capture unit 943. The ground wire is electrically attached to a ground lug that grounds the stereo cameras 944, 945. The completed cable and image capture unit subassembly 901 (example of a first subassembly) is shown in Figure 9A .

[0132] After the cable-camera connection process 801 is completed, the cable and image capture unit subassembly 901 is tested in the electrical conductivity test (ELECTRICAL CONDUCTIVITY TEST) process 802 (sometimes referred to as process 802). In process 802, the electrical conductivity of the cable and image capture unit subassembly 901 is checked by powering the stereo cameras 944, 945 and observing and inspecting the video feed from the stereo cameras 944, 945.

[0133] After successfully completing the electrical conductivity testing process 802, the image capture subassembly 742 is assembled in a camera shell mount (CAMERA SHELL MOUNT) process 803, sometimes referred to as process 803. In process 803, the distal ends of the light pipes 562-1 and 562-2 are directly canned into enclosures inside the shell 946 prior to mounting the cable and image capture unit subassembly 901 in the shell 946. Then, the cable and image capture unit subassembly 901 is loaded from the distal end of the shell 946 and arranged so that the light pipes 562-1 and 562-2 are on either side of the image capture unit 943, as shown. Figure 9B The pressure sealed cable 361 extends from the proximal end of the shell 946 in the proximal direction, as do the light pipes 562-1 and 562-2. In Figure 9B the shell 946 is removed on one side so that the light pipes 562-1 and 562-2 and the image capture unit 943 are visible. Finally, a cap 947 is welded to the distal end of the shell 946 to form a sealed image capture subassembly 742, which is sometimes referred to as a second subassembly. The cap 947 includes a window for each camera and each light pipe.

[0134] After completing the camera shell mount process 803, a pressure test is performed to verify that the weld between the cap 947 and the shell 946 is water tight in a seal verification test (SEAL VERIFICATION TEST) process 804 by pressure decay. In one aspect, the pressure test is accomplished by establishing a pressure differential between the inside and outside of the shell, including the image capture unit 943 and the light pipe ends 562-1 and 562-2, and measuring the pressure decay. The orientation of the pressure differential is not important.

[0135] After successfully completing the seal verification test process 804, a central lumen assembly (CENTRAL LUMEN ASSEMBLY) process 805, sometimes referred to as process 805, is performed. The central tube 765 is further described prior to considering process 805. As described above, in one aspect, the central tube 765 is a molded single continuous silicone tube with a single central lumen. In one aspect, the central tube 765 is made from an injection molded hollow cylindrical tube that is in turn injection molded into a tapered oblong tube.

[0136] In one aspect, the center tube 765 is made of a medical grade silicone elastomer. First, a proximal cylindrical tube portion of the center tube 765 is formed using a two-part, enhanced tear resistance (ETR) silicone elastomer consisting of dimethylsiloxane copolymer and methylvinylsiloxane copolymer and reinforcing silica. The two parts are thoroughly mixed together prior to injection molding. The elastomer is heat cured through an addition-cure (platinum-cure) chemistry. The two-part, enhanced tear resistance silicone elastomer is provided under the trade designation BioMedical Grade ETR Elastomer Q7-4780 by Dow Corning Corporation. BioMedical Grade ETR Elastomer Q7-4780 The two-part, enhanced tear resistance silicone elastomer is provided under the trade designation BioMedical Grade ETR Elastomer Q7-4780 by Dow Corning Corporation.

[0137] Next, the proximal cylindrical tube portion of the center tube 765 is molded to a distal portion of the center tube 765. The distal portion of the center tube 765 is a molded transition between the distal end of the image capture assembly flange 966 and the proximal cylindrical tube portion of the center tube 765 that fits around the image capture assembly flange 966. The distal portion of the center tube 765 is made using a two-part platinum-catalyzed silicone elastomer. The two parts are thoroughly mixed together prior to injection molding. The elastomer is heat cured through an addition-cure (platinum-catalyzed) reaction. When mixed and cured, the resulting elastomer consists of cross-linked dimethylsiloxane copolymer and methylvinylsiloxane copolymer and reinforcing silica. The elastomer is heat stable up to 204°C (400°F) and can be hot pressed. The two-part platinum-catalyzed silicone elastomer is provided under the trade designation BioMedical Grade Liquid Silicone Rubber Q7-4850 by Dow Corning Corporation. BioMedical Grade Liquid Silicone Rubber Q7-4850 The two-part platinum-catalyzed silicone elastomer is provided under the trade designation BioMedical Grade Liquid Silicone Rubber Q7-4850 by Dow Corning Corporation.

[0138] In one aspect, both the inner and outer walls of the center tube 765 are coated with a friction-reducing coating. One suitable friction-reducing coating is a parylene-N coating. In this aspect, the outer insulating jacket 403 of the pressure-sealed cable 361 is a silicone jacket that is coated with a friction-reducing coating such as a parylene-N coating. In one aspect, all of the insulating jackets in the pressure-sealed cable 361 are coated with a friction-reducing coating. Similarly, the outer surface of the protective sheath 502, which includes the protective sheath 502-1 of the first end 562-1 of the light pipe 362 and the protective sheath 502-2 of the second end 562-2 of the light pipe 362, is a silicone sheath that is coated with a friction-reducing coating such as a parylene-N coating.

[0139] First, the image capture assembly flange 966 Figure 9C) in the distal end of the center tube 765. As described above, the circumference of the distal end of the center tube lumen is slightly smaller than the outer circumference of the flange 966, such that when the center tube 765 is pressed against the flange 966, a pressure tight seal is formed. In one aspect, a heat shrink tube is shrunk around the outer circumference of the distal end of the center tube 765 to further ensure that a pressure tight seal is formed between the center tube 765 and the flange 966.

[0140] Next, the pressure sealed cable 361 and the light tube 362 are threaded through the flange 966 and the center tube 765 to obtain Figure 9C the configuration shown. The friction reducing coating on the wall of the center tube lumen of the center tube 765, on the outer insulating jacket 403 of the pressure sealed cable 361, and on the outer surface of the jacket 502 of the light tube 362 facilitate threading the pressure sealed cable 361 and the light tube 362 through the center tube 765 without the use of forces that can damage one or both of the pressure sealed cable 361 and the light tube 362. The flange 966 is welded to the proximal end of the image capture assembly 742 to obtain the center tube bundle subassembly 701, which is sometimes referred to as a third subassembly.

[0141] After the completion of the center tube lumen assembly process 805, the MAIN TUBE FEEDING process 806, which is sometimes referred to as process 806, is performed. In process 806, the center tube bundle 701 is fed through the wrist joint assembly 780, the parallel kinematic mechanism 770, and the shaft 737 such that the proximal end of the center tube bundle 701 comes out of the proximal end of the shaft 737. The friction reducing coating on the outer surface of the center tube 765 facilitates feeding the center tube bundle from the distal end of the base instrument subassembly 702 into the base instrument subassembly 702. In this example, the longitudinal axis of the center tube 765 coincides with the longitudinal axes of the shaft 737, the parallel kinematic mechanism 770, and the wrist joint assembly 780.

[0142] After the completion of the main tube feeding process 806, the MANIFOLD ASSEMBLY process 807, which is sometimes referred to as process 807, is performed. In process 807, a heat shrink tube is slipped over the proximal end of the center tube 765 and then the proximal ends of the pressure sealed cable 361 and the light tube 362 are threaded through the opening 660-1 in the flange 661 of the manifold 660. Next, the proximal ends of the pressure sealed cable 361 and the light tube 362 are threaded through the respective passages in the pressure seals 666 and the pressure seals 666 are installed in the end of the manifold 660 opposite the flange 661. The test port holder 650 is installed on the manifold 660 and screws are used to tighten the test port holder around the manifold 660 such that the manifold 660 compresses the pressure seals 666 around the pressure sealed cable 361 and around the light tube 362 to form pressure tight seals.

[0143] The circumference of the proximal end of the central lumen is slightly smaller than the outer circumference of the flange 661, such that when the proximal central tube 765 is pressed against the flange 661, a pressure tight seal is formed. In one aspect, a heat shrink tube is shrunk around the outer circumference of the proximal end of the central tube 765 to further ensure that a pressure tight seal is formed between the central tube 765 and the flange 661.

[0144] Finally, to complete the process 807, the proximal end of the pressure sealed cable 361 is connected to the repeater board in the base instrument subassembly 702. After the completion of the manifold assembly process 807, which is sometimes referred to as the process 807, the central lumen pressure test and distal illumination test (CENTRAL LUMEN PRESSURE TEST AND DISTAL ILLUMINATION TEST) process 808 is performed.

[0145] Before considering the central lumen pressure test and distal illumination test process 808, consider the basic principles of the pressure test. For patient safety, it is desirable to detect leaks that are sufficient to allow blood to enter the pressure chamber of the endoscope when pressurized at the inflation pressure of about 15 mmHg. Due to surface tension, there is some minimum hole size below which the inflation pressure cannot force blood through the leak. However, air flow through the leak occurs to some extent regardless of the hole size. Thus, a method to ensure that there are no leaks that are sufficient to allow blood through at the inflation pressure is to pressurize the pressure chamber in the endoscope to a predetermined pressure, such as 150 mmHg, and observe whether the pressure drops below a predetermined minimum pressure within a predetermined time interval. If the pressure does not drop below the predetermined minimum pressure at the end of the predetermined time interval, then the endoscope is considered to have no leaks that are sufficient to allow blood to enter the pressure chamber volume when pressurized at the inflation pressure. This is a worst case assessment because the pressure test interrogates all leaks, including those that are too small to allow blood through. The details of the pressure test are determined empirically by assessing the leak rates of different leaks and their corresponding blood flow characteristics.

[0146] In the central lumen pressure test and distal illumination test process 808, a test probe is inserted into the pressure test port of the endoscope and the pressure test chamber is pressurized to a predetermined pressure, such as 150 mmHg, as defined above. If the pressure test chamber maintains the pressure greater than a predetermined minimum pressure, such as 40 mmHg, for a predetermined time interval, such as 30 seconds, then there are no fluid paths for communication between the environment outside of the endoscope at the inflation pressure and the interior of the pressure test chamber, which is important during a surgical procedure. Thus, the pressure test chamber is not subject to contamination during a surgical procedure in which the endoscope is used at the inflation pressure. In the illumination test, characteristics such as the optical transmission of the light pipe and the number of undamaged illumination optical fibers are measured.

[0147] In one aspect, after the master feed process 806, the distal disc 1081 of the wrist joint assembly 780 ( Figure 10A The wrist actuation cable 1082 is soldered to the proximal end of the image capture subassembly 742. Multiple wrist actuation cables are connected to the distal disc 1081. One of the multiple wrist actuation cables, actuation cable 1082, is shown. Figure 10A In the cross-sectional view, the actuation cable 1082 enters the distal disc 1081 from a through-hole on the proximal surface of the distal disc 1081 and extends into the slot 1081A. A coiled fitting 1083 (which is an example of a cable end fitting) on ​​the distal end of the actuation cable 1082 is positioned in the slot 1081A in the distal disc 1081 of the wrist joint assembly 780. (A cable end fitting is sometimes referred to as a fitting.) The slot 1081A extends from the distal surface of the distal disc 1081 in a proximal direction into the distal disc 1081. In this respect, to block potential leakage paths from the distal end of the slot 1081A proximal to the external environment around the coiled fitting 1083 and around the cable 1082, the slot 1081A is filled from the distal end with room temperature vulcanizing silicone resin to encapsulate the coiled fitting 1083 and fill the open volume of the slot 1081A.

[0148] In another aspect, the need for filling slot 1081A and encapsulating coiled fitting 1083 is eliminated. In this aspect, the distal disc 1081 is divided into two distal discs 1081-1 and 1081-2 of the wrist joint assembly 780. Disc 1081-2 is referred to as the second distal disc 1081-2 because it is the second disc from the distal end of the wrist joint assembly 780. Disc 1081-1 is referred to as the first distal disc 1081-1 because it is the first disc at the distal end of the wrist joint assembly 780.

[0149] Multiple wrist actuation cables for the wrist joint assembly 780 are connected to a mating combination of the first distal disc 1081-1 and the second distal disc 1081-2. Figure 10B The cross-sectional view shows one of the multiple wrist actuation cables, actuation cable 1082.

[0150] Actuation cable 1082 passes through a through-hole extending from the proximal surface of the second distal disc 1081-2 to the distal surface of the second distal disc 1081-2. Actuation cable 1082 extends into slot 1081B in the first distal disc 1081-1. A coiled fitting 1083 at the distal end of actuation cable 1082 is positioned in slot 1081B of the first distal disc 1081-1 of the wrist joint assembly 780. Slot 1081A extends from the proximal surface of the first distal disc 1081 in a distal direction into the first distal disc 1081-1.

[0151] An outer circumferential distal surface 1081-1DS of the first distal disk 1081-1 is welded to the housing of the image capture assembly 742. An outer circumferential edge distal edge surface 1081-2DS of the second distal disk 1081-2 is welded to an outer circumferential proximal edge surface 1081-1PS of the first distal disk 1081-1. As the first distal disk 1081-1 blocks any leak path to the volume inside the pressure chamber, there is no longer a leak path to the outside environment around the crimp fitting 1083 and around the cable 1082. The crimp fitting 1083 is encapsulated in the volume formed by mating the first distal disk 1081-1 with the second distal disk 1081-2, and there is no significant path between the pressure test chamber and the volume formed by mating the first distal disk 1081-1 and the second distal disk 1081-2 during the surgical procedure.

[0152] Thus, as shown, the articulation assembly includes a first disk 1081-1, a second disk 1081-2, an actuation cable 1082 having a distal end, and a crimp fitting 1083. The actuation cable 1082 passes through the second disk 1081-2, and the crimp fitting 1083 is attached to the distal end of the actuation cable 1082. The crimp fitting 1083 is contained in a cavity formed by the mating of the first disk 1081-1 and the second disk 1081-2. Figure 10B

[0153] As used herein, “first,” “second,” “third,” “fourth,” and the like, are adjectives used to distinguish different components or elements. Thus, “first,” “second,” “third,” “fourth,” and the like, do not mean any order or any specific number of components or elements.

[0154] The above description and the accompanying drawings that illustrate various aspects and embodiments of the present application should not be deemed to be limiting— the claims define the protected application. Various mechanical, compositional, structural, electrical, and operational changes can 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 in order not to obscure the application.

[0155] ​Furthermore, the terms of the present description are not intended to limit the present application. For example, spatially relative terms— such as “under,” “below,” “lower,” “over,” “upper,” “proximal,” “distal,” and the like— can be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. These spatially relative terms are in

[0156] The singular forms “a,” “an,” and “the” also include the plural unless the context clearly dictates otherwise. The terms “comprise,” “comprising,” “includes,” and / or “including” specify the presence of 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 can be directly electrically or mechanically coupled, or they can be indirectly coupled via one or more intermediate components.

[0157] All examples and illustrative references are non-limiting and should not be used to limit the claims to the particular embodiments and examples described herein and their equivalents. Any headings are for formatting only and should not be used to limit the subject matter in any way, as text under one heading can cross-reference or apply to text under one or more headings. Finally, given the disclosure, a particular feature described with respect to one aspect or embodiment can be applied to other disclosed aspects or embodiments of the application, even if not specifically shown or described in the figures or text.

Claims

1. A method of assembling an endoscope, the method comprising: assembling a first assembly, the first assembly comprising a pressure sealed cable connected to an image capture unit, the pressure sealed cable comprising a pressure seal, the pressure seal having no passage for gas flow; performing a conductivity test on the pressure sealed cable and the image capture unit of the first assembly; and after performing the conductivity test, assembling a second assembly, the second assembly comprising the first assembly, a housing, a light pipe, and a cap, the housing having a distal end and a proximal end, the image capture unit being mounted in the housing from the distal end of the housing, the pressure sealed cable extending proximally through the proximal end of the housing, the light pipe having a distal end, the distal end of the light pipe being mounted in the housing and extending proximally through the proximal end of the housing, and the cap being attached to the distal end of the housing.

2. The method of claim 1, further comprising: performing a seal verification test on the second assembly.

3. The method of claim 1, further comprising: assembling a center tube assembly, the center tube assembly comprising the second assembly, a center tube, and a flange, wherein assembling the center tube assembly comprises: mounting the center tube onto the flange; screwing the pressure sealed cable and the light pipe through the flange and the center tube; and attaching the flange to the housing.

4. The method of claim 3, further comprising: screwing the center tube of the center tube assembly through a shaft of a base instrument assembly.

5. The method of claim 4, further comprising: passing the pressure sealed cable and the light pipe through a second pressure seal.

6. The method of claim 5, further comprising: mounting the second pressure seal in a manifold; and attaching the center tube to the manifold.

7. The method of claim 6, further comprising: performing a pressure test using a port in the manifold.

8. The method of claim 7, wherein the pressure test is performed by a test port holder located between the manifold and a pressure test port.

9. The method of claim 8, wherein the test port holder comprises a probe seal and a liquid barrier.

10. The method of claim 9, wherein the test port holder further comprises a hydrophobic membrane located on an opposite side of the liquid barrier from the probe seal.

11. The method of claim 1, wherein a ground wire is woven into an outer woven shield of the pressure sealed cable.

12. The method of claim 1, wherein performing the conductivity test on the first assembly comprises powering the image capture unit and checking a video feed from the image capture unit.

13. The method of claim 1, wherein an interior of the housing comprises an enclosure configured to receive the distal end of the light pipe.

14. The method of claim 1, further comprising welding the cover to the distal end of the housing.

15. The method of claim 2, wherein performing the seal verification test on the second component includes establishing a pressure difference between the inside and outside of the housing and measuring the pressure decay.

16. The method of claim 3, wherein attaching the flange to the housing comprises welding the flange to the proximal end of the housing.

17. The method of claim 1, wherein the pressure-sealed cable comprises a pressure-sealed shield.

18. The method of claim 1, wherein the pressure-sealed cable has no passage for gas flow.

19. The method of claim 1, wherein the second component further comprises a second light tube having a distal end, the distal end of the second light tube being mounted in the housing, and the second light tube extending proximally through the proximal end of the housing.

20. The method of claim 19, wherein the pressure-sealed cable is located within the housing between the optical tube and the second optical tube.

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