Pressure test port contained within body of surgical instrument
The integrated test port retainer with a hydrophobic membrane and x-slit valve in endoscopes ensures accurate pressure testing and prevents damage during cleaning and sterilization by maintaining internal pressure, addressing the issues of vent cap reliance and moisture interference.
Patent Information
- Application Number
- JP2025121915
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2016-07-14
- Filing Date
- 2025-07-22
- Publication Date
- 2025-09-30
AI Technical Summary
Existing endoscopes require vent caps for pressure equalization and liquid exclusion during cleaning, sterilization, and transportation, which can be improperly used, leading to damage or false pressure test results due to moisture interference.
A test port retainer with a hydrophobic membrane and x-slit valve, integrated into the endoscope, ensures pressure equalization and prevents liquid ingress during sterilization and testing, eliminating the need for vent caps and ensuring accurate pressure readings.
The integrated test port retainer maintains proper pressure within the endoscope, preventing damage and false positives during testing, while simplifying the cleaning and sterilization process by eliminating the reliance on vent caps.
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Figure 2025142228000001_ABST
Abstract
Description
[Technical Field]
[0001] (Related Applications) This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 362,188, filed July 14, 2016, entitled "A PRESSURE TEST PORT CONTAINED WITHIN A BODY OF SURGICAL INSTRUMENT," which is incorporated herein by reference in its entirety.
[0002] The present invention relates generally to endoscopes, and more particularly to features that facilitate testing and assembly of endoscopes. [Background technology]
[0003] One or more endoscopes are commonly used in computer-assisted surgery. An endoscope typically has a flexible or rigid shaft that extends into the patient's body. At the end of the endoscope inside the patient's body are one or more ports that provide illumination of the surgical site and one or more ports used to capture one or more images of the surgical site. Electrical and fiber optic cables typically extend through the endoscope shaft.
[0004] Because at least a portion of an endoscope is introduced into a patient's body during a surgical procedure, it must be cleaned and sterilized before and after each surgical procedure. Typically, endoscopes are cleaned and disinfected by scrubbing the endoscope and then placing it in a bath and exposing it to ultrasound. Endoscopes are sterilized by autoclaving, which exposes the endoscope to a vacuum and high-pressure, high-temperature steam. Therefore, the cleaning and sterilization process exposes the endoscope to liquid immersion and various pressures and temperatures. Additionally, when an endoscope is transported by air, it is also exposed to various pressures and temperatures.
[0005] Finally, to ensure that the endoscope is not damaged, it is pressure tested before each use.
[0006] Problems associated with cleaning, sterilization, and pressure testing are known, and various different approaches have been taken to address these problems. For example, U.S. Patent No. 5,629,999 discloses a device that allows for pressure equalization between the interior space of an endoscope and the environment outside the endoscope. This device is reportedly a vent cap that equalizes pressure while restricting the flow of liquids, water vapor, and hydrogen peroxide into the interior space of the endoscope. The vent cap was designed to accept a port connected to the interior space of the endoscope.
[0007] However, while some manufacturers produce endoscopes that include ports that can accept vent caps, the use of vent caps has required the use of different caps depending on the process used according to U.S. Patent No. 5,629,992. U.S. Patent No. 5,629,992 describes yet another example of a pressure compensating cap that can be placed on an endoscope port. [Prior art documents] [Non-patent literature]
[0008] [Non-Patent Document 1] “Are You Properly Leak Testing Your Flexible Endoscope?”, Fibertech Medical USA, 2 pgs.(2006) [Patent documents]
[0009] [Patent Document 1] U.S. Patent No. 5,868,667 [Patent Document 2] U.S. Patent Application Publication No. 2014 / 0100425 Summary of the Invention
[0010] According to one 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 exclusion barrier. The probe seal and the liquid exclusion barrier are mounted within the test port retainer housing.
[0011] In one embodiment, the test port retainer also includes a hydrophobic membrane mounted within the test port retainer housing. In this embodiment, the liquid exclusion barrier is mounted between the probe seal and the hydrophobic membrane. In one embodiment, the hydrophobic membrane is a polyvinylidene difluoride membrane, while the liquid exclusion barrier includes an X-slit valve.
[0012] The pressure test chamber includes a manifold. A test port retainer is mounted between the pressure test port and the manifold such that the pressure test port communicates with the manifold through the test port retainer.
[0013] According to one embodiment, the surgical device also 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 and second ends. The first end of the central tube is secured 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 communicates with the central lumen of the central tube through the test port retainer. More specifically, the second end of the central tube is secured to the manifold such that the pressure test port communicates with the central lumen of the central tube through the manifold.
[0014] The surgical device, according to one embodiment, also includes a pressure-sealed electrical cable connected to the image capture assembly and extending through a central lumen into the manifold, the manifold including a pressure seal, and the pressure-sealed electrical cable extending through the pressure seal and out of the manifold.
[0015] The pressure-sealed electrical cable 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 within the first shield. In one embodiment, the pressure-sealed electrical cable also includes a second shield surrounding the second insulating jacket and a third insulating jacket surrounding the second shield, with a second pressure seal formed around and within the second shield and extending between the second insulating jacket and the third insulating jacket. The pressure-sealed electrical cable has a first end and a second end. In one embodiment, 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 one embodiment, the endoscope includes an image capture subassembly and a central tube bundle subassembly. The image capture subassembly (second subassembly) includes an electrical cable and image capture unit subassembly (first subassembly). The electrical cable and image capture unit subassembly includes an electrical cable and an image capture unit. The electrical 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 electrical cable is threaded through the distal end of the central tube to form the central tube bundle subassembly, and the electrical cable extends from the 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 also includes a light pipe coupled to the image capture subassembly and extending through the central tube. In one aspect, the electrical cable is a pressure-sealed electrical cable.
[0017] In one aspect, the central tube is a single continuous tube having a single lumen. The single continuous tube has an outer surface and an inner surface. The inner surface defines a single lumen. In yet another aspect, the anti-friction coating coats both the outer surface and the inner surface of the single continuous tube.
[0018] According to one embodiment, the endoscope also includes a base instrument subassembly (fourth subassembly). The base instrument subassembly includes a base, a shaft, and optionally an articulating assembly. The shaft is coupled between the base and the articulating assembly. A central tube extends through the articulating assembly and the shaft. The articulating assembly is connected to the image capture subassembly.
[0019] In one aspect, the articulation assembly includes a first disc, a second disc, an actuation cable having a distal end, and a fitting. When mated, the first and second discs form part of an articulation joint. The distal end of the actuation cable passes through the second disc, and the fitting is then attached to the distal end of the actuation cable. The fitting is housed within a cavity formed by mating the first disc to the second disc.
[0020] According to one embodiment, the base instrument subassembly also includes a manifold and a manifold pressure seal. Pressure-sealed electrical cables and light pipes pass through the manifold pressure seal, which is attached to the manifold. The base instrument subassembly also includes a test port retainer attached to the manifold.
[0021] In another embodiment, the endoscope includes a pressure-sealed electrical cable connected to the image capture unit to form a first subassembly. The endoscope further includes a shell having a distal end and a proximal end. The image capture unit is attached to the shell from the distal end of the shell, and the pressure-sealed electrical cable extends proximally through the proximal end of the shell. A light pipe has a distal end attached within the shell, and the light pipe extends proximally through the proximal end of the shell. A lid is secured to the distal end of the shell. The shell, lid, light pipe, and first subassembly are a second subassembly.
[0022] According to one embodiment, the endoscope further includes a central tube having a flange and a distal end, the distal end of the central tube being attached to the flange, and the flange being secured to the shell, the central tube, the flange, and the second subassembly being a central tube bundle subassembly.
[0023] In yet another aspect, an endoscope, according to one embodiment, includes a central tube bundle subassembly and a base instrument subassembly. The central tube bundle subassembly includes an image capture assembly, a light pipe having a distal end attached to the image capture assembly, a pressure-sealed electrical cable having a distal end connected to the image capture assembly, and a central tube having a distal end and a lumen. The distal end of the central tube is connected to the image capture unit. The light pipe and pressure-sealed electrical cable pass through the lumen of the central 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 central tube extends through the articulation assembly and the shaft. The articulation assembly is connected to the image capture assembly.
[0024] In one aspect, the central tube of the endoscope is a single continuous tube. The single continuous tube has an outer surface and an inner surface. The inner surface defines a single lumen. An anti-friction coating coats both the outer and inner surfaces of the single continuous tube. The pressure-sealed electrical cable has an outer surface with an anti-friction coating on the outer surface of the pressure-sealed electrical 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 disc, a second disc, an actuation cable having a distal end, and an attachment. The distal end of the actuation cable passes through the second disc, and the attachment is then attached to the distal end of the actuation cable. The attachment is housed within a cavity formed by mating the first disc to the second disc. The mating of the first and second discs forms part of an articulation joint. The first disc is connected to the image capture assembly.
[0026] According to one embodiment, a method for manufacturing an endoscope includes assembling a first subassembly including a pressure-sealed electrical cable connected to an image capture unit. A conductivity test is performed on the first subassembly, and then a second subassembly is assembled including the first subassembly, a shell, a light pipe, and a lid. The shell has a distal end and a proximal end. During assembly of the second subassembly, the image capture unit is attached to the shell from its distal end with the pressure-sealed electrical cable extending proximally through the proximal end of the shell. The distal end of the light pipe is attached within the shell, and the light pipe extends proximally through the proximal end of the shell. Finally, the lid is secured to the distal end of the shell.
[0027] After the second subassembly is assembled, a seal verification test is performed on the second subassembly. Upon successful completion of the seal verification test, the center tube assembly is assembled. The center tube assembly includes the second subassembly, a center tube, and a flange. Assembling the center tube includes attaching the center tube to the flange, threading pressure-sealed electrical cables and light pipes through the flange and center tube, and securing the flange to the shell.
[0028] The center tube of the center tube assembly is threaded onto the shaft of the base fixture subassembly, and then a pressure-sealed electrical cable and light pipe are passed through the pressure seal. The pressure seal is attached to the manifold, and the center tube is secured to the manifold. Finally, a pressure test is performed using the ports on the manifold.
[0029] Thus, in one embodiment, an endoscope includes a first subassembly, a second subassembly, a third subassembly, and a fourth subassembly, which are assembled and tested sequentially during endoscope manufacturing. The first subassembly includes a pressure-sealed electrical cable connected to an image capture unit. The second subassembly includes the first subassembly, a shell, a light pipe, and a lid. The third subassembly includes the second subassembly, a central tube, and a flange. The fourth subassembly includes the third subassembly, a base, a shaft, and an optional articulating assembly. [Brief explanation of the drawings]
[0030] [Figure 1] 1 is a schematic side view illustrating an embodiment of a surgical system including a pressure test port, a test port retainer, and a surgical device for rocking a pressure test chamber. [Figure 2A] 2 illustrates an alternative embodiment of the surgical device of FIG. 1. [Figure 2B] 2 illustrates an alternative embodiment of the surgical device of FIG. 1. [Figure 2C] 2 illustrates an alternative embodiment of the surgical device of FIG. 1. [Figure 2D] 2 illustrates an alternative embodiment of the surgical device of FIG. 1. [Figure 3] FIG. 2 is a more detailed schematic diagram of a test port retainer and pressure test chamber suitable for use with any of the surgical devices of FIGS. 1 and 2A-2D. [Figure 4A] FIG. 1 is an end view of one embodiment of a pressure-sealed electrical cable. [Figure 4B] 1 is a cross-sectional view of one embodiment of a pressure-sealed electrical cable. [Figure 5] FIG. 4 is a diagram of a light pipe suitable for use in the surgical device of FIGS. 1, 2A-2D, and 3. [Figure 6] 1, 2A-2D, and 3. FIG. 3 is a cross-sectional view of a manifold and test port holder suitable for use with the surgical device of FIGS. [Figure 7A] FIG. 1 is a diagram of a central tube bundle subassembly of an endoscope. [Figure 7B] FIG. 7B is a diagram of a base instrument subassembly of the endoscope of FIG. 7A. [Figure 7C] 7B is a view of the central tube bundle subassembly of FIG. 7A installed in the base instrument subassembly and an instrument to endoscopic imaging system cable connected in combination. [Figure 8] FIG. 1 is a process flow diagram for assembling and testing subassemblies in an endoscope assembly. [Figure 9A] 9 shows a subassembly used in the process of FIG. 8. [Figure 9B] 9 shows a subassembly used in the process of FIG. 8. [Figure 9C] 9 shows a subassembly used in the process of FIG. 8. [Figure 10A] 10 illustrates how to modify the discs of an articulation assembly to eliminate potential fluid flow paths. [Figure 10B] 10 illustrates how to modify the discs of an articulation assembly to eliminate potential fluid flow paths.
[0031] In drawings with single digit numbers, the first digit of an element's reference number is the number of the drawing in which the element first appears. In drawings with two digit numbers, the first two digits of an element's reference number are the number of the drawing in which the element first appears. DETAILED DESCRIPTION OF THE INVENTION
[0032] A novel structure and method according to one embodiment eliminates the drawbacks of the prior art associated with endoscope ports that require some type of cap to seal the port. Although vent caps can provide pressure compensation and prevent liquids from entering the interior space of the endoscope, their use still requires the user to remember to use and correctly install the vent cap. If the user forgets to install the vent cap or installs it improperly, the endoscope may be damaged by liquid entering the interior space of the endoscope during sterilization. As explained more fully below, this problem is eliminated by test port 138, which is coupled to a test port holder inside endoscope 135-1. Endoscope 135-1 is an imaging instrument and, therefore, may be referred to as instrument 135-1.
[0033] Additionally, vent caps containing filters made from materials that allow gas to pass under pressure but prevent liquids from passing can result in false positives during pressure testing. If the filter is covered with liquid or becomes wet during a pressure test, gas is prevented from passing through the filter, causing the pressure tester to see a positive pressure. However, this positive pressure is not the result of the endoscope's interior space being properly sealed, but rather the membrane's inability to allow gas to pass due to moisture on or covering the filter. Furthermore, as explained more fully below, not only does this eliminate reliance on vent caps, but a test port retainer coupled to test port 138 ensures that moisture or liquids do not impede the flow of gas into the interior space of endoscope 135-1 during pressure testing of endoscope 135-1.
[0034] 1 is a schematic side view illustrating an embodiment of a computer-assisted teleoperated surgery system 100 including an endoscopic imaging system 192, a surgeon's console 194 (master), and a patient-side support system 110 (slave), all interconnected by wired (electrical or optical) or wireless connections. One or more electronic data processors may be variously located within these major components to provide the functionality of the system. An example is disclosed in U.S. Pat. No. 9,060,678, which is incorporated herein by reference.
[0035] The patient side support system 110 includes an entry guide manipulator 130. At least one surgical device assembly is coupled to the entry guide manipulator. Each surgical device assembly includes an instrument, including either a surgical instrument or an image capture assembly. For example, in FIG. 1 , one surgical device assembly includes an instrument 135-1 having a shaft 137-1 and an image capture assembly that extends through the entry guide 115 during surgery. The instrument 135-1 is sometimes referred to as an endoscope, an imaging system, or a 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, as described more fully below. Typically, the entry guide 115 includes multiple lumens.
[0036] Imaging system 192 performs image processing functions, for example, on captured endoscopic imaging data of the surgical site and / or pre-operative or real-time image data from other imaging systems external to the patient. Imaging system 192 outputs processed image data (e.g., images of the surgical site and associated control and patient information) to the surgeon at surgeon's console 194. In some embodiments, the processed image data is output to an optional external monitor that is visible to other operating room personnel or at one or more locations remote from the operating room (e.g., a surgeon in another location can monitor the video; live feed video can be used for training, etc.).
[0037] The surgeon's console 194 includes multiple degrees of freedom ("DOF") mechanical input devices ("masters") that allow the surgeon to manipulate instruments, entry guide(s), collectively referred to as slaves, and imaging system devices. These input devices may, in some embodiments, provide tactile feedback to the surgeon from the surgical equipment assembly components. The console 194 also includes a stereoscopic video output display positioned so that 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 more fully described in U.S. Pat. No. 6,671,581, which is incorporated herein by reference.
[0038] Control during instrument insertion can be achieved, for example, by the surgeon using one or both of the masters to move the instrument and / or the image capture assembly presented in the image. The surgeon uses the master to move the instrument left and right in the image, pulling the instrument toward the surgeon. The movement of the master commands the imaging system and associated surgical device assembly to steer toward a fixed center point on the output display and advance inside the patient.
[0039] In one aspect, the camera control is designed to give the impression that the master is fixed in the image so that the image moves in the same direction as the master handle is moved. This design ensures that the master is in the correct position to control the instrument when the surgeon terminates camera control; thus, this design avoids the need to clutch (disconnect), move, and declutch (engage) the master back into position before starting or resuming instrument control.
[0040] In some embodiments, the master position can be made proportional to the insertion speed to avoid using a large master workspace. Alternatively, the surgeon can clutch and disengage the master to use a ratcheting action for insertion. In some embodiments, insertion can be controlled manually (e.g., by a hand wheel), followed by automatic insertion (e.g., servo motor-driven rollers) 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 space available for the insertion trajectory can be used to assist insertion.
[0041] The patient side support system 110 includes a floor-mounted or ceiling-mounted base 101 (not shown), which may be movable or fixed (e.g., relative to the floor, ceiling, wall, or other equipment such as an operating table).
[0042] The base 101 supports arm assemblies including a passive, uncontrolled setup 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.
[0043] A cannula 116 is removably coupled to the cannula mount. In this description, the cannula is typically used to prevent the instrument or entry guide from scraping against the patient's tissue. Cannulas can be used with both incisions and natural orifices. In situations where the instrument or entry guide does not frequently translate or rotate relative to its insertion (longitudinal) axis, a cannula may not be used. In situations requiring insufflation, the cannula may include a seal to prevent excess insufflation gas from leaking past the instrument or entry guide. An example of a cannula assembly supporting procedures requiring insufflation and insufflation gas at a surgical site can be found in U.S. Patent Application No. 12 / 705,439 (filed February 1, 2010; disclosing "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 not requiring insufflation, the cannula seal can be omitted, and the cannula itself can be omitted if movement of the insertion axis of the instrument or entry guide is minimal. A rigid entry guide may function as a cannula in some configurations for instruments to be inserted relative to the entry guide. The cannula and entry guide may be, for example, steel or extruded plastic. Plastic, being less expensive than steel, may be suitable for one-time use.
[0044] Various passive setup joints / links and active joints / links allow the positioning of the instrument manipulator to move the instrument over a wide range of motion as the patient is positioned in various positions on the movable table. In some embodiments, the cannula mount can be coupled to the first manipulator link.
[0045] Certain setups and active joints and links of the manipulator arm may be omitted to reduce the size and shape of the surgical system, or joints and links may be added to increase degrees of freedom. It should be understood that the manipulator arm may include various combinations of links, passive joints, and active joints (redundant DOF may be provided) to achieve the range of postures required for surgery. Additionally, surgical device assemblies including various instruments alone or coupled to an instrument manipulator (e.g., an actuator assembly) via various configurations (e.g., on the proximal or distal face of the instrument transmission means or instrument manipulator) are applicable to embodiments of the present disclosure.
[0046] Each of the plurality of surgical device assemblies 180 includes an instrument manipulator assembly and an instrument including one of a surgical instrument and an image capture assembly. Two of the plurality of surgical device assemblies 180 are visible in FIG. 1 , and each of the two visible surgical device assemblies includes an instrument manipulator assembly, one with a surgical instrument and the other with an image capture assembly. Each of the instrument manipulator assemblies 140-1 and 140-2 is computer-assisted in one aspect and may therefore each be referred to as a computer-assisted instrument manipulator assembly. Each of the instrument manipulator assemblies 140-1 and 140-2 is coupled to the entry guide manipulator assembly 133 by a different insertion assembly; for example, the instrument manipulator assembly 140-1 is coupled to the entry guide manipulator assembly 133 by the insertion assembly 136-1.
[0047] In one aspect, the insert assembly 136-1 is a telescoping assembly that moves a corresponding surgical device assembly away from and toward the entry guide manipulator assembly 133. In FIG. 1, the insert assembly 136-1 is in a fully retracted position.
[0048] Each instrument manipulator assembly 140-1, 140-2 includes multiple motors that drive multiple outputs within the 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 multiple inputs. Each of the instruments 135-1, 135-2 also includes a shaft 137-1, 137-2, sometimes referred to as a main tube, extending distally from the body. An end effector is coupled to the distal end of the shaft of one instrument assembly, and an image capture assembly, e.g., a camera, is included at the distal end of a different instrument assembly. For an example of an instrument manipulator assembly and a surgical instrument, see U.S. Patent Application Publication No. 2016 / 0184037, which is incorporated herein by reference.
[0049] Each of the instruments 135-1, 135-2 is coupled to an instrument mount interface of a corresponding instrument manipulator assembly 140-1, 140-2 such that multiple inputs in the input interface of the transmission unit of the instrument 135-1, 135-2 are driven by multiple outputs of the instrument mount interface of the instrument manipulator assembly 140-1, 140-2. See U.S. Patent Application Publication No. 2016 / 0184037.
[0050] In one aspect, one or more instrument manipulator assemblies may be configured to support and actuate a particular type of instrument, such as instrument 135-1. As shown in FIG. 1 , the shafts of multiple surgical device assemblies 180 extend distally from the instrument bodies. The shafts extend into the patient (e.g., through the body wall or through a natural orifice) through a common cannula 116 disposed at the entry port. In one aspect, an entry guide 115 is positioned within cannula 116, and each instrument shaft extends through a channel in entry guide 115 to provide additional support for the instrument shaft.
[0051] The procedures that can be performed using surgical system 100 can be performed on different regions of the body. For example, one procedure can be performed through the patient's mouth. Another procedure can be performed between the patient's ribs. Other procedures can be performed through other orifices in the patient or through an incision in the patient. Each different entry into the patient can require a different shaped and / or sized entry guide. Thus, an appropriate entry guide 115 is selected for the particular procedure.
[0052] Figures 2A-2D show different embodiments of endoscope 135-1. In Figures 2A-2D, only those aspects of endoscope 135-1 necessary to understand the embodiments of the present invention are shown. Some of these aspects are shown with dashed lines to indicate that the aspect is included within the endoscope.
[0053] Endoscope 235A (FIG. 2A) includes housing 241A from which extends hollow shaft 237A. In this embodiment, connected in series to the distal end of shaft 237A are parallel motion mechanism 270A and wrist joint assembly 280A, which are examples of articulation assemblies. Image capture assembly 242A is connected to parallel motion mechanism 270A by wrist joint assembly 280A.
[0054] Test port retainer 250A connects pressure test port 238A in housing 241A to a pressure test chamber that includes test port retainer 250A, manifold 260A, and center tube 265A.
[0055] Test port retainer 250A connects pressure test port 238A to manifold 260A. When endoscope 235A is not being pressure tested, test port retainer 250A allows any pressurized gas in the pressure test chamber to be vented. Therefore, there is no possibility of pressure buildup inside endoscope 235A during autoclaving, which heats endoscope 235A to approximately 140°C, or during shipping of endoscope 235A. When endoscope 235A is being cleaned, either manually or in an ultrasonic cleaner, test port retainer 250A prevents liquids or moisture from entering the interior of the pressure test chamber through test port retainer 250A.
[0056] Manifold 260A is connected between test port retainer 250A and central tube 265A. A first end of central tube 265A is connected to image capture assembly 242A by a pressure-tight seal, and a second end of central tube 265A is connected to manifold 260A by another pressure-tight seal. As used herein, a pressure-tight seal refers to a seal that is sufficient to maintain the minimum pressure required during pressure testing.
[0057] Thus, in this embodiment, central tube 265A is a single, continuous tube with a single lumen or channel, and in another embodiment, it is a molded, single, continuous silicone tube with a single lumen. Central tube 256A has an outer surface and an inner surface. The inner surface defines a single lumen. As shown in FIG. 2A, the longitudinal axis of central tube 265 is aligned with the longitudinal axis of shaft 237A, the longitudinal axis of parallel motion mechanism 270A, and the longitudinal axis of wrist joint assembly 280A as central tube 265 passes through parallel motion mechanism 270A and wrist joint assembly 280A.
[0058] Typically, image capture assembly 242A includes one or more cameras and one or more illumination ports. A pressure-sealed electrical cable 261A, sometimes referred to as cable 261A, is connected to the one or more cameras and extends through a central lumen of central tube 265A, through a first opening in manifold 260A, into the interior volume of manifold 260A, and out of manifold 260A. Specifically, pressure-sealed electrical cable 261A has a distal end connected to image capture assembly 242A. Pressure-sealed electrical cable 261A passes through a single lumen in central tube 265A, through manifold 260A, and out of manifold 260A, and a proximal end of pressure-sealed electrical cable 261A is connected to repeater board 268A.
[0059] In one embodiment, pressure-sealed electrical cable 261A is a shielded cable having one or more conductors. One or more of the conductors are each connected to a connector that is connected to one or more cameras. The one or more conductors are embedded in the connector. One or more shields of cable 261 are also pressure-sealed. As used herein, pressure-sealed means that a seal sufficient to maintain the minimum pressure required during pressure testing is formed in and around the shield. Thus, a pressure-sealed electrical cable is one that does not have through-paths for gas flow between the insulating jacket or within portions of the electrical cable, such as the shield. These through-paths would prevent the endoscope from maintaining the minimum pressure required during pressure testing.
[0060] In this embodiment, a light-emitting diode on the repeater board 268A is used to indicate whether the laser is on. 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 embedded in a metal ferrule connected to a connector 269A. Both ends of the light pipe 262A are attached such that the connection is pressure-sealed. The light pipe 262A also extends through the central lumen of the central tube 265A.
[0061] The use of light pipe 262A is exemplary only and is not intended to be limiting. If an illuminator were included in image capture assembly 242A, light pipe 262A would not be used.
[0062] Cable 261A and light pipe 262A enter manifold 260A through a first opening and exit through a second opening. In one embodiment, pressure seals are used around cable 261A and light pipe 262A at the first and second openings. In another embodiment, manifold 260A is configured so that a single pressure seal is used.
[0063] Repeater board 268A is connected to connector 269A. An access to endoscopic imaging system cable is connected to connector 269A for coupling endoscope 235A to an endoscopic imaging system, such as endoscopic imaging system 192.
[0064] Test port retainer 250A includes a body, a probe seal 251A, a liquid exclusion barrier 252A, and a hydrophobic membrane 253A. Each of probe seal 251A, liquid exclusion barrier 252A, and hydrophobic membrane 253A is mounted within the body of test port retainer 250A, with probe seal 251A closest to pressure test port 238A and hydrophobic membrane 253A furthest from pressure test port 238A; i.e., liquid exclusion barrier 252A is mounted between probe seal 251A and hydrophobic membrane 253A.
[0065] Probe seal 251A has a central opening designed to form a seal around the tip of a pressure test probe. In one embodiment, liquid exclusion barrier 252A is an x-slit valve. When there is a pressure differential across the x-slit valve, the x-slit valve opens until the pressure equalizes. When endoscope 235A is being flushed, the water pressure on the x-slit valve is not sufficient to force the x-slit valve open, and therefore the x-slit valve prevents liquid from entering the pressure test chamber, which includes the central lumen of the manifold and central tube.
[0066] In one embodiment, hydrophobic membrane 253A is a polyvinylidene fluoride (PVDF) membrane with pore sizes between 0.22 and 0.45 micrometers. PVDF is resistant to solvents and is a highly non-reactive and pure thermoplastic fluoropolymer produced by polymerization of vinylidene difluoride. PVDF melts at approximately 177°C, which is higher than the temperatures encountered during autoclaving. Hydrophobic membrane 253A protects the pressure test chamber from the ultrasonic fluid and prevents pressure buildup within the pressure test chamber during autoclaving.
[0067] Additionally, liquid exclusion barrier 252A keeps moisture and liquid away from hydrophobic membrane 253A, ensuring proper operation of membrane 253A during pressure testing. In prior art systems, if the hydrophobic membrane became wet, the moisture could prevent the gas used in pressure testing from passing through the hydrophobic membrane, resulting in a false positive pressure reading. Test port retainer 250A eliminates the possibility of such a false positive pressure reading by preventing moisture and / or liquid from reaching the surface of hydrophobic membrane 253A.
[0068] To ensure there is no leakage from the environment outside endoscope 235A to the pressure test chamber, a pressure test probe is inserted into test port 238A and the pressure test chamber is pressurized to a predetermined pressure. If the pressure test chamber maintains a pressure higher than a predetermined minimum pressure for a predetermined time interval, there is no fluid (liquid or gas) path for communication between the environment outside endoscope 235A and the interior of the pressure test chamber, which is important during surgery. As a result, the pressure test chamber cannot become contaminated during surgery when endoscope 235A is used at insufflation pressure.
[0069] In another embodiment, endoscope 235B (FIG. 2B) includes housing 241B from which extends shaft 237B. In this embodiment, image capture assembly 242B is connected to the distal end of shaft 237B.
[0070] Test port retainer 250B connects pressure test port 238B of housing 241B to a pressure test chamber. The pressure test chamber includes test port retainer 250B, manifold 260B, and central tube 265B. Manifold 260B is connected between test port retainer 250B and central tube 265B.
[0071] The configuration and structure of repeater board 268B, connector 269B, test port holder 250B including probe seal 251B, liquid exclusion barrier 252B, and hydrophobic membrane 253B, manifold 260B, and central tube 265B including pressure-sealed electrical cable 261B and light pipe 262B are the same as those of repeater board 268A, connector 269A, test port holder 250A including probe seal 251A, liquid exclusion barrier 252A, and hydrophobic membrane 253A, manifold 260A, and central tube 265A including pressure-sealed electrical cable 261A and light pipe 262A, respectively. Therefore, a description of test port holder 250A including probe seal 251A, liquid exclusion barrier 252A, and hydrophobic membrane 253A, manifold 260A, and central tube 265A including cable 261A and light pipe 262A will not be repeated here.
[0072] In another embodiment, endoscope 235C (FIG. 2C) includes housing 241C from which shaft 237C extends. In this embodiment, connected in series to the distal end of shaft 237C are parallel motion mechanism 270C and wrist joint assembly 280C. Image capture assembly 242C is connected to parallel motion mechanism 270C by wrist joint assembly 280C.
[0073] Test port retainer 250C connects pressure test port 238C of housing 241C to a pressure test chamber. The pressure test chamber includes test port retainer 250C, manifold 260C, and central tube 265C. Manifold 260C is connected between test port retainer 250C and central tube 265C.
[0074] The configuration and structure of repeater board 268C, connector 269C, parallel motion mechanism 270C, wrist joint assembly 280C, manifold 260C, central tube 265C containing pressure-sealed electrical cable 261C and light pipe 262C, and image capture assembly 242C are the same as those of repeater board 268A, connector 269A, parallel motion mechanism 270A, wrist joint assembly 280A, manifold 260A, central tube 265A containing pressure-sealed electrical cable 261A and light pipe 262A, and image capture assembly 242A, respectively. Accordingly, descriptions of parallel motion mechanism 270A, wrist joint assembly 280A, manifold 260A, central tube 265A containing cable 261A and light pipe 262A, and image capture assembly 242A will not be repeated here.
[0075] Test port retainer 250C includes a body, a probe seal 251C, and a liquid exclusion barrier 252C. Probe seal 251C and liquid exclusion barrier 252C are mounted within the body of test port retainer 250C, with probe seal 251C closest to pressure test port 238C and liquid exclusion barrier 252C furthest from pressure test port 238C.
[0076] In another embodiment, endoscope 235D (FIG. 2D) includes housing 241D from which extends shaft 237D. In this embodiment, image capture assembly 242D is connected to the distal end of shaft 237D.
[0077] Test port retainer 250D connects pressure test port 238D of housing 241D to a pressure test chamber. The pressure test chamber includes test port retainer 250D, manifold 260D, and central tube 265D. Manifold 260D is connected between test port retainer 250D and central tube 265B.
[0078] The configurations and structures of repeater board 268D, connector 269D, test port holder 250D including probe seal 251D and liquid exclusion barrier 252D, manifold 260D, central tube 265D including cable 261D and light pipe 262D, and image capture assembly 242D are the same as those of repeater board 268C, connector 269C, test port holder 250C including probe seal 251C and liquid exclusion barrier 252C, manifold 260C, central tube 265C including cable 261C and light pipe 262C, and image capture assembly 242C, respectively. Accordingly, descriptions of test port holder 250C including probe seal 251C and liquid exclusion barrier 252C, manifold 260C, central tube 265C including cable 261C and light pipe 262C, and image capture assembly 242C will not be repeated here.
[0079] 3 is a more detailed schematic diagram of a test port holder 350 and pressure test chamber 370 suitable for use with any one of endoscopes 235A-235D. Pressure test port 338 in the endoscope housing is the first opening in test port holder 350. Test port holder 350 includes probe seal 351 and liquid exclusion barrier 352, and optionally hydrophobic membrane 353. Pressure test chamber 370, in this embodiment, includes manifold 360 and central tube 365.
[0080] Test port retainer 350 includes a first opening, which is pressure test port 338, to the interior volume of test port retainer 350. A second opening to the interior volume of test port retainer 350 communicates with second opening 360-2 of manifold 360, i.e., at least a portion of the second opening of test port retainer 350 is aligned with second opening 360-2 of manifold 360.
[0081] Probe seal 351 is mounted in the interior volume of test port retainer 350 closest to pressure test port 338 and furthest from second opening 360-2 in manifold 360 (as measured from the center of probe seal 351 to the center of the pressure test port along the longitudinal axis 355 of test port retainer 350). Optional hydrophobic membrane 353 is mounted in the interior volume of test port retainer 350 closest to second opening 360-2 in manifold 360 and furthest from pressure test port 338 (as measured from the center of hydrophobic membrane 353 to the center of second opening 360-2 in manifold 360 along the longitudinal axis 355 of the test port).
[0082] If optional hydrophobic membrane 353 is included in test port retainer 350, liquid exclusion barrier 352 is attached to the interior volume of test port retainer 350 between probe seal 351 and optional hydrophobic membrane 353. In this embodiment, the centers of probe seal and liquid exclusion barrier 352 and hydrophobic membrane 353 intersect longitudinal axis 355 of test port retainer 350. If optional hydrophobic membrane 353 is not included in test port retainer 350, liquid exclusion barrier 352 is attached to the interior volume of test port retainer 350 closest to second opening 360-2 of manifold 360 and farthest from pressure test port 338 (as measured from the center of liquid exclusion barrier 352 to the center of second opening 360-2 of manifold 360 along longitudinal axis 355 of test port retainer 350).
[0083] Similar to the probe seals described above, probe seal 351 has an opening in its center shaped to form a pressure seal around the tip of a pressure test probe when the tip is inserted through probe seal 351. In one embodiment, 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 that will be inserted into test port 338.
[0084] Similar to the liquid exclusion barriers described above, liquid exclusion barrier 352 is, in one embodiment, an x-slit valve. Also, as described above for hydrophobic membranes, in one embodiment hydrophobic membrane 353 is a PVDF membrane.
[0085] In this embodiment, the manifold 360 includes three openings 360-1, 360-2, and 360-3. The first opening 360-1 is in the flange and communicates with the central lumen of the central tube 365. A piece of heat shrink tubing is fitted over the second end of the central tube 365, which is pressed against the flange. The heat shrink tubing is then moved over the second end of the central tube and the flange and shrunk. The combination of the pressure fit of the central tube onto 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 onto a flange that is welded to the camera module 342, sometimes referred to as the image capture assembly 342.
[0086] A pressure-sealed electrical cable 361, sometimes referred to as cable 361, and two light pipes 362A and 362B extend proximally from the proximal end of image capture assembly 342. The two light pipes 362A and 362B join into a single light pipe 362 that passes through a central lumen of central tube 365 and through first opening 360-1 into the interior volume of manifold 360. The use of two light pipes is exemplary only, i.e., optional, and not intended to be limiting. In other embodiments, a single light pipe or no light pipes may be used.
[0087] Cable 361 and light pipe 362 exit the interior volume of manifold 360 through third opening 360-3. Pressure seal 366 surrounds cable 361 and light pipe 362 at third opening 360-3. In one embodiment, pressure seal 366 is fabricated from a two-part, platinum-catalyzed, heat-cured silicone elastomer. A two-part, platinum-catalyzed, heat-cured silicone elastomer suitable for use in fabricating pressure seal 366 is sold by Dow Corning® under the trade name QP1-20 Liquid Silicone Rubber.
[0088] 4A and 4B are end and cross-sectional views, respectively, of one embodiment of a pressure-sealed electrical cable 361. Arrows 490 define first and second directions. In one embodiment, the first direction is distal and the second direction is proximal.
[0089] In this embodiment, cable 361 is a double-shielded cable. Each of the multiple conductors 410 of cable 361 is surrounded by its own insulating jacket 401. A first braided shield 411 surrounds the multiple conductors 410. A second insulating jacket 402 surrounds the first braided shield 411. A second braided shield 412 surrounds the second insulating jacket, and a third insulating jacket 403 surrounds the second braided shield 412. In one embodiment, the third insulating jacket 403 does not extend the entire length of cable 361. In one embodiment, the third insulating jacket 403 is a silicone insulating jacket. An end of the third insulating jacket 403 is removed from the end of cable 361 to facilitate connecting cable 361 to connectors 426, 425. In cable 361, the insulating jacket is an electrical insulating jacket.
[0090] Prior to connecting connectors 425 and 426 to both ends of cable 361, a strip of outer insulating jacket 403 is removed near the first end of cable 361 to expose the outer circumferential surface of second braided shield 412. (In FIG. 4B , the first end of cable 361 is adjacent connector 425, which is the image capture unit connector.) A piece of heat shrink tubing is secured to the third insulating jacket 403 adjacent to the edge of the exposed braided shield. Silicone is injected into the heat shrink tubing around the exposed outer circumferential surface of second braided shield 412, and the heat shrink tubing is then shrunk to replace the removed strip of third insulating jacket 403. The shrinking of the heat shrink tubing forces the silicone into any openings in second braided shield 412 to form a first pressure seal 421 in and around second braided shield 412.
[0091] After pressure seal 421 is formed, connector 425 is secured to the second end of cable 361. A first end of each of multiple conductors 410 is embedded within connector 425.
[0092] The second braided shield 412 is pushed back from the second end of the cable 361 that connects to the connector 426 to form a pressure seal within the first braided shield 411 and around the multiple conductors 410. A strip of the second insulating jacket 402 is removed to expose the outer periphery of the first braided shield 411. A piece of heat shrink tubing is secured to the second insulating jacket 402 adjacent to the exposed edge of the first braided shield 411. Silicone is injected into the heat shrink tubing around the exposed outer periphery of the first braided shield 411 and around the multiple conductors 410. The heat shrink tubing is then shrunk to replace the removed strip of the second insulating jacket 402. The shrinking of the heat shrink tubing forces the silicone into any openings in the first braided shield and into openings between the multiple conductors 410, and the silicone is injected around and between the multiple conductors 410. The multiple conductors 410 may include multiple wires. This forms a second pressure seal 422 in and around the first braided shield 411 and around the plurality of conductors 410. After the pressure seal 422 is formed, the second braided shield 412 returns to its appropriate position and the connector 426 is secured to the second end of the cable 361. Each of the plurality of conductors 410 is embedded within the connector 426.
[0093] In another embodiment, seals 421 and 422 are made during the manufacturing process of the cable. Also, in one embodiment, the outer surface of all insulating jackets is coated with an anti-friction coating during manufacturing of the cable.
[0094] Figure 5 is an example of a light pipe 362 suitable for use in the surgical device of Figures 1, 2A-2D, and 3. Light pipe 362 includes a fiber optic bundle 501, a protective sheath 502, and a ferrule 503. A first end, the distal end, of fiber optic bundle 501 splits into two smaller fiber optic bundles 501-1 and 501-2. A second end of fiber optic bundle 501 is embedded within ferrule 503.
[0095] 5, and a third end 502-3 that is sealed to the outer surface of ferrule 503. When fiber optic bundle 501 is connected to image capture assembly 342, first end 502-1 and second end 502-2 of protective sheath 502 are sealed within image capture assembly 342 so that there is no fluid flow path between the outer surface of fiber optic bundle 501 and the inner surface of protective sheath 502, which is important during surgery.
[0096] 6 is a cross-sectional view of one embodiment of manifold 660 and test port retainer 650. Manifold 660 is an example of manifold 360 and manifolds 260A-260D. Test port retainer 650 is an example of test port retainers 250A-250D and test port retainer 350.
[0097] Test port retainer 650 connects pressure test port 638 to manifold 660. Test port retainer 650 includes a body 654, a seal retainer 655, and an end cap 656. A probe seal 651, a liquid exclusion barrier 652, and a hydrophobic membrane 653 are mounted within test port retainer 650, with probe seal 651 closest to pressure test port 638 and hydrophobic membrane 653 furthest from pressure test port 638. Hydrophobic membrane 653 is optional.
[0098] Body 654 includes an interior wall 654-3 having an opening 654-4 directly adjacent opening 660-2 in manifold 660 so that there is a two-way fluid communication path between test port retainer 650 and manifold 660. Within body 654, an O-ring 657 presses against the outer periphery of a first surface of hydrophobic membrane 653 to seat the outer periphery of a second surface of hydrophobic membrane 653 against a step 654-5 that extends from wall 654-3 into the interior volume of body 654.
[0099] Second end 655-2 of seal retainer 655 includes opening 655-3. A tapered surface of seal retainer 655 holds O-ring 657 against the outer periphery of the first surface of hydrophobic membrane 653. First end 655-1 of seal retainer 655 is disposed between first end 654-1 of body 654 and second end of end cap 656 to form the outer surface of test port retainer 650. First end 655-1 forms a groove with second end of end cap 656. Probe seal 651 and liquid exclusion barrier 652 are mounted in this groove.
[0100] Probe seal 651, in this embodiment, has a central circular opening and is designed to form a seal around the tip of a pressure test probe. In one embodiment, liquid exclusion barrier 652 is an x-slit valve. Hydrophobic membrane 653, in one embodiment, is a polyvinylidene fluoride (PVDF) membrane, as described above.
[0101] Probe seal 651 is an example of probe seals 251A-251D and probe seal 351. Liquid exclusion barrier 652 is an example of liquid exclusion barriers 252A-252D and liquid exclusion barrier 352. Hydrophobic membrane 653 is an example of hydrophobic membranes 253A-253B and hydrophobic membrane 353.
[0102] End cap 656 , seal retainer 655 , and body 654 are welded together to form a unitary body for test port retainer 650 .
[0103] Manifold 660 includes three openings 660-1, 660-2, and 660-3. In one embodiment, manifold 660 is made of a polymer formed by injection molding polyphenylsulfone (PPSU). Polyphenylsulfone is heat- and chemical-resistant. Polyphenylsulfone offers a tensile strength of up to 55 MPa (8000 psi). Therefore, PPSU can withstand continuous exposure to moisture and high temperatures and absorb impact without cracking or breaking. One example of a polyphenylsulfone suitable for forming manifold 660 is medical-grade Radel® R5500 resin. (Radel® is a U.S. registered trademark of Solvay Advanced Polymers LLC.)
[0104] A first opening 660-1 in the flange 661 of the manifold 660 communicates with the central lumen of the central tube because the inner diameter of the central tube is sized so that the central tube can be press-fit onto the flange to form a pressure-tight seal. A pressure seal 666 is attached adjacent to the third opening 660-3. Cables and light pipes (not shown) pass through the pressure seal 666 and then through the third opening 660-3. The pressure seal 666 is made from a two-part platinum-catalyzed heat-cure silicone elastomer. A two-part platinum-catalyzed heat-cure silicone elastomer suitable for use in manufacturing the pressure seal 666 is sold by Dow Corning® under the trade name QP1-20 Liquid Silicone Rubber.
[0105] As described more fully below, in assembly, light pipe 362 and pressure-sealed electrical cable 361 are passed through pressure seal 666, and then this assembly is attached to manifold 660. Test port retainer 650 is then attached to the end of manifold 660, including pressure seal 666. In this embodiment, the interface between test port retainer 650 and manifold 660 is stepped. Test port retainer 650 is secured to the end of manifold 660, including pressure seal 666, such that manifold 660 exerts a radially inward force that compresses pressure seal 666 around light pipe 362 and pressure-sealed electrical cable 361 to form a pressure-tight seal. As used herein, a pressure-tight seal is a seal that allows a pressure chamber within an endoscope to maintain a predetermined minimum pressure required to pass a pressure test.
[0106] The following description applies to each of endoscopes 135-1, 235A, 235B, 235C, and 235D. Specifically, descriptions of elements in Figures 7A-7C, 8, and 9A-9C that have the same name as the name of an element in endoscopes 135-1, 235A, 235B, 235C, and 235D apply to the element in endoscopes 135-1, 235A, 235B, 235C, and 235D that has that name. Similarly, descriptions of elements in endoscopes 135-1, 235A, 235B, 235C, and 235D that have the same name as the name of an element in Figures 7A-7C, 8, and 9A-9C apply to the element in Figures 7A-7C, 8, and 9A-9C that has that name. Accordingly, correspondence between elements in the various figures is not explicitly indicated in the following description to avoid distracting from the aspects of the invention.
[0107] Typically, prior art endoscopes used in computer-assisted teleoperation systems included a single, continuous electrical and illumination bundle. The electrical and illumination components within the bundle were separate. The bundle extended from the endoscopic imaging system to the endoscope housing, through the endoscope housing, down the endoscope shaft to the distal end of the shaft. The electrical and illumination components followed different paths through the shaft to the distal end of the shaft. The endoscope was assembled from proximal to distal.
[0108] In contrast, instead of a single continuous electrical and illumination bundle threaded through the endoscope from an endoscopic imaging system remote from the endoscope, the endoscope is divided into multiple testable subassemblies that are integrated together when the endoscope is assembled. Figures 7A-7C show examples of three subassemblies 701, 702, 703.
[0109] One subassembly is the central tube bundle subassembly 701 (FIG. 7A), sometimes referred to as the central tube bundle 701 and the third subassembly. The central tube bundle 701 includes a central tube 765, an image capture subassembly 742 (sometimes also referred to as the second subassembly), a pressure-sealed electrical cable 361, and a light pipe 362. In one embodiment, the central tube 765 is a single continuous tube with a single central lumen. In another embodiment, the central tube 765 is a molded single continuous silicone tube with a single central lumen. The single continuous tube eliminates potential leak paths. The image capture subassembly 742 is equivalent to the image capture assembly described above.
[0110] Central tube 765 is connected to image capture subassembly 742 such that a pressure-tight seal is formed between central tube 765 and image capture subassembly 742. Pressure-sealed electrical cable 361 is electrically connected to the image capture unit within image capture subassembly 742. Ends 501-1 and 501-2 of fiber optic bundle 501 terminate at image capture subassembly 742 to output light through the distal end of image capture subassembly 742. Pressure-sealed electrical cable 361 and light pipe 362 are routed through the central lumen of central tube 762.
[0111] As described more fully below, in one embodiment, the cable 361 and image capture unit are assembled as a subassembly. The image capture unit of this subassembly is inserted into the shell, with the cable 361 extending proximally through the proximal end of the shell. The distal end of the light pipe 362 is mounted within the shell, with the light pipe 362 also extending proximally through the proximal end of the shell. A lid is secured to the distal end of the shell, and the subassembly undergoes a seal verification test. The cable 361 and light pipe 362 are then threaded through the lumen of the central tube 765, which is secured to the shell to form the central tube bundle subassembly 701. The central tube bundle subassembly 701 can be tested to determine whether the camera or cameras of the capture unit are operating properly and whether the light pipes are providing adequate illumination.
[0112] Another subassembly is base instrument subassembly 702 (FIG. 7B), sometimes referred to as the fourth subassembly. In this embodiment, base instrument subassembly 702 includes a base, a shaft, a parallel motion mechanism 770, and a wrist joint assembly 780. Parallel motion mechanism 770 and wrist joint assembly 780 are each examples of articulation assemblies. Other articulation assemblies can be used for base instrument subassembly 702, or base instrument subassembly 702 may include no articulation assembly (see FIGS. 2B and 2D) or only one articulation assembly, such as wrist joint assembly 780.
[0113] Base instrument subassembly 702 includes a repeater board, a manifold such as manifold 660, a test port holder such as test port holder 350, and a cable subassembly connector 705. Base instrument subassembly 702 is connected to the proximal end of the shaft. The repeater board includes a laser-on indicator, e.g., one or more light-emitting diodes, a voltage regulator, a first connector configured to connect to the proximal end of pressure-sealed electrical cable 361, and a second connector configured to electrically connect to instrument-endoscopic imaging system cable subassembly 703. The repeater board receives power and control signals from instrument-endoscopic imaging system cable subassembly 703 (FIG. 7C) and provides them to image capture subassembly 742. The repeater board receives video signals from image capture subassembly 742 and provides them to instrument-endoscopic imaging system cable subassembly 703.
[0114] The distal end of shaft 757 is connected to the proximal end of parallel motion mechanism 770. The distal end of parallel motion mechanism 770 is connected to the proximal end of wrist assembly 780.
[0115] A wrist joint assembly suitable for use as wrist joint assembly 780 is described, for example, in U.S. Patent Application Publication No. 2003 / 0036748 (filed June 28, 2002, and disclosing "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 parallel motion mechanism 770 is described, for example, in U.S. Patent Application Publication No. 7,942,868. No. B2, filed June 13, 2007, disclosing "Surgical Instrument With Parallel Motion Mechanism," which is also incorporated herein by reference. Parallel motion mechanism 770 and wrist joint assembly 780 are constructed, and the cables are tensioned in the same manner as in the prior art, except for, in one embodiment, the most distal disk of wrist joint assembly 780, as described below with respect to FIG. 10B.
[0116] In one embodiment, the range of motion is tested for the parallel motion mechanism 770 and wrist joint assembly 780. Also, the cable friction through the shaft 737 and the friction within the parallel motion mechanism 770 and wrist joint assembly 780 are tested.
[0117] After testing of subassemblies 701 and 702, central tube bundle 701 is routed from the distal end of shaft 737 to the proximal end of shaft 737. Pressure-sealed electrical cable 361 and light pipe 362 are routed through manifold 660, and pressure-sealed electrical cable 361 is connected to the repeater board. The distal end of central tube 765 is secured to manifold 660, and image capture subassembly 742 is secured to wrist joint assembly 780. After subassemblies 701 and 702 are combined, electrical, lighting, and camera testing can be repeated to ensure nothing was damaged during the assembly process.
[0118] To complete the assembly for testing, yet another subassembly, an example fifth subassembly, instrument-endoscopic imaging system cable subassembly 703 (FIG. 7C), is connected to base instrument subassembly 702. The test can then be repeated using instrument-endoscopic imaging system cable subassembly 703 to determine if the system is functioning properly.
[0119] FIG. 8 is a process flow diagram for assembling and testing endoscope subassemblies during endoscope assembly. In a cable-camera connection process 801, each of the multiple conductors 410 at the distal end of the pressure-sealed electrical cable 361 is connected to a corresponding conductor of the image capture unit 943 ( FIG. 9A ). In this embodiment, the connector 425 at the distal end of the pressure-sealed electrical cable 361 is connected to a connector of the image capture unit 943. In this example, the image capture unit 943 is a stereo image capture unit and therefore includes two stereo cameras 944, 945. The use of stereo cameras is optional, as the assembly and testing process is the same as if only a single camera were used. In the case of a single camera, there may be a different number of conductors among the multiple conductors 410 in the pressure-sealed electrical cable 361.
[0120] A ground wire is woven into the outer braided shield 412 of the pressure-sealed electrical cable 361, which is then electrically connected to the body of the image capture unit 943. The ground wire is electrically attached to the ground crimp where the stereo cameras 944, 945 are mounted. A first example subassembly, the completed electrical cable and image capture unit subassembly 901, is shown in FIG. 9A.
[0121] Once the cable-camera connection process 801 is complete, the electrical cable and image capture unit subassembly 901 is tested in an electrical conductivity test process 802, sometimes referred to as process 802. In process 802, the electrical conductivity of the electrical cable and image capture unit subassembly 901 is checked by applying power to the stereo cameras 944, 945 and observing and checking the video feed from the stereo cameras 944, 945.
[0122] Upon successful completion of electrical conductivity test process 802, image capture subassembly 742 is assembled in camera shell attachment process 803, sometimes referred to as process 803. In process 803, the distal ends of light pipes 562-1 and 562-2 are embedded directly within the internal enclosure of shell 946 prior to attaching electrical cable and image capture unit subassembly 901 to shell 946. Electrical cable and image capture unit subassembly 901 is then loaded into the distal end of shell 946 and positioned so that light pipes 562-1 and 562-2 are on opposite sides of image capture unit 943, as shown in FIG. 9B . Pressure-sealed electrical cable 361 extends proximally from the proximal end of shell 946, as do light pipes 562-1 and 562-2. In FIG. 9B , the side of shell 946 has been removed to reveal light pipes 562-1 and 562-2 and image capture unit 943. Finally, a lid 947 is welded to the distal end of the shell 946 to form a sealed image capture subassembly 742, sometimes referred to as the second subassembly. The lid 947 includes windows for each of the cameras and each of the light pipes.
[0123] Once camera shell attachment process 803 is complete, a pressure test is performed to verify by pressure decay that the weld between lid 947 and shell 946 is watertight in seal verification test process 804. In one aspect, the pressure test is accomplished by creating a pressure differential between the inside and outside of the shell (including image capture unit 943 and light pipe ends 562-1 and 562-2) and measuring the decay of the pressure. The direction of the pressure differential is irrelevant.
[0124] Following successful conclusion of seal verification test process 804, central lumen assembly process 805, sometimes referred to as process 805, is performed. Before discussing process 805, central tube 765 will be further described. As explained above, in one embodiment, central tube 765 is a molded single continuous silicone tube having a single central lumen. In one embodiment, central tube 765 is made from an injection molded hollow cylindrical tube, which is in turn injection molded into a tapered oval tube.
[0125] In one embodiment, the central tube 765 is made from a medical-grade silicone elastomer. First, the proximal cylindrical tube portion, central tube 765, is formed using a two-component, reinforced, tear-resistant (ETR) silicone elastomer consisting of a dimethyl and methylvinyl siloxane copolymer and reinforcing silica. Equal amounts (by weight) of the two components are thoroughly mixed together prior to injection molding. The elastomer is thermally cured by an addition cure (platinum cure) chemical reaction. The two-component, reinforced, tear-resistant silicone elastomer is offered by Dow Corning under the trade name SILASTIC® BioMedical Grade ETR Elastomer Q7-4780. (SILASTIC is a U.S. registered trademark of Dow Corning Corporation.)
[0126] The proximal cylindrical tube portion of the central tube 765 is then molded onto the distal portion of the central tube 765. The distal portion of the central tube 765 is a molded transition between the distal end that fits around the image capture assembly flange 966 and the proximal cylindrical tube portion of the central tube 765. The distal portion of the central tube 765 is made using a two-part platinum-catalyzed silicone elastomer. Equal parts (by weight) are thoroughly mixed prior to injection molding. The elastomer is heat-cured via an addition cure (platinum-catalyzed) reaction. When mixed and cured, the resulting elastomer consists of a cross-linked dimethyl and methylvinyl siloxane copolymer and reinforcing silica. This elastomer is heat-stable up to 204°C (400°F) and can be autoclaved. Two-part platinum-catalyzed silicone elastomers are available from Dow Corning under the trade name SILASTIC® BioMedical Grade Liquid Silicone Rubber Q7-4850.
[0127] In one embodiment, both the inner and outer walls of the central tube 765 are coated with an anti-friction coating. One suitable anti-friction coating is a Parylene-N coating. In this embodiment, the outer insulating jacket 403 of the pressure-sealed electrical cable 361 is a silicone jacket coated with an anti-friction coating, such as a Parylene-N coating. In one embodiment, all insulating jackets within the pressure-sealed electrical cable 361 are coated with an anti-friction coating. Similarly, the outer surface of the protective sheath 502, including the protective sheath 502-1 at the first end 562-1 of the light pipe 362 and the protective sheath 502-2 at the second end 562-2 of the light pipe 362, is a silicone sheath coated with an anti-friction coating, such as a Parylene-N coating.
[0128] First, an image capture assembly flange 966 (FIG. 9C) is attached to the distal end of the central tube 765 in process 805. As mentioned above, the circumference of the distal end of the central lumen is slightly smaller than the circumference of the flange 966 so that a pressure-tight seal is formed when the central tube 765 is pressed against the flange 966. In one embodiment, a piece of heat shrink tubing is shrunk around the circumference of the distal end of the central tube 765 to further ensure that a pressure-tight seal is formed between the central tube 765 and the flange 966.
[0129] Next, the pressure-sealed electrical cable 361 and light pipe 362 are threaded through the flange 966 and central tube 765 to obtain the structure shown in FIG. 9C. Anti-friction coatings on the wall of the central lumen of the central tube 765, on the outer insulating jacket 403 of the pressure-sealed electrical cable 361, and on the outer surface of the sheath 502 of the light pipe 362 facilitate stringing the pressure-sealed electrical cable 361 and light pipe 362 through the central tube 765 without the use of force that might damage one or both of the pressure-sealed electrical cable 361 and light pipe 362. The flange 966 is welded to the proximal end of the image capture subassembly 742 to obtain the central tube bundle subassembly 701, also referred to as the third subassembly.
[0130] Following completion of central lumen assembly process 805, main tube feeding process 806, also referred to as process 806, is performed. In process 806, central tube bundle 701 is fed through wrist joint assembly 780, parallel motion mechanism 770, and shaft 737 so that the proximal end of central tube bundle 701 emerges from the proximal end of shaft 737. An anti-friction coating on the outer surface of central tube 765 facilitates feeding of the central tube bundle from the distal end of base instrument subassembly 702 into base instrument subassembly 702. The longitudinal axis of central tube 765, in this example, coincides with the longitudinal axes of shaft 737, parallel motion mechanism 770, and wrist joint assembly 780.
[0131] Following completion of main tube feed process 806, manifold assembly process 807, also referred to as process 807, is performed. In process 807, a piece of heat shrink tubing is slid over the proximal end of central tube 765, and then the proximal ends of pressure-sealed electrical cable 361 and light pipe 362 are threaded through opening 660-1 in flange 661 of manifold 660. Next, the proximal ends of pressure-sealed electrical cable 361 and light pipe 362 are threaded through corresponding channels in pressure seal 666, which is attached to the end of manifold 660 opposite flange 661. Test port retainer 650 is attached to manifold 660, and screws are used to tighten the test port retainer around manifold 660 so that manifold 660 compresses pressure seal 666 around pressure-sealed electrical cable 361 and light pipe 362 to form a pressure-tight seal.
[0132] The circumference of the proximal end of the central lumen is slightly smaller than the circumference of flange 661 so that a pressure-tight seal is formed when central tube 765 at the proximal end is pressed against flange 661. In one embodiment, a piece of heat shrink tubing is shrunk around the circumference of the proximal end of central tube 765 to further ensure that a pressure-tight seal is formed between central tube 765 and flange 661.
[0133] Finally, to complete process 807, the proximal end of the pressure sealed electrical cable 361 is connected to the repeater board of the base instrument subassembly 702. Following completion of the manifold assembly process 807, sometimes referred to as process 807, a central lumen pressure test and distal illumination test process 808 is performed.
[0134] Before discussing the central lumen pressure test and distal illumination test process 808, the rationale for pressure testing will be discussed. Patient safety requires the detection of breaches large enough to allow blood to pass into the endoscope's pressure chamber when pressurized with an injection pressure of approximately 15 mmHg. Due to surface tension, there is a minimum hole size below which injection pressure cannot force blood through the breach. However, regardless of hole size, some air flow through the breach occurs. Therefore, a method to ensure that there are no breaches large enough to allow blood to pass through the injection pressure is to pressurize the pressure chamber in the endoscope to a predetermined pressure, such as 150 mmHg, and observe whether the pressure falls below the predetermined minimum pressure for a predetermined time interval. If the pressure does not fall below the predetermined minimum pressure at the end of the predetermined time interval, the endoscope is deemed not to have breaches that would allow blood to pass into the pressure chamber volume when pressurized with injection pressure. This is a worst-case assessment, as the pressure test examines all breaches, including those too small to allow blood to pass through. The details of the pressure test are determined empirically by evaluating the leak rates and corresponding blood flow characteristics of various breaches.
[0135] 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, e.g., 150 mmHg, as defined above. If the pressure test chamber maintains a pressure above a predetermined minimum pressure, e.g., 40 mmHg, for a predetermined time interval, e.g., 30 seconds, there is no fluid path at insufflation pressure between the environment external to the endoscope and the interior of the pressure test chamber, which is important during surgery. As a result, the pressure test chamber cannot be contaminated during surgery when the endoscope is used at insufflation pressure. In the illumination test, characteristics such as the light transmittance of the light pipe and the number of unbroken illumination fibers are measured.
[0136] In one aspect, the distal disk 1081 ( FIG. 10A ) of the wrist joint assembly 780 is welded to the proximal end of the image capture subassembly 742 after the main tube feeding process 806. Multiple wrist actuation cables are connected to the distal disk 1081. One actuation cable 1082 of the multiple wrist actuation cables is shown in cross section in FIG. 10A . The actuation cable 1082 enters the distal disk 1081 through a through-hole in the proximal end face of the distal disk 1081 and extends into a slot 1081A. A crimp fitting 1083, an example of a cable end fitting, on the distal end of the actuation cable 1082 is positioned within the slot 1081A in the distal disk 1081 of the wrist joint assembly 780. (A cable end fitting is sometimes referred to as a fitting.) The slot 1081A extends proximally from the distal end face of the distal disk 1081 into the distal disk 1081. To block potential leak paths from the distal end of slot 1081A around crimp fitting 1083 and proximally around cable 1082 to the external environment, in this embodiment slot 1081A is filled from the distal end with room temperature vulcanizing silicone to encapsulate crimp fitting 1083 and fill the open volume of slot 1081A.
[0137] In another embodiment, the need to fill slot 1081A and enclose crimp fitting 1083 is eliminated. In this embodiment, distal disc 1081 is divided into two distal discs 1081-1 and 1081-2 of 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 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 wrist joint assembly 780.
[0138] A plurality of wrist actuation cables for the wrist joint assembly 780 are connected to the mated combination of the first distal disc 1081-1 and the second distal disc 1081-2, one actuation cable 1082 of which is shown in cross section in FIG.
[0139] The actuation cable 1082 passes through a through-hole extending from the proximal end face of the second distal disc 1081-2 to the distal face of the second distal disc 1081-2. The actuation cable 1082 extends into the slot 1081B of the first distal disc 1081-1. A crimp fitting 1083 at the distal end of the actuation cable 1082 is positioned in the slot 1081B of the first distal disc 1081-1 of the wrist joint assembly 780. The slot 1081A extends distally from the proximal end face of the first distal disc 1081 into the first distal disc 1081-1.
[0140] The outer peripheral distal end surface 1081-1DS of the first distal disc 1081-1 is welded to the shell of the image capture subassembly 742. The outer peripheral distal end surface 1081-2DS of the second distal disc 1081-2 is welded to the outer peripheral proximal end surface 1081-1PS of the first distal disc 1081-1. Because the first distal disc 1081-1 blocks the leak path to the volume inside the pressure chamber, there is no longer a leak path to the external environment around the crimp fitting 1083 and around the cable 1082. The crimp fitting 1083 is enclosed within the volume created by the connection of the first distal disc 1081-1 to the second distal disc 1081-2, and there is no significant path during surgery between the pressure test chamber and the volume created by the connection of the first distal disc 1081-1 to the second distal disc 1081-2.
[0141] 10B, the articulation assembly includes a first disc 1081-1, a second disc 1081-2, an actuation cable 1082 having a distal end, and a crimp fitting 1083. The actuation cable 1082 passes through the second disc 1081-2, and the crimp fitting 1083 is attached to the distal end of the actuation cable 1082. The crimp fitting 1083 is received within a cavity formed by the connection of the first disc 1081-1 to the second disc 1081-2.
[0142] As used herein, "first," "second," "third," "fourth," etc. are adjectives used to distinguish between different components or elements. Thus, "first," "second," "third," "fourth," etc. are not intended to denote an order of components or elements or a specific number of components or elements.
[0143] The above description and accompanying drawings illustrating aspects and embodiments of the present invention should not be construed as limiting, but rather define the invention protected by the claims. 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.
[0144] Furthermore, the terms of this description are not intended to limit the invention. For example, spatially relative terms such as "lower," "below," "lower side," "upper," "superior," "proximal," "distal," etc. may be used to describe the relationship of one element or feature to other elements or features, as depicted in the figures. These spatially relative terms are intended to encompass various positions (i.e., locations) and orientations (i.e., rotational orientations) of the device during use or operation, in addition to the position and orientation shown in the figures. For example, if the device in the figures is turned over, elements described as "below" or "below" other elements or features would then become "above" or "above" the other elements or features. Thus, the exemplary term "below" can encompass both upper and lower positions and orientations. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein would be interpreted accordingly. Similarly, descriptions of movement along and about various axes encompass various spatial device positions and orientations.
[0145] The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context indicates otherwise. The terms "have," "comprise," "include," and the like specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups. Components that are described as being coupled may be directly coupled electrically or mechanically, or they may be indirectly coupled through one or more intermediate components.
[0146] All examples and illustrative references are non-limiting and should not be used to limit the scope of the claims to the specific implementations and embodiments described herein, and their equivalents. Headings are for formatting purposes only, as text under one heading may cross-reference or apply to text under one or more headings. Finally, in light of this disclosure, a particular feature 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.
[0147] The following additional note is added: (Appendix 1) A housing having a pressure test port; pressure test chambers and; a test port retainer mounted within the housing, the test port retainer coupling the pressure test port to the pressure test chamber, the test port retainer having a test port retainer housing, a probe seal, and a liquid exclusion barrier, the probe seal and the liquid exclusion barrier mounted within the test port retainer housing; A surgical device comprising: (Supplementary Note 2) The test port retainer further comprises: a hydrophobic membrane mounted within the test port retainer housing; 10. The surgical device of claim 1. (Supplementary Note 3) The liquid exclusion barrier is attached between the probe seal and the hydrophobic membrane. 10. The surgical device of claim 2. (Supplementary Note 4) The hydrophobic membrane includes a polyvinylidene fluoride membrane. 4. The surgical device of claim 2 or 3. (Supplementary Note 5) The liquid exclusion barrier includes an X-slit valve. 4. A surgical device according to any one of claims 1 to 3. (Supplementary Note 6) The pressure test chamber comprises: a manifold, the test port retainer being 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; 4. A surgical device according to any one of claims 1 to 3. (Supplementary Note 7) The pressure test chamber further comprises an image capture assembly, wherein: a central tube having a first end, a second end, and an interior volume, the first end secured to the image capture assembly to form a pressure seal, and the second end coupled to the test port retainer such that the pressure test port communicates with the interior volume of the central tube through the test port retainer; 4. A surgical device according to any one of claims 1 to 3. (Supplementary Note 8) The pressure test chamber further comprises an image capture assembly, wherein: a central tube having a first end, a second end, and an interior volume, the first end secured to the image capture assembly to form a pressure seal, and the second end coupled to the manifold such that the pressure test port communicates with the interior volume of the central tube through the manifold; 7. The surgical device of claim 6. (Supplementary Note 9) The imaging device further includes a pressure-sealed electrical cable, the pressure-sealed electrical cable being connected to the image capture assembly and extending through the central tube into the manifold. 9. The surgical device of claim 8. (Supplementary Note 10) The manifold further includes a cable seal, and the pressure-sealed electrical cable extends through the cable seal to the outside of the manifold. 10. The surgical device of claim 9. (Supplementary Note 11) Further comprising an image capture assembly and a pressure-sealed electrical cable, the pressure-sealed electrical cable being connected to the image capture assembly and extending into and out of the manifold. 7. The surgical device of claim 6. (Supplementary Note 12) The pressure-sealed electrical cable comprises: one or more conductors, each of the one or more conductors having an insulating jacket; a first shield surrounding the one or more conductors; a second insulating jacket surrounding the first shield; a first pressure seal formed around and within the first shield within the first insulating jacket; 12. The surgical device of claim 11. (Supplementary Note 13) The pressure-sealed electrical cable comprises: a second shield surrounding the second insulating jacket; a third insulating jacket surrounding the second shield; a second pressure seal formed around and within the second shield and extending between the second insulating jacket and the third insulating jacket; 13. The surgical apparatus of claim 12. (Supplementary Note 14) The pressure-sealed electrical cable has a first end and a second end, the first pressure seal being adjacent to one of the first end and the second end, and the second pressure seal being adjacent to the other of the first end and the second end. 14. The surgical apparatus of claim 13. (Appendix 15) A surgical device having a pressure-sealed electrical cable, the pressure-sealed electrical cable comprising: one or more conductors, each of the one or more conductors having an insulating jacket; a first shield surrounding the one or more conductors; a second insulating jacket surrounding the first shield; a first pressure seal formed in the first shield; Surgical equipment. (Supplementary Note 16) The pressure-sealed electrical cable comprises: a second shield surrounding the second insulating jacket; a third insulating jacket surrounding the second shield; a second pressure seal formed around and within the second shield and extending between the second insulating jacket and the third insulating jacket; 16. The surgical apparatus of claim 15. (Supplementary Note 17) The pressure-sealed electrical cable has a first end and a second end, the first pressure seal being adjacent to one of the first end and the second end, and the second pressure seal being adjacent to the other of the first end and the second end. 17. The surgical device of claim 15 or 16. (Appendix 18) A housing having a pressure test port; manifold and; a test port retainer mounted within the housing, the test port retainer coupling the pressure test port to the manifold, the test port retainer having a test port retainer housing, a probe seal, and a liquid exclusion barrier, the probe seal and the liquid exclusion barrier mounted within the test port retainer housing; An endoscope having (Supplementary Note 19) The test port retainer further comprises: a hydrophobic membrane mounted within the test port retainer housing; 19. The endoscope of claim 18. (Supplementary Note 20) The liquid exclusion barrier is attached between the probe seal and the hydrophobic membrane. 19. The endoscope of claim 18.
Claims
1. 1. A method comprising: assembling a first assembly including a pressure-sealed electrical cable connected to an image capture unit; performing an electrical conductivity test on the first assembly; and assembling a second assembly including the first assembly, a shell, a light pipe, and a lid; the shell has a distal end and a proximal end, the image capture unit is mounted within the shell at the distal end of the shell; the pressure-sealed electrical cable extends proximally through the proximal end of the shell; the light pipe has a distal end, the distal end of the light pipe is mounted within the shell, and the light pipe extends proximally through the proximal end of the shell; the lid is secured to the distal end of the shell; method.
2. further comprising the step of performing a seal verification test on the second assembly. The method of claim 1.
3. The method further includes assembling a central tube assembly, the central tube assembly including the second assembly, a central tube, and a flange, and the step of assembling the central tube assembly includes: attaching the center tube to the flange; threading the pressure-sealed electrical cable and the light pipe through the flange and the center tube; and attaching the flange to the shell; The method of claim 1.
4. further comprising the step of threading the central tube of the central tube assembly through the shaft of a base instrument assembly. The method of claim 3.
5. further comprising passing the pressure sealed electrical cable and the light pipe through a pressure seal. The method of claim 4.
6. installing the pressure seal within a manifold; and further comprising the step of securing the central tube to the manifold. The method of claim 5.
7. performing a pressure test using a port in the manifold; The method of claim 6.
8. 1. A method comprising: assembling an image capture assembly including a pressure-sealed electrical cable connected to an image capture unit, the pressure-sealed electrical cable including a seal sufficient to maintain a threshold pressure and prevent a through path for gas flow within the pressure-sealed electrical cable; assembling a central tube assembly including the image capture assembly and a tube having a lumen, the tube being connected to the image capture assembly by a first pressure-tight seal, the pressure-sealed electrical cable being routed through the lumen of the tube; and assembling a base instrument assembly including a base and the central tube assembly, the base including a manifold and an electrical connector, the tube connected to an opening in the manifold by a second pressure resistant seal, the pressure sealed electrical cable connected to the electrical connector through the opening in the manifold, and a third pressure resistant seal surrounding the pressure sealed electrical cable within the opening in the manifold. method.
9. testing the image capture assembly before assembling the central tube assembly; and further comprising the step of testing the central tube assembly prior to assembling the base instrument assembly. The method of claim 8.
10. performing a seal verification test on the image capture assembly prior to assembling the central tube assembly. The method of claim 8.
11. the image capture assembly further includes a shell, a light pipe, and a lid; the shell has a distal end and a proximal end, the image capture unit is mounted within the shell at the distal end of the shell; the pressure-sealed electrical cable extends proximally through the proximal end of the shell; the light pipe has a distal end, the distal end of the light pipe is mounted within the shell, and the light pipe extends proximally through the proximal end of the shell; the lid is secured to the distal end of the shell; The method of claim 8.
12. and after assembling the central tube assembly, performing a test to determine whether one or more cameras of the image capture unit are operating properly. The method of claim 8.
13. The threshold pressure is the minimum pressure required during pressure testing of an endoscope. The method of claim 8.
14. further comprising connecting an instrument-imaging system cable assembly to the base instrument assembly. The method of claim 8.
15. the manifold includes a second opening that mates with a test port retainer, the test port retainer connecting a pressure test port to the manifold, the method further including performing a pressure test using the pressure test port. The method of claim 8.
16. The steps of performing the pressure test using the pressure test port include: pressurizing the manifold to a predetermined pressure using a probe inserted into the pressure test port; and monitoring the pressure in the manifold for a predetermined period of time; 16. The method of claim 15.
17. the tube is a single continuous tube; The method of claim 8.
18. the base instrument assembly further includes a shaft and an articulation assembly, and assembling the base instrument assembly further includes connecting a distal end of the shaft to a proximal end of the articulation assembly. The method of claim 8.
19. further comprising testing cable friction through the shaft and with the articulation assembly.
20. The method of claim 18.
20. the articulation assembly includes a first disc, a second disc, an actuation cable having a distal end, and a cable end fitting; the distal end of the actuation cable passes through the second disc; the cable end fitting is attached to the distal end of the actuation cable passing through the second disk; the cable end fitting is received within a cavity formed by connecting a peripheral proximal end surface of the first disc to a peripheral distal end surface of the second disc; an outer peripheral distal end surface of the first disk connected to the image capture assembly; 20. The method of claim 18.
Citation Information
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