Instrument seal

Abstract

The present application relates to instrument seals. A medical device can include a septum seal including a septum wall having a portion defining a septum opening, and a plurality of flaps extending over the septum seal toward the septum opening, wherein the flaps define a flap opening overlapping the septum opening.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202211189062.2 entitled "Medical Device Seal", filed on May 8, 2019. Chinese Patent Application No. 202211189062.2 is a divisional application of Chinese Patent Application No. 201980046040.0 (PCT / US2019 / 031393) entitled "Medical Device Seal", filed on May 8, 2019.

[0002] Priority Declaration This application claims the benefit of priority to U.S. Patent Application No. 62 / 671,862, filed May 15, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application generally relates to medical devices, and more specifically, to instrument seals for creating a seal for surgical instruments during surgical procedures. Background Technology

[0004] During surgical procedures, it may be necessary to create a seal between surgical instruments. Maintaining this seal can, for example, allow pressure to be created within the patient's body (e.g., blow-in pressure), which can facilitate the surgical procedure or benefit the patient. Summary of the Invention

[0005] An example medical device seal (“Example 1”) may include: a diaphragm seal having a portion defining a diaphragm opening; and a plurality of flaps extending over the diaphragm seal toward the diaphragm opening, wherein the flaps define flap openings that overlap with the diaphragm opening.

[0006] In Example 2, the medical device of Example 1 can be configured such that the diaphragm seal includes a bellows portion extending around the diaphragm wall.

[0007] In Example 3, the medical device of Example 1 or 2 may also include a slit seal comprising a slit portion and an edge portion.

[0008] In Example 4, any one or any combination of the medical devices in Examples 1-3 may be configured such that the edge portion of the slit seal directly contacts and abuts against the bellows portion of the diaphragm seal.

[0009] In Example 5, the medical device of any or any combination of Examples 1-4 may also include a puck structure to which the plurality of flaps and the diaphragm seal are coupled.

[0010] In Example 6, any one or any combination of the medical devices in Examples 1-5 may be configured such that the flexure of the bellows portion allows the disc structure, the wing, and the diaphragm opening to move to accommodate the movement of an instrument inserted through the wing and the diaphragm opening.

[0011] In Example 7, any one or any combination of the medical devices in Examples 1-6 may be configured such that the disk structure includes a first disk part and a second disk part, the first disk part having a protrusion extending through a second opening in the diaphragm seal and engaging the second disk part to connect the first disk part to the second disk part and the diaphragm seal.

[0012] In Example 8, any one or any combination of the medical devices in Examples 1-7 may be configured such that the diaphragm seal includes a reinforcing structure surrounding the second opening.

[0013] In Example 9, any one or any combination of the medical devices in Examples 1-8 may be configured such that the disk structure includes a lubrication channel extending from the top surface of the disk structure into the space between the plurality of vanes and the diaphragm wall.

[0014] In Example 10, any one or any combination of the medical devices in Examples 1-9 may be configured such that the diaphragm seal includes a retaining structure that engages the disk structure to restrain movement of the diaphragm wall relative to the disk structure.

[0015] In Example 11, the medical device of any or any combination of Examples 1-10 may further include a housing, wherein the diaphragm seal, slit seal and disc structure are located within the housing.

[0016] In Example 12, any one or any combination of medical devices from Examples 1-11 may be configured such that the housing includes an upper housing part and a lower housing part coupled to the upper housing part.

[0017] In Example 13, the medical device of any one or any combination of Examples 1-12 may further include a cover between the bellows portion and the housing, wherein the cover inhibits the expansion of the bellows portion in response to pressure changes.

[0018] In Example 14, any one or any combination of the medical devices in Examples 1-13 may be configured such that the housing includes a guide portion whose size and shape are set to guide an instrument toward the septum opening, wherein the guide portion extends beyond the cover.

[0019] In Example 15, any one or any combination of the medical devices in Examples 1-14 may be configured such that the slit seal includes a retaining structure that engages the housing to restrain movement of the slit seal.

[0020] In Example 16, the medical device of any or any combination of Examples 1-15 may further include a cannula having a proximal portion and a distal portion of a predetermined size, and an elongated body extending between the proximal and distal portions, the proximal portion being shaped to receive the housing, wherein the housing is inserted into the proximal portion of the cannula.

[0021] In Example 17, any one or any combination of medical devices from Examples 1-16 may be configured such that the cannula includes a cannula bowl and the housing is located within the cannula bowl, the cannula bowl extending beyond the most distal portion of the housing.

[0022] In Example 18, any or any combination of medical devices from Examples 1-17 may be configured such that the most distal portion of the housing enters less than three-quarters of the path of the cannula bowl.

[0023] In Example 19, any or any combination of medical devices from Examples 1-18 may be configured such that the housing includes a guiding surface whose size and shape are set to guide an object into the housing.

[0024] In Example 20, the medical device of any or any combination of Examples 1-19 may further include a disc structure, wherein the disc structure, the diaphragm seal, the plurality of flaps, the slit seal, and the lower housing component are coupled together.

[0025] In Example 21, any one or any combination of medical devices from Examples 1-20 may be configured such that the slit seal is adhered to the lower housing part and the diaphragm seal.

[0026] In Example 22, any or any combination of the medical devices in Examples 1-21 may be configured such that the disc structure, the diaphragm seal, the plurality of flaps, the slit seal, and the lower housing part are set as disposable parts, while the upper housing part is reusable.

[0027] In Example 23, any one or any combination of medical devices from Examples 1-22 can be configured such that the size and shape of the lower housing part are set to abut against the cannula for a seal.

[0028] In Example 24, any one or any combination of the medical devices in Examples 1-23 may be configured such that the lower housing part is made of rubber.

[0029] In Example 25, any one or any combination of medical devices from Examples 1-24 can be configured such that the upper housing part is removably attached to the lower housing part.

[0030] In Example 26, any one or any combination of the medical devices in Examples 1-25 may be configured to allow the upper housing part to be removed from the lower housing part by manually squeezing the upper housing part.

[0031] In Example 27, any one or any combination of the medical devices in Examples 1-26 may be configured such that the upper housing part is elliptical and that squeezing an elongated portion of the upper housing part releases the upper housing part from the lower housing part.

[0032] Each of these non-restrictive examples may exist independently or may be combined with one or more other examples in various permutations or combinations.

[0033] This summary is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. Detailed descriptions are included to provide more information about this patent application. Attached Figure Description

[0034] In the accompanying drawings, which may not be drawn to scale, the same numbers may describe similar parts in different views. The same numbers with different letter suffixes may represent different instances of similar parts. The accompanying drawings illustrate, by way of example and not limitation, the various embodiments discussed in this document.

[0035] Figure 1A This is a floor plan illustration of an example medical system, which may include a user control system, an auxiliary system, and a control system.

[0036] Figure 1B This is a diagram of an example operating system.

[0037] Figure 1C This is a diagram of an example user control system.

[0038] Figure 1D This is a diagram of an example auxiliary system.

[0039] Figure 2A This is a diagram of a device seal.

[0040] Figure 2B yes Figure 2A The top view of the instrument seal shown.

[0041] Figure 2C yes Figure 2A-2B The diagram shown is an exploded view of the instrument seal.

[0042] Figure 2D This is an exploded view of the disk assembly.

[0043] Figure 2E This is the bottom view of the upper disc part.

[0044] Figure 2F This is a bottom view of the diaphragm seal.

[0045] Figure 2G This is an enlarged view of the bottom of the diaphragm seal.

[0046] Figure 2H This is a diagram of the instrument seal on the cannula.

[0047] Figure 3A yes Figure 2A-2B The cross-sectional view of the instrument seal shown.

[0048] Figure 3B yes Figure 2A-2B The cross-sectional view of the instrument seal shown.

[0049] Figure 3C yes Figure 2A-2B The cross-sectional view of the instrument seal shown.

[0050] Figure 3D yes Figure 2A-2B The cross-sectional view of the instrument seal shown.

[0051] Figure 3E yes Figure 2A-2B The diagram shows a cross-sectional view of the instrument seal being engaged with the cannula.

[0052] Figure 4A This is a perspective view of an example seal.

[0053] Figure 4B This is a bottom view of the example sealing cap.

[0054] Figure 4C yes Figure 4B The perspective view of the sealing cap shown.

[0055] Figure 4D yes Figure 4A An exploded perspective view of the example seal and the cannula that can be used with the seal.

[0056] Figure 4E This is an exploded view of an example seal.

[0057] Figure 4F yes Figure 4A The seal shown is engaged with the cross-section of the cannula.

[0058] Figure 5AThis is a perspective view of an example seal and cannula.

[0059] Figure 5B yes Figure 5A The cross-sectional view of the seal and the insertion tube is shown. Detailed Implementation

[0060] Overview Medical devices (e.g., sealing assemblies) may include a diaphragm seal and multiple flaps extending above the diaphragm seal. The flaps protect the diaphragm seal from puncture or damage when an instrument or other object is inserted through the seal. The flaps may come together to define an opening that overlaps with an opening in the diaphragm seal. For ease of assembly, the flaps may be separate pieces that can be attached to the diaphragm seal.

[0061] Medical devices may also include a bellows structure to which a diaphragm seal and vanes can be attached. The bellows allows lateral movement of the diaphragm and vanes via flexure of corrugated regions within the bellows. In some examples, the bellows may be connected to the diaphragm seal. For instance, the bellows and diaphragm seal may be parts of a single component.

[0062] Medical devices may also include slit seals, such as cross-shaped slit seals. In some examples, the slit seal may be in direct contact with the diaphragm seal, which facilitates an effective seal of the device.

[0063] Medical devices may include disc components that facilitate assembly. For example, a vane may be coupled to a top disc component, and a bottom disc component may engage (e.g., extend through) a diaphragm seal and be coupled to the top disc component to form a disc assembly including a vane, a bellows, a diaphragm seal, and the top and bottom disc components. One or more retaining structures (e.g., anchor rings) on the diaphragm seal or slit seal may engage the top or bottom disc component to retain relative movement of the components. The top or bottom disc component may include lubrication channels that may, for example, allow lubricant to be applied to the surface of the diaphragm seal.

[0064] Medical devices may include, or be contained within, a housing. The housing may include, for example, an upper housing and a lower housing, which are joined together to contain seals and other components within the housing. In some examples, a cover may be positioned between the bellows and the upper housing to prevent movement (e.g., expansion) of the bellows through inlet holes or other openings in the housing.

[0065] The example medical device can be used with a remotely operated robotic surgical system. For example, the medical device described herein can be an instrument seal for use with a cannula that can be attached to the patient at the surgical entry site. Instruments, which can be manually operated or controlled using a remotely operated robotic surgical system, can be inserted through the diaphragm seal and slit seal into the patient for surgical procedures. When an instrument is inserted through the medical device, the diaphragm seal seals against the instrument shaft. When no instrument is inserted, the slit seal seals against itself, which maintains the blow-in pressure within the patient.

[0066] Example System Figure 1A This is a floor plan illustration of an example medical surgical environment in which the medical devices described herein can be used. The environment may include a multi-arm manipulation system 100 adjacent to an operating table 101 that can support a patient 103.

[0067] The manipulation system 100 may be part of a larger system 10, which may include other subsystems. For example, the manipulation system 100 may be operatively coupled to a user control system 150 or an assistive system 175, or both. The user control system 150 may include one or more user input devices (e.g., controls) configured to receive input from a user (e.g., a clinician). The user control system 150 may also include one or more user feedback devices (e.g., a viewing system or haptic or auditory feedback) configured to provide the user with information about the movement or position of the end effector or an image of the surgical area. The assistive system 175 may include, for example, processing devices (e.g., processor circuitry or graphics hardware) or communication devices (e.g., wired or wireless communication circuitry).

[0068] Figure 1B This is an illustration of an example manipulation system 100. The manipulation system 100 may include a base 102, a support tower 104, and one or more manipulator arms 110, 111, 112, 113 that can be mounted on the support tower. An instrument 130 may be mounted on an instrument mount 120 on one of the manipulator arms. The instrument mount 120 may, for example, include an instrument mount carriage 122, which can be mounted to a rod 124, which may be a telescopic rod. A cannula may be mounted to a cannula mount 126, and the instrument 130 can be inserted through a cannula seal and into the patient 103 for surgical or other medical procedures. The orientation of the instrument can be controlled in multiple dimensions by movement of the manipulator arms, such as lateral movement, horizontal movement, vertical movement, and angular movement in one, two, or three planes.

[0069] Figure 1CThis is an illustration of an example user control system 150. The user control system 150 may include manual controls 155, 156 and pedal controls 160, 161, 162. The manual controls 155, 156 and pedal controls 160, 161, 162 can be used to control devices at the manipulation system 100. For example, instrument controls can be used to manipulate a portion of the distal end of an instrument 130. The controls may include tactile feedback features, allowing a physician to interpret physical information (such as resistance or vibration) through the controls. The user control system 150 may also include a viewing system 165 that can display video or other images of the surgical site.

[0070] Figure 1D An example assistive system 175 is shown. Assistive system 175 may include a processing device 180 for handling controls, thereby facilitating communication between the user control system and the operating system or remote site. Assistive system 175 may also include a display 190 that can display images seen by a user (e.g., a clinician) on the user control system, video feeds from cameras inside the patient's body, or other information. In the example configuration, signals input at the user control system 150 may be transmitted to the device 180 on the assistive system, which can interpret the input and generate commands that are transmitted to the operating system 100 to induce manipulation of a portion of the manipulator arm 110 or the instrument 130. The device 180 is shown as being on a trolley for illustrative purposes, but may also be arranged in various configurations; for example, it may be integrated as part of the user control system, the operating system, or both, or it may be separate from the user control system and the operating system. The device may also be provided as software, hardware, or both on an installed or remote system.

[0071] Figures 2A to 2H and Figures 3A to 3E An example instrument seal 200 is shown. Seal 200 may include a plurality of flaps 202, 204, 206, 208, which may be stacked on top of each other and joined together to form a flap opening 210. The flaps may be formed, for example, of polyurethane (e.g., polyurethane with a hardness of 90), which provides the desired durability or flexibility properties. The flaps may be positioned on a diaphragm seal 212. Diaphragm seal 212 may be made of polyisoprene (e.g., polyisoprene with a hardness of 43). The flaps may be joined together to form opening 210, which is slightly larger than opening 217 in the diaphragm seal. The flap opening 210 may be, for example, polygonal (e.g., square), or circular (e.g., circular or oval), or irregular. The flap opening may advantageously be symmetrical about the instrument insertion axis to provide consistent friction or consistent performance. The instrument shaft may be inserted through the flaps and through the diaphragm seal 212. When an instrument is inserted through the diaphragm seal, flaps 202, 204, 206, and 208 protect the diaphragm seal from being punctured or damaged by the instrument.

[0072] The diaphragm seal 212 is stretchable to accommodate an instrument shaft larger than the opening 214 in the diaphragm seal 212. During insertion, the flaps can rotate distally to accommodate the instrument shaft. During retraction, the flaps provide structural support to prevent excessive proximal movement or inversion of the diaphragm seal, which could result in undesirable frictional characteristics or uncoordinated movement. Consistent frictional forces are expected during retraction (or insertion) to facilitate manual (e.g., by a clinician) movement of the instrument shaft or movement by a remotely operated surgical system. Excessive or inconsistent frictional forces can cause confusion as to whether the instrument or attached object has become hooked or entangled on another object (which may need to be resolved before retraction) or whether the frictional forces are due to variations in seal friction.

[0073] The example shown includes four blades. Other examples may include more blades (e.g., five, six, seven, or more blades) or fewer blades (e.g., three blades). Increasing the number of blades reduces the size of the gap between the cylindrical instrument shaft and the profile of the opening formed by the blades, but increases the friction between the instrument shaft and the blades. Reducing the number of blades (e.g., using three blades instead of four) increases the size of the gap between the blades and the cylindrical instrument shaft inserted through the blades.

[0074] Figure 2C This is an exploded view of seal 200. The seal may include upper housing part 216, latch 218, and disk assembly 220 (in...). Figure 2D The upper housing part 216 (shown as a disassembled portion), slit seal 222 (e.g., a cross slit seal), lower housing part 224, and stopcock valve 226 are all stackable together to form seal 200. For example, ultrasonic welding can be used to join the upper housing part 216 to the lower housing part 224. The stopcock valve 226 can be used to control the flow rate of blown gas into the lower housing part 224.

[0075] Figure 2D This is an exploded view of disk assembly 220. Disk assembly 220 may include a disk structure comprising an upper disk part 228 and a lower disk part 230, which may be joined together using one or more retaining features (e.g., pins), as further described below. The disk structure may be circular (e.g., round or oval), polygonal (e.g., triangular, square, or pentagonal), or irregular. Disk assembly 220 may also include flaps 202, 204, 206, 208 and a diaphragm seal 212. Figure 3B As shown, when the disc assembly is assembled with other parts of the seal 200, the upper surface 223 of the upper disc part 228 can engage with the cover portion 324 of the latch 218 (as shown). Figure 3B(As shown) adjacent (e.g., touching or next to) or spaced apart, and the lower surface 225 of the lower disc part 230 (in) Figure 3B The center mark (marked) may be adjacent to or spaced apart from the edge portion 268 of the slit seal.

[0076] like Figure 2D As shown, the flap 202 (or any or all of the flaps) may include a flange portion 232 and a flap portion 234 extending distally and centrally (towards the instrument insertion axis). The flap portion 234 may be connected to the flange portion by a flexure portion 233, which may bend or flex to allow downward movement of the flap portion 234, for example, when an instrument is inserted through the seal 200. The flap portion 234 may be shaped (e.g., cup-shaped) such that the flaps are assembled together to form a 3-D curved surface. For example, flap side portions 236, 238 may be bent upward (proximally) from the central portion 240 of the flap. The flap may also include one or more openings 242 for attaching the flap to another component. The openings 242 may be in the flange portion 232 of the flap. In some examples, the seal 200 may include a plurality of flaps (e.g., three, four, five or more), each flap configured with one or more openings and shaped flap portions. The plurality of flaps may be identical or may be different from each other.

[0077] The diaphragm seal 212 may include a diaphragm portion 243 comprising a diaphragm wall 244 defining an opening 246 that seals against an instrument shaft inserted through the opening 246. The diaphragm seal 212 may also include an edge portion 248. The diaphragm wall 244 may extend distally from the edge portion 248 (e.g., forming a frustum) to the opening 246 to guide the instrument toward the opening. The diaphragm seal 212 may also include a bellows portion 250, which may include a plurality of corrugated walls 252, 254, 256, 258. The bellows portion may allow edge-to-edge movement of the disc assembly 220 (e.g., perpendicular to the instrument insertion axis), which may protect the diaphragm portion 243 of the diaphragm seal 212 when the instrument is manipulated in the cannula, or allow a greater range of motion or easier movement of the instrument shaft performed by a clinician or a clinician-controlled remote surgical system.

[0078] Edge portion 248 may include one or more openings 260 that may be surrounded by reinforcing structure 261 (e.g., ring), such as Figure 2F and Figure 2G As shown. The lower disc component 230 may include one or more protrusions 262, the size and shape of which may be configured to extend through an opening 260 in the diaphragm seal and into a corresponding opening 265 in the receiving portion 264 of the upper disc component 228. Figure 2E(As shown). The size and shape of the opening 265 can be configured to provide a press fit, snap fit, or ultrasonic welding with the protrusion 262 to hold the upper disc part, one or more fins, diaphragm seal 212, and lower disc part 230 together. In some examples, the lower disc part 230 may have multiple pairs of protrusions 262 (e.g., pins), each pair of protrusions 262 being sized and shaped to extend through a corresponding opening 260 in the diaphragm seal 212 into a receiving portion 264 on the upper disc part 228 (e.g., as shown). Figure 3D (As shown). The reinforcing structure 261 on the diaphragm seal 212 can provide local structural support at a location surrounding the protrusion 262. In an alternative configuration, the upper disk part 228 may include the protrusion, and the lower disk part 230 may include a receiving portion configured to receive the protrusion, or both the upper disk part 228 and the lower disk part 230 may include a protrusion and a receiving portion aligned with a protrusion on the other disk part to join the disk parts together.

[0079] Constructing a disk assembly from a diaphragm seal 212 with a connecting bellows portion 250, flaps 202, 204, 206, 208, and upper and lower disk parts advantageously provides a simple assembly procedure and a simple overall disk assembly architecture. For example, forming the diaphragm portion 243 and the bellows portion 250 as a single part avoids the need to align the diaphragm portion and the bellows portion (which would be necessary if they were separate parts). The assembly process is also advantageously simple. For example, the diaphragm seal 212 can be assembled onto the lower disk part 230, wherein a protrusion 262 (e.g., a pin) extends through an opening 260 in the diaphragm seal 212. Flaps 202, 204, 206, 208 can be assembled onto a protrusion 267 on the underside of the upper disk part 228. Figure 2E As shown in the diagram, a protrusion 267 extends through an opening 242 in the wing. The wing may optionally be held by a retainer part, such as a clip (not shown), a portion of which extends into a hole 269 in the protrusion 267. As previously described, the upper disk part 228 is coupled to the lower disk part 230 by inserting the protrusion 262 into a hole in the receiving portion 264 of the upper disk part 228. This holds the upper disk part 228, the lower disk part 230, the winglets 202, 204, 206, 208, and the diaphragm seal 212 together to form the disk assembly 220.

[0080] like Figure 2C and Figure 3AAs shown in Figure D, the disc assembly 220 can be assembled on top of the slit seal 222. The slit seal 222 may include a sealing portion 266 and an edge portion 268. The sealing portion may be, for example, a cross-shaped slit seal, a single-slit seal, or a triple-slit seal. The slit seal may include folded sidewalls that come together to form a slit.

[0081] In some examples, the diaphragm seal 212 may directly contact the slit seal 222. For example, the bellows portion 250 of the diaphragm seal 212 may reliably rest on the edge portion 268 of the slit seal. Seal-to-seal contact creates a seal to prevent leakage. Direct seal-to-seal contact can be advantageous for sealing, for example, because seal-to-seal contact (e.g., rubber (polyisoprene) to rubber contact) provides a better seal than if another part (e.g., plastic or polycarbonate) were between the seals. The size and shape of the diaphragm seal 212 may be configured to fit over the slit seal 222. The slit seal 222 may include an outer lip 282 that reliably rests on an outer lip 284 of the diaphragm seal (e.g., ...). Figure 3C (As shown).

[0082] The seal 200 can be assembled onto the cannula 290, such as Figure 2H As shown. The cannula 290 can be connected to the seal via latch 218. The seal 200 can be used with a non-intercepting cannula (e.g., Figure 2H (as shown), or alternatively with a dockable cannula (e.g., Figure 4D The cannula 406 shown may include blades 408 for docking the cannula to a portion of a remotely operated surgical system.

[0083] Figure 3A yes Figure 2B The cross-sectional view of seal 200 at section AA is shown. Diaphragm seal 212 may optionally include an upper retaining structure (e.g., ring) 270, the size and shape of which may be configured to extend into a corresponding groove 272 on upper disc part 228. Diaphragm seal 212 may additionally or alternatively include a lower retaining structure (e.g., ring) 274, which may extend into a groove 276 on lower disc part 230. Slit seal 222 may have a portion defining a receiving space (e.g., groove) 278 that receives a protrusion 280 on lower housing part 224. When an object is inserted into or withdrawn through diaphragm seal 212, the upper retaining structure 270 or the lower retaining protrusion 274 prevents diaphragm seal 212 from shifting toward the center of seal 200.

[0084] Figure 3BThis is a cross-sectional view of the seal 200 at section BB, shown as having an instrument shaft 301 inserted along the insertion axis 351 through the flaps and diaphragm seal 212. The flaps 202, 206, 208 are pivotable downwards (distally) to make room for the instrument shaft 301. The opening 214 in the diaphragm seal 212 is stretchable to accommodate the instrument shaft. The upper housing part 216 may include an instrument guide portion 302, the size and shape of which may be configured to guide the instrument to the opening 214 in the diaphragm seal. The instrument guide portion 302 may extend distally beyond the latch 218, which helps prevent the instrument from getting caught in the gap between the disc assembly 220 and the latch 218. In some examples, the instrument guide portion 302 may include an introduction channel 303, such as... Figure 3B As shown. In some examples, the instrument guide portion 302 may optionally contact the upper disk part 228 at the upper engagement surface 305.

[0085] Figure 3C This is a cross-sectional view of seal 200 at section CC. Seal 200 may include a lubrication path 304 through one or more components. For example, upper disk component 228 may have a passage 306 that may include an upper opening 308 at the top of the upper disk component and a lower opening 310 in a space 314 between the diaphragm portion 343 of the connecting vanes and diaphragm seal 212. Lubricant may be injected into the upper opening 308 and may travel through the passage 312 in the upper disk component to the lower opening 308 and into the space 314 between the vanes 202, 204, 206, 208 and the diaphragm wall 244. Placing the lubricant below the vanes helps to prevent contamination of optical components (e.g., lenses) of camera instruments inserted through the seal. In some examples, lubricant may be injected into disk assembly 220 before the latch 218 and upper housing component 216 are assembled on top of disk assembly 220. The disk assembly may include a lubrication path 304 through upper disk component 228 (e.g., Figure 2D Multiple lubrication paths 304 with multiple openings in the diaphragm seal (as shown) are used to distribute lubricant to different locations on top of the diaphragm portion 243 of the diaphragm seal (e.g., to cover most or all of the diaphragm portion with lubricant).

[0086] The edge portion 268 of the slit seal 222 may include one or more retaining structures 316 (e.g., protrusions, such as annular rings) sized and shaped to engage with the lower housing part 224. For example, the retaining structure 316 may extend downward (distally) from the bottom side 318 of the edge portion and into a receiving space 320 (e.g., a recess) on the lower housing part 224. The receiving space 320 may be defined by a protrusion 278 and a second protrusion 322 on the lower housing part. The protrusion 316 may be a continuous ring or may be segmented (e.g., including gaps in the ring) to accommodate a blow-in channel 317 (…). Figure 3A(As shown). When an object or instrument is inserted or withdrawn through the slit seal 222, the protrusion 316 prevents the slit seal 222 from sliding toward the center of the seal.

[0087] like Figures 3A-3C As shown, a cover portion 324, which may be connected to or is part of latch 218, may extend above the top of the bellows portion 250 of the diaphragm seal. The cover portion 324 of the latch may suppress expansion or deformation of the bellows portion 250 in response to sudden pressure changes, such as when an object is inserted through the diaphragm. The cover portion 324 may include a cutout portion 326 that may align with an opening 328 in the upper housing part. The size and shape of the opening 328 may be configured to latch with another device. The presence of the cover portion 324 between the bellows portion 250 and the upper housing part 215 may provide additional space (e.g., a gap) for a latching part (not shown) inserted through the opening.

[0088] Figure 3E A seal 200 is shown assembled with a cannula 290, the cannula having a proximal portion 397 sized and shaped to engage with the seal 200 and a distal portion 299 sized and shaped to attach to the patient for delivery of surgical instruments. Figure 2H (As shown). The lower housing part 224 may extend into the cannula cup 396 at the proximal portion 397 of the cannula 290. In some examples, for example, due to manufacturing tolerances and the need to assemble the lower housing part within the cannula, a small gap may exist between the lower housing part 224 and the inner wall 330 of the cannula 290. The cannula cup 396 may extend beyond the lower housing part 224; for example, the lower housing part 224 and the diaphragm may not extend to the bottom 394 of the cannula cup 396. For example, the lower housing may extend to less than three-quarters (75%) of the path into the cannula cup, or to less than half (50%) of the path into the cannula cup. To facilitate the extraction of an object (e.g., an instrument) into the sealing portion 266 of the lower housing part 224 and the slit seal 222, the distal portion 332 of the lower housing part 224 may include an extraction guide surface 334, the size and shape of which may be configured (e.g., at an angle to the insertion axis 351) to guide the instrument or other object into the cavity 336 of the lower housing part or toward the sealing portion 266 of the slit seal.

[0089] A seal (e.g., an O-ring) 338 may form a seal between the lower housing part 224 and the cannula 290. In some examples, the lower housing part 224 may include a channel 340 extending around an outer surface 342 of the lower housing part 224, and an O-ring (or other seal) may extend radially outward beyond the outer surface 342 within this channel, such that the inner wall 330 of the cannula 290 abuts against the O-ring 338 for sealing. In some examples, the O-ring 338 may hold the lower housing part 224 within the cannula 290.

[0090] In some examples, latch 218 may also hold seal 200 to cannula 290. For example, the lower portion 344 of latch 218 may be sized and shaped to engage engagement features (e.g., a lip) on cannula 290. In some examples, latch may be spaced apart from lip (as shown) to prevent seal 200 from separating from cannula 290 if lower housing parts slide upward within cannula 290. In some examples, the lower portion 344 of latch may be formed as a hook to reach below and engage the lower side 348 of engagement feature. Latch may include an inwardly extending protrusion 350 that prevents movement of the outer wall 258 of bellows portion 250 from the side of cannula.

[0091] Figure 4A Another example seal 400 is shown. Seal 400 may include a reusable cap 402 and a disposable bottom portion 404. In some examples, seal 400 may be designed as a low-cost seal. Seal 400 may not include a blow-in air passage and a stop valve (such as...). Figure 4A (As shown), this can reduce costs, or the seal 400 may optionally include an inlet air passage and a stop valve, for example in Figure 2A As shown in -C.

[0092] Figure 4D yes Figure 4A The example seal 400 and the cannula 406 that can be used with the seal 400 are shown in an exploded perspective view. The cap 402 can be assembled onto the bottom portion 404, and the assembled seal 400 can be coupled to the cannula 406, for example, as shown... Figure 4F As shown.

[0093] like Figure 4B and Figure 4CAs shown, the cover 402 may have an elliptical or rectangular shape with a long dimension (e.g., along the long axis 403) and a short dimension (e.g., along the short axis 405), which allows for assembly and disassembly with the bottom portion 404 by pressing along the long axis (longer dimension) of the cover. The cover may include a top portion 414, one or more side portions 416, and one or more ridges 418 on the inner surface 420 of the side portions. The ridges 418 may have a tapered height decreasing toward the short axis 405. The ridges may engage the bottom portion 404 (e.g., ...). Figure 4F One or more engagement features 422 (e.g., grooves or lips) on the cap (as shown). The cap is pressed along its long axis (e.g., Figure 4A The arrow (as indicated in the diagram) can cause the ridge 418 to move outward (as indicated by the arrow), which allows the ridge to engage or disengage with the engagement feature 422 on the seal. In this way, the cap 402 can be assembled with the bottom portion 404 and removed from the seal after use, so that the bottom portion 404 can be discarded or recycled, while the cap 402 can be retained and reused (e.g., sterilized and attached to a new seal for another procedure).

[0094] Figure 4E This is an exploded view of the bottom portion 404 of an example seal 400. Figure 4F This is a cross-section of the assembled seal 400 connected to the cannula 406. The bottom portion 404 may include a sealing portion 410 and a cannula mounting base 412. In some examples, the sealing portion 410 and the cannula mounting base 412 may be coupled together (e.g., by adhesive, snap-fit, screw-on, or assembled via a connector) and may be provided as a single, integral part, which may be provided under aseptic conditions (e.g., sterilized and bagged or packaged). The size and shape of the cannula mounting base 412 may be configured to engage (mount) onto the upper portion of the cannula 406. In some examples, the cannula mounting base may be made of rubber.

[0095] The sealing portion 410 may include multiple vanes 424, 426, 428, a diaphragm seal 440, an upper disc 432, and a lower disc 434. Figure 4F (as shown) and slit seal 458. The sealing portion 410 may also include a protrusion 446 (e.g., an annular ring) that engages with an engagement feature 448 (e.g., a groove) in the lower disc 434 (e.g., as described above with reference to the components forming the disc assembly 220) to hold the parts together and prevent slippage of the diaphragm portion 442 relative to the upper disc part 432 and the lower disc part 434 when an instrument is inserted through the opening 438 in the diaphragm portion 442 of the diaphragm seal 440. The bellows 436 may allow lateral movement of the diaphragm portion 442 and the upper disc part 432 and the lower disc part 434 (e.g., perpendicular to the insertion axis 401), which may protect the diaphragm portion of the seal or allow the instrument shaft inserted through the seal ( Figure 4F (not shown) easier movement or a greater range of motion. In some examples, the sealing portion 410 may be or include as described above and... Figure 2A The disk assembly 220 and diaphragm seal 212 are shown in the figure.

[0096] The cannula mounting base 412 may include an engagement feature 422, which may be a recess (as shown) or a lip or other structure. The size and shape of the engagement feature 422 may be configured to engage with a ridge 418 on the interior of the cap 402. The engagement feature 422 may extend all the way around the cannula mounting base 412 and may have a uniform height, or the engagement feature 422 may be segmented or tapered; for example, the size and shape of the engagement feature may be similar to a segmented tapered ridge 418 on the underside of the cap. Figure 4A As shown, squeezing the cap 402 causes the side portion to move outward, thereby disengaging (or reducing) the engagement of the ridge 418 with the engagement feature 422 and thus allowing the cap 402 to be removed from the seal. Alternatively, the cannula mount 412 may be squeezed inward (towards the insertion axis 401) to move the engagement feature 422 away from the cap 402. In some examples, it may be necessary to both squeeze the cap 402 and move the cannula mount 412 inward to release the cap 402 from the bottom portion 404. In some examples, mounting the cannula mount 412 onto the cannula 406 prevents full squeezing of the cannula mount 412 toward the insertion axis, which prevents the cap 402 from being removed from the bottom portion 404 when the seal 400 is mounted onto the cannula 406.

[0097] like Figure 4F As shown, the cannula mounting base 412 may include a cannula engagement feature 450 (e.g., a lip and a groove) whose size and shape are designed to engage with an engagement feature 452 (e.g., a lip) on the cannula 406. In some examples, the size and shape of the engagement feature 450 may be set to seal against the cannula 406, which eliminates the need for an O-ring seal (as opposed to...). Figure 3E (Compared to the example shown). For example, the bottom portion 454 of the engagement feature 452 may extend around and below the engagement feature 452 on the cannula to hold the cannula 406 and press the cannula into the upper portion 456 of the engagement feature 452, for example, such that several surfaces of the cannula mount 412 abut against the cannula 406 to seal. The cannula mount 412 may be formed of polyisoprene or another rubber or flexible plastic material. Forming the cannula mount 412 of rubber may provide advantages for sealing against the cannula 406 or for removable engagement with the cap 402.

[0098] Figures 5A to 5BAnother example seal 500 is shown, which may include a slit seal 502 comprising a cannula engagement feature 504 whose size and shape are configured to engage and seal against a cannula 506. In some examples, the engagement feature 504 may be wrapped around a lip 507 on the cannula 506, similar to that described above. Figure 4F The engagement feature 450 is shown in the figure. The slit seal 502 may include a receiving space 524, the size and shape of which are configured to receive a disk assembly 508, which may be... Figure 2C The disc assembly 220 is shown and described above. The slit seal 502 may be formed, for example, from polyisoprene or another rubber.

[0099] The disc assembly 508 may include a diaphragm seal 526, which may have abutment against the instrument shaft (in Figures 5A-5B (Not shown in the image) A sealed opening 528. The disk assembly may also include a plurality of blades 512, 514, 516, 518, each of which may include a blade portion, a flexural portion, and a flange portion having an opening, as shown in reference. Figure 2D The winglet is illustrated. The disk assembly may also include an upper disk part 520 and a lower disk part 522. As described above and as... Figure 3D As shown, the lower disk component 522 may include a protrusion that extends through openings in the flaps 512, 514, 516, 518 and the diaphragm seal 526 and into a corresponding receiving portion in the upper disk (or vice versa, or a combination of protrusions and receiving portions may be used between the upper and lower disks).

[0100] In various examples, the slit seal 502 may be stretched to receive the disk assembly 508 into the receiving space 524, and the disk assembly 508 may be held in place by the compressive force applied by the slit seal 502 (e.g., the disk assembly may be designed to provide an interference fit with the receiving space 524), or holding features on the slit seal (e.g., a lip engaging a recess or another lip) may retain the disk assembly 508 in the receiving space 524, or a cover (in...) Figures 5A-5B Not shown, optionally configured as Figure 4A The cover 402 can be placed above the disc, or the disc can be left unsecured (e.g., in a non-pressurized system). The seal 500 is desirable due to its low cost or simpler assembly, or because it uses fewer parts while still providing the desired sealing and performance characteristics.

[0101] Those skilled in the art will understand that any of the features described above can be combined with any of the features in the other example features, provided that these features are not mutually exclusive. All possible combinations of features may be considered depending on clinical or other design requirements. Furthermore, if the manipulation system units are combined into a single system (e.g., a remote surgical system), each individual unit may have the same feature configuration, or one manipulation system may have one feature configuration while another manipulation system may have a second, different feature configuration.

[0102] The examples described herein (e.g., methods, systems, or devices) are applicable to surgical procedures, non-surgical medical procedures, diagnostic procedures, cosmetic procedures, and non-medical procedures or applications. These examples can also be applied to training or acquiring information, such as imaging procedures. Examples can be applied to the handling of tissue that has been removed from human or animal anatomy and will not regenerate in an adult or animal, or for use with human or animal cadavers. These examples can be used in industrial applications, general robotic purposes, manipulation of non-tissue workpieces (as part of an artificial intelligence system), or in transportation systems.

[0103] The above detailed description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples that provide only those elements shown or described. Furthermore, the inventors contemplate examples using any combination or arrangement of those elements (or one or more aspects thereof) shown and described relative to a particular example (or one or more aspects thereof) or relative to other examples (or one or more aspects thereof) shown or described herein.

[0104] In the event of any inconsistency between the usage of this document and any other document incorporated by reference, the usage in this document shall prevail.

[0105] In this document, as is common in patent documents, the terms “a” or “an” are used to include one or more of them, independent of any other use of “at least one” or “one or more.” In this document, unless otherwise stated, the term “or” is used to indicate non-exclusivity or to make “A or B” include “A but not B,” “B but not A,” and “A and B.” In this document, the terms “including” and “in which” are used as common English equivalents to the corresponding terms “comprising” and “wherein.” Similarly, in the following claims, the terms “comprising” and “including” are open-ended, meaning that a system, device, article, composition, formulation, or process that includes elements other than those listed after the term in the claim is still considered to be within the scope of that claim. Furthermore, in the appended claims, the terms “first,” “second,” and “third,” etc., are used merely as labels and are not intended to impose numerical requirements on their objects.

[0106] Unless the context otherwise indicates, geometric terms such as “parallel,” “perpendicular,” “circular,” or “square” are not intended to demand absolute mathematical precision. Rather, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “circular” or “generally circular,” the description still includes parts that are not precisely circular (e.g., slightly elliptical or polygonal parts). A coordinate system or frame of reference is provided to aid in illustration, and other reference systems or coordinate systems besides those described herein may be used.

[0107] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used by those skilled in the art after reviewing the above description. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. The abstract is submitted and should be understood that it is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the above detailed description, various features may be grouped together to simplify this disclosure. This should not be construed as making unclaimed disclosed features essential to any claim. Rather, the inventive subject matter may lie in fewer than all features of a particular disclosed embodiment. Therefore, the following claims are thus incorporated into the detailed description as examples or embodiments, wherein each claim exists independently as a separate embodiment, and it is contemplated that such embodiments may be combined or arranged in various ways. The scope of the invention should be determined by reference to the appended claims and the full scope of the equivalents conferred by such claims.

Claims

1. A medical device comprising: A diaphragm seal, the diaphragm seal including a diaphragm wall having a portion defining a diaphragm opening; as well as A plurality of flaps extend above the diaphragm seal toward the diaphragm opening, wherein the flaps define flap openings that overlap with the diaphragm opening.

2. The medical device of claim 1, wherein the diaphragm seal includes a bellows portion extending around the diaphragm wall.

3. The medical device according to claim 1 or 2 further includes a slit seal, the slit seal comprising a slit portion and an edge portion.

4. The medical device of claim 3, wherein the edge portion of the slit seal directly contacts and seals against the bellows portion of the diaphragm seal.

5. The medical device according to claim 3 further includes a disk structure, wherein the plurality of vanes and the diaphragm seal are connected to the disk structure.

6. The medical device of claim 5, wherein the flexure of the bellows portion allows the disk structure, the vane, and the diaphragm opening to move to accommodate movement of an instrument inserted through the vane and the diaphragm opening.

7. The medical device of claim 5, wherein the disk structure includes a first disk part and a second disk part, the first disk part having a protrusion extending through a second opening in the diaphragm seal and engaging the second disk part to connect the first disk part to the second disk part and the diaphragm seal.

8. The medical device of claim 7, wherein the diaphragm seal includes a reinforcing structure surrounding the second opening.

9. The medical device of claim 5, wherein the disk structure includes a lubrication channel extending from the top surface of the disk structure to the space between the plurality of vanes and the diaphragm wall.

10. The medical device of claim 5, wherein the diaphragm seal includes a retaining structure that engages the disk structure to constrain movement of the diaphragm wall relative to the disk structure.

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