Instrument seal

Abstract

To solve problems with the prior art.SOLUTION: A medical device includes a septum seal including a septum wall having portions defining a septum opening, and a plurality of flaps extending over the septum seal toward the septum opening, where the flaps define a flap opening that overlaps with the septum opening.SELECTED DRAWING: Figure 3E

Description

[Technical Field]

[0001] (Reference to Related Application) 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.

[0002] This document relates generally to medical devices, and more particularly to instrument seals that create a seal against surgical instruments during surgical procedures. [Background technology]

[0003] During surgical procedures, it may be necessary to create a seal between surgical instruments. Maintaining such a seal may, for example, allow for the creation of pressure (e.g., insufflation pressure) within the patient, which may facilitate the surgical procedure or may otherwise provide a benefit to the patient. Summary of the Invention

[0004] An exemplary medical device seal ("Example 1") includes 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, the flaps defining flap openings that overlap the septum opening.

[0005] In Example 2, the medical device of Example 1 can be configured such that the septum seal includes a bellows portion that extends around the periphery of the septum wall.

[0006] In Example 3, the medical device of Examples 1 or 2 can further include a slit seal including a slit portion and a rim portion.

[0007] In Example 4, the medical device of any one or any combination of Examples 1-3 may be configured such that the rim portion of the slit seal directly contacts the bellows portion of the septum seal to seal the bellows portion of the septum seal.

[0008] In Example 5, the medical device of any one or any combination of Examples 1-4 can further include a pack structure, wherein the plurality of flaps and the septum seal are coupled to the pack structure.

[0009] In Example 6, the medical device of any one or any combination of Examples 1-5 may be configured such that deflection of the bellows portion allows the puck structure, flaps, and septum opening to move to accommodate movement of an instrument inserted through the flaps and septum opening.

[0010] In Example 7, the medical device of any one or any combination of Examples 1-6 may be configured such that the pack structure includes a first pack part and a second pack part, the first pack part having a protrusion extending through a second opening in the septum seal and engaging the second pack part to couple the first pack part and the second pack part to the septum seal.

[0011] In Example 8, the medical device of any one or any combination of Examples 1-7 can be configured such that the septum seal includes a reinforcing structure around the second opening.

[0012] In Example 9, the medical device of any one or any combination of Examples 1-8 can be configured such that the pack structure includes a lubrication channel extending from a top surface of the pack structure to a space between the plurality of flaps and the septum wall.

[0013] In Example 10, the medical device of any one or any combination of Examples 1-9 can be configured such that the septum seal includes a retention structure that engages with the pack structure to inhibit movement of the septum wall relative to the pack structure.

[0014] In Example 11, the medical device of any one or any combination of Examples 1-10 can further include a housing, wherein the septum seal, the slit seal, and the puck structure are within the housing.

[0015] In Example 12, the medical device of any one or any combination of Examples 1-11 can be configured such that the housing includes an upper housing portion and a lower housing portion coupled to the upper housing portion.

[0016] In Example 13, the medical device of any one or any combination of Examples 1-12 can further include a cap between the bellows portion and the housing, the cap constraining expansion of the bellows portion in response to pressure changes.

[0017] In Example 14, the medical device of any one or any combination of Examples 1-13, wherein the housing includes a guide portion sized and shaped to guide an instrument toward the septum opening, and the guide portion can be configured to extend beyond the cap.

[0018] In Example 15, the medical device of any one or any combination of Examples 1-14, wherein the slit seal includes a retention structure, the retention structure configured to engage with the housing and inhibit movement of the slit seal.

[0019] In Example 16, the medical device of any one or any combination of Examples 1-15 may further include a cannula having a proximal portion, a distal portion, and an elongate body extending between the proximal portion and the distal portion, the proximal portion shaped to receive the housing, and the housing inserted into the proximal portion of the cannula.

[0020] In Example 17, the medical device of any one or any combination of Examples 1-16 can be configured such that the cannula includes a cannula bowl, the housing is within the cannula bowl, and the cannula bowl extends beyond a distal-most portion of the housing.

[0021] In Example 18, the medical device of any one or any combination of Examples 1-17 can be configured such that the distal-most portion of the housing is less than 3 / 4 of the way into the cannula bowl.

[0022] In Example 19, the medical device of any one or any combination of Examples 1-18 can be configured such that the housing includes a guide surface sized and shaped to guide an object into the housing.

[0023] In Example 20, the medical device of any one or any combination of Examples 1-19 can further include a pack structure, wherein the pack structure, the septum seal, the plurality of flaps, the slit seal, and the lower housing portion are coupled to one another.

[0024] In Example 21, the medical device of any one or any combination of Examples 1-20 can be configured such that the slit seal is adhered to the lower housing portion and the septum seal.

[0025] In Example 22, the medical device of any one or any combination of Examples 1 to 21 may be configured such that the pack structure, septum seal, multiple flaps, slit seal, and lower housing portion are provided as disposable components, and the upper housing portion is reusable.

[0026] In Example 23, the medical device of any one or any combination of Examples 1-22 can be configured such that the lower housing portion is sized and shaped to seal over a cannula.

[0027] In Example 24, the medical device of any one or any combination of Examples 1-23 can be configured such that the lower housing portion is made of rubber.

[0028] In Example 25, the medical device of any one or any combination of Examples 1-24 can be configured such that the upper housing portion is removably attached to the lower housing portion.

[0029] In Example 26, the medical device of any one or any combination of Examples 1-25 can be configured such that the upper housing portion is removable from the lower housing portion by manually squeezing the upper housing portion.

[0030] In Example 27, the medical device of any one or any combination of Examples 1-26 can be configured such that the upper housing portion is oval and squeezing the elongated portion of the upper housing portion releases the upper housing portion from the lower housing portion.

[0031] Each of these non-limiting examples can stand on its own or can be combined with one or more of the other examples in various permutations or combinations.

[0032] This Abstract is intended to provide an overview of the subject matter of this patent application. This Abstract is not intended to provide an exclusive or exhaustive description of the invention. The Detailed Description is included to provide further information about this patent application.

[0033] In the drawings, which are not necessarily drawn to scale, like numbers may describe similar components in different drawings. Like numbers with different letter suffixes may represent different instances of similar components. The drawings generally illustrate, by way of example only, and not by way of limitation, various embodiments discussed in this document. [Brief explanation of the drawings]

[0034] [Figure 1A] FIG. 1 is a plan view of an exemplary medical system that may include a user control system, an auxiliary system, and an operating system.

[0035] [Figure 1B] 1 is a diagram of an exemplary operating system.

[0036] [Figure 1C]1 is a diagrammatic representation of an exemplary user control system.

[0037] [Figure 1D] 1 is a diagrammatic illustration of an exemplary auxiliary system.

[0038] [Figure 2A] 1 is a diagram of an instrument seal.

[0039] [Figure 2B] FIG. 2B is a top view of the instrument seal shown in FIG. 2A.

[0040] [Figure 2C] FIG. 2C is an exploded view of the instrument seal shown in FIGS. 2A-2B.

[0041] [Figure 2D] FIG. 1 is an exploded view of the pack assembly.

[0042] [Figure 2E] FIG. 10 is a bottom view of the upper pack section.

[0043] [Figure 2F] FIG. 1 is a bottom view of the membrane seal

[0044] [Figure 2G] FIG. 10 is a close-up view of the bottom of the septum seal.

[0045] [Figure 2H] 1 is a diagrammatic view of an instrument seal on a cannula.

[0046] [Figure 3A] FIG. 2C is a cross-sectional view of the instrument seal shown in FIGS. 2A-2B.

[0047] [Figure 3B] FIG. 2C is a cross-sectional view of the instrument seal shown in FIGS. 2A-2B.

[0048] [Figure 3C]FIG. 2C is a cross-sectional view of the instrument seal shown in FIGS. 2A-2B.

[0049] [Figure 3D] FIG. 2C is a cross-sectional view of the instrument seal shown in FIGS. 2A-2B.

[0050] [Figure 3E] FIG. 2C is a cross-sectional view of the instrument seal shown in FIGS. 2A-2B engaged with a cannula.

[0051] [Figure 4A] FIG. 1 is a perspective view of an exemplary seal.

[0052] [Figure 4B] FIG. 2 is a bottom view of an exemplary seal cap.

[0053] [Figure 4C] FIG. 4C is a perspective view of the seal cap shown in FIG. 4B.

[0054] [Figure 4D] 4B is an exploded perspective view of the exemplary seal shown in FIG. 4A and a cannula in which the seal may be used.

[0055] [Figure 4E] FIG. 2 is an exploded view of an exemplary seal.

[0056] [Figure 4F] FIG. 4B is a cross-sectional view of the seal shown in FIG. 4A engaged with a cannula.

[0057] [Figure 5A] FIG. 1 is a perspective view of an exemplary seal and cannula.

[0058] [Figure 5B] FIG. 5B is a cross-sectional view of the seal and cannula shown in FIG. 5A. DETAILED DESCRIPTION OF THE INVENTION

[0059] (overview) A medical device (e.g., a seal assembly) may include a septum seal and multiple flaps extending over the septum seal. The flaps may protect the septum 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 an opening in the septum seal. For ease of assembly, the flaps may be separate pieces that may be coupled to the septum seal.

[0060] The medical device may also include a bellows structure, and the septum seal and flaps may be coupled to the bellows structure. The bellows allows lateral movement of the septum and flaps through flexing of corrugated regions within the bellows. In some instances, the bellows may be connected to the septum seal. For example, the bellows and septum seal may be part of a single piece.

[0061] The medical device may include a slit seal, such as a cross-slit seal. In some instances, the slit seal may be in direct contact with the septum seal, which may facilitate effective sealing of the device.

[0062] The medical device may include puck components that may facilitate assembly. For example, a flap may be coupled to the top pack portion, and the bottom pack portion may engage with (extend through) the septum seal and be coupled to the top pack portion to form a puck assembly including the flap, bellows, septum seal, top pack portion, and bottom pack portion. One or more retention structures (e.g., anchorings) on the septum seal or slit seal may engage with the top or bottom pack portion to retain relative movement of the components. The top or bottom pack portion may include lubrication channels, for example, to allow application of a lubricant on the surface of the septum seal.

[0063] The medical device may include or be contained within a housing. The housing may include, for example, an upper housing and a lower housing that mate together to capture the seal and other components within the housing. In some examples, a cap may be provided between the bellows and the upper housing to prevent movement (e.g., expansion) of the bellows through an access hole or other opening in the housing.

[0064] An exemplary medical device may be used with a telerobotically controlled surgical system. For example, a medical device as described herein may be an instrument seal for use with a cannula that may be connected to a patient at a surgical access site. An instrument, which may be manually operated or controlled using a telerobotic surgical system, may be inserted into the patient through the septum seal and slit seal to perform a surgical procedure. The septum seal may seal against the instrument shaft when an instrument is inserted through the medical device. The slit seal may seal itself when no instrument is inserted, which may maintain insufflation pressure within the patient.

[0065] (Example System) 1A is a plan view of an exemplary medical procedure environment in which the medical devices described herein may be used. The environment may include a multi-arm manipulation system 100 adjacent to a surgical table 101 that may support a patient 103.

[0066] 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 auxiliary system 175, or both. The user control system 150 may include one or more user input devices (e.g., controllers) that may be configured to receive input from a user (e.g., a clinician). The user control system 150 may include one or more user feedback devices (e.g., a vision system, tactile or auditory feedback) that may be configured to provide the user with information regarding the movement or position of an end effector or an image of the surgical field. The auxiliary system 175 may include, for example, processing equipment (e.g., processor circuitry or graphics hardware) or communication equipment (e.g., wired or wireless communication circuitry).

[0067] FIG. 1B is an illustration of an exemplary manipulation system 100. Manipulation system 100 may include a base 102, a support tower 104, and one or more manipulator arms 110, 111, 112, 113, which may be attached to the support tower. An instrument 130 may be attached to an instrument mount 120 on one of the manipulator arms. Instrument mount 120 may include an instrument carriage 122, which may be attached to a spar 124, which may be, for example, a telescoping spar. A cannula may be attached to a cannula mount 126, and the instrument 130 may be inserted through a cannula seal within the cannula into a patient 103 for use in a surgical or other medical procedure. Through movement of the manipulator arms, the orientation of the instrument may be controlled in multiple dimensions, e.g., lateral, horizontal, vertical, and angular movement in one, two, or three planes.

[0068] 1C is an illustration of an exemplary user control system 150. User control system 150 may include manual controls 155, 156 and pedal controls 160, 161, 162. Manual controls 155, 156 and pedal controls 160, 161, 162 may be used to control equipment in operating system 100. For example, a distal end portion of instrument 130 may be manipulated using the instrument controls. The controls may include haptic feedback configurations so that a physician may interpret physical information, such as resistance or vibration, through the controls. User control system 150 may also include a vision system 165, which may display video or other images of the surgical site.

[0069] FIG. 1D illustrates an exemplary auxiliary system 175. The auxiliary system 175 may include processing equipment 180 for processing controls and facilitating communication between the user control system and the operation system or remote site. The auxiliary system 175 may also include a display 190, which may show the image the user (e.g., a clinician) is viewing on the user control system, a video feed from a camera within the patient, or other information. In an exemplary configuration, signals input at the user control system 150 may be transmitted to equipment 180 on the auxiliary system, which may interpret the input and generate commands that are transmitted to the operation system 100 to cause manipulation of the instrument 130 or portions of the manipulator arm 110. While the equipment 180 is shown on a cart for illustrative purposes, it may be arranged in various configurations; for example, the equipment 180 may be integrated as part of the user control system, the operation system, or both, or may be split between the user control system and the operation system. The equipment may be provided as software, hardware, or both, on an installed system or a remote system.

[0070] 2A-2H and 3A-3E illustrate an exemplary instrument seal 200. Seal 200 may include multiple flaps 202, 204, 206, 208 that may overlap and together form flap opening 210. The flaps may be formed of polyurethane, such as 90 durometer polyurethane, which may provide desirable durability or flexibility properties. The flaps may be positioned over septum seal 212. Diaphragm seal 212 may be made of polyisoprene, such as 43 durometer polyisoprene. Flaps 202, 204, 206, 208 may together form opening 210 that is slightly larger than septum seal opening 217. Flap opening 210 may be, for example, polygonal (e.g., square) in shape, round (e.g., circular or oval), or irregular. The flap openings may advantageously be symmetrical about the instrument insertion axis to provide consistent friction or consistent performance. An instrument shaft may be inserted through the flaps as well as through septum seal 212. Flaps 202, 204, 206, 208 may protect the septum seal from damage or puncture by an instrument as it is inserted through the septum seal.

[0071] The septum seal 212 may stretch to accommodate an instrument shaft that is larger than the opening 214 in the septum seal 212. The flap rotates distally to accommodate the instrument shaft during insertion. During retraction, the flap may provide structural support to prevent excessive proximal movement or inversion of the septum seal, which may result in undesirable frictional characteristics or non-smooth movement. It may be desirable to have a consistent frictional force during retraction (or insertion) to facilitate manual movement (e.g., by a clinician) or movement by a teleoperated surgical system of the instrument shaft. Excessive or inconsistent frictional forces may create confusion as to whether the instrument or attached object has caught or become caught on another object (which may need to be resolved before retraction) or whether the frictional force is due to variations in seal friction.

[0072] The illustrated example includes four flaps. Other examples may include more flaps (e.g., five, six, seven, or more flaps) or fewer flaps (e.g., three flaps). Increasing the number of flaps may reduce clearance between the cylindrical instrument shaft and the contour of the opening formed by the flaps, but may increase friction between the instrument shaft and the flaps. Reducing the number of flaps (e.g., three flaps instead of four flaps) may increase clearance between the flaps and the cylindrical instrument shaft inserted through them.

[0073] 2C is an exploded view of seal 200. Seal 200 may include an upper housing portion 216, a latch 218, a puck assembly 220 (shown in an exploded view in FIG. 2D), a slit seal 222 (e.g., a cross-shaped slit seal), a lower housing portion 224, and a stopcock 226, all of which may be stacked together to form seal 200. Upper housing portion 216 may be coupled to lower housing portion 224 using, for example, an ultrasonic welding process. Stopcock 226 may be used to control the flow of vent gas into lower housing portion 224.

[0074] 2D is an exploded view of puck assembly 220. Puck assembly 220 may include a puck structure, which may include an upper pack portion 228 and a lower pack portion 230, which may be connected to one another using one or more retention features (e.g., pins) as described further below. Puck structure may be round (e.g., circular or oval), polygonal (e.g., triangular, square, or pentagonal), or irregular. Puck assembly 220 may also include flaps 202, 204, 206, 208 and a septum seal 212. As shown in FIG. 3B, when the pack assembly is assembled with other components of the seal 200, the upper surface 223 of the upper pack portion 228 may be adjacent to (e.g., in contact with or close to) or spaced apart from the cap portion 324 of the latch 218 (shown in FIG. 3B), and the lower surface 225 of the lower pack portion 230 (marked in FIG. 3B) may be adjacent to or spaced apart from the rim portion 268 of the slit seal.

[0075] As shown in FIG. 2D , the flap 202 (or some or all of the flap) may include a flange portion 232 and a flap portion 234 extending distally and centrally (toward the instrument insertion axis). The flap portion 234 may be connected to the flange portion 232 by a flex portion 233, which may bend or flex to allow the flap portion 234 to move downward, for example, when an instrument is inserted through the seal 200. The flap portion 234 may be shaped (e.g., cupped) so that the flaps fit together to form a 3D curved surface. For example, the flap side portions 236, 238 may be curved upward (proximally) from a central section 240 of the flap. The flap may also include one or more openings 242 for connecting the flap to another portion. The openings 242 may be within the flange portion 232 of the flap. In some examples, the seal 200 may include multiple flaps (e.g., three, four, five, or more flaps), each configured with one or more openings and shaped flap portions. The multiple flaps may be identical or different from one another.

[0076] Diaphragm seal 212 may include a diaphragm portion 243 that includes a diaphragm wall 244, which may define an opening 246 that may seal against an instrument shaft inserted therethrough. Diaphragm seal 212 may also include a rim portion 248. Diaphragm wall 244 may extend distally from rim portion 248 to opening 246 (e.g., forming a truncation) to guide an instrument toward the opening. Diaphragm seal 212 may include a bellows portion 250, which may include a plurality of corrugated walls 252, 254, 256, 258. Bellows portion 250 may allow lateral movement of puck assembly 220 (e.g., perpendicular to the instrument insertion axis), which may protect septum portion 243 of septum seal 212 as an instrument is manipulated within the cannula, or may allow a greater range of movement or easier movement of the instrument shaft by the clinician or by a remotely operated surgical system controlled by the clinician.

[0077] 2F and 2G, the rim portion 248 may include one or more openings 260 that may be surrounded by a reinforcing structure 261 (e.g., a ring). The lower pack portion 230 may include one or more protrusions 262 that may be sized and shaped to extend through the openings 260 in the diaphragm seal 212 and into corresponding openings 265 in the receiving portion 264 of the upper pack portion 228 (shown in FIG. 2E). The openings 265 may be sized and shaped to provide a press-fit, snap-fit, or ultrasonic welded interface with the protrusions 262 to hold the assembly of the upper pack portion, flaps, diaphragm seal 212, and lower pack portion 230 together. In some examples, the lower pack part 230 may have a pair of protrusions 262 (e.g., pins), each of which may be stamped and shaped to extend through a corresponding opening 260 in the septum seal 212 and into a receiving portion 264 in the upper pack part 228, as shown in FIG. 3D. A reinforcing structure 261 on the septum seal 212 may provide localized structural support at locations around the protrusions 262. In an alternative configuration, the upper pack part 228 may include the protrusions and the lower pack part 230 may include a receiving portion configured to receive the protrusions, or both the upper pack part 228 and the lower pack part 230 may include protrusions and receiving portions that align with the protrusions of the other pack part to connect the pack parts to each other.

[0078] The construction of the pack assembly from the diaphragm seal 212 with the connected bellows portion 250, flaps 202, 204, 206, 208, upper pack portion, and lower pack portion may advantageously provide a simple assembly procedure and a simple overall pack assembly architecture. For example, forming the diaphragm portion 243 and bellows portion 250 into a single piece avoids the need to align the diaphragm portion and the bellows portion (as would be necessary if the diaphragm portion and the bellows portion were separate pieces). The assembly process may advantageously be simple. For example, the diaphragm seal 212 may be assembled onto the lower pack portion 230 with a protrusion 262 (e.g., a pin) extending through an opening 260 in the diaphragm seal 212. The flaps 202, 204, 206, 208 may be assembled onto a protrusion 267 (shown in FIG. 2E) on the bottom side of the upper pack portion 228, with the protrusion 267 extending through the opening 242 in the flaps. The flaps may optionally be retained using a retainer such as a clip (not shown), a portion of which may extend into a hole 269 in the protrusion 267. As previously mentioned, the upper pack part 228 may be coupled to the lower pack part 230 by inserting the protrusion 262 into a hole in the receiving portion 264 of the upper pack part 228, which holds the upper pack part 228, the lower pack part 230, the flaps 202, 204, 206, 208, and the septum seal 212 together to form the pack assembly 220.

[0079] The pack assembly 220 may be assembled onto a slit seal 222, as shown in Figures 2C and 3A-3D. The slit seal 222 may include a seal portion 266 and a rim portion 268. The seal portion may be, for example, a cross slit seal, a single slit, or a triple slit seal. The slit seal may include folded side walls that together form a slit.

[0080] In some examples, the diaphragm seal 212 may be in direct contact with the slit seal 222. For example, the bellows portion 250 of the diaphragm seal 212 may rest against the rim portion 268 of the slit seal. Seal-to-seal contact may create a seal that prevents leakage. Direct seal-to-seal contact may be advantageous for sealing, for example, because seal-to-seal contact (e.g., rubber (polyisoprene)-to-rubber contact) may provide a better component seal than if another part (e.g., plastic or polycarbonate) were between the seals. The diaphragm seal 212 may be sized and shaped to fit within the slit seal 222. The slit seal 222 may include an outer lip 282 that may rest against an outer lip 284 on the diaphragm seal 212 (as shown in FIG. 3C ).

[0081] Seal 200 may be assembled onto cannula 290, as shown in Figure 2H. Cannula 290 may be coupled to the seal by latch 218. Seal 200 may be used with a dockless cannula, as shown in Figure 2H, or alternatively, with a dockable cannula, such as cannula 406 shown in Figure 4D, which includes blade 408 for docking the cannula to part of a teleoperated surgical system.

[0082] 3A is a cross-sectional view of the seal 200 taken along section A-A shown in FIG. 2B. The diaphragm seal 212 may optionally include an upper retention structure (e.g., ring) 270 that may be compressed and shaped to extend into a corresponding groove 272 in the upper pack portion 228. The diaphragm seal 212 may additionally or alternatively include a lower retention structure (e.g., ring) 274 that may extend into a groove 276 in the lower pack portion 230. The slit seal 222 may include a portion that defines a receiving space (e.g., groove) 278 that may receive a protrusion 280 in the lower housing portion 224. The upper retention structure 270 or lower retention protrusion 274 may prevent the diaphragm seal 212 from displacing toward the center of the seal 200 when an object is inserted or withdrawn through the diaphragm seal 212.

[0083] FIG. 3B is a cross-sectional view of seal 200 at section BB, shown with instrument shaft 301 inserted along insertion axis 351 through flaps and septum seal 212. Flaps 202, 206, 208 may pivot downward (distally) to create space for instrument shaft 301. Opening 214 in septum seal 212 may extend to accommodate the instrument shaft. Upper housing portion 216 may include an instrument guide portion 302 that may be sized and shaped to guide an instrument toward opening 214 in the septum seal. Instrument guide portion 302 may extend distally beyond latch 218, which helps to avoid the instrument becoming caught in the gap between puck assembly 220 and latch 218. In some examples, instrument guide portion 302 may include a lead-n channel 303, as shown in FIG. 3B. In some examples, the instrument guide portion 302 may optionally contact the upper puck portion 228 at an upper engagement surface 305 .

[0084] 3C is a cross-sectional view of seal 200 taken along section CC. Seal 200 may include a lubrication path 304 through one or more of its components. For example, upper pack portion 228 may have a passageway 306 that may include an upper opening 308 above the upper pack portion and a lower opening 310 that joins a space 314 between the flaps and diaphragm portion 343 of diaphragm seal 212. Lubricant may be injected into upper opening 308, and the lubricant may enter lower opening 308 through passageway 312 in the upper pack portion and proceed into space 314 between flaps 202, 204, 206, 208 and diaphragm 244. Placing lubricant under the flaps may help avoid contamination on optics (e.g., lenses) of a camera instrument inserted through the seal. In some examples, lubricant may be injected into puck assembly 220 prior to assembling latch 218 and upper housing portion 216 onto puck assembly 220. The pack assembly may include multiple lubrication paths 304 through multiple openings in the upper pack portion 228 (as shown in FIG. 2D ) to distribute lubrication to different locations on the diaphragm portion 243 of the diaphragm seal (e.g., to cover most or the front of the diaphragm portion with lubricant).

[0085] The rim portion 268 of the slit seal 222 may include one or more retention structures 316 (e.g., protrusions such as annular rings) sized and shaped to engage with the lower housing portion 224. For example, the retention structures 316 may extend downward (distal) from a bottom surface 318 of the rim portion and into a receiving space 320 (e.g., a groove) in the lower housing portion 224. The receiving space 320 may be defined by the protrusion 278 and the second protrusion 322 in the lower housing portion. The protrusion 316 may be a continuous ring or may be segmented (e.g., include a gap within the ring) to accommodate the vent channel 317 (shown in FIG. 3A ). The protrusion 316 may prevent the slit seal 222 from sliding toward the center of the seal when an object or instrument is inserted or withdrawn through the slit seal 222.

[0086] As shown in FIGS. 3A-3C , a cap portion 324, which may be connected to the latch 218 or a portion of the latch 218, may extend over the bellows portion 250 of the septum seal. The latch cap portion 324 may inhibit expansion or distortion of the bellows portion 250 in response to sudden pressure changes, for example, when an object is inserted through the septum. The cap portion 324 may include a notch portion 326 that may be aligned with an opening 328 in the upper housing portion. The opening 328 may be sized and shaped to latch with another device. The presence of the cap portion 324 between the bellows portion 250 and the upper housing portion 215 may provide more space (e.g., clearance) for a latch portion (not shown) to be inserted through the opening.

[0087] 3E shows seal 200 assembled with cannula 290, which has a compressed and shaped proximal portion 397 for engaging seal 200 to facilitate delivery of surgical instruments, and a compressed and shaped distal portion 299 (shown in FIG. 2H) for coupling to a patient. Lower housing portion 224 may extend into cannula bowl 396 at proximal portion 397 of cannula 290. In some instances, a small gap may exist between lower housing portion 224 and inner wall 330 of cannula 290, for example, due to manufacturing tolerances and the need to fit the lower housing portion inside the cannula. Cannula bowl 396 may extend beyond lower housing portion 224; for example, lower housing portion 224 and the septum may not extend to the bottom 394 of cannula bowl 396. For example, the lower housing may extend less than three-quarters (75%) of the way into the cannula bowl, or may extend less than half (50%) of the way into the cannula bowl. To facilitate withdrawal of an object (e.g., an instrument) into sealing portion 266 of slit seal 222 and lower housing portion 224, distal portion 332 of lower housing portion 224 may include a retraction guide surface 334 that may be sized and shaped (e.g., angled toward insertion axis 351) to guide an instrument or other object into inner cavity 336 of the lower housing portion or toward sealing portion 266 of the slit seal.

[0088] A seal such as an O-ring 338 may form a seal between lower housing portion 224 and cannula 290. In some examples, lower housing portion 224 may include a channel 340 extending around an outer surface 342 of lower housing portion 224, and an O-ring (or other seal) may reside within channel 340 and extend radially outward beyond outer surface 342 such that inner wall 330 of cannula 290 seals against O-ring 338. In some examples, O-ring 338 may retain lower housing portion 224 within cannula 290.

[0089] In some examples, latch 218 may retain seal 200 on cannula 290. For example, a lower portion 344 of latch 218 may be sized and shaped to engage an engagement feature (e.g., a lip) on cannula 290. In some examples, the latch may be spaced from the lip (as shown) to prevent seal 200 from separating from cannula 290 if the lower housing portion slides upward within cannula 290. In some examples, lower portion 344 of the latch may be formed with a hook shape to reach below and engage a lower surface 348 of the engagement feature. The latch may include an inwardly extending protrusion 350 that may prevent movement of outer wall 258 of bellows portion 250 out the side of the cannula.

[0090] 4A shows another exemplary seal 400. The seal 400 may include a cap 402, which may be reusable, and a bottom portion 404, which may be disposable. In some examples, the seal 400 may be designed as a low-cost seal. The seal 400 may not include a vent gas passageway and stopcock (as shown in FIG. 4A), which may reduce costs, or the seal 400 may optionally include a vent gas passageway and stopcock, as shown in FIGS. 2A-2C.

[0091] 4A and a cannula 406 in which the seal 400 may be used. The cap 402 may be assembled to the bottom portion 404, and the assembled seal 400 may be coupled to the cannula 406, for example, as shown in FIG. 4F.

[0092] As shown in FIGS. 4B and 4C , the cap 402 may have an oval or elliptical shape with a long dimension (e.g., along the major axis 403) and a short dimension (e.g., along the minor axis 405), which may allow assembly and disassembly with the bottom portion 404 by squeezing along the major axis (longer dimension) of the cap. The cap 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 that decreases toward the minor axis 405. The ridges may engage with one or more engagement features 422 (e.g., grooves or lips) on the bottom portion 404 (as shown in FIG. 4F ). Squeezing the cap along the major axis (as shown by the arrows in FIG. 4A ) may move the ridges 418 outward (as shown by the arrows), allowing the ridges to engage or disengage with the engagement features 422 on the seal. In this manner, the cap 402 is assembled with the bottom portion 404 and, after use, disassembled from the seal portion so that the bottom portion 404 may be discarded or recycled and the cap 402 may be retained and reused (e.g., sterilized and attached to a new seal for use in another procedure).

[0093] FIG. 4E is an exploded view of an exemplary bottom portion 404 of seal 400. FIG. 4F is a cross-sectional view of assembled seal 400 coupled to cannula 406. Bottom portion 404 may include a seal portion 410 and a cannula mount 412, which in some examples may be provided in a sterile state (e.g., sterilized and bagged or packaged) or may be coupled to one another (e.g., glued, snap-fit, threaded, or assembled with a connector) to be provided as a single unit. Cannula mount 412 may be pressed and shaped to couple (attach) to an upper portion of cannula 406. In some examples, cannula mount may be made of rubber.

[0094] The sealing portion 410 may include a plurality of flaps 424, 426, 428, a septum seal 440, an upper puck 432, a lower puck 434 (shown in FIG. 4F ), and a slit seal 458. The sealing portion 410 may include a protrusion 446 (e.g., an annular ring) that may engage with an engagement feature 448 (e.g., a groove) on the lower puck 434 (e.g., as in the manner described above in connection with the components forming the puck assembly 220) to hold the parts together and prevent slippage of the septum portion 442 relative to the upper and lower puck portions 432, 434 when an instrument is inserted through an opening 438 in the septum portion 442 of the septum seal 440. Bellows 436 may allow diaphragm portion 442 and upper and lower puck portions 432, 434 to move laterally (e.g., perpendicular to insertion axis 401), which may protect the diaphragm portion of the seal or may allow easier movement or a greater range of motion for an instrument shaft (not shown in FIG. 4F) inserted through the seal. In some examples, seal portion 410 may be or include puck assembly 220 and diaphragm seal 212, described above and shown in FIG. 2A.

[0095] Cannula mount 412 may include engagement feature 422, which may be a groove (as shown) or, alternatively, a lip or other structure. Engagement feature 422 may be sized and shaped to engage with ridge 418 on the inside of cap 402. Engagement feature 422 may extend the entire circumference of cannula mount 412 and have a consistent height, or engagement feature 422 may be segmented or tapered, e.g., the engagement feature may be sized and shaped similarly to segmented, tapered ridge 418 on the underside of the cap. Squeezing cap 402 may move the side portions outward, as shown in FIG. 4A , disengaging ridge 418 from engagement feature 422 (or reducing their engagement), thereby allowing cap 402 to be removed from the seal. Alternatively, cannula mount 412 may be squeezed inward (toward insertion axis 401) to move engagement feature 422 away from cap 402. In some instances, both squeezing cap 402 and inward movement of cannula mount 412 may be required to release cap 402 from bottom portion 404. In some instances, attachment of cannula mount 412 to cannula 406 may prevent sufficient squeezing of cannula mount 412 toward the insertion axis, which may prevent cap 402 from being removed from bottom portion 404 when seal 400 is attached to cannula 406.

[0096] As shown in FIG. 4F , cannula mount 412 may include a cannula engagement feature 450 (e.g., a lip and groove) that may be sized and shaped to engage with an engagement feature 452 (e.g., a lip) on cannula 406. In some examples, engagement feature 450 may be sized and shaped to seal against cannula 406, which may eliminate the need for an O-ring seal (as opposed to the example shown in FIG. 3E ). For example, a bottom portion 454 of engagement feature 452 may extend around and below engagement feature 452 on the cannula to retain cannula 406 and press the cannula into an upper portion 456 of engagement feature 452 so that multiple surfaces of cannula mount 412 seal against cannula 406. Cannula mount 412 may be formed of polyisoprene or another rubber or flexible plastic material. Forming cannula mount 412 from rubber may be advantageous for sealing against cannula 406 or for removable connection with cap 402 .

[0097] 5A-5B show another exemplary seal 500 that may include a slit seal 502 including a cannula engagement feature 504 sized and shaped to engage and seal with a cannula 506. In some examples, the engagement feature 504 may wrap around a lip 507 on the cannula 506, similar to the engagement feature 450 described above and shown in FIG. 4F. The slit seal 502 may include a receiving space 524 sized and shaped to receive a puck assembly 508, which may be the puck assembly 220 shown in FIG. 2C and described above. The slit seal 502 may be formed of, for example, polyisoprene or another rubber.

[0098] The pack assembly 508 may include a septum seal 526, which may have an opening 528 for sealing against an instrument shaft (not shown in FIGS. 5A-5C). The pack assembly may also include a plurality of flaps 512, 514, 516, 518, each of which may include a flap portion, a flexible portion, and a flange portion with an opening as described for the flap shown in FIG. 2D. The pack assembly may also include an upper pack portion 520 and a lower pack portion 522. As described above and shown in FIG. 3D, the lower pack portion 522 may include protrusions that extend through openings in the flaps 512, 514, 516, 518 and the septum seal 526 into corresponding reservoir portions in the upper pack portion (or vice versa), or the protrusions and reservoir portions may be intermixed between the upper and lower packs.

[0099] In various examples, the slit seal 502 may stretch to receive the puck assembly 508 into the receiving space 524, and the puck assembly 508 may be retained by a compressive force applied by the slit seal 502 (e.g., the puck assembly may be designed to provide an interference fit with the receiving space 524), or a retention feature on the slit seal (e.g., a lip that engages a groove or another lip) may retain the puck assembly 508 within the receiving space 524, or a cap (not shown in FIGS. 5A-5B , optionally configured as cap 402 in FIG. 4A ) may be placed over the puck, or the puck may not be retained (e.g., in a non-pressurized system). The seal 500 may be desirable because of lower cost or easier assembly, or because it uses fewer parts, while still providing desirable sealing and performance characteristics.

[0100] Those skilled in the art will understand that any of the above-described configurations may be combined with any of the other exemplary configurations, so long as the configurations are not mutually exclusive. All possible combinations of configurations are contemplated, depending on clinical or other design requirements. Additionally, if operation system units are combined into a single system (e.g., a telesurgery system), each individual unit may have the same configuration features, or one operation system may have one configuration feature and another operation system may have a second, different configuration feature.

[0101] The examples (e.g., methods, systems, or devices) described herein may be applicable to surgical, non-surgical, diagnostic, cosmetic, and non-medical procedures or applications. These examples may be applicable for training or to obtain information, such as imaging procedures. These examples may be applicable to handling tissue removed from a human or animal anatomy and not returned to the human or animal, or for use with human or animal cadavers. These examples may be used in industrial applications, general robotics applications, for manipulation of non-tissue workpieces, as part of artificial intelligence systems, or in transportation systems.

[0102] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only the elements shown or described are provided. Furthermore, the inventors also contemplate examples using any combination or permutation of those elements (or one or more aspects thereof) shown or described with respect to a particular example (or one or more aspects thereof) or with respect to any other example (or one or more aspects thereof) shown or described herein.

[0103] In the event of inconsistent usage between this document and a document incorporated by reference, the usage in this document controls.

[0104] In this document, the indefinite article (the term "a" or "an") is used to include one or more, as is common in patent literature, regardless of other instances or uses of "at least one" or "one or more." In this document, the term "or" is used to refer to a non-exclusive, or "A or B" is used to include "A but not B," "B but not A," and "A and B," unless otherwise specified. In this document, the terms "including" and "in which" are used as the plain English equivalents of the terms "comprising" and "wherein." Also, in the claims that follow, "including" and "comprising" are open-ended; that is, systems, devices, articles, compositions, formulations, or processes that include elements in addition to those recited after such terms in a claim are still considered to be within the scope of that claim. Furthermore, in the following claims, the terms "first," "second," and "third," etc., are used as indicators only and are not intended to impose numerical requirements on their objects.

[0105] Geometric terms such as "parallel," "perpendicular," "circular," or "square" are not intended to require absolute mathematical precision unless the context indicates otherwise. Rather, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as "circular" or "approximately circular," elements that are not exactly circular (e.g., elements that are slightly elliptical or multi-sided polygonal) are still encompassed by this description. Coordinate systems or reference frames are provided to aid in explanation, and embeddings may use other reference frames or coordinate systems than those described herein.

[0106] The above description is intended to be illustrative, not limiting. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be utilized, for example, by one of ordinary skill in the art after reviewing the above description. The Abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. It is understood that the Abstract is not used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that unclaimed features of the disclosure are essential to any claim. Rather, inventive subject matter may reside in less than all features of a particular disclosed embodiment. Thus, the following claims are incorporated into the Detailed Description herein as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments may be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full range of equivalents to which such claims are entitled.

Claims

1. a pack assembly; a slit seal disposed distally from the pack assembly; The pack assembly includes: a septum seal including a septum wall defining a septum opening and a septum rim portion, the septum wall extending distally from the septum rim portion; a plurality of flaps extending over the septum seal to define flap openings adjacent to and aligned with the septum opening; the plurality of flaps includes a first pair of flaps and a second pair of flaps; the first pair of flaps overlapping the second pair of flaps; The slit seal includes a slit portion and a slit seal rim portion. Medical devices.

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

3. 3. The medical device of claim 2, wherein the slit seal rim portion of the slit seal directly contacts and seals against the bellows portion of the septum seal.

4. 3. The medical device of claim 2, wherein deflection of the bellows portion allows the pack assembly, the flap, and the septum opening to move to accommodate movement of an instrument inserted through the flap and the septum opening.

5. 2. The medical device of claim 1, wherein the pack assembly includes a first pack part and a second pack part, the first pack part including at least one protrusion that extends through at least one opening in the septum rim portion and engages with the second pack part to couple the first pack part to the second pack part and the septum seal.

6. The medical device of claim 5 , wherein the septum seal includes a reinforcing structure around the at least one opening in the septum rim portion.

7. The medical device of claim 1 , wherein the puck assembly includes a lubrication channel extending from a top surface of the puck assembly to a space between the flap and the septum wall.

8. the pack assembly includes an upper pack portion and a lower pack portion; the lubrication channel includes an upper opening in a top surface of the upper pack portion, a passageway, and a lower opening in a bottom surface of the upper pack portion; The medical device of claim 7.

9. 8. The medical device of claim 7, wherein the lubrication channel is a first lubrication channel and the pack assembly further includes one or more additional lubrication channels, each of the one or more additional lubrication channels extending from the top surface of the pack assembly to the space between the plurality of flaps and the septum wall.

10. The medical device of claim 1 , wherein each of the flaps includes a curved upper surface, and the flaps, together with the curved upper surfaces, form a curved three-dimensional upper surface.

11. The medical device of claim 10 , wherein each of the flaps includes two flap side portions on either side of a central flap section, the two flap side portions curving upwardly from the central flap section.

12. each of the flaps includes a flange portion connected to a flap portion by a flexure portion; the flange portion is coupled to the puck assembly; the flexible portion is configured to bend or flex upon insertion of an instrument through the flap. The medical device of claim 1 .

13. The medical device of claim 12 , wherein a flap portion of each flap comprises a cup-like shape.

14. The medical device of claim 1 , wherein the shape of the flap opening comprises a polygon.

15. The medical device of claim 14 , wherein the shape of the flap opening comprises a square or a rectangle.

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