This document relates generally to medical devices, and more particularly, to instrument seals for creating a seal against a surgical instrument during a surgical procedure.
In a surgical procedure it may be necessary to create a seal between a surgical instrument. Maintaining such a seal may, for example, allow for creation of a pressure (e.g., insufflation pressure) in a patient, which may facilitate the surgical procedure or benefit the patient.
An example medical device seal (“Example 1”) may include 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, wherein the flaps define a flap opening that overlaps with the septum opening.
In Example 2, the medical device of Example 1 may be configured such that the septum seal includes a bellows portion extending around the septum wall.
In Example 3, the medical device of Example 1 or 2 may further include a slit seal comprising a slit portion and a rim portion.
In Example 4, the medical device of any one or any combination of Examples 1-3 may be configured such that wherein the rim portion of a slit seal directly contacts and seals against a bellows portion of the septum seal.
In Example 5, the medical device of any one or any combination of Examples 1-4 may further include a puck structure, the plurality of flaps and septum seal coupled to the puck structure.
In Example 6, thee medical device of any one or any combination of Examples 1-5 may be configured such that flexing of a bellows portion allows a puck structure, the flaps, and the septum opening to move to accommodate movement of an instrument inserted through the flaps and septum opening.
In Example 7, the medical device of any one or any combination of Examples 1-6 may be configured such that a puck structure includes a first puck part and a second puck part, the first puck part having a protrusion that extends through a second opening in the septum seal and engages the second puck part to couple to the first puck part to the second puck part and the septum seal.
In Example 8, the medical device of any one or any combination of Examples 1-7, may be configured such that the septum seal includes a reinforcement structure around the second opening.
In Example 9, the medical device of any one or any combination of Examples 1-8, may be configured such that a puck structure includes a lubrication channel extending from a top surface of the puck structure to a space between the plurality of flaps and the septum wall.
In Example 10, the medical device of any one or any combination of Examples 1-9, may be configured such that the septum seal includes a retaining structure that engages a puck structure to restrain movement of the septum wall with respect to the puck structure.
In Example 11, the medical device of any one or any combination of Examples 1-10 may further include a housing, wherein the septum seal, a slit seal, and a puck structure are in the housing.
In Example 12, the medical device of any one or any combination of 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.
In Example 13, the medical device of any one or any combination of Examples 1-12 may further include a cap between a bellows portion and the housing, wherein the cap inhibits inflation of the bellows portion in response to a pressure change.
In Example 14, the medical device of any one or any combination of Examples 1-13, may be configured such that the housing includes a guide portion sized and shaped to guide an instrument toward the septum opening, wherein the guide portion extends past the cap.
In Example 15, the medical device of any one or any combination of Examples 1-14 may be configured such that a slit seal includes a retaining structure that engages the housing to restrain movement of the slit seal.
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 sized, a distal portion, and an elongated body extending between the proximal portion and the distal portion, the proximal portion is shaped to receive the housing, wherein the housing is inserted into the proximal portion of the cannula.
In Example 17, the medical device of any one or any combination of Examples 1-16 may be configured such that the cannula includes a cannula bowl and the housing is in the cannula bowl, the cannula bowl extending past a most distal portion of the housing.
In Example 18, the medical device of any one or any combination of Examples 1-17 may be configured such that the most distal portion of the housing is less than three-fourths of the way into a cannula bowl.
In Example 19, the medical device of any one or any combination of Examples 1-18 may be configured such that the housing includes a guide surface that is sized and shaped to guide an object into the housing.
In Example 20, the medical device of any one or any combination of Examples 1-19 may further include a puck structure, wherein the puck structure, the septum seal, the plurality of flaps, a slit seal, and the lower housing part are coupled together.
In Example 21, the medical device of any one or any combination of Examples 1-20, may be configured such that a slit seal is adhered to the lower housing part and to the septum seal.
In Example 22, the medical device of any one or any combination of Examples 1-21 may be configured such that a puck structure, the septum seal, the plurality of flaps, a slit seal, and the lower housing part are provided as a disposable part and the upper housing part is reusable.
In Example 23, the medical device of any one or any combination of Examples 1-22, may be configured such that the lower housing part is sized and shaped to seal against a cannula.
In Example 24, the medical device of any one or any combination of Examples 1-23 may be configured such that the lower housing part is made of rubber.
In Example 25, the medical device of any one or any combination of Examples 1-24 may be configured such that the upper housing part is removably attached to the lower housing part.
In Example 26, the medical device of any one or any combination of Examples 1-25 may be configured such that the upper housing part is removable from the lower housing part by manually squeezing the upper housing part.
In Example 27, the medical device of any one or any combination of Examples 1-26 may be configured such that the upper housing part is oval shaped and squeezing an elongated portion of the upper housing part releases the upper housing part from the lower housing part.
Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.
This Summary is intended to provide an overview of subject matter of the present patent application, It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
A medical device (e.g., seal assembly) may include a septum seal and a plurality of flaps that extend 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 with an opening in the septum seal. To facilitate assembly, the flaps may be separate pieces, which may be coupled to the septum seal.
The medical device may also include a bellows structure, to which the septum seal and flaps may be coupled. The bellows may allow for lateral movement of the septum and flaps via flexing of a corrugated region in the bellows. In some examples, the bellows may be connected to the septum seal. For example, the bellows and septum seal may be portions of a single part.
The medical device may also include a slit seal, such as a cross-slit seal. In sonic examples, the slit seal may be in direct contact with the septum seal, which may promote effective sealing of the device.
The medical device may include puck components, which may facilitate assembly. For example, the flaps may be coupled to a top puck part, and a bottom puck part may engage (e.g., extend through) the septum seal and couple to the top puck part to form a puck assembly that includes the flaps, bellows, septum seal, and top and bottom puck parts. One or more retaining structures (e.g., an anchoring ring) on the septum seal or slit seal may engage the top puck part or bottom puck part to retain relative movement of the components. The top puck part or bottom puck part may include a lubrication channel, which may for example allow for application of a lubricant on a surface of the septum seal.
The medical device may include a housing, or be contained within a housing. The housing may for example include an upper housing and a lower housing that couple together to capture the seals and other components in the housing. In some examples, a cap may be provided between the bellows and the upper housing to avoid movement (e.g., inflation) of the bellows through an access hole or other opening in the housing.
Example medical devices may be used with a telerobotically-controlled surgical system. For example, medical devices as described herein may be an instrument seal for use with a cannula that may be coupled 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 through the septum seal and slit seal and into a patient to perform a surgical procedure. The septum seal may seal against an instrument shaft when the instrument is inserted through the medical device. The slit seal may seal against itself when an instrument is not inserted, which may maintain an insufflation pressure in the patient.
The manipulating system 100 may be part of a larger system 10, which may include other sub-systems. For example, the manipulating 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., controls) that may be configured to receive inputs from a user (e.g., clinician). The user control system 150 may also include or one or more a user feedback devices (e.g., viewing system or tactile or auditory feedback) that may be configured to provide information to the user regarding the movement or position of an end effector, or an image of a surgical area. The auxiliary system 175 may, for example, include processing equipment (e.g., a processor circuit or graphics hardware) or communication equipment (e.g., wired or wireless communication circuits).
The septum seal 212 may stretch to accommodate an instrument shaft that is larger than the opening 214 in the septum seal 212. The flaps my rotate distally to accommodate the instrument shaft during insertion. During retraction, the flaps may provide structural support to avoid excessive proximal movement or inversion of the septum seal, which may create undesirable friction characteristics or unsmooth movements. It may desirable to have consistent frictional forces during retraction (or insertion) to facilitate manual (e.g., by a clinician) movement of an instrument shaft or movement by a teleoperated surgical system. Excessive or inconsistent frictional forces may create confusion about whether an instrument or attached object has been caught or snagged on another object (which may need to be resolved prior to retraction) or whether the friction forces are due to variations in seal friction.
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., 3 flaps.) increasing the number of flaps may reduce the size of gaps between a cylindrical instrument shaft and the contours 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) may increase the size of gaps between the flaps and a cylindrical instrument shaft inserted through the flaps.
As shown in
The septum seal 212 may include a septum portion 243 that includes a septum wall 244, which may define an opening 246, which may seal against an instrument shaft inserted through the opening 246. The septum seal 212 may also include a rim portion 248. The septum wall 244 may extend distally (e.g., form a frustum) from the rim portion 248 to the opening 246 to guide an instrument toward the opening. The septum 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 side-to-side movement (e.g., perpendicular to an instrument insertion axis) of the puck assembly 220, which may protect the septum portion 243 of the septum seal 212 as an instrument is manipulated in a cannula or allow for greater range of motion or easier movement of an instrument shaft by a clinician or by a teleoperated surgical system controlled by a clinician.
The rim portion 248 may include one or more openings 260, which may be surrounded by a reinforcing structure 261 (e.g., a ring) as shown in
The construction of the puck assembly from the septum seal 212 with connected bellows portion 250, flaps, 202, 204, 206, 208 and upper and lower puck parts may advantageously provide a simple assembly procedure and simple overall puck assembly architecture. For example, forming the septum portion 243 and bellows portion 250 in a single part avoids a need to align the septum portion and bellows portions (as would be required if they were separate parts.) The assembly process may also be advantageously simple. For example, the septum seal 212 may be assembled over the lower puck part 230 with the protrusions 262 (e.g., pins) extending through the openings 260 in the septum seal 212. The flaps 202, 204, 206, 208 may assembled onto protrusions 267 (shown in
The puck assembly 220 may be assembled on top of the slit seal 222, as shown in
In some examples, the septum seal 212 may directly contact the slit seal 222. For example, the bellows portion 250 of the septum seal 212 may rest against the rim portion 268 of the slit seal. The seal-to-seal contact may create a seal to avoid leakage. The direct seal-to-seal contact may be advantageous for sealing, e.g., because the seal-to-seal contact (e.g., rubber (polyisoprene) to rubber contact) may provide a better sealing of the components than if another part (e.g., plastic or polycarbonate) was between the seals. The septum seal 212 may be sized and shaped to fit over the slit seal 222. The slit seal 222 may include an outer lip 282, which may rest against an outer lip 284 on the septum seal (as shown in
The seal 200 may be assembled onto a cannula 290, as shown in
The rim portion 268 of the slit seal 222 may include one or more retaining structures 316 (e.g., protrusion such as annular ring) sized and shaped to engage the lower housing part 224. For example, the retaining structure 316 may extend downward (distally) from the bottom side 318 of the rim portion and extend into a receiving space 320 (e.g., groove) on the lower housing part 224. The receiving space 320 may be defined by 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., include a gap in a ring) to accommodate an insufflation channel 317 (shown in
As shown in
A seal such as 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 that extends around an outer surface 342 of the lower housing part 224 and the O-ring (or other seal) may be in the channel and extend radially outward past the outer surface 342 so that the inner wall 330 of the cannula 290 seals against the O-ring 338. In some examples, the O-ring 338 may retain the lower housing part 224 in the cannula 290.
In some examples, the latch may 218 may also retain the seal 200 to the cannula 290. For example, a lower portion 344 of the latch 218 may be sized and shaped to engage an engagement feature (e.g., lip) on the cannula 290. In some examples, the latch may be spaced (as shown) from the lip to prevent the seal 200 from separating from the cannula 290 if the lower housing part slips upward in the cannula 290. In some examples, the lower portion 344 of the latch may be formed with a hook shape to reach below the engagement feature and engage an underside 348 of the engagement feature. The latch may include an inwardly-extending protrusion 350 that may avoid movement of the outer wall 258 of the bellows portion 250 from moving out the side of the cannula.
As shown in
The seal 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
The cannula mount 412 may include engagement feature 422, which may be a groove (as shown), or alternatively may be a lip or other structure. The engagement feature 422 may be sized and shaped to engage with the ridges 418 on the inside of the cap 402. The engagement feature 422 may extend all the way around the cannula mount 412 and may be have a consistent height, or the engagement feature 422 may be segmented or tapered, e.g. the engagement feature may be sized and shaped similar to the segmented tapered ridges 418 on the underside of the cap. Squeezing the cap 402 may cause the side portions to move outward as shown in
As shown in
The puck assembly 508 may include a septum seal 526 that may have an opening 528 for sealing against an instrument shaft (not shown in
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 compression forces exerted 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 retaining feature (e.g., a lip that engages a groove or another lip) on the slit seal may hold the puck assembly 508 in the receiving space 524, or a cap (not shown in
Persons of skill in the art will understand that any of the features described above may be combined with any of the other example features, as long as the features are not mutually exclusive. All possible combinations of features are contemplated, depending on clinical or other design requirements. In addition, if manipulating system units are combined into a single system (e.g., telesurgery system), each individual unit may have the same configuration of features, or, one manipulating system may have one configuration of features and another manipulating system may have a second, different configuration of features.
The examples (e.g., methods, systems, or devices) described herein may be applicable to surgical procedures, non-surgical medical procedures, diagnostic procedures, cosmetic procedures, and non-medical procedures or applications. The examples may also be applicable for training, or for obtaining information, such as imaging procedures. The examples may be applicable handling of tissue that has been removed from human or animal anatomies and will not be returned to a human or animal, or for use with human or animal cadavers. The examples may be used for industrial applications, general robotic uses, manipulation of non-tissue work pieces, as part of an artificial intelligence system, or in a transportation system.
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 present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round”, a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) still encompassed by this description. Coordinate systems or reference frames are provided for aiding explanation, and implantations may use other reference frames or coordinate systems other than those described herein.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be 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 interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description 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 scope of equivalents to which such claims are entitled.
This application claims the benefit of priority to U.S. Patent Application No. 62/671,862, filed on May 15, 2018, which is incorporated by reference herein in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2019/031393 | 5/8/2019 | WO | 00 |
Number | Date | Country | |
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62671862 | May 2018 | US |