SURGICAL ACCESS SYSTEMS
20200155196 ยท 2020-05-21
Inventors
- IAN DARISSE (SOUTHBOROUGH, MA, US)
- Pat Koczela (Bridgewater, MA, US)
- Liam O'Shea (Westwood, MA, US)
- Andras Pungor (Bridgewater, MA, US)
- Leland Witherspoon (Elk Grove, CA, US)
- David Zitnick (Warwick, RI, US)
- R. Maxwell Flaherty (Auburndale, FL, US)
- J. Christopher Flaherty (Auburndale, FL, US)
Cpc classification
A61B2017/2908
HUMAN NECESSITIES
A61B17/3423
HUMAN NECESSITIES
A61B2017/3466
HUMAN NECESSITIES
A61B90/50
HUMAN NECESSITIES
A61B34/76
HUMAN NECESSITIES
A61B2034/301
HUMAN NECESSITIES
A61B2017/00398
HUMAN NECESSITIES
International classification
Abstract
A system for performing a medical procedure at a target location of a patient, including: an articulating probe including at least a distal portion; a feeder configured to advance, retract, and steer the articulating probe; a first introducer attached to the feeder and configured to slidingly receive the articulating probe; and a second introducer for providing access to an internal location of the patient. The first introducer operably attaches to the second introducer, such that the articulating probe can be advanced through the second introducer to the target location. The system further includes at least one sealing element configured to maintain insufflation pressure at the target location.
Claims
1. A system for performing a medical procedure at a target location of a patient, comprising: an articulating probe comprising at least a distal portion; a feeder configured to advance, retract, and steer the articulating probe; a first introducer attached to the feeder and configured to slidingly receive the articulating probe; and a second introducer for providing access to an internal location of the patient; wherein the first introducer operably attaches to the second introducer, such that the articulating probe can be advanced through the first and second introducers to the target location; wherein the system further comprises at least one sealing element configured to maintain insufflation pressure at the target location.
2.- 229. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0182]
[0183]
[0184]
[0185]
[0186]
[0187]
[0188]
[0189]
[0190]
[0191]
[0192]
[0193]
[0194]
[0195]
[0196]
[0197]
[0198]
[0199]
[0200]
DETAILED DESCRIPTION OF THE DRAWINGS
[0201] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. The same reference numbers are used throughout the drawings to refer to the same or like parts.
[0202] It will be understood that the words comprising (and any form of comprising, such as comprise and comprises), having (and any form of having, such as have and has), including (and any form of including, such as includes and include) or containing (and any form of containing, such as contains and contain) when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
[0203] It will be further understood that, although the terms first, second, third etc. may be used herein to describe various limitations, elements, components, regions, layers and/or sections, these limitations, elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.
[0204] It will be further understood that when an element is referred to as being on, attached, connected or coupled to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being directly on, directly attached, directly connected or directly coupled to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g. between versus directly between, adjacent versus directly adjacent, etc.).
[0205] It will be further understood that when a first element is referred to as being in, on and/or within a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and/or internal surface of the second element; and combinations of one or more of these.
[0206] As used herein, the term proximate shall include locations relatively close to, on, in and/or within a referenced component or other location.
[0207] Spatially relative terms, such as beneath, below, lower, above, upper and the like may be used to describe an element and/or feature's relationship to another element(s) and/or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and/or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as below and/or beneath other elements or features would then be oriented above the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
[0208] The terms reduce, reducing, reduction and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence.
[0209] The term and/or where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example, A and/or B is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.
[0210] As described herein, room pressure shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term vacuum can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.
[0211] The term diameter where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term diameter shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.
[0212] The terms major axis and minor axis of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.
[0213] The term working channel where used herein is to be taken to include a lumen or other elongate space through which an elongate component such as an elongate tool, a guide tube or other tube, or other elongate element can be translated.
[0214] The term seal, and its iterations, where used herein is to be taken to describe an arrangement that prevents or at least limits leakage of a fluid (e.g. air or water) out of a space (e.g. an internal body space of a patient and/or a chamber of a device). A seal can describe a fluid-tight seal or a seal that simply limits egress of fluid. A seal can be provided by one or more sealing elements, such as an adhesive, 0-ring, gasket, and/or washer that provides a seal between two or more components, or between a component and tissue of a patient (e.g. tissue of an orifice of a patient). A sealed environment (also referred to as simply a seal) can be provided to allow one or more internal body locations of a patient to be insufflated, such as to distend tissue to enhance access to a target site within the patient. The seal can be configured to limit leakage of fluid from the sealed environment, such as to limit the number of times insufflation fluid needs to be delivered into the environment to maintain sufficient distension of the tissue. In some embodiments, a sufficient seal comprises a seal that limits leakage to a rate of no more than 5 L/min, no more than 4 L/min, no more than 3 L/min, and/or no more than 2 L/min (e.g. at an insufflation pressure between 0.2 psi and 0.4 psi, or approximately 0.3 psi).
[0215] The term pressurize, and its iterations, where used herein is to be taken to describe a process of providing a fluid to a defined volume, the volume constructed and arranged to maintain the fluid for at least a period of time such that a measurable pressure change occurs within the volume while and/or after the fluid is provided (i.e. the volume is capable of maintaining fluid pressure). For example, a pressurizable volume can comprise a volume within a component, having all openings from the volume sealed to limit fluid egress, and/or operably attached to one or more additional pressurizable volumes, the multiple pressurizable volumes defining a closed system, capable of maintaining a pressure.
[0216] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.
[0217] It is to be understood that at least some of the figures and descriptions of the disclosure concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive conceptse. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts , a description of such elements is not provided herein.
[0218] Provided herein are systems for providing access to a target site within a patient. The system can include one or more tools for performing a surgical, diagnostic, and/or other clinical procedure (surgical procedure herein) on the patient. Each of the components of the system of the present inventive concepts can comprise one or more sealing elements, such as to support an insufflation procedure (e.g. prevent or at least limit leaks of insufflation fluid from an insufflated area within the patient).
[0219] Referring now to
[0220] Articulating probe system 10 can be used to perform a surgical procedure at a target location within a patient's body cavity (e.g. a non-line of site surgical procedure via a natural orifice such as the anus or a percutaneously accessed location such as the abdomen), and provide sealed access into the orifice such that the cavity can be insufflated (e.g. by a component of system 10), without unwanted loss of significant insufflation through the access point or any component of system 10. In some embodiments, body introducer 400 provides sealed access to a location via an orifice selected from the group consisting of: the anus; the vagina; the meatus (distal end of the urethra); a nostril; the mouth; an ear; a surgical incision; and combinations of one or more of these.
[0221] Articulating probe 300 can comprise a multi-link probe including an inner probe comprising a set of inner links, and a surrounding outer probe comprising a set of outer links, such as is described in reference to applicant's co-pending U.S. patent application Ser. No. 15/378,723, filed Dec. 14, 2016, the contents of which are incorporated herein by reference in their entirety for all purposes, and/or as described in further detail herebelow in reference to
[0222] Console 50 can comprise a user interface 52 configured to receive commands from a surgeon, technician, and/or other operator of articulating probe system 10. User interface 52 can include one or more user input devices, such as a joystick, a multi axis input device, a mouse, a keyboard, and/or a touchscreen device. User interface 52 can further include one or more output devices, such as a monitor, speaker, haptic controller, and/or an indicator light. In some embodiments, console 50 includes one or more functional elements 59, such as a sensor or a transducer. Functional element 59 can comprise a sensor and/or a transducer. In some embodiments, functional element 59 comprises a sensor configured to produce a signal related to the proper operation of console 50. In some embodiments, functional element 59 comprises an element selected from the group consisting of: an accelerometer; a gyroscope; a pressure sensor; a flow meter; a source of pressurized fluid, such as insufflation gas; a pumping assembly for delivering and/or removing insufflation and/or other fluids; and combinations of one or more of these. In some embodiments, console 50 includes one or more conduits 51 (e.g. wires, optical fibers, fluid tubes, and the like) configured to operably attach console 50 to base unit 600.
[0223] Base unit 600 can include a processor 610, including one or more algorithms, algorithm 615, for execution by processor 610, which enables the operation of articulating probe system 10. Processor 610 can further include an image processing unit 616 for receiving and processing optical signals (e.g. signals received from one or more cameras) and/or other image data. In some embodiments, base unit 600 includes an electrical connector port, connector 642, configured to operably connect with a corresponding electrical connector, connector 112 of feeder 100. Electrical connectors 642,112 can comprise physical, optical, near field, RFID, magnetic, and/or other electrical connectors. In some embodiments, base unit 600 and/or console 50 is configured to identify (e.g. via electrical connector 642) one or more properties of an attached feeder 100. For example, base unit 600 and/or console 50 can identify a property selected from the group consisting of: the type of feeder 100 attached, for example a feeder intended for colorectal and or ENT use; a serial number; the number of procedures the feeder has been used in; other operational parameters of the feeder; and combinations of one or more of these. In some embodiments, console 50 and/or base unit 600 modifies and/or reconfigures one or more system parameters based on the identified properties of the attached feeder, such as to enable or disable specific modes of operation. Additionally, base unit 600 can include a camera connector port, camera port 643, configured to operably connect with a corresponding camera connector 383 of a camera assembly 380, as described herein. Base unit 600 can comprise one or more manipulation assemblies 660, manipulation assemblies 660a,b shown, configured to advance, retract, steer, and/or otherwise manipulate articulating probe 300.
[0224] Manipulation assembly 660a includes one or more gears 661 configured to engage with corresponding bobbins 111 of feeder 100. Steering cables 311,351 are each operably attached to a bobbin 111 (e.g. wrapped around), such that rotation of a bobbin 111 causes the tightening or loosening (pay out or take up) of the respective cable. Gears 661 are independently driven by manipulation assembly 660a, as instructed by processor 610, in response to one or more user inputs, to cause the rotation of bobbins 111, and subsequent manipulation of probe 300. Manipulation assembly 660b includes connectors 667,669 configured to engage with corresponding projections 317, 359 of feeder 100, respectively. Connectors 667 and 669 are independently linearly translated by manipulation assembly 660b, such as along one or more lead screws or other linear translation assemblies, as instructed by processor 610, in response to one or more user inputs, to cause the advancement of inner probe 310 and/or outer probe 350. In some embodiments, retraction of connector 667 and/or 669 causes the respective retraction of probe 310 and/or 350. Alternatively, connectors 667,669 provide a contact pushing force, but do not lockingly engage with projections 317,359, respectively, and a combination of retracting connectors 667,669 and tightening of the cables 311,351 is required to retract inner and outer probes 310, 350, respectively.
[0225] Base unit 600 can further include one or more alignment pins 644 constructed and arranged to align corresponding recesses 114 of feeder 100. Alignment pins 644 and recesses 114 can be employed at one or more locations along the interface between base unit 600 and feeder 100, such as to ensure alignment and stability between the two. In some embodiments, an alignment pin 644a is positioned adjacent electrical connector 642, and recess 114a is positioned adjacent electrical connector 112 of feeder 100, such as to ensure the alignment of connectors 642 and 112 when feeder 100 is operably attached to base unit 600. In some embodiments, recess 114a is positioned such that it aligns with a corresponding recess in electrical connector 112, such that alignment pin 644a engages electrical connector board 112 directly.
[0226] Introducer 200 can comprise a distal portion of feeder 100, and/or it can comprise a separate component that can be removably attached to a distal portion of feeder 100. Introducer 200 surrounds (i.e. defines) a chamber 205. Chamber 205 can comprise a pressurizable chamber, as described herein. Articulating probe 300 can extend through feeder 100 and into chamber 205, and exit the distal end of introducer 200. Feeder 100 can comprise one or more sealing elements, providing a seal between chamber 205 and the proximal portion of feeder 100, and establishing the proximal seal location for the surgical system when in use. Feeder 100 can comprise a sealed opening 213, which slidingly receives probe 300, and maintains a seal around probe 300 by sealing around sheath 352. In some embodiments, sealed opening 213 maintains a seal directly around probe 300 (e.g. without sheath 352). Introducer 200 can comprise one or more additional sealed openings, each configured to slidingly receive one or more elongate elements, such as sealed opening 223 shown. Sealed opening 223 can be configured to slidingly receive a cable, cable 382 of camera assembly 380, such as to allow camera cable 382 to translate through the proximal seal location while maintaining a seal. Alternatively or additionally, sealed opening 223 can be configured to slidingly receive an elongate element selected from the group consisting of: an electrical conduit; a fluid conduit; an optical fiber; a surgical tool; and combinations of one or more of these. In some embodiments, sealed openings 213, 223, and or other sealed openings described herein configured to slidingly receive an elongate object can comprise an element configured to at least one of increase the seal effectiveness and/or promote the translation of the elongate element through the opening (e.g. reduce friction). In some embodiments, this element can comprise a projection into (e.g. around the perimeter of) the sealed opening, such as an O-ring, a flexible flange, or the like. In some embodiments, this element can comprise a lubricious material, such as a silicone material with an impregnated lubricant.
[0227] Introducer 200 can include one or more guide tube access ports, ports 263, with attached connector 264 (263a,b and 264a,b shown), each port 263 configured to receive a tool guide, tool guides 510a,b, each comprising a rigid tube and a fluid tight proximal end. Connectors 264a,b can each comprise a flexible connector, such as to allow flexible positioning of tool guides 510a,b relative to introducer 200. Connectors 264a,b provide a seal to each tool guide 510a,b such as to maintain a seal about chamber 205. Tool guides 510a,b are slidingly received by connectors 264a,b, and projections from connectors 264a,b, projections 266a,b, maintain a seal between connectors 264a,b and tool guides 510a,b, respectively. Tool guides 510a,b can each comprise a proximal sealing element, seal assembly 530a,b, such as a duck bill valve or other sealing element configured to slidingly receive an elongate object while maintaining a seal around the object. Tool guides 510a,b can each slidingly receive a flexible tube, guide tubes 377a,b, operably attached to the distal end of probe 300, for example when guide tubes 377a,b are attached to a portion of a distal link assembly 370, working port 376a,b. Guide tubes 377a,b are attached to working ports 376a,b such that an elongate object, such as a flexible surgical tool, tool 20, can be slidingly received by a guide tube 377 and exit working port 376. Tool 20 can comprise a diameter of less than 6 mm, less than 4 mm, or less than 3 mm.
[0228] At least a portion of each of guide tubes 377a,b can translate within tool guides 510a,b, such that when probe 300 is advanced (e.g. away from tool guides 510a,b), the proximal ends of guide tubes 377a,b translate distally within tool guides 510a,b, respectively, and when probe 300 is retracted (e.g. towards tool guides 510a,b), the proximal ends of guide tubes 377a,b translate proximally within tool guides 510a,b, respectively. Tool guides 510a,b are each configured to also slidingly receive a tool 20. A tool 20 that is inserted into a tool guide 510, and through sealing assembly 530, is slidingly received by guide tube 377 (which is also slidingly received by tool guide 510). Tool 20 exits guide tube 377 at working port 376, which can be positioned at the distal end of probe 300. Tool 20, tool guides 510a,b, sealing assembly 530, and/or guide tube 377 can be constructed and arranged as is described herebelow in reference to
[0229] A distal portion of introducer 200 is configured to operably attach (e.g. in a sealed manner) to body introducer 400. Body introducer 400 can comprise an interior hollow portion, chamber 415, configured to fluidly attach to chamber 205 of introducer 200. Body introducer can further comprise a distal end 410, configured to operably attach (e.g. in a sealed manner) to a body orifice (e.g. a natural and/or surgically created orifice), such that chambers 205, 415 and the body cavity accessed via the body orifice establish a single, sealed environment. Chamber 415 can comprise a pressurizable chamber, as described herein. The single, sealed environment established by chambers 205, 415, and the body cavity can comprise a single, pressurizable chamber, as described herein. Body introducer 400 can comprise components configured to operably connect to an insufflation source and provide insufflation within chamber 415, insufflation port assembly 420. Insufflation port assembly 420 can comprise a luer or other connector configured to attach to a source of insufflation fluid, and a lumen from the connector (outside of chamber 415) to a location inside of chamber 415, such as a location proximate the distal end 410 of body introducer 400. In some embodiments, body introducer 400 further comprises a tool port, 465, operably attached to a lumen 466, each configured to slidingly receive an elongate element, such as a surgical tool with at least a flexible portion. Tool port 465 can comprise a valve, configured to seal tool port 465, and/or to seal around an elongate object positioned within tool port 465. In some embodiments, lumen 466 comprises a lumen within a wall of body introducer 400. The distal end of lumen 466 can be positioned proximate the distal end of body introducer 400, such that an inserted flexible tool exits lumen 466 proximate the distal end of body introducer 400. In some embodiments, lumen 466 comprises a curved or otherwise non-linear geometry.
[0230] Camera assembly 380 of system 10 comprises, at its distal end, a camera 381, operably attached to an image data conduit (e.g. a fiber optic conduit and/or a power and/or data carrying conduit), cable 382, terminating in connector 383, and configured to operably attach to camera port 643 of base unit 600. Camera 381 can be operably attached to distal link assembly 370, and cable 382 can be positioned along at least a portion of the length of probe 300. In some embodiments, cable 382 is removably attached to probe 300 with one or more attachment mechanisms, clips 361.
[0231] In some embodiments, introducer 200 comprises a housing 210, with a relatively large opening, and a cover 220 configured to attach to housing 210 and seal the opening, providing a seal about chamber 205. Introducer 200 can be constructed and arranged as described in detail herebelow in reference to
[0232] In some embodiments, system 10 comprises one or more sensors, transducers, and/or other functional elements such as functional elements 199, 299, 399, and/or 499 shown. Functional element 199 comprises one or more functional elements positioned in one or more chambers of feeder 100. Functional element 299 comprises one or more functional elements positioned in one or more chambers of introducer 200. Functional element 399 comprises one or more functional elements positioned in one or more chambers of probe 300. Functional element 499 comprises one or more functional elements positioned in one or more chambers of body introducer 400. In some embodiments, functional elements 199, 299, 399, and/or 499 comprise a sensor configured to produce a signal related to the status of insufflation and/or the status of tissue treatment. In these embodiments, functional elements 199, 299, 399, and/or 499 can comprise one or more sensors selected from the group consisting of: a pressure sensor such as a pressure sensor configured to measure insufflation pressure or a surrogate of insufflation pressure; a light sensor such as a light sensor configured to detect smoke; a position transducer such as an accelerometer or gyroscope configured to track the position of the distal or other portion of probe 300; an accelerometer; a flow sensor; and combinations of one or more of these.
[0233] In some embodiments, a sterile barrier can be provided between one or more portions and/or components of system 10, such as is described in reference to applicant's co-pending U.S. Provisional Application Ser. No. 62/504,175, filed May 10, 2017, the contents of which are incorporated herein by reference in their entirety for all purposes.
[0234] Referring now to
[0235] In some embodiments, base unit 600 comprises a base assembly 620 and a top assembly 630 that is removably attached to base assembly 620. Additionally, a first top assembly 630 can be replaced with another, such as a second top assembly 630, after one or more uses, such as in a disposable (e.g. single use) or resposable (e.g. multiple but limited use) manner. A use may include a single procedure performed on a single patient and/or multiple procedures performed on the same and/or multiple patients. In some embodiments, base assembly 620 and top assembly 630 are fixedly attached to one another (e.g. in a manufacturing process). Top assembly 630 can include a proximal portion 640, and a portion extending distally (e.g. towards the patient) from proximal portion 640, extension 650 with a distal end 651. Feeder 100 can be configured to removably attach to base unit 600, and can be replaced with another or second feeder 100, after one or more uses. In some embodiments, camera assembly 380 is configured to be used in two or more procedures (e.g. assembly 380 is cleaned and/or sterilized between procedures) and is removably installed to probe 300 and attached to base unit 600 at camera port 643 prior to use.
[0236] Base unit 600 includes a manipulation assembly 660a, such as is described hereabove in reference to
[0237] As shown in
[0238] In some embodiments, proximal portion 640 includes one or more alignment pins 644b constructed and arranged to align with corresponding recesses 114b of housing 110 of feeder 100. Alignment pins 644 and the corresponding receiving recesses 114 of housing 110 can be employed at one or more locations along the length of top assembly 630 and extension 650 to ensure alignment and stability with feeder 100 when attached to base unit 600. For example, alignment pins 644b can be employed at one or more locations on proximal portion 640 and alignment pins 644c can be employed at one or more locations on extension 650, as shown. Recesses 114b,114c can be positioned along the length of feeder 100 to correspond to alignment pins 644b, 644c. In some embodiments, extension 650 includes one or more release mechanisms, quick release buttons 652, near distal end 651, configured to release feeder 100 from base unit 600. The depression of quick release buttons 652, also referred to as emergency release buttons, disconnects feeder 100 from base unit 600.
[0239] Introducer 200 can be configured to removably attach to the distal end of feeder 100, and articulating probe 300 can extend from feeder 100 and through introducer 200. Introducer 200 includes a cover 220 and a connector 250. Cover 220 can comprise one or more retention elements, clip 224 shown, to releasably secure cover 220 to at least a portion of introducer 200, such as to cover an opening in introducer 200 and form/maintain chamber 205 within introducer 200 as described herein. Connector 250 comprises an upper portion 260 and a lower portion 270. Upper portion 260 can be fixedly attached to the housing of introducer 200, and provide a platform for locating one or more access ports, such as one or more ports 263 and/or tool ports 265. Lower portion 270 can comprise one or more rings 271, one or more projections 272, and one or more bellows 275 (such as those shown in an expanded state in
[0240] Instrument support 500 can comprise one or more tool guides 510 (tool guides 510a,b shown). In some embodiments, a support brace 501, also referred to as a dogbone connector, is coupled between the proximal ends of one or more tool guides, 510a,b shown. Support brace 501 can be constructed and arranged to maintain a relative position between tool guides 510a,b. As shown in
[0241] In some embodiments, instrument support 500 includes one or more attachment points 502 (attachment points 502a,b shown) constructed and arranged to removably attach instrument support 500 to a stabilizing brace (not shown). The stabilizing brace can be further attached to other locations related to articulating probe system 10, such as an operating room floor, the patient operating table, and/or feeder 100.
[0242] Referring additionally to
[0243] Probe 300 comprises inner probe 310, slidingly received within outer probe 350. Inner probe 310 can comprise a proximal segment 316 (e.g. an elongated proximal link), operably attached to the proximal-most articulating link 315 (link not shown) of inner probe 310. Inner proximal segment 316 can comprise a length such that segment 316 remains within a straight portion of housing 110 as probe 300 is extended from housing 110. Outer probe 350 can also comprise a proximal segment (e.g. an elongated proximal link), 356, operably attached to the proximal-most articulating link 355p, and comprising a length such that segment 356 remains within a straight portion of housing 110 as probe 300 is extended from housing 110. Inner proximal segment 316 and outer proximal segment 356 each comprise lengths such that inner segment 316 does not extend beyond the distal end of outer proximal segment 356 during the operation of probe 300. Projections 317, 359 each comprise projections from inner and outer proximal segments 316,356, respectively.
[0244] Proximal segment 356 can comprise an attachment point such as a depression, recess 357, where sheath 352 is sealed and fixedly attached near its proximal end to outer probe 350. In some embodiments, sheath 352 can be adhesively attached (e.g. glued) to recess 357, and/or sheath 352 can comprise a resilient (e.g. elastic) material configured to self-seal within recess 357. In some embodiments, the medial portion of sheath 352 slidingly receives outer probe 350, such that sheath 352 and links 355 of outer probe 350 are free to move relative to each other, and sheath 352 minimally affects the articulation of links 355 of outer probe 350. Sheath 352 can comprise a durometer of less than 90 A, such as less than 85 A, or less than 80 A, such that it minimally affects the articulation (e.g. steering) of links 355 of outer probe 350. Sheath 352 can comprise a thickness of less than 0.005, such as less than 0.004 or approximately 0.003. In
[0245] Outer probe 350 can comprise, along at least a distal portion, a cable management mechanism, for example clip strip 360, comprising a plurality of clips 361a,b, each comprising a recess 362, configured to axially receive and removably attach to cable 382 of camera assembly 380. In some embodiments, the plurality of clips comprises one or more retention clips, clips 361a, comprising a stiff material, configured so secure cable 382 to probe 300. The plurality of clips can also comprise one or more alignment clips, clips 361b, comprising a more flexible material (i.e. more flexible than clips 361a), configured to align cable 382 to probe 300 between retention clips 361a (clips 361a and 361b referred to collectively herein as clips 361). Prior to, during, and/or between surgical procedures, camera assembly 380 can be installed onto probe 300. Camera 381 can be removably attached to distal link assembly 370 of outer probe 350 (as shown), and cable 382 can be attached along at least a portion of the length of probe 300 to clip strip 360 (also as shown). Clip strip 360 is configured to maintain the position of cable 382 relative to probe 300 and to help prevent or at least limit unwanted slack in the cable from bunching or otherwise taking an unwanted orientation near the distal portion of probe 300 and preventing or at least limiting damage to cable 382. In some embodiments, clip strip 360 is fixedly attached to sheath 352. In some embodiments, outer proximal segment 356 of outer probe 350 comprises one or more retention mechanisms, clip 358 shown, for maintaining the position of cable 382 relative to a portion of probe 300.
[0246] Referring additionally to
[0247] Distal link assembly 370 can comprise a camera housing, housing 375, in which camera 381 can be positioned and secured. Camera 381 is shown secured in housing 375, with its lens oriented in a distal direction. Sheath 352 can be sealed to a distal-most link 355D of probe 300 and/or to housing 375, to provide the sealed configuration of probe 300. Seal 354 can comprise sheath 352 adhesively attached to distal-most link 355D, and/or a compression seal between sheath 352 and link 355o. In the embodiment shown, housing 375 comprises a solid proximal wall (e.g. a sealing surface), proximal wall 379, distal link 355o is sealed to housing 375 by sealing element 371 (e.g. a glue or filler type sealing element), and sheath 352 is sealed to distal link 355D, such that sheath 352, distal link 355D, sealing element 371, and proximal wall 379 function as distal sealing elements and establish a seal around the distal end of probe 300. Sheath 352, along with these distal sealing elements, define a chamber within which probe 300 resides, and is segregated from its insufflated surroundings. In some embodiments, probe 300 comprises one or more internal working channels, such as working channels 390 (not shown but such as are described herein in reference to
[0248] Distal link assembly 370 can include one or more working ports, ports 376a,b shown, each configured to attach to a working channel, removed for illustrative clarity, but as described herein.
[0249] Referring additionally to
[0250] Referring additionally to
[0251] Referring additionally to
[0252] In some embodiments, connector 450 includes a support arm 401 with an attachment point 402, constructed and arranged to removably attach body introducer 400 to a stabilizing brace (not shown). The stabilizing brace can be further attached to other locations related to articulating probe system 10, such as an operating room floor, the patient operating table, and/or feeder 100.
[0253] Referring now to
[0254] Instrument support 500, introducer 200, probe 300, and other components of system 10 can be of similar construction and arrangement to the similar components described hereabove in reference to
[0255] Instrument support 500 comprises a tool guide 510 that includes a flange, flange 511, configured to operably attach to connector 264, as described herein. Tool guide 510 can be fixedly attached to one or more other tool guides 510 via a support brace 501, such as is described hereabove in reference to
[0256] Instrument support 500 can further comprise an optional extension, adapter 540, configured to be positioned between support brace 501 and seal assembly 530, such as to extend the working length of tool guide 510. Adapter 540 comprises a housing 545, surrounding a lumen, with a distal end configured to be slidingly received within projection 503 of support brace 501. Adapter 540 further comprises a proximal end configured to be slidingly received by seal assembly 530. Adapter 540 can comprise an insert, sleeve 541, configured to provide a lubricious surface to the lumen within adapter 540. Adapter 540 can further comprise an 0-ring 542 configured to engage projections 503 (e.g. and provide a seal).
[0257] Upper portion 260 of introducer connector 250 can further include one or more ports 263. As shown, port 263 can comprise an opening 263, and a retention element, compression ring 263n. Connector 264 can be sealed to port 263 via compression of the distal end of connector 264 between upper portion 260 and compression ring 263n. Connector 264 can include a flared proximal end, funnel 269. As shown in
[0258] Connector 264 can include a projection 267 configured to frictionally engage a portion of flange 511, such that the interface of projection 267 and flange 511 creates a seal. Guide tube 377 can comprise a flared proximal end, funnel 378, and can be slidingly received by tool guide 510, when tool guide 510 is slidingly received by connector 264. Guide tube 377 extends through opening 263.sub.i, distally through bellows 275, lower portion 270, and body introducer 400 (not shown), and operably connects to working port 376 (port 376a shown), such that a tool 20, inserted into the proximal end of tool guide 510, traverses tool guide 510, into guide tube 377, and exits working port 376.
[0259] Upper portion 260 can further include one or more tool ports 265. Port 265 can comprise a valve 268, configured to slidingly receive an elongate element while maintaining a seal about the elongate element. Additionally or alternatively, valve 268 can maintain a seal limiting insufflation fluid from exiting port 265 when an elongate element is not positioned thru port 265.
[0260] Referring now to
[0261] In some embodiments, one mechanism starts limp and the other starts rigid. For the sake of explanation, assume outer probe 350 is rigid and inner probe 310 is limp, as seen in step 1 in
[0262] In medical applications, operation, procedures, and so on, once articulating probe 300 arrives at a desired location, the operator, such as a surgeon, can slide one or more tools through one or more working channels of outer probe 350, inner probe 310, or one or more working channels formed between outer probe 350 and inner probe 310, such as to perform various diagnostic and/or therapeutic procedures. In some embodiments, the channel is referred to as a working channel that can, for example, extend between first recesses formed in a system of outer links and second recesses formed in a system of inner links. Working channels may be included on the periphery of articulating probe 300, such as working channels comprising one or more radial projections extending from outer probe 350, these projections including one or more holes sized to slidingly receive one or more tools. As described with reference to other embodiments, working channels may be positioned on other locations extending from, on, in, and/or within articulating probe 300.
[0263] Inner probe 310 and/or outer probe 350 are steerable and inner probe 310 and outer probe 350 can each be made both rigid and limp, allowing articulating probe 300 to drive anywhere in three-dimensions while being self-supporting. Articulating probe 300 can remember each of its previous configurations and for this reason, articulating probe 300 can retract from and/or retrace to anywhere in a three-dimensional volume such as the intracavity spaces in the body of a patient such as a human patient.
[0264] Inner probe 310 and outer probe 350 each include a series of links, i.e. inner links 315 and outer links 355 respectively, that articulate relative to each other. In some embodiments, outer links 355 are used to steer and lock articulating probe 300, while inner links 315 are used to lock articulating probe 300. In a follow the leader fashion, while inner links 315 are locked, outer links 355 are advanced beyond the distal-most inner link 315D. Outer links 355 are steered into position by the system steering cables, and then locked by locking the steering cables. The cable of inner links 315 is then released and inner links 315 are advanced to follow outer links 355. The procedure progresses in this manner until a desired position and orientation are achieved. The combined inner links 315 and outer links 355 may include working channels for temporary or permanent insertion of tools at the surgery site. In some embodiments, the tools can advance with the links during positioning of articulating probe 300. In some embodiments, the tools can be inserted through the links following positioning of articulating probe 300.
[0265] One or more outer links 355 can be advanced beyond the distal-most inner link 315D prior to the initiation of an operator controlled steering maneuver, such that the quantity extending beyond the distal-most inner link 315D will collectively articulate based on steering commands. Multiple link steering can be used to reduce procedure time, such as when the specificity of single link steering is not required. In some embodiments, between 2 and 20 outer links can be selected for simultaneous steering, such as between 2 and 10 outer links or between 2 and 7 outer links. The number of links used to steer corresponds to achievable steering paths, with smaller numbers enabling more specificity of curvature of articulating probe 300. In some embodiments, an operator can select the number of links used for steering (e.g. to select between 1 and 10 links to be advanced prior to each steering maneuver).
[0266] Referring now to
[0267] In STEP 1040, articulating probe 300 is advanced in a follow the leader mode within the luminal pathway, such as is described hereabove in reference to
[0268] In some embodiments, algorithm 615 of processor 610 comprises one or more algorithms configured to determine the most efficient advance and/or retract mode for the commands received from a user. For example, algorithm 615 can be configured to determine the tortuosity of probe 300 (e.g. by remembering the steering commands received and calculating the overall shape of the probe when a target location is reached), and compare the tortuosity to a threshold, such as to determine the safety and/or efficiency of retracting in an advanced and/or a double limp mode. In some embodiments, for example when system 10 is being used in a procedure in which probe 300 is near and/or articulated around or behind the heart of the patient, algorithm 615 can prevent double limp advancement and/or retraction (e.g. as described hereabove). Alternatively or additionally, algorithm 615 can be configured to prevent enhanced follow the leader retraction (e.g. also as described hereabove) and/or other enhanced modes (e.g. other enhanced advancement and/or retraction of inner probe 310 and/or outer probe 350 configured to increase speed and/or reduce operator steps).
[0269] Referring now to
[0270] Referring now to
[0271] Outer links 355,355 can each comprise a tapered opening, tapers 3554,3554, respectively. Tapers 3554,3554 can be constructed and arranged such that the inner walls of links 355,355 do not interfere with inner probe 310 when probe 300 is in an articulated position (e.g. a minimum radius of curvature corresponding to a maximally articulated orientation), such as is described in reference to applicant's co-pending U.S. patent application Ser. No. 14/587,166, filed Dec. 31, 2014, the contents of which are incorporated herein by reference in their entirety for all purposes. Taper 3554 of distal outer links 355 can comprise an angle that is greater than the angle of taper 3554 of proximal outer links 355, such as a greater angle configured to accommodate a smaller radius of curvature achievable by distal outer links 355 (as described hereabove). In some embodiments, taper 3554 of distal outer links 355 comprises an angle that is at least 2, at least 5, or at least 10 greater than the angle of taper 3554 of proximal outer links 355. In some embodiments, angle is approximately 23.5 and angle is approximately 13.5.
[0272] Proximal outer links 355 can further comprise one or more anti-rotation features configured to prevent or at least limit axial rotation between adjacent proximal outer links 355. Proximal outer link 355 shown comprises slot 3553, configured to slidingly engage pin 3555, projecting from the articulating surface of an adjacent proximal outer link 355. The engagement of pin 3555 and slot 3553 limits axial rotation of adjacent proximal outer links 355 relative to each other. Links 355 can comprise one or more anti-rotation features similar to features described in reference to applicant's U.S. Pat. No. 9,572,628, filed Mar. 8, 2016, the contents of which are incorporated herein by reference in their entirety for all purposes. In some embodiments, distal links 355 do not comprise an anti-rotation feature (e.g. due to their limited quantity, and such as to simplify manufacture). In some embodiments, distal outer links 355 do comprise an anti-rotation feature (not shown), such as a similar or dissimilar anti-rotation feature as proximal outer links 355.
[0273] Outer links 355,355 can comprise one or more recesses, recesses 3551,3551 shown, respectively, configured to provide (in cooperation with mating recesses of inner links) working channels within probe 300, such as are described hereabove in reference to
[0274] Referring additionally to
[0275] Connector portion 450 comprises an opening constructed and arranged to receive probe 300. In some embodiments, the connector portion 450 is constructed and arranged to couple with a bellows 275. Bellows 275 can be of similar construction and arrangement to bellows 275 described hereabove in reference to
[0276] Introducer 4020 can further comprise a flexible portion 4121. Flexible portion 4121 can comprise an access conduit 4122 and an anchoring flange 4123. Distal link assembly 370 of probe 300 comprises a width configured to fit through (e.g. to be advanced through) access conduit 4122.
[0277] In some embodiments, flexible portion 4121 is collapsible to allow for easier insertion into the patient. Upon insertion into the body, access conduit 4122 can apply an outward radial force on the body. In some embodiments, access conduit 4122 applies an outward radial force on the sphincter. This application of force allows the muscles to loosen gradually and thereby reduce trauma to tissue of the patient, as opposed to a rigid body introducer which requires dilation of tissue in the process of gaining access.
[0278] The distal end of flexible portion 4121 can comprise an anchoring flange 4123. Anchoring flange 4123 maintains the placement of body introducer 4020 within the patient.
[0279] The force applied by flexible portion 4121 can be modified by adjusting characteristics of flexible portion 4121, such as by varying materials of construction and/or cross-sectional area. For example, the rigidity of the material can be selected to provide an appropriate resistance to sphincter contraction, while still allowing for collapse during insertion into the patient. The cross-sectional dimensions of flange 4123, access conduit region 4122, and flexible portion 4121 can be selected for different patient parameters, such as body configuration and age and the like. In some embodiments, one or more of flange 4123, access conduit region 4122, and/or flexible portion 4121 comprise a circular cross-section. In some embodiments, one or more of flange 4123, access conduit region 4122, and/or flexible portion 4121 comprise an oval or elliptical cross-section. Similarly, the length L of access conduit region 4122 can be selected to accommodate one or more patient parameters.
[0280] In some embodiments, a rigid portion 4128 couples flexible portion 4121 to connector portion 450. In some embodiments, flexible portion 4121 is sealed to the connector portion 450, such as to support an insufflation procedure. In some embodiments, rigid portion 4128 is directly connected to flexible portion 4121. In some embodiments, introducer 4020 includes one or more insufflation ports, such as port 4125 shown.
[0281] In some embodiments, connector portion 450 includes a support arm 401 constructed and arranged to removably attach introducer 4020 to a stabilizing brace (not shown). The stabilizing brace can be further attached to other locations related to articulating probe system 10, such as an operating room floor, the patient operating table, and/or feeder 100.
[0282] In some embodiments, introducer 4020 comprises a rigid introducer portion (e.g. a standard non-flexible rectoscope) and a flexible portion 4121, each interchangeably attachable to rigid portion 4128 and bellows 275. In these embodiments, a user of system 10 can choose which introducer portion to use (e.g. rigid or flexible) at the time of a procedure.
[0283] Referring additionally to
[0284] When inserting adapter 4130, the tension on sleeve 4132 between anchoring ring 4133 and roller 4136 is selected to be sufficiently low to allow the orientation of anchoring ring 4133 to be adjusted. In some embodiments, once anchoring ring 4133 is positioned within the patient (for example, positioned on the interior wall of the sphincter), sleeve 4132 can be pulled in the proximal direction (e.g. manually pulled or pulled with mechanical assistance), such that sleeve 4132 passes between roller 4136 and locking collar 4135. As sleeve 4132 is pulled in the proximal direction, sleeve 4132 drives rollers 4136 against spring plate 4137, creating room for sleeve 4132 to pass. During this process, spring plates 4137 can push back on rollers 4136, pinching sleeve 4132 against locking collar 4135, and thereby ensuring tension on sleeve 4132 between anchoring ring 4133 and rollers 4136. In some embodiments, rollers 4136 are arranged to rotate only in a single direction, thereby ensuring that the tension on sleeve 4132 between rollers 4136 and anchoring ring 4133 does not change unexpectedly. In some embodiments, as the tension on sleeve 4132 between rollers 4136 and anchoring ring 4133 increases, the outward radial force on sleeve 4132 increases, causing the diameter of sleeve 4132 to dilate. To release sleeve 4132, locking ring 4135 can be removed, allowing sleeve 4132 to pass over rollers 4136 in the distal direction. In some embodiments, adapter 4130 is configured to seal against a rectoscope or other ports. In some embodiments, the path of rollers 4136 comprises a surface comprising an acute angle to the corresponding surface on locking ring 4135, which pinches sleeve 4132.
[0285] Referring additionally to
[0286] In the embodiment shown in
[0287] In some embodiments, body introducer 400 includes a support arm 401, which can be constructed and arranged to removably attach body introducer 400 to a stabilizing brace (not shown). The stabilizing brace can be further attached to other locations related to articulating probe system 10, such as an operating room floor, the patient operating table, and/or feeder 100.
[0288] Referring additionally to
[0289] Brace 5101, also referred to herein as a dogbone connector, can be coupled between the proximal ends of one or more tool guides 510. Brace 5101 can be constructed and arranged to maintain a relative position between tool guides 510. As shown in
[0290] Tool guides 510 can connect to ports 263 of introducer 200 as previously described. In some embodiments, a distal portion of tool guide 510 comprises a bend region 513, such that when tool guides 510 are coupled to instrument support 5101, the distal portions 518 extend along an axis orthogonal to tool ports 265. Tool guides 510 can each comprise a sealing segment, segment 517, located between a radial projection, proximal stop 519, and bend region 513. Segments 517 can comprise an outer diameter configured to slidingly seal to projection 267 of sealing element 264 (not shown, but described hereabove in reference to
[0291] In some embodiments, instrument support 5100 includes one or more attachment points 502 constructed and arranged to removably attach instrument support 5100 to a stabilizing brace (not shown). The stabilizing brace can be further attached to other locations related to articulating probe system 10, such as an operating room floor, the patient operating table, and/or feeder 100.
[0292] Referring additionally to
[0293] Referring additionally to
[0294] In some embodiments, the shaped brace 5101 comprises a curved geometry in a plane transverse to an axis of extension of a first tool guide 510 and an axis of extension of a second tool guide 510. The curved geometry in the shaped brace 5101 creates a viewing space region 5111 between the first and second tool guides 510. In some embodiments, the viewing space region 5111 is positioned along a center line taken between the proximal ends of the first and second tool guides 510. At the same time, as shown in the embodiment of
[0295] In some embodiments, the first tool guide 510 and second tool guide 510 include proximal portions extending at a non-zero angle, for example an acute or obtuse angle, with respect to each other. For example, upper portions of the guides 510 of the embodiment of
[0296] Referring additionally to
[0297] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which is defined in the accompanying claims.