The present application claims the benefit of priority under 35USC 11 (e) from U.S. provisional application serial No. 61/384288, applied on 9/19/2010, and U.S. provisional application serial No. 61/493423, applied on 6/4/2011, both entitled "micro-laparoscopic system and method".
The contents of the above documents, as if fully set forth herein, are incorporated by reference.
Disclosure of Invention
According to a broad scope of some embodiments, there is provided an apparatus for reverse unblocking an access closure at a laparoscopic access port and providing a continuous passage between the laparoscopic access port and a remote location within a body cavity. In some embodiments, the laparoscopic port may be applied for deployment over the abdominal cavity.
In one aspect of some embodiments, a laparoscopic system is provided that may be adapted to deploy a detachable end-effector to the end of the needle portion of the needle unit. In some embodiments, the system includes a laparoscopic port and at least one of: (1) reverse access closure, (2) catheter, (3) needle unit containing needle, optionally proximal to needle, (4) needle strengthening device for strengthening needle, and (5) laparoscopic element retractor. In some embodiments, the catheter is adapted to capture the distal end of the needle portion, whereby the distal end is pushed to the external environment through said catheter, thus allowing the end-effector to be deployed to the distal end of the needle portion. In some embodiments, the camera head is detachably connected to the distal portion of the second needle unit.
In one aspect of some embodiments, a catheter is provided that includes an elongated tubular member having an outer diameter adapted to fit within a lumen of a laparoscopic port having a port closure, the elongated tubular member being introducible through the laparoscopic port while reversing the port closure. In some embodiments, the elongated tube member comprises at least one lumen extending axially from one distal opening to one adjacent opening. In some embodiments, the at least one lumen is adapted to receive a laparoscopic device from the distal opening and/or the proximal opening. The laparoscopic device may comprise at least one capturing member, a visualization system, a suction tube and a needle portion, optionally a distal needle portion. The at least one lumen may comprise a minimum diameter of equal to or greater than 2mm, optionally equal to or greater than 5 mm. In some embodiments, the elongated tubular member is telescopically extendable to any position of the distal end of the needle portion, thereby providing a passage between the distal end of the needle portion and the laparoscopic port.
In some embodiments, the elongate tubular body is provided with means for selectively securing it in a selected degree of space within a body lumen.
In one aspect of some embodiments, a closure member is provided that can be deployed in a laparoscopic port, a catheter, an elongated tubular member, and/or any of its lumens. In some embodiments, the closure member is a reverse portal closure constructed to be deployed in a laparoscopic portal and assembled for closing a direction from a distal opening to a proximal opening in the laparoscopic portal, whereby a sealed passageway is provided between the body cavity and the extracorporeal environment.
The closure member may be positionable in the lumens and may include a plug, a cover, a sliding means in at least one of the lumens while covering at least a portion of its cross-section. In some embodiments, the closing member is arranged for closing a direction from the distal opening to the proximal opening. Optionally, the closure member comprises at least one closure member (e.g., a flap-like member hingedly supported in the lumen) adapted to detach, and/or otherwise reversibly disengage, in one or both directions of travel from the distal end to the proximal end.
In some embodiments, the closure member comprises a plug adapted to fit snugly within an adjacent entry port of the lumen, which plug may be closed or may comprise a minimal opening sized to fit snugly within a laparoscopic device, such as a slender endoscopic and/or surgical instrument, thereby minimizing or completely avoiding migration of gas through the laparoscopic entry port and/or catheter, or any lumen thereof. The catheter may be provided as a kit comprising a plurality of plugs differentiated by passive sealing properties and/or by the size of their openings.
In some embodiments, the elongate tube member includes at least two lumens adapted to receive at least two parallel laparoscopic devices. In some embodiments, the first lumen includes a first proximal opening coaxial with its first distal opening and the second lumen contains a second proximal opening at an angle to its second opening. The catheter may be provided as a kit comprising a rigid endoscope adapted to fit within the first lumen, and a flexible tube adapted to fit within the second lumen, optionally connectable to a fluid inhaler and/or pressurizing means.
In some embodiments, the elongated tube member has a maximized extension length to reach the needle portion at its entrance, upon which the elongated tube member is telescopically extendable to a farthest position on the opposite wall portion within the body cavity. The elongated tubular member of the present invention may be substantially straight and/or bendable to a selected shape between the laparoscopic port and a selected position adjacent to or on the body cavity wall portion.
Features located at a distal portion of the elongate tubular member, or provided thereby, may be used to simplify, facilitate and/or control the capture and optional insertion of the needle portion therein. In one aspect of some embodiments, there is provided a laparoscopic system, a selectively operable capturing member adapted to capture an end portion of a needle extending from an entry point into a body cavity away from a laparoscopic port performing site in the body cavity. In some embodiments, the capture member comprises an elongated member having an extendable and/or contractible end portion.
In some embodiments, the laparoscopic device of the present invention may be introduced into an elongated tubular member lumen, and in some embodiments, the laparoscopic device is provided at a remote location within the body cavity and is a distal opening insertable into the lumen. Such a distally insertable laparoscopic device may comprise a maximum diameter of equal to or less than 3 mm. Alternatively, the laparoscopic device is provided at a laparoscopic port and comprises a maximum diameter of 10mm or less, optionally 5mm or less.
In some embodiments, the laparoscopic device comprises an elongated slender body and a retractable member (e.g., a ring, a lasso, a grasper, or a magnet), and optionally the retractable member of the laparoscopic device is adapted to at least one of the following: through the distal opening, the distal end of the needle portion is captured, collapsed and guided into the elongated tube member out of the proximal opening.
In some embodiments, the distal end of the elongated tubular member includes a portion including a selectively extendable or retractable edge for guiding the needle portion into the elongated tubular member and out through the closure member. In some embodiments, the extendable and/or contractible edge is at least partially funnel-shaped when selectively alterable by extension and/or use of the drive device. In some embodiments, the extendable and/or contractible edge includes an inextensible proximal end and an extensible distal end. In some embodiments, the extendable and/or contractible edge includes a distal extendable portion that may extend to at least twice the diameter of the non-extendable proximal end or to a maximum diameter equal to or greater than 20 mm.
In some embodiments, the drive member for the selectively extendable and/or contractible edge may comprise an outer tube portion that is slidable over a snug inner tube portion, and the outer tube portion is adapted to selectively cover or uncover the extendable and/or contractible edge portion. Optionally, the extendable and/or contractible edge is self-expandable to an expanded state and/or contractible, optionally cylindrical, state. In some embodiments, the extendable and/or contractible edge comprises an iris diaphragm comprising a plurality of overlapping flap-like members. Optionally, additionally or alternatively, the extendable and/or contractible edge includes a substantial amount of curl, thereby allowing for a uniform fold from a funnel-shaped shape to a cylindrical shape. Additionally or alternatively, the extendable and/or contractible edge includes a smooth surface to facilitate unimpeded sliding of the needle portion into the elongated tubular member while adjusting the longitudinal axis of the needle portion. Optionally, the smooth surface is adapted to resist cleaving by a sharp needle tip.
In some embodiments, at least one of the nozzles is arranged with a visualization system, such as an endoscope. Alternatively or additionally, other visual means may be introduced into the body cavity, such as a camera (e.g. a removably attached camera placed at the end of the second needle), possibly for monitoring the deployment process and/or any of its steps, including positioning the needle portion and/or its entry point into the body cavity, mounting the needle portion, dropping it and pulling/pushing it through the catheter.
In one aspect of some embodiments, a laparoscopic system is provided for deploying a detachable laparoscopic end effector to a distal end of an elongated shaft manipulator. In some embodiments, the system includes a cannula for providing a sealable passage between the body cavity and the extracorporeal environment. In some embodiments, the laparoscopic system includes a capture member provided through the cannula and adapted to access the catheter, capture the distal end and pull it out of the body cavity through the cannula to an extracorporeal environment, whereby a detachable laparoscopic end sensor may be deployed to the distal end under direct visualization. In some embodiments, the catch member comprises at least one loop, optionally two loops. In some embodiments, there is at least one ring to which the component is bonded or attached.
In some embodiments, a detachable camera is provided that is attachable to an elongated manipulator and is maneuverable within a body cavity to a direct-view angle at which the distal end is captured and/or pulled out.
In an aspect of some embodiments, a needle strengthening device is provided, the device comprising a plurality of telescopically connected tubular members, wherein the plurality of telescopically connected tubular members are axially slidably arranged and the plurality of telescopically connected tubular members are lumens adapted to at least partially accommodate needle portions in a needle unit. In some embodiments, the needle-like reinforcement device includes a connector for connecting adjacent implements in the needle unit. Optionally, additionally or alternatively, the needle-like strengthening device comprises a distal end having a protruding edge-like surface adapted to approach the skin surface. In some embodiments, the protruding rim-like surface is adapted to continuously approach and/or engage the skin surface in use. The protruding rim-like surface may comprise a binding element to the skin surface. In some embodiments, the plurality of telescopically connected tubular members are self-expanding to a state of maximum extension. Optionally, additionally or alternatively, the plurality of telescopically coupled tubular members are fixedly extendable or retractable to a selected length, and in some embodiments may be provided as a laparoscopic device retractor, further comprising a grasper adapted to grasp human tissue, and/or a device attachable or readily attachable to a needle unit.
In an aspect of some embodiments, there is provided a method of deploying a detachable end-effector to a distal end of a needle portion of a needle unit, the method comprising at least one of the following steps: providing a laparoscopic port having a port sealing member; filling gas into the body cavity; introducing a conduit of an elongated tubular member through a laparoscopic port while reversibly deactivating the port sealing element; telescopically adjusting the catheter to access the distal end of the needle portion to create a passage between the needle portion and the laparoscopic port; passing the distal end through the catheter to an extracorporeal environment by passing a second sealing member disposed in the lumen of the catheter; and deploying the tip inductor to a distal end of the needle portion.
The method may include a step of capturing the distal end of the needle portion and pulling it into the catheter. The capture is achieved by using a capture member comprising an extendable and/or contractible edge, but the capture member comprises at least one loop, a snare, a grasper and a magnet.
The method may include a step of withdrawing the distal end with the end-effector into the body cavity.
The method may include a step of removing the catheter prior to deployment of the end-effector, whereby the needle portion is received in a laparoscopic port sealed by the port sealing member.
In one aspect of some embodiments, there is provided a method of deploying a laparoscopic system within a body cavity, the laparoscopic system including an elongated shaft manipulator having a distal end and a detachable laparoscopic end effector connectable to said distal end, said method comprising at least one of the following steps: providing a laparoscopic port; filling a body cavity with a gas satisfying a selected expansion volume; providing a reverse seal element at the laparoscopic port, thereby allowing a sealed passage from the body cavity through it to the extracorporeal environment; delivering the distal end from the body cavity through the laparoscopic port to the extracorporeal environment, and mounting a detachable laparoscopic end effector at the distal end.
In some embodiments, the reverse seal component prevents excessive movement of gas from the body cavity through the laparoscopic port, thereby maintaining a selected inflation volume during deployment.
The method may comprise at least: providing a channel at the laparoscopic port and the distal end, said channel having a length allowing extension to the distal end, and a lumen extending through the length sized to accommodate movement of the distal end therethrough; and providing a channel with a distal end, thereby providing a closed channel through the laparoscopic port.
In one aspect of some embodiments, there is provided a method of connecting a detachable end-effector to a distal end of an elongate shaft-like manipulator, comprising at least one of the following steps: inserting the distal end into the body cavity through the first opening; inserting a catheter through the sealing sheath disposed at the second opening, the extension catheter engaging the distal end; delivering the distal end to an extracorporeal environment through the sheath; and attaching the detachable end-effector to the distal end. In some embodiments, the catheter comprises an extendable distal end and the method comprises the step of extending the edge of the catheter.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments, example methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
Detailed Description
It is of course understood that the invention is not limited to the particular methodology, protocols, reagents, etc. described herein as these may vary as recognized by the skilled artisan. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. Also, it is noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The embodiments of the invention and the various features and specific advantages thereof are explained in more detail with reference to non-limiting embodiments and examples that are depicted and/or described in connection with the accompanying drawings and detailed below. It should be noted that the features depicted in the drawings are not necessarily drawn to scale and features of one embodiment may be employed by other embodiments as deemed necessary by the skilled artisan, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the invention. The embodiments used herein are intended merely to facilitate an understanding of ways in which the invention may be practiced and to further enable those of skill in the art to practice the invention. Accordingly, the examples and embodiments herein should not be used to limit the scope of the invention, which is defined only by the following claims and their legal equivalents. Moreover, it should be noted that like reference numerals refer to like parts throughout the different views of the drawings.
For purposes of illustration and understanding, the following preferred embodiment may be described in the context of a typical laparoscopic surgery. However, the invention is not limited to the specifically described apparatus and methods and may be applied to a wide variety of clinical applications without departing from the overall scope of the invention. For example, devices and related methods, including concepts described herein, may be used to deploy and/or operate surgical treatment systems and/or devices, such as, but not limited to, gynecological procedures, thoracic procedures, abdominal procedures, orthopedic procedures, minimally invasive surgical procedures in general, and others.
The present invention relates generally to a system and method for performing surgery and, more particularly, to a method and apparatus for laparoscopic surgery. According to a broad aspect of some embodiments, there is provided an apparatus for reverse unblocking an access port enclosure at a laparoscopic access port and providing a continuous passage between the laparoscopic access port and a remote location within a body cavity. In some embodiments, the laparoscopic port may be applied for deployment over the abdominal cavity.
In one aspect, some embodiments of the present invention relate to a method and surgical technique for providing an enclosed passageway for easy and safe movement of a tissue sensing device from within a body cavity to an environment outside the body. An enclosed channel may be any guided and/or channeled device (e.g., a catheter) having a constant or variable cross-section and/or shape, and/or which is disposed at least along a portion of its length at a generally enclosed portal, such as a laparoscopic portal connecting a body cavity and an extracorporeal environment.
The tissue sensing device may be any surgical instrument or other device that may actively or passively injure, modify, or otherwise act upon living tissue, directly contact, and/or when operated upon, such as a surgical needle or other elongated instrument that includes a sharp or blunt distal tip. The tissue sensing device may be provided as an end effector that is removably attachable to the distal end of the operating rod, such as a needle portion of a needle unit.
In the present invention, "distal" shall mean away from the manipulating hand and towards or within the patient's body, whereas "proximal" shall mean adjacent to the manipulator and away from the interior of the body. The distal portion, the tail or the tip of the needle, in the present invention, comprises a manipulator capable of manual or mechanized manipulation, which comprises a thin rod or tubular rod connected or capable of detachable connection with a surgical tool (e.g., a replaceable surgical head). An enclosed channel, according to the present invention, should facilitate movement of an empty, steerable elongate shaft from a first access point or port into a body cavity or chamber and through a second, remote port to an extracorporeal environment, while minimizing or completely avoiding interference with any tissue or internal organs. When the distal end of the manipulator shaft is planned outside the body, it may then be deployed, functionalized, or attached to the surgical device head, and then pulled back into the body cavity.
In addition to safety considerations, the occlusive device may alternatively or additionally provide a selected path or route for the tissue sensing device to traverse, thereby mitigating and controlling its movement from the in vivo to the in vitro environment.
Alternatively, or additionally, an enclosed passageway may be provided that is enclosed and/or selectively sealable at least during the separate tissue sensing movement. In abdominal related procedures (e.g., laparoscopic procedures), it is common practice to inflate the abdominal cavity with an inert gas to maintain sufficient inflation, thereby separating the internal organs or other tissues from one another in order to allow more room for surgery and tool manipulation and movement. In laparoscopy, a cannula or access port is then provided with a sealing method that allows insertion and removal of endoscopes, surgical devices, aspirators and other devices through that port from outside the body with minimal or no gas leakage. However, in embodiments of the present invention, the portal sealing means may be compromised or rendered ineffective and may even become lodged therein by a known, common or commercially available laparoscopic portal reverse-direction movement device. Thus, a closed channel of the present invention may be used to pass, bypass and/or relieve or alter the sealing means of a laparoscopic port to a low back channel, and/or help provide a selectively and/or continuously closed environment to enable the device to be moved from inside and outside the body.
In some embodiments, the closed channel of the present invention can be used to facilitate connection to an access port from and between the access port (e.g., a laparoscopic access port) and any selected location within a body cavity. In some embodiments, the enclosed channel is extendable or configurable between at least two remotely spaced portals, incisions or otherwise, in a single body cavity, such as an abdominal cavity entry area. Accordingly, it may be advantageous to use the tissue sensing device to precisely protrude the body lumen out of the body lumen, and to bite and/or entrap it with and/or within the enclosed channel, thereby avoiding equally sharing the smallest smaller/unsafe and/or smaller/uncontrolled excursions within the body lumen. In some embodiments, the addition of a capture or catching member may serve to ease, enhance and/or control the engagement, connection, transport and/or adjustment of a tissue sensing device associated with or entering an enclosed passageway portal. Such a capture member may be attached to or part of the distal end entrance of the closed channel and may be, for example, an extendable entrance that may or may not be shaped to a shape (e.g., funnel-shaped) that improves the inward passage of the capture device. Additionally or alternatively, the capture member may be introduced away from, along, or through a closed channel for capture. The capture may be passive (e.g., in the case of expanding a distal end inlet to a funnel-type) or active (e.g., providing a selectively compressible, graspable or looped member (e.g., snare) to actively connect to and trap the target device within the body cavity).
Other possibilities for assisting deployment, delivery, control and monitoring, and/or for surgical methods are also described.
Referring to the drawings, FIGS. 1A-D depict various stages of deployment of a first exemplary micro-laparoscopic system 1000 depicted schematically, in accordance with an exemplary embodiment of the present invention. The system 1000 is deployed prior to application within a body cavity, optionally the abdominal cavity ABD. System 1000 comprises a laparoscopic working channel, trocar or portal, referenced as sheath 1100, and at least one hand-held mini-laparoscopic manipulator, referenced as needle unit 1200. Needle unit 1200 includes a needle portion 1210 and a lever 1220. Needle portion 1210 is configured to be attached at its distal end to a detachable and/or replaceable surgical end effector or tool 1300 (shown in fig. 1C).
In fig. 1A, sheath 1100 and needle unit 1200 are placed after insertion into abdominal cavity ABD and before connection tool 1300. Optionally, sheath 1100 carries an endoscope (not shown in the figures) therein for visualization, and optionally connects a trocar and/or other sharp component provided to establish penetration. To connect tool 1300 to the distal end of needle portion 1210, the surgeon may pass it through the lumen of sheath 1100, through the endoscope facing (or "toward his eye" as shown on the controller), to the external body environment (as shown in fig. 1B). The endoscope is removed before or during passage of needle portion 1210 through sheath 1100. Next, as shown in fig. 1C, tool 1300 is optionally manually attached to needle portion 1210, and needle unit 1200 is then pulled back into abdominal cavity ABD with tool 1300, and the surgical procedure or step can begin. Alternatively or additionally, sheath 1100 may be used to deliver resected body tissue via use of needle portion 1210 and tool 1300.
The tool 1300 may be any operable element (e.g., a probe or instrument) that is deployable within the body, including but not limited to: surgical tools, grasping elements, dissectors, stylus holders, forceps, scissors, attaching (e.g., stapling) elements, biopsy related instruments, sensing elements, imaging elements, forceps, cutting elements or grasping devices, probes capable of generating heat (including RF, laser, IR, light, etc.), cryosurgical probes, illumination element cutting and dissecting devices or energy sources, ultrasound probes, cameras or other imaging probes, lenses, lens barrels, or any other optical instrument, and the like.
In some embodiments, sheath 1100 includes an air-tight two-way valve or other sealing device (not shown) that can allow instruments to pass therethrough in both directions, completely or significantly without air/gas (typically but not necessarily-CO) that previously and/or continuously introduced into body cavity ABD2) Is lost. Such a sealing device should be removed or deactivated when the needle or other elongate rod-like component is slid from the proximal segment to the distal end, or from the distal end to the proximal end, and snapped in as it is moved. The definition of "airtight" or "sealed" in relation to an inlet, lumen, channel, valve or any other means allowing direct communication between or including a body cavity (e.g. abdominal cavity, stomach or otherwise) and the external environment (e.g. outside the patient's body) refers in the present invention to either a substantially closed channel through which gas is transported from the body cavity to the external environment, or to a reduction in its flow rate to substantially equal the rate of expansion of the gas supplied to the body cavity continuously or successively by the auxiliary component.
Sheath 1100 may be of any preferred size and is typically 3-20mm in diameter, optionally about 10mm or 12mm in diameter (e.g., similar in size to a typical laparoscopic port). Sheath 1100 can be sized (e.g., smallest cross-section) to accommodate the largest surgical tool in a particular set of tools. In some embodiments, system 1000 includes a single, normal-size laparoscopic port that may be used for insertion of tool 1300 into the body and/or attachment of needle unit 1200.
In some embodiments, needle portion 1210 includes a distal tip. The largest cross-section of the needle portion and tip may be 0.5-5mm in diameter, alternatively 1-2.5mm, alternatively around 1mm, around 1.5mm or around 2mm or more or less or in the intermediate range. The needle tip is optionally sharp and/or pointed in order to allow penetration of at least one tissue and easier coupling with the tool 1300. Optionally, the needle tip is a pneumoperitoneum needle that can selectively penetrate skin and abdominal wall tissue while preventing internal organs (e.g., bowel) from being injured when not "shielded". Alternatively, the needle tip is substantially blunt. Optionally, needle portion 1210 includes interlocking features, such as threads or grooves (not shown) for snap locks, or by any friction, compression or other means known in the art, for tight attachment to tool 1300. Handle 1220 may be any manually operated type of laparoscopic instrument handle, or may be replaced by any automated or other non-manually operated arm. In some embodiments, the handle 1220 includes manipulation tool 1300 mechanisms and/or combinations thereof (e.g., locking or releasing modes or operations).
At least part of the instrument is made of a rigid biocompatible material known to those skilled in the art and may comprise stainless steel, optionally hardened or reinforced by a carbon coating or carbon fiber, a ceramic material, a plastic/polymer material (e.g., polyetheretherketone), a composite material (e.g., carbon-epoxy), or any combination thereof.
In some embodiments, the system 1000 further comprises at least one, optionally at least two, surgical imaging devices (e.g., a microscopic camera and/or an endoscope). Optionally, a master microscopic camera is introduced into the body through sheath 1100 and attached to one of needle units 1200, positioned in a preferred location to monitor the surgical procedure and/or system deployment. Other microscopy cameras and/or endoscopes may be deployed elsewhere with different manipulators.
In some cases, the method of manipulating needle unit 1200 until positioning and delivery through sheath 1100 may be difficult, time consuming and/or unsafe because of the potential for the needle to injure adjacent tissue. Referring to fig. 2A-B, a second, schematically depicted, different (incomplete) deployment phase of a typical micro-laparoscopic system is illustrated, in accordance with an exemplary embodiment of the present invention. In this embodiment, a new instrument, called catheter 1400, is employed to help position and guide the distal end of needle portion 1200 therethrough and into the extracorporeal environment in a safer manner. Catheter 1400 is telescopically introduced through sheath 1100 and delivered into abdominal wall ABD until it is adjacent the distal end of needle portion 1210 (as shown in fig. 2A). Needle portion 1210 may then be inserted into a lumen opening (not shown) of catheter 1400 until it protrudes outward into the extracorporeal environment (as shown in fig. 2B) for safe and easy placement of tool 1300, as previously depicted in fig. 1C. In this embodiment, an endoscope (not shown) may be placed inside catheter 1400 and/or sheath 1100. The inner diameter (e.g., lumen diameter) of the catheter 1400 may be about 3-10mm, or alternatively about 8mm, and its outer diameter may be about 4-13 mm. In some embodiments, other positioning and/or guiding and/or grasping/connecting devices (not shown) may be used in addition to or in lieu of catheter 1400 to position and/or guide and/or grasp needle portion 1210 within abdominal cavity ABD and assist or serve to deliver it through sheath 1100 to an extracorporeal body environment.
Fig. 2C-D illustrate a slightly different approach using a substantially longer or more distally advanced catheter 140 sized and/or positioned to reach or be adjacent to the entry/incision through which needle 1200 passes and into abdominal cavity ABD, such that the needle tip may be captured when it enters and is not too deep within body cavity ABD. In some cases, this approach may be preferable because it can not only prevent injury to the organ, but also prevent work in the out-of-sight direction that is considered difficult to handle, which may be important.
Referring now to FIGS. 3A-D, various stages of deployment of a laparoscopic system 2000 are depicted, in accordance with an exemplary embodiment of the present invention. As previously described with reference to fig. 2A-B and 2C-D, the trocar system 2000 includes a sheath 2200 and a mating catheter 2100 sized and configured to be passed therethrough. Catheter 2100 is shown in isolation in fig. 3A, and in one deployment, in fig. 3B, the catheter is shown telescoped with and/or secured to sheath 2200. Catheter 2100 includes an elongate portion 2110, optionally tubular, and a lumen 2120 running along its length. At its proximal end, there is a lateral extension 2130 to aid and improve its grip and/or to limit inward delivery of the sheath 2200. Lumen 2120 also contains an airtight valve 2140, optionally a two-way valve or a valve that only allows proximal infiltration, along its passage, optionally in its vicinity. Alternatively or additionally to a valve, such as valve 2140, a cap (not shown) may be provided that seals or substantially reduces the movement of gas through lumen 2120, but may be selectively removed and placed as desired.
An instrument set (not shown) may contain a single catheter, or several catheters of different lengths, which may vary between e.g. 4cm and 50cm in length. The catheter 2100 may be substantially rigid or substantially soft, at least in part. To improve the compliance of the distal end of the needle portion in some embodiments, catheter 2100 may include an extension (not shown) at its distal end. In some embodiments, catheter 2100 is substantially transparent, at least in part, to allow improved visualization (as shown in fig. 3C) by the shuttle movement of endoscope 2600, and/or to allow for direct visualization through the procedure to ascertain that the tip of the intraluminal needle is safely placed in the sheath and placed as desired. Endoscope 2300, or any other device delivered remotely through lumen 2120, interacts with valve 2140 so that the lumen channel remains closed to the external environment. Endoscope 2300 may be attached and applied during the positioning and/or guiding of needle portion 1210, however, before, during, or after the positioning or guiding described above, endoscope 2300 may be removed in order to allow needle portion 1210 to complete delivery until sufficiently extended outwardly to the extracorporeal environment. In fig. 3D, needle portion 1210 is shown as such a fully extended and has been attached to tool 1300 (shown merely as an example of a grasper). Needle portion 1210, or any other device delivered proximally through lumen 2120, interacts with valve 2140 in such a way that the lumen passageway remains closed to the environment outside the body. The same may apply when needle portion 1210 is pulled back to abdominal cavity ABD that is substantially larger in size than tool 1300.
In some instances, it may be more preferable to close the guide lumen around the endoscope. When the tip of the needle passes over the proximal or outer end of the sheath tip, the lumen is removed with the endoscope and the tip of the needle is left protruding from the proximal or outer end of the sheath tip. The sensor is then manually attached to the tip and pulled back into the abdominal cavity.
Referring now to fig. 4A-B, various stages of deployment of a retractable laparoscopic trocar unit 3000 are depicted, in accordance with an exemplary embodiment of the present invention. The trocar unit 3000 includes an inner cannula 3100 that can be telescopically disposed within the outer cannula 3200, optionally from a fully retracted state (as shown in fig. 4A) to a fully extended state (as shown in fig. 4B) or any intermediate state therebetween. In some embodiments, the relative positioning between inner sleeve 3100 and outer sleeve 3200 is accomplished with a bolt and nut mechanism. In some embodiments, inner sleeve 3100 comprises an outer linear portion 3200, while outer sleeve 3200 comprises an inner rotating member comprising linear portion 3220 and a switch 3230, which inner rotating member is only capable of rotating about its longitudinal axis, but is not capable of advancing or retracting along the axis. Thus, when switch 3230 is rotated clockwise, inner sleeve 3100 is moved distally, and vice versa. Alternatively, the implementation of rotation utilizes motorized principles known in the art. In some embodiments, an air-tight two-way valve 3250, similar or identical to valve 2140, is present, optionally placed at the proximal end 3240 of trocar unit 3000, to facilitate bi-directional delivery of tools, devices (e.g., endoscopes) and body tissue therethrough, such that the luminal passageway is closed to the external environment and inflation gas filling the abdominal cavity ABD does not leak out.
Referring now to fig. 5A-B, two exemplary laparoscopic trocar systems incorporating a needle capture component are depicted. In FIG. 5A, a schematic cross-sectional view of a laparoscopic trocar system is depicted showing a detailed stage of deployment, endoscope 1500 containing sheath 1100, an inner sleeve 4000 telescopically engaging sheath 1100, and an inner sleeve 4000 telescopically engaging inner sleeve 4000. In some embodiments, the system is sealed against gas leakage from the body cavity being treated using valve 1550 between sheath 1100 and inner sleeve 4000, and optionally seal 1540 between inner sleeve 4000 and endoscope 1500. In this exemplary embodiment, inner sleeve 4000 includes a deployable distal end 4050. Alternatively, distal end 4050 may be expanded from the original smaller diameter of sleeve 4000 to a selected and/or predetermined diameter, either axially symmetric or non-cylindrical (as shown in FIG. 5A). Deployed distal end 4050 provides a simpler method for capturing the distal end of needle portion 2010 as shown. This is very normal: the visualization system for laparoscopy has a visualization range that is angled with respect to the longitudinal axis, and in the embodiment shown, endoscope 1500 includes a tapered field-of-view extractor 1560 at its distal end. In some embodiments, the exemplary deployable tip 4050 is substantially transparent for field of view and illumination.
In some embodiments, when the needle portion is pushed proximally through the orifice of internal sleeve 4000, endoscope 1500 is suitably withdrawn until completely through closure 1540, then needle portion 1210 takes its place and reseals the trocar system through closure 1540. Alternatively, when needle portion 1210 is removed through valve 1550, inner sleeve 4000 may then be removed along with endoscope 1500, and valve 1550 will cover needle portion 1210 to re-close the trocar system.
In FIG. 5B, a cross-sectional schematic view of a second exemplary laparoscopic trocar system is shown, including a sheath 1100, a capture device 4000 'telescopically coupled within the sheath 1100, and an endoscope 1500' telescopically coupled to the capture device 4000. In this exemplary embodiment, the capture device includes a separate capture portion 4200, which may be integral (not shown) with the capture device distal end 4100 or detachably connected to the capture device distal end 4100. Capturing portion 4200 may be a sleeve with an internal orifice sized to allow needle portion 1210 to be introduced (not shown), but may be any other capturing element that may or may not contain a grasper, a magnet, a thread, an adhesive, or any other feature. The capture portion 4200 can be disposable, while the capture device 4000 can be designed for single or multiple use. This option may be particularly useful in cases where needle portion 1210 is advanced in parallel through sheath 1100 to extract capture device 4000. One benefit may be: the endoscope 1500 may not be removed from the capture device 4000 (now replacing one catheter) and allows visual monitoring throughout deployment. In this option, the closed distal end 4100, which is preferably transparent, may act as a protective barrier between the needle portion 1210 and the endoscope 1500. Different sealing elements (not all shown) may be placed between the sheath 1100 and the capture device 4000, and between the capture device 4000 and the endoscope 1500, either one-way sealing or two-way sealing.
In an exemplary embodiment, an annulus 1520 incorporating a sealing core 1540 is introduced between the capture device 4000 and the endoscope 1500. The sealing core 1540 may be a soft rubber-like material with an inner diameter slightly smaller than the outer diameter of the endoscope 1500 and an outer diameter larger than the inner diameter of the capture device 4000, and the ring 1520 may be integral with the capture device endoscope 1500 or the capture device 4000, or alternatively be a separate element and optionally attached to either device. This may be useful for practical reasons, although not necessary, the sealing core 1540 is a one-way seal that comes into play once the endoscope 1500 is introduced and is installed in the capture device, but does not come into play once the endoscope 1500 is pulled proximally.
Referring now to fig. 6A, a cross-sectional schematic view of a typical manipulator system 5000 in a deployed state after attachment of a tool 1300 is shown. Manipulator system 5000 comprises a handle unit 5100, an elongated shaft 5200 and an external telescopic frame 5300 and an internal telescopic frame 5400, which are connected to proximal and distal ends of shaft 5200 by proximal and distal springs 5310 and 5410, respectively. Shaft 5200 may have a diameter similar to or even smaller than previously described needle 1200, and/or may be made of a less rigid material and/or form, with improved bending resistance, bending arch resistance, shear resistance, and the like, achieved by telescoping frames 5300 and 5400. Telescoping frame 5300 and/or 5400 comprises at least one tubular member, optionally at least two members capable of telescoping and extending relative to each other. Springs 5310 and/or 5410 may be used to provide the telescoping frame 5300 and/or 5400, respectively, in a normally extended state, such as by connecting them at a first end to the proximal end (5300)/distal end (5400) of the most proximal tubular member and at a second end to the proximal end (5300)/distal end (5400) of the most proximal tubular member of the telescoping frame. The telescoping manner of frames 5300 and 5400 further allows an operator to maneuver shaft 5200 and tool 1300 in an in-out motion, but does not include external support for elongated shaft 5200. The telescoping frame 5300 and/or 5400 can be integral with the handle 5100 and/or implement 1300, detachably connected to the handle 5100 and/or implement 1300, or ultimately separate from the handle 5100 and/or implement 1300, respectively. The distal end of the most distal tubular member of telescoping frame 5300 and/or the proximal end of the most proximal tubular member of telescoping frame 5400 may be enlarged and/or include a soft material to help improve the engagement characteristics, making contact of the abdominal wall portions easier to control and/or safer. In an alternative, the operator first assembles handle 5100, shaft 5200 and adjacent telescoping frame 5300 and introduces the manipulator system to abdominal cavity ABD. The tool 1300, attached to the distal telescoping frame 5400, is then fitted to the distal end of the shaft 5200 through the sheath lumen, as previously described. Tool replacement and/or system disassembly can be implemented in a similar fashion. In some embodiments, only telescoping framework 5300 is used. In some other embodiments, only telescoping frame 5400 is used.
Referring now to fig. 6B-6D, an exemplary externally retracted needle fortifier 5500 is depicted, according to an exemplary embodiment of the present invention. Fortifier 5500 includes an adjacent portion 5520 connectable (e.g., via wires) to a handle control unit (not shown), a telescoping body 5510, and a distal portion 5530. Fig. 6B depicts a needle portion 1210 attached to tool 1300 enhanced by an enhancing unit 5500. The strength cell body 5510 includes a plurality of elements, such as element 5512i, that are slidably and telescopically connectable in sequence one to another so that the strength cell body 5510 can extend to any length from a fully compressed length L1 to a fully extended length L2. The reinforcement unit body 5510 and any of its components may be rigid or semi-rigid, optionally made of stainless steel or hard plastic. In some embodiments, length L2 is at least 0.3 times, optionally at least 0.5 times, optionally about 2/3 times, the entire effective length of needle portion 1210. A typical length of L2 may be between 10cm and 50cm, alternatively between 20 and 30 cm. In some embodiments, length L1 is at most 0.75 times the length of L2, alternatively at most 0.5 times its length, alternatively about 1/3 times its length. In some embodiments, at least one of the members, optionally at least two members, such as the proximal most and distal most members, comprises an inner portion having a length that is attached to or closely fits over a corresponding length portion of needle portion 1210, thereby reducing flexing of the needle in augmentation unit 5500. In some embodiments, such an inner portion has a soft composition and/or contains a smooth surface to slide easily with minimal friction.
The reinforcement unit body 5510 may have a spring along at least part of its length to achieve a regular elongate characteristic. This feature may facilitate the application of continuous pressure around the entrance of needle 1210 to the outer abdominal portion. Alternatively, no spring is used, and optionally the reinforcement unit body can be selectively attached at any length between L1 and L2. In some embodiments, the latter arrangement maintains a continuous seal and/or contact with the distal end portion 5530 and is coupled to the contact surface 5532 of the distal end 5530 by providing an adhesive or other affixing means (e.g., a patch). This way the surgeon may extend or shorten the retractable reinforcing unit 5500 to a selected length while its distal portion 5530 remains adhered to the patient's skin. Reinforcement unit 5500 may be locked at any selected length, and thus, a selected length of the needle portion protruding within the abdominal cavity remains unchanged. If the needle is coupled to the capture member, it may be used as a retractor to maintain the organ at a fixed height or position within the body cavity throughout the treatment. In this case, the means of affixing the stiffening unit 5500 to the patient's skin may be aimed at resisting external forces of up to 10kg, optionally up to 5kg, optionally up to 3kg, or higher or lower or in between. In some embodiments, distal end portion 5530 is disposable for a single use, but other portions of reinforcement unit 5500 may be disposable or multiple uses.
In some embodiments, other components may be provided for active grasping and/or adjustment of the needle portion within the patient, particularly when the field of view is incomplete or not aligned with the longitudinal axis of the sheath. The active component may be directed to any mechanical, electrical, electromechanical system, magnetic, and/or any other device that may be placed on the distal end of an externally working sheath, trocar or inner sleeve, or may be provided as a separate capture device that may be conveyed into the body through any sheath and inner sleeve lumen. These active components may be operated outside the body cavity, either manually or automatically. In some embodiments, such active components are provided in a kit further comprising a camera head removably attached to the distal end of the needle portion. In some embodiments, visualization is achieved by using a laparoscopic camera that is removably attachable to the percutaneous needle, rather than, or in conjunction with, a laparoscopic visualization unit provided intraluminally through a trocar and/or internal sleeve.
Referring now to fig. 7A-F, various stages of using a capturing needle portion 1210 of an annular needle capture device 6100 are depicted, in accordance with an exemplary embodiment of the invention. As shown in fig. 7A-B, a laparoscopic surgical system 6000 is provided and deployed for surgical treatment in a body cavity of a patient, the laparoscopic system including a catheter 1400 telescopically connectable and/or slidable through a sheath 1100 ', a needle portion 1210 percutaneously inserted into the body cavity and operable outside the patient's body, a camera 1800 detachably connected to a distal end 1210 ' of a second percutaneously inserted needle manipulator. An annular capture device 6100 is delivered through the catheter 1400 and maneuvered toward the needle portion 1210 for capture and grasping under the view of the camera 1800. Needle portion 1210 can then be pulled out of the patient's body through catheter 1400 for additional placement of a surgical head.
In some embodiments, needle capture device 6000 comprises an elongated elongate body 6110 coupled to or terminating in a loop 6120. In some embodiments, the capture device 6100 or any portion thereof, either the body 6110 or the ring 6120, is made at least in part of a resilient, optionally spring-type and/or a super-elastic material, optionally made of a shape memory plastic or alloy. Such materials may include Ni-Ti alloys, Co-Cr alloys, 316L alloys, 17-4 alloys, Custom 465 alloys, BioDurTMAlloys or any other metallic and/or polymeric materialAny one of the materials.
In some embodiments, the capture device 6100 is configured such that, in a relaxed state (e.g., when there is substantially no external force or pressure), the shape of the body 6110 will be substantially linear along the elongated axis, while the ring 6120 is angled with respect to the corresponding elongated axis, optionally with its distal end projecting forward as depicted in fig. 7D and 7E. In some embodiments, the capture device 6100 is also configured to be deformable, selectively resilient (e.g., constricted and/or substantially straightened) when the ring 6120 is placed or forced into the orifice of the diametric compression member. In some embodiments, the capture device 6100 further comprises an outer tube 6130 slidably mountable over the body 6110 and the ring 6120, causing the ring 6120 to expand and contract therein when it is pushed over (as shown in fig. 7C), and allowing the ring 6120 to regain an open loop form upon removal (as shown in fig. 7D).
Fig. 7C-F provide a gradually enlarged schematic view of needle portion 1210 capture using needle device 6100. As shown in fig. 7C, catheter 1400 is proximate needle portion 1210, visible to camera 1800. When adjacent to the needle portion 1210, a collapsed capture device 6100 is pushed through the catheter 1400 lumen until at least the loops 6120 are fully deployed outside the outer tube 6130, in an open loop, and at an angle to the corresponding body 6110, as shown in fig. 7D.
In some embodiments, capture device 6100 is then pushed forward and/or maneuvered in any selected direction until the operator decides that needle portion 1210 is placed inside the lumen of loop 6200 (as shown in fig. 7E). Once the needle portion 1210 is surrounded by the loop 6200, the operator may then push the outer tube 6130 forward over the body 6110 to re-retract while simultaneously tightening the grip of the needle portion 1210 (as shown in fig. 7F), thereby minimizing optional unwanted release of the needle portion 1210.
To selectively improve the alignment of the needle portion 1210, several loops may be used, as shown in FIG. 8, where another exemplary needle capture device 6200 includes a distal loop 6230 and a proximal loop 6220 angularly projected along the body 6210. Grasping the needle at two or spaced points along its length will improve or assist in the predetermined alignment and easier access to the catheter.
In some embodiments, other components may be adapted to the ring-shaped catching device in order to selectively improve its gripping properties of the needle. Fig. 9 depicts another exemplary ring-like needle capture device 6300, comprising a ring 6320 having a plurality of protrusions or teeth 6322i (where "i" represents a number in the total number of 1 and any selected teeth). The teeth 6322i may be made of metal or a polymer material, and may be sharp or blunt. Other possibilities may include the use of adhesives, magnetic materials, woven or other fabric parts, or otherwise. Needle portion 1210 may itself contain at least one groove or any other alternative feature to enhance gripping and/or attachment (not shown).
To make it easier to catch and/or slide the needle portion to the catheter 1400, the latter may be adapted to extend alongside its distal end. Referring now to fig. 10A-B, various views of an exemplary laparoscopic trocar unit 1000 including a deployable funnel mechanism 7000 are depicted in accordance with an exemplary embodiment of the present invention. In some embodiments, the mechanical device 7000 includes an elongated body 7100 distally attached to a funnel 7200 (as shown in fig. 10A) containing a plurality of petal-like elements 7250i (i represents a number in 1 and any selected total number of petals) forming a flower-like shaped pattern. In some embodiments, each petal-shaped element 7250i may be attached to a wire, strip, or rod, upon which all such elements collectively assemble the body 7100. In some embodiments, the elements of the funnel portion are substantially rigid and/or stiff, thereby avoiding unwanted penetration of sharp objects therethrough, such as the sharp tip of a micro-laparoscopic needle, like needle 1200. In some embodiments, mechanical apparatus 7000 is at least partially resilient. In some embodiments, the mechanism 7000 is adapted to be pushed or pulled through the orifice of the catheter 1400 in one of the following ways: capable of projecting distally until fully opened outside the catheter 1400 and/or re-retracted into the catheter 1400, capable of selectively surrounding and capturing a needle portion collected in the catheter 1400.
In some embodiments, a deployable funnel-like mechanism may also be used to grasp the end portion of a needle, such as needle 1210, either instead of, or in combination with other active grasping components, such as an annular grasper. Fig. 10C-D provide two exemplary deployable catch funnel embodiments. Fig. 10C shows a cross-section of an expandable funnel with a plurality of petal-like elements 7260i that can be combined into an iris diaphragm. Fig. 10D shows a cross-section of another different embodiment in which two petal-like elements, called outer petals 7270j and outer gripping petals 7280j are provided, capable of tightly covering the needle portion. Petals 7280j are specifically designed to compress around the needle portion, while petals 7270j may be designed and configured to transfer at least a portion of the external force applied by the user to grasp petals 7280 j.
Fig. 10E shows another configuration of a deployable funnel-like mechanism comprising an elongated body 7300 distally connected to a plurality of laterally deployable bar-like structures 7400. Between each two adjacent bars of the bar-like structure 7400, there is provided a corrugated panel 7450 bonded to and extending between the bars and being of limited expansion and contraction depending on the relative positions of the adjacent bars. In some embodiments, the corrugated panel 7450 is substantially rigid and/or hard and/or smooth.
Referring now to FIGS. 11A-E, various views of an exemplary laparoscopic system 8000 and its components are depicted, in accordance with an exemplary embodiment of the present invention. Laparoscopy system 8000 includes a needle engager unit 8100 telescopically introduced through trocar 8200. Trocar unit 8200 may be a commercially available laparoscopic port (also referred to as a laparoscopic cannula) having a proximal head 8210 and a distal tube 8220 optionally terminating in a beveled or sharpened tip 8230. Head 8210 and/or 8220 may contain an access seal adapted to its lumen (not shown) and may allow devices and/or instruments to be introduced therethrough from outside the environment into the abdominal cavity without compromising its sealing capabilities. Trocar unit 8200 may further contain connection and/or valve components to provide gas to the abdominal cavity. Such trocar units may be provided with different nozzle sizes, typically 5.5mm, 10mm, 12mm and 15mm, but for ease of description, trocar unit 8200 refers to a nozzle having a 12nm nozzle unless otherwise stated.
Needle engager unit 8100 comprises an inner and outer sleeve arrangement, including an outer sleeve 8110 slidable over an inner sleeve 8120. Needle engager 8100 is sized and configured to bridge across the entrance seal of trocar unit 8200, passing therethrough, thereby deactivating or removing the entrance seal, optionally reversibly releasing it so that it can regain its seal once needle engager 8100 is removed. Commercially available laparoscopic trocars or inlet units may contain different kinds of inlet seals, such as one iris type seal. An access seal may include at least one retractable member adapted to maintain a normally extended position but may be forced to at least partially retract when the laparoscopic device has a smaller diameter delivered through its distal end while maintaining constant contact with its periphery. In this way, the at least one retractable member maintains a sealed environment around the laparoscopic device. Needle engager unit 8100 may have an outer diameter configured to be advanced into the lumen of trocar instrument 8200 until closely nested therein, thereby sufficiently contracting at least one contractible member.
Once positioned in trocar unit 8200, the lumen provided along both ends of inner sleeve 8120 is used to accommodate the delivery of the needle distal end from within the patient to the extracorporeal environment, but preferably allows sealing, optionally, of its lumen.
Needle engager 8100 has a length large enough to reach any location of the abdominal cavity and/or to reach the opposite inner wall portion of the abdominal cavity. Outer sleeve 8110 includes an outer sleeve body 8112 and an adjacent handle 8114 that may be used to push or pull outer sleeve body 8112 over inner sleeve 8120. The inner sleeve 8120 includes an inner sleeve body 8122 that is proximally connected to or terminates at a handle 8126 and distally connected to or terminates at an expandable funnel 8124. Handle 8126 may be provided fully open, allowing unimpeded movement of gas through inner sleeve 8120 lumen, or may be covered by plug 8128. Plug 8128 may be completely sealed or include a small opening for introduction of laparoscopic devices and/or instruments of similar or identical diameter. Needle engager 8100 may be provided with a set of plugs, one of which may be plug 8128, with different opening sizes. A typical opening size may be about 5mm diameter for introduction of a standard endoscope or tool, about 2mm diameter for introduction of a needle, and the above mentioned fully sealed plug.
Thus, according to a particular embodiment, the catheter is provided in a kit containing a plurality of plugs differentiated according to the passive sealing properties and/or the size of its opening. Thus, a wide range of different sized tools or needles may be used in such catheters.
In some embodiments, funnel 8124 is a self-expandable conical structure that is expandable and collapsible from a generally tubular shape into a generally tubular structure. In its tubular shape, funnel 8124 can pass through both sides of trocar 8200 lumen with or without outer sleeve 8110. In its expanded conical shape, funnel 8124 has a substantially larger span, which increases the needle end coverage area and increases its chance of catching. In addition, the flared funnel 8124 helps provide a smoother introduction and adjustment of non-functioning needles (e.g., a protrusion with an angle of 180 ° to any coordinate axis associated with the sleeve/trocar longitudinal axis) so that the needles will slide gently over the curved wall of the funnel-shaped unit until their longitudinal axes are aligned, rather than impacting or even penetrating the funnel.
Funnel 8124 may optionally be made of a resilient material so that it can expand and contract, but still maintain minimal rigidity or strength characteristics to reduce or prevent needle tips from penetrating it. Funnel 8124 is preferably made of a soft material and has, at least in part, a resilient and/or plastic portion, optionally possessing self-expanding characteristics. A typical material may be PVC or polycarbonate with a hardness of 70-100 shore, and it may be cast or vacuum formed. The funnel portion may be of a variety of designs and types, including a funnel design 8124a having a plurality of petal-shaped members 10i arranged in a 3D iris diaphragm configuration (as shown in FIG. 11D); a funnel design 8124B comprising a cone 20 having a plurality of elliptical portions 22i segmented by corrugations 24i in a readily controlled and/or symmetrically converging manner; and a funnel design 8124C of a fully conical body 30. It may be advantageous to have minimal grooves and slits, and the funnel will be less or non-stretchable to mitigate the possibility of needle penetration.
By pushing outer tubular body 8112 distally over funnel 8124, the latter will be forced to compress to a substantially tubular shape having a minimal size, whereas retracting the outer tubular body from the funnel will allow it to regain the expanded size and conical shape. In an alternative design, the funnel would expand and/or contract without the aid of external means such as an outer sleeve, and in some other designs an external covering could be applied only to deploy trocar 8200, however after penetrating the body, the funnel would expand immediately until it is pulled through the trocar and out of the patient. In a compressed mode, funnel 8124 may have a maximum inner diameter of equal to or less than 10mm, alternatively about 8mm or about 5mm, whereas in a fully deployed mode it may have a maximum inner diameter of equal to or less than 50mm, alternatively about 30mm or about 20 mm. When at least partially opened, funnel 8124 may be used to capture a distal end of a needle, such as needle portion 1210 located within a body cavity and/or adjacent to an entry point thereto. In some embodiments, needle engager unit 8100 as a whole, or any portion of its components, is substantially transparent so that the surgical procedure can immediately notice the protrusion of the needle therethrough, particularly as it passes through the trocar sealing tool.
The next exemplary stage may be performed sequentially or partially in parallel, using the laparoscopy system 8000, to engage and capture the needle portion in order to assemble it with the tool. Initially, laparoscopic trocar unit 8200 is introduced and deployed at a location (optionally, at the navel) to provide a selectively open passageway with an internally penetrable sealing tool (not shown). Gases, usually CO2And then compressed into the abdominal cavity until the final inflation volume is reached, and a gas compression tool (connected to a dedicated inlet of the trocar) may then be used to continuously maintain a selected level of inflation or pressure, allowing for a small portion of gas to continuously leak through natural and/or artificial openings. Needle engagement unit 8100 then extends its distal end through the lumen of trocar 8200 into the body cavity. At this stage, funnel 8124 is covered by outer sleeve 8112, which outer sleeve 8112 forces it to collapse, while handle 8126 is optionally sealed with a sealing plug. The sealing plug may be replaced with a plug having an opening sized to receive an endoscope (before, during, or after deployment of trocar unit 8200), and the endoscope may optionally be placed within inner sleeve 8120 to help provide a field of view. Alternatively or additionally, other visualization tools may be applied to the abdominal cavity, either through inner sleeve 8120 or through a different portal or a different trocar. The needle distal end is then tracked using a deployed visualization tool, optionally including its entry point into the abdominal cavity. Optionally, outer sleeve 8110 is then retracted to a position that allows funnel 8124 to be deployed to its maximum size or to any selected sizeThe intermediate size of (a). The deployed funnel is then manipulated towards the needle distal tip to encircle and capture it. This may be done at any point or region within the abdominal cavity volume, and in some preferred examples, at and around the needle tip entrance when funnel 8124 is connected, and may even be pushed towards the corresponding abdominal interior wall portion. In some embodiments, funnel 8124 has no sharp edges to avoid injury to contacting body tissue. Manipulation is accomplished by altering the entire needle engager unit 8100, or simply the inner sleeve 8120 associated with the outer sleeve 8110. The captured needle tip may be grasped by the funnel that is collapsed over it (by pushing tubular body 8112 over it). Alternatively, the needle is advanced deep into the lumen of inner sleeve 8120 (either simultaneously or after withdrawing the endoscope from the same port). Funnel 8124 may then be re-collapsed and needle engager unit 8100 can be removed, leaving the needle protruding through and adjacent to the sealing means beyond trocar unit 8200 (thus the channel remains sealed after needle engager unit 8100 is removed). A tool may be coupled to the distal end of the needle and the needle may be withdrawn into the abdominal cavity.
Referring now to fig. 12A-C, various views of a needle engagement unit 8300 containing an asymmetric deployable member 8320 are depicted, in accordance with an exemplary embodiment of the present invention. Figure 12A shows an isometric view of needle engager unit 8300 as it is deployed through trocar unit 8200. Fig. 12B shows an enlarged view of the distal end of needle adaptor unit 8300, and fig. 12C shows a front view of the conversion of needle adaptor unit 8300. Needle engagement unit 8300 comprises an elongated tubular body 8310 connected at a distal end to an asymmetrical funnel 8320 and connected at or terminating at a proximal end adjacent to handle 8330. The tubular body 8310 includes a lumen 8328 open at both ends and extending along its entire length, and is sized and designed to allow passage of a laparoscopic needle in both directions, with or without an additional attached surgical tool (not shown). In some embodiments, the asymmetric funnel assembly 8320 comprises an expandable funnel member 8322 and a distal non-expandable tubular member 8326 for attachment to or tightly compressed and/or bonded (e.g., glued) to the distal end of the elongate tubular body 8310. In some embodiments, the deployable funnel member 8322 is single-sided and includes a tapered edge 8324 and has a first closed side and a second substantially open side. Such a shape allows continuous accurate visualization and capture and deployment with an endoscope or a video camera toward the end of the detection needle that protrudes toward or from the open end of funnel portion 8322. Such visualization may allow and improve the verification capabilities of the needle and placement within the funnel 8322 and lumen 8328. Such a design further allows for faster and easier recompression of the funnel component 8322, and as shown, it can make the need for the upper tube redundant and can collapse when withdrawn through the trocar unit 8200.
In some cases, it may be advantageous to use an elongated introducer that is easily passed through the trocar lumen and has more than one entry port and lumen extending along its length. One advantage is to provide different parallel assemblies while avoiding potential interactions thereof and/or providing separate slide rails for each. A small portion of such an elongated guide (having an outer diameter, for example, equal to or slightly greater than 12 mm) has a substantial effect on the design and/or buckling characteristics of the elongated guide and/or the components intended to pass through it. Referring to fig. 13A-B, front and side views, respectively, of an elongate dual lumen introducer 8400 suitable for introducing the tail portion of an endoscope and a suction tube (not shown) are depicted, in accordance with an exemplary embodiment of the present invention. The proposed arrangement allows the use of a suction tube as needed, without first removing the endoscope from the trocar port or inserting a suction tube through a second trocar. In addition, the suction tube can be used to clean an endoscope or other visual tool, or its lens, by first injecting a liquid (e.g., saline) into it and then aspirating the liquid with a suction device. Providing a suction tube in parallel with the endoscope is also useful because it saves much time for aligning and using the suction tube. In fig. 13A, an elongated introducer 8400 is shown deployed in a standard trocar 8200. The elongated introducer comprises a tubular body 8410 that terminates in a proximal end 8420 that optionally has radially extending edges to limit sliding within the lumen of the trocar 8200. Proximally extending from head end 8420 are endoscope extension 8430 and suction tube extension 8440. In some embodiments, as shown, the endoscope extension 8430 is straight and coaxial with the respective endoscope lumen 8432, whereas the suction tube 8440 is curved corresponding to its respective suction tube lumen 8442. This design can be used to introduce a standard rigid endoscope and a flexible or semi-rigid suction tube. Alternative designs may also be used. In some embodiments, straw extension 8440 may be selectively closed with straw extension plug 8450, as may occasionally occur between straw gaps from which straws are withdrawn. In some embodiments, the elongated guide is substantially rigid and covers a length approximating the length of the endoscopic protrusion so that the flexible suction tube can be uncontrollably scattered in the abdominal cavity and held in place and almost completely surrounding the lumen 8442. The insertion of the endoscope and the suction tube into the elongated guide 8400 in parallel is performed at a specific angle set from the following angle ranges: this range of angles allows the pipette to be manipulated with one hand and the endoscope with the other without interference or conflict between them. Preferably, the presence of appropriately sized endoscopes and suction tubes at their respective lumens may reduce any leakage of gas therefrom, so these lumens may be considered to be air tight or sealed, in accordance with the definition of the present invention.
Although the present invention has been described herein in conjunction with specific embodiments, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. Further, the introduction and identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. To the extent paragraph headings are used, they are not to be construed as necessarily limiting.