US20140058205A1 - Methods, Systems, and Devices for Surgical Access and Insertion - Google Patents

Abstract

The various embodiments herein relate to systems, devices, and/or methods relating to surgical procedures, and more specifically for accessing an insufflated cavity of a patient and/or positioning surgical systems or devices into the cavity.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S)
• This application claims priority to Provisional Application No. 61/584,947, filed Jan. 10, 2012; and Provisional Application No. 61/683,483, filed Aug. 15, 2012, both of which are hereby incorporated herein by reference in their entireties.
FIELD OF THE INVENTION
• The various embodiments herein relate to systems, devices, and/or methods relating to surgical procedures, and more specifically for accessing an insufflated cavity of a patient and/or positioning surgical systems or devices into the cavity.
BACKGROUND OF THE INVENTION
• Invasive surgical procedures are essential for addressing various medical conditions. When possible, minimally invasive procedures such as laparoscopy are preferred.
• However, known minimally invasive technologies such as laparoscopy are limited in scope and complexity due in part to 1) mobility restrictions resulting from using rigid tools inserted through access ports, and 2) limited visual feedback. Further, the technologies are also limited due to difficulties relating to maintaining access to the surgical cavity while also maintaining insufflations of the cavity.
• There is a need in the art for improved surgical methods, systems, and devices.
BRIEF SUMMARY OF THE INVENTION
• Discussed herein are various surgical access and insertion devices and methods.
• In Example 1, a surgical insertion device comprises a canister defining a lumen, a top cap coupled to a proximal end of the canister, and an incision port removably coupled to a distal end of the canister. The canister is sized to receive a surgical device in the lumen. The top cap comprises at least one lumen defined in the top cap, wherein the at least one lumen is configured to receive a support rod. The incision port comprises a fluidic sealing component configured to maintain a fluidic seal.
• Example 2 relates to the surgical insertion device according to Example 1, wherein the lumen is fluidically sealed in relation to ambient air.
• Example 3 relates to the surgical insertion device according to Example 1, wherein the canister comprises a flexible material or a substantially rigid material.
• Example 4 relates to the surgical insertion device according to Example 1, wherein the canister comprises a flexible portion and a substantially rigid portion.
• Example 5 relates to the surgical insertion device according to Example 1, wherein the canister has a cylindrical shape, a spherical shape, or a conical shape.
• Example 6 relates to the surgical insertion device according to Example 1, wherein the canister comprises at least one rib structure.
• Example 7 relates to the surgical insertion device according to Example 1, wherein the fluidic sealing component comprises a sealable sleeve device, a flexible seal component, a removable lid seal component, or a flap seal component.
• Example 8 relates to the surgical insertion device according to Example 1, wherein the top cap comprises at least one of a pressure relief valve, at least one threaded lumen, a detachable cable harness, and a clamp projection.
• Example 9 relates to the surgical insertion device according to Example 1, further comprising an outer handle set coupleable to the top cap.
• Example 10 relates to the surgical insertion device according to Example 1, further comprising at least one measurement mechanism coupled to the top cap or the incision port.
• Example 11 relates to the surgical insertion device according to Example 1, wherein the canister comprises at least one access port, wherein the at least one access port is a hand access port or a side access port.
• In Example 12, a surgical insertion device comprises a flexible canister defining a lumen, a top cap coupled to a proximal end of the canister, an incision port removably coupled to a distal end of the canister, and a first measurement mechanism coupled with the top cap or the incision port. The canister is sized to receive a surgical device in the lumen. The top cap comprises at least one lumen defined in the top cap, wherein the at least lumen is configured to receive a support rod. The incision port comprising a fluidic sealing component is configured to maintain a fluidic seal. The first measurement mechanism is configured to measure the insertion depth of the surgical device.
• Example 13 relates to the surgical insertion device according to Example 12, wherein the first measurement mechanism comprises a sensor, a string measurement system, a substantially rigid structure system, or a camera.
• Example 14 relates to the surgical insertion device according to Example 12, wherein the fluidic sealing component comprises a sealable sleeve device, a flexible seal component, a removable lid seal component, or a flap seal component.
• Example 15 relates to the surgical insertion device according to Example 12, wherein wherein the top cap comprises at least one of a pressure relief valve, at least one threaded lumen, a detachable cable harness, and a clamp projection.
• Example 16 relates to the surgical insertion device according to Example 12, further comprising a second measurement mechanism coupled to the top cap or the incision port, the second measurement mechanism configured to measure any tilt of the flexible canister.
• In Example 17, a surgical insertion device comprises a canister defining a lumen, a top cap coupled to a proximal end of the canister, and an incision port removably coupled to a distal end of the canister. The canister is sized to receive a surgical device in the lumen, wherein the surgical device is a robotic surgical device comprising two arms. The top cap comprises a pressure relief valve and at least one lumen defined in the top cap, wherein the at least one lumen is configured to receive a support rod. The incision port comprises a fluidic sealing component configured to maintain a fluidic seal.
• Example 18 relates to the surgical insertion device according to Example 17, wherein the fluidic sealing component comprises a sealable sleeve device, a flexible seal component, a removable lid seal component, or a flap seal component.
• Example 19 relates to the surgical insertion device according to Example 17, wherein the top cap comprises at least one of at least one threaded lumen, a detachable cable harness, and a clamp projection.
• Example 20 relates to the surgical insertion device according to Example 17, further comprising at least one measurement mechanism coupled to the top cap or the incision port.
• While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a side view of an external pressurized system or apparatus, according to one embodiment.
• FIG. 1B is a perspective view of the external pressurized system or apparatus ofFIG. 1A with a surgical device positioned therein.
• FIG. 2A is an exploded side view of the external pressurized system or apparatus ofFIG. 1A.
• FIG. 2B is an exploded perspective view of the external pressurized system or apparatus ofFIG. 1A.
• FIG. 3A is an exploded side view of a top cap, according to one embodiment.
• FIG. 3B is an exploded perspective view of the top cap ofFIG. 3A.
• FIG. 4A is an exploded perspective view of a port, according to one embodiment.
• FIG. 4B is an exploded side view of the port ofFIG. 4A.
• FIG. 5A is an upper perspective view of a base ring and port ring, according to one embodiment.
• FIG. 5B is a lower perspective view of the base ring and port ring ofFIG. 5A.
• FIG. 6A is a top schematic view of a sealable sleeve device being positioned in an incision, according to one embodiment.
• FIG. 6B is a top schematic view of the sealable sleeve device ofFIG. 6A being positioned in an incision, according to one embodiment.
• FIG. 6C is a top schematic view of the sealable sleeve device ofFIG. 6A being positioned in an incision, according to one embodiment.
• FIG. 6D is a top schematic view of the sealable sleeve device ofFIG. 6A being positioned in an incision, according to one embodiment.
• FIG. 7A is a side view of a fully assembled port, according to one embodiment.
• FIG. 7B is a perspective view of the fully assembled port ofFIG. 7A.
• FIG. 8A is a side view of the coupling of a canister and connector ring, according to one embodiment.
• FIG. 8B is a side view of the coupling of the canister and connector ring ofFIG. 8A.
• FIG. 9 is a side view of an external pressurized system or apparatus with a surgical device positioned therein, according to one embodiment.
• FIG. 10 is a perspective view of the external pressurized system or apparatus ofFIG. 9, in which the surgical device has been urged out of the system or apparatus and into the patient's cavity.
• FIG. 11 is a perspective view of the external pressurized system or apparatus ofFIG. 10, in which the canister has been removed.
• FIG. 12 is a perspective view of an balloon seal insertion system or apparatus, according to one embodiment.
• FIG. 13A is a perspective view of an balloon seal insertion system or apparatus, according to one embodiment.
• FIG. 13B is an exploded perspective view of the balloon seal insertion system or apparatus ofFIG. 13A.
• FIG. 14A is a perspective view of a port housing, according to one embodiment.
• FIG. 14B is a cutaway perspective view of the port housing ofFIG. 14A.
• FIG. 14C is a cutaway perspective view of the port housing ofFIG. 14A.
• FIG. 15 is a perspective view of a standard sealable sleeve device, according to one embodiment.
• FIG. 16A is a cutaway side view of a balloon seal insertion system or apparatus, according to one embodiment.
• FIG. 16B is a cutaway perspective view of the balloon seal insertion system or apparatus ofFIG. 16A.
• FIG. 17A is a cutaway perspective view of a balloon seal insertion system or apparatus with a first arm of a surgical device disposed therethrough, according to one embodiment.
• FIG. 17B is a cutaway perspective view of the balloon seal insertion system or apparatus ofFIG. 17A in which the first arm is positioned using a connection rod.
• FIG. 18 is a cutaway perspective view of a rubber seal access/insertion device, according to one embodiment.
• FIG. 19A is an exploded side view of a rubber seal access/insertion device, according to one embodiment.
• FIG. 19B is an exploded perspective view of the rubber seal access/insertion device ofFIG. 19A.
• FIG. 20 is an exploded perspective view of the separate rubber seals of a rubber seal access/insertion device, according to one embodiment.
• FIG. 21 is a top view of a rubber seal access/insertion device, according to one embodiment.
• FIG. 22 is a base ring of a rubber seal access/insertion device, according to one embodiment.
• FIG. 23 is a side view of a rubber seal access/insertion device, according to one embodiment.
• FIG. 24A is a side view of an external pressurized system or apparatus having one or more additional access ports, according to one embodiment.
• FIG. 24B is another side view of the external pressurized system or apparatus ofFIG. 24A.
• FIG. 24C is a top view of the external pressurized system or apparatus ofFIG. 24A.
• FIG. 24D is a perspective view of the external pressurized system or apparatus ofFIG. 24A.
• FIG. 24E is another top view of the external pressurized system or apparatus ofFIG. 24A.
• FIG. 24F is a cutaway side view of the external pressurized system or apparatus ofFIG. 24A along the cross-section shown with the dotted line inFIG. 24E.
• FIG. 25 is a perspective view of an access port with a hand disposed therethrough, according to one embodiment.
• FIG. 26 is a top view of another access port, according to another embodiment.
• FIG. 27A is a perspective view of a port adaptor ring coupling an access port to a tube, according to one embodiment.
• FIG. 27B is a perspective view of a device access port having a device attachment component, according to one embodiment.
• FIG. 28A is a perspective view of a glove port, according to one embodiment.
• FIG. 28B is a perspective view of the glove port inFIG. 28A in use.
• FIG. 29A is a top schematic view of a sealable sleeve device being positioned in an incision, according to one embodiment.
• FIG. 29B is a top schematic view of the sealable sleeve device ofFIG. 29A being positioned in an incision, according to one embodiment.
• FIG. 30 is a cutaway side view of an incision port, according to one embodiment.
• FIG. 31A is a top view of a base ring of an incision port, according to one embodiment.
• FIG. 31B is a perspective view of the base ring ofFIG. 31A.
• FIG. 32 is a perspective view of a tube bracket, according to one embodiment.
• FIG. 33 is a perspective view of a tube bracket coupling a main tube to a base ring, according to one embodiment.
• FIG. 34 is a perspective view of a sleeve clamp, according to one embodiment.
• FIG. 35 is a cutaway side view of an incision port, according to one embodiment.
• FIG. 36 is a perspective view of an incision port with an internal coupling component, according to one embodiment.
• FIG. 37A is a cutaway side view of an incision port coupled to a port seal, according to one embodiment.
• FIG. 37B is a cutaway perspective view of the incision port and the port seal ofFIG. 37A.
• FIG. 37C is a perspective view of the underside of a base seal ring, according to one embodiment.
• FIG. 38A is a cutaway side view of an incision port having a flap seal component, according to one embodiment.
• FIG. 38B is a cutaway side view of an incision port having a flap seal component and coupled to a port seal, according to one embodiment.
• FIG. 38C is a perspective top view of the incision port and a port seal ofFIG. 38B.
• FIG. 39A is a perspective side view of an external pressurized device, according to another embodiment.
• FIG. 39B is a perspective side view of the external pressurized device ofFIG. 39A.
• FIG. 40 is a side view of an external pressurized device having two slots, according to a further embodiment.
• FIG. 41A is a side view of a positioning tube, according to one embodiment.
• FIG. 41B is a top view of the positioning tube ofFIG. 41A.
• FIG. 42 is a perspective view of a stacked incision port, according to one embodiment.
• FIG. 43 is a perspective view of an incision port having two seals, according to one embodiment.
• FIG. 44 is a perspective view of an incision port having two seals, according to another embodiment.
• FIG. 45A is a top view of an incision port, according to a further embodiment.
• FIG. 45B is a perspective view of the incision port ofFIG. 45A.
• FIG. 46A is a top view of an air barrier incision port system, according to one embodiment.
• FIG. 46B is a top view of the air barrier port of the port system ofFIG. 46A.
• FIG. 47 is a perspective side view of a rubber seal incision port, according to one embodiment.
• FIG. 48A is a perspective side view of a dual brush incision port, according to one embodiment.
• FIG. 48B is another perspective side view of the dual brush incision port ofFIG. 48A.
• FIG. 49A is a perspective top view of a triple brush incision port, according to one embodiment.
• FIG. 49B is a perspective side view of the triple brush incision port ofFIG. 49A.
• FIG. 50A is a side view of an insertion device, according to one embodiment.
• FIG. 50B is another side view of the insertion device ofFIG. 50A.
• FIG. 50C is another side view of the insertion device ofFIG. 50A.
• FIG. 51A is a side view of an insertion device, according to another embodiment.
• FIG. 51B is a top view of the insertion device ofFIG. 51A.
• FIG. 52 is a side view of an insertion device, according to a further embodiment.
• FIG. 53 is a side view of a surgical device positioned in a positioning rod, according to one embodiment.
• FIG. 54A is a side view of an internal pressurized bag device, according to one embodiment.
• FIG. 54B is another side view of the internal pressurized bag device ofFIG. 54A.
• FIG. 55 is a side view of another external pressurized system or apparatus, according to one embodiment.
• FIG. 56A is a perspective side view of a top cap, according to one embodiment.
• FIG. 56B is another perspective side view of the top cap ofFIG. 56A.
• FIG. 57A is a perspective side view of a top cap and a canister, according to one embodiment.
• FIG. 57B is another perspective side view of the top cap and canister ofFIG. 57A.
• FIG. 58A is a perspective view of a top cap with a portion of a device assembly positioned therethrough, according to one embodiment.
• FIG. 58B is a perspective view of the underside of the top cap ofFIG. 58A.
• FIG. 59A is a perspective view of a top cap with a portion of a device assembly positioned therethrough, according to one embodiment.
• FIG. 59B is a another perspective view of the top cap ofFIG. 59A.
• FIG. 60 is a cutaway perspective view of a top cap, according to one embodiment.
• FIG. 61A is a perspective side view of a top cap coupled to a canister with a portion of a device assembly positioned therethrough, according to one embodiment.
• FIG. 61B is another perspective side view of the top cap ofFIG. 61A.
• FIG. 62A is a perspective side view of a base coupling component, according to one embodiment.
• FIG. 62B is another perspective side view of the base coupling component ofFIG. 62A.
• FIG. 63A is a perspective side view of a base coupling component and an access port, according to one embodiment.
• FIG. 63B is another perspective side view of the base coupling component and the access port ofFIG. 63A.
• FIG. 63C is a perspective side view of a portion of the base coupling component and the access port ofFIG. 63A.
• FIG. 63D is another perspective side view of a portion of the base coupling component and the access port ofFIG. 63A.
• FIG. 63E is a cutaway side view of the base coupling component and the access port ofFIG. 63A.
• FIG. 64A is side view of an external pressurized system or apparatus with a base coupling component and access port, according to one embodiment.
• FIG. 64B is a top view of the external pressurized system ofFIG. 64A.
• FIG. 65A is a side view of an external pressurized system or apparatus with a base coupling component and access port, according to one embodiment.
• FIG. 65B is another side view of the external pressurized system or apparatus ofFIG. 65A.
• FIG. 66A is a side view of an external pressurized system or apparatus when the robotic device is lowered through an opening created by an access port, according to one embodiment.
• FIG. 66B is another side view of the external pressurized system or apparatus ofFIG. 66A.
• FIG. 67A is a side view of an external pressurized system or apparatus in which the forearms of the robotic device are positioned at an angle of or near 45° in relation to the upper arms, according to one embodiment.
• FIG. 67B is another side view of the external pressurized system or apparatus ofFIG. 67A.
• FIG. 68A is a side view of an external pressurized system or apparatus in which the forearms of the robotic device are positioned in a particular position, according to one embodiment.
• FIG. 68B is another side view of the external pressurized system or apparatus ofFIG. 67A.
• FIG. 69A is a side view of an external pressurized system or apparatus in which the forearms of the robotic device are positioned in an appropriate starting position for a procedure, according to one embodiment.
• FIG. 69B is another side view of the external pressurized system or apparatus ofFIG. 67A.
• FIG. 70 is a side view of an external pressurized system or apparatus having a flexible container, according to another embodiment.
• FIG. 71A is a perspective side view of a base coupling component, according to one embodiment.
• FIG. 71B is another perspective side view of the base coupling component ofFIG. 71A.
• FIG. 72A is a perspective side view of a port attachment having a removable lid and an access port, according to one embodiment.
• FIG. 72B is another perspective side view of the port attachment and access port ofFIG. 72A.
• FIG. 73A is a perspective side view of a port attachment having a removable lid and an access port, according to one embodiment.
• FIG. 73B is another perspective side view of the port attachment and access port ofFIG. 73A.
• FIG. 74A is a cutaway side view of a port attachment having a removable lid and an access port, according to one embodiment.
• FIG. 74B is another cutaway side view of the port attachment and access port ofFIG. 74A.
• FIG. 75A is a perspective side view of an external pressurized insertion device having a port attachment with a removable lid, according to one embodiment.
• FIG. 75B is another perspective side view of the external pressurized insertion device ofFIG. 75A.
• FIG. 75C is another perspective side view of the external pressurized insertion device ofFIG. 75A.
• FIG. 76 is a perspective side view of a top cap having a pressure relief valve, according to one embodiment.
• FIG. 77A is a perspective side view of a top cap having a pressure relief valve and port seal, according to one embodiment.
• FIG. 77B is a perspective cutaway view of the top cap ofFIG. 77A.
• FIG. 78A is a side view of an insertion device having an actuator and sensor package.
• FIG. 78B is another side view of the insertion device ofFIG. 78A.
• FIG. 78C is another side view of the insertion device ofFIG. 78A.
• FIG. 79 is a side cutaway view of an insertion device having a measurement mechanism associated with the top cap, according to one embodiment.
• FIG. 80 is a side cutaway view of an incision port of an insertion device having a measurement mechanism associated with the incision port, according to one embodiment.
• FIG. 81 is a top view of a top cap of an insertion device having a string measurement system, according to one embodiment.
• FIG. 82A is a top view of a top cap of an insertion device having a substantially rigid structure measurement mechanism, according to one embodiment.
• FIG. 82B is an underside view of the top cap ofFIG. 82A.
• FIG. 82C is an underside view of an incision port of the insertion device ofFIG. 82A.
• FIG. 82D is a perspective view of the substantially rigid structure having a pegged ball of the insertion device ofFIG. 82A.
• FIG. 82E is a top view of the incision port ofFIG. 82C.
• FIG. 83 is a cutaway side view of an incision port having an insufflations port, according to one embodiment.
• FIG. 84A is a cutaway side view of an insertion device having a spherically shaped canister, according to one embodiment.
• FIG. 84B is a cutaway side view of an insertion device having a conically shaped canister, according to one embodiment.
• FIG. 85A is a cutaway side view of an insertion device having a canister with vertical rib structures, according to one embodiment.
• FIG. 85B is a cutaway side view of an insertion device having a canister with horizontal rib structures, according to one embodiment.
• FIG. 85C is a cutaway side view of an insertion device having a canister with spiral-shaped rib structures, according to one embodiment.
• FIG. 86A is a side view of a base coupler that can be releasably coupled to a canister, according to one embodiment.
• FIG. 86B is another side view of the base coupler and canister ofFIG. 86A.
• FIG. 86C is another side view of the base coupler and canister ofFIG. 86A.
• FIG. 86D is another side view of the base coupler and canister ofFIG. 86A.
• FIG. 87A is a perspective side view of a top cap and outer handle set, according to one embodiment.
• FIG. 87B is a cutaway side view of the top cap and outer handle set ofFIG. 87A.
• FIG. 87C is a perspective cutaway view of the top cap and outer handle set ofFIG. 87A.
• FIG. 88A is a side view of an insertion device, according to one embodiment.
• FIG. 88B is a perspective view of a top cap of the insertion device ofFIG. 88A.
• FIG. 88C is a perspective view of a mobile seal and outer handle set of the insertion device ofFIG. 88A.
• FIG. 88D is a perspective view of an incision port of the insertion device ofFIG. 88A.
• FIG. 89 is a side view of an insertion device having a substantially non-flexible canister portion and a substantially flexible canister portion, according to one embodiment.
DETAILED DESCRIPTION
• The various embodiments described herein relate to systems, devices, and/or methods for accessing an insufflated cavity of a patient and/or positioning surgical systems or devices into the cavity.
• Certain embodiments provide for insertion of the surgical systems/devices into the cavity while maintaining sufficient insufflation of the cavity. Further embodiments minimize the physical contact of the surgeon or surgical users with the surgical devices/systems during the insertion process. Other implementations enhance the safety of the insertion process for the patient and the systems/devices. For example, some embodiments provide visualization of the system/device as it is being inserted into the patient's cavity to ensure that no damaging contact occurs between the system/device and the patient. In addition, certain embodiments allow for minimization of the incision size/length. Further implementations reduce the complexity of the access/insertion procedure and/or the steps required for the procedure. Other embodiments relate to devices that have minimal profiles, minimal size, or are generally minimal in function and appearance to enhance ease of handling and use.
• It is understood that any of the various embodiments disclosed herein could also be automated or made into fully automatic devices/systems and thus could be used by lightly-trained users, such as on the battlefield or during a space mission or the like.
• One embodiment relates to an external pressurized system or apparatus. For example, one implementation of an external pressurized system orapparatus10 is depicted inFIG. 1A. Theapparatus10 has acanister12 with atop cap14 coupled to atop portion16 of thecanister12. In this embodiment, thecanister12 has aport18 that is coupled to thecanister12 at abase portion20 of thecanister12. Theport18 is positioned in an incision in theskin22 of the patient, thereby providing access to acavity24 of the patient. As shown inFIG. 1B, theapparatus10 is configured to receive asurgical device26 such that thedevice26 can be inserted into thepatient cavity24 through theport18 of theapparatus10.
• In one implementation, thecanister12 is made of a hard plastic, such as, for example, poly(methyl methacrylate) (“PMMA”). Alternatively, thecanister12 can be made of any known rigid material that can be used in medical devices. It is understood that certain embodiments of thecanister12 are transparent, such as those depicted in the figures provided. Thetransparent canister12 allows for the user to see thesurgical device26 during insertion. Alternatively, thecanister12 is not transparent and thedevice26 can be inserted without being able to view thedevice26 in thecanister12.
• FIGS. 2A and 2B provide an exploded view of the externalpressurized apparatus10 according to one embodiment. As discussed above, thetop cap14, also depicted inFIGS. 3A and 3B, is coupled to thetop portion16 of thecanister12. Thetop cap14 has aseal30 that is held in place with acover32. According to one implementation, the cover is coupled to thetop cap14 with bolts, other similar mechanical fasteners, or any other known mechanism, device, or method for coupling two such components together.
• In one implementation as best shown inFIGS. 2B and 3B, theseal30 has anorifice34 defined in theseal34. As best shown inFIG. 1B, theorifice34 is configured to receive apositioning rod28, as described in further detail below. In one embodiment, theseal30 is made of some type of rubber. Alternatively, theseal30 can be made of any number of known materials that can be used to provide a fluid seal around a smooth rod, including a gel material or the like. In a further alternative, thetop cap14 can have any known configuration that provides a seal having an orifice or other type of access for apositioning rod28 or the like.
• As best shown inFIGS. 2A,2B,4A, and4B, the port18 (also referred to herein as an “incision port”), in accordance with one implementation, has multiple components. In this particular embodiment, theport18 has aconnector ring40, abase ring42, aport ring44, and asealable sleeve device46. Thesealable sleeve device46 has anupper sleeve ring46A and alower sleeve ring46B, both of which are coupled together by aflexible sleeve46C. In certain embodiments, theflexible sleeve46C has elastic properties. As best shown inFIGS. 5A and 5B, theport ring44 has multiple teeth or protrusions44A defined in a top portion of thering44 in a circular configuration around ahole50. In addition, in one embodiment, thering44 has alip52 extending from the bottom portion of thering44 and defining an outer edge of thehole50. As described below, thislip52 can be positioned within the incision made in the patient, thereby defining the smallest circumference of the incision. Further, theport ring44 has threeguide projections54 extending from the top portion of thering44, which can aid in keeping thebase ring42 positioned appropriately when it is placed on top of theport ring44 as described below. In addition, according to one embodiment, theport ring44 can also haveindentations60 around its circumference that allow a user to grasp theport ring44 during use as described below. Alternatively, theport ring44 can have any exterior feature or mechanism that a user can use to better grasp thering44.
• As also shown inFIGS. 5A and 5B, thebase ring42 has an underside that hasmultiple indentations42B defined in thering42. In one embodiment, theindentations42B correspond to the protrusions44A in theport ring44 such that thebase ring42 andport ring44 can be coupled and rotational force can be transferred from one to the other, as described in further detail below. Alternatively, the features on thebase ring42 and theport ring44 can be ridges that can easily couple together. In a further alternative, the features can be any known features or physical components that can be coupled together to allow for transmission of rotational force as described herein. In addition, as best shown inFIG. 5B, the underside of thebase ring42 has an exterior lip orridge62, according to one embodiment. When thebase ring42 is in contact with theport ring44, theridge62 is in slidable contact with theport ring44. In one implementation, the contact of theridge62 with theport ring44 can provide a better seal that theridges42B,44A provide alone. As such, this seal can be a secondary seal that can actually be strengthened as thesleeve device46 is rotated and the tworings42,44 are urged together.
• Theconnector ring40 is configured to be coupleable with thecanister12, as will be described in further detail below. In addition, theconnector ring40 is coupleable to the rest of theport18 by being configured to be coupleable to thebase ring42. In one embodiment, as best shown inFIG. 2B, theconnector ring40 has multiple threadedholes40A defined through thering40 that correspond to multiple threadedholes42A defined through thebase ring42, such that screws, bolts, or the like can be inserted into and through the threadedholes40A,42A of the tworings40,42, thereby coupling the tworings40,42 together. Alternatively, any known coupling components or methods can be used to couple the tworings40,42.
• Thebase ring42 is coupleable to theport ring44. When thebase ring42 is placed on and in contact with the top of theport ring44, the protrusions44A are positioned in theindentations42B and rotational friction is established such that any rotational force applied to thebase ring42 will be transmitted to the port ring44 (or vice versa) without any slippage between the tworings42,44. Further, thebase ring42 andport ring44 are coupled such that theholes48,50 in eachring42,44 correspond as well. Alternatively, any known coupling components or methods can be used to couple the tworings42,44 in the same fashion.
• In use, the externalpressurized system10 can be used to insert a surgical device or system into a cavity of a patient. One method of insertion will now be described, but it is understood that the embodiments disclosed herein are not limited to a single procedure and instead can be used in any procedure that falls within the spirit of the various implementations contemplated herein.
• In one embodiment, theport18 is placed in an incision in the following manner to create a seal for the incision that fluidly seals the patient's cavity from the ambient air outside the patient. First, an incision is made in the patient that provides access to the patient's target cavity. In one embodiment, the cavity is the peritoneal cavity, but the target could be any known cavity. Once the incision has been made, thesealable sleeve device46 is positioned in the incision, for example as shown inFIGS. 6A,6B,6C, and6D. In this embodiment, thedevice46 is positioned throughincision58. Thedevice46 is positioned in the incision by inserting thelower sleeve ring46B (not shown inFIGS. 6A-6D) through theincision58 such that thelower ring46B is positioned within the patient and theupper ring46A is positioned outside the patient, with thesleeve46B extending through theincision58. According to one embodiment, thelower sleeve ring46B of thedevice46 is aflexible ring46B that can be deformed such that thering46B can be inserted through theincision58.
• In one embodiment, prior to positioning thesealable sleeve device46 in theincision58 as described above, thedevice46 is first positioned in a similar fashion through thehole50 in theport ring44 and thehole48 in thebase ring42. That is, thelower sleeve ring46B is deformed and inserted through thehole50 and thehole48, thereby resulting in theupper sleeve ring46A being positioned on the top portion of the base ring42 (which is positioned on the top portion of the port ring44) and thelower sleeve ring46B being positioned on the bottom portion of theport ring44. Thelower sleeve ring46B is then inserted through theincision58 in the patient as described above. Alternatively, thesealable sleeve device46 can be positioned through thehole50 in theport ring44 and thehole48 in thebase ring42 after thedevice46 has been positioned through theincision58.
• Once thelower ring46B is inserted through theincision58 as shown inFIG. 6A and further positioned in thehole50 in theport ring44, theupper ring46A is positioned over theincision58 such that theincision58 is centered within thering46A, as shown inFIG. 6B. For ease of understanding, theport ring44 is not depicted in these figures. Thesealable sleeve46 is then tightened to create a seal and position thelower ring46B snugly to the underside of theincision58 and theupper ring46A snugly to the top portion of thebase ring42. This tightening occurs by rotating theupper ring46A. In one embodiment, theupper ring46A is less flexible (more rigid) than thelower ring46B, thereby allowing a user to grasp it and rotate it.FIG. 6C depicts thesealable sleeve device46 after thering46A has been rotated, thereby causing thesleeve46C to gather and begin to close the opening in thesleeve46C (or “collapse on itself”).FIG. 6D shows thesleeve device46 after the user has successfully rotated thering46A to the point that a seal is formed in thesleeve46C by closing the opening therein.
• It is understood that thebase ring42 and theport ring44 are intended to be generally rotatable relative to each other during the process of positioning theport18 and thereby sealing theincision58. That is, when thebase ring42 is initially positioned on theport ring44, the tworings42,44 are rotatable in relation to each other. This relative rotation of the tworings42,44 allows for rotation of thesleeve device46, thereby resulting in the seal created by thesleeve device46 when it is sufficiently constricted. However, when thesleeve device46, theport ring44, and thebase ring42 are positioned in theincision58 and thesealable sleeve device46 is tightened to close the hole in theincision58 as described above, the elasticity of thesleeve46C urges thebase ring42 andport ring44 together as described above, causing the bottom surface of thebase ring42 and the top surface of theport ring44 to come into contact such that the ridges44A on theport ring44 couple with theridges42B on thebase ring42 as described above. The interfacingridges44A,42B provide an interface or coupling that will result in rotational coupling of therings42,44 when the rings are in contact, but also is releasable when desired. It is understood that the more force applied to urge the tworings42,44 together (the more that thesleeve device46 is rotated), the more secure the coupling of the ridges44A,44B becomes.
• Once thesleeve device46, theport ring44, and thebase ring42 are positioned in theincision58 as described above, theconnector ring40 is coupled to thebase ring42. In one embodiment as described above, theconnector ring40 is coupled to thebase ring42 via nuts or bolts. Alternatively, any standard coupling device or method can be used. Once theconnector ring40 is coupled to thebase ring42, theport18 is fully assembled, as shown inFIGS. 7A and 7B.
• According to one embodiment, the coupling of theconnector ring40 to thebase ring42 as shown inFIG. 7A, in combination with the tightening of thesleeve device46 as described above, creates a fluid seal that seals the patient's cavity from the ambient air outside the patient. More specifically, at this point thesealable sleeve device46 provides a seal as best shown inFIG. 6D. One of ordinary skill in the art understands that this fluidic seal is sufficient to maintain the increased air pressure of the insufflated cavity of the patient.
• Once this seal is established, thecanister12 with the medical device/system26 positioned inside can be coupled to theconnector ring40 as best shown inFIG. 1B such that the device/system26 can then be inserted into theinsufflated cavity24 of the patient. Prior to that coupling, the device/system26 (coupled to a positioning rod28) must be positioned in thecanister12. While it is understood that any number of known procedures within the spirit of the embodiments contemplated herein could be used to position the device/system26 in thecanister12, one implementation provides for—prior to coupling thecanister12 to theport18—inserting the device/system26 through the open end (not shown) at thebase portion20 of the canister12 (as best depicted inFIG. 1A) and inserting thepositioning rod28 through theorifice34 defined in theseal30 in thetop cap14. It is understood that thepositioning rod28, in accordance with some embodiments, can have one or more lumens therein that can contain one or more connection components (such as wires, cords, or the like) that connect the device/system26 to an external controller of some kind, thereby allowing for the controller to control the device/system26 via the connection component(s).
• Once the device/system26 is positioned in thecanister12 with thepositioning rod28 extending out of thetop cap14 through theorifice34 in theseal30 as best shown inFIG. 1B, thecanister12 can be coupled to theconnector ring40. In one embodiment as best shown inFIGS. 8A and 8B, thebase portion20 of thecanister12 has at least 2projections12A extending from thecanister12 that correspond to theslots40B in theconnector ring40. More specifically, in the implementation depicted inFIGS. 8A and 8B, thecanister12 has 4projections12A (one of which is not shown) that correspond to 4slots40B in theconnector ring40. To couple thecanister12 to thering40, the fourprojections12A are inserted into theslots40B and thecanister12 is rotated in a counterclockwise fashion to position theprojections12A in the fully coupled position in theslots40B as shown inFIG. 8B. Alternatively, any known coupling mechanism, device, or procedure can be used to couple thecanister12 to thering40.
• Once thecanister12 is coupled to theport18 as best shown inFIG. 9, a seal has been achieved that fluidically separates and seals fluid within thecanister12 from fluid outside thecanister12. At this point, the pressure inside thecanister12 is increased until it matches the pressure of theinsufflated cavity24. By equalizing the pressure in thecanister12 to the pressure in theinsufflated cavity24, the device/system26 positioned in thecanister12 can then be inserted into thecavity24 through the seal created by thesealable sleeve device46 without causing a loss of pressure or loss of insufflation in thecavity24. According to one embodiment, the fluidic seal is maintained in thecanister12 by the seal created between thecanister12 and theport18 and further by the seal created between the positioningrod28 and theseal30. More specifically with respect to thepositioning rod28 and theseal30, it is understood that therod28 is sized to contact the inner circumference of theorifice34 in theseal30, thereby resulting in an airtight fluidic seal between therod28 and theseal30. It is understood that, at this point, if a user wants to adjust the positioning of the device/system26, the user can do so using thepositioning rod28.
• Once the air pressure in thecanister12 is substantially the same as the air pressure in theinsufflated cavity24, the device/system26 is moved out of thecanister12, through theport18 and theincision58, and into the patient'scavity24. According to one embodiment as best shown inFIG. 1B, the device/system26 can be moved through theport18 and into thecavity24 using thepositioning rod28, which is coupled at its distal end to the device/system26. That is, a user can grasp a proximal end of therod28 and move therod28 in a distal direction as desired to move the device/system26 distally out of thecanister12 and into thecavity24. In those implementations in which the device/system is a robotic device having operational arms, the device, including the arms, can be advanced through theport18 and into theinsufflated cavity24. It is understood that the user can also turn therod28 to turn the device/system26 as needed/desired as well. In this fashion, the user can position the device/system26 as desired within the patient'scavity24 in order to perform a procedure.
• In alternative embodiments, thepositioning rod28 can be a larger rod than that depicted in these figures such that therod28 can have multiple lumens defined within therod28, including one or more larger lumens that could be used for tool and/or camera insertion. Insufflation after removal of thecanister12 could also be accomplished through such arod28. In a further alternative, instead of a rod, a port such as a known SILS port could be used.
• Once the device/system26 has been inserted into, and is positioned as desired in, the patient'scavity24, the fluidic seal is re-established between theinsufflated cavity24 and the interior of thecanister12 via thesealable sleeve device46. As a result, the pressure inside thecanister12 can be lowered until it is substantially equal to the ambient pressure. At that point, thecanister12 can be de-coupled from theconnector ring40. That is, according to one embodiment, thecanister12 is rotated in the clockwise direction, thereby urging theprojections12A out of theslots40B in thering40. Once thecanister12 is removed, as best shown inFIG. 11, only theport18 itself remains with the fluidic seal established by the combination of theport18 components, including thesealable sleeve device46 as described above. Thus, the user can freely position and operate the device/system using the positioning rod28 (and, in some embodiments, the external controller (not shown) connected to the device/system via the connection component(s)). For example, the removal of thecanister12 can provide for additional accessibility and freedom of movement for therod28. As such, the medical procedure using the system/device26 is typically performed once thecanister12 is removed as shown inFIG. 11.
• Another access and insertion embodiment relates to a balloon seal insertion method and device for inserting a surgical device/system into a patient's cavity and performing a surgical procedure using a balloon seal insertion device that operates to maintain a fluidic seal around the surgical device such that the higher air pressure of the insufflated cavity is not lost during the procedure. One example of a balloonseal insertion device100 being used to position and operate asurgical device102 in a patient'sinsufflated cavity106 is depicted inFIG. 12. As depicted, theinsertion device100 is positioned on the patient's skin (schematically depicted as106) and through the incision in the skin (not shown). The connectingrod104 coupled to thedevice102 is positioned through theinsertion device100, with thesurgical device102 positioned within the patient'sinsufflated cavity108.
• As best shown inFIGS. 12,13A, and13B, theinsertion device100 can maintain a fluidic seal during a surgical procedure because thedevice100 has an expandable seal114 (also referred to as an “expandable balloon” or “balloon” herein) disposed through ahole112 defined in theport housing110 of thedevice100. Theballoon114 provides a fluidic seal around any surgical device positioned through thehole112 because theballoon114 is flexible, expandable, and elastic. As such, as theballoon114 is inflated, it provides “odd geometry molding,” which means it can be expanded around, come into contact with, and conform to the shape of any object positioned through thehole112, thereby creating a fluidic seal around that object, regardless of its shape.
• As best shown inFIG. 13B, theinsertion device100 comprises aport housing110 that defines ahole112 as discussed above. As also discussed above, theballoon114 is positioned within thehole112. Thehousing110 further has two balloon inflation/deflation ports116A,116B and a cavity insufflation/deflation port118. In addition, thehousing110 has twoattachment components120 configured to allow for the attachment of thecoupling components122. Thecoupling components122 are used to couple thehousing110 to a standardsealable sleeve46 as will be discussed below.
• Theports116A,116B,118 are configured to receive various types of standard valves and/or connections such as Luer locks, each of which is configured to provide an interface for external tubes, hoses, or the like for providing inflation or deflation as desired/needed. In this specific embodiment, twoconnections124,126 are Luer locks and oneconnection128 is a Schrader valve. According to one implementation, a Schrader valve is used forconnection128 inport116B to accommodate connection to a standard air pump while also providing a release valve to deflate theballoon seal114 when necessary. It is understood that any other known valves or connections used with medical devices—such as, for example, any connections using standard UNF or NPT size fittings—can be used in place ofconnections124,126,128 with various implementations of thisdevice100.
• It is understood that thevarious ports116A,116B,118 are intended to couple to external hoses, tubes, or the like, one or more of which are in turn coupled to external air pressure sources. It is further understood that one or all of the external air pressure sources can be an insufflation device or an air pump typically used for inflation of a medical device. In one embodiment, the external air pressure source is a self-regulating device that self-regulates the level of the air pressure. Alternatively, the external air pressure source can be any known air pressure source that is used with inflatable medical devices.
• According to one embodiment, theballoon114 has atop ring140, abottom ring144, and anexpandable body142 connecting the tworings140,144. It is understood that these parts of theballoon114 can be part of a single integral piece that makes up theballoon114. Alternatively, theballoon114 can be made up of separate components. Thetop ring140 is positioned on and coupled to thetop lip130 on the top portion of thehole112, while thebottom ring144 is positioned on and coupled to thebottom lip132 on the bottom portion of thehole112, as best shown inFIGS. 14B and 14C. In accordance with one implementation, therings140,144 can be coupled to thelips130,132 chemically (a glue or other type of adhesive) or mechanically (clamps, screws, or any other known mechanical attachment mechanisms). Alternatively, theexpandable seal114 can be any known expandable device or component that is used with medical devices and can provide a fluidic seal via odd geometry molding. In one embodiment, theballoon114 is comprised of latex or some type of rubber. Alternatively, theballoon114 can be made of any known material used in medical devices that is expandable, elastic, and can provide a fluidic seal via odd geometry molding.
• In one implementation, the thickness of theseal114 can be modified to influence how theseal114 operates. For example, various parts of theseal114 can have different thicknesses to influence the way in which theseal114 expands when it is inflated. Alternatively, theseal114 can have a single thickness that can be varied to influence the resistance of theseal114 when an object is inserted through it. Alternatively, the thickness can be varied for other reasons as well. In a further alternative embodiment, in addition to at least one expandable elastic material, an additional material or materials can be added to theseal114. For example, a fabric or other type of material that is less elastic and/or less expandable can be included in theseal114 to influence or control the way theseal114 expands when it is inflated. For example, a fabric could be included in a top and bottom portion of theseal114 to prevent theseal114 from expanding vertically (up or down) and thereby influence theseal114 to expand horizontally.
• In the embodiment as shown, theattachment components120 are threaded holes configured to receive screws or bolts or the like. Further, in this implementation, the threadedholes120 are positioned on opposite sides of thehousing110. Alternatively, any appropriate knownattachment component120 can be used to allow for attachment of thecoupling components122 to thehousing110. Further, it is understood by one of ordinary skill that the number and positioning of theattachment components120 on the housing can vary as desired to allow for different configurations and different types ofcoupling components122.
• FIGS. 14A,14B, and14C depict additional details about the configuration of theport housing110, according to one embodiment. More specifically, as best shown inFIG. 14B (which depicts a cross-section of the housing110), theport housing110 has two balloon inflation/deflation lumens150A,150B defined in thehousing110. The balloon inflation/deflation lumen150A provides a fluid connection between the balloon inflation/deflation port116A and thehole112, thereby allowing for inflation or deflation of theexpandable seal114 via theport116A. Similarly, the balloon inflation/deflation lumen150B provides a fluid connection between the balloon inflation/deflation port116B and thehole112, thereby also allowing for inflation or deflation of theexpandable seal114 via theport116B.
• As best shown inFIG. 14C (which depicts a different cross-section of the housing110), theport housing110 also has a cavity insufflation/deflation lumen152 defined in thehousing110 that provides a fluid connection between the cavity insufflation/deflation port118 and patient'scavity108 which is in fluid communication with the underside of thehousing110 when the housing is positioned on the incision in the patient. Thislumen152 thus allows for insufflation or deflation of the patient'scavity108 via theport118.
• In use, thedevice100 is positioned on theincision160 in the patient in combination with a standardsealable sleeve device162 as best shown inFIGS. 16A and 16B. The standardsealable sleeve device162 is shown inFIG. 15. It has anupper ring164 and alower ring166 that are coupled together by aflexible sleeve168. According to one embodiment, thedevice162 is substantially similar to the sealable sleeve device described above with respect toFIGS. 2A,2B,6A,6B,6C, and6D.
• In one implementation, thesealable sleeve device162 is first positioned in theincision160. It is understood that thesleeve device162 can be inserted using steps similar to those described above. Alternatively, any known insertion steps can be used to insert thedevice162 into the incision such that theupper ring164 is positioned outside of theincision160 and thelower ring166 is positioned inside the patient's cavity, with thesleeve168 disposed through theincision160 itself, as best shown inFIG. 16A.
• Once thesleeve device162 is positioned in theincision160, thehousing110 is coupled to thesleeve device162 as best shown inFIGS. 16A and 16B. More specifically, according to one implementation, thehousing110 is positioned over theupper ring164 of thesleeve device162 such that theupper ring164 is positioned into the circular indentation or notch170 defined in the bottom of thehousing110. The configuration of thenotch170 corresponds to the configuration of theupper ring164 and thus is configured to receive theupper ring164 such that thering164 fits snugly into thenotch170.
• Once thering164 is positioned in thenotch170, thecoupling components122 are coupled to theattachment components120 on thehousing110 and thereby firmly couple thehousing110 to thesleeve device162. Thecoupling components122 in this embodiment are components having avertical piece122A and ahorizontal piece122B. Thevertical pieces122A are coupled to theattachment components120 using a screw or bolt or similar mechanism. As best shown inFIG. 16a, when thevertical pieces122A are coupled to theattachment components120, thehorizontal pieces122B are positioned under thehousing110 such that they are also positioned under theupper ring164 disposed in thenotch170. As such, thecoupling components122 operate to retain or lock theupper ring164 in thenotch170. As a result, the retention of theupper ring164 into thenotch170 can provide a fluidic seal between thehousing110 andsleeve device162. Alternatively, any appropriate known interface between thehousing110 andsleeve device162 that provides a fluidic seal can be used.
• Once thehousing110 andsleeve device162 are coupled, theballoon114 can be inflated using eitherport116A orport116B or both. When theballoon114 has been sufficiently inflated such that theexpandable body142 of theballoon114 contacts itself, a fluidic seal is created between the patient's cavity and the ambient air outside the patient's body. Once this fluidic seal is established, the patient'scavity108 can be insufflated usingport118 to the desired pressure inside thecavity108 and the appropriate devices and/or instruments can be inserted into thecavity108 through the expandedballoon114 seal with loss of pressure inside thecavity108.
• In one particular example as depicted inFIGS. 17A and 17B, a device/system having tworobotic arms180,182 are positioned in the patient'scavity108 through the expandedballoon114 seal. More specifically, the firstrobotic arm180 is inserted into the expandedballoon114 seal inFIG. 17A. Due to the odd geometry formation of the expandedballoon114, the fluidic seal is maintained even as thefirst arm180 is being inserted through theballoon114. Once thefirst arm180 is successfully inserted into thecavity108 and positioned as desired as shown inFIG. 17B using aconnection rod184, thesecond arm182 is inserted into theballoon114 seal. Again, the odd geometry formation of theballoon114 allows this to occur without losing the fluidic seal and thus without losing the higher pressure of theinsufflated cavity108.
• Returning toFIG. 12, this figure depicts a final position of the robotic system having twoarms180,182. With thearms180,182 positioned as desired, the system can now be operated by a user or surgeon to perform the desired procedure.
• It is contemplated that alternative embodiments of the balloon seal devices could have more than one balloon seal provided in a single device. Those two or more balloon seals could be provided in various configurations. For example, in one configuration, in addition to the central seal similar to that described above, a second seal could be provided off to one side of the first seal and positioned at an angle so that any device or object inserted through the second seal would be inserted at an angle. It is understood that these two or more balloon seals could be pneumatically connected to the same air pressure source(s), or, alternatively, each seal could be pneumatically separate so that each has its own pressure source and can be set at its own independent level of air pressure.
• Another access and insertion embodiment relates to a rubber seal insertion method and device for inserting a surgical device/system into a patient's cavity and performing a surgical procedure using a rubber seal access/insertion device that operates to maintain a fluidic seal at the incision such that the higher air pressure of the insufflated cavity is not lost during the procedure. One example of a rubber seal access/insertion device200 is depicted in cross-sectional view inFIG. 18. As depicted, the access/insertion device200 is positioned on the patient's skin (schematically depicted as202) over theincision206 in theskin202 and is coupled to a standardsealable sleeve device204, which is disposed through theincision206.
• As best shown inFIGS. 19A and 19B, the access/insertion device200 has abase ring210 that is coupleable to thesleeve device204. Thedevice200 also has threeseals212A,212B,212C positioned between thebase ring210 and the firsttop ring214. In some embodiments, thedevice200 has only the first set of seals (212A,212B,212C) and the firsttop ring214. In alternative embodiments such as the implementation as shown, thedevice200 also has a second set of threeseals216A,216B,216C positioned between the firsttop ring214 and a secondtop ring218. In this implementation, the first and secondtop rings214,126 are coupled to thebase ring210, thereby maintaining the first set ofseals212A,212B,212C and second set ofseals216A,216B,216C in place such that each of the sets of seals212,216 and the twotop rings214,218 maintain a fluidic seal. According to one embodiment, a set of screws or bolts are positioned through theholes210A,214A,218A defined in the outer circumference of each of thebase ring210, the firsttop ring214, and the secondtop ring218, respectively, and fastened to fix therings210,214,218 in place. Alternatively, any known device or mechanism for holding or fixing therings210,214,218 (and thus the seals212,214) in place can be used.
• According to one embodiment, the fluidic seal created by the set of seals (212A,212B,212C, for example) is created by providing separate rubber seals having different types of openings defined in each such seal. For example, as best shown inFIG. 20, in this implementation, theseals212A,212B,212C each have two different openings formed through them that are different from the corresponding openings in the other seals.Seal212A has two substantiallycircular holes230A,230B formed through theseal212A. Thehole230A is larger, is positioned more centrally on theseal212A, and is intended to receive a surgical device or system such as a robotic surgical device. Thehole230B is smaller, is positioned closer to an edge of theseal212A, and is intended to receive a peripheral device or component such as a trocar, a camera, or some other accessory tool. Theseholes230A,230B are intended to provide a fluidic seal around the perimeter of any object(s) passed through them.
• In contrast,seal212B has twoslits232A,232B formed through theseal212B. Theslit232A is larger and is positioned in a location that corresponds to hole230A, whileslit232B is smaller and is positioned in a location that corresponds to hole230B. Similarly,seal212C has a larger slit234A positioned in a location corresponding to hole230A and slit232A and further has a smaller slit234B positioned in a location corresponding to hole230B and slit232B. In addition, the slits234A,234B inseal212C are positioned at a 90 degree angle with respect to theslits232A,232B inseal212B. According to one implementation, the combination of theslits232A,232B inseal212B with the slits234A,234B inseal212C results in a stronger fluid seal that can withstand the increased pressure of theinsufflated cavity208 of the patient without the slits opening and allowing that increased pressure to be lost.
• By incorporating two sets of seals212,216 as shown inFIGS. 19A,19B, the overall fluidic seal created by thedevice200, even when surgical devices are inserted through thedevice200, is further strengthened. More specifically, as best shown inFIG. 19B, the firsttop ring214 defines ahole214B at its center. When the firsttop ring214 is positioned between the first set of seals212 and the second set of seals216, thehole214B in the firsttop ring214 creates a cavity between the two sets ofseals212,214. As such, according to one embodiment, any loss of the fluidic seal in one set of the seals (either212 or214) will not cause a loss of the overall fluidic seal or leak pressure directly from the patient'scavity208 into the ambient air outside the patient. Hence, the cavity created by the firsttop ring214 can minimize the overall pressure loss from any such leak.
• In accordance with one implementation, each of theseals212A,212B,212C,216A,216B,216C is a relatively thin sheet of rubber. Alternatively, each of the seals can be made of any known flexible material that can serve as a seal in a medical device. In one exemplary embodiment, each of the seals is about 0.125 inches thick. Alternatively, the thickness of each of the seals can vary between about 0.0625 and about 0.25 inches thick. In a further alternative, each set of three seals212,216 can be replaced with a single seal having a thickness ranging from about 0.1875 inches to about 0.75 inches. This thickness in a single seal, according to some embodiments, can provide substantially the same type of fluidic seal strength as the set of three thin seals.
• As discussed above, according to certain embodiments, thedevice200 has only one set ofseals212A,212B,212C and only the firsttop ring214. While such embodiments do not have the cavity created by the firsttop ring214 as described above, thedevice200 with a single set of seals212 can still provide a sufficient fluidic seal. For example, such adevice200 would provide a sufficient fluidic seal for insertion of any robotic device having sufficiently smooth external features and surfaces. In addition, adevice200 with a single set of seals212 can reduce the size of theoverall device200 and can potentially reduce any trauma to the surgical device inserted through thedevice200 as a result of only having to pass through a single set of seals212.
• FIG. 21, according to one implementation, depicts a top view of thedevice200. More specifically,FIG. 21 shows the secondtop ring218 positioned over theseal216A. Theholes236A,236B in theseal216A are visible as well.
• In use, the rubber seal access/insertion device200 can be positioned for use in the following manner. First, as described above with respect to other embodiments, according to one implementation, thesealable sleeve device204 is first positioned in theincision206. It is understood that thesleeve device204 can be inserted using steps similar to those described above. Alternatively, any known insertion steps can be used to insert thedevice204 into the incision such that theupper ring240 is positioned outside of theincision206 and thelower ring242 is positioned inside the patient's cavity, with thesleeve244 disposed through theincision206 itself, as best shown inFIG. 18.
• Once thesleeve device204 is positioned in theincision206, the base ring210 (and thus the entire device200) is coupled to thesleeve device204 as best shown inFIGS. 18 and 22. More specifically, according to one implementation, thebase ring210 is positioned over theupper ring240 of thesleeve device204 such that theupper ring240 is positioned into the circular indentation or notch250 defined in the bottom of thebase ring210. The configuration of thenotch250 corresponds to the configuration of theupper ring240 and thus is configured to receive theupper ring240 such that thering240 fits snugly into thenotch250.
• Once theupper ring240 is positioned in thenotch250, thecoupling components220 are coupled to theattachment components252 on thebase ring210 and thereby firmly couple thebase ring210 to thesleeve device204. Thecoupling components220 in this embodiment are components having avertical piece220A and ahorizontal piece220B as best shown inFIG. 19A or22. Thevertical pieces220A are coupled to theattachment components252 using a screw or bolt or similar mechanism. As best shown inFIG. 18, when thevertical pieces220A are coupled to theattachment components252, thehorizontal pieces220B are positioned under thebase ring210 such that they are also positioned under theupper ring240 disposed in thenotch250. As such, thecoupling components220 operate to retain or lock theupper ring240 in thenotch250. As a result, the retention of theupper ring240 into thenotch250 can provide a fluidic seal between thebase ring210 andsleeve device204. Alternatively, any appropriate known interface between thebase ring210 andsleeve device204 that provides a fluidic seal can be used.
• Once thedevice200 andsleeve device204 are coupled as best shown inFIGS. 18 and 23, a fluidic seal has been established between the patient'scavity208 and the external air outside of the patient. At this point, the patient's cavity can be insufflated to the desired amount of air pressure. Subsequently, one or more surgical devices can be inserted through the seals212,216 at the appropriate holes/slits and into the patient'sinsufflated cavity208. In one embodiment, each arm of a robotic surgical device can be separately and consecutively inserted through the larger hole (and larger slits) of the seals and into thecavity208. Alternatively, any known devices can be inserted into thecavity208 so long as they fit through the holes and slits as contemplated herein.
• Another embodiment of an access/insertion device relates to another external pressurized system or apparatus similar to the system or apparatus depicted inFIGS. 1-11 and described in detail above. Like the device inFIGS. 1-11, the instant device is coupled to a port that is positioned over and/or in an incision in the skin of the patient, thereby providing access to a cavity of the patient. However, in the instant implementations as shown inFIGS. 24A-38 and discussed below, the external pressurized system/apparatus has a external body having one or more access ports for the insertion of not only surgical devices, but also additional equipment and/or the hands of one or more users or medical professionals, providing access to the interior of the pressurized system/apparatus without loss of the higher pressure inside the system/apparatus.
• For example, one implementation of such an external pressurized system orapparatus300 is depicted inFIGS. 24A-24F. As best shown inFIGS. 24C (top view) and24D (perspective view), thedevice300 has anexternal body302 having a main tube (also referred to as the “canister”)304, aleft hand tube306 with a lefthand access port308, aright hand tube310 with a righthand access port312, and aside access tube314 with aside access port316. In addition, themain tube304 has adevice port318 coupled to a top portion of thetube304.
• The bottom portion of themain tube304 is coupleable to anincision port320, as best shown inFIGS. 24A and 24B. In turn, as best shown inFIG. 24F, theincision port320 is coupleable to a standardsealable sleeve device322, which can be positioned in theincision324 made in the patient'sskin326 to access atarget cavity328 of the patient. Theincision port320 and its coupling to both themain tube304 and thesealable sleeve device322 are described in detail below.
• In the depicted implementation, the left and righthand access ports308,312 can be configured to allow a user or medical professional to insert her or his hands through theports308,312 and into the interior of thebody302. Further, theside access tube314 withaccess port316 can be used for storage of equipment and/or for assistance of another user by inserting her or his hand through theport316. In addition, thedevice access port318 can be configured such that various medical devices/systems can be inserted into thebody302 through theport318. Alternatively, any of theaccess ports308,312,316,318 can be configured to allow for insertion of hands and/or equipment/devices. Further, in various alternative embodiments, it is understood that thebody302 could have amain tube304 with one, two, or more than three additional tubes with access ports for various uses, including any of those discussed above. It is also understood that various embodiments contemplated herein include tubes and/or ports that are different sizes or shapes than those depicted. For example, in some implementations, the tubes and/or ports could be square or oval in shape.
• In one implementation, the external body302 (themain tube304 and theaccess tubes306,310,314) is made of a hard plastic, such as, for example, poly(methyl methacrylate) (“PMMA”). Alternatively, thebody302 can be made of any known rigid material that can be used in medical devices. It is understood that certain embodiments of thebody302 are transparent, such as those depicted in the figures provided. Thetransparent body302 allows for the user to see the interior of thetubes304,306,310,314 including any equipment or devices being inserted during the procedure. Alternatively, thebody302 is not transparent and the equipment/devices can be inserted without being able to view them in thedevice300.
• According to one implementation, thesealable sleeve device322, as best shown inFIGS. 24F,29A,29B, and30, can be a standard, commercially available device as described in the various embodiments above. Thedevice322 has anupper ring420 and alower ring422 that are coupled together by aflexible sleeve424. According to one embodiment, thedevice322 is substantially similar to the sealable sleeve device described above with respect toFIGS. 2A,2B,6A,6B,6C, and6D.
• According to one embodiment, theaccess ports308,312,316,318 are standard commercially-available ports that allow various objects, including devices or hands, to be inserted through them and into a surgical space. One example of anaccess port340 in use is depicted inFIG. 25. As shown in that figure, theport340 allows for insertion of a hand through theport340. Anotherexemplary access port342 is depicted inFIG. 26. Thisport342 is the GelSeal® port that is commercially available from Applied Medical in Rancho Santa Margarita, Calif. In this embodiment, theport342 has abody344, arigid support ring346, and amoveable clamp lever348 that can be used to tighten theport342 and thus secure theport342 to any ringed object to which it is attached. More specifically, theclamp lever348 is depicted in three different positions. In position A, thelever348 is in the open position A and theport342 thus has its widest circumference. In position B, thelever348 is midway between the open position A and the closed position C and theport342 has a circumference that is less than when it is in the open position A. Finally, in position C, thelever348 is positioned against theport342 in the closed position C and theport342 has its smallest circumference. In use, thelever348 is typically in position A when theport342 is positioned and then thelever348 is moved to position C to clamp theport342 in place. In one embodiment, thebody344 is made of the soft, gel-like material in the product as provided by Applied Medical. Alternatively, thebody344 can be made of any material that allows for objects and/or hands to be inserted through the material such that the fluidic seal is maintained so that the higher pressure of the surgical cavity is not lost when an object is inserted through the material.
• In accordance with one implementation as shown inFIG. 27A, theaccess ports308,312,316,318 are coupled to thetubes304,306,310,314 via aport adaptor ring350. Theport adaptor ring350 has afirst ring portion352 that is sized to mate with any one of thetubes304,306,310,314 of thebody302. (In this particular depiction, the lefthand access tube306 is used as an example.) Thering350 also has asecond ring portion354 that is sized to mate with a port—in this case the lefthand access port308.
• According to one embodiment, thefirst ring portion352 is coupled to thetube306 by positioning thefirst ring portion352 over the end of thetube306 and holding thefirst ring portion352 in place usingthumb screws356 that are inserted through threadedholes358A in thefirst ring portion352 and into threadedholes358B in thetube306. Alternatively, any attachment devices or mechanisms, such as bolts, clamps, or the like, can be used to attach thefirst ring portion352 to the tube306 (and, by extension, to any of thetubes304,306,310,314). In one embodiment, a gasket (not shown), such as a foam or rubber gasket, is positioned between thetube306 and thefirst ring port352 to ensure that a fluidic seal is established between the two components.
• Theaccess port308, in accordance with one implementation, is coupled to thesecond ring portion354 in a fashion similar to that described above. That is, theclamp lever308A on theport308 is placed in position A, and theport308 is positioned over thesecond ring portion354. Then thelever308A is moved into the closed position—position C—such that theport308 is clamped onto thesecond ring portion354. Alternatively, any known mechanism or method for coupling a port similar toport308 to a device component can be used.
• According to one embodiment as shown inFIG. 27B, thedevice access port318 can have one or more additional structures to allow a user to easily stabilize or position a surgical device within thebody302 of thedevice300 prior to or during use. More specifically, thedevice access port318 in certain implementations has one or more device attachment components357 (also referred to as “device clips”) positioned along the inner lumen of theport318. Thedevice clip357 is configured to retain a device such as apositioning rod359 within theclip357, thereby providing a way to couple a portion of the surgical device being used for the intended procedure to the interior of thebody302. In one embodiment, theattachment component357 is an actual clip as shown inFIG. 27B. Alternatively, thecomponent357 can be a notch or other type of specifically configuredindentation357 defined in the inner lumen of theport318 that is configured to receive a medical device such as apositioning rod359 or the like. In a further alternative, theattachment component357 can be any mechanical or structural mechanism or component that allows for coupling to a medical device. In further embodiments,such attachment components357 can be positioned elsewhere in thebody302, such as, for example, on an interior port of another access port or elsewhere on an interior portion of one of the tubes.
• In various alternative embodiments, other types of access ports can be used instead of the ports described above and depicted inFIGS. 24-27B. For example, in one specific alternative implementation, one or more glove ports can be used such as theglove port360 depicted inFIGS. 28A and 28B. Theglove port360 has aglove component362 coupled to aglove port ring364. In various embodiments, theglove port360 could be coupled at theglove port ring362 to one or more of thetubes304,306,310,314 on thebody302. In one embodiment, theglove port ring362 is coupled to the tube via a clamp lever similar to the clamp lever described with respect toFIG. 26. Alternatively, any known coupling mechanism can be used. Unlike theaccess ports308,312,316,318, theglove port360 does not require that a fluidic seal be established around the surgeon's arm or whatever object is inserted through it. As such, theglove port360 can help to ensure that the pressure differential between the patient's cavity and the ambient air outside the patient will be maintained. In one embodiment, theglove port360 has a pressure relief valve (not shown) that can be used to adjust the volume, thereby accounting for the volume change caused when a user inserts her or his hand into thebody302 using theglove component362.FIG. 28B depicts theglove port360 in use.
• As mentioned above, theincision port320 is configured to be coupleable to both themain tube304 and to thesealable sleeve device322, as shown inFIGS. 24F and 29. As best shown inFIGS. 24A and 30, theincision port320 has abase ring370. The upper portion of thebase ring370 can be coupled to aninternal coupling component372, which can couple to theport seal450 as described in further detail below. Further, the lower portion of thebase ring370 can be coupled to external coupling components374 (also referred to in certain embodiments as “sleeve clamps”), which couple thering370 to thesealable sleeve device322. In addition, thebase ring370 can also be coupled to coupling components376 (also referred to in certain embodiments as “tube brackets”), which couple thering370 to themain tube304 of thedevice300.
• FIGS. 31A and 31B depict thebase ring370, according to one implementation. Thering370 has a curved indentation or notch378 configured to receive and couple with the bottom portion of themain tube304. In addition, thering370 has threebracket receiving components380 configured to receive thetube brackets376. Further, as best shown inFIGS. 24F,30, and35, the bottom portion of thering370 defines a circular indentation orlumen381 that is configured to be positioned over and receive theupper ring420 of thesleeve device322. Thering370 also hasmultiple holes384 defined in aninterior ring382. Themultiple holes384 correlate toholes436 in thebase plate430 of theinternal coupling component372, as described in detail below. Each of thebracket receiving components380 have aprojection386 andhorizontal portion388 on which thetube bracket376 is positioned and ahole390 that corresponds to thehole394 in thetube bracket376 as described in detail below. In one embodiment, a gasket (not shown), such as a silicon, foam or rubber gasket, is provided between thenotch378 and the bottom portion of themain tube304 to strengthen the fluidic seal between the two components.
• FIG. 32 depicts atube bracket376, according to one embodiment. Thetube bracket376 has abase portion392 having ahole394 defined therein that corresponds to thehole390 in thebracket receiving component380 on thebase ring370. Thebracket376 also has atube contacting portion396 having twoholes398 defined therein that correspond to theholes404 in the bottom portion of themain tube302, as described below.
• According to one embodiment, thetube bracket376 is used to couple themain tube302 to thebase ring370, as shown inFIG. 33. More specifically, thetube bracket376 is positioned on thebracket receiving components380, with thebase portion392 of thebracket376 positioned on thehorizontal portion388 and thetube contacting portion396 positioned on theprojection386. In that position, thebracket376 is coupled to thebase ring370 by inserting a threadedscrew400 throughhole394 in thebracket376 and intohole390 in thering370. Further, thebracket376 is coupled to themain tube302 by inserting two threadedscrews402 throughholes398 in thebracket376 and intoholes404 in thetube302. Thus, thetube302 is attached in position against theincision port320 and specifically thebase ring370 using thebrackets376. In the embodiments depicted inFIGS. 24A-24F, there are threetube brackets376—spaced about 120 degrees from each other around the circumference of theport320—that are used to couple thetube302 to theport320. Alternatively, two brackets or more than three brackets could be used in different positions around theport320. In a further alternative, any known type of coupling mechanism could be used to keep thetube302 coupled to theport320.
• As discussed above, theincision port320 is coupled to thesealable sleeve device322 using the sleeve clamps374.FIG. 34 depicts one embodiment of asleeve clamp374. Theclamp374 has ahole406 defined in a top portion of theclamp374,projections408 configured to fit into thenotches410 defined under thebracket receiving components380 on the base ring370 (as best shown inFIG. 31B), and aprojection412 configured to help retain theupper ring420 of thesealable sleeve device322 in position on theclamp374, as discussed below. Thehole406 corresponds to thehole394 in thebracket376 and thehole390 in thebase ring370 such that when thesleeve clamp374 is positioned under thebracket receiving component380 of thebase ring370 and the threaded screw is inserted throughhole394 andhole390, it is also threaded intohole406 such that thesleeve clamp374 is coupled to thebase ring370.
• As best shown inFIGS. 30 and 35, when theport320 is positioned over thesleeve device322 such that theupper ring420 is positioned within thelumen381 on the bottom portion of thebase ring370, thesleeve clamp374 can be coupled to thebase ring370 as described and theupper ring420 of thesealable sleeve device322 is contacted by theclamp374 and thereby retained in its desired position as shown. Further, thenotch412 in theclamp374 can further help to retain theupper ring420. In one embodiment, a gasket (not shown), such as a foam, rubber, or silicone gasket, is placed between theupper ring420 and the underside of thebase ring370, thereby providing a stronger fluidic seal between the two components.
• As discussed above, according to one embodiment, the upper portion of thebase ring370 can be coupled to aninternal coupling component372, as best shown inFIGS. 24A,30, and36. Theinternal coupling component372 has abase plate430 and amale component432 projecting from thebase plate430. Thebase plate430 hasmultiple holes436 defined in theplate430. Theseholes436 correspond to theholes384 defined in theinterior ring382 of thebase ring370 such that screws438 (or bolts or any other known coupling mechanisms) can be used to couple thebase plate430 to theinterior ring382 of thebase ring370 as shown. In addition, the interior portion of themale component432 has two device attachment components440 (also referred to herein as “device clips”) (only onesuch clip440 is shown inFIG. 36). Eachdevice clip440 is configured to be able to allow a user to couple a positioning rod (as described elsewhere herein) or some other device component to theclip440 before or during a surgical procedure, thereby stabilizing or maintaining the position of the device.
• As best shown inFIG. 36, themale component432 has threenotches434 formed or engineered on its outer circumference (one of which is fully depicted inFIG. 36). Thenotches434 have avertical portion434A and ahorizontal portion434B in communication with thevertical portion434A. Eachnotch434 is configured to received a corresponding projection formed on an internal circumference of any device intended to couple with themale component432. As such, to couple the device to themale component432, the device is positioned over themale component432 with the projections on the device positioned over the correspondingnotches434 on themale component432. The device is then positioned onto themale component432 such that each projection moves along thevertical portion434A of thenotch434 until it reaches thehorizontal portion434B. At that point, the device can be rotated and thereby move each projection circumferentially along thehorizontal portion434B of thenotch434, thereby coupling the device to themale component432 of theinternal coupling component372.
• In one implementation, as best shown inFIGS. 37A,37B, and37C, one of the components that can be coupled to theinternal coupling component372 is aport seal450. Theport seal450 has aseal clamp452 coupled to abase seal ring454. Aseal component456 is positioned between theclamp452 and thering454 so that the coupling of theclamp452 to thering454 fixes theseal component456 in place in theport seal450. In one embodiment as shown, theseal clamp452 hasmultiple holes458 defined in theclamp452 that correspond to holes (not shown) in thebase seal ring454 such that threaded screws460 (or bolts, or the like) can be inserted through theholes458 and into the holes in thering454 to couple the two components together. Alternatively, any other known attachment mechanisms can be used. In one embodiment, a gasket (not shown), such as a foam, silicone, or rubber gasket, can be positioned between themale component432 and thebase seal ring454 to strengthen the fluidic seal between the two components.
• Theseal clamp452, in one embodiment, has multiple projections464 extending from the top surface of theclamp424. These projections464 can be easily grasped by a user to place theport seal450 on themale component432 or remove it therefrom. Further, as best shown inFIG. 37C, the underside of thebase seal ring454 has threeprojections462 disposed on the inner circumference of thering454. The threeprojections462 correspond to the threenotches434 defined in the outer circumference of themale component432 such that thebase seal ring454 can be coupled to themale component432 as described above.
• According to one implementation, the seal component456 (also referred to herein as a “flexible seal component” or an “elastic seal component”) is a circular sheet of flexible or elastic material that is configured to allow a device or other equipment to be inserted through the seal component456 (or to allow theseal component456 to be positioned over such equipment, like a positioning rod, as described in further detail below). In one embodiment, theseal component456 is a circular rubber sheet having a small hole (not shown) in the sheet through which equipment can be inserted. Alternatively, theseal component456 can be any known material configured to maintain a fluidic seal when a device or equipment is inserted through theseal component456.
• In accordance with one embodiment, a different type of seal component can also be incorporated into thedevice300. As shown inFIGS. 38A,38B, and38C, aflap seal component470 is provided. Theflap seal component470 has two flaps—afirst flap472 and asecond flap474—that contact each other at a midpoint in thecomponent470. Each of theflaps472,474 has ridges orteeth472A,474A on the surfaces that are in contact such that theridges472A onflap472 correspond to theridges474A onflap474 and thus interface or couple with each other. In one implementation as shown, theflap seal component470 is positioned between thebase ring370 and theinternal coupling component372. According to one implementation, the configuration of theflaps472,474 extended downward toward the patient's cavity and the coupledridges472A,474A can provide structural strength to prevent a mechanical failure (also referred to as a “blowout”) in which theflaps472,474 are forced outward by the higher air pressure until theflaps472,474 are extending outward away from the patient's cavity and the fluidic seal is lost.
• In one embodiment as shown inFIG. 38A, theflap seal component470 can be incorporated into theincision port320 and used when theport seal450 is not coupled to theport320. Alternatively, as shown inFIG. 38B, theflap seal component470 can be incorporated into theincision port320 and used when theport seal450 is coupled to theport320.
• In use, the various embodiments disclosed or contemplated herein relating to access and insertion systems, devices, and methods that relate specifically to an external device having one or more ports for the insertion of not only medical devices, but also related equipment and/or the hands of one or more medical professionals to access the interior of the device during medical procedures while being able to maintain a higher air pressure within the device that is substantially the same as the insufflated cavity of the patient. According to one implementation, the high pressure is around 18 mmHg above atmospheric pressure, which is around the amount of pressure that is used to insufflate a patient's abdominal cavity during a laparoscopic procedure. Alternatively, any known higher pressure amount that is used during medical procedures can be used.
• The method of using thedevice300, according to one embodiment, includes at least some of the following steps. First, as described above with respect to other embodiments, according to one implementation, thesealable sleeve device322 is first positioned in the incision324 (seeFIGS. 24F,29A,29B, and30). It is understood that thesleeve device322 can be inserted using steps similar to those described above. Alternatively, any known insertion steps can be used to insert thedevice322 into theincision324 such that theupper ring420 is positioned outside of theincision324 and thelower ring422 is positioned inside the patient's cavity, with thesleeve424 disposed through theincision324 itself, as best shown inFIG. 30.
• Next, theincision port320 and thedevice300 are coupled to thesealable sleeve device322. As best shown inFIGS. 30,33, and35, thebase ring370 of theincision port320 is positioned over theupper ring420 of thesleeve device322 such that theupper ring420 is positioned in thelumen381 on the bottom portion of thebase ring370. In addition, the bottom portion of themain tube304 of thedevice body302 can be positioned in thecurved notch378 on thebase ring370. At this point, both thedevice300 and the sleeve device are positioned as desired with respect to theincision port320 and must be coupled to theport320. To do so, thetube brackets376 and the sleeve clamps374 are positioned on thebase ring370 as described above and fixed in place using the threaded screws400. Then the threadedscrews402 are placed as well. As such, theincision port320 is coupled to both thedevice300 and thesleeve device322 and a fluidic seal is created between the interior of thebody302 and the exterior.
• According to one embodiment, at least one medical device or piece of equipment that will be used during the procedure can be placed in thebody302 prior to coupling thebody302 to theincision port320. For example, in one embodiment, thedevice480 disposed within thebody302 as best shown inFIGS. 24A,24B,24D, and24F can be positioned within thebody302 and, in some implementations, secured to a device clip357 (as shown inFIG. 27B). More specifically, in the particular embodiment depicted inFIGS. 24A,24B,24D, and24F, thedevice480 is made up of twoarms482A,482B that are positioned within thebody302. Alternatively, any medical device that will be used for the surgical procedure could be positioned within thebody302 in the same or a similar fashion.
• It is understood, in accordance with one implementation, that theport seal450 is not coupled to the internal coupling component372 (which is coupled to the incision port320) at this point during the placement of thedevice300. As such, according to one embodiment, theport seal450 is stored in theside access tube314 while thebody302 is being coupled to theport320, as best shown inFIGS. 24B,24C, and24D. Alternatively, theport seal450 can be uncoupled from theinternal coupling component372 and placed in theside access tube314 prior to positioning the medical device inside thebody302 and coupling thebody302 to theincision port320.
• Once thedevice300 is coupled to theincision port320 and theincision port320 is coupled to thesealable sleeve device322, the fluidic seal within thedevice300 has been established, and the patient's cavity can be insufflated. This insufflation will result in an increase in air pressure within the patient's cavity and within the device300 (because neither theport seal450 nor theflap seal470 is nt coupled to the internal coupling component372).
• Once insufflation is achieved, thedevice480 is positioned through theincision port320 and into the patient's cavity. More specifically, the user or medical professional inserts her or his hands into the left and righthand access ports308,312 and moves the medical device through theincision port320 and into position within the cavity. At this point, if the medical device has apositioning rod359, thatrod359 can be coupled to adevice clip440 on the interior of themale component432 of theinternal coupling component372 of theport320, thereby establishing, maintaining, or fixing the position of the medical device within the patient's cavity. Alternatively, the device can be positioned and maintained in that position using any type of mechanism or method, including some type of device or method independent of thedevice300.
• Once the medical device is positioned as desired, theport seal450 can be positioned in place over the device (or thepositioning rod359—or rods—of the device). That is, the user reaches in through thehand access ports308,312 and removes theseal450 from theside access tube314 and placed over the device/rod359 so that the device and/orrod359 is inserted through theseal component456 of theseal450 and then coupled to themale component432 of theinternal coupling component372 as described above.
• Once theport seal450 is in place, thebody302 can be removed from theincision port320. More specifically, the user can remove the threadedscrews402 and then remove themain tube304 from theport320. The fluidic seal between the patient's cavity and the ambient air outside the patient's body is maintained by theport seal450.
• The user/medical professional can then begin performing the medical procedure.
• An alternative external pressurized device embodiment is depicted inFIGS. 39A and 39B. In this embodiment, thedevice500 is asingle tube502 having asingle access port504 disposed at the top of thetube502. Theaccess port504 serves to establish a fluidic seal when a medical device or a surgeon's hand is inserted through theport504. Thetube502 also has twocamera ports506 extending from a bottom portion of thetube502. According to one implementation, thetube502 is configured to couple to an incision port, including any incision port disclosed elsewhere herein or any known incision port.
• A further embodiment depicted inFIG. 40 is another alternative externalpressurized device510. Thedevice510 has atube514 that is coupleable to anincision port516 and has twoslots511,513 formed on opposite sides of thetube514. Theseslots511,513 provide fluid communication between the interior of thetube514 and the exterior of thetube514. In one embodiment, therod slots512 are each configured to receive a positioning rod. Thedevice510 further has twoslot seals512, with oneseal512 positioned in each of theslots511,513. These slot seals512 are configured to maintain a fluidic seal at each of theslots511,513 such that an object can be positioned through either or bothslots511,513 and the fluidic seal is not lost. Thetube514 also has two sets ofdevice attachment components518A,518B (also referred to as “rod clips”). Each set ofrod clips518A,518B has two device clips—ahorizontal clip515A and anangled clip515B.
• In use, a device can be positioned within thetube514 such that a positioning rod coupled to the device extends out of thetube514 through one of theslots511,513. The device can be fixed in position in thetube514 by coupling the positioning rod to thehorizontal clip515A. The patient's cavity can then be insufflated. When ready, the positioning rod can be moved down the slot (511 or513) such that the device is being moved down the interior of thetube514 and inserted through theport516 and into the patient's cavity. At this point, the positioning rod is angled upward and clipped to theangled clip515B, thereby fixing the positioning of the device inside the patient's cavity.
• Another implementation relates to a positioning tube520 as depicted inFIGS. 41A and 41B. In this embodiment, the positioning tube520 can also act as a large positioning rod. The tube520 has twoguide slots522 defined in or attached to an inner portion of the tube520. Theguide slots522 are each configured to receive apositioning rod524. In this implementation, each device526 (or device arm) is coupled to an end of one of thepositioning rods524 and can be inserted through the tube520 and into the patient's cavity. Due to the size of the tube520, thedevices526 must be inserted one at a time. Alternatively, the tube520 can be sized so that bothdevices526 can be inserted at the same time. The tube520 also has anair lock528 disposed in the tube520. Theair lock528 is configured to be capable of fluidically dividing the tube520 into two fluidically separate compartments when theair lock528 is closed.
• In use, the positioning tube520 (having arobotic arm526 disposed within the tube520) can be inserted through any of the various incision ports described elsewhere herein. When the tube520 is positioned so that the distal end of the tube520 is extending into the patient's cavity, a seal is created at the top of the top by placing a seal cap (not shown) on the top of the tube520. Once the inside of the tube520 is sealed, thepositioning rod524 can be urged distally and thereby thearm526 is urged out of the tube520 and into the patient's cavity. If asecond arm526 is going to be inserted, theair lock528 is then closed. That is, theair lock528 is closed to create a fluidic seal between the top of the tube520 and the bottom of the tube520. Once theair lock528 is in place, the seal cap is removed, and thesecond arm526 can be positioned in the tube520. At this point, the seal cap can be replaced, theair lock528 can be released, and thesecond arm526 can be inserted into the patient's cavity.
• Several additional embodiments relate to various types of incision ports. For example,FIG. 42 depicts astacked incision port540. Theport540 actually has twoaccess ports542,544 that are coupled together, with acavity546 between the twoaccess ports542,544. In one embodiment, theaccess ports542,544 are commercially available GelSeal® ports. Thecavity546 between the twoaccess ports542,544 strengthens the overall fluidic seal of theport540. In other words, thecavity546 reduces the amount of air pressure loss because any air pressure loss is lost in the cavity and not lost to the ambient air, thereby reducing the overall loss.
• Another incision port embodiment is depicted inFIG. 43. Thisincision port550 actually has two seals combined in the port: arubber seal552 and aflap seal554. Theport550 also has twocamera ports556 extending out from theport550. In one embodiment, therubber seal552 has three different rubber disks (not shown) similar to the different disks depicted inFIG. 20 and described above. The disks in thisrubber seal552 can have openings/incisions that differ for each disk in the same fashion as the disks shown inFIG. 20. Alternatively, therubber seal552 can be similar to any rubber or flexible seal described elsewhere herein. Theflap seal554, according to one embodiment, is similar to the flap seal depicted inFIGS. 38A-38C.
• FIG. 44 depicts another incision port embodiment. More specifically, this port is a two-seal port560 having afirst rubber seal562 and asecond rubber seal564. Theport560 also has abase ring570, amiddle ring568, and atop ring566. Themiddle ring568 creates a cavity (not shown) between the twoseals562,564 that is configured to compartmentalize any lose of pressure by either of theseals562,564. The presence of the cavity makes this embodiment fairly similar to the incision port depicted inFIG. 42. According to one embodiment, each sheet ofrubber562,564 is about 0.5 inches thick and has a single slit (not shown) formed through the middle of it. Alternatively, eachsheet562,564 can have two openings (not shown) formed through the middle of it.
• FIGS. 45A and 45B depict a further incision port embodiment. This port is a three-sheetrubber seal port580 having asingle ring582 in which three sheets of rubber (only thetop sheet584 is shown). In one embodiment, each of the three sheets has an opening in it that corresponds to the openings in the other two sheets. In a further embodiment, the openings are similar to those depicted inFIG. 20 and described. Alternatively, each sheet can have two corresponding openings.
• FIGS. 46A and 46B depict a further incision port system embodiment. This system is an airbarrier port system590 having anair barrier port592. Thisport592 is coupled to fourair tubes596A,596B,596C,596D that are coupled to anair intake port594. In operation, high pressure air is provided at theair intake port594 and is forced through the fourtubes596A-D and into theport592. The fourtube connections598A,598B,598C,598D are positioned on theport592 such that the air is forced into a channel (not shown) that encircles thehole600 in theport592. The air is then forced through a circular nozzle (not shown) in communication with the channel (not shown) that projects the air out of the nozzle and across thehole600. The air flow projected across thehole600, according to one implementation, is both directed and has a high velocity—both of which have an impact on the creation of an air barrier. As a result, an air barrier is created in thehole600 defined in theport592. That is, the high velocity air movement across or within thehole600 creates a fluidic seal that is sufficient to maintain the insufflation of a patient's cavity.
• FIG. 47 depicts another incision port embodiment—in this case, a one-sheetrubber seal port610 having a single sheet of rubber612 (other flexible seal material) positioned between abase ring614 and atop ring616. In one embodiment, the sheet has slit (not shown) formed in it through which a surgical device or other equipment can be inserted. Alternatively, the sheet can have two slits or other types of openings.
• Another incision port embodiment is shown inFIGS. 48A and 48B. This port is adual brush port620. Thisport620 has abody622 with afirst brush holder624 and asecond brush holder626. Thefirst brush628 is positioned in thefirst brush holder624 and thesecond brush630 is positioned in thesecond brush holder626. Further, thebody622 has anopening632 formed in a bottom portion of thebody622 that can provide access to the patient's cavity. The brush bristles of the twobrushes628,630 are mingled and meshed together at thebrush seal634 such that the mesh of bristles creates a fluidic seal that is sufficient to maintain a patient's insufflated cavity.
• FIGS. 49A and 49B depict another brush port—in this case, atriple brush port640. Thisport640 has abody642 with first, second, andthird brush holders644,646,648. Thefirst brush650 is positioned in thefirst brush holder644, thesecond brush652 is positioned in thesecond brush holder646, and thethird brush654 is positioned in thethird brush holder648. Further, thebody642 has an opening (not shown) formed in a bottom portion of thebody642 that can provide access to the patient's cavity. The brush bristles of the threebrushes650,652,654 are mingled and meshed together at thebrush seal656 such that the mesh of bristles creates a fluidic seal that is sufficient to maintain a patient's insufflated cavity.
• According to another implementation,FIGS. 50A,50B, and50C depict aninsertion device670 that can be used to insert both arms of a robotic surgical device into a patient's cavity. Theinsertion device670 has aninsertion tube672 through which aninsertion rod674 is slidably disposed. In addition, the device has afirst arm676A and asecond arm676B, both of which are coupled to the distal end of thetube672. Thefirst arm676A is coupled to anend bracket680A coupled to an end of thefirst device body682A, while thesecond arm676B is coupled to anend bracket680B coupled to an end of thesecond device body682B. Further, theinsertion rod674 is coupled to two center brackets (only bracket678A is visible in the figures)—one center bracket678A coupled to a middle portion of thefirst body682A and a second center bracket (not shown) coupled to a middle portion of thesecond body682B.
• In use, theinsertion device670 can be used to insert a two-armed surgical device through a hole (such as an incision, a port, or the like) and into a patient's cavity prior to operating the device within the cavity. To accomplish this insertion, theinsertion device670 initially maintains an insertion configuration (as best shown inFIG. 50A) such that the surgical device has its smallest circumferential profile, thereby allowing it to pass through smaller holes. Once the surgical device has been inserted into the patient's cavity, theinsertion device670 can be moved into its deployed configuration (as best shown inFIG. 50C) such that the surgical device is in its operational configuration. To accomplish this, a user or surgeon retracts theinsertion rod674 in a proximal direction (away from the surgical device. This retraction of therod674 urges the two center brackets (with only center bracket678A ofbody682A depicted) in the same proximal direction. Because the twoend brackets680A,680B are retained in substantially the same position by the twoarms676A,676B, the result is that the twodevice bodies682A,682B move through a transition depicted inFIG. 50B and into the operational configuration depicted inFIG. 50C. At this point, the user or surgeon can use the surgical device, including its twoarms684A,684B to perform the planned surgery or procedure.
• There are numerous device access and insertion devices and methods disclosed in the instant application. All of the various devices and methods that allow for access to a cavity and insertion of devices having two arms can also generally be used with respect to devices that can be uncoupled into separate arms so as to allow each arm to be inserted individually. In one embodiment, one advantage of inserting each arm separately is that inserting a first arm and then a second arm in a serial manner (and possibly more arms) can likely be accomplished through a smaller incision when compared to inserting both arms simultaneously.
• FIGS. 51A and 51B depict an alternative embodiment of an insertion device690 (in the same spirit as the insertion device depicted inFIGS. 50A-C). While the above embodiment inFIGS. 50A-C depict an insertion device for use with a two-armed device, thisinsertion device690 is used with asingle arm704 or with two arms that are inserted separately. That is, in this embodiment, asingle device arm704 is coupled to theinsertion device690. As shown, this device is positioned through an insertion tube692 (which can also be a positioning or support rod). The device has twomoveable rods694,696 slidably disposed within thesupport rod692. The firstmoveable rod694 is coupled at its distal end to a firstrobotic arm704 and at its proximal end to acontrol lever698. The secondmoveable rod696 is coupled at its distal end to a coupling link700 (that is coupled to the arm704) and at is proximal end to a coupling link702 (that is coupled to the lever698).
• In use, thelever698 can be actuated to cause the first andsecond rods694,696 to move in relation to each other. This movement of therods694,696 can be used to move thearm704 and thereby position thearm704 as desired or needed inside the patient's cavity.
• As shown inFIG. 51B, which is a cross-section of thesupport rod692, showing that thesupport rod692 can have twoseparate lumens706,708 or slots, one for each of themoveable rods694,696. In one embodiment, the firstmoveable rod694 is positioned in thefirst lumen706 and the secondmoveable rod696 is positioned in thesecond lumen708.
• In a further embodiment, it is understood that thissupport rod692 could have two halves—aright half710 and aleft half712—that are coupleable at themating feature714. Alternatively, the two halves can be coupleable by any known mechanical means. Theright half710 is configured to hold the first andsecond rods694,696 relating to the first (or right)arm704, while the left half is configured to hold the first andsecond rods716,718 relating to a second (or left) arm (not shown). This embodiment can thus be used with two arms, with each arm being inserted and positioned separately.
• FIG. 52 depicts another embodiment in which two separate arms can be inserted and positioned separately by using anovertube722. In thisdevice720, the firstmoveable rod724 and secondmoveable rod726 are still positioned within asupport rod728. However, in this embodiment, thesupport rod728 is positioned within anovertube722. Theovertube722 can be pass over the top of thesupport rod728 in order to couple thesupport rod728 to a second support rod (not shown) or another half of a support rod. This embodiment is another way to couple the two support rods or two halves of a support rod just as themating feature714 accomplishes that task in the prior embodiment.
• Of course, as shown inFIG. 53, in any embodiment in which the surgical device or robotic arm has amotor740 provided that can be positioned in the positioning orsupport rod744 and is coupled to therobotic arm742, there is no need for a separate insertion device. Instead, thearm742 can easily be positioned by actuating themotor740 and transfer the motive force through the beveled gears746 and to thearm742.
• FIGS. 54A and 54B depict a different type of access/insertion device in comparison to the devices described above. Unlike the above devices, which are generally incision ports or devices positioned outside the patient's cavity, the internalpressurized bag device750 shown in these two figures is initially positioned in the patient's cavity. Thedevice750 has aport seal752, anouter sleeve754, and aninner sleeve756. Theouter sleeve754 is releasably sealed at thedistal end758. That is, theouter sleeve754 has a releasable seal that can be intentionally broken or released at a desired time during the procedure, as described below.
• In use, theentire device750 can be positioned through an incision port such that the inner andouter sleeves754,756 are positioned inside the patient's cavity with theport seal752 coupled to the incision port (thereby creating a fluidic seal). Once thedevice750 is positioned, the patient's cavity can be insufflated, and theouter sleeve754 can be pressurized to a pressure that is greater than the pressure of the insufflated cavity, thereby expanding theouter sleeve754 to its maximum expansion (and, in some cases, making theouter sleeve754 substantially rigid). At this point, the surgical device can be inserted through the incision port and into theouter sleeve754 and positioned as desired. At this point, theouter sleeve754 can be removed by releasing the releasable seal at the distal end of thesleeve754. That is, the releasable seal could be a chemical seal such as an adhesive that can be deactivated by applying a different composition to it. Alternatively, the releasable seal could be a mechanical release such as a pull cord or something of the like. In a further alternative, the releasable seal could be any known mechanism or method for being able to release the seal. Once the seal is released, theouter sleeve754 can be pulled out of the cavity over theinner sleeve756 and other components as best shown inFIG. 54B.
• FIG. 55 depicts another implementation of an external pressurized system or apparatus800. The apparatus800 has acontainer802 with atop cap804 coupled to a top portion of thecontainer802. In this embodiment, thecontainer802 has aport806 that is coupled to thecontainer802 at a base portion of thecontainer802. Theport806 is configured to be positionable in an incision in the skin of the patient, thereby providing access to a cavity of the patient. As shown inFIG. 55, the apparatus800 is configured to receive asurgical device808 such that thedevice808 can be inserted into the patient cavity through theport806 of the apparatus800.
• According to one embodiment, in contrast to thecanister12 described above and depicted inFIGS. 1A-10, thecontainer802 in this device800 is made of a flexible material such as, for example, polyethylene plastic, latex, nylon, or silicone rubber. As such, thecontainer802 can be manipulated and configurable with respect to the shape of thecontainer802, and more specifically can be compressed longitudinally such that the height of thecontainer802 can be reduced during insertion of a robotic device into a patient's cavity. This will be described in further detail herein.
• Thetop cap804 is depicted in further detail inFIGS. 56A-61B. As shown inFIGS. 56A and 56B, thetop cap804 has acap body810, adetachable cable harness812, anaccess lumen814,support rod lumens816, threadedlumens818, and aclamp projection820. Thecap804 has a notch822 defined in thecap804 that is configured to receive theharness812. In addition, the notch822 has fivechannels824A defined or formed in the notch822. Thechannels824A match with thechannels824B defined in thedetachable harness812 such that when theharness812 is positioned in the notch822 and thus coupled with thecap body810, thechannels824A and thechannels824B match up to formlumens824 as best shown inFIG. 56B. In one implementation, thelumens824 can be formed in different sizes and configured to receive various cables and/or suction/irrigation tubes the extend from an external controller through thetop cap804 to thesurgical device808.
• In addition, thecap body810 has agroove826 formed or defined around the outer edge of thebody810, including the outer edge of theharness812, such that when theharness812 is coupled to thebody810, an O-ring can be positioned around the outer edge of thebody810 in thegroove826.
• FIGS. 57A and 57B depict thetop cap804 being coupled to thecanister802. Theflexible canister802 is positioned over the peripheral edge of thebody810 as best shown inFIG. 57B and an elastic ring (also referred to as an “O-ring”)828 is positioned around thecanister802 at thegroove826 such that a portion of thecanister802 is positioned between thebody810 and thering828 in thegroove826 and thering828 urges thecanister802 into thegroove826, thereby creating a fluidic seal between thecanister802 and thetop cap804. Additionally, in one alternative embodiment, silicone sealant can be applied to thegroove826 to enhance the strength of the fluidic seal. In accordance with one implementation, the O-ring828 can also help to secure thecap body810 and theharness812 together. In a further alternative, the O-ring828 can be any elastic member that can be used to maintain a fluidically sealed coupling of thecanister802 and thetop cap804. In yet another alternative, any coupling mechanism can be used.
• FIGS. 58A and 58B depict a portion of thedevice assembly808 being positioned through thetop cap804. More specifically, thesupport rods830 coupled to thedevice808 are slidably positioned through thelumens816 in thecap body810. Further, according to one implementation, a portion of thedevice808 also couples to or mates with thetop cap804. More specifically, astabilization protrusion832 on thedevice808 is coupleable with amating hole834 defined or formed in an underside of thebody810 as best shown inFIG. 58B. The positioning of thestabilization protrusion832 in themating hole834 creates a pathway fromlumen814 into and through thestabilization protrusion832, thereby allowing for passage of additional tools or cameras through the device800 without losing pressure.
• As shown inFIGS. 59A,59B, and60, thetop cap804 is coupled to thesupport rods830 with two threadedset screws840. Theset screws840 are threaded throughlumens818 as best shown inFIG. 59B. More specifically, theset screws840 can be screwed into the threadedlumens818 until thescrews840 contact thesupport rods830. Theset screws840 are configured to exert pressure on thesupport rods830, thereby creating frictional resistance that helps to secure thesupport rods830 and thus thedevice808 to thetop cap804.
• As best shown inFIG. 60, aconnection cable842 that is coupled at its distal end to therobotic device808 is positioned through one of thelumens824. It is understood that other cables can be positioned through theadditional lumens824 as well. In accordance with one embodiment, the cables are positioned in thechannels824A or824B prior to coupling theharness812 to thebody810. Alternatively, one or more of the cables can be inserted through one of thelumens824 after thebody810 and harness812 are coupled together.
• FIGS. 61A and 61B show thecontainer802 coupled to thetop cap804.
• FIGS. 62A and 62B depict the base coupling component (also referred to as the “base coupler”)850 that is coupled to a bottom portion of thecontainer802. Thebase coupler850 has anupper groove852, alower groove854, and three coupling protrusions (also referred to as “coupling notches”)856 that extend from a portion of thecoupler850 between the upper andlower grooves852,854.
• Like with thetop cap804 described above, thecontainer802 is coupled to thebase coupler850 using an O-ring858. More specifically, thecontainer802 is positioned over the upper portion of thecoupler850 such that thecontainer802 is positioned over theupper groove852 and adjacent to or against the threeprotrusions856. The O-ring858 is positioned over thecontainer802 at theupper groove852 such that the O-ring858 urges a portion of thecontainer802 into thegroove852, thereby creating a fluidic seal between thecontainer802 and thebase coupler850.
• FIGS. 63A,63B,63C,63D, and63E depict the coupling of thebase coupler850 to theaccess port806. Theaccess port806 has a top portion (or “top ring”)860, a bottom portion (or “bottom ring”)862, and a middle portion (or “neck”)864. Thetop ring860 has three coupling protrusions (also referred to as “coupling tabs”)866 that extend from a portion of thetop ring860 and are configured to mate with thecoupling notches856.
• In one embodiment, theaccess port806 is a known standard device used in hand-assisted laparoscopic surgery. As is understood in the art, theaccess port806 provides a structured open pathway through the cavity wall, such as the abdominal wall. at the incision site. In one particular example, theaccess port806 is a commerciallyavailable retractor port806 called the DEXTRUS® Retractor, which is available from Ethicon Endo-Surgery.
• As best shown inFIGS. 63A and 63B, thebase coupler850 is coupled to theaccess port806 using an O-ring868. More specifically, the O-ring868 is positioned in thelower groove854 of thecoupler850 and thetop ring860 is positioned over the lower portion of thecoupler850 and the O-ring868 in thegroove854 such that the O-ring868 is compressed between thecoupler850 and thetop ring860, thereby creating a fluidic seal between those two components.
• As best shown inFIGS. 63C and 63D, as thetop ring860 is positioned over the lower portion of thecoupler850 and the O-ring868 as described above, thecoupling tabs866 of theaccess port806 are coupled with thecoupling notches856 of thebase coupler850, thereby enhancing the stability of the coupling of thecoupler850 and theaccess port806.
• FIG. 63E depicts the entire coupling of thecontainer802 to theaccess port806 via thecoupler850 as described above. Further,FIGS. 64A and 64B depict the external pressurized insertion device800 in use, with the device800 coupled to anaccess port806 that is positioned in an incision in a patient'sskin870.
• In use, according to one embodiment, theaccess port806 and the external pressurized device800 are positioned for a surgical procedure in the following manner. As an initial matter, according to one embodiment, therobotic device808 is positioned inside the insertion device800 prior to placing theport806 and the device800 in the appropriate surgical position. That is, therobotic device808 is positioned inside thecontainer802, thesupport rods830 coupled to thedevice808 are secured to thetop cap804 with theset screws840, any connection cables coupled to thedevice808 are positioned through thelumens824 in thetop cap804, and theflexible container802 is coupled and fluidically sealed to thetop cap804 and thebase coupler850 via the O-rings828,858. Alternatively, therobotic device808 is positioned inside the insertion device800 after positioning theport806 and device800. Regardless, as far as positioning theport806 and device800, theport806 is positioned first in certain implementations. That is, in one embodiment, thebottom ring862 is first inserted through the incision previously made in the patient's cavity wall. Once thering862 is positioned through the incision and inside the cavity, thering862 can help constrain theentire port806 within the incision by expanding to a diameter that is greater than the diameter of the incision, as best shown inFIG. 64A. In one embodiment, thecontainer802 and thecoupler850 are coupled to theaccess port806 prior to positioning theport806 in the incision. Alternatively, theport806 is first positioned in the incision, and then thecoupler850 and the container are coupled to theport806. Regardless, once theaccess port806 and insertion device800 are positioned, the patient's cavity can then be insufflated. Due to the fluidic communication between the cavity and the interior of thecontainer802 that is created by theaccess port806, the entire interior of the insertion device800 will be under the same pressure as the cavity.
• In accordance with one implementation, once theaccess port806 and insertion device800 are positioned correctly, the process of inserting therobotic device808 into the patient's insufflated cavity can take place in the following manner as best shown inFIGS. 65A-69B. Initially, therobotic device808 begins with both arms parallel and vertical to the incision, as best shown inFIGS. 65A and65B. Then, therobot808 is lowered through the opening created by theaccess port806 as shown inFIGS. 66A and 66B. In accordance with one embodiment, as best shown by comparingFIGS. 65A and 65B withFIGS. 66A and 66B, as therobot808 is lowered, theflexible container802 shrinks in height by allowing portions of the flexible material of thecontainer802 to “crumple” or begin forming folds such that thetop cap804 moves closer to theaccess port806.
• As best shown inFIGS. 67A and 67B, according to one embodiment, once the “elbow joints” of the arms of therobotic device808 have cleared the cavity wall andaccess port806, the forearms are rotated at the elbow joints until the forearms are positioned at an angle of or near 45° in relation to the upper arms (as best shown inFIG. 67A). Concurrently, the “upper arms” are rotated at the “shoulder joints” until the upper arms are positioned at an angle of or near 20°, as best shown inFIG. 67B. This rotation of the forearms and upper arms can help to ensure that thedevice808 will fit within the patient's target cavity so that any contact of therobotic device808 with any internal tissues or organs is minimized or eliminated. Alternatively, the forearms and upper arms can be rotated to any angle that minimizes the risk of contact with tissues or organs.
• As best shown inFIGS. 68A and 68B, according to one embodiment, thedevice808 can be inserted further into the patient's cavity by further positioning the arms of thedevice808 while thecontainer802 continues to crumple, thereby resulting in further shrinkage of the insertion device800. More specifically, the upper arms can be rotated further until they are positioned at an angle of or near 45°, as best shown inFIG. 68B. This process of moving thedevice808 further into the cavity while positioning the arms to avoid contact with organs or tissues and causing thecontainer802 to crumple is continued until the shoulder joints of thedevice808 have cleared the cavity wall andaccess port806.
• At this point, as best shown inFIGS. 69A and 69B, the forearms can be rotated back to center and the upper arms can be further rotated up, leaving the arms in an appropriate starting position for a surgical procedure. Once in the desired starting position, thedevice808 can be locked or otherwise stabilized in place using a known external clamping mechanism such as, for example, an Iron Intern®, which is commercially available from Automated Medical Products Corp.
• FIG. 70 depicts another implementation of an external pressurized system orapparatus900. Theapparatus900 has acontainer902 with atop cap904 coupled to a top portion of thecontainer902. In this embodiment, thecontainer902 has aport906 that is coupled to thecontainer902 at a base portion of thecontainer902. Theport906 is configured to be positionable in an incision in the skin of the patient, thereby providing access to a cavity of the patient. As shown inFIG. 70, theapparatus900 is configured to receive asurgical device908 such that thedevice908 can be inserted into the patient cavity through theport906 of theapparatus900.
• According to one embodiment, like thecontainer802 described above and depicted inFIGS. 55-69B, thecontainer902 in thisdevice900 is made of a flexible material such as, for example, polyethylene plastic, latex, nylon, or silicone rubber.
• In this embodiment, thetop cap904, thecontainer902, and therobotic device908 are substantially similar to thetop cap804 andcontainer802 depicted and described above. All the various features and components described above apply to thesetop cap904,container902, anddevice908 embodiments as well.
• FIGS. 71A and 71B depict the base coupling component (also referred to as the “base coupler”)920 that is coupled to a bottom portion of thecontainer902. Thebase coupler920 has agroove922 and threecoupling protrusions924 that extend from thecoupler920. In accordance with one implementation, each of thecoupling protrusions924 has alumen926 configured to receive athumb screw928. Thecontainer902 is coupled to thebase coupler920 using an O-ring930. More specifically, thecontainer902 is positioned over the upper portion of thecoupler920 such that thecontainer902 is positioned over thegroove922 and adjacent to or against the threeprotrusions924. The O-ring930 is positioned over thecontainer902 at thegroove922 such that the O-ring930 urges a portion of thecontainer902 into thegroove922, thereby creating a fluidic seal between thecontainer902 and thebase coupler920.
• In this embodiment, theinsertion device900 has aport attachment940 that is coupleable to thebase coupler920 and theaccess port906 such that theport attachment940 is positioned between thecoupler920 and theport906. Theport attachment940 has aremovable lid944 that maintains a fluidic seal when thelid944 is in place on theport attachment940, thereby making it possible to maintain insufflation of the patient's cavity even when theinsertion device900 is not yet coupled to theaccess port906.
• FIGS. 72A and 72B depict the coupling of theport attachment940 to theaccess port906. Theport attachment940 has threecoupling notches942 similar to thecoupling notches856 described and depicted above. In addition, theport attachment940 has a removable lid944 (also referred to as a “removable seal component,” “removable lid seal component,” or “removable seal component”) that provides a fluidic seal when it is positioned in its closed position in relation to theport attachment940. In the embodiment depicted inFIGS. 72A and 72B, theremovable lid944 is aslidable lid944.
• Like theaccess port806 described and depicted above, this access port906 (as best shown inFIG. 72A) has atop ring946 that has three coupling protrusions (also referred to as “coupling tabs”)948 that extend from a portion of thetop ring946 and are configured to mate with thecoupling notches942 in theport attachment940.
• As best shown inFIG. 72A, theport attachment940 has an O-ring950 that can be positioned between theport attachment940 and theaccess port906 such that the O-ring950 creates a fluidic seal when the two components are coupled together.
• In use, theport attachment940 can be coupled to theaccess port906 by positioning the bottom portion of theport attachment940 in the top portion of thetop ring946 with the O-ring950 positioned between the two components, with thecoupling notches942 on theport attachment940 mating with thecoupling protrusions948 on thetop ring946.
• Theport attachment940 also has another O-ring952 that is configured to be positioned in thegroove954 formed in the top of theport attachment940. In one embodiment, the O-ring952 can be placed in thegroove954 to help create an airtight seal when theport attachment940 is coupled to thebase coupler920.
• Further, theport attachment940 also has three threadedlumens956 in the top of theattachment940. In one embodiment, theselumens956 are configured to receive the thumb screws928 that are positioned through thelumens926 in thebase coupler920, thereby allowing for coupling thebase coupler920 to theport attachment940 via thescrews928. Of course, it is understood that other coupling mechanisms besides thumb screws can be used. In various alternative embodiments, any known attachment or coupling mechanism or component can be used. Some non-limiting examples include magnets, quick clamps, quarter turn features, snap-in features, and the like.
• As best shown inFIGS. 73A and 73B, theslidable lid944 can be moved between a closed position (as shown inFIG. 73B) and an open position (as shown inFIG. 73A). In this embodiment, theslidable lid944 is positioned in theport attachment940 via alid slot958 in theport attachment940. In the open position, tools or robotic devices can be passed through theport attachment940 and theaccess port906. In the closed position, a fluid seal is established between thelid944 and theport attachment940, which makes it possible to insufflate the patient's cavity prior to attaching theinsertion assembly900. It is understood that while this embodiment of theremovable lid944 is aslidable lid944, any other known method or device for establishing a fluidic seal could be used. Non-limiting examples include a mechanical iris, leaf shutter, or any other known method of providing a removable fluidic seal.
• FIGS. 74A and 74B depict cross-sectional views of the entire lower subassembly as described above, including thebase coupler920, theport attachment940, and theaccess port906. More specifically,FIG. 74A shows theport attachment940 coupled to theaccess port906, with theslidable lid944 fully inserted into theport attachment940 in the closed position, thereby creating a fluidic seal.FIG. 74B shows all three components coupled together, including thebase coupler920, theport attachment940, and theaccess port906.
• FIGS. 75A,75B, and75C depict the externalpressurized insertion device900 in use, according to one embodiment. Once theaccess port906 is positioned in the incision as discussed above, theport attachment940 can be coupled to theport906, as best shown inFIG. 75A. With theslidable lid944 in the closed position, a fluidic seal is established between theport attachment940 and theport906 such that the patient's cavity can be insufflated to the desired Insufflation pressure. Theinsertion device900 can then be coupled to theport attachment940 as best shown inFIG. 75B. Once thebase coupler920 is coupled to theport attachment940 such that a fluidic seal is established between the two components, theslidable lid944 can then be moved to its open position (or fully remove) as best shown inFIG. 75C, thereby providing fluidic communication between the patient's cavity and the interior of theinsertion device900, resulting in equalized pressure in thedevice900 and the cavity. Therobotic device908 can be inserted via any of the same steps as described previously. If thedevice908 completes the desired surgical procedure and a different robotic device or other type of tool needs to be used, therobotic device908 can be removed from the cavity, theslidable lid944 can be replaced in the closed position, and thebase coupler920 can be removed fromport attachment940. This allows pressure to be maintained within the cavity, even during tool changes.
• FIG. 76 depicts an alternative embodiment having atop cap960 that has apressure relief valve962. During the process of lowering either of therobotic devices808,908 out of theinsertion device embodiments800,900 and into the cavity as described above with respect toinsertion devices800 and900, there is a pressure increase in the patient's cavity due to the decreasing change in volume of thecontainer802,902. Thepressure relief valve962 can be configured to release pressure if the internal insufflation pressure increases above a typical value, thereby aiding the process of inserting therobotic device808,908 such that the attendant will not need to wait for the pressure to equalize between the cavity and theinsertion device800,900.
• Another implementation of atop cap1000 having apressure relief valve1002 is depicted inFIGS. 77A and 77B. Thiscap1000 also has a dualport seal component1004 that can be configured to receive one or more surgical instruments or devices such as a standard laparoscopic tool. Alternatively, it is contemplated that a top cap can have only one of thepressure relief valve1002 or thedual seal component1004.
• As best shown inFIG. 77B, according to one implementation, thepressure relief valve1002 has an adjustment component (also referred to as an adjustment “door,” “wall,” or “button,” or “block”)1006 that is operably coupled to (or positioned against) one end of atension spring1008 and has twoholes1010A,1010B that are configured to receive retention mechanisms such as bolts, screws, or other such standard devices or components configured to hold theadjustment component1006 in place. The other end of thespring1008 is coupled to avalve ball1012 that is positioned against arim1016 of anopening1014 on the underside of thetop cap1000. Thespring1008 is configured to urge theball1012 toward theopening1014 such that the ball1012 (which has a larger outer diameter than the inner diameter of the rim1016) contacts therim1016 of theopening1014 and thereby establishes a fluidic seal between theball1012 and therim1016. In this embodiment, theadjustment block1006 is adjusted using the retention mechanisms to move theblock1006 toward or away from theball1012, thereby increasing or decreasing, respectively, the force applied by thespring1008 against the ball1012 (and thereby increasing or decreasing, respectively, the strength of the seal between theball1012 and therim1016 of the opening1014). Thus, theadjustment block1006 can be used to adjust the strength of the seal based on the target maximum pressure threshold such that when the target maximum pressure threshold is reached (such as while lowering either of therobotic devices808,908 out of theinsertion device embodiments800,900 as described above), theball1012 is urged away from therim1016 and the seal between therim1016 and theball1012 is broken such that the pressure is reduced by the gas escaping through thevalve1002.
• In an alternative embodiment, any known pressure relief valve for use in medical devices can be incorporated into thetop cap1000.
• Continuing withFIG. 77B, the dualport seal component1004 in this embodiment has two seal components: an elasticcircular seal1018 defining anopening1020 and aflap seal1022 in fluid communication with thecircular seal1018. The elasticcircular seal1018 is configured to form a strong seal around the smooth surfaces of a standard laparoscopic tool positioned through theopening1020. In one implementation, theflap seal1022 is a secondary seal that provides a fluid seal when no tool is positioned through the dualport seal component1004. That is, when no tool is positioned therethrough, the twoflaps1024A,1024B are urged into contact with each other by the pressure in the patient's insufflated cavity such that the twoflaps1024A,1024B form a fluidic seal.
• In an alternative embodiment, any known port seal component for use in establishing a fluidic seal with a laparoscopic tool positioned therethrough can be used.
• According to various additional implementations, the insertion devices disclosed or contemplated herein can have one or more sensors or other types of measurement mechanisms for measuring the insertion depth of the surgical device being inserted into the patient's cavity.
• As an example,FIGS. 78A,78B, and78C depict anautomatic insertion device1030 having aflexible container1038 and an actuator andsensor package1032. The actuator can be any known actuation device, including, for example, motor and gears, motor and timing belts, linear screw, pneumatics, hydraulics, or the like. The sensor could be any known sensing device, including, for example, a potentiometer, an encoder, optical sensors, or the like. When actuated, the actuator andsensor package1032 lowers thesurgical device1034 through the incision. That is, as shown inFIG. 78B, the top portion of thedevice1030 is urged toward the bottom portion of thedevice1030 such that the overall height of thedevice1030 is reduced and thesurgical device1034 is moved distally out of the bottom portion of theinsertion device1030. As the insertion occurs, the sensor in thepackage1032 is configured to read the distance thesurgical device1034 has been inserted into the patient's cavity. Based on this distance, in one embodiment, the control program of thesurgical device1034 can actuate the motors of thesurgical device1034 to move the arms into desirable positions so as to avoid making contact with any organs or a cavity wall. The process can then be reversed to remove thesurgical device1034 from the incision. In another implementation, anadditional actuator1036 could be used to grossly position thesurgical device1034 during the insertion process or during the surgery in order to access multiple quadrants of the patient's cavity. Thisactuator1034 rotates the upper portion of theinsertion device1030 relative to the access port. This rotation is possible because of the flexible nature of thecontainer1038.
• FIG. 79 depicts another embodiment of aninsertion device1050 having one ormore measurement mechanisms1054 for measuring the insertion depth of the surgical device that is being inserted into the patient's cavity using theinsertion device1050. In this embodiment, the insertion depth of the surgical device is determined by measuring the relative distance between thetop cap1052 and theport1056. Further, in this embodiment, themeasurement mechanism1054 is asensor1054 that is coupled to, integrated into, or otherwise associated with thetop cap1052. Alternatively, thetop cap1052 can have two ormore sensors1054. According to one embodiment, thesensor1054 uses ultrasonic or infrared energy and transmits the energy toward theport1056. The energy is reflected by theport1056 back to thesensor1054. In this embodiment, thesensor1054 is a range finder that can utilize the energy reflected back from theport1056 to determine the distance between thetop cap1052 and theport1056. The distance between the top cap1502 and theport1056 can then be used to calculate the insertion depth of the surgical device.
• In an alternative embodiment using a continuous sensor system, theinsertion device1050 has not only thesensor1054 associated with thetop cap1052, but also a sensor (not shown) associated with theport1056. In this implementation, thesensor1054 emits energy that is received by the sensor associated with theport1056, which triggers the sensor associated with theport1056 to transmit energy back to thesensor1054 associated with thetop cap1052. Thesensor1054 or a separate controller can then calculate the distance between thetop cap1052 and theport1056, which can then be used to calculate the insertion depth of the surgical device.
• In a further alternative, themeasurement mechanism1054 in thetop cap1052 is acamera1054. Thecamera1054 can utilize known image processing techniques on known features of the surgical device to determine the insertion depth of the device.
• FIG. 80 depicts another embodiment relating to aport1060 of an insertion device having one ormore measurement mechanisms1062 for measuring the insertion depth of a surgical device. In this implementation, as the surgical device (not shown) is urged through theport1060 and into the patient's cavity, characteristics of the surgical device can be detected using the measurement mechanism(s)1060 associated with theport1060. And those characteristics can be used to estimate or determine the insertion depth of the surgical device. In one embodiment, themeasurement mechanism1062 is acamera1062 that can use image processing to capture and recognize the portion of the surgical device that is passing through theopening1064 in theport1060. Alternatively, the surgical device can be marked with some type of markers that are easily recognized by the image processing technology. Upon recognition of the device portion or the marker, thecamera1062 or a separate processor or controller can calculate the insertion depth of the surgical device based on that information.
• In a further implementation, themeasurement mechanism1062 is anRFID sensor1062 that can sense one or more RFID markers (not shown) that are coupled to or implanted in the surgical device (not shown) passing through theport1060. Alternatively, the RFID markers in this embodiment could also contain extra information that could be used in a two-way communication system. That is, one or more of the markers associated with the surgical device could be configured to transmit information through the same RF link to the sensor and/or a controller.
• FIG. 81 depicts another embodiment of an insertion device having a measurement mechanism that measures the relative distance between the top cap and the port to determine the insertion depth of the surgical device. This embodiment relates to atop cap1070 that has astring measurement system1072, which, in some embodiments, is astring potentiometer system1072. Thestring measurement system1072 is a system in which a string is extended from thetop cap1070 to the port (not shown) at the bottom of the insertion device (not shown) and the amount of string that extends from a rotatable drum is measured. In this embodiment, thesystem1072 has arotatable sensor1074, arotatable drum1076, a spring-loadedstring dispenser1078, and string (not shown) extending from the dispenser and around thedrum1076. According to one embodiment, thesensor1074 is apotentiometer1074, and in some specific embodiments, thesensor1074 is a multiple-turn potentiometer1074. Therotatable sensor1074 is coupled to therotatable drum1076 such that thesensor1074 rotates when thedrum1076 rotates. In one embodiment as shown, thedrum1076 is adual drum1076 having a measurementstring drum half1076A and a spring-loadedstring drum half1076B. More specifically, the string that extends down to the port (not shown) of the insertion device (not shown) wraps around the measurementstring drum half1076A, while a separate spring-loaded string (not shown) that is coupled at the other end to the spring-loadedstring dispenser1078 wraps around the spring-loadedstring drum half1076B.
• Alternatively, thesystem1072 can have a single string (not shown). For example, in one embodiment, a string (not shown) is coupled directly to therotatable sensor1074. In a further embodiment, thestring measurement system1072 can be used to measure the tilt of the insertion device (or the canister of the insertion device). According to one implementation, thestring measurement system1072 uses three strings to measure the tilt.
• In use, thesensor1074 can detect the distance between thetop cap1070 and the port (not shown) by sensing the number of turns of thedrum1076, as the number of turns is directly related to the length of the string extending down to the port (not shown) and thus directly related to the distance between thetop cap1070 and the port (not shown). This information can be used to calculate the insertion depth of the surgical device.
• In an alternative embodiment, more than one measurement mechanism can be incorporated into an insertion device. That is, a first measurement mechanism can be incorporated into the insertion device to measure the insertion depth of the surgical device while a second measurement mechanism can be incorporated to measure the amount of “tilt” in the insertion device. It is understood that this could be any combination of the measurement devices that are capable of measuring depth and/or tilt. It is further understood that any known device for measuring tilt as described herein can be used within the insertion devices contemplated herein. In this context, “tilt” is intended to mean the angle of the longitudinal axis of the canister in relation to the plane parallel to the radius of the incision port. Several embodiments of the canisters and insertion devices herein are configured to allow for such tilt, which can be utilized to better position the surgical device in the cavity once it has exited the interior of the canister prior to or during a procedure.
• FIGS. 82A,82B,82C,82D, and82E depict yet another implementation of an insertion device having a measurement mechanism that measures the relative distance between the top cap and the port to determine the insertion depth of the surgical device. This embodiment relates to atop cap1090 that has a substantially rigidstructure measurement system1092. Themeasurement system1092 is a system in which a substantiallyrigid structure1094 extends from thetop cap1090 to theport1096 at the bottom of the insertion device and the displacement of thestructure1094 is measured to determine the distance between thetop cap1090 and theport1096, which can be used to calculate the insertion depth of the surgical device.
• In this embodiment, as shown inFIG. 82A, the substantially rigid structure is asquare bar1094 that has acoupler1098 at the top of thebar1094. Thebar1094 extends through aseal1100 in the top cap1090 (as best shown inFIG. 82A), through ahole1102 in the underside of the top cap1090 (as best shown inFIG. 82B), and through ahole1104 in the port1096 (as best shown inFIG. 82E). In one embodiment, thehole1102 in thetop cap1090 is square and thus thesquare bar1094 cannot rotate in relation to the top cap1090 (and thus can't rotate in relation to the insertion device). According to one implementation, theseal1100 in thetop cap1090 is anelastomeric seal1100. Alternatively, theseal1100 is any seal that can maintain the pressure in the insertion device with thebar1094 disposed therethough.
• In one embodiment, the actual measurement of the displacement of thesquare bar1094 is accomplished using a string measurement system such as the system described above with respect toFIG. 81. Thecoupler1098 on the top end of thesquare bar1094 is configured to be coupleable to a string (not shown) that is coupled in turn to thedrum1106 of thestring measurement system1108. In one embodiment thestring measurement system1108 operates in the same fashion as the similar system above.
• As best shown inFIGS. 82C,82D, and82E, the bottom of thesquare bar1094 is constrained in theport1096 via a peggedball1110 having four pegs that is positioned in acavity1112 defined in the underside of theport1096, wherein thecavity1112 is in fluid communication with thehole1104 in the top side of theport1096. Thecavity1112 is configured to match the configuration of the peggedball1110 as shown (with the four slots in thecavity1112 matching with the four pegs of the ball1110) such that theball1110 can move within thecavity1112 in a way that allows angular offset but not rotation about the longitudinal axis of thebar1094. According to one embodiment, the combination of this constraint and the rotational constraint at thetop cap1090 allows the surgical device to be maneuvered into the body (that is, the insertion device can be tilted as described elsewhere herein and thereby maneuver and position the surgical device), but will maintain the centerline of the robot lined up with the insertion point.
• In an alternative embodiment, the substantially rigid structure is another shape other than square. In a further implementation, the structure can have any shape that can match with a hole in the top cap such that the structure cannot rotate in relation to the top cap. Alternatively, the substantially rigid structure can be made up of more than one bar. For example, in one alternative embodiment, there can be two substantially rigid structures extending from the top cap to the port. In a further alternative, there are three or more structures.
• Various other implementations of measurement mechanisms can be envisioned that fall within the scope and spirit of the embodiments disclosed herein. For example, while various embodiments discussed above relate to measurement of the relative distance between the top cap and the port, other alternative embodiments can measure the relative angular and linear displacement between the top and bottom of the insertion device. In addition, while various embodiments discuss above relate to sensors configured to emit and/or sense particular types of energy (such as infrared or ultrasonic energy), it is understood than any type of wireless technology that would work with a sensor can be used.
• It is understood that any of these measurement technologies can be incorporated into any of the insertion device embodiments disclosed herein.
• FIG. 83 depicts an alternative embodiment of anincision port1120 that can be used with any of the insertion devices described above. In this implementation, theincision port1120 has aslidable lid1122 similar to the lid depicted inFIGS. 72A-75C. Further, theport1120 also has aninsufflation port1124 that is in fluidic communication with the interior lumen or opening of theincision port1120. In this embodiment, theinsufflation port1124 is aflow valve port1124 that is positioned on theport1120 such that it is below theslidable lid1122. In one implementation, theinsufflation port1124 is used to insufflate the patient's cavity or to provide supplemental insufflation during a procedure. In use, thelid1122 is positioned in the closed position to establish a fluid seal in the cavity (and in the insertion device, as described elsewhere above), and then gas is added to the patient's cavity via theinsufflation port1124.
• FIGS. 84A and 84B depict alternative insertion device embodiments that, unlike the cylindrical canisters described above, have canisters with different shapes. More specifically,FIG. 84A is aninsertion device1130 with aflexible canister1132 that is spherical in shape. Further,FIG. 84B is aninsertion device1140 with aflexible canister1142 that is conical in shape. According to one embodiment, during compression, the spherical andconical canisters1132,1142 collapse or compress or otherwise allow the top cap to be moved toward the incision port such that the walls of thecanisters1132,1142 expand or move outward. That is, thecanisters1132,1142 do not bend inward and thereby interfere with the surgical device disposed within thecanisters1132,1142 during collapse or compression of thecanisters1132,1142.
• FIGS. 85A,85B, and85C depict alternative insertion device embodiments that have canisters that are reinforced with rib structures. More specifically,FIG. 85A is aninsertion device1150 with aflexible canister1152 havingvertical rib structures1154.FIG. 85B is aninsertion device1160 with aflexible canister1162 havinghorizontal rib structures1164. Further,FIG. 85C is aninsertion device1170 with aflexible canister1172 having spiral-shapedrib structures1174. In accordance with one embodiment, the rib structures in these exemplary embodiments create the structure of each canister while the flexible material in the canisters maintain the pressure therein. Alternatively, any combination of the rib structures can also be incorporated into a canister. In one implementation, the rib structures provide reinforcement for each canister such that the structures reduce the amount of undesired bending or collapsing of the canister during use.
• FIGS. 86A,86B,86C,86D depict an embodiment of a base coupler1182 (of an incision port1180) that is releasably coupled to thecanister1184 of the incision device. In this embodiment, the surgical device (not shown) can be positioned in thecanister1184 prior to the procedure and then releasably coupled to theincision port1180. Thecoupler1182 has at least onefixed support1186 and at least onereleasable latch1188. According to one embodiment, there are two fixed supports1186 (one is not visible). Thecanister1184 has alip1190 on the bottom of the canister that can couple with thecoupler1182. In use, thecanister1184 is positioned against the top of thecoupler1182 in a tilted position as shown inFIGS. 86B and 86C such that thelip1190 is positioned under the two fixedsupports1186. Then the entire bottom of thecanister1184 is placed into contact with thecoupler1182, thereby creating a seal between thelip1190 and thecoupler1182. When thelip1190 is positioned correctly, thelatch1188 is moved into the latched position such that thelip1190 is retained in its position against thecoupler1182 via the two fixedsupports1186 and thelatch1188 as best shown inFIG. 86D.
• FIGS. 87A,87B, and87C depict an embodiment of an insertion device havingtop cap1200 that is coupled to an outer handle set1202 such that thetop cap1200 and handle set1202 can be moved relative to theflexible canister1204. Theouter handle set1202 has anouter ring1206 that is positioned around the outer circumference of thetop cap1200 such that there is a fluid seal established between the two components. In one embodiment, the fluidic seal is enhanced by arubber seal1210 disposed between thetop cap1200 andouter ring1206. Further, theset1202 also has twohandles1208 coupled to thering1206 such that a user or medical professional can easily grasp theset1202. More specifically, as best shown inFIG. 87B, thetop cap1200 andouter handle set1202 are moved down over the walls of theflexible canister1204 such that thecanister1204 walls are disposed between thetop cap1200 and thehandle set1202. Thus, unlike certain embodiments above, thetop cap1200 is not fixed to the top of thecanister1204, but rather can be moved distally toward the bottom of thecanister1204 while pulling the walls of thecanister1204 through the seal of thetop cap1200 and outer handle set1202 so as to reduce any bunching of thecanister walls1204 during compression of the device. In use, thetop cap1200 is free to slide within theflexible canister1204 and is controlled via theouter handle set1202, which hashandles1208 that provide direct control of the position and orientation of thetop cap1200.
• FIGS. 88A,88B,88C, and88D depict an alternative embodiment of aninsertion device1220 having top cap1222 (as best shown inFIGS. 88A and 88B, a mobile seal1224 (as best shown inFIG. 88C, an outer handle set1226 (as best shown inFIGS. 88A and 88C) coupled to themobile seal1224, and an incision port1228 (as best shown inFIGS. 88A and 88D). This embodiment differs from the previous embodiment in that thetop cap1222 in thisdevice1220 is not mobile and instead is coupled to the proximal end of thedevice1220 as shown inFIG. 88A. Further, this embodiment has amobile seal1224 that is capable of moving along the length of thedevice1220 in the same fashion as thetop cap1200 described above and depicted inFIGS. 87A-87C. Further, theouter handle set1226 is coupled to themobile seal1224, instead of thetop cap1222.
• According to one embodiment, thetop cap1222 in thisdevice1220 is the primary seal of thedevice1220 such that it is not essential that themobile seal1224 maintains a fluidic seal as it is moved along the length of thedevice1220. As such, thetop cap1222 can have all the sealing features and components of any of the top cap embodiments described above, including seals and access openings for wires, suction, irrigation, and auxiliary tools. In accordance with one implementation, themobile seal1224 is used primarily, along with theouter handle set1226, to position the surgical device into the patient's cavity. Themobile seal1224 and theouter handle set1226 are coupled together, according to one embodiment, in a similar fashion and with similar components as theouter handle set1202 and thetop cap1200 described above. When theouter handle set1226 is moved, themobile seal1224 moves as well, and thehandle set1226 andseal1224 can be moved relative to the canister walls in the same way as thetop cap1200 and handle set1202 above.
• According to one implementation, the external circumference of themobile seal1224 is non-circular such that coupling theseal1224 to theouter handle set1226 restrains themobile seal1224 from any axial movement in relation to thehandle set1226. As an example, the outer circumference of theseal1224 can have the shape of a hexagon or an ellipse. Alternatively, any mechanism or component to restrain such axial movement can be used.
• In one embodiment, the interface of themobile seal1224 and outer handle set1226—where the canister is positioned and must pass through—need not provide a fluidic seal. Further, in certain implementations, the additional mechanisms or components such as ball bearings or surfaces conducive to movement can be incorporated into the interface, thereby enhancing the ability of the canister wall to pass through the interface easily. It is understood that these mechanisms or components can be incorporated into theseal1224 or thehandle set1226 or both.
• FIG. 89 depicts an alternative embodiment of aninsertion device1240 having a substantiallynon-flexible canister portion1242 that is coupled to aflexible canister portion1244, which in turn is coupled to theincision port1246. In this embodiment, the top cap (not shown) can be coupled to an outer handle set similar to that described above such that the top cap can move along thenon-flexible canister portion1242 with ease. Theflexible canister portion1244 provides a flexible connection or interface (which could also be described as a “ball joint like” interface) that allows the movement of the surgical device as needed. That is, theflexible canister portion1244 enhances the ability to tilt theinsertion device1240 as described above, thereby enhancing the ability to move the surgical device during insertion and during any procedure being performed. In one implementation, the coupling of the top cap and the outer handle set can be a magnetic connection so as to avoid the necessary sealing. Alternatively, different canister shapes and sizes can be envisioned. Further, the flexible canister portion can be located elsewhere on the device. In a further alternative, more than one flexible canister portion can be provided.
• It is understood with respect to all of the various embodiments described herein that the medical devices being inserted into the patient are any known medical or surgical devices for performing procedures within a cavity of a patient. In certain embodiments, it is understood that the medical devices are robotic surgical devices having one or two arms. In various alternatives, the robotic surgical devices or systems can have or use three or more arms. In further alternatives, the devices (or additional devices) can be cameras or camera systems. Yet other alternatives, include the use of “helper” tools that can be inserted along with one or more medical devices or robotic devices.
• Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims (20)

What is claimed is:

1. A surgical insertion device comprising:

(a) a canister defining a lumen, wherein the canister is sized to receive a surgical device in the lumen;

(b) a top cap coupled to a proximal end of the canister, the top cap comprising at least one lumen defined in the top cap, wherein the at least one lumen is configured to receive a support rod; and

(c) an incision port removably coupled to a distal end of the canister, the incision port comprising a fluidic sealing component configured to maintain a fluidic seal.

2. The surgical insertion device ofclaim 1, wherein the lumen is fluidically sealed in relation to ambient air.

3. The surgical insertion device ofclaim 1, wherein the canister comprises a flexible material or a substantially rigid material.

4. The surgical insertion device ofclaim 1, wherein the canister comprises a flexible portion and a substantially rigid portion.

5. The surgical insertion device ofclaim 1, wherein the canister has a cylindrical shape, a spherical shape, or a conical shape.

6. The surgical insertion device ofclaim 1, wherein the canister comprises at least one rib structure.

7. The surgical insertion device ofclaim 1, wherein the fluidic sealing component comprises a sealable sleeve device, a flexible seal component, a removable lid seal component, or a flap seal component.

8. The surgical insertion device ofclaim 1, wherein the top cap comprises at least one of a pressure relief valve, at least one threaded lumen, a detachable cable harness, and a clamp projection.

9. The surgical insertion device ofclaim 1, further comprising an outer handle set coupleable to the top cap.

10. The surgical insertion device ofclaim 1, further comprising at least one measurement mechanism coupled to the top cap or the incision port.

11. The surgical insertion device ofclaim 1, wherein the canister comprises at least one access port, wherein the at least one access port is a hand access port or a side access port.

12. A surgical insertion device comprising:

(a) a flexible canister defining a lumen, wherein the canister is sized to receive a surgical device in the lumen;

(b) a top cap coupled to a proximal end of the canister, the top cap comprising at least one lumen defined in the top cap, wherein the at least lumen is configured to receive a support rod;

(c) an incision port removably coupled to a distal end of the canister, the incision port comprising a fluidic sealing component configured to maintain a fluidic seal; and

(d) a first measurement mechanism coupled with the top cap or the incision port, the first measurement mechanism configured to measure the insertion depth of the surgical device.

13. The surgical insertion device ofclaim 12, wherein the first measurement mechanism comprises a sensor, a string measurement system, a substantially rigid structure system, or a camera.

14. The surgical insertion device ofclaim 12, wherein the fluidic sealing component comprises a sealable sleeve device, a flexible seal component, a removable lid seal component, or a flap seal component.

15. The surgical insertion device ofclaim 12, wherein the top cap comprises at least one of a pressure relief valve, at least one threaded lumen, a detachable cable harness, and a clamp projection.

16. The surgical insertion device ofclaim 12, further comprising a second measurement mechanism coupled to the top cap or the incision port, the second measurement mechanism configured to measure any tilt of the flexible canister.

17. A surgical insertion device comprising:

(a) a canister defining a lumen, wherein the canister is sized to receive a surgical device in the lumen, wherein the surgical device is a robotic surgical device comprising two arms;

(b) a top cap coupled to a proximal end of the canister, the top cap comprising a pressure relief valve and at least one lumen defined in the top cap, wherein the at least one lumen is configured to receive a support rod; and

(c) an incision port removably coupled to a distal end of the canister, the incision port comprising a fluidic sealing component configured to maintain a fluidic seal.

18. The surgical insertion device ofclaim 17, wherein the fluidic sealing component comprises a sealable sleeve device, a flexible seal component, a removable lid seal component, or a flap seal component.

19. The surgical insertion device ofclaim 17, wherein the top cap comprises at least one of at least one threaded lumen, a detachable cable harness, and a clamp projection.

20. The surgical insertion device ofclaim 17, further comprising at least one measurement mechanism coupled to the top cap or the incision port.

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