Gas-tight access cap for robotic cannulas
The gas-tight access cap for robotic cannulas addresses the challenge of maintaining pneumoperitoneum without mechanical seals, achieving stable pressure and efficient access for laparoscopic surgery.
Patent Information
- Application Number
- JP2024505350
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-08-10
- Filing Date
- 2022-07-28
- Publication Date
- 2025-05-26
- Estimated Expiration
- 2042-07-28
AI Technical Summary
Existing robotic cannulas for laparoscopic surgery require mechanical seal assemblies to maintain pneumoperitoneum, which can complicate access and increase the risk of gas leakage.
A gas-tight access cap that creates a stable pneumoperitoneum without mechanical seals, using an annular jet assembly and flexible clips to secure the cap to the robotic cannula, allowing for valve-free access and efficient smoke evacuation.
The gas-tight access cap maintains a stable pneumoperitoneum even during suction and leakage, enabling confident surgery with low intraperitoneal pressure, while allowing for intact specimen extraction and constant smoke evacuation.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 227,449, filed July 30, 2021, and U.S. Provisional Patent Application No. 63 / 231,390, filed August 10, 2021, the disclosures of which are incorporated by reference in their entireties (including all excipients thereof) herein.
[0002] Field of Disclosure The present disclosure is directed to endoscopic surgery, and more specifically, to a gas-tight access cap for performing robotic-assisted laparoscopic surgery using a robotic cannula, and methods of using the same. [Background technology]
[0003] 2. Description of Related Art Laparoscopic or "minimally invasive" surgical techniques are becoming more common in the performance of procedures such as cholecystectomies, appendectomies, hernia repairs, and nephrectomies. Advantages of such procedures include less trauma to the patient, less chance of infection, and faster recovery time. Such procedures within the abdominal (peritoneal) cavity are typically performed through devices known as trocars or cannulas, which facilitate the introduction of laparoscopic instruments into the patient's abdominal cavity.
[0004] In addition, such procedures typically involve filling or "insufflating" the abdominal cavity with a pressurized fluid, such as carbon dioxide, to create a surgical space referred to as a pneumoperitoneum. Insufflation can be accomplished by a surgical access device, such as a trocar, equipped to deliver an insufflation fluid, or by a separate insufflation device, such as an insufflation (Veress) needle. To maintain the pneumoperitoneum, it is desirable to introduce surgical instruments into the pneumoperitoneum without substantial loss of insufflation gas.
[0005] During a typical laparoscopic procedure, the surgeon makes three to four small incisions (usually about 12 millimeters or less each), which are made using the surgical access device itself, often with a separate inserter or obturator placed within it. After insertion, the obturator is removed and the trocar allows access for instruments to be inserted into the abdominal cavity. A typical trocar provides a path for insufflation into the abdominal cavity so that the surgeon has an open interior space in which to work.
[0006] Trocars must provide a method of maintaining pressure within the cavity by sealing between the trocar and the surgical instruments being used, while still allowing at least a minimal amount of freedom of movement for the surgical instruments. Such instruments may include, for example, scissors, graspers and obturators, cauterization units, cameras, light sources, and other surgical instruments. Sealing elements or mechanisms are typically provided on the trocar to prevent escape of insufflation gases from the abdominal cavity. These sealing mechanisms often include a duckbill-type valve made of a relatively flexible material to seal around the outer surface of the surgical instruments passing through the trocar.
[0007] SurgiQuest, Inc., a wholly owned subsidiary of ConMed Corporation, has developed unique gas-tight surgical access devices that provide ready access to insufflated surgical cavities without the need for traditional mechanical valve seals, as described, for example, in U.S. Patent No. 8,795,223. These devices are constructed from several nested components including an inner tubular body portion and a coaxial outer tubular body portion. The inner tubular body portion defines a central lumen for introducing traditional laparoscopic surgical instruments into the patient's abdominal cavity, and the outer tubular body portion defines an annular lumen surrounding the inner tubular body portion for delivering insufflation gases to the patient's abdominal cavity and for facilitating periodic sensing of abdominal pressure.
[0008] Robot-assisted minimally invasive surgical procedures are also becoming increasingly common. One well-known system for performing these procedures is called the Da Vinci Robotic Surgical System, which is manufactured and sold by Intuitive Surgical, Inc. of Sunnyvale, Calif. The Da Vinci system utilizes a proprietary trocar or cannula that is adapted and configured to receive robotic instruments and to be engaged by a robotic arm. The proprietary Da Vinci cannula has a proximal housing that forms a bowl for receiving components such as a gas-tight seal assembly, as disclosed, for example, in U.S. Pat. No. 10,463,395. The Da Vinci gas-tight seal assembly utilizes a mechanical seal to seal around the outer surfaces of surgical instruments passing through the cannula and to prevent leakage of insufflation gases from the abdominal cavity.
[0009] It would be beneficial to provide a seal assembly for use with a Da Vinci cannula that provides ready access to an insufflated surgical cavity without the need for a mechanical seal assembly. Indeed, one recent example of such a valveless seal assembly is disclosed in commonly assigned U.S. Patent No. 11,026,717, which describes a gas-tight access cap for use with a Da Vinci robotic cannula. The present disclosure improves upon this previous gas-tight access cap and provides a useful method of installing and using the access cap with a robotic cannula to perform laparoscopic surgery. Summary of the Invention
[0010] The present disclosure is directed to a new and useful gas-tight access cap for use with robotic cannulas that provides a stable pneumoperitoneum for constant exposure, even during suction and leakage, allowing the surgeon to operate confidently with low intraperitoneal pressure, provides constant smoke evacuation to ensure visibility throughout surgery, and provides valve-free access to the surgical site to enable intact specimen extraction.
[0011] The gas-tight access cap of the present disclosure includes a housing having a lid defining a central access port in communication with an internal cavity for receiving pressurized gas through an inlet port to create a gas-tight zone within a robotic cannula and directing spent gas from the gas-tight zone to an outlet port, the inlet and outlet ports of the housing communicating with a manifold associated with a bullseye connector fitting for communicating with pressurized and return gas lines of a filtered tubing set.
[0012] A central access tube aligns with the central access port of the housing and extends distally from the internal cavity for communication with the tubular portion of the robotic cannula. A distal end of the housing extends distally beyond the distal end of the central access tube for reception within the proximal bowl portion of the robotic cannula, and a pair of diametrically opposed flexible clips extend from a circumferential flange integrally formed with an exterior surface of the housing for removably securing the access cap to the proximal bowl portion of the robotic cannula.
[0013] The annular jet assembly is supported in the interior cavity of the housing for creating a gas-tight zone within the robotic cannula to maintain a stable pressure within the patient's surgical cavity. The annular jet assembly includes a central opening aligned with the central access port of the lid. A plurality of circumferentially spaced radially inwardly extending wings are integrally formed with the housing and positioned within the interior cavity below the annular jet assembly for directing spent gas from the gas-tight zone to an exit port of the housing.
[0014] A circumferential groove is formed in an exterior surface of the housing distal to the diametrically opposed flexible clips for receiving an O-ring seal. The circumferential groove is located proximal to the plurality of spaced wings. Each of the diametrically opposed flexible clips includes a proximal portion, an intermediate portion, and a distal portion. The proximal portions of the diametrically opposed flexible clips are parallel to one another, the distal portions of the diametrically opposed flexible clips extend to the circumferential groove, and a circumferential flange is proximal to the circumferential groove.
[0015] The gas-tight access cap further includes an obturator having a proximal handle portion for cooperatively engaging the lid of the housing, and an elongated obturator shaft extending distally from the handle and having a distal cutting tip. An annular seal is supported on the obturator shaft at locations along its length for sealing against the inner surface of the central access tube when the obturator shaft is extended through the central access port of the housing.
[0016] The present disclosure is also directed to a novel and useful method of performing robotically assisted laparoscopic surgery within a patient's abdominal cavity, the method including inserting a first robotic cannula with a valve-sealing cannula cap connected thereto into the patient's abdominal cavity, connecting a single lumen tubing portion of a tubing set to the valve-sealing cannula cap, inserting a second robotic cannula with a valve-sealing cannula cap connected thereto into the patient's abdominal cavity, and connecting a dual lumen tubing portion of a filtered tubing set to the gas-tight cannula cap.
[0017] More specifically, the method includes providing a surgical access system including a gas delivery device, a Veress needle, a valve-sealing cannula cap, a gas-tight cannula cap having an obturator connected to the gas-tight cannula cap, a first robotic cannula, a second robotic cannula, and a filtered tubing set including a filter cartridge, a single lumen tubing section, and a dual lumen tubing section, wherein a removable plug is initially attached to a fitting at a distal end of the dual lumen tubing section of the filtered tubing set.
[0018] The method further includes inserting a filter cartridge of the filtered tubing set into a receiving port of the gas delivery device, locking the filter cartridge within the receiving port by rotating a mechanical lever arm of the gas delivery device, and then verifying that the flow rate and pressure settings of the gas delivery device are appropriate for the patient.
[0019] The method further includes inserting a Veress needle into the patient's abdominal cavity, connecting a single lumen tubing portion of a filtered tubing set to a connector of the Veress needle, and then insufflating the abdominal cavity through the Veress needle until a set intraperitoneal pressure is reached.
[0020] The method further includes connecting a gas-tight cannula cap along with the obturator to a second robotic cannula, inserting the first robotic cannula with the valve-tight cannula cap connected thereto into the abdominal cavity of the patient, and then inserting the second robotic cannula with the gas-tight cannula cap connected thereto into the abdominal cavity of the patient.
[0021] The method further includes removing the plug from a fitting on a distal end of the dual lumen tubing section of the filtered tubing set and then connecting the fitting of the dual lumen tubing section of the filtered tubing set to a connector of the gas tight cannula cap. The method further includes disconnecting the single lumen tubing section of the tubing set from the Veress needle and then connecting the single lumen tubing section of the tubing set to a connector of the valve tight cannula cap, whereupon the gas delivery device will begin circulating pressurized gas through the gas tight cannula by the dual lumen section of the tubing set, whereupon the gas delivery device will perform a calibration process. The obturator is then removed from the gas tight cannula cap.
[0022] After completion of the robotic-assisted laparoscopic surgery, the method involves replacing the obturator in the gas-tight cannula cap, at which point circulation of pressurized gas through the gas delivery device is stopped and the method includes disconnecting the dual lumen portion of the tubing set from the connector of the gas-tight cannula cap.
[0023] These and other features of the presently disclosed devices, systems and methods will become more readily apparent from the following detailed description of the disclosed embodiments taken in conjunction with the drawings. [Brief description of the drawings]
[0024] DETAILED DESCRIPTION OF THE DRAWINGS Embodiments of the present disclosure will now be described in detail with reference to the drawings so that those of ordinary skill in the art will readily understand how to make and use the gas-tight access cap of the present disclosure without undue experimentation.
[0025] [Figure 1] FIG. 1 is a diagram of an operating room containing a robotic surgical system in which the gas-tight access cap of the present disclosure is used. [Diagram 2] FIG. 2 is a perspective view of a gas-tight access cap of the present disclosure, as well as a filtered tubing set operatively associated with the valve-tight access cap for use therewith. [Diagram 3]FIG. 3 is a diagram of the filtered tubing set shown in FIG. 2 installed within a surgical gas delivery apparatus, with a gas-tight access cap and two valve-tight access caps of the present disclosure supported by respective robotic manipulator arms depicted in FIG. 1 and inserted into a patient's abdominal cavity. [Figure 4] FIG. 4 is a perspective view of a gas-tight access cap of the present disclosure separated from a proximal bowl portion of a robotic cannula. [Diagram 5] FIG. 5 is a perspective view of the obturator separated from the gas-tight access cap, shown installed within the proximal bowl portion of the robotic cannula. [Figure 6] FIG. 6 is a perspective view of an obturator mounted within a gas-tight access cap that is mounted within the proximal bowl portion of the robotic cannula. [Figure 7] FIG. 7 is an exploded perspective view of a gas-tight access cap of the present disclosure with parts separated for ease of illustration. [Figure 8] FIG. 8 is an enlarged side view of the connector manifold of the gas tight access cap of the present disclosure. [Figure 9] 9 is a cross-sectional view of the housing of the gas tight access cap taken along line 9-9 of FIG. [Figure 10] FIG. 10 is a partial cross-sectional view taken along line 10-10 of FIG. [Figure 11] FIG. 11 is a diagram of a filtered tubing set being inserted into a surgical gas delivery apparatus. [Figure 12] FIG. 12 is a diagram of a filter cartridge with a filtered tube that is locked into place by rotating a mechanical lever. [Figure 13] FIG. 13 illustrates a graphical user interface screen of a surgical gas delivery device that provides the user with the ability to verify proper settings for operating mode, gas flow, and intraperitoneal pressure. [Figure 14]FIG. 14 illustrates a graphical user interface screen of a surgical gas delivery device that provides the user with the ability to verify proper settings for operating mode, gas flow, and intraperitoneal pressure. [Figure 15] FIG. 15 illustrates the connection of the gas-tight access cap on the proximal bowl portion of the robotic cannula, where an audible click is produced to ensure a stable connection. [Figure 16] FIG. 16 illustrates the insertion of a conventional Veress needle into a patient's abdominal cavity. [Figure 17] FIG. 17 illustrates the connection of the air line to the stopcock valve of the Veress needle shown in FIG. [Figure 18] FIG. 18 illustrates a graphical user interface screen of a surgical gas delivery device that provides a user with the ability to initiate insufflation of the abdominal cavity. [Figure 19] FIG. 19 illustrates a graphical user interface screen of a surgical gas delivery device notifying the user that the set intraperitoneal pressure has been reached, after which the cannula may be inserted into the abdominal cavity and a tubing set can be connected to the cannula with the obturator in place. [Figure 20] FIG. 20 illustrates the insertion of a robotic cannula into a patient's abdominal cavity with a gas-tight access cap of the present disclosure securely attached to the robotic cannula. [Figure 21] FIG. 21 illustrates the removal of the plug from the dual lumen fitting of the tubing set so that the dual lumen portion of the tubing set can be attached to the bullseye connector of the gas tight access cap. [Figure 22] FIG. 22 illustrates the connection of the air line of the filtered tubing set to the luer fitting of the valve-sealing access cap attached to the robotic cannula. [Diagram 23]FIG. 23 illustrates a graphical user interface screen of a surgical gas delivery device indicating to the user that the gas delivery device is automatically booting into a gas-sealed use mode after which the system will calibrate with the obturator in place. [Figure 24] FIG. 24 illustrates the graphical user interface screen of the surgical gas delivery device once calibration is complete, after which the gas-sealing use mode is declared active and the obturator can be removed from the gas-sealing access cap. [Diagram 25] FIG. 25 illustrates removal of the obturator from the gas tight access cap after calibration is completed. [Figure 26] FIG. 26 illustrates a graphical user interface screen of a surgical gas delivery device that provides the user with the ability to disable the gas-sealed use mode so that the obturator can be replaced prior to disconnecting the access cap from the filtered tubing set to prevent loss of intra-abdominal pressure. [Figure 27] FIG. 27 illustrates a message on the graphical user interface screen of the surgical gas delivery device indicating that the surgical gas delivery device will perform a final calibration, after which the gas delivery device can be turned off and the filtered tubing set can be removed from the gas delivery device and cannula. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0026] Referring now to the drawings, a surgical suite containing a robotic surgical system 10 and a multi-modal gas delivery device 20, along with the novel gas-tight access cap 30 of the present disclosure, is illustrated in FIG. 1 to perform a laparoscopic surgical procedure on a patient.
[0027] The robotic surgical system 10 shown in Figure 1 is depicted as the Da Vinci robotic surgical system, which is manufactured and sold by Intuitive Surgical, Inc. of Sunnyvale, Calif. The system basically includes a console 12 where a surgeon sits to remotely perform surgery on a patient, and a patient side cart 14 having four interactive robotic arms 16a-16d that are controlled by the surgeon from the console 12.
[0028] The multimodal gas delivery device 20 shown in FIG. 1 is illustrated as an iFS Intelligent Flow System, manufactured and sold by Conmed Corporation of Largo, Florida. One example of such a device is disclosed in U.S. Patent No. 9,526,849, the disclosure of which is incorporated herein by reference in its entirety. The gas delivery device 20 is supported on a mobile tower cart 22 having a monitor screen 24 to allow operating room staff to see what the surgeon is seeing in the abdominal cavity at the console 12 with the endoscope during the surgical procedure. The gas delivery device 20 is adapted and configured to operate in multiple modes during the surgical procedure to insufflate the patient's abdominal cavity to measure intraperitoneal pressure, maintain a stable pneumoperitoneum to facilitate valve-free instrument access to the abdominal cavity, and facilitate smoke evacuation from the abdominal cavity.
[0029] 2 and 3, the gas-tight access cap 30 of the present disclosure is shown in conjunction with a filtered tubing set 40 and a valve-sealing access cap 60. The gas-tight access cap 30 and the valve-sealing access cap 60 are each operatively connected to respective robotic cannulas 35c and 35a. These are Da Vinci Xi / X type robotic cannulas. An example is disclosed in U.S. Pat. No. 10,463,395, which is assigned to Intuitive Surgical Operation Inc. and is incorporated herein by reference in its entirety. The valve-sealing access cap 60 is also manufactured by Intuitive Surgical, Inc. A similar example of a valve-sealing access cap is disclosed in U.S. Pat. No. 10,463,395.
[0030] The filtered tubing set 40 shown in FIG. 2 includes a disposable filter cartridge 42 sized and configured for insertion into the receiving port 27 of the gas delivery device 20. A rotatable lever arm 25 is used to lock the filter cartridge 42 into the receiving port 27. The filter cartridge 42 includes a generally cylindrical housing 45 that defines a plurality of internal filtered flow passages (not shown) extending between a rear end cap 44 and a front end cap 46. A filter cartridge of this type is disclosed in commonly assigned U.S. Pat. No. 9,067,030, the disclosure of which is incorporated herein by reference in its entirety. The internal filtered flow passages of the filter cartridge are shown and described therein.
[0031] The insufflation and sensing lumens or tubes 48, gas supply lumens or tubes 50, and gas return lumens or tubes 52 extend from a manifold 54 on the front end cap 46 of the filter cartridge 42. In one embodiment of the present disclosure, the insufflation lumen 48 is comprised of clear tubing, while the gas supply tube 50 and the gas return tube 52 are comprised of colored tubing. This helps to visually distinguish these tubes from one another in the operating room. The insufflation and sensing lumens 48 have a standard luer fitting 56 at their distal ends for mating with a luer connector 58 on the valve-sealing access cap 60. The gas supply lumen 50 and the gas return lumen 52 extend distally to a common multi-lumen bullseye fitting 62 for mating with a multi-lumen bullseye connector 96 on the gas-tight access cap 30 (see FIG. 8).
[0032] Bull eye fitting 62 is of the triple lumen type disclosed in commonly assigned U.S. Patent No. 9,526,886, the disclosure of which is incorporated herein by reference in its entirety. Bull eye fitting 62 differs somewhat from the triple lumen fitting disclosed in U.S. Patent No. 9,526,886 in that only two of the fitting's three gas flow paths are utilized for gas flow. More specifically, the gas delivery and gas return paths of fitting 62 are utilized. The remaining unused flow paths are intentionally blocked during manufacture, as best seen in FIG. 3. Gas delivery device 20 is programmed to recognize this difference.
[0033] However, it is contemplated and within the scope of the present disclosure that fitting 62 may be constructed as a dual lumen bull's eye fitting having only two gas flow paths, for example as disclosed in commonly assigned U.S. Patent No. 10,736,657, which is incorporated herein by reference in its entirety. Other types of dual lumen fittings and connectors may also be used, such as the type disclosed in commonly assigned U.S. Patent No. 11,065,430, which is also incorporated herein by reference in its entirety.
[0034] As shown in FIG. 3, the robotic arms 16a-16c of the patient side cart 14 are used to grasp and manipulate the respective robotic cannulas 35a-35c during a robotic-assisted laparoscopic surgical procedure. More specifically, the first robotic arm 16a is shown grasping a first robotic cannula 35a associated with a valve-sealing access cap 60a connected to the insufflation and sensing lumen 48 of the tubing set 40 by a luer fitting 56. The second robotic arm 16b is shown grasping a second robotic cannula 35b associated with a second valve-sealing access cap 60b, and the third robotic arm 16c is shown grasping a third robotic cannula 35c associated with a gas-tight access cap 30 of the present disclosure. The gas-tight access port 30 is connected to the gas supply lumen 50 and the gas return lumen 52 by a bullseye fitting 62.
[0035] In this exemplary view of FIG. 3, a first valve-sealed access cap 60a connected to lumen 48 is used for insufflation of the patient's abdominal cavity and to allow gas delivery device 20 to periodically sense intraperitoneal pressure. This valve-sealed first access cap can also be used for instrument access. A second valve-sealed access port 60b is used to provide abdominal access for laparoscope A, and gas-sealed access ports 30 connected to lumens 50 and 52 are used to maintain a stable pneumoperitoneum during surgery and to provide valve-free access for surgical instruments B and to allow smoke evacuation from the abdominal cavity. Those skilled in the art will readily appreciate that the size, orientation, and / or placement of the robotic cannula and surgical instruments shown in FIG. 3 may vary depending on the patient's anatomy and the surgical procedure being performed.
[0036] 4-6, the gas-tight access cap 30 of the present disclosure is shown in conjunction with a robotic cannula 35 and an obturator 70. The obturator 70 is adapted and configured to facilitate percutaneous introduction of the robotic cannula 35 into a patient's abdominal cavity during a surgical procedure, which is typically performed by a surgeon under visualization through a small incision in the abdominal wall.
[0037] The robotic cannula 35 (i.e., the Da Vinci X / Xi robotic cannula) includes a generally cylindrical proximal bowl portion 32 and an elongated tubular body portion 34 extending distally from the proximal bowl portion 32. The proximal bowl portion 32 includes an interior bowl region 37 that is sized and configured to receive the gas-tight access cap 30. A grasping handle 36 extends radially outwardly from an outer wall of the proximal bowl portion 32 to facilitate manipulation of the cannula 35 by the robotic arms 16a-16d, as shown in FIG. 3. An annular engagement flange 38 is formed at an upper end of the proximal bowl portion 32 of the cannula 35. The engagement flange 38 cooperates with a pair of diametrically opposed cantilevered flexible engagement clips 102 and 104 that are integrally formed with the access cap 30, as shown in FIGS. 5 and 6. The engagement clips 102, 104 and the manner in which they cooperate and releasably engage the flange 38 are described in more detail below with reference to FIGS.
[0038] When access cap 30 is inserted into interior bowl region 37 of proximal bowl portion 32 of robotic cannula 35, annular O-ring seal 118 seated on the exterior surface of access cap 30 will sealingly engage with the interior surface of bowl region 37, as depicted in Figure 4. This sealing interface will also be described in more detail below with reference to Figures 9 and 10.
[0039] 5 and 6, the obturator 70 is of the type disclosed in commonly assigned U.S. Patent No. 9,545,264, the disclosure of which is incorporated herein by reference in its entirety. The obturator 70 has a proximal handle portion 72 having a pair of diametrically opposed spring-loaded clasps 73a, 73b for cooperatively engaging a pair of diametrically opposed recesses 83 in a housing lid 84 (see FIG. 10).
[0040] An elongated tubular obturator shaft 74 extends distally from the handle portion 72 of the obturator 70. The shaft 74 has a transparent optical cutting tip 76 at its distal end for visualization during insertion. An annular seal 78 is supported on the obturator shaft 74 at locations along its length for interaction with an inner surface of the access cap 30, which will be described in further detail below with reference to FIG. 10. The proximal handle portion 72 of the obturator 70 defines a central port 75 (see FIG. 25). The central port 75 of the handle portion 72 communicates with a central bore 77 that extends through the elongated obturator shaft 74 to the distal optical cutting tip 76 (see FIG. 5). The central bore 77 of the shaft 74 is sized and configured to accommodate a rigid scope for visualization through the cutting tip 76 during insertion through the patient's abdominal wall.
[0041] 7-10, the gas-tight access cap 30 includes a generally cylindrical housing 82 formed by an injection molding process from a lightweight medical grade thermoplastic material. The material may be transparent, translucent, or opaque. The housing 82 of the access cap 30 has an interior cavity 88 surrounded by a cover or lid 84 that defines a central access port 86. As previously shown in FIG. 6, diametrically opposed recesses 83 are formed in the lid 84 to cooperate with diametrically opposed spring-loaded clasps 73a and 73b on the obturator housing 72.
[0042] The interior cavity 88 of the housing 82 receives pressurized gas from the pump of the gas delivery device 20 through an inlet port 90. The pressurized gas is used to create a gas-tight zone within the robotic cannula 35. The gas-tight zone maintains a stable pneumoperitoneum and facilitates valve-less gas-tight instrument access to the abdominal cavity through the cannula 35. Spent gas used to create the gas-tight zone within the robotic cannula 35 is directed from the interior cavity 88 of the housing 82 to an outlet port 92 and returned by the filter cartridge 42 to the gas delivery device 20 for recirculation.
[0043] 7 and 8, the inlet port 90 and outlet port 92 of the housing 82 communicate with a manifold 94 associated with a multi-lumen bullseye connector 96 that is designed to communicate with the bullseye fitting 62 of the tubing set 40. The bullseye connector 96 and the manner in which it cooperates with the fitting 62 are described in more detail in commonly assigned U.S. Patent No. 9,526,886.
[0044] As best seen in FIG. 7, a two-piece annular jet assembly 110 is sealingly supported in the interior cavity 88 of the housing 82 of the access cap 30 for creating a gas-tight zone within the robotic cannula 35 to maintain a stable pressure within the patient's surgical cavity. The annular jet assembly 110 is of the type disclosed in commonly assigned U.S. Pat. No. 9,907,569, the disclosure of which is incorporated herein by reference in its entirety. The jet assembly 110 includes a central opening 112 aligned with the central access port 86 of the lid 84 (see FIG. 10). A sound-damping disk 87 made from a foam material is positioned within the housing 82 between the lid 84 and the annular jet assembly 110. The foam disk 87 functions to filter, attenuate, or otherwise reduce noise that may result from the jet assembly 110 creating a gas-tight zone.
[0045] 9 and 10, a plurality of circumferentially spaced apart radially inwardly extending wings or fins 114 are integrally formed with the housing 82 and located within the interior cavity 88 thereof below the annular jet assembly 110. These wings 114 are adapted and configured to direct spent gas from the gas sealing zone of the cannula 35 to the exit port 92 of the housing 82. The arrangement of the wings or fins 114 is similar to the arrangement of wings disclosed in commonly assigned U.S. Patent No. 8,795,223, the disclosure of which is incorporated herein by reference in its entirety. However, in that patent, the circumferentially spaced apart wings are formed within a separate nested insert rather than integrally formed with the housing 82 of the access cap 30.
[0046] The central access tube 98 extends distally from the location of the circumferential wings 114 within the lower portion of the interior cavity 88 and is aligned with the central access port 86 in the lid 84 of the housing 82 and the central opening 112 of the jet assembly 110. As best seen in FIG. 10, the central access tube 98 communicates with the interior bowl region 37 of the robotic cannula 35 and the central bore of the tubular body portion 34. As best seen in FIG. 9, the distal end of the housing 82 of the access cap 30 extends distally beyond the distal end of the central access tube 98.
[0047] The dimensional relationship between the distal end of the housing 82 and the distal end of the central access tube 98 ensures that the gas-tight access cap 30 will be properly seated within the proximal bowl portion 32 of the robotic cannula 35 when the two components are connected together. As mentioned above, the annular seal 78 is supported on the obturator shaft 74 of the obturator 70 at locations along its length. More specifically, the annular seal 78 is positioned to seal against the inner surface central access tube 98 adjacent its distal end, as shown in FIG. 10. This prevents the escape of insufflation gas through the gas-tight access cap 30 at certain times during a surgical procedure, such as during calibration or when the gas-tight mode is not active.
[0048] As mentioned above, a pair of diametrically opposed cantilevered flexible engagement clips 102 and 104 are integrally formed with housing 82 of access cap 30 for releasably engaging annular flange 38 on the top of proximal bowl portion 32 of robotic cannula 35. More specifically, engagement clips 102 and 104 are integrally formed with, and operatively connected to, a circumferential flange 106 that extends radially outward from an outer surface of housing 82 of access cap 30.
[0049] Each of the two engaging clips 102, 104 includes a proximal portion 102a, 104a, an intermediate portion 102b, 104b, and a distal portion 102c, 104c. The proximal portions 102a, 104a of the flexible clips 102, 104 extend parallel to one another and have outer gripping surfaces that can be pushed inwardly or bent by a user to release or otherwise disengage the clips 102, 104 from the flange 38. The intermediate portions 102b, 104b are angled inwardly toward the housing 82 to provide a transition to the distal portions 102c, 104c. The distal portions 102c, 104c of the clips 102, 104 are integrally formed with opposed radially outwardly extending lateral bridges of respective integral circumferential flanges 106. The distal ends of distal portions 102c, 104c of clips 102, 104 are bent radially inward to form diametrically opposed feet 102d, 104d that releasably engage beneath annular flange 38 in a mechanically retaining manner, best seen in FIG.
[0050] As previously mentioned, when access cap 30 is inserted into interior bowl area 37 of proximal bowl portion 32 of robotic cannula 35, annular O-ring seal 118 seated on the exterior surface of access cap 30 will sealingly engage the interior surface of bowl area 37. O-ring seal 118 is seated within a circumferential groove 116 formed in the exterior surface of housing 82, as best seen in FIG. 9. O-ring seal 118 is located distal to opposing feet 102d, 104d of flexible clips 102, 104. This ensures that O-ring seal 118 is properly seated against the inner wall of interior bowl area 37 of proximal bowl portion 32 of robotic cannula 35, as best seen in FIG.
[0051] 11-27, to perform robotic assisted laparoscopic surgery according to the present disclosure, a method includes providing a surgical access system including a gas delivery device 20, a standard Veress needle 120, a gas tight access cap 30, a valve-sealing access cap 60 having an obturator 70 connected to the valve-sealing access cap 60, a first robotic cannula 35a, a second robotic cannula 35b, and a filter cartridge 42 and a filtered tubing set 40 including a single lumen portion including a pneumoperitoneum / sensing lumen 48 and a dual lumen portion including a gas supply lumen 50 and a gas return lumen 52. A removable plug 85 is attached to a fitting 62 at the distal end of the dual lumen portions 50, 52, as best seen in FIG.
[0052] The method includes first inserting the filter cartridge 42 of the filtered tubing set 40 into the receiving port 27 of the gas delivery device 20, as shown in FIG. 11, and then locking the filter cartridge 42 into the receiving port 27 by rotating the mechanical lever arm 25 of the gas delivery device 20, as shown in FIG. 12. At such point, the user refers to the graphical user interface (GUI) screen 26 of the gas delivery device 20, as depicted in FIG. 13, to verify that the flow rate setting (L / min) and pressure setting (mmHg) of the gas delivery device 20 are appropriate for the patient. The gas delivery device 20 can operate in a pediatric or adult mode with different flow rate and pressure settings. If the settings are correct, the user will press the confirm button, as shown in FIG. 14.
[0053] The method further includes connecting the gas-tight access cap 30 along with the obturator 70 to the robotic cannula 35, as shown in Figure 15. An audible click sound is generated to ensure a stable connection between the cannula cap 30 and the cannula 35. The audible click sound will be generated by the mechanical interaction of the flexible engagement clips 102, 104 and the annular flange 38 of the cannula 35.
[0054] The method further includes percutaneously inserting a Veress needle 120 into the patient's abdominal cavity, as shown in Figure 16, and then connecting the single lumen tubing portion 48 of the fitting 56 of the filtered tubing set 40 to the luer connector 122 of the Veress needle 120, as shown in Figure 17. The GUI screen 26 of the gas delivery device 20 will then indicate that the device is ready, and the user presses a start button to begin initial insufflation of the abdominal cavity through the Veress needle 120, as shown in Figure 18. When a set intraperitoneal pressure is reached (e.g., 8 mmHg), a message will be displayed on the GUI screen 26 indicating that the user may safely connect the dual lumen portions 50, 52 of the tubing set 40 to the gas tight cannula cap 30, as shown in Figure 19. At such point, the plug 85 on the bullseye fitting 62 on the distal end of the dual lumen portions 50, 52 can be removed.
[0055] The method further includes inserting the robotic cannula 35a with the valve-sealing cannula cap 60 connected thereto into the abdominal cavity of the patient (see FIG. 22), and then inserting the robotic cannula 35 into the abdominal cavity of the patient with the gas-tight cannula cap 30 using the obturator 70 connected thereto, as shown in FIG. 20. Next, as shown in FIG. 21, the bulls-eye fitting 62 associated with the dual lumen portion 50, 52 of the set of filtered tubing 40 is inserted onto and rotatably engaged with the connector 96 of the gas-tight cannula cap 30. Those skilled in the art will readily appreciate that the gas-tight cannula should be inserted last, after all valve-sealing cannulas associated with the procedure have been placed. This allows for the stiffest abdominal wall during insertion of the cannula with the gas-tight cannula cap 30.
[0056] Once the cannula 35a with the valve-sealing cannula cap 60 is in place, the fitting 56 at the distal end of the single lumen tubing portion 48 of the tubing set 40 is disconnected from the Veress needle 120 and then rotatably connected to the luer connector of the valve-sealing cannula cap 60, as shown in FIGURE 22. The gas delivery apparatus 20 will then automatically begin circulating pressurized gas through the gas-sealing cannula 30 by way of the dual lumen portions 50, 52 of the tubing set 40, and the gas delivery apparatus 20 will perform a calibration process.
[0057] 23 illustrates a graphical user interface screen 26 of the surgical gas delivery apparatus 20 indicating to the user that the gas delivery apparatus 20 has automatically initiated or otherwise activated into a gas-sealed use mode after which the system will calibrate with an obturator (e.g., obturator 70) in place. At this point, the seal 78 on the obturator shaft 74 will prevent escape of insufflation gas through the access cap 30. The graphical user interface screen 26 of the surgical gas delivery apparatus 20 will provide a message indicating that the gas-sealed use mode is active once calibration is complete, as depicted in FIG. 24. The user can then remove the obturator 70 from the gas-sealed cannula cap 30 and begin the robotic-assisted laparoscopic surgery, as shown in FIG. 25.
[0058] Once the robotic-assisted laparoscopic surgery is completed, the method involves replacing the obturator 70 in the gas-tight cannula cap 30. At such time, circulation of pressurized gas through the gas delivery device 20 is stopped and the fittings 62 at the distal ends of the dual lumen portions 50, 52 of the tubing set 40 are disconnected from the connectors 96 of the gas-tight cannula cap 30.
[0059] 26 illustrates a graphical user interface screen 26 of the surgical gas delivery apparatus 20 that provides the user with the ability to discontinue gas-sealed use mode after which the obturator 70 can be replaced within the access cap 30, 60 prior to disconnecting the cannula 35 from the filtered tubing set 40 to prevent loss of intraperitoneal pressure. The GUI shown in FIG. 27 illustrates that the system will perform a final calibration after which the gas delivery apparatus 20 can be powered off and the filtered tubing set 40 can be unlatched and removed from the gas delivery apparatus 20. The robotic-assisted laparoscopic procedure will then be terminated.
[0060] While the present disclosure has been shown and described with reference to preferred embodiments, those skilled in the art will readily appreciate that changes and / or modifications can be made therein without departing from the spirit or scope of the present disclosure.
Claims
1. A gas-sealing access cap for a robotic cannula, a) a housing having a lid defining a central access port communicating with an internal cavity for receiving pressurized gas through an inlet port to create a gas-sealed zone within the robotic cannula and directing used gas from the gas-sealed zone to an outlet port; b) a central access tube aligned with the central access port of the housing and extending distally from the internal cavity for communicating with a tubular portion of the robotic cannula, the distal end of the housing extending distally beyond the distal end of the central access tube for reception within a proximal bowl portion of the robotic cannula; c) a pair of diametrically opposed flexible clips extending from a circumferential flange integrally formed with an outer surface of the housing for removably securing the access cap to the proximal bowl portion of the robotic cannula; d) an obturator having a proximal handle portion for cooperatively engaging with the lid of the housing and an elongated obturator shaft extending distally from the handle and having a distal cutting tip, the obturator shaft extending through the central access port of the housing, and an annular seal being supported on the obturator shaft at a position along its length for sealing against an inner surface of the central access tube. A gas-sealing access cap.
2. The gas-sealing access cap according to claim 1, wherein an annular jet assembly is supported within the internal cavity of the housing for creating the gas-sealed zone within the robotic cannula to maintain a stable pressure within a surgical cavity of a patient, the annular jet assembly including a central opening aligned with the central access port of the lid.
3. The gas-sealing access cap according to claim 2, wherein a plurality of circumferentially spaced radially inwardly extending vanes are integrally formed with the housing and are located within the internal cavity below the annular jet assembly for directing the used gas from the gas-sealed zone to the outlet port of the housing.
4. The circumferential groove is formed on the outer surface of the housing distal to the flexible clips facing each other in the diametrical direction for accommodating an O-ring seal, the gas-sealing access cap according to claim 1.
5. The circumferential groove is located proximal to the plurality of spaced-apart wing portions, the gas-sealing access cap according to claim 1.
6. Each of the flexible clips facing each other in the diametrical direction includes a proximal portion, an intermediate portion, and a distal portion, the gas-sealing access cap according to claim 1.
7. The proximal portions of the flexible clips facing each other in the diametrical direction are parallel to each other, the gas-sealing access cap according to claim 6.
8. The distal portions of the flexible clips facing each other in the diametrical direction extend to the circumferential groove, the gas-sealing access cap according to claim 4.
9. The circumferential flange is proximal to the circumferential groove, the gas-sealing access cap according to claim 4.
10. The proximal handle portion of the obturator has a pair of diametrically opposed spring-biased latches for cooperating engagement with the lid of the housing, and the distal cutting tip of the obturator is a transparent distal optical cutting tip, the gas-sealing access cap according to claim 1.
11. The proximal handle portion of the obturator defines a central port communicating with a hole extending through the elongated obturator shaft to the distal optical cutting tip for receiving a scope, the gas-sealing access cap according to claim 10.
12. When the obturator shaft extends through the central access port of the housing, the annular seal is supported on the obturator shaft at a position along its length for sealing against the inner surface of the central access tube adjacent to its distal end, to prevent outflow of the insufflation gas through the gas-sealing access cap during surgery, the gas-sealing access cap according to claim 1.
13. The inlet port and the outlet port of the housing communicate with a manifold associated with a bull's-eye connector fitting for communicating with a pressurized gas line and a return gas line of a filtered tube set, the gas-sealing access cap according to claim 1.
14. A gas-sealing access cap for a robotic cannula, a) A housing having a lid that defines a central access port extending to an internal cavity that supports an annular jet assembly for receiving pressurized gas from an inlet port of the housing, the annular jet assembly including a central opening aligned with the central access port of the lid and being adapted to create a gas-tight zone within the robotic cannula to maintain a stable pressure within the surgical cavity of the patient. b) A plurality of circumferentially spaced radially inwardly extending vanes located within the internal cavity below the annular jet assembly and integrally formed with the housing for directing used gas from the gas-tight zone to an outlet port of the housing. c) A central access tube extending distally from the internal cavity of the housing below the vanes and aligned with the central access port of the housing and the central opening of the annular jet assembly for communicating with a tubular portion of the robotic cannula, the distal end of the housing extending distally beyond the distal end of the central access tube for receipt within a proximal bowl portion of the robotic cannula. d) A pair of diametrically opposed flexible clips extending from a circumferential flange integrally formed with an outer surface of the housing for removably securing the access cap to the proximal bowl portion of the robotic cannula. e) An obturator having a proximal handle portion for cooperatingly engaging with the lid of the housing and an elongated obturator shaft extending distally from the handle and having a distal cutting tip, an annular seal being supported on the obturator shaft at a position along its length for sealing against an inner surface of the central access tube when the obturator shaft extends through the central access port of the housing. A gas-tight access cap.
15. The gas-tight access cap according to claim 14, wherein a circumferential groove is formed in the outer surface of the housing distal to the opposing flexible clips for receiving an O-ring seal.
16. The gas-tight access cap according to claim 14, wherein the circumferential groove is located proximal to the spaced vanes.
17. The gas-sealing access cap according to claim 14, wherein the flexible clips facing each other in the diametrical direction each include a proximal portion, an intermediate portion, and a distal portion.
18. The gas-sealing access cap according to claim 17, wherein the proximal portions of the flexible clips facing each other in the diametrical direction are parallel to each other.
19. The gas-sealing access cap according to claim 17, wherein the distal portions of the flexible clips facing each other in the diametrical direction extend to the circumferential groove.
20. The gas-sealing access cap according to claim 15, wherein the circumferential flange is proximal to the circumferential groove.
21. The proximal handle portion of the obturator has a pair of diametrically opposed spring-biased latches for cooperating engagement with the lid of the housing, and the distal cutting tip of the obturator is a transparent distal optical cutting tip. The gas-sealing access cap according to claim 14.
22. The gas-sealing access cap according to claim 21, wherein the proximal handle portion of the obturator defines a central port that communicates with a hole extending through the elongated obturator shaft to the distal optical cutting tip for receiving a scope.
23. When the obturator shaft extends through the central access port of the housing, the annular sealing flange is supported on the obturator shaft at a position along its length to seal against the inner surface of the central access tube adjacent to its distal end, preventing the outflow of the supply gas through the gas-sealing access cap during surgery. The gas-sealing access cap according to claim 14.
24. The gas-sealing access cap according to claim 14, wherein the inlet port and the outlet port of the housing communicate with a manifold associated with a bull's-eye connector fitting for communicating with a pressurized gas line and a return gas line of a filter-equipped tube set.
Citation Information
Patent Citations
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