Patent Application
20230389960
A surgical apparatus that provides instrument access to a procedure's inherent or created cavity while maintaining pressurization of the cavity is disclosed. The cavity can be an annular orifice of an animal body (e.g., vaginal orifice) where the invention provides the procedure's instrument access via a central ring while maintaining cavity inflation (pneumoperitoneum) via an expandable outer surface, bladder or balloon like-structure, surrounding the central ring.
Most hysterectomies are performed under pneumoperitoneum where the abdominal cavity is inflated, creating space between internal organs and tissues, making it easier for the surgeon to perform the procedure. Similar to many other abdominal procedures, a hysterectomy is performed laparoscopically through the abdominal wall. In these procedures, trocars are used to maintain the pneumoperitoneum while acting as a portal for surgical instruments through the abdominal wall into the abdominal cavity.
A trocar is pneumo-occluder that is inserted through the abdominal wall. It typically includes a cannula and has an airtight port at its center. The port maintains an airtight seal beyond the trocar into the cavity as graspers, scissors, staplers, cameras and other surgical instruments may pass through the port to access the abdominal cavity during procedures.
Hysterectomies pose a unique challenge that is not seen in other abdominal procedures. In most other procedures, the abdominal tissue inherently creates an airtight chamber that in effect maintains pneumoperitoneum until the procedure is complete. In those cases, the typical trocar works effectively. However, during a hysterectomy the uterus is cut from the inner portion of the vagina in what is known as a colpotomy or vaginotomy. When the colpotomy is performed, pneumoperitoneum is lost through the incision and out through the vagina with the following affects: without sufficient pneumoperitoneum, the space between internal organs and tissues begins to close-in making it difficult for the surgeon to complete the procedure; as air escapes out through the colpotomy incision, it pushes bodily fluids with it which inhibits the procedure and exposes the incision to infection; the procedure time is increased with more potential follow-up, and may, therefore, be more expensive with increased medical risk; there is an increased opportunity for error, such as in the sponge count; risks of bowel injury; and increased anesthesia exposure.
U.S. Pat. No. 8,287,552 (the '552 Patent) discloses a surgical device for accessing a hollow cavity via an elongated body including an outer sealing member engaging an inner surface of the passage and a working channel or port extending therethrough into the hollow cavity. A plurality of suction holes formed through an outer wall of the elongated body provides a vacuum channel for increasing the sealing force between the tissue of the entrance passage to the outer surface of the elongated body. While the '552 Patent provides for a negative pressure to seal the cavity to the organ, the passage of instruments through the device appears to be taught by reference to the working channel “to permit therapeutic fluids and/or instruments to be inserted into the hollow organ therethrough.” '552 Patent, Col. 2, line 45-47. The working channel preferably extends substantially along a longitudinal axis of the sealing member, to provide a passage into the uterus.
U.S. Patent Publication No. 2013/0345714 discloses a uterine manipulator having an elongate shaft and a tip hub. The distal end is inserted into a vagina. The tip hub is disposed at the distal end and is configured to releasably receive and support a tip mount for engaging a uterus. The elongate shaft includes one or more channels to receive catheter tubing. In one embodiment, a vaginal occluder includes a main body having an expandable balloon cuff, wherein a balloon cuff tube inflates the cuff when desired. The openings allow the catheter tubes to be inserted into and removed from the channels. The channel can have sufficient depth such that the catheter tubes lie flush with the outer surface of the shaft. This can facilitate devices, such as other medical instrumentation, to be advanced, e.g., coaxially, along the shaft.
U.S. Pat. No. 5,840,077 discloses a colpotomy assembly for insertion into a vaginal cavity for use in female pelvic surgical procedures employing the inflation of an abdominal cavity with a gas to facilitate the accessibility to, and visibility of, female pelvic organs. The assembly has a vaginal extender, a uterine manipulator and a flexible occluder. The occluder is mounted on a shaft of the uterine manipulator such that it permits relative movement of the shaft during use.
U.S. Patent Publication No. 2015/0005780 discloses a uterine manipulator comprising a pneumo-occluder that enables rotation of the manipulator shaft while maintaining pneumoperitoneum. The pneumo-occluder can be positioned within the vagina when the uterine manipulator is set within the uterus. Once in position, the balloon can be inflated via the filling tube in order to seal the distal vaginal cavity from the proximal vaginal cavity.
U.S. Patent Publication No. US 2013/0023896 (the '896 Publication) provides for uterine manipulators having a vaginal occlusion portion comprising a resilient deformable member including a channel having an opening sized to fit against a manipulation rod, while minimizing movement of the vaginal occlusion member when the rod is manipulated, and wherein the member is configured to fit against the contours of an inner vaginal tissue surface. Also provided are surgical methods using the device to provide for a snug fit with the cervix, while sealing the vagina, to maintain abdominal insufflation during surgery.
Notably, Paragraph [0081] of the '896 Publication states:
U.S. Pat. No. 5,643,285 (the '285 Patent) includes an occluder which is inflated to seal the distal vaginal cavity from the proximal vaginal cavity. The vaginal occluder prevents the escape of gas used to inflate the abdominal cavity. See '285 Patent, Col. 4, line 7 (“Occluder may also be provided with an access port and is configured to permit the insertion of surgical tools therethrough.”)(reference numerals omitted).
An exemplary aspect of the present invention may be directed to a pneumo-occluder with an expandable sealing port at its center. In one aspect, the pneumo-occluder is specifically designed to fit into the vagina of a patient, forming a seal that is capable of maintaining pneumoperitoneum during and after the colpotomy is performed. The flexible sealed port maintains pneumoperitoneum while instruments are passed through the port and the severed reproductive organs may be removed through it.
In a further aspect of the present invention, non-limiting examples of a pneumo-occluder may include one or more of the following features: an expanding outer diameter that actively seals against the walls of the vagina; a flexible outer construction allowing the outer diameter (OD) of the occluder to be variable and controllable by inflation; a flexible port, having a contracting inner diameter (ID) that actively seals against instruments when inserted through the occluder port; a flexible outer OD construction expansion potential (e.g., 2″-4″); a port configured to be compatible with camera, forceps, scalpel, suction devices, graspers, suture devices, surgical instruments and other common procedure tools; and inflation/deflation devices.
In another aspect, the present invention includes a surgical apparatus for insertion into an annular orifice of an animal body to provide access to a cavity defined by the animal body while the surgical apparatus creates a seal within the annular orifice to maintain pneumoperitoneum during a surgical procedure. The surgical apparatus comprising a central support member, an outer expandable member, and a flexible opening member. The outer expandable member is coupled to the central support member and is configured to expand to create a seal with the annular orifice. The flexible opening member is disposed within the central support member and has a first state and a second state. In the first state, the flexible opening member is normally closed or sealed to prevent fluidic communication between opposing sides of the flexible opening member. In the second state, a device or an instrument is passed through the flexible opening member and the flexible opening member conforms and seals against the device or the instrument to prevent fluidic communication between opposing sides of the flexible opening.
In another aspect, the outer expandable member may be adjustably expandable to control the contact and seal with the annular orifice to resist the flow of fluid between the cavity and an ambient operating room pressure. The outer expandable member may be configured to be inflatable using an external inflation device, wherein the external inflation device includes a pressurization source for providing a fluid volume within a cavity defined by the outer expandable member. The fluid volume may be provided manually or automatically by the pressurization source which expands the outer expandable member to maintain the seal with the annular orifice. The apparatus may further include a valve that is configured to selectively maintain the fluid volume within the outer expandable member and maintain the seal between the annual orifice and the outer expandable member.
In yet another aspect, a first side of the apparatus faces a surgical procedure within the cavity, and a second side of the apparatus faces a surgeon using the apparatus. The apparatus isolates the cavity pneumoperitoneum pressure from ambient atmospheric pressure. When the surgeon inserts the device or the instrument through the flexible opening member into the cavity, the flexible opening member expands by the insertion of the device or the instrument allowing the passage of the device or the instrument into the cavity while sealing against an outer surface of the device or the instrument which allows for maintaining pneumoperitoneum pressure. The flexible opening member and the device or the instrument may both have outer surfaces configured to ensure the seal between the flexible opening member and the device or the instrument. In the first state, the flexible opening member may be a normally collapsed aperture, and in the second state, the aperture is expandable to permit non-permanent displacement and penetration by, yet circumferentially sealed about, the outer surface of the device or the instrument.
In another aspect, the central support member, the outer expandable member, and the flexible opening member may be singularly constructed out of a single material using a process such as casting or molding, wherein the central support member is at least twice the thickness of either the outer expandable member or the flexible opening member, and wherein the central support member will resist deformation when the outer expandable member is expanded and/or the flexible opening member is moved from the first state to the second state. The outer expandable member may be expanded by inflating a cavity defined by the outer expandable member with an expansion fluid, wherein the expansion fluid is supplied by an external pressure generator through a tube connected to the outer expandable member.
In yet another aspect, the outer expandable member may originally be a separate piece and attached to the central support member. Further, the central support member has an opening defined therein, wherein the flexible opening member is a separate piece relative to the central support member and is attached to the opening of the central support member. The opening of the central support member may be circular and have a diameter less than 50 millimeters.
Disclosed in embodiments herein is a surgical apparatus for insertion into an annular orifice of an animal body to provide cavity access while maintaining pneumoperitoneum during a surgical procedure. The surgical apparatus may comprise an expandable outer bladder or balloon-like structure surrounding a central region ring and a penetrable port affixed within an interior of the central region ring, through which an instrument or device may be inserted to provide surgical access to the cavity.
As noted above, hysterectomies pose a unique challenge not present in other abdominal surgery. In other abdominal procedures the abdominal tissue inherently seals against the instrument creating an airtight chamber or envelope that effectively maintains pneumoperitoneum until the procedure is complete. In such cases a conventional trocar works effectively. During a hysterectomy, however, the uterus is cut from the inner portion of the vagina in what is known as a colpotomy (or vaginotomy). When the colpotomy is performed, pneumoperitoneum is lost through the incision and through the vagina. Without sufficient pneumoperitoneum, space between internal organs and tissues begins to close contributing to aforementioned risks which cause difficulty for a surgeon to complete the procedure.
Referring now to
Turning now to
With continued reference to
Bulb valve 123 allows the compressed air to communicate between the bulb interior 121 and plenum 114 of bladder 112. Bulb 122 naturally expands after squeezing to thereby refill bulb 122 with ambient air 111 passing through valve 123. Bladder 112 remains pressurized until the air released from plenum 114 by manually opening manual vent screw 132, which is typically done after the surgical procedure is completed. While shown and described as a blood pressure inflation valve, it should be noted that any suitable alternate source of inflation may replace bulb 122, such as but not limited to a number of industry known devices including regulated pressurized gas commonly available in operating rooms.
In one embodiment, as shown in
With additional reference to
In another embodiment, aperture 119 may be defined by a material which is non-homogeneous with the remainder of penetrable sealing port 118. For example, aperture 119 may be formed within a material that is co-molded or insert molded with the remainder of penetrable sealing port 118. One non-limiting example may be similar to a duck bill valve configuration molded onto the support structure of the penetrable sealing port 118.
Examples of the type of materials and configuration of a passive sealing port are those that may be described as a puncturable sealing port employed to maintain pneumoperitoneum (e.g., U.S. Pat. No. 4,746,023). Other examples of materials and techniques to effect a passive seal about a surgical device inserted through the passive seal include not only self-sealing or conformable elastomeric “valves” (e.g., duckbill, U.S. Pat. Nos. 5,330,437; 5,350,364; 8,147,457) used to seal trocar-type or colpotomy devices, but also seals disclosed in the following U.S. Pat. Nos. 5,158,553, 5,554,124. All of the foregoing being hereby incorporated by reference in their entirety.
And, in yet another alternative embodiment, penetrable sealing port 118 may be a non-homogenous part of inflatable pessary that is assembled, for example inserted and/or attached, into bladder 112 after molding. Such an embodiment would permit the inclusion of dissimilar materials for pneumo-occluder 110, and are attached to one another.
In an alternative embodiment, for example as depicted in
The inflatable sealing ports 133, 135 described above may be generally referred to as active sealing ports.
Although not forming part of the disclosed apparatus or embodiments, the following list of surgical instruments and devices are contemplated as being suitable for use with one or more of the penetrable/sealing port embodiments: Tenaculum (e.g., Single Tooth, Double Tooth, etc.) Graspers (e.g., Kelly, Babcock, Allis, etc.), Bags (e.g., Endobags), Hysteroscope and other cameras, Ring Forcep, Biopsy instrument(s), any Laparoscopic instrument(s), Speculum and VCare.
It should also be noted that the intention of the sealing portions of the apparatus and body tissue may result in leaks. The ability to offset any small leaks can be accomplished any number of ways, such as re-inflation of the bladder via the pressurization bulb, or in the case of operating room regulated air pressure, that the regulated pressure maintains inflation automatically.
In summary and without limitation thereto, the integrated design of the pessary-like inflatable bladder encompasses one of two sealing port configurations: the passive/penetrable sealing port, and the inflatable sealing port. As described above, the passive approach employs one or more passive sealing ports through which implements, and tissues can be passed while maintaining pneumoperitoneum. Similarly, the active approach also employs one or more active seals through with implements and tissues can be passed while maintaining pneumoperitoneum, where the active port is an inflatable/deflatable independent of the pessary.
It should be understood that various changes and modifications to the embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present disclosure and without diminishing its intended advantages. It is therefore anticipated that all such changes and modifications be covered by the instant application.
