US20110125084A1 - Trocar assembly with pneumatic sealing - Google Patents

Abstract

A trocar for use in a minimally invasive surgical procedure includes an elongated body, nozzle means and means for delivering a pressurized flow of fluid to the nozzle means. The elongated body has a generally tubular configuration with coaxially arranged inner and outer walls and longitudinally opposed proximal and distal end portions, with the inner wall defining a lumen to accommodate passage of an instrument therethrough. The nozzle means is operatively associated with the inner wall of the body for directing pressurized fluid into the lumen to develop a pressure differential in an area within a region extending from a location adjacent a distal end portion of the lumen to a location adjacent a proximal end portion of the lumen, to form a fluid seal around an instrument passing therethrough.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a division of and claims the benefit of priority to U.S. patent application Ser. No. 11/517,929, filed Sep. 8, 2006, which in turn is a continuation-in-part of U.S. patent application Ser. No. 10/776,923, filed Feb. 11, 2004, which is a continuation-in-part of U.S. patent application Ser. No. 10/739,872, filed Dec. 18, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/441,149, filed May 17, 2003. Each of the foregoing applications also claims priority to U.S. Provisional Application Ser. No. 60/461,149, filed Apr. 8, 2003. Each of the foregoing applications is expressly incorporated herein by reference.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to surgical devices for providing access into a body cavity of a patient during a surgical procedure, and more particularly, to a pneumatically sealed trocar assembly.
• 2. Description of the Related Art
• Laparoscopic, or “minimally invasive” surgical techniques are increasingly more common in hospitals today. Benefits of such procedures include reduced trauma to the patient, reduced opportunity for infection, and decreased recovery time. Such procedures within the abdominal cavity are typically performed through a device known as a trocar or cannula, which facilitates the introduction of laparoscopic instruments into the abdominal cavity of a patient.
• Additionally, such procedures commonly involve filling or “insufflating” the abdominal (peritoneal) cavity with a pressurized fluid, such as carbon dioxide, to create what is referred to as a pneumoperitoneum. The insufflation can be carried out by a trocar equipped to deliver insufflation fluid, or by a separate insufflation device, such as an insufflation needle. Introduction of surgical instruments into the pneumoperitoneum without a substantial loss of insufflation gas is desirable, in order to maintain the pneumoperitoneum.
• During typical laparoscopic procedures, a surgeon makes three to four small incisions, usually no larger than about twelve millimeters each, which are typically made with the trocar devices themselves, typically using a separate inserter or obturator placed therein. Following insertion, the inserter is removed, and the trocar allows access for instruments to be inserted into the abdominal cavity. Typical trocars often provide means to insufflate the abdominal cavity, so that the surgeon has an open interior space in which to work.
• The trocar must provide a means to maintain the pressure within the cavity by sealing between the trocar and the surgical instrument being used, while still allowing at least a minimum freedom of movement of the surgical instruments. Such instruments can include, for example, scissors, grasping instruments, occluding instruments, cauterizing units, cameras, light sources and other surgical instruments. Sealing elements or mechanisms are typically provided on trocars to prevent the escape of insufflation gas. Sealing elements or mechanisms typically include a duckbill-type valve made of a relatively pliable material, to seal around an outer surface of surgical instruments passing through the trocar. However, sealing in this manner is not usually complete, such seals cannot seal between multiple instruments, and such seals also inhibit free movement of the surgical instruments and/or removal of tissue through the trocar. Such seals are also vulnerable to damage during the surgical procedure. Alternatively, a flapper valve or spring-loaded trap door can be used. However, these types of mechanical valves suffer from similar drawbacks.
• Most valves, and particularly duckbill-type valves, which include resilient valve members that directly contact surgical instruments, not only interfere with the movement of surgical instruments, but reduce the ability of a surgeon to accurately sense the patient anatomy on which the surgeon is operating. Minimally invasive surgical procedures are carried out with a visualization aid such as a camera, and as a result, depth perception on the part of the surgeon is inhibited. Accordingly, the ability to physically sense resistance of structures and of tissues through movement of the surgical instruments plays an important role in a successful and safe surgical procedure. Frictional forces imparted on surgical instruments by contact of the aforementioned mechanical valves can mask the sensory signals, i.e., the haptic perception, that the surgeon might otherwise use to determine precisely what is occurring at the opposite end of the surgical instruments being used. Accordingly, improvements to sealing technologies that allow unencumbered access while maintaining a pneumoperitoneum, are desired.
SUMMARY OF THE INVENTION
• The purpose and advantages of the present invention will be set forth in and apparent from the description that follows. Additional advantages of the invention will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.
• In accordance with one aspect of the invention, a trocar for use in a minimally invasive surgical procedure is provided. The trocar includes an elongated body, nozzle means and means for delivering a pressurized flow of fluid to the nozzle means. The elongated body has a generally tubular configuration with coaxially arranged inner and outer walls and longitudinally opposed proximal and distal end portions, with the inner wall defining a lumen to accommodate passage of an instrument therethrough. The nozzle means is operatively associated with the inner wall of the body for directing pressurized fluid into the lumen to develop a pressure differential in an area within a region extending from a location adjacent a distal end portion of the lumen to a location adjacent a proximal end portion of the lumen, to form a fluid seal around an instrument passing therethrough.
• The aforementioned fluid seal is not a mechanical seal, as set forth above in the Background section of this paper. Rather, a barrier is created to the egress of insufflation fluid from a pneumoperitoneum, which barrier consists only of fluid. As set forth above, no mechanical sealing element is necessary to create an effective seal. Any friction created due to such fluid seal is minimal in comparison with friction that would otherwise be created through the interference of mechanical valves. As a result, the haptic perception of the surgeon is essentially unencumbered, providing the surgeon with the ability to perform more accurate and safer minimally invasive procedures where insufflation of a body cavity is required.
• In accordance with the invention, the inner and outer walls can be of any shape desired. For example, the walls can be cylindrical, having a circular cross-section or can have an elliptical, lenticular, oval or rectangular cross-section. Moreover, virtually any geometry is envisioned. The nozzle means can be configured to direct the pressurized fluid at an angle of between about 0 and 90 degrees with respect to a longitudinal axis of the trocar, or any angle in-between. For example, the nozzle means can direct fluid at any angle between about 0 and 90 degrees and at any one-degree increment therebetween. In one preferred embodiment, the nozzle means directs fluid at an angle between 30 degrees, 60 degrees, or at any 0.1 degree increment therebetween, for example at an angle of about 45.0 degrees. The nozzle means can be provided at a point along a longitudinal axis of the trocar body such that a fluid stream maintains a pressure gradient substantially within the lumen of the trocar. The means for delivering a pressurized flow of fluid can be a fluid passageway defined between the inner and outer walls. The nozzle means can be a substantially annular nozzle defined in the inner wall of the body. One or more nozzles can be provided, and each can be shaped substantially as a frustoconical annulus.
• The nozzle means can be provided in the distal end portion and/or the proximal end portion of the trocar body. Alternatively or additionally, the nozzle means can include first and second and/or third substantially annular nozzles, longitudinally spaced from one another. Fourth and subsequent nozzles can be provided if desired. The nozzles can be spaced so that one nozzle is arranged adjacent to the other, to a distance, for example, where nozzles are arranged at opposite ends of the interior lumen of the trocar. The first and second nozzles can be spaced from one another by a distance of 1.0 mm, 15 cm, or at any 1.0 mm increment therebetween, as necessary to achieve the desired flow characteristics through the trocar.
• Trocars in accordance with the invention can further include pressure sensing means for detecting a pressure within a cavity of a patient. The pressure sensing means can include a fluid passageway carried by the trocar, configured and adapted to be in fluid communication with the cavity of a patient when in use, for measuring pressure within the cavity. Such fluid passageway can be defined on an outer surface of the outer wall of the trocar body or concentrically disposed around the outer wall of the trocar body, in which case the second fluid passageway can have a substantially annular cross-section. Alternatively, the fluid passageway can be defined within the outer wall of the trocar and terminates in a substantially annular aperture defined in an outer surface of the outer wall of the trocar body.
• Further, helical grooves can be provided on an inner surface of the inner wall to impart a rotation to fluid exiting the trocar. Such grooves can be provided at an angle of zero degrees, 90 degrees, or at any 0.1 degree increment therebetween, with respect to the longitudinal axis of the trocar. More preferably, such grooves can be arranged between about 15 and 75 degrees, or at any 0.1 degree increment therebetween, with respect to the longitudinal axis of the trocar.
• Trocars of the present invention can further include a recirculation chamber defined in the proximal end region of the trocar body. The recirculation chamber is in fluid communication with the lumen, and configured and adapted to provide a collection region for removal and/or recirculation of fluid flowing toward the proximal end of the trocar. A collection conduit can further be provided, the conduit being in fluid communication with an outer circumferential region of the recirculation chamber to carry fluid collected thereby to a treatment means or recirculation means. Such treatment means can be configured and adapted to remove particulate and liquid matter from the fluid received from the recirculation chamber and otherwise treat the fluid. For example, treatment means can include a filter device, a settling chamber for allowing particulate matter to separate from gas, and/or a drying device such as, a cooling element for causing vapor to condense into a liquid, for removal from a gaseous flow.
• Also, trocars of the present invention can include a pressure chamber defined in the proximal end portion of the trocar body. The pressure chamber can be in fluid communication with the lumen, and configured and adapted to provide a region of increased pressure to inhibit flow of fluid flowing toward the proximal end of the trocar. A gas supply port can be provided in fluid communication with the pressure chamber, for connection to a supply line to provide a gas flow sufficient to maintain a predetermined pressure within the pressure chamber. The pressure within the pressure chamber can be about 0 mmHg, 3500 mmHg, or any 0.1 mmHg increment of pressure therebetween. More preferably, the pressure can be between about 40 mmHg and about 100 mmHg. Gas supplied to the gas supply port can be the insufflation gas or can be a different fluid from the pressurized fluid used to maintain a pressure differential within the lumen and abdominal cavity. The pressure chamber can be shaped to promote formation of a fluid vortex therein. An exhaust port can further be provided for connection to an exhaust line, to carry fluid collected thereby to a treatment means and/or recirculation means.
• Further, trocars of the present invention can include an inner wall made of first and second substantially tubular members, held within an outer wall, wherein a first nozzle is defined between the first and second substantially tubular members. A second substantially annular nozzle can be defined between one of the first and second substantially tubular members and the outer wall.
• A cap can be provided and configured and adapted to secure to the proximal end portion of the trocar body. The cap can include a valve means, such as a duckbill-type valve, for example. The cap can alternatively or additionally include a pressure sensing means. The cap can include a conduit for fluid communication with a pressure sensing means, to detect pressure within a cavity of a patient and/or a lumen for insertion of a surgical instrument.
• Further, a cap can be provided having a lumen defined within a wall of the cap, a chamber within the cap, and a ball held within the chamber. The chamber is configured and adapted to accommodate the ball, such that gas flow from the trocar body urges the ball into a position at which the ball substantially occludes the cap lumen, and such that when an instrument is inserted through the cap lumen, the ball is urged away from the cap lumen toward a periphery of the chamber.
• Any trocar of the present invention can include a baffle chamber defined near the proximal end of the trocar body. Such baffle chamber can be in fluid communication with the lumen, and configured and adapted to absorb at least a portion of sound emitted from the lumen of the trocar. Such baffle chamber(s) can include a plurality of stacked baffle units, each having a central lumen positioned to be substantially coaxial with the lumen of the trocar.
• A chamber can further be defined in the proximal end portion of trocar bodies of the present invention, with a ball held within the chamber. Such chambers can be configured and adapted to accommodate the ball, such that the ball can substantially occlude a proximal aperture of the lumen, and such that when an instrument is inserted into the lumen, the ball is urged away from the proximal aperture of the lumen toward a periphery of the chamber. Gas flow within the trocar body can urge the ball into a position at which the ball can substantially occlude a proximal aperture of the lumen. Optionally, one or more resilient tethers can be provided to urge the ball into a position at which the ball can substantially occlude a proximal aperture of the lumen. Alternatively, the ball can be provided with a mass sufficient so that in a substantially upright orientation, gravity urges the ball into a position at which the ball can substantially occlude a proximal aperture of the lumen.
• In accordance with another aspect of the invention, a trocar is provided, including a trocar body, a first fluid passageway and a first nozzle, which can be substantially annular in shape. In accordance with this embodiment, the trocar body has a substantially elliptical inner wall and a substantially elliptical outer wall. Alternatively, the walls can be of any other desired shape. The trocar body has a proximal end and a distal end, with the inner wall defining a lumen to provide access through the trocar. The first fluid passageway is defined between the inner wall and the outer wall. The first substantially annular nozzle is defined in the inner wall, and is in fluid communication with the first fluid passageway and configured and adapted to direct a pressurized fluid into the lumen to maintain a pressure differential within the lumen, or proximate the distal end thereof. The pressure differential is capable of inhibiting proximal egress of insufflation gas from a body cavity of a patient. The inner wall and outer wall together can include two substantially tubular elements.
• A trocar for providing sealable access to a pressurized patient cavity is provided having an inner tubular member, an outer tubular member and a trocar fluid seal is also provided. The inner and outer tubular members have proximal and distal ends, and the outer tubular member is substantially concentrically disposed about the inner tubular member. A trocar fluid seal nozzle is associated with the inner tubular member, and the nozzle is adapted and configured to direct a flow of fluid toward the patient cavity to prevent loss of pressure therein.
• Further, a method is provided of sealing a pressurized cavity of a patient to enable a surgical procedure. The method includes providing a trocar in accordance with the invention, supplying a flow of pressurized fluid to the trocar, and inserting a surgical instrument through the lumen of the trocar, whereby the pressurized fluid supplied to the trocar forms a seal around the surgical instrument, preventing loss of pressure within the cavity of the patient. Such method can further include inserting a second surgical instrument through the lumen of the trocar, wherein the pressurized fluid supplied to the trocar seals around and between first and second surgical instruments, preventing loss of pressure from the cavity of the patient.
• Additionally, a method is provided of sealing a pressurized cavity of a patient to enable a surgical procedure. The method includes providing a trocar, supplying a pressurized fluid stream to the trocar and inserting a surgical instrument through a lumen of the trocar. The trocar has means to direct a stream of fluid through a lumen of the trocar to prevent loss of pressure within the cavity of the patient, due to loss of insufflation fluid past a surgical instrument inserted therethrough. The pressurized fluid supplied to the trocar can seal around the surgical instrument, preventing loss of pressure within the cavity of the patient. The means to direct a stream of fluid can include at least a first nozzle arranged in a proximal end portion of the trocar. The means to direct a stream of fluid can include at least a first nozzle arranged in a proximal end portion of the trocar and a second nozzle arranged in the trocar, axially spaced from the first nozzle. The means to direct a stream of fluid can additionally or alternatively include at least one nozzle which extends substantially circumferentially about the lumen of the trocar.
• The invention also includes a system for providing pressurized fluid, which is preferably gas to an insufflation trocar. Alternatively, the gas can include vaporized or atomized liquids mixed or suspended therein, for example. The system includes a supply for providing insufflation fluid/gas to the system, pressure sensing means for measuring a pressure inside a body cavity, a pressure reservoir for maintaining a constant output pressure to the insufflation trocar, and pressure regulating means, for regulating pressure output to the trocar. The pressurization means and pressure sensing means can be provided in a surgical insufflator. Alternatively, the pressurization means can be a compressor and the pressure sensing means can an adjustable diaphragm-type pneumatic actuator. The pressure sensing means can alternatively be an electro-pneumatic transducer.
• The pressure regulating means can include a control element, for setting by a user to select a desired pressure for the surgical cavity and an electromechanical flow-control valve for adjusting a flow of insufflation gas to maintain the desired pressure within the surgical cavity. The pressure regulating means can be a two-stage pressure regulator.
• The gas supply can be connected to a pressure reservoir, to supply insufflation gas thereto, a surgical insufflator can be provided to receive gas from the supply, and output pressurized gas to the reservoir, with the insufflator having a pressure sensing conduit in fluid communication with the surgical cavity. The pressure reservoir can be connected to and can supply pressurized insufflation gas through the pressure regulating means, and the pressure regulating means can allow an amount of insufflation gas into the trocar to maintain a predetermined pressure within the surgical cavity. A pressure sensing conduit can be connected between the trocar and the pressure regulating means to control the volume of insufflation gas being provided to the trocar.
• Alternatively, the gas supply can be connected to the pressurization means, to supply insufflation gas thereto. The pressurization means can be provided and connected to the pressure reservoir to provide pressurized insufflation gas to the reservoir. The pressure reservoir can be connected to and can supply pressurized insufflation gas through the pressure regulating means. The pressure regulating means can allow an amount of insufflation gas into the trocar to maintain a predetermined pressure within the surgical cavity. A pressure sensing conduit can be connected between the trocar and the pressure regulating means to control the volume of insufflation gas being provided to the trocar.
• A tubing kit for use in conjunction with a trocar assembly with pneumatic sealing is also provided in accordance with the present invention. The kit can include a plurality of tubes and other elements contained within a package, which is preferably sterile or capable of being sterilized. A first tube can be provided for connection between an insufflation port on the trocar and a fluid supply port on a pressure regulating means, and a second tube can be provided for connection between a pressure sense port on the trocar and a pressure sense port on the pressure regulating means. The first and second tubes can be connected along their length, or alternatively can be coaxially arranged, one inside the other. If coaxially arranged, a splitter, or another splitting separation means, such a preformed transition from coaxial to parallel tubes, would typically be necessary to enable connection to different ports on the system components.
• Additionally, a third tube can be provided for connection between a proximally arranged pressure chamber on the trocar and a pressurized fluid supply. Further, an additional, fourth tube can be provided for connection to the proximally arranged pressure chamber and a recycling means for removal of fluid from the chamber. Additionally, a reservoir can be provided, for connection between the fluid supply port on the pressure regulating means and the first tube. Connection kits in accordance with the invention can be provided in a sterile package for distribution and storage, prior to use.
• It should be noted that although the term “trocar” is used herein, the term is intended to mean a surgical access device, that allows insertion of surgical instruments, a surgeon's hand or the like, into a surgical cavity, while maintaining insufflation pressure.
• It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed. It is also to be understood that features of each embodiment can be incorporated into other embodiments, and that optional features described in connection with one embodiment of a trocar in accordance with the invention can be incorporated into other embodiments of trocars in accordance with the invention.
• The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the invention. Together with the description, the drawings serve to explain the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• So that those having ordinary skill in the art to which the subject invention pertains will more readily understand how to make and use trocar assemblies with pneumatic sealing of the subject invention, preferred embodiments thereof will be described in detail hereinbelow, with reference to the drawings, wherein:
• FIG. 1 is an isometric view from a distal end of a first embodiment of a trocar including a single fluid seal nozzle, in accordance with the invention.
• FIG. 2 is an isometric view from a proximal end of the embodiment ofFIG. 1, illustrating the trocar and a removable inserter which, when inserted through the central lumen of the trocar, facilitates insertion of the trocar through the abdominal wall of a patient.
• FIG. 3 is an exploded view of the embodiment ofFIG. 1, illustrating inner and outer tubular members, which cooperate to form fluid channels and a fluid seal nozzle therebetween.
• FIG. 4 is an operational view of the embodiment ofFIG. 1, illustrating the trocar ofFIG. 1 in use, inserted through the abdominal wall of a patient, with a surgical instrument inserted therethrough.
• FIG. 5 is a partial cross-sectional view of the trocar ofFIG. 1, illustrating a pressure sense channel defined between tubular members and additionally illustrating a connected system, which can include an insufflation gas supply, and a pressure sensing means, for measuring the pressure within the abdominal cavity of the patient.
• FIG. 6ais a detailed cross-sectional view of the proximal end of the trocar ofFIG. 1, illustrating formation of a nozzle between inner tubular members, and formation of insufflation and pressure sensing plenums between the outer tubular member and respective ones of the inner tubular members.
• FIG. 6bis an enlarged cross-sectional view of the nozzle region of the trocar ofFIG. 1, illustrating in more detail that embodiment of a nozzle in accordance with the invention.
• FIG. 7ais a cross-sectional view of a flow control valve in accordance with the invention, illustrating a state where pressures in chambers on each side of a dividing membrane are experiencing equal pressures, leaving a valve plunger in a first position.
• FIG. 7bis a cross-sectional view of the flow control valve ofFIG. 7a, illustrating a state where pressure in the upper chamber is higher than pressure in the lower chamber, causing the valve plunger to obscure a lower aperture, thereby stopping fluid flow through the lower chamber of the valve.
• FIG. 7cis a cross-sectional view of the flow control valve ofFIG. 7, illustrating a state where pressure in the upper chamber is lower than pressure in the lower chamber, causing the valve plunger to move upwardly, thereby increasing fluid flow through the lower chamber of the valve.
• FIG. 8 is an isometric view from a distal end of a second embodiment of a trocar in accordance with the invention, wherein the trocar includes two fluid seal nozzles.
• FIG. 9 is an isometric view from a proximal end of the embodiment ofFIG. 8, illustrating the trocar and a removable inserter which, when inserted through the central lumen of the trocar, enables insertion of the trocar through the abdominal wall of a patient.
• FIG. 10 is an exploded view of the embodiment ofFIG. 8, illustrating inner and outer tubular members, which cooperate to form fluid channels and two fluid seal nozzles therebetween.
• FIG. 11 is an operational, partial cross-sectional view of the embodiment ofFIG. 8, illustrating the trocar thereof in use, inserted through the abdominal wall of a patient, with a surgical instrument inserted therethrough. A pressure sense channel is defined on an outer wall of the trocar. Also illustrated is a system, which can include an insufflation gas supply, and a pressure sensing means, for measuring the pressure within the abdominal cavity of the patient via the pressure sense channel.
• FIG. 12 is a detailed cross-sectional view of the proximal end of the trocar ofFIG. 8, illustrating the structure of an insufflation supply plenum between inner and outer tubular members.
• FIG. 13 is a detailed view of the respective region ofFIG. 11, illustrating in further detail the structure of nozzles in accordance with this embodiment of the invention.
• FIG. 14 is an isometric view from a distal end of a third embodiment of a trocar in accordance with the invention, wherein the trocar includes a proximally oriented pressure chamber.
• FIG. 15 is an isometric view from a proximal end of the embodiment ofFIG. 14, illustrating the trocar and a removable inserter which, when inserted through the central lumen of the trocar, facilitates insertion of the trocar through the abdominal wall of a patient.
• FIG. 16 is an exploded view of the embodiment ofFIG. 14, illustrating an outer tubular member, and proximal insert members, which cooperate to form a fluid seal nozzle and a proximal pressure chamber, respectively.
• FIG. 17 is an operational, partial cross-sectional view of the embodiment ofFIG. 14, illustrating the trocar thereof in use, inserted through the abdominal wall of a patient. A pressure sense channel is defined on an outer wall of the trocar. Also illustrated is a system, which can include an insufflation gas supply, and a pressure sensing means, for measuring the pressure within the abdominal cavity of the patient via the pressure sense channel.
• FIG. 18 is a detailed cross-sectional view of the proximal end of the trocar ofFIG. 14, illustrating the structure of an insufflation supply plenum between inner and outer tubular members, as well as the proximal pressure chamber, and fluid/gas supply thereto.
• FIG. 19 is an isometric view from a distal end of a fourth embodiment of a trocar in accordance with the invention, wherein the trocar includes a proximally oriented pressure chamber with a recirculation capability.
• FIG. 20 is an isometric view from a proximal end of the embodiment ofFIG. 19, illustrating the trocar and a removable inserter which, when inserted through the central lumen of the trocar, facilitates insertion of the trocar through the abdominal wall of a patient.
• FIG. 21 is an exploded view of the embodiment ofFIG. 19, illustrating an outer tubular member, and insert members, which cooperate to form two fluid seal nozzles and a proximal pressure chamber, respectively.
• FIG. 22 is an operational, partial cross-sectional view of the embodiment ofFIG. 19, illustrating the trocar thereof in use, inserted through the abdominal wall of a patient. A pressure sense channel is defined on an outer wall of the trocar. Also illustrated is a system, which can include an insufflation gas supply, and a pressure sensing means, for measuring the pressure within the abdominal cavity of the patient via the pressure sense channel.
• FIG. 23 is a detailed cross-sectional view of the proximal end of the trocar ofFIG. 19, illustrating the structure of an insufflation supply plenum between inner and outer tubular members, as well as the proximal pressure chamber, a fluid/gas supply thereto, and further illustrating a fluid/gas capture port for removal and/or recycling of exiting fluid.
• FIG. 24 is an isometric view from a proximal end of a fourth embodiment of a trocar in accordance with the invention, wherein the trocar includes proximally oriented baffle chamber to reduce noise.
• FIG. 25 is an exploded view of the embodiment ofFIG. 24, illustrating an outer tubular member, and insert members, which cooperate to form two fluid seal nozzles and a proximal baffle chamber, respectively.
• FIG. 26 is a detailed cross-sectional view of the proximal end of the trocar ofFIG. 19, illustrating the structure of an insufflation supply plenum, as well as a pressure sense plenum. Further illustrated is a proximally arranged baffle chamber to reduce noise being emitted through the proximal opening of the trocar lumen.
• FIG. 27 is a partial exploded view of a baffle chamber insert, which is received in the proximal end of the trocar ofFIG. 24. The insert at its distal end cooperates with the more distal tubular insert to form a nozzle therebetween.
• FIG. 28 is an environmental view illustrating a trocar in accordance with the invention, having a cap attached to the proximal end thereof. A surgical instrument is inserted through the cap and through the lumen of the trocar, into the abdominal cavity of the patient.
• FIG. 29 is an exploded view of the cap and trocar ofFIG. 28.
• FIG. 30 is a partial cross-sectional view of the cap and trocar ofFIG. 28, with the surgical instrument inserted therethrough.
• FIG. 31 is an exploded view of a cap in accordance with the invention, wherein the cap includes a valve and a secondary sealing element to seal between a surgical instrument and the cap body.
• FIG. 32 is an isometric view of a further embodiment of a cap in accordance with the invention. The cap includes two apertures for sealable insertion of two instruments.
• FIG. 33 illustrates a cap having a main aperture, which accepts a plug having a plurality of apertures formed therein, so that a user can select the size of aperture to use.
• FIG. 34 is an exploded view of a cap having a duckbill-type valve and a secondary sealing element to seal between a surgical instrument and the cap body.
• FIG. 35 illustrates a trocar in accordance with the invention, and a cap for insertion thereon. The cap includes a pressure sense line incorporated therewith to enable sensing of pressure within the abdominal cavity of the patient.
• FIG. 36aillustrates a proximal ball valve for use in conjunction with trocars in accordance with the invention. The ball occludes a proximal aperture of the ball chamber due to a pressure differential between the chamber and the surrounding environment.
• FIG. 36billustrates the ball valve ofFIG. 36a, with a surgical instrument inserted therethrough. The surgical instrument urges the ball away from the aperture, allowing the instrument access to the lumen of the trocar attached thereto.
• FIG. 37aillustrates a ball valve for use in sealing trocars in accordance with the invention. The ball is attached with one or more tethers to a proximal end wall of its housing, so that the tethers maintain a seal.
• FIG. 37billustrates a ball valve for use in sealing trocars in accordance with the invention. The ball has a mass such that it is capable of sealing the trocar when oriented in an upright position.
• FIG. 38 illustrates a sixth embodiment of a trocar in accordance with the invention, where the trocar includes a substantially elliptical shape. A pressure sense channel is defined on the outer wall of the trocar.
• FIG. 39 is an operational, partial cross-sectional view of the trocar ofFIG. 38, illustrating the trocar in use, inserted through an abdominal wall of a patient, having a plurality of surgical instruments inserted therethrough.
• FIG. 40 illustrates an example system in accordance with the invention. The system includes a gas supply, an insufflator, and a pressure reservoir and regulator. The system is connected to two trocars, one of which includes a pressure sense capability incorporated therein, and which is connected to a pressure sense line connected to the insufflator.
• FIG. 41 illustrates another example embodiment of a system in accordance with the invention. The system includes a gas supply, an insufflator, and a pressure reservoir and regulator. The system is connected to a single trocar, which includes a pressure sense line incorporated therein, which is connected to the regulator portion of the system via a pressure sense line.
• FIG. 42 illustrates a further system in accordance with the invention, where an insufflator provides pressure through a diaphragm valve to an insufflation trocar. A pressure sense line is connected to the diaphragm valve and the trocar to control flow of insufflation gas to the trocar.
• FIG. 43 illustrates still another system in accordance with the invention, with a diaphragm valve and surgical insufflator arranged in parallel.
• FIG. 44 illustrates one connection setup, including three tubes connecting trocars in accordance with the invention to a single control unit.
• FIG. 45 illustrates another connection setup, including two tubes, one of which is bifurcated to supply pressurized fluid to two trocars in accordance with the invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
• Referring now to the drawings, wherein like reference numerals identify similar structural aspects of the subject trocars and systems therefor, an exemplary embodiment of the pneumatically sealable trocar in accordance with the invention is shown inFIGS. 1-6, and is designated generally byreference character100. Other embodiments of pneumatically sealable trocars in accordance with the invention, or aspects thereof, are provided in subsequent figures, which are described in detail below.
• With reference toFIGS. 5 and 6a, thetrocar100 includes an elongated body having an outertubular member110, and a coaxial innertubular member120. The innertubular member120 includes aninner surface105 surrounding a lumen orchannel106, through which an instrument (e.g., instrument490) can be inserted into a cavity, such asabdominal cavity430 of a patient. Spiral or helical grooves can be provided in thesurface105 of the trocar to impart a rotation to fluid either entering or exiting the trocar. Such spin can help separate liquid or other particulate matter from fluid exiting the trocar from its proximal end, thereby facilitating collection of such waste. The outertubular member110 includes anouter surface107, which in use, contacts theabdominal wall410 of a patient through which thetrocar100 is inserted. Anopening109, which is at the distal end of thelumen106, allows passage of a surgical instrument or a plurality of instruments into, and communication of insufflation gas with theabdominal cavity430. The proximal end portion of thetrocar100 includes an expandeddiameter portion115, which provides space for certain functional elements of the trocar. As best seen in FIG.6a, these functional elements include aninsufflation plenum137 andpressure sense plenum139. Other embodiments, described in detail below, include additional functional elements.
• Referring in-particular toFIG. 6a, thetrocar100 includes at its proximal end portion, anozzle145, in fluid communication with thelumen106 and theinsufflation plenum137. he plenum127 is supplied with insufflation gas through aninsufflation port117, to which insufflation gas is supplied from an external system, described in further detail below. Insufflation gas entering through theinsufflation port117, through a conduit440 (e.g., seeFIG. 4) enters theinsufflation plenum137, where it is distributed to thenozzle145. As illustrated, thenozzle145 is substantially annular and is defined between the innertubular member120 and an innertubular insert130.
• The precise configuration of nozzles for use with trocars in accordance with the invention can vary. If desired, a plurality of discrete nozzle apertures can be defined in place of theannular nozzle145. These discrete nozzle apertures can be arranged as necessary, about the wall of the trocar, to form an effective barrier to proximal egress of insufflation gas from the abdominal cavity of the patient. Such discrete nozzles can each be substantially round in shape, or alternatively can be oblong or another shape. The nozzles can be places at regular intervals about the circumference of the lumen, can extend part way around, or can be spaced from each other in groups. If turbulence is desired, surface features such as protrusions, vanes, grooves, surface texture can be added in the path of fluid flow, as desired.
• As best seen inFIG. 3,standoffs135 can be provided to maintain a desired nozzle width. Thestandoffs135 can be formed such that they have little or no effect on the flow of insufflation gas entering thecentral channel106. Alternatively, thestandoffs135 can be configured such that they affect fluid flow in a desired manner, such as by enhancing laminar flow or turbulent flow of insufflation gas. The distal portion of thetubular insert130 orstandoffs135, if they are provided, abut aseat portion122 of the innertubular member120, thereby forming thenozzle145, which here, appears essentially as a gap along theinterior wall105 of thetrocar100. In this and other embodiments, standoffs can alternatively or additionally be provided in an abutting portion of the innertubular member120, or other corresponding component. Standoffs can be arranged at any location desired, including in the nozzle itself.
• The thickness610 (SeeFIG. 6a) of thenozzle145 is preferably between about 0 and 10/1000 inch, more preferably about 2/1000 inch, for a trocar having a lumen diameter of about 12.7 mm and a length of between about 100 mm and 120 mm. However, lumen diameters of trocars in accordance with the invention can range from about 3.0 mm and about 100 mm, at any 1.0 mm increment therebetween, inclusive, to accommodate insertion of, for example, a surgeon's hand. Lengths for trocars in accordance with the invention can range from about 50 mm to about 400 mm, at any 1.0 mm increment therebetween, inclusive, for trans-esophageal or trans-anal applications. However, the precise size of lumen diameter, and length, and nozzle thickness can vary as desired or necessary. For example, for lumens with larger cross-sectional diameters, a larger nozzle, capable of outputting a larger volume of insufflation fluid/gas may be desirable. While one nozzle is illustrated in this embodiment, other embodiments include two or more nozzles. The precise number of nozzles can be as many as desired. This can be done to create a series of pressure differentials at different axial locations along the length of thetrocar100, in order to better inhibit escape of pressure from theabdominal cavity430.
• Moreover, if desired, the nozzle width can be adjustable, allowing a user to adjust the precise volume of air entering through the nozzle. Adjustability can be accomplished by providing, for example, threads on the outer edge of thetubular insert130, with corresponding threads on the inner edge of expanded-diameter portion115 of the trocar100 (SeeFIG. 6a).
• Apressure sense channel121 is also formed between the innertubular member120 and the outertubular member110.Standoffs125 can be provided to maintain the desired width of opening of thepressure sense channel121. Thepressure sense channel121 terminates in a substantiallyannular opening124 in a distal end portion of thetrocar100, and at apressure sense plenum139 formed in the proximal end portion of thetrocar100. As illustrated, thepressure sense plenum139 is defined between the innertubular member120 and the expandeddiameter portion115 of the outertubular member110, although other configurations are possible, as described below. Structurally, theinsufflation plenum137 and thepressure sense plenum139 are separated by an expandeddiameter portion123 of the innertubular member120. An expanded-diameter portion133 of theinsert130 similarly serves as an upper wall for the insufflation plenum, however variations of this configuration are possible. The distalpressure sense aperture124, which is the distal termination of thepressure sense channel121, communicates with the gas in theabdominal cavity430 of the patient. The pressure in thechannel121, is thus the same as in the patient'sabdominal cavity430. Accordingly, the pressure in thepressure sense plenum139 is also equal to the pressure within theabdominal cavity430. Thepressure sense port119, which is in fluid communication with thepressure sense plenum139, is in-turn, connected to a pressure sensing device, which is part of thesystem550, viapressure sense conduit450. The pressure sensing device can be a surgical insufflator, electronic pressure transducer or a diaphragm valve (e.g., seeFIG. 7), for example.
• Insufflation gas is provided from a supply, such as atank560. Asystem550, which can include elements such as an insufflator, reservoir, pressure regulator, conditioning elements, such a humidifier, dehumidifier or heater, recirculation devices and/or flow booster, receive the insufflation gas. The system pressurizes the gas to the desired pressure and treats or conditions the gas as necessary. As set forth above, the pressure supplied to trocars in accordance with the invention can be between about 0 mmHg and 3500 mmHg at any 0.1 mmHg increment of pressure therebetween. Such pressures are suitable for pressure chambers such aschamber1475 ofFIG. 18. However, relatively high pressures can also be supplied to the nozzles of trocars in accordance with the invention, such asnozzle145 inFIG. 6a. In one embodiment, pressure supplied to the nozzle(s) is between about 1000 mmHg and about 2000 mmHg, and can be at any 0.1 mmHg increment of pressure therebetween. In one preferred embodiment, the pressure supplied to the nozzle(s) is about 1530 mmHg. Naturally, pressures can vary as needed or desired.
• Thetrocar100 is connected to thesystem560 by way of at least one conduit, which supplies the insufflation gas to theinsufflation plenum137. The pressurized gas then passes into and through thenozzle145, into thecentral channel106. The precise configuration of thenozzle145 can vary, but in any case inhibits flow of insufflation gas from theabdominal cavity430 of the patient. The angle of the nozzle, with respect to alongitudinal axis108 of thetrocar100 is designated herein as a (alpha). Such angle α can vary from 90 degrees, where a gas jet is injected across thechannel106, to 0 degrees where a gas jet is formed parallel to theinterior wall105 of thetrocar100, or can be an angle any increment of 0.1 degree therebetween. Typically, the angle α will be greater than 0 and less than 90 degrees. In some embodiments, the angle α is preferably between about 0 and 10 degrees, but the precise value can depend on the length of the trocar. In a preferred embodiment, the angle of the nozzle will approach 0 degrees, in cases where a relatively long trocar, or cannula is provided (such as trocar for trans-esophageal use). In instances where the trocar is relatively short, an angle approaching 90 degrees can be selected.
• In accordance with a preferred embodiment of the invention, thenozzle145 forms a jet of pressurized fluid, such as a pressurized gas, that is directed toward the distal end of thetrocar100. Such jet can be substantially conical if desired. While theabdominal cavity430 is being filled with insufflation gas, the gas from thenozzle145 passes down thechannel106 of thetrocar100, and into theabdominal cavity430. The pressure within theabdominal cavity430 will eventually reach equilibrium with the pressure of the gas provided by thetrocar100, at which time theabdominal cavity430 of the patient will essentially cease expansion, as no additional volume of gas will be able to enter the cavity. The gas ejected from thenozzle145 will be directed distally, and any additional fluid entering theabdominal cavity430 will displace fluid already in thecavity430. Excess insufflation gas, or displaced gas will exit from the proximal end of thetrocar100. In effect, what is created is a region in which the force of gas entering from thenozzle145 at least equals that of the force of pressure within the abdominal cavity, acting in the region of thelumen106. A pressure gradient is created and maintained by thetrocar100, between the pressure of theabdominal cavity430 and that of the surrounding environment, such as that of an operating room. As mentioned above, if a plurality of nozzles (e.g., nozzle145) are provided, then a plurality of pressure zones can be created, limiting the burden on any one nozzle to create and maintain a large pressure differential.
• With insufflation fluid/gas being provided and distributed about the circumference of theinner wall105 of thetrocar100, a singlesurgical instrument490 or a plurality of instruments, can be inserted through thelumen106 of thetrocar100. The pressurized fluid entering from thenozzle145 will simply flow around the one ormore instruments490 and/or between adjacent instruments inserted through thechannel106, and maintain pressure within theabdominal cavity430. Since the nozzle(s) encircle each instrument, pressurized insufflation gas can impinge and be directed completely around each surgical instrument. Accordingly, a reliable fluid seal is achieved.
• Further, the fluid seal is capable of sealing around cables, around and within bundles of cables, or any other object inserted through the lumen of the trocar. If no instrument or object is inserted through the lumen, the seal is still maintained. Accordingly, a surgeon can have an unobstructed view through the trocar and into the abdominal cavity of the patient, while still maintaining a seal for pressure of the abdominal cavity. Heretofore such unobstructed view has been impossible.
• An additional benefit of the devices set forth herein, is that during a procedure, the insufflation fluid can be set to flow at a velocity such that the fluid can clean remove debris from an instrument in the fluid flow, particularly at regions of higher velocity. The speed of the fluid flow will typically be highest at the location of a nozzle. For example, if a fiber-optic camera is inserted through the lumen of the trocar and into the abdominal cavity of a patient, and such lens becomes soiled, the surgeon need only move the lens temporarily into the path of the fluid seal fluid flow, to blow any debris off of the lens. Accordingly, the lens need not be removed for cleaning.
• While thepresent trocar100 is capable of providing insufflation gas into anabdominal cavity430 of a patient, it is to be understood that alternatively, a secondary insufflation device can be used to provide the initial insufflation of the abdominal cavity, with thetrocar100 being used mainly to provide sealable access to theabdominal cavity430.
• As best seen inFIG. 2, anobturator190 or inserter can also be provided, and can be used to facilitate insertion of thetrocar100 into theabdominal cavity430 of the patient. Theobturator190 can be of any type desired, including but not limited to blunt tip obturators.
• As discussed briefly above and in more detail below, subject trocars are supplied with insufflation fluid/gas from an external system. Such systems, e.g.,system550, can include elements such as an insufflator, reservoir, pressure regulator, conditioning elements, such a humidifier, dehumidifier or heater, recirculation devices and/or flow booster, receive the insufflation gas. Thetrocar100 is connected to thesystem560 by way of at least one conduit, which supplies the insufflation gas to theinsufflation plenum137. The trocar can be connected directly to a pressure-sensing flow booster valve, such as that illustrated inFIGS. 7a-7c.
• FIGS. 7a-7cillustrate three states of adiaphragm valve700 that can be used in conjunction with trocars in accordance with the present invention. Thevalve700 includes ahousing710, and adiaphragm720, which separates thehousing710 into twochambers711,712. Theupper chamber712 is a pressure sense chamber, which includes apressure sense port750 in fluid communication with theabdominal cavity430 of the patient, by way of, for example, apressure sense channel121 andpressure sense conduit781 of a trocar in accordance with the invention. Asupply conduit783 is attached toinlet port760, which receives a supply of pressurized insufflation gas from, for example, a compressor. Theoutlet port740 is connected via aconduit785 to an insufflation port (e.g., port117) of a trocar in accordance with the invention.
• Thevalve700 adjusts flow through thelower chamber711, depending on the pressure sensed by theupper chamber712. A knob andspring arrangement730 can be adjusted to bias the diaphragm to a position, such that a desired set point is achieved. As can be seen, if the pressures of both chambers are equalized, then theplunger750 of thevalve700 remains in a predetermined position, which in this embodiment is a slightly open position, as illustrated (SeeFIG. 7a). Alternatively, this criteria can result in aclosed valve700 if it is adjusted accordingly. As illustrated, if the pressure sense line andchamber712 experience a pressure increased over that of the supply pressure oflower chamber711, the valve can be set to close under these circumstances (SeeFIG. 7b). Similarly, as seen inFIG. 7c, if the pressure inupper chamber712 drops, with respect to the supply pressure, thediaphragm720 moves upward, movingplunger750 upward and opening thevalve700, causing increased fluid flow out ofoutlet port740, and into the a insufflation trocar.
• Referring toFIGS. 8-13 another trocar constructed in accordance with the invention is illustrated and is designated generally byreference numeral800. Thetrocar800 differs from thetrocar100 ofFIGS. 1-6 in placement and quantity ofnozzles835,845, as well as in the configuration of thepressure sense channel820. As best seen inFIGS. 11 and 12, atubular body member810 is provided, which includes an expanded diameterproximal end portion815 that houses theinsufflation plenum837, and adistal opening811 at its distal end, which allows access to and fluid communication with theabdominal cavity430 of the patient. An expandeddiameter end portion833 of theproximal insert member830 helps seal and define theinsufflation chamber837 from the surrounding environment. As embodied, twotubular insert members830,840 are provided. A lower, moredistal nozzle845 is defined between an increasedthickness portion818 of thebody member810, and the most distaltubular insert840. A second, moreproximal nozzle835, is defined between the proximal edge of the distaltubular insert840, and the distal edge of the proximaltubular insert830.
• As with the foregoing embodiment oftrocar100 ofFIGS. 1-6, and other embodiments described herein,standoffs839 can be provided to orient the tubular inserts830,840 and to maintain the width of thenozzles835,845. Thestandoffs839 can also help maintain the width of thenozzle supply channel1111, which is defined between the outertubular body member810, and the innertubular insert members830,840. The nozzle supply channel is in fluid communication with each nozzle, and is supplied with pressurized insufflation gas from theinsufflation plenum837. Alternatively, if desired, multiple nozzle supply channels can be provided, each of which receive pressurized gas from theinsufflation plenum837, and supply respective nozzles with pressurized gas.
• Thenozzles835,845 form barriers to escape of gas from within theabdominal cavity430, similarly to the above description, in connection with the embodiment ofFIGS. 1-6. A pressure gradient is created and maintained by thenozzles835,845 of thetrocar800, between the pressure of theabdominal cavity430 and that of the surrounding environment. As mentioned above, a plurality of nozzles create a plurality of pressure zones, limiting the burden on any one nozzle to create and maintain a large pressure differential. Such plurality of nozzles also provide redundancy, and therefore a better chance that a complete seal will be maintained around and between surgical instruments inserted through trocars in accordance with the invention. The number of nozzles can be as many as desired, so as to create a series of pressure differentials, to inhibit escape of pressure from theabdominal cavity430. Such an end can be achieved by providing a plurality of inner tubular inserts, similar to that ofinsert840, defining nozzles in-between each adjacent insert. In situations with a plurality of nozzles, it may be beneficial to provide nozzle supply channels with increasing cross-sectional area, to provide sufficient pressurized fluid to nozzles arranged nearer the distal end of the trocar.
• Aninsufflation port817 is provided and is in fluid communication with and supplies pressurized insufflation fluid to theinsufflation plenum837, and in-turn to thenozzle supply channel1111 and thenozzles835,845 themselves.
• As best seen inFIG. 8, apressure sense port819 is provided on thetrocar800 ofFIGS. 8-13. On one end, theport819 interfaces with a pressure-monitoring element of theexternal system550. Thepressure sense port819 transitions into a pressure-sense channel1121 formed on thebody member810, which terminates in the distal end portion of thetrocar800, so that it can be exposed to the pressure within theabdominal cavity430. Alternatively, thepressure sense channel1121 can be formed within a wall of thebody member810. Alternatively still, as described below, the pressure sense member can even be a separate element.
• With reference toFIGS. 14-18, another embodiment of a trocar constructed in accordance with the present invention is designated generally byreference numeral1400. Thistrocar1400 differs from thetrocar100 ofFIGS. 1-6, in the placement of thepressure sense channel1420, which is instead similar to that of thetrocar800 ofFIGS. 8-13, in that it is disposed on an outside surface of thetrocar body1410.
• As best seen inFIGS. 14,17 and18, thepressure sense channel1420 is in fluid communication with apressure sense port1419, provided on thetrocar1400. Naturally, a pressure sense channel similar to that of thetrocar100 ofFIGS. 1-6 can be substituted. As also can be seen, aninsufflation port1417 is provided in the expanded diameterproximal portion1415 of thetrocar1400, which connects to theinsufflation plenum1437, which in-turn provides pressurized insufflation fluid through a substantially annularnozzle supply channel1811, to thenozzle1445. Thetubular insert member1430 terminates at thenozzle1445, and can includestandoffs1439, as set forth above. Aninserter190, can be provided, as with other embodiments described above and below.
• With reference toFIG. 18, thetrocar1400 ofFIGS. 14-18 includes a proximally arrangedpressure chamber1475. The chamber is defined within the expandeddiameter portion1415 of thetrocar body1410, and is bordered proximally by areduction annulus1470, with acentral aperture1471 defined therein to allow passage of surgical instruments and the like. Thepressure chamber1475 is bordered on a distal end by an expandeddiameter portion1433 of thetubular insert1430, which insert1430, helps define anozzle1445 at its distal end (SeeFIG. 17). Thepressure chamber1475 receives a flow of pressurized fluid from apressure port1418, which is supplied by theexternal system550. The fluid supplied to thepressure chamber1475 can be the insufflation gas, or alternatively, can be another gas. By creating a region of increased pressure in thechamber1475, proximal egress of insufflation gas through the trocar, from theabdominal cavity430 of the patient, can be reduced. While the pressurized fluid entering thechamber1475 will ultimately be lost to the surrounding environment through theaperture1471, a recovery and recycling facility can be provided, as will be described in connection with the embodiment ofFIGS. 19-23, below.
• Reference will now be made toFIGS. 19-23, which illustrate a further embodiment of a trocar constructed in accordance with the invention. Thistrocar1900 is similar to thetrocar1400 ofFIGS. 14-18, but includes a nozzle arrangement similar to thetrocar800 ofFIGS. 8-13. Additionally, however, as best seen inFIG. 23, thepressure chamber1975 includes arecovery port1916 to enable removal and/or recirculation of gas that would otherwise exit through the proximal end of thetrocar1900.
• Thepressure sense channel1920 is in fluid communication with apressure sense port1919, provided on thetrocar1900. As with any embodiment, a pressure sense channel similar to that of thetrocar100 ofFIGS. 1-6 can be substituted in place of thepressure sense channel1920. As also can be seen, aninsufflation port1917 is provided in the expandeddiameter portion1915 of thetrocar1900, which connects to theinsufflation plenum1937. Theinsufflation plenum1937 in-turn provides pressurized insufflation fluid/gas through a substantially annularnozzle supply channel1911, to thenozzles2235,2245.
• As can be seen, atubular body member1910 is provided, which includes an expanded diameterproximal end portion1915 that houses theinsufflation plenum1937. As can be seen inFIG. 23, an expandeddiameter end portion1933 of theproximal insert member1930 helps seal and define theinsufflation chamber1937 from thepressure chamber1975, above. As best seen inFIGS. 22 and 23, twotubular insert members1930,1940 are provided. A lower, moredistal nozzle2245 is defined between an increasedthickness portion1901 of thebody member1910, and the most distaltubular insert1940. A second, moreproximal nozzle2235, is defined between the proximal edge of thedistal tubular insert1940, and the distal edge of theproximal tubular insert1930. As with any embodiment described herein, aninserter190, can be provided to aid insertion through theabdominal wall410 of a patient.
• The proximally arrangedpressure chamber1975 is defined within the expandeddiameter portion1915 of thetrocar body1910, and is bordered proximally by areduction annulus1970, with acentral aperture1971 defined therein to allow passage of surgical instruments and the like.
• Thepressure chamber1975 is bordered on a distal end by an expandeddiameter portion1933 of thetubular insert1930. Thepressure chamber1975 receives a flow of pressurized fluid from apressure port1918, which is supplied by theexternal system550. The fluid supplied to thepressure chamber1975 can be the insufflation gas, or alternatively, can be another gas. By creating a region of increased pressure in thechamber1975, proximal egress of insufflation gas from the distal end of the trocar, and from theabdominal cavity430 of the patient can be reduced.
• The pressurized fluid entering thechamber1975 will at least in-part, be collected and recycled through therecovery port1916, and can be sent to atreatment device2255, and recycled. The recovered fluid/gas can be treated to remove particulate matter, including smoke and/or liquids, can be humidified or dehumidified, heated or cooled, as desired. The recycled fluid can then be pressurized and sent back to thepressure port1918, or can be re-inserted into a main supply, so that it can be used either for thepressure chamber1975, or sent to the nozzle(s)2235,2245. Alternatively still, the recovered fluid can be discarded if desired. The collection and removal and/or recycling of recovered fluid/gas can accomplish certain desirable results. For example, if the fluid can be recycled, there is less waste, and therefore less expense for insufflation fluid/gas for each procedure. Even if the collected fluid is discarded, such fluid is still prevented from exiting the proximal end of the trocar, preventing such fluid from escaping into the environment untreated. This also helps prevent fluid from being ejected toward those in the operating room.
• Moreover, therecovery port1916 can recover liquids that may exit through the trocar. As the liquids exit the trocar, they are directed radially outwardly, toward therecovery port1916. Also, although therecovery port1916 is illustrated on an opposite side of the expandeddiameter portion1915, it can be arranged so that any tube would connect in the same region as the other three ports, to reduce encumbrance to a surgeon.
• As with the foregoing embodiments,standoffs1939 can be provided to orient the tubular inserts1930,1940 and to maintain the width of thenozzles2235,2245. Thestandoffs1939 can also help maintain the width of thenozzle supply channel1911, which is defined between the outertubular body member1910, and the innertubular insert members1930,1940.
• Reference will now be made toFIGS. 24-26, which illustrate yet another embodiment of a trocar in accordance with the present invention, which is designated generally byreference numeral2400. Thistrocar2400 includes asimilar pressure channel2421 to thetrocar100 illustrated inFIGS. 1-6. Thepressure sense channel2421 is defined between the outertubular body member2410 and a second, innertubular body member2420. Thepressure sense channel2421 is in fluid communication with apressure sense plenum2439, which in-turn is in fluid communication with apressure sense port2419. As can best be seen inFIG. 26, aninsufflation port2417 is provided in the expanded diameterproximal portion2415 of thetrocar2400, which connects to theinsufflation plenum2437, which in-turn provides pressurized insufflation fluid to thenozzle2645. Theinner tubular member2420 helps define thenozzle2645 at its proximal end portion, in conjunction with abaffle insert2430, which defines the upper limit of thenozzle2645. Standoffs2435, as set forth above, can be provided to maintain nozzle geometry.
• As with the foregoing embodiments, the principle of operation of thenozzle2645 is such that a region in which the force of gas entering from thenozzle2645 at least equals that of the force of pressure within the abdominal cavity, acting within the channel2401, or just beyond the channel2401, in theabdominal cavity430. A pressure gradient is created and maintained by thetrocar2400, between the pressure of theabdominal cavity430 and that of the surrounding environment, such as an operating room.
• As can best be seen inFIG. 26, thetrocar2400 additionally includes a proximally arrangedbaffle insert2430, which aids in reducing noise created by the flow of insufflation gas in thetrocar2400. A sound-absorbent material2438, such as a foam rubber, for example, can be used, and be inserted betweenseparation portions2433 of theinsert2430. The sound-absorbent material2438 can be provided in cut halves, as illustrated, or in complete rings. Alternatively, theinsert2430 can be provided without additional sound absorbent material. The rigid portion of theinsert2430 can be a unitary component as illustrated, or can include multiple stacked elements, each of which engages adjacent stacked element. As illustrated inFIG. 27, the distal end of theinsert2430 can be provided withstandoffs2435, and helps define thenozzle2645, in conjunction with aproximal nozzle surface2427 of theinner tubular member2420.Standoffs2423 can additionally be provided between theinner tubular member2420 and theouter tubular member2410.Interior openings2431 in therigid portion2430 can be provided, to enable the sound-absorbent material2438 to absorb sound.
• Further, a recovery means such as in the embodiment ofFIGS. 19-23, can be configured in this embodiment, to aid collection of gas that would otherwise exit thetrocar2400.
• Reference will now be made toFIGS. 28-35, which illustrate various embodiments of caps that can be secured to a proximal end of trocars, to help seal the trocars and prevent excessive loss of insufflation gas, and/or prevent contaminants from entering the lumen of the trocar and thus the abdominal cavity. A cap may be desirable since, in use, while a net loss of pressure in theabdominal cavity430 is not experienced, some amount of insufflation gas typically will escape through the proximal aperture of the lumen of thetrocar2801. This effect is minimized by use of a gas recovery and recirculation system. However, use of a cap can be helpful under some circumstances. For example, if it is desired to reduce the flow of, or shut off the insufflation gas completely, then escape of fluid from theabdominal cavity430 of the patient must be inhibited to maintain the pneumoperitoneum.
• Thecap2870 ofFIGS. 28-30 includes acentral aperture2875, surrounded by a resilient ring ofmaterial2873, which can compress and help seal the junction between therigid body portion2871 of thecap2870 and asurgical instrument2890, when inserted into theaperture2875. This cap and other caps described herein can be joined to the proximal end of thetrocar2801 by any suitable means, including but not limited to a latching element, snap fit, friction fit, adhesive or mechanical fasteners, such as hook-and-loop fasteners.
• Referring toFIG. 31, which illustrates a cap constructed in accordance with the invention, which includes amain body portion3170, aquadricuspid valve element3120 having four cusps separated by slits, and aresilient ring element3110 that enhances the sealing of the cap when an instrument is inserted therethrough. Naturally, thevalve element3120 can include more or less cusps, e.g., 2, 3 or 5.
• Referring toFIG. 32, the cap illustrated therein is designated generally withreference number3200. Thecap3200 includes twoapertures3210, and amain body portion3270. Theapertures3210 can enable sealed insertion of two separate instruments. Naturally, three ormore apertures3210 can alternatively be provided. Theapertures3210 can be provided with resilient inserts or portions and/or with a valve portion, such asvalve3120 shown in the embodiment ofFIG. 31.
• With reference toFIG. 33, thecap3300 includes amain body portion3370, and aplug3310, which in-turn has twoapertures3311,3313 formed therein. Theplug3310 can be inserted into themain body portion3370 to enable use of two relatively small-diameter surgical instruments. Theplug3310 can be removed to enable insertion of a larger-diameter instrument, or for other reasons, depending on the particular situation.
• As shown inFIG. 34, thecap3400 includes a duckbill-type valve element3420, which is inserted into a receivingaperture3410. Aresilient ring3430 can further be provided to additionally enhance sealing between an instrument and the cap body340, when an instrument is inserted therethrough. This may be desirable, since when theduckbill valve3420 is opened, and a round instrument is inserted therethrough, the duckbill valve might not completely seal around such instrument.
• FIG. 35 illustrates acap3500, which includes anaperture3550, amain body portion3570, and apressure sense line3560. The pressure sense line can terminate in or near thecap body3570 itself, or can extend through the lumen of thetrocar2810 to sense pressure within theabdominal cavity430.
• FIGS. 36aand36billustrate atrocar end3600 having a ball valve arranged at the proximal end portion thereof. The substantially spherical valve member or “ball”3660 is housed within aball chamber3650 and capable of closing off a proximal aperture3571. Theball3660 can be urged into place by a difference in pressure between theball chamber3650, trocar lumen, and abdominal cavity of a patent, with which it is in fluid communication. As shown inFIG. 36b, when aninstrument3690 is inserted through theaperture3671, theball3660 is urged toward the outer circumference of thechamber3650, until theinstrument3690 is removed. As can be seen, aninsufflation port3617 andinsufflation plenum3639 can be easily accommodated alongside theball valve chamber3650.
• As shown inFIG. 37a, theball3770 can be resiliently tethered to a proximal portion of theinterior wall3655 of theball chamber3650. For example, atether3773 can be attached at or near the outer circumference of the proximal end of theball chamber3650. As illustrated, asingle tether3773 passes through the ball2770, and is attached toposts3775, although any suitable connection method can be used. Theball3770 is preferably secured to thetether3773, so that theball3770 can reliably seal the centrally locatedaperture3671. When an instrument, such asinstrument3690, is inserted into the chamber, theball3770 will move to one side, stretching the tether(s)3773 as needed. When the instrument is removed, theball3770 will revert to its initial position.
• As shown inFIG. 37b, a valve can alternatively be provided having aball3780 with sufficient mass so that theball3780 can effectively occlude thelumen3680 of the trocar simply by laying over the opening thereto. When a surgeon wishes to insert an instrument, such asinstrument3690, the surgeon need only slightly tilt the trocar to move theball3780 aside, and expose thelumen3680 of the trocar. It is to be understood that such ball valves can be incorporated into any of the foregoing embodiments to provide addional encumbrance to loss of insufflation gas. Moreover, such ball valves can be provided in a separate cap, for attachment to a proximal end of the trocar. Of course, such ball valves can be provided, which can be universally utilized with any trocar, not only those described herein.
• FIGS. 38-39 illustrate atrocar3800 in accordance with the invention, having a generally elliptical cross-sectional shape. With the exception of the elliptical shape, thetrocar3800 is similar to thetrocar1400 ofFIGS. 14-18. Thetrocar3800 includes a proximally arranged pressure chamber (not shown). The chamber is defined within the expandeddiameter portion3815 of thetrocar body3810, and is bordered proximally by areduction annulus3870, with acentral aperture3871 defined therein to allow passage ofsurgical instruments3991,3993 and the like. The elliptical shape of the inner and outer surfaces also enables easier introduction of multiple surgical instruments. The pressure chamber receives a flow of pressurized fluid from apressure port3918, which is supplied by an external system. A recovery and recycling capability can be provided, as in the above embodiments. Aninsufflation port3917 provides pressurized insufflation gas to thetrocar3800, and apressure sense port3919 interfaces with apressure sense conduit3820.
• Systems in accordance with the invention include one or more of the trocars described hereinabove.FIGS. 40 and 41 illustrate system elements in accordance with the invention. Agas supply4060 or acompressor4161 are connected to and supply eachsystem4000,4100, respectively, with insufflation gas, such as carbon dioxide, helium or xenon gas. Thecompressor4161 can pressurize insufflation gas provided through a centralhospital distribution system4180, fromgas cylinders4060 or filtered air from the surrounding environment, the latter being potentially useful for gas that will not come into direct contact with the patient, such as for providing pressurized fluid to thechamber1975 ofFIG. 23. Pressure sensing means for measuring a pressure inside a body cavity can be provided in a diaphragm type valve, as illustrated inFIG. 7, by an electronic pressure transducer, or alternatively, by utilizing the pressure sensing capability of a surgical insufflator.
• Apressure reservoir4030 can be provided for maintaining a constant output pressure to the insufflation trocar. The pressure reservoir can simply be a closed volume where pressure builds by compressing fluid held therein, or can be a pressure accumulator that mechanically stores received pressure until it is needed, such as by compression of a spring-loaded diaphragm. Alternatively still, the pressure reservoir can include an active compression means, such as a compressor, to set fluid within the reservoir to the desired pressure. Since typical surgical insufflators cycle between pressurizing and pressure sensing modes, a reservoir can be used to even out the supply of pressurized fluid, so the fluid seals in the trocar are not starved of pressurized fluid, and don't allow the abdominal cavity of the patient to lose pressure. A pressure regulating means, for regulating pressure output to the trocar can be provided, and can be embodied in adiaphragm type valve700, as illustrated inFIG. 7, or alternatively can be an electromechanical device, which is controlled by a computer controller to set a valve so that an appropriate pressure is released into thetrocar4010 by way ofconduit4013. Alternatively, the pressurization means and pressure sensing means can both be provided in asurgical insufflator4020. Alternatively still, the pressurization means can be a separate compressor.
• The pressure regulating means can include a control element for setting by a user to select a desired pressure for the surgical cavity and/or output to the seal nozzles, and an electromechanical flow-control valve for adjusting a flow of insufflation gas to maintain the desired pressure within the surgical cavity. Moreover, the pressure regulating means can be a two-stage pressure regulator, capable of simultaneously regulating output at two set pressures. Alternatively or additionally, such pressure regulator can include variable-output capability, to allow control of the output pressure(s), based on a control signal.
• FIG. 40 illustrates afirst trocar4010, which is used for insufflation and is connected by aninsufflation conduit4013 to the reservoir andregulator4030. Asecond trocar4040, which is used to sense pressure within the abdominal cavity of a patient, is connected to the insufflator via apressure sense conduit4015 connected between thesecond trocar4040 and theinsufflator4020. Thesecond trocar4040 need only be a needle to sense pressure, but alternatively can be, itself, an insufflation trocar. If the second trocar is also an insufflation trocar, then asupply conduit4016 is also provided to thesecond trocar4040 from the reservoir/regulator. Since in this embodiment, use of a second insufflation trocar is optional, thepressure supply conduit4016 is provided in phantom line.
• Theinsufflator4020, in accordance with the embodiment ofFIG. 40, receives insufflation gas from thesupply4060 by aconduit4011, and provides pressurized fluid to thereservoir4030 by way of anotherconduit4012. Since typical surgical insufflators operate using a pulsed supply, separated by periods of pressure sensing, thereservoir4030, advantageously provides a constant fluid flow, even when in insufflator has paused to take a pressure measurement.
• The embodiment ofsystem4100 ofFIG. 41 differs from thesystem4000 ofFIG. 40, in that apressure sense conduit4119 and ainsufflation conduit4118 are both connected to asingle trocar4110. Further, acompressor4161 is provided rather than simply acanister4060 of gas, as in the embodiment ofFIG. 40. Optionally, filtered ambient air can be used for the purpose of insufflation. However, more likely, the pressure of gas from acentral gas supply4180, which typically deliver gas at relatively low pressures, can be increased to the required pressure to form and create a fluid seal between the operative pneumoperitoneum and the surrounding environment.
• Further, treatment devices can be provided to treat fresh or recirculated insufflation gas. Such treatment elements can include filtration elements, desiccating elements, such as a dryer, temperature control elements, such as heaters or coolers, or any other elements necessary to properly condition the insufflation gas.
• With reference toFIG. 42, a further system in accordance with the invention is illustrated in which an insufflator4220 provides pressure through a conduit4217 to a diaphragm valve700 (SeeFIGS. 7a-7c). Thediaphragm valve700, which can alternatively be a different device serving the same function, controls flow therethrough, and into anotherconduit4216 to aninsufflation trocar4210. Apressure sense line4215 is connected to thediaphragm valve700 as well as to thetrocar4210 in order to control flow of insufflation gas to thetrocar4210.
• FIG. 43 illustrates still another system in accordance with the invention, with adiaphragm valve4330 andsurgical insufflator4320 arranged in parallel. Fluid is supplied from the cylinder or “bottle”4360, through a regulatingvalve4361 intosupply conduits4325 and4327. Gas is supplied to theinsufflator4320, which pressurizes the insufflation fluid and outputs pressurized insufflation fluid throughconduit4321 to thetrocar4310. In parallel, fluid is supplied through aconduit4327 to the diaphragm valve, which is controlled, as set forth hereinabove. Fluid is then output throughconduit4324 to thetrocar4310. Thediaphragm valve4330 is controlled through a commonpressure sense channel4323, shared with that of the insufflator.
• FIG. 44 illustrates a connection setups, including three tubes4421-4423, connectingtrocars4410,4412 in accordance with the invention to asingle control unit4420.FIG. 45 illustrates another connection setup, including twotubes4525,4526, one of which (tube4526) is bifurcated atpoint4527, to supply pressurized fluid to twotrocars4410,4412 in accordance with the invention. As can be seen, the setup ofFIG. 45 utilizes one fewer port, due to the use of abifurcated tube4526. If desired, additional trocars can be added by connection to additional ports and/or through use of additional bifurcated tubes.
• Also in accordance with the invention, a method is provided of sealing a pressurized cavity of a patient to enable a surgical procedure. The method includes providing one or more trocars in accordance with the invention, inserting the trocar(s) into the patient, connecting the trocar(s) to a supply of pressurized fluid, and supplying a flow of pressurized fluid to the trocar, which can include actuating a system in accordance with the invention. The method can further include inserting a surgical instrument through the lumen of the trocar, whereby the pressurized fluid supplied to the trocar forms a seal around the surgical instrument. Accordingly, loss of pressure is prevented from within the cavity of the patient. This and other methods in accordance with the invention can further include inserting a second surgical instrument through the lumen of the trocar, wherein the pressurized fluid supplied to the trocar seals around, and between, first and second surgical instruments, preventing loss of pressure from the cavity of the patient. This and other methods in accordance with the invention can further include removing one or more instruments from the lumen of the trocar. Such methods can also include providing one or more caps in accordance with the invention, so as to seal off proximal ends of the trocar(s).
• Another method in accordance with the invention includes providing a trocar, supplying a pressurized fluid stream to the trocar and inserting a surgical instrument through a lumen of the trocar. The trocar has means to direct a stream of fluid through a lumen of the trocar to prevent loss of pressure within the cavity of the patient, due to loss of insufflation fluid past a surgical instrument inserted therethrough. The pressurized fluid supplied to the trocar can seal around the surgical instrument, preventing loss of pressure within the cavity of the patient. The means to direct a stream of fluid can include at least a first nozzle arranged in a proximal end portion of the trocar. The means to direct a stream of fluid can include at least a first nozzle arranged in a proximal end portion of the trocar and a second nozzle arranged in the trocar, axially spaced from the first nozzle. The means to direct a stream of fluid can additionally or alternatively include at least one nozzle which extends substantially circumferentially about the lumen of the trocar. Naturally, the immediately foregoing method can further include steps discussed in connection with the immediately preceding method and vice versa.
• It will be apparent to those skilled in the art that various modifications and variations can be made in the device and method of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims (21)

1. A method of sealing a pressurized cavity of a patient for a surgical procedure, the method comprising the steps of:

a) providing a trocar for use in a minimally invasive surgical procedure, the trocar including:

i) an elongated body having a generally tubular configuration with coaxially arranged inner and outer walls, the body having longitudinally opposed proximal and distal end portions, the inner wall defining a lumen to accommodate passage of an instrument therethrough;

ii) nozzle means operatively associated with the inner wall of the body for directing pressurized fluid into the lumen to develop a pressure differential in an area within a region extending from a location adjacent a distal end portion of the lumen to a location adjacent a proximal end portion of the lumen, to form a fluid seal around an instrument passing therethrough; and

iii) means for delivering a pressurized flow of fluid to the nozzle means.

c) supplying a flow of pressurized fluid to the trocar; and

d) inserting a surgical instrument through the lumen of the trocar, whereby the pressurized fluid supplied to the trocar forms a seal around the surgical instrument, thereby preventing loss of pressure within the cavity of the patient.

2. The method ofclaim 1, further comprising the step of:

inserting a second surgical instrument through the lumen of the trocar, whereby the pressurized fluid supplied to the trocar seals around and between the first and second surgical instruments, preventing loss of pressure within the cavity of the patient.

3. A method of sealing a pressurized cavity of a patient for a surgical procedure, the method comprising the steps of:

a) providing a trocar having means to direct a stream of fluid through a lumen of the trocar to prevent loss of pressure within the cavity of the patient, due to loss of insufflation fluid past a surgical instrument inserted therethrough;

b) supplying a pressurized fluid stream into the lumen of the trocar; and

c) inserting a surgical instrument through the lumen of the trocar, whereby the pressurized fluid supplied to the trocar seals around the surgical instrument, thereby preventing loss of pressure within the cavity of the patient.

4. The method ofclaim 3, further comprising the step of providing means to direct a stream of fluid that includes at least a first nozzle arranged in a proximal end portion of the trocar.

5. The method ofclaim 4, further comprising the step of providing means to direct a stream of fluid that includes at least a first nozzle arranged in a proximal end portion of the trocar and a second nozzle arranged in the trocar, axially spaced from the first nozzle.

6. The method ofclaim 4, further comprising the step of providing means to direct a stream of fluid that includes at least one nozzle which extends substantially circumferentially about the lumen of the trocar.

7. A system for providing pressurized fluid to an insufflation trocar, the system comprising:

a) a supply for providing insufflation fluid to the system;

b) pressure sensing means for taking a measurement indicative of a pressure inside a body cavity of a patient;

c) a pressure reservoir for storing pressurized fluid and for maintaining a constant output pressure to the insufflation trocar; and

d) pressure regulating means, for regulating pressure output from the reservoir to the trocar based upon a measured pressure detected by the pressure sensing means.

8. The system ofclaim 7, wherein the pressurization means and pressure sensing means are provided in a surgical insufflator.

9. The system ofclaim 7, wherein the pressurization means is a compressor.

10. The system ofclaim 7, wherein the pressure sensing means is an adjustable diaphragm-type pneumatic actuator.

11. The system ofclaim 7, wherein the pressure sensing means is an electro-pneumatic transducer.

12. The system ofclaim 7, wherein the pressure regulating means includes:

a) a control element, for setting by a user to select a desired pressure for the surgical cavity; and

b) an electromechanical flow-control valve for adjusting a flow of insufflation gas to maintain the desired pressure within the surgical cavity.

13. The system ofclaim 7, further comprising pressurization means for pressurizing the insufflation gas to a predetermined pressure.

14. The system ofclaim 7, wherein:

a) the gas supply is connected to a pressure reservoir, to supply insufflation gas thereto;

b) a surgical insufflator is configured and adapted to receive gas from the gas supply, pressurize the gas and supply the pressurized gas to the reservoir, the insufflator having a pressure sensing conduit in fluid communication with the surgical cavity;

c) the pressure reservoir is connected to and supplies pressurized insufflation gas through the pressure regulating means; and

d) the pressure regulating means allows an amount of insufflation gas into the trocar to maintain a predetermined pressure within the surgical cavity.

15. The system ofclaim 14, wherein a pressure sensing conduit is connected between the trocar and the pressure regulating means to control the volume of insufflation gas being provided to the trocar.

16. The system ofclaim 7, wherein:

a) the gas supply is connected to the pressurization means, to supply insufflation gas thereto;

b) the pressurization means is provided and is connected to the pressure reservoir to provide pressurized insufflation gas to the reservoir;

c) the pressure reservoir is connected to and supplies pressurized insufflation gas through the pressure regulating means;

d) the pressure regulating means allows an amount of insufflation gas into the trocar to maintain a predetermined pressure within the surgical cavity; and wherein

e) a pressure sensing conduit is connected between the trocar and the pressure regulating means to control the volume of insufflation gas being provided to the trocar.

17. A connection kit for use in conjunction with a trocar assembly with pneumatic sealing, the kit comprising:

a) a first tube for connection between an insufflation port on the trocar and a fluid supply port on a pressure regulating means;

b) a second tube for connection between a pressure sense port on the trocar and a pressure sense port on the pressure regulating means; and

c) a sterile package containing the first and second tubes.

18. The connection kit ofclaim 17, wherein the first tube is coaxially arranged within the second tube, the kit further including a splitter on at least one end to separate the first and second tubes for connection to respective ports on the pressure regulating means.

19. The connection kit ofclaim 17, further including:

a third tube for connection between a proximally arranged pressure chamber on the trocar and a pressurized fluid supply.

20. The connection kit ofclaim 19, further including:

a fourth tube for connection to the proximally arranged pressure chamber and a recycling means for removal of fluid from the chamber.

21. The connection kit ofclaim 18, further comprising a reservoir for connection between the fluid supply port on the pressure regulating means and the first tube.

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