Patent Description:
In order to introduce an endoscopic instrumentation into a body cavity, a device known as a "trocar" may be used to puncture and/or cannulate the wall of the body cavity. Trocars may comprise an obturator and a cannula. The obturator may include a sharply pointed or appropriately structured tip that facilitates penetration of the body cavity wall. The cannula provides a channel or opening through the body cavity wall through which endoscopic instruments may be introduced and removed by the surgeon.

Endoscopic surgery might be performed with an insufflatory fluid present within the body cavity, such as carbon dioxide, to provide adequate space to perform the intended surgical procedures. The insufflated cavity is generally under pressure and is sometimes referred to as being in a state of pneumoperitoneum. A seal or sealing arrangement can be integrally formed to a cannula, or directly attachable to the cannula, in order to maintain a state of pneumoperitoneum. The seals will generally prevent the insufflatory fluid from escaping while an endoscopic instrument may be positioned in the trocar cannula.

Some examples of trocars and related devices are disclosed in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Some surgical systems provide robotic control of a surgical instrument. With minimally invasive robotic surgery, surgical operations may be performed through a small incision in the patient's body. A robotic surgical system may be used with various types of surgical instruments, including but not limited to surgical staplers, ultrasonic instruments, electrosurgical instruments, and/or various other kinds of instruments, as will be described in greater detail below. An example of a robotic surgical system is the DAVINCI™ system by Intuitive Surgical, Inc. By way of further example, one or more aspects of robotic surgical systems are disclosed in the following: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Additional examples of instruments that may be incorporated with a robotic surgical system are described in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

<CIT> discloses a releasably attachable upper seal for a trocar which includes a rigid distal support, a rigid proximal support, a rotatable flexible seal with upper portions sandwiched between the supports, a movable ring disposed between the flexible seal and the lower support, and a generally non-compliant, but bendable protective guide attached to the inside of the seal. The opening in the ring is sized smaller than the opening in the lower supports. Cannulas and trocar systems can employ such a seal.

It may be desirable to provide an adapter for coupling modular trocar seal assembly with a trocar cannula that is made for use in a robotic surgical system.

The present invention provides an apparatus as recited in claim <NUM>. Optional features are recited in the dependent claims.

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

<FIG> show an exemplary trocar instrument (<NUM>) that is sized for providing an access port for performance of minimally invasive surgery. Trocar instrument (<NUM>) includes an obturator (<NUM>), a cannula (<NUM>), and a seal assembly (<NUM>). Obturator (<NUM>) includes an obturator grip (<NUM>) for grasping by the operator, a shaft portion (<NUM>), and an obturator tip (<NUM>). As shown in <FIG>, obturator (<NUM>) is configured for insertion through seal assembly (<NUM>) and cannula (<NUM>) such that obturator tip (<NUM>) passes through seal assembly (<NUM>) and cannula (<NUM>), with obturator tip (<NUM>) extending distally past the distal end of cannula (<NUM>) to thereby enable obturator tip (<NUM>) to penetrate or dissect through tissue layers of a patient to provide an opening adjacent to the surgical site. Shaft portion (<NUM>) is rigid to withstand force exerted by tissue layers during penetration and dissection through the tissue. Obturator tip (<NUM>) is configured to provide sufficient pressure to facilitate the penetration or dissection of tissue layers as obturator (<NUM>) is inserted through the tissue layers toward the surgical site, and is therefore shaped to enlarge an opening in the tissue as trocar instrument (<NUM>) is inserted toward the internal surgical site.

After obturator (<NUM>) and cannula (<NUM>) are inserted through the tissue, obturator (<NUM>) is removed from the rest of trocar instrument (<NUM>), while cannula (<NUM>) remains within the tissue to provide a pathway for insertion of instruments within the body cavity of the patient to perform minimally invasive surgery. Cannula (<NUM>) includes threading (<NUM>) for coupling with seal assembly (<NUM>), a seal assembly housing (<NUM>), a hollow shaft (<NUM>) distal to seal assembly housing (<NUM>), ridges (<NUM>) along the outer surface of hollow shaft (<NUM>), and an open tip (<NUM>) configured to enable surgical instruments to access the surgical site. When obturator (<NUM>) is removed from the surgical site, hollow shaft (<NUM>) maintains the opening adjacent to the surgical site. Ridges (<NUM>) are configured to provide extra stability for trocar instrument (<NUM>) by providing additional contact to the surrounding tissue layers of the patient. Ridges (<NUM>) may be particularly helpful in providing stability when pressurized insufflation fluid (e.g., pressurized air, etc.) is introduced to the surgical site, since the insufflation may provide a natural tendency to push cannula (<NUM>) away from the surgical site.

Seal assembly (<NUM>) allows for obturator (<NUM>) or surgical instruments to access the surgical site via cannula (<NUM>) while simultaneously maintaining pneumostasis of the body cavity of the patient by preventing or minimizing escape of pressurized insufflation fluid from the body cavity of the patient. In trocar instrument (<NUM>) of the present example, seal assembly (<NUM>) includes threading (<NUM>) for coupling with cannula (<NUM>), an instrument port (<NUM>), and a valve (<NUM>). Valve (<NUM>) is configured to permit the operator to selectively introduce or relieve pressurized insufflation fluid through trocar instrument (<NUM>) into the body cavity of the patient.

<FIG> show seal assembly (<NUM>) in greater detail. As shown, seal assembly (<NUM>) further includes a top valve housing (<NUM>), a connecting ring (<NUM>), an instrument seal (<NUM>), a closure valve base (<NUM>), and a closure valve (<NUM>). Top valve housing (<NUM>) includes instrument port (<NUM>), an insufflation fluid port (<NUM>), and valve (<NUM>). Instrument port (<NUM>) provides access for obturator (<NUM>) or a surgical instrument to the surgical site. Insufflation fluid port (<NUM>) is in fluid communication with top valve assembly (<NUM>) so that the insufflation fluid may pass through top valve assembly (<NUM>), around instrument seal (<NUM>) and the proximal face of closure valve (<NUM>), through cannula (<NUM>), out open tip (<NUM>) and to the surgical site in order to provide an insufflated body cavity in the patient.

Instrument seal (<NUM>) and closure valve (<NUM>) form a sealing arrangement that work together to maintain pneumostasis in the insufflated body cavity of the patient. In this example, closure valve (<NUM>) is a "duck bill" valve. However, other types of closure valves may also be used, including flapper valves, etc. When an endoscopic instrument is passed through closure valve (<NUM>), closure valve (<NUM>) will open but will generally not provide a complete seal against the instrument. When the endoscopic instrument is removed from trocar instrument (<NUM>), closure valve (<NUM>) closes and substantially prevents insufflation fluid from escaping trocar instrument (<NUM>). To supplement closure valve (<NUM>) when obturator (<NUM>) or an endoscopic surgical instrument is inserted through seal assembly (<NUM>), instrument seal (<NUM>) seals against the inserted obturator (<NUM>) or endoscopic surgical instrument to prevent insufflation fluid from escaping through trocar instrument (<NUM>). However, instrument seal (<NUM>) generally will not maintain pneumostasis on its own unless obturator (<NUM>) or endoscopic instrument is positioned in trocar instrument (<NUM>). Therefore, instrument seal (<NUM>) and closure valve (<NUM>) may together maintain a state of pneumostasis regardless of whether obturator (<NUM>) or an endoscopic surgical instrument is disposed in trocar instrument (<NUM>).

Connecting ring (<NUM>) simultaneously connects seal assembly (<NUM>) with cannula (<NUM>) while also providing sealing surfaces for instrument seal (<NUM>) and closure valve (<NUM>). Connecting ring (<NUM>) has outer threading (<NUM>) that is compatible with threading (<NUM>) of cannula (<NUM>). Connecting ring (<NUM>) also has a plurality of inserts (<NUM>) on its distal side that are compatible with a plurality of pillars (<NUM>) present on closure valve base (<NUM>). This allows for connecting ring (<NUM>) and closure valve base (<NUM>) to effectively provide a seal around the perimeter of closure valve (<NUM>). Similarly, top valve housing (<NUM>) and connecting ring (<NUM>) also come together with instrument seal (<NUM>) in between to provide a seal around the perimeter of instrument seal (<NUM>).

In order to maintain pneumostasis in the insufflated body cavity of the patient, the contact point between proximal lip of the cannula (<NUM>), as shown in <FIG>, and some distal surface (<NUM>, <NUM>) of seal assembly (<NUM>) may effectively create a seal. <FIG> shows cannula (<NUM>) coupled with seal assembly (<NUM>) via compatible threading (<NUM>, <NUM>). Compatible threading (<NUM>, <NUM>) extends far enough along the interior of cannula (<NUM>) to provide sufficient force to create a seal between distal surface (<NUM>) of seal assembly (<NUM>) and proximal lip of the cannula (<NUM>). In order to further facilitate this seal, an elastomeric material may be used, such as an o-ring (not shown), in between proximal lip of cannula (<NUM>) and distal surface (<NUM>) of seal assembly (<NUM>).

In addition to or in lieu of the foregoing, the various components and features of trocar assembly (<NUM>) may be constructed and operable in accordance with at least some of the teachings of <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and/or <CIT>.

<FIG> show another exemplary cannula (<NUM>). Cannula (<NUM>) of this example is configured for use with a robotic surgical system such as the robotic surgical systems described in <CIT>; <CIT>; and <CIT>. By way of example only, cannula (<NUM>) may be constructed and operable in accordance with at least some of the teachings of <CIT>. Similar to cannula (<NUM>) described above, cannula (<NUM>) of this example has a proximal angled opening (<NUM>) leading to a hollow shaft (<NUM>), ridges (<NUM>), and an open tip (<NUM>) that is configured to enable surgical instruments to access the surgical site. Hollow shaft (<NUM>) defines a longitudinal axis. However, cannula (<NUM>) differs from cannula (<NUM>) described above as it does not have seal assembly housing (<NUM>) configured for supporting seal assembly (<NUM>). Instead of having seal assembly housing (<NUM>) at the proximal end of cannula (<NUM>), there are two raised, annular flanges (<NUM>, <NUM>) and a mounting section (<NUM>) that are configured to mate with cannula mounting bracket jaws (not shown). The annular flanges (<NUM>, <NUM>) define lips (<NUM>, <NUM>, <NUM>, <NUM>) that are substantially perpendicular to the longitudinal axis defined by hollow shaft (<NUM>). Cannula mounting bracket jaws (not shown) reach part way around annular flanges (<NUM>, <NUM>) and mounting section (<NUM>) in order to secure cannula (<NUM>) to a manipulator arm (not shown) of the robotic surgical system.

Since cannula (<NUM>) includes annular flanges (<NUM>, <NUM>) and a mounting section (<NUM>) instead of seal assembly housing (<NUM>) in order to provide robotic manipulation, seal assembly (<NUM>) might not be directly compatible with cannula (<NUM>). As shown in <FIG>, cannula (<NUM>) of the previous example has seal assembly housing (<NUM>) to support seal assembly (<NUM>); and compatible threading (<NUM>) and proximal lip (<NUM>) configured to mate with distal surface (<NUM>) of seal assembly (<NUM>). All of these features help provide a sealed connection between the seal assembly and the cannula in order to maintain pneumostasis. By contrast, <FIG> shows an exemplary seal assembly (<NUM>) positioned over cannula (<NUM>) of the present example. While cannula (<NUM>) has lip (<NUM>) capable of contact with at least one distal surface (<NUM>) of seal assembly (<NUM>), cannula (<NUM>) is lacking a compatible housing for providing support for seal assembly (<NUM>) and a means to provide enough force to create a sufficient sealed connection to maintain pneumostasis. Thus, some additional component is required in order to provide an appropriate coupling between seal assembly (<NUM>) and cannula (<NUM>). An example of such a component is described in greater detail below.

<FIG> show an adaptor (<NUM>) for connecting cannula (<NUM>) with a seal assembly (<NUM>) while maintaining pneumostasis in an insufflated body cavity of a patient. Adaptor (<NUM>) includes a seal assembly housing (<NUM>) defined by a housing floor (<NUM>), a housing ramp (<NUM>), and a housing wall (<NUM>). Adaptor (<NUM>) is composed of a rigid plastic, such as Radel, and has threading (<NUM>) that is compatible with threading (<NUM>) of seal assembly (<NUM>). Of course, many kinds of rigid plastic material maybe used and will be apparent to a person having ordinary skill in the art. Some examples of possible rigid plastic material include but are not limited to SustaPEEK MG, Susta PEI MG, and Polysulfone. This compatible threading (<NUM>, <NUM>) allows for proximal end (<NUM>) of adaptor (<NUM>) and distal surface (<NUM>) of seal assembly (<NUM>) to couple together, effectively creating a seal to maintain pneumostasis. However, adaptor (<NUM>) could be made entirely of an elastomeric material with dimensions configured to create interference between threading (<NUM>) of seal assembly (<NUM>) and housing wall (<NUM>) of adaptor (<NUM>), creating a seal to maintain pneumostasis. Therefore, threading (<NUM>) might not necessarily be required on adaptor (<NUM>). Elastomeric material may be used in addition to or in lieu of using rigid plastic. In some versions of adaptor (<NUM>), an elastomeric component, such as an o-ring (not shown), is positioned between proximal end (<NUM>) of adaptor (<NUM>) and distal surface (<NUM>) of the seal assembly (<NUM>) to provide or enhance a seal between proximal end (<NUM>) and distal surface (<NUM>), further maintaining pneumostasis.

Adaptor (<NUM>) further includes a channel (<NUM>) defined by a channel surface (<NUM>). Channel (<NUM>) allows for obturator (<NUM>) or a surgical instrument to pass from seal assembly (<NUM>) to cannula (<NUM>) via adaptor (<NUM>) to thereby access a surgical site. Channel (<NUM>) further provides a pathway for fluid communication between seal assembly (<NUM>) and cannula (<NUM>).

Adaptor (<NUM>) also has two annular walls, an exterior taper (<NUM>), and an interior taper (<NUM>), both tapers (<NUM>, <NUM>) being located below housing floor (<NUM>). Exterior taper (<NUM>) may have an inner diameter that is less than the outer diameter of flange (<NUM>). In some versions, the distal end of interior taper (<NUM>) may have an outer diameter that is less than the inner diameter of proximal angled opening (<NUM>); while the proximal end of interior taper (<NUM>) may have an outer diameter that is greater than the inner diameter of proximal angled opening (<NUM>). In other words, interior taper (<NUM>) may taper at an angle that is wider than the taper angle of proximal angled opening (<NUM>). This may provide for an enhanced interference fit. Together, exterior taper (<NUM>) and interior taper (<NUM>) terminate at a trocar roof (<NUM>). Interior taper (<NUM>) is sized with a circumference to fit inside proximal angled opening (<NUM>) of the cannula (<NUM>), and is tapered at an angle similar to that of interior wall defining proximal angled opening (<NUM>). Exterior taper (<NUM>) is sized with a circumference to complement the circumference of flange (<NUM>), and a depth not exceeding the depth of flange (<NUM>). Due to the circumferences of exterior taper (<NUM>) and interior taper (<NUM>), trocar roof (<NUM>) complements lip (<NUM>) of cannula (<NUM>).

<FIG> shows adaptor (<NUM>) connected to seal assembly (<NUM>). Threading (<NUM>) of adaptor (<NUM>) is connected to threading (<NUM>) of seal assembly (<NUM>). Through this engagement of threading (<NUM>, <NUM>), connections between distal surface (<NUM>) of seal assembly (<NUM>) and proximal end (<NUM>) of adaptor (<NUM>) are sufficient to provide a seal maintaining pneumostasis in an insufflated body cavity of a patient. Also, seal assembly housing (<NUM>) is supporting seal assembly (<NUM>), so that if adaptor (<NUM>) is stable, so is seal assembly (<NUM>).

<FIG> shows the complementary geometry of adaptor (<NUM>) interacting with cannula (<NUM>). A seal between adaptor (<NUM>) and flange (<NUM>) maintaining pneumostasis can be created using multiple materials. If adaptor (<NUM>) is made entirely out of elastomeric material, interior taper (<NUM>) could be dimensioned for interference with interior wall defining proximal angled opening (<NUM>), exterior taper (<NUM>) could be dimensioned for interference with flange (<NUM>), or both interior taper (<NUM>) and exterior taper (<NUM>) could be dimensioned for interference with interior wall defining proximal angled opening (<NUM>) and flange (<NUM>) respectively. All of these possibilities could create a seal, in effect maintaining pneumostasis in an insufflated body cavity of a patient.

Adaptor (<NUM>) could be partially made from a rigid body. If so, there could be elastomeric material overmolded around interior taper (<NUM>) where the overmold is dimensioned for interference with interior wall defining proximal angled opening (<NUM>). There could also be elastomeric material overmolded around exterior taper (<NUM>) where overmold is dimensioned for interference with flange (<NUM>). There could be elastomeric material overmolded around both interior taper (<NUM>) and exterior taper (<NUM>), where overmold is dimensioned for inference with interior wall defining proximal angled opening (<NUM>) and flange (<NUM>) respectively. Again, all of these possibilities could create a seal, in effect maintaining pneumostasis in an insufflated body cavity of a patient.

Adaptor (<NUM>) could be made entirely from a rigid body, and an elastomeric o-ring could be added in between any of the contact points of cannula (<NUM>) and adaptor (<NUM>). For instance, an elastomeric o-ring could be added in between interior taper (<NUM>) and interior wall defining proximal angled opening (<NUM>). Or, there could be an elastomeric o-ring in between exterior taper (<NUM>) and flange (<NUM>). Additionally, there could be an elastomeric o-ring in between trocar roof (<NUM>) and lip (<NUM>) of cannula (<NUM>). All of these possibilities or combinations thereof are capable of creating a seal between the adaptor (<NUM>) and the cannula (<NUM>). If cannula (<NUM>) has threading (not shown), adaptor (<NUM>) could be modified to have complementary threading (not shown) in order to create the necessary force to maintain pneumostasis. However, a person having ordinary skill in the art would recognize other methods of creating necessary force to maintain pneumostasis, such as but not limited to latches and snap-fitting features. <FIG> shows how adaptor (<NUM>) provides a path for insertion of obturator (<NUM>) through seal assembly (<NUM>), adaptor (<NUM>), and cannula (<NUM>), with the ability to maintain pneumostasis in an insufflated body cavity of a patient.

Versions described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times.

Claim 1:
An apparatus comprising:
(i) an adaptor (<NUM>) comprising:
a seal assembly housing (<NUM>), wherein said seal assembly housing (<NUM>) comprises a proximal end and a distal end;
a channel (<NUM>), wherein the channel (<NUM>) defines a longitudinal axis, wherein the channel (<NUM>) comprises a proximal end and a distal end, wherein the proximal end of the channel (<NUM>) is in fluid communication with the distal end of the seal assembly housing (<NUM>);
an interior tapered surface (<NUM>) encompassing at least the distal end of the channel (<NUM>), wherein the interior tapered surface (<NUM>) comprises a proximal end and a distal end, wherein the proximal end has a larger perimeter than the distal end;
an exterior tapered surface (<NUM>), wherein the exterior tapered surface (<NUM>) comprises a proximal end and a distal end; and
a trocar roof (<NUM>), wherein the trocar roof (<NUM>) is defined between the termination of proximal ends of the interior tapered surface (<NUM>) and the exterior tapered surface (<NUM>); and
(ii) a hollow cannula (<NUM>), wherein the cannula (<NUM>) comprises an annular flange (<NUM>), characterized in that:
(a) the annular flange (<NUM>) has a proximal angled opening (<NUM>) and the interior tapered surface (<NUM>) comprises elastomeric material, wherein the elastomeric material is configured to provide an interference fit with the proximal angled opening (<NUM>) of the cannula (<NUM>); and/or
(b) the annular flange (<NUM>) has a proximal angled opening (<NUM>) and the exterior tapered surface (<NUM>) comprises an elastomeric material, wherein the elastomeric material is configured to provide an interference fit with an outer perimeter of the annular flange (<NUM>) of the cannula (<NUM>); and/or
(c) an elastomeric material is overmolded around the exterior tapered surface, wherein the elastomeric material is configured for interference with the outer perimeter of the annular flange of the cannula.