Patent Description:
The present disclosure relates to a surgical access device. More particularly, the present disclosure relates to surgical access devices having adjustable cannula portions.

Endoscopic and laparoscopic minimally invasive procedures have been used for introducing medical devices inside a patient and for viewing portions of the patient's anatomy. To operate on a desired anatomical site, a surgeon may insert a rigid or flexible endoscope inside the patient to physically engage with the anatomical site.

Typically, a trocar assembly includes a cannula and an obturator. The cannula remains in place for use during the laparoscopic procedure, and the obturator includes a tip for penetrating body tissue. In endoscopic surgical procedures, surgery is performed in any hollow organ or tissue of the body through a small incision or through a narrow endoscopic tube (e.g., a cannula) inserted through a small entrance wound in the skin. In laparoscopic procedures, surgical operations in the abdomen are performed through small incisions (usually about <NUM> to about <NUM>). Laparoscopic and endoscopic procedures often require the surgeon to act on organs, tissues, and vessels at varying distances from the incision. Examples of prior art cannulas that are movable between different configurations are disclosed in <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

Accordingly, it may be helpful to provide an adjustable trocar assembly that is configured to provide flexibility of depth within a surgical site.

The present invention provides an adjustable trocar assembly as claimed in claim <NUM> appended hereto, the assembly including a housing configured to facilitate insertion of one or more surgical tools into a patient's body and an elongated tubular member extending distally from the housing and defining a longitudinal axis. The elongated tubular member includes a channel configured to facilitate passage of surgical instruments through the elongated tubular member, an adjustable portion configured to facilitate axial movement of the elongated tubular member, a collar of fixed diameter, and a rim of fixed diameter equal to the diameter of the collar.

The adjustable portion is defined by a plurality of adjacent circular ridges centered along the longitudinal axis of the elongated tubular member.

Each circular ridge of the plurality of circular ridges is operably coupled to one or more adjacent circular ridges of the plurality of circular ridges by a flexible material interconnecting adjacent circular ridges.

The collar may be positioned along the elongated tubular member where the channel transitions into the adjustable portion and the rim is disposed on the distal end of the adjustable portion.

A small portion of excess material defines a fold in each circular ridge of the plurality of circular ridges. The fold is configured to collapse inward and facilitate partial insertion of one circular ridge of the plurality of circular ridges into a proximally adjacent circular ridge of the plurality of circular ridges.

The proximal end of each circular ridge of the plurality of circular ridges may be configured to be inserted into the distal end of the proximally adjacent circular ridge of the plurality of circular ridges, and the distal end of each circular ridge of the plurality of circular ridges may be configured to receive the proximal end of the distally adjacent circular ridge of the plurality of circular ridges when in a retracted state.

The distal end of each circular ridge of the plurality of circular ridges may be configured to be separated from the proximal end of the distally adjacent circular ridge of the plurality of circular ridges by a length of a fold when in an extended state.

The collar and the rim may be made from a rigid material.

Each pair of adj acent circular ridges may interact independently from all other non-adjacent circular ridges, such that the adjustable portion can be partially extended or partially retracted.

Adjacent circular ridges of the plurality of circular ridges are interconnected by a layer of thin and flexible material.

Falling outside the scope of the present invention but disclosed herein is a method of using an adjustable trocar assembly. The method includes introducing one or more surgical tools into a channel defined by an elongated tubular member, wherein the elongated tubular member includes a plurality of adjacent circular ridges coupled to one another by a flexible material defining an adjustable portion, and wherein a collar of fixed diameter and a rim of fixed diameter cooperate to ensure that axial uniformity is maintained along the adjustable portion of the elongated tubular member. The method further includes moving the one or more surgical tools through the channel and the adjustable portion until the distal ends of the one or more surgical tools engage the rim of the adjustable portion.

The method may further include extending the adjustable portion toward a target site in a patient's body by exerting a force on the rim in the distal direction until the separation between the distal ends of at least one pair of adj acent of circular ridges, of the plurality of circular ridges, is increased. Additionally, the method includes retracting the adjustable portion away from the target site in the patient's body by exerting a force on the rim in the proximal direction, until at the proximal end of at least one circular ridge of the plurality of circular ridges is partially inserted into the distal end of an adjacent circular ridge of the plurality of circular ridges.

Various aspects of the present disclosure are illustrated herein with reference to the accompanying drawings, wherein:.

Aspects of the presently disclosed surgical access device with an adjustable cannula portion are described in detail with reference to the drawings, wherein like reference numerals designate corresponding elements in each of the several views.

As used herein, the term "distal" refers to that portion of the instrument, or component thereof which is farther from the user while the term "proximal" refers to that portion of the instrument or component thereof which is closer to the user.

Various aspects of a surgical access device are described herein. Generally, the surgical access device includes a trocar assembly which may be employed during surgery (e.g., laparoscopic surgery) and may, in various aspects, provide for the sealed access of laparoscopic surgical instruments into an insufflated body cavity, such as the abdominal cavity. As will be described in additional detail below, the step of the present disclosure includes a cannula and an obturator insertable therethrough. The cannula and obturator are separate components but are capable of being selectively connected together. For example, the obturator may be inserted into and through the cannula until the handle of the obturator engages, e.g., selectively locks into, a proximal housing of the cannula. In this initial position, the trocar assembly is employed to tunnel through an anatomical structure, e.g., the abdominal wall, either by making a new passage through the structure or by passing through an existing opening through the structure. Once the trocar assembly has tunneled through the anatomical structure, the obturator is removed, leaving the cannula in place in the structure, e.g., in the incision created by the trocar assembly. The proximal housing of the cannula may include seals or valves that prevent the escape of insufflation gases from the body cavity, while also allowing surgical instruments to be inserted into the body cavity. Further details of a surgical access device including a cannula and an obturator are described in <CIT>, and <CIT>.

With initial reference to <FIG>, an adjustable trocar assembly <NUM> is shown. The adjustable trocar assembly <NUM> includes a cannula <NUM>, and an obturator <NUM>. The obturator <NUM> is insertable through a channel <NUM> defined by an elongated tubular member <NUM> of cannula <NUM>, which defines a longitudinal axis X-X. Additionally, obturator <NUM> is selectively engageable with or attachable to cannula <NUM>. More particularly, a proximal portion <NUM> of obturator <NUM> is selectively engageable with or attachable to a proximal portion or housing <NUM> of cannula <NUM>. In use, when obturator <NUM> is engaged with cannula <NUM>, a distal end <NUM> of obturator <NUM> is advanced into tissue "T" to create or enlarge an incision or opening in tissue "T" (<FIG>). Alternatively, a distal end <NUM> of cannula <NUM> can be used to create or enlarge an opening in tissue "T," without the use of an obturator, for instance. In either situation, it may be important to limit or control the insertion depth of cannula <NUM> with respect to the tissue "T" to help provide optimal access to the target tissue, and to minimize accidental contact between portions of cannula <NUM> or obturator <NUM> with tissue located distally of the target tissue. The adjustable portion <NUM> of the present disclosure is positionable on cannula <NUM>, and is configured to provide a wider range of motion in which cannula <NUM> can be extended or retracted with respect to the tissue "T.

With particular reference to <FIG>, several views of the adjustable portion <NUM> are shown, which illustrate how the adjustable portion <NUM> has been configured to facilitate axial extension or axial retraction of the elongated tubular member <NUM>. More specifically, the adjustable portion is comprised of a plurality of adjacent concentric circular ridges <NUM> centered along the longitudinal axis X-X of the elongated tubular member <NUM>. Adj acent concentric circular ridges <NUM> of elongated tubular member <NUM> are interconnected by a thin layer of flexible material that defines an internal surface <NUM> and an external surface <NUM>.

Each of the plurality of circular ridges <NUM> includes a proximal end 410a and a distal end 410b such that the radius of the proximal end 410a is less than the radius of the radius of the distal end 410b, as can be seen in <FIG>. The difference in radius corresponds to a difference in circumference between the proximal end 410a and the distal end 410b, and creates a tapering effect along the external surface <NUM> between adjacent ridges <NUM>, as can be seen in <FIG>. Within channel <NUM> of the elongated tubular member, the tapering effect of each of the plurality of circular ridges <NUM> allows for the proximal end 410a to be partially inserted into the proximally adjacent circular ridge <NUM>, such that the minimum axial radius of the internal surface <NUM> never decreases below the radius of the proximal end 410a. As such, the tapering effect ensures that a minimum axial radius exists along the internal surface <NUM> of the adjustable portion <NUM> regardless of whether adjustable portion <NUM> is retracted, extended, or unaltered, as can be seen in <FIG>. The minimum axial radius along the internal surface <NUM> of the adjustable portion <NUM> ensures that there is axial uniformity throughout the entire length of the elongated tubular member <NUM> including adjustable portion <NUM>, i.e., adjustable portion <NUM> has a uniform inner and outer diameter. Correspondingly, this axial uniformity along internal surface <NUM> allows for any standard sized obturator <NUM> to be inserted through channel <NUM> regardless of whether the adjustable portion <NUM> is retracted, extended, or unaltered.

In addition to the proximal end 410a and the distal end 410b, each circular ridge of the plurality of circular ridges <NUM> includes a fold <NUM> made of a small portion of excess material from the thin and flexible material used to interconnect adjacent circular ridges <NUM>. In order to facilitate the partial insertion of one of the ridges <NUM> into the proximally adjacent ridge <NUM>, the internal surface <NUM> of the fold <NUM> is configured to fold/collapse in on itself between the adjacent circular ridges <NUM> when the adjustable portion <NUM> is compressed/retracted, as shown in <FIG> and <FIG>. Conversely, when adjustable portion <NUM> is fully extended, as shown in <FIG> and <FIG>, the fold <NUM> is configured to unfold and to extend distally outward to increase the separation between adjacent circular ridges <NUM>.

When adjustable portion <NUM> is compressed/fully retracted, as shown in <FIG> and <FIG>, the tapering effect allows for each proximal end 410a to pass through the distal end 410b and be partially inserted into the adjacent circular ridge <NUM>. Measurement of a distance D1 between the proximal ends 410a of adjacent circular ridges <NUM> when the adjustable portion <NUM> is compressed/retracted shows where the distance D1 is less than a similarly measured distance D2 between the proximal ends 410a of adjacent circular ridges <NUM> when the adjustable portion <NUM> is in an unaltered state, as seen in <FIG> and <FIG>. Further, both distances D1 and D2 are shown to be less than a distance D3 measured between the proximal ends 410a of adjacent circular ridges <NUM> when the adjustable portion <NUM> is fully extended, as shown in <FIG> and <FIG>.

Now referring to <FIG>, in use the adjustable trocar assembly <NUM> is inserted through a patient's abdominal wall to provide the obturator <NUM> with access to area being targeted for treatment. Depending on where the area being targeted is located within the patient's body, obturator <NUM> may need to be inserted farther into the body cavity. Correspondingly, the length of obturator <NUM> being used will also vary according to this need and the length of the channel <NUM> through which obturator <NUM> is inserted will also need to be variable. Traditionally, when a need arises to operate on a target area deeper than expected, the surgeon would need to remove the cannula in use and replace it with a longer cannula. This process of exchanging one cannula for another can be time consuming and introduces an additional risk of complication to the procedure. Adjustable portion <NUM> provides benefit of variable length without a need to exchange one cannula for another, and without adding any risk of complications to the procedure. Instead of removing one piece of equipment from the patient's body and inserting another, the adjustable portion <NUM> of the elongated tubular member <NUM> can simply be extended as needed. Additionally, the variable length of adjustable portion <NUM> can be easily adjusted to match the thickness of a patient's tissue layer(s).

<FIG> shows another aspect of the adjustable trocar assembly <NUM>, where the elongated tubular member <NUM> further includes a collar <NUM> positioned along the elongated tubular member <NUM> at the point where the channel <NUM> transitions into the adjustable portion <NUM> of elongated tubular member <NUM>, and a rim <NUM> positioned at the distal end of the elongated member <NUM>. Together the collar <NUM> and rim <NUM> cooperate to ensure that axial uniformity is maintained along the elongated tubular member <NUM>. Unlike the retractable and extendable circular ridges <NUM> positioned in between the collar <NUM> and the rim <NUM>, the collar <NUM> and rim <NUM> are rigid structures that cannot extend or retract. Instead, both the collar <NUM> and the rim <NUM> define rings of equal radii configured to ensure that a minimum axial radius throughout the length of adjustable portion <NUM>.

From the earlier discussion of the tapering effect between adjacent circular ridges <NUM>, as shown in <FIG>, it will be appreciated that each of the plurality of circular ridges <NUM> is configured to be partially inserted into the distal end 410b of the proximally adjacent circular ridge <NUM>, and that the distal end 410b of each of the plurality of circular ridges <NUM> is configured to receive the proximal end 410a of the distally adjacent circular ridge <NUM> when in the retracted state. The rigidity of collar <NUM> allows the collar <NUM> to act as a brace that can receive the proximal end 410a of the proximal-most circular ridge <NUM> of the adjustable portion <NUM>. Once inserted into the collar <NUM> the second most proximal circular ridge <NUM> can then receive the proximal end 410a of the third most proximal circular ridge <NUM> and so on until eventually all of the adjacent circular ridges <NUM> have been partially inserted and the adjustable portion <NUM> is in a fully retracted state.

Given the thinness and flexibility of the material used to interconnect the plurality of circular ridges <NUM>, the tapering effect between adjacent circular ridges <NUM> requires an initial rigid form to support the first partial insertion of one ridge <NUM> into another. The collar <NUM> provides that initial rigid support structure that is relied upon by all subsequent adjacent circular ridges <NUM>. As such, the collar <NUM> defines the minimum axial radius and by extension ensures axial uniformity along the elongated tubular member <NUM>. Similarly, the rim <NUM> disposed on the distal end of elongated member <NUM> acts as a brace for the final circular ridge <NUM> and provides a well-defined stopping point that can independently maintain its shape and rigid form. The rigidity of rim <NUM> ensures that the distal-most circular ridge <NUM> maintains its shape and as such also ensures axial uniformity along the elongated tubular member <NUM>. Additionally, the rim <NUM> acts as a guide for any surgical instruments inserted therethrough by ensuring that upon exiting the rim said surgical instruments are facing in the direction of the area being targeted for treatment.

In other aspects of the adjustable portion <NUM>, a semi-rigid material can also be used to interconnect the plurality of circular ridges <NUM>, such that each pair of adjacent circular ridges <NUM> can interact completely independently of all other non-adjacent circular ridges <NUM> comprising the adjustable portion <NUM>. This independence can facilitate partial extension and retraction of the adjustable portion <NUM>, regardless of the rigidity of the collar <NUM>.

Claim 1:
An adjustable trocar assembly (<NUM>) comprising:
a housing (<NUM>) configured to facilitate insertion of one or more surgical tools into a patient's body; and
an elongated tubular member (<NUM>) extending distally from the housing and defining a longitudinal axis, the elongated tubular member including:
a channel (<NUM>) configured to facilitate passage of surgical instruments through the elongated tubular member;
an adjustable portion (<NUM>) configured to facilitate axial extension or axial retraction of the elongated tubular member, wherein the adjustable portion is defined by a plurality of adjacent extendable and retractable circular ridges (<NUM>) centered along the longitudinal axis of the elongated tubular member, each of the circular ridges (<NUM>) including a proximal end (410a) and a distal end (410b), wherein the radius of the proximal end is less than the radius of the distal end to create a tapering effect along an external surface (<NUM>) between adjacent ridges to allow for the proximal end (410a) to be partially inserted into the proximally adjacent circular ridge (<NUM>) so that the minimum axial radius of the internal surface (<NUM>) of the tubular member never decreases below the radius of the proximal end (410a) of each circular ridge (<NUM>);
a collar (<NUM>) of fixed diameter; and
a rim (<NUM>) of fixed diameter equal to the diameter of the collar; characterized by each of the circular ridges (<NUM>) of the adjustable portion being operably coupled to one or more adjacent circular ridges of the plurality of circular ridges by a flexible material interconnecting adjacent circular ridges wherein each circular ridge includes a fold (<NUM>) made by an excess of a small portion of the flexible material, the fold configured to collapse inward between adjacent circular ridges to facilitate partial insertion of one circular ridge into an adjacent circular ridge during retraction of the adjustable portion (<NUM>).