Patent Description:
The use of thoracotomy tubes or chest tubes in clinical medicine dates back to the World War II era. Chest tubes are inserted into the chest cavity to evacuate blood, fluid, air, or infectious material. The chest tube ideally is located in the pleural space defined as the space between the outer lining of the lung (visceral pleura) and the inner lining of the chest wall (parietal pleura). This space is normally a potential space as the area is effectively under vacuum. Air and fluid can be introduced into this space by way of trauma, infection, cancer, and inflammatory conditions among others. Once a tube is appropriately inserted, the tube is attached to a vacuum source and the material is evacuated. This is clinically important to avoid further damage to the lung and allow the lung to re-inflate for proper functioning.

Classically the technique used to insert large bore chest tubes includes the following steps: first, sterile cleaning and draping to the surgical site; second, administering local anesthesia; third, creating an incision at a lateral or superior chest site; fourth, dissecting down through the subcutaneous fat and tissues to reach the rib at the target entry point; fifth, puncturing the intercostal fascia, muscle, and finally the parietal pleura with a large curved hemostat clamp having a blunt tip; sixth, forcibly spreading the clamp jaws to stretch the tissues and create a hole large enough for the tube to pass; seventh, inserting the operator's finger to ensure the opening is proper, the lung is not scarred to the chest wall, and there is adequate space for the tube; eighth, blindly inserting the tube, either with the large clamp initially guiding the tube through the opening, or just advancing the tube itself; and ninth, suturing the tube in place and hooking up to suction.

There are numerous problems with the standard technique and instruments used for insertion of a chest tube into the chest cavity. The intercostal space between the ribs varies greatly from patient to patient, but is often only a small or tight space. There are times that the operator's index finger will hardly fit through the intercostal space as described in the standard technique. Because of the limited space and possible thick adipose tissue under the skin, the guidance of the chest tube can be a challenge.

Generally, the most superior part of the pleural space, or apex, is the desired location for the tip of the tube if there is a pneumothorax. If blood or fluid is to be evacuated, then the base of the pleural space is the best target. Many studies have documented a high complication rate with chest tube placement. The complications vary from malposition of the tube in a fissure to perforation of the heart. The operator has very little control of the tube once it passes between the ribs of the patient. Attempts at turning the tube are often ineffective, and the operator, as a result of the standard procedure, is unaware in which direction the tube is directed. If a chest tube is found to be malfunctioning after insertion, or is malpositioned on a post-procedure chest x-ray, a new tube must be placed via a new insertion site. Current standard of care does not allow for repositioning of an existing chest tube secondary to high risk of infection.

<CIT> discloses a chest tube introducer which can be inserted without a need of surgical procedures. The chest tube introducer comprises a series of compartmentalized leakproof sealing devices, which is configured for safe introduction of the chest tube introducer minimizing a risk of pneumothorax.

<CIT> discloses a method and a device for accurately guiding a curved chest tube to an intended position within a pleural cavity of an animal or human being.

What is needed then are improvements in chest tube insertion devices.

Aspects of the present invention are recited by the appended independent claim with the dependent claims reciting optional features.

This Brief Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description.

One aspect of the disclosure is a chest tube insertion device having a sheath body with proximal and distal ends. The chest tube insertion device also includes proximal and distal openings positioned at the proximal end and the distal end, respectively. A lumen is defined axially through the sheath body from the distal end to the proximal end. A tapered pneumostatic tube clamp is disposed at the distal end of the sheath body, the tube clamp including one or more clamp tabs angled radially inward toward the distal end opening.

Another aspect of the disclosure includes a chest tube insertion device having a first groove on the sheath body extending from the distal end to the proximal end of the sheath body and a second groove on the sheath body extending from the distal end to the proximal end of the sheath body.

A further aspect of the disclosure includes a chest tube insertion device having a first handle and a second handle positioned on the proximal end of the sheath body, the first handle positioned between the first groove and the second groove on a first side of the sheath body and the second handle positioned opposite the first handle between the first groove and the second groove on a second side of the sheath body.

Another aspect of the present disclosure includes a chest tube insertion device disposed about a curvilinear axis.

A further aspect of the present disclosure includes a stylet insertable into a chest tube insertion device. The stylet may include an axial lumen via which a stylet or introducer unit may be inserted or advanced over a wire.

Numerous other objects, advantages and features of the present disclosure will be readily apparent to those of skill in the art upon a review of the following drawings and description of a preferred embodiment.

While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts that are embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention.

In the drawings, not all reference numbers are included in each drawing, for the sake of clarity. In addition, positional terms such as "upper," "lower," "side," "top," "bottom," etc. refer to the apparatus when in the orientation shown in the drawing. A person of skill in the art will recognize that the apparatus can assume different orientations when in use.

The present disclosure provides a chest insertion sheath apparatus for use in surgical procedures including but not limited to chest tube insertions. As shown in <FIG>, an embodiment of a chest tube insertion device <NUM> includes sheath body <NUM> having a distal end <NUM> and a proximal end <NUM>. The distal end <NUM> of the sheath body <NUM> is the end that is insertable into chest cavity of the patient. The proximal end <NUM> of the sheath body <NUM> is handled or manipulated by the user.

Referring again to <FIG>, the chest tube insertion device <NUM> further includes a lumen <NUM> or bore defined axially through the insertion device <NUM> from the distal end <NUM> to the proximal end <NUM>. The lumen <NUM> includes a distal end opening <NUM> at the distal end <NUM> of the insertion device <NUM> and a proximal end opening <NUM> at the proximal end <NUM> of the insertion device <NUM>. The lumen <NUM> is defined in the insertion device <NUM> such that the lumen <NUM> and the insertion device <NUM> are defined about a first axis <NUM>. When the chest tube insertion device <NUM> has been surgically installed into the patient's chest cavity, the user may insert a chest tube <NUM> through the lumen <NUM> such that the chest tube <NUM> is introduced into the patient's chest cavity.

With further reference to <FIG>, the insertion device <NUM> may further include a tube clamp <NUM> positioned at the distal end <NUM> of the sheath body <NUM>. The tube clamp <NUM> may be tapered. The tube clamp <NUM> is operable to provide resistance to axial movement of a chest tube <NUM> relative to the chest tube insertion device <NUM> when the chest tube <NUM> is inserted into the proximal opening <NUM>, through the lumen <NUM>, and out the distal opening <NUM>. The tube clamp <NUM> is positioned such that the tube clamp <NUM> contacts the chest tube <NUM> when disposed through the distal opening <NUM>. In one embodiment, the tube clamp <NUM> includes one or more clamp tabs <NUM> angled radially inward toward the distal opening <NUM>. Thus, when the chest tube <NUM> is installed in the insertion device <NUM> and in contact with the tube clamp <NUM>, a threshold force must be applied to the chest tube <NUM> in order for the chest tube <NUM> to move relative to the insertion device <NUM>. The radial orientation of the flexible tabs <NUM> allows for the engagement of multiple chest tube sizes and diameters. Additionally, the tube clamp <NUM> provides relative pneumostasis when suction is applied to the chest tube <NUM> while it remains engaged with the chest tube insertion device <NUM>. This allows for a chest x-ray to be obtained with the chest tube <NUM> on suction, thus giving a real time assesment of the tube's <NUM> position and function before the chest tube insertion device <NUM> is removed. If the tube's <NUM> position is not satisfactory, the suction can be stopped, then the tube <NUM> can be partially withdrawn until the distal tip of the tube <NUM> is within the chest tube insertion device <NUM>. Then, the chest tube insertion device <NUM> can be turned and repositioned followed by readvancement of the chest tube <NUM>. The chest tube insertion device <NUM> acts as a barrier between the tube <NUM> and skin of the patient during repositioning.

Again referring to <FIG>, the insertion device <NUM> may further include a first groove <NUM> and a second groove <NUM>. The first groove <NUM> may be on the insertion device <NUM> extending from the distal end <NUM> to the proximal end <NUM> of the insertion device <NUM>. The second groove <NUM> may likewise be on the insertion device <NUM> extending from the distal end <NUM> to the proximal end <NUM> of the insertion device <NUM>. The first groove <NUM> and the second groove <NUM> may be a fracture, or parting, line. The first groove <NUM> and the second groove <NUM> may be milled into the sheath body <NUM> or they may be designed into the product such as would be obvious to one of skill in the art, including molds having the grooves in injection molding and in the design for production in additive manufacturing settings. Regardless of the manufacturing, the first groove <NUM> and the second groove <NUM> may be positioned opposite each other relative to the lumen <NUM>. The first groove <NUM> and the second groove <NUM> provide a portion of the insertion device <NUM> which is positioned to allow tears to form between a sheath body first portion 12a and a sheath body second portion 12b, such that the tears extend from the proximal end <NUM> to the distal end <NUM>, when desired. In one embodiment, a user may remove the distal end <NUM> of the sheath body <NUM> from the patient's chest cavity while maintaining the chest tube <NUM> in the chest cavity. The sheath body <NUM> may be removed from the chest tube <NUM>, which is still disposed in the lumen <NUM> of the insertion device <NUM>, by tearing the insertion device <NUM> via the first groove <NUM> and the second groove <NUM>.

In some embodiments, the grooves <NUM>, <NUM> may include a V-shape. The V-shaped grooves <NUM>, <NUM> may be disposed at an angle of <NUM> degrees to <NUM> degrees. In some embodiments, the angle of the V-shaped grooves <NUM>, <NUM> may be at an angle of <NUM> degrees to <NUM> degrees. In other embodiments, the angle of the V-shaped grooved may be at an angle of <NUM> degrees. The angle of the V-shaped grooves <NUM>, <NUM> may be operable to promote separation of the first and second portions of the sheath body 12a, 12b, while maintaining the integrity of the sheath body <NUM> while the separation would be undesirable.

Referring further to <FIG>, the sheath body <NUM> may further include a first handle <NUM> and a second handle <NUM>. The first handle <NUM> and the second handle <NUM> may be positioned on the proximal end of the sheath body <NUM>. The first handle <NUM> and the second handle <NUM> may be positioned opposite each other relative to the lumen <NUM>. In some embodiments, the first handle <NUM> is positioned on the sheath body first portion 12a between the first groove <NUM> and the second groove <NUM>. The second handle <NUM> may be positioned on the sheath body second portion 12b between the first groove <NUM> and the second groove <NUM> opposite the first handle <NUM> relative to the lumen <NUM>. A user may use the first handle <NUM> and the second handle <NUM> to manipulate the sheath body <NUM> into the patient's chest cavity and when it is surgically installed in the chest cavity. Likewise, a user may use the first handle <NUM> and the second handle <NUM> to grasp and tear the sheath body <NUM> via the first groove <NUM> and the second groove <NUM>.

In some embodiments, the handles <NUM>, <NUM> may be positioned on a collar <NUM> of the sheath body <NUM>. The collar <NUM> may be a portion of the sheath body <NUM> at the proximal end <NUM>. When the sheath body <NUM> is injection molded, the collar <NUM> may be formed such that the sidewalls of the sheath body <NUM> are thicker at the proximal end <NUM>, the thicker portions of the sidewalls forming the collar <NUM>. In some embodiments, the first and second grooves <NUM>, <NUM> extend from the distal end <NUM> to the proximal end <NUM>, including the collar <NUM>. In order to allow the separation of the first portion 12a and the second portion 12b of the sheath body <NUM> via the first and second grooves <NUM>, <NUM>, some embodiments may include a first notch <NUM> and a second notch <NUM>. The first notch <NUM> is positioned on the first groove <NUM> at the proximal end <NUM> of the insertion device <NUM> and the second notch <NUM> is positioned on the second groove <NUM> at the proximal end <NUM> of the sheath body <NUM>. The notches <NUM>, <NUM> are configured to provide a starting point for tearing the sheath body <NUM> into two portions 12a, 12b.

In some embodiments, the notches <NUM>, <NUM> may include a V-shape. The V-shaped notches <NUM>, <NUM> may be disposed at an angle of <NUM> degrees to <NUM> degrees. In some embodiments, the angle of the V-shaped notches <NUM>, <NUM> may be at an angle of <NUM> degrees to <NUM> degrees. In other embodiments, the angle of the V-shaped notches <NUM>, <NUM> may be at an angle of <NUM> degrees. The angle of the V-shaped notches <NUM>, <NUM> may be operable to promote separation of the first and second portions of the sheath body 12a, 12b, while maintaining the integrity of the sheath body <NUM> while the separation would be undesirable.

<FIG> provides an alternate view of the embodiment demonstrated in <FIG>. As can be seen, the second groove <NUM> may be positioned similarly on the sheath body <NUM> as the first groove <NUM>, but in a position opposite the first groove <NUM> relative to the lumen <NUM>.

Now referring to <FIG>, the sheath body <NUM> and the lumen <NUM> are disposed about a first axis <NUM>. In some embodiments the first axis <NUM> is curvilinear. When the insertion device <NUM> is formed of a rigid or semi-rigid material, the curvilinear shape of the insertion device <NUM> allows a user to position the distal end <NUM> of the sheath body <NUM> inside the target cavity, such as a chest cavity, with increased accuracy and precision. A user may manipulate the insertion device <NUM> via the handles <NUM>, <NUM> on the proximal end <NUM> to insert and rotate the curvilinear and rigid insertion device <NUM> into the chest cavity of a patient in order to position the chest tube <NUM> in the desired position for optimum functioning. The insertion device <NUM> may have a curvilinear shape that allows for the turning of the chest tube <NUM> under the rib <NUM> then hugging the underside of the chest wall for desired positioning and avoidance of lung fissures or deflection off the lung.

Referring now to <FIG>, a stylet <NUM> is provided having a stylet body <NUM>, a distal end <NUM>, and a proximal end <NUM>. The stylet <NUM> may further comprise a grip <NUM> disposed on the proximal end <NUM> and a flange <NUM> positioned on the stylet <NUM> between the grip <NUM> and the stylet body <NUM>. The stylet <NUM> is insertable into the insertion device <NUM>. Specifically, the stylet <NUM> may be inserted into the lumen <NUM> of the sheath body <NUM>. The stylet <NUM> is operable to provide support to the insertion device <NUM> during the process of inserting the insertion device <NUM> into the chest cavity of a patient. In some instances, even when the insertion device <NUM> is formed of a rigid material, the insertion of the device <NUM> into the chest cavity may be met with resistance due to narrow intercostal space between the ribs or due to difficult tissue to navigate such as thick layers of adipose tissue. The stylet <NUM> is operable to reinforce the insertion device <NUM> during insertion into the desired space and during manipulation of the insertion device <NUM> into the desired position such that the distal end <NUM> of the insertion device <NUM> is positioned proximate the location for tube suction.

Referring further to <FIG>, the stylet body may be formed to include ridges extending radially outward from the center of the stylet body <NUM>. In other embodiments, the stylet <NUM> may be formed into a variety of shapes, which would allow the stylet <NUM> to support the sheath body <NUM> during insertion and manipulation. In the embodiment shown in <FIG>, the stylet <NUM> includes a diameter substantially equal to or slightly less than the diameter of the lumen <NUM>, thus allowing the stylet <NUM> to be positioned in the lumen <NUM> of the insertion device <NUM>.

Now referring to <FIG>, the stylet <NUM> may installed into the insertion device <NUM> by feeding the distal end <NUM> of the stylet <NUM> into the lumen <NUM> at the proximal opening <NUM> of the insertion device <NUM>. The stylet <NUM> may be translated along the axis <NUM> of the insertion device <NUM> until the flange <NUM> contacts the proximal end <NUM> of the insertion device <NUM>. In some embodiments, the insertion device <NUM> and the stylet <NUM> may be curvilinear. The stylet <NUM> may be arced such that the stylet <NUM> is curved, the arc being formed at a distance offset from a center point, the distance comprising a stylet radius <NUM>. Likewise, the insertion device <NUM> may be arced such that the insertion device <NUM> is curved, the arc being formed at a distance offset from a center point, the distance comprising a sheath radius <NUM>. In some embodiments, the stylet radius <NUM> and the sheath radius <NUM> are approximately the same.

Referring now to FIG's. <NUM>-<NUM>, the stylet <NUM> may also include a clamp support <NUM>. When the stylet <NUM> is fully installed in the insertion device <NUM>, the clamp support <NUM> contacts the tube clamp <NUM>. The flange <NUM> of the stylet <NUM> prevents the clamp support <NUM> from extending out through the distal opening <NUM> of the insertion device <NUM>. When the insertion device <NUM> is being inserted into the patient, the clamp support <NUM> prevents the tube clamp <NUM> from being deflected inward. This allows the distal end <NUM> to move through the patient's tissue without accumulating any of the tissue or fluids in the lumen <NUM> of the insertion device <NUM> and it minimizes the snagging and damage to the tissue that can be caused by using the insertion device <NUM> to probe and explore for the appropriate position for insertion and placement of the chest tube <NUM>. The clamp support <NUM> may be positioned on the distal end <NUM> of the stylet <NUM> such that the angle between the stylet body <NUM> and the clamp support <NUM> match the clamp tab angle <NUM> of the insertion device <NUM>.

With reference to FIG's 8a-8d, the insertion device <NUM> in some embodiments may include a tube clamp <NUM> positioned at the distal end <NUM> of the sheath body <NUM>. The tube clamp <NUM> is operable to provide resistance to axial translation of a chest tube <NUM> relative to the insertion device <NUM> when the chest tube <NUM> is positioned in the lumen <NUM> and extends through the distal opening <NUM>. The resistance provided by the tube clamp <NUM> may be overcome with a threshold force. This allows the chest tube <NUM> to be positioned in the insertion device <NUM> without the chest tube <NUM> freely extending or retracting through the insertion device <NUM>. The tube clamp <NUM> may include a second function. More specifically, the tube clamp <NUM> may provide relative pneumostasis when the tube <NUM> is on suction while the insertion device <NUM> is still engaged.

Still referring to FIG's 8a-8d, the tube clamp <NUM> may include one or more clamp tabs <NUM>. Each clamp tab <NUM> may extend from the sheath body and may be angled radially inward toward the distal end opening <NUM>. The clamp tabs <NUM> may be angled relative to the sheath body <NUM> at the distal end <NUM> toward the center of the distal end opening <NUM> such that the angle formed between the sheath body <NUM> and the clamp tabs <NUM> is greater than <NUM> degrees and less than <NUM> degrees. The angle formed is the tab angle <NUM>. In some embodiments, the tab angle <NUM> is greater than <NUM> degrees and less than <NUM> degrees. In other embodiments, the tab angle <NUM> is approximately <NUM> degrees. The tab angle <NUM> may be adjusted to a variety of angles in order to provide various utility features, including varying levels of resistance and clamping force on the chest tube <NUM>. However, the clamp tabs <NUM> may be positioned on the insertion device <NUM> such that when a chest tube <NUM> extends through the distal opening <NUM>, the clamp tabs <NUM> contact the chest tube <NUM> and the chest tube <NUM> remains uncollapsed. This may be further facilitated by the clamp tabs <NUM> being semi-flexible. The tube clamp <NUM> is positioned distally so pneumostatsis may be maintained even as the insertion device <NUM> is withdrawn and removed. In other embodiments, the tube clamp <NUM> may be positioned along the insertion device <NUM> at various points axially spaced from the distal tip of the insertion device <NUM>.

Referring specifically to FIG's. 8b and 8d, in some embodiment the clamp tabs <NUM> may be dimensioned such that the clamp tab wall thickness T1 is less than the sheath body wall thickness T2. For example, in some embodiments where the insertion device <NUM> is extruded or injection molded, the wall thickness of the insertion device <NUM> decreases at the clamp tabs <NUM> relative to the sheath body <NUM>. This may allow for greater flexion at the tube clamp <NUM>, thus allowing the tube clamp <NUM> to engage a chest tube <NUM> without collapsing the chest tube <NUM>.

Referring again to FIG's. 8a-8d, in some embodiments the clamp tabs <NUM> may be separated from each other by a clamp tab gap <NUM>. The clamp tab gaps <NUM> allow the clamp tabs <NUM> to be deflected radially outward from the resting position. The material rigidity of the clamp tabs <NUM> will determine the force with which the clamp tabs <NUM> retain the chest tube <NUM> in the insertion device <NUM>. Likewise, the clamp tabs <NUM> may include clamp tab hinges <NUM>. The clamp tab hinges <NUM> may be disposed proximate the sheath body <NUM>. When the insertion device <NUM> is a single, injection-molded device, the clamp tab hinges <NUM> may be a living hinge. Thus, the tube clamp <NUM> may accommodate chest tubes of various sizes and may provide various levels of resistance as a function of the clamp tabs <NUM>, the clamp tab gaps <NUM>, the clamp tab angle <NUM>, and the clamp tab hinges <NUM>, alone or in various combinations.

Furthermore, the clamp tab gaps <NUM> allow for the clamp tabs <NUM> to flex in order to provide a variable diameter of the distal end <NUM> of the insertion device <NUM>. Because the tabs <NUM> are angled relative to the body <NUM>, the distal opening <NUM> is defined by a first diameter D1 that is less than the diameter of the body D2, when the clamp tabs <NUM> are in a resting or neutral position. Because the clamp tabs <NUM> are capable of flexion and/or pivoting about the tab hinge <NUM>, the diameter D1 at the distal opening <NUM> is variable. Thus, the clamp tabs <NUM> in a neutral position will define a neutral position or first diameter D1 of the distal opening <NUM> and a variable diameter, which is different from the first diameter, during flexion. See <FIG> for example of flexion of clamp tabs <NUM>. The clamp tab gaps <NUM> likewise prevent the stretching, tearing, and deformation of the distal end <NUM> of the insertion device <NUM> when a chest tube <NUM> having an outer diameter greater than the first diameter (when the tabs <NUM> are in a neutral or resting position) of the distal opening <NUM> when the chest tube <NUM> is advanced through the distal opening <NUM> of the insertion device <NUM>.

Again referring to FIG's. 8a-8d, the tube clamp <NUM> may act as a pneumostatic valve, as previously discussed. In some embodiments, the tube clamp <NUM> may prevent fluid communication between two volumes including the pleural space <NUM>. Air leaks during insertion, positioning, and retraction of the insertion device <NUM> and chest tube <NUM> may result in negative or undesirable states and clinical outcomes. Thus, the tube clamp <NUM> may likewise be referred to as a pnuemostatic tube clamp <NUM> in some embodiments.

In some embodiments, the first and second grooves <NUM>, <NUM> extend through the clamp tabs <NUM>. This permits a user to remove the insertion device <NUM> from the chest tube <NUM> when the chest tube is appropriately positioned in the patient's chest cavity. With the grooves <NUM>, <NUM> extending the full length of the insertion device <NUM>, including the clamp tabs <NUM>, the user is able to conveniently remove the insertion device <NUM> without disturbing and displacing the chest tube <NUM>.

Now referring to FIG's. <NUM>-<NUM>, the chest cavity of a patient is provided. The chest cavity includes a rib <NUM>, an intercostal space <NUM>, a pleural cavity <NUM>, a lung <NUM>, and a normal lung fissure <NUM>. <FIG> demonstrates generally the relative positions of the recited anatomy. More specifically, <FIG> demonstrates a patient with a first normally inflated lung 206a and a second deflated or collapsed lung 206b. The collapsed lung 206b may be due to the introduction or formation of fluid <NUM> or air <NUM> into the pleural cavity <NUM>. The fluid <NUM> or air <NUM> or both may become trapped in the pleural cavity <NUM>, which is bounded medially by the visceral pleura <NUM> and laterally by the parietal pleura <NUM>. This clinically results in a pneumothorax if air <NUM> is trapped in the pleural cavity <NUM> or a pleural effusion if fluid <NUM> is trapped. On occasion, both fluid <NUM> and air <NUM> may be present. At least one method of removing the fluid <NUM> or air <NUM>, and thus treating, are disclosed herein.

Referring now to <FIG>, a user may begin the insertion of the chest tube <NUM> by creating an incision through the skin and intercostal space <NUM> between the ribs <NUM>. <FIG> demonstrates the insertion of the distal end <NUM> of the insertion device <NUM> through the intercostal space <NUM> and into the pleural cavity <NUM>. The insertion device is advanced through the intercostal space <NUM> until the distal end <NUM> of the insertion device <NUM> is correctly positioned in the pleural cavity <NUM>. In some embodiments, the insertion device <NUM> is advanced until the collar <NUM> is contacting the skin of the patient, such that the insertion device <NUM> is unable to advance further through the intercostal space <NUM>.

Now referring to FIG's. <NUM> and <NUM>, once the insertion device <NUM> is inserted between the intercostal space <NUM>, the proximal end <NUM> of the insertion device <NUM> may be positioned in the pleural space <NUM> by adjusting the insertion device <NUM> via the handles <NUM>, <NUM>. For example, in some embodiments the sheath body <NUM> may be rotated in order to orient the distal opening <NUM> of the insertion device <NUM> in the superior or inferior, anterior or posterior, medial or lateral directions, or a combination thereof. A user may manipulate or orient the insertion device <NUM> by rotating the insertion device <NUM> via the handles <NUM>, <NUM>. In those embodiments in which the insertion device <NUM> is oriented about a curvilinear axis, the proximal end <NUM> may be rotated allowing the distal end <NUM> to be repositioned or translated within the pleural space <NUM>. This allows the distal end <NUM> of the insertion device <NUM> to be repositioned without having to articulate or pivot the proximal end <NUM> of the insertion device <NUM> within the intercostal space <NUM>, thus preventing additional damage to the tissues located in or near the intercostal space <NUM> and the pleural space <NUM>.

Referring to <FIG>, once the distal end <NUM> of the insertion device <NUM> is properly positioned, the user may remove the stylet <NUM> from the lumen <NUM> of the insertion device <NUM>. The stylet <NUM> may be removed by grasping the grip <NUM> of the stylet <NUM> and translating the stylet <NUM> along the axis <NUM> relative to the insertion device <NUM>, thus the insertion device <NUM> remains in the desired position while the stylet <NUM> is removed. In those embodiments in which the stylet <NUM> and the insertion device <NUM> are disposed about a curvilinear axis <NUM>, the stylet <NUM> is operable to slide relative to the insertion device <NUM>, thus evacuating the lumen <NUM> of the insertion device <NUM>.

With reference to FIG's. <NUM>, 16a, and 16b, the insertion device <NUM> may be positioned between the ribs <NUM> with the distal opening <NUM> positioned in the pleural space <NUM> and the proximal opening <NUM> positioned exterior to the patient. A chest tube <NUM> may be inserted through the proximal opening <NUM> of the insertion device <NUM>, fed through the lumen <NUM>, and passed through the distal opening <NUM> into the pleural space <NUM>. In some embodiments, the tube clamp <NUM> may engage the chest tube <NUM> such that the chest tube <NUM> is retained in the distal opening <NUM> of the insertion device <NUM> until a threshold force is applied to overcome the resistance provided to the chest tube <NUM> by the tube clamp <NUM>. For example, the clamp tabs <NUM> may contact the chest tube <NUM> and prevent the chest tube <NUM> from translating axially within the distal opening <NUM> when the insertion sheath <NUM> is being repositioned within the pleural space <NUM>. In some embodiments, the insertion device <NUM> may be partially opaque to an X-ray such that the position of the insertion device <NUM> within the pleural space <NUM> may be visible when an X-ray is taken. This allows the user to appropriately position the chest tube <NUM> within the pleural cavity <NUM> before and after the chest tube <NUM> has been installed in the insertion device <NUM>.

Referring now to <FIG>, once the chest tube <NUM> has been placed at the desired position within the pleural space <NUM>, the insertion device <NUM> may be removed from the patient's chest cavity. This can be accomplished by retaining the chest tube <NUM> in its position while translating the insertion device <NUM> along the chest tube <NUM> until the distal end <NUM> has been removed from the pleural space <NUM>, the intercostal space <NUM>, and out of the patient's body. Accordingly, the chest tube <NUM> remains in the position into which it was inserted and the insertion device <NUM> is clear from the patient's body.

Referring to FIG's. <NUM>-<NUM>, once at least a portion of the sheath body <NUM> is clear from the intercostal space <NUM>, the insertion device <NUM> is still disposed about the chest tube <NUM> and may require removal. In some embodiments, the opposite end of the chest tube <NUM> may be free and the insertion device <NUM> may be slid off from the opposite end. However, in some embodiments, the chest tube <NUM> may not have a free end and cannot be removed in this manner. Thus, the present disclosure includes an embodiment in which the insertion device <NUM> may be separated. For example, the user may separate the insertion device <NUM> by grasping the handles <NUM>, <NUM> and pulling the handles <NUM>, <NUM> in opposite directions. For example, the handles <NUM>, <NUM> may be pulled apart in a direction perpendicular to the axis <NUM> at the proximal end <NUM>. A tear begins to form at the proximal end <NUM> of the insertion device <NUM> when the handles <NUM>, <NUM> are pulled apart. This may be facilitated by the notches <NUM>, <NUM> at the proximal end <NUM>, in some embodiments. The tear may expand as the first side and second side of the sheath body 12a, 12b are further separated. The tear may run along the first and second grooves <NUM>, <NUM>. Thus, the first and second grooves <NUM>, <NUM> provide and form a fracture line along the length of the insertion device <NUM>.

Now referring to <FIG>, the insertion device <NUM> may be fully removed from the chest tube <NUM>. Once the insertion device <NUM> is removed from the chest tube <NUM>, the user may secure the chest tube <NUM> to the patient using traditional procedures. In those embodiments in which the insertion device <NUM> is removed from the chest tube <NUM> by separating the insertion device <NUM> into two portions, the insertion device <NUM> may be disposable or a one-time-use device. The two halves may be appropriately disposed of in order to maintain a sanitary environment for patients.

In some embodiments, the insertion device <NUM> may be advanced into the intercostal space <NUM> along a guidewire <NUM>. <NUM> and <NUM> demonstrate an alternative embodiment in which the insertion device <NUM> may be advanced along a guidewire <NUM>. As seen in <FIG>, specifically, the stylet <NUM> may include an interior stylet lumen <NUM>, which runs from a proximal end <NUM> to a distal end <NUM> of the stylet <NUM> and has a proximal opening <NUM> and a distal opening <NUM>. The stylet lumen <NUM> may be disposed about the axis <NUM>.

<FIG> demonstrates one embodiment in which the stylet <NUM> is installed into the insertion device <NUM>, and the stylet lumen <NUM> and the stylet <NUM> are aligned around the same axis <NUM> about which the insertion device <NUM> and the lumen <NUM> are oriented. This embodiment, in which the stylet <NUM> includes a stylet lumen <NUM>, may be used with various surgical techniques, including the Sedlinger technique. For example, a surgeon may insert a trochar through the intercostal space <NUM> into the pleural cavity <NUM>. With a trochar inserted, the surgeon may insert the guidewire <NUM> through the trochar and such that the distal end <NUM> of the guidewire <NUM> is positioned in the pleural cavity <NUM>. The guidewire <NUM> may be positioned in the appropriate space with the aid of ultrasound technology.

Once the guidewire <NUM> is positioned where the surgeon desires, the trochar may be removed from the patient. The stylet <NUM> installed into the insertion device <NUM> may than be used in conjunction with the guidewire <NUM>. This may be accomplished by installing the free end of the guidewire <NUM> into the distal opening <NUM> of the stylet <NUM>. The stylet <NUM> and insertion device <NUM> may be advanced along the guidewire <NUM> until the insertion device <NUM> is appropriately positioned in the pleural cavity <NUM>. Once the positioning is correct, the guidewire <NUM> may be removed from the patient by translating the guidewire <NUM> through stylet lumen <NUM>. The surgeon may continue to position the insertion device <NUM> after the guidewire has been removed. Once the insertion device <NUM> is correctly positioned, the stylet <NUM> may be removed from the insertion device <NUM>. This is an alternative method for the insertion of insertion device <NUM> and may continue with the remainder of the method disclosed herein of insertion of the chest tube <NUM> and the removal of the insertion device <NUM>.

This technique of using a guidewire <NUM> during the installation of the insertion device <NUM> with the stylet <NUM> positioned therein may draw from the Seldinger Technique. In some embodiments, as seen in FIG's. <NUM> and <NUM>, the guidewire <NUM> may include a curved tip <NUM> at a distal end <NUM> of the guidewire <NUM>.

Claim 1:
A chest tube insertion sheath apparatus (<NUM>), comprising:
a sheath body (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>), wherein the sheath body (<NUM>) is rigid and disposed about a curvilinear axis (<NUM>); and
a lumen (<NUM>) defined axially through the sheath body (<NUM>) from the distal end (<NUM>) to the proximal end (<NUM>), the lumen (<NUM>) including a distal end opening (<NUM>) at the distal end (<NUM>) and a proximal end opening (<NUM>) at the proximal end (<NUM>);
characterised by
a tapered tube clamp (<NUM>) at the distal end (<NUM>) of the sheath body (<NUM>), the tube clamp (<NUM>) including one or more clamp tabs (<NUM>) angled radially inward toward the distal end opening (<NUM>).