Patent Description:
Surgical drains are used in a wide variety of different surgical procedures, for example, to drain fluid from a surgical area. Some examples where such drains are used may include plastic surgery, breast surgery (to prevent collection of blood, lymph fluid, or both), orthopedic procedures, chest drainage, infected cysts, pancreatic surgery (to drain secretions), biliary surgery, thyroid surgery, neurosurgery (to remediate risk of intracranial pressure), urinary catheters, nasogastric tubes, and other procedures.

One class of such surgical drains may be used on patients with cutaneous and oral abscesses, or collections of pus, hematomas, seromas or any other fluids requiring drainage. For example, abscesses can form anywhere in the body, from a superficial skin (subcutaneous) abscess to deep abscesses in muscle, organs, or body cavities. Treatment of such abscesses typically involves draining the accumulated fluid (such as pus) to resolve the infection or cause of the abscess and to facilitate recovery. One class of such surgical drains may require the patient or a care giver to adjust the drain to reopen clogged drainage paths to facilitate drainage.

The approach used to drain the accumulated fluid may depend on the size and location of the abscess. For subcutaneous abscesses, treatment typically includes creating an incision through the layers of the skin into the abscess cavity using a scalpel, expressing fluid (e.g., pus) from the abscess, and optionally using a hemostat to explore the wound and to break up pockets or localized areas of hardened pus. In some instances, packing material (such as a strip of gauze) may be inserted into the abscess cavity to prevent skin closure and re-accumulation of fluid in the abscess and to enable continued drainage. In other instances, a drainage catheter may be inserted through the incision and into the abscess to facilitate drainage and optionally irrigation of the abscess cavity.

The approach to draining abscesses in the oral cavity typically includes incision through the mucosa to the abscess cavity using a scalpel, expressing fluid (e.g., pus) from the abscess, and optionally using a hemostat to explore the wound and to break up pockets or localized areas of hardened pus. In most instances, a small drain is sutured into the cavity of the abscess cavity to mucosal closure and re-accumulation of fluid in the abscess and to enable continued drainage.

<CIT> relates to drainage catheter systems including a hub and discloses subject-matter according to the preamble of claim <NUM>.

The present invention is defined in the appended independent claim. The dependent claims relate to preferred embodiments. No surgical methods are claimed per-se.

In some embodiments, a drainage device may include a catheter including a proximal end and a distal end. The drainage device may further include a connector coupled to the proximal end of the catheter. The connector may include a body portion including a port sized to receive a tip of a syringe and including a lumen extending from the port to the proximal end of the catheter. The body portion may further include a hinged element configured to secure the distal end of the catheter against the body portion and to clamp the distal end of the catheter closed.

In some embodiments, a drainage device may include a catheter having a proximal end and a distal end and may include a connector coupled to the proximal end of the catheter and including a hinged fastener. The hinged fastener may be configured to close over a portion of the catheter near the distal end to form a loop and to clamp the distal end closed to prevent fluid flow through the distal end.

In some embodiments, a catheter device may include a catheter including a proximal end and a distal end. The catheter device may further include a connector coupled to the proximal end of the catheter. The connector may include a base having a recess configured to receive the distal end of the catheter and may include a hinged portion configured to couple to the base to clamp the catheter within the recess.

In other embodiments, a catheter device may include a catheter including a proximal end and a distal end and defining a lumen extending from the proximal end to the distal end. The catheter may include a plurality of openings extending from the lumen through a wall of the catheter. The catheter device may further include a connector coupled to the proximal end of the catheter. The connector may include a clamp configured to close over a portion of the catheter to compress the lumen to prevent fluid flow.

In still other embodiments, a catheter device may include a catheter including a proximal end and a distal end. The catheter may define a lumen extending from the proximal end to the distal end. The catheter device can further include a connector including a catheter-engagement element coupled to the proximal end. The connector may include a fluid port and may define a fluid passage extending from the fluid port to the lumen of the catheter through the catheter-engagement element. The connector may further include a base and a hinged element configured to couple to the base to clamp a portion of the catheter to compress the lumen to prevent fluid flow.

In the following discussion, the same reference numbers are used in the various embodiments to indicate the same or similar elements.

<FIG> depicts a diagram of a catheter device <NUM> including a connector <NUM>, in accordance with certain embodiments of the present disclosure. The catheter device <NUM> may include a needle <NUM>, a catheter <NUM> coupled to the needle <NUM>, and a connector <NUM> coupled to the catheter <NUM>. In the illustrated example, the catheter <NUM> may define a lumen extending from a proximal end coupled to the needle <NUM> to a distal end coupled to the connector <NUM>. The connector <NUM> may be releasably coupled to a syringe <NUM>.

The needle <NUM> may include a point or tip <NUM> configured to puncture a surface or a plurality of layers, such as layers of skin. The needle <NUM> may further include a body portion <NUM> extending between the point <NUM> and a cutting blade <NUM>. The body portion <NUM> may be curved according to a selected radius. The cutting blade <NUM> may be substantially triangle-shaped and may include a cutting edge along at least one side. In some embodiments, the point or tip <NUM> may puncture the surface and advance through underlying layers along a curved path defined by the curvature of the needle <NUM>. The cutting blade <NUM> may trail the point or tip <NUM> along the curved path and the cutting edges of the cutting blade <NUM> may operate to widen the opening created by the point or tip <NUM>. Further, trailing edges of the cutting blade <NUM> may be blunt or rounded such that reversing the direction of the force applied to the needle <NUM> may cause the blunt or rounded trailing edges to break up pockets or localized-areas of hardened pus.

The catheter <NUM> may include a long, flexible tube defining a lumen. The catheter <NUM> may be configured to allow fluid received from the connector <NUM> to flow through the lumen. Further, the catheter <NUM> may include a plurality of openings or holes, generally indicated at <NUM>, which may be arranged in a spiral or helical pattern along a length of a portion of the catheter <NUM>. The openings or holes <NUM> extend from the lumen within the catheter <NUM> through the exterior surface of the catheter <NUM> to allow fluid to flow from the lumen through the openings or holes <NUM>.

The connector <NUM> may include a catheter-engagement element <NUM> configured to fit within the lumen of the catheter <NUM> and to secure the catheter <NUM> to the connector <NUM>. The connector <NUM> may further include a base portion including clip <NUM> configured to engage and secure a hinged portion <NUM>. The base portion may further include a recess or groove <NUM> sized to receive a distal end of the catheter <NUM>. The recess or groove <NUM> may further include an opening or further recess <NUM> sized to receive a corresponding post <NUM> of the hinged portion <NUM>. The connector <NUM> may also include a port <NUM> including an opening sized to receive a tip <NUM> of the syringe <NUM>. The connector <NUM> may define a fluid passage extending from the fluid port <NUM> through the connector and to the lumen of the catheter <NUM> through the catheter-engagement element <NUM>.

The syringe <NUM> may further include a barrel portion <NUM> coupled to the tip <NUM> and defining an enclosure. The barrel portion <NUM> may further include a flange <NUM>. The syringe <NUM> may further include a plunger <NUM> sized to fit within the enclosure and configured to push fluid from the enclosure, through an opening in the tip <NUM>, through the connector <NUM> and into the lumen of the catheter <NUM>. Other embodiments are also possible.

In some embodiments, the needle <NUM> is inserted and pulled through one or more layers by a physician, drawing the catheter <NUM> through the layers. The physician may place a distal end of the catheter <NUM> into the recess <NUM> and may close the hinged portion <NUM>, clamping the hinged portion <NUM> against the base portion and securing the post <NUM> within the recess <NUM> to close and seal the lumen of the catheter <NUM> between the post <NUM> of the hinged portion <NUM> and the opening or further recess <NUM> of the recess <NUM>. By clamping down on the catheter <NUM>, the lumen of the catheter <NUM> is closed off to fluid flow through the connector <NUM>.

<FIG> depicts a portion <NUM> of the catheter device <NUM> of <FIG> including the connector <NUM> coupled to a syringe <NUM>, in accordance with certain embodiments of the present disclosure. The connector <NUM> may include a catheter-engagement element <NUM> including a lumen configured to engage the lumen of the catheter <NUM>. In this example, the catheter-engagement element <NUM> may include a polygonal shape including a neck portion <NUM> and a head portion <NUM>. The distal end of the catheter <NUM> may stretch over the head portion <NUM> and tighten about the neck portion <NUM>, securing the catheter <NUM> to the connector <NUM>.

The connector <NUM> may further include a base portion <NUM>, which defines a plurality of features configured to engage the hinged portion <NUM> and secure the catheter <NUM>. The base portion <NUM> may include a latch or clip feature <NUM> configured to engage a corresponding feature or recess <NUM> formed beneath a reinforcing rib <NUM> on the hinged portion <NUM>. The base portion <NUM> further includes the groove or recess <NUM> including an opening or notch <NUM> sized to receive the post <NUM> of the hinged portion <NUM>. In operation, a portion of the catheter <NUM> may be placed into the groove or recess <NUM> and the hinged portion <NUM> may be closed, latching the hinged portion to the base portion <NUM> via the latch or clip feature <NUM> and the recess <NUM>. Further, the post <NUM> may push into the notch <NUM> clamping the catheter <NUM> and compressing the lumen of the catheter <NUM> to close the catheter <NUM> to fluid flow.

<FIG> depicts a side view <NUM> of the connector <NUM>, in accordance with certain embodiments of the present disclosure. The connector <NUM> includes the port <NUM> to receive the tip of the syringe. Further, the connector <NUM> includes the base <NUM> coupled to a hinged portion <NUM> by a hinge <NUM>. The base <NUM> includes a clip <NUM> including an extension <NUM> configured to engage a recess <NUM> in a reinforcing rib <NUM>. Further, the hinged portion <NUM> includes a post <NUM> configured to fit within the opening or notch <NUM>.

As shown in the illustrated example, the hinged portion <NUM> opens and closes along a path indicated by the dashed arrow <NUM>. The extension <NUM> of the clip <NUM> may snap into the recess <NUM>. Further, the post <NUM> may extend into the recess <NUM> and into the opening or notch <NUM> to clamp the catheter <NUM> within the recess <NUM>. Other embodiments are also possible.

<FIG> depicts a top view <NUM> of the needle <NUM> of the catheter device <NUM> of <FIG>, in accordance with certain embodiments of the present disclosure. The needle <NUM> includes the tip <NUM>, the body portion <NUM>, and the cutting blade <NUM>. In this example, the cutting blade <NUM> may be substantially planar, while the tip <NUM> and the body portion <NUM> may define a curvature. The cutting blade <NUM> may extend outward from the body portion <NUM>, forming wings or edges <NUM> and <NUM>, which may be sharpened to facilitate widening of the opening formed by the tip <NUM> and the body <NUM> of the needle <NUM>. In this example, one side of each of the edges <NUM> and <NUM> is sharpened. Trailing edges <NUM> and <NUM> may be blunted or rounded. The practitioner may manipulate the needle <NUM> to use the trailing edges to break up pockets within an abscess, for example.

A catheter-coupling element <NUM> may extend from an end of the needle <NUM> adjacent to the trailing edges <NUM> and <NUM>. The element <NUM> may include an arrow-shaped or other-shaped feature <NUM> that can be pushed into the lumen of the catheter <NUM>, such that the catheter <NUM> expands around the arrowhead of the element <NUM> and narrows to secure the catheter <NUM> to the needle <NUM>.

<FIG> depicts a portion <NUM> of the catheter <NUM> including a helical arrangement of openings <NUM>, in accordance with certain embodiments of the present disclosure. As shown, openings <NUM> are provided in the catheter <NUM>, which openings <NUM> extend from the lumen through the wall of the catheter <NUM> to provide drainage holes through which saline, antibiotics, other fluids, or any combination thereof may be delivered. In an example, the openings <NUM> may be positioned within an abscess by a practitioner, and the practitioner may press the plunger of a syringe coupled to the connector <NUM> to deliver fluid to the abscess via the lumen of the catheter <NUM> and through the openings <NUM>.

In some embodiments, the arrangement of openings <NUM> may be helical, which allows for a substantially even distribution of fluid from the catheter <NUM>, even if the catheter <NUM> is twisted. Other embodiments are also possible.

<FIG> depicts a diagram <NUM> of an embodiment of the catheter device <NUM> of <FIG> configured to drain an abscess, in accordance with certain embodiments of the present disclosure. The catheter device <NUM> includes a base <NUM> including a clip <NUM> configured to couple to the hinged portion <NUM> to clamp the distal end of the catheter <NUM> after the catheter <NUM> has been drawn into position within the abscess <NUM> by the needle <NUM>. The catheter device <NUM> is coupled to a proximal end of the catheter <NUM> and is configured to provide a fluid conduit from a port <NUM> sized to receive the tip of a syringe to a lumen of the catheter <NUM>. The base <NUM> and the hinged portion <NUM> may cooperate to clamp the distal end of the catheter <NUM>.

In this example, the catheter <NUM> may extend through a first incision through the epidermis <NUM> and optionally through one or more layers of the dermis <NUM>, through an abscess <NUM>, and out from a second incision. The connector <NUM> includes the fluid port <NUM> to receive a sterile irrigation fluid, such as saline, medication, sterilized water, other fluids, or any combination thereof. The catheter <NUM> includes a lumen coupled to the irrigation port <NUM> and coupled to openings <NUM>, which are positioned within the abscess <NUM>, to deliver irrigation fluid into the abscess <NUM>.

In the illustrated embodiment of <FIG>, the catheter <NUM> and the connector <NUM> cooperate to facilitate the introduction of irrigation fluid via the irrigation port <NUM> and the openings <NUM>. The connector <NUM> secures both ends of the catheter <NUM> to provide a secure loop that prevents the catheter <NUM> from being pulled out of the abscess. Further, the connector <NUM> prevents fluid flow through the portion of the catheter <NUM> that is clamped within the connector <NUM>, making it possible to push irrigation fluid through a port in the connector <NUM> and through openings <NUM> into the abscess so that the fluid does not flow out the other end of the catheter <NUM>. Other embodiments are also possible.

<FIG> depicts a flow diagram of a method <NUM> of producing a catheter device, in accordance with certain embodiments of the present disclosure. At <NUM>, the method <NUM> can include forming a needle including a puncture tip at a first end, a cutting blade adjacent to a second end, and an attachment feature at the second end. Between the puncture tip and the cutting blade, the needle may include a curved body portion.

At <NUM>, the method <NUM> can include coupling a first end of the catheter to the attachment feature. In some embodiments, the attachment feature may include a narrow portion and bulbous or wider portion. The attachment feature may be pressed into the lumen of the catheter, and the catheter may stretch to accommodate the bulbous or wider portion and may retract about the narrow portion to couple the catheter to the needle.

At <NUM>, the method <NUM> can include coupling a second end of the catheter to a hub to form a catheter device, where the hub includes a clip feature and a port sized to receive a tip of a syringe to deliver fluid to the catheter. The catheter may fit over a catheter-engagement element, which may couple the catheter to the connector.

At <NUM>, the method <NUM> may include inserting the catheter device into a package. The package may be a cardboard packaging including openings and securing features configured to secure the catheter device within the packaging. Other embodiments are also possible.

In conjunction with the devices described above with respect to <FIG>, a catheter device is disclosed that includes a needle, a catheter including a distal end coupled to the needle and including a proximal end, and a connector coupled to the proximal end. The connector may include a port sized to receive a tip of a syringe and may include a catheter-coupling element configured to couple the port to the lumen of the catheter to allow fluid to flow from the port into the lumen. The connector may further r include a base including a clip and a hinged element including a recess configured to engage the clip to clamp the hinged element to the base. The base may further include a recess configured to receive a distal portion of the catheter, and the hinged element may clamp the distal portion of the catheter to the base. Further, the hinged portion may include a post configured to compress the catheter to block fluid flow.

It should be appreciated that the catheter device described above may be used in a variety of contexts including but not limited to plastic surgery, breast surgery (to prevent collection of blood. lymph fluid, or both), orthopedic procedures, chest drainage, infected cysts, pancreatic surgery (to drain secretions), biliary surgery, thyroid surgery, neurosurgery (to remediate risk of intracranial pressure), urinary catheters, nasogastric tubes, and other procedures. In some embodiments, such as oral surgery, the size of the catheter device may be implemented with a smaller size in order to reduce irritation. In other embodiments, the hub may be larger in order to facilitate access to fluid ports. Other embodiments are also possible.

Claim 1:
A device comprising:
a catheter (<NUM>) including a proximal end and a distal end and defining a lumen extending from the proximal end to the distal end, the catheter including a plurality of openings (<NUM>) extending from the lumen through a wall of the catheter; and
a connector (<NUM>) coupled to the proximal end of the catheter and including a clamp configured to close over a portion of the catheter to compress the lumen to prevent fluid flow
a needle (<NUM>) including a connection element configured to couple the needle to the distal end of the catheter, wherein the needle includes a tip (<NUM>), a cutting blade (<NUM>), and a body portion (<NUM>) extending between the tip and the cutting blade,
wherein
the body portion (<NUM>) is curved to form an arcuate shape, and
the cutting blade (<NUM>) is substantially planar and comprises first and second sharpened edges (<NUM>, <NUM>) that extend outward and away from the body portion (<NUM>),
characterised in that
the first sharpened edge is sharpened on a first side of the cutting blade but not a second side of the cutting blade and wherein the second sharpened edge is sharpened on the second side of the cutting blade but not the first side of the cutting blade.