SURGICAL DRAIN SYSTEM WITH INTERCHANGEABLE ATTACHMENTS

A surgical drain system for draining fluid from a patient is provided. The surgical drain system includes a tube for insertion into the patient through which the fluid drains. The tube extends into the patient and is connected to an adapter having first and second valves for controlling movement of the fluid through the adapter. An attachment includes an insert for opening the first and second valves when inserted into the adapter allowing the fluid to drain into the attachment when the insert is fully seated. A retraction mechanism may be incorporated preventing more than one use of the insert.

TECHNICAL FIELD

This document relates generally to surgical drains, and more specifically to a surgical drain system having interchangeable attachments.

BACKGROUND

Surgical drains have been in use for many years and are an industry standard. Most modern surgical drains are closed suction drains in which a flexible tube, usually silicone, is placed into the surgical space. Holes or slots in the tube allow fluid egress into the lumen of the tube. The tube extends external to the body via an opening in the skin. Externally, a variable length of tubing is connected to a reservoir. The reservoir collects the body fluid exiting the drain and may also be used to generate suction to aid in fluid evacuation.

While the above surgical drains and methods are simple and time tested, they have several limitations including, for example, difficulty concealing and fitting clothing around the external tube and reservoir, encumbered ambulation and thereby retarded and diminished patient mobility, a need to periodically empty the reservoir, a need to periodically reset the reservoir to keep suction on the system, discomfort for the patient due to traction on the external tubing and reservoir, patient compliance with using the drain appropriately and recording drainage output, pressure felt by physicians to remove drains prematurely because of patient complaints, risk of infection from manipulation of the drain during regular operation and the presence of a static external to internal conduit, the risk of body fluids escaping the reservoir if the reservoir plug comes loose, the exposure of the nurse or caretaker to the patient's body fluid when emptying the reservoir, ease of dislodgment of the drain due to a large external extension and difficulty replacing once removed, designs necessitating continuous evacuation, and single use functionality.

Accordingly, a drain system and related methods are needed which allow for improved patient comfort, compliance, and mobility. Such a drain system would permit multiple functionality including, for example, continuous versus intermittent evacuation, continuous egress of fluid without the need to periodically reset the system suction, and provision of varied treatment modalities including sampling and irrigation. The drain system could also avoid exposure of the caretaker to the patient's body fluids, and accommodate clothing over the drain.

SUMMARY OF THE INVENTION

In accordance with the purposes and benefits described herein, a surgical drain system for draining fluid from a patient is provided. The surgical drain system may be broadly described as comprising an adapter for insertion into the patient through which the fluid drains. The adapter includes first and second valves for controlling movement of the fluid through the adapter. An attachment includes a male insert for opening the first and second valves when inserted into the adapter and allowing the fluid to drain into the attachment when the male insert is fully seated.

In another possible embodiment, a portion of the male insert is bulbous and a portion of the adapter is a bulbous cavity positioned between the first and second valves for receiving the bulbous portion of the male insert.

In still another possible embodiment, the bulbous portion of the male insert and the bulbous cavity form an interference fit when the male insert is fully seated.

In yet another possible embodiment, the system further includes a tube extending from the adapter into the patient.

In still one other possible embodiment, the adapter includes a flange positioned externally of the patient.

In another possible embodiment, the first valve is positioned inside of the patient. In another, the second valve is positioned outside of the patient.

In still another possible embodiment, the system further includes an attachment tube extending between the male insert and the attachment.

In accordance with another aspect of the invention, a surgical drain system for draining fluid from a patient includes a tube for insertion into the patient through which the fluid drains, the tube extending from an adapter into the patient and having first and second valves for controlling movement of the fluid through the adapter, and an attachment including a male insert for opening the first and second valves when inserted into the adapter, wherein the male insert acts as a stent maintaining the first and second valves in an open position allowing the fluid to drain into the attachment.

In another possible embodiment, the male insert includes a stem maintaining the first valve in the open position and a neck maintaining the second valve in the open position.

In still another possible embodiment, the male insert includes a substantially bulbous portion, and the adapter includes a bulbous cavity positioned between the first and second valves for receiving the substantially bulbous portion.

In yet another possible embodiment, the system further includes an attachment tube extending between the male insert and the attachment.

In still yet another possible embodiment, the attachment further includes one of a cap for sealing the port, a syringe, a vacuum source, a bulb reservoir, a reservoir, a reservoir having osmotic matter positioned therein for absorbing fluid, a fitting connected to a fluid source for injecting the fluid of the fluid source into the patient, and a surgical access fitting.

In still another possible embodiment, the tube includes a plurality of holes in at least a proximal portion of the tube.

In yet another possible embodiment, the tube is substantially elliptical in shape. In another, the tube includes ribs along a lumen of the tube. In still another, the adapter and the tube are integrally formed.

In accordance with yet another aspect of the invention, a surgical drain system for draining fluid from a patient includes an adapter for insertion into the patient through which the fluid drains, the adapter having first and second valves for controlling movement of the fluid through the adapter, and an attachment including a male insert positioned within the adapter for opening the first and second valves and allowing the fluid to drain into the attachment, the male insert including a valve which precludes fluid flow when the male insert is withdrawn from the adapter.

In another possible embodiment, the adapter includes a tube having a proximal end within the patient and a distal end adjacent the adapter.

In still another possible embodiment, the tube includes a plurality of holes in at least a proximal portion of the tube.

In accordance with still yet another aspect of the invention, a surgical drain system for draining fluid from a patient includes a tube for insertion into the patient through which the fluid drains, the tube connected to an adapter having first and second valves for controlling movement of the fluid, an insert for opening the first and second valves when inserted into the adapter and allowing the fluid to drain when the insert is fully seated, and a retraction mechanism for preventing more than one use of the insert.

In another possible embodiment, the system further includes an attachment for collecting the fluid drained from the patient.

In still another possible embodiment, the retraction mechanism includes the insert, a connector, a spring, and a lock ring.

In yet another possible embodiment, the system further includes a housing supporting the retraction mechanism.

In still another possible embodiment, one or more of the components of the system may have antimicrobial properties. In another, the attachment includes a valve to prevent drained fluid from exiting the attachment. In yet another, intermittent suction may be applied to the system.

In the following description, there are shown and described several preferred embodiments of the surgical drain system for draining fluid from a patient. As it should be realized, the various systems are capable of other, different embodiments and their several details are capable of modification in various, obvious aspects all without departing from the systems as set forth and described in the following claims. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive.

Reference will now be made in detail to the present embodiments of the surgical drain system, examples of which are illustrated in the accompanying drawing figures, wherein like numerals are used to represent like elements.

DETAILED DESCRIPTION

Reference is now made toFIGS. 1 and 2which illustrate an embodiment of a surgical drain system. The surgical drain system includes an adapter20having a flange22, and drain tube24which passes through an incision in the patient's skin. Thus, drain tube24is primarily contained internally within the patient's body. An interior face of the flange22rests adjacent to the patient's skin surface when the drain tube24is inserted into the patient. Suture material may be passed through flange22to secure it in place. Alternatively, the flange22could contain a hole for suture material to pass through or an anchor post.

In the present described embodiment, the drain tube24is integrally formed with the adapter20so that they form one continuous, uniform unit. The drain tube24includes a distal end, adjacent the flange22, and a proximal end which extends into the body cavity to be drained. Along a portion of the proximal portion of the drain tube24, the tube includes a plurality or a multiplicity of holes or channels to allow body fluids to enter a central lumen26of the tube. Along a portion of the drain tube24near the proximal end, the tube does not include such holes or channels providing a fluid tight tube adjacent the flange.

As best shown inFIG. 2, a removable attachment28(shown attached inFIG. 1) may be detached from the adapter20. As best shown inFIG. 4, the attachment28includes attachment tubing30, in the described embodiment, and male insert32(shown in detail inFIG. 7) having a valve stem34. As shown, the attachment tubing30is connected to the male insert32to allow drainage of the fluid. In various embodiments, the attachment tubing30may lead to a reservoir or another component of the attachment as described below. Alternatively, the attachment may not include attachment tubing dependent upon what the other component may be. Several such components are described below which can be connected directly to the male insert.

In operation, a user inserts male insert32and valve stem34into adapter20. More specifically, the male insert32is inserted into an external valve38as shown inFIGS. 3 and 5causing the external valve38to be opened which provides access to a port of the adapter20. As shown inFIG. 6, the external valve38may optimally include a shallow central detent40to encourage alignment between the external valve and the valve stem34of the male insert32. When the drain tube24is inserted, the flange22remains external to the body and rests comfortably adjacent the skin surface as described above.

In the described embodiment best shown inFIG. 6, an internal valve42is positioned adjacent the distal portion of the drain tube24. More specifically, the mechanical components of the valve42are positioned within the drain tube24in the described embodiment. Of course, positioning of the internal valve can vary in different embodiments and depending on how the drain tube and adapter are connected. The external valve38is integrally molded with flange22in the described embodiment and is near flush with an outwardly facing surface of the flange. The external valve38includes two valve leaflets which are recessed slightly. Again, the valve may be non-integral and formed of other materials and varying types of valves utilized in alternate embodiments.

In the described embodiment, internal valve42is integrally model with drain tube24. External valve38and internal valve42work together, as shown inFIG. 5, to prevent any leakage from or contamination of the port of adapter20and the internal body cavity to which it is connected through drain tube24. To allow access to the port of adapter20and allow fluid flow, the valve stem34of the male insert32is first inserted through external valve38and then through internal valve42. Internal valve42is a duckbill configuration in the described embodiment and may be a separate component which is insert molded or may be integrally molded with drain tube24. Of course, other valves may be utilized which may or may not be integrally molded.

As best shown inFIG. 6, a portion44of the male insert32and a portion46of the adapter20form an interference fit. An interference fit, also known as a press fit or a friction fit, is a fastening between two parts which is achieved by friction after the parts are pushed together, rather than by any other means of fastening. More specifically as shown inFIG. 7, the portion44of the male insert32is a substantially bulbous radius that mates and forms the interference fit with the portion46of the adapter20which is a substantially bulbous cavity. When the male insert32is fully seated, the valve stem34will stent open internal valve42, the bulbous radius44will be stably positioned within the cavity46, and a body of the male insert positioned between the bulbous radius44and a stop ring48will stent open external valve38. SeeFIG. 8for a close-up of the male insert32.

In this fully seated position, the stop ring48forming a part of the male insert32abuts or rests flush with the flange22. Stop ring48prevents over insertion of male insert32and when the stop ring is flush with the flange22serves as a sign that male insert32is properly seated. In the described embodiment, stable fluid flow is established between the body cavity, through the drain tube26, adapter20, and to the attachment28. However, with a sufficient amount backward traction on attachment28or attachment tubing30or male insert32, the bulbous radius44will pop out of or otherwise be dislodged from bulbous cavity46and be withdrawn through external valve38, pulling valve stem34out of internal valve42and stopping fluid flow without dislodging adapter20from the patient's body.

As shown inFIG. 5, the external valve38and internal valve42of adapter20are open thus allowing a central channel for fluid flow. Stop ring48prevents over insertion and provides an additional seal to avoid fluid leak. In an alternate embodiment, a twist lock mechanism could be incorporated to provide a stronger connection between male insert32and adapter20.

As shown inFIG. 7, valve stem34of male insert32extends proximally and the bulbous radius44is in a mid-portion of the male insert. Stop ring48extends radially outward. Shown distally is a hose barb64to promote secure connection of attachment tube30in the described embodiment. A lumen66runs the length of male insert32.

As shown inFIG. 8, drain tube24is a closed system without any holes adjacent its distal end closest to flange22as described above. At its proximal end, drain tube24has a multiplicity of drain holes50. Of note, in the described embodiment, drain tube24is elliptically shaped to allow both improved healing of the wound after the drain tube is removed and to provide an enhanced seal through a linear incision. This design also adds rigidity to the system preventing inadvertent collapse of the drain tube24by surrounding tissue, and allows improved fluid flow through drain holes50by preventing surrounding tissue from obstructing the holes. In an alternate embodiment, additional rigidity may be added to drain tube24by incorporating drain tube ribs52that run longitudinally along a central lumen26.

In accordance with the method of use of the present invention as illustrated inFIG. 9, adapter20is positioned on the skin surface with drain tube24inserted through the skin. Drain tube24extends internally into the body cavity to be drained. Multiplicities of drain inlet holes52are located at the proximal end of drain tube24to allow fluid egress into the lumen. The user may cut off a portion of the proximal end of drain tube24as desired for the specific application. Alternatively, channels may be placed in the proximal end of drain tube24to encourage fluid egress out of the body cavity and into the lumen. External to the skin, the proximal aspect of attachment28is shown here configured as a bulb reservoir68connected to adapter20. In this embodiment, attachment tubing30extends from male insert32to an industry standard bulb reservoir68.

Placement of the drain tube24is perhaps best shown inFIGS. 10 and 11wherein the drainage system is shown as utilized in a patient. Drain tube24resides inside the body cavity or surgical space54. The adapter20is external and secured to the skin surface by adhesive, suture, or combinations thereof. A removable attachment28is connected to the adapter20for receiving the fluid drained from the patient. As shown, the attachment28includes a bulbous reservoir. This attachment may be left connected to the adapter20for as long as desired, or may be intermittently removed and/or replaced so long as sterility is maintained. With this attachment in place, the system functions identically to a current industry standard drain. In this embodiment, fluid egress is encouraged by vacuum pressure as the collapsed bulb expands. The standard bulbs contain a valve for removal of fluid and air from the bulb. The valve is then re-capped with the bulb collapsed generating suction.

Of course, the attachment28may take many forms as will be generally described below. Primarily the removable attachments are single use disposable devices each of which includes a male insert32to connect into the adapter20. Various attachments are provided that accommodate the multiplicity of function inherent in the system. Several exemplary attachments are provided in the subsequent description but additional extensions may be developed with time and need. Although not described in each exemplary attachment, a valve such as a check valve, may be utilized to prevent leakage of drained fluid collected within the attachments. Such a valve may be positioned distal to the valve stem34to prevent leakage after disconnection of the attachment28.

As shown inFIG. 12, the attachment28may include a male insert32attached to a chamber58. In the described embodiment, the chamber58includes an absorbent or superabsorbent material therein and the chamber itself is flexible. The chamber58may be of various shapes, and preferably is designed to conform to the natural curves of the body. Thus, flexible chamber58may be cylindrical, rectangular as shown, or curved depending on the planned anatomic area of use. Note that male insert32is positioned in a corner, generally offset a distance equal to the adapter20, so that it can move and seek a comfortable position when the patient moves. Flexible chamber58is sealed with the exception of the opening through male insert32. A one-way check valve59(e.g., a duck bill valve as is known in the art) could also be incorporated to prevent fluid egress out of the chamber after the super absorbent material has been saturated. In the present described embodiment, flexible chamber58is transparent or semi-transparent to allow the user to visually evaluate the superabsorbent material. Alternatively, a length of flexible tubing which may or may not contain an osmotically active material could extend between male insert32and flexible chamber58.

The presently described embodiment of the chamber58provides a colorimetric indication of when the super-absorbent material has been fully saturated. The capacity of each reservoir is indicated on its housing. Determination of the amount of fluid egress from the drain is important to determine the time for drain removal. An alternate embodiment may provide a dry weight for the reservoir. The user could calculate the amount of fluid which has been absorbed by weighing the reservoir upon removal.

The reservoir may be supplied in multiple different capacities and shapes, including an expandable housing. Thus, early in the postoperative phase, when drainage is copious, a large capacity reservoir would be utilized. Later, when drainage has tapered off and the patient is becoming more mobile, a smaller anatomically contoured reservoir may be utilized. Fluid egress from the surgical space is thus provided by osmotic action upon the fluid column extending outward to the absorbent material in the reservoir58.

Another attachment shown inFIG. 13, includes a male insert32, inserted into adapter20, with an integrally molded Luer or slip-on fitting on an opposing distal end to connect to a syringe60. Alternatively, an intervening length of an attachment tube30may extend between the male insert32and Leur or slip fitting to allow easier connection of syringe60. The user would attach the syringe60to the Leur or slip-on fitting and then insert the male insert32into the adapter20. The user could then draw out body fluids from the surgical space by means of vacuum pressure with the syringe60. Alternatively, the user could instill fluids or medications contained within the attached syringe60.

Another attachment might include only a removable and/or replaceable cap (not shown) to seal off the adapter20. The cap would further minimize the risk of fluid entering the surgical site in addition to the barrier already provided by the external and internal valves38,42. The cap may be made of rigid or flexible material. It attaches to the adapter20utilizing a fitting or by means of an adhesive, a slide fitting, a clip, a screw fitting, or a magnetic coupling. Preferably, the cap is a single use disposable component which is supplied sterilely. Alternatively, the cap may be fixed to the adapter20. In one embodiment, the cap is a single use disposable self-adherent membrane which completely covers the adapter20with or without a portion of the surrounding skin. The cap also serves to minimize the risk of fluid escape from adapter20. As a further alternative embodiment, the removable cap could be designed to allow perforation of it with a needle to permit fluid flow.

Another attachment includes a wall suction adapter which consists proximally of a male insert32connected to a hollow bore flexible tubing30and distally to a fitting compatible with standard hospital suction tubing. Commonly when drains are initially placed, fluid output is high, thus this system provides a convenient method to evacuate and quantitate the fluid. A further benefit is that continuously applied suction may help to collapse or close the body cavity in which the proximal end of the drain resides.

An alternate embodiment could also include a method to generate suction either by expansion of a partially collapsed reservoir or a spring loaded mechanism. The osmotic reservoir, for example, has the same male insert32directly attached or molded to it to connect with the adapter20. Alternately, there may be a tubing30running between the reservoir58and the male insert32. A fluid conductive medium could also be contained in the lumen of the drain tube24inside the patient's body to serve as a wick to enhance flow of fluid along an osmotic pathway. Alternatively, a superabsorbent material could be placed inside the drain tube24and changed periodically to soak up body fluids without requiring the external reservoir. Of note, in this latter embodiment, the superabsorbent material would have to be provided sterilely.

As noted above, the attachment may be utilized for irrigation. Such an attachment28would provide a route for installation of irrigation fluid and drugs. The irrigation attachment28includes the male insert32affixed to a hollow tubing30which distally includes an attachment point for a syringe, IV tubing, three way valve or other medical connector familiar to those skilled in the art. This provides access for irrigation of the body cavity into which the proximal aspect of the drain tube24resides to decrease bacterial contamination. Drugs such as antibiotics, chemotherapeutics or sclerosants could also be instilled via this conduit. Fluid egress could occur sequentially through the same flow pathway, or a second complete drain system setup could provide for fluid removal.

Another attachment28includes a surgical access fitting (not shown). This attachment would enter sterilely through the adapter20into the patient's body and would serve as a conduit through which treatment could be administered. Through this access point, the inner body cavity could be inspected under direct or video assisted visualization. A biopsy may be performed or fluid collected to assist with diagnosing possible medical conditions. Treatments may also be performed through this access point including directed application of suction and/or debridement. In one embodiment, a port that is similar to a laparoscopic port would connect to the adapter20and could be used as a conduit for the introduction of laparoscopic instruments. Subsequently the attachment could be removed leaving the adapter20intact. As with the other attachments, a male insert32provides the conduit through which the instruments pass.

In still another attachment28, the attachment includes an automated evacuation system. This attachment provides for automated evacuation of the drain powered by any of several means including but not limited to compressed gas, electrically driven pump, Archimedes screw or a vacuum reservoir. The automated evacuation system could include electrical timing control as well as an automated monitoring of fluid output or precisely regulating outward fluid flow by way of a second valve or a mechanical pump. On its distal end, this attachment could have a connection point for a reservoir.

In certain alternate embodiments of the invention, an insert70which actively prevents more than a single use may be utilized in place of insert32. Broadly speaking, the insert70works generally like a ball point pen retraction/extension mechanism except the mechanism is limited to a single cycle. As shown inFIG. 15, the insert70attaches to the drain tube24and may include a housing72wherein a retraction mechanism74generally resides. The housing72may be a connector bulb made of silicone rubber, rubber, or another elastomeric material and may further include a connector76for connecting various attachments, drain tubes, etc. thereto. In the described embodiment, the retraction mechanism74automatically prevents subsequent use of the insert70when triggered. In other words, the retraction mechanism74ensures that the insert70cannot be re-inserted into the drain tube24after it is removed.

FIGS. 16 and 17provide cross-sectional views of the retraction mechanism74positioned within the housing72. The housing72is shown in a retracted position inFIG. 16and an extended position inFIG. 17. As shown inFIG. 16, a proximal tip76of a valve stem78of the insert70extends from the housing72. In operation, the user aligns the valve stem tip76with the adapter20. Once aligned, the valve stem tip76may be inserted into the external valve38as previously described. Depressing the housing72as shown inFIG. 17, extends the valve stem78into the external valve38causing the external valve to be opened which provides access to the port of the adapter20in much the same manner the earlier described insert32behaved. The valve stem78includes an aperture79allowing fluid to outlet into the housing72and out the drain tube24. As shown inFIG. 17, the insert70even includes a bulbous radius80which forms a portion of an interference fit used for fastening the insert70and the adapter20together during use. The bulbous radius80mates with the cavity46and the interference fit performs as described above.

Upon either planned or inadvertent removal of the insert70from the port, the insert is retracted and the retraction mechanism74locks the insert in a retracted position preventing re-insertion. Although not shown, a check valve may also be included to prevent flow out of the insert70when retracted. The user could also retract the insert70for removal by pushing in slightly on the housing72and the retraction mechanism74and then releasing same thereby triggering retraction of the insert.

As shown in exploded view inFIG. 18, the retraction mechanism74positioned within connector housing72includes a connector82, a spring84, the valve stem78and a rotating lock ring86. In the described embodiment, the lock ring86includes at least one tooth or tab88protruding from an outer surface of the lock ring. The lock ring86is bifurcated and snaps together over the valve stem78. More specifically, flanges87of the valve stem78hold the rotating lock ring86in position during operation.

The connector82is shown in cross-sectional views inFIGS. 19 and 20. As shown inFIG. 19, the connector82includes an insertion track90for rotating the lock ring86, advancement spurs or teeth92, and internal ratchets94for holding the lock ring86in the extended position. As shown inFIG. 20, the connector82further includes a track96and a final track98to hold the lock ring86captive and to prevent re-extension of the valve stem78.

During insertion, the user applies pressure using a thumb, or otherwise, to an exterior of housing72. The pressure forces the insert70and the valve stem78to advance from the initial retracted position shown inFIG. 16to the extended position shown inFIG. 17. Extension of the valve stem78causes a rotation of the lock ring86within the connector82and the internal ratchets94hold the lock ring in the extended position throughout use. To remove the insert70and the valve stem78, the user applies additional pressure to the exterior of the housing72in order to advance the valve stem an additional partial step. Once advanced, the lock ring86is sufficiently further rotated to release from the internal ratchets94holding the lock ring in the extended position. A rearward traction is placed on the housing72causing the housing to move distally in relation to the insert70and the valve stem78. This forces the lock ring86to interact with gear teeth92causing a radial motion of the valve stem78into alignment with slots of the housing82and triggering a sliding motion of the valve stem distally into the housing. The pre-loaded spring84provides a sufficient amount of force to drive valve stem78back into the housing82. If the user attempts to re-insert the valve stem78, the lock ring86is further rotated into a fixed, locked position which prevents extension of the valve stem.

In summary, numerous benefits result from providing a surgical drain system that allows for improved patient comfort, compliance, and mobility. The surgical drain system permits multiple functionality including, for example, continuous versus intermittent evacuation, continuous egress of fluid without the need to periodically reset the system suction, and provision of varied treatment modalities including sampling and irrigation. The drain system also avoids exposure of the caretaker to the patient's body fluids, and accommodates clothing over the drain.

The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. As shown inFIG. 14, for example, an alternate adapter20may include a stabilizing insert62supporting internal valve42. The stabilizing insert62may be made of a rigid material including polymer, metal, or metal alloy to provide an antimicrobial effect, and other components may be selected that have antimicrobial properties. All such modifications and variations are within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.