This document relates generally to surgical drains, and more specifically to a surgical drain system having interchangeable attachments.
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.
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.
The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the surgical drain system for draining fluid from a patient and together with the description serve to explain certain principles thereof. In the drawing figures:
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.
Reference is now made to
In the present described embodiment, the drain tube 24 is integrally formed with the adapter 20 so that they form one continuous, uniform unit. The drain tube 24 includes a distal end, adjacent the flange 22, and a proximal end which extends into the body cavity to be drained. Along a portion of the proximal portion of the drain tube 24, the tube includes a plurality or a multiplicity of holes or channels to allow body fluids to enter a central lumen 26 of the tube. Along a portion of the drain tube 24 near the proximal end, the tube does not include such holes or channels providing a fluid tight tube adjacent the flange.
As best shown in
In operation, a user inserts male insert 32 and valve stem 34 into adapter 20. More specifically, the male insert 32 is inserted into an external valve 38 as shown in
In the described embodiment best shown in
In the described embodiment, internal valve 42 is integrally model with drain tube 24. External valve 38 and internal valve 42 work together, as shown in
As best shown in
In this fully seated position, the stop ring 48 forming a part of the male insert 32 abuts or rests flush with the flange 22. Stop ring 48 prevents over insertion of male insert 32 and when the stop ring is flush with the flange 22 serves as a sign that male insert 32 is properly seated. In the described embodiment, stable fluid flow is established between the body cavity, through the drain tube 26, adapter 20, and to the attachment 28. However, with a sufficient amount backward traction on attachment 28 or attachment tubing 30 or male insert 32, the bulbous radius 44 will pop out of or otherwise be dislodged from bulbous cavity 46 and be withdrawn through external valve 38, pulling valve stem 34 out of internal valve 42 and stopping fluid flow without dislodging adapter 20 from the patient's body.
As shown in
As shown in
As shown in
In accordance with the method of use of the present invention as illustrated in
Placement of the drain tube 24 is perhaps best shown in
Of course, the attachment 28 may take many forms as will be generally described below. Primarily the removable attachments are single use disposable devices each of which includes a male insert 32 to connect into the adapter 20. 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 stem 34 to prevent leakage after disconnection of the attachment 28.
As shown in
The presently described embodiment of the chamber 58 provides 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 reservoir 58.
Another attachment shown in
Another attachment might include only a removable and/or replaceable cap (not shown) to seal off the adapter 20. 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 valves 38, 42. The cap may be made of rigid or flexible material. It attaches to the adapter 20 utilizing 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 adapter 20. In one embodiment, the cap is a single use disposable self-adherent membrane which completely covers the adapter 20 with or without a portion of the surrounding skin. The cap also serves to minimize the risk of fluid escape from adapter 20. 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 insert 32 connected to a hollow bore flexible tubing 30 and 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 insert 32 directly attached or molded to it to connect with the adapter 20. Alternately, there may be a tubing 30 running between the reservoir 58 and the male insert 32. A fluid conductive medium could also be contained in the lumen of the drain tube 24 inside 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 tube 24 and 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 attachment 28 would provide a route for installation of irrigation fluid and drugs. The irrigation attachment 28 includes the male insert 32 affixed to a hollow tubing 30 which 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 tube 24 resides 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 attachment 28 includes a surgical access fitting (not shown). This attachment would enter sterilely through the adapter 20 into 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 adapter 20 and could be used as a conduit for the introduction of laparoscopic instruments. Subsequently the attachment could be removed leaving the adapter 20 intact. As with the other attachments, a male insert 32 provides the conduit through which the instruments pass.
In still another attachment 28, 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 insert 70 which actively prevents more than a single use may be utilized in place of insert 32. Broadly speaking, the insert 70 works generally like a ball point pen retraction/extension mechanism except the mechanism is limited to a single cycle. As shown in
Upon either planned or inadvertent removal of the insert 70 from the port, the insert is retracted and the retraction mechanism 74 locks 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 insert 70 when retracted. The user could also retract the insert 70 for removal by pushing in slightly on the housing 72 and the retraction mechanism 74 and then releasing same thereby triggering retraction of the insert.
As shown in exploded view in
The connector 82 is shown in cross-sectional views in
During insertion, the user applies pressure using a thumb, or otherwise, to an exterior of housing 72. The pressure forces the insert 70 and the valve stem 78 to advance from the initial retracted position shown in
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 in
This application is a National Stage of International Application No. PCT/US2016/018046, filed Feb. 16, 2016, which claims the benefit of U.S. Provisional Application No. 62/116,611, filed Feb. 16, 2015, the disclosures of which are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US16/18046 | 2/16/2016 | WO | 00 |
Number | Date | Country | |
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62116611 | Feb 2015 | US |