The present invention relates to a device and system for removing fluid from a wound on a patient.
After a surgical procedure, body fluid may tend to collect near a wound created by the procedure. It is generally desirable to withdraw such body fluid from the wound site because doing so may accelerate wound healing and prevent a number of possible complications, such as hematomas, seromas and the like.
Evacuator systems for removing body fluid from a wound on a patient are known. Such systems typically include a drain, a conduit and a fluid container. The drain is usually inserted into the patient's wound before the site is surgically closed. Proper surgical closure of the wound site usually creates an essentially airtight seal for the drain within the wound site. The conduit is typically connected to the drain before the wound site is closed, and the conduit extends outside the patient's wound site. The other end of the conduit is normally attached to the fluid container. The fluid container is usually a plastic vessel having an internal reservoir, an entry port, to which the conduit is attached, and an exit port for expelling fluid collected in the internal reservoir.
In operation, vacuum is applied from the fluid container through the conduit to the drain. This draws body fluid, particularly blood, at or near the wound site through the drain, through the conduit and into the fluid container. Vacuum is often created from expansion (or decompression) of the fluid container after it has been compressed, or from an external vacuum source supplying the fluid container.
There are a number of problems with such evacuator systems, particularly related to clogging. One problem is that either the drain, the conduit, the entry port or exit port may clog. The drains in common use today, typically include a lumen (i.e., an internal passage in a drain or conduit), and know lumens have a diameter of approximately 3 millimeters or less. The size of the lumen for the conduit connected to the drain as well as the size of the passage in the entry port of the fluid container are essentially the same as that of the drain. Therefore, the conduit lumen and the entry port passage typically have diameters of approximately 3 millimeters or less. With such diameters, it is common for the drain, the conduit and/or the passage to clog with matter, such as clots, drawn from the wound site.
Another problem with such evacuator systems is that the diameter of the passage of the exit port is also typically 3 millimeters or less. Consequently, when it is desirable to expel the fluid from the fluid container, due to the narrow diameter of the exit port it may clog and create difficulties in draining and/or increase the time to drain the fluid container.
Yet another problem with such evacuator systems is their limited volumetric capacity. Typical evacuator systems today may be able to collect a body-fluid volume of less than 100 cubic centimeters. Consequently, the fluid containers of such evacuator systems must be more frequently drained than would be the case for larger-capacity fluid containers.
Still another problem with such evacuator systems is their use of valves, such as duck-bill-type valves, on the entry port passage through which fluid enters the internal reservoir of the fluid container. Such valves are structured to open and allow fluid to enter the reservoir of the fluid container, and to close and prevent fluid from being expelled back into the wound. Known designs, however, have such a small opening for allowing fluid to enter the reservoir that they tend to clog. Duck-bill valves typically have two members angled towards one another in a shape resembling a duck's bill and include an opening resembling a slit that faces inward towards the container reservoir. The bill essentially restricts fluid flow to one direction—into the fluid container's reservoir. When in use, such valves may become clogged, rendering the system ineffective until the clog is removed.
In accordance with an embodiment of the invention, a device is disclosed comprising a container having an internal reservoir and a passage in communication with the internal reservoir. The passage is preferably cylindrical and has a diameter greater than 3 millimeters. A conduit in communication with the wound is connected to the passage. (In this context, “connected” simply means that the conduit and passage are in fluid communication.) Vacuum is applied through the passage and the conduit to draw fluid from the wound and into the internal reservoir of the container.
In accordance with another embodiment of the invention, a device is disclosed comprising a container having an internal reservoir and three or more passages in the container, wherein each passage is in communication with the internal reservoir. Either of two of the passages may be connected to a conduit and used to transfer vacuum from the reservoir through a conduit to a wound. The remaining passage is used for expelling fluid collected in the reservoir. Preferably the two passages that may be connected to a conduit are of different sizes so that one size conduit (such as a conduit having a lumen diameter of about 3 mm) may be used with one of the passages, and another size conduit (such as a conduit having a lumen diameter of about 6 mm) may be used with the other of the passages.
In accordance with still another embodiment of the invention, a device is disclosed comprising (1) a container having an internal reservoir and a passage in communication with the internal reservoir, and (2) a valve that prevents fluid from flowing from the reservoir through the passage, wherein the valve has an opening designed so that clogging is alleviated, and preferably has an opening approximately equal to the size of the passage.
Features and benefits of the invention will be set forth in part in the description which follows, and will in part be obvious from the description, or may be learned by practice of the invention.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention.
Reference will now be made to the exemplary embodiments of the invention, which are illustrated in the accompanying drawings.
Referring to
Drain 16 receives body fluid from patient 14. Any structure suitable for this purpose may be employed. In one embodiment, drain 16 may comprise a drain with a lumen having a diameter above 3 millimeters, such as the drain available from J.S. Vascular of Scottsdale, Ariz. and disclosed in copending U.S. Patent Provisional Application No. 60/476,663 filed on Jun. 5, 2003 and entitled “Improved Surgical Drains,” the disclosure of which is incorporated herein by reference.
Conduit 18 conveys body fluid received from drain 16 to fluid container 12. Any structure suitable for this purpose may be employed. In one embodiment, conduit 18 may comprise any conduit with a lumen having a diameter above 3 millimeters.
In one embodiment, fluid container 12 may include a container cover 12A and a container body 12B, which when assembled together define an internal reservoir 12F. Container cover 12A and container body 12B may be assembled in any suitable manner prior to use, such as by heat sealing during manufacturing or by cover 12A being threadingly received on body 12B. Fluid container 12 includes one or more passages, such as passages 12G-121, which as further described with respect to
Vacuum is applied to draw body fluid from wound site 14A, via drain 16 and conduit 18 into internal reservoir 12F. Any structure or device suitable for this purpose may be employed. Moreover, the vacuum may be created from expansion (or decompression) of fluid container 12 after it has been compressed, and/or from an external vacuum source (not shown) that provides vacuum to fluid container 12.
Referring to
When in use, fluid container 12 may lie on its side or be configured to stand upright, as shown in
A variation of container cover 12A is shown in
Port 28 may serve as a fluid output from fluid container 12 and may have a diameter corresponding to its respective passage 121, e.g., greater than 3 millimeters, to improve the draining efficiency of fluid container 12. In one embodiment of fluid container 12, the respective diameters passages 12H, 12G and 121 are 3 millimeters, 6 millimeters and 15 millimeters.
Ports 20 and 26 may include respective retainers 22 and 24, such as chevrons, to retain respective conduits (not shown), by pressing a respective conduit over the port. However, any structure for placing a conduit in fluid communication with internal reservoir 12F may be utilized.
Port 28 may include a neck 29 to receive a band 30 for retaining stoppers 36, 34 and 32 for their respective ports 20, 26 and 28. Any material may be used for lanyard 40, so that it may be reused to attach fluid container 12 to an article, such as an article of clothing or bedding near patient 14. Container cover 12A may also include one or more valves to prevent backflow through any input passages, such as passages 12G and 12H, back to patient 14.
In operation, one of the fluid input ports 20 or 26 may be blocked with its respective stopper 36 or 34. The other input port 20 or 26 may be connected to a conduit 18 that may be attached to a drain 16 in wound site 14A. With the output port stopper 32 removed, fluid container 12 may be compressed to force fluid, e.g., air and/or body fluid, out of internal reservoir 12F through output port 28. The output port stopper 30 may then be reinserted. Fluid container 12 may then, due its resiliency, begin expanding to an uncompressed state, thus creating suction or vacuum via conduit 18 and drain 16 to remove body fluid from wound site 14A.
Referring to
Regarding
In
A variation of container cover 12A is shown in
Port 42 may serve as an output port so that fluid from fluid container 12 may be expelled there through. Port 42 has a diameter corresponding to its respective passage 121, e.g., greater than 3 millimeters, to improve the draining efficiency of fluid container 12.
In one embodiment of fluid container 12, the respective lumen diameters for passages 121, 12H and 12G are 15 millimeters, 3 millimeters and 6 millimeters.
Ports 44 and 46 may include respective retainers 48 and 50, such as chevrons, to selectively retain conduits (not shown). Port 44 may retain bands 54, 60 and 66 for retaining stoppers 52, 58 and 64 for their respective ports 42, 44 and 46. Grippers 56, 62 and 68 may be provided to help handling respective stoppers 52, 58 and 64. A lanyard may be similarly employed, as previously described, to attach fluid container 12 to an article, such as an article of clothing or bedding near patient 14.
While container cover 12A shown in
The bottom view of fluid container 12A′ in
When appropriate vacuum is provided within reservoir 12F and passages 12G and 121 are sealed with their respective stoppers 58 and 52. The differential pressure across flapper 86 will be transferred into conduit 18 and drain 16 and will cause fluid flow into reservoir 12F. When vacuum is reduced enough, the biasing of flapper 86 may seal inlet passage 12H. Moreover, if positive pressure is applied to internal reservoir 12F the pressure pushes flapper 86 shut and helps to prevent fluid from moving from reservoir 12F through passage 12H.
For inlet passage 12G, a second section of material or flapper 88 may be provided to restrict flow through inlet passage 12G when flapper 88 seals inlet passage 12G. Flapper 88 preferably operates similarly to flapper 86. Flapper 88 may be biased to seal inlet passage 12G. Any suitable material and biasing may be employed. Moreover, the diameter of flapper 88 may be greater than or equal to the diameter of its corresponding inlet passage 12G, so that a proper seal may be effected.
A section of material 90 may interconnect flappers 86 and 88. A post 92 may be inserted through an aperture in interconnecting material section 90 to prevent flappers 86 and 88 from rotating off-axis with respect to their respective passages 12H and 12G. For example, post 92 may have an angled cross section, e.g., square, which may prevent interconnecting material section 90 and flappers 86 and 88 from rotating off-axis. Other designs may be utilized to prevent interconnecting material section 90 and flappers 86 and 88 from rotating off-axis.
In operation, one of the fluid input ports 44 or 46 is blocked with its respective stopper 58 or 64. The other input port 44 or 46 is connected to a conduit 18 that may be attached to a drain 16 in wound site 14A. With the output port stopper 52 removed, fluid container 12 may be compressed to force air and/or body fluid, out of internal reservoir 12F through output port 42. The output port stopper 52 may then be reinserted into port 42. Fluid container 12 may then, due its resiliency, begin expanding to an uncompressed state, thus creating suction or vacuum through unblocked fluid port 44 or 46 and through conduit 18 and drain 16 in fluid communication with port 44 or 46 in order to remove body fluid from wound site 14A and transfer it to internal reservoir 12F.
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application is a continuation of and claims priority to U.S. patent application Ser. No. 10/863,009, filed Jun. 7, 2004, which claims the benefit of U.S. Provisional Application Ser. No. 60/476,663, filed Jun. 5, 2003 and U.S. Provisional Application Ser. No. 60/539,158, filed Jan. 26, 2004, and is a continuation of U.S. patent application Ser. No. 10/559,400, filed May 25, 2006, which is the National Stage of International Application No. PCT/US04/18134, filed on Jun. 7, 2004, which claims the benefit of U.S. Provisional Application Ser. No. 60/476,663, filed Jun. 5, 2003 and U.S. Provisional Application Ser. No. 60/539,158, filed Jan. 26, 2004, the disclosures of which are hereby incorporated by reference in the entirety for all purposes.
Number | Date | Country | |
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60476663 | Jun 2003 | US | |
60539158 | Jan 2004 | US | |
60476663 | Jun 2003 | US | |
60539158 | Jan 2004 | US |
Number | Date | Country | |
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Parent | 10863009 | Jun 2004 | US |
Child | 11600597 | Nov 2006 | US |
Parent | 10559400 | May 2006 | US |
Child | 11600597 | Nov 2006 | US |