EP1715901A2 - Systeme d'evacuation de fluide - Google Patents

Systeme d'evacuation de fluide

Info

Publication number
EP1715901A2
EP1715901A2 EP05712537A EP05712537A EP1715901A2 EP 1715901 A2 EP1715901 A2 EP 1715901A2 EP 05712537 A EP05712537 A EP 05712537A EP 05712537 A EP05712537 A EP 05712537A EP 1715901 A2 EP1715901 A2 EP 1715901A2
Authority
EP
European Patent Office
Prior art keywords
container
fluid
conduit
passage
valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP05712537A
Other languages
German (de)
English (en)
Inventor
John C. Opie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of EP1715901A2 publication Critical patent/EP1715901A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains

Definitions

  • the present invention relates to a device and system for removing fluid from a wound on a patient.
  • 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.
  • evacuator systems 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 channel in either the drain, conduit or both), and known lumens have a diameter of approximately 3 millimeters or less.
  • the size of the lumen for the conduit connected to the drain and the size of the passage (or opening) in the entry port of the fluid container are essentially the same size as the drain lumen.
  • 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 (or opening) of the exit port is also typically 3 millimeters or less.
  • 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 valve 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.
  • a device 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.
  • a device 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.
  • the two passages that may be connected to a conduit to transfer vacuum to a wound are of different sizes so that one size conduit (such as a conduit having a lumen diameter of about 3mm) may be used with one of the passages, and another size conduit (such as a conduit having a lumen diameter of about 6mm) may be used with the other of the passages. In this manner the container can be used with different sized conduits.
  • a device 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.
  • Figure 1 is a block diagram of an evacuator system in accordance with the present invention.
  • Figure 2 is a perspective diagram of a container that may be used as part of the evacuator system of Fig. 1 with the cover removed.
  • Figure 3 is a perspective diagram of the cover for the container of Fig. 2.
  • Figures 4A-4D are plan views of different covers that may be used with the container of Fig. 2.
  • Figure 5A is a top, perspective view of a cover that may be used with the container of Fig. 2.
  • FIG. 5B is a bottom, perspective view of a cover that may be used with the container of Fig. 2.
  • System 10 includes a fluid container 12, and may further include a drain 16 and a conduit 18. Drain 16 is shown in dashed lines to signify that it may be covered by surgical closure of wound site 14A, preferably, but not necessarily, creating an airtight seal for drain 16 within wound site 14A.
  • Conduit 18 may be connected to drain 16 before wound site 14A is closed, so conduit 18 may extend outside wound site 14A and be connected to fluid container 12. Drain 16 receives body fluid from patient 14. Any structure suitable for this purpose may be employed, and surgical drains are well known to persons skilled in this art. In one embodiment, drain 16 may comprise a drain with a lumen having a diameter above 3 millimeters, such as the drains disclosed in copending U.S. Patent Application Serial No. 10/863,009 filed on June 7, 2004 and entitled "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.
  • conduit 18 may comprise any conduit with a lumen having a diameter above 3 millimeters.
  • 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-12I, which as further described with respect to Figures 3-5, permit passage of fluid, such as body fluid from wound 14A into reservoir 12F or out of reservoir 12F.
  • Fluid container 12 may also include markings 12D to indicate the quantity of fluid that may be collected in fluid container 12.
  • fluid container 12 may include markings 12D in 50 cubic-centimeter increments up to 300 cubic centimeters. 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.
  • fluid container 12 may comprise a single, integral component or multiple assembled components. Fluid container 12 may be manufactured using any compressible and resilient material.
  • fluid container 12 may be compressed and then allowed to expand to create vacuum suitable to draw, or assist in drawing, fluid from wound 14A into internal reservoir 12F.
  • the uncompressed shape of fluid container 12 may generally resemble an ellipsoid, however, fluid container 12 may have any material property and any shape that is suitable for the purposes of evacuator system 10.
  • fluid container 12 may lie on its side or be configured to stand upright, as shown in Figure 2.
  • fluid container 12 may include a variation from the embodiment shown in Figure 2, namely having a lower section, such as section 12E, removed and sealed to create a flat surface to be supported. Such a variation may be formed during the manufacture of fluid container 12.
  • Fluid container 12 may also include any structure suitable for attaching fluid container 12 to any article, e.g., attaching fluid container 12 to an article such as clothing or bedding near patient 14.
  • a shown in Figure 3, a lanyard 40 and an attaching pin (not shown) may serve this purpose.
  • a variation of container cover 12A is shown in Figure 3. Extending from and in communication with passages 12G, 12H and 121 may be respective ports 20, 26 and 28. Port 26 may serve as a fluid input to reservoir 12F and may have a diameter corresponding to its respective passage 12H that accommodates a first type of conduit for a first drain 16, such as a drain with a lumen diameter of 3 millimeters or less.
  • Port 20 may serve as a fluid input to reservoir 12F and may have a diameter corresponding to its respective passage 12G that accommodates a second type of conduit for a second drain 16, such as a drain with a lumen diameter greater than 3 millimeters.
  • 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.
  • 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.
  • 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.
  • 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.
  • Figures 4A-4D different configurations are shown in plan view of the passages in container cover 12A, understanding that any other number or configuration of passages is permissible.
  • Figure 4A depicts a plan view of passages 12G-12I in container cover 12A from Figures 2 and 3.
  • Figure 4B depicts a plan view of passages 12G-12I in container cover 12A' from Figures 5A-5B.
  • Figure 4C depicts a plan view of passages 12G-12I not aligned in single-row fashion, but in another arrangement, such as triangular.
  • passage 12G may comprise a fluid inlet of diameter greater than 3 millimeters, e.g., 6 millimeters;
  • passage 12H may comprise a fluid inlet of diameter 3 millimeters or less, e.g., 3 millimeters;
  • passage 121 may comprise a fluid outlet of diameter greater than 3 millimeters, e.g. 15 millimeters.
  • container cover 12A may include two or more passages, such as passages 12J and 12K.
  • Passage 12J may comprise a fluid inlet of diameter greater than 3 millimeters, e.g., 6 millimeters; and passage 12K may comprise a fluid outlet of diameter greater than 3 millimeters, e.g. 15 millimeters.
  • Passage 12 L shown in broken lines, represents an adaptor permitting fluid inlet passage 12J, which may have a diameter greater than 3 millimeters to be selectively reduced to 3 millimeters or less in diameter. Any conventional adaptor for this purpose may be utilized.
  • a variation of container cover 12A is shown in Figures 5A-5B.
  • Port 46 may serve as a fluid input to reservoir 12F and has a diameter corresponding to its respective passage 12H that accommodates a first type of conduit for a first drain 16, such as a drain with a lumen diameter of 3 millimeters or less.
  • Port 44 may serve as a fluid input to reservoir 12F and has a diameter corresponding to its respective passage 12G that accommodates a second type of conduit drain 18, such as a drain with a lumen diameter greater than 3 millimeters.
  • 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.
  • 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.
  • Ghppers 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.
  • container cover 12A shown in Figures 2-3 may have a generally smooth, dome-like shape
  • the container cover may be of any suitable shape.
  • container cover 12A' in Figures 5A-5B may have a more tiered, dome-like shape
  • the assembled fluid container 12 may have the general shape of an ellipsoid, regardless of whether container cover 12A or 12A' is used.
  • fluid container 12 could be any shape or size suitable to collect fluid from a wound in any of the manners described herein.
  • the more-tiered structure of container cover 12A' may include, as shown from top to bottom in Figure 5A, a flat top surface 70, a beveled surface 72, a circular sidewall 74, a flared portion 76, a support rim 78, a circular sidewall 80, a flange 82 and a rim 84.
  • the bottom view of fluid container 12A in Figure 5B shows a pair of valves that may restrict fluid flow to one direction through inlet passages 12H and 12G, namely into the fluid container 12. Consequently, backflow of body fluid to patient 14 may be prevented.
  • the valves may comprise flapper-type valves.
  • a first section of material or flapper 86 may be provided to restrict flow through inlet passage 12H when flapper 86 seals inlet passage 12H. Flapper 86 may be biased to seal inlet passage 12H. Any suitable material and biasing may be employed. Moreover, the diameter of flapper 86 may be greater than or equal to the diameter of its corresponding inlet passage 12H, so that a proper seal may be effected.
  • 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.
  • flapper 86 shut and helps to prevent fluid from moving from reservoir 12F through passage 12H.
  • 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.
  • 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.
  • 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.
  • 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 the true scope and spirit of the invention being set forth in the following claims and legal equivalents thereof.

Landscapes

  • Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Vaporization, Distillation, Condensation, Sublimation, And Cold Traps (AREA)

Abstract

L'invention concerne un dispositif permettant d'éliminer un fluide corporel du site d'une plaie, et qui a moins tendance à se boucher que les dispositifs connus. Le dispositif comprend un contenant à fluide et éventuellement un drain (qui se place dans le site de la plaie), et un tuyau dont une extrémité se connecte au drain et l'autre extrémité au contenant à fluide. Le contenant à fluide comprend au moins un passage d'entrée, dont les dimensions sont supérieures à celles de passages de contenants connus et utilisés à cet effet, est de préférence circulaire et présente un diamètre supérieur à 3 mm. Un passage d'entrée supplémentaire peut également être prévu ; si de multiples passages d'entrée sont prévus, ceux-ci présentent de préférence différentes tailles pour pouvoir être raccordés à des tuyaux de différentes tailles. Le contenant à fluide peut aussi comprendre au moins un passage de sortie, de taille relativement grande pour améliorer l'efficacité de drainage. Le contenant utilise de préférence une soupape d'un type qui empêche l'écoulement du fluide indésirable hors du contenant.
EP05712537A 2004-01-26 2005-01-26 Systeme d'evacuation de fluide Withdrawn EP1715901A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US53915804P 2004-01-26 2004-01-26
PCT/US2005/003128 WO2005072789A2 (fr) 2004-01-26 2005-01-26 Systeme d'evacuation de fluide

Publications (1)

Publication Number Publication Date
EP1715901A2 true EP1715901A2 (fr) 2006-11-02

Family

ID=34826035

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05712537A Withdrawn EP1715901A2 (fr) 2004-01-26 2005-01-26 Systeme d'evacuation de fluide

Country Status (4)

Country Link
EP (1) EP1715901A2 (fr)
AU (1) AU2005209309A1 (fr)
CA (1) CA2566876A1 (fr)
WO (1) WO2005072789A2 (fr)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2604623C (fr) 2006-09-28 2018-10-30 Tyco Healthcare Group Lp Systeme portatif pour therapie de blessures
US9033942B2 (en) 2008-03-07 2015-05-19 Smith & Nephew, Inc. Wound dressing port and associated wound dressing
US8298200B2 (en) 2009-06-01 2012-10-30 Tyco Healthcare Group Lp System for providing continual drainage in negative pressure wound therapy
US20100324516A1 (en) 2009-06-18 2010-12-23 Tyco Healthcare Group Lp Apparatus for Vacuum Bridging and/or Exudate Collection
EP3520830B1 (fr) 2009-12-22 2023-10-18 Smith & Nephew, Inc. Appareils pour le traitement de plaies par pression négative
USRE48117E1 (en) 2010-05-07 2020-07-28 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
USD714433S1 (en) 2010-12-22 2014-09-30 Smith & Nephew, Inc. Suction adapter
WO2012087376A1 (fr) 2010-12-22 2012-06-28 Smith & Nephew, Inc. Appareils et procédés pour thérapie de plaie à pression négative
GB201811449D0 (en) 2018-07-12 2018-08-29 Smith & Nephew Apparatuses and methods for negative pressure wound therapy

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Publication number Priority date Publication date Assignee Title
SE351785B (fr) * 1970-02-02 1972-12-11 Astra Meditec Ab
US3900029A (en) * 1973-10-26 1975-08-19 Irving Melnick Closed surgical evacuator
US3993080A (en) * 1974-03-01 1976-11-23 Loseff Herbert S Suction tube and retrograde flushing for wounds, body cavities and the like
US4392858A (en) * 1981-07-16 1983-07-12 Sherwood Medical Company Wound drainage device
US4493701A (en) * 1982-08-19 1985-01-15 American Hospital Supply Corporation Wound drainage device of resilient sidewalls with a constant rate of recovery
US4828546A (en) * 1987-08-21 1989-05-09 Surgidyne, Inc. Bulb evacuator for closed wound suction
US5116327A (en) * 1989-06-05 1992-05-26 Helix Medical, Inc. Hysterectomy drain appliance

Non-Patent Citations (1)

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Title
See references of WO2005072789A3 *

Also Published As

Publication number Publication date
AU2005209309A1 (en) 2005-08-11
WO2005072789A3 (fr) 2005-10-06
WO2005072789A2 (fr) 2005-08-11
CA2566876A1 (fr) 2005-08-11

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