WO1994014486A1 - Woven surgical drain and woven surgical sponge - Google Patents

Woven surgical drain and woven surgical sponge Download PDF

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Publication number
WO1994014486A1
WO1994014486A1 PCT/US1993/009342 US9309342W WO9414486A1 WO 1994014486 A1 WO1994014486 A1 WO 1994014486A1 US 9309342 W US9309342 W US 9309342W WO 9414486 A1 WO9414486 A1 WO 9414486A1
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WO
WIPO (PCT)
Prior art keywords
drain
yarns
tube
surgical
conductive
Prior art date
Application number
PCT/US1993/009342
Other languages
French (fr)
Inventor
Miriam H. Feibus
Original Assignee
Feibus Miriam H
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 Feibus Miriam H filed Critical Feibus Miriam H
Priority to EP93923188A priority Critical patent/EP0693945A1/en
Priority to AU52957/93A priority patent/AU5295793A/en
Publication of WO1994014486A1 publication Critical patent/WO1994014486A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/36Surgical swabs, e.g. for absorbency or packing body cavities during surgery

Definitions

  • This invention relates to an appliance or material which provides a channel of exit or discharge from a wound cavity and, more specifically, to a woven surgical drain fabric and woven hollow-tube, hollow-track-tube, or hollow-flat-tube surgical drains comprised of electrically conductive yarns and nonconductive yarns that allows: the improved, i.e., more rapid and continuous removal of discharge from a wound cavity, improved removal of particulates from a wound cavity, and in the case of the hollow- tube or track-tube surgical drains, a conduit through which medication can be directly administered to the wound site.
  • the surgical drains of this invention may also improve drain- off of particulate material suspended in the liquid to be drained.
  • the surgical drain fabric and the surgical drains of this invention when filled with an absorptive material, can also be folded, rolled wrapped or otherwise formed into a wad or sponge useful in medical procedures (especially dental procedures) for collecting and rapidly removing excess liquid such as blood or saliva.
  • the therapeutic effect of promoting drainage from wound cavities is well known and there are conventional devices designed to promote such drainage. These devices which afford a route of exit or discharge from a wound cavity have come in various forms and can be classified generally in three groups.
  • the first group employs a nollow structure, such as a tube, which is placed in the wound to allow the removal of wound discharge by, e.g., capillary action and/or siphonage and/or gravity.
  • a number of these "tube” type drains have also been used in conjunction with vacuum producing apparatus to assist drainage.
  • Features shared by tube-type surgical drains include 1) ease of insertion into a wound cavity and 2) their drainage function is not generally affected by the volume of discharge. Further, since they provide constant drainage, the need to replace them is significantly reduced.
  • There are, however, a number of disadvantages of tube-type surgical drains including, the difficulties of avoiding infection and promoting healing inherent in a device inserted in a wound cavity that is
  • Tube-type surgical drains can also be any nondegradable.
  • Tube-type surgical drains can also be any nondegradable.
  • Tube-type surgical drains can also be any nondegradable.
  • tube-type surgical drains may be prone to blockage and other forms of obstruction, e.g., when the tube opening contacts body tissue the passage of discharge may be obstructed.
  • the second group of surgical drain devices includes those made of various forms of fibers and fabrics having aosorptive properties which are placed in a wound cavity to allow removal of wound discharges, e.g., by absorption.
  • These "fabric" type surgical ⁇ rams are tnat they can be relatively easily sized and manipulated regardless of the size of the wound cavity and may be less prone to blockage or oDstruction than tube- type drains.
  • fabric -type drams suffer from a number of disadvantages, such as susceptibility to sluffmg or linting, which may promote irritation and associated infection, ana tneir drainage capacity may be limited to the fluid retention capacity of the fabric, i.e., the drainage is not continuous. Drainage capacity problems may be aggravated by using hydrophiiic fibers, e.g., cellulose yarns, due to their water binding properties. A consequence of the drainage capacity limitation is that fabric- type surgical drains must ordinarily be replaced at relatively short intervals.
  • fabric-type drain materials are often so loosely woven that they fragment which increases the risk of infection. Natural fibers like cotton, and other cellulosics, are themselves prone to siuffing small fragments that also increase the risk of infection. Depending on the fibers selected, known fabric-type surgical drains may decompos over time, again necessitating more frequent replacement, and, not uncommonly, debriding of the wound cavity. Known fabric- type surgical may also be difficult to relocate or retrieve. Another disadvantage of fabric-type drain materials is that the often do not remove particulates from the wound cavity.
  • the third group of surgical drain devices is a hybrid of the above described tube-type and fabric-type drains including both a hollow structure and absorptive fibers.
  • a fabric is usually either wrapped around or arranged within a hollow structure to form a composite structure which may be inserted into a wound.
  • Combination-type drains share some of the advantageous features of both tube-type and fabric-type drains.
  • a disadvantage of these combination- type surgical drains is that they may not effectively remove particulates from a wound cavity.
  • gauze e.g., a loosely wove cotton fabric
  • the surgical sheathing or rubber glove part is used to prevent loose fragments or threads of the gauze from entering the wound cavity. Gauze is prone to fragmenting and leaves many loose threads when it is cut. Additional fragments of gauze may fall away under minimal pressure, i.e., sluffing and linting.
  • the use of the sheath or glove to limit such sluffing and linting is not completely effective or convenient for use in an operating room setting.
  • drainage with this type of surgical drain may be limited to the fluid
  • U.S. Patent No. 3,957,054 issued to McFarlane, describes a tube- type drain which is flexible and pliable and comprises a plurality of ribs arranged in such a fashion about the interior of the column of the tube so that the tube cannot be coliaDsed.
  • a desirable surgical dram fabric would provide improved continuous drainage properties for extended periods that is not limited to the fluid retention capacity of the fabric or evaporation time.
  • An object of the present invention is to provide a readily manufactured woven surgical dram fabric having finished edges which is comprised of a woven structure of conductive yarns and nonconductive yarns woven together so that tne fabric has finished longitudinal edges and the conductive yarns make electrical contact with one another so as to form an
  • It is another object of the present invention to provide a woven surgical drain comprising an elongate body defining a tube-like channel for fluids and particulates formed with conductive and nonconductive yarns woven together so that the surgical drain has a finished longitudinal edge and said conductive yarns make electrical contact with one another so as to form an electrically conductive woven matrix.
  • the matrix is not continuous except when stop-stitched.
  • composition composition, and amount of a filler material disposed therein.
  • the invention also embraces methods for ma ⁇ ng and using both the surgical dram fabric and surgical drain
  • FIG. 1 shows a woven surgical dram fabric pattern illustrating the underlaps and overlaps of the weft and warp arrangement of a woven fabric, dram, or sponge woven in accordance with the present invention
  • FIG. 2 shows a close-up cross-section of a warp of the surgical dram fabric snown m FIG. 1;
  • FIG. 3 snows a close-up cross-section of a weft of the surgical dram fabric shown in FIG. 1;
  • FIG. 4 shows a hollow-tube surgical drain
  • FIG. 5 shows a nollow-track-tube surgical dram made in accordance with the invention
  • FIG. 6 shows a nollow-flat-tube surgical dram made in accordance with the invention
  • FIG. 7 snows the nollow-tube surgical dram shown in FIG. 4 with a stop--stit.h;
  • FIG. 8 snows tne hollow-flat-tuoe surgical drain of FIG. 6 with a stop-stitch
  • FIG. 9 shows a hollow-tube surgical drain with filler material
  • FIG. 10 illustrates a plastic hollow surgical' drain having the surgical drain of the invention disposed therein.
  • FIG. 11 illustrates a plastic hollow surgical drain (implanted in a wound) having a surgical dram of the invention disposed therein;
  • FIG. 12 shows the hollow-tube surgical dram of FIG. 9 encased by thermal sealing yarns
  • FIG. 13 shows the hollow-tuoe surgical dram of FIG. 9 with a non-stick coating applied to the external surface.
  • FIG. 1 shows a woven surgical dram fabric and the arrangement of underlaps and overlaps of warps 1 and wefts 2 formed in a fabric or surgical drain woven m accordance with the invention.
  • the warps 1 and wefts 2 are shown loosely woven together.
  • the warps 1 and wefts 2 would be tightly woven together.
  • FIG. 2 is an enlargement of a warp 1 of FIG. 1 showing that the warp 1 is a multi-filament yarn comprised of
  • 3oth warps 1 and wefts 2 may be comprised of any number of filaments.
  • characteristics of the woven fabric may be modified as needed by varying the type and denier of the warp yarn ends and weft yarn ends, the number of warps, and the number of picks per inch.
  • FIG. 3 is an enlargement cf a weft 2 of FIG. 1 showing that tne weft is comprised of approximately one conductive filament 3 and approximately one nonconductive filament 4.
  • FIG. 4 shows a hollow-tube surgical drain and includes warps 1, wefts 2, and a tube- like channel 5 for draining fluids and particulates.
  • FIG. 5 shows a hollow-track-tube surgical drain and includes laterally located warps 1, wefts 2, and a tube-like channel 5 for draining fluids and particulates.
  • FIG. 6 shows a hollow-flat-tube surgical drain and includes warps 1, wefts 2, and a tube-like channel 5 for draining fluids and particulates.
  • the flat-tube-drain is woven so as to remain "flat" when there is a minimal amount of space or patient comfort is a major concern, e.g., when performing facial plastic surgery or draining skin ulcers.
  • FIG. 7 shows a hollow-tube surgical drain that includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, and a stop-stitch 6 sewn along the longitudinal edge of the drain parallel to the warps 1 and perpendicular to the wefts 2 to prevent continuous weft 2 unraveling.
  • FIG. 8 shows a hollow-flat-tube surgical drain and includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, and a stop-stitch 6 sewn along the longitudinal edge of the drain parallel to the warps 1 and perpendicular to the wefts 2 to prevent continuous weft 2 unravelling.
  • FIG. 9 shows a hollow-tube surgical drain and includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, and a filler material 7 inserted into said tubelike channel 5.
  • the filler cord 7 may be inserted as the hollow-tube dram is woven and allows the tube to maintain a desired shape while the drain is "finished” .for example by scouring, boiling, or heat setting).
  • the shape of the drains ranging from circular to flat, can be varied by the amount and shape of the filler cord inserted. After finishing, the filler material must be removed so as to form a drain.
  • the filler cord may be comprised of absorptive fibers and left in place after finishing so as to form a sponge.
  • FIG. 10 shows a surgical drain 8 which is a biocompatible plastic tube 9 preferably having a discharge connector 10 disposed at one end thereof for attachment to a drainage bag (not shown) or similar means for collecting wound drainage.
  • discharge connector 10 could be attached to a vacuum assist device or simply left open.
  • the opposing end 11 of tube 9 may be provided with perforations 12 to aid in collection of wound drainage.
  • the tube 9 may be rigid or flexible, as dictated by particular applications, and may also include one or more flexing sections 13 to provide bending at desired locations.
  • a bendable wire 14 can be passed through the tube 9 so that the drain 8 can be bent to any desired angle for selected applications.
  • the wire 14 is copper, silver, gold or other material having antimicrobial properties. It may also be advantageous to treat the surgical drain fabric 15 and/or tube 9 with known antimicrobial agents to reduce the risk of infection and/or to apply antithrombogenic agents to the tube 9, or portions thereof, such as heparin or sodium citrate.
  • FIG. 11 shows surgical drain 8 extending from wound 16 in patient 17.
  • the tube 9 which encloses the surgical drain fabric 15 can be made of any biologically acceptable material, synthetic plastics being preferred.
  • the tube may be as rigid as a drinking straw or flexible as the finger of a latex surgical glove. Tube structures are easily formed by conventional plastic working processes such as extrusion. The tube would also provide a conduit through which medication can be directly administered to the site.
  • FIG. 12 shows a hollow-tube surgical drain and includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, a filler cord 7 inserted into said tube-like channel 5, and thermal sealing fibers 18.
  • the thermal sealing yarns 18 should have a lower melting point than the conductive and nonconductive yarns that comprise the warps 1 and wefts 2 of the drain. Thus, when the encased drain is exposed to sufficient heat to melt the thermal sealing yarns, the thermal sealing yarns will fuse into one another and the conductive and nonconductive yarns of the drain will be encased in a non-permeable outer tube.
  • FIG. 13 shows the hollow-tube surgical drain of FIG. 4 and includes warps 1, wefts 2, a tube-like channel 5 for draining fluids and particulates and a non-stick external coating 20.
  • the sequence of woven yarns shown in FIG. 1 may be formed on a narrow loom knitting machine of the type well known in the art.
  • Preferred machines for making surgical drain fabric and hollow-tube, hollow-track-tube, hollow-flat-tube surgical drains, and surgical sponges are weaving machines also capable of producing tubular woven fabrics with finished edges such as the "HIGH-CAPACITY NARROW-FABRIC LOOM (NF, NFS)" manufactured by Engineering Works Jakob Mueller Ltd., Frick, Switzerland.
  • the material may also be produced on a braiding machine.
  • finished edge means that the marginal edges of the fabric are substantially free of loose yarn ends that are susceptible to breaking away from the fabric.
  • selvedging, bonding and similar known techniques can be employed to finish edges on alternative fabric
  • a fabric or surgical drain useful for drawing wound drainage out of a patient's body should be woven from conductive and nonconductive fibers.
  • Fabrics and drains woven using only nonconductive yarns are durable but do not produce acceptable drainage. Fabrics and drains woven using only conductive yarns produce acceptable drainage but tend to be fragile and expensive. Thus, a
  • conductive yarns and non- conductive yarns should be employed.
  • the ratio of conductive fibers to non- conductive fibers in the surgical fabrics and surgical drains prepared by Applicant is about 1:1, however, any ratio may be employed depending upon specific drainage and strength requirements.
  • the surgical drain fabric of this invention can be any knitted, woven or non-woven material of staple or monofilament or muitifilament yarns that includes an electrically conductive matrix and is woven to form a fabric that will provide effective wound drainage over extended periods of time, e.g., up to 2 or more days.
  • the preferred form for the fabric is a hollow-tube, track-tube, or hollow- flat -tube having finished longitudinal edges. Hollow- tubes, track- tubes, or hollow-flat-tubes, can either be woven with finished edges or cut from sheets followed by finishing the edges.
  • the drain width is in the range of about 5 to 25 mm.
  • a filler material may be temporarily or permanently inserted in the longitudinal opening of the drains depending upon whether a dram or a sponge is desired.
  • One function of the filler cord is to shape the tube during final treatment or "finishing" (for example by scouring, boiling, or heat setting) . After finishing, the filler cord may be removed leaving the drain in the desired shape.
  • the filler material may be comprised of absorptive fibers and may be left in place after finishing if it is desired to make a sponge rather than a drain.
  • the nonconductive yarn used to make the surgical drain fabric of this invention can be any of the well known
  • biocompatible yarns and preferably is a monofiiament or multifilament synthetic yarn such as a texturized polyester, e . g . , UNIFI 1 - 150 - 50 , (20 to 200 denier) .
  • Polyesters are preferred because they are not easily degraded by body fluids or medicaments.
  • Other available microfilament yarns, such as 1150 100 and 1-150-272 available from DuPontTM and texturized by UNIF may be advantageously incorporated in this product. Staple yarns should be avoided because small pieces of these yarns can sluff-off in use and may cause infection.
  • the conductive yarns are preferably monofiiament or multifilaments made of any electrically conductive material, e.g., see: US Patent No. 4,422,483.
  • Preferred conductive yarns are carbon suffused nylon yarn such as BASFTM ResiStatTM and the tri-lobal carbon core polyester yarn such as DupontTM Nega-StatTM one advantage that Nega-StatTM has over ResiStatTM is that Nega- StatTM has a better radiographic signature than ResiStatTM.
  • Nega-StatTM Fabrics and drams woven with Nega-StatTM only as the conductive yarn drained more rapidly than fabrics and drains woven with ResiStatTM only as the conductive fiber.
  • a disadvantage of fibers and drams woven with Nega-StatTM only as the conductive yarn is that the rate of drainage is drastically reduced by the presence of oil in the fluid to be drained.
  • fibers and drains prepared with ResiStatTM only as the conductive yarn drain more slowly and have a smaller radiographic signature, they are not affected by oil in the fluid to be .drained.
  • the Nega- StatTM and the ResiStatTM perform better in concert than either does alone.
  • the Nega-StatTM and ResiStatTM may be utilized in any ratio, however, best results are obtained when the ratio of ResiStatTM to Nega-StatTM is about 1:1.
  • Other conductive fibers may also be utilized.
  • the conductive and nonconductive yarns may also be encased in thermal sealing yarns.
  • thermally sealed yarns to encase the conductive an nonconductive yarns of the surgical drains results in more rapid removal of discharge from a wound cavity and provides a conduit through which medication can be directly administered to the site.
  • the surgical drain fabric and the surgical drains of this invention when prepared with an absorptive filler material can also be folded, rolled, wrapped, or otherwise formed into a wad or sponge useful in medical procedures, especially dental procedures, for collectin and rapidly draining excess liquid such as blood or saliva.
  • the surgical drains of this invention will also drain off
  • Non- linting and non-sluffing woven surgical drain fabric of the present invention was woven on a narrow loom machine.
  • the woven weft and warp yarns of the conductive fibers form an electrically conductive matrix.
  • the woven pattern is important because the woven pattern provides finished edges and, as previously discussed, the lack of loose threads reduces the chance of infection.
  • the result of the above procedure is a finished edge surgical drain fabric or finished edge .hollow- tube, track- tube, or hollow-flat-tube surgical drain that has a diameter of approximately 3/8" (7.5 mm) and can be made into any desired length.
  • the woven surgical drain fabric or woven hollow-tube, track- tube, or hollow-flat-tube surgical drains of the present invention may then be treated by the steps of:
  • finishing i.e., scouring or boiling
  • heat setting i.e., scouring or boiling
  • a benefit of the woven patterns of the present invention is that no additional mechanical finishing, e.g., sewing or burning, of the fabric's edges is needed to bind loose threads.
  • a hydrophobic fabric such as that used in the present invention, can drain more quickly, i.e., begin to move blood sooner if the fabric is prewet with a liquid such as, for example, water or mixtures of water and alcohol or heparin particularly 1 to 5% vol. aqueous isopropyl (rubbing) alcohol.
  • a liquid such as, for example, water or mixtures of water and alcohol or heparin particularly 1 to 5% vol. aqueous isopropyl (rubbing) alcohol.
  • the fabric or drain is pre-wetted with an alcohol-water solution.
  • Tap water was used to wet woven surgical drains constructed in accordance with the present invention. Three samples of a hollow- tube surgical drain- were prepared with each drain having a diameter of approximately 7mm and measuring approximately 17cm in length. Drain No. 1 was totally immersed in the tap water so that it became soaked; Drain No. 2 was only dampened; and Drain No. 3 was dry.
  • a hollow track-tube surgical dram approximately 17cm long and having a diameter of approximately 7mm was prepared in accordance with tne invention.
  • the dram was pre-soa ⁇ ed with tap water.
  • the dram was used to dram 75ml of sterilized water from a 75ml peaker.
  • the collecting vessel was placed lower than the vessel containing the liquid to be drained. The results ar summarized m Table II.
  • a flat-tube surgical drain approximately 17cm long and having a diameter of approximately 7mm was prepared in
  • the drain was pre-soaked with tap water.
  • the drain was used to drain 75ml of tap water from a 75ml beaker.
  • the collecting vessel was placed lower than the vessel containing the liquid to be drained. The results are summa] rized m Taple lll .
  • a first surgical sponge was prepared by preparing a hollow- tube surgical drain in accordance with the invention having a length of approximately 2.5cm and a diameter of approximately 7mm. This hollow-tube surgical drain was filled with 100 ends of UNIFI 1-150-68 texturized polyester.
  • second surgical sponge was prepared using a section of hollow- tube surgical drain prepared in accordance with the invention and having the same dimensions as the drain prepared for the first surgical sponge.
  • the second hollow-tube surgical drain was filled with 100 ends of UNIFI 1-150-68 texturized polyester and 100 ends of ResiStatTM.
  • a third surgical sponge was prepared using a section of hollow- tube surgical dram prepared in accordance with the invention and having the same dimensions as the drain prepared for the first and second sponges.
  • the third hollow-tube surgical drain was filled with 150 ends of UNIFI 1- 150-68 texturized polyester and 150 end of ResiStatTM.
  • the sponges were placed in a container containing 40 cc of H 2 O to determine their absorption rates.
  • the first surgical sponge absorbed 5cc of H 2 O, the second sponge absorbed 30cc of H 2 O and the third sponge absorbed 40cc of H 2 O .
  • Table IV The results are summarized in Table IV.
  • the woven surgical drai fabric or hollow-tube, hollow-track-tube, or hollow-flat-tube woven surgical drains and surgical sponges of the present invention may be autoclaved and gamma ray sterilized and may be hypoallergenic depending on the choice of material used to make the fabric and/or tube. m addition, were the fabric or drains to be enclosed in a surgical sheath, the physician would have the flexibility to increase or decrease the rapidity of drainage, or even change the dram altogether from outside the patients body.
  • the dram is covered with a medically approved "non- stick" coating of material navmg proven tissue rejection characteristics, i.e., body tissue will not readily adnere to the material.
  • the non-stick material may be selected from a wide range of materials well Known to those skilled in the art as suitable for this purpose such as VectranTM and SpectraTM manufactured by Allied Fibers, a division of Allied-Signal, Inc. 101 Columbia Road, P.O. Box 2245, Morristown, New Jersey 07962.
  • the non-stick material is TeflonTM, available from E. I.
  • the non- stick dram coating may oe applied in a variety of ways such as by spraying or crushing.
  • the non- stick coating forms a knitted, woven, or braided tube or sleeve surrounding tne dram.

Abstract

The present invention relates to a surgical drain device fabric and surgical drain device and surgical sponge for providing a channel or exit (5) for discharge from a wound or wound cavity and, more specifically, a woven surgical sponge having finished longitudinal edges useful for drawing wound drainage out of a patient's body. Preferably, the surgical drain fabric, surgical drain, and surgical sponges are woven with conductive yarns and nonconductive yarns so as to provide enhanced drainage characteristics. The fabric, drains, and sponges prepared in accordance with the invention minimize the danger of sluffing and linting and other disadvantages associated with previous surgical drain and sponge materials. A non-stick coating is applied to the external surface of the drain to reduce tissue adhesion to the drain.

Description

WOVEN SURGICAL DRAIN AND WOVEN SURGICAL SPONGE
FIELD OF THE INVENTION
This application is a continuation-in-part of U.S. Serial No. 07/694,748 filed on May 2, 1991.
This invention relates to an appliance or material which provides a channel of exit or discharge from a wound cavity and, more specifically, to a woven surgical drain fabric and woven hollow-tube, hollow-track-tube, or hollow-flat-tube surgical drains comprised of electrically conductive yarns and nonconductive yarns that allows: the improved, i.e., more rapid and continuous removal of discharge from a wound cavity, improved removal of particulates from a wound cavity, and in the case of the hollow- tube or track-tube surgical drains, a conduit through which medication can be directly administered to the wound site. The surgical drains of this invention may also improve drain- off of particulate material suspended in the liquid to be drained.
The surgical drain fabric and the surgical drains of this invention, particularly the track-tube drain, when filled with an absorptive material, can also be folded, rolled wrapped or otherwise formed into a wad or sponge useful in medical procedures (especially dental procedures) for collecting and rapidly removing excess liquid such as blood or saliva. BACKGROUND OF THE INVENTION
The therapeutic effect of promoting drainage from wound cavities is well known and there are conventional devices designed to promote such drainage. These devices which afford a route of exit or discharge from a wound cavity have come in various forms and can be classified generally in three groups. The first group employs a nollow structure, such as a tube, which is placed in the wound to allow the removal of wound discharge by, e.g., capillary action and/or siphonage and/or gravity. A number of these "tube" type drains have also been used in conjunction with vacuum producing apparatus to assist drainage. Features shared by tube-type surgical drains include 1) ease of insertion into a wound cavity and 2) their drainage function is not generally affected by the volume of discharge. Further, since they provide constant drainage, the need to replace them is significantly reduced. There are, however, a number of disadvantages of tube-type surgical drains, including, the difficulties of avoiding infection and promoting healing inherent in a device inserted in a wound cavity that is
nondegradable. Tube-type surgical drains can also be
uncomfortable for the patient because of their stiffness, lack of flexibility, and relatively large diameter. In addition, tube-type surgical drains may be prone to blockage and other forms of obstruction, e.g., when the tube opening contacts body tissue the passage of discharge may be obstructed.
The second group of surgical drain devices includes those made of various forms of fibers and fabrics having aosorptive properties which are placed in a wound cavity to allow removal of wound discharges, e.g., by absorption. Features shared by these "fabric" type surgical αrams are tnat they can be relatively easily sized and manipulated regardless of the size of the wound cavity and may be less prone to blockage or oDstruction than tube- type drains. As with tuoe-type drains, fabric -type drams suffer from a number of disadvantages, such as susceptibility to sluffmg or linting, which may promote irritation and associated infection, ana tneir drainage capacity may be limited to the fluid retention capacity of the fabric, i.e., the drainage is not continuous. Drainage capacity problems may be aggravated by using hydrophiiic fibers, e.g., cellulose yarns, due to their water binding properties. A consequence of the drainage capacity limitation is that fabric- type surgical drains must ordinarily be replaced at relatively short intervals.
Further, conventional fabric-type drain materials are often so loosely woven that they fragment which increases the risk of infection. Natural fibers like cotton, and other cellulosics, are themselves prone to siuffing small fragments that also increase the risk of infection. Depending on the fibers selected, known fabric-type surgical drains may decompos over time, again necessitating more frequent replacement, and, not uncommonly, debriding of the wound cavity. Known fabric- type surgical may also be difficult to relocate or retrieve. Another disadvantage of fabric-type drain materials is that the often do not remove particulates from the wound cavity.
The third group of surgical drain devices is a hybrid of the above described tube-type and fabric-type drains including both a hollow structure and absorptive fibers. In these combination-type surgical drains, a fabric is usually either wrapped around or arranged within a hollow structure to form a composite structure which may be inserted into a wound. Combination-type drains share some of the advantageous features of both tube-type and fabric-type drains. A disadvantage of these combination- type surgical drains is that they may not effectively remove particulates from a wound cavity.
An example cf a combination-type drain routinely used in surgical procedures is made from gauze, e.g., a loosely wove cotton fabric, which may be layered, cut to size, shaped, and then placed in either surgical sheathing or a tubular part (finger) cut from a rubber glove prior to insertion into a wound cavity. The surgical sheathing or rubber glove part is used to prevent loose fragments or threads of the gauze from entering the wound cavity. Gauze is prone to fragmenting and leaves many loose threads when it is cut. Additional fragments of gauze may fall away under minimal pressure, i.e., sluffing and linting. The use of the sheath or glove to limit such sluffing and linting however, is not completely effective or convenient for use in an operating room setting. Furthermore, drainage with this type of surgical drain may be limited to the fluid
retention capacity of the fabric and a small amount of
evaporation.
Other known surgical drains, include "cigarette drains," made by surrounding a strip of gauze with a protective covering of rubber, gutta-percha, or the like; and "Mikulicz" drains formed by pushing a single layer of gauze into a wound cavity, the layer of gauze being packed with several thick wicks of gauze as it is pushed into the cavity. These drains also suffer from disadvantages including susceptibility to sluffing or linting, and that their drainage capacity may be limited to the fluid retention capacity of the fabric.
U.S. Patent No. 3,957,054, issued to McFarlane, describes a tube- type drain which is flexible and pliable and comprises a plurality of ribs arranged in such a fashion about the interior of the column of the tube so that the tube cannot be coliaDsed.
U.S. Patent No. 4,139,012, and its related
:ontinuaticn application, now U.S. Patent No. 4,217,904, both issued to Zahorsky, describe surgical αrain tunes navmg a construction said to minimize the problem of clogging found in known tube designs via a protective snield memoer.
Other known surgical drains are described in U.S.
Patents Nos. 4,257,422; 4,551,141; 4,623,329; 4,315,509;
4,579,555; 4,080,970; 4,781,678; 4,692,153; 4,523,920;
4,654,032; 4,508,533; 4,856,299; and 4,815,299.
A need exists, therefore, for a relatively inexpensive and easily manufactured surgical dram capable of providing improved drainage and other advantageous properties without some of the disadvantages of known surgical drains such as clogging, sluffing, linting, slow drainage, non- continuous drainage, inability to remove particulates, and inability to provide a conduit for administering medication directly to the site, and decomposition. Similarly, a desirable surgical dram fabric would provide improved continuous drainage properties for extended periods that is not limited to the fluid retention capacity of the fabric or evaporation time. OBJECTS AND SUMMARY OF THE INVENTION
An object of the present invention is to provide a readily manufactured woven surgical dram fabric having finished edges which is comprised of a woven structure of conductive yarns and nonconductive yarns woven together so that tne fabric has finished longitudinal edges and the conductive yarns make electrical contact with one another so as to form an
electrically conductive matrix so as to form an electrically conductive woven matrix to provide aosorptive properties without tne sluffing or linting associated with Known surgical dram fabrics. It is another object of the present invention to provide a woven surgical drain fabric that can be sterilized by conventional processes and is comprised of conductive yarns and nonconductive yarns woven together and possesses a radio opaque means so that the resulting fabric is radiographically visible and thereby can be readily positioned and repositioned without further exploratory surgery or otherwise intrusive procedures.
It is another object of the present invention to provide a woven surgical drain comprising an elongate body defining a tube-like channel for fluids and particulates formed with conductive and nonconductive yarns woven together so that the surgical drain has a finished longitudinal edge and said conductive yarns make electrical contact with one another so as to form an electrically conductive woven matrix.
It is another object of the present invention to provide a woven surgical drain comprising conductive and nonconductive yarns woven together to form woven hollow-tube, track- tube, or hollow-flat-tube surgical drains having finished longitudinal edges wherein the conductive yarns form an electrically conductive matrix. The matrix is not continuous except when stop-stitched.
It is another object of the present invention to provide a woven surgical drain comprising a hollow member whose shape and function can be varied by varying the shape,
composition, and amount of a filler material disposed therein.
It is another object of the present invention to provide a surgical drain in the form of a woven surgical drain drawn through a plastic tube that is easy to use and provides improved, i.e., more rapid and continuous drainage, without the dangers of clogging, linting or sluffing. It is another ooject of tne present invention to provide for woven non-linting, highly compact, re-usaole, and highly absorptive wads or sponges which are resistant to tissue adhesion.
The invention also embraces methods for maκιng and using both the surgical dram fabric and surgical drain
described above.
The invention is described in greater detail below based on a few exemplified emoodiments. BRIEF DESCRIPTION OF THE DRAWINGS
The invention snall be further explained ana described in the following text and accompanying drawings.
FIG. 1 shows a woven surgical dram fabric pattern illustrating the underlaps and overlaps of the weft and warp arrangement of a woven fabric, dram, or sponge woven in accordance with the present invention;
FIG. 2 shows a close-up cross-section of a warp of the surgical dram fabric snown m FIG. 1;
FIG. 3 snows a close-up cross-section of a weft of the surgical dram fabric shown in FIG. 1;
FIG. 4 shows a hollow-tube surgical drain;
FIG. 5 shows a nollow-track-tube surgical dram made in accordance with the invention;
FIG. 6 shows a nollow-flat-tube surgical dram made in accordance with the invention;
FIG. 7 snows the nollow-tube surgical dram shown in FIG. 4 with a stop--stit.h;
FIG. 8 snows tne hollow-flat-tuoe surgical drain of FIG. 6 with a stop-stitch; FIG. 9 shows a hollow-tube surgical drain with filler material;
FIG. 10 illustrates a plastic hollow surgical' drain having the surgical drain of the invention disposed therein; and
FIG. 11 illustrates a plastic hollow surgical drain (implanted in a wound) having a surgical dram of the invention disposed therein;
FIG. 12 shows the hollow-tube surgical dram of FIG. 9 encased by thermal sealing yarns; and
FIG. 13 shows the hollow-tuoe surgical dram of FIG. 9 with a non-stick coating applied to the external surface.
DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a woven surgical dram fabric and the arrangement of underlaps and overlaps of warps 1 and wefts 2 formed in a fabric or surgical drain woven m accordance with the invention. For purposes of illustration only the warps 1 and wefts 2 are shown loosely woven together. In an actual woven fabric or surgical drain woven m accordance with the invention, the warps 1 and wefts 2 would be tightly woven together.
FIG. 2 is an enlargement of a warp 1 of FIG. 1 showing that the warp 1 is a multi-filament yarn comprised of
approximately four conductive filaments ("yarn ends") 3 and four nonconductive filaments ("yarn ends") 4. 3oth warps 1 and wefts 2 may be comprised of any number of filaments. The
characteristics of the woven fabric may be modified as needed by varying the type and denier of the warp yarn ends and weft yarn ends, the number of warps, and the number of picks per inch.
FIG. 3 is an enlargement cf a weft 2 of FIG. 1 showing that tne weft is comprised of approximately one conductive filament 3 and approximately one nonconductive filament 4.
FIG. 4 shows a hollow-tube surgical drain and includes warps 1, wefts 2, and a tube- like channel 5 for draining fluids and particulates.
FIG. 5 shows a hollow-track-tube surgical drain and includes laterally located warps 1, wefts 2, and a tube-like channel 5 for draining fluids and particulates.
FIG. 6 shows a hollow-flat-tube surgical drain and includes warps 1, wefts 2, and a tube-like channel 5 for draining fluids and particulates. The flat-tube-drain is woven so as to remain "flat" when there is a minimal amount of space or patient comfort is a major concern, e.g., when performing facial plastic surgery or draining skin ulcers.
FIG. 7 shows a hollow-tube surgical drain that includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, and a stop-stitch 6 sewn along the longitudinal edge of the drain parallel to the warps 1 and perpendicular to the wefts 2 to prevent continuous weft 2 unraveling.
FIG. 8 shows a hollow-flat-tube surgical drain and includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, and a stop-stitch 6 sewn along the longitudinal edge of the drain parallel to the warps 1 and perpendicular to the wefts 2 to prevent continuous weft 2 unravelling.
FIG. 9 shows a hollow-tube surgical drain and includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, and a filler material 7 inserted into said tubelike channel 5. The filler cord 7 may be inserted as the hollow-tube dram is woven and allows the tube to maintain a desired shape while the drain is "finished" .for example by scouring, boiling, or heat setting). The shape of the drains, ranging from circular to flat, can be varied by the amount and shape of the filler cord inserted. After finishing, the filler material must be removed so as to form a drain. Alternatively, the filler cord may be comprised of absorptive fibers and left in place after finishing so as to form a sponge.
FIG. 10 shows a surgical drain 8 which is a biocompatible plastic tube 9 preferably having a discharge connector 10 disposed at one end thereof for attachment to a drainage bag (not shown) or similar means for collecting wound drainage. Of course, discharge connector 10 could be attached to a vacuum assist device or simply left open. The opposing end 11 of tube 9 may be provided with perforations 12 to aid in collection of wound drainage. The tube 9 may be rigid or flexible, as dictated by particular applications, and may also include one or more flexing sections 13 to provide bending at desired locations. In addition, or alternatively, a bendable wire 14 can be passed through the tube 9 so that the drain 8 can be bent to any desired angle for selected applications.
Preferably, the wire 14 is copper, silver, gold or other material having antimicrobial properties. It may also be advantageous to treat the surgical drain fabric 15 and/or tube 9 with known antimicrobial agents to reduce the risk of infection and/or to apply antithrombogenic agents to the tube 9, or portions thereof, such as heparin or sodium citrate.
FIG. 11 shows surgical drain 8 extending from wound 16 in patient 17. The tube 9 which encloses the surgical drain fabric 15 can be made of any biologically acceptable material, synthetic plastics being preferred. The tube may be as rigid as a drinking straw or flexible as the finger of a latex surgical glove. Tube structures are easily formed by conventional plastic working processes such as extrusion. The tube would also provide a conduit through which medication can be directly administered to the site.
FIG. 12 shows a hollow-tube surgical drain and includes warps 1, wefts 2, tube-like channel 5 for draining fluids and particulates, a filler cord 7 inserted into said tube-like channel 5, and thermal sealing fibers 18. The thermal sealing yarns 18 should have a lower melting point than the conductive and nonconductive yarns that comprise the warps 1 and wefts 2 of the drain. Thus, when the encased drain is exposed to sufficient heat to melt the thermal sealing yarns, the thermal sealing yarns will fuse into one another and the conductive and nonconductive yarns of the drain will be encased in a non-permeable outer tube.
FIG. 13 shows the hollow-tube surgical drain of FIG. 4 and includes warps 1, wefts 2, a tube-like channel 5 for draining fluids and particulates and a non-stick external coating 20.
The sequence of woven yarns shown in FIG. 1 may be formed on a narrow loom knitting machine of the type well known in the art. Preferred machines for making surgical drain fabric and hollow-tube, hollow-track-tube, hollow-flat-tube surgical drains, and surgical sponges are weaving machines also capable of producing tubular woven fabrics with finished edges such as the "HIGH-CAPACITY NARROW-FABRIC LOOM (NF, NFS)" manufactured by Engineering Works Jakob Mueller Ltd., Frick, Switzerland. The material may also be produced on a braiding machine. The term finished edge means that the marginal edges of the fabric are substantially free of loose yarn ends that are susceptible to breaking away from the fabric. Those skilled in the art will appreciate that selvedging, bonding and similar known techniques can be employed to finish edges on alternative fabric
constructions.
In accordance with the invention, a fabric or surgical drain useful for drawing wound drainage out of a patient's body should be woven from conductive and nonconductive fibers.
Fabrics and drains woven using only nonconductive yarns are durable but do not produce acceptable drainage. Fabrics and drains woven using only conductive yarns produce acceptable drainage but tend to be fragile and expensive. Thus, a
combination of conductive yarns and non- conductive yarns should be employed. The ratio of conductive fibers to non- conductive fibers in the surgical fabrics and surgical drains prepared by Applicant is about 1:1, however, any ratio may be employed depending upon specific drainage and strength requirements.
It should be appreciated that the surgical drain fabric of this invention can be any knitted, woven or non-woven material of staple or monofilament or muitifilament yarns that includes an electrically conductive matrix and is woven to form a fabric that will provide effective wound drainage over extended periods of time, e.g., up to 2 or more days. The preferred form for the fabric is a hollow-tube, track-tube, or hollow- flat -tube having finished longitudinal edges. Hollow- tubes, track- tubes, or hollow-flat-tubes, can either be woven with finished edges or cut from sheets followed by finishing the edges. Preferably, the drain width is in the range of about 5 to 25 mm. A filler material may be temporarily or permanently inserted in the longitudinal opening of the drains depending upon whether a dram or a sponge is desired. One function of the filler cord is to shape the tube during final treatment or "finishing" (for example by scouring, boiling, or heat setting) . After finishing, the filler cord may be removed leaving the drain in the desired shape. Alternatively, the filler material may be comprised of absorptive fibers and may be left in place after finishing if it is desired to make a sponge rather than a drain.
The nonconductive yarn used to make the surgical drain fabric of this invention can be any of the well known
biocompatible yarns; and preferably is a monofiiament or multifilament synthetic yarn such as a texturized polyester, e . g . , UNIFI 1 - 150 - 50 , (20 to 200 denier) . Polyesters are preferred because they are not easily degraded by body fluids or medicaments. Other available microfilament yarns, such as 1150 100 and 1-150-272 available from DuPont™ and texturized by UNIF may be advantageously incorporated in this product. Staple yarns should be avoided because small pieces of these yarns can sluff-off in use and may cause infection.
The conductive yarns are preferably monofiiament or multifilaments made of any electrically conductive material, e.g., see: US Patent No. 4,422,483. Preferred conductive yarns are carbon suffused nylon yarn such as BASF™ ResiStat™ and the tri-lobal carbon core polyester yarn such as Dupont™ Nega-Stat™ one advantage that Nega-Stat™ has over ResiStat™ is that Nega- Stat™ has a better radiographic signature than ResiStat™.
Fabrics and drams woven with Nega-Stat™ only as the conductive yarn drained more rapidly than fabrics and drains woven with ResiStat™ only as the conductive fiber. A disadvantage of fibers and drams woven with Nega-Stat™ only as the conductive yarn is that the rate of drainage is drastically reduced by the presence of oil in the fluid to be drained. Although fibers and drains prepared with ResiStat™ only as the conductive yarn drain more slowly and have a smaller radiographic signature, they are not affected by oil in the fluid to be .drained. Thus, the Nega- Stat™ and the ResiStat™ perform better in concert than either does alone. The Nega-Stat™ and ResiStat™ may be utilized in any ratio, however, best results are obtained when the ratio of ResiStat™ to Nega-Stat™ is about 1:1. Other conductive fibers may also be utilized.
The conductive and nonconductive yarns may also be encased in thermal sealing yarns. The use of thermally sealed yarns to encase the conductive an nonconductive yarns of the surgical drains results in more rapid removal of discharge from a wound cavity and provides a conduit through which medication can be directly administered to the site.
The surgical drain fabric and the surgical drains of this invention, particularly the track- tube drain, when prepared with an absorptive filler material can also be folded, rolled, wrapped, or otherwise formed into a wad or sponge useful in medical procedures, especially dental procedures, for collectin and rapidly draining excess liquid such as blood or saliva. The surgical drains of this invention will also drain off
particulate material' suspended in the liquid to be drained. EXAMPLE 1
An example of a non- linting and non-sluffing woven surgical drain fabric of the present invention was woven on a narrow loom machine. The woven weft and warp yarns of the conductive fibers form an electrically conductive matrix. The woven pattern is important because the woven pattern provides finished edges and, as previously discussed, the lack of loose threads reduces the chance of infection.
The result of the above procedure is a finished edge surgical drain fabric or finished edge .hollow- tube, track- tube, or hollow-flat-tube surgical drain that has a diameter of approximately 3/8" (7.5 mm) and can be made into any desired length. The woven surgical drain fabric or woven hollow-tube, track- tube, or hollow-flat-tube surgical drains of the present invention may then be treated by the steps of:
1. "finishing", i.e., scouring or boiling; and 2. heat setting the scoured fabric or drains at
about 350 degrees Fahrenheit.
As will be appreciated, a benefit of the woven patterns of the present invention is that no additional mechanical finishing, e.g., sewing or burning, of the fabric's edges is needed to bind loose threads.
In order to achieve wider hollow-tube, track-tube, or hollow-flat-tube surgical drains (up to two inches (2") in diameter), the same loom machine can be utilized in
substantially the same manner as described but would require more creel space. For widths greater than one-and-one-quarter (1 1/4") inches diameter a modified loom should be employed. EXAMPLE 2
It has also been discovered that a hydrophobic fabric, such as that used in the present invention, can drain more quickly, i.e., begin to move blood sooner if the fabric is prewet with a liquid such as, for example, water or mixtures of water and alcohol or heparin particularly 1 to 5% vol. aqueous isopropyl (rubbing) alcohol. In a preferred embodiment, the fabric or drain is pre-wetted with an alcohol-water solution.
Tap water was used to wet woven surgical drains constructed in accordance with the present invention. Three samples of a hollow- tube surgical drain- were prepared with each drain having a diameter of approximately 7mm and measuring approximately 17cm in length. Drain No. 1 was totally immersed in the tap water so that it became soaked; Drain No. 2 was only dampened; and Drain No. 3 was dry.
In the first test "A", 250cc of Povidone™ iodine prep solution (which is quite viscous and has a tendency to dry rapidly) was placed in three separate coupe shaped containers. One end of each woven hollow- tube surgical drain was submerged in the Povidone and the opposite end draped over the side of the glass tube into a collection vessel. The collecting vessel was placed lower than the vessel containing the liquid to be drained. The volume of liquid in each collection vessel was periodically measured and the results are summarized in Table I.
In the second test "B", the woven hollow-tube surgical drains were wet with tap water. Drain 1 was soaked; Drain 2 was only dampened; and Drain 3 was dry. The three sample Drains were used to drain Povidone™ as in Test A and the results are also summarized in Table I, wherein the cumulative amount of fluid drained (in milliliters) over a given period is
illustrated.
Figure imgf000019_0001
The effects of soaking, dampening, and leaving the surgical dram dry as summarized in Table I demonstrate that th most rapid drainage occurs wnen the dram is either pre-soaked or pre-dampened instead of being merely left dry.
EXAMPLE 3
A hollow track-tube surgical dram approximately 17cm long and having a diameter of approximately 7mm was prepared in accordance with tne invention. The dram was pre-soaκed with tap water. The dram was used to dram 75ml of sterilized water from a 75ml peaker. The collecting vessel was placed lower than the vessel containing the liquid to be drained. The results ar summarized m Table II.
Table II
DRAINAGE RATE FOR HOLLOW-TRACK-TUBE SURGICAL DRAIN
Figure imgf000019_0002
EXAMPLE 4
A flat-tube surgical drain approximately 17cm long and having a diameter of approximately 7mm was prepared in
accordance with the invention. The drain was pre-soaked with tap water. The drain was used to drain 75ml of tap water from a 75ml beaker. The collecting vessel was placed lower than the vessel containing the liquid to be drained. The results are summa] rized m Taple lll .
Figure imgf000020_0001
The drainage properties of the pre-soaked hollow track- tube and hollow-flat- tube surgical drains as summarized in Tables II and III demonstrate that the hollow-track-tube drain drains more rapidly than the hollow-flat-tube drain.
EXAMPLE 5
Three surgical sponges were prepared in accordance with the invention. A first surgical sponge was prepared by preparing a hollow- tube surgical drain in accordance with the invention having a length of approximately 2.5cm and a diameter of approximately 7mm. This hollow-tube surgical drain was filled with 100 ends of UNIFI 1-150-68 texturized polyester. second surgical sponge was prepared using a section of hollow- tube surgical drain prepared in accordance with the invention and having the same dimensions as the drain prepared for the first surgical sponge. The second hollow-tube surgical drain was filled with 100 ends of UNIFI 1-150-68 texturized polyester and 100 ends of ResiStat™. A third surgical sponge was prepared using a section of hollow- tube surgical dram prepared in accordance with the invention and having the same dimensions as the drain prepared for the first and second sponges. The third hollow-tube surgical drain was filled with 150 ends of UNIFI 1- 150-68 texturized polyester and 150 end of ResiStat™. The sponges were placed in a container containing 40 cc of H2O to determine their absorption rates. The first surgical sponge absorbed 5cc of H2O, the second sponge absorbed 30cc of H2O and the third sponge absorbed 40cc of H2O . The results are summarized in Table IV.
Figure imgf000021_0001
The absorptive properties of surgical sponges as summarized in Table IV demonstrate that absorption properties are enhanced by including conductive fibers and increasing the number of yarn ends and/or varying the yarn types in the filler material.
It should be appreciated that the woven surgical drai fabric or hollow-tube, hollow-track-tube, or hollow-flat-tube woven surgical drains and surgical sponges of the present invention may be autoclaved and gamma ray sterilized and may be hypoallergenic depending on the choice of material used to make the fabric and/or tube. m addition, were the fabric or drains to be enclosed in a surgical sheath, the physician would have the flexibility to increase or decrease the rapidity of drainage, or even change the dram altogether from outside the patients body.
In some applications it may be desirable or necessary to leave the dram m the patient for extended periods of time, e.g., 2-10 days. A problem associated with applications which leave the dram positioned m the body for extended periods of time is that body tissue tends to adhere to the drams.
Removing the dram after oooy tissue has adhered to it causes pulling and tugging wnich can be painful to the patient and may also result m trauma and hemorrhagmg.
In an alternative emoodiment (FIG. 13) of Applicant's invention, the dram is covered with a medically approved "non- stick" coating of material navmg proven tissue rejection characteristics, i.e., body tissue will not readily adnere to the material. The non-stick material may be selected from a wide range of materials well Known to those skilled in the art as suitable for this purpose such as Vectran™ and Spectra™ manufactured by Allied Fibers, a division of Allied-Signal, Inc. 101 Columbia Road, P.O. Box 2245, Morristown, New Jersey 07962. In a preferred embodiment, the non-stick material is Teflon™, available from E. I. Dupont DeNemours, & Co., Inc., Barley Mill Plaza, Bldg. 29, Wilmington, Delaware 19880- -0029. The non- stick dram coating may oe applied in a variety of ways such as by spraying or crushing. In a preferred embodiment the non- stick coating forms a knitted, woven, or braided tube or sleeve surrounding tne dram.
It should be understood that this invention is not limited to tne illustrations described and shown herein, wnich are deemed to oe merely illustrative of various modes of carrying out tne invention. As will ce appreciated by tnose SKilled m the art, an infinite compinacion of woven patterns, shapes, sizes, and fillers is possible.

Claims

WHAT IS CLAIMED IS:
1. A woven surgical drain comprising: a first plurality of yarns and a second plurality of yarns, the yarns of said first plurality of yarns being substantially parallel to each other and extending in a first direction, the yarns of said second plurality of yarns being substantially parallel to each other and extending in a second direction substantially
perpendicular to said first direction and woven with said first plurality of yarns to form an elongate woven fabric defining a tube- like channel and wherein said first plurality of yarns and said second plurality of yarns include conductive and
nonconductive yarns and said conductive yarns make electrical contact with one another so as to form an electrically
conductive matrix.
2. The drain of claim 1 wherein the tube-like channel is in hollow-tube form.
3. The drain of claim 1 wherein the tube- like channel is in track-tube form.
4. The drain of claim 1 wherein the tube-like channel is in hollow-flat-tube form.
5. The drain of claim 1 wherein said nonconductive yarns are synthetic yarns.
6. The drain of claim 5 wherein said synthetic yarns are 1-150-50 polyester yarns.
7. The drain of claim 5 wherein the synthetic yarns are 1-150-272 polyester yarns.
8. The drain of claim 1 wherein said conductive yarns consist of two or more conductive yarns plied together.
9. The drain of claim 1 wherein said conductive yarns consist of a conductive yarn plied together with a nonconductive yarn.
10. The drain of claim 1 wherein the conductive yarns are chosen from the group consisting of caroon suffused nylon; filamentary polymer substrates having finely divided
electrically- conductive particles embossed on the yarn surface; and graphite yarns.
11. The drain of claim 1 wherein said conductive yarns are selected from the group consisting of ResiStat™ and Nega-Stat™.
12. The dram of claim 1 wherein said conductive yarns consist of ResiStat™ and Nega-Stat™.
13. The dram of claim 12 wnerein the ratio of
ResiStat™ to Nega-Stat™ is about 1:1.
14. The drain of claim 1 wherein the ratio of conductive yarns to nonconductive yarns is about 1:1.
15. The drain of claim 1 further comprising thermal sealing yarns woven about the periphery of said drain so as to encase said drain, said thermal sealing yarns having a lower melting point than said conductive and nonconductive yarns.
16. The dram of claim 1 further comprising a lockstitch on the longitudinal edge of said drain.
17. A surgical drain comprising a biocompatible plastic tube having disposed therein the drain of claim 1.
18. The drain of any of the preceding claims further comprising a non-stick coating applied to the external surface of said drain.
19. The dram of claim 18 wherein said coating is a woven sleeve applied to the external surface of said drain.
20. The dram of claim 19 wnerein said coating is Teflon™.
21. The drain of claim 19 wherein said coating is Spectra™.
22. The drain of claim 19 wherein said coating is Vectran™.
23. The drain of claim 18 wherein said coating is a braided sleeve applied to the external surface of said drain.
24. The drain of claim 23 wherein said coating is Teflon™.
25. The drain of claim 23 wherein said coating is Spectra™.
26. The drain of claim 23 wherein said coating is Vectran™.
27. The drain of claim 18 wherein said coating is a knitted sleeve applied to the external surface of said drain.
28. The drain of claim 27 wherein said coating is Teflon™.
29. The drain of claim 27 wherein said coating is Spectra™.
30. The drain of claim 27 wherein said coating is Vectran™.
31. A method of making a surgical drain comprising the steps of:
(a) weaving a first plurality of yarns and a second plurality of yarns, the yarns of said first plurality of yarns being substantially parallel to each other and extending in a first direction, the yarns of said second plurality of yarns being substantially parallel to each other and extending in a second direction substantially perpendicular to said first direction to form an elongate woven fabric defining a tube-like channel and wherein said first plurality of yarns and said second plurality of yarns include conductive yarns and
nonconductive yarns and said conductive yarns make electrical contact with one another so as to form an electrically
conductive matrix;
(b) inserting a filler material into said tube- like channel;
(c) treating the surgical drain;
(d) applying a non-stick coating to the external surface of said drain; and
(e) removing the filler material from said tube- like channel.
32. The method of claim 31 wherein step (d) precedes step (c) .
PCT/US1993/009342 1992-09-30 1993-09-30 Woven surgical drain and woven surgical sponge WO1994014486A1 (en)

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US5358492A (en) 1994-10-25
EP0693945A1 (en) 1996-01-31
AU5295793A (en) 1994-07-19
EP0693945A4 (en) 1995-08-08

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