Wound Management Method and Apparatus
20170274126 · 2017-09-28
Inventors
Cpc classification
H10K59/00
ELECTRICITY
A61M1/915
HUMAN NECESSITIES
H10K71/00
ELECTRICITY
H01L29/43
ELECTRICITY
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
Wound drain (100) includes a body of soft and flexible elastomeric material. The body includes a flange (110) having a generally planar form and an elongate shaft (120) having a first portion extending to one side of the flange (110), and optionally a second portion extending to the opposite side of the flange. The flange (110) has a cross-sectional length in a direction perpendicular to a longitudinal direction of the shaft (120) that is larger than a cross-sectional length of the shaft (120). The shaft (120) includes one or more channels (123) each extending along its entire length or a portion of its length, and along both the first and second portions of the shaft (120) when the second portion of the shaft (120) is present.
Claims
1. A wound drain, comprising: a body of soft and flexible elastomeric material, the body including an elongate shaft and a flange having a generally planar form and having a portion extending radially outward from the shaft to define a surface radially outward from an outer surface of the shaft that operatively limits insertion of the shaft into a wound, the shaft having a first portion extending axially from one side of the flange, at least a portion of the flange having a cross-sectional length in a direction perpendicular to a longitudinal direction of the shaft that is larger than a cross-sectional length of the shaft, the shaft including at least one channel extending along a portion of its length, the flange including at least one aperture or groove each in flow communication with one of the at least one channel of the shaft, whereby when used, draining fluid from the wound passes into and through the at least one channel of the shaft and outward through the at least one aperture or groove in the flange.
2. The wound drain of claim 1, wherein the body has a unitary structure.
3. The wound drain of claim 1, wherein the at least one aperture or groove in the flange has a cross-sectional dimension that is equal to or exceeds the cross-sectional dimensions of the at least one channel of the shaft and is surrounded by elastomeric material of the flange.
4. The wound drain of claim 1, wherein the at least one channel consists of two channels, and the flange contains two grooves that each are continuous with a respective one of the two channels of the shaft.
5. The wound drain of claim 1, wherein the shaft has a smooth tip, the at least one channel in the shaft terminating at a location apart from the tip.
6. The wound drain of claim 1, wherein the shaft has a second portion extending axially from an opposite side of the flange from the first portion, the channels in the shaft extending in both the first and second portions.
7. The wound drain of claim 1, wherein the flange has a uniform cross-sectional length and the shaft has a uniform cross-sectional length less than the cross-sectional length of the flange.
8. A wound drain, comprising: a body of soft and flexible elastomeric material, the body including an elongate shaft including at least one channel extending longitudinally along at least a portion of its length and integral insertion limiting means that limit insertion of the shaft into an incision, the insertion limiting means including a portion that extends radially outward from the shaft to define a surface radially outward from an outer surface of the shaft that operatively limits insertion of the shaft into the incision, the insertion limiting means including at least one aperture or groove each in flow communication with one of the at least one channel of the shaft, whereby when used, draining fluid from a wound passes into and through the at least one channel of the shaft and outward through the at least one apertures or groove.
9. A method for draining a wound and providing negative pressure to a wound, comprising: inserting into a wound at least one drain including a body of soft and flexible elastomeric material, the body including an elongate shaft and a flange having a generally planar form and having a portion extending radially outward from the shaft to define a surface radially outward from an outer surface of the shaft that operatively limits insertion of the shaft into a wound, the shaft having a first portion extending axially from one side of the flange, at least a portion of the flange having a cross-sectional length in a direction perpendicular to a longitudinal direction of the shaft that is larger than a cross-sectional length of the shaft, the shaft including at least one channel extending along a portion of its length, the flange including at least one aperture or groove each in flow communication with one of the at least one channels of the shaft, and applying suction to urge fluid in the wound to pass through the at least one channel in the shaft and through the communicating aperture or groove in the flange.
10. The method of claim 9, further comprising inserting the at least one drain into the wound perpendicular to a plane of a body wall and such that the flange remains above a surface of the skin.
11. The method of claim 10, where the wound is a surgical incision and the skin of the incision is closed so that only the drain perforates the incision.
12. The method of claim 11, wherein the at least one drain comprises a plurality of drains, further comprising placing the drains along a length of the wound.
13. The method of claim 12, further comprising placing a single sponge over the multiple drain flanges and over the wound, securing the sponge with an occlusive adhesive membrane that is fixed to the skin surrounding the sponge and wound.
14. The method of claim 13, further comprising attaching a tube to an aperture in the membrane and applying the negative pressure through the tube to the sponge, multiple drains and wound.
15. The method of claim 10, further comprising placing a sponge over the drain flange and over the wound and securing the sponge with an occlusive adhesive membrane that is secured to the skin surrounding the sponge and wound.
16. The method of claim 15, further comprising attaching a tube to an aperture in the membrane and applying the negative pressure through the tube to the sponge, at least one drain and wound.
17. The method of claim 16, further comprising attaching an internal space of the tube to the sponge in flow communication with a pump that provides the negative pressure to the sponge and through the at least one drain to the wound.
18. The method of claim 15, wherein the shaft has a second portion extending axially from an opposite side of the flange than the first portion of the shaft and the sponge has a linear groove to accommodate the second portion of the shaft.
19. The method of claim 9, further comprising securing the drain to the skin with at least one stitch that runs through the skin and the elastomeric material of the flange.
20. The method of claim 9, further comprising securing the drain to the skin with at least one stitch that runs through the skin and an aperture in the flange that is surrounded by elastomeric material of the flange.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0018] The invention, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals identify like elements.
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BEST MODE FOR CARRYING OUT INVENTION
[0042] Referring now to
[0043] The flange 110 has a cross-sectional length, i.e., the length from one edge to an opposite edge and in a direction perpendicular to the axial or longitudinal direction of the shaft 120, that is larger than the cross-sectional length of the shaft 120 to thereby form an overhang. As shown in
[0044] Flange 110 may contain any number of openings or apertures 111 (see
[0045] Shaft 120 may be flexible, i.e., made of a flexible, biocompatible material. The material forming the drain 100 may be doped with radiopaque material, or a radiopaque material may be molded into the drain 100, e.g., as a stripe or strand, so that the drain 100 may be detected by radiographic means. Shaft 120 of drain 100 has a preferred diameter of about 5 mm and a preferred length of about 5 cm. Flange 110 has a preferred diameter of about 10 mm and a preferred thickness of about 1 mm. Also, shaft 120 includes one or more channels 123 that extend in the longitudinal direction of the shaft 120, each from a respective opening in the flange 110 to the bottom of the shaft 120. The openings in the flange 110 may have the same cross-sectional shape as the channels 123. The channels 123 may vary in their longitudinal length, although preferably, they extend to the bottom of the shaft 120 and open at the bottom (see
[0046] Shaft 120 has a generally cylindrical form with the outer circumferential surface of the shaft 120 being interrupted by the openings of the channels 123 (see
[0047] Referring now to
[0048] Referring now to
[0049]
[0050] In the plane of flange 110C, apertures 111C are completely surrounded by elastomeric material, whereas grooves 112C are not, i.e., grooves 112C are open radially outward (as shown in
[0051] The flange 110C has a cross-sectional length, i.e., the length from one edge to an opposite edge and in a direction perpendicular to the longitudinal direction of the shaft 120C, that is larger than the cross-sectional length of the shaft 120C, i.e., one or more portions of the flange 110C extend radially outward beyond the outermost radial edge of the shaft 120C. Some portions of the flange 110C may have a cross-sectional length that is the same as or smaller than the cross-sectional length of the shaft 120C, e.g., those portions at which the grooves 112C are formed.
[0052] Channels 123C preferably stop short of tip 124C, i.e., extend only along a portion of the longitudinal dimension of the shaft 120C, so that the surface of tip 124C may be smooth without openings. Each channel 123C may end abruptly in a squared-off manner, or become more shallow in the direction toward the tip 124C and disappear as it approaches the tip 124C. The particular cross-section shapes of the apertures 111C, grooves 112C and channels 123C shown in
[0053] Drains 100, 100A and 100C may be formed as a single unit using a molding process, preferably from a soft and flexible elastomeric material. The drains may thus be a unitary structure, a single piece structure, a homogenous structure, and combinations of such. The particular singular material or combination of materials, such as biocompatible materials, from which the drains are formed would be readily apparent to those skilled in the art of wound drainage in view of the disclosure herein. Also, the molding process used to form the drains may be any process that is capable of providing the drains with the characteristics disclosed herein.
[0054] Referring now to
[0055]
[0056] Each drain 100 may be secured in this position by a suitable securing mechanism or technique, for example, with a suture tie 7 by passing a suture needle and thread through the skin and the flange 110 of the drain 100 and tying to form one or more stitches that pass through the skin 3 and flange 110 of the drain 100. The suture may be passed through the aperture 111 in the flange 110 or through the elastomeric substance of the flange. Instead of a suture tie 7, other comparable securing mechanisms known to those skilled in this field may be used. Such securing mechanisms are collectively referred to as securing means herein.
[0057] To avoid damage to intact skin by suction to be applied through a sponge 30 that will be placed over the drains 100, protective adhesive film strips 20 are placed along both sides of the incision 2 for the length of the incision 2 (see
[0058] Adhesive film strips 20 and the adhesive film dressing described in the previous paragraph, serve to protect the underlying skin from damage caused by direct contact with a sponge under negative pressure. The semipermeable nature of the adhesive film dressings and strips allows vapor produced by the skin to traverse the film and be absorbed by the sponge.
[0059] An open cell foam sponge 30 is then preferably placed over drains 100 to cover the drains, incision 2 (see
[0060] An occlusive transparent adhesive film drape 40 with its adhesive surface facing downward, is preferably placed over the sponge 30 to cover the entire sponge 30 and incision 2, and then firmly secured to the healthy skin 3 around the wound margin. Coverage of the entire sponge 30 and incision 2 by the adhesive film drape 40 prevents an air leak from developing that would adversely impact the vacuum and suction application. One or more additional adhesive film drapes or dressings may be placed over those described to reinforce all seals.
[0061] An aperture 41 is cut into or otherwise provided in the adhesive film 40 above the sponge 30 (see
[0062] When the suction source 70 is activated, constant or variable negative pressure is applied to the sponge 30, each drain 100 and wound 1. Free fluid in the wound 1 is aspirated through channels 123 of each wound drain 100 (see
[0063] Sponge 30 may contain one or more grooves or slits 32 on its undersurface (
[0064] Alternatively, foam sponge 30 may be provided with narrow strips of adhesive film fixed, for example, to its undersurface by adhesive or other technique known in the art. These narrow strips may run the full length of foam sponge 30, or a portion of the length, one strip on either side of the groove, neither strip covering the groove, and be provided with liners, so that when the liners are removed the sponge 30 may be secured in place over the incision and drains, to the skin by the adhesive film strips, with portions 122A of shaft 120A of drain 100A or 122B of shaft 120B of drain 100B projecting into the groove 32.
[0065] Drains 100, 100A and 100B may be provided at a longer length, e.g., with shaft 120 or portion 121A of shaft 120A, or portion 121B of shaft 120B, preferably about 5 cm, and can be individually trimmed by the surgeon to a length suitable for its position in the incision. Drains 100D may be provided in varying lengths so as to accommodate varying thicknesses of the fatty subcutaneous layer and wound depths.
[0066] To summarize the basic steps of the method of this invention, which can be seen in chart form in
[0075] This order of steps is not an absolute requirement and may be altered. For example, step 3 may be performed before step 2.
[0076] While the apparatus and methods of this invention may be used at the time of the surgical operation, the same apparatus and methods may be used in the postoperative period to drain the wound if a wound infection or seroma develops or is suspected.
[0077] With the foregoing apparatus and methods, several objectives and advantages are achieved, such as providing apparatus and methods for expediting healing of a surgical wound, providing apparatus and methods for reducing the chance of developing a wound infection, providing apparatus and methods for reducing labor required for postoperative care of a surgical wound, and/or providing apparatus and methods to reduce cost of postoperative care of a surgical wound.
[0078] While particular embodiments of the invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the invention in its broader aspects, and, therefore, the aim in the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of the invention.