Apparatus and method for wound infection prevention
10085892 ยท 2018-10-02
Assignee
Inventors
- Mychailo Fulmes (Brooklyn, NY, US)
- Ihor Turkevych (Southampton, PA, US)
- Michael McGough (Southampton, PA, US)
Cpc classification
A61F13/01021
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
A61F13/0223
HUMAN NECESSITIES
A61F13/00063
HUMAN NECESSITIES
International classification
Abstract
A wound healing device and method that greatly reduces the risk of infection of an incision or wound by removing fluid from the subcutaneous skin layers. The wound healing device includes a first portion that is positioned external of, and on top of, the wound. At least one strip, cord, finger, member is in fluid communication at one end with the first portion while the second free end of the at least one strip, cord, finger, member is pushed down into the wound, in between the sutures or staples of a closed incision. Both the first portion and the at least one strip comprise fluid absorbable material for absorbing the wound fluid. The device remains in place for approximately 1-3 days after which it is removed. Upon removal, natural temporary type of fistulae are formed in the subcutaneous skin layers to continue draining wound fluids outward for another 1-2 days.
Claims
1. A wound healing device comprising: a first portion that is configured to be applied over and external to a wound, said first portion comprising a first fluid absorbent material; a second portion that is in fluid communication with said first portion at a first end of said second portion and a second end of said second portion that is configured to be positioned within the wound in a subcutaneous skin layer, said second portion comprising a second fluid absorbent material; and wherein said first portion comprises a central portion to which said first end is coupled and wherein said first portion is adapted to form a cover over the wound when said second end is positioned within the wound, said first and second portions being a removable device, wherein the first fluid absorbent material with a first fluid-absorbing characteristic and the second fluid absorbent material with a second fluid-absorbing characteristic different from the first fluid-absorbing characteristic are configured to wick liquids from the second portion to the first portion to facilitate removal of fluid and potentially infectious materials from the subcutaneous skin layer.
2. The wound healing device of claim 1 wherein said second portion comprises at least one strip and wherein said first end is physically coupled to said first portion.
3. The wound healing device of claim 1 wherein the first fluid absorbent material and the second fluid absorbent material are further constructed to wick infectious materials from the second portion to the first portion.
4. The wound healing device of claim 1 wherein the second portion is one of a plurality of second portions that are in fluid communication with said first portion.
5. The wound healing device of claim 1 wherein the second portion is configured to be placed in the wound between sutures or staples.
6. The wound healing device of claim 1 wherein the second portion is configured to be placed in the wound where no sutures or staples are used to close the wound.
7. The wound healing device of claim 1 wherein the first portion and the second portion are physically connected.
8. The wound healing device of claim 1 wherein the second portion within the wound is configured to allow air to enter the wound.
9. The wound healing device of claim 1 wherein said second portion comprises at least one strip and wherein said first end is stitched to said first portion.
10. The wound healing device of claim 9 wherein said at least one strip comprises a loop.
11. The wound healing device of claim 9 wherein said at least one strip comprises a packing strip.
12. The wound healing device of claim 1 wherein said first portion comprises gauze.
13. The wound healing device of claim 1 wherein said second portion is extendable.
14. The wound healing device of claim 13 wherein said first portion comprises a material cartridge for said second portion, said material cartridge is configured to be activatable to dispense material to permit a length of said second portion to be extended.
15. The wound healing device of claim 13 wherein said second portion comprises at least one strip and wherein said first portion comprises a slack loop configured to be adjustable to permit a length of said at least one strip to be extended.
16. The wound healing device of claim 13 wherein said second portion comprises at least one strip that comprises a slip knot configured to be adjustable to permit a length of said at least one strip to be extended.
17. The wound healing device of claim 13 wherein said second portion comprises a foldable portion configured to be expandable to expand along a length of the wound within the subcutaneous skin layer.
18. The wound healing device of claim 1 wherein said first portion comprises a packing strip.
19. A wound healing device comprising: at least one fluid absorbent material formed into a strand having a first end that is configured to be positioned within a wound in direct contact with a subcutaneous skin layer, said at least one fluid absorbent material strand further comprising a second end; and a dressing portion that is coupled with said second end of said at least one fluid absorbent material strand; and wherein said dressing portion comprises a central portion with a fold line configured to position and facilitate a fold to which said second end is coupled and wherein said dressing portion is adapted to unfold to form a cover over and external to the wound when said first end is positioned within the wound, said at least one fluid absorbent material strand and said dressing portion being a removable device, wherein said at least one fluid absorbent material strand and said dressing portion are constructed to control wicking of liquids from the subcutaneous skin layer to the dressing portion to facilitate transfer of the liquids and material from the wound.
20. The wound healing device of claim 19 wherein the wound is a closed incision and wherein said first end that is configured to be positioned within the wound is positioned in between sutures or staples of the closed incision.
21. The wound healing device of claim 19 wherein the at least one fluid absorbent material strand and the dressing portion are further constructed to control wicking of infectious materials from the subcutaneous skin layer to the dressing portion.
22. The wound healing device of claim 19 wherein the at least one fluid absorbent material strand is one of a plurality of fluid absorbent strands that are in fluid communication with the dressing portion.
23. The wound healing device of claim 19 wherein the at least one fluid absorbent material strand is physically connected to the dressing portion.
24. The wound healing device of claim 19 wherein the at least one fluid absorbent material strand and the dressing portion that are physically separate are configured to be in contact over the wound.
25. The wound healing device of claim 19 wherein the first end within the wound is configured to allow air to enter the wound.
26. An apparatus comprising: a first fluid absorbent material that is configured to be applied over and external to a wound; and a second fluid absorbent material in fluid communication with the first fluid absorbent material, the second fluid absorbent material configured to be positioned within the wound in direct contact with a subcutaneous skin layer to facilitate wicking of liquids and waste materials towards the first fluid absorbent material, wherein the first fluid absorbent material and the second fluid absorbent material are composed of different materials.
27. The apparatus of claim 26 wherein the first fluid absorbent material and the second fluid absorbent material are further configured to wick infectious materials towards the first fluid absorbent material.
28. The apparatus of claim 26 wherein the second fluid absorbent material is one of a plurality of second fluid absorbent materials that are in fluid communication with the first fluid absorbent material.
29. The apparatus of claim 26 wherein the second fluid absorbent material is configured to be placed in the wound between sutures or staples.
30. The apparatus of claim 26 wherein the first fluid absorbent material and the second fluid absorbent material are physically connected.
31. The apparatus of claim 26 wherein the second fluid absorbent material within the wound reduces risk of infection and encourages formation of a fistula within the subcutaneous skin layer, thereby promoting continuing drainage of the liquids from the subcutaneous skin layer subsequent to removal of the second fluid absorbent material from the subcutaneous skin layer approximately 1-3 days after positioned within the wound.
32. The apparatus of claim 26 wherein the second fluid absorbent material encourages formation of a fistula within the subcutaneous skin layer that promotes continuing drainage of the liquids from the subcutaneous skin layer subsequent to removal of the second fluid absorbent material from the subcutaneous skin layer.
33. The apparatus of claim 26 wherein second fluid absorbent material configured within the wound is configured to permit air into the wound.
34. The apparatus of claim 26 wherein said second fluid absorbent material comprises at least one strip physically coupled to said first fluid absorbent material.
35. The apparatus of claim 26 wherein said second fluid absorbent material comprises at least one strip stitched to said first fluid absorbent material.
36. The apparatus of claim 35 wherein said at least one strip comprises a loop.
37. The apparatus of claim 35 wherein said at least one strip comprises a packing strip.
38. The apparatus of claim 26 wherein said first fluid absorbent material comprises gauze.
39. The apparatus of claim 26 wherein said second fluid absorbent material is extendable.
40. The apparatus of claim 39 wherein said first fluid absorbent material comprises a material cartridge for said second fluid absorbent material, said material cartridge is configured to be activatable to dispense material to permit a length of said second fluid absorbent material to be extended.
41. The apparatus of claim 39 wherein said second fluid absorbent material comprises at least one strip and wherein said first fluid absorbent material comprises a slack loop configured to be adjustable to permit a length of said at least one strip to be extended.
42. The apparatus of claim 39 wherein said second fluid absorbent material comprises at least one strip that comprises a slip knot configured to be adjustable to permit a length of said at least one strip to be extended.
43. The apparatus of claim 39 wherein said second fluid absorbent material comprises a foldable portion configured to be expandable to expand along a length of the wound within the subcutaneous skin layer.
44. The apparatus of claim 26 wherein said first fluid absorbent material comprises a packing strip.
45. An apparatus comprising: a first portion that is configured to be applied over and external to a wound in a body, said first portion comprising a first fluid absorbent material; and a second portion is in fluid communication with said first portion at a first end of said second portion, and a different, second end of said second portion is configured to be positioned within the wound in a subcutaneous skin layer, the different, second end of said second portion comprising a second fluid absorbent material, wherein said first portion has a fold line configured to position and facilitate a fold in said first portion to position the different, second end within the wound and said first portion is adapted to unfold to form a cover over the wound when the different, second end is positioned within the wound, and the second portion is configured to facilitate wicking of liquids and materials in the subcutaneous skin layer out of the body from the different, second end of the second portion to the first portion, wherein the first fluid absorbent material and the second fluid absorbent material have different fluid-absorbing characteristics.
46. The apparatus of claim 45 wherein the first portion and the second portion are further configured to wick infectious materials from the different, second end of the second portion to the first portion.
47. The apparatus of claim 45 wherein the second portion is one of a plurality of second portions that are in fluid communication with the first portion.
48. The apparatus of claim 45 wherein the second portion is configured to be placed in the wound between sutures or staples.
49. The apparatus of claim 45 wherein the first portion and the second portion are in physical contact.
50. The apparatus of claim 49 wherein the first portion and the second portion are physically connected.
51. The apparatus of claim 45 wherein the second portion is configured to expand through absorption of the liquids and to be removed from the wound in approximately 1-3 days, wherein removal of the second portion leaves behind a fistula within the subcutaneous skin layer that promotes continuing drainage of the liquids from the subcutaneous skin layer.
52. The apparatus of claim 45 wherein the second portion positioned within the wound in the subcutaneous skin layer is configured to permit air into the wound.
Description
BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS
(1) Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
(24) Referring now to the figures, wherein like reference numerals represent like parts throughout the several views, exemplary embodiments of the present disclosure will be described in detail. Throughout this description, various components may be identified having specific values, these values are provided as exemplary embodiments and should not be limiting of various concepts of the present invention as many comparable sizes and/or values may be implemented.
(25) The wound healing device (WHD) 20 of the present application absorbs fluid from all three layers of skin, removes fluid where infection is most commonalong the incision. The WHD 20 does not clog, does not involve making additional holes in patient and exhibits the highest success rate of any infection reduction system on the highest infection risk patientspatients with multiple additional high risk factors including but not limited to: contaminated incision, diabetes, and malnutrition. As will be discussed in detail, the WHD 20 is a complete fluid absorption system.
(26) As will also be discussed below, the WHD 20 is completely removed from the patient without re-stitching or stapling usually two days following surgery. In many patients once the WHD 20 is removed, no other dressings are necessary. In most cases where an additional light dressing is required, it is usually removed within another day or two.
(27) One of the key features of the WHD 20, as will also be discussed below, is that it is the only device that absorbs fluid and infectious materials at the source during and after the source has formed and the WHD 20 moves the fluid and materials out of the body. Recent data using the WHD 20 cites the infection rate using at 4.2% and in cases where infection did occur, the infection was less severe and covered a smaller area. This data is virtually identical to the probe techniques studies where the patient's wound is cleaned daily with a deep insertion of cotton swabs, for five days following surgery. The probe methodology data is very similar to that related to the WHD 20; with infection rates of 3% and 4% and patients' hospital stays being reduced from 7 to 5 days, per patient. However, even though the probe technique is highly effective, it still requires daily cleaning of wound by physician for five days, and involves significant patient discomfort. It is a labor intensive solution. In contrast, the WHD 20 offers virtually identical results, using very similar concept but without the need of extensive physician labor, potentially high patient discomfort and mental anguish and still only removes the fluid and potentially infectious material after it has collected subcutaneously.
(28) The preferred embodiment of the WHD 20 (see
(29) In fluid communication with the first portion 22 is a second portion 24 that may comprise at least strip 24 that also comprises a fluid-absorbing characteristic. This second portion or strip 24 may comprise a single element of fluid-absorbing characteristic or it may comprise a looped construction, such as that shown by 24A in
(30) The fluid communication of the second portion 24 to the first portion 22 can be achieved in several ways, one of which is by stitching or via any other method of physically-connecting the first 22 and a first end 25A of the second portion 24, as shown by way of example only in
(31) The length of the second portion 24 is approximately 2-3 inches, although the length could vary to 4 inches or even 8 inches, depending upon the size of the patient.
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(34) Moreover, upon removal of the WHD 20/20A from the wound in approximately 1-3 days, removal of the strips 24 leaves behind respective type of fistulae 34 (see
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(36) After the surgery, in the domain of sutures or staples 17 of the skin 14 of the subcutaneous, of the subcutaneous 16, and of the fascia, the wound and subject area 15, may be contaminated or clean contaminated or infected wound in which liquid may accumulate and/or colonize bacteriologically, collecting from any and or all layers.
(37) As mentioned earlier, the absorbent dressing 22 is located on the surface of the wound 15 and subject area. Transfer of liquid and waste material from the wound and subject area to the dressing 22 is realized by capillary transfer and any other method of transfer of the absorbent strip, loop, cord or tube or appendage 24 connected or adjacent to the dressing 22 to facilitate the transfer of liquid and material from the wound area dressing 22 is provided with one or more strip, loop, cord or tube or appendage 24 which is, or is located in the area of the wound 15, infected or potentially infected area and therefore facilitates the flow of liquid and bodily waste materials from the subcutaneous 16 to the dressing absorbent material 22 outside the patient body.
(38) The facilitation of the liquid and bodily materials especially from the incision wound 15, infected or potentially infected area or injury area, from potentially any and all subcutaneous areas and levels 16, into absorbent or liquid extractable strips, loops, cords, tubes or absorbent appendage 24 towards and into the adjacent or attached absorbent materials external to the body.
(39) In particular,
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(44) At this point, the surgeon needs only to secure the first portion (dressing) 22 down onto the skin 14 of the patient using the adhesive border.
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(48) Another key improvement to the WHD 20/20A is the ability to extend the length of the at least one strip 24A. This can be advantageous for a number of reasons. Allowing the surgeon to adjust the length of the at least one strip 24 permits the surgeon to customize the absorbing capability of the present invention 20 based on the patient's physiology. If, by way of example, the patient has a large girth, it may be necessary to extend the length of the at least one strip 24, deeper into the subcutaneous layer 16.
(49) To that end,
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(52) A further variation 20J of the present invention 20 is the use of free absorbent members 24 being placed into the wound in between the staples or sutures 17, wherein the upper ends 24C of the absorbent members are free, as shown most clearly in
(53) It should be understood that it is within the broadest scope of the present invention to include the use of all of the embodiments of the WHD in open wounds also. By way of example only, as shown
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(56) It should be noted that although not required, an anti-microbial composition may be applied to either the first portion 22 and/or the second portion 24.
(57) Thus, the present invention relates to an apparatus/method of wound infection prevention and healing acceleration and life. The WHD 20 provides the effective post-surgical clean contaminated, contaminated, clean and infected incision when the rate of infection potential is considered significant. The apparatus/method may also be used in a variety of medical surgeries interventions and procedures. The present invention 20 can also be used in veterinary medicine.
(58) The apparatus & method for wound infection device (WHD) 20 is useful for preventing SSI infection for the following surgeries including but is not limited to: general surgery procedures, colorectal, OBGYN procedures, urology, vascular surgeries, and neurosurgery procedures. The incisions or wounds closed following their respective surgeries are susceptible to high infection rates and slow patient recovery periods which also impact the physician, staff, hospital, insurer, etc. Moreover, SSI costs hospitals billions of dollars every year in the U.S. and insurance companies do not reimburse hospitals for maladies caused by infection, and corresponding complications, due to surgical site infection.
(59) It should be further understood that the term WHD includes any all of kinds of kits that comprise the WHD and any associated components (e.g., a plurality of WHDs; tools that may be used by the surgeon to insert the second portion 24 into wound site (e.g., pliers, tweezers, dissectors, etc.) that are provided with the WHD 20 itself.
(60) Thus, the apparatus and method for wound infection device (WHD) 20 accelerates the healing process by reducing the healing time by an average of 2 days per patient, which among other things, reduces hospital stay periods.
(61) While the invention has been described in detail and with reference to specific examples thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof.