Multilayer surgical binder

Abstract

The present invention is a multilayer surgical wrap that includes a top layer including a barrier material having a first section and a second section. Each of the first and second sections are releasably attached to at least one attachment substrate and a bottom layer fabricated as a surgical wrap to provide compression to protect a surgical site that has been closed after surgery. In a preferred embodiment, the attachment substrate may have one or two sections.

Description

MULTI LAYER SURGICAL BINDER

[0001] This application claims the benefit under 35 U.S.C. § 119 (e) from U.S. Provisional Application No. 63 / 629,005 filed September 8, 2023 and further claims priority to U.S. Patent Application No. 18 / 827,426 filed September 6, 2024 which applications sre incorporated herein by reference in their entireties.FIELD OF THE INVENTION

[0002] The field of the invention relates generally to medical devices, particularly to surgical devices, and more particularly to post-operative surgical wraps.BACKGROUND

[0003] . After completion of surgery, the incisions are closed by sutures, staples or other mechanical means of rejoining the tissue. In surgeries of the trunk and abdomen, the closed wounds are then typically covered with a dressing. The most usual procedure then is to move the patient off the surgical table to a bed or gurney by sitting them up and lifting them physically, and only then placing a secondary securement of compression binder to provide extra support to the wound site. Another typical process is to roll the patient side to side to remove the surgical drape and place a binder under them before securing the binder. In both cases the physical movement induces high strains on the freshly closed wound, and movement of the sutures and tissue can delay healing of the incision. The effects of this can be immediate with sutures or securement failing, or may manifest as poor and delayed healing that can lead to re-opening of the wound site.

[0004] Therefore, what is needed is a wrap designed to hold both sutures and dressing in the upper body in place after surgery that can be positioned when the patient is placed on the operating table The placement of this binder on the surgical table is enabled by use of a barrier layer(s) between the patient and the binder that can be easily removed with minimal manipulation of the patient because it is designed for easy removal under patient by inclusion of perforations or other method to facilitate removal.SUMMARY OF THE INVENTION

[0005] The present invention broadly comprises a multilayer surgical wrap comprising: a top layer that includes a barrier material having a first section and a second section wherein each of the first and second sections are releasably attached to at least one attachment substrate; and, a bottom layer fabricated as a surgical wrap or binder. The top layer (directly under the patient) can be absorbent or water repellent, but in all cases should function as a barrier, having a non- permeable bottom that prevents the underlying surgical wrap from becoming contaminated.

[0006] A surgical wrap is defined as a covering or support wrapped over / around a sutured incision and its dressing to hold the dressing in place and support the sutured incision to prevent its opening or rupture by minimizing strain on that area. In an alternate embodiment, the inventive wrap may also include a middle antimicrobial layer having two separate sections, each attached to either the same attachment substrate or a separate attachment substrate. Any of the layers may also have antimicrobial properties, but most importantly the binder that comprises the bottom-most layer is covered by the top layer and, if present, the middle layer.

[0007] The present invention also broadly comprises a method for applying a multilayer surgical wrap to a least one incision located at a surgical site on a surgical patient comprising: positioning the wrap in an open condition on the opposite of the surgical site; performing at least one surgical procedure, wound dressing change or wound securement repair;; cleaning at least a portion of the surgical site with a first section of the top layer; removing the first section from the top layer; cleaning a remaining portion of the surgical site with a section of the top layer; removing the second section from the top layer; and, wrapping a bottom layer of the multilayer wrap over the surgical site. The multilayer surgical wrap includes a top layer including a material having a first section and a second section wherein each of the first and second section are releasably attached to at least one attachment substrate; and, a bottom layer fabricated as a surgical dressing. The multilayer surgical wrap may also include a middle layer which may possess antimicrobial properties that is removed in a similar manner to the top layer. The middle layer will cover the bottom layer is similar fashion as the top layer.

[0008] One object of the invention is to provide a surgical binder that is placed under a patient that includes one or more upper layers that cover the binder and that absorb or otherwise prevent surgical blood and detritus from contaminating the binder.

[0009] A second object of the invention is to provide a surgical wrap having at least two layers that enables easy removal of the layers that receive and collect any debris and blood, i.e. functioning as an effective surgical drape.

[0010] A third object of the invention is to prevent rupturing of surgical stitches caused by extensive manipulation of the patient while trying to remove the surgical drape from under a patient.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0011] The nature and mode of the operation of the present invention will now be more fully described in the following detailed description of the invention taken with the accompanying drawing Figures, in which:

[0012] Figure 1 depicts an operating table covered by the inventive surgical wrap;

[0013] Figure 1 A depicts an operating table covered by a surgical drape of the prior art.

[0014] Figure 2 schematically depicts surgeons performing an abdominal incision with the patient lying on the inventive surgical wrap;

[0015] Figure 2A schematically depicts a second patient undergoing an abdominal incision with the patient lying on a prior art surgical drape;

[0016] Figures 3 and 3A demonstrate the same abdominal incisions can be performed on both the inventive surgical wrap and prior art surgical drape, respectively, that generate a similar amount of blood and detritus, indicated by the irregular blotches;

[0017] Figures 4 depicts surgical waste and blood absorbed on the upper layers of the inventive surgical wrap as indicated by the irregular blotches;

[0018] 4A shows surgical waste and blood absorbed on the prior art drape under the patient;

[0019] Figures 5A and 5B demonstrate from each side the ease of removal of the upper layers of the inventive binder directly under the patient after the incisions are closed and dressed;

[0020] Figure 6 depicts the surgeon wrapping the support layer around the patient’s abdominal incisions without moving the patient;

[0021] Figures 7, 7A, and 7B depict the typically significant movement of the patient necessary to remove the prior art drape from under the patient;

[0022] Figures 8, 8 A, and 8B show the minimal movement of the patient after the inventive binder is secured around the patient; and,

[0023] Figure 9 depicts an enlarged view of the ruptured sutures caused by the movement of the patient after removal of the surgical drape.DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0024] At the outset, it should be appreciated that like drawing numbers on different drawing views identify identical structural elements of the invention. It also should be appreciated that figure proportions and angles are not always to scale in order to clearly portray the attributes of the present invention.

[0025] While the present invention is described with respect to what is presently considered to be the preferred embodiments, it is understood that the invention is not limited to the disclosed embodiments. The present invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

[0026] Furthermore, it is understood that this invention is not limited to the particular methodology, materials and modifications described and as such may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to limit the scope of the present invention, which is limited only by the appended claims.

[0027] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention belongs. It should be appreciated that the term “substantially” is synonymous with terms such as "nearly", "very nearly”, “about", "approximately", "around", "bordering on", "close to", "essentially", "in the neighborhood of', “in the vicinity of’, etc., and such terms may be used interchangeably as appearing in the specification and claims. It should be appreciated that the term "proximate" is synonymous with terms such as "nearby", "close", "adjacent", "neighboring", "immediate", "adjoining", etc., and such terms may be used interchangeably as appearing in thespecification and claims. Although any methods, devices or materials similar or equivalent to those described herein can be used in the practice or testing of the invention, the preferred methods, devices, and materials are now described. Unless otherwise specified the words “wrap” and “binder” can be used interchangeably.

[0028] Adverting to the drawings, Figure 1 is schematic front view of the open multilayer inventive surgical wrap 10 (“wrap 10”) as it would be on an operating table T. Wrap 10 includes a top layer 20 that possesses two separate sections 20a and 20b that are releasably attached to each other. Such releasable attachment 21 can be a perforated joint, pressure sensitive adhesive (psa), a hook and loop attachment such as VELCRO® or other easily releasable connection known to those with skill in the art. Bottom layer 22 that is made of typical surgical wrap or binder material well known in the art that can be bound around the patient after an operation is performed. Top layer 20 is non-permeable to prevent blood and surgical detritus (collectively “surgical waste” or “waste”) from reaching and thus contaminating bottom layer 22 as discussed below.

[0029] In one embodiment, top layer 20 may include antimicrobial materials, such as silver, peroxide or other antimicrobial agents in the top layer. In an alternate embodiment seen in Figure 1, an additional middle layer 24, for example a “microbial barrier 24 may be positioned between top layer 20 and bottom layer 22 to act as a microbial and / or surgical barrier between the absorbent layer 20 and bottom wrapping layer 22. Middle layer 24 is divided into two sections 24a and 24b directly under sections 20a and 20b. In the embodiment shown, sections 20a and 24a and sections 20b and 24b, respectively, may be attached to the same sides of the same or separate attachment substrate 21. Top layer 20 catches any surgical waste produced during surgery and shields bottom wrap layer 22 from the waste. It will be recognized that the components of wrap 10 as described above are separate in Figure 1 and subsequent drawings for clarity but at the during use are in contact with each other to form a complete wrap as well table T, however, each component is separable from each other as described below. Both top layer 20 and, if present, middle layer 24 are larger enough to cover bottom binder layer 22 to prevent surgical waste from contaminating bottom layer 22 during the operation.

[0030] Figure 1A depicts an example of a prior art operating table cover lacking the microbial and / or surgical barriers attached to release points described above. In the embodiment shown, drape D is not a surgical wrap suitable for use as a post operation binder as it will most probably become contaminated during an operation

[0031] As will be detailed in the discussion below, inventive wrap 10 is designed to overcome the tendency of sutures, particularly abdominal sutures to open after an operation because of the need that detritus and waste be cleaned from the patient’s torso before the dressing is wrapped. It is well known in the surgical field that even well placed sutures can rupture or partly move under strains from body movement and manipulation, which is why compression is often applied to reduce strain on the wound site.

[0032] Figure 2 depicts surgeons S performing an abdominal incision with patient P lying in a supine position on the inventive surgical wrap 10, while Figure 2A schematically depicts a second patient undergoing an abdominal incision with the patient lying on a table cover demonstrating that the same operations can be performed on both the inventive wrap 10 and the prior art drape D. Figures 3 and 3A demonstrate that the same type of abdominal incisions I or other types of incisions that typically generate approximately the same amount of blood and surgical detritus can be performed using both wrap 10 and prior art wrap W. Similarly, Figures 4 and 4A illustrate that similar dressings are used to cover incisions I regardless of the surgical wrap used in the operation. It can be seen that blood is on layers 20 and 24 on wrap 10 while blood and waste are on the drape or cover D.

[0033] Figures 5 and 5A demonstrate the ease of removal of the surgical layers, i.e., top layers 20a and 20b (collectively “layers 20”) and microbial barriers 24a and 24b directly under the patient after the incisions are closed. Surgeon S pulls (either separately or together) barrier 24 and top layer 22 from underneath patient P by pulling them from releasable attachment substrate 21 (not seen but located approximately under the supine patient in the middle of wrap 10 as seen in Figure 1). The advantage of inventive wrap 10 over the prior art drape D is that little or no movement of patient P is needed to remove upper protective layers 20 and 24 enabling uncontaminated bottom layer 20 to be wrapped around undisturbed incisions I while significant movement is required to completely remove drape D from under patient P and place a surgical wrap under patient in order to wrap and support the abdominal incisions. Figure 6 shows bottom binder layer 22 being wrapped around patient P to support the sutures. Releasable attachment substrates may be, but are not limited to, perforated connections between sections 20a and 20b, suitable adhesives attaching each section to each other or to a common attachment substrate, or other attachment substrates or methods that allow the user to easily pull a top layer 20 or middle layer 24 from underneath a patient P with minimal movement of patient hem / herself.

[0034] Figure 7 demonstrates the degree patient P must be rolled to the side to remove drape D after the incisions are closed. To remove drape D and any other items and other any surgical barriers that were originally placed under patient P, patient P must be rolled considerably as seen in the figure. Alternatively, or additionally, patient P may need to be rolled to the opposite or lifted up off the cover to remove drape D as seen in Figures 7A and 7B. This disruptive movement is also necessary to place a binder under the patient or to move a patient to another surface to apply a separate binder. This extensive movement significantly increases the chances of rupturing the sutures thereby often requiring replacing the stitches in the same location as seen in Figure 9. In contrast, Figures 8 and 8A demonstrate the minimal movement of the patient to move the patient because of the inventive surgical wrap is already in place around the incision as explained above.

[0035] It can be seen by the description and accompanying figures that using the inventive multilayer surgical wrap 10 for binding dressings on abdominal sutures provides the advantage of minimal disturbance of dressings and more importantly, minimizes the chance of disrupting sutures in locations when the absorbent layer 20 is removed from under the patient. Using at the most a small lateral roll to the side each of the patient after sutures and dressings are applied allows the two sections of protective layer 20a and 20b ( and / or barrier layers 24a and 24b) of the inventive wrap 10 to be removed by pulling to easily release the layers from each of their attachment points 21 in a less disruptive manner than would be necessary by removing one or more layers, including drape D that each extend as a single unitary (s) under the patient, thereby protecting the integrity of the sutures. It will be noted that during the operation layers 22 and 24 prevent surgical waste from contacting and contaminating bottom layer 20 thus allowing uncontaminated bottom layer 20 to be wrapped around the torso of patient P. Persons having skill in the art will recognize that surgical wrap 10 with releasable sections 20a-20b and / or 24a- 24b can be used on arms, legs, chest, upper and lower torso and other parts of the body in a similar manner so as not to significantly move the limbs to place a surgical wrap under the limbs. It should also be noted that wrap 10 can be place under patient P when that patient is in a prone or side position as well as the prone position depicted in the figures. For example, surgical wrap 10 is suitable for spinal surgery where the patient would be in the prone position.

[0036] Thus, it is seen that the objects of the invention are efficiently obtained, although changes and modifications to the invention should be readily apparent to those having ordinary skill in the art, which changes would not depart from the spirit and scope of the invention as claimed.

Claims

Claims1. A multilayer surgical wrap comprising: a top layer having a first section and a second section wherein each of said first and second section are releasably attached to at least one attachment substrate; and, a bottom layer fabricated as a surgical wrap; wherein said top layer is sized to completely cover said bottom layer.

2. The multilayer surgical wrap of claim 1 further comprising a middle layer wherein said middle layer includes two separate sections wherein each separate section is releasably attached to said at least attachment substrate; wherein said middle layer is sized to completely cover said bottom layer.

3. The multilayer surgical wrap of claim 2 wherein said each of said two separate sections of said middle layer are attached to a second at least attachment substrate.

4. The multilayer surgical wrap of claim 1 further comprising an anti-contamination barrier backing in said top layer.

5. The multilayer surgical wrap of claim 1 wherein said top layer includes antimicrobial properties.

6. The multilayer surgical wrap of claim 1 wherein said bottom layer includes antimicrobial properties.

7. The multilayer surgical wrap of claim 1 wherein one of said at least one attachment substrate is on said first section.

8. The multilayer surgical wrap of claim 1 wherein one of said at least one attachment substrate is on said second section.

9. The multilayer surgical wrap of claim 2 wherein said at least one attachment substrate is on said first section10. The multilayer surgical wrap of claim 2 wherein said at least one attachment substrate is on said second section.

11. A method for applying a multilayer surgical wrap to a least one incision located at a surgical site on a surgical patient wherein said multilayer surgical wrap includes: a top layer including having a first section and a second section wherein each of said first and second section are releasably attached to at least one attachment substrate; and, a bottom layer fabricated as a surgical wrap / binder ; said method comprising: positioning said wrap in an open condition on the opposite of said surgical site; removing said first section of said top layer from said at least one attachment substrate; removing said second section of said top layer from said attachment substrate; and, wrapping a bottom layer of said multilayer wrap over said surgical site;12. The method of claim 11 wherein said multilayer surgical wrap further comprises a middle layer wherein said middle layer includes two separate sections wherein each separate section is releasably attached to said at least attachment substrate.

13. The method of claim 11 further comprising: removing said first section of said middle layer from said at least one attachment substrate; and, removing said second section of said middle layer from said at least one attachment substrate.

14. The method of claim 12 further comprising: cleaning at least a portion of said surgical site with a first section of said top layer; and, cleaning a remaining portion of said surgical site with a second section of said top layer.

15. The method of claim 11 further comprising performing at least one medical procedure.

16. The method of claim 11 wherein said surgical site is on an arm.

17. The method of claim 11 wherein said surgical site is on a leg.

18. The method of claim 11 wherein said surgical site is on the back.

19. The method of claim 11 wherein said surgical site is on the upper torso.

20. the method of claim 11 wherein said surgical site in on the lower torso.

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