Fecal containment obstetric drape

Abstract

A device for preventing fecal matter of a patient from contacting a delivery area during the delivery of a child. The device includes a drape configured to be tucked beneath a body of the patient. The device further includes a flap disposed on the drape. The flap is configured to act as a barrier between a rectum and the delivery area such that the fecal matter is prevented from contacting the delivery area.

Description

FECAL CONTAINMENT OBSTETRIC DRAPECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63 / 649,870 filed May 20, 2024, the specification of which is incorporated herein in its entirety by reference.FIELD OF THE INVENTION

[0002] The present invention is directed to a drape for preventing fecal matter from contacting a delivery area during a birthing procedure.BACKGROUND OF THE INVENTION

[0003] Bowel movements are extremely common during the second stage of labor due to the muscles utilized during pushing to bring the infant down the birth canal. Patients are often self-conscious when this occurs, which adds stress to an already overwhelming and exhausting experience. On top of that, providers and nursing staff continuously use and dispose of resources to clean the patient to help alleviate that stress and attempt to maintain a sterile field to deliver the infant. The current standard for sterile under-buttocks draping addresses the collection of blood and other fluids expelled during vaginal delivery, but it does not address fecal contamination or disposal. Thus, there exists a present need for a sterile under-buttocks drape that addresses the collection of blood and fluids as well as fecal matter to minimize contamination and contact with the area where the baby will be delivered.BRIEF SUMMARY OF THE INVENTION

[0004] It is an objective of the present invention to provide devices that allow for preventing fecal matter from contacting a delivery area during a birthing procedure, as specified in the independent claims. Embodiments of the invention are given in the dependent claims. Embodiments of the present invention can be freely combined with each other if they are not mutually exclusive.

[0005] The present invention features a device for preventing fecal matter of a patient from contacting a delivery area during the delivery of a child. The device may comprise a drape configured to be tucked beneath a body of the patient. The device may further comprise a flap disposed on the drape. The flap may be configured to act as a barrierbetween a rectum and the delivery area, such that the fecal matter is prevented from contacting the delivery area.

[0006] The present invention features a method for preventing fecal matter of a patient from contacting a delivery area during the delivery of a child. The method may comprise providing a device comprising a drape and a flap disposed on the drape. The method may further comprise tucking the drape beneath a body of the patient. The method may further comprise attaching the flap to the patient such that the flap acts as a barrier between a rectum and the delivery area, such that the fecal matter is prevented from contacting the delivery area.

[0007] The present invention features an obstetric under-buttocks drape that has an additional flap located above the fluid collection portion. The one-size-fits-all flap will have an adhesive lining at the top that allows for adhesion to the patient’s perineum and across the patient’s back thighs. The flap will not interfere with the delivery of the infant, as it will be located inferior to the vaginal introitus. The flap will improve care during vaginal delivery in 3 ways.

[0008] The flap will stick just above the anus and create a sealed barrier between the sterile field and any defecation. The infant will not encounter any fecal matter, and any lacerations that require repair after delivery will not be at risk for fecal contamination. Providers can remain focused on supporting the patient through their pushing without pausing to wipe fecal matter, dispose of it, and change their gloves before continuing their attention on the patient. Patients may focus on delivering their infant into the world without the added stress of having their loved ones and others witness and tend to their defecation. If access to the rectum is required for any reason, such as 3rd or 4th-degree perineal laceration repair, the adhesive flap can easily be removed. If the use of the attachment is not wanted or needed, the drape can be used as a normal sterile under-buttocks drape.

[0009] One of the unique and inventive technical features of the present invention is the implementation of an adhesive flap disposed on an obstetric drape for acting as a barrier between the rectum and vaginal area of a patient. Without wishing to limit the invention to any theory or mechanism, it is believed that the technical feature of thepresent invention advantageously provides for a safer, cleaner, and less stressful process of delivering a child. None of the presently known prior references or works have the unique inventive technical feature of the present invention.

[0010] Furthermore, the inventive technical feature of the present invention contributed to a surprising result. One of ordinary skill in the art would expect that the introduction of a flap in an obstetric drape, whether it is used or not, would obstruct the delivery area and interfere with the delivery process. The present invention implements a semicircular flap shaped to adhere to the perineum of a patient without contacting the vaginal area or the rectum. Surprisingly, the present invention achieves a non-obstructive flap able to collect fecal matter while all other fluids are collected in the standard collection vessel, allowing for a safer, cleaner, and less stressful process of delivering a child. Thus, the inventive technical feature of the present invention contributed to a surprising result.

[0011] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0012] The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:

[0013] FIG. 1 shows a prior art obstetric drape for collecting fluid during delivery of a child.

[0014] FIG. 2A shows a schematic diagram of the device of the present invention with the flap unattached to the patient.

[0015] FIG. 2B shows a schematic diagram of the device of the present invention with the flap attached to the patient such that it acts as a barrier between the rectum and the delivery area.

[0016] FIG. 3A shows a schematic diagram of a device for preventing fecal matter of apatient from contacting a delivery area during delivery of a child while the flap is not in use.

[0017] FIG. 3B shows a schematic diagram of a device for preventing fecal matter of a patient from contacting a delivery area during delivery of a child while the flap is in use.

[0018] FIG. 3C shows a flow chart diagram of the method for preventing fecal matter of a patient from contacting a delivery area during the delivery of a child of the present invention.

[0019] FIG. 3D shows a schematic diagram of an alternate embodiment of the device for preventing fecal matter of a patient from contacting a delivery area during delivery of a child while the flap is not in use.

[0020] FIG. 3E shows a schematic diagram of an alternate embodiment of the device for preventing fecal matter of a patient from contacting a delivery area during delivery of a child while the flap is in use.

[0021] FIG. 4A shows a diagram of an embodiment of the device of the present invention, where the flap is tucked into the collection vessel.

[0022] FIG. 4B shows a diagram of the embodiment of the device of FIG. 4A, wherein the flap is untucked from the collection vessel.

[0023] FIG. 5 shows a diagram of the device of the present invention with a focus on the adhesive strip. The adhesive strip may be covered by a removable layer until the flap is to be applied to the patient.DETAILED DESCRIPTION OF THE INVENTION

[0024] Following is a list of elements corresponding to a particular element referred to herein:

[0025] 100 device

[0026] 110 drape

[0027] 120 flap

[0028] 130 fluid collection vessel

[0029] 1000 patient

[0030] 1100 delivery area

[0031] The term “spunbond-meltblown-spunbond fabric” is defined herein as a multilayer polypropylene fabric comprising a spunbound layer applied on top of a meltblown layer applied on top of another spunbound layer.

[0032] The term “spunbound” is defined herein as a process where fibers are spun and then directly dispersed into a web by deflectors or air streams.

[0033] The term “meltblown” is defined herein as a process where hot air is blown onto molten thermoplastic resin that is extruded through a linear die containing hundreds of small holes, to form a fine-fibered self-bonded nonwoven web.

[0034] Referring now to FIGs 3A-3B, the present invention features a device (100) for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during delivery of a child. In some embodiments, the device (100) may comprise a drape (110) configured to be tucked beneath a body of the patient (1000). The device (100) may further comprise a flap (120) disposed on the drape (110). The flap (120) may be shaped to act as a barrier between a rectum and the delivery area (1100), such that the fecal matter is prevented from contacting the delivery area (1100).

[0035] In some embodiments, the flap (120) may comprise an adhesive strip configured to adhere to a perineum of the patient (1000), above the rectum of the patient (1000). In some embodiments, the adhesive strip may comprise a width such that the adhesive strip adheres only to the perineum of the patient (1000) without contacting the rectum or the delivery area (1100) of the patient (1000). In some embodiments, the device (100) may further comprise a fluid collection vessel (130) disposed on the drape (110), configured to collect fluid from the patient (1000). In some embodiments, the fluid may comprise blood, vaginal fluid, or a combination thereof. In some embodiments, a material of the drape (110), the flap (120), or a combination thereof may comprise a spunbond-meltblown-spunbond fabric. In some embodiments, a shape of the flap (120) may comprise a semicircle, a hexagon, or a combination thereof. In some embodiments, the delivery area (1100) may comprise a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof.

[0036] Referring now to FIG. 3C, the present invention features a method for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during delivery of a child. In some embodiments, the method may comprise providing a device (100) comprising a drape (110), and a flap (120) disposed on the drape (110) shaped to act as a barrier between a rectum and the delivery area (1100), such that the fecal matter isprevented from contacting the delivery area (1100). The method may further comprise tucking the drape (110) beneath a body of the patient (1000). The method may further comprise attaching the flap (120) to the patient (1000) such that the fecal matter is prevented from contacting the delivery area (1100).

[0037] In some embodiments, the flap (120) may comprise an adhesive strip, wherein the method further comprises adhering the flap (120) to a perineum of the patient (1000), above the rectum of the patient (1000) by the adhesive strip. In some embodiments, the adhesive strip may comprise a width such that the adhesive strip adheres only to the perineum of the patient (1000) without contacting the rectum or the delivery area (1100) of the patient (1000). In some embodiments, the device (100) may further comprise a fluid collection vessel (130) disposed on the drape (110), wherein the method further comprises collecting, by the fluid collection vessel (130), fluid from the patient (1000). In some embodiments, the fluid may comprise blood, vaginal fluid, or a combination thereof. In some embodiments, a material of the drape (110), the flap (120), or a combination thereof may comprise a spunbond-meltblown-spunbond fabric. In some embodiments, a shape of the flap (120) may comprise a semicircle, a hexagon, or a combination thereof. In some embodiments, the delivery area (1100) may comprise a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof.

[0038] Referring now to FIGs 3D-3E, the present invention features a device (100) for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during delivery of a child. The device (100) may comprise a drape (110) configured to be tucked beneath a body of the patient (1000). The device may further comprise a flap (120) disposed on the drape (110), comprising an adhesive strip configured to adhere to a perineum of the patient (1000), above the rectum of the patient (1000). The flap (120) may be shaped to act as a barrier between a rectum and the delivery area (1100) such that the fecal matter is prevented from contacting the delivery area (1100). The device (100) may further comprise a fluid collection vessel (130) disposed on the drape (110), configured to collect fluid from the patient (1000).

[0039] In some embodiments, the adhesive strip may comprise a width such that the adhesive strip adheres only to the perineum of the patient (1000) without contacting therectum or the delivery area (1100) of the patient (1000). In some embodiments, a shape of the flap (120) may comprise a semicircle, a hexagon, or a combination thereof. In some embodiments, the delivery area (1100) may comprise a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof.

[0040] The present invention features a device (100) for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during the delivery of a child. In some embodiments, the device (100) may comprise a drape (110) configured to be tucked beneath a body of the patient (1000). The device (100) may further comprise a flap (120) disposed on the drape (110). The flap (120) may be configured to act as a barrier between a rectum and the delivery area (1100) such that the fecal matter is prevented from contacting the delivery area (1100).

[0041] In some embodiments, the drape (110), the flap (120), or a combination thereof may be sterilized. In some embodiments, the flap (120) may comprise an adhesive strip configured to adhere to a perineum of the patient (1000), above the rectum of the patient (1000). In some embodiments, the device (100) may further comprise a fluid collection vessel (130) disposed on the drape (110), configured to collect fluid from the patient (1000). In some embodiments, the fluid may comprise blood, vaginal fluid, or a combination thereof. In some embodiments, a material of the drape (110) may comprise a spunbond-meltblown-spunbond fabric. In some embodiments, a material of the flap (120) may comprise a spunbond-meltblown-spunbond fabric. In some embodiments, the delivery area (1100) may comprise a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof. In some embodiments, the delivery area (1100) may further comprise an area where the child is going to be delivered (e.g. below the vagina).

[0042] The present invention features a method for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during the delivery of a child. In some embodiments, the method may comprise providing a device (100) comprising a drape (110) and a flap (120) disposed on the drape (110). The method may further comprise tucking the drape (110) beneath a body of the patient (1000). The method may further comprise attaching the flap (120) to the patient (1000) such that the flap (120) acts as a barrier between a rectum and the delivery area (1100), such that the fecal matter isprevented from contacting the delivery area (1100).

[0043] In some embodiments, the method may further comprise sterilizing the drape (110), the flap (120), or a combination thereof. In some embodiments, the flap (120) may comprise an adhesive strip. The method may further comprise adhering the flap (120) to a perineum of the patient (1000), above the rectum of the patient (1000) by the adhesive strip. In some embodiments, the device (100) may further comprise a fluid collection vessel (130) disposed on the drape (110). The method may further comprise collecting, by the fluid collection vessel (130), fluid from the patient (1000). In some embodiments, the fluid may comprise blood, vaginal fluid, or a combination thereof. In some embodiments, a material of the drape (110) may comprise a spunbond-meltblown-spunbond fabric. In some embodiments, a material of the flap (120) may comprise a spunbond-meltblown-spunbond fabric. In some embodiments, the delivery area (1100) may comprise a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof. In some embodiments, the delivery area (1100) may further comprise an area where the child is going to be delivered (e.g. below the vagina).

[0044] In some embodiments, the drape may comprise a surface, a first edge, and an opposing second edge. In some embodiments, a flap may be disposed on the drape, the flap having a first flap edge attached to the surface of the drape and an opposing second flap edge having an adhesive strip. In some embodiments, the flap may be positioned on the drape closer to the first edge than the second edge. In some embodiments, a fluid collection device may be disposed on the drape, comprising a first end and a second end. In some embodiments, the first end of the fluid collection device may be open and the second end of the fluid collection device may be closed. In some embodiments, the first end of the fluid collection device may be facing the first edge of the drape. In some embodiments, the fluid collection device may be positioned on the drape between the second edge of the drape and the flap.

[0045] In some embodiments, a shape of the flap (120) may comprise a semicircle, a hexagon, a combination thereof, or any other polygonal shape. In some embodiments, the flap (120) may be shaped such that it fits the shape of the perineum of the patient, the patient’s buttocks, the patient’s inner thighs, the patient’s bottom-of-thighs, or acombination thereof. In some embodiments, the adhesive strip of the flap (120) may comprise a rectangular strip of adhesive material disposed along a perimeter of the flap (120) (e.g., the second flap edge). In some embodiments, the adhesive strip may comprise a width of 1 to 2 inches. In some embodiments, the adhesive strip may comprise a width about matching the distance between the rectum and the vaginal area such that the adhesive strip does not contact the rectum or the vaginal area. In some embodiments, as depicted in FIG. 5, the adhesive strip may comprise a cover layer disposed over the adhesive such that the adhesive is covered. The cover layer may be removed when the flap is ready for use.

[0046] In some embodiments, the fluid collection vessel (130) may comprise a plastic material (e.g., polyethylene). The fluid collection vessel (130) may comprise a funnel shape, a pouch shape, or a combination thereof. In some embodiments, the fluid collection vessel (130) may be fluidly coupled to a container configured to capture the fluid, such that the fluid captured by the fluid collection vessel (130) flows into the container. In some embodiments, the fluid may comprise blood, vaginal fluid, amniotic fluid, placenta, or a combination thereof. In some embodiments, the delivery area (1100) may comprise current or expected incisions on or around the perineum (e.g., for episiotomy), below the bikini line (e.g., for a C-section), or a combination thereof.

[0047] In some embodiments, the drape may comprise a length of 100 to 120 cm. In some embodiments, the drape may comprise a width of 90 to 110 cm. In some embodiments, the flap may be secured to the drape such that a first edge of the flap is secured about 28 cm from the superior edge of the drape. In some embodiments, the flap may comprise a length of 30 to 40 cm. In some embodiments, the flap may comprise a width of 60 to 70 cm. In some embodiments, the flap may be tucked into the fluid collection vessel when not in use. In some embodiments, the flap may be tucked under the fluid collection vessel when not in use. Examples of this are depicted in FIGs 4A-4B.

[0048] As used herein, the term “about” refers to plus or minus 10% of the referenced number.

[0049] Although there has been shown and described the preferred embodiment of thepresent invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as “consisting essentially of’ or “consisting of’, and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase “consisting essentially of’ or “consisting of’ is met.

[0050] The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.

Claims

WHAT IS CLAIMED IS:

1. A device (100) for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during delivery of a child, the device (100) comprising: a. a drape (110) configured to be tucked beneath a body of the patient (1000); and b. a flap (120) disposed on the drape (110), wherein the flap (120) is shaped to act as a barrier between a rectum and the delivery area (1100), such that the fecal matter is prevented from contacting the delivery area (1100).

2. The device (100) of claim 1 , wherein the flap (120) comprises an adhesive strip configured to adhere to a perineum of the patient (1000), above the rectum of the patient (1000).

3. The device (100) of claim 2, wherein the adhesive strip comprises a width such that the adhesive strip adheres only to the perineum of the patient (1000) without contacting the rectum or the delivery area (1100) of the patient (1000).

4. The device (100) of claim 1 further comprising a fluid collection vessel (130) disposed on the drape (110), configured to collect fluid from the patient (1000).

5. The device (100) of claim 4, wherein the fluid comprises blood, vaginal fluid, or a combination thereof.

6. The device (100) of claim 1 , wherein a material of the drape (110), the flap (120), or a combination thereof comprises a spunbond-meltblown-spunbond fabric.

7. The device (100) of claim 1 , wherein a shape of the flap (120) comprises a semicircle, a hexagon, or a combination thereof.

8. The device (100) of claim 1 , wherein the delivery area (1100) comprises a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof.

9. A method for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during delivery of a child, the method comprising: a. providing a device (100) comprising: i. a drape (110); and ii. a flap (120) disposed on the drape (110) shaped to act as a barrier between a rectum and the delivery area (1100), such that the fecal matter is prevented from contacting the delivery area (1100); i ib. tucking the drape (110) beneath a body of the patient (1000); and c. attaching the flap (120) to the patient (1000) such that the fecal matter is prevented from contacting the delivery area (1100).

10. The method of claim 9, wherein the flap (120) comprises an adhesive strip, wherein the method further comprises adhering the flap (120) to a perineum of the patient (1000), above the rectum of the patient (1000) by the adhesive strip.

11. The method of claim 10, wherein the adhesive strip comprises a width such that the adhesive strip adheres only to the perineum of the patient (1000) without contacting the rectum or the delivery area (1100) of the patient (1000).

12. The method of claim 9, wherein the device (100) further comprises a fluid collection vessel (130) disposed on the drape (110), wherein the method further comprises collecting, by the fluid collection vessel (130), fluid from the patient (1000).

13. The method of claim 12, wherein the fluid comprises blood, vaginal fluid, or a combination thereof.

14. The method of claim 9, wherein a material of the drape (110), the flap (120), or a combination thereof comprises a spunbond-meltblown-spunbond fabric.

15. The method of claim 9, wherein a shape of the flap (120) comprises a semicircle, a hexagon, or a combination thereof.

16. The method of claim 9, wherein the delivery area (1100) comprises a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof.

17. A device (100) for preventing fecal matter of a patient (1000) from contacting a delivery area (1100) during delivery of a child, the device (100) comprising: a. a drape (110) configured to be tucked beneath a body of the patient (1000); b. a flap (120) disposed on the drape (110), comprising an adhesive strip configured to adhere to a perineum of the patient (1000), above the rectum of the patient (1000), wherein the flap (120) is shaped to act as a barrier between a rectum and the delivery area (1100) such that the fecal matter is prevented from contacting the delivery area (1100); and c. a fluid collection vessel (130) disposed on the drape (110), configured to collect fluid from the patient (1000).

18. The device (100) of claim 17, wherein the adhesive strip comprises a width such that the adhesive strip adheres only to the perineum of the patient (1000) without contacting the rectum or the delivery area (1100) of the patient (1000).

19. The device (100) of claim 17, wherein a shape of the flap (120) comprises a semicircle, a hexagon, or a combination thereof.

20. The device (100) of claim 17, wherein the delivery area (1100) comprises a vaginal area, one or more incision zones, one or more potential incision zones, or a combination thereof.

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