Medical containment device

Abstract

A low-profile medical device for containing a wound or surgical site includes a ring-shaped body defining an interior, a self-sealing gel contained within the interior, and an attachment pad for removably securing the device to a patient. The device is mounted on a patient such that the body surrounds the wound or surgical site and the gel covers the wound or surgical site, inhibiting contamination to or from the wound or surgical site. A surgical instrument may access the wound or surgical site by insertion through the gel, which forms a seal around the instrument upon insertion and seals the entry site upon removal of the instrument.

Description

033659059795MEDICAL CONTAINMENT DEVICECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority to United States provisional patent application serial no. 63724987, filed November 26, 2024, for MEDICAL CONTAINMENT DEVICE, incorporated herein by reference.FIELD OF THE INVENTION

[0002] A low-profile medical device for containing a wound or surgical site includes a ring-shaped body defining an interior, a self-sealing gel contained within the interior, and an attachment pad for removably securing the device to a patient. The device is mounted on a patient such that the body of the device surrounds the wound or surgical site and the gel covers the wound or surgical site, inhibiting contamination to or from the wound or surgical site. A surgical instrument may access the wound or surgical site by insertion through the gel, which forms a seal around the instrument upon insertion and seals the entry site upon removal of the instrument.BACKGROUND OF THE INVENTION

[0003] Spaceflight and other microgravity environments are challenging locations for addressing healthcare issues. While there is always a need to protect surgical sites and wounds from contamination from the environment, there is an additional need to protect the environment from contamination from surgical sites and wounds. Without significant gravity, blood or other bodily fluids may float away from a wound or during a surgical procedure, posing a health and safety hazard to others in the environment. A need exists for a medical containment device for containing a wound or surgical site while still allowing access to the wound or surgical site. Preferably, the device would be physically small, lightweight, and suitable for long-term storage, while remaining available for immediate use in the event of a health emergency, such as an open wound in a space vehicle, emergency surgery in a space station or on the surface of another celestial body. Such a device would also be useful in earthbound medical applications.SUMMARY

[0004] The present invention addresses this need by providing a low-profile medical containment device. The device is useful for (i) containing a site for minimally033659059795 invasive surgical instrument placement, (ii) containing a site of skin trauma or other wound until care can be provided, (iii) providing a sealed enclosure for wound dressing that must be protected from outside contamination or moisture, (iv) containing a site of skin trauma or other wound to prevent bodily fluids from contaminating the outside environment, and (v) other related situations wherein tissue containment is advantageous. In one embodiment, the present invention is a medical containment device comprising a body, the body including a top, a bottom opposite the top, an exterior side extending between the top and the bottom, an interior side opposite the exterior side, a central axis extending through the body substantially perpendicular to the exterior side and substantially perpendicular to the interior side, a lower inner flange extending from the interior side at the bottom, the lower inner flange extending substantially perpendicularly toward the central axis, an upper inner flange extending from the interior side at the top, the upper inner flange extending substantially perpendicularly toward the central axis, wherein the top includes a top opening defined by the upper inner flange, wherein the bottom includes a bottom opening defined by the lower inner flange, and wherein the body includes an interior defined by the interior side, upper inner flange, top opening, lower inner flange and bottom opening; an attachment pad including a central hole, wherein the attachment pad is attached to the bottom of the body, and wherein the top opening, bottom opening, and central hole are aligned along the central axis; and a transparent gel sized and shaped to fit within the interior of the body. In some embodiments, the attachment pad includes an upper surface and a lower surface opposite the upper surface, and, wherein the upper surface is attached to the bottom of the body. In further embodiments, the upper surface is composed of a wound dressing material and wherein the lower surface is composed of a surgical drape material. In certain embodiments, the lower surface includes a biocompatible adhesive. In some embodiments, the body includes a lower outer flange extending from the exterior side at the bottom, the lower outer flange extending substantially perpendicularly away from the central axis. In further embodiments, the lower outer flange is formed of a mesh structure. In certain embodiments, the gel is a transparent thermoplastic elastomer. In some embodiments, the gel has a hardness value within the range of 5 to 50 Shore OO, within the range of 20 to 30 Shore OO, within the range of 22 to 26 Shore OO, or is about 24 Shore OO. In further033659059795 embodiments, the body is manufactured of 3-D printed material. In certain embodiments, the body is manufactured from a thermoplastic polyurethane material with a hardness value within the range of 70 to 100 Shore A, within the range of 80 to 90 Shore A, or is about 85 Shore A.

[0005] It will be appreciated that the various systems and methods described in this summary section, as well as elsewhere in this application, can be expressed as a large number of different combinations and subcombinations. All such useful, novel, and inventive combinations and subcombinations are contemplated herein, it being recognized that the explicit expression of each of these combinations is unnecessary.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] A better understanding of the present invention will be had upon reference to the following description in conjunction with the accompanying drawings.

[0007] FIG. 1 A depicts a top perspective view of a medical containment device.

[0008] FIG. 1 B depicts a top view of the medical containment device.

[0009] FIG. 1 C depicts a side view of the medical containment device.

[0010] FIG. 2 depicts the medical containment device mounted on the abdomen of a subject.

[0011] FIG. 3 depicts the medical containment device mounted on the subject with a trocar and surgical instrument inserted therethrough.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The details of one or more embodiments of the presently-disclosed subject matter are set forth in this document. Modifications to embodiments described in this document, and other embodiments, will be evident to those of ordinary skill in the art after a study of the information provided in this document. The information provided in this document, and particularly the specific details of the described exemplary embodiments, is provided primarily for clarity of understanding and no unnecessary limitations are to be understood therefrom. In case of conflict, the specification of this document, including definitions, will control.

[0013] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the presently-disclosed subject matter belongs. Although any methods,033659059795 devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the presently-disclosed subject matter, representative methods, devices, and materials are now described.

[0014] Following long-standing patent law convention, the terms “a”, “an”, and “the” refer to “one or more” when used in this application, including the claims. Thus, for example, reference to “a cell” includes a plurality of such cells, and so forth.

[0015] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in this specification and claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently-disclosed subject matter. As used herein, the term “about,” when referring to a value or to an amount is meant to encompass variations of ±10% of the most precise digit in the value or amount (e.g., “about 1” refers to 0.9 to 1.1 , “about 1.1” refers to 1.09 to 1.11 , etc.). The term “substantially,” when modifying a term associated with a number, has the same meaning as “about” (e.g., “substantially perpendicular” to an element means an orientation within ±10% of 90 degrees with respect to that element).

[0016] As used herein, ranges can be expressed as from “about” one particular value, and / or to “about” another particular value. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11 , 12, 13, and 14 are also disclosed.

[0017] The presently-disclosed subject matter relates to a low-profile medical containment device. Referring now to FIGS. 1A-1 C, 2 and 3, the medical containment device 10 includes a generally ring-shaped body 12, the body including a top 14, a bottom 16 opposite the top 14, an exterior side 18 extending between the top 14 and the bottom 16, and an interior side 20. For the purposes of orientation, the distance between the top 14 and bottom 16 is referred to as the height and a central axis 22 extends through the center of the body 12 substantially perpendicular to the exterior and interior sides 18, 20 and substantially parallel to the height.033659059795

[0018] The body 12 includes a lower outer flange 24 extending substantially perpendicularly away from the axis 22 from the exterior side 18 at the bottom 16. The body 12 further includes a lower inner flange 26 extending substantially perpendicularly toward the axis 22 from the interior side 20 at the bottom 16. The body 12 further includes an upper inner flange 28 extending substantially perpendicularly toward the axis 22 from the interior side 20 at the top 14. The top 14 includes a top opening 30 as defined by the upper inner flange 28, or more specifically, an inner perimeter 29 of the upper inner flange 28. The top opening 30 and inner perimeter 29 are circular in the depicted embodiment, so the inner perimeter 29 is an inner circumference in this embodiment. The bottom 16 includes a bottom opening 32 as defined by the lower inner flange 26, or more specifically, an inner perimeter 27 of the lower inner flange 26. The bottom opening 32 and inner perimeter 27 are circular in the depicted embodiment, so the inner perimeter 27 is an inner circumference in this embodiment. The body 12 includes an interior 34 defined by the interior side 20, upper inner flange 28, top opening 30, lower inner flange 26 and bottom opening 32.

[0019] In preferred embodiments, the body 12 is formed of a flexible, resilient material. In certain embodiments, the body 12 is formed of a flexible, resilient plastic, such as, for example, polyurethane. In some embodiments, the body 12, including flanges 24, 26, 28, is of unitary construction formed by 3-D printing using a thermoplastic polyurethane material with a hardness value within the range of 70 to 100 Shore A, within the range of 80 to 90 Shore A, or about 85 Shore A. In some embodiments, as most easily seen in FIGS. 1 A and 1 B, the lower outer flange 24 is formed of a mesh structure rather than as a solid piece to reduce weight and increase flexibility.

[0020] The medical containment device 10 further includes an attachment pad 36 including an upper surface 38, a lower surface 40 opposite the upper surface 38, and a central hole 42 extending between the upper surface 38 and the lower surface 40. Upper surface 38 is attached to the bottom 16 of the body 12. In some embodiments, the attachment pad 36 is substantially circular. In other embodiments, the attachment pad 36 may be oval in shape or another regular or irregular shape. The upper surface 38 is attached to the bottom 16 of the body 12 with the central hole 42 aligned with the bottom opening 32. The lower surface 40 includes a biocompatible033659059795 adhesive material for removably attaching the medical containment device 10 to a subject, such as, to the skin of a patient. In some embodiments, the upper surface 38 is composed of wound dressing material, such as, for example, gauze or cloth dressing made of woven cotton fabric or other natural or synthetic materials, polymer film, or hydrocolloid dressing. In the example shown in FIGS. 2 and 3, the upper surface 38 of the attachment pad 36 is a hydrocolloid wound dressing material. In some embodiments, the lower surface 40 is composed of surgical drape material, such as, for example, cloth drapes, paper drapes, or plastic adhesive drapes. In the example shown in FIGS. 2 and 3, the lower surface 40 of the attachment pad 36 is an antimicrobial adhesive incise drape material. In other embodiments (not shown), the upper and lower surfaces of the attachment pad may be formed of the same material, with a biocompatible adhesive applied to the lower surface. In further embodiments (not shown) the attachment pad may be formed of three or more layers of materials, with one or more intermediate layers located between the upper surface adhered to the body and the lower surface including the biocompatible adhesive material. In certain embodiments, the attachment pad is attached to the body or the subject by means other than adhesion as are generally known in the art.

[0021] The medical containment device 10 further includes a medical grade, selfsealing (alternatively referred to as “self-healing”), transparent gel 44 sized and shaped to fit substantially within the interior 34 of the body 12 and fill substantially all of the interior 34. As such, the shape of the gel 44 may be described as a thick disk or a flat cylinder. In some embodiments, the gel 44 is formed of transparent thermoplastic elastomer. In certain embodiments, the gel 44 has a hardness value within the range of 5 to 50 Shore OO, within the range of 10 to 40 Shore OO, within the range of 20 to 30 Shore OO, or within the range of 22 to 26 Shore OO.

[0022] In an exemplary embodiment, the attachment pad 36 has a diameter of about 5 inches and the central hole 42 has a diameter of about 2.5 inches. The body 12, including the lower outer flange 24, has a diameter or width of about 4.0 inches, and a height of about 0.5 inches. The diameters of the top and bottom openings 30, 32 are each about 2.5 inches, corresponding with the diameter of the central hole 42 of the attachment pad 36. The lower outer flange 24, lower inner flange 26, and upper inner flange 28 each have a height of about 0.06 inches. The interior side 20 of the body 12 has a diameter of about 2.9 inches and the exterior side 18 of the033659059795 body 12 has a diameter of about 3.0 inches. Each of the lower and upper inner flanges 26, 28 extends about 0.2 inches towards the central axis 22. The lower outer flange 24 extends about 0.5 inches away from the central axis 22. Thus, the 4.0 inch width of the body 12 constitutes 0.5 inches of lower outer flange 24, 0.05 inches of the body 12 extending between the exterior side 18 and interior side 20, 0.2 inches of lower inner flange 26, 2.5 inches of bottom opening 32, 0.2 inches of lower inner flange 26, 0.05 inches of the body 12 extending between the exterior side 18 and interior side 20, and 0.5 inches of lower outer flange 24.

[0023] The gel 44 has a diameter of about 2.9 inches and a height of about 0.35 inches and is generally cylindrical in shape. As the height of the body 12 is about 0.5 inches and the height of each inner flange 26, 28 is about 0.06 inches, the height of the interior 34 between the inner flanges 26, 28 is about 0.38 inches. The slight 0.03 inch difference between the height of the interior 34 and the height of the gel 44 provides clearance to acommodate a sealant between the gel 44 and body 12, as described below, while still allowing the gel 44 to substantially fill the interior 34 and remain mechanically secured therein between the lower inner flange 26 and upper inner flange 28. These dimensions may vary based on surgical need, expected wound size or patient size (e.g., a smaller sized device for pediatric patients). Also, while the medical containment device 10 has been described and shown as generally circular in shape when viewed from a top view perspective, in other embodiments the medical containment device may be oval or other geometric shape as may be appropriate for particular surgeries or wounds.

[0024] In some embodiments, the medical containment device 10 composed of the body 12, attachment pad 36 attached to the body 12, and gel 44 positioned within the interior 34 of the body 12 is stored in a sealed, sterile package. The package may be opened and the medical containment device 10 ready for immediate application onto a subject patient. After use, the medical containment device 10 may be discarded.

[0025] In use, the medical containment device 10 is positioned on a patient such that the body 12 surrounds a wound or surgical site on the patient and the gel 44 substantially covers the wound or surgical site, inhibiting contamination to or from the wound or surgical site. A surgical instrument may access the wound or surgical site by insertion of the instrument through the gel 44. This functionality is particularly033659059795 useful in a microgravity environment, where blood or other bodily fluids may float away from a wound or surgical site, posing a health and safety hazard to others, while remaining useful in earthbound environments as well.

[0026] As shown in FIGS. 2 and 3, an exemplary laparoscopic appendectomy was performed on a subject 11 , in this instance, a female cadaver, to evaluate the medical containment device 10. Following skin incisions (marked with a skin pen), 5 mm and 12 mm trocars were inserted through the gel with little difficulty in the standard sequence with insufflation pressure of 12 to 15 mm Hg being established and a good scope camera image obtained. The appendix was identified and dissected from connecting tissue sufficient to position the stapler / scalpel for easy separation of the appendix from the cecum. The appendix was secured by a grasper. The appendix was then placed inside a retrieval bag that had been inserted through the 12 mm trocar followed by retrieval bag removal by pulling the bag cord to exit the trocar. Following completion of the procedure, routes of insufflation gas leaks were explored, then the trocars were withdrawn from the cadaver through the gel 44. Trocars and other instruments can be inserted, manipulated, then withdrawn from the gel multiple times during a surgical procedure without the need to replace the gel, as the gel self-seals. FIG. 2 depicts the medical containment device 10 as mounted on the cadaver 11 prior to surgery, while FIG. 3 depicts the medical containment device 10 with the 5 mm trocar 46 inserted therethrough. A medical containment device 10 with the exemplary dimensions recited herein can accommodate a trocar size range from 3 mm to 15 mm. A larger embodiment of the medical containment device could accommodate larger trocars, while a smaller embodiment could accommodate a narrower range of trocar sizes.

[0027] In some embodiments, a lubricant such as, for example, saline or a surgical lubricant, may be applied to a surgical instrument prior to insertion into the gel 44 to reduce drag. In further embodiments, a sealant such as, for example, a silicone rubber sealant, is applied to the interior side 20 of the body 12, to the gel 44, or both, to further secure the gel 44 to the body 12.

[0028] In some embodiments, the central hole 42 of the attachment pad 36 has a diameter substantially equal to the diameters of the top and bottom openings 30, 32 of the body, or a diameter smaller than the diameters of the top and bottom openings 30, 32 of the body 12. In some embodiments, the diameter of the central hole 42 is033659059795 less than 2 inches, less than 1.5 inches, less than 1 inch, less than 0.5 inches, or about 0.4 inches or 1 cm.

[0029] The foregoing detailed description is given primarily for clearness of understanding and no unnecessary limitations are to be understood therefrom for modification can be made by those skilled in the art upon reading this disclosure and may be made without departing from the spirit of the invention.

Claims

033659059795CLAIMS1 . A medical containment device comprising: a body, the body including a top, a bottom opposite the top, an exterior side extending between the top and the bottom, an interior side opposite the exterior side, a central axis extending through the body substantially perpendicular to the exterior side and substantially perpendicular to the interior side, a lower inner flange extending from the interior side at the bottom, the lower inner flange extending substantially perpendicularly toward the central axis, an upper inner flange extending from the interior side at the top, the upper inner flange extending substantially perpendicularly toward the central axis, wherein the top includes a top opening defined by the upper inner flange, wherein the bottom includes a bottom opening defined by the lower inner flange, and wherein the body includes an interior defined by the interior side, upper inner flange, top opening, lower inner flange and bottom opening; an attachment pad including a central hole, wherein the attachment pad is attached to the bottom of the body, and wherein the top opening, bottom opening, and central hole are aligned along the central axis; and a transparent gel sized and shaped to fit within the interior of the body.0336590597952. The medical containment device of claim 1 , wherein the attachment pad includes an upper surface and a lower surface opposite the upper surface, and, wherein the upper surface is attached to the bottom of the body.

3. The medical containment device of claim 2, wherein the upper surface is composed of a wound dressing material and wherein the lower surface is composed of a surgical drape material.

4. The medical containment device of claim 2, wherein the lower surface includes a biocompatible adhesive.

5. The medical containment device of claim 1 , further comprising a lower outer flange extending from the exterior side at the bottom, the lower outer flange extending substantially perpendicularly away from the central axis.

6. The medical containment device of claim 1 , wherein the lower outer flange is formed of a mesh structure.

7. The medical containment device of claim 1 , wherein the lower surface of the attachment pad includes a biocompatible adhesive material.

8. The medical containment device of claim 1 , wherein the gel is a transparent thermoplastic elastomer.0336590597959. The medical containment device of claim 1 , wherein the gel has a hardness value within the range of 5 to 50 Shore 00.

10. The medical containment device of claim 9, wherein the gel has a hardness value within the range of 20 to 30 Shore 00.11 . The medical containment device of claim 1 , wherein the body is manufactured of 3-D printed material.

12. The medical containment device of claim 11 , wherein the body is manufactured from a thermoplastic polyurethane material with a hardness value within the range of 70 to 100 Shore A.

13. The medical containment device of claim 12, wherein the body has a hardness value within the range of 80 to 90 Shore A.

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