Patent ID: 12220341

DETAILED DESCRIPTION

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The Figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.

While exemplary embodiments are described, it is not intended that these embodiments describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various implementing embodiments may be combined to form further embodiments of the invention.

It should be appreciated that any of the components or modules referred to with regards to any of the present invention embodiments discussed herein, may be integrally or separately formed with one another. Further, redundant functions or structures of the components or modules may be implemented. Moreover, the various components may be communicated locally and/or remotely with any user/operator/customer/client or machine/system/computer/processor. Moreover, the various components may be in communication via wireless and/or hardwire or other desirable and available communication means, systems and hardware. Moreover, various components and modules may be substituted with other modules or components that provide similar functions.

It should be appreciated that the apparatus and related components discussed herein may take on all shapes along the entire continual geometric spectrum of manipulation of x, y and z planes to provide and meet the environmental, anatomical, and structural demands and operational requirements. Moreover, locations and alignments of the various components may vary as desired or required.

It should be appreciated that various sizes, dimensions, contours, rigidity, shapes, flexibility and materials of any of the components or portions of components in the various embodiments discussed throughout may be varied and utilized as desired or required.

It should be appreciated that while some dimensions are provided on the aforementioned Figures, the apparatus may constitute various sizes, dimensions, contours, rigidity, shapes, flexibility and materials as it pertains to the components or portions of components of the apparatus, and therefore may be varied and utilized as desired or required.

It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and/or to the other particular value.

By “comprising” or “containing” or “including” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

In describing example embodiments, some terminology will be used for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. It is also to be understood that the mention of one or more steps of a method does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Steps of a method may be performed in a different order than those described herein without departing from the scope of the present disclosure. Similarly, it is also to be understood that the mention of one or more components in an apparatus or system does not preclude the presence of additional components or intervening components between those components expressly identified.

Some references, which may include various patents, patent applications, and publications, are cited in a reference list and discussed in the disclosure provided herein. The citation and/or discussion of such references is provided merely to clarify the description of the present disclosure and is not an admission that any such reference is “prior art” to any aspects of the present disclosure described herein. In terms of notation, “[n]” corresponds to the nth reference in the list. All references cited and discussed in this specification are incorporated herein by reference in their entireties and to the same extent as if each reference was individually incorporated by reference.

It should be appreciated that as discussed herein, a subject may be a human or any animal. It should be appreciated that an animal may be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal may be a laboratory animal specifically selected to have certain characteristics similar to human (e.g. rat, dog, pig, monkey), etc. It should be appreciated that the subject may be any applicable human patient, for example.

As discussed herein, a “subject” may be any applicable human, animal, or other organism, living or dead, or other biological or molecular structure or chemical environment, and may relate to particular components of the subject, for instance specific tissues or fluids of a subject (e.g., human tissue in a particular area of the body of a living subject), which may be in a particular location of the subject, referred to herein as an “area of interest” or a “region of interest.”

The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5).

Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g. 1 to 5 includes 1-1.5, 1.5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 14, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”

In one embodiment, for example, the apparatus is applied to the intended site with a medical balloon facing outward. A semi-flexible frame for balloon securement was printed at UVA Biomedical Engineering Lab from NinjaFlex material (FIG.1A). A medical silicone balloon was manufactured from biocompatible materials by Polyzen, Inc. Medical Device Developer and Manufacturer, Apex. NC based on design depicted inFIG.1B. Although depicted as an octagon (eight-sided polygon), the frame/skirt may usefully have other polygonal perimeters or a curved perimeter that may assume a rounded, oval, elliptical or another curved perimeter. The silicone balloon is not applied to the skin directly, but through a suitable ointment or medical gauze covering the wound (as per post-procedure protocol) which is part of standard clinical care.

In an alternative embodiment, the frame is effectively a skirt that extends at least partially around and extends laterally away from a lower or basal face of a balloon. In this design, the balloon and the skirt are monolithic. The skirt when suitably expanded may have the optional ability for direct strapping over the landing pads.

In an embodiment, a modified sling is part of the apparatus to facilitate post surgical shoulder restriction as the clinical situation demands. The sling may be an arm cuff, forearm cuff, or wrist cuff which can be adhered to one of the adhesive landing pads, thus minimizing the material needed on the patient's arm and allowing for comfort with reliable shoulder restriction for the intended period or duration. In an embodiment, the sling may be attached or in communication with any stable body surface or inanimate surface. In an embodiment, for example, the sling may be attached or in communication with abdomen surface or upper back surface or the hospital bed or railing.

One set of method steps (seeFIG.2) includes, not necessarily in this sequence:

Step 1: Placing four (or another specified number such as greater than or less than four as desired or required) adhesive pads or films around the incision site.

Step 2: Looping four (or another specified number) straps (e.g., sleeve, belt, or loop) through slits that in one alternative embodiment may have teeth clasps located on the frame or balloon skirt (SeeFIGS.3and4). It should be appreciated that less than or greater than four straps may be used as desired or required with the frame. Multiple frames may be deployed if desired. The straps are affixed on the landing pad either directly or via an inbuilt collapsible suspension/slot system which allows the straps to fold back upon themselves to varying degrees depending on the amount of required stretch, and provide a consistent surface area of intended contact to exert a reliable compressive force. The suspension system is collapsible and is preferably made of atraumatic medically inert material to avoid pressure points or reactions on the patient.

Step 3: Placing the apparatus on the incision/surgical/intended target site with the balloon facing towards the site (SeeFIG.5). Preferably, the balloon is transparent, clear, or translucent, such that it provides the advantage of viewing the hematoma, sensor, and/or body region. The balloon may be placed on the surgical site after a medically effective ointment or other lotion is applied to the surgical wound. Alternatively, a gauze-like material may cover the site before balloon emplacement.

Step 4: Adjusting tension by pulling one end of the strap (e.g., sleeve, belt, or loop), thereby creating the suspension system or suspension mechanism (seeFIGS.6and7). If desired, a small bridge may be disposed on the landing pads which could serve as a fulcrum or pivot for the sleeves (e.g., sleeve, belt, or strap). There are several alternative ways to provide a visual indicator of a satisfactory stretch, i.e., a reliable pressure exerted by the apparatus on the surgical site. One visual clue may be embedded in the slots of the balloon frame where the distortion can provide feedback to the user. The second alternative visual clue may be embedded in the straps where the degree of stretch will modify the visual feedback. The third alternative visual clue is in the balloon frame apparatus which will indicate the degree of inflation or downward pressure on the surgical site. Such feedback cues can include a distortion of a printed symbol or a color change with increasing pressure/stretch or another simplified visual cue. One or more of the clues can be employed as feedback for proper placement and adjustment of the system. Early clinical testing has suggested that a baseline lateral stretch can increase the efficacy of downward pressure on the intended site with lower volumes of inflation.

Step 5: Optionally placing a pressure sensor under the apparatus to detect compressive forces and send a signal to a suitable receiver that indicates the sensed pressure. Illustrated is one type of suspension system or suspension mechanism that includes a sub-balloon pressure sensor in communication with an optional GUI and a balloon inflation pressure gauge with the same or another optional GUI. It will be appreciated that the sub-balloon pressure sensor need not be co-located with the pressure gauge. One such device is available under the name Kikuhime. As noted earlier, an embodiment, the balloon may be made of the same material as the frame or be monolithic therewith.

Referring toFIG.8, for example, the (optional) sensor is illustrated as being external to the patient (subject). If desired, the sensor may be implanted in the patient (subject). Alternatively, a sensor may be implanted internally within the patient (subject) and another sensor may be implanted on the outside of the patient (subject). If desired, a plurality of sensors may be utilized. Optionally, multiple pressure meters (or processors or other hardware or software) may be utilized.

An aspect of an embodiment that may utilize related components is disclosed in U.S. Pub. No 20220104988, entitled “Tissue Retention System and Methods”. This publication is incorporated by reference. An aspect of an embodiment that may utilize other components related to the TRS straps or pads may be obtained under the name of Stetrix Tissue Retention Package. See, e.g., stetrix.com. SeeFIG.9.

An aspect of an embodiment of this disclosure may utilize components and aspects related to a Polyzen balloon, such as one that includes a polyether polyurethane film (Part #: SIP1-133). See, e.g., www.polyzen.com. Details of a suitable medical balloon appear inFIG.10.

In one set of experiments, 160 patients were subjected to placement of a device for 4 hours and a pressure of 40 mmHg. (IRB #21759). Pressure was assessed every 30 minutes using a sphygmomanometer. The pressure sensor probe was placed under the subject apparatus. Pressure was added if the sensed pressure dropped. This pilot trial confirmed safety, tolerability, ease of application and removal. It showed lower swelling rates, which were systematically assessed by an instrument called a durometer and a signal for improved wound healing. The durometer enabled an assessment to be made of skin recoil and turgor, which is a metric for skin healing. Such indicia were improved in the balloon group. If desired, we add introducing an embedded durometer could be introduced into the balloon. It will be appreciated that the 4-hour period was selected arbitrarily. However, the durometer could provide feedback and thus enable the amount of time needed to be monitored. This would permit customizing the time and pressure required on an individual patient, thereby allowing for tailored therapies.

In summary, while the present invention has been described with respect to specific embodiments, many modifications, variations, alterations, substitutions, and equivalents will be apparent to those skilled in the art. The present invention is not to be limited in scope by the specific embodiment described herein. Indeed, various modifications of the present invention, in addition to those described herein, will be apparent to those of skill in the art from the foregoing description and accompanying drawings. Accordingly, the invention is to be considered as limited only by the spirit and scope of the disclosure including all modifications and equivalents.

Still other embodiments will become readily apparent to those skilled in this art from reading the above-recited detailed description and drawings of certain exemplary embodiments. It should be understood that numerous variations, modifications, and additional embodiments are possible, and accordingly, all such variations, modifications, and embodiments are to be regarded as being within the spirit and scope of this application. For example, regardless of the content of any portion (e.g., title, field, background, summary, abstract, drawing figure, etc.) of this application, unless clearly specified to the contrary, there is no requirement for the inclusion in any claim herein or of any application claiming priority hereto of any particular described or illustrated activity or element, any particular sequence of such activities, or any particular interrelationship of such elements.

Moreover, any activity can be repeated, any activity can be performed by multiple entities, and/or any element can be duplicated. Further, any activity or element can be excluded, the sequence of activities can vary, and/or the interrelationship of elements can vary. Unless clearly specified to the contrary, there is no requirement for any particular described or illustrated activity or element, any particular sequence or such activities, any particular size, speed, material, dimension or frequency, or any particularly interrelationship of such elements. Accordingly, the descriptions and drawings are to be regarded as illustrative in nature, and not as restrictive. Moreover, when any number or range is described herein, unless clearly stated otherwise, that number or range is approximate. When any range is described herein, unless clearly stated otherwise, that range includes all values therein and all sub ranges therein.

Any information in any material (e.g., a United States/foreign patent, United States/foreign patent application, book, article, etc.) that has been incorporated by reference herein, is only incorporated by reference to the extent that no conflict exists between such information and the other statements and drawings set forth herein. In the event of such conflict, including a conflict that would render invalid any claim herein or seeking priority hereto, then any such conflicting information in such incorporated by reference material is specifically not incorporated by reference herein.