Patent Application
20190307601
The present invention relates generally to a cooling compression apparatus to assist a patient with post-surgery recovery, and more specifically, to a wrap and bladder system designed to assist with the healing process after breast augmentation or facial surgery.
Plastic surgery, and more specifically, breast augmentation and facial surgery are big business in the United States and around the world. Recent numbers suggest that Americans alone spent $8 billion on plastic surgery in 2016, and that this number continues to grow. The advancements in surgeries, implants, medical devices, recovery solutions, and other technologies are growing along with these numbers. One area where the advancements and technology have been lacking relates to the recovery process for plastic surgery patients. These surgeries, including breast augmentation, breast reduction, face lifts, nose reconstructions, and other procedures, are serious medical procedures that require recovery time.
Plastic surgery patients experience severe pain and discomfort after these medical procedures. For this pain, doctors prescribe extreme medications, including opioids, to ease the pain and discomfort. These drugs include morphine, hydrocodone, oxycodone, OxyContin®, Percocet®, Vicodin®, and others that can lead to patient dependencies. Often these post-surgery prescriptions are the beginning of serious addictions. Thus, a medical device or procedure that limits the pain and discomfort from these types of surgeries can assist in limiting a patient's reliance on these types of medications.
Applying cold temperatures and compression to the area of the body affected by the surgery is known to assist in the healing process. Thus, cooling (or ice) and compression may be recommended by the doctor after surgery, but devices that provide these therapies are lacking for plastic surgery patients. Cooling and compression devices for orthopedic surgeries are widely known, but the breast and face have largely been ignored by medical device manufacturers, forcing patients to use ill-fitting ice or gel packs and even cooling devices for other body parts. Cooling and compression bras and face masks that are specifically tailored to assist with the recovery process would be invaluable to these patients. The speedy recovery time may also reduce patients' dependency on medications, which can help prevent addictions from developing.
After breast augmentation or breast reduction surgery, the patient may have difficulty in raising his or her arms above the shoulders. This can make it difficult for the patient to don a sports bra, surgical bra, or gel pack to the affected area. Because current sports bras or surgical bras are not designed to allow for this type of movement, a new cooling and compression technology that could be donned by the patient without lifting his or her arms above the shoulders is needed. Further, traditional sports and surgical are not fully adjustable, which could be designed to allow the patient to increase or reduce the compression applied to the affected area.
With any facial reconstructive surgery, the reduction of swelling, tightening of the skin, and decrease in the appearance of wrinkles are goals of the surgery and recovery. Conventional ice packs or gel packs that are not specially adapted to the contours of the face are ill-equipped to accomplish these results. Thus, a face mask that is designed to match the patient's facial features and provides cooling and compression to the affected area would be an improvement over the current options. Novel technologies that can improve a plastic surgery patient's recovery outcome are needed.
The present invention comprises a breast cooling and compression apparatus that is intended to be used in the home or health care facility to assist with a patient's recovery after a breast-related surgery. The apparatus may be prescribed by a doctor. The apparatus pumps cool water through an inflatable bladder that covers the patient's chest area (e.g., breasts and sternum) and provides compression to this area. With these capabilities, the present invention (1) aids in pain reduction, (2) enhances recovery of the affected area, (3) reduces healing time, and (4) reduces swelling through compression.
In some embodiments, the present invention includes a garment with an attached inflatable bladder that is designed to be adjacent to the patient's breasts during use. The inflatable bladder has an inlet tube and an outlet tube that connects to a pumping apparatus to supply cold water to the inflatable bladder for cooling therapy. The inflatable bladder may include a tortuous water passageway so that the cool water continues to be recycled through the inflatable bladder without sitting and becoming warm. The garment includes a set of adjustable shoulder straps and a set of adjustable chest straps, which enable the patient to adjust the tightness of the breast cooling and compression apparatus. Therefore, cooling and compression are applied to the patient to improve recovery time.
In some embodiments, the inflatable bladder includes a left breast section, a right breast section, and a sternum section. The left breast section and the right breast section includes numerous dividers and dams to create the tortuous water passageway. The sternum section, which also includes numerous dividers and dams, connects the water passageway from the left breast section to the right breast section. Thus, the cold water from the pumping apparatus would flow from an inlet tube into one breast section, to the sternum section, to the other breast section, and out of the outlet tube. Additional peninsula sections may be connected to the left breast section and the right breast section to account for various patient and breast sizes. Numerous slits and cutouts may be added to the left breast section, right breast section, and sternum section to improve flexibility and further account for various patient and breast sizes.
In some embodiments, the garment of the breast cooling and compression apparatus may resemble a bra with adjustable straps at the shoulder area and at the chest area. These four straps (right shoulder, left shoulder, right chest, left chest) allow the patient to adjust the tightness of the apparatus in the front of the patient, so that assistance from a health care worker or family member is unnecessary. Further, the adjustable shoulder straps should be designed to enable the patient to don or remove the apparatus without raising her arms about her shoulders. Hook and loop fasteners over the shoulders and at the chest area may be used for these adjustable shoulder and chest straps.
The present invention comprises a face mask cooling and compression apparatus that is intended to be used in the home or health care facility to help with a patient's recovery after a face-related surgery and to avoid wrinkles during the healing process. The apparatus may be prescribed by a doctor. The apparatus accomplishes this by pumping cool water that moves through an inflatable bladder covering the patient's face area and providing compression to this area with a face mask. With these capabilities, the present invention (1) aids in pain reduction, (2) enhances recovery of the affected area, (3) reduces healing time, (4) reduces swelling and inflammation through compression, and (5) decreases wrinkles on the face.
In some embodiments, the present invention includes a face mask with an attached inflatable bladder that is designed to be in contact with the patient's face during use. The inflatable bladder has an inlet tube and an outlet tube that connects to a pumping apparatus to supply cold water to the inflatable bladder. The inflatable bladder provides a tortuous water passageway such that the cool water continues to be recycled through the inflatable bladder without sitting and becoming warm. The face mask may include a set of adjustable head straps, which enable the patient to adjust the tightness of the face mask cooling and compression apparatus. Therefore, cooling and compression are applied to the patient to improve recovery time.
In some embodiments, the inflatable bladder includes numerous dividers and dams to create the tortuous water passageway. Thus, the cold water from the pumping apparatus would flow from an inlet tube into one side of the inflatable bladder and out of the other side through an outlet tube. Positioning of the dividers and dams may be adjusted around the nose and eye areas to adapt to the facial features of the patient. Specifically, eye dams or dividers may be configured to surround and mimic the shape of the eyes of the patient and provide a pocket or open space for the patient's eyes. Nose dams or dividers may surround the nose of the patient and provide fluid passageways that mimic the contours of the nose. In some embodiments, the water passageways run north and south to allow the fluid to run smoothly and fit the profile of the patient's head.
In some embodiments, a flexible nose clip is used to hold the face mask cooling and compression apparatus in place. Further, the inlet tube and the outlet tube of the inflatable bladder may be designed to protrude towards the bottom of the apparatus and on opposite sides. Then, the inlet and outlet tubes of the inflatable bladder can be easily connected to the pumping apparatus by the patient and be out of the way during movement or sleep. For both the breast cooling and compression apparatus and the face mask cooling and compression apparatus, warm fluid could also be applied to the inflatable bladder to provide heat to the breast or face area of the user.
For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which:
As mentioned above, cooling and compression are both recommended during the recovery for any surgery. For plastic surgery on a woman's breasts (i.e., breast augmentation, breast reduction, etc.), doctors have traditionally recommended (1) ice packs or gel packs for cooling treatment and (2) sports bras or surgical bras for compression treatment. However, these disparate solutions are difficult to manage and uncomfortable for the patient. Up to this point, devices designed to accomplish both of these treatments have been unavailable. The ice or gel packs may be sufficient for cold therapy, but lacking for compression therapy, while sports bras only provide compression. Ice or gel packs are also difficult to use for long periods of time. Further, the incision areas for breast surgery can be in many different places, so the cooling and compression apparatus must be flexible and adapted to this part of the female body.
Two adjustable chest straps 110, 112 are provided to assist with chest adjustment and compression. Instead of attaching around the shoulders of the patient 102, these adjustable chest straps 110, 112 attach around a waist or lower chest of the patient 102. A right adjustable chest strap 110 and a left adjustable strap 112 can be manipulated by the patient 102 to increase or decrease the compression applied to the breast area. These adjustable chest straps 110, 112, also assist in holding the inflatable bladder (not shown) in place while attached. Hook and loop or adhesive mechanisms may be used for attaching and manipulating the adjustable chest straps 110, 112. Similar to the adjustable shoulder straps 104, 106, the adjustable chest straps 110, 112 can be adjusted with one strap on each side (right and left) in the front of the patient 102, one strap on each side in the back of the patient 102, or two straps on each side in the front and back of the patient 102. The desired configuration will determine how many hook and loop or adhesive straps and rings or brackets are required for the breast cooling and compression apparatus 100. In an exemplary embodiment, each adjustable chest strap 110, 112 has a single strap that fits into a bracket or ring 140 and connects in the front of the patient 102. The bracket or ring 140 holds the adjustable chest strap 110 in place, while allowing the patient to adjust the fit or compression. The brackets or rings 140 also enable the patient to detach the adjustable shoulder straps or chest straps to assist with donning or removing the apparatus 100.
The adjustable shoulder straps 104, 106 and adjustable chest straps 110, 112 are adjustable in the front of the patient 102 for easy access. This enables the patient to adjust the breast cooling and compression apparatus 100 without assistance from a health care provider, significant other, or family member. The adjustable shoulder straps 104, 106 and adjustable chest straps 110, 112 should be loose and flexible to enable the patient 102 to don and adjust the apparatus 100 by herself. In light of the pain and discomfort from these types of surgeries, these features provide significant advantages over traditional solutions.
The garment portion of the apparatus can be thought of as two panels (dorsal and ventral) that are made of elastic materials. During use, four sets of hook and loop fasteners connect the dorsal panel to the ventral panel (i.e., adjustable shoulder straps 104, 106 and adjustable chest straps 110, 112). In some embodiments, the hook and loop fasteners are designed to be adjusted on the ventral panel for easy access by the patient.
The breast cooling and compression apparatus 100 can be made from various materials, but flexible and temperature resistant materials are used in some embodiments. Flexible materials will assist with providing support and compression for various breast sizes and types of surgeries. And since an inflatable bladder (not shown) will be applying fluids at a cold temperature to the patient, temperature and water-resistant materials will assist with keeping the patient comfortable while using the invention. The design of the apparatus 100 has features to fit a variety of patient body forms and breast shapes. The adjustable shoulder straps 104, 106, adjustable chest straps 110, 112, and the materials provide a one size fits all flexibility that has been unavailable in conventional devices.
An inlet tube 344 and an outlet tube 346 provide the connection of a fluid pumping apparatus (not shown) to the inflatable bladder 300. Inlet tube 344 and outlet tube 346 correspond to the inlet tube 144 and outlet tube 146 shown in
The inflatable bladder 300 consists of three sections areas—a right breast section 302, a left breast section 304, and a sternum section 306. These flexible sections are designed to adapt to different breast sizes and corresponding types of surgery. A right circular section 312 and a right peninsula section 310 make up the right breast section 302. Numerous tabs 314 surround the right circular section 312 and the right peninsula section 310. These tabs 314 are used to be sewn into or attached to the garment or bra-like portion of the breast cooling and compression apparatus 100. Tabs 314 are used to prevent puncturing, damaging, or stretching the inflatable portions of the bladder 300 during assembly or use. In some embodiments, hook and eye connections could be used to connect the inflatable bladder 300 to the apparatus 100. The tortuous pathway for the cool fluid is defined by edges 316 and dams or dividers 318 within the inflatable bladder 300. These edges 316 and dams 318 are sealed so that water cannot leak from the bladder 300 or veer off the tortuous passageway. The right circular section 312 is designed to fit over the patient's breast during use. The right peninsula section 310 is designed to fit over larger breasts, but also fit under smaller breasts. Thus, the flexibility provided by the peninsula section 310 enables the inflatable bladder 300 and cooling technology to cover and conform to multiple patient and breast sizes.
Similar to the right breast section 302, a left circular section 320 and a left peninsula section 322 make up the left breast section 304. Numerous tabs 314 surround the right circular section 320 and the right peninsula section 322. The tortuous pathway for the cool fluid is defined by edges 324 and dams or dividers 326 within the inflatable bladder 300. These edges 324 and dams 326 are sealed so that water cannot leak from the bladder 300 or veer off the tortuous passageway. The left circular section 320 is designed to fit over the patient's breast during use, while the left peninsula section 322 is designed to fit over larger breasts, but also fit under smaller breasts. This configuration provides relief to the various incision sites from breast surgery, including incision sites that are under the patient's breast. The right circular section 312 and the left circular section 320 were designed in circular petal shapes to cover all body and breast sizes. More specifically, the cutouts in the petals (312, 320) enable the inflatable bladder 300 to adjust, reduce, or expand in size to fit different breast sizes.
The sternum section 306 connects the right breast section 302 and the left breast section 304. Numerous tabs 314 surround the sternum section 306 for attachment to the garment or bra-like portion of the breast cooling and compression apparatus 100. The sternum section 306 also includes edges 330 and dams or dividers 336 that create a tortuous pathway for the cool fluid. Not only does the sternum section 306 connect the two breast sections 302, 304, but it cools the patient's sternum, which can be damaged, bruised, sore, and uncomfortable after surgery. Unlike conventional solutions that solely focus on the patient's breasts, the present invention also provides cooling and compression to the patient's sternum to improve recovery outcomes. In addition, the inlet tube 344 and outlet tube 346 run along the patient's sternum to provide added cooling and compression. In some embodiments, the inlet tube 344 and outlet tube 346 are free floating or not attached to each other, except at the distal end where attached to the pumping apparatus (not shown). This separation feature allows the right breast section 302 and left breast section 304 to separate to accommodate different chest circumferences and allows the inlet tube 344 and outlet tube 346 to adjust for the breast height aspect, while still applying cooling therapy to the sternum. A central sternum slot 332 provides additional flexibility for the sternum section 306 by enabling it to adjust and expand for different breast forms, while still allowing the sternum section 306 to rest upon the patient's body during operation.
The sternum section 306 provides increased flexibility and independence for the right breast section 302 and the left breast section 304. The flexible fluid passageways between the sternum section 306 and the breast sections 302, 304, the central sternum slot 332, and the unconnected inlet tube 344 and outlet tube 346, enhance the ability of the right breast section 302 and the left breast section 304 to move independently to fit all body and breast sizes. In some embodiments, the inflatable bladder 300 may include multiple bladders for different portions of the patient's body. For example, the right breast section, left breast section, and sternum section may be three separate bladders that are not connected. In other embodiments, the right breast section and left breast sections are separate, larger sections that also cover the sternum. Further, additional fluid pathways, dams, and dividers for the inflatable bladder 300 are within the scope of the present invention. In some embodiments, the peninsula sections 310, 322 may not be included.
An inlet valve or tube 552 and an outlet valve or tube 554 are also shown. These tubes 552, 554 were designed to be easily accessed by the patient for attaching to the pumping apparatus (not shown). Two rings or brackets 530, 532 are used in combination with adjustable shoulder straps 536, 534 to position and hold the apparatus 100 on the patient. To don this breast cooling and compression apparatus 100, the patient must flip the bra-like portion over her head so that the inflatable bladder 300 is adjacent to the patient's breasts. Because the adjustable shoulder straps 534, 536 are already attached, the patient must then attach and manipulate adjustable chest straps 560 to achieve the proper fit. When fully attached, the sternum section 506 would be adjacent to the top of the patient's sternum (right below the neck) and the centers of the right breast section 502 and left breast section 504 would be adjacent to the center or nipple of the patient's breasts.
As for the inflatable bladder 300, it can be designed to touch the patient, to fit in a pocket of the apparatus 100, or be sewn into a material so that the material touches the patient. Materials for the bra-like portion of the apparatus must be selected in view of cooling and condensation concerns.
Because many patients have difficulty moving after a plastic surgery, another novel feature is that a health care provider 570 can don the apparatus on a prone patient 580. As shown in
After the breast cooling and compression apparatus 100 is fully adjusted, the pumping apparatus (not shown) can be attached. The pumping apparatus includes inlet and outlet tubes or valves that should be connected to the inlet and outlet tubes or valves (
The patient may wear the breast cooling and compression apparatus 100 from the time period right after surgery until a few weeks after surgery. As with other similar devices, the water temperature should be around 50° F. to provide cooling therapy, but not cause burns or irritation to the patient. Patients can wear the breast cooling and compression apparatus 100 for up to 10-12 hours and can even sleep with it on. As mentioned above, these therapies can reduce recovery time and can limit the patient's need for pain medications, thereby reducing any potential addiction risks from the patient's reliance on these pain medications.
For plastic surgery on a man or woman's face (i.e., rhinoplasty, face lifts, facial balance surgeries, botox, etc.), doctors have traditionally recommended (1) ice packs or gel packs for cooling treatment and (2) face masks or bandages for compression treatment. However, these disparate solutions are difficult to manage and uncomfortable to the patient. Up to this point, devices that are adapted to accomplish both of these treatments have been unavailable. The ice or gel packs may be sufficient for cold therapy, but lacking for compression therapy, while sports bras only provide compression. Ice or gel packs are also difficult to use for long periods of time on an area like the face. Further, the affected areas for facial surgery or procedures can be in many different places, so the cooling and compression apparatus must be flexible and adapted to the face.
The nose clip 1004 and straps 1010, 1012 provide flexibility and enable the apparatus 1000 to adapt to various sizes and compression tightness for the patient. The upper strap 1010 and lower strap 1012 may further comprise hook and loop fastener connections at the back of the patient's head to enable the patient to further adjust compression tightness.
Throughout the inflatable bladder 1202 there are dams or extensions that create a tortuous pathway for the fluid to travel through the inflatable bladder. These features of the present invention are designed to prevent any pockets where water might sit, not move, and become warm. The inflatable bladder 1202 may be made from polyvinyl chloride (PVC) or other plastic materials that enable flexible movement but prevent fluids from escaping the tortuous pathways. The cool water from the pumping apparatus (not shown) enters the inflatable bladder at an inlet tube or valve 1020. The cool water then travels through the tortuous pathway to the outlet tube or valve 1022. Edges and dams within the inflatable bladder 1202 create this water passageway that ensures that the cool water continuously travels from inlet valve 1020 to outlet valve 1022 and avoids any pockets where water might sit, not move, and become warm. The path of the cool water also ensures that the face of the patient receive the cooling benefits of the water.
This simple access of the tubing to the pumping apparatus is an improvement over conventional face masks. Specifically, the patient may connect to a pumping apparatus in the same manner that he or she connects to a cell phone or music device. In this configuration, the tubing stays out of the patient's way during relaxation, movement, or sleep.
In this embodiment, eye and nose dams or dividers are used to provide additional comfort to the patient. Specifically, eye dams or dividers 1310 and 1312 surround the eyes of the patient and provide a pocket or open space for the patient's eyes. These generally elliptical shapes may provide convex surface shapes when inflated with water, which facilitate cooling of the patient's eyes. In some embodiments, these pockets or open spaces for the eyes may be raised to enable movement of the eyelids. These dividers 1310, 1312 are designed to mimic the size and shape of the patient's eyes. Nose dams or dividers 1314, 1316, 1320 surround the nose of the patient and provide fluid passageways that mimic the contours of the nose.
As for the inflatable bladder 1300, it can be designed to touch the patient, to fit in a pocket of the face mask cooling and compression apparatus 1000, or be sewn into a material so that the material touches the patient. Outer materials for the apparatus must be selected in view of cooling and condensation concerns.
In some embodiments of the present invention, including
In some embodiments, the inflatable bladder 1300, 1500 may include various configurations. It may include numerous bladders for different portions of the patient's face. For example, the left side and right side of the apparatus may be two separate bladders that are not connected. The portion of the inflatable bladder 1300 that covers the eyes of the patient may be devoid of water. Further, additional fluid pathways, dams, and dividers for the inflatable bladder 1300, 1500 are within the scope of the present invention.
After the face mask cooling and compression apparatus 1000 is fully attached, the pumping apparatus (not shown) can be attached. The pumping apparatus includes inlet and outlet tubes or valves that should be connected to the inlet and outlet tubes or valves (
The patient may wear the face mask cooling and compression apparatus 1000 from the time period right after surgery until a few weeks after surgery. As with other similar devices, the water temperature should be around 50° F. to provide cooling therapy, but not cause burns or irritation to the patient. Patients can wear the face mask cooling and compression apparatus 1000 for up to 10-12 hours and can sleep with it on. These features of the present invention can improve recovery outcomes and reduce the patient's need for pain medications. While most of this disclosure focused on the application of cold fluid to the patient, warm fluid may also be applied without making substantial changes or improvements to the present invention.
Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.
