Not Applicable.
Not Applicable.
1. Field of the Invention
This invention relates to the field of medical products. More specifically, the invention comprises a lumbar cryotherapy system which allows convenient access to a surgical site for placement of cryotherapy devices and other purposes.
2. Description of the Related Art
The minimization of swelling following a surgical procedure is a common goal. One method is to employ “cold therapy,” which is also known as “cryo therapy.” Cryo therapy assumes a variety of forms—ranging from simple ice or gel packs to sophisticated chilled water circulating devices. These devices must provide sufficient cooling to minimize swelling yet not cool the tissue to the point where damage might occur.
The simplest form of cryo therapy involves placing a sealed bag of ice against the affected portion of the patient and retaining it in position using a compressive wrap. Some type of insulating layer is typically placed next to the patient's skin in order to prevent the ice pack from overcooling the tissue it lies proximate to. The use of ice is somewhat risky in this situation. Although ice can absorb a significant amount of heat—owing to the phase change from a solid to a liquid—its melting temperature is lower than would be ideal. During the phase change an ice pack can cool adjacent tissue to near the freezing point of water. A temperature this low can cause tissue damage.
Gel packs reduce this concern by eliminating the phase change. Gel packs do not freeze when placed in a typical freezer. They emerge instead as very cold liquids. When they are applied to the patient, no phase change is produced. Thus, as those skilled in the art will know, the adjacent tissue is able to warm the gel above its initial temperature in a fairly short time. Of course, the lack of a phase change means that the gel pack cannot absorb nearly as much heat as a cooling medium which employs a phase change.
The preferred cooling medium would therefore employ a phase change. However, it would also have a freezing temperature significantly above the freezing point of water in order to minimize the risk of tissue damage. The preferred cooling medium is one that freezes between about 5 degrees Celsius and about 20 degrees Celsius. Such a medium can absorb considerable heat via the phase change from a solid to a liquid. In addition, such a cooling medium poses little risk of tissue damage (as its phase change temperature is above 0 degrees Celsius). Although the present invention can function with a wide variety of cooling media, it preferably uses a cooling medium with a freezing point between about 5 degrees and about 20 degrees Celsius.
One common application for cryo therapy is in post-surgical swelling reduction for lumbar spinal surgery. It is known to use a compressive “belt” to hold cold packs in position over the patient's lumbar spine. The cold packs used for this purpose must be changed every few hours. Thus, the device used to hold the cold packs in position must be regularly loosened and then reapplied. This has traditionally been a cumbersome process. The present invention alleviates this concern by providing convenient access to the lumbar surgical site. The invention also includes features allowing it to be easily installed and adjusted.
The present invention comprises a cryo therapy system suitable for use on a patient's lumbar area. A belt is provided with a front closure and a posterior window. The belt is looped mound the patient's abdomen, with the posterior window lying over the lumbar spine. The front closure is secured using VELCRO fasteners. A pocket is preferably provided on each end of the belt. The pockets allow the user to more easily apply and tighten the belt.
A cover panel is provided to selectively cover and close the posterior window in the belt. The cover panel attaches to the belt using VELCRO features. The cover panel preferably also includes adjustable straps so that it may be selectively tightened in position. The cover panel includes an inward facing surface which is at least partially covered in loop material. One or more cold packs are provided. Each cold pack includes a hook panel configured to engage the loop material on the inward facing surface of the cover panel.
A cold pack may be placed on the patient without having to remove the belt. The patient is rolled onto his or her side. One side of the cover panel may then be detached from the belt, which allows the cover panel to swing away from the posterior window like a door. The patient's lumbar area is thereby exposed. One or more cold packs may then b attached to the inward facing surface of the cover panel by pressing the hook panel(s) on the cold pack against the mop material on the cover panel. The loose side of the cover panel is then reattached to the belt in order to close the posterior window. The cold pack is thereby held against the patient's lumbar area.
Cold packs may be placed and exchanged at desired intervals by opening the cover panel. This task may easily be performed without disturbing the belt itself. Other features are preferably provided to allow adjustment of the belt as the condition of a patient's abdomen changes. For example, an abdominal pad may be provided on the inward facing portion of the anterior section of the belt. The abdominal pad is preferably attached to the belt using VELCRO material so that it may be easily positioned. Abdominal pads of different sized and/or shapes are preferably provided to accommodate changes in patient geometry.
The present invention uses two main components a belt and a cover panel.
Window 32 is an opening lying in the middle of the belt. Attachment features are provided around this opening in order to attach the cover panel to the belt. In the embodiment shown, tension strap 24 and tension strap 26 lie on the right side of window 32. Tension straps 28 and 30 lie on the left side of the window.
Pockets are preferably provided adjacent to the right and left edges of the belt. These assist the user in applying the belt—as will be explained subsequently. It is preferable to divide each pocket into a finger pocket and a thumb pocket. Thus, the pocket proximate right edge 80 is divided into right thumb pocket 16 and right finger pocket 18. Similarly, the pocket adjacent to left edge 78 is divided into left thumb pocket 20 and left finger pocket 22.
The second major component—cover panel 38—is shown in
Attachment features are provided to facilitate the attachment of the cover panel to the belt. In the embodiment shown in
The lumbar stay is preferably a semi-rigid material such as a sheet of flexible plastic. It is preferably contoured to match the shape of a patient's lumbar area. The use of the stay helps conform cover panel 38 to the patient's anatomy. It is possible to provide a variety of different shapes for lumbar stay 54. It is also possible to provide an embodiment in which the lumbar stay may be selectively deformed by the clinician.
The assembly is thus united so that it may be handled as one unit and placed on the patient as one unit. However, the inclusion of the tension strap assemblies allows the assembly to be progressively tightened after it is in place (explained in detail subsequently).
The reader will recall from the prior description that each side of the belt preferably includes a pocket to facilitate installation.
In
If the user then brings her right hand in over her left, hook panel 76 will be pressed against the loop covering on the outward facing surface of the belt. (Including the outward facing surfaces of left thumb pocket 20 and left finger pocket 22).
The reader will therefore perceive that the belt is a band with a gap or break in its anterior portion which allows it to be opened and installed. A VELCRO link is preferably used to close the break. As shown in
The cover panel will often be attached to the belt before the belt is placed on the user (though this need not always be the case). Once the belt is fastened as shown in
Other components may be selectively added to the belt assembly.
Abdominal pad 73 is thereby properly positioned with respect to the belt. Even if the belt is removed and reinstalled hook panel 74 will remain engaged to loop panel 34 and retain the proper position.
One of the advantages of the present invention is the fact that it allows cryo therapy cold packs to he added and/or exchanged without requiring the removal of the entire belt.
Tension straps 24 and 26 are disconnected from belt 10 so that the right edge of cover panel 38 can swing open.
The opposite surface is intended to face away from the patient. It includes one or more hook panels 118. This surface is facing upward for the cold pack illustrated near the bottom of
In the preferred embodiment, each cold pack includes vent 114. The cooling medium is preferably one which forms a highly ordered crystalline structure upon freezing—much like snow. The freezing process therefore requires the volume within the cold pack to expand. Vent 114 admits air during the freezing process so that the volume inside the cold pack can freely expand. Vent 114 allows the escape of air as the cooling medium returns to a liquid.
Turning to
Once the cold pack is in the desired position, the user closes window 32 by lifting cover panel 38 back into position. Right hook panel 64 will engage the loop covering on the belt and hold the panel in place. The user may then reattach and tighten tension straps 24 and 26 to complete the process.
Those skilled in the art will realize that the steps thus described allow the user to quickly add or swap cold packs. During cryo therapy to the lumbar region, it will be necessary to swap cold packs approximately every four hours. Using the present invention, the swap may be made without removing the belt. The user simply opens the window, peels away the existing cold packs, places new cold packs, and closes the window.
Those skilled in the art will also realize that the convenient access to the lumbar region allows a wound dressing to be more rapidly inspected and changed. It also facilitates the addition of other treatment devices, such as a TENS unit.
The belt remains around the patient's abdomen throughout this process. The belt's presence provides structural reinforcement, which is particular important in cases where the lumbar fascia has been incised. It is important to limit motion in such cases. The cover panel not only retains the cold packs, it also provides a significant retention force across the patient's lower back.
Although the preceding descriptions present considerable detail they should be properly viewed as illustrating preferred embodiments of the present invention rather than limiting the scope of the invention. Many more embodiments following the same principles will occur to those skilled in the art. As a first example, the order of the steps presented in the descriptions of how the belt is applied and removed are generally unimportant. One may choose to attach the cover panel prior to applying the belt to the patient. One may also choose to attach the cover panel after the belt is in place. As a second example, snaps or buckles could be substituted for the hook-and-loop attachments described. As a third example, one side of the cover panel could be permanently attached to the belt, leaving the other side to swing open. Accordingly, the scope of the invention should be fixed by the following claims rather than by the examples given.
This application is a non-provisional application claiming priority to U.S. Provisional Application No. 61/525,812 tiled on Apr. 18, 2012.