Abstract:
A mechanism for supporting and relieving pain of an abdominal incision comprises a radially expandable bladder, a rigid waist band and a partial body garment. The expandable bladder comprises a pad, which spans a substantial portion of the abdominal region, is pressurized to apply pressure forces to the abdomen. The encircling and inelastic band overlays the entire inflatable bag and is adjustably closable at the back of the patient by fastener means. In an initial recovery period after the surgical procedure, the radially expandable bladder and the encircling band are both encompassed within a flexible body garment which can encircle at least upper-thigh region, and which compresses all zones above, below and on the sides of the incision zone, limiting the forces in the plane of the tissues that tend to act upon the incision zone, but without interfering with or impeding body movements. Thus, in the initial period after surgery, the patient can sleep and engage in permissible movements with less discomfort, and less danger of disruption of the sutures, while accelerating recovery. At a later interval, the bladder and encircling band need not be employed, and the patient can use only the partial or full body suit.

Description:
FIELD OF THE INVENTION 
     This invention relates to safeguarding against damage to weakened abdominal areas, and more particularly to devices and methods for relieving pain and promoting healing after invasive abdominal surgery and promoting healing. 
     BACKGROUND OF THE INVENTION 
     After surgery in the abdominal region of a patient, the patient is exposed to dangers and subjected to discomfort that is not encountered when surgery is conducted in other regions of the body. In a sense, physical activity of the trunk of the body or of the limbs cannot be conducted without affecting the muscle and tissue in the abdominal region, since even though it is not actively involved in work or exercise activities, it is passively affected by forces acting from all sides. Even when asleep, a person&#39;s motions can affect the central abdominal region, which by its geometry cannot readily be bound up or confined against motion without extreme discomfort to the patient. 
     If an incision is made in the abdominal region for surgical procedures, for example, the incision is closed and sutured at the end of the procedure, and the patient must thereafter protect the sutured zone against forces which would strain the sutures and/or tend to reopen the wound, while also undergoing the pain that accompanies an incision in this sensitive region. The acute phase of the healing process takes a few hours to several days, as the incision space first fills with serum and blood and then neutrophilic infiltration of the dermis takes place. At this point the edges of the incision which are held in place have little resistance to tensile forces except that provided by the suture. This condition gradually changes as neutrophilic activity first increases and then is supplanted by macrophage activity and subsequently by the formulation of granulation tissue and then neovascularization and collagen fiber formation. This leads to increasing tensile strength as the granulation tissue transforms into a collagen filled scar. 
     Thus care may have to be exercised for a considerable time because of the slowness and gradual changes in the healing procedure. However, although there are a number of abdominal supports that are known, typically in the form of elastic garments covering the body and the waist to thigh region, there are no accepted expedients of this character which aid in reducing pain, promote healing and provide protection against reopening of the incision. 
     The known elastic garments function essentially to compress all of the lower body region, thus typically limiting tissue movement from the zone of the incision in different directions instigated by bodily movements. A person having substantial adipose tissue in this region cannot control forces that impel motion in the incision zone because of body movement elsewhere, which may not only induce pain but actually contribute to separation of the joined tissue walls at the incision. A close fitting elastic garment that covers the entire region can have some beneficial restraining effect, but actually in most instances, depending on body structure, this tends to increase, rather than alleviate the discomfort. Straps and belts are also used in different configurations and while they can be even more restrictive on tissue displacement they have less local benefit in the zone of the incision and tend to inhibit bodily freedom. 
     SUMMARY OF THE INVENTION 
     Devices and methods in accordance with the invention provide at least two different pressure exerting constraints in the regions proximate to and surrounding the incision zone. One constraint is provided by an expandable element of limited area in contact with the incision and the area immediately around it. The expandable element is expanded to a comfortable pressure level by an interior compressible fluid. The expandable element is confined within another element, which encircles the body and is inelastic, but conformable to the body configuration. By locally exerting distributed forces on the abdominal surface at and about the incision zone, the tissues in that zone are restricted from drastic movement, and the facing walls of the incision are forced together while at the same time, the pressure on the incision reduces pain and irritation. Concurrently, the compressible fluid, such as gas, allows local yielding to forces and movements in the proximal zone. Both the gas pressure and encircling band can be adjusted for comfort and pain relief. In an initial recovery period after the surgical procedure, the radially expandable element or bladder, and the encircling band are both encompassed within a flexible body garment which can encompass at least the upper-thigh region, so as to lightly compress all zones above, below and on the sides of the incision zone, limiting the forces in the plane of the tissues that tend to act upon the incision zone, but without interfering with or impeding body movements. Thus, in the initial period after surgery, the patient can sleep and engage in natural involuntary movements with less discomfort, and less danger of disruption of the sutures, while accelerating recovery. At later stages, as healing progresses, either the body garment or the bladder and encircling band need not be employed. 
     In a more particular example of a device in accordance with the invention, the radially expandable bladder comprises a pad which spans a substantial portion of the side of the abdomen as well as the major part of the frontal portion of the abdomen, while the encircling and elastic band overlays the entire expandable bladder and is adjustably closable at the back of the patient by fastener means such as buckles, Velcro or other known methods. This structure is adjustable for size, shape and comfort and readily reusable. 
     A number of alternatives in accordance with the invention are also feasible, including an encircling band or belt which has an aperture in the abdominal region which is smaller in area than the expandable bladder, thus holding the bladder about its periphery against the body but modifying the forces acting on the incision zone, because the bladder can be pumped to a higher pressure, since it is free to expand outwardly. As another alternative, the expandable bladder, a pump for generating pressure in the bladder and the encircling waistband can be made as a single integral unit. In addition, an optional elastic body garment can be of different sizes, but nonadjustable except for its inherent elasticity, or made in one size and provided with adjustable enclosures. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     A better understanding of the invention may be had by reference to the following description, taken in conjunction with the accompanying drawings, in which: 
     FIG. 1 is a front view of a preferred embodiment of the abdominal support mechanism; 
     FIG. 2 is a plan view of a restraining band in accordance with the invention; 
     FIG. 3 is a sectional view of the restraining band in FIG.  2 . in accordance with the invention; 
     FIG. 4 is a perspective view of the principal elements of the abdominal support mechanism in FIG. 1 while in use, and showing further details thereof; 
     FIG. 5 is a fragmentary cross-sectional view of a preferred embodiment of the abdominal support mechanism in support of the frontal abdominal area in accordance with the invention; 
     FIG. 6 is a front view of a casual support suit in accordance with the invention; 
     FIG. 7 is a fragmentary cross-sectional view of an alternative embodiment of the abdominal support mechanism in support of the frontal abdominal area in accordance with the invention; 
     FIG. 8 is fragmentary cross-sectional view of a second alternative embodiment of the abdominal support mechanism in support of the frontal abdominal area in accordance with the invention; 
     FIG. 9 is a rear view of a third alternative embodiment of the abdominal support mechanism in accordance with the invention; and 
     FIG. 10 is a fragmentary cross-sectional view of the alternative embodiment of the abdominal support mechanism in FIG. 8 in support of the frontal abdominal area in accordance with the invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Most abdominal incision are made in the central region of the lower torso. These incisions are generally a few inches in length, spanning a length, along the central portion of the abdomen. Once the surgery has been completed, the incision is closed, typically by a suture. Healing of the incision involves a critical period of several days that is most critical at the outset, with tissue integrity being restored over the course of a few weeks. During the initial period it is very important for the incision not to be subjected to sudden movements which might strain the suture or otherwise cause the incision walls to tear or reopen. It is therefore important to provide support at the incision area in order to restrain any unnecessary abdominal movement, but to do so in a manner which itself is not uncomfortable. Applying a sufficient amount of pressure to a sutured area has been found to alleviate abdominal pain, as the pressure both desensitizes and provides a feeling of security. The present invention provides a mechanism and method of providing abdominal support that enhances healing of post surgical incisions that are typically closed by sutures, although other means are now available for use. FIG. 1 depicts an abdominal support system comprising a restraining band  20  and a compression suit  70 , which overlies the band  20  and the trunk of the body. 
     In preferred embodiments, as shown in FIG. 2, the restraining band  20  is designed to adjustably fit around a patient&#39;s waist. The restraining band  20  comprises a band  22 , for fitting about the waist of the user, and a radially expandable bladder  50  within the band for engagement against the incision in the abdomen. Once the restraining band is secured around the patient&#39;s waist, the bladder  50  can be inflated in a controlled manner to apply radial circumferential pressure to the abdomen. 
     The waist band  22  is preferably made from a pliant material, such as a tightly woven canvas, and is designed to be fastened around the patient&#39;s waist for holding the interior bladder  50  against the abdomen. The waist band  22  comprises an elongated, substantially flat central band  24  having an inner surface  21 , an outer surface  23  and length A. The central band  24  is coupled to a first strap end  26  and a second strap end  28 . The waist band  22  is tapered such that its width is approximately 13 inches in the center of the central band  24  and approximately 11 inches at both ends  26  and  28 . The total length B of the waist band  22 , which includes the length of the central band  24  and the first strap end  26  and second strap end  28 , is preferably slightly greater than that of the waist of the patient so the strap ends  26  and  28  may be overlapped to encircle the waist. For example, for a waist of about 36 inches, the length of A is preferably about 24 inches and each of the strap ends  26  and  28  are about 8 inches such that the total length B of the waist band  22  is about 40 inches. 
     In alternative embodiments, the waist band  22  may comprise other materials, such as, but not limited to, hard rubber, leather and other materials exhibiting similar material properties. Additionally, the dimension of the waist band  22  will vary according to dimension of the user. 
     The first strap end  26  includes an attached fastener  34 , such as a buckle. The second strap end  28  comprises a series of holes  36  displaced along its length for receiving the fastener  34 . The first strap end  26  acts in conjunction with the second strap end  28  to secure the waist band  22  around the patient&#39;s waist and enables the waist band  22  to be adjustable. In alternative embodiments, other adjustable fastening methods made be used to secure the waist band  22 , including, but not limited to, Velcro fabrics and adjustable snap locks. 
     With reference to FIG. 3, the expandable bladder  50  is designed to substantially encircle the abdominal area and may extend about the sides and a portion of the lower back. The expandable bladder  50  is pressurizable with gas to apply a constant pressure distributed across the patient&#39;s abdomen regardless of how tight the waist band  22  is initially applied. The bladder  50  is made of an impermeable material, such as a nylon fabric coated with polyurethane, and comprises an inner wall  52  and an outer wall  54 , each having surface dimensions 11 inches by 20 inches. The walls  52  and  54  thus define an enclosed volume  56 , which can be filled with a compressible fluid, such as air. The bladder  50  is fastened to the inner surface  21  in the middle of the central band  24  at a seam  58 . This design geometry allows the bladder  50  to expand radially, relative to the body, when inflated. Radial expansion is achieved by the use of an inextensible material, having no significant ballooning when inflated, and the circumferential inelasticity of the supporting central band  24 , which permits extension of the bladder  50  only in one direction. When the bladder  50  is inflated it expands radially, contacting the abdominal area and conforming to the patient&#39;s contour. Once in contact with the abdomen, the bladder  50  can be further pressurized to apply a consistent circumferential compression to the suture. Both the bladder  50  and the waist band  22  can be individually adjusted for fit, comfort, and alleviation of pain. 
     The expandable bladder  50  may comprise other materials, including, but not limited to, plastic, nylon, silicone and latex. The dimensions of the expandable bladder  50  are to vary in proportion to the dimensions of the waist band  22  and the user. 
     A hand pump  60  is used to control the pressurization of the bladder  50 . The pump  60  is attached to the bladder  50 , via a pressure line  62 , pressurizing the bladder  50  with a compressible fluid. The hand pump  60  includes a pressure release valve such that the bladder  50  may be inflated or deflated to achieve a comfortable circumferential pressure on the abdomen. 
     The compression suit  70 , as presented in FIG. 1, is made of a flexible material, such as a light canvas, and encircles the patient&#39;s whole torso and upper-thigh region. The compression suit  70  includes an inner liner  72 , a fastening seam  74  and a pair of adjustable secondary fasteners  76 . The compression suit is designed to fit over the retaining belt  20  with the inner liner  72  compressing against outer surfaces of the retaining band  20 . The suit  70  additionally provides secondary compressive pressure to the upper torso and upper thigh areas that surround and support the abdominal area as well. 
     The fastening seam  74 , such as a zipper, extends along the frontal area of the suit to enable the user to dress or remove the suit  70 , as well as providing a means for initializing the suit&#39;s  70  compressive forces on the body. A pair of secondary fasteners  76 , such as snap locks, are located on the frontal area of the body suit, and configured, perpendicular to the fastening seam  74 , to provide additional compression means for the suit  70  and enabling the suit to taper with the body. 
     In alternative embodiments, the suit  70  may be made of other materials, such as nylon, rubber, neoprene, or elastic foam composites. Other fastening means may be used along the seam  74 , including Velcro, in addition to locating the seam  74  in alternative configurations, such as along the side of the suit  70  or along it&#39;s back. Additionally, other secondary fastening means may be used to taper the suit  70 , including, but limited to, an adjustable belt loop and Velcro straps. 
     In usage, as seen in FIGS. 4 and 5, the restraining band  20  is wrapped circumferentially around the waist of the patient after surgery. Assistance of a medical technician may be required to provide proper fitting and comfort. The restraining belt  20  can be adjusted to provide adequate restraint about the abdominal area. Once the restraining belt  20  is secured in place, the inflatable bladder  50  is then pressurized to a sufficient pressure to support the crucial abdominal area  12  containing the incision  11 . Once pressurized, the restraining belt  20  conforms to the dimensions of the user and exerts localized pressure forces perpindicularly on the incision  11  and the proximal area  12 . The localized pressure forces are determined by interior forces of the compressible gas and the exterior circumferential tension created by the restraining belt  20 . These are set to provide distributed pressure loads in the abdominal area, which act to restrain the sutured wall tissues at the incision, and the tissues encompassing the incisions, from lateral movement relative to the incision and at the same time, pressing in on the incision  12 . The hoop stresses created by the restraining band  20  act to bring all the compressive forces to a focal pressure point within the abdomen. The pressure acts to force the facing walls of the incision  12  together, facilitating the healing process and further, reducing pain and irritation. Because the bladder  50  is pressurized with a compressible fluid, it yields to the counter forces from the body side that are adequate to overcome the constraint. This means the user does not feel extra resistance to movement, even though the incision is securely held. The dual function of the bladder  50  and belt  22  provides the pressure to restrain the incision  12  separation or tearing. The restraining belt  20  is designed to be worn consistently throughout the healing process. 
     During the first few weeks after surgery, the compression suit  70  is preferably worn in tandem with the restraining band  20  during the patent&#39;s sleeping hours. The compression suit  70  acts to provide secondary support and pressure to abdominal area, restricting unconscious bodily motions which might cause the incision  12  to open or tear while sleeping. The suit  70  also acts to restrict motion in areas surrounding the abdomen to relieve any additional stress which might be transferred from the trunk of any adjacent limbs to the abdomen. The adjustable fasteners  76  provide additional comfort and taper. 
     After about three weeks, a casual suit  78  may be worn alone during waking hours, as shown in FIG.  6 . The suit  78  comprises an elastic material, such as neoprene, and encircles the patient&#39;s whole torso and upper-thigh region. The suit  78  having compressive material properties, provides adequate support to the abdomen and surrounding areas, as progressive healing of the incision  12  now requires less pressure to provide relieve. After about 5 weeks, the incision will likely have had adequate time to heal. Use of the body suit is recommended as needed. 
     In alternative embodiments, the casual suit  78 , may be replaced by a compliant full body suit which extending from the ankles to the upper torso. This suit is inflatable in various sections of the body to provide pressure to working muscles during physical activities. Use of the full body suit during physical activities has been observed to aid in the preservation of muscle tone while one is expending fat cells, resulting in a reduction of flab or excess skin. 
     The present invention provides a system and method for advancing healing to an abdominal incision at a faster than normal rate. The system helps to reduce pain, while permitting the patient to engage in normal, though restricted, activities that put stress on the abdominal muscles. By securing the sutured area, the invention enhances healing and prevents accidental tearing caused by coughing, laughing and sneezing, among other activities. The system further allows the patient to participate in breathing exercises and walk sooner than would normally be possible. 
     While the description above has set forth a preferred embodiment of the invention, alternative embodiments may be prescribed to achieve the same benefits. One of such embodiments, as shown in FIG. 7, includes a separable inflatable bladder  50  and waist band  22 , where the bladder  50  is placed against the suture and the waist band  22  is wrapped around the bladder  50  to hold it in place. FIG. 8 presents a further embodiment, which includes an inflatable bladder  50  integrated into a cutout  40  within the waist band  22 , allowing the bladder  50  to expand in opposite directions. 
     FIGS. 9 and 10 describe a further alternative embodiment in which the waist band  20  and the bladder  50  are integral with the compression suit  70 . The waist band  20  and bladder  50  are housed within a pocket  80  circumferentially stitched into the suit  70  in the area surrounding the waist having an opening  81  to allow the bladder  50  to expand beyond the inner liner  72 . 
     It is to be understood that even though numerous characteristics and advantages of various embodiments of the present invention have been set forth in the foregoing description, together with details of the structure and function of various embodiments of the invention, this disclosure is illustrative only and changes may be made in detail, especially in matters of structure and arrangement of elements within the principles of the present invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed. For example, although the preferred embodiment described herein is directed to providing support and healing to abdominal incisions, the invention may be applied to provide support and healing to incision in the upper torso. Thus, it will be appreciated by those skilled in the art that the teachings of the present invention can be applied to other systems without departing from the scope and spirit of the present invention.