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.
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""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.
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.
USPTO Backgrounds
USPTO Backgrounds