Device and method for minimizing implant effects

A method and device effective for inhibiting the contracture of scar tissue following breast implantation, comprising a pair of pivotally coupled arms for contacting the breast on opposite sides and applying static pressure thereto. Each arm includes a curved bottom portion that extends around the lower surface of the breast means and includes means for adjusting the pivot point of the arms in relation to the size of the breast. The upper ends of the arms extend above the breast and means connect the arms to adjust the pressure of the side portions against the breast.

BACKGROUND OF THE INVENTION 
The present invention relates to elimination or minimization of scar tissue 
contracture resulting from cosmetic surgery, and more particularly is 
directed to assuring that the scar tissue that forms following breast 
implantation will not contract within the breast to cause hardness, pain 
or asymmetry. 
Plastic surgery involving breast implantation by silicone injection is well 
known and was once widely practiced but is no longer in vogue. Preferred 
techniques now use implantation of an enclosed silicone gel. In the breast 
implantation operation, the sac implant of circular outline is introduced, 
in one common approach, into the breast via a semi-lunar incision around 
the areola. Because the implant is a foreign object the body builds a 
layer of scar tissue around the implant to seek to wall it off from the 
surrounding tissues. A circular internal scar, which is initially soft, 
forms about the outline of the sac. However, because scar tissue tends to 
contract in a linear dimension, there is a subsequent tendency to internal 
contracture in a ring-like pattern around the implant. Scar contracture 
results in breast hardening, sometimes asymmetry, and occasionally causes 
pain by distorting nerves in the region. Unless the scar tissue area is 
vigorously massages on a regular basis scar tissue contracture can take 
place. Accordingly, it has been the practice for women following breast 
implantation to require post-operative treatment by a physician or medical 
aide. The doctor must advise the patient to massage and compress the 
breast vigorously on a daily basis for a period of time in an effort to 
insure that the breast stays soft and to inhibit the scar tissue 
contracture that takes place. 
However, this procedure is very time consuming for the patient. Women 
usually cannot exert the force that strong professional hands can apply, 
and they may be uncertain of the particular actions that must be 
undertaken. Moreover, dormant scar tissue can be reactivated and commence 
contracture again under stressful circumstances, such as infection or some 
illness. Also it may be required under some circumstances of contracture 
for a doctor to use a manual capsulotomy procedure, physically breaking 
down contracted scar tissue. When this is done against strongly resisting 
tissue the gel implant can also burst or commence leaking, requiring 
emergency procedures to evacuate the fluid. 
A need therefore exists for some means, readily usable, which is effective 
for preventing the breasts from hardening due to scar contracture 
following implantation. Such means should soften scar tissue following 
breast implantation and be effective under a variety of circumstances. 
Further it must be simple, relatively inexpensive, adjustable for use 
regardless of the individual's physique, and readily and conveniently 
applicable by the patient. It must manipulate and apply pressure to the 
breast in such fashion that the requisite forces act to prevent the 
contracture of scar tissue without other adverse effects. 
SUMMARY OF THE INVENTION 
Methods and apparatus in accordance with the invention stretch the circular 
scar tissue formed after breast implantation by periodically applying 
continuous consistent pressure for selected intervals in a manner that 
inhibits contracture. Laterally directed compressive forces, steadily 
applied for substantial time intervals on a daily basis, act to 
repetitively deform the scar tissue in a direction opposite to the 
tendency to contract, and prevent contracture. The device and method can 
also be used to prevent reactivation and in many instances to stretch scar 
tissue previously contracted. With a very firm breast the device can be 
applied for 30 minutes on the breast and will stretch the scar, making 
manual capsulotomy easier. 
A device effective for inhibiting scar contracture following breast 
implantation comprises a breast compressor defined by a pair of arm 
members pivotable about an adjustable pivot point. The arm members each 
include side pads or contact areas for squeezing the breast laterally and 
perpendicularly in the scar tissue plane and applying pressure to stress 
and stretch the scar. The arms include curved, diverging, bottom portions 
that are adapted to pass around the lower surface of the breast without 
engagement as pressure is applied. The bottom portions include a number of 
spaced apart pivot pin holes for adjusting the pivot position in relation 
to the size of the breast. The arm members are configured so that pressure 
can be exerted laterally on the breast without interference or pinching in 
the pivot region. A pair of free ends extend upwardly from the arms of the 
device and are also shaped with curvatures so as to be non-interfering as 
compression is applied. Means are provided for drawing and engaging the 
free ends to adjust and hold the breast in compression by drawing the side 
pads together to a desired spacing. 
The means for adjusting the pivot position for the arms can comprise a 
threaded pin and sleeve fitting through the structure in the bottom 
portion. The means for adjusting the contact pressure of the side portions 
against the breast, can be, for example, a flexible string or band 
connected between the upper ends of the arms and means on the string and 
arms for selectively controlling the tightness of the squeeze of the side 
portions against the breast. Such a string, for example, can include 
spaced apart beads engaging in restricted slots in the arm ends for 
controlled application of continued pressure against the breast by locking 
to a given position.

DETAILED DESCRIPTION OF THE INVENTION 
The method of inhibiting contracture of scar tissue following breast 
implantation is, in accordance with the invention, based upon periodic 
application of substantial lateral pressure for a significant duration. 
The lateral pressure is typically exerted against the sides of the breast, 
deforming substantially the entire breast by compressing the sides while 
forcing the top and bottom portion outwardly. All of the interior 
ring-like or circular scar tissue is thus acted upon, being placed under 
substantial tension along the scar line whether being deformed inwardly or 
outwardly. The pressure exerted is well within the limits that can be 
sustained by the implant sac so that there is a minimal danger of rupture 
or internal leakage. The forces that can be exerted are well below the 
pain threshold, but substantially above what can be applied manually. The 
forces are exerted by side contact members and although considerable 
pressure is applied and distortion is substantial, the procedure is not 
painful. Thus the constant tendency of internal scar tissue to contract 
along the scar line is effectively opposed by the periodic deformation. 
Compression is maintained for 15-30 minutes per application, three times a 
day for the first six months and once daily thereafter. The forces are 
most conveniently applied laterally, in the horizontal direction for an 
upright person, but in some instances it can be efficacious to apply the 
forces vertically. 
Application several times each day for a period of six months following 
breast implantation and daily thereafter is generally sufficient to 
inhibit scar tissue contracture. Inhibit in this sense does not preclude 
the possibility of scar reactivation, by illness or other traumatic 
causes. If such occurs, however, reinstitution of the compression 
procedure will generally cause the scar tissue to stretch and resoften a 
breast that is becoming firm. Where scar tissue has contracted, and must 
be subjected to manual capsulotomy, which breaks down the scar tissue by 
the application of high, concentration forces, the use of the present 
compression method prior to manual capsulotomy is generally found to make 
the latter procedure easier to perform successfully. 
A device 10 for use in accordance with the method is shown in FIGS. 1-4, to 
which reference is now made. The device 10 is shown as applied to the left 
breast 12 of a subject who has previously received a breast implant (not 
shown). The incision is typically made around the areola and the implant 
is placed within the pocket created. Scar tissue forms in a ring-like 
fashion and in a plane parallel to the front of the chest wall. The device 
10 comprises a pair of arm members 14, 15 formed integrally to define 
different sections, and being substantially alike so that extra molds are 
not needed. In an intermediate region of each arm member 14, 15, is 
disposed a side or pressure pad 17, 18 respectively (best seen in FIGS. 2 
and 3). The side pads 17, 18 face each other, with facing surfaces that 
lie in vertical planes and are approximately 3/4" wide by 2.0" high. The 
areas of the side pads 17, 18 distribute the forces for comfortable, 
non-painful application. Smaller side pads, a number of small contact 
surfaces, or other expedients may be used depending on the purpose of use, 
pain threshold and other factors. The side pads lie on inwardly protruding 
portions of the arm members 14, 15 so as to avoid interference of the arms 
with other parts of the breast when compression is applied. In this 
intermediate region, each arm member includes an inset portion 20, 21 
along its outer periphery, for firmly receiving a stretchable encircling 
cover pad 22, 23 respectively for further extending the area of contact 
and providing a cushioning effect. Advantageously, these cover pads 22, 23 
are of tubular rubber or other elastomer, although they may also be of 
other suitable cushioning materials, such as fabric covered foam, that can 
be stretched over the pad and seated in the insets 20, 21. The outer 
margins of the arms 14, 15 in the intermediate region are approximately 
linear, apart from the insets 20, 21. The inner edges however curve 
outwardly and then back toward the opposing arm along approximately 
circular arc segments in both the bottom and upper regions (as seen in 
FIGS. 1 and 2). These curvatures provide substantial clearance both above 
and below the breast that is to be compressed by the side pads 17, 18 and 
cover pads 22, 23. The bottom portions of the arms 14, 15, comprise 
diverging extensions 25, 26 which cross adjacent a pivot axis. To 
establish the pivot axis, each diverging extension 25, 26 includes a 
sequence of spaced apart pivot holes 28 having an adjacent number 30 
molded into or fixed on the plastic. Dependent on the span of the breast 
to be compressed, a removable pivot is defined by an internally threaded 
sleeve 32 inserted into a selected pivot hole 28. An externally threaded 
pin or screw 34 is removably coupled into the sleeve 32. The surface 
numbers 30 make it convenient to match up the pivot holes so as to provide 
a symmetrical geometry, in which the side or pressure pads 17, 18 act 
directly and perpendicularly against the sides of the breast. 
At the upper end, each arm 14, 15 curves inwardly to a free end 36, 37 
which is substantially vertical and includes means for seating a retainer, 
such as a high strength "Nylon" string or band 40 having integrally molded 
beads 42. The upper end 36 of one arm 14 includes an elongated slot 44 
having an upper opening larger than the beads 42 and a narrow bottom end 
into which the string 40 is slidable, but which is smaller than the beads 
42. When the string 40 is slid down into position a conforming plug (not 
shown) may be inserted and adhesively secured to the slot 44 walls to 
provide positive backing of the one end of the string 40. The engaged bead 
42 within the small part of the slot 44 retains the string 40 against 
reactive forces exerted in the perpendicular direction by the compressed 
breast. The upper end 37 of the other arm 15, as seen in FIG. 3, has a 
similar slot 46 with an opening at its top end larger than at its bottom 
portion, but which is not closed by a plug. The slot 46 thus permits the 
string 40 to be pulled so as to draw the arms 14, 15 together, then to 
draw the string 40 and beads 42 down into the small part of the slot 46, 
preventing release. 
In use, the patient places the device 10 against the chest wall encircling 
the breast and around the base of the breast 12 in FIG. 1, with the 
somewhat semicircular diverging bottom extensions 25, 26 free of close 
contact with the lower surface of the breast 12. The two side pads 17, 18 
and covering members 22, 23 are then brought together into tight contact 
with the opposite sides of the breast 12. In this position compressive 
pressure is exerted symmetrically and in opposition in the plane of the 
ring-like scar tissue. If the breast is too large or small the pivot 
position can be adjusted by replacement of the pivot sleeve 32 and pin 34 
into different matched pivot holes 28. 
With a desired force of compression established by pulling the string 40 
end to bring the arms 14, 15 together, the free end of the string 40 is 
brought down into the slot 46 in the upper end 37 and the device 10 is 
then locked into position. When it is desired to release the pressure on 
the breast 12 and remove the device 10, the string 40 is merely pulled 
upwardly out of the small end of the slot 46. This permits the arms 14, 15 
and the contact padss 22, 23 to move outwardly, thus permitting removal of 
the device from the breast. 
When applied, the breast compressor provides a consistent pressure to the 
breast, more than can be produced by the patient herself. The 
configuration avoids pinching and interference both above and below the 
contact areas. The use of the breast compressor approach also avoids the 
problem of long nails when the patient massages the breasts by hand. With 
firm pressure the nails dig into the breast tissue, causing pain. If the 
breast is already starting to become firm, the breast compressor may help 
soften it by continuous use, and will soften scar tissue around the 
breast, which causes the hardness and often asymmetry of the breast. The 
amount of pressure applied to the breast can be adjusted to control the 
tightness of the squeeze, by bringing in or letting out the beaded string 
or band. It will be recognized that other cushioning pads and other 
tightening means, such as elastic bands, can be employed with this device. 
The breast compressor can be used by the patient herself to apply pressure 
to the breast each time for a period say from about 15 to 25 minutes 
several times a day for a period of for example six months following 
breast implantation. Used once daily thereafter it properly maintains the 
breast in a soft condition and opposes scar tissue contracture, without 
the aid of a physician. To save time, two breast compressors can be 
employed simultaneously, one on each breast. 
From the foregoing, it is seen that the invention provides a simple breast 
compressor device formed of only a few components, and which can be 
readily used by a patient for maintaining the breast soft and breaking 
down and stretching scar tissue following breast implantation. 
Since further changes and modifications of the invention will occur to and 
can be made readily by those skilled in the art without departing from the 
invention concept, the invention is not to be taken as limited except by 
the scope of the appended claims.