Collector for Amniotic Fluid

I have established by my prior work that the amniotic fluid, which surrounds the fetus and is released by the mother prior to child birth, is possessed of significant and potentially valuable therapeutic properties and thus constitutes a valuable therapeutic resource. Among other things, the amniotic fluid has been found to contain certain isoantigens which have been experimentally established to have important therapeutic value. A pregnant woman typically will hold as much as a liter or more of amniotic fluid, and the collection, preservation and processing of such fluid can have substantial medical value. Unfortunately, amniotic fluid is released by the prospective mother shortly before child birth, typically without much advance warning and frequently during the night while the expectant mother is asleep. Accordingly, as a general rule, this valuable liquid is lost.

In accordance with the invention, a simple and convenient article of apparel is provided, which may be worn at all times by the expectant mother with comfort and convenience and which is capable of effectively collecting and retaining for subsequent use the amniotic fluid, when released. The article of the invention includes a fluid receptacle of relatively large volumetric capacity (e.g. up to three liters) which nevertheless may be worn unobtrusively. To this end, the receptacle is in the form of a flexible plastic bag, which is normally retained, by a pocket or other facility in the garment, in collapsed and folded condition, occupying a minimum of space. For ambulatory use, the collection receptacle is maintained in its folded and compressed condition, but is capable of being instantly opened and made ready for the reception of fluid, in the event of the sudden onset of fluid release. For nighttime wear, the receptacle may be extended upon retiring so as to be able to collect amniotic fluid if released during sleep.

Desirably, the fluid collector device of the invention includes a non-elastically conformable reinforcement secured to and surrounding the opening of the receptacle. This reinforcement may be shaped by the wearer for maximum comfort, consistent with maintaining a proper opening at the top of the receptacle. Upon discharge of amniotic fluid into the receptacle, the conformable reinforcement may be pressed closed, to facilitate retention of the fluid until its delivery to a processing center.

Representative of prior art known to the applicant are the following U.S. Patents: Schilling U.S. Pat. No. 205,912, Kirwin U.S. Pat. No. 514,717, Shtuchka U.S. Pat. No. 844,198 and Kargul U.S. Pat. No. 3,230,956. The first three recited patents relate to varieties of catamenial receptacles. However, none of them envisions the volumetric requirements of a device for the collection of amniotic fluid, and none provides for the collection receptacle to be pre-folded into a compact, unobtrusive form for normal, ambulatory use. The Kargul patent illustrates a form of a pre-folded container attached to a sanitary napkin. However, the container is neither intended for nor used as a receptacle for fluids, but is merely a facility for enclosing and disposing of the used napkin.

For a more complete understanding of the above mentioned and other features and advantages of the invention, reference should be made to the following detailed description of preferred embodiments and to the accompanying drawing.

FIG. 1 is a perspective view of the device of the invention as shown in condition for normal ambulatory use.

FIG. 2 is a fragmentary plan view of the article of FIG. 1.

FIG. 3 is an enlarged cross sectional view as taken generally on line 3--3 of FIG. 2, showing the article with the receptacle in a folded, compressed condition suitable for ambulatory use.

FIG. 4 is an enlarged cross sectional view, similar to FIG. 3, but with the receptacle fully extended for the reception of fluid.

FIG. 5 is a simplified, perspective view illustrating the manner in which the article of the invention may be incorporated in a hospital garment, for example.

Referring now to the drawing, and initially to FIGS. 1-4 thereof, one advantageous form of the invention is constructed in a manner similar to a conventional belt support for sanitary napkins. Thus, a waste-encircling belt 10 is provided, which, in this instance is provided with a substantial length adjustment capability, in order to accommodate the pregnant condition of the expectant mother. To advantage, in this respect, the belt 10 may incorporate one or more sections 11 of hook and loop fastening tape, such as is available under the trademark Velcro.

Secured to and extending downwardly from the belt 10 are front and back supporting straps 12, 13. These supporting straps, which may also incorporate Velcro adjustment portions 12a, 13a are secured to each end of a receptacle-retaining envelope 14. Typically and advantageously, the envelope 14 may have length and width dimensions not unlike those of a conventional sanitary napkin, for example. The envelope 14 may be constructed of a lightweight, limp, open mesh fabric, edge margins of which are folded under along longitudinal side edges 15, 16. The circumference dimension of the fabric section is somewhat greater than twice the overall width of the envelope 14 such that, in the folded condition, one fabric edge 17 overlaps and extends beyond the other edge 18 by a substantial amount. By way of example only, in a practical embodiment in which the envelope has a width on the order of 75 mm, the construction may be such as to provide for folded-under flap-like fabric margins of around 60 mm, so that an outer flap 19 overlaps the under flap 20 by, say, around 50 mm.

At the ends, the envelope 14 desirably is folded to form tapered ends 21, 22, and these may be seamed across at 23, 24 to close the ends of the envelope. In addition, the respective fabric edges 17, 18 desirably are stitched at 25-28, for a short distance from the end seams 23, 24 toward the center of the envelope. Significantly, the longitudinal seams 25-28 extend only a portion of the length of the envelope between the end seams. In the illustrated, typical embodiment, having a representative overall length between the end seams 23, 24 of around 350 mm, the longitudinal seams 25-28 may extend for a distance of, say, 70 or 75 mm, being connected at their inner ends by short rows of cross stitching 29, 30. Between the inner rows of cross stitching 29, 30, the overlapping margins 19, 20 are left free, forming an internal pocket 31 in the envelope which is accessible by displacement of the outer fabric section 19 in one direction and similar displacement in the opposite direction of the inner fabric layer 20. Although specific dimensions are not in any sense critical to the invention, the length of the envelope pocket, formed between the rows of cross stitching 29, 30, may typically be on the order of 170-180 mm. The closed portions of the envelope 14, extending beyond the pocket at each end, serve to primarily provide a convenient and comfortable support for the pocket section.

On the upper side of the pocket 31, there is formed a relatively large opening 32 which, in normal use may be of generally oval shape, having typical major and minor dimensions of around 130 mm and around 60 mm respectively, it being again understood that specific dimensions are not critical to the invention. Around the opening 32 there is provided a reinforcing member 33, of generally endless configuration, which is of a yieldable, conformable material, substantially non-elastic in nature. The arrangement is such that the reinforcement may be shaped three-dimensionally by the expectant mother to conform most comfortably to her body contours. As illustrated in FIG. 3, the reinforcing member 33 is completely enveloped by the fabric material and is secured to the edges of the pocket opening 32, such that, in general, the reinforcing member 33 defines the size and the shape of the pocket opening.

Securely attached to the upper layer of the pocket forming fabric, and also to the reinforcing member 33, is a relatively large bag-like receptacle 34, which is formed of a lightweight, strong, highly flexible plastic material. Desirably, the width of the bag-like receptacle (measured in the longitudinal direction of the envelope 14) is approximately equal to the length of the pocket 31. The receptacle is of substantial vertical length, sufficient to provide for a maximum volumetric capacity of as much as three liters, although that is typically considerably in excess of the amount of amniotic fluid to be received.

In accordance with the invention, the open upper end 35 of the bag-like receptacle 34 is secured about its periphery to the reinforcing member 33, or at least to the fabric in the area of the reinforcing member. When fully extended, the receptacle 34 extends through the open pocket bottom formed by the displaced fabric flaps 19, 20 (see FIG. 4).

In accordance with a significant aspect of the invention, the flexible, bag-like receptacle 34 may be folded acordion fashion, forming four or five flat layers of material, and tucked inside the pocket 31, with the pocket-closing flaps 19, 20 being closed over the receptacle, serving to effectively retain the accordion folded receptacle in a flat, unobtrusive condition inside the pocket 31. This enables the article to be worn by the expectant mother with convenience and comfort and in an entirely unobtrusive manner. The overall dimensions of the envelope 14, containing the accordion folder receptacle are not unlike those of a conventional sanitary napkin, for example.

Since experience indicates that the onset of discharge of the amniotic fluid may proceed with very little advance warning, provision is made for effecting instant release of the folded receptacle from its pocket 31, to bring the receptacle into its fully extended condition ready to receive the fluid. To this end, the bottom of the bag is provided with a tab or cord 36, which is permitted to extend through the normally overlapped pocket-closing flaps 19, 20, and is capable of being easily and quickly grasped. Thus, when the expectant mother detects the onset of fluid release, she need only pull the tab or cord 36 and draw the bag downwardly out of the pocket to receive the fluid discharge.

Frequently, the onset of amniotic fluid discharge occurs without warning, while the mother is asleep at night. Accordingly, it is generally desirable for the expectant mother to draw the receptacle 34 out to its fluid-receiving condition before retiring at night. The next morning, the article may be prepared for ambulatory use by simply refolding the receptacle and tucking it back into the pocket 31.

As mentioned above, the non-resiliently comformable reinforcing members 33 may be shaped by the user to a comfortable, body-conforming contour for normal use. In addition, after amniotic fluid has been discharged into the receptacle bag 34, and the bag has been removed from the body of the user, the opening 32 may conveniently be closed by squeezing tightly together opposite sides of the conformable reinforcing member (see phantom line illustration, FIG. 4). While not providing an absolute seal, this can largely prevent accidental loss of fluid by free surface action as well as contamination of the fluid by entry into the receptacle of foreign matter. It further enables the filled receptacle to be conveniently carried to another location where the fluid can be processed in a suitable fashion and stored for subsequent use.

The form of the invention shown in FIG. 5 may be advantageous for institutional use, as well as for use at night. The modification of FIG. 5 includes a suitable loose fitting garment 40, which may advantageously be of a one-piece design. The garment 40 is fitted with Velcro or similar fasteners for the adjustable engagement of front and back envelope-supporting straps 41, 42, engaging the opposite ends of a receptacle containing envelope 43. The envelope structure 43 is in all respects the same as that described with reference to FIGS. 1-4, it being understood, however, that the envelope 43 is supported directly by the garment 40, rather than by a separate belt structure. When ready for use, the receptacle may be drawn out to extend into one of the loosefitting, abbreviated by portions 44 of the garment.

In any of its various forms, the article of the invention provides a comfortable and convenient, yet entirely practical arrangement for the collection of valuable amniotic fluids when discharged from an expectant mother. The article of the invention accommodates the circumstance, that the onset of fluid discharge occurs with little or no advance warning, thus rendering it impractical for an expectant mother to wear a catamenial device of conventional construction having adequate volumetric capacity to receive the amniotic fluid discharge. With the article of the present invention, the fluid-receiving receptacle is accordion folded into flat, compact, body-conforming configuration of a size and shape to which the average female is already accustomed. On a moment's notice, however, this may be converted into a usable receptacle of substantial volumetric capacity.

With the article of the invention, the heretofore wasted, but nevertheless therapeutically valuable and important amniotic fluid may be collected and utilized in a practical manner, affording significant benefits not only to the mother and infant, but in many cases also to third parties. Thus, while the device itself is relatively simple and inexpensive in nature, its practical advantages and benefits are far-reaching and medically significant.

It should be understood, of course, that the specific form of the invention herein illustrated and described are intended to be representative only, as certain changes may be made therein without departing from the clear teachings of the disclosure. Accordingly, reference should be made to the following appended claims in determining the full scope of the invention.