Patent Application
20170239147
1. Field of Invention
This invention pertains to a shield for protecting a post-surgical wound. More particularly, this disclosure pertains to an open-end shield sutured to the portion of a patient's skin that surrounds a reconstructed nipple.
2. Description of the Related Art
The current preferred method for nipple reconstruction is to make small incisions on the skin of a breast that has been reconstructed either by autologous reconstruction or breast implant. The cut tissue is then elevated, and formed and shaped into a living tissue projection that mimics the natural nipple. A common incision/elevation method is the “star” dermal flap pattern, which comprises elevation of the skin flaps of the cut “star” pattern and wrapping the star “wings” around each other.
Nipple construction is the last stage of breast reconstruction and is performed when the surgeon is confident that the prior reconstruction stages have sufficiently healed and that both the contour and shape of the reconstructed breast have achieved their final acceptable symmetry.
The technical challenges of nipple reconstruction include maintaining a desirable nipple projection and leaving an inconspicuous scar. Tissue heals in response to the forces that are placed upon it and the position the tissue is in. Thus, during the post-operative stage the protection of a newly created nipple from outside forces is crucial. A newly constructed nipple is extremely sensitive to shearing and pressure forces, which may result in flattening of a nipple.
Typical prior art for shielding nipples is found in, for example, U.S. Pat. No. 4,870,977 by Imonti (hereinafter “Imonti”), which discloses a cone-shaped nipple protector member having an outwardly-disposed flange. More recent art is found in U.S. Pat. No. 7,938,122 by Clark (hereinafter “Clark”), which discloses a nipple guard with a hollow core component, padding, and adhesive tape.
Both Imonti and Clark's devices may be appropriate for protecting a post-operative nipple under certain circumstances but do not fully address many of the collateral concerns related to the nipple healing process. For example, the earlier art by Imonti does not allow cleansing and proper medication ointment application without removal of the protector, and the slope of Imonti's cone-shaped nipple guards prevents effective cleaning by making it more difficult to insert a cleaning implement into the area around the nipple. As another example, both of the cited prior arts ordinarily use anchoring devices such as tape, which may produce allergic reactions in a patient and not adhere to skin correctly. Moreover, the devices taught by Imonti and Clark cover more skin tissue than may be necessary, thereby preventing proper air circulation on the tissue and creating constant moisture around the wound areas. In addition, Clark's device requires that the guard be changed “one to two times per day for up to sixteen weeks or longer,” rather than use one guard that may be used for the entire recovery period. See Clark, Col. 8, 1. 48-50. Requiring so many changes will either reduce average patient compliance from missed appointments, or increase the likelihood of patient error if the patient is the one responsible for changing the guard.
According to one embodiment of the present invention, a shield is provided. The shield includes a hexagonal base with rounded corners and at least one adjacent wall extending from the base. The wall is sized to surround a patient's post-surgical wound. The base is perpendicular to the wall.
The base has a front-back and left-right symmetry. The wall is centered on the base. The base includes a left tab and a right tab. Two of the four apertures are on the left tab, and two of the four apertures are on the left tab. Both the base and the wall are essentially inflexible.
In one embodiment, the wall is a cylinder with a top end and a bottom end. The cylinder is open on both ends and sized to encase a patient's post-surgical wound. The base is perpendicular to the cylinder.
The base includes four apertures. The centers of the four apertures define the corners of a rectangle whose short sides are shorter than the cylinder outer diameter and whose long sides are longer that the cylinder outer diameter. The apertures are operable to allow a suture needle to pass through each of said apertures and secure said shield to a patient's skin with sutures.
In other embodiments, the shield protects a post-surgical body portion other than a reconstructed nipple. For example, in one embodiment, the shield protects an incision area resulting from an invasive surgery. In another embodiment, the shield protects a connection wound resulting from a reattachment surgery.
The present disclosure provides, in one embodiment, a shield that allows a post-operation reconstructed nipple to heal properly.
The present disclosure provides, in one embodiment, a shield that is easy to clean.
The present disclosure provides, in one embodiment, a shield that allows the patient to take a shower the first day after surgery.
The present disclosure provides, in one embodiment, a shield that allows the protected wound to dry properly.
The present disclosure provides, in one embodiment, a shield that allows easy access and drying, cleaning, and medication application on the reconstructed nipple and surrounding area without requiring removal of the shield.
The present disclosure provides, in one embodiment, a shield that does not require removal or replacement during its use.
The present disclosure provides, in one embodiment, a shield made of strong durable material that may be affixed firmly in a single position and not subject to dislodging, torquing, rotating or shifting from external jostling caused by clothing, bras, or sleeping on one's stomach.
The present disclosure, in one embodiment, prevents necrosis as a result of poor healing, detachment, and lack of blood flow caused by shearing forces.
The present disclosure provides, in one embodiment, a shield that is affixed easily to a patient.
The present disclosure provides, in one embodiment, a shield that is removed easily from a patient.
The present disclosure provides, in one embodiment, a cost-effective shield.
The present disclosure provides, in one embodiment, a shield that does not require tape to affix the shield to the patient's skin.
The present disclosure provides, in one embodiment, a shield that covers a minimal amount of skin tissue.
The present disclosure provides, in one embodiment, a shield that properly protects the post-operation nipple from flattening.
The present disclosure provides, in one embodiment, a shield that improves patient compliance and reduces patient error by requiring less changing of the shield.
The present disclosure provides, in one embodiment, a patient with the psychological benefit of achieving realistic-looking breasts after undergoing reconstructive nipple surgery.
The present disclosure, in one embodiment, allows a post-surgical wound to heal without the use of lining, padding, or adhesives, which cause allergic reaction in some patients.
As used herein, positional terms such as “top”, “bottom”, “right”, “left”, “front”, and “back” are relative within the disclosed drawings as labeled, and not intended to be absolute. The positional terms are only meant to provide a frame of reference for the displayed embodiments rather than how the embodiments may be positioned when in use. For example, left tab 120 and right tab 122 may in fact be positioned such that they define a patient's sagittal plane (i.e., a vertically for a standing patient) rather than the patient's transverse plane.
The above-mentioned features will become more clearly understood from the following detailed description read together with the drawings in which:
The apparatus for shielding post-operative nipple reconstruction is disclosed. The shield is generally indicated as 100, with various embodiments designated with a letter suffix, e.g., 100-A and 100-B. The shield 100 is configured to protect a healing nipple. In other embodiments, the shield 100 is shaped to protect other post-surgical wounds.
In one embodiment the shield 100 is contained in packaging that allows the shield to remain sterile prior to use. In one method of use, the shield 100 is used on a single patient over a period of days or weeks.
The shield 100 is made of one single molded piece or a combination wall 108 fused to an anchor/base 102. The base 102 includes a left and right tab 120, 122. The wall 108-A defines a cylinder. In other embodiments, the wall 108 is another ordinary shape, such as an oval or square. In other embodiments, the wall 108 is configured such that the inner wall is slightly larger than the surgical wound it is protecting. In other embodiments, such as shown in
In some embodiments, the shield material is homogenous, thereby allowing for a simpler manufacturing process. The shield material is sufficiently light such that it does not substantially deform the skin when the shield is pulled by gravity. The shield material is inert. The shield material is composed of matter that is chemically nonreactive with a patient's skin. The shield material is capable of being molded to have a smooth surface. The shield material does not have a molecular structure susceptible to shattering. The shield material is resistant to puncturing. For example, in one embodiment the shield 100 consists of a plastic similar to the types of polyethylene plastics found in syringes. In another embodiment, the shield material is silicon, with a hardness similar to that of the silicon found in nursing shields. The thickness of both the wall 108 and the base 102 are sufficient such that both the wall 108 and the base 102 are essentially rigid and inflexible, i.e., neither the base bottom surface 302 nor the wall 108 are subject to bending or misshaping when sutured to a patient. The base bottom surface 302 is flat rather than dome-shaped, thereby avoiding a suction effect and avoiding the base 102 edges pressing into the patient's skin or incisions. Stability is also increased. The base bottom surface 302 is smooth, thereby avoiding patient discomfort or damage to the patient's skin.
As shown in
Base 102 includes at least four suture holes 104 that pass orthogonally from the base top surface 106 to the base bottom surface 302 and that are of sufficient diameter relative to base 102 thickness such that a desired curved suture needle is able to pass through the suture hole 104. In one embodiment, the suture holes 104 depths and widths are sized such that a standard ⅜ suture needle fits through each hole 104. The base top and bottom surfaces 106, 302 are parallel. The base 102 is solid between base top and bottom surfaces 106, 302. Suture holes 104 are aligned such that the centers of the holes 104 collectively define the corners of a rectangle.
Each of the four suture holes 104 is between a corresponding rounded corner 116 and the wall 108. Two holes are on each tab 120, 122.
In order to minimize the skin area covered by the embodiment during use, base 102 is sufficiently narrow such that wall outer surface 114 is completely interposed between left and right side suture holes 104, and completely interposed between right and left side and rounded corners 116. The wall outer surface 114 is not interposed between at least a portion of the suture holes 104 on the left tab 120. The wall outer surface 114 is not interposed between at least a portion of the suture holes 104 on the right tab 122.
Front and rear rounded corners 118, 202 are located on opposite sides of the outer surface 114 of the wall 108 and each are a minimal distance from the wall 108 such that suture holes 104 would not fit between wall 108 and rounded corners 118, 202. There is, however, enough distance between wall 108 and rounded corners 118, 202 to allow for structural integrity of the device and allow for a flat surface such that wall bottom surface 304 alone does not press into the patient's skin.
As shown in
In an exemplary protoctol, a surgeon uses the shield 100 immediately following a surgical procedure. The surgeon applies, for example, an iodiform gauze or other thin dressing type of choice on the skin around the nipple, and then places the shield 100 on the gauze such that the incisions on the sides of the newly formed nipple do not directly touch the shield.
A 2-inch square iodiform gauze, for example, is fitted directly between the base 102 and the patient's incisions, i.e., the base 102 is imposed on the iodiform gauze. However, each surgeon has his or her own style of wound dressing and may use different dressing, other dressing patterns, or no dressing at all.
The surgeon then uses, for example, a ⅜ suture needle and suture thread 404 to suture the shield 100 to the patient's skin 402 through the suture holes 104. The sutures 404 should be short and binding enough so that the shield 100 cannot contact the reconstructed nipple even when lateral or torque forces are exerted against the wall top surface 110.
In this method embodiment, affixing the shield is performed as outpatient surgery. The patient has the option of showering the night of surgery or the following morning. Medication or disinfectant is applied to the reconstructed nipple without removing or unsuturing the shield 100.
From the foregoing description, it will be recognized by those skilled in the art that a simple, sturdy disposable shield for post-surgical wounds has been provided.
While the present inventions have been illustrated by embodiments and while the illustrative embodiments have been described, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The inventions in their broader aspects are therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant's general inventive concepts.
This application is a continuation-in-part of application Ser. No. 14/658,231, filed Mar. 15, 2015.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14658231 | Mar 2015 | US |
| Child | 15591277 | US |
