The present invention concerns a method of providing a bra; a bra and a kit of parts for 5 providing a bra that will give an impression of the final result after augmenting breast surgery.

Background art

In augmenting breast surgery breast implants are used, which can be made of different w materials and have several different shapes and sizes. The size is usually measured in volume and/or weight and/or dimensions of the implanted substance. The shapes of the implants are different due to which surgical operation that is to be performed but in all cases the implants come in different widths, heights, projections and profiles. It is difficult for the patient to grasp how the final result and size will be after the augmenting breast sur-

15 gery.

Summary of the invention

An object of the present invention is to make it possible to try out a suitable size and shape of a breast before an augmented breast surgery is made. With the method it is pos-0 sible to provide a bra that will give an impression of the final result after augmenting breast surgery on a patient.

According to a first aspect of the present invention a method of providing a bra having two cups and connecting wings that will give an impression of the final result after aug-5 menting breast surgery on a patient is provided. The method comprises the steps of measuring a circumferential torso band size and a circumferential torso bust size of said patient pre surgery, selecting a breast implant to be used in said augmenting breast surgery, determining a cup size based on a projected post-surgery bust size, in turn being0 the measured torso bust size plus a difference between a horizontal ventral curvature length of said selected breast implant and a horizontal footprint width of said implant; selecting the bra having a band size corresponding to the measured torso band size.

According to an embodiment the method comprises selecting an outer inlay, with a first filling or being a flexible solid, having a cup size of said two cups based on said determined cup size and said band size, providing the selected outer inlays in an outer pocket of each the cups of the bra.

According to an embodiment the measuring of the torso bust size is performed across the patient's nipples when the patient holds her hands on top of her head. Preferably, the measuring of the torso bust size is performed using a tape measure which is spring-loaded with between 0.1 and 10 N, and preferably the same load should be used throughout the method.

According to an embodiment each of the cups of said bra comprises also a respective inner pocket, and wherein the method comprises the further steps of - selecting at least one inner inlay, having a second filling, at least one inner inlay of the selected type(s) being provided in each of said inner pockets, the at least one inner inlay having a total volume corresponding to a difference between a volume of the selected implant and a volume of said outer inlay. According to an embodiment the first filling has a higher viscosity or hardness than the second filling. Preferably, the first filling has a hardness according to the Shore Durometer hardness scale 00 between 0-60, preferably between 5-50, and most preferred between 10-20. The second filling may be a liquid/viscous material, preferably having a viscosity of between 5000-2 500 000 centistokes (cSt). According to an embodiment the outer inlay has a shape which is selected to simulate a final shape of the breast in question post-surgery.

According to an embodiment the method further comprises selecting at least two inner in- 5 lays from a set of available inner inlays of standard sizes.

According to a second aspect of the present invention a bra for use in the method comprising two cups and connecting wings, all connected to each other is provided. The bra is provided with at least two pockets, an outer pocket provided for an outer inlay and at least one w pocket for at least one inner inlay. The outer inlay has a first filling or being a flexible solid, and the outer inlay is stable in shape but pliable and provides a cup shape within the bra. The at least one inner inlay having a second filling, where the first filling has a higher viscosity or hardness than the second filling. is According to an embodiment the pockets are made up of stretchy material.

According to an embodiment the outer inlay has a predetermined volume.

According to an embodiment the at least one inner inlay has a volume corresponding to the0 difference between a selected breast implant volume and a volume of the cup shaped outer inlay.

According to an embodiment the bra comprises an underwire below each cup determining the width of the cups. 5

According to a third aspect of the present invention a kit of parts for providing a bra that will give an impression of the final result after augmenting breast surgery on a patient is provided. The kit comprises a set of bras of different band size and two cups, said cups each having an inner0 pocket and an outer pocket; a set of different outer inlay pairs having a first filling of high viscosity or being a flexible solid, each of said outer inlay pairs being arranged with a respective shape arranged to simulate a particular breast shape; a set of different inner inlay pairs having a second filling of relatively low viscos- 5 ity, each of said inner inlay pairs being arranged with a respective predetermined volume.

According to a fourth aspect the present invention a method of selecting a breast implant, prior to cosmetic augmenting breast surgery, based on a desired post-surgery cup size of a w bra is provided. The method is based on the same inventive findings as the first aspect but taken in another order and comprises the steps measuring a circumferential torso band size and a circumferential torso bust size of said patient pre surgery, selecting a desired circumferential post-surgery torso bust size, is - determining a breast implant to be used in said cosmetic augmenting breast surgery by calculating the difference between the desired circumferential post-surgery torso bust size and the circumferential torso bust size of said patient pre surgery, said difference equals the difference between a horizontal ventral curvature0 length of a breast implant to be selected and a horizontal footprint width of the same implant, and selecting an implant having said difference.

In the special event that the woman needs different sizes of implants for the two breasts it5 would be possible to take half of the measurements from a first implant (left) and half of the measurements from the second implant (right), i.e. the total difference between the horizontal ventral curve length (HVC) and the horizontal footprint width (HF) will be the difference between the sum of half of the length of the left HVC and half of the length of the right HVC and the sum of half of the length of the left HF and half of the length of the0 right HF. Short description of the drawings

The present invention will now be described in more detail under referral to the appended drawing, in which

Fig. 1 shows sizes to measure on a woman's torso. s Fig. 2a and 2b show a breast implant, the horizontal footprint width and the horizontal ventral curvature length, respectively.

Fig. 3 shows a bra.

Fig. 4a and 4b show an outer and several inner inlays, respectively.

Fig. 5a and b show a respective sectional view of a cup of the bra. w Fig. 6 shows different pockets in a cup.

Detailed description of embodiments of the invention

The present method of providing a bra 1 that will give an impression of the final result after augmenting breast surgery on a patient will now be described in more detail. The bra 1 is comprises two cups 3 and connecting wings 4. The bra will be described in further detail below. The method comprises several steps of measuring a patient's body. In Fig. 1 a woman's torso is shown.

To start, measure a circumferential torso band size BA just below the breasts (infra-mam-0 mary fold) and a circumferential torso bust size BU across the nipples of said patient while the patient keeps her hands on top of her head, pre surgery. (Documented to be a good prediction of post-operative nipple position). Thereafter select a breast implant I to be used in said augmenting breast surgery. These three steps may be made in any order. 5 Breast implant selection and preoperative markings are commonly done arbitrary based on the surgeon's experience and artistry. This is a common reason for poor results. Implant selection should take patients desires into considerations but also importantly be tissue-based as it is necessary that the tissue accommodate the implant in an optimal way. 0 The selection starts, according to a previously known method, with a suitable footprint of the implant, thus its width and the height. The existing breast width is measured with a caliper and in addition to this the tissue cover should be analyzed. The tissue cover is measured with a caliper compressing the tissue to simulate the compression that the implant exerts on the overlying tissue. Subtract this from the desired breast width which will provide the desired implant width.

5 The projection of the implant is greatly dependent on the patient's preference but the covering skin must be respected. A more projecting implant with a larger footprint needs longer distance of skin between the nipple areola complex and the new inframammary fold. Also, the amount of breast gland affects how long the distance should be. w The amount of skin needed, or filled, in the lower pole of the breast relates to the so called LVC distance of the implant (the Lower Ventral Curvature = distance between the nipple projection point on the implants ventral surface down to its lower border). The vertical axis represents the projection of the implant and the horizontal axis half of the height of the implant (for anatomical implants) or as much of the implant that is estimated to be is positioned distal to the nipple areola complex after the procedure (55% of round implants diameter=height).

The length of skin needed to be added to this LVC distance in relation to the amount of glandular cover can be measured, during arm elevation 45° above horizontal plane, be-0 tween the nipple and the implants lower pole position (ILP line). From this distance the "inside of the breast" is subtracted - this is equal to half the height of the implant if half of the implant is placed distal to the nipple areola complex.

The height of the breast is important to consider when it comes to selecting implant5 height and it is important to consider where different implant heights end up in relation to the inferior and upper border of the breast's glandular tissue. (Reference for implant selection: Heden P. Breast augmentation with anatomic, high-cohesiveness silicone gel implants (European experience). In: Surgery of the Breast: Principles and Art. 3rd Editor: Spear SL, ed. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins;1322-1345.0 2011) Thereafter it is possible to determine a cup size 20 for the bra 1 based on a projected postsurgery bust size BU2. In Fig. 2a and 2b an implant I is shown in a plan view and a perspective view, respectively. Calculate a difference between a horizontal ventral curvature length HVC of said selected breast implant I and a horizontal footprint width HF of said implant I. Add s this measure to the measured torso bust size BU. The result will give a new torso bust size post-surgery BU2. Thereafter it is possible to select a bra 1 having a cup size 20 corresponding to the measured torso band size BA. This is for example done by finding the respective measurements torso band size BA and new torso bust size BU2 in a table for cup sizes 20. w Preferably, a measuring tape is used, which is spring-loaded between 0,1 and 10N. Preferably the same load should be used throughout the method in order to provide a as precise result as possible.

In a more detailed embodiment, an outer inlay 2 is selected having a cup shape for said two is cups 3 based on the previous determined cup size 20 (and said band size BA). The outer inlay 2, see Fig. 4a, is placed in an outer pocket 5 of each cup 3 of the bra 1. See Fig. 5a and b. The outer inlay 2 is filled with a first filling or being a flexible solid. Preferably, the outer inlay 2 has a predetermined volume. For example, 100 ml. The outer inlay 2 forms a more or less shape stable cup. The shape of the outer inlay 2 comes in several sizes and shapes0 simulating a final shape of a breast post-surgery based on the type and shape of breast implant used.

At least one inner inlay 6, see Fig. 4b, is placed in an inner pocket 7 in each cup 3 of the bra 1, see Fig. 5a and b. The at least one inner inlay 6 provides a volume corresponding to the5 difference between a volume of a selected implant I and a volume of said out inlay 2. The inner inlays 6 may be selected from several different shapes and volumes, preferably of standard volumes. It is possible to have more than one inner inlay 6 placed in the inner pocket 7 in order to comfortably fill out a space between the natural breast and the outer inlay 2. If needed the inner inlay or inlays 6 may be provided with means for securing the0 position in the inner pocket 7. This could be made by means of high friction surface, Velcro, adhering surface or tape, for example. The inner inlays 6 are filled with a second filling, preferably a viscous material. The first filling or flexible solid of the outer inlay 2 has a higher viscosity or hardness than the second filling of the inner inlay 6. The first filling has preferably a hardness according to the Shore Durom- s eter hardness scale 00 between 0-60, preferably between 5-50, and most preferred between 10-20. The second filling may be a liquid/viscous material, preferably having a viscosity of between 5000-2 500 000 centistokes (cSt).

A total volume of a selected implant I should correspond to the total volume of the outer w inlay and the at least one inner inlay together.

According to an embodiment of a bra 1 it comprises two cups 3 and two wings 4. See fig. 3. These parts may be connected fixedly or detachably. For example, the cups 3 are fixedly connected and on an opposite side a wing 4 is fixedly provided on each cup 3. The free ends is of the wings 4 may be detachably connected. Preferably shoulder straps 8 are provided, fixedly or detachably connected to an upper rim of the cup 3 and at an upper portion of the wing 4, usually about halfway. Preferably, an underwire 9 is provided underneath each cup, providing a possibility to determine a width of each cup 3. 0 The bra is preferably made of a stretchy and flexible fabric, especially the cups 3. An outer pocket 5 is provided between the cup 3 and an outer pocket wall 10 for an outer inlay 2. The outer inlay 2 provides a correct shape of a post-surgery breast and the inlay is soft and pliable, although keeps its shape. Also, the outer pocket wall 10 is made of a stretchy and flexible fabric. An inner pocket 7 is provided between the outer pocket wall 10 and an inner5 pocket wall 11 for at least one inner inlay 6. Also, the inner pocket wall 11 is made of a stretchy and flexible fabric. In Fig. 6 pocket openings 12, 13 for the inner and outer inlays, respectively, are shown as an example. Also, an incision 14 is shown.

Preferably, both the outer inlays 2 and the inner inlays 6 are made of silicon. For example,0 it would be possible to use the same type of outer encapsulation as is used in a silicon breast implant forthe inlays. The outer inlay 2 may be filled (first filling) with silicon having a higher viscosity, more cross-links, than the second filling of an inner inlay 6. Or the outer inlay 2 may be formed all through with a type of implant encapsulation silicon material. The inner inlays 6 may be filled (second filling) with silicon having less viscosity then the first filling of the outer inlays 2 or any other suitable liquids, for example, saline solutions.

According to the invention a kit of parts is provided for a bra that will give an impression of the final result after augmenting breast surgery for a patient. The kit of parts comprises a set of bras 1 having different band sizes as described above, having two cups 3, two wings 4 and the cups 3 are provided with an outer pocket 5 and an inner pocket 7 each. The wings 4 may have different length in order to provide different band sizes. For example, three different lengths of wings 4 may be provided and then a connection between the free ends of the wings 4 may be provided to further give more detailed options of band sizes.

Further, a set of different outer inlays 2 of different shapes and cup sizes are provided. From this set of inlays 2, an outer inlay 2 of desired shape and cup size 20 is selected for each cup

3. Thereafter, the selected outer inlays 2 are put into respective outer pockets 5 of the bra 1. Preferably, each outer inlay has a predetermined volume. This could be the same for each cup size or differ for each size or have a predetermined volume for a group of consecutive sizes. For example, an outer inlay 2 may have a predetermined volume of 100 ml.

K set of different inner inlays 6 are provided. In order to reach the same volume as a selected implant I for a later augmenting breast surgery, at least one inner inlay 6 shall be selected, which volume together with the volume of the selected outer inlay 2 shall be equal to the volume of the selected implant I. Thus, the total volume of the at least one inner inlay 6 is the volume of the selected implant I minus the volume of the selected outer inlay 2. In order to reach the desired total volume of the inner inlay/s 6 one or more inner inlays 6 may be selected. It or they may be selected from a set of inner inlays 2 of different predetermined volumes, for example. There may be different sizes, shapes and volumes of the inner inlays 6 to choose from in order to provide a comfortable shape of the inner side of the inner pocket wall 11 for the natural breast when the bra is worn. Obviously, it is possible to instead select implants (I) by deciding desired cup size post augmenting breast surgery by using the presented relation between implant and body measurements. This could be of use when a woman asks to have a specific cup size after an augmented breast surgery. By using a method of selecting a breast implant, the right size of 5 implant can be found. However, the natural prerequisites of the woman's body must always be respected as outer limits of desired cup sizes. The method comprises several steps that can be taken in any order. To start, measure a circumferential torso band size (BA) and a circumferential torso bust size (BU) of said patient pre surgery, as indicated in Fig. 1 and select a desired circumferential post-surgery torso bust size (BU2) corresponding to the de- w sired cup size post augmenting breast surgery. Thereafter, determine a breast implant (I) to be used in said cosmetic augmenting breast surgery by calculating the difference between the desired circumferential post-surgery torso bust size (BU2) and the circumferential torso bust size (BU) of said patient pre surgery (BU). Since said difference equals the difference between a horizontal ventral curvature length (HVC) of a breast implant (I) to be selected is and a horizontal footprint width (HF) of the same implant (I) it is possible to select an implant having said difference between the horizontal ventral curvature length (HVC) and the horizontal footprint width (HF).

In the special event that the woman needs different sizes of implants for the two breasts it0 would be possible to take half of the measurements from a first implant (left) and half of the measurements from the second implant (right), i.e. the total difference between the horizontal ventral curve length (HVC) and the horizontal footprint width (HF) will be the difference between the sum of half of the length of the left HVC and half of the length of the right HVC and the sum of half of the length of the left HF and half of the length of the5 right HF.

Study

In a series of 95 consecutive breast augmentation patients the chest circumference was measured immediately under the breasts. In addition to this the chest circumference at0 the height of the breast nipple areola complex was measured. These measurements were then repeated directly (3-4 hrs.) after the breast augmentation operation, and then 2 weeks, 3 months and finally 6 months postoperatively. A correlation between the inserted implants dimensions and the differences between the preoperative and postoperative measurements was noted. These correlations confirm the statements in this patent application. These finding have not previously been described in the literature. Our results and findings will be submitted to a well-recognized peer-reviewed medical journal.