ES2750801T3 - A post-surgery bra type garment - Google Patents

Abstract

A post-surgery or post-treatment bra type garment of breast cancer (1) for a user, comprising: connecting means comprising strap means (10) operable to secure the type of garment bra on the wearer's shoulders, and a band region (11) to enclose a portion of the wearer's torso to secure the bra-like garment to the wearer; first operable adjusting means (12) for adjustably closing the band region of the bra-like garment, and second operable adjusting means (20) for adjustably connecting the strap means to a front region (6a) of the band region of the bra-like garment, wherein the first and second adjustment means are operable together to adjustably compress the wearer's torso in a region of the wearer's chest, in wherein the garment comprises an inner layer (2) and an outer layer (3), characterized in that the inner and / or outer layer of the garment have a material composition comprising between 70% and 95% fiber bamboo.

Description

DESCRIPTION

A post-surgery bra type garment

The present invention relates to a post-surgery bra-type garment for use by a person after breast surgery, including a mastectomy, lumpectomy, reconstruction, breast augmentation and / or reduction surgery, or cancer treatments breast implants such as radiation therapy, chemotherapy, hormone therapy, or a combination thereof.

A post-surgery bra, such as those described in US 6,135,975 or DE 202004007 323, are worn by patients after breast surgery, such as a mastectomy, lumpectomy, reconstruction, augmentation surgery, and / or or breast reduction. Following a mastectomy or lumpectomy surgical procedure, a patient typically wears an orthopedic bra-type garment that is provided with built-in pockets capable of being filled with a filling or prosthetic material to simulate the appearance of one or both breasts.

However, such post-surgery bras have many disadvantages, including that they often provide inadequate post-surgery support and are often uncomfortable and can irritate areas in contact with the garment. Furthermore, since they reduce postsurgical lynching, and the compression levels required for the wound region are reduced, patients require purchasing different post-surgery bras to ensure that appropriate compression levels are maintained throughout the healing process. .

In addition, post-surgery bras are typically not aesthetically appealing or comfortable clothing and are not very stylish for a user to wear as a result of post-surgical scarring or difficulty with movement. Additionally, and when required, proper placement of a prosthesis inserted into the bra relative to a wearer's torso is often difficult to achieve, especially since such prostheses are prone to movement thereby revealing that the wearer has had a mastectomy or lumpectomy surgery.

It is therefore an object of the present invention to overcome at least one of the aforementioned problems.

Additional aspects of the present invention will become apparent from the following description provided by way of example only.

Summary of the invention

In accordance with the invention, there is provided a bra type garment for post-breast cancer or post-surgery treatment for a user, comprising:

connection means comprising operable strap means for securing the bra-like garment to the wearer's shoulders, and a region for enclosing a portion of the wearer's torso to secure the bra-like garment to the wearer;

operable first adjusting means for adjustably closing the band region of the bra-like garment, and

second operable adjusting means for adjustably connecting the strap means in a region of the band region of the bra-like garment,

whereby the first and second adjustment means are operable together to adjustably compress the wearer's torso in the wearer's waist region.

The provision of the first and second adjustment means together ensures that the wound region, and in particular, the swelling that is expected by the user, can be compressed both from the user's shoulders and from the chest area. simultaneously in order to thereby provide support to the post-surgical wound region and improve healing. Furthermore, the fact of providing such first and second adjusting means makes patients able to adjust compression levels themselves when necessary when swelling starts, to reduce and thereby avoid the prerequisites of purchasing undergarments. Dress in additional post-surgery as the healing processes progress. The present invention provides a comfortable bra that resembles an article of lingerie and can be worn until the user is fully healed from the surgery. The double adjustment means also ensure that the garment can be worn by users of different sizes and worn with different body types. Preferably, the garment comprises an inner layer and an outer layer.

Preferably, the inner layer and the outer layer are connected such that the bra-like garment is unitary. Preferably, the inner layer and the outer layer are seamlessly joined.

Preferably, the bra comprises an edge band that extends along at least a portion on the perimeter of the garment. Preferably, an elastic is housed within the edge band to prevent irritation of the wearer by skin contact with the elastic.

In an alternative embodiment, the inner layer and / or the outer layer comprise a plurality of panels connected together to form the garment.

Preferably, at least one opening is formed between the inner and outer layer defining a receiving pocket in a front region of the bra for a prosthesis or filler material that simulates a wearer's chest.

Preferably, the first and second adjusting means are further operable together to enable the wearer to adjust the position of the receiving pocket relative to the wearer's waist when wearing the bra-like garment. In this way, the bra receiving pocket (s) and the inserted prosthesis or filler material can be positioned correctly and aligned and held adjustably adjacent to the breast when the user needs to simulate a natural event.

In another embodiment of the invention, the first adjusting means extends vertically from an upper edge to a lower edge of the front region or a rear region.

Preferably, the front region comprises left and right side panels and the first adjusting means comprise a first clamping device operable to adjustably connect the left side panel to the right side panel, which when connected closes the clamp band region .

Preferably, the rear region comprises left and right side panels and the first adjusting means comprise a first operable clamping device for adjustably connecting the left side panel to the right side panel, which when connected closes the band region of the article of clothing. In another embodiment of the invention, the first clamping device comprises a hook and eye configuration. In such an embodiment, at least one column of hook elements may be provided on one of the left and right side panels, and separate columns of eyelet elements on the other of the left and right side panels.

Preferably, the first adjusting means is disposed adjacent to the or each receiving pocket of the bra.

In an alternative embodiment, the first fastening device comprises a VelcroTM arrangement or a rack arrangement.

In another embodiment of the invention, the second adjusting means comprises a second fastening device for releasably connecting the strap means to the front region of the fastener-type garment. Preferably, the second adjusting means connects the strap means to the front region of the garment adjacent to the position of a garment receiving pocket.

Preferably, the strip means comprise a first end connected to a rear region of the garment, and a free second end is adapted to be connectable to a front region of the garment, optionally adjacent to the garment receiving pocket. To wear.

Preferably, the second free end mounts one of: a receiver and a connector of the second clamping device, and the front region mounts the other of the receiver and the connector of the second clamping device, whereby the receiver and connector are coupled to adjustably connecting the strap means to the front region of the bra-like garment.

Preferably, the receiver of the second clamping means comprises a plurality of adjacent loop formations.

Preferably, the loop formations extend from an intermediate position to the first and second free ends of the strap means in a sequence toward the second free end.

Preferably, the ties are formed by a strip of material or tape connected to the outer layer.

Preferably, the ties are formed of a strip of material or tape connected to the outer layer along one face of the free end of the strap means or the front region of the bra-like garment or the rear region of the strap. article of clothing.

Preferably, the strip of material or tape is connected to the outer layer of the garment by connections, so that the gaps formed between the connections provide adjacent loop formations to mate with the connector.

Preferably, the connector of the second fastening means comprises a hook operable to connect with a loop.

In an alternative embodiment, the second fastening device comprises a VelcroTM arrangement or a rack arrangement.

The garment of the present invention further comprises delicate molded cups within the receiving pockets on or between the first and second layers for prosthetic insertion. Optionally, the garment has removable soft foam pads.

The garment is optionally seamless to avoid irritation of scars after surgery. The garment offers natural curing, cooling and antibacterial properties due to the manufacturing method. The garment also improves the wound healing and the well-being of the user.

The garment is optionally elastic-free on the bottom band and thus prevents excessive squeezing and irritation. The provision of a front opening by means of the first adjustment means ensures the ease of movement of the user when wearing the garment. Alternatively, the provision of a rear opening by means of the first adjustment means ensures ease of use and familiarity with the user.

Preferably, the inner and / or outer layer of the garment have a material composition comprising at least 20% to 95% bamboo fiber, which is at least 20% to 25% to 30% up to 35% up to 40% up to 45% up to 50% up to 55% up to 60% up to 65% up to 70% up to 75% up to 80% up to 85% up to 90% or up to 95% of bamboo fiber.

Preferably, the inner and / or outer layer of the garment has a material composition comprising at least 70% bamboo fiber

Preferably, the inner and / or outer layer of the garment has a material composition comprising at least 75% bamboo fiber

Preferably, the inner and / or outer layer of the garment has a material composition comprising at least 80% bamboo fiber

Preferably, the inner and / or outer layer of the garment has a material composition comprising at least 85% bamboo fiber

Preferably, the inner and / or outer layer of the garment has a material composition comprising at least 90% bamboo fiber

Preferably, the inner and / or outer layer of the garment has a material composition comprising at least 95% bamboo fiber

Preferably, the inner and / or outer layer of the garment has a material composition comprising between 70% and 95% of bamboo fiber, that is, 70% and up to 75% up to 80% up to 85% up to 90 % or up to 95% bamboo fiber.

Preferably, the inner and / or outer layer of the garment has a material composition comprising between 70% and 80% bamboo fiber. This is 70% and up to 75% up to 80% bamboo fiber.

Preferably, the inner and / or outer layer of the garment has a material composition comprising between 80% and 90% bamboo fiber. This is 80% and up to 85% up to 90% bamboo fiber.

Preferably, the inner and / or outer layer of the garment has a material composition comprising between 90% and 95% bamboo fiber. This is 90%, 91%, 92%, 93%, 94%, or 95% bamboo fiber. Preferably, the inner and / or outer layer of the garment is made of bamboo fiber.

Preferably, the bamboo fiber is organic bamboo fiber, such as oek-otex® certified bamboo material. In one embodiment, the inner layer and / or the outer layer of the garment have a material composition comprising 80% bamboo fiber, 12% nylon, 6% spandex, and 2% polyester.

In an alternative embodiment, the inner and / or outer layer of the garment has a material composition comprising 95% bamboo fiber and 5% elastane.

Preferably the inner and outer layers have the same material composition.

A further embodiment of the invention provides a post-treatment or post-surgery bra type garment of clothing, as described above, for use in improving the well-being of the wearer following breast surgery and / or a treatment for breast cancer.

A further embodiment of the invention provides a post-surgery or post-treatment bra type of clothing for breast cancer, as described above, for use in accelerating a user's wound healing process after breast surgery and / or breast cancer treatment.

In one embodiment, the wound is a surgical scar, skin irritation, skin lesions due to radiation therapy, and other wounds typically associated with surgery and / or cancer treatments such as burns, blisters, itching, seromas, fungal lesions, and tissue necrosis.

In one embodiment, the user has received a treatment for breast cancer selected from the group of radiation therapy, chemotherapy, hormone therapy, or a combination thereof.

In one embodiment, the user has undergone at least one process of breast surgery selected from the group of mastectomy, lumpectomy, breast augmentation and / or reduction surgery.

In memory, the term "post-surgery" is to be understood as a person who has undergone breast surgery, such as mastectomy, lumpectomy, breast augmentation and / or reduction surgery, and "treatment of breast cancer". It is to be understood as a treatment for breast cancer such as radiation therapy, chemotherapy, hormonal therapy, or a combination thereof.

Brief description of the drawings

The invention will be more clearly understood from the following description of some embodiments thereof, with reference to the accompanying drawings, in which:

Fig. 1 is a perspective view of a post-surgery bra type garment according to the invention;

Fig. 2 is a perspective view of a post-surgery bra type garment shown in Fig. 1 in a closed configuration;

Fig. 3 is a perspective view of a part of the post-surgery bra type garment showing the inner layer and the receiving pocket;

Fig. 4 is a sectional view of a part of the post-surgery bra type garment showing the receiving pocket;

Fig. 5 is a sectional view of a part of the post-surgery bra type garment showing the receiving pocket and the prosthetic insert;

Figs. 6a and 6b are sectional views showing post-surgery bra type garment adjusting means;

Figs. 7a and 7b are sectional views showing post-surgery bra type garment adjusting means;

Figs. 8 and 9 are perspective views of a post-surgery bra type garment according to an alternative embodiment of the invention; Y

Fig. 10 is a graph illustrating the EQ-5D-3L results from a pilot study comparing the pre-study score and the post-study score, where the post-study score is the result of the subject wearing the garment. post-surgery bra-type clothing of the invention; n = 15. On the scale, 100 represents the "best imaginable health status" and 0 represents the "worst imaginable health status".

Detailed description

Materials and methods

A study to measure and explore patient experiences of post-surgery or post-treatment clothing compared to the current standard of care.

The study takes place in four Dublin Academic Teaching hospitals; Beacon Hospital, St. James's Hospital, St. Vincent's Hospital and the Mater Misericordiae University Hospital. Two of these being, St. Vincent's and Mater Misericordiae Breast Cancer Centers of Excellence specific with the National Breast Cancer Screening Clinic, BreastCheck on site.

49% of women diagnosed with breast cancer were between 45-64 years old and 37% of those diagnosed were over 65 years old, while 14% of those diagnosed were under 45 years old (NCRI, 2012) . For this study, a sample size of 100 patients, who had undergone breast surgery (either mastectomy or lumpectomy), will be divided into 3 age groups, with number assignments based on recent recent statistics:

- 8 participants from each age group of 18-44 years,

- 24 participants in each age group from 44-64 years, and

-18 participants in each age segment over 65 years.

Total: 50 per group

Patient inclusion criteria:

1. Woman over 18 years of age, with no maximum age limit once all the criteria criteria are met.

2. Have a comprehensive understanding and influence in the English language with the ability to provide informed consent.

3. Be scheduled to undergo a mastectomy or lumpectomy for a first-time new diagnosis of breast cancer within a 3-month recruitment period - given that this group includes the primary users of post-surgery bras.

4. Not having existing severe co-morbidities and / or documented psychological diagnosis ie depression, severe chronic illnesses - since we do not wish to overload a person who has any other ailments other than the restlessness of surgery. In addition to that, the bra is designed to aid in recovery from breast surgery, and having additional ailments can alter the data that is received.

5. Be available for the entire duration of the study, which will be 3 months from recruitment to subsequent evaluation.

Patient exclusion criteria

1. Be under 18 years old.

2. Not having the intellectual capacity to provide informed consent.

3. Not scheduled to undergo mastectomy or lumpectomy within 3 months after recruitment.

4. Having persistent severe co-morbidities or morbidities and / or documented psychological diagnosis, since the diagnosis of breast cancer is challenging enough and can impair any psychological condition, the researcher would like to avoid any additional perceived stress for them.

5. Those who are not fluent in English, have low understanding or have poor speech.

The data will be collected by a) three questionnaires and b) qualitative data collection.

a) Mainly, the study comparative judgment design will collect data by the quantitative method of the questionnaires. After providing informed consent, patients will be reunited one day postoperatively. Day one postoperative, or post-treatment for breast cancer, the researcher will ask the consenting participant to complete the pre-assessment measure consisting of three questionnaires. They will be asked to complete the prior assessment measure of the three questionnaires. All three questionnaires have been previously published and validated, with permission for their use. The participant will then be dressed in the garment for external treatment of breast cancer or post-surgery, of the invention or not, depending on the group randomly assigned by means of a sealed envelope. The researcher, having completed a lingerie use course will dress the intervention group in the correct size bra, provide two post-surgery bras, explain and teach bra care. The researcher will ask the participant to wear the post-surgery bra for a period of four weeks after surgery. After four weeks, the researcher will meet with the participant who will complete the exact same three questionnaires evaluating the intervention.

Participants will be administered questionnaires, as planned

1) Body Image Scale: A validated scale, used internationally, comprising 10 questions that measure body satisfaction based on the well-referenced nature of this scale among studies of breast cancer patients (Akaya et al., (2011 ) Impact of Body Image on Quality of Life and Mood in Mastectomized Patients and Amputees in Turkey. Asian Pacific Jourmal of Cancer Prevention (12): 2669-2673; Helms et al., (2008) Body Image Issues in Women with Breast Cancer. Psychology, Health & Medicine 13 (3): 313-325; Hopwood et al., (2001) 'A Body Image Scale For Use With Cancer Patients'. European Journal of Cancer 37.2: 189-197.).

2) The Chest-Q questionnaire: an internationally used validated questionnaire tailored specifically for women with breast cancer to measure the impact that the surgery has had on the participant's perceptions regarding their appearance, pain, sexuality, and emotional state ( Pusic et al., (2009) "Measuring Patient Outcomes In Breast Augmentation: Introducing The BREAST-Q © Augmentation Module". Clinics in Plastic Surgery 36.1: 23-32).

3) Short Form 12 (SF-12); Internationally used and widely referenced quality of life measure that has been recently validated (Hodgkinson et al., (2007) Breast Cancer Survivor's supportive care needs 2-10 years after diagnosis. Support Care Cancer. 15: 515-523).

b) A qualitative method of data collection will also be used in this research through semi-structured interviews in post-study assessments. Due to the risk of the researcher reaching data saturation, the researcher will complete the interviews of a total of 30 participants; 5 randomly taken from each group. After the four-week period, when the participant returns for review in the outpatient department, to ensure that there is no extra burden on the participants, the investigator will meet with the participant and complete the post-study assessment. This consists of redoing the three questionnaires previously mentioned. In addition to this, a semi-structured interview will be completed in 30 participants to obtain a better understanding of their experience and impact wearing the bra in the psychosocial environment and in the quality of life of the patient, which may not be obtained in the questionnaires.

In addition to this, specific demographic information such as: age, height, weight, marital status, level of education, and employment status will be documented. Details of the process, including any complications and postoperative pain relief, will be reviewed and collected from the patient's medical records. The investigator considers these data necessary to collect and fully understand other factors / variables that may differ between the experiences of patients in the postoperative recovery state.

Example 1

This pilot study follows the same criteria as the larger study described above, and involves a group of women (n = 15) who have undergone lumpectomy surgery (also known as local excision) and / or radiation therapy for newly diagnosed breast cancer at Beacon Clinic and St. James' University Hospital, Dublin. The mean age of a participant was 59 years within a range of 34-90 years. Recruitment was divided between the two hospitals; one group represented those patients who, at the time of the study, were in a post-lumpectomy surgery situation without radiation therapy n = 10; while the rest represented those who, at the time of the study, had undergone a lumpectomy in addition to radiation therapy n = 5. The results of this pilot study are expected to indicate the results of the study described above with a larger group of women.

The study took a mixed methods approach - it involved both quantitative (questionnaires) and qualitative (semi-structured interviews) tools (as described above). Each participant received the same type of post-surgery clothing and wore it over a period of 4 weeks. Participants were informed about the study and their postoperative appointment at their assigned clinic. If they were interested in participating, they will receive an information document and a consent form and were asked to bring the signed consent form with them to assess the previous study the morning after their surgery - participants were given a minimum of 24 hours to review forms.

The lingerie specialist then:

- established for each participant the correct size post-surgery garment;

- taught the participants how to wear the clothing;

- provided participants with two post-surgery clothing items (one to wear while the other was being washed). The garments were of two different styles; one had an ideal front support for the period immediately after surgery and the other had a rear support; Y

- participants were asked to wear the post-surgery garment for 4 weeks after surgery.

Participants returned for post-study assessment 4 weeks after their pre-assessment appointment. Participants were provided with questionnaires regarding:

- Body Image Scale

- European Measure of Quality of Life (EQ 5D 3L)

- Questionnaire of good disposition for payment.

The BIS assesses body image and body image changes after cancer treatment and related interventions. Respondents are asked questions with reference to last week. The scale consists of ten points that include affective points (for example, feeling "of being aware of oneself", "less feminine / masculine", "less physically attractive"), cognitive points (for example, dissatisfied "with the aspect" " with scars ") and behavioral points (for example," avoiding people "," difficulty observing oneself naked "). The response regions range from "not at all" (score 0), "a little" (score 1), "quite a lot" (score 2) to "a lot" (score 3). Question 10 ("dissatisfied with the scar") has an additional answer option "not applicable". Adding the scores, a total score is obtained between 0 and 30 per patient, 0 represents no distress and no symptoms, while increasing scores represent increased distress and symptoms.

The EQ-5D is a standard measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical or economic evaluations. The level 3 version of the EQ-5D was introduced in 1990. This version essentially consists of 2 pages - the EQ-5D descriptive system and the visual analog scale of the EQ. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ VAS records self-rated health on an analogous vertical scale where the endpoints are labeled "Best Health Condition imaginable" and "Health Condition worst imaginable". This information was used to provide a quantitative measure of the health outcome judged by the individual respondents. This questionnaire was administered before and after the study to measure the presence of changes in the quality of life of the participants.

One researcher conducted a semi-structured post-assessment interview with 5 participants. The objective of this interview was to bring to light the experience of using and living with the post-surgery bra or post-treatment garment for breast cancer that offered an opportunity to collect daily insights that were not captured in the questionnaires. The interviews lasted no more than 30 minutes.

Antibacterial test of clothing

Referring to the 2006 American Association Of Textile Chemists And Colorists, Technical Manual, AATCC Test Method 100-2012 "Antibacterial Finishes on Textile Materials: Assessment of ', the samples were tested as follows:

The samples were sterilized in an autoclave (121 ° C, 15 min) before testing.

Neutralization Solution: phosphate buffer solution

Contact time: 18-24 Hours

Incubation temperature: 37 ± 2 ° C

Incubation Period: 24 hours

Medium Agar: Nutrient agar.

Cultural Essay: Staphylococcus Aureus (ATCC 6538)

Test Sample Number: 4 pieces / circular / @ 4.8 cm in diameter with 1.0 ± 0.1 ml of inoculum per test.

Referring to the drawings, a post-surgery or post-treatment bra type of clothing for breast cancer, generally indicated by reference number 1, is shown for a user. Such user typically, but not exclusively, will be a person who has undergone breast surgery, such as mastectomy, lumpectomy, breast augmentation and / or reduction surgery, and also treatment for breast cancer such as radiation therapy, chemotherapy, hormone therapy , or a combination thereof.

A garment 1 comprises an inner layer 2 and an outer layer 3. In the embodiment shown in Figs.

1 to 7, the inner layer 2 and the outer layer 3 are formed as a single piece of material having a material composition comprising 80% bamboo fiber, 12% nylon, 6% spandex and 2% polyester . A Santomi ™ machine, which is a seamless knitting machine known in the art, can be used to manufacture the garment 1 shown in Figs. 1 to 7, which will be understood to be an article of clothing 1 without seams. In the embodiment shown in Figs. 1 to 7, the inner layer 2 and the outer layer 3 are thus integrally or seamlessly connected, so that the bra-like garment 1 is unitary.

In an alternative embodiment, the inner layer 2 and / or the outer layer 3 may be constructed from a plurality of separate panels of material, for example, panels 3a to 3m, as shown in Figs. 8 and 9. Although it will be understood that the number and configuration of the panels can be connected as required or as desired. In the embodiment shown in Figs. 8 and 9, the inner layer 2 and the outer layer 3 have a material composition comprising 95% bamboo fiber and 5% elastane.

The garment 1 further comprises printed heat-sealed care labels. One or both of the inner layer 2 and the outer layer 3 may also be attractively decorated so that the garment has a physical appearance that resembles an article of lingerie.

The garment 1 optionally comprises at least one opening, generally indicated by the reference number 4, formed between the inner layer 2 and the outer layer 3 of the material defining a receiving pocket 5 in a front region, generally indicated by the reference number 6a, of the garment 1 for the insertion by the user of a prosthesis or filler material 7 that simulates a breast of the user. Such prosthetic material 7 may be a molded plastic sponge or a similar material shaped and contoured to simulate a natural chest. The opening 4 can have a diameter of 6 cm to 8 cm to make possible the insertion of a prosthesis. In the case shown, the opening is 7 cm, although it will be understood that the opening can be of any suitable size that is required or desired.

The garment 1 optionally comprises contoured and molded cups within the receiving pockets 5 between the inner layer 2 and the outer layer 3 for insertion of the prosthesis. The garment 1 further comprises removable pads 8, which may be made of soft foam or other suitable material. An edge band extending along at least part of the perimeter of the garment 1 and the required elastic is housed within the edge band to prevent irritation of the wearer's skin from contact with the elastic material .

Also shown are connecting means comprising strap means 10 operable to secure the bra-like garment 1 over the wearer's shoulders and a band region 11 to enclose a portion of the wearer's torso to secure the garment. of bra type 1 to the user.

The garment 1 comprises first adjusting means 12 that are operable to adjustably close the front region 6a of the bra-like garment. A rear region of the garment 1 is generally indicated with the reference number 6b. The front region 6a comprises a left side panel 13 and a right side panel 14 and the first adjusting means 12 comprise a first clamping device 15 for adjustable connection of the left side panel 13 with the right side panel 14, which when they are connected they close the band region 11 of the garment 1.

The first adjusting means 12 comprise in a hook and eye arrangement in which a column of hook elements 16 is arranged in one of the left side panel 13 and the right side panel 14, and separate columns 30, 30 ', 30 " of eyelet elements 17 on the other of the left side panel 13 and right side panel 14, the hooks 16 engaging with the eyelet elements 17 to close the front region 6a of the garment 1. The hook elements 16 and / or the ring elements 17 are optionally arranged in flap members 15. As shown, the connection of the hook elements 16 with the column 30 '' of the ring elements 17 will close the front region 6a of the garment 1 and will provide the maximum level of compression and post-surgery support.To reduce compression when the wound region heals, the user can select the 30 or 30 'spine as required or desired. Since three columns 30, 30 ', 30' 'of ring elements 17 are shown, it will be understood that any number of columns or arrangements of ring elements 17 may be arranged according to the needs of the user and the nature of the surgery. .

As shown, the first adjusting means 12 extends vertically from adjacent the top edge of the front region 6a to adjacent the bottom edge of the front region 6a. The first adjusting means 12 also connects the inner layer 2 and the outer layer 3 in the region of the receiving pockets 5, to close the pockets 5 in one or both of the left side panel 13 and the right side panel 14 of the region front 6a. The garment 1 further comprises second adjusting means 20 which are operable to adjustably and releasably connect the strap means 10 with a front region edge 9 of the bra-like garment 1. The strap means 10 comprise a first end, generally indicated with the reference number 10a, that connects the rear region 6b of the garment, and a second free end 10b adapted to be connected by means of the second adjustment means 20 to the edge of front region 9 of clothing 1.

The straps 10 may optionally comprise padding to protect the shoulders of the wearers to provide improved comfort. The strap means 10 can also be wider than the straps of a conventional bra. For example, the straps may have a width of the order of 3 cm to 4 cm, and they may taper inward toward the second free end 10b. In the case shown in Figs. 1 to 7, the straps are approximately 3.2 cm, although it will be understood that the

The second free end 10b of the strap 10 mounts one of: a receiver 21 and a connector 22 of the second adjusting means 20, and the front region 6a mounts the other of: the receiver 21 and connector 22 of the second fastening device 20. The receiver 21 and connector 22 can thus be located either at the second free end 10b of the strap means 10 or at the front region edge 9 of the garment 1. As shown, the Receiver 21 of second holding means 20 comprises a plurality of loop formations 21 each providing a hole or gap through which connector 22 can be threaded. A user, when wearing the garment 1 thereby selects one of the loop formations 21 on each strap 10 to connect with a connector 22 to secure the shoulder straps 10 to the front region 6a. Loops 21 extend in a sequence arrangement along strap means 10 and are optionally formed of a layer of material or ribbon 23 connected by stitching at intervals to outer layer 3 of garment 1.

As shown, the connector 22 of the second clamping means 20 is formed as an operable hook to connect with each arm 21. In use, as shown in Figs. 6a and 7a, connector 22 is threaded through loop 21 'to provide a minimum level of post-surgery support and compression from the user's shoulders to the wound region. To increase the vertical elevation of the garment relative to the torso and to apply an increase in compression and support, the user can select an alternative loop 21 that is located closer to the end 10a of the strap 10, than in the case shown in Figs. 6b and 7b, is loop 21 ''. For maximum shoulder compression, the user should thus select and connect hook 22 with loop formation 21 '' '. It will be understood that although seven loop formations 21 are shown, it will be understood that any number may be arranged according to the user's requirements and the nature of the surgery. The use of the first adjusting means 12 and the second adjusting means 20 thus makes it possible for them to be operable together to enable the application of a desired level of compression, and importantly, adjustable by the user to a wound region from both the user's shoulders and chest area simultaneously, thereby providing support to the wound region and reducing post-operative swelling.

By selecting a suitable loop formation 21 of the second adjustment means 20 and threading the connector 22 through the desired loop 21, the vertical elevation of the garment relative to the wearer's torso and the associated compression and support can be selected from the wearer's shoulders, and by selecting and connecting the first adjustment means at the front of the garment 1 the horizontal displacement of the garment 1 relative to the torso the wearer can be adjusted to increase or decrease the compression and associated support across the wearer's chest.

Accordingly, when swelling begins, to reduce swelling, a user can use the first and second adjustment means as required to avoid the prior need to purchase additional post-surgery clothing as the curing process progresses. The double adjustment means also ensure that the garment can be worn by users of different sizes and conforms to different body types. The provision of such first and second adjusting means further ensures that the receiving pocket or pockets 5 of the garment 1, when present, and thereby the prosthesis installed by the filler 7, can be correctly positioned, aligned and adjusted by the wearer relative to the wearer's chest to simulate the appearance of natural breasts.

An article of clothing 1 is optionally seamless to avoid irritation of scars after surgery. The garment offers healing, cooling and natural antibacterial properties due to the manufacturing method. The garment 1 is optionally elastic-free on the bottom band and thus prevents excessive squeezing and irritation. The provision of the front opening by means of the first adjustment means ensures the ease of movement of the user when wearing the garment.

Results of the pilot study

All 15 participants in the initial study were administered and completed the BIS questionnaire before and after the intervention. The mean score obtained by the participants before the invention was 9.5 while the mean score obtained at the end of the test was 4.5. This result indicates that at the time of the start of the test, the group of samples experienced a moderate level of distress with their body image and that at the end of the test they experienced a very low level of distress with their body image. Qualitative data would suggest that the garment of the claimed invention would have a positive impact on the participants' body image perception and therefore it is fair to assume that the post-surgery bra type garment of the claimed invention it was a contributing factor to the low levels of body image distress recorded at the end of the test.

A lumpectomy (wide local excision) involves removal of the breast tumor (the "lump") and some normal tissue that surrounds it. In many cases one or more lymph nodes will be removed to aid in diagnosis and to decide what treatment will be recommended. In approximately 25% of cases, the nerves in the surrounding tissues were damaged during breast surgery. This can lead to burning or stabbing pain in the surgical wound area and / or armpit area on the affected side. Pain after surgery is usually treated with light pain relievers.

For those who received radiation therapy during breast cancer, they may experience some skin irritation. The treated chest may feel rough to the touch, red (like a sunburn), and slightly swollen. In some cases, the skin can peel off much like a sunburn as a result and become delicate and tender (called a reaction to moisture). This is most common in the folds of the skin and the lower side of the chest. In addition, radiation therapy can also cause shooting pains due to nerve damage. The discomfort caused by wound pain was a significant topic of conversation for the participants. However, participants reported that due to the comfortable nature of the garment, they benefited from increased feelings of relaxation and well-being, with additional psychological benefit in terms of pain reduction. The participants spoke well about the fabric of the garment of the claimed invention. Each participant commented on its softness and how good it felt against the skin.

In both cases, the pain caused by the participants' wounds acted as a reminder of their surgery, occupying their thoughts and having difficulty concentrating on other daily activities. However, due to the comfortable material that the garment of the present invention is made of, women experienced lower levels of wound pain that gave them more time to focus on more daily activities rather than constantly thinking about their surgery. . This is an example of the invisible scars of breast cancer - although the wound is a physical phenomenon the impact it has on the psychological well-being of the participants due to pain is sometimes not easily observable by others; this is an additional stress that the individual has to bear internally. From their explanations, the use of the garment of the present invention gave rise to the participants' ability to cope with the pain and discomfort of their wound offering increased levels of physical and therefore psychological comfort.

Studies have shown that before breast cancer surgery, the occurrence of sleep disturbance was between 33% and 88%. Furthermore, during adjuvant chemotherapy and radiation therapy, reports of sleep disturbance ranged from 65% to 66%, respectively. The use of the garment of the present invention also improved the sleep of the participants.

The results of the EQ-5D-3L were presented in terms of the visual analog score representing the self-assessed health status of the respondents before and after the study (a period of 5 weeks) - Fig. 10 represents the results. The mean score recorded before the study was 49.8 while the mean score recorded after the study was 73.7. A on the scale, 100 represents the "best imaginable health status" and 0 represents the "worst imaginable health status"; the results suggest that, after the study, the group perceived that their health status was related more to the "best" node of the spectrum than to the "worst" node.

In terms of willingness to pay, 87% of the participants were willing to pay to continue using the garment of the present invention, while 100% of the participants answered that they would like to buy the garment once their wounds would have healed. This illustrates that participants were more than satisfied with the comfort and effect that the garment had had on their post-surgical wounds and with post-treatment well-being.

It can be predicted that studying a larger group will also produce similar or improved results. Antibacterial aspects of the invention

The results of the antibacterial properties of the garment of the invention are clearly illustrated in Table 1.

Table 1. Results indicating the antibacterial properties of the article of clothing described herein

The number of S. aureus colony forming units (CFUs) of the garment after a 24 hour incubation period shows a more than significant reduction in bacteria when compared to the control. Indeed, there was an increase in bacterial growth in the control sample, which is a typical cotton material or a cotton / polyester blend used in a bra.

The results have shown that a post-surgery or post-cancer treatment bra type garment is provided, which has the physical appearance of a lingerie article, and also enhances or accelerates post-surgery wound healing. or after treatment of breast cancer and increases the well-being of the user.

Aspects of the present invention have been described by way of example only and it should be appreciated that additions and / or modifications may be made thereto without departing from the scope thereof.

Claims (15)

1. A post-surgery or post-treatment bra type of clothing for breast cancer (1) for a user, comprising: connection means comprising operable strap means (10) to secure the bra-like garment to the wearer's shoulders, and a band region (11) to enclose a portion of the wearer's torso to secure the garment from dress the user in a bra type; first adjusting means (12) operable to adjustably close the band region of the bra-like garment, and second adjusting means (20) operable to adjustably connect the strap means to a front region (6a) of the band region of the bra-like garment, wherein, the first and second adjusting means are operable together to adjustably compress the wearer's torso in a region of the wearer's chest, wherein the garment comprises an inner layer (2) and an outer layer ( 3), characterized in that the inner and / or outer layer of the garment have a material composition that comprises between 70% and 95% bamboo fiber. 2. The garment according to Claim 1, wherein the bamboo fiber is organic bamboo fiber, such as oek-otex® certified bamboo material. The garment according to Claim 1 or 2, wherein the inner layer and the outer layer are connected in such a way that the bra-like garment is unitary and where the inner layer and the outer layer are seamlessly connected. The garment according to Claims 1 to 3, wherein the inner layer and / or the outer layer comprise a plurality of panels (3a-3m) connected together to form the garment. The garment according to any one of the preceding claims, wherein the garment comprises an edge band extending along at least a part of the perimeter of the garment and wherein an elastic it is housed inside the edge band to avoid irritation of the user by skin contact with the elastic. The garment according to any one of Claims 1 to 5, wherein at least one opening (4) is formed between the inner and outer layer defining a receiving pocket (5) in a front region (6a ) of the garment for a prosthesis or filling material (7) that simulates a wearer's chest. The garment according to Claim 6, wherein the first and second adjusting means are together and operable to enable the wearer to adjust the position of the receiving pocket relative to the wearer's chest when wearing the bra type garment. The garment according to any one of the preceding claims, wherein the first adjusting means extends vertically from an upper edge to a lower edge of the front region or a rear region of the band region. The garment according to any one of the preceding claims, wherein the front region comprises left and right side panels (13, 14) and the first adjusting means comprise a first fastening device (15) operable to connect The left side panel is adjustable with the right side panel, which when connected closes the band region of the garment. The garment according to Claim 9, wherein the second adjusting means comprise a second fastening device for releasably connecting the strap means to the front region of the fastener type garment. The garment according to Claim 10, wherein the strap means comprise a first end (10a) connected to the rear region of the garment, and a second free end (10b) adapted to be connectable to a front region of the garment, optionally adjacent to a garment receiving pocket. The garment according to Claim 11, wherein the second free end mounts one of: a receiver (21) and a connector (22) of the second fastening device, and the front region mounts the other of: the receiver and connector of the second fastening device, whereby the receiver and connector are coupled to adjustably connect the strap means to the front region of the fastener-type garment. The garment according to Claim 12, wherein the receiver of the second fastening means comprises a plurality of adjacent loop formations (21) extending from an intermediate position to the first end and to the second end free of the strap means in a sequence towards the second free end. The garment according to any one of Claims 11 to 13, wherein the ties are formed of a strip or tape material connected to the outer layer along one face of the free end of the strap means or the front region of the garment or the rear region of the garment and where the strip or tape material is connected to the outer layer of the garment by connections such that the gaps formed between the connections provide Adjacent loop formations to mate with the connector. The garment according to Claims 10 to 14, wherein the first fastening device comprises a hook and eye arrangement (16, 17) or a zipper configuration, or a combination thereof and the second means Attachments comprise a hook operable to connect with a loop or with a zipper arrangement.