Therapeutic support for being worn by a subject
10918556 ยท 2021-02-16
Assignee
Inventors
Cpc classification
A61H1/008
HUMAN NECESSITIES
International classification
A61H1/00
HUMAN NECESSITIES
Abstract
A flexible therapeutic support (32, 35, 40, 48, 54) for the prophylaxis or treatment of the accumulation of a fluid in the body of a subject. The therapeutic support has a plurality of protruberances (14) for respectively applying localised pressure to an area of the subject's body with, or subject to, accumulation of the fluid, the support being configured to be worn by the subject over the area and press the protruberances (14) against the body of the subject, and the protruberances being spaced apart from one another about the face (12) of the support. There are also provided methods for the prophylaxis or treatment of the accumulation of a fluid in the subject's body. The accumulated fluid can, for instance, be lymphoedema or other form of oedema.
Claims
1. A garment adapted for the prophylaxis or treatment of the accumulation of fluid in an area of a subject body, the garment comprising a flexible support and means for fitting the flexible support to the body area, the support being formed from an outermost front layer of webbing and an outermost rear layer of webbing, said support having a plurality of spaced apart foam protuberances formed by raised elements disposed on the rear layer of the webbing and each having an upper outermost surface extending toward the front layer of the webbing, the front and rear layers of webbing being directly adhered together in areas between the raised elements, so that the front layer of the webbing conforms to the shape of each of the raised elements over its upper outermost surface, so as to present said protuberances on an inner surface of the support to face the body area, wherein the areas adhered between the raised elements having perforations to provide ventilation through the front and rear layers of webbing, the protuberances being flexible and adapted to be partially compressed when fitted against the body area so as to operatively apply localized pressure to the body area, whereby movement of the subject body induces a passive massaging action by the protuberances.
2. A garment according to claim 1, wherein the raised elements are fixedly mounted to the rear layer of the webbing on respective lower outermost surfaces of the raised elements, and the front layer of the webbing conforms to the shape of the raised elements over the entire upper outermost surface of each of the raised elements.
3. A garment according to claim 1, wherein the raised elements are mound shaped elements.
4. A garment according to claim 1, being air and moisture permeable between respective protuberances in a direction from said inner surface of the support toward an opposite outer surface of the support.
5. A garment according to claim 1, wherein the support is an undergarment.
6. A garment according to claim 1, wherein the protuberances are generally dome shaped.
7. A garment according to claim 1, wherein the body area has a deficient lymphatic system.
8. A garment according to claim 1, wherein the raised elements are constructed from a sheet of foam material on which the areas adhered between the raised elements are formed, leaving the foam material as the raised elements between the areas adhered between the raised elements.
9. A method for the prophylaxis or treatment of the accumulation of fluid in the area of a body of a subject in need thereof, comprising: supplying a garment, the garment including a flexible support, the support being formed from an outermost front layer of webbing and an outermost rear layer of webbing, said support having a plurality of spaced apart foam protuberances formed by raised elements disposed on the rear layer of the webbing and each having an upper outermost surface extending toward the front layer of the webbing, the front and rear layers of webbing being directly adhered together in areas between the protuberances, the front layer of the webbing conforms to the shape of each of the raised elements over its upper outermost surface, so as to present said protuberances on an inner surface of the support to face the body area, wherein the areas adhered between the raised elements having perforations to provide ventilation through the front and rear layers of webbing, the protuberances being flexible and adapted to be partially compressed when pressed against the body area so as to operatively apply localized pressure to the body area; fitting said garment to the body of the subject so as to operatively press the protuberances against the body area such that movement of the body of the subject induces a passive massaging action by the protuberances.
10. A method according to claim 9, wherein the raised elements are fixedly mounted to the rear layer of the webbing on respective lower outermost surfaces of the raised elements, and the front layer of the webbing conforms to the shape of the raised elements over the entire upper outermost surface of each of the raised elements.
11. A method according to claim 9, wherein the raised elements are mound shaped elements.
12. A method according to claim 9, wherein the support is air and moisture permeable between respective protuberances in a direction from said inner surface face of the support to an opposite outer surface of the support.
13. A method according to claim 9, wherein the support is an undergarment.
14. A method according to claim 9, wherein the body area has a deficient lymphatic system.
15. A method according to claim 9, wherein the raised elements are constructed from a sheet of foam material on which the areas adhered between the raised elements are formed, leaving the foam material as the raised elements between the areas adhered between the raised elements.
16. A garment adapted for the prophylaxis or treatment of the accumulation of fluid in an area of a subject body, the garment comprising a flexible support and means for fitting the flexible support to the body area, the support being formed from an outermost front layer of webbing and an outermost rear layer of webbing, said support having a plurality of spaced apart foam protuberances formed by raised elements disposed on the rear layer of webbing and each having an upper outermost surface extending toward the front layer of webbing, said support comprising an exterior surface configured to face away from the body formed from an outer surface of the rear layer of webbing, the front and rear layers of webbing being directly adhered together in areas between the raised elements, the front layer of webbing conforms to the shape of each of the raised elements over its upper outermost surface so as to present said protuberances on an inner surface of the support configured to face the body area, wherein the areas adhered between the raised elements having perforations to provide ventilation through the front and rear layers of webbing, and outermost surfaces of the areas adhered between the raised elements being formed by the outer surface of the rear layer of webbing and the inner surface of the front layer of webbing, the protuberances being flexible and adapted to be partially compressed when fitted against the body area so as to operatively apply localized pressure to the body area, whereby movement of the subject body induces a passive massaging action by the protuberances.
17. A garment according to claim 16, wherein the raised elements are constructed from a sheet of foam material on which the areas adhered between the raised elements are formed, leaving the foam material as the raised elements between the areas adhered between the raised elements.
18. A garment according to claim 16, wherein the raised elements are fixedly mounted to the rear layer of the webbing on respective lower outermost surfaces of the raised elements, and the front layer of the webbing conforms to the shape of the raised elements over the entire upper outermost surface of each of the raised elements.
Description
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION
(12) A fabric 10 that can be used in the manufacture of a therapeutic support embodied by the invention as described herein is shown in
(13) In the embodiment shown, each mound 14 is formed by a respective raised mound shaped element in the form of a gas-filled bubble or blister 18 retained in position between front and rear layers 22 and 20 of the webbing 16 as illustrated in
(14) In the embodiment shown, the front and rear layers 22 and 20 of the webbing each consist of relatively lightweight cotton cloth. As such, the fabric 10 is soft to the touch and is permeable to air as well as moisture which may arise due to perspiration when the fabric is worn, and so is breathable. Accordingly, the fabric and a therapeutic support in accordance with the invention that is made from it are suitable for being worn in warm and/or higher humidity climates such as occur in many parts of Australia and elsewhere during the summer months.
(15) A jig can be used for manufacture of a therapeutic support as described herein wherein the jig as a plurality of spaced apart openings for individual placement of the mound shaped elements such that they protrude rearwardly from the jig. A heat reactive Adhesive (e.g., a quilting appliqu such as ODIF 606 spray-on adhesive, Odd, New Milford, Conn., USA) is applied to their exposed rear surface, and a rear layer 20 of fabric webbing is laid flatly over the mound elements. Heat is then applied to that layer of webbing to activate or set the adhesive whereby the mound elements are fixed to the webbing. This can be readily achieved by ironing the rear layer of the webbing. The webbing is then removed from the jig and laid flatly with the attached mound elements facing up, an excess length of the webbing is folded over the mound elements to provide a front webbing layer 22, and the layers of the webbing are sewn together as described above. Whilst heat reactive adhesive is particularly suitable for fixing the bubbles 18 to the rear layer of the fabric, any suitable adhesive may be used. Moreover, and suitable method for fixing the front and rear layers 22, 20 of the webbing together can be employed. For example, seams fixing the front and rear layers of the webbing together may be formed by heat or sonic welding rather than by sewing the layers together.
(16) Suitable bubbles 18 that can be utilised in the manufacture of the fabric 10 can be provided by plastic air cell sheeting conventionally used for covering swimming pools. The bubbles of plastic air cell sheeting used for packaging and for wrapping delicate or breakable items for storage or transport purposes may also be used provided the plastic membrane of the bubbles is of sufficient thickness and strength with withstand the pressures applied to the bubbles during use of a therapeutic support of the invention. However, as plastic is impermeable to air and moisture, the bubbles of the wrapping are generally cut intact from the sheeting and sewn either individually or in the form of perforated individual rows into position in the webbing 16 such that the wrap does not form a continuous impermeable plastic barrier across that area of the fabric presenting the bubbles 18. In still other embodiments, a sheet of bubbles or other mound shaped elements that are interconnected by fine (e.g., plastic) strips, tendrils or filaments, or which is otherwise perforated between the mound shaped elements to provide adequate ventilation/permeability through the sheet may be employed in a therapeutic support in accordance with the invention. Rather than bubbles 18, the raised mound shaped insert elements can be in the form of mounds formed of an open or closed-cell foamed plastics material of a predetermined density (either as individual mounds or in sheet form), or other suitable material (e.g., polyurethane or rubberised plastics).
(17) In use, a therapeutic support embodied by the invention is worn by the subject such that the mounds are in direct contact with the subject's skin over the area to be treated so as to be pressed against the skin so as to form dimple like depressions in the skin. It is not necessary that the mounds be pressed against the skin with the same level of pressure as a compression bandage or stocking, only a firm pressure against the skin is desirable. In instances where, for example, oedema has arisen as a result of surgery, depressions or cavities may be formed in the subject's body as a result of tissue removal (e.g., a depression in the chest wall as a result of a mastectomy), such that the mounds of the support either do not press against that region or only contact that region with less than optimum pressure. To address this, a support embodied by the invention can be provided with padding arranged to press the affected mounds into the depression or cavity so as to make firm contact with the skin. For example, the support can be provided with a rear pocket into which the padding can be inserted. The padding can, for instance, be a prosthesis such as a breast prosthesis, a gel or fluid filled padding element, or fabric padding. Rather than being provided in a pocket of the support, the padding can be sewn or otherwise incorporated into the support.
(18) The support can be worn over the region of the body exhibiting, or which is otherwise subject to, fluid accumulation and/or the region of the subject's body where a blockage or tissue damage (e.g., scar tissue) responsible for oedema or fluid accumulation whether with or without visible associated symptoms such as noticeable swelling is located (e.g., a site of surgery). For example, where a subject has lymphoedema in the arm due to removal of auxiliary lymph nodes in the armpit region, the wearing of a support in accordance with the invention pressed against the area of surgery in the armpit or chest side wall may be sufficient to assist drainage of accumulated fluid in the arm itself by acting on scar tissue to at least partially open lymph vessels and/or other fluid drainage pathways for passage of the accumulated fluid from the subject's arm, even though that area does not exhibit oedema itself. The therapeutic support in such instances may be an insert fitted inside a brassiere or other undergarment as described further below. However, the subject may also wear a sleeve embodied by the invention on their affected arm to alleviate the observed swelling in the arm, though this may not be necessary in all cases. In at least some embodiments, a therapeutic support as described herein can be provided for being worn over the oedema affected area and an adjacent region of the body which has a blocked or restricted fluid drainage pathway responsible for that oedema.
(19) Further examples of areas of a subject's body which may be responsible for oedema but which may or may not exhibit swelling or other symptoms of oedema are the torso and groin areas. In these instances, a fluid pathway blockage in these areas such as may arise from surgery can result in oedema in one or both legs of the subject (e.g., the upper thigh, lower thigh and/or lower leg region(s)). In these situations, the subject may wear a support embodied by the invention to treat the observed swelling resulting from the oedema and/or the site of the fluid drainage pathway blockage or obstruction(s) in the groin or torso area.
(20) A diagrammatic view of a lymphatic vessel is illustrated in
(21) Without being limited by theory, it is believed the mounds of a support embodied by the invention act to apply gentle but firm localised pressure to tissues and lymphatic vessels whereby in the case of lymphoedma, lymph is progressively driven along the vessels and drained from the affected tissue or limb as generally illustrated by
(22) Accordingly, the invention also extends to the provision and use of therapeutic supports herein for effecting passive massaging of body tissues. More specifically, in another aspect of the invention there is provided a flexible support for effective passive massage of the body of a subject, wherein the support has a face with a plurality of raised protruberances for respectively applying localised pressure to an area of the subject's body, the support being configured to be worn by the subject over the area and press the protruberances against the body of the subject, and wherein the protruberances are spaced apart from one another about the face of the support.
(23) Still further, there is provided a method for effecting passive massage of the body of a subject, comprising providing a flexible support having a face with a plurality of raised protruberances for respectively applying localised pressure to an area of the subject's body, the mounds being spaced apart from one another about the face of the support; and placing or fitting the support over the area whereby the support is retained in position and the protruberances press against said area, for the support to be worn by the subject.
(24) An example of a therapeutic support 32 embodied by the invention is illustrated in
(25) It will be understood that a therapeutic support 32 embodied by the invention may be provided in various different forms. For example, the support may be a garment such as a brassier type undergarment as shown in
(26) A further therapeutic support embodied by the invention in the form of a wrap 35 for being worn over the upper thigh region and having a ribbon 36 threaded through spaced apart islets 38 for being tightened and tied to hold the support in position whilst being worn is shown in
(27) Still another embodiment is shown in
(28) In addition, the invention extends to the provision and use of supports for being inserted into, or otherwise fitted to, undergarments or other garments as described herein. An example of this type of therapeutic support is shown in
(29) As yet another embodiment, an insert with integrally formed mounds 14 can be inserted are fastened to a garment, wrap or the like to form a therapeutic support in accordance with the invention.
(30) Typically, a support or support insert in accordance with the invention does not include any band (e.g., of elastic or the like) that when the support/insert is worn wraps around the subject forming a band of constriction in the subject's skin, as this may impede or potentially block the passage of accumulated oedema fluid under the band and thereby, the action of the support or insert.
(31) Whilst cotton cloth is particularly suitable for use as the webbing 16, other materials can be employed such as cloth made from other natural and/or synthetic fibres and yarns (e.g., nylon, polyester, rayon, acrylic fibre, viscose and spandex), woven or felted materials, elastomeric materials, and combinations of such fibres and materials (e.g., bamboo cotton spandex combinations). Hence, the term webbing as used herein is to be taken to encompass any material deemed suitable for use in a support embodied by the invention, and is not to be restricted to a particular cloth, material or the like unless otherwise expressly stated or implied herein. When the fabric 10 is fabricated from synthetic fibres it may include a layer of cotton or other suitably soft material for contact with the skin of the subject for reasons of comfort.
(32) The care of subjects/patients post operatively typically involves education about the risk of developing oedema, identification of the symptoms of oedema, and physiotherapy for e.g., scar tightness, cording (i.e., a sensation of a cord across the chest restricting arm movement), seroma development, and/or muscle tightness. The development of oedema post surgery (e.g., following removal of auxiliary lymph nodes) can take a number of years. However, there can be a sudden onset of the swelling associated with oedema, and a subject may not be aware that the oedema has been developing until noticeable swelling occurs. For example, there can be accumulation of fluid in the torso area but the presence of oedema may only become apparent with swelling of the leg or legs of the subject.
(33) It is thought that regular gentle lymph drainage massaging of the wound and tissues proximal thereto during and post healing of the wound may assist in maintaining open, or otherwise developing, lymph and/or other drainage pathways through the wound area thereby in at least the case of lymphoedema, lessening the risk of lymphoedema occurring or potentially avoiding the development of lymphoedema in the subject altogether. The wearing of a support embodied by the invention may facilitate this. In any event, the wearing of a support embodied by the invention for prophylaxis of lymphoedema is to be taken in its broadest sense as encompassing use of the support to maintain existing oedema at a reduced, controlled level, and for instance, to ameliorate existing oedema.
(34) Whilst a therapeutic support embodied by the invention is particularly suitable for the prophylaxis or treatment of oedema (e.g., lymphoedema and other forms of oedema) in humans (both male and female), the invention is not limited thereto and extends to the provision and use of therapeutic supports as described herein on non-human mammals such as, but not limited to, horses, greyhounds and companion animals (e.g., dogs and cats) and, for example, members of the bovine, porcine and primate animal families. Indeed, at least some embodiments of therapeutic supports embodied by the invention may have application in alleviating build-up of fluid with high levels of lactic acid in tissues in athletes or animals (e.g., greyhounds and race horses) following training, exercise or racing. Likewise, embodiments of the invention may find application in treating other conditions in which passive massage by the supports may be of assistance such as in the treatment of varicose veins (e.g., blood pooling in varicose veins and associated varicose vein pain).
(35) Whilst the protruberances of the embodiments described above are mound shaped, therapeutic supports embodied by the invention may be provided with protruberances that are other than mound shaped. Indeed, protruberances of any suitable shape that may be utilised (e.g., e.g., protruberances having a pyrimidal shape or a triangular, oval, elliptical, or generally square transverse cross-section).
(36) From the above description it will be apparent that embodiments of therapeutic supports in accordance with the invention may provide one or more of the following advantages: An alternative to conventional compression bandaging for the prophylaxis or treatment of oedema, and particularly lymphoedema; An option for the treatment of oedema resistant to compression bandaging or compression sleeve treatment, or for which conventional compression bandaging or sleeve treatment is not suitable or provides little benefit; The treatment of the oedema is essentially continuous whilst the therapeutic support is worn by the subject; The therapeutic support may provide passive fluid (e.g., lymph) drainage massaging whilst being worn; There is no special training required; The provision of the mounds 14 may avoid or lessen the risk of lymphatic vessel(s) and/or fluid drainage pathway(s) being held continuously closed for the duration the support is worn as a result of compression applied by the support, as may occur with the use of conventional compression bandaging or compression sleeving. The fabric 10 used in the support is breathable, lessening the risk of sweating or overheating under the support occurring; The support can be lightweight and unobtrusive; A cost effective and readily accessible way of treating forms of oedema; and The support can be used in conjunction with other therapeutic treatments such as, but not limited to, massaging of the affected areas.
(37) The invention will now be described further below with reference to a number of non-limiting Examples of the use of supports embodied by the invention.
EXAMPLES
Treatment of Lymphoedema in Human Subjects
(38) Case 1
(39) CP is a gynaecological cancer patient and was suffering with lymphoedema in her groin and abdomen. Her initial management of lymphoedema involved the use of conventional compression garments which was unsuccessful. Underpant supports with bubble panels in accordance with the present invention were worn by CP for two years and found to control the lymphoedema. CP found that lymphatic fluid built up in her abdomen rendering her much discomfort during periods in which the garment was not worn.
(40) Case 2
(41) GS is also a gynaecological cancer patient. She had tried several ways (including compression garments) to reduce her leg and abdominal lymphoedma. After wearing an underwear support garment having panels with mounds for being pressed against affected areas in accordance with the invention she has reduced lymphoedema and is now on the lowest level of compression stockings, and is expected to not require the stockings in the near future. Her leg and abdominal swelling has reduced as well as physical discomfort that she previously experienced. GS also noted that when she stopped wearing the support, her swelling accumulated back to the original level which was painful and uncomfortable for her.
(42) Case 3
(43) SF had a swollen foot and ankle arising from reconstructive surgery. After wearing an ankle and foot support in accordance with the invention the fluid retention problem rapidly disappeared.
(44) Case 4
(45) BS suffered from lymphoedema in her leg and tried wearing an underwear garment in accordance with the invention but as she did not receive instant relief she instead chose to wear compression stockings recommended by her physiotherapist. BS was also undergoing weekly dialysis treatments and so was not a suitable candidate for trial with the underwear garment.
(46) Case 5
(47) K is a young girl and suffered from lymphoedema around her knee, ankle and foot after sustaining an injury 3 years previously. Pursuant to wearing an ankle and foot support and then a knee wrap in accordance with the invention, K had a reduction in swelling of her foot and ankle of approximately 2.5 cm, improved movement in her knee, ankle and foot, and no pain or tightness in her leg after 2 weeks of wearing the support(s).
(48) Case 6
(49) KB suffered from breast cancer and had a left mastectomy with auxiliary node clearance in 2001 followed by chemotherapy treatment over a period of 4 months. As a result of her surgery, she developed lymphoedema in her left underarm region. She managed her lymphoedema with regular fortnightly remedial massage which gave given her limited relief for a short amount of time. KB also trialled a compression bandage (from a physiotherapist) but felt that the bandage only aggravated the problem.
(50) KB started wearing a brassier style support with appropriately located panelling according to the invention in October 2010 and felt that she had improvement within the first few days of wearing the support. She also found that she had longer periods where she was not conscience of any sensation of lymphatic fluid build-up. KB noted that whilst the support did not stop this sensation completely, it was a welcome improvement that resulted in her experiencing longer periods of time when she completely is unaware of any fluid build-up. After 9 years of persisting with alternative management, she considered her quality of life has been enhanced considerably by wearing the support embodied by the invention which gave her quality relief that she previously did not have.
(51) Case 7
(52) SP is a breast cancer patient who developed lymphoedema in her left arm post surgery, the lymphoedema being of a level that she was unable to work in her profession as a Midwife. Since wearing a brassiere insert embodied by the invention, SP has ceased wearing conventional compression bandaging altogether and has returned to midwifery. SP indicated that whilst fluid accumulates when she goes to the gym or doesn't wear the support, the fluid soon dissipates once she wears the support enhancing her quality of life.
(53) As will be understood, various changes and modifications may be made to embodiments of the invention described above without departing from the scope of the invention. Accordingly, the above embodiments are to be taken in all respects as merely illustrative and not restrictive.