Patent Grant
9579237
The present invention relates to binders used for support and compression after surgical interventions or trauma to parts of the human body. In particular, the invention relates to a compression binder for use after major surgeries in the abdominal region, including, but not limited to, surgeries in the internal organs e.g. liver, pancreas, stomach, kidneys, small and large intestines, bladder and uterus, and for bariatric and other surgeries that require access through the abdominal wall. More in particular the invention relates to a compression binder made of breathable and color-stimulating material which has individual compression-adjustments at several vertical sections of the binder to comply with the type of trauma or surgery performed, and to the comfort level for compression of the patient. More in particular the invention relates to a compression binder that maintains support during wound inspection and care and allows for such wound inspection and care without it being necessary to open the total compression binder. More in particular the invention relates to a compression binder that can be transformed into a lower compression binder to relieve pressure on the upper abdominal area when patients sit down and to increase back support. More in particular the invention relates to a compression binder which can accommodate drainage tubes, ostomy devices, driver lines from Left Ventricular Assist Devices (LVAD's) or other apparatus that may exit through the abdominal wall, without the need to separate said devices from their counterparts on the external side of the abdomen, and without the need to cut holes in the material of the compression binder. More in particular the invention relates to a compression binder which has accessories to organize and fixate drainage lines and collection bottles of all sizes, driver lines for VLAD's and other items that need to be secured at a fixed position with respect to the external side of the compression binder.
Abdominal muscles are crucial for most activities human beings do: they assist with respiration; they control the expulsive effort of coughing, sneezing, urination and defecation and assist with childbirth; they cooperate with the back muscles to flex and extend the trunk at the hips and to rotate the trunk at the waist; and they protect the internal organs by becoming rigid.
Major surgeries in the abdominal region necessitates incisions through the abdominal wall and muscles. The loss of the abdominal muscular integrity after such surgical interventions causes considerable pain and soreness in the postoperative period during respiration, coughing, movements and during all daily day activities as listed above. Such pain and soreness will continue until the abdominal muscles have healed and fully recovered their strength. Furthermore the intra-abdominal pressure (IAP) increases dramatically during coughs, sneezes, vomits, defecation, movements during exercises and when lifting anything heavy which exerts a sudden increase in stress on a wound with increased risk for dehiscence. Therefore, as well known in the art, abdominal muscles must be supported from the outside by a compression binder to prevent wound dehiscence and related wound infections, to lessen pain, to give the muscular tissue peace to heal and to increase comfort for patients and speed up recovery. Various types of interventions may in addition cause some degree of swelling and bruising after surgery. Abdominal compression will help diminish such swelling and promote the healing process and thereby decrease the time of recovery and related health care costs.
Compression binders are common and a large selection of commodity binders are available. Typically the binders consist of a wide band made of a variety of elastic or non-elastic materials, or a combination thereof, and they wrap around the patient's abdominal region and are usually closed by means of one common fabric hook and loop closure or a series of hook and eye closures. The materials used are often heavy and non-ventilated and usually created in white or beige colors. Such binders can be warm, uncomfortable to wear for a patient, and usually have the problem that they crawl up, roll or robe on the body making them further uncomfortable. Therefore, to avoid such problems a compression binder should be made of a ventilated, light, comfortable material, that does not curl up, crawl or robe on the body, and, as an additional feature, the material should be made of colors that has a stimulating psychological effect on the patient in the typical “sterile-colored” hospital environment.
The position and size of a wound depends on the type of intervention, as for example an abdominal wound after major abdominal surgery or other interventions requiring access through the abdominal wall. Accordingly the need for compression and support to the wound and abdomen will be different across the vertical width of a patients abdomen and will vary from patient to patient, and it will not be comfortable for patients to have the full abdominal region compressed, as is the state of art for most existing compression binders. Therefore it will increase comfort for a patient if the degree of compression can be adjusted at various vertical sections across the binder.
Furthermore a wound will hurt and be sensitive to manipulation, pressure, movements, temperature changes and chemicals such as wound cleaning agents. Every time a wound needs inspection and/or care, it will cause extra pain and stress for the patient. In particular such wound inspection and care is a problem for large, obese patients that have undergone surgery in the abdominal area, and for bariatric surgery patients. This is due to the gravity pull on the wound from the excess abdominal fat tissues. Such pull will not only cause pain for the obese patient, but will also increase the risk for wound infection since the wound edges will be drawn apart and the sutures may tear through the skin and cause the wound to break open. Therefore the abdominal muscles and fat tissues must be supported continuously, also during wound inspection and care, particularly for obese patients, to decrease pain and the risk for complications and infections that will lead to increased health care costs.
A compression binder that has been completely opened for inspection and care of an abdominal wound, may present a problem for large and obese patients. Not only does the excess fat tissues create a gravity pull on the wound which increases pain and risk of complications, it also makes reattachment after wound care of such binders difficult to do. Often more than one health care person is required to perform such reattachment which increases demand for availability of health care staff. Therefore, it would be desirable that reattachment of compression binders be possible without adding additional pain, stress or strain to the patient and his/her wound, and without the need to have more than one health care person present.
Postoperative pain after abdominal surgeries makes patients naturally reluctant to breathe deeply, to cough and to do their respiratory exercises since such activities increase pain and hurt due to the integral and significant part the abdominal muscles and the diaphragm take in the respiration process. It is well known in the art that inactivity increases postoperative pulmonary complications which continue to be an important risk after major abdominal surgeries. Pain and worry about straining the abdominal wound makes patients hesitate to move and get out of their hospital bed early after surgery. Such postoperative immobilization contributes to cardiovascular instability and thromboembolic complications, leading to increased health care costs. Therefore the abdominal and back muscles must be firmly supported by a compression binder to improve a patient's posture which helps patients to an improved and deeper respiration and lessened pain during their respiratory exercises and daily activities, and furthermore encourage and stimulate the patients to mobilize as early as possible.
Early mobilization after surgery is crucial for the patient's early recovery and an external compression support to the abdominal region will help the patients to walk and keep a better posture thereby improving respiration. However, a newly operated patient needs to rest often and will want to sit down with regular intervals. It is difficult and uncomfortable to sit down with a wide abdominal binder that covers the upper abdominal area, and it may cause nausea having additional pressure from such binder exerted on the stomach area in the sitting position. Therefore, a compression binder should not only help patients to achieve a better posture for improved respiration, it should also improve comfort by being able to relieve the additional pressure on the stomach when patients need to sit down for rest, which will encourage to more and earlier mobilization and less time in the hospital bed.
Major abdominal surgeries after which the patient must have one or more drainage tubes, ostomy devices or other items that exit through the abdominal wall, including driver lines from LVAD's and other apparatus, need access through wound dressings, bandages and binders that may cover the wound and abdominal area, so they can be attached to their external corresponding device and fixed to the patient or to the bed. Elastic bands and compression binders of various width that presently are used for abdominal support, can only accommodate drainage tubes and lines by separating such items from their corresponding external devices and by leading said items through existing pre-cut holes, or by cutting one or several holes in the band or binder material, before reattaching the drainage tubes, lines or other devices. Such separation and reattachment will increase the risk of infection and associated increase in health care costs. Therefore, due to the cumbersome method of accommodating such devices to existing abdominal binders, they are often not applied to the patients, if at all, until they have had drainage tubes, lines and other devices removed. Yet it has been evidenced that “when patients are provided with abdominal compression support as early as possible after surgery, it enhances early mobilization, improves patient's hospital experience by an optimized pain control and diminishes emotional stress.”
Cheifetz et al., The Effect of Abdominal Support on Functional Outcomes in Patients Following Major Abdominal Surgery. Physiotherapy Canada, Volume 62, Number 3. Pg. 242-253
For these reasons drainage tubes, drainage lines, ostomy devices, driver lines and other devices must be able to exit through an abdominal compression support without the need to separate such tubes and lines from their external connection devices. Avoiding any separation and reattachment of drainage tubes and lines and other devices that may exit a patient's abdomen after surgery, will decrease the risk for complications, infections and related health care costs.
Similarly, when patients have one or more drainage tubes, stoma devices or other items that exit through the abdominal wall after major abdominal surgeries, including driver lines from LVAD's and other apparatus, abdominal binders are often not applied to the patients, if at all, since such application represents a further practical challenge to staff that have no easy method to organize and attach such devices and their accessories to the patient in order to liberalize him/her from the bed for mobilization. Staff may be prompted to wait mobilizing the patients until devices that can be removed days later, such as drains, have been taken out. In addition, patients often have more pain and will worry about accidental pulling on such drains or devices, which would hurt and increase the risk of complications. Therefore drainage tubes, lines, collection bottles, driver lines and other devices must be organized and fixated to the patient in an easy, secure and quick manner for staff so patients can get mobilized as early as possible postoperatively with less worry and less pain.
Accordingly, there is a need for an advanced compression support that provides features to decrease pain, to improve patient comfort, spirit and feeling of security, to stimulate a better posture, respiration and early mobilization, to decrease the risk of complications, infections and related health care costs, and to increase functional convenience for health care staff.
There is a great need for an advanced compression binder that can address many more of the problems that todays patient population is facing after surgery and trauma, and which health care personnel needs to handle on a daily basis. None of the abdominal support devices currently in use takes an overall approach to solve such problems. Generally, such devices are directed towards just one or two of the following: 1. Ease of closure, 2. Conformity to the body contour, 3. Universal sizing, 4. Improved wound visibility with a closed binder, 5. Dressing holder and openings for passage of drains, 6. Improve drainage bulb holding.
For example, the QualiBelly abdominal support manufactured by Qualiteam s.r.l., Chiaverano, Italy, consists of two longer and one shorter elastic band with the bands being just slightly overlapped by about 0.5 cm and being held together by large, vertical stitches which extend past the edges of the bands at the locations of connection. The large vertical stitches are about 1.4 cm in length and are spaced apart about 5 cm along the lengths of the bands. The three bands each having a closure with hook and loop fasteners. The large vertical stitches may pinch the skin on the body and make the device uncomfortable to wear. Further, the large stitches can make it uncomfortable for the patient if the upper band is folded down as is advocated in the brochures describing the product. In addition, the small overlapping of the bands, the large vertical stitches that hold the bands together with large intervals between them, fail to prevent the extrusion of fat tissue between the stitches on the bands which can be a problem, particularly in obese patients. The device also represents a fitting problem for many patients due to the difference in length of the elastic bands. If the shorter band-compression fits to a patient, the two longer band-compressions might be too long and therefore too loose, and if the two longer band-compressions fit, the shorter band-compression might be too short and therefore too tight, which in both situations can make the support uncomfortable to wear and makes it difficult to individually adjust the compression per band.
In view of the foregoing, it is the general object of the invention to provide an advanced postoperative compression binder that provides features to help patients to have decreased pain and improved comfort.
It is another object of the invention to provide an advanced postoperative compression binder that encourages a patient's spirit in the postoperative period through an increased sense of security and by color stimulation.
Another object of the invention is to provide an advanced postoperative compression binder which improves a patient's posture to achieve a deeper and more effective respiration, which helps to decrease postoperative complications and related costs of healthcare.
Another object of the invention is to provide an advanced postoperative compression binder that comfortably can be used directly on the patients skin without irritation and without heat and moisture generation.
Another object of the invention is to provide a postoperative compression binder with individual compression adjustments at various vertical sections across the binder to adapt the compression to the patient's comfort level and type of surgery performed.
Another object of the invention is to provide a postoperative compression binder where support is maintained during wound inspection and care thereby diminishing pain and stress on the wound.
Another object of the invention is to provide a postoperative compression binder where one or more sections of the support can be opened for wound inspection and care thereby increasing the functional convenience for health care staff.
Another object of the invention is to provide a postoperative compression binder for all sizes of patients, including the morbidly obese, which can be opened and closed by just one health care person.
It is yet another object of the invention to provide a postoperative compression binder that can easily and comfortably transform into a lower abdominal binder to avoid pressure on the upper abdomen and to increase comfort and respiration for patients while supporting their lower back when patients sit down.
A further object of the invention is to provide a postoperative compression binder that eliminates the need to separate drainage tubes, drainage lines, ostomy devices, driver lines for LVAD's and other apparatus that may exit from the patients abdominal wall, thereby decreasing risk of infection and complications, and the related health care costs.
A still further object of the invention is to provide a postoperative compression binder that accommodates drainage tubes, drainage lines, ostomy devices, driver lines for LVAD's and other devices that may exit from the patients abdominal wall, without the need to cut the material comprising the compression binder for allowing passage of said devices.
It is yet another object of the invention to provide a postoperative compression binder with one or more accessories that allows easy accommodation, organization and attachment of any type and size of drainage tubes and lines, drainage collection bottles or other devices attached to drainage tubes, lines or other apparatus exiting from the patient's abdominal wall to the external side of the abdominal compression support.
Yet another object of the invention is to provide a postoperative compression binder with easy means to allow measurement of eventual internal fluid build-up such as bleeding and/or seroma.
Other objects and advantages will become apparent from reading of the specifications and a study of the accompanying drawings.
The present invention provides for a postoperative compression binder with advanced features for compression, wound Inspection and care, drainage, ostomy and other device accommodation, accessories for line organization and collection device support, and for stimulation of improved posture, spirit and security sense.
The compression binder consists of at least two elastic bands that overlap and are attached to each other by small, vertical stitches that integrates into the material forming the compression binder and are arranged with an equal relatively short distance between them along the length of the elastic bands. Each elastic band has fabric hook and loop fasteners at first and second ends of the bands. The vertical stitch method of conjoining the elastic bands allows for individual compression adjustments of each elastic band which allows compression to be varied along a vertical line on the patient's abdomen so compression can be adapted to the type of surgery performed and to the level of comfort desired by the patient.
The invention provides access to the compression area for wound inspection and care by opening one or two of the bands and leaving at least one or two of the bands closed. This eliminates the need to open the total compression binder, whereby pain is decreased and comfort for the patient is increased. This maintains compression support to the patient's abdomen at all times. The compression binder achieves this access by spacing the vertical stitches a desired calculated distance from the first and second ends of each of the elastic bands. This spacing results in the first and second ends of each band being unattached to the adjoining band's over a length equal to the desired calculated distance. Thus, if one of the bands is open an access area is created by moving the ends of the open band apart to expose the abdomen. The access area will have a width equal to the distance between the first vertical stitch adjacent the first end and the first vertical stitch adjacent the second end.
Furthermore the invention allows drainage tubes, drainage lines, ostomy devices, driver lines from Left Ventricular Assist (LVAD) devices, and other devices that may exit from a patients abdomen after major surgeries or trauma, to pass from the patients abdomen to the external side of the abdominal compression binder by closing the fabric hook and loop fastener on one band above such devices, and close the fabric hook and loop fastener on the adjoining band below such devices. The invention thereby effectively eliminates the need to separate drainage tubes, drainage lines, ostomy devices, driver lines from Left Ventricular Assist (LVAD) devices, and other apparatus in order to pass them from the inside to the outside of the compression support thereby decreasing the potential for complications, infections and related health care costs.
The invention furthermore eliminates any need to cut holes in the compression binder material which avoids any tear and wear of the material.
The invention provides for accessories to organize and fixate drainage lines and drainage collection bottles of all sizes, driver lines and other devices that may need to be fixed to the external side of the compression binder for a period of time in a secure manner.
The invention provides further the possibility to be transformed into a lower compression binder when the fabric hook and loop fastener on the upper elastic band is opened and the upper band is folded down over the adjoining band, after which the fabric hook and loop fastener is closed again. Thereby any pressure on the upper abdomen is relieved, and comfort and back support for patients is increased when sitting down.
The present invention is designed taking the total needs of a postoperative patient and the health care personnel in mind. The invention promotes less pain and less wound complications, improves wound access and maintains wound support during inspection and care, improves overall comfort for the patient and functional convenience for staff, and it stimulates patients to earlier mobilization in the postoperative period, which leads to earlier discharge from the hospital with related decrease in costs of care.
Referring now to
The width of each of the elastic bands 10, 11, 12 may vary according to the size of the patient. In one embodiment the compression binder 1 is available as an abdominal support with each band having a width of 4 inches or 6 inches. The length of the elastic bands 10, 11, 12 may vary according to the size of the patient. It should be noted that the use of the advanced compression binder 1 is not limited to use on a patient's abdomen, but may be used on other regions of a patient's torso, head, upper or lower extremities.
Referring to
Referring now to
Referring now to
In one embodiment of the invention the elastic bands 10, 11, 12 may be positioned on a patient's abdominal region by encircling the patient's body and by placing a first end 17 and a second end 18 of each single elastic band on top of each other. Closure of each band may be effectuated by hook and loop fasteners 14, 15, 16 positioned on each elastic band 10, 11, 12 with at least one fabric hook material 14 at a first end 17 of each of the conjoining bands 10, 11, 12, and at least one fabric loop material 15, 16 positioned at a second end 18 of each elastic band 10, 11, 12. A fabric hook material 14 may be stitched along the width of a first end 17 of each of the elastic bands 10, 11 and 12, and the fabric loop material 15, 16 may be stitched along the width of a second end 18 of each of the elastic bands 10, 11 and 12. In one embodiment the hook and loop fastener closure potential is increased along the length of each elastic band 10, 11, 12 by stitching the fabric loop materials 15 and 16, parallel to each other and spaced apart a desired distance, for example, 2 inches.
It should be noted that the predetermined receiving fabric loop fasteners do not dictate the closure point, since the fabric hook attachments may be fastened directly on the elastic band material.
The first end 17 and second end 18 of each elastic band 10, 1112 may have a grasping fold for comfort and to make it easier for the wearer and staff to open and close the compression binder 1. It should be noted that the closure of an abdominal compression binder 1 may be effectuated by other types of closure and is not limited to a fabric hook and loop type closure.
Referring now to
It should be noted that the closure position of the fabric hook and loop fastener 14, 15, 16 of the elastic bands may be anywhere along the circumferential line of the body region where it is used.
Referring now to
Referring to
Referring to
In one embodiment of the invention the vertical stitches 13 may be placed in a series along the length of the conjoining and overlapping elastic bands 10, 11, 12 with such series of vertical stitches 13 ending a desired calculated distance from the first end 17 and from the second end 18 of the elastic bands as best seen in
It should be noted that the spaces between stitches 13 along the overlapping and conjoining bands 10, 11, 12 are open and may allow for passage of tubes, lines and other devices that may exit from a patient's abdomen after surgery and which may be desirable to pass from the inside to the outside of an abdominal compression support 1. Said passage between stitches 13 may be achieved after separation of said devices from their external counterparts, after which said devices may be guided through the open space between stitches 13 and reattached to their external counterparts.
The calculated distance of the vertical stitches 13 from a first and second end of the bands 10, 11, 12 in combination with the optimal spacing between vertical stitches 13 allows for individual circular compression adjustments of each of the elastic bands 10, 11 and 12, individually, around a patients abdomen or other body part. More specifically, the bands are not connected together along those portions of the bands not joined by the vertical stitches. This allows not only access to the abdominal area as shown in
The size, spacing and configuration of vertical stitches 13 provide additional benefits. For example, the short vertical length of the stitch combined with the stitch position within the overlap of the bands without crossing over the edge of either conjoined band allows the stitch to be integrated into the material of the binder so that the stitches do not irritate or harm the skin of the patient. Further, by maintaining a minimum band overlap as specified herein and by maintaining a maximum spacing between vertical stitches as specified herein the problem of fat tissue bulging through the binder between the stitches joining the bands is virtually eliminated.
In one embodiment strips 31 each have a fabric hook fastener 41 of a size 4 inches by 1 inch (10.16 cm×2.54 cm) stitched on the lower inside first end of the strips 31, and a fabric hook fastener 42 of a size 1.5 inches by 0.5 inch (3.81 cm×1.27 cm) stitched on the lower outside first end of the strips 31 as shown in
Now referring to
Various modifications and alterations to this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention. It should be understood that this invention is not intended to be unduly limited to by the illustrative embodiments and examples set forth herein and that such examples and embodiments are presented by way of example only with the scope of the invention intended to be limited only by the claims set forth herein as follows.
| Number | Date | Country | Kind |
|---|---|---|---|
| 13425134 | Oct 2013 | EP | regional |
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| Number | Date | Country | |
|---|---|---|---|
| 20150094638 A1 | Apr 2015 | US |
